Summary:
Summary Statement of Deficiencies D0000 A Certification Survey was performed on February 12, 2019 at Claiborne Family Medicine Clinic, CLIA ID # 19D0463210. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 personnel, the laboratory failed to ensure supplies have not exceeded their expiration date. Findings: 1. Observation by surveyor during laboratory tour on February 12, 2019 revealed the following expired items: a) BD Universal Viral Transport for Viruses, Chlamydiae, Mycoplasmas, and Ureaplasmas swabs (11 swabs) Lot 171381000 Exp 12/18 b) BD Universal Viral Transport for Viruses, Chlamydiae, Mycoplasmas, and Ureaplasmas swabs (4 swabs) Lot 171598300 Exp 1/19 2. In interview on February 12, 2019 at 10:30 am, Personnel 1 stated she was unaware the swabs were expired since the laboratory does not use those supplies for any testing. Personnel 1 confirmed the above items were expired. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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. (e) The laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation, and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed testing as required. Refer to D5417. -- 2 of 2 --