Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted onsite November 5, 2024 and completed offsite on November 8,2024, Conemaugh Physicians Group was identified to have had 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(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 agency policy, emergency operations program and staff (EMP) interview, it was determined that the facility failed to conduct additional full-scale or tabletop exercise to test the Emergency Preparedness Plan.
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) ...Documentation, Facility/organization information. Date of Review and Approval form, HVA-Risk assessments, Training logs, testing/Drill logs, Contact information internally and external with local, state and federal emergency officials or agencies, other facilities, etc. *Starter list* ... "
Review of facility emergency operation preparedness program on 11/5/2024 at approximately 12:40 PM revealed a tabletop document, " EMERGENCY PREPAREDNESS ACTIVATION-EVALUATION FORM Drill (marked) Actual Disaster/Emergency (blank) Date: 2/9/2024 Time: (blank) Type of Disaster: Active Shooter ... "
The agency documentation confirmed a tabletop exercise was conducted on 2/9/2024. During an interview with EMP3 on 11/5/2024 at approximately 1:40 PM prior emergency preparedness documentation could not be located. The agency did not provide documentation of a tabletop, actual emergency or a full-scale community-based exercise being conducted in 2021, 2022 or 2023.
Exit Interview with Office Coordinator on November 8, 2024 at 2:30pm confirmed 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 exercise was conducted on 2/9/24, the manager was unable to locate an exercise being conducted in 2021, 2022, or 2023. This RHC had a different manager during these years and the current manager was not able to locate her 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 every other year. 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: 11/19/2024
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: The minutes of a staff meeting held on 11/19/24 are shown below. At this meeting the results of the survey were discussed and the lack of documentation of an exercise to test the emergency preparedness plan was not produced. The importance of conducting these exercises was discussed as well as the importance of meeting the requirements for a Rural Health clinic
meeting minutes:
CPG Davidsville RHC
Staff Meeting 11/19/2024
RHC survey Results
An onsite unannounced Medicare recertification survey was conducted on November 5, 2024.
During the survey, the office was identified as having the following deficiencies.
1. The clinic was unable to provide documentation of a tabletop, actual emergency or a full-scale community exercise being conducted in 2021, 2022, or 2023 which is not in compliance with the RHCs emergency preparedness certification. Although we cannot correct mistakes of the past, these exercises will be completed moving forward to remain in compliance.
2. The clinic failed to ensure that all essential mechanical, electrical and patient-care equipment is maintained in safe operating condition. An EKG machine located in the lab had an inspection sticker on the machine indicating inspection due 2024 thus failing to meet this requirement. To prevent any future occurrences, in addition to the annual inspection by the biomed department, a designated person will also spot check the equipment quarterly and report audit finding to the manager to ensure that no equipment is missed.
3. An audit of the medication samples in the clinic resulted in the discovery of Synthroid and Soliqua samples that had expired. Failure to dispose of medications that have expired puts patients at risk for receiving ineffective or harmful treatments and the clinic out of compliance with the Medicare requirements. An audit of all samples will occur monthly. This audit will be performed by a staff member that has been assigned by the manager and will report their findings to the manager and remove any items that have expired. The manager will also perform random spot checks to ensure that this process is being carried out correctly and efficiently.
In order to provide the best possible care to our patients, we must remain in compliance with all requirements for a Rural Health Clinic as set forth by the Pennsylvania Department of Health
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted onsite November 5, 2024 and completed offsite on November 8,2024, Conemaugh Physicians Group was identified to have had the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42CFR, Part 405, Subpart X and 42CFR Part 491.1-491.11 Subpart A, Conditions for Certification: Rural Health Clinics.
Plan of Correction:
491.6(b) and (b)(1) STANDARD
PHYSICAL PLANT AND ENVIRONMENT
Name - Component - 00
491.6(b) Maintenance:
The clinic . . . has a preventive maintenance program to ensure that:
(1) All essential mechanical, electrical and patient-care equipment is maintained in safe operating condition;
Observations:
Based on a review of clinic policies/procedures and observation, the clinic failed to ensure that all essential mechanical, electrical and patient-care equipment is maintained in safe operating condition.
Findings include:
A review of clinic policies/procedures was conducted on November 5, 2024 at approximately 2:45pm revealed " ... Preventative Maintenance Program... POLICY/PROCEDURE Clinical equipment, defined as al mechanical, electrical and patient-care equipment, will be inspected annually, at a minimum, or at a frequency specified by the manufacturer, if different ... "
Facility tour conducted November 5, 2024, at approximately 10:45am identified a Burdick brand Atria 3100 electrocardiogram (ECG) machine located in central laboratory area. Machine labeled with identification number 600642657. Inspection sticker on machine indicated inspection due September 2024. Review of service logs on November 8, 2024 at approximately 1:00pm failed to include ECG machine 600642657 and no additional documentation to confirm inspection.
Exit Interview with Office Coordinator on November 8, 2024, at 2:30pm confirmed findings.
Plan of Correction:Plan to Correct Deficiency: The clinic was cited for failing to ensure that all essential mechanical, electrical and patient-care equipment was maintained in safe operating condition. An ECG machine (ID # 600642657) had an inspection sticker indicating inspection due Sept 2024. The manager stated that this must have been missed during the recent biomed inspections.
Procedure for implementing plan: The biomed department was notified immediately post survey and the ECG machine was put out of use until biomed performed an inspection. The biomed department performed the inspection on 11/21/24 and the equipment was put back in use. The biomed department will continue annual inspections of all essential mechanical, electrical and patient-care equipment.
Plan completion date: 11/21/2024
Monitoring Procedure ensuring plan is effective: The biomed department will continue to inspect all equipment annually. Additionally, the office manager and the biomed department will review the list of equipment to ensure that all equipment is inspected and accounted for. Also, the practice manager will perform spot checks to ensure that all equipment is inspected. The practice manager will also provide at the next scheduled office meeting an update of this item from the survey and well as conduct training to all staff and providers on the need to ensure that all equipment is maintained and inspected on an annual basis
Title of staff responsible for Implementation: Practice Manager
Evidence of Correction Documents: Meetings from the staff meeting held on 11/19/2024 are below:
CPG Davidsville RHC
Staff Meeting 11/19/2024
RHC survey Results
An onsite unannounced Medicare recertification survey was conducted on November 5, 2024.
During the survey, the office was identified as having the following deficiencies.
1. The clinic was unable to provide documentation of a tabletop, actual emergency or a full-scale community exercise being conducted in 2021, 2022, or 2023 which is not in compliance with the RHCs emergency preparedness certification. Although we cannot correct mistakes of the past, these exercises will be completed moving forward to remain in compliance.
2. The clinic failed to ensure that all essential mechanical, electrical and patient-care equipment is maintained in safe operating condition. An EKG machine located in the lab had an inspection sticker on the machine indicating inspection due 2024 thus failing to meet this requirement. To prevent any future occurrences, in addition to the annual inspection by the biomed department, a designated person will also spot check the equipment quarterly and report audit finding to the manager to ensure that no equipment is missed.
3. An audit of the medication samples in the clinic resulted in the discovery of Synthroid and Soliqua samples that had expired. Failure to dispose of medications that have expired puts patients at risk for receiving ineffective or harmful treatments and the clinic out of compliance with the Medicare requirements. An audit of all samples will occur monthly. This audit will be performed by a staff member that has been assigned by the manager and will report their findings to the manager and remove any items that have expired. The manager will also perform random spot checks to ensure that this process is being carried out correctly and efficiently.
In order to provide the best possible care to our patients, we must remain in compliance with all requirements for a Rural Health Clinic as set forth by the Pennsylvania Department of Health
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 clinic policies/procedures and observation, the clinic failed to ensure that drugs were appropriately stored for one (1) of one (1) observation.
Findings include:
A review of clinic policies/procedures was conducted on November 5, 2024, at approximately 2:45pm 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..."
Facility tour conducted November 5, 2024, at approximately 10:45am identified the following expired medications to be stored in the medication cabinets.
2 boxes - Synthroid (levothyroxine sodium tablets) 75mcg - lot 1208372, expiration August 24, 2024
4 boxes - Synthroid (levothyroxine sodium tablets) 88mcg - lot 1209441, expiration September 11, 2024
2 boxes - Synthroid (levothyroxine sodium tablets) 112mcg - lot 1209440, expiration August 29, 2024
4 boxes - Synthroid (levothyroxine sodium tablets) 125mcg - lot 1209556, expiration September 18, 2024
4 boxes - Synthroid (levothyroxine sodium tablets) 137mcg - lot 1208371, expiration August 16, 2024
The following expired medications found to be stored in the medication refrigerator.
2 boxes - SOLIQUA 110/33 (insulin glargine and lixisenatide) injection - lot 3F687A, expiration 8-31-2024
Exit Interview with Office Coordinator on November 8, 2024, at 2:30pm confirmed findings.
Plan of Correction:Plan to Correct Deficiency: The clinic was cited for having medication samples exceeding their beyond use dates (BUD).
The practice manager stated that these must have been overlooked during the clinic review process and in the exit interview on 11/8/24 confirmed the findings
Procedure for implementing plan: The practice manager, or their designee, will complete an audit of all medications on a going forward basis to ensure that all expired items are removed from the clinic. All of the staff and the providers will be made aware of not only the findings of the survey, but also the need to dispose of such items on a timely basis to ensure appropriate care for patients of the clinic
Plan completion date: 11/19/2024
Monitoring Procedure Ensuring Plan is Effective: The practice manager will review the audit records in addition to preforming random spot checks in all areas of the clinic. In addition, the practice manager will also provide at the next scheduled office meeting an update of this item from the survey as well as conduct training to all staff and providers on the need to ensure that all expired medications are removed from the site.
Title of Staff responsible for implementing: Office manager
Evidence of Correction : the minutes of a post survey staff meeting held on 11/19/24 are shown below:
CPG Davidsville RHC
Staff Meeting 11/19/2024
RHC survey Results
An onsite unannounced Medicare recertification survey was conducted on November 5, 2024.
During the survey, the office was identified as having the following deficiencies.
1. The clinic was unable to provide documentation of a tabletop, actual emergency or a full-scale community exercise being conducted in 2021, 2022, or 2023 which is not in compliance with the RHCs emergency preparedness certification. Although we cannot correct mistakes of the past, these exercises will be completed moving forward to remain in compliance.
2. The clinic failed to ensure that all essential mechanical, electrical and patient-care equipment is maintained in safe operating condition. An EKG machine located in the lab had an inspection sticker on the machine indicating inspection due 2024 thus failing to meet this requirement. To prevent any future occurrences, in addition to the annual inspection by the biomed department, a designated person will also spot check the equipment quarterly and report audit finding to the manager to ensure that no equipment is missed.
3. An audit of the medication samples in the clinic resulted in the discovery of Synthroid and Soliqua samples that had expired. Failure to dispose of medications that have expired puts patients at risk for receiving ineffective or harmful treatments and the clinic out of compliance with the Medicare requirements. An audit of all samples will occur monthly. This audit will be performed by a staff member that has been assigned by the manager and will report their findings to the manager and remove any items that have expired. The manager will also perform random spot checks to ensure that this process is being carried out correctly and efficiently.
In order to provide the best possible care to our patients, we must remain in compliance with all requirements for a Rural Health Clinic as set forth by the Pennsylvania Department of Health
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