Initial Comments:
Based on the findings of an on-site unannounced recertification survey completed on November 8, 2021, Upper Allegheny Medical Center, Port Allegany, was found to be in compliance with the following requirement(s) 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 November 8, 2021, Upper Allegheny Medical Center was found not to be in compliance with the following requirement of 42 CFR, Part 405, Subpart X and 42 CFR 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
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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;
Observations:
Based on observations, a review of facility documentation, a review of facility policy, and staff interviews, it was determined the rural health clinic failed to ensure preventative maintenance (PM) was performed on electrical/electronic equipment per facility policy and procedure.
Review of clinic policy: " ELECTRICAL/ELECTRONIC EQUIPMENT INSPECTION ... ALL PATIENT CARE EQUIPMENT IS INSPECTED ANNUALLY BY A QUALIFIED BIO-MEDICAL TECHNICIAN WHO AFFIXED AN INSPECTION STICKER TO EACH ITEM AND COMPLETES AN INSPECTION RECORD WHICH IS RETAINED ON FILE. THE AUDIOMETER, CENTRIFUGE, AND EKG UNIT ARE CALIBRATED AT THIS TIME ... IF EQUIPMENT IS IN NEED OF REPAIR, APPROPRIATE STEPS WILL BE TAKEN TO HAVE EQUIPMENT REPAIRED. "
Findings:
Observation of exam room #1 at approximately 10:25 a.m. revealed:
1 (one) EKG machine labeled with PM ISS solutions control #050241914 on free standing cart with wheels.
1 (one) Welch Allyn wall mounted otoscope/ophthalmoscope model 74710, PM ISS solutions control #050005155.
1 (one) Prestige Medical countertop (sterilizer) autoclave 2100 classic unit PM ISS solutions control #050005153.
1 (one) Birtcher, wall mounted cauterizer (hyfrecator) equipment Model 732, serial # B22525 labeled with PM ISS solutions control #050005154.
All the above equipment observed in exam room #1 displayed the date of the last inspection that was performed on 7/2018 and the due date for next inspection of 7/2019 on the affixed ISS solution labels.
Observation of equipment in the hallway (between exam room #1 and exam room #2) revealed:
A free-standing floor scale manufactured by Detecto Model # 6850, serial #8906-96 labeled with PM ISS Solutions control #050005158 denoting last inspection of equipment dated 7/2018 and due date for next inspection of 7/2019.
Observation of exam room #2 at approximately 10:15 a.m. revealed:
A Welch Allyn wall mounted otoscope/ophthalmoscope model 76710 labeled with PM ISS Solutions label control #050005159. The above equipment displayed the date the last inspection was performed dated 7/2018 and due date for next inspection of 7/2019.
Observation of exam room #3 at approximately 12:25 p.m. revealed:
A Welch Allyn wall mounted otoscope/ophthalmoscope model 76710 labeled with PM ISS Solutions label with control #050005162. The above equipment displayed the date the last inspection was performed dated 7/2018 and due date for next inspection of 7/2019.
Observation of exam room #4 at approximately 9:55 a.m. revealed:
A Welch Allyn wall mounted otoscope/ophthalmoscope 74710 labeled with PM ISS Solutions control #050005169. The above equipment displayed the date the last inspection was performed dated 7/2018 and due date for next inspection of 7/2019.
Observation of exam room #5 at approximately 9:45 a.m. revealed:
A Welch Allyn wall mounted otoscope/ophthalmoscope model 74710 labeled with PM ISS Solutions control #050005171. The above equipment displayed the date the last inspection was performed dated 7/2018 and due date for next inspection of 7/2019.
Observation of exam room #6 at approximately 9:35 a.m. revealed:
A Welch Allyn wall mounted otoscope/ophthalmoscope model 74710 labeled with PM ISS Solutions control #050005173. The above equipment displayed the date the last inspection was performed dated 7/2018 and due date for next inspection of 7/2019.
Observation of Lab room at approximately 10:05 a.m. revealed:
A centrifuge labeled with PM ISS Solutions label with control # 050241913. The above equipment displayed the date the last inspection was performed dated 7/2018 and due date for next inspection of 7/2019.
Interview with EMP #2 on November 8, 2021 at approximately 1 p.m. confirmed the above findings related to PM of equipment being overdue. " I knew that we did not have the equipment serviced since 2018 and will bring it to the attention of the medical director/doctor again. I know it needs done yearly. "
Plan of Correction:To ensure that all essential medical equipment is maintained in safe operAting condition,the center supervisor will contact and establish inspection/callibration of equipment by a biomedical technician now and annually thereafter.The equipment will be repaired/replaced if necessary.
The medical director will conduct an inservice to review the policy with the patient care staff.
A quality assurance plan will be set up and performed monthly after the inspection
then quarterly thereafter under the direction of the center supervisor.
THIS WILL BE COMPLETED BY 12/16/2021.
491.9(b)(3)(iii) STANDARD
PROVISION OF SERVICES
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491.9(b) Patient care policies.
(3) The policies include:
(iii) Rules for the storage, handling, and administration of drugs and biologicals.
Observations:
Based on a review of clinic policy and procedure, observation, and interview with staff (EMP), it was determined the clinic failed to ensure proper storage and handling of vaccinations for patient use.
Review of clinic policy on November 8, 2021, at approximately 3:00 p.m. revealed: " Policy: ROUTINE VACCINATION STORAGE ...2. TEMPERATURES OF THE REFRIGERATOR AND/OR FREEZER WILL BE MONITORED TWICE DAILY (EARLY AM AND LATE PM) AND THEN RECORDED ON APPROPRIATE FORM - FOR TEMPERATURES THAT ARE FOUND TO BE OUT OF RANGE, A NOTIFICATION IS TO BE MADE TO DOH FOR FURTHER INSTRUCTION ...5. REVIEW FOR OUT-OF-RANGE TEMPERATURES EACH MONDAY ON THE ELECTRIC THERMOMETER FOR " WEEKEND,HOLIDAY OBSERVATION " .
Findings include:
Observation of storage/sample medication room on November 8, 2021, at approximately 9:30 a.m. revealed:
A refrigerator for " personal/private/employee " use containing food and beverages, without a temperature log or thermometer present, also contained the following medications in the bottom drawer on left side:
6 (six) unopened boxes of multi-dose injection influenza vaccine vials manufactured by Seqirus with expiration year date of 2022.
4 (four) unopened boxes of regen-cov. manufactured by Regeneron Pharm (for injection use) with expiration year date 2023.
Interview with EMP #2 on November 8, 2021 at approximately 10:50 a.m. confirmed the above findings. " We store them in that refrigerator to avoid overcrowding of the medication refrigerator. It is small and we are going to order new refrigerators that are larger. "
Plan of Correction:TO ENSURE PROPER STORAGE OF MEDICATION/VACCINE,CENTER SUPERVISOR MOVED VACCINE TO MEDICATION REFRIGERATOR WHERE TEMPERATURES ARE MONITORED TWICE DAILY PER POLICY.CENTER SUPERVISOR WILL REVIEW POLICY FOR VACCINE STORAGE.
MEDICAL DIRECTOR WILL INSERVICE THOSE THAT HANDLE MEDICINE(NURSES) ON POLICY. NEW NURSES WILL BE INSERVICED ON POLICY DURING EMPLOYEE ORIENTATION.
A QUALITY ASSURANCE PROGRAM WILL BE CREATED TO MONITOR THAT MEDICINE IS STORED PROPERLY AND TEMPERATURES ARE MONITORED REGULARLY PER POLICY. QA WILL BE DONE MONTHLY X2 THEN QUARTERLY AFTER INSERVICE.
THE POC WILL BE COMPLETED 12/16/2021.
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