QA Investigation Results

Pennsylvania Department of Health
Health Inspection Results
Health Inspection Results For:

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Initial Comments:
Based on the findings of an onsite unannounced Medicare Recertification Survey conducted 1/04/2023 through 1/05/2023, Conneaut Lake Health Center was found to be in compliance with the requirements of 42 CFR, Part 491.12, Subpart A, Conditions for Certification: Rural Health Clinics - Emergency Preparedness.

Plan of Correction:

Initial Comments:
Based on the findings of an onsite unannounced Medicare Recertification Survey conducted 1/04/2023 through 1/05/2023, Conneaut Lake Health Center 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:


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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.


Based upon observation, policy and procedure review, and staff (EMP) interview, it was determined that the facility failed to ensure Covid-19 Daily Symptom Screenings were performed per Agency Policy.

Findings Include:

Review of Policy "PANDEMIC Policy-01"on 1/05/2023 at approximately 11:00 a.m. revealed "SUBJECT: Daily Symptom Screenings during COVID-19 Pandemic... PURPOSE: The Pennsylvania Department of Health and OSHA recommends daily symptom screenings for all individuals entering Healthcare areas to aide in infection prevention and control of COVID-19. POLICY: Effective April 13, 2020 (Agency) has implemented mandatory screening questions for all employees... entering (Agency)... Staff are to self-screen and the Employee Logs are kept in their departments."

Review of "Covid-19 Screening Log" on 1/04/2023 at approximately 3:00 p.m. revealed a lapse of recorded Covid-19 Screening data from 12/02/2022 through 1/03/2023. Daily Schedule Data showed that Agency was open and Patients were treated on 12/05/2022, 12/08/2022, 12/14/2022, 12/16/2022, 12/19/2022 - 12/23/2022 & 12/28/2022 - 12/29/2022.

An interview with the EMP1, EMP2 & EMP3 on 1/05/2023 at approximately 2:00 PM confirmed the above findings.

Plan of Correction:

All staff were notified by manager verbally and in writing that they must self-screen as set forth in Pandemic Policy-01 and must maintain a daily log at the clinic until notified by practice manager that there is no longer a policy requiring them to do.

To prevent this from occurring again, staff were advised that they should be reminding their co-workers of this requirement and practice manager will include this policy in training of new staff.

On a weekly basis, practice manager will review the log to ensure it is being completed daily and maintained at the clinic. The administrative manager for the RHC clinics will audit the clinic every six months to ensure that this policy is being followed by all.

491.6(b) and (b)(1) STANDARD

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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;


Based on observation, and staff (EMP) interview, the Agency failed to maintain "Equipment Inventory Report" to include all essential mechanical, electrical and patient-care equipment was maintained and in safe operating condition.

Findings included:

During the initial tour of the facility on 1/04/2023 at approximately 9:15 a.m., Surveyor observed a gage on the wall in the hallway that led to Patient Treatment Rooms. The gage appeared to be utilized in monitoring Negative Pressure in one of the Exam Rooms. On 1/05/2023 at approximately 9:30 a.m. Agency Practice Manager provided a "Equipment Inventory Report".

A review of the "Equipment Inventory Report" was conducted on 1/05/2023 at approximately 1:00 p.m. It was noted that there was no mention of any "Negative Pressure Equipment" or the associated maintenance records.

An interview with EMP1, EMP2 & EMP3 on 1/5/2023 at approximately 2:00 p.m. confirmed the above findings. EMP3 stated "the Biomedical Department Manager was on vacation and that the agency was unable to provide any information about the Manufacturer's recommendations for the Maintenance and safe operation of the Negative Pressure Room equipment utilized at the facility or proof that the equipment had been Evaluated by the Biomedical Engineering Department."

Plan of Correction:

The negative air pressure equipment was installed during the pandemic to create a negative pressure room to safely evaluate patients known to or suspected of having Covid-19. It was designed and installed by a qualified ventilation company, Rabe Environmental from Erie PA.
The negative pressure was validated at the time of installation by the means of an air flow test. In order to ensure that the pressure relationship remains as designed, the MMC facility engineering department has created a preventive maintenance testing process. The motor and fan are self-lubricated and direct drive so no physical maintenance on the equipment is required.
The preventive maintenance validation testing will occur Thursday 1/18/2023. Air exchange testing results will be kept in the facility engineering department's preventive maintenance file and used as the benchmark against future testing. Any degradation to the air changes will be assessed and resolved immediately.