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The Survey Process: Certification and Recertification of Rural Health Clinics Sandy Canally, RN, Founder and President Kate Hill, RN, Director of Clinical Services ICAHN Webinar August 11, 2014 “Every patient deserves exemplary care.” The provider must focuses on what matters most to Patients ….. safety, honesty & caring™ RHC Compliance All RHC’s must be in compliance with: Conditions for Certification and also: OSHA FDA DEA CDC CLIA Office of the Inspector General (OIG) As well as local, State and Federal Regulations Operational Excellence leads to Clinical Excellence! In order to manage all that, we need to focus on Day-to-Day operations. RHC STANDARDS Universal Standards CORPORATE COMPLIANCE ADMINISTRATION BILLING HUMAN RESOURCES QUALITY IMPROVEMENT RISK MANAGEMENT RHC STANDARDS Specialty Standards EQUIPMENT MANAGEMENT INFECTION CONTROL PATIENT SERVICES PHARMACEUTICAL SERVICES DIAGNOSTIC SERVICES GOVERNMENT/REGULATORY RHC certification must be done by a CMS approved accreditation organization (AO) The Compliance Team was approved on July 18, 2014. The AO’s Standards must meet or exceed CMS Conditions for Certification. CMS RECENT CHANGES 491.2 The definition of “physician” has been revised to include a doctor of dental surgery or dental medicine, a doctor of podiatry or surgical chiropody, with the limitations of services these types of physicians are permitted to offer under Section 1861(r) of the Social Security Act. However, it continues to be the case that only MDs or Dos may fulfill the requirements for supervision, collaboration and oversight of non-physician practioners in an RHC or FQHC. 491.8(a)(3) was revised to permit an RHC to have a nurse practitioner or physician assistant provide services under contract to the RHC, so long as the RHC has at least one employee who is a nurse practitioner or physician assistant. (effective July 1, 2014) CMS RECENT CHANGES Changes continued: 491.8(a)(6) was revised for RHCs that a nurse practitioner, physician assistant or certified nurse-midwife is available to furnish patient care services at least 50% of the time the RHC operates. This aligns the regulatory language with the current statutory requirement. Note that since the statutory provision was self-implementing, CMS has enforced the 50% standard standard even prior to this regulation change. 491.8(b) has been revised to delete the requirement formerly at 491.8(b)(2) for a physician to be present in the RHC or FQHC at least once every two weeks. This recognizes that many of the physician’s required functions may be performed remotely via electronic means, but does not remove the requirement that a practioner, whether a physician or nonphysician practitioner, must be present at all times the RHC or FQHC operates. (effective July 11, 2014) Survey Process: Overview Meet with the management staff and providers Tour the facility Observe infection control practices Inspect medicine/supplies storage area Inspect exam rooms Interview staff members conducted throughout the day Interview two or three patients throughout the day Wrap-up conference Survey Process: Corporate Compliance Evidence of Compliance Disclosure of ownership Free from Medicare sanctions – OIG exclusion list Standards of conduct Fraud and abuse policy License verification process Training of employees, specifics of what is involved and documentation in personnel file Common Deficiency: No signed standards of conduct Survey Process: It starts in the parking lot! Common Deficiency: Hours not posted. Survey Process: The waiting room Common Deficiencies: Toys which cannot be disinfected, no child proof plugs Survey Process: Patient Rooms Common Deficiencies: No red bags in treatment room Lack of knowledge of “wet” time for the disinfectant Survey Process: Administration Evidence of Compliance: Location is in a shortage area. Organized governing body Organizational chart P & P regarding who is in charge on a day to day basis Medical Director provides oversight and does chart review NP, PA or MD furnishes care at all times during posted hours Policy for referring patients Policy for maintaining patient health records with designated oversight person Evidence that records are maintained for at least 6 years Common deficiency: No evidence of MD chart review Limited follow up for referrals Survey Process: Administration Patient records: Identification and social data Consent forms Medical history Assessment of health care status Summary of episode Report of exams, diagnostic tests, lab results and general findings All physicians orders Signature of clinician Evidence of patient chart audit Common Deficiency: Incomplete Medical History Unsigned lab reports Survey Process: Administration Evidence of Compliance continued… Evidence of emergency treatment as needed Evidence of safety of patients in a non-medical emergency Emergency medication box Training staff in handling emergencies Lighted exit signs at appropriate locations Preventative maintenance program Equipment in safe operating condition Premises are clean and orderly Common Deficiency: Equipment not inspected/calibrated yearly Provider based clinic’s emergency box is inadequate Survey Process: Human Resources Evidence of Compliance: HR policy which specifies personnel qualifications, training, experience and continuing education. Training documentation & competency updated annually. Job responsibilities in personnel files and signed. Files on all employees and independent contractors: • W4, I9, Application, Resume, References • Health status letter • Signed job description, signed standard of conduct • Proof of verification of license and copy of that license Common deficiencies: Staff training not documented, I9 is not complete, No job descriptions Survey Process: Quality Improvement Evidence of Compliance: Written Quality Improvement Plan Plan for new services or locations Goals for improving patient outcomes Operational areas in need of improvement Monitoring staff development Fraud awareness and prevention Results of patient chart audit Evidence of quarterly QI/staff meeting Common deficiency: no evidence of QI/staff meeting Survey Process: Quality Improvement Evidence of Compliance: Evidence that the QI plan is reviewed on an annual basis Evidence of data collected regarding patient satisfaction survey form Process for reviewing the responses and addressing issues Evidence of claim monitoring and quarterly audit of same Improving Quality Through Measurement 1 • Consider calling patients vs. mailing. 2 • Focus on questions on what matter to patients. 3 • Data collection efforts send a POWERFUL message to patients that you care. Survey Process: Annual Meeting Evidence of Compliance: Evidence of Annual program evaluation meeting Evaluation performed by the clinic, professional personnel One member not a member of the clinic staff Must include: UR of all services Clinic overall organization Review of active policies for admin, personnel, fiscal areas Number of patients served Review of open and closed patient records Review of all policies affecting patient care Guidelines for medical management of health problems Common Deficiency: Incomplete documentation Policy review does not include NP or PA Survey Process: Annual Meeting cont.… Evidence of Compliance: Evaluation results used to determine: Was our utilization of services appropriate? Were we consistent? Were our policies followed? What changes are needed? What follow up is needed to assure and maintain change? Survey Process: Risk Management Evidence of Compliance: Incidents incident reports documentation of resolution corrective action taken safe of work environment Common Deficiency: Lack of follow up on incidents Survey Process: Risk continued Evidence of Compliance: Process for handling product hazards, defects or recalls List of all equipment by manufacturer, model and serial number Process exists for tracking preventative maintenance due dates Oxygen: Written policy for oxygen handling and recalls Cylinder log Full tanks are separate from empty or partially full Tanks are checked and labeled Common Deficiency: No patient ready oxygen tank i.e. no cannula or mask nearby Survey Process: Risk continued Common Deficiency: Inappropriate storage of oxygen Survey Process: Equipment Management Evidence of Compliance Written equipment management policy Equipment organized, labeled, tested Clean/dirty areas clearly labeled and equipment separated Equipment off the floor Written cleaning policies and procedures Equipment cleaned, disinfected prior to each patient’s use MSDS sheets, manufacture guidelines and manuals Equipment testing log and or checklist Common Deficiency: Equipment cannot be identified as clean or dirty Survey Process: Equipment Management Common Deficiency: No sticker for annual calibration or sticker outdated Survey Process: Infection Control Evidence of Compliance Infection control policy: Hand washing issues (sinks, alcohol based gels, signs) Utilization of gloves Universal precautions and documented training Handling and disposal of infectious waste Preventing cross contamination Patient and care-giver education Expired packaging of sterilized instruments or suture material Instruments open when being sterilized Common Deficiency: No expiration date on sterilized instruments Survey Process: Infection Control Common deficiencies: Instruments are sterilized closed. Date on the package: processing date or the expiration date? What does this manufacturer say about length of time? Survey Process: Infection Control Common Deficiency: No longer a non-porous surface for disinfecting Survey Process: Patient Services Evidence of Compliance Complete patient care policy Written information given to all patients at first appointment Rights and responsibilities List and description of services provided List of services by arrangement, agreement or referral posted Employee documentation of patient care policies Process for handling patient grievances handled within 7 days Common Deficiency: Rights and responsibilities not given to patients nor posted. Survey Process: Patient Services cont.. Evidence of Compliance Scope of treatment by an NP, PA, CNM Policy for oversight of NP,PA, CNM MD/PA/NP Collaborative agreement Guidelines for medical management, incl. what requires referral Criteria for diagnosing and treating various health conditions Follow up process Common Deficiency: Collaborative agreement is more than one year old Survey Process: Pharmaceutical Management Evidence of Compliance Pharmaceutical policy Records of the receipt and disposition of all scheduled drugs Process for complete and legible labeling Drug reference and antidote info available Drugs in cabinets are within-date Refrigerated drugs properly stored and at the right temperature All schedule II drugs are double locked Common Deficiency: Out-dated sample medications Survey Process: Pharmaceutical Management Common Deficiencies: Expired medications Survey Process: Pharmaceutical Management Common Deficiencies: Temperature log inconsistent and pharmaceuticals in the door No water bottles in dead spaces Survey Process: Diagnostic Services Evidence of Compliance: • Evidence of the following lab services: Urine, ketones Hemoglobin or hematocrit Glucose Pregnancy tests Exam of stool for occult blood Primary culturing for transmit to lab • CLIA license posted and up to date Survey Process: Regulatory Evidence of Compliance: All licenses displayed All exit signs marked and illuminated Fire extinguishers mounted, checked, tagged Evidence of fire safety training Written work exposure plan Hepatitis B vaccinations or declination Personal protective equipment available TB testing Survey Process: Regulatory Evidence of Compliance Evidence of OSHA’s “Right to Know” training in personnel files MSDS sheets filed for all hazardous material in the workplace All mandatory posters posted Organized process for handling an on-site emergency Organized process for handling an off-site emergency Plan for alternative provider if clinic can’t service it’s own patients Evidence of emergency preparedness training in personnel files Survey Process: Postings Common Deficiency: Last year’s postings Survey Process: Common Deficiencies • No preventative maintenance policy • Clinic not under the supervision of an MD or DO • i.e. charts not signed • Policies and procedures are not up to date or non-existent • Medications expired • Staff training not documented • No evidence of annual meeting • No MSDS sheets • Physical plant not clean and orderly • Oxygen not stored safely • BAA (Business Associates Agreements) • Lack of current agreement with Medicare approved hospital Scoring Basics 100 % compliance is necessary for certification and re-certification. Clinic is to receive a Statement of Deficiency within 10 business days. The clinic is to submit a Plan of Correction within 10 calendar days. A revisit is required for condition level deficiencies which must occur within 45 calendar days of the survey date. A revisit is not required for standard level deficiencies, however all must be corrected within 60 calendar days from survey. Thank You Sandy Canally, RN [email protected] Kate Hill, RN [email protected] 215-654-9110 www.thecomplianceteam.org