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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
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CORPORATE COMPLIANCE
ADMINISTRATION
BILLING
HUMAN RESOURCES
QUALITY IMPROVEMENT
RISK MANAGEMENT
RHC STANDARDS
Specialty Standards
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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
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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
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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
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Common deficiency: No evidence of MD chart review
Limited follow up for referrals
Survey Process: Administration
Patient records:
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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…
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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:
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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
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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
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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
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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
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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:
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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
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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