Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was performed at Citizens Medical Center, CLIA #19D0465006 on December 14, 2022 through December 19, 2022. 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 direct observation by surveyors, review of patient records and interview with personnel, the laboratory failed to ensure supplies and reagents did not exceed their expiration dates. Findings: 1. Direct observation by surveyors during the laboratory tour on December 14, 2022 at 0930am revealed the following expired items: a) Blood Transfer Units Lot 450225 Expiration 08/05/22 Quantity: 2 boxes b) Azer Scientific Orange Glucose Drink Lot 59559 Expiration 03/31/22 Quantity: 60 bottles 2. Review of patient records from April 1, 2022 through December 14, 2022 revealed the laboratory performed patient testing on expired Azer Scientific Orange Glucose drink for the following ten (10) of ten (10) patients reviewed: a) Accession No. 2206220019: Glucose Tolerance Test 3 hour performed on June 22, 2022 at 07:38 am b) Accession No. 2207120124: Glucose Tolerance Test 1 hour performed on July 11, 2022 at 09:17 am c) Accession No. 2208040113: Glucose Tolerance Test 2 hour performed on August 4, 2022 at 15:27 pm d) Accession No. 2208310045: Glucose Tolerance Test 2 hour performed on August 31, 2022 at 07:22 am e) Accession No. 2209210062: Glucose Tolerance Test 2 hour performed on September 21, 2022 at 09: 10 am f) Accession No. 2210050092: Glucose Tolerance Test 2 hour performed on October 5, 2022 at 10:32 am g) Accession No. 2210050098: Glucose Tolerance Test 2 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 -- hour performed on October 5, 2022 at 10:32 am h) Accession No. 2209300045: Glucose Tolerance Test 3 hour performed on September 30, 2022 at 08:15 am i) Accession No. 2211140019: Glucose Tolerance Test 3 hour performed on November 14, 2022 at 07:33 am j) Accession No. 2212020072: Glucose Tolerance Test 3 hour performed on December 2, 2022 at 10:39 am 3. In interview on December 14, 2022 at 9:54 am, General Supervisor 1 stated the laboratory does not use the transfer units because they do not fit the vacutainers. General Supervisor 1 confirmed the transfer units exceeded the expiration date and not disposed. 4. In interview on December 14, 2022 at 9:54 am, General Supervisor confirmed the glucola drinks exceeded the expiration date and the above identified patients were performed on expired supplies. 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 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 by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5417. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and records as well as interview with personnel, the Technical Consultant failed to provide technical and scientific oversight to the laboratory. Refer to D5417. -- 2 of 2 --