Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on February 22,2023, Armstrong Primary Care Center - South Bethlehem was identified to be in substantial compliance with the following requirements of 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 completed February 22, 2023, Armstrong Primary Care Center - South Bethlehem was found to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirement(s) 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:
491.9(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 review of policies/procedures, observations and interview with the clinic manager (EMP1) the clinic failed to ensure the disposal of expired medications for two (2) of two (2) observations made. OBS #1 and OBS#2.
Findings include:
Review of facility policy #502 title: "use of multi dose medication vials" completed on February 22, 2023 at approximately 10:30 AM revealed: "...All open vials are good for 30 days after they are opened. ... The only exeption to this is if the manufacturer specifies a date less than 30 days for discarding the vial."
OBS #1 conducted on February 22, 2023 at approximately 10:00 AM revealed one (1) vial of IPOL/polio vaccine Lot # U1A452M, serial number: 120H275MVPR81R with manufacturer expiration date of 20Feb2023.
Interview with EMP1 on February 22, 2023 at approximately 10:15 AM confirmed the above findings.
OBS# 2 conducted February 22, 2023 at approximately 10:30 AM revealed the following:
One (1) open vial of Xylocaine with epinephrine 1:100,000 - MDV (multi-dose vial), Lot # 6127967, open date "1-19-23" on label in the patient supply of medication dispensory system for nurse to administer.
Interview with EMP1 on December 12, 2022 at approximately 10:45 AM confirmed the above findings regarding Xylocaine medication. "Our policy is to discard open vials at 30 day mark. That vial should not be in the patient supply of medications."
Plan of Correction:In order to mitigate any further "medication administration" policy violations, the office will order color coded stickers and label all multi-dose vaccine and medications based off of expiration date. There will be a color coded chart added to the already existing log sheet with double staff signoff.
When a multi-dose vial is used, the expiration data will be reassigned using the appropriate color coded sticker and include the revised expiration date following the ACMH policy for multi-dose medication usage and the 30-day expiration date from the date of opening. This will be signed off by two staff members.
Color coded stickers have been ordered and this procedure will be implemented upon delivery, no later than Monday March 27, 2023. The office manager will assure the process is being followed on a weekly basis for a period of three months, then review monthly.
491.10(a)(3)(i)-(iv) STANDARD
PATIENT HEALTH RECORDS
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491.10(a) Records system.
(3) For each patient receiving health care services, the clinic . . .. maintains a record that includes, as applicable:
(i) Identification and social data, evidence of consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient;
(ii) Reports of physical examinations, diagnostic and laboratory test results, and consultative findings;
(iii) All physician's orders, reports of treatments and medications, and other pertinent information necessary to monitor the patient's progress;
(iv) Signatures of the physician or other health care professional.
Observations:
Based on review of Clinical Records (CR), interview with EMP #1 (facility manager) the clinic failed to ensure each record contained the social data documentation of each patient for (five) 5 of 20 records reviewed. (CR #s 13, 14, 18, 19 and 20) and failed to obtain consent from each patient prior to receiving health care services for (two) 2 of 20 clinical records reviewed (CR# 17 and 18).
Findings include:
Review of Medical records completed on February 22, 2023 between approximately 11:00 a.m. and 2:00 p.m. revealed the following:
MR #13, treatment date: 1-3-23, did not contain any documented evidence that social data was obtained by the clinic practitioner.
MR #14, treatment date: 1-9-23, did not contain any documented evidence that social data was obtained by the clinic practitioner.
MR #17, treatment date: 2-1-23, did not contain any documented evidence that consent was obtained by the clinic.
MR #18, treatment date: 1-9-23, did not contain any documented evidence that social data was obtained by the practitioner and did not contain any evidence that consent was obtained by the clinic.
MR #19, treatment date: 1-13-23, did not contain any documented evidence that social data was obtained by the practitioner.
MR #20, treatment date: 1-2023, did not contain any documented evidence that social data was obtained by the practitioner.
An interview completed with EMP #1 the facility manager on February 22, 2023 at approximately 3:30 PM confirmed the above findings.
Plan of Correction:Social Data: The users for these records failed to "verify" the social data section to pull the information into the progress note. These users are newer staff members. Due to this finding, staff reeducation in the South Bethlehem office took place on March 9, 2023 to ensure all users follow the verification process. This will also be discussed at the next office managers meeting on March 16, 2023 so the managers can relay this importance of the verification to their respective offices. Subsequently, office manager will spot check patient charts to ensure information is being verified and pulling over to the progress note. Spot checks will be done weekly for a period of 30 days, then monthly thereafter.
Consent: During COVID, staff signed the consent form after obtaining verbal patient consent to decrease high touch points. Outpatient offices were not included in the follow-up communication that ACMH hospital was moving back to the "pre-covid" consent process where patients physically sign the consent form. As a result of this finding, the breakdown in communication from ACMH hospital to the outpatient offices has been corrected. When there is a policy change, the communication from ACMH will now include the Director of Physician Practices to disseminate to the office managers and staff. The current and updated consent policy was distributed to the office managers on February 23, 2023 to assure all offices had the correct and updated information. Office policies will be reviewed annually with all office coordinators and/or anytime there is a change in policy.
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