Toxicology Center

Summary Statement of Deficiencies D0000 The survey was performed on 2/12,13,14/18 The findings were reveiwed with the technical supervisor and testing person #1 at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1213; D5022: Toxicology 493.1441; D6076: Laboratory Director 493.1447; D6108: Technical Supervisor D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, procedure manuals, manufacturer's instructions, and interview with the general supervisor, technical supervisor, and testing person #1, the laboratory failed to ensure the requirements were met for the subspecialty of Toxicology. Findings include: (1) The laboratory failed to verify the accuracy of testing at least twice annually. Refer to D5217; (2) The laboratory failed to have a written procedure for specimen submission, handling and processing. Refer to D5311; (3) The laboratory failed to provide written instructions to clients collecting and referring urine drug specimens. Refer to D5317; (4) The laboratory failed to have written procedures for the analytical phase of testing. Refer to D5403; (5) The laboratory failed to ensure an analyzer was stored as required by the manufacturer. Refer to D5413; (6) The laboratory failed to verify the acceptable performance of the laboratory computer system. Refer to D5421; (7) The laboratory failed to establish analytical specificity and validate specimen integrity for urine and saliva drug testing. Refer to D5423; (8) The laboratory failed to define a function check protocol to ensure the centrifuge was functioning properly. Refer to D5435; (9) The laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- failed have an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. 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 a review of records and interview with the technical supervisor and testing person #1, the laboratory failed to ensure the accuracy of testing was verified at least twice annually. Findings include: (1) On the first day of the survey, testing person #1 stated to surveyor #2 the laboratory began performing urine drug testing using the AB Sciex Triple Quad 4500 LCMS (liquid chromatography-mass spectrometry) analyzer (see below for drugs tested) on 10/04/16; (2) On the second day of the survey, the surveyors reviewed records for testing performed in 2016 and 2017 and identified the accuracy of the testing had not been verified twice annually between 10/19/16 and 10 /26/17; (3) The surveyors reviewed the records with the technical supervisor and testing person #1, who stated the accuracy of urine drug testing had not been verified twice in 2017. LCMS testing includes the following drugs: 6MAM (Monoacetylmorphine), 7-Aminoclonazepam, Acetaminophen, Alpha Hydroxyalprazolam, Alprazolam, Amitriptyline, Amphetamine, Benzyolecgonine, Buprenorphine, Carisoprodol, Clonazepam, Codeine, Cotinine, Dextromethorphan, Dextrorphan, Duloxetine, EDDP (Methadone Metabolite), Ethyl-glucuronideuornide, Fentanyl, Gabapentin, Hydrocodone, Hydromorphone, Hydromorphone-Glucuronide, Lorazepam Glucuronideuronide, MDA(3,4-ethylenedioxyamphetamine), MDEA (3,4- methylenedioxy-N-ethylamphetamine), MDMA(methylenedioxymethamphetamine), Meperidine, Meprobamate, Methadone, Methamphetamine, Methylphenidate, Morphine, Morphine-Glucuronide, Naloxone-Glucuronideuronide, Norbuprenorphine, Norbuprenorphine-Glucuronide, Nordiazepam, Norfentanyl, Norhydrocodone, Norketamine, Normeperidine, Noroxycodone, Nortriptyline, O-desmethylvenlafaxine, Oxazepam-Glucuronide, Oxycodone, Oxymorphone, Oxymorphone-Glucuronide, PCP (Phencyclidine), Pentazocine, Phentermine, Pregabalin, Propoxyphene, Ritalinic Acide, Tapentadol, Tapentadol-glucuronide, Temazepam, Temazepam-Glucuronide, THC-COOH (Tetrahydrocannabinol-9-carboxylic acid), THC-COOH-Glucuronide, Tramadol, Venlafaxine, Zolpidem, and Zolpidem P4CA 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 a review of the procedure manual, and interview with the general supervisor, technical supervisor and testing person #1 the laboratory failed to have a -- 2 of 11 -- written procedure for specimen submission, handling and processing. Findings include: (1) On the first day of the survey, surveyor #2 reviewed the procedure manual. A specimen submission, handling and processing procedure could not be located for urine or saliva samples received in the laboratory for testing; (2) Surveyor #2 explained to the general supervisor, technical supervisor and testing person #1 that a specimen submission, handling and processing procedure could not be located. The general supervisor, technical supervisor and testing person #1 stated that a procedure had not been written. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on an interview with the technical supervisor and testing person #1, the laboratory failed to provide written instructions to clients collecting and referring urine drug specimens. Findings include: (1) On the first day of the survey, testing person #1 stated the following to surveyor #2: (a) The laboratory began performing urine drug testing using the AB Siex Triple Quad 4500 LCMS (liquid chromatography-mass spectrometry) analyzer on 10/04/16 (see below for drugs tested); (b) The urine specimens were transported to the laboratory from two outside clinics. (2) Surveyor #2 asked testing person #1 if instructions (e.g., client service manual) had been written and provided to the two clients which would explain the laboratory's specimen handling policies (e.g., collection, preservation, storage, transport, testing schedule times, and how to obtain additional assistance for unusual circumstances). Testing person #1 stated specimen handling instructions had not been written and provided to the clients. LCMS testing includes the following drugs: 6MAM (Monoacetylmorphine), 7-Aminoclonazepam, Acetaminophen, Alpha Hydroxyalprazolam, Alprazolam, Amitriptyline, Amphetamine, Benzyolecgonine, Buprenorphine, Carisoprodol, Clonazepam, Codeine, Cotinine, Dextromethorphan, Dextrorphan, Duloxetine, EDDP (Methadone Metabolite), Ethyl-glucuronideuornide, Fentanyl, Gabapentin, Hydrocodone, Hydromorphone, Hydromorphone-Glucuronide, Lorazepam Glucuronideuronide, MDA(3,4-ethylenedioxyamphetamine), MDEA (3,4- methylenedioxy-N-ethylamphetamine), MDMA(methylenedioxymethamphetamine), Meperidine, Meprobamate, Methadone, Methamphetamine, Methylphenidate, Morphine, Morphine-Glucuronide, Naloxone-Glucuronideuronide, Norbuprenorphine, Norbuprenorphine-Glucuronide, Nordiazepam, Norfentanyl, Norhydrocodone, Norketamine, Normeperidine, Noroxycodone, Nortriptyline, O-desmethylvenlafaxine, Oxazepam-Glucuronide, Oxycodone, Oxymorphone, Oxymorphone-Glucuronide, PCP (Phencyclidine), Pentazocine, Phentermine, Pregabalin, Propoxyphene, Ritalinic Acide, Tapentadol, Tapentadol-glucuronide, Temazepam, Temazepam-Glucuronide, THC-COOH (Tetrahydrocannabinol-9-carboxylic acid), THC-COOH-Glucuronide, Tramadol, Venlafaxine, Zolpidem, and Zolpidem P4CA 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, -- 3 of 11 -- 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)