Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 25, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP), observation, and staff interview, the laboratory failed to establish and make accessible safety procedures to ensure protection from chemical, biochemical, and biohazardous materials as required. Findings include: 1. SOP review revealed the lack of an eyewash procedure. 2. Observation during the laboratory area tour revealed there was no eyewash equipment or bottled eyewash. 3. An interview with the laboratory director (LD) in the laboratory area on 9/25/2019 at approximately 2:00 p.m. confirmed there was no eyewash equipment in the office. During the same interview the LD confirmed there was no policy and procedure for eyewash equipment in the SOP. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to establish and follow written polices and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the general laboratory systems as required. Findings include: 1. SOP review revealed the lack of a quality assurance (QA) policy and procedure. 2. An interview with the laboratory director in the front office on 9/25/2019 at approximately 3:00 p.m. confirmed the lack of a QA policy and procedure. in the SOP. 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 review of the laboratory policy and procedure manual (SOP) the laboratory failed to include required policies and procedures. Findings include: 1. SOP review revealed the lack of a policy and procedure for record retention. 2. An interview with the laboratory director in the front office area on 9/25/2019 at approximately 3:00 p. m. confirmed there was not a record retention policy and procedure in the SOP. 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)