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qwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjkl zxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiop asdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmq wertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklz xcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopa sdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqw Policy & Procedure Manual ertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxc vbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasd fghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwert yuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvb nmqwertyuiopasdfghjklzxcvbnmrtyuiopasdfghjklz xcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopa sdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqw ertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxc October 2016 1 Table of Contents Patient Care Page # 1.1 Statement of Policies 7 1.2 Patient Rights 7 1.3 Informing Patients of their Rights and Responsibilities 7-8 1.4 Patient Involvement Regarding Care and/or Services 8 1.5 Patient Admission Information 9 1.6 The Patient Right to Accept, Refuse or Withdraw Medical Care 9-10 1.7 Investigative or Experimental Studies and the Unapproved use 10 Of Equipment/Devices 1.8 Patient Privacy and Confidentiality 10 1.9 Patient Complaint or Concern Process 10-11 1.10 Patient Communication Needs 11 1.11 Ethical Issues in the Patient Care or Service 11 1.12 Patient Admission Assessment 12 1.13 Patient Environmental Assessment 13-14 1.14 Reassessment of the Patient 14 1.15 Victims of Abuse/Neglect 14-15 1.16 The Unique Needs of the Dying Patient 15 1.17 Patient and Family Education 15 1.18 Providing Patient Education 15-16 1.19 Tailoring Education and Training to Specific Patient Needs 16 2 1.20 Basic Home Safety 16-18 1.21 Patient Infection Prevention Control 18 1.22 Patient Education Addressing Specific Care Issues 18-19 1.23 Patient Medical Equipment Education and Set-up 19 1.24 Coordination of Care and Services to the Patient 19-20 1.25 Patient Referral, Transfer and/or Discharge 20 1.26 Others Involved with the Care of the Patient 20 1.27 Clinical Associate Training 20-21 1.28 Do Not Use Abbreviations Appendix “A” 80-81 Equipment Set-up Guidelines 1.28 Oxygen Concentrator 21-22 1.29 Oxygen Cylinder 22 1.30 Oxygen/Liquid System 23 1.31 Oximetry 23-24 1.32 Suction Unit 24 1.33 BiPAP 24-25 1.34 CPAP 25-26 1.35 Hand Held Aerosol Therapy 26-27 1.36 Large Volume Humidity Therapy 27 1.37 Hospital Bed 28 1.38 Wheel Chair 28-29 1.39 Alternating Pressure Pad 29 1.40 Durable Medical Equipment 29 1.41 Walk Aids 29-30 3 1.42 Low Air Loss Mattress 1.43 Ventilator 30 Appendix “D” 84-85 Management 2.1 Authority and Responsibility 31 Organization Chart 32-33 2.2 Developing the Company’s Mission and Plan 34 Mission Statement 35 2.3 Establishing Alpine Medical Supply, LLC Operating Budget 35 2.4 Leadership Involvement in the Quality Assurance Program 35-36 2.5 Manager’s Responsibility 36 2.6 Policy Implementation and Review 36 2.7 Conflict of Interest 36-37 2.8 Company Communication 37 2.9 Staff Safety 38 Environmental Safety 3.1 Structural/Environmental Concerns in the Patient’s Home 39 3.2 Equipment Set-up in a Patient’s Home 39-40 3.3 Emergency Patient response 40 3.4 Patient Education 41 3.5 Equipment Suitability for Patient Use 42 3.6 Safety Programs 42-44 3.7 Emergency Preparedness 44-45 3.8 Safety Management Monitoring 45 4 3.9 Sentinel Event Policy Appendix “C” 83 For the following policies *Refer to: Safety/ 5 Keys STHB Fire Extinguisher Usage STHB Proper Lifting Protocol STHB Equipment Management & Distribution 4.1 Reporting Product Defects/Incidents 46 & Appendix “B” 82 4.2 Equipment Returned to Alpine Medical Supply, LLC 46-47 4.3 Equipment Tracking, Recalls, Hazards 48-49 4.4 Routine and Preventive Maintenance 50 4.5 Delivery of Equipment and Supplies 50-51 4.6 Inventory Ordering 51 4.7 Exception or Stat Product Ordering Approval 52 4.8 Stocking and Ordering 52-53 4.9 Inventory Transfer 53-54 4.10 Inventory Receiving 54-55 4.11 Cylinder Receipt and Distribution 55 For the following policies *Refer To: Route Sheet & Tank Manifest STHB Vehicle Use/Passengers STHB Gas Card/Daily Vehicle Inspection/Violations STHB Vehicle On Call Use STHB Mandatory Vehicle Stock STHB Accidents and Incidents/Conduct at an Accident STHB 5 Human Resources 5.1 Establishing Staff Responsibility and Accountability 56 5.2 Selecting Staff 56-57 5.3 Personnel Records 57-58 5.4 Staff Evaluations 58 5.5 Employee Health Status 58 5.6 Staff Orientation 58-59 5.7 Continuous Training of Staff 59 5.8 Staff Competence 59-60 5.9 Spending Limits (Travel & Sponsorships), Expense Reports 60-61 and American Express Cards For the following policies * Refer To: Employment at Will EHB Categories of Employment EHB Payroll Administration EHB Time Off from Work EHB Other Benefits of Employment EHB Anti-Harassment and Anti-Discrimination EHB Drug and Alcohol Use and Abuse EHB Other Personnel Policies EHB Drug Free Workplace Policy EHB Uniform and Appearance STHB Cellular Phone Use STHB 6 On Call Policy STHB Smoking Policy STHB Surveillance, Prevention and Control of Infection 6.1 Infection Control Program 62-67 6.2 Universal Precautions 67-71 For the following policies * Refer to: Hand Washing STHB Dirty Equipment Handling/Infection Control STHB Improving Organizational Involvement with QA 7.1 Management/Leadership Involvement with QA 72 7.2 Establishing the Plan 72-73 7.3 Measuring the Results 73-74 7.4 Assessing the Results of the QA Process 74 7.5 Performance Improvement 75 7.6 Patient Satisfaction 75 Information Management 8.1 Information Management Plan 76-77 8.2 Documentation Standardization 77 8.3 Record Retention 78 8.4 Record Confidentiality, Security and Integrity 78 8.5 Admission Documentation 79 8.6 Transferring and Discharging Patients from Service 79 * STHB – The Service Technician Handbook EHB – The Employee Handbook 7 Patient Care 1.1 Statement of Policies All employees are expected to adhere to the policies and procedures set forth in this manual. Employees shall direct any concerns or questions regarding these policies to their managers. 1.2 Patient Rights All patients receiving care from Alpine Medical Supply, LLC have individual rights, which are to be respected by all staff members involved with the care of the patient. It is Alpine Medical Supply, LLC policy to respect each patient during the provision of care. Alpine Medical Supply, LLC will not discriminate because of sex, age, race, religion or the ability to pay. Alpine Medical Supply, LLC recognizes that each individual has unique health care needs. It is Alpine Medical Supply, LLC intent to respect those individual needs. Alpine Medical Supply, LLC respect of the rights of our patients is consistent with Alpine Medical Supply, LLC mission, philosophy, and applicable laws and regulation. If Alpine Medical Supply, LLC is unable to meet the patient’s individual needs, the patient will be transferred to another organization or level of care as determined by the Hospice organization. 1.3 Informing Patients of Their Rights and Responsibilities Patients serviced by Alpine Medical Supply, LLC will receive written information from the Hospice organization regarding his/her rights and responsibilities throughout the course of care with Alpine Medical Supply, LLC. During the initial contact, or whenever a staff member comes in contact with a patient, it is the staff member’s responsibility to respect the patient’s rights, such as Honoring patient wishes; Following advance directives; Providing adequate information to allow the patient to make informed decisions; Maintaining patient privacy and confidentiality; Respecting patient property; Obtaining patient consent for care; and Providing processes for the patient to express his/her complaints or concerns. The first step in the patient education process is patient responsibility. Patients who assume responsibility for their own care can greatly and positively impact the outcome of their care. The Hospice nurse will review with the patient his/her responsibilities: 8 notifying The Hospice Organization/ Alpine Medical Supply, LLC of his/her change of address; informing staff of changes to advance directives; verbalizing complaints or concerns; respecting staff; respecting company equipment; notifying company when equipment is no longer needed; using equipment as instructed; notifying staff and complying with changes to physician orders; notifying staff of changes in the patient’s condition; and notifying company if he/she is unable to meet during a prearranged home visit. All staff members will receive training on their responsibility to honor patients’ rights and responsibilities during the orientation period. As part of Alpine Medical Supply, LLC performance improvement activities, the staff will be continually assessed of their understanding and implementation of patient rights and responsibilities as outlined by the Hospice organization. It is the staffs’ responsibility to recognize changes in the patient’s condition and to inform the Hospice organization It is the staff member’s responsibility to document any such occurrences on the appropriate document and notify his/her supervisor and Hospice organization. 1.4 Patient Involvement Regarding Care and/or Services It is the responsibility of all staff members to ensure both the patient and his/her family are involved in the care decisions made by the Hospice Organization and Alpine Medical Supply, LLC. If the patient involved is unable to participate, or is judged incompetent to make care decisions, the patient’s family or legal guardian should exercise the patient’s right. To ensure the patient remains involved in his/her care Alpine Medical Supply, LLC will provide the following information to the patient at the start of care and on an ongoing basis: Hours of service and/or after hour service; Phone numbers to access Alpine Medical Supply, LLC. If for any reason the patient chooses to forgo care and services from Alpine Medical Supply, LLC, staff will document any such concerns raised by the patient and notify the manager of the patient’s concern. The Hospice Organization will be notified of the patient’s refusal of care and, if appropriate, staff may discuss and resolve such conflicts and issues that may arise regarding care or services provided with the patient’s physician. 1.5 Patient Admission Information 9 As part of admitting the patient to care staff will familiarize the patient with the information contained in the Patient Admission Information. The Admission Information has been assembled to help the patient learn more about the services provided by Alpine Medical Supply, LLC, staff will provide information to patient upon admission. The Admission Information contains the following information: Hours of service Address and phone numbers Complaint process Safety Statement HIPPA Instructional Material. All staff will be trained on the content of and proper education of the patient regarding the Admission Information. Staff will be assessed on an ongoing basis on their use of the information contained in the Admission Information. 1.6 The Patients Right to Accept, Refuse or Withdraw Medical Care Advance Directives/Living Will Alpine Medical Supply, LLC recognizes that all people have a fundamental right to make decisions regarding their medical care (Patient SelfDetermination Act of 1990, Public Law 10 1-508, Sections 4206 and 4751, was enacted November 5, 1990, as part of OBRA 90, the Omnibus Budget Reconciliation Act.), such as the right to accept, refuse or withdraw medical care. An Advance Directive/Living Will is a document that states the wishes of an individual in the event he/she is unable to speak on his/her own behalf due to a sudden illness or medical crisis (e.g., heart attacks, stroke, and severe trauma). The Hospice Organization will provide patients, with written information advising the patient of his/her right to formulate advance directives, as required by law and regulation. Withholding Resuscitation It is Alpine Medical Supply, LLC policy that staff members are not required to initiate cardiopulmonary resuscitation (CPR). When appropriate, it is the family/patient’s responsibility to contact the proper emergency service organizations. 10 Withdrawal of Life-Sustaining Treatment The patient/family will be informed in writing by the Hospice Organization, of the process for the withdrawal of life-sustaining treatment. Alpine Medical Supply, LLC will participate in the withdrawal of life-sustaining treatment only if the following events occur: A physician’s order directing withdrawal is presented; A Durable Power of Attorney for Health Care requests the withdrawal of the treatment or the patient knowingly and voluntarily requests withdrawal and A signed Waiver of Liability document is provided by the Hospice Organization. 1.7 Investigative or Experimental Studies and the Unapproved Use of Equipment/Devices Alpine Medical Supply, LLC does not currently participate in research, investigative or experimental studies or clinical trials. However, in the event Alpine Medical Supply, LLC was to participate in such a program, all staff and patients will be trained in the program before a study is commenced. If a physician orders that Alpine Medical Supply, LLC provide a patient with equipment for use in a manner not approved by the FDA, Alpine Medical Supply, LLC will only provided the equipment for such use if two conditions are met. First, the ordered use must be deemed an acceptable standard of practice in clinical settings. Second, Alpine Medical Supply, LLC must obtain the patient’s consent before care or services are rendered. In requesting the patient’s consent, staff will inform the patient about how equipment is to be used, any potential risks or hazards, the anticipated benefits of care /services and alternative interventions. Alpine Medical Supply, LLC will ensure the patient clearly understands the care or service requested by patient’s physician is an “Off Label” practice and that such care or service has not been approved for use in the manner requested by the physician. The physician will also sign the consent form acknowledging his/her request of equipment/services ordered. 1.8 Patient Privacy and Confidentiality Alpine Medical Supply, LLC will respect and protect the privacy and all information addressing the care of the patient. Staff will avoid discussing or displaying patient information in public areas. Staff will not identify a patient by name when using patient information for statistical data collection. All staff will be trained on maintaining patient confidentiality (HIPPA) and will be asked to sign a confidentiality statement at the time of employment. 1.9 Patient Compliant or Concern Process Alpine Medical Supply, LLC will provide the patient, upon admission, with information regarding its procedure for receiving and reviewing complaints and/or concerns about care or service. The Admission Information will provide the patient with information about whom to contact at 11 Alpine Medical Supply, LLC to lodge a complaint or concern. Staff will also assure the patient that he/she is free to voice a complaint regarding care or service without fear of reprisal, discrimination or interruption of care or service. Staff will attempt to resolve any patient concerns and complaints to the best of their ability. Staff will document such occurrences and notify the Hospice Organization. Providing excellent service to the patient is important to the success of Alpine Medical Supply, LLC. Therefore, staff will receive extensive training regarding the patient complaint process during orientation and will be evaluated on the handling of patient complaints throughout their employment. Staff members are reminded that it is better to resolve a problem with the patient immediately rather than have a referral source intervene on the patient’s behalf. 1.10 Patient Communication Needs Alpine Medical Supply, LLC will make every attempt to meet the language needs of its patients. In the event a patient receiving care does not speak English, Alpine Medical Supply, LLC will contact the hospice to assist with a translator. 1.11 Ethical Issues in Patient Care or Service Alpine Medical Supply, LLC and its management pride themselves in maintaining high ethical standards as they conduct business with their staff, patients, and the general public. Ethical patient care practices and ethical business practice go hand in hand. The management staff will act as an advisory committee to address all ethical issues involving patient care or services. Management will review all marketing materials, advertisements and policies before these items are finalized and distributed to staff and general public. Management will also evaluate and review the billing practices of Alpine Medical Supply, LLC. Management will ensure the organization complies with billing practices in accordance with law and regulation. All staff must disclose any potential conflicts of interest with Alpine Medical Supply, LLC. For example, if an employee is working for another homecare company or is employed at an organization that refers business to Alpine Medical Supply, LLC, the employee must disclose this information to Alpine Medical Supply, LLC. A broad range of conflicts of interest may exist for managers or board members. Therefore, both managers and members of the board of directors are under an obligation to disclose potential conflicts of interest. 12 1.12 Patient Admission Assessment Staff members responsible for the intake processing of information must collect all pertinent information from the patient or referral source in order to evaluate whether Alpine Medical Supply, LLC can meet the patient’s expectation of service and care. Pertinent information includes the following: Patient’s name Address Phone number Hospice Contact Height and weight (if appropriate) Prescription available through the hospice Based on the above information, staff will be able to determine: 1) whether Alpine Medical Supply, LLC can comply with the Hospice/physician’s order; 2) whether Alpine Medical Supply, LLC has the equipment or personnel to meet the patient’s needs; and 3) the level of reimbursement for Staff will notify their manager if a situation that arises that they are unable to resolve. If Alpine Medical Supply, LLC is unable to meet the needs of the patient, he/she will contact Hospice organization. The scope of services provided by Alpine Medical Supply, LLC is provided to the Hospice organization. All new staff members will receive extensive training regarding these services, as well as the geographic region serviced by Alpine Medical Supply, LLC. The scope of services offered by Alpine Medical Supply, LLC includes: Compressors Suction Machine Oxygen Therapy (Concentrator, cylinders and LOX) CPAP/BiPAP Walk Aids Bathroom Safety Beds Support Surfaces Wheelchairs Patient lifts Lift Chairs Medical Supplies 13 Alpine Medical Supply, LLC will continue to assess the patient’s needs as requested by the Hospice organization. The areas of follow-up assessment include 1) the patient’s environment; 2) the ability of the patient (and/or the caregiver) to care for him/herself (the patient); and 3) the patient’s understanding of the company’s policies and procedures. Staff trained in the set-up and/or delivery of home medical equipment will perform the assessment. Staff qualified to perform assessments shall include delivery technicians and/or respiratory therapist as needed. Assessments are to be performed during the initial set-up of equipment and on an ongoing basis as needed. If during the assessment process a staff member is concerned about the patient or about Alpine Medical Supply, LLC being unable to meet the patient’s needs, the staff member will notify his/her manager and/or the Hospice organization. 1.13 Patient Environment Assessment After acceptance into Alpine Medical Supply, LLC service or care, a qualified individual from Alpine Medical Supply, LLC will perform further assessment activities on the patient. The staff member will perform an on-site evaluation to determine and assess that the prescribed medical equipment is appropriate and safe for use in the patient’s environment. Staff will use the “Equipment Checklist” form as a guide in evaluating the patient’s home environment. Staff will continue to assess the patient’s environment throughout the course of the patient’s care with Alpine Medical Supply, LLC. The types of assessments and reassessments to be performed by staff will include the following: Home Safety Environmental safety - throw rugs, stairs, doorways, clutter Electrical safety - grounded outlets, extension cords, circuit breakers Fire safety - fire extinguishers, smoke detectors, fireplaces, heaters, stoves Storage and handling of supplies Oxygen cylinder storage Enteral supplies and storage Facilities to clean and/or dispose of infections waste Appropriateness of equipment in the home Electrical safety - grounded outlets, no extension cords, no liquids near equipment 14 Mechanical safety - patient able to operate equipment safely Environment - proper placement of equipment The assessment of the patient’s needs does not stop after the initial set-up. Staff will continue to assess the patient’s needs throughout the course of care with Alpine Medical Supply, LLC. Staff working with a patient who is receiving oxygen will assess the patient’s compliance with Alpine Medical Supply, LLC environmental standards during every visit with the patient. If during the assessment process a staff member is concerned about the patient or about Alpine Medical Supply, LLC being able to meet the patient’s needs, the staff member will notify his/her manager and/or the Hospice Organization. 1.14 Reassessment of the Patient The level of care and type of services provided to the patient will determine the reassessment of the patient. Patients receiving durable medical equipment (beds, wheelchairs, walk aids, bathroom safety, etc.) will be reassessed on an as needed basis or as requested by the patient and/or referral source. If during the patient’s course of care with Alpine Medical Supply, LLC staff member is concerned about the patient, Alpine Medical Supply, LLC will perform a follow-up visit to the patient’s home to reassess the patient’s needs. Patients receiving oxygen, respiratory or enteral care will be reassessed based on the patient’s needs and/or frequency for equipment maintenance. The routine and preventive maintenance schedule for each piece of equipment is outlined in the equipment maintenance chapter. During the preventive maintenance service of equipment in the patient’s home staff will perform an assessment of the patient’s compliance to therapy and the patient’s needs. Situations that may trigger a need for further reassessment include the following: Change in the patient’s order Change in the patient’s diagnosis Change in the patient’s condition Change with the patient’s support system Change in the patient’s environment 1.15 Victims of Abuse/Neglect 15 All staff will receive training in the identification of and appropriate responses to suspected patient abuse or neglect. If staff suspects abuse during a home visit, they will immediately notify the manager. The manger will carefully interview the staff member to evaluate whether there may, in fact, be abuse or neglect. If the manager determines there is abuse or neglect in the patient’s home, he/she will contact the Hospice Organization. Signs of abuse and/or neglect may include any of the following: financial exploitation, bruises, cuts, welts, scalding, fractures, unnecessary physical restraint, sexual abuse, threats, harassment, and verbal intimidation. Neglect may also occur from the failure to provide personal hygiene, clothing, nutrition, essential medical care or non-compliance with medical regimen. 1.16 The Unique Needs of the Dying Patient In the event staff encounters patients who are dying, the care and/or services provided will be modified to respect the wishes of the patient or family. Staff will treat the death and dying of the patient with dignity and respect. 1.17 Patient and Family Education The goal of patient education is to help promote patient recovery and facilitate the patient’s safe and effective use of the prescribed equipment and services. As a company we can best meet the goals of patient education by incorporating the following fundamentals to achieve the desired outcomes. Alpine Medical Supply, LLC and its staff shall keep the following in mind throughout the patient education process: Involve the patient and family in all aspects of care and services; Consider the patient’s unique care, service and teaching needs; Assist the patient and family in understanding the patient’s health status; Tailor the patient education process to the specific patient and equipment; Enhance patient and family involvement in care and services; Provide educational information in an easy to understand manner; Involve qualified and properly trained staff in patient care; and Continually assess the patient’s and staffs’ learning needs. All staff members will receive training and ongoing education in the patient education process. 1.18 Providing Patient Education 16 All staff will receive extensive training in the process of educating the patient. Alpine Medical Supply, LLC will provide staff with resources to help them meet patient and family learning needs. Teaching materials Alpine Medical Supply, LLC has teaching materials available on the different types of equipment and services provided. These teaching aids include manufacturer generated patient equipment guidebooks; company developed instruction and information handouts, as well as education checklists. The learning materials used by Alpine Medical Supply, LLC are constantly expanding and changing as result of equipment changes and staff involvement in the development of new material. Alpine Medical Supply, LLC encourages all staff members to assist in these efforts and share educational ideas with Alpine Medical Supply, LLC. Ideas and new education tools should be forwarded to managers. Resource members Alpine Medical Supply, LLC has identified individuals who are to serve as resource people to staff. These individuals will also be responsible for staff training and the development of education material. These resource people include: Respiratory/clinical Issues – Patient Problems/Complaints – 1.19 Tailoring Education and Training to Specific Patient and Needs Staff will tailor the educational process to meet the specific needs of the patient. Staff is able to do this as the result of comprehensive training and with the use of available instructional material. Staff will assess the patient’s learning needs on an ongoing basis. Staff will provide the patient with both verbal and written educational information. Staff will assess whether the patient is comfortable with instructions given to him/her regarding his/her care and service of equipment. Staff will ask the patient to perform return demonstrations on all of the procedures involved in the care of the equipment and patient. Staff will document all training activities on the appropriate documents, such as the delivery ticket/invoice. Because patient involvement is critical to the patient’s well being, all learning and discharge goals should be included in the patient’s plan of care. 1.20 Basic Home Safety 17 Staff will provide the patient with both verbal and written information about basic home safety during the initial set-up and delivery of equipment. Staff will continually assess the patient’s compliance and environment to determine whether further education is needed to ensure safety in the patient’s home. Basic home safety education will include sharing the following information with the patient: Fire Safety Electrical Safety Environmental Safety Emergency phone numbers Emergency/Disaster plan In the event unsafe circumstances/conditions are identified, staff will document and communicate any such concerns to the Hospice Organization. If a situation is unsafe and may threaten the patient’s health, staff will contact the manager to report the problem. The manager will contact the patient’s Hospice Organization. Alpine Medical Supply, LLC will make every attempt to help the patient correct the unsafe condition. The areas of patient safety education will involve the following topics: Fire Safety Staff will review the need for fire extinguishers, the benefit of smoke detectors, the hazards of smoking in bed, fire hazards while oxygen is in use and the benefit of an evacuation plan. Electrical Safety Staff will review precautions regarding using extension cords, hazards of overloading electrical outlets and the dangers of having liquids around electrical appliances. Staff will encourage the use of grounded outlets. Environmental Safety Staff will review the advantages of removing items that may present a potential hazard or obstacle while ambulating through the home. Hazards may include throw rugs, extension cords, stairs, narrow doorways, shag carpets, furniture, the improper placement of the equipment, etc. Patient education may also involve the proper use and storage of equipment and supplies. Patients who receive oxygen cylinders will need to know how to properly store oxygen cylinders and disposable supplies. Emergency Contact Numbers Staff will review with the patient how to contact the appropriate emergency services in the community. 18 Emergency/Disaster Plan Staff will review with the patient what to do in the event of an emergency or natural disaster (ice storms, earthquakes, fires, tornadoes, etc.). The emergency procedures taught to the patient will include how to use emergency back-up equipment, Alpine Medical Supply, LLC procedure for contacting patients, who the patient should contact in the event he/she is unable to contact Alpine Medical Supply, LLC, and where to go to seek help or cover. Emergency back-up equipment may include an emergency oxygen cylinder or hand cranks for hospital beds. Staff will provide each patient, during initial set-up and delivery, instructions on where to obtain emergency phone numbers. 1.21 Patient Infection Prevention and Control Staff will provide information to patients about the control and prevention of infections. Patients who are using equipment with supplies that need to be cleaned and disinfected will receive both verbal and written instruction about properly cleaning equipment and disposing of infectious waste. Patient education issues may include: hand washing as the most important means of preventing infection; disposal of disposable supplies in garbage; the use and disposal of gloves or dressing and/or The disposal of bodily waste. The disposal of infectious waste may be accomplish by either flushing waste products in the patient’s toilet or disposing waste in his/her garbage. Staff should not Pick-up or transport any sharps container. Alpine Medical Supply, LLC currently does not supply patients with needles. Therefore, it is the patient’s responsibility to contact the company from whom they received such supplies for information regarding disposal. 1.22 Patient Education Addressing Specific Care Issues Alpine Medical Supply, LLC will provide additional information for equipment and supplies requiring special care. These items include oxygen cylinders and nutritional supplements. Oxygen Cylinders 19 Staff will review with the patient the proper storage and transportation of cylinders. Cylinders will always be stored in either an oxygen cart or stand. Portable cylinders may be stored on their sides to prevent cylinders from falling and damaging cylinder stems. For example, a patient may be instructed that portable cylinders may be stored under the patient’s bed. Staff will instruct the patient to protect oxygen cylinders from excessive heat or cold. For example, cylinders should not be stored in the patient’s car trunk. The patient will also be instructed to ensure cylinders are secured to prevent movement while driving. Nutritional Supplements Staff will instruct patients who are using nutritional supplements in conjunction with feeding pumps on the proper handling and storage of nutritional supplements. Patient education will focus on the proper temperature for the storage of nutritional supplements. 1.23 Patient Medical Equipment Education and Set-Up The following information will serve as a guide to staff in the education of the effective use and operation of equipment. Durable Medical Equipment Education and Set-up Staff responsible for the set-up and delivery of equipment will review the order for accuracy. Staff will only use equipment from the designated equipment ready area. Staff will inspect and evaluate the functional readiness of the ordered equipment. Staff will contact the patient to arrange a set-up time if one has not been prearranged. Staff will gather all necessary documents, such as -patient education information -delivery ticket Staff will determine the appropriate place for patient instruction and set-up. Prior to set-up, staff will determine the appropriateness of the home environment Staff will all follow DME Education and Set-up procedures for any equipment ordered. Staff will instruct the patient in the use of the equipment in accordance with manufacturer guidelines. Staff will review education material with the patient/care giver. 1.24 Coordination of Care and Services to the Patient 20 Alpine Medical Supply, LLC has a responsibility to provide care and services in a continuous and coordinated manner to the patient who is at home. Therefore, Alpine Medical Supply, LLC will only admit patients who have identified needs that can be met by Alpine Medical Supply, LLC. Alpine Medical Supply, LLC effectively coordinates services by empowering properly trained staff members, who understand Alpine Medical Supply, LLC responsibilities, to take the necessary actions and alert others about the patient’s needs. Managers and designated staff identified by Alpine Medical Supply, LLC will coordinate their actions to assure continuity of care for the patient. Staff members identified to coordinate these activities are qualified through experience, training and education to address the following care issues: Admitting only those patients with needs Alpine Medical Supply, LLC can meet; Understanding Alpine Medical Supply, LLC scope of services; Understanding the patient population serviced; Coordinating the patient’s with staff who can best meet patient’s needs; Understanding the patient admission criteria; and Through ongoing communication with staff, Alpine Medical Supply, LLC will make every attempt to minimize the duplication or conflict of services. It is the responsibility of the managers and designated staff to correct any such situations that may arise. Patients are always informed of efforts to coordinate care among various providers. The organization will always notify the patient if there are changes to patient delivery or service times. The patient will always be notified if there are delays in providing requested equipment or supplies. 1.25 Patient Referral, Transfer and/or Discharge If Alpine Medical Supply, LLC is unable to meet the needs of or can no longer provide services to the patient, Alpine Medical Supply, LLC will notify the Hospice Organization and the patient of its inability to provide continued care to the patient. Alpine Medical Supply, LLC, when appropriate, will assist the patient and refer the patient to an alternate care source. 1.26 Others Involved with the Care of the Patient Alpine Medical Supply, LLC will make every attempt to coordinate its care and services with others involved in the care of the patient. Alpine Medical Supply, LLC will identify others involved with the care of the patient during the assessment and reassessment visits with the patient. Alpine Medical Supply, LLC recognizes that coordination of care is important to the overall care of the patient. Therefore, Alpine Medical Supply, LLC will participate in interdisciplinary rounds with Hospice organizations, as requested. 21 1.27 Clinical Associate Training Procedure: 1. The a Site Supervisor or his/her designee, will train the clinicians in the various respiratory programs, such as: -oxygen therapy -aerosol therapy -suctioning -IPPB therapy -CPAP,BiPAP 2. The training program will provide training in every aspect of the various types of equipment used by the organization. 3. The training program will include: -a review of the policies and procedures -a review of the manufacturer’s reference materials -demonstration of patient set-ups 4. Each clinical specialist will perform the various services under supervision before working independently. 1.28 Oxygen Concentrator Procedure: 1. Staff will deliver to the patient’s home the appropriate equipment and supplies. The correct concentrator will be provided to meet the prescribe liter flow as ordered by the physician. 2. Staff will ensure that the equipment selected is clean and functions properly. 3. Prior to set-up of equipment staff will conduct an environment assessment for the appropriateness of the patient’s home environment. Staff will identify any unsafe situations and corrective measures taken. 4. Staff will instruct the patient/caregiver in the use of the concentrator. - hazards and safety issues related to use of oxygen in the home: such as electrical and fire safety 22 -operation of the oxygen concentrator: on/off switch, liter flow adjustment, and alarms -maintenance and cleaning filters: gross particle filter(s) -common problems and trouble shooting -how to assemble nasal cannula, tubing and humidifier -infection control: cleaning and changing schedule of disposable items -regular and after hour phone numbers 7. The staff will provide an appropriate backup system for the patient based on liter flow and number of hours of use per day. The backup system will consist of a high pressure “E” cylinder of compressed oxygen. Staff will instruct the patient in the use of oxygen cylinder. 8. Staff will ask patient/caregiver for return demonstrations on the use of oxygen equipment to evaluate patient/caregiver needs for on-going education. 9. Staff will review the following documents with the patient/caregiver: -patient welcome packet -education checklist -no smoking sign -oxygen safety statement -invoice/delivery ticket 1.29 Oxygen Cylinder Procedure: 1. Staff will deliver to the patient’s home the appropriate equipment and supplies. The correct oxygen regulators will be provided to meet the prescribe liter flow as ordered by the physician. 2. Staff will ensure that the equipment selected is clean and functions properly. Staff will document serial numbers of equipment and Lot numbers from the tanks delivered. 3. Staff will leave all cylinders delivered to the patient’s home in a base designed to prevent tipping of the cylinders, or a cart designed for portable use. For safety purposes, extra E cylinders are stored lying down on the floor. 4. Staff will instruct the patient/caregiver in the use of the oxygen cylinders. - hazards and safety issues related to use of oxygen cylinders in the home -operation of oxygen cylinder(s) 23 -identification of the remaining contents of the cylinder -common problems and troubleshooting -how to assemble nasal cannula, tubing and humidifier -infection control: cleaning and changing schedule of disposable items -regular and after hour phone numbers 6. The organization will provide an appropriate size or number of cylinders for the patient based on liter flow and number of hours of use per day. 7. Staff will ask patient/caregiver for return demonstrations on the use of oxygen equipment to evaluate need for on-going education. 8. Staff will review the following documents with the patient/caregiver: -patient welcome packet -education checklist -no smoking sign -oxygen safety statement -invoice/delivery ticket 1.30 Oxygen/Liquid Oxygen System Procedure: 1. Staff will deliver to the patient’s home the appropriate equipment and supplies. The correct liquid oxygen system will be provided to meet the prescribe liter flow as ordered by the physician. 2. Staff will ensure that the equipment selected is clean and functions properly. Staff will document serial numbers of equipment and Lot numbers of liquid oxygen used to fill system 3. Staff will leave all systems delivered to the patient’s home in a base designed to prevent tipping of the system, or a cart designed for portable unit. Staff will also leave all necessary supplies needed for using the portable unit. 4. Staff will instruct the patient/caregiver in the use of the liquid oxygen system. - hazards and safety issues related to use of liquid oxygen in the home -operation of the liquid oxygen system -refilling the portable unit -identification of the remaining contents of the system or portable unit -common problems and troubleshooting -how to assemble nasal cannula, tubing and humidifier 24 -infection control: cleaning and changing schedule of disposable items -regular and after hour phone numbers 6. Staff will ask patient/caregiver for return demonstrations on the use of oxygen equipment to evaluate need for on-going education. The patient will be asked to demonstrate the refill procedures. 7. Staff will review the following documents with the patient/caregiver: -patient welcome packet -education checklist -no smoking sign -oxygen safety statement -invoice/delivery ticket 1.31 Oximetry Procedure: 1. Staff will deliver to the patient’s home the appropriate equipment and supplies. 2. Staff will ensure that the equipment selected is clean and functions properly. Staff will document serial numbers of equipment. 3.. Staff will instruct the patient/caregiver in the use of the oximeter. -operation of the oximeter -common problems and troubleshooting -how to assemble probes and cables. -infection control: cleaning and changing schedule of disposable items -regular and after hour phone numbers 4. Staff will ask patient/caregiver for return demonstrations on the use of oximeter equipment to evaluate need for on-going education. 5. Staff will review the following documents with the patient/caregiver: -patient welcome packet -education checklist -invoice/delivery ticket 1.32 Suction Units 25 Procedure: 1. Staff will deliver to the patient’s home the appropriate equipment and supplies. 2. Staff will ensure that the equipment selected is clean and functions properly. Staff will document serial numbers of equipment. 3.. Staff will instruct the patient/caregiver in the use of the suction unit. -operation of the suction unit -common problems and troubleshooting -how to assemble tubing and suction catheter. -infection control: cleaning and changing schedule of disposable items -regular and after hour phone numbers 4. Staff will ask patient/caregiver for return demonstrations on the use of suction unit to evaluate need for on-going education. 5. Staff will review the following documents with the patient/caregiver: -patient welcome packet -education checklist -invoice/delivery ticket 1.33 BiPAP (Bi Level Positive Airway Pressure) Procedure: 1. Staff will deliver to the patient’s home the appropriate equipment and supplies. 2. Staff will ensure that the equipment selected is clean and functions properly. Staff will document serial numbers of equipment. 3. Staff will instruct the patient/caregiver in the use of the BiPAP: -operation of the BiPAP -understand how to use ramping feature and time cycling of unit -maintenance of machine -cleaning or changing inlet filters -cleaning mask, headgear and humidifier 26 -common problems and trouble shooting -how to assemble tubing, mask and headgear -if unit is being used with oxygen explain use of adapter unit and follow -proper placement of unit so that intake vents are free from obstructions -infection control: cleaning and changing schedule of disposable items -regular and after hour phone numbers oxygen setup procedures 4. Staff will ask patient/caregiver for return demonstrations on the use of the equipment to evaluate need for on-going education. 5. Staff will provide suggested cleaning schedules and replacement of supplies: -tubing: clean once weekly -mask: clean daily -humidifier: twice a week -filters: change as needed bases on color change -headgear: as needed, hand wash 6. Staff will review and complete all related documents and patient education material with the patient. The following documents include: -patient welcome packet -patient education checklist -invoice/delivery ticket 1.34 CPAP (Continues Positive Airway Pressure) Procedure: 1. Staff will deliver to the patient’s home the appropriate equipment and supplies. 2. Staff will ensure that the equipment selected is clean and functions properly. Staff will document serial numbers of equipment. 3. Staff will instruct the patient/caregiver in the use of the CPAP: -operation of the CPAP -maintenance of machine -cleaning or changing inlet filters -cleaning mask, headgear and humidifier -common problems and trouble shooting -how to assemble tubing, mask and headgear -if unit is being used with oxygen explain use of adapter unit and follow oxygen setup procedures 27 -proper placement of unit so that intake vents are free from obstructions -infection control: cleaning and changing schedule of disposable items -regular and after hour phone numbers 4. Staff will ask patient/caregiver for return demonstrations on the use of the equipment to evaluate need for on-going education. 5. Staff will provide suggested cleaning schedules and replacement of supplies: -tubing: clean once weekly -mask: clean daily -humidifier: twice a week -filters: change as needed bases on color change -headgear: as needed, hand wash 6. Staff will review and complete all related documents and patient education material with the patient. The following documents include: -patient welcome packet -patient education checklist -invoice/delivery ticket 1.35 Hand held Aerosol Therapy Procedure: 1. Staff will deliver to the patient’s home the appropriate equipment and supplies. 2. Staff will ensure that the equipment selected is clean and functions properly. Staff will document serial numbers of equipment. 3. Staff will instruct the caregiver in the use of the aerosol therapy: -operation of the aerosol therapy unit -maintenance of machine -changing or cleaning filters -cleaning and changing hand held nebulizers -common problems and trouble shooting -how to assemble equipment -infection control: cleaning and changing schedule of disposable items -regular and after hour phone numbers 4. Staff will ask caregiver for return demonstrations on the use of the equipment to evaluate need for on-going education. 28 5. Staff will provide the patient an adequate amount of disposable supplies, such as hand held nebulizers, aerosol mask, and filters 6. Staff will review and complete all related documents and patient education material with the patient. The following documents include: -patient welcome packet -patient education checklist -cleaning instructions -invoice/delivery ticket 1.36 Large Volume Humidity Therapy Procedure: 1. Staff will deliver to the patient’s home the appropriate equipment and supplies. 2. Staff will ensure that the equipment selected is clean and functions properly. Staff will document serial numbers of equipment. 3. Staff will instruct the caregiver in the use of the humidity therapy: -operation of the humidity therapy compressor -maintenance of machine -changing or cleaning filters -cleaning and changing hand held nebulizers -common problems and trouble shooting -how to assemble equipment -if oxygen is being used assemble ancillary equipment -infection control: cleaning and changing schedule of disposable items -regular and after hour phone numbers 4. Staff will ask caregiver for return demonstrations on the use of the equipment to evaluate need for on-going education. 5. Staff will provide the patient an adequate amount of disposable supplies, such as large volume nebulizers, aerosol mask, tubing, drain bags, and filters. 6. Staff will review and complete all related documents and patient education material with the patient. The following documents include: -patient welcome packet -patient education checklist -cleaning instructions 29 -invoice/delivery ticket 1.37 Hospital Bed Procedure: 1. Staff will set-up hospital bed in appropriate area as determine by patient/caregiver. 2. Staff will evaluate electrical safety with patient/caregiver 3. Staff will assemble bed and safety rails according to manufacturer’s specifications 4. Staff will review how to lower and raise the head and foot of the bed. For manual beds, staff will show how to use hand cranks at the foot of the bed. For semi and full electric beds staff will demonstrate using the electric hand control. 5. Staff will demonstrate how to properly lower and raise the bed using either the electric hand control or hand crank at the foot of the bed. 6. Staff will demonstrate what to do in the event the patient loses electrical power. Staff will demonstrate how to use the emergency hand crank to adjust the height of the bed. 8. Staff will demonstrate how to safely raise and lower the safety rail. 9. Staff will review the safety precautions when using a hospital bed, such as preventing falls, staying clear of moving parts, and smoking in bed. 10. Staff will review all necessary paper work with patient/caregiver. 1.38 Wheelchair Procedure: 1. The staff member will review the safety precautions when using a wheelchair. 2. Staff will demonstrate how to open and fold the wheelchair. 3. If the chair provided has removable armrest staff will demonstrate how to remove and reattach armrest. 4. Staff will demonstrate how to remove and reattach foot rigging. If the wheelchair ordered has elevating leg-rest staff will demonstrate how to properly elevate and lower the footrest. 30 5. Staff will adjust the footrest for proper positioning while patient is in the wheelchair. 6. Staff will demonstrate how to use wheel locks. 7. Staff will review how to properly care for and/or clean wheelchair. 8. Staff will review all necessary paper work with patient/caregiver. 1.39 Alternating Pressure Pad Procedure: 1. Staff will evaluate electrical safety with patient/caregiver 2. Staff will place pad on unmade bed and attach tubing to pad and control unit (pump). Plug pump into grounded outlet. 3. Staff will explain how to clean pad with warm soap water. 4. The staff member will review the safety precautions when using an alternating pressure pad. 5. Staff will review all necessary paper work with patient/caregiver. 1.40 Durable Medical Equipment Setup Procedure: 1. Staff will deliver to the patient’s home the appropriate equipment and supplies. 2. Staff will ensure that the equipment selected is clean and functions properly. Staff will document serial numbers of equipment. 3. The delivery staff will setup and assemble equipment according to manufacturer’s instructions. 4. The delivery staff will instruct the patient in the use of the equipment according to the equipment checklist. 5. The delivery staff will review and complete all related forms and patient education material with the patient. 31 1.41 Walk Aids Procedure: 1. The staff member will review the safety precautions when using a walk aids. 2. Walker -review features such as folding, adjusting height, wheels and glide brakes - demonstrate how adjust walker to the proper height -adjust walker height so that the patient is standing straight with wrists is level with hand grips of walker -demonstrate how to hold and walk with walker Canes -review features of canes such as: regular, quad, adjustable, hand grips - demonstrate how adjust cane to the proper height -adjust cane so that the patient is standing straight with wrists is level with hand grip -demonstrate how to hold and walk with cane Crutches -review features of crutches such as: underarm, forearm and platform - demonstrate how adjust crutches to the proper height -adjust crutches: underarm-should fit under axilla while patient is standing straight forearm-cuff section should fit above elbow and hand grips adjusted to keep arms in a straight position platform-arm should rest comfortably on the padded platform with the hand grip adjusted to keep the wrist in a comfortable position -demonstrate how to hold and walk with crutches 3. Staff will review all necessary paper work with patient/caregiver. 1.42 Low Air Loss Mattress Procedure: 1. Staff will evaluate electrical safety with patient/caregiver 2. Staff will place pad on unmade bed and attach tubing to pad and control unit (pump). Plug pump into grounded outlet. 32 3. Staff will explain how to clean pad with warm soap water. 4. The staff member will review the safety precautions when using an alternating pressure pad. 5. Staff will review all necessary paper work with patient/caregiver. Management 2.1 Authority and Responsibility Management has the ultimate responsibility and legal authority for itself and has the ultimate responsibility and legal authority for Alpine Medical Supply, LLC as a State Name Corporation. Management has the responsibility to insure the company possesses all licenses necessary to operate a business that provides care and services for the home care patient in this state. Management operates pursuant to a set of bylaws and articles of incorporation. The general manager has ultimate responsibility for securing and directing upper level management, who conduct the day-to-day operations. The general manager’s responsibilities include overseeing that the actions and activities of management personnel result in quality patient care and service. The primary responsibilities of leadership relate to monitoring the following leadership processes: Planning: Establishing a mission statement that is directed toward long-range, strategic and operational plans, resource allocation, and company policies. Directing: Organizing, directing and staffing the patient care and support operation in a level commensurate with the scope of services provided. Implementing and Coordinating: Effectively integrating patient care and support services throughout the company. Improvement: Setting expectations and plans and managing processes to measure assess and improve the performance of Alpine Medical Supply, LLC management, patient care and support services. Management monitors financial conditions, including budgeting and adequate long term financing. As markers for evaluating the company’s ability to meet its mission and objectives, management evaluates such factors as: Financial goals; Staffing; 33 Patient population; Improvement of Performance; Effectiveness of operational practices, policies, and procedures; Effectiveness of administrative practices, policies, and procedures; and Effects of government regulations and competition on achieving objectives. 34 COMPANY CHART Alpine Medical Supply, LLC 35 2.2 Developing the Company’s Mission and Plan A business plan has been established for Alpine Medical Supply, LLC consisting of strategic, operational and program-related plans based on the mission, business philosophy, and goals of the company. The mission statement is used by management as the basis to develop long range objectives for Alpine Medical Supply, LLC. The strategic plan contains both administrative and operational elements that provide the framework for achieving the objectives. The plan addresses the following administrative elements: Budgeting and finance Facilities Capital expenditures Marketing and sales Administrative staffing and education Improvement of performance The plan addresses the following service related operational elements: The rights, responsibilities and ethics of the organization as they relate to the patients served The care, treatment and services provided by company to the patient The education of patients and family members The ongoing process of matching the patient's needs with the care and services provided The improvement of the organization’s performance The leadership process for effectively planning, directing, implementing, coordinating and monitoring of care and service activities The environmental safety of both patients and staff with respect to care and services provided The selection and development of a competent, well-trained staff The management of information relative to patient care and the development and expansion of educational resources for staff personnel The process to ensure reduction in risk of infection to both patients and staff Management ensures that all policies and procedures reflect the intent of the plan. It is the responsibility of the manager to communicate Alpine Medical Supply, LLC plans to staff. The Mission Statement is clearly displayed and all employees are made aware of the Goals and Vision therein stated. 36 The Mission Statement is: Reviewed annually by the Management staff Revised as deemed necessary after the annual review Approved annually by the CEO 37 MISSION STATEMENT: Alpine Medical Supply, LLC strives to be recognized as a leader in our industries by consistently meeting the needs of our patients and providing the highest quality of services, equipment and knowledgeable staff possible in a caring and compassionate and cost effective manner. VISION: Our vision is to be a top industry provider in the state of Oklahoma for Hospice Medical Equipment Services. GOALS: Alpine Medical Supply, LLC will strive to provide true health care solutions and fill a need within all communities in which hospice service is provided. The organization will strive to become a “TOTAL SOURCE” to clients, patients and caregivers in a home or institutional setting by providing unique full service Hospice Durable Medical Equipment services. 2.3 Establishing Alpine Medical Supply, LLC Operating Budget Management will prepare and maintain an annual operating budget as required by applicable law and regulation. Alpine Medical Supply, LLC establishes an annual budget to ensure compliance with regulations and financial stability within Alpine Medical Supply, LLC, and to develop a plan to meet the needs of the patients served. Management will develop an annual operating budget, which considers: Current and anticipated new patient services Staffing to provide those services Capital expenditures, when appropriate 38 Performance improvement/measuring activities Marketing expenditures Management will monitor the financial posture of Alpine Medical Supply, LLC against the operating budget by directing the finance department to analyze data each month. Management may recommend modifications to the current, ongoing budget, as deemed necessary, at any appropriate time during the fiscal year. 2.4 Leadership Involvement in Quality Assurance Program Management shall provide adequate resources and support the performance improvement activities of Alpine Medical Supply, LLC. Leadership will monitor the effective operation of the Performance Improvement Program (PI), and applying that knowledge: May provide input on who should be part of the PI team; Aid in developing and reviewing the PI; Review implementation and provide guidance and correction, if deemed necessary; and Analyze and assess the effectiveness of the PI Program. Management allots the financial resources necessary, including the cost of management and staff personnel, to develop, implement and maintain the Performance Improvement Program. Management ensures that the staff assigned to PI activities understands its importance, devotes adequate time and effort to its success, and is sufficient and competent enough to develop, implement and maintain the PI program. 2.5 Manager’s Responsibilities The manager has the education, experience and authority to fulfill his/her responsibilities for the overall operation of the company. The manager displays, through day-to-day management activities, that his/her academic and professional background is sufficient to manage and guide Alpine Medical Supply, LLC effectively. The manager has operational responsibility for the following major management areas: Planning and Budgeting Controlling Marketing and Sales Staff hiring, terminating and evaluations Job Assignments 39 The manager is responsible for acquiring and maintaining required licensing or certification and assures compliance to federal, state, and local laws governing the business. The manager takes action on any reports or recommendations received from authorized planning, regulatory, and inspection agencies. 2.6 Policy Implementation and Review The policies and procedures of Alpine Medical Supply, LLC shall be implemented, reviewed and revised as necessary. All company procedures are developed by individuals knowledgeable in that procedure and are checked and approved by management. 2.7 Conflict of Interest Alpine Medical Supply, LLC will implement a written conflict-of-interest policy that includes guidelines for the disclosure of any existing or potential conflict of interest, define and guard against any and all activities that constitute a conflict of interest among individuals or groups directly involved with Alpine Medical Supply, LLC whether from a financial or operational perspective. The following constitute conflicts of interest: An operational or financial association of the principal with any group or company regarded as a competitor to Alpine Medical Supply, LLC. Participation, directly or indirectly, with a source of patient referrals in a captive referral arrangement wherein patients are directed to utilize the company in derogation of the patient's right to select the suppliers of his/her choice. Any administrative, management or staff personnel encountering an existing or potential conflict of interest must adhere to the following procedure: Provide to the management team with adequate information, in writing, that Outlines, in detail, the potential conflict; The management team shall review the information and monitor investigations, as necessary, designating those individuals responsible for carrying out said Investigations; The individual(s) responsible for the investigation reports back to the management team with details and/or recommendations within a 30 day time period; and If a conflict of interest is ascertained, the management team will take whatever Action is necessary to resolve the conflict. All company staff members, including managers are informed at the time of hire of the existing conflict of interest policy and must document their understanding on a form, which is kept in their personnel file. 40 2.8 Company Communication Management has developed, implemented and monitors the effective mechanisms for fostering communication between and among individuals and components of Alpine Medical Supply, LLC. The goal is to improve the effectiveness and teamwork of Alpine Medical Supply, LLC in providing its scope of care and service through timely disbursement of information and by fostering an environment of open communication between all individuals. Alpine Medical Supply, LLC will establish mechanisms for communication between staff. To accomplish communication between staff, staff will use one or more of the following methods: Bulletin board postings Staff meetings Distribution of memos, reports, and meeting minutes Telephone conferences Workshops Management has an "open door" policy to encourage all staff members to communicate their concerns and thoughts. 2.9 Staff Safety Alpine Medical Supply, LLC will address the safety and security of staff members both in providing patient care and at the company facility. It is management’s responsibility to ensure that staff members traveling into unsafe areas or working at the company after hours are provided safety and security from potentially dangerous encounters. Alpine Medical Supply, LLC will require staff to abide by the following guidelines when assigned to perform an unsafe call: Discuss the situation with the immediate supervisor; Arrange to make a joint visit; Arrange visit during daylight hours. Employees working after hours at Alpine Medical Supply, LLC are provided a level of security commensurate with the crime level in the area. This includes: Having all entryways securely locked; Ensuring the parking area is well lighted. 41 Environmental Safety 3.1 Structural/Environmental Concerns in the Patient’s Home Staff providing equipment and related services to patients will receive training and competency testing in specific structural, electrical, and environmental requirements for the safe and effective home use of equipment. The objective is to ensure that patients served by Alpine Medical Supply, LLC are made aware of structural, electrical, or environmental factors that may mitigate the use of the equipment or pose potentially hazardous situations to the patient or caregiver. The following are examples of structural considerations and concerns staff will monitor: Potential barriers to access such as doorway and hallway width; Adequate space considerations for effective use of equipment; Potentially hazardous structural factors such as stairways, temporary walls or partitions, unstable structures or items that may prove hazardous due to the weight, size or transportation of the equipment provided; Availability and adequacy of electrical power in the home; and Appropriate use of ground connections, extension cords, and adapters. 3.2 Equipment Set-Up in the Patient’s Home When equipment is set-up in the patient’s home Alpine Medical Supply, LLC will ensure the patient is provided with properly installed equipment and appropriate information, and that the patient can demonstrate safe use of the equipment. To ensure equipment has been properly set-up and the patient has received the proper training, staff will observe competency in the following: Arrangement of the home to accommodate the physical, electrical and other requirements for effective and safe equipment set-up; Unpacking, assembling equipment, and performing needed operational checks; Verification of appropriate considerations for equipment adaptation or fitting, when applicable; and Instructing the patient in the following, according to manufacturer guidelines: - All aspects of safe and proper operation of equipment and related accessories and supplies - Proper care or preventive maintenance - Proper cleaning and/or disinfecting procedures - Problem identification and problem solving skills and troubleshooting procedures - Operational and safety check procedures 42 At time of set-up staff will train the patient or caregiver. Staff will request and observe a return demonstration by the patient or caregiver. Staff will provide additional patient training if the return demonstration is inadequate. Staff will conduct all safety check procedures according to the processes and recommended frequency set forth in both the manufacturer's and Alpine Medical Supply, LLC guidelines. Staff will inform users verbally and/or in writing of any known significant safety hazard(s). Staff may also provide patients with verbal and written instructions relative to preventive maintenance and equipment breakdown avoidance. Staff may also conduct ongoing assessment and re-education. 3.3 Emergency Patient Response Alpine Medical Supply, LLC will implement routine and emergency procedures relative to the equipment and services provided. Patients will receive a prompt response to routine or emergency equipment/supply problems. Staff will respond to all routine calls occurring during normal business hours on the day of the call, if feasible. Staff will respond to routine calls occurring after normal business hours on the next business day. Emergency calls will be received by the after-hours answering service. Alpine Medical Supply, LLC will provide the answering service with a current list of on-call assignments and a list of management and potential back-up staff member names, beeper and home phone numbers. After hour emergency call procedures: The answering service is instructed to immediately contact the on-call individual. If that person has not responded within 20 minutes, the service is to contact the supervisory level person on-call. The person receiving the call contacts the answering service for patient information and then directly contacts the patient within 20 minutes. From the information obtained, the staff member decides whether the call can be effectively handled on the phone or whether someone should proceed to the patient's location. Documentation will reflect all emergency on-call activity and include the date, time and the initials of the staff members involved. 43 3.4 Patient Education Staff will provide education and training to the patient, which is appropriate to the equipment or medical supplies provided. Staff will ensure that the patient/caregiver who is using a specific piece of medical support equipment and related supplies understands and can demonstrate proper operation and care of said equipment and supplies. Staff will also brief the patient/caregiver on any known significant safety hazards related to the use of those items. The training of patients, including verbal explanations and educational demonstrations of equipment operation, is conducted only by personnel qualified to perform that duty. Staff will use the appropriate patient education materials and equipment to in-service the patient on the particular piece of equipment. Staff will train patients on the proper application and operation of backup systems, when ordered and/or supplied, along with appropriate emergency plans and actions. Staff will discuss in detail the patient's responsibilities in the use and care of the equipment provided and explain to the patient that Alpine Medical Supply, LLC has the right to remove equipment if and when there is evidence of equipment abuse. Staff will provide written or verbal instructions for all categories of equipment covering the following training elements: Operation of equipment and accessories; Relative safety aspects; Preventive maintenance in the home; Cleaning, disinfecting, and infection control; On-site troubleshooting procedures; and Ordering and storage of supply items. Alpine Medical Supply, LLC will provide all instructions to the patient in an effective and understandable manner. During and/or following instruction, staff will request that the patient demonstrate properly the information previously provided. Patient demonstration must indicate an understanding sufficient to ensure safe and trouble-free operation of the equipment provided. If not, the staff member will repeat the training in those areas which the patient did not demonstrate proper skill or adequate knowledge. Staff will provide the patient with written or verbal information regarding Actions to be taken in event of equipment malfunction; Regular and after hour phone numbers; and Alpine Medical Supply, LLC's policy regarding emergency service and replacement equipment. 3.5 Equipment Suitability for Patient Use 44 Following the patient evaluation, if a qualified representative has reason to believe that equipment other than what was prescribed by the physician, or a different application of the equipment, is more appropriate to the care specified, staff will contact the physician, informing him/her of the recommended change and the rationale supporting that recommendation. Staff will document the recommendation and place it in the patient's file. If the physician agrees with the recommended change, staff will request a new prescription, if appropriate, and place it in the patient's file. Should Alpine Medical Supply, LLC, due to equipment shortage, be unable to supply the patient with a specific piece of equipment, and Alpine Medical Supply, LLC does have an equivalent substitute in stock, staff will notify the Hospice Organization and seek and receive approval prior to said substitution. Staff will monitor the use of and adequate stock of equipment accessory items or supplies at the patient's residence, act appropriately to correct any uncovered problem, and document same. Staff will document any home safety hazards or the lack of appropriate safety precautions that are related to the equipment provided. 3.6 Safety Programs Alpine Medical Supply, LLC has an ongoing safety program relating both to Alpine Medical Supply, LLC operations and to the care/service provided to patients in their home. Alpine Medical Supply, LLC safety Management will monitor the day to day operations to assess safety of Alpine Medical Supply, LLC. Management will monitor the following areas: Safety-related training; Compliance with government standards; Maintenance of all safety-related records, including training, accidents, injuries, hepatitis B vaccinations, and TB test results; Creation, maintenance and review of Alpine Medical Supply, LLC's safety policies; and Training of all appropriate staff personnel according to the latest OSHA requirements and FDA regulations, as applicable. Managers or designated staff will train all appropriate staff personnel on the following areas: Equipment operation; Electrical safety; Fire hazards; 45 Mechanical safety; Cleanliness, storage and handling of equipment and supplies; and Transportation of equipment and supplies to and from the patient's site of service When applicable, Alpine Medical Supply, LLC provides initial and ongoing verbal or written instruction to all appropriate staff on the following elements of safety relative to the storage and handling of: Medical gases (covered storage in a stable, protected area, with protection from extreme heat in accordance with appropriate FDA and OSHA laws and regulations); Proper handling of sterile supplies; Proper weighing, identity and/or purity testing, and flow meter testing of oxygen; Dated product storage for preservation of sterility and/or optimal use (ostomy, glucose monitoring, etc.), covering dated solutions, refrigeration, and protection from temperature extremes; and Hazardous materials and wastes (including gloves, protective garments) disposal per state and local laws and, regulation and in accordance with applicable OSHA guidelines; and Review emergency procedures to be implemented in the event of a waste spill or exposure. Safety in the Home Staff will provide training, at admission or at the time of delivery and set-up, to the patient or caregiver on safety aspects relating to the care or services being provided. Training may include providing written safety materials covering all oxygen delivery methods, selected DME products, and wheelchairs and when appropriate, instructions relating to the preparation for and recommended action in the event of a fire or natural disaster. Staff will provide to the patient contact information for Alpine Medical Supply, LLC and refer them to the front section of the their local telephone book for emergency phone numbers. Staff will also provide “No Smoking” signs and affix warnings to units providing supplemental oxygen. Additionally, staff will assess the safety knowledge and skills of patients at intervals appropriate to the services or the care provided. At admission of the patient, and at any other time deemed appropriate, staff will conduct a home safety assessment involving general patient safety and those safety factors relative to the care or services provided. This may include: Fire safety; 46 Electrical safety; Environmental and mobility safety; Operational, electrical, mechanical and fire hazard safety involving supplied equipment Patients must sign or initial the Equipment Education Form attesting to satisfactory safety orientation at the time of admission or equipment delivery. Alpine Medical Supply, LLC also provides written or verbal instructions to the patient, when applicable, regarding the storage and handling of oxygen cylinders. 3.7 Emergency Preparedness Alpine Medical Supply, LLC has an emergency preparedness plan designed to provide continuing care and support appropriate to the care or service provided in the event of an emergency that would result in interruption to patient services. Assembling Of Staff The manager is designated as the disaster coordinator. All employees are provided with an up-to-date list of all other employees along with their addresses and office and home telephone numbers. Should a state of emergency be declared, the manager and/or appropriate backup personnel notifies, via a phone tree, all personnel who will be on a standby basis for possible call. Upon notification, each individual proceeds to Alpine Medical Supply, LLC or to any other location designated by management personnel. All personnel having pagers or vehicular radios will monitor those devices for emergency messages. Should normal avenues of communication be disrupted, the staff will be instructed to listen for instructions via emergency radio messages over designated commercial radio frequencies. Pre-Emergency Planning Delivery vehicles are fueled to at least 1/2 of a tank each evening and filled at beginning of deliveries each day. Delivery vehicles are equipped with a standard first aid kit, and other emergency items appropriate to the service area. An up-to-date priority list of patients who would receive immediate attention in the event of an emergency is available at the office and at the manager's place of residence. 47 Patients are provided oxygen back-up systems. If the patient has waived or refuses back-up equipment for use in the event of power outages or equipment malfunction, the patient is advised of the consequences of refusal in writing and the refusal is documented in the patient’s file (care plan). Transportation Establish phone contact, if possible, with patients by priority and determine the urgency of needed care or service. Coordinate a delivery schedule based on available patient data and road condition information. Assign driver/technicians staff based on data acquired. Should a patient to whom physical immediate access is not possible require immediate urgent care, staff will: Establish contact with an alternate supplier of the care or service in closer proximity to the patient. Follow up on any alternate action with the patient to ensure that patient’s immediate needs have been met. Explain to the patient that emergency medical service (call 911) may be the only source for care or service available to him/her. Internal Measures Training programs are conducted to develop the knowledge and skills necessary to allow personnel in one job category to adequately perform in another patient related job category, if so needed. Alpine Medical Supply, LLC is prepared to call upon alternate organizations providing the same equipment and services should Alpine Medical Supply, LLC be unable to adequately service its patient population with available staff or equipment. 3.8 Safety Management Monitoring The safety management and emergency preparedness plans shall be monitored and evaluated semi-annually. Alpine Medical Supply, LLC incorporates Safety Management monitoring into the company’s Performance Improvement program. Management will insure that safety and/or emergency preparedness is regularly reviewed as a part of the QA program. Equipment Management 48 4.1 Reporting Product Defects/Incidents Alpine Medical Supply, LLC has a process in place for obtaining hazard, defect and recall information from the manufacturer. The manager is the recipient of hazard, defect, and recall information. He will instruct staff personnel to report any identified equipment problems/incidents immediately to him or her. Alpine Medical Supply, LLC management has the authority to remove all suspect or recalled equipment, as appropriate from the home of a patient. Alpine Medical Supply, LLC management is responsible for the appropriate training of all clinical personnel on preparing medical device reports, as required by the Safe Medical Devices Act as it relates to any medical devices indicated by state or federal regulation. The manager is responsible for maintaining complete records and files of verbal and written information related to medical device (MDR) reports. He/she will maintain the files by device and retain files for a minimum of two years from the date the report or information was submitted to the FDA, or for a period of time equivalent to the design and life expectancy of the device. In the event of a reportable incident, management will ensure a report is made within 10 days to both the manufacturer and the FDA. A "reportable incident" occurs when an equipment malfunction was a probable cause, the cause, or a contributing factor to a death, serious injury or serious illness. 4.2 Equipment Returned to Alpine Medical Supply, LLC Staff will transport and return "Contaminated" equipment and reusable accessories to the designated “Dirty Equipment Area” for cleaning and disinfecting in accordance with infection control protocol. Staff will not store or process any unsanitary or contaminated equipment or accessories in any location where contamination of sanitary or sterile equipment could occur. Cleaning and Disinfecting Disassemble all dirty/contaminated equipment to the level that is appropriate for that piece of equipment and in accordance with the manufacturer’s instructions (10 minute contact times). Thoroughly clean each disassembled item, removing dust, dirt, or any foreign matter with cleaning agents appropriate for the equipment. Wipe dry or permit moisture evaporation of equipment not requiring disinfection before bagging. During the cleaning process, change filters or other specific replaceable items - If within the time frame recommended by the manufacturer, or 49 - In the case of filters, if the equipment has been used in an infectious environment. Appropriately cover and log all equipment and accessory items following disinfection, indicating readiness for future patient use. Equipment Functional Testing Staff will perform an equipment operational check to ensure the unit functions properly before placing equipment in the patient ready area. Staff shall Conduct a visual cleanliness examination; Conduct an electrical check to ascertain that all electrical cords are intact, unfrayed and undamaged, and that grounded plugs have three secure prongs; Check the physical integrity of wheelchair brakes, bearings, upholstery; hydraulics on patient lifts, and for bends or breaks in bed frames, etc.; Test all equipment according to manufacturer's guidelines; and Ascertain that each piece of equipment checked or tested is documented with the manufacturer and serial number on the Equipment Ready tag and/or oxygen concentrator log. See equipment cleaning/function check logs. Storage of Patient Ready Equipment Store all sanitary or clean equipment, accessories and supplies in the patient ready area covered with plastic. Tools Used For Repair Alpine Medical Supply, LLC will ensure that a separate set of tools is used only for repair of oxygen equipment, both in the shop and in the home. This tool set will not be used for general repair of such items as vehicles, shop equipment, etc. Inventory Rotation: Alpine Medical Supply, LLC employees practice a FIFO (First in, First Out) procedure. By definition, the oldest stock of date sensitive items (tanks, enteral product, etc.) is distributed before the newest stock of date sensitive items. Normally, the rotation of tanks is so frequent that the physical rotation is not applicable. 4.3 Equipment Tracking, Recalls, Hazards 50 Alpine Medical Supply, LLC has a process to provide documentation of the manufacturer, model, serial number and maintenance instructions for all appropriate equipment in event of hazards, defects, and/or recalls. Alpine Medical Supply, LLC ensures that all equipment provided to patients is identifiable for documentation of maintenance and repair and to comply with FDA mandates that ensure protection from potential equipment problems. Therefore, all staff responsible for processing information must ensure that serial numbers are recorded on all delivery/pickup invoices. The individual responsible for repairing and servicing equipment maintains operation and service manuals from each manufacturer for all items Alpine Medical Supply, LLC services and repairs. Only staff members who have received proper training may perform routine and preventive maintenance on equipment. All service and maintenance personnel are familiar with the location, use, and maintenance of manufacturer documentation. Alpine Medical Supply, LLC will maintain a file of all equipment documentation according to serial number and product category. The maintenance log provides the ongoing record history of each piece of equipment (including oxygen concentrators). Potential hazards to patients, caregivers, or staff due to equipment failure, malfunction, or design deficiencies shall be reported to the USPC via the Product Problem Reporting Program (PRP). Documents submitted to USPC for reporting product problems shall be signed by the Chief Executive Officer. When reporting device problems to USPC, the following information shall be provided: a) b) c) d) e) f) g) h) Manufacturer name Complete device name Identification numbers (lot, model, and serial number) Nature of problem including any actual or potential adverse effects upon the patient, caregiver, or practitioner Indication whether or not the device was being used according to recommended directions Location where event occurred Whether or not a sample of the device has been retained The identity and practice specialty of the practitioner reporting the problem Completed reports shall be sent via first class postage to: Product Problem Reporting Program, The United States Pharmacopoeia Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20352. If additional questions arise about what, when, or how to report medical device problems, staff may call USPC at 1-300-633-6725. Recall Procedure: (Compressed Gas Oxygen Tanks &/or Liquid Oxygen Vessels) 51 Upon receipt of written recall notice from either re-filler or manufacturer to the Site Supervisor (regarding defect, or recall for safety hazard, etc.) the supervisor will then take the following steps: a. Contact the source of the recall, if necessary, to verify the correct and complete information. Complete an ALPINE MEDICAL SUPPLY, LLC Incident Report and attaché a copy to the notice. b. Notify the appropriate individuals (staff members) at each location of the current situation along with specific instructions. c. Maintain a file of recall reports obtained from the manufacturer and save these for at least 2 years or the life expectancy of the equipment. d. The affected lot numbers will be looked up on the delivery manifests and the patients with affected tanks will be contacted and notified not to use. e. Schedule appropriate personal to retrieve and replace the affected tanks within a reasonable amount of time. (Attempt will be made to pick-up all affected tanks within 24 hours of the recall notice, when possible). f. Segregate affected tanks in the “Quarantine Area” and identify as a recall/defect. Device: This section includes tanks. All devices (equipment) which are no longer in working order will be placed in the appropriate area for either repair, obsolete (no longer in use), or in an area that the items are stored prior to being picked up by an approved service/repair center. Food: Nutritional food supplies (enteral) will be monitored on an ongoing basis for expiration; and when due to expire prior to the expiration date; product must be pulled and moved to the “Obsolete Area” of the warehouse so that staff does not accidently deliver the product. Nutritional food supplies will also be monitored for proper temperature storage. A thermometer will be located in the enteral supply section of the warehouse or office storage area and the temperature will be documented on a temperature log based on the following conditions: If the storage area is climate controlled than documentation should be done once per month. Storage range needs to be maintained between 32 – 95 degrees F. If the storage area is not climate controlled than documentation should be done once per day in the afternoon. Storage range needs to be maintained between 32 – 95 degrees F. 4.4 Routine and Preventive Maintenance 52 All equipment will receive routine maintenance on an ongoing basis to ensure that all equipment is and remains safe and dependable for use in the patient's place of residence. All appropriate DME and respiratory equipment items will receive routine preventive maintenance at time intervals recommended by the manufacturer. These items will not receive maintenance between patient uses unless requested by the patient or required by equipment failure. Staff will perform routine evaluations annually for oxygen concentrators. Preventive maintenance is performed according to manufacturer guidelines. All in-warranty repair and service will be performed by the manufacturer, unless the manufacturer provides authorization to Alpine Medical Supply, LLC for in-house repair and/ or service. Preventive maintenance performed on all equipment will be document on the equipment log book, this information will then be transfer to the on-line equipment tracking module. 4.5 Delivery of Equipment and Supplies Alpine Medical Supply, LLC will deliver only equipment and supplies that are prescribed, sanitary, and in proper working order. To ensure delivered equipment and supplies are sanitary and in proper working order staff will adhere to the following guidelines: Following check-in, cleaning, disinfecting, operational checks, and repair of equipment, bag all appropriate equipment and/or identify equipment with an appropriate label to allow warehouse workers and delivery personnel to rapidly identify operational and sanitary equipment. Keep disposable supplies in their original packaging to assure warehouse workers and delivery personnel know that they are to use supplies that are new, unused, sanitary and in proper working order. Determine proper identification of delivered equipment and supplies from the prescription order. Train and monitor appropriate personnel on the use of pre-delivery and delivery checklists. Base the frequency of service on the prescription order, the usage rate and communications with the patient to insure an adequate supply (i.e. for disposable items) and appropriate delivery of items consistent with prescribed care. Bag or cover all equipment and supplies to assure proper protection from the elements during transport to the patient's location. Separate sanitary items from dirty or contaminated equipment in each delivery vehicle to ensure equipment and supplies are sterile and sanitary when delivered to the patient. Adequately secure equipment in the delivery vehicles to prevent instability and possible damage. The driver/technician is responsible for maintaining consistent cleanliness in the delivery vehicle. 53 Distribution: (Compressed Gas Oxygen Tanks and LOX) Oxygen is only distributed by authorized personnel. Distribution of tanks are documented on the “Delivery Manifest” and the “Delivery Ticket”. Upon arrival to the patient’s home, the employee documents the number of cylinders delivered and all of the associated lot numbers. 4.6 Inventory Ordering PROCEDURE: 1. Site completes a purchase request using the “Inventory Order Form” 2. Site Supervisor or designee fills out and signs the purchase request. The purchasing request is then sent to AOM for approval. a. The shipping Site will at a minimum fill in the following details on the Inventory Purchase Order form: i. Manufacture Item # ii. Unit of Measure iii. Description iv. Quantity v. Quantity in Stock 3. After review, the AOM will approve the purchase request and send it to Purchasing. 4. If the purchase request is greater than $2000.00 the Purchaser will insure CEO approval. 5. Purchasing will check surplus availability in Sites throughout the Company. If the requested product is found to be available it will be transferred to the requesting Site (see “Inventory Transfer” policy). 6. If the product is not available within the Company, the Purchaser will assign the appropriate purchase order number and order the product through the Company’s primary vendor. 7. Upon receipt of the product at the Site, the Site personnel will receive the shipment (see “Inventory Receiving” policy). 8. The original packing slip will be sent to Accounts Payable within 3 days of product receipt to be matched up with the invoice for payment (see “Inventory Receiving” policy). 4.7 Exception or STAT Product Ordering Approval 54 POLICY: When a Site requires a product from a manufacture that is not the “Primary Supplier” as identified by Corporate, then AOM and CEO approval must be obtained prior to purchasing the item. In addition, whenever a product has to be received quicker than denoted by the normal ordering process, a complete explanation must accompany the order with clear receiving deadlines outlined. PROCEDURE: 1. If the Primary Supplier item is not acceptable and an alternative supplier is to be used, approval is to be obtained by the AOM & CEO. The purchase order request must include a complete explanation. a. The shipping Site will at a minimum fill in the following details on the Inventory Purchase Order form: i. Manufactures Item # ii. Unit of Measure iii. Description iv. Quantity v. Complete explanation in the remarks column 2. Purchasing will review the justification for validity. If questions arise, the AOM will be contacted. 3. After review, the Purchaser will contact the requesting Site and advise them of the approval status (with possible receive date and any additional pertinent information pertaining to the order). 4.8 Stocking and Ordering All Sites are to use the “Inventory Order” form for ordering and managing their inventory. The sheets reflect product information and the established minimum and maximum levels established for each item stocked. PROCEDURE: 1. The initial Inventory Order sheet with the newly established Site minimum and maximum levels will be approved for usage by the AOM, CFO & CEO. 2. A continual review process will exist to update the established levels as dictated by usage. 3. It is the responsibility of the AOM to communicate to the Purchaser any product additions or changes in levels. 4. The reorder level is the quantity needed to be on hand or on order to sustain operations for a 7 day cycle minus the number of assets on POLICY: 55 hand in inventory (AOH) plus the number of days that it takes to order and receive the asset (ORA) 5. The formula for the establishment of the reorder is as follows: Reorder level = Daily Demand Rate (DDR) X 7 – the number of assets on hand (AOH) + ORA. Example: 1 each is used each day (DDR) and the site has 4 in stock it takes 3 days (ORA) to receive new orders. Minimum = 1 (DDR) X 7 (# of days in the order cycle) – 4 in stock (AOH) + 3 (ORA) = 6 each. 6. Purchasing will review all orders. In those instances where a question arises on possible excessive quantities, the AOM will be called to determine the ordered quantity. Any order over $2000 will be approved by the CEO. 7. Area Emergency Inventory volume: i. Each AOM will have a Site designated to have a set volume of “Emergency Inventory”. This inventory is to be used only in the event that a client set-up has to be done immediately and no other inventory recourse is available to service the client. ii. The AOM must approve the use of the emergency inventory by filling out an Inventory Order form (checking the Emergency Inventory box and filling out a detailed comment in the remarks column. 4.9 Inventory Transfer POLICY: A standard process will be used to transfer inventory between Company Sites. PROCEDURE: 1. The shipping Site will fill out an “Inventory Purchase Order” form and will check off the “Transfer” box. a. The shipping Site will at a minimum fill in the following details on the Inventory Purchase Order form: i. Manufactures Item # ii. Unit of Measure iii. Description iv. Quantity v. Manufactures Serial Numbers vi. ALPINE MEDICAL SUPPLY, LLC Asset Number 56 2. All items will be shipped clean, patient ready and properly labeled unless the receiving Site is otherwise notified. 3. The transfer of the product in the system will be the responsibility of AOM and will be done the same day that the transfer occurred. 4. The AOM will then send a copy of the completed Transfer form to the Corporate Analyst. 4.10 Inventory Receiving POLICY: A standard process will be used to receive inventory purchases and transfers from other Company Sites. PROCEDURE: 1. Inventory Transfers: a. Upon receipt of an inventory transfer from another site, the receiving Site will insure that the correct product number and quantity was received. If a discrepancy is noted the receiving Site will contact the shipping Site for resolution. b. See “Inventory Transfer Policy” 2. Vendor Receipts: a. The Site will receive the product and match all items with the packing list. b. Matched packing list must be faxed to Corporate Analyst within ONE DAY of the items being received. c. Site supervisor/designee responsible for entering received item into MITS i. Following menu path in MITS to be followed: Division; Inventory Maintenance; Serial Numbers (for corresponding type of equipment); Add ii. Following fields MUST be populated: Inventory Item; Status; Division; Serial Number; Manufacturer d. Item entry screen in MITS must be printed and faxed with packing list (s) to Corporate Analyst (within ONE DAY of the items being received). e. Purchase Order will be closed at Corporate when all packing lists, MITS order entry screens, and invoices are received and matched at Corporate. 3. Receipt Discrepancies/Errors 57 a. Any items on packing list that are not physically received at the locations should immediately be brought to the attention of the Corporate Analyst. b. Corporate Analyst will contact vendor and resolve the discrepancy and ensure that items not received are not invoiced by the vendor. 4.11 Cylinder Receipt and Distribution POLICY: Alpine Medical Supply, LLC, Inc. employees shall inspect and complete the “Cylinder Inspection Log” upon the receipt of medical cylinders from supplier fillers. Also stated in this policy is the distribution method for medical cylinders. PROCEUDRE: Prior to releasing cylinders for distribution, the facility will ensure that the medical cylinders are check for the following: 1. Labels and Tags are legible and present 2. Lot numbers are legible and present 3. Quantity of contents 4. Valve Stem Intact 5. Condition of Cylinder appears in order Once each of the above items is inspected for each different style of cylinder (E, D, C, and B), a check will be placed in the column accordingly on the Cylinder Inspection Log. Any actions taken for problems should be noted in the underlying section. Every blank space on the Cylinder Inspection Log should be filled out with the appropriate information for the facility. All other medical gases will only be distributed to individuals allowed by law to possess prescription drugs (i.e. licensed wholesale drug distributors, pharmacies, practitioners, hospitals, and clinics operated by a licensed practitioner). The distribution of medical cylinders will follow the principle of FIRST IN, FIRST OUT and shall be rotated as such. Human Resources 5.1 Establishing Staff Responsibility and Accountability 58 It is the responsibility of management to ensure that patient care and services are appropriately integrated by defining responsibilities and establishing methods to measure the accountability of all individuals within Alpine Medical Supply, LLC. Alpine Medical Supply, LLC establishes specific lines of responsibility throughout all levels of Alpine Medical Supply, LLC through the use of Job Descriptions and Management Processes. Job descriptions are used both in hiring and evaluating employees. These descriptions include: A general overview of the job Minimum educational or experience requirements Specific responsibilities within the overall job description Measurable objectives for accountability Management processes include: Hiring and firing policies; Education processes relative to enhancing and maintaining knowledge and skill levels related to stated job responsibilities; and Personnel evaluation policies and procedures. 5.2 Selecting Staff Alpine Medical Supply, LLC hires or utilizes people who have competence and abilities appropriate to the scope of care provided by Alpine Medical Supply, LLC. Company management considers the following factors in the evaluating the competence and qualifications of staff: The mix of patients and the degree of complexity of care required; The type of care or service provided by Alpine Medical Supply, LLC; The technology employed in the care of patients; Expectations of both Alpine Medical Supply, LLC and its patients; License or certification requirements for each category of personnel providing care or service; and Health requirements for the staff member as they relate to his/her patient care responsibilities. Potential employees whose qualifications are commensurate with anticipated job responsibilities are considered for employment without regard to sex, race, age, creed, handicap, marital status or national origin. Individuals seeking employment are provided with a standardized approach to selection including: Review of resume; 59 A personal interview by one or more evaluators, as deemed appropriate; A qualification assessment based on a written job description; An assessment of the individual's health status relative to the individual's ability to perform essential job functions; An assessment of the individual's ability to communicate and carry out directions commensurate with the demands of the job; and An assessment of the maturity of the individual and the ability to deal effectively with the demands of the job. As a part of the selection process, Alpine Medical Supply, LLC will verify applicants’ education, experience and training. All applicants who indicate that they possess special licensing, certification or registration must provide verification of same prior to hiring. At or before the time of orientation, all new employees are provided with a copy of the employee handbook. During the initial orientation all new employees are provided with a copy of their job description and informed that all evaluations shall be based on the job description. See “Orientation Checklist”. 5.3 Personnel Records Alpine Medical Supply, LLC has standardized its employee records, orientation, evaluations and treatment of employees. Alpine Medical Supply, LLC is responsible for creating and maintaining written personnel policies covering: Equal Employment Opportunity Policy; Summary of Wage and Fringe Benefits; Termination policy; Leaves of Absence; Confidentiality; Safety Rules; Employee Insurance Benefits; Company Rules and Regulations; A Guide to Personal Conduct; and Management Rights. Alpine Medical Supply, LLC provides each employee with a copy of the personnel handbook. Each staff member participates in an orientation program appropriate to his/her job classification and responsibilities. 60 Alpine Medical Supply, LLC maintains personnel records, which include periodic performance reviews, job-related health status, training record, DMV records, evidence of licenses or certification, and all required governmental forms, as appropriate. 5.4 Staff Evaluations All Alpine Medical Supply, LLC staff members have a right to and shall receive an annual evaluation of performance competency. Evaluations are based on the written job description of the employee and measured against identified objectives. This process ensures that employees understand how their individual job performance matches the job description and expectations of Alpine Medical Supply, LLC. Evaluations help ensure continuous, high quality care for patients. Evaluations are based upon information and data gained by direct observation, patient input, and employee-related documentation and/or questioning by the evaluator. New employees are hired with a probationary period of 90 days from date of hire. 5.5 Employee Health Status Personnel records shall include the individual staff member's health status as it relates to his/her care responsibilities and the company’s requirements. Alpine Medical Supply, LLC reserves the right to require a physical examination of any newly hired individual who is or will be assigned to on-site patient care. Individuals having an infectious disease or an impaired immune system will not be assigned to patient contact positions. 5.6 Staff Orientation Staff personnel providing shall participate in a general orientation. This will ensure that all employees have adequate knowledge and skills to perform in a competent manner relative to their assigned function. Training materials, such as texts and audio visual aids are sometimes used for orientation/training of staff. Orientation programs include, but shall not be limited to, the following topics: Equipment Delivery and Setup Safety Patient Training Infection Control Hazardous Wastes and Materials Confidentiality Incidents and Accidents 61 HIPPA Training Appropriate administrative and clinical policies and procedures that apply to the care and services being provided. All employees, drivers, warehouse personnel, as well as all other staff members, who come into direct contact with patients, will complete an orientation program appropriate to the level of their responsibility. Proficiency testing to evaluate the staff's knowledge and skills utilizes written testing, when appropriate, and skill demonstration reviewed by a qualified observer. All training documentation is placed in the employee's personnel file. Specific supervisors via spot checks shall perform on-going assessment of staff competence. Equipment competence shall be based on demonstration of equipment set-up. An in-service education program shall be utilized to provide ongoing education for all services provided by Alpine Medical Supply, LLC. 5.7 Continuous Training of Staff In-service training and continuing education programs are provided for all staff. Alpine Medical Supply, LLC provides training to ensure all staff members possess and maintain knowledge and skills appropriate to their responsibilities and the effective care of patients. All employees receive continuing education appropriate to their job description responsibilities and recognized needs. Alpine Medical Supply, LLC will, on an ongoing basis, assess the educational needs of the staff and take appropriate action to correct detected deficiencies. 5.8 Staff Competence Staff will receive competency exams every three years and ongoing in-service training appropriate to their job descriptions. Staff members providing equipment and services to patients shall undergo initial ongoing in-service training, supervised on-the-job training and shall have effectively demonstrated their knowledge and skills within the scope of equipment/services they provide. Staff involved with equipment will receive training and show competence on the following topics relative to their individual responsibilities: Equipment safety and troubleshooting; 62 Equipment setup; Operation of equipment; Cleaning of equipment; and Communication and teaching skills. Alpine Medical Supply, LLC will monitor and measure the competence of all personnel assigned to equipment-related activities. These findings offer management a guide to determine educational opportunities for Alpine Medical Supply, LLC. 5.9 Spending Limits (Travel & Sponsorships), Expense Reports and American Express Cards Expense Reports Due three days prior to pay date on Med-Depot standardized expense reporting form All receipts must be attached (taped on copy paper) Reports will be sent back that are not completed or receipts are not attached. American Express Individual AMEX statements will be sent out via e-mail to each card carrier by Corporate on a monthly basis Receipts supporting each purchase must be attached (taped on copy paper) Return statement with attached receipts within one week of receiving the statement Travel Reimbursement Guidelines When possible, air travel should be booked 1 month in advance using lowest available rate through discount travel websites (Expedia, Travelocity, Sidestep, etc…) Round trip air tickets in excess of $400 must be approved by CFO Hotel charges should be less than the following amounts based on zone of travel: Oklahoma, Kansas, Missouri, Texas (College Station, Tyler, Amarillo, Temple/Waco, Lubbock, El Paso, Rio Grande Valley), Indiana, Michigan, Ohio Texas (DFW, Houston, Austin, San Antonio) California (greater LA metro area) All other areas $89 $109 $119 $89 Deviations from this guideline must be approved by CFO 63 Food allowance - $35.00 per day Rental cars must be booked through >>>**checking into national contract with Enterprise or Hertz** Sponsorships Paid according to Hospice annual revenue produced o Below $100K - Allowance $75 o $101K – $250K - Allowance $150 o $251K - $500K - Allowance $250 o Above $501K - Allowance $500 Deviations from this guideline must be approved by CEO 64 Surveillance, Prevention and Control of Infection 6.1 Infection Control Program Alpine Medical Supply, LLC has an ongoing infection control program, based on current scientific knowledge, which is designed to prevent, identify, and control infections in patients and staff. Alpine Medical Supply, LLC infection control program will address the following elements: Identification of infectious conditions; Universal blood and body fluid precautions; Personal hygiene; Precautions against airborne transmission; Precautions against transmission from direct/indirect contact with the source of infection; Immunization and testing of exposure prone employees; Precautions to protect patients and/or staff who have compromised immunity; Controls over infectious waste management; Requirements for use of aseptic techniques; Processes to be followed for communicable infections; Equipment reuse, including cleaning and disinfecting procedures; Transportation of clean/sterile items; and Surveillance and record keeping. Infection Control Coordinator Alpine Medical Supply, LLC infection control coordinator will be responsible for the implementation, ongoing evaluation, updating and revision of the Infection Control Program. These procedures follow CDC guidelines and meet or exceed federal OSHA regulations applicable to occupational exposure to blood borne pathogens. These standards are designed to comply with OSHA blood borne pathogen standards (Blood Borne Pathogen Standards, 29 CRF 1910.1030). The Infection Control Program is mandatory. Personnel ignoring or circumventing the procedures are subject to disciplinary action. The infection control coordinator, with the assistance of management, will identify various jobs within Alpine Medical Supply, LLC with the greatest potential of occupational exposure. The infection control coordinator will ensure that all employees with potential for occupational exposure are properly trained and comply fully with the infection control program. 65 The organization has identified the following positions for greatest risk of exposure to blood borne pathogens: Drivers Clinical Staff Warehouse staff Employee Health Records Alpine Medical Supply, LLC shall maintain health records for each employee identified as having potential occupational exposure. The employee health records include the following: The employee's Hepatitis B vaccination status TB test results A copy of all results of examinations, medical testing, and follow-up procedures The health record is kept separate from personnel records and free from disclosure to anyone not authorized by the employee’s consent, except as allowed by law and by OSHA regulations. Hepatitis B Vaccination Alpine Medical Supply, LLC shall offer to every employee who has occupational exposure to blood and bodily fluids an HBV inoculation at Alpine Medical Supply, LLC expense. The HBV inoculation (3-dose vaccination series over a six month time period) to prevent a Hepatitis B virus infection will be offered to staff: After initial training and/or Within 10 days of initial assignment to an exposure-prone job classification. OSHA Directive CPL 2-2.44D, Enforcement Procedures for the Occupational Exposure to Blood borne Pathogens requires screening for hepatitis antibody following completion of the vaccination series. Therefore one to two months after the completion of the 3-dose vaccination series staff should be tested for antibody to hepatitis B surface antigen (antiHBs). An exemption to this policy will be approved if: The employee declines vaccination and signs the Hepatitis Declaration form. However, the employee can, at a later date, reconsider and receive the vaccination, if still occupationally exposed; The employee previously received the complete Hepatitis B vaccination series and this can be documented by medical records; 66 Antibody testing indicates that the employee is immune. However, testing cannot be required by the employer to pre-screen for vaccination; or The vaccine is contraindicated. TB Identification/Prevention Protocol All staff will meet the protocol for the control of occupational exposure to tuberculosis, which consists of screening, education, procedural training, work practice controls and record keeping. Staff will take the following steps: At the time of referral, Alpine Medical Supply, LLC, through its standard infectious condition identification procedure, identifies patients with known air or blood borne pathogens. Employees are properly trained regarding tuberculosis, its mode of transmission, symptoms, risks, precautions and prevention; Every employee who is at risk of occupational exposure is offered, at no cost to the employee, the Mantoux Skin test by a certified practitioner. This offer occurs: - After initial training - Within 10 days of initial assignment to an exposure-prone job classification or - Annually for all at-risk employees Each employee will receive training in the use of PPE. In the event a staff member is exposed, the following steps will be implemented: An Incident Report Form will be completed and filed with the infection control coordinator; A Mantoux skin test is performed as soon as possible following exposure; If the initial skin test is negative, the test is repeated 12 weeks after date of exposure; If the skin test is greater than or equal to an area of 5mm or the employee displays symptoms suggestive of tuberculosis, a chest X-ray is performed; Records of exposure incidents are maintained as part of the employee's medical file. These shall include: -The employee's exposure record -Results of the Mantoux skin test -Medical practitioner's evaluation -Medical treatment, if applicable Positive test results, infections and/or determination of the presence of the disease with any employee are recorded on the OSHA 200 Log. This is not applicable to pre-employment screening; Work-related activities of employees developing active TB are restricted in accordance with safe infection control practices and within the guidelines of the ADA and state law; All associated medical records are treated in a confidential manner. 67 OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS In the event a staff member is exposed to a blood borne pathogen such as HIV or Hepatitis, the following steps will be implemented: Employee should wash site with soap and water or if mucous membrane exposed, flush with running water. Report exposure incident to supervisor. Incident report to be completed by staff and supervisor. Medical evaluation and follow-up by staff’s physician. Lab testing is performed. Supervisor will provide a copy of regulations cited 29CFR section 1910.1030 if staff is unfamiliar with regulation. Organization maintains staff confidentiality of information. Advise employee rest 6 week post-exposure and on a periodic basis approximately 12 weeks to determine exposure. Medical records regarding post exposure evaluation and follow-up shall be maintained for duration of employment plus 30 years. OCCUPATIONAL EXPOSURE TO TUBERCULOSIS Definition: Tuberculosis is an infectious disease caused by the tubercle bacillus, which adversely affects the respiratory system. Transmission via blood flow to other parts of the body can result in diseased conditions in other organs, primarily the kidneys and bones. Transmission Cross transmission occurs via microscopic airborne particulate matter containing tubercle bacilli, which is generated by individuals having clinically active tuberculosis. Once inhaled, the bacilli enter the lungs, which provide an ideal environment for multiplication and transmission of the disease to other systems and organs of the body. High Risk Categories Persons with HIV infection or risk factors; Persons with pulmonary signs or symptoms; Blacks, Asians, Pacific Islanders, Native Americans, Alaskan Natives, Hispanics; Current or past prison inmates, alcoholics, intravenous drug users; Foreign-born persons from areas of high TB prevalence; and Persons living in households with members of these groups. 68 Symptoms Fever; Weakness Lethargy Nighttime sweating Loss of weight Productive cough Coughing up blood Risks Airborne transmission via coughing, sneezing, spitting, or saliva, frequent close contact with patient and/or prolonged indoor contact. Universal Precautions Using gloves, gown, eye protection Using three micron or less HEPA respirator masks Understanding of OSHA respirator training guidelines 1910.134 Training employees on the proper fit and use of HEPA equipment immediately upon employment and as needed thereafter Disposing of protective equipment on site or return equipment in a clearly marked bag (not red) closed with wire ties; and Washing and disinfecting hands prior to the next patient visit or handling equipment. High Risk Procedures Incubation Suctioning Aerosol administration. Medical TB Screening Employee screening after employment, annually at the option of present employees, and at six-month intervals for exposure-prone employees. Surveillance Required Surveillance is required for employees who have been exposed, tested positive, or contracted the disease. Exposure Procedure Report exposure immediately to infectious control coordinator; Document incident; Test employee; 69 Follow up positive tests; Implement appropriate work restrictions; and Provide treatment. 6.2 Universal Precautions All staff who come into contact with body fluids and/or patients suspected or identified as having an infectious disease shall, at all times, follow the Universal Precautions for infection control. It is the responsibility of the infection control coordinator to make all appropriate personnel aware of risks and ensure staff members know, understand and apply the following procedures when attending to such patients, especially when the potential for contact with the patient blood or body fluids exists. Staff prevention and protection Hand Washing Hand washing is the most basic method to control occupational exposure. The following procedures must be observed and strictly enforced. Hands will be washed with an anti-bacterial product Before and after caring for each patient and/or their equipment; Following removal of any personal protective items; Following lavatory use; and Prior to eating or drinking. Gloves All personnel are instructed to wear disposable gloves when: Handling items, contacting surfaces, or cleaning equipment soiled by blood, body fluids or other observable body substances, and when dealing with items from known infectious conditions. Whenever a staff member's hands are exposed (non-intact skin) due to cuts, abrasions, dermatitis, chafing, etc. Whenever any potential for exposure to infectious blood or body fluids exists. When picking up or cleaning any equipment returned from patients (as appropriate). Dispose of gloves, towels or any other related disposable item on site. Hand washing, as instructed above, is mandatory after glove removal. Masks Masks are recommended in the following situations, and shall be disposed on site: 70 Lengthy contact with a patient exhibiting an excessive cough or having an airborne transmitted condition, e.g. influenza; When TB is known or suspected, wear a HEPA respirator mask, 3M #9970, or equivalent when entering the residence of patient, caring for the patient or handling equipment used by that patient. Protective Eye Covering Protective eye covering (goggles, face shields, or eyeglasses having solid side shields) must be used in situations where there is the possibility of fluids splashing. Handling of equipment Alpine Medical Supply, LLC shall implement and monitor procedures relative to retrieving, transporting, cleaning and disinfecting equipment that has been used or located at a patient residence, as well as the storage and delivery of clean equipment. The infectious control coordinator will monitor other processes to prevent cross contamination or transmission of an infectious disease between a patient and staff or other patients. All medical equipment is universally considered to be disinfectable and is to be transported, cleaned, disinfected and stored in accordance with these procedures. Single patient use (disposable) items must be discarded at the patient's residence and must not be disinfected or returned to stock. Stored equipment and supply items having expiration dates are tracked and removed from stock at the time the expiration date is reached. The cleanliness and sterility of sterile supplies is maintained, via these procedures, during storage and delivery. In accordance with OSHA standards, Alpine Medical Supply, LLC maintains Material Safety Data Sheets on all solutions. All equipment subject to infectious contamination shall be segregated from clean equipment when placed in company vehicles. Acceptable Disinfectants Alpine Medical Supply, LLC will use commercially purchased disinfectants that have a phenylic or iodophor base or cavacide. The warehouse manager will monitor the expiration date of disinfecting solution. Staff will maintain contact time between the equipment and the disinfecting solution as recommended by the manufacturer. Supplies Each driver/technician maintains a supply of PPE in the advent that blood or air borne pathogens are identified prior to delivery. Similar supplies are located in specified cleaning and disinfecting areas. 71 General Transportation Procedures Clean equipment is segregated in the delivery vehicle area, as appropriate. Remove dirty equipment from the home and place in the company vehicle segregated from the clean equipment. After removing or handling used (potentially contaminated equipment), cleanse with an appropriate disinfectant. Discard disposable gloves, disposable garments and disposable supplies on site at the patient's residence or place in a bag for disposal at Alpine Medical Supply, LLC. Cleanse hands using the appropriate disinfectant prior to entering the patient's residence for their protection. Wash hands upon leaving, using disinfectant for your protection. Upon return to the facility, route dirty equipment immediately to the dirty equipment receiving area. Dirty Equipment Receiving Area Physically isolate the dirty equipment receiving area from other warehouse or storage areas. Eating, drinking, smoking, applying lip balm or cosmetics and handling contact lenses is prohibited in the dirty equipment area. Always use gloves, gowns and protective eyewear (when splashing may occur) when cleaning and/disinfecting items returned to the facility. Clean and disinfect items using this seven step procedure: - Disassemble the dirty equipment to the proper cleaning level. - Clean in an appropriate solution. - Rinse in clean water (when appropriate). - Clean with an approved disinfecting solution and allow contact with the equipment surface for the time prescribed by the manufacturer. - Rinse away the disinfecting solution. - Place equipment in a drying area. - After equipment is thoroughly dried, package and tag as rental "Ready Equipment." Place it in a clean holding area to await restocking. Clean items that were disinfected in the field prior to restocking. Remove and replace intake or HEPA filter on equipment employing same prior to restocking. Clean external cabinets on large equipment with disinfecting solution. Remove gowns and gloves used with contaminated equipment and wash hands thoroughly before handling disinfected items. Follow state bedding license requirements for mattresses and upholstered equipment, as appropriate. Clean Storage Area 72 Place all clean and bagged or covered equipment and supplies in a clean storage area. Organize the equipment storage area to easily identify dated equipment and supplies. Stock early dated items for use first. Keep clean equipment, other than normal floor standing equipment, from resting directly on the floor of the warehouse. Track all supplies and accessories having expiration dates and remove from stock when the expiration date is reached. Staff and Patient Education All employees with exposure to blood borne pathogens shall participate in a training program, conducted by a knowledgeable professional, which covers identification, prevention, and control of infections from blood borne and airborne pathogens. The training program initially occurs upon a staff member’s assignment to tasks with potential exposure, when a change in job assignment leads to potential exposure, and at yearly refresher in-services. Identifying, Tracking and Monitoring Infections Alpine Medical Supply, LLC shall evaluate, report and maintain records of infections among staff personnel as related to the care or service provided. It is the responsibility of the infection control coordinator to monitor staff for infectious conditions and take whatever action is necessary to ensure against cross contamination and to appropriately document any cross contamination incidents. Monitoring the Infection Control Program It is the infection control coordinator’s responsibility to insure that all procedures involving patient and staff infection control are implemented and updated to maintain appropriate care. Infection Control monitoring is part of the QA program under the direction of the infection control coordinator. The infection control coordinator ensures that infection control is being monitored as a part of the QA program at all times. Management requisitions the time, personnel and resources needed to ensure the ongoing effectiveness of implementing and monitoring the infection control program. The infection control coordinator will insure that any new procedures, employee tasks and/or services instituted by Alpine Medical Supply, LLC comply with the Infection Control Program. The infection control coordinator will monitor all incidences of infectious conditions and take appropriate action to control occurrences of nosocomial infections. All such results are presented to the QA Team. 73 Staff not complying with company infection control policies will be counseled and a written warning will be place in their personnel file. Subsequent failure to comply with policy will result in corrective counseling and/or possible termination. 74 IMPROVING ORGANIZATIONAL PERFORMANCE 7.1 Management/Leadership Involvement with QA Alpine Medical Supply, LLC will set goals, formulate plans, and manage processes and resources relative to improving organization performance in all aspects of management and patient services. Management will obtain and utilize appropriate educational opportunities to ensure staffs’ understanding of the concepts and methods involved in performance improvement. Leaders will review as necessary, but not less than annually, the mechanisms for: The improvement process; The systematic assessment of performance; The priorities for organizational improvement; Implementation of improvements based upon assessments; and Maintenance of instituted improvements. Management, in conjunction with appropriate staff members, will identify those processes and activities (high volume, high risk, problem-prone) that most significantly affect patient outcomes. It is also their responsibility to ensure that these processes and activities are continuously and systematically assessed and improved. Management will allocate appropriate resources to organizational improvement, including proper funding, assignment of personnel, and provide and schedule adequate time for involved personnel to participate in the process. Alpine Medical Supply, LLC will educate and train staff in approaches and methods for organizational improvement. The extent and frequency of training will reflect staff needs. Management will analyze and assess staff efforts in performance improvement through discussion, evaluation of results and comparison of findings with established objectives. It is important that the company establish systematic and effective communication between leadership and all members of Alpine Medical Supply, LLC involved with performance improvement activities and results. 7.2 Establishing the Plan To ensure that performance improvement activities are initiated and maintained throughout Alpine Medical Supply, LLC, a planned, systematic and organization wide approach is taken. With input from appropriate staff, management can determine the plan and the approach or methodology to be used in carrying out organizational performance improvement activities. 75 The Performance Improvement Plan is written independently or as part of a broader management plan. The Plan may be expressed verbally (for example, at management and staff meetings) as long as it is communicated to and completely understood throughout Alpine Medical Supply, LLC. Management will seek input from staff in different disciplines, thereby assuring an organization wide assessment of Alpine Medical Supply, LLC. The information obtained will assist the organization to develop a Plan that addresses the following items: The objectives of the performance improvement process; The major processes and functions carried out by Alpine Medical Supply, LLC; The role and responsibility of each level of staff in Performance Improvement Activities; Identification of performance measures within each function; Data collection methodologies; Identification of performance improvement approach or model (if appropriate); and The reporting path for activities. 7.3 Measuring the Results (Data Collection) Alpine Medical Supply, LLC collects appropriate and sufficient data to facilitate the assessment of current levels of performance. Data collection will be ongoing, systematic, uniform and companywide. The item being measured and the reason for the measurement determine the frequency of data collection. Through knowledge gained about the current levels of performance, Alpine Medical Supply, LLC makes informed decisions concerning the need to redesign activities or processes, the degrees of variance in the performance of current processes, the effects of previous improvement activities and additional opportunities for Alpine Medical Supply, LLC‘s improvement. Alpine Medical Supply, LLC will establish a set of performance measures (indicators). These measures will evaluate both processes and outcomes, as well as address aspects related to high volume, high-risk activities and areas prone to problems. Alpine Medical Supply, LLC considers the following nine (9) dimensions of care in developing PI indicators, which assess the degree of success Alpine Medical Supply, LLC has achieved in meeting and responding to the needs, expectations, suggestions, and feedback of clients, staff, and other interested parties: Efficacy Appropriateness Availability Timeliness Effectiveness 76 Continuity Safety Efficiency Respect and caring Alpine Medical Supply, LLC will collect data addressing priority areas identified by Alpine Medical Supply, LLC leadership and areas needed for continuous measurement (high volume, high risk, problem-prone). 7.4 Assessing the Results of the QA Process Data collected during the measurement process of the PI function is systematically analyzed (assessed) to determine the responses or answers to the predetermined performance question(s) that initiated the measurement. The assessment process of Alpine Medical Supply, LLC is designed to convert raw data into useful information, which facilitates the decision making process. This information allows Alpine Medical Supply, LLC to improve the quality of its decisions on issues such as the need to redesign activities or processes, the degree of variance of current processes, the results of previous improvement activities, and opportunities for further improvement. Alpine Medical Supply, LLC will assess the data by using statistical analysis techniques that are selected to reveal trends and variance, as well as other significant information. Included in the assessment comparisons are: The internal stability of measures over time; Organizational results of process measures against current published information (i.e. practice guidelines); and Alpine Medical Supply, LLC results of process measures against those of outside organizations and external databases. An intensive assessment will be initiated when an unacceptable variance has occurred or is thought to be occurring. An intensive assessment will be triggered by: A significant single event; Significant variance of performance compared to that of other organizations; and The organization’s desire to improve existing processes. 7.5 Performance Improvement The results of the measurement and assessment process of the QA function are used to improve the performance of Alpine Medical Supply, LLC in selected dimensions of care and important functions. 77 Alpine Medical Supply, LLC will identify, prioritize and address undesirable variances as well as improvement opportunities. Elements considered in this selection process include: Opportunities to improve in the important function areas. The needs and expectations of clients, staff, and other interested parties. Areas selected as high volume, high risk or problem prone. Areas of quality control. The resources required for the improvement. The mission of Alpine Medical Supply, LLC. The expected impact on relevant dimension(s) of care. The development of performance expectations which result from the activity. The selection of appropriate performance measures for the "new" process. The input of those staff members closest to the area(s) affected by the "new" process. The PI process will always address the plan of action to be taken. As a result of the measurement and assessment actions taken, whether on a trial basis or fully implemented, a determination is made as to the effectiveness of Alpine Medical Supply, LLC in meeting its predetermined expectations. When actions fail to meet predetermined expectations, new actions will be developed. Therefore, the organization will be able to implement all actions found effective. 7.6 Patient Satisfaction In developing indicators, patient satisfaction plays a key role in determining how Alpine Medical Supply, LLC can ascertain, on an ongoing basis, from the patient's perspective, whether the care received meets or exceeds the patient’s expectations, particularly as related to care, courtesy, respect and timeliness. A Customer Satisfaction Survey will be distributed upon set-up of services. Alpine Medical Supply, LLC will conduct surveys on patients who represent a cross-section of the total patient population by means of telephone contact. 78 Information Management 8.1 Information Management Plan Management’s goal is to provide an ongoing focus on the development, execution, follow-up and improvement of Alpine Medical Supply, LLC processes for the management of information, both internal and external that relate to staff disciplines and to the care and services provided. Assignments to monitor particular aspects of information management are directed to the PI committee. Factors to be investigated include, but are not being limited to, the following: The effectiveness of current forms, data storage and retrieval of information; The effectiveness of the chain of command and the internal flow of information between the various disciplines/locations; The methods used to ensure timely receipt of external information related to local, state, and national regulations, modifications in safety or infection control recommendations, clinical procedures, etc.; The methods that ensure transmission of new information to appropriate staff members; Verbal and written admission and ongoing information to patients; and Updating and changing methods for managing information. The information management process ensures those in Alpine Medical Supply, LLC who generates, collect and analyzes data have been trained in the following elements, as appropriate: Security and confidentiality of data; Use of charts, graphs, etc. and methods to transform these into relevant information; Methods of collecting and interpreting data for use in decision making; and Educating and supporting the patient and family members in the transmittal of pertinent information. To assist management and leadership decisions and Alpine Medical Supply, LLC operation, as well as performance improvement and patient care, the information management process will collect, analyze and report on information gathered from these and other sources: Patient records; Safety inspections and records; Infection control records; Equipment maintenance records; Incident and accident records; PI studies and records; 79 Government reports, where applicable; Industry publications: Dealer, HME News, etc.; Participation in Industry Association seminars, meetings, and trade shows: State association meetings and seminars, annual trade show, etc.; and Equipment manufacturer’s recommendations. The primary focus for measuring and monitoring such information is improved flow of information within Alpine Medical Supply, LLC. The monitoring of such information will assist Alpine Medical Supply, LLC in the following ways: Specific determinations relating to financial data including accounts receivable, accounts payable, budget management, fee setting, billing and collection; Hazards, risk management, safety practices and infection control including summaries of deficiencies, problems, recalls, user errors in safety management, fire safety and equipment management; Inventory control, including inventory tracking processes, inventory purchasing processes and preventive maintenance records; and Assessing performance in selected areas through measuring and documenting applicable processes and relating outcomes. 8.2 Documentation Standardization The home equipment care record for each patient utilizes a standardized electronic format documenting all care/service provided and is maintained in a manner that allows pertinent information to be assembled routinely and in a timely manner. All staff and Hospice personnel are responsible for creating and updating patient’s electronic records. Physician Orders The Hospice Organization will maintain all original physician orders. The ordering Hospice agent will acknowledge the existence of a physician order in the electronic chart. File Definition Active files are those belonging to patient’s currently receiving equipment or service from Alpine Medical Supply, LLC. Inactive files are defined as those belonging to patients whose equipment has been discontinued and who have a "zero" balance. Staff Documentation All staff at Alpine Medical Supply, LLC are authorized to make entries into and/or review patient electronic record. 80 When entries are made into patient records, they are authenticated with the signature or initial of the entry maker, the month, day, and year of entry and the current title of the entry maker. 8.3 Record Retention Alpine Medical Supply, LLC shall retain all patient records for those time periods outlined in state and/or Federal regulations. Upon discharge, Alpine Medical Supply, LLC completes all necessary documentation within 30 working days. All patient records are maintained by Alpine Medical Supply, LLC in safe storage. This ensures confidentiality for a period of seven years or longer if dictated by state law. All pediatric patient records are maintained by Alpine Medical Supply, LLC in storage that ensures confidentiality for five years after the patient is 18 years of age or as dictated by state law. 8.4 Record Confidentiality, Security and Integrity Alpine Medical Supply, LLC has in effect reasonable precautions to safeguard the confidentiality, security and integrity of patient's records against loss, defacement, tampering and unauthorized disclosure or use. All staff will be oriented or in-serviced on maintaining patient confidentiality. This will ensure that only those individuals with a need-to-know are provided access to patient files, hard copy or computerized information. All current patient records are kept in an area inaccessible to unauthorized individuals, and at the end of each business day the building and/or the room or rooms containing the patient records are locked. Computer keys and/or passwords are established, maintained and distributed to personnel holding jobs that require computer access. These passwords may be changed whenever password confidentiality has been compromised. Patients are requested to sign a Disclosure of Information form or statement to facilitate release of patient information to designated individuals or agencies. For example: Authorized staff personnel; The attending physician; Medicare/Medicaid and/or intermediaries; Other third-party reimbursement agencies; Family members involved in care/service; and The Joint Commission on Accreditation of Health Care Organizations. Staff will reject requests from others not identified above who do not present evidence of the express written consent of the patient. Nonetheless, records may be released without 81 patient consent in compliance with a valid court order, subpoena or other legally recognized information access procedure. 8.5 Admission Documentation Alpine Medical Supply, LLC maintains a standard to capture patient admission information. Admission documentation shall be detailed and accurate. All staff is responsible for obtaining adequate data from referral sources, the patient and from an on-site survey in order to determine whether the patient does or does not meet the organizations’ admission criteria for care and/or service. Equipment Management Services The Hospice agent, Alpine Medical Supply, LLC designated individual obtains the data necessary to complete the electronic record. 8.6 Transferring and Discharging Patients from Service Alpine Medical Supply, LLC will discontinue service to a patient if one or more of the following criteria are met: Care/service objectives made been met Insufficient funding is available to support continued service Patient declines prescribed service (requires a signed Release of Liability) Patient moves outside of geographical service boundaries Patient is deceased. Alpine Medical Supply, LLC will process and provide the following information: Notify the patient of the impending transfer or discharge along with associated alternatives, arrangements and estimated timetable for transfer/discontinuance of service; Confirm the transfer with the new service provider noting that no transfer is to be made without the consent of the receiving organization; With rental-to-sales transactions, supply the patient with appropriate information relative to equipment operation, warranty, maintenance and repair, including location of services and repair facilities; and 82 Appendix “A” Do Not Use Abbreviations 83 Appendix “B” Medical Device Requirements (Complaint Records for Device Distributors) 21 CFR Sec. 803.18 Medical Device Reporting What are the requirements for establishing and maintaining MDR files or records that apply to me? d)(1) If you are a device distributor, you must establish and maintain device complaint records (files). Your records must contain any incident information, including any written, electronic, or oral communication, either received or generated by you, that alleges deficiencies related to the identity (e.g., labeling), quality, durability, reliability, safety, effectiveness or performance of a device. You must also maintain information about your evaluation of the allegations, if any, in the incident record. You must clearly identify the records as device incident records and file these records by device name. You may maintain these records in written or electronic format. You must back up any file maintained in electronic format. (2) You must retain copies of the required device incident records for a period of 2 years from the date of inclusion of the record in the file or for a period of time equivalent to the expected life of the device, whichever is greater. You must maintain copies of these records for this period even if you no longer distribute the device. (3) You must maintain the device complaint files established under this section at your principal business establishment. If you are also a manufacturer, you may maintain the file at the same location as you maintain your complaint file under part 820 of this chapter. You must permit any authorized FDA employee, at all reasonable times, to access, to copy, and to verify the records required by this part. 21 CFR Sec. 820.198 Complaint files. (e) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include: The record of the investigation shall include: (1) The name of the device; (2) The date the complaint was received; (3) Any device identification(s) and control number(s) used; (4) The name, address, and phone number of the complainant; (5) The nature and details of the complaint; (6) The dates and results of the investigation; (7) Any corrective action taken; and (8) Any reply to the complainant. 84 Appendix “C” Sentinel Event Policy Any sentinel event occurring at Alpine Medical Supply, LLC will be investigated and reported according to the standard procedure outlined below. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) defines a sentinel event as an unexpected occurrence that involves death, serious psychological or physical injury, or risk thereof. Serious injury includes loss of limb or function. Risk thereof includes any process for which a recurrence would carry a significant chance of serious adverse outcome. Alpine Medical Supply, LLC will follow the below procedures: Sentinel events are too reported to the following: the insurance carrier Alpine Medical Supply, LLC, the Food and Drug Administration (when applicable), legal counsel and local authorities (when applicable). Reporting to JCAHO is the decision of the President, CEO of Alpine Medical Supply, LLC and legal counsel. Reporting is to occur as soon as possible, but no later than five business days after the event of five business days after Alpine Medical Supply, LLC became aware of the event. All sentinel events will be investigated and a root cause analysis will be completed by the President, CEO and/or designee with input from staff and the Performance Improvement Committee as appropriate to the event. The root cause analysis is to be completed within 45 days of the event. The root cause analysis that is conducted will focus on systems and processes, including special causes and common causes as appropriate to the event. The analysis will include recommendations for changes in systems or processes to reduce the risk of re-occurrence of the event in the future. The President, CEO and/or designee is responsible for implementing the recommendations. Actions taken will be evaluated periodically by Alpine Medical Supply, LLC as appropriate for the situation to assess the effectiveness of the actions. All inquires, including media inquiries, relative to sentinel events are to be handled by the office of the CEO, CFO or designee and/or legal counsel. 85 Appendix “D” 1.43 Mechanical “Home” Ventilator Set-up Procedure: 1. Clinical associate will deliver to the patient the appropriate equipment and supplies. The correct ventilator will be provided to meet the ventilator needs of the patient as ordered by the physician. 2. Clinical associate will ensure that the equipment selected is clean and functions 3. To provide the appropriate equipment ordered the clinician will need to gather the following information before discharge: a. Ventilator -type (brand) -times on and off ventilator -oxygen needs -mode of ventilation -respiratory rate -tidal volume -flow rate -PEEP -alarm settings -back-up ventilator should be available b. Ventilator accessories -ventilator breathing circuits -filters -humidification unit -in-line thermometer -PEEP valve -back-up external battery properly. c. Other ancillary equipment: such as oxygen and suction units 4. Clinical associate will instruct the patient/caregiver in the use of all the prescribed equipment and supplies in the home before the patient is discharged. The clinician will assist the patient’s caregivers to ensure that they obtain practical experience in setting up and checking out ventilator equipment. The clinician will ensure that the care givers understand: - principles of home ventilation therapy - hazards and safety issues related to the equipment -operation of all the equipment -the placement of equipment in the home -maintenance and cleaning filters -common problems and trouble shooting 86 -how to assemble circuits -infection control: cleaning and changing schedule of disposable items -the use of the emergency back up equipment: external battery -who to contact in the event of an emergency -regular and after hour phone numbers 6. The clinical staff will work with the caregivers in setting up a reorder levels for all supplies and notifying the local power company, phone company, and emergency medical service that there is a ventilator-assisted patient at home. 7. The organization will provide appropriate backup systems for the patient based on the number of hours of use per day. The backup system will consist of back-up ventilator with external battery, battery powered suction unit and a high pressure cylinder of compressed oxygen. 8. Clinical associate will ask patient/caregiver for return demonstrations on the use of all the equipment to evaluate need for on-going education. 9. Clinical associate will review the following documents with the patient/caregiver: -patient welcome packet -No Smoking sign -oxygen safety statement -environmental assessment 87
