Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on August 18, 2021 through August 19, 2021, Coudersport Family Medicine, was identified to be in 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 August 18, 2021 through August 19, 2021, Coudersport Family Medicine, was identified to have the following standard level deficiency that was 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:
491.6(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 upon observation, policy and procedure review, and interview with the facility practice supervisor and facility administrator, it was determined that the facility failed to ensure proper disposal of expired laboratory supplies for four (4) of four (4) observation made. Observations #1-#4.
Findings include:
An interview with the facility administrator conducted on 08/19/21 at approximately 3:00 PM revealed: administrator stated "I don't think we have a specific policy for that."
1. Observation #1: On 08/18/21 at approximately 2:15 PM, review of Laboratory and supplies revealed the following:
One (1) box of Respiratory Syncytial virus (RSV) Sofia lab testing kits with expiration date of 05/31/21
One (1) box of Strep A Sofia lab testing kits with expiration date of 07/31/21
2. Observation #2: On 08/18/21 at approximately 2:30 PM, review of Laboratory and supplies revealed the following:
Two (2) boxes of Ipratropium Bromide and Albuterol Sulfate inhalation solution with expiration date of 05/22/21. Sixty (60) vials total.
Sixty seven (67) eighteen (18) gauge by one and a half (1.5) inches hypodermic needle Pro Edge safety device with expiration date of 11/20/2020
3. Observation #3: On 08/19/21 at approximately 10:30 AM, review of Pediatric Emergency box revealed the following:
Four (4) eighteen (18) gauge by one and a half (1.5) inches hypodermic needle Pro Edge safety device with expiration date of 11/20/2020
4. Observation #4: On 08/19/21 at approximately 2:30 PM, review of Internal Medicine's laboratory and supplies revealed the following:
Five (5) thirty (30) gauge by a half inch (0.5) Hypodermic needle Pro Edge safety device with expiration date of 06/20/20
An interview conducted on 08/19/21 at approximately 3:15 PM with the Rural Health Center Administrator and Rural Health Center Practice Supervisor confirmed the above findings.
Plan of Correction:Expired items were immediately removed from the patient care area when identified during survey.
Quality Nurse will develop formal procedure for checking areas for soon to expire items. This new procedure will be implemented by 9/30/21. Any supply found during the inspection that will expire before the end of the respective month or month immediately following inspection will be removed from the patient care area and disposed of properly.
The new procedure will reflect the formal procedure of:
1. Each month a designated clinical staff member (RN, LPN or MA) will inspect the storage areas for soon to expire medications and supplies.
2. Any supply found during the inspection that will expire before the end of the respective month or month immediately following inspection will be removed from the patient care area and disposed of properly.
3. The staff member must document the inspection on the log for the area being reviewed.
4. The inspection will occur on or before the last day of every month.
Clinical staff responsible for reviewing supplies will be trained by review of the procedure through education session completed by 9/15/21. They will be given an opportunity to ask questions and sign off that they have reviewed and understand the procedure. Signature sheet will be sent to the director for record keeping.
Office manager will verify that staff responsible for completing the monthly inspection has done so and documented inspection on the log for the area and will sign off on the log which will then be submitted to the director for review and record keeping. This will be done on a monthly basis for 3 months to ensure the process is sustained.
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