White Oak Family Physicians, Pa

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with TP (testing personnel) #1 on 9/26/24, the laboratory failed to discard KOH (potassium hydroxide) that exceeded the expiration date. Findings: During a tour of the laboratory at approximately 3:10 p.m., the surveyor observed one bottle of KOH (lot #3234-00 with expiration date 3/31/24) in the Side A microscope area, available for use. During interview at approximately 3:10 p.m., TP #1 confirmed the KOH was expired and should have been discarded. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, observation, and review of the October 2022 rapid strep patient log 11/1/22, the laboratory failed to follow manufacturer's instructions for performance of the Henry Schein One Step + Strep A Dipstick test. The laboratory failed to discard an expired rapid strep kit, and the kit was used to test three patients. Findings: Review of manufacturer's instructions for the Henry Schein One Step + Strep A Dipstick test revealed "... PRECAUTIONS ... Do not use after expiration date. ... STORAGE AND STABILITY ... Do not use beyond the expiration date. ..." During a tour of the facility at approximately 3:10 p.m., the surveyor observed an open Henry Schein One Step + Strep A Dipstick kit lot #STA0102019 with expiration date 9/30/22 in a cabinet in the nurses' station, available for use. Review of the October 2022 patient log revealed the expired strep kit was used to perform testing on three patients: 1. #1079190 was tested 10/3/22; 2. #857901 was tested 10/7/22; 3. #1155920 was tested 10/28/22. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of personnel records, and interview with the laboratory supervisor 9/17/19, the laboratory director failed to ensure technical consultant duties were performed by personnel meeting the qualification requirements for technical consultant. Findings: The laboratory's "LAB TESTING PERSONNEL COMPETENCY POLICY" states "The Lab Supervisor is responsible for training, the semi-annual, and the annual competency evaluation for each employee that performs lab testing. The Lab Director will sign off on each employee's training when it is completed and competency is established. ..." Review of personnel records revealed: 1. The laboratory supervisor has an associate degree in medical laboratory technology and does not meet the requirements to serve as technical consultant. 2. One of the duties listed on the laboratory supervisor's job description was "Provide annual evaluation and competency to all testing personnel." 3. The laboratory supervisor performed the competency evaluations for TP #2 and TP #3 and the laboratory director. During interview at approximately 11:20 a.m., the laboratory supervisor confirmed that she performed the competency evaluations and the laboratory director signed off on them. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --