Diagnostic Affiliates Of Northeast Hou, Llc

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 the laboratory's policies, a review of the laboratory's College of American Pathologists (CAP) proficiency testing records from 2020, and staff interview, it was revealed that the laboratory failed to have documentation of performing twice annual accuracy assessments in 2020 for 7 of 34 unregulated analytes tested on the Applied Biosystems Quant Studio 12K Flex analyzer. Findings include: 1. A review laboratory's policy titled 'Proficiency Testing' revealed the following: "Proficiency testing (PT) must be performed for each analyte being reported by the laboratory, whether it be a regulated or unregulated analyte...the accuracy of all analytes must be tested at least twice per year." 2. A review of the laboratory's College of American Pathologists proficiency testing records revealed the laboratory failed to perform twice annual accuracy assessments in 2020 for the following 7 analytes tested on the Applied Biosystems Quant Studio 12K Flex analyzer: - Mycoplasma Hominis - Megasphaera Species 1 - Megasphaera Species 2 - Ureaplasma Urealyticum - Haemophilus Ducreyi - Mycoplasma Genitalium - Treponema Pallidum 3. The laboratory was asked to provide documentation of assessing the accuracy, twice annually, for the above listed analytes. No 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 -- documentation was provided. 4. An interview with technical supervisor #1 (as indicated on the CMS 209 form, signed by the laboratory director on 1/25/21) on 1/26 /21 at 1:00 p.m. in the conference room, after review of the records, confirmed the above findings. 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: I. Based on review of the laboratory records, patient test records from October 2020 to January 2021 and confirmed in interview, the laboratory failed to document complete preanalytical studies for the Vaginits Open Array Panel with Copan eSwab. A) temperature B) specimen stability Findings were: 1. Review of the laboratory records revealed the laboratory performed Vaginits Open Array Panel for the qualitative detection of the following 34 organisms on vaginal Copan eSwabs. Atopobium Vaginae BVAB2 Megasphaera Species 1 Megasphaera Species 2 Mycoplasma Hominis Ureaplasma Urealyticum Gardnerella vaginalis Bacteroides Fragilis Lactobacillus Crispatus Prevotella Bivia Mobiluncus Curtisil Mobiluncus Mulieris Lactobaccillus Gasseri Lactobaccillus Iners Lactobaccillus Genitalium Mycoplasma Genitalium Haemophilus Ducreyi Treponema Pallidum Chlamydia Trachomatis Neisseria Gonorrhoeae Trichomanas Vaginalis Herpes Simplex 1 Herpes Simplex 2 Enterococcus Faecalis Escherichila Coli Staphylococcus Aureus Streptococcus Agalactiae Candida Tropicalis Candida Albicans Candida Lusitaniae Candida Dubliensis Candida Parapsilosis Candida Glabrata Candida Krusel 2. Review of the laboratory client service manual Instructions for Use for the Vaginal Panel Specimen Collection under swab storage and transport revealed stability at 2-30 C for 8 days and 2-8C for 14 days. 3. Review of the laboratory policy Specimen Hold, Rejection, Send Out, and Missing information (GEN-012.00) under Rejected Specimens "specimen is outside of established stability requirements (e.g. too old) Women's Health Specimens [vaginal panel specimen] are stable for 19 days at 4 C." A) temperature 4. Review of the laboratory preanalytical studies revealed no documentation of stability temperature studies to include 2-30 C for 8 days or 2-8 C for 14 days or 19 days at 4 C. B) specimen stability 5. Review of the laboratory preanalytical studies revealed no documentation of stability of the presence of 7 of 34 organisms for any temperature range assessed (4 C or -20 C). Megasphaera Species 2 Mobiluncus Mulieris Mycoplasma Genitalium Haemophilus Ducreyi Treponema Pallidum Candida Lusitaniae Candida Dubliensis 6. An interview with the technical supervisor on 1/26 /21 at 1250 hours in the conference room and confirmed with one of the lab couriers revealed that all specimens collected are stored in a cooler during transport. No temperature is monitored before, during, or after transport of all specimens. The courier also confirmed that there is no set criteria for "refrigerated" specimens. 7. Random review of the Women's Health Panel testing for the Vaginits Panel from October 2020-January 2021 using the Copan eSwab revealed the following elapsed time in days. accn # collection date run date elapsed time 49777 10/29/2020 10/30 /2020 1 52827 11/06/2020 11/11/2020 5 58465 11/18/2020 11/20/2020 2 65947 12/01 -- 2 of 5 -- /2020 12/03/2020 2 68946 12/07/2020 12/08/2020 1 97800 01/18/2021 01/19/2021 1 96638 01/15/2021 01/19/2021 4 98605 01/19/2021 01/23/2021 4 100157 01/21/2021 01/23/2021 2 83759 12/28/2020 01/01/2021 4 75372 12/15/2020 12/18/2020 3 68996 12/07/2020 12/11/2020 4 75371 12/15/2020 12/18/2020 3 70675 12/09/2020 12/11 /2020 2 8. An interview with the technical supervisor #1 on 1/27/21 at 1120 hours in the conference room confirmed the above findings. She agreed that the laboratory should establish the temperature range used in the client service manual. She also acknowledged that the presence of the organism should be used to determine stability. II. Based on review of the laboratory records, patient test records from December 2020 to January 2021 and confirmed in interview, the laboratory failed to document complete preanalytical studies for the SARS-CoV 2 testing. A) specimen stability and temperature B) specimen transport media Findings were: 1. Review of the laboratory records revealed the laboratory started SARS-CoV 2 testing on 05/2020. 2. Review of the laboratory client service manual Respiratory Specimen Collection Guide under materials revealed 4 acceptable transport media: VTM (viral transport media), MTM (molecular transport media), Liquid amies, or PBS (phosphate buffered saline). 3. Review of the laboratory policy Specimen Hold, Rejection, Send Out, and Missing information (GEN-012.00) under Rejected Specimens "specimen is outside of established stability requirements (e.g. too old) respiratory swabs are stable for 24 hours at room temperature or 14 days at 4 C." A) specimen stability and temperature 4. Review of the laboratory preanalytical studies revealed no documentation of stability temperature studies to include 24 hours at room temperature or 14 days at 4 C. B) specimen transport media 5. Review of the laboratory preanalytical studies revealed no documentation of complete stability studies for 3 of the 4 acceptable transport media: VTM, liquid Amies, and MTM. 6. An interview with the technical supervisor on 1/26/21 at 1250 hours in the conference room and confirmed with one of the lab couriers revealed that all specimens collected are stored in a cooler during transport. No temperature is monitored before, during, or after transport of all specimens. The courier also confirmed that there is no set criteria for "refrigerated" specimens. 7. Random review of the SARS-CoV 2 patient testing from December 2020-January 2021 revealed the laboratory performed 15 patient testing with the following elapsed time in days. All specimen received were nasopharangeal swabs with PBS transport media. accn # collected run date elapsed time 97381 01/18/2021 01 /19/2021 1 97378 01/18/2021 01/19/2021 1 97386 01/18/2021 01/19/2021 1 93668 01 /12/2021 01/13/2021 1 93693 01/12/2021 01/13/2021 1 94422 01/13/2021 01/14/2021 1 94421 01/13/2021 01/14/2021 1 96946 01/16/2021 01/17/2021 1 93994 01/12/2021 01/13/2021 1 65941 12/01/2020 12/02/2020 1 71873 12/11/2020 12/12/2020 1 72271 12/11/2020 12/12/2020 1 100812 01/22/2021 01/23/2021 1 94510 01/13/2021 01/14 /2021 1 95834 01/14/2021 01/15/2021 1 8. An interview with the technical supervisor #1 on 1/27/21 at 1120 hours in the conference room confirmed the above findings. She agreed that the laboratory should establish the temperature range used in the client service manual. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, and staff interview it was revealed the -- 3 of 5 -- laboratory failed to have documentation of a quality assurance plan to identify and correct problems in preanalytic systems. Refer to D5311 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 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: Based on review of the laboratory records, patient test records from October 2020 to January 2021 and confirmed in interview, the laboratory failed to document complete establishment studies for for 2 of 2 laboratory developed tests: Vaginits Open Array Panel and SARS-CoV 2 testing. A) Vaginits Open Array Panel B) SARS-CoV 2 Findings were: 1. Review of the laboratory policy Method Validation Plan (GEN- 008.0) revealed "a method validation plan/proposal should be created and approved by the laboratory director prior to the start of the validation study. This policy is to be used to create the validation plan, validation specifics may be added or taken out, as appropriate for the test system being validated." 2. Review of the laboratory establishment records for both lab developed tests: Vaginits Open Array Panel and SARS-CoV 2 revealed no documentation of the validation plan/proposal to include the acceptance criteria of all studies performed: precision, accuracy, limit of detection, preanalytical studies, and any other performance characteristics required for test performance for all acceptable specimen types. 3. Random review of the Women's Health Panel testing for the Vaginits Panel from October 2020-January 2021 revealed the laboratory performed 14 patient testing. accn # 49777 52827 58465 65947 68946 97800 96638 98605 100157 83759 75372 68996 75371 70675 4. Random review of the SARS-CoV 2 patient testing from October 2020-January 2021 revealed the laboratory performed 15 patient testing. accn # 97381 97378 97386 93668 93693 94422 94421 96946 93994 65941 71873 72271 100812 94510 95834 5. An interview with the technical supervisor #1 on 1/27/21 at 1230 hours in the conference room confirmed the above findings. D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory records, manufacturer's instructions and confirmed in interview, the laboratory failed to establish and document performance -- 4 of 5 -- specifications for their QC (quality control) material used for 2 of 2 laboratory developed tests: Vaginits Open Array Panel and SARS-CoV 2 testing. A) Vaginits Open Array Panel B) SARS-CoV 2 Findings included: A) Vaginits Open Array Panel 1. Review of the laboratory records from October 2020- January 2021 revealed the laboratory performed Vaginits Open Array Panel with the qualitative detection of the following 34 organisms on vaginal Copan eSwabs. Atopobium Vaginae BVAB2 Megasphaera Species 1 Megasphaera Species 2 Mycoplasma Hominis Ureaplasma Urealyticum Gardnerella vaginalis Bacteroides Fragilis Lactobacillus Crispatus Prevotella Bivia Mobiluncus Curtisil Mobiluncus Mulieris Lactobaccillus Gasseri Lactobaccillus Iners Lactobaccillus Genitalium Mycoplasma Genitalium Haemophilus Ducreyi Treponema Pallidum Chlamydia Trachomatis Neisseria Gonorrhoeae Trichomanas Vaginalis Herpes Simplex 1 Herpes Simplex 2 Enterococcus Faecalis Escherichila Coli Staphylococcus Aureus Streptococcus Agalactiae Candida Tropicalis Candida Albicans Candida Lusitaniae Candida Dubliensis Candida Parapsilosis Candida Glabrata Candida Krusel 2. Review of the laboratory records revealed no documentation of the establishment of 3 of 3 quality control (NTC, POSA, POSB) the laboratory used for the Vaginits Open Array Panel. 3. Random review of the Women's Health Panel testing for the Vaginits Panel from October 2020- January 2021 revealed the laboratory performed 14 patient testing using the 3 quality controls (NTC, POSA, POSB). accn # 49777 52827 58465 65947 68946 97800 96638 98605 100157 83759 75372 68996 75371 70675 B) SARS-CoV 2 4. Review of the laboratory records from October 2020-January 2021 revealed the laboratory performed SARS-CoV 2 using 2 quality control (NTC, POS CON). 5. Review of the laboratory records available revealed no documentation of the verification of both quality control above. 6. Random review of the SARS-CoV 2 patient testing from October 2020-January 2021 revealed the laboratory performed 15 patient testing using the 2 quality control (NTC, POS CON). accn # 97381 97378 97386 93668 93693 94422 94421 96946 93994 65941 71873 72271 100812 94510 95834 7. An interview with the technical supervisor on 1/27/21 at 1100 hours in the conference room confirmed the above findings. key: NTC - no template control POSA - positive control POSB - positive control POS CON - positive control D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, and staff interview, the laboratory failed to have documentation of a quality assurance plan to monitor and detect errors in the analytic systems. (refer to D5423) -- 5 of 5 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to establish a uni-directional workflow for the molecular amplification that included a separate area for specimen preparation and reagent preparation for PGX (pharmacogenomics) patient testing on the Applied Biosystems Quant Studio 12k Flex analyzer. Findings were: 1. Surveyor observations on 10/11/18 at 1020 hours revealed the testing person prepared reagents and specimen in the same area in the PGX amplification room. 2. An interview with the general supervisor on 10/11/18 at 1040 hours in the laboratory confirmed the above findings. He was unaware that the reagent preparation and sample preparation need to be in separate areas. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of the 2016 and 2017 personnel records, laboratory policies, and confirmed in interview, the laboratory failed to document the competency assessment for 1 of 1 general supervisor (GS) and 2 of 2 technical supervisors (TS). Findings were: 1. Review of the 2016 and 2017 personnel records revealed no documentation of the competency assessments for 1 of 1 general supervisor (hire date 12/2016) and 2 of 2 technical supervisors (TS #1 hire date 12/2016, TS#2 hire date 05/2017). 2. An interview with the general supervisor on 10/11/18 at 1420 hours confirmed the above findings. He was unaware the GS and TS required competencies. 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 College of American Pathologists (CAP) proficiency testing records from 2016 and 2017 and confirmed in interview, the laboratory failed to verify twice annually the accuracy of all tests it performed on the API-3000 LC/MS /MS analyzer. The findings were: 1. The laboratory's test menu included a total of 76 toxicology tests performed on the API-3000 LC/MS/MS analyzer: 6- Monoacetylmorphine (6-MAM) 11-Nor-9-carboxy -tetrahydrocannabinol (11-COOH- THC or THC-COOH) 7 Amino-clonazepam Alpha-hydroxyalprazolam Alprazolam Amitripyline Amphetamine Benzolecgonine Buprenorphine Butalbital Carisoprodol Citalopram Clomipramine Codeine Cotinine Cyclobenzaprine Desipramine Desalkylflurazepam Dextromethorphan Doxepin Duloxetine EDDP ETS ETG Fentanyl Fluoxetine Gabapentine Hydrocodone Hydromorphone Hydroxymidazolam Imapramine Ketamine Lorazepam MDA MDMA MDPV Meperidine Meprobamate Mephedrone Methadone Methylone Methamphetamine Mitraginine Morphine N- Desmethyl-Tapentadol Naloxone Naltrexone Norbuprenorphine Nordiazepam Norfentanyl Norfluoxetine Norketamine Nortripyline Noroxycodone Norhydrocodone Normeperidine o-desmethyltramadol o-desmethylvenlafaxine Oxazepam Oxycodone Oxymorphone Paroxetine Phenobarbital Phencyclidine Phentermine Pregabalin Ritalinic acid Sertraline Secobarbital Sufantanil Tapentadol Tramadol Temazepam Trimipramine Venlafaxine Zolpidam-4-Carboxylic Acid 2. Review of the 2016 proficiency testing records revealed no documentation of twice annual assessment for 18 of 76 analytes on the API-3000 LC/MS/MS analyzer Codeine, Tramadol, Tapentadol, Alprazolam, aOH-Alprazolam, Carisoprodol, Meprobamate, PCP Hydrocodone Hydromorphone Fentanyl Methadone EDDP Nordiazepam Benzolecogine 6-MAM Methamphetamine THC-COOH 3. Review of the 2017 proficiency testing records revealed no documentation of twice annual assessment for 18 of 76 analytes on the API-3000 LC/MS/MS analyzer Codeine, Tramadol, Tapentadol, Alprazolam, aOH-Alprazolam, Carisoprodol, Meprobamate, PCP Hydrocodone Hydromorphone Fentanyl Methadone EDDP Nordiazepam Benzolecogine 6-MAM Methamphetamine THC-COOH 4. An interview with the primary testing person on 10/10/18 at 1100 hours in the laboratory confirmed the above findings. He stated that he had trouble finding another laboratory to perform the accuracy assessment for the missing analytes. -- 2 of 8 -- 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 review of the laboratory policy, establishment studies, patient final reports, and confirmed in interview, the laboratory failed to document a stability study that substantiated the conclusions of the Client Service Manual for laboratory-developed tests for urine confirmatory toxicology testing on the API-3000 LC/MS/MS toxicology analyzer. Findings were: 1. Review of the laboratory records revealed the laboratory performed toxicology testing on the API-3000 LC/MS/MS toxicology analyzer for the following analytes. 6-Monoacetylmorphine (6-MAM) 11-Nor-9- carboxy -tetrahydrocannabinol (11-COOH-THC or THC-COOH) 7 Amino- clonazepam Alpha-hydroxyalprazolam Alprazolam Amitripyline Amphetamine Benzolecgonine Buprenorphine Butalbital Carisoprodol Citalopram Clomipramine Codeine Cotinine Cyclobenzaprine Desipramine Desalkylflurazepam Dextromethorphan Doxepin Duloxetine EDDP ETS ETG Fentanyl Fluoxetine Gabapentine Hydrocodone Hydromorphone Hydroxymidazolam Imapramine Ketamine Lorazepam MDA MDMA MDPV Meperidine Meprobamate Mephedrone Methadone Methylone Methamphetamine Mitraginine Morphine N-Desmethyl- Tapentadol Naloxone Naltrexone Norbuprenorphine Nordiazepam Norfentanyl Norfluoxetine Norketamine Nortripyline Noroxycodone Norhydrocodone Normeperidine o-desmethyltramadol o-desmethylvenlafaxine Oxazepam Oxycodone Oxymorphone Paroxetine Phenobarbital Phencyclidine Phentermine Pregabalin Ritalinic acid Sertraline Secobarbital Sufantanil Tapentadol Tramadol Temazepam Trimipramine Venlafaxine Zolpidam-4-Carboxylic Acid 2. Review of the laboratory manual BAS Premier Lab Client Service Manual (Toxicology) revealed "specimens should be sent on the same day of collection. Specimens are stable at room temperature up to 12 days." 3. Review of the laboratory establishment studies revealed documentation the laboratory performed room temperature (18-25C) stability for 76 of 76 analytes at Day 0, Day 1, Day 3, Day 5, Day 7, Day 9, Day 12, and Day 15. 4. Further review of the room temperature stability study revealed no documentation of the stability for 76 of 76 analytes for Day 2, Day 4, Day 8, Day 10, Day 11, Day 13, and Day 14. Note: Review of the laboratory CMS116 revealed the laboratory hours of operation was Monday to Friday 9 am to 5 pm. 5. Random review of July to September 2018 laboratory records revealed the laboratory performed toxicology patient testing with elapsed time of Day 2, Day 4, and Day 6. 7/23/18 Patient accession TOX000007716; collected 7/19/18; received 7/23/18; elapsed time 4 days 8/6/18 Patient accession TOX000008176; collected 7/31/18; received 8/06/18; elapsed time 6 days 8/6/18 Patient accession TOX000008181; collected 7/31/18; received 8/06/18; elapsed time 6 days 8/13/18 Patient accession TOX000008405; collected 08/09/18; received 8/13/18; elapsed time 4 days 9/11/18 Patient accession TOX000009299; collected 09/07/18; received 09/11/18; elapsed time 2 days 6. An interview with the general supervisor on 10/10/18 at 1215 hours in the laboratory confirmed the above findings. He was unaware the laboratory was required to perform stability studies for each day. -- 3 of 8 -- 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 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: Based on observations, review of the laboratory establishment studies, laboratory quality control records and patient logs, and confirmed in interview, the laboratory failed to document complete establishment studies for the calibrations, controls, and internal standards working solutions used for the laboratory-developed tests for urine toxicology confirmatory testing on the API-3000 LC/MS/MS toxicology analyzer. Findings were: 1. A tour of the laboratory on 10/10/18 at 1100 hours revealed the following 6 standards, controls, and internal standards working solutions stored in the Tox laboratory freezer (-20 C). Method 2 IS [internal standard] working solution prepared 7/18/18 expiration 10/18/18 Method 1/3 IS working solution prepared 9/18 /18 expiration 3/18/19 Method 2 QC [quality control] stock prepared 06/04/18 expiration 06/04/19 Method 2 Cal [calibrators] stock prepared 8/4/18 expiration 6/4 /19 Method 1/3 QC stock prepared 6/4/18 expiration 6/4/19 Method 1/3 Cal stock prepared 6/4/18 expiration 6/4/19 2. Review of the laboratory establishment studies revealed no documentation of stability studies for the above standards, controls, and internal standard working solutions. 3. Random review of the July to September 2018 toxicology patient log sheets and quality control records revealed the laboratory performed patient testing using the above calibrations, controls, and internal standards working solutions. 7/23/18 Patient accession TOX000007695 7/23/18 Patient accession TOX000007716 8/3/18 Patient accession TOX000008143 8/6/18 Patient accession TOX000008176 8/6/18 Patient accession TOX000008181 8/10/18 Patient accession TOX000008357 8/13/18 Patient accession TOX000008405 9/11/18 Patient accession TOX000009299 9/28/18 Patient accession TOX000009828 4. An interview with testing person #1 on 10/10/18 at 1115 hours in the laboratory confirmed the above findings. She stated that she prepared calibrators, standards and controls every few months but was unaware stability studies were required for them. D5453 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iv)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each test system that has an extraction phase, include two control materials, including one that is capable of detecting errors in the extraction process; (g) The laboratory must document all control procedures performed. -- 4 of 8 -- This STANDARD is not met as evidenced by: Based on surveyor observations, review of laboratory extraction worksheets, and confirmed in interview, the laboratory failed to perform two control materials during the extraction phase every day of PGX (pharmacogenomics) patient testing on the Applied Biosystems Quant Studio 12k Flex. Findings were: 1. Surveyor observations on 10/11/18 at 1020 hours in the PGX extraction room revealed the general supervisor failed to perform 2 external quality controls for during extraction of PGX testing. He only performed 1 of 2 external quality control (NTC- no template control). 2. Random review of the laboratory extraction worksheets from June to October 2018 revealed 3 of 3 days when the laboratory had documentation of 1 of 2 extraction control (NTC) for the following days of patient testing. 6/30/18 7/2/18 10/11/18 3. Random review of laboratory patient records of the above dates revealed the laboratory performed patient testing on the above dates. 6/30/18 Patient ID GEN000001988 7/2/18 Patient ID GEN000001980 10/11/18 Patient ID GEN000002348 Patient ID GEN000002338 Patient ID GEN000002350 Patient ID GEN000002351 4. An interview with the general supervisor on 10/11/18 at 1120 hours in the laboratory confirmed the above findings. He was unaware he needed to perform 2 extraction controls every day of patient testing. According to the CMS-116 signed by the laboratory director on 10/2 /18, the facility performed 79860 PGX testing annually. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, laboratory quality control records, laboratory patient records, and confirmed in interview, the laboratory failed to establish the quality control (QC) acceptable range for the API-3000 LC/MS/MS toxicology analyzer. Findings were: 1. Review of the laboratory quality control (QC) toxicology records from June to September 2018 revealed the laboratory performed quality control toxicology testing on the API-3000 LC/MS/MS toxicology analyzer for the following 76 analytes using the analyte target range +/- 25 %. Method 2 QC [quality control] stock prepared 06/04/18 expiration 06/04/19 Method 1/3 QC stock prepared 6/4/18 expiration 6/4/19 6-Monoacetylmorphine (6-MAM) (Low: 12.8 - 19.2 ng/mL; Mid: 64 - 96 ng/mL; High 320 - 480 ng/mL) THC-COOH (Low: 32 - 48 ng /mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) 7 Amino-clonazepam (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Alpha- hydroxyalprazolam (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng /mL) Alprazolam (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng /mL) Amitripyline (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng -- 5 of 8 -- /mL) Amphetamine (Low: 64 - 96 ng/mL; Mid: 320 - 480 ng/mL; High 1600 - 2400 ng/mL) Benzolecgonine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Buprenorphine (Low: 9.4 - 9.6 ng/mL; Mid: 32 - 48 ng/mL; High: 160 - 240 ng/mL) Butalbital (Low: 128 - 192 ng/mL; Mid: 640 - 960 ng/mL; High 3200 - 4800 ng/mL) Carisoprodol (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Citalopram (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Clomipramine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Codeine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Cotinine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng /mL) Cyclobenzaprine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Desipramine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Desalkylflurazepam (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Dextromethorphan (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Doxepin (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Duloxetine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) EDDP (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng /mL) ETS (Low: 128 - 192 ng/mL; Mid: 640 - 960 ng/mL; High 3200 - 4800 ng/mL) ETG (Low: 320 - 480 ng/mL; Mid: 1600 - 2400 ng/mL; High 8000 - 12000 ng/mL) Fentanyl (Low: 9.4 - 9.6 ng/mL; Mid: 32 - 48 ng/mL; High: 160 - 240 ng/mL) Fluoxetine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Gabapentine (Low: 128 - 192 ng/mL; Mid: 640 - 960 ng/mL; High 3200 - 4800 ng /mL) Hydrocodone (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng /mL) Hydromorphone (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Hydroxymidazolam (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Imapramine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Ketamine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Lorazepam (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) MDA (Low: 64 - 96 ng/mL; Mid: 320 - 480 ng/mL; High 1600 - 2400 ng /mL) MDMA (Low: 64 - 96 ng/mL; Mid: 320 - 480 ng/mL; High 1600 - 2400 ng/mL) MDPV (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Meperidine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Meprobamate (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Mephedrone (Low: 32 - 48 ng/m(Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Methadone (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Methylone (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Methamphetamine (Low: 64 - 96 ng/mL; Mid: 320 - 480 ng/mL; High 1600 - 2400 ng/mL) Mitraginine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Morphine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) N-Desmethyl-Tapentadol (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Naloxone (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Naltrexone (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng /mL; High: 800 - 1200 ng/mL) Norbuprenorphine (Low: 12.8 - 19.2 ng/mL; Mid: 64 - 96 ng/mL; High 320 - 480 ng/mL) Nordiazepam (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Norfentanyl (Low: 9.4 - 9.6 ng/mL; Mid: 32 - 48 ng /mL; High: 160 - 240 ng/mL) Norfluoxetine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng /mL; High: 800 - 1200 ng/mL) Norketamine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng /mL; High: 800 - 1200 ng/mL) Nortripyline (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng /mL; High: 800 - 1200 ng/mL) Noroxycodone (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Norhydrocodone (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Normeperidine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) o-desmethyltramadol (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) o-desmethylvenlafaxine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Oxazepam (Low: 32 - 48 -- 6 of 8 -- ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Oxycodone (Low: 32 - 48 ng /mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Oxymorphone (Low: 32 - 48 ng /mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Paroxetine (Low: 32 - 48 ng /mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Phenobarbital (Low: 128 - 192 ng/mL; Mid: 640 - 960 ng/mL; High 3200 - 4800 ng/mL) Phencyclidine (Low: 9.4 - 9.6 ng/mL; Mid: 32 - 48 ng/mL; High: 160 - 240 ng/mL) Phentermine (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Pregabalin (Low: 128 - 192 ng/mL; Mid: 640 - 960 ng/mL; High 3200 - 4800 ng/mL) Ritalinic acid (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Sertraline (Low: 32 - 48 ng /mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Secobarbital (Low: 128 - 192 ng/mL; Mid: 640 - 960 ng/mL; High 3200 - 4800 ng/mL) Sufentanyl (Low: 9.4 - 9.6 ng/mL; Mid: 32 - 48 ng/mL; High: 160 - 240 ng/mL) Tapentadol (Low: 32 - 48 ng /mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Tramadol (Low: 32 - 48 ng /mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Temazepam (Low: 32 - 48 ng /mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Trimipramine (Low: 32 - 48 ng /mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Venlafaxine (Low: 32 - 48 ng /mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) Zolpidam-4-Carboxylic Acid (Low: 32 - 48 ng/mL; Mid: 160 - 240 ng/mL; High: 800 - 1200 ng/mL) 2. Review of the 2018 toxicology quality control records revealed no documentation of the laboratory establishing the above acceptable quality control ranges. 3. An interview with testing person #1 on 10/10/18 at 1115 hours in the laboratory confirmed the above findings. She stated that the laboratory used the target value +/- 25%, but the laboratory did not establish them. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, establishment studies, patient final reports, and confirmed in interview, the laboratory director failed to ensure the laboratory documented a complete stability study for urine confirmatory toxicology testing on the API-3000 LC/MS/MS toxicology analyzer. Refer to D5311 D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on observations, review of the laboratory establishment studies, laboratory quality control records and patient logs, and confirmed in interview, the laboratory director failed to ensure the laboratory documented complete establishment studies for urine toxicology confirmatory testing on the API-3000 LC/MS/MS toxicology analyzer. Refer to D5423 -- 7 of 8 -- D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, laboratory quality control records, laboratory patient records, and confirmed in interview, the laboratory director failed to ensure the laboratory established the quality control (QC) acceptable range for the API-3000 LC/MS/MS toxicology analyzer. Refer to D5469 D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of the laboratory competency records and confirmed in interview, the technical supervisor failed to document competency assessment for quality control and preventive maintenance records. Findings were: 1. Review of the 2017 and 2018 competency records revealed 1 of 1 testing person (TP #1) with no documentation of competency for 2 of 2 annual competency assessment for quality control and preventative maintenance for the API-3000 LC/MS/MS toxicology analyzer. 2. An interview with the general supervisor on 10/10/18 at 0955 hours in the laboratory confirmed the above findings. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of the laboratory competency records and confirmed in interview, the technical supervisor failed to document competency assessment of test performance through testing previously analyzed specimens, internal blind testing or external proficiency testing samples. Findings were: 1. Review of the 2017 and 2018 competency records revealed 1 of 1 testing person (TP #1) with no documentation of competency for 2 of 2 annual competency assessment of test performance through testing previously analyzed specimens, internal blind testing or external proficiency testing samples for the API-3000 LC/MS/MS toxicology analyzer. 2. An interview with the general supervisor on 10/10/18 at 0955 hours in the laboratory confirmed the above findings. -- 8 of 8 --