Initial Comments:
Based on the findings of an on site unannounced recertification survey completed on 2/27/19, Penn Highlands Brookville Family Practice New Bethlehem was found to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 491.12, Subpart A, Conditions for Certification: Rural Health Clinics - Emergency Preparedness.
Plan of Correction:
491.12(b)(1) STANDARD
Policies for Evac. and Primary/Alt. Comm.
Name - Component - 00
§403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2)
[(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:]
[(3) or (1), (2), (6)] Safe evacuation from the [facility], which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance.
*[For RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):]
Safe evacuation from the [RNHCI or ASC or REHs] which includes the following:
(i) Consideration of care needs of evacuees.
(ii) Staff responsibilities.
(iii) Transportation.
(iv) Identification of evacuation location(s).
(v) Primary and alternate means of communication with external sources of assistance.
* [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):]
Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients.
* [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients.
Observations:
Based on observation, review of agency documentation and interview with staff, it was determined that the clinic failed to have exit signs located within the clinic suite which identified appropriate exits.
Findings included:
Observation during the initial tour of the clinic on 2/25/2019 at approximately 9:45 AM revealed there were no exit signs identifying either primary or alternative exits locations within the clinic suite.
Review of the clinic's evacuation route document on 2/25/2019 at approximately 10:00 AM identified three possible evacuation routes from within the suite.
Interview with the clinic director on 2/25/2019 @ approximately 10:30 AM confirmed the absence of exit signage in the suite.
Plan of Correction:Practice Director submitted work order to maintenance on 2/27/19 to install three (3) lighted exit signs in the identified locations.
Exit signs will be installed by 3/29/19.
Ongoing compliance/monitoring: The Director will verify and document on the RHC Compliance Checklist that appropriate exit signs are present and operating. The RHC Compliance Checklist will be presented to the Professional Advisory Committee on an annual basis.
491.12(d)(2) STANDARD
EP Testing Requirements
Name - Component - 00
§416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2).
*[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]:
(2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following:
(i) Participate in a full-scale exercise that is community-based every 2 years; or
(A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or
(B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed.
*[For Hospices at 418.113(d):]
(2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following:
(i) Participate in a full-scale exercise that is community based every 2 years; or
(A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or
(B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or
(B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed.
*[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):]
(2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or
(B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed.
*[For PACE at §460.84(d):]
(2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or
(B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed.
*[For LTC Facilities at §483.73(d):]
(2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise.
(B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed.
*[For ICF/IIDs at §483.475(d)]:
(2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or.
(B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed.
*[For HHAs at §484.102]
(d)(2) Testing. The HHA must conduct exercises to test the emergency plan at
least annually. The HHA must do the following:
(i) Participate in a full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or.
(B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed.
*[For OPOs at §486.360]
(d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following:
(i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event.
(ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed.
*[ RNCHIs at §403.748]:
(d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following:
(i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed.
Observations:
Based on a review of the clinic's emergency preparedness plan and staff interview (EMP), the clinic failed to conduct a community based or individual, facility based exercise in order to determine the effectiveness of the emergency plan and revise the plan as needed.
Findings Included:
A review of the clinic's emergency preparedness plan conducted on 1/25/19 at approximately 12:45 p.m. failed to reveal documentation that any community based or individual based drills were ever conducted to evaluate the effectiveness of the emergency plan developed by the clinic.
An interview with EMP1 and EMP2 on 2/26/19 at approximately 1:00 p.m. confirmed the findings. EMP2 provided this surveyor with documentation to show that the staff at the clinic were all trained on emergency procedures, but was unable to provide documentation that any actual drills were conducted to include an after action report to determine the effectiveness of the training. EMP1 confirmed stating "we have not participated in any drills".
Plan of Correction:The facility will participate in both a community based and table top exercise before 3/29/19. The Penn Highlands Emergency Management Coordinator or other qualified designee will facilitate these exercises. Clarion County emergency management coordinator and New Bethlehem fire department Chief have been contacted.
After each testing exercise the clinic will analyze the response, identify areas for improvement and update the EOP, if required. The after test evaluation will be conducted by Penn Highlands Emergency Management Coordinator or other qualified designee, Practice Director and clinic staff and will be completed by 3/29/19.
The EOP will be updated to include RHC EOP testing and evaluation requirements by the PH Emergency Management Coordinator and Practice Director before 3/29/19.
Ongoing compliance/monitoring: The EOP, testing exercises and exercise after evaluation will be reviewed annually by the Professional Advisory Committee and documented in the meeting minutes.
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed 2/27/19, Penn Highlands Brookville Family Practice New Bethlehem was found to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 405, Subpart X and 42 CFR, Part 491.1 - 491.12, Subpart A, Conditions for Certification: Rural Health Clinics.
Plan of Correction:
491.8(b)(3) STANDARD
PHYSICIAN RESPONSIBILITIES
Name - Component - 00
(3) Periodically reviews the clinic's ... patient records, provides medical orders, and provides medical care services to the patients of the clinic ... .
Observations:
Based on review of the clinic policy and procedure, the clinic annual evaluation, and staff interview (EMP) the clinic failed to ensure the physician performed and documented periodic reviews of patient clinical records cared for by mid-level providers.
Findings Included:
A review of agency policy and procedure, conducted on 2/27/19 at approximately 9:30 a.m. revealed "... TITLE: ... ADVANCED PRACTICE PROFESSIONALS CREDENTIALING AND PRIVILEGING POLICY AND PROCEDURE ... 10. Submits ... five (5) completed performance evaluation forms ... every twelve months ... The evaluation forms are to be signed and dated by the sponsoring Medical Staff member. ... ."
A review of the Clinic's "PROFESSIONAL PRACTICE/QUALITY ASSURANCE ADVISORY BOARD ANNUAL EVALUATION" Dated 5/16/18 revealed " ... ACTIVE AND CLOSED MEDICAL CHARTS A sample of open/closed medical charts were reviewed ... Overall the records were found to be in generally good order. Progress notes and medication lists were up to date. All charts were found to be in good order and the results of laboratory work, radiology, and consultations were recorded accordingly. ... ."
During an interview on 1/26/19 at approximately 9:23 a.m., this surveyor asked EMP1 to provide a list of open and closed charts that were audited over the past twelve months as well as the corresponding data to support the findings of the aforementioned annual review. EMP1 stated "The physician reviews charts but doesn't sign off on any". EMP1 confirmed that the agency did not have any way to track which charts were being audited by the physician stating "we are going to start a new process where reviewed notes are approved and signed off". When asked what was the agency policy on the number of charts reviewed, EMP1 stated "10 per year".
Plan of Correction:The Director and Medical Director will develop a chart audit tool and policy that will outline the process for the physician and APP to periodically review the patient records by 3/15/19.
This policy will also require that the patient record review be presented and reviewed by the Professional Advisory Committee on an annual basis.
Professional Advisory Committee will review/approve the chart review policy by 3/22/19.
Physician and APP will review and document patient records review by 3/29/19.
Ongoing compliance/monitoring: The RHC Patient Health Record Review policy will require Professional Advisory Committee review of health record audit results on an annual basis. PAC review will be documented in the meeting minutes.
491.9(c)(2) STANDARD
DIRECT SERVICES - LABORATORIES
Name - Component - 00
Laboratory. These requirements apply to RHCs but not ... The RHC provides laboratory services in accordance with part 493 of this chapter, which implements the provisions of section 353 of the Public Health Service Act. The RHC provides basic laboratory services essential to the immediate diagnosis and treatment of the patient, including:
(i) chemical examinations of urine by stick or tablet methods or both (including urine ketones),
(ii) hemoglobin or hematocrit,
(iii) blood glucose;
(iv) examination of stool specimens for occult blood;
(v) pregnancy tests; and
(vi) primary culturing for transmittal to a certified laboratory.
Observations:
Based an a tour of the clinic's laboratory, and staff interview the clinic failed to provide basic laboratory services essential to the immediate diagnosis and treatment of the patient. Specifically, the clinic was unable to provide direct examination of stool specimens for occult blood.
Findings Included:
During a tour of the clinic's laboratory area on 2/25/19 at approximately 9:20 a.m., it was revealed that the clinic utilized the FIT [fecal immunochemical test] to test stool for occult blood [hidden blood]. EMP1 revealed during the tour that the patient would take this test home, collect the sample and then could either deliver it directly to the hospital lab [approximately 15 miles from the clinic] or bring it back to the clinic for the courier to transport to the hospital lab. EMP1 confirmed that the FIT test could not be tested and measured directly at the clinic.
A further interview on 2/26/19 at approximately 12:30 p.m. with EMP1 and EMP2 confirmed the above findings with EMP2 stating that the clinic had changed vendors and that the test they previously used (that allowed for direct examination of the test results at the clinic) was not available from the new vendor so a substitution was made.
Plan of Correction:Staff responsible for processing the onsite occult blood testing results will be trained and competency verified on 3/12/19.
Onsite occult blood testing will commence on 3/15/19.
Ongoing compliance/monitoring: The Director will confirm and document on the RHC Compliance Checklist that occult blood testing is available onsite by reviewing testing logs and verifying that all appropriate supplies are onsite. In addition, the Director will confirm that all appropriate staff have completed a competency for occult blood testing (annual occult blood testing competency required for each person performing this test). Director will report findings and present RHC Compliance Checklist and annual staff occult blood testing competency form at the annual Professional Advisory Committee meeting and document in the meeting minutes.
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