Summary:
Summary Statement of Deficiencies 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 lack of safety standard operating procedures (SOPs) and interview with the testing person (TP), the laboratory failed to draft, approve safety protocols to protect staff from physical, chemical, biochemical, biohazard materials, and electrical hazards. FINDINGS: 1. The laboratory failed to draft, approve safety protocols in compliance with universal precautions. 2. The TP confirmed the findings on February 29, 2024, at approximately 2:00 P.M. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of TP six-month and annual competency evaluation records, lack of training documentation, lack of competency evaluation policy, as well as interview with TP, the LD failed to draft, approve a competency evaluation policy as well as perform, document TP training, six-month, and annual competency evaluations. FINDINGS: 1. The LD failed to draft, approve a competency evaluation policy including the following guidelines: a. Direct observations of routine patient test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- performance, specimen preparation, processing, and testing. b. Monitoring the recording and reporting of test results. c. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. d. Direct observations of instrument maintenance performance and function checks. e. Assessment of patient test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples. f. Assessment of problem-solving skills. 2. It was noted that the TP was trained on the TOSOH AIA 900, ABX Horiba Pentra 400, and Micros 60 analyzers when the technical service representative installed the instruments October 24, 2023. 3. There was no documentation of TP training, six-month, and annual competency evaluation from June 2023 hire through date of survey. 4. The TP confirmed the findings on February 29, 2024, at 2:30 P.M. 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 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) policy and interview with the LD, the laboratory failed to draft, approve a QA policy. FINDINGS: 1. The current, approved 360 Complete Medical, PC standard operating procedures (SOPs) did not include a QA policy. 2. The TP confirmed the findings on February 29, 2024, at approximately 2:30 P.M. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's current, approved SOP manual and interview with the TP, the laboratory failed to include written instructions for performing the following activities: FINDINGS: 1. Requirements for specimen labeling, criteria for specimen acceptability, and rejection. 2. The TP confirmed the findings on February 29, 2024, at approximately 2:30 P.M. 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 -- 2 of 5 -- 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)