Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Technical Supervisor (TS), the laboratory lacked copies of all PT records for testing performed with the American Proficiency Institute (API) for the 2nd Coagulation PT event of 2024. The findings include: 1. The laboratory lacked the work records and the attestation page for the 2nd Coagulation PT event of 2024. 2. The TS confirmed on 11/13/24 at 11:30 am, all PT records were not retained. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: A) Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to review PT performance codes "See note [20]", " Response was not formally graded due to insufficient peer group data. Please see the participation summary for additional information" results obtained for PT performed with the College of American Pathologists (CAP) in the calendar year 2024 The findings include: 1. "See note [20]" results were received for event K-B 2024 Ligand-Generaln as follows: a) Triiodthyronie (T3) samples K-06, K- 07, K-08, K-09, K-10. b) Free Triiodthyronie (FT3) samples K-06, K-07, K-08, K-09, K-10. c) Thyroxine (T4) samples K-06, K-07, K-08, K-09, K-10. d) free Thyroxine Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- (FT4) samples K-06, K-07, K-08, K-09, K-10. e) Thyroid Stimulating Hormone (TSH) samples K-06, K-07, K-08, K-09, K-10. f) Vitamin B-12 samples K-06, K-07, K-08. 2. "See note [20]" results were received for event K-A 2024 Ligand-General as follows: a) Triiodthyronie (T3) samples K-01, K-02, K-3, K-04, K-05. b) Thyroxine (T4) samples K-01, K-02, K-3, K-04, K-05. 3. The TS confirmed on 11/12/24 at 11:30 am that the laboratory failed to evaluate PT performance codes. 48354 B) Based on surveyor review of the PT records and interview with the TS, it was revealed that the laboratory failed to review PT performance codes "See note [30]" (Scientific committee decision) results obtained for PT performed with the College of American Pathologists (CAP) for Urine Drug Screening (UDS) event A of 2024. The findings include: 1. Ethanol samples UDS 01,02,03,04, and 05 and had coded results for see note 30 which were not evaluated. 2. The TS confirmed on 11/13/24 at 2:15 pm, the laboratory did not evaluated coded results for PT results obtained for UDS event A of 2024 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the surveyor review of the Procedure Manual (PM) and interview with the Technical Supervisor (TS), the PM lacked all applicable procedures for Coagulation tests performed from 9/7/24 to 11/13/24. The findings include: 1) The PM lacked a procedure to establish new normal patient mean and reference ranges with each new lot of thromboplastin. 2) The TS confirmed on 11/13/24 at 2:20 pm, the above mentioned procedure was not available for review. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)