Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 25, 2018. The laboratory was found not in compliance with all 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 surveyor observation and an interview with the Technical Supervisor (TS), the laboratory failed to assure that the fire extinguishers were maintained in a fully charged and operable condition and kept in a designated area at all times except during use. The findings include: 1. An observation of the laboratory's fire extinguishers revealed that it had not been inspected and certified by a fire protection equipment company since January 2016. 2. The TS confirmed on January 25, 2018, at 1:15 PM, in the breakroom, that the fire extinguisher had not been inspected and certified since 2016. 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. 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 -- This STANDARD is not met as evidenced by: A review of the procedure manual and interview with the Technical Supervisor (TS), determined that the laboratory failed to have a separate competency assessment for their toxicology and chemistry panels for 2017. The findings include: 1. A review of testing personnel records revealed that a competency assessment was performed on testing personnel but the assessment included both the toxicology and chemistry test panels. 2. The laboratory must monitor each individual's competency and identify remedial training for each test procedure performed in the laboratory. 3. An interview with the Technical Supervisor (TS), in the breakroom on January 25, 2018 at 11:30 AM, confirmed that the laboratory did not have separate competency assessments for each test performed in the laboratory. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency test (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to have a written proficiency test procedure and policy for performing and evaluating their non-regulated toxicology analytes for 2017. The findings include: 1. The laboratory had no written policy or procedure for proficiency testing of their non-regulated toxicology analytes for 2017. The laboratory is enrolled in a CMS approved PT provider for their regulated toxicology analytes. 2. The laboratory must verify the accuracy of the test or procedure twice annually for their non-regulated analytes. 3. An interview with the Technical Supervisor (TS), in the break room on 1/25/18 at 11:30 AM, confirmed that the laboratory did not have a written policy and procedure for evaluating proficiency for their non-regulated toxicology analytes for 2017. 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)