Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed at Houma Health Clinic, CLIA ID # 19D1000384, on September 17, 2019. Houma Health Clinic was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing, Laboratory Director 42 CFR 493.1421 CONDITION: Laboratories Performing Moderate Complexity Testing, Testing Personnel 42 CFR 493.1441 CONDITION: Laboratories Performing High Complexity Testing, Laboratory Director 42 CFR 493.1447 CONDITION: Laboratories Performing High Complexity Testing, Technical Supervisor 42 CFR 493.1487 CONDITION: Laboratories Performing High Complexity Testing, Testing Personnel 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 record review and interview with personnel, the laboratory failed to establish written policies and procedures to assess competency assessment policies for testing personnel. Findings: 1. Review of the laboratory's records revealed the laboratory did not have a written policy for assessing the competency of personnel performing laboratory testing that includes the following six (6) procedures as a minimal requirement: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 30 -- through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. In interview on September 17, 2019 at 11:15 am, the office practice manager stated the laboratory did not have a policy and procedure manual. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to verify the accuracy of all non-regulated analytes at least twice annually. Findings: 1. Review of the laboratory's records revealed the laboratory did not have a written policy and procedure for twice a year verification of accuracy for Toxicology testing. 2. Further review of the laboratory's records revealed the laboratory did not verify the accuracy of the following tests: Amphetamine, Barbiturate, Benzodiazepine, Buprenorphine, Cannabinoid (THC),Cocaine, Ethyl Alcohol, Methadone, Opiate, Oxycodone, Phencyclidine (PCP), and Urine Creatinine. 3. In interview on September 17, 2019 at 10:51 am, the Testing Personnel stated he was unfamiliar with proficiency testing and twice a year verification. The Testing Personnel confirmed the laboratory did not perform a verification of the accuracy of Toxicology testing since the start of patient testing in February 2019. 4. In interview on September 17, 2019 at 11:15 am, the office practice manager stated the laboratory did not have a policy and procedure manual. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401. 2. The laboratory failed to establish a policy and procedure manual. Refer to D5403. 3. The laboratory failed to monitor the room temperature and humidity of the laboratory where the instrument and supplies are stored per manufacturer requirements. Refer to D5413 I. 4. The laboratory failed to monitor the temperature of the two (2) refrigerators where laboratory reagents are stored. Refer to D5413 II. 5. The laboratory failed to store reagents per manufacturer requirements. Refer to D5413 III. 6. The laboratory failed to ensure supplies did not exceed their expiration date. Refer to D5417. 7. The laboratory failed to have complete performance verification studies. Refer to D5421. 8. The laboratory failed to establish performance specifications for urine creatinine testing on the Thermo Scientific Indiko Plus -- 2 of 30 -- analyzer. Refer to D5423. 9. The laboratory failed to establish their own means and ranges for quality control (QC) material utilized for Urine Drug Screen (UDS) testing. Refer to D5469. 10. The laboratory failed to take