Initial Comments:
Based on the findings of an onsite unannounced recertification survey completed on 11/27/2024, Conemaugh Nason Physician Group was found to have the following standard level deficiency that was determined to be in substantial compliance with the following requirement of 42 CFR, Part 491.12, Subpart A, Conditions for Certification: Rural Health Clinics - Emergency Preparedness.
Plan of Correction:
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 review of emergency operations plan and staff interview (EMP), it was determined that the facility failed to conduct an additional full-scale or tabletop exercise to test the Emergency Preparedness Plan for 2022 and 2023.
Findings included:
Review of facility emergency operation preparedness program on 11/5/2024 at approximately 12:40 PM revealed document, " EMERGENCY PREPAREDNESS PROGRAM ...Policy & procedure Manual EMERGENCY PREPAREDNESS SUMMARY AND RESOURCES ...Training and Testing policy and procedures in accordance with 42 CFR 491.12(d) ...DESCRIPTION ...Establish initial and biennial policy and procedure training for all staff. Establish testing (exercises) annually to include at least one full-scale community-based exercise every other year. Document training and testing activities in accordance with 42 CFR 491.12(d) ...2. TESTING a. Pursuant to 491.12(d)(2)(i), (Agency) will participate in a FULL-SCALE COMMUNITY-BASED EXERCISE biennially, at minimum. Over a period of time, all staff will participate in exercises to ensure adequate exposure to the training and testing program. Testing or exercise scenarios will be based on the clinic ' s Hazard Vulnerability Analysis and varied from year to year ...Pursuant to 491.12 (d)(2) (ii), (Agency) will conduct an ADDITIONAL EXERCISE every other year (between full-scale exercises) that may include: i. A second full-scale exercise that is community-based or facility-based; ii. A tabletop exercise that includes 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 and emergency plan."
Review of facility emergency operation preparedness program on 11/26/2024 at approximately 10:35AM revealed documents:
Tabletop exercise 10/9/2020
Tabletop exercise 1/30/2024
Actual event 3/19/2024
Actual Event 10/24/2024
The agency did not provide documentation of a tabletop, actual emergency or a full-scale community-based exercise being conducted in 2022 or 2023.
An exit interview was conducted with the director of primary care on 11/26/2024 at approximately 2:35 PM which confirmed the findings.
Plan of Correction:Plan to Correct Deficiency: The clinic was cited for failure to conduct additional full-scale or tabletop exercise to test the Emergency Preparedness Plan.
Although an event was recorded for 2024, the interim manager was unable to locate an exercise being conducted in 2022 or 2023. The manager of the clinic during those years had resigned and the interim manager was unable to locate these records.
Procedure for implementing plan: Moving forward, the clinic will establish and conduct exercises annually to include at least one full-scale community-based exercise or facility based functional exercise every two years. Documentation of the training and testing activities will be maintained to be in accordance with RHC regulations and requirements. All of the staff and providers will be made aware of the survey findings and the importance of completing and documenting the required exercises to test the clinic's emergency preparedness plan.
Plan Completion Date: 12/13/2024.
Monitoring procedure to Ensure that the plan is effective: The office manager will ensure that the emergency preparedness training of staff and providers is well documented and demonstrates knowledge of emergency procedures.
Title of staff responsible for implementing: Office manager.
Evidence of Correction documents:A staff meeting was held on 12/13/2024 with all RHC providers and staff in attendance. At this meeting, the results of the survey were discussed which included the lack of documentation of an exercise to test the emergency preparedness plan. The importance of conducting these exercises was discussed as well as the importance of meeting all requirements for a Rural Health Clinic. The plan for ensuring that this plan of correction is carried out to remain in compliance with RHC requirements was discussed with the staff and providers
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed 11/27/2024, Conemaugh Nason Physician Group 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:
491.4 STANDARD
COMPLIANCE WITH FED., STATE & LOCAL LAWS
Name - Component - 00
Standard-level Tag
491.4 Compliance with Federal, State and local laws
The rural health clinic . . . and its staff are in compliance with applicable Federal, State and local laws and regulations.
Observations:
Based on review of Centers for Disease Control and Prevention CDC guidance, agency policy, personnel files (PF) and staff (EMP) interview it was determined the agency failed to ensure an updated education for mycobacterium tuberculosis (TB) at least every twelve (12) months for five (5) of five (5) PFs reviewed who were employed by the agency for at least 12 months (PF1, PF2, PF3 PF4 and PF5).
Finding included:
Review of the Centers for Disease Control and Prevention CDC guidance was conducted on 11/27/2024 at approximately 3:00 PM revealed, "DECEMBER 15, 2023 Clinical Testing Guidance for Tuberculosis: Health Care Personnel...TB screening programs in health care setting, TB screening programs should include anyone working or volunteering in health care settings, including: *Inpatient settings *Outpatient settings...All health care personnel should receive annual TB education. TB education should include: *Information on TB risk factors, *Signs and symptoms of TB disease, and *TB infection control policies and procedures..."
A review of facility policy on 11/26/2024, at approximately 12:30 PM revealed, "Tuberculosis Exposure Control Plan...C. OPTIMUM TB CONTROL PROGRAM FOR ALL HEALTHCARE FACILITIES...2.Scope of MMC Program a. All inpatient and outpatient areas, including off-campus ambulatory care that provides a service and bills under the (Facility) provider number will be covered by this TB Infection Control Program...D. All HCWs should receive baseline TB screening upon hire, using two-step TST to test for infection with M. Tuberculosis...EDUCATION A. The Infection Control, Epidemiology, and Prevention Department will construct and facilitate specific information and training for all employees annually, addressing the occupational hazards and required protective measures for tuberculosis in the health care setting...B. The training program is designed to give employees precise information on the dangers poised by tuberculosis exposure, how the disease is acquired, and how to apply the Centers for Disease Control Prevention Guidelines for protecting themselves from exposure while performing their jobs safely..."
A review of PF1 was conducted on 11/26/2024 at approximately 11:30 AM revealed, date of hire 8/15/2017. Initial TST two step testing was completed on 8/30/2017 and 9/6/2017 with negative results. No documentation was available to verify annual TB education was conducted since 9/6/2017.
A review of PF2 was conducted on 11/26/2024 at approximately 11:43 AM revealed, date of hire 6/1/2023. Initial TST two step testing was completed on 5/5/2023 and 5/14/2023 with negative results. No documentation was available to verify annual TB education was conducted since 5/14/2023.
A review of PF3 was conducted on 11/26/2024 at approximately 11:47 AM revealed, date of hire 10/1/2022. Chest X-ray was completed on 8/22/2022 with negative results. No documentation was available to verify annual TB education was conducted since 8/22/2022.
A review of PF4 was conducted on 11/26/2024 at approximately 11:53 revealed, date of hire 4/25/2022. Initial TST two step testing was completed on 4/11/2022 and 4/20/2022 with negative results. No documentation was available to verify annual TB education was conducted since 4/20/2022.
A review of PF5 was conducted on 11/26/2024 at approximately 12:05 PM revealed, date of hire 12/1/2020. Initial TST two step testing was completed on 12/4/2020 and 12/14/2020 with negative results. No documentation was available to verify annual TB education was conducted since 12/14/2020.
An exit interview was conducted with the director of primary care on 11/26/2024 at approximately 2:35 PM which confirmed the findings.
Plan of Correction:Plan to Correct Deficiency: Based on review of clinic personnel files, it was determined that the clinic failed to ensure that annual education for mycobacterium tuberculosis occurred annually per the Centers for Disease Control and Prevention guidance and facility policy.
Plan to address deficiency and procedure for implementing plan: On 12/13/24 a staff meeting was held that included all clinic personnel including providers. During the meeting, results of the RHC survey were discussed which included a failure to ensure annual TB education. TB education occurred at this meeting. The educational material presented was "Tuberculosis Education for Health Care Personnel" created by the Pennsylvania Department of Health.
Plan Completion Date:12/13/2024
Monitoring Procedure Ensuring Plan is Effective: The Office manager will ensure that TB education is provided annually to all clinic personnel to remain in compliance with CDC recommendations and clinic policies. The office manager will also ensure that the annual education is recorded and kept on file at the clinic.
491.6(b)(2) STANDARD
PHYSICAL PLANT AND ENVIRONMENT
Name - Component - 00
The clinic . . . has a preventive maintenance program to ensure that:
491.6(b)(2) Drugs and biologicals are appropriately stored; and
Observations:
Based on a review of policies/procedures, direct observation (OBV) and staff (EMP) interview the facility failed to ensure that medications were appropriately stored for one (1) of one (1) observation.
Findings include:
A review of clinic policies/procedures was conducted on 11/25/2024, at approximately 2:10 PM revealed "...Drugs and Biological Storage... POLICY/PROCEDURE All drugs and biologicals will be inspected monthly, at a minimum, to verify the Beyond Use Date (BUD). Outdated drugs and biologicals will be disposed of in accordance with instructions issued by the manufacturer or your state...MULTI-DOSE VIAL (MDV) Drugs or medications in a Multi-Dose Vial will follow the Centers for Disease Control and Prevention's 28-day practice. *When a MDV is opened, the individual will label the MDV with: *Initials, *Date opened, and * Date of expiration 28-days from the date opened..."
Facility tour was conducted on 11/25/2024, at approximately 1:55 PM which identified the following medications stored in the medication cabinets that were not correctly labeled:
"NDC 16714-140-01 Triamcinolone Acetonide Injectable Suspension, USP 200 mg per 5ml ...5 mL Multiple-Dose Vial..." A date was on a label "DO NOT USE AFTER Date 12-20-24" Staff initials were not listed on the medication vial or label.
"5 mL Multidose Vial NDC 0009-0306-02 Depo-Medrol..." A date was on a label "DO NOT USE AFTER Date 12-20-24" Staff initials were not listed on the medication vial or label.
An exit interview was conducted with the director of primary care on 11/26/2024 at approximately 2:35 PM which confirmed the findings.
Plan of Correction:Plan to Correct deficiency: The clinic was cited for failure to follow CDC guidelines regarding labeling for Multi-dose vials. During the facility tour, two multi-dose vials were determined to be labeled incorrectly on opening. a 28-day label was on the vials with the date of opening but these vials were not initialed by the staff member. A plan to correct this deficiency has been implemented.
Procedure for implementing Plan: All clinical staff and providers have been educated on the proper labeling of multi-dose vials when they are opened. This labeling includes a 28 day label with a "Do Not Use After" date clearly visible and initialed by staff. Failure to properly label multi-dose vials on opening could result in harm to a patient as well as placing the clinic out of compliance with the CDC and RHC regulations.
Plan completion date: 12/13/2024. An office meeting was held on 12/13/24 with all providers and staff present. RHC deficiencies were discussed during this meeting which included the improper labeling of two multi-dose vials and the importance of correcting this deficiency immediately.
Title of Staff Responsible for Implementing: Office Manager.
In addition to educating staff on proper labeling of MDVs, the office manager will perform spot checks to ensure proper labeling of multi-dose vials. The office manager will also ensure that all new hires are educated on the proper labeling of multi-dose vials.
|