Summary:
Summary Statement of Deficiencies D0000 An Initial Survey was performed at Bayou Tox, LLC dba Parish Labs, CLIA ID # 19D2165579 on January 6, 2020 through January 7, 2020. Parish Labs was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director 42 CFR 493.1447 CONDITION: Laboratories performing high complexity tesing; Technical Supervisor 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: I. Based on record review and interview with personnel, the laboratory failed to follow written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's "PAR-QA-DCO-001" policy under section "4.8 Competency Assessment" revealed the following: "The procedures for evaluation of the competency of the staff must include, but are not limited to -Direct observations of routine test performance, including preparation, if applicable, specimen handling, processing and testing -Monitoring the recording and reporting of test results -Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records -Direct observation of performance of instrument maintenance and function checks -Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples, and -Assessment of problem-solving skills" 2. Review of the laboratory's "PAR-QA Form-002" used for competency assessment of testing personnel revealed the identified six (6) procedures were not included. 3. In interview on January 6, 2020, the Operations Personnel confirmed the identified form is for the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- semi-annual and annual competency evaluation of testing personnel. The Operations Personnel confirmed the identified form did not include the six (6) procedures as indicated in their policy and per CLIA. II. Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to address competency for General Supervisor were complete. Findings: 1. Review of the the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Testing Personnel 1 also serves as the General Supervisor. 2. Review of the laboratory's "PAR- QA-DCO-001" policy under section "4.8 Competency Assessment" revealed the laboratory did not include competency assessment criteria or frequency for personal serving as General Supervisor. 3. In interview on January 6, 2020, the Operations Personnel confirmed the laboratory's competency assessment policy did not include criteria and frequency of performance for personnel serving as General Supervisor. 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 record review and interview with personnel, the laboratory failed to reject samples that exceeded the laboratory's sample stability criteria. Findings: 1. In interview on January 6, 2020 at 10:35 am, Testing Personnel 1 stated urine samples received have a ten (10) day stability from the date of collection. 2. Review of patient test reports from November 2019 and December 2019 revealed the following patients exceeded the laboratory's ten (10) day stability criteria: Patient 191125011, Collection Date: Novmeber 15,2019 at 10:00 am, Date Received: Novmeber 25,2019 at 10:15 am Patient 191226002, Collection Date: December 16, 2019 at 8:34 am, Date Received: December 26, 2019 at 8:39 am 3. In interview on January 7, 2020 at 10:48 am, the Owner/Vice President stated the laboratory does not factor in the time of collection for rejection of samples. The Owner/Vice President confirmed the laboratory reported the identified patients that exceeded the laboratory's stability criteria. 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 record review and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's "PAR-PRE-SOP-001" under "Proficiency Testing" section revealed the laboratory did not include the following: a) Twice a year verification (split sample -- 2 of 15 -- testing) for the accuracy of Toxicology testing: