Southeast Texas Guidance Center, Pllc

Summary Statement of Deficiencies D0000 Based on the survey conducted 06-21-2018, the laboratory was found to be out of compliance with the following conditions of 42 CFR: 493.1447 Laboratory Technical Supervisor High Complexity . D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: . Based on review of the package insert for the Immunalysis buprenorphine HEIA assay, laboratory procedure, patient testing records for 2017 and 2018 and staff interview, the laboratory failed to follow manufacturer's instructions regarding storage of urine specimens for toxicology testing. Findings: 1. The manufacturer's package insert for Immunalysis buprenorphine urine enzyme immunoassay states: "Urine specimens stored at 22 C to 30 C (ambient room temperature) up to 3 days may be used. Repeated freezing and thawing should be avoided. A minimum temperature of -20 C is recommended for frozen samples." No mention of specimen stability under refrigeration is made. (Buprenorphine Urine HEIA Product Insert, IMMUNALYSIS document #:KI-336UR-IMM 2. Laboratory policy for specimen handling states: "If not analyzed within 5 days, store the specimens at 2-8C until testing." (American Wellness Lab Policy/Procedure, Specimen Collection/Labeling, page 2, effective date 10-25-2017) 3. Patient testing records from 2017 and 2018 were requested. In an interview at the site on 06-21-2018, testing person 1 (CMS form 209) stated that the records provided represented all patient testing performed by the laboratory up to that date. Each accession number given represented an identical panel of tests consisting of amphetamines (AMP-500), barbiturates (BARB-200), benzodiazepines (BZO-200), 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 -- buprenorphine (BUP 5), opiates (OPI 100), oxycodone (OXY 300), phencyclidine (PCP 25), cannabinoids (THC 20), cocaine metabolites (COC 150) and methamphetamine (MTH 500). This information was confirmed via e-mail by the office administrator on 07-06-2018. 4. Elapsed time (ET) in days between specimen collection and testing was calculated using the information provided: Specimen Collected Performed ET 180103001 12/28/2017 01/05/2018 8 180103002 12/29/2017 01/05/2018 7 180103003 12/29/2017 01/05/2018 7 180112008 01/03/2018 01/15 /2018 12 180112005 01/04/2018 01/15/2018 11 Specimen Collected Performed ET 180112007 01/04/2018 01/15/2018 11 180112013 01/04/2018 01/15/2018 11 180112004 01/05/2018 01/15/2018 10 180112006 01/05/2018 01/15/2018 10 180112003 01/08/2018 01/15/2018 7 180112001 01/09/2018 01/15/2018 6 180119003 01/10/2018 01/23/2018 13 180119004 01/10/2018 01/23/2018 13 180112014 01/12/2018 01/15/2018 3 180117001 01/12/2018 01/23/2018 11 180119005 01/12/2018 01/23/2018 11 180117002 01/15/2018 01/23/2018 8 180119001 01/15/2018 01/23/2018 8 180119002 01/15/2018 01/23/2018 8 180119006 01/15/2018 01/23/2018 8 180126006 01/17/2018 01/27/2018 10 171207005 01/18/2018 01/25/2018 7 180126002 01/18/2018 01/27/2018 9 180126005 01/18/2018 01/27/2018 9 180126004 01/19/2018 01/27/2018 8 180126003 01/19/2018 01/27/2018 8 180126004 01/19/2018 01/27/2018 8 180126001 01/22/2018 01/27/2018 5 180207003 02/01/2018 02/10/2018 9 180207002 02/02/2018 02/10/2018 8 180207004 02/02/2018 02/10/2018 8 180207005 02/02/2018 02/10/2018 8 180207001 02/05/2018 02/10/2018 5 180215001 02/12/2018 02/17/2018 5 180215002 02/12/2018 02/17/2018 5 180215003 02/12/2018 02/17/2018 5 180222001 02/14/2018 02/23/2018 9 180222004 02/15/2018 02/23/2018 8 180222002 02/16/2018 02/23/2018 7 180222003 02/19/2018 02/23/2018 4 180302003 02/20/2018 03/02/2018 10 Specimen Collected Performed ET 180309001 02/28/2018 03/10/2018 10 180309003 03/01 /2018 03/10/2018 9 180309002 03/02/2018 03/10/2018 8 180314003 03/06/2018 03 /16/2018 10 180314002 03/07/2018 03/16/2018 9 180314001 03/09/2018 03/16/2018 7 180322001 03/19/2018 03/24/2018 5 180322002 03/19/2018 03/24/2018 5 180322003 03/19/2018 03/24/2018 5 180322004 03/19/2018 03/24/2018 5 180329001 03/23/2018 03/30/2018 7 180329002 03/26/2018 03/30/2018 4 180404001 04/02/2018 04/07/2018 5 180404002 04/02/2018 04/07/2018 5 180413001 04/05/2018 04/13/2018 8 180413002 04/05/2018 04/13/2018 8 180419002 04/16/2018 04/19/2018 3 180425002 04/18/2018 04/26/2018 8 180425003 04/18/2018 04/26/2018 8 180425004 04/18/2018 04/26/2018 8 180425001 04/19/2018 04/26/2018 7 180425006 04/20/2018 04/26/2018 6 180425005 04/21/2018 04/26/2018 5 180502003 04/27/2018 05/02/2018 5 180509001 05/02/2018 05/09/2018 7 180516002 05/11/2018 05/16/2018 5 180516004 05/11/2018 05/16/2018 5 180516003 05/12/2018 05/16/2018 4 180524001 05/18/2018 05/25/2018 7 180607001 05/30/2018 06/09/2018 10 180606001 05/31/2018 06/09/2018 9 180607002 06/01/2018 06/09/2018 8 180607003 06/02/2018 06/09/2018 7 5. Of 74 patient specimens tested for buprenorphine, 2 were tested within the 3 days allowed in the manufacturer's instructions. Laboratory policy states that specimens are stored at 2-8C if not analyzed within 5 days or receipt, rejected if not received within 14 days of collection, and makes no mention of freezing specimens. . D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed -- 2 of 5 -- in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: . I. Based on review of laboratory method validation documentation and staff interview, the laboratory failed to evaluate the effects of storage outside the reagent manufacturer's stated time limits for urine specimens for toxicology testing using the Thermo-Fisher Indiko chemistry analyzer. Findings: 1. Laboratory procedure for specimen handling states: "If not analyzed within 5 days, store the specimens at 2-8 C until testing." (American Wellness Lab Procedures: Specimen Collection/Labeling, effective 10-25-2017) 2. The manufacturer's package insert for Immunalysis methamphetamine urine enzyme immunoassay states: "Urine specimens stored at ambient temperature up to 30 C up to 14 days may be used." No mention of specimen stability under refrigeration is made. (Methamphetamine Urine HEIA Product Insert, IMMUNALYSIS document #:KI-311UR-IMM) 3. The manufacturer's package insert for Immunalysis buprenorphine urine enzyme immunoassay states: "Urine specimens stored at 22 C to 30 C (ambient room temperature) up to 3 days may be used. Repeated freezing and thawing should be avoided. A minimum temperature of -20 C is recommended for frozen samples." No mention of specimen stability under refrigeration is made. (Buprenorphine Urine HEIA Product Insert, IMMUNALYSIS document #:KI-336UR-IMM) 4. Method validation records include a study dated 05- 22-2018 in which 3 groups of urine specimens were tested (a) after collection, (b) after 1 week refrigerated at 2-8C, and (c) after 1 week at RT (room temperature, not specified). Note: Test panel includes amphetamines (AMP-500), barbiturates (BARB- 200), benzodiazepines (BZO-200), buprenorphine (BUP 5), opiates (OPI 100), oxycodone (OXY 300), phencyclidine (PCP 25), cannabinoids (THC 20), cocaine metabolites (COC 150) and methamphetamine (MTH 500). Tests were performed using the Indiko analyzer and Thermo Scientific DRI reagents with the exception of assays for buprenorphine and methamphetamine, which utilized the Indiko analyzer and Immunalysis HEIA reagents. Use of Immunalysis HEIA reagents with the Indiko analyzer is not approved by the Food and Drug Administration (FDA), requiring establishment of performance characteristics for the modified system. Group 1 Collected Tested 04-19-2018 After collection Specimen Results 180419001U Negative for all 180419002U Negative for all 180419003U Negative for all 184019004U Positive for OPI 100 Collected Tested 04-19-2018 1 Week @ 2-8C Specimen Results 180419001U Negative for all 180419002U Negative for all 180419003U Negative for all 184019004U Positive for OPI 100 Collected Tested 04- 19-2018 1 Week @ RT Specimen Results 180419001U Negative for all 180419002U Negative for all 180419003U Negative for all 184019004U Positive for OPI 100 Group 2 Collected Tested 04-26-2018 After Collection Specimen Results 180425001U Positive for OPI 100 180425002U Positive for BZO-200, OPI 100 184025003U Positive for BZO-200, OPI 100 180425004U Positive for OPI 100 180425005U Negative for all 180425006U Positive for OPI 100 Collected Tested 04- 26-2018 1 Week @ 2-8C Specimen Results 180425001U Positive for OPI 100 180425002U Positive for BZO-200, OPI 100 184025003U Positive for BZO-200, OPI 100 180425004U Positive for OPI 100 180425005U Negative for all 180425006U -- 3 of 5 -- Positive for OPI 100 Collected Tested 04-26-2018 1 Week @ RT Specimen Results 180425001U Positive for OPI 100 180425002U Positive for BZO-200, OPI 100 184025003U Positive for BZO-200, OPI 100 180425004U Positive for OPI 100 180425005U Negative for all 180425006U Positive for OPI 100 Group 3 Collected Tested 05-02-2018 After collection Specimen Results 180502001U Positive for BZO- 200 180502002U Positive for THC 20 180502003U Negative for all 180502004U Positive for OPI 100 Collected Tested 05-02-2018 1 Week @ 2-8C Specimen Results 180502001U Positive for BZO-200 180502002U Positive for THC 20 180502003U Negative for all 180502004U Positive for OPI 100 Collected Tested 05-02-2018 1 Week @ RT Specimen Results 180502001U Positive for BZO-200 180502002U Positive for THC 20 180502003U Negative for all 180502004U Positive for OPI 100 5. None of the specimens showed positive results for methamphetamine (MTH 500) or buprenorphene (BUP 5) in initial testing. In an interview at the site on 06-21-2018, the laboratory technical supervisor (CMS form 209) confirmed that no specimens positive for methamphetamine or buprenorphene were included in the validation study; the study is, therefore, of no value in establishing performance specifications for the modified system. II. Based on review of laboratory method validation documentation and staff interview, the laboratory failed to validate performance characteristics against the effects of interfering substances in urine specimens for toxicology testing using the Thermo-Fisher Indiko chemistry analyzer and Immunalysis HEIA reagents. Findings: 1. Method validation documentation for toxicology testing using the Indiko analyzer with Immunalysis methamphetamine and buprenorphene HEIA reagents was reviewed. 2. Documentation did not include performance specifications for analytical specificity in the presence of interfering substances. 3. In an interview at the site on 06-21-2018, the laboratory technical supervisor confirmed that no such specifications had been established during method validation. Note: The laboratory director and technical supervisor are one and the same. . D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: . Based on review of laboratory performance verification documentation , patient testing results, manufacturer's instructions and laboratory procedure, confirmed by staff interview, the laboratory technical supervisor failed to provide technical supervision for performance verification of toxicology testing using modified procedures. Refer to D6115. . D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: -- 4 of 5 -- . Based on review of performance verification documentation, reagent manufacturer's instructions and staff interview, the laboratory technical supervisor failed to ensure that test performance characteristics were adequately verified for non-FDA approved toxicology testing using modified procedures. Refer to D5423. . -- 5 of 5 --