Prism Lab Llc

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review, observation, and interview, the laboratory failed to have sufficient reagents to perform quantitative urine toxicology testing before specimens were no longer stable (refer to D3007) and failed to retain its documentation for its verification of accuracy (refer to D3031). D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: . Based on observation and interview with Testing Personnel #3, the laboratory failed to have sufficient reagents to perform quantitative urine toxicology testing before specimens were no longer stable for 56 of 56 patient urine specimens observed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Findings include: 1. A review of the laboratory's "PSYCH Panel Validation Report Summary" establishment of performance specifications revealed a section stating the following, "Pre-preparative (storage) stability was assessed by preparing multiple sets of samples at low, mid, and high concentrations and storing them at refrigerated temperature (2-8 degrees C) for up to 7 days." 2. A review of the laboratory's "MAIN PANEL Validation Report Summary" establishment of performance specifications revealed a section stating the following, "Storage stability (pre-preparative stability) for the analytes in urine at refrigerated temperatures (2-8 degrees C) was demonstrated for up to 7 days." 3. A review of the laboratory's "Urine Specimen Collection and Patient Instructions Policy" revealed a section stating, "If the samples are not analyzed immediately, specimens may be stored up to 7 days refrigerated and frozen for 30 days." 4. The surveyor observed 56 patient specimens with collection dates of 7/18/23 and 7/19/23 in the refrigerator on 7/31/23 at 10:30 am. 5. An interview on 7/31/23 at 10:30 am with Testing Personnel #3 revealed the specimens collected on 7/18/23 and 7/19/23 had not been tested yet due to a lack of a synthetic urine reagent. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the Lab Scientist, the laboratory failed to retain its documentation for its verification of accuracy for 1 (April 2022 Event) of 2 events reviewed. Findings include: 1. A review of the laboratory's April 2022 verification of accuracy testing event revealed a lack of documentation of the reference laboratory reports used to compare the accuracy of its quantitative toxicology testing. 2. The surveyor requested the documentation of the reference laboratory reports used to compare the accuracy of its quantitative toxicology testing on 7/31/23 at 12:17 pm and it was not made available. 3. An interview on 7/31/23 at 4: 20 pm with the Lab Scientist confirmed the laboratory did not have documentation of the reference laboratory reports used to compare the accuracy of its quantitative toxicology testing available. 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 record review, observations, and interviews, the laboratory failed to assess the competency of its General Supervisor (refer to D5209), failed to perform verification of accuracy testing at least twice annually (refer to D5217), failed to follow its policies and procedures for specimen storage, preservation, acceptability, and rejection (refer to D5311), failed to establish policies and procedures for urine quantitative toxicology specimen transportation and calibration (refer to D5403), the -- 2 of 6 -- laboratory failed to label its urine quantitative toxicology reagents with the preparation and expiration dates (refer to D5415 A), failed to label its urine quantitative toxicology control materials with the preparation and expiration dates (refer to D5415 B), and failed to perform

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the Laboratory Director (LD) and the Testing Personnel (TP) failed to attest to the routine integration of the proficiency testing samples into the patient workload for 1 (UT-C 2021) of 4 testing events reviewed. Findings include: 1. A review of the College of American Pathologists' (CAP) proficiency testing records revealed a lack of signatures on the attestation statement sheet of the LD and the TP for 1 (UT-C) of 4 testing events in 2020 and 2021. 2. An interview on 1/10/2022 at 3:12 pm, the GS confirmed the LD and TP did not attest to the integration of samples into the patient workload. 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: A - Quantitative Analysis Comprehensive Tox Pain Panel Based on record review and interview with the General Supervisor, the laboratory failed to verify the accuracy of its laboratory testing for 2 (January 2020 to January 2022) of 2 years reviewed. Findings include: 1. A record review of the "Quantitative Analysis Comprehensive Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Tox Pain Panel" on the patient test requisition revealed the following tests are being performed: a. Buprenorphine b. Norbuprenorphine c. Codeine d. Dihydrocodeine e. Morphine f. Hydrocodone g. Norhydrocodone h. Hydromorphone i. Oxycodone j. Noroxycodone k. Oxymorphone l. Noroxymorphone m. Fentanyl n. Norfentanyl o. Sufentanil p. Methadone q. EDDP r. Merperidine s. Normeperidine t. Naloxone u. Naltrexone v. Tapentadol w. Tramadol x. O-Desmethl-cis-tramadol y. Alprazolam z. Hydroxyalprazolam aa. Clonazepam bb. 7-Amino Clonazepam cc. Flunitrazepam dd. Flurazepam ee. Lorazepam ff. Midazolam gg. Diazepam hh. Nordiazepam ii. Temazepam jj. Oxazepam ll. Triazolam ll. Amphetamine mm. Benzoylecgonine (Cocaine) nn. Cocaethylene oo. Cocaine pp. 6-MAM (Heroin) qq. Methamphetamine rr. MDA ss. MDEA tt. MDMA uu. THC-COOH vv. PCP ww. Gabapentin xx. Methylphenidate yy. Pregabalin zz. Carisoprodol aaa. Meprobamate bbb. Norpropoxyphene ccc. Propoxyphene ddd. Ritalinic Acid eee. Zaleplon fff. Zopiclone ggg. Zalpidem hhh. Amobarbital Pentobarbital iii. Butabarbital jjj. Butalbital kkk. Phenobarbital lll. Secobarbital mmm. Nicotine nnn. Continine 2. The surveyor requested documentation of twice annual verification of accuracy for the toxicology testing listed above at 1:11 pm and it was not made available. 3. An interview on 01/10 /2022 at 1:11 pm, the General Supervisor confirmed the laboratory did not have documentation of twice annual verification of accuracy testing from January 2020 to January 2022 for the toxicology testing listed above. B - Quantitative Analysis Comprehensive Tox Pysch Panel Based on record review and interview with the General Supervisor, the laboratory failed to verify the accuracy of its laboratory testing for 2 (January 2020 to January 2022) of 2 years reviewed. Findings include: 1. A record review of the "Quantitative Analysis Comprehensive Tox Pysch Panel" on the patient test requisition revealed the following tests are being performed: a. Carbamazepine b. Carbamazepine Epoxide c. Hydroxy-Carbamazepine d. Oxcarbazepine e. Bupropion f. Hydroxybupropion g. Citalopram Escitalopram h. Duloxetine i. Fluoxetine j. Norfluoxetine k. Mirtazapine l. Desmethylmirtazapine m. Paroxetine n. Selegline o. Sertraline p. Trazodone q. Venlafaxine r. O- Desmethylvenlafaxine s. Ariprazole t. Asenapine u. Clozapine v. Fluphenazine w. Haloperidol x. Iloperidone y. Lamotrigine z. Lurasidone aa. Olanzapine bb. Desmethylolanzapine cc. Quetiapine dd. 7-Hydroxyquetiapine ee. Norquestiapine ff. Risperidone gg. 9-Hydroxyrisperidone hh. Ziprasidone ii. Lisdexamfetamine jj. Phentermine kk. Amitriptyline ll. Clomipramine mm. Desipramine nn. Doxepin oo. Imipramine pp. Nortriptyline qq. JWH-018 rr. JWH-073 ss. LSD tt. MDPV uu. Mephedrone vv. Methcathinone ww. Methylone xx. Buspirone yy. Cyclobenzaprine zz. Dextromethorphan aaa. Diphenhydramine bbb. Ketamine ccc. Methylephedrine ddd. Mitragynine eee. 7-Hydroxymitragynine 2. The surveyor requested documentation of twice annual verification of accuracy for the toxicology pysch testing listed above at 1:11 pm and it was not made available 3. An interview on 01/10 /2022 at 1:11 pm, the General Supervisor confirmed the laboratory did not have documentation of twice annual verification of accuracy testing from January 2020 to January 2022 for the toxicology pysch testing listed above. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when -- 2 of 4 -- they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the laboratory failed to perform quality control testing each day of patient testing for 2 (2011080012 and 1953) of 11 patient testing dates reviewed. Findings include: 1. A review of patient test records revealed a lack of acceptable quality control (QC) results for the following tests: a. Patient 2011080012 tested on 11/08/2020 - no acceptable QC for Zaleplon b. Patient 1953 tested on 3/29/2021 - no acceptable QC for Cocaine and Sufentanil 2. A review of the patient testing logs revealed 31 patient were tested on 11/08/2020 and 55 patients on 3/29/2021. 3. A review of the laboratory's "Procedure for "OUT OF CONTROL" Controls" revealed "If the Controls are "Out of Control" the following steps will be followed to correct the problem: 1. Check controls and reagents for contamination, out dating or poor storage. 2. Re- analyze the same control - if results are OK run patient - if they are still out of limits - 3. Use a fresh vial of controls - if they are OK, run patient - if they are still out of limits - 4. Calibrate the instrument (if applicable) and run controls again - if they are OK run patient - if they are still out of limits - 5. Call manufacturers for help or service if problem can be corrected by phone and controls come out - run patient - if not corrected - notify the ordering physician, send specimen out to reference lab for testing - or - specimens may be stored until problem is corrected - if storage is acceptable for test and result is not needed immediately. The decision to send out or store will be made by the ordering physician or laboratory director. 6. Record all QC

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #2 (GS2), the laboratory failed to have a test request for patient testing for 7 (patients #1-#7) of 7 patients reviewed. Findings include: 1. A record review of patient test requests revealed patients #1-#7 did not have orders indicated on the test request submitted to the laboratory upon receipt of the specimens. 2. A record review of patient test results revealed patients #1-#7 had toxicology test reports generated for the test requests submitted without testing indicated for the laboratory to perform. 3. An interview on 1 /13/2020 at 1:48 pm with GS2 confirmed the patient specimens submitted to the laboratory did not have tests indicated to perform on the test request and the laboratory does not have a standing order policy established. ***Repeat Deficiency from 11/07/2019 survey*** Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: . A. Based on record review and interview with the Technical Supervisor (TS) and General Supervisor #2 (GS2), the laboratory failed to ensure the test requisition had the tests to be performed indicated for 5 (patients #1, #5, #6, #7, and #8) of 8 patient charts audited. Findings include: 1. A patient chart audit revealed the following patients had test requisitions without the tests to be performed indicated on the requisition for the following dates: a. Patient #1 had testing performed on 4/24/19 b. Patient #5 had testing performed on 10/12/19 c. Patient #6 had testing performed on 10 /18/19 d. Patient #7 had testing performed on 10/26/19 e. Patient #8 had testing performed on 11/3/19 2. An interview on 11/7/19 at 2:50 pm with the TS and GS2 confirmed the patients listed above did not have the tests to be performed indicated on the corresponding test requisitions. B. Based on record review and interview with the Technical Supervisor (TS) and General Supervisor #2 (GS2), the laboratory failed to 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 -- ensure the test requisition indicated the patient's name or unique identifier, sex, and age or date of birth for 1 (patient #5) of 8 patient charts audited. Findings include: 1. A patient chart audit revealed patient #5 had a test requisition on file for 10/12/19 when testing was performed. 2. A review of the test requisition for patient #5 revealed it was missing the patient's name or unique identifier, sex, and age or date of birth. 3. An interview on 11/7/19 at 2:50 pm with the TS and GS2 confirmed the information listed above was missing from the test requisition for patient #5. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor (TS) and General Supervisor #2 (GS2), the laboratory failed to enter test requisitions accurately for 8 (#1 - #8) of 8 patients reviewed. Findings include: 1. Record review of patient #1-#8 test requisitions and final reports from April to November 2019 revealed the following discrepancies: Patient #1 a. The test requisition revealed a "Comprehensive Quantitative Analysis" panel was ordered. b. The tests indicated in the "Comprehensive Quantitative Analysis" panel signed by the ordering physician on 04 /15/19 included the following tests that were not on the final report: "Alcohol - ETG and ETS, Methylphenidate, Anticonvulsant - Gabapentin and Pregabalin, Barbiturates - Secobarbital, Phenobarbital, and Butalbital, Benzodiazepine - 2-Hydroxyethyl, Desalkflyrazepam, Midazolam, Alpha-Hydroxymidazolam, and Chlordiazeproxide, Naloxone, Cathinones (Bath Salts) - MDPV, Methedrone, Methylone, and Pentedrone, Muscle Relaxant - Carisoprodol and Meprobamate, Nicotine Metabolite - Cotinine, Opiates - Norhydrocodone and Dihydrocod, Oxycodone - Noroxyeodone, Sleep aid - Zaleplon and Zolpidem, Synt. Marijuana (SPICE) - JWH-073 N- (5Hydroxybtyl, JWH-250 5-Hydroxypentyl, JWH-018 N-4Hydroxypentyl, and JWH- 018 Pentanoic Acid, N-Desmethyltapentadol, Trycyclic Antidepressant - Amtriptyline, Nortryptline, Doxepin, Desipramine, and Impramine." Patient #2 a. The test requisition revealed a "Comprehensive Quantitative Analysis" panel was ordered. b. The tests indicated in the "Comprehensive Quantitative Analysis" panel signed by the ordering physician on 9/18/19 included the following tests that were not on the final report: "Alcohol - ETG and ETS, Methylphenidate, Anticonvulsant - Gabapentin and Pregabalin, Barbiturates - Secobarbital, Phenobarbital, and Butalbital, Benzodiazepine - 2-Hydroxyethyl, Desalkflyrazepam, Midazolam, Alpha- Hydroxymidazolam, and Chlordiazeproxide, Naloxone, Cathinones (Bath Salts) - MDPV, Methedrone, Methylone, and Pentedrone, Muscle Relaxant - Carisoprodol and Meprobamate, Nicotine Metabolite - Cotinine, Opiates - Norhydrocodone and Dihydrocod, Oxycodone - Noroxyeodone, Sleep aid - Zaleplon and Zolpidem, Synt. Marijuana (SPICE) - JWH-073 N-(5Hydroxybtyl, JWH-250 5-Hydroxypentyl, JWH- 018 N-4Hydroxypentyl, and JWH-018 Pentanoic Acid, N-Desmethyltapentadol, Trycyclic Antidepressant - Amtriptyline, Nortryptline, Doxepin, Desipramine, and Impramine." Patient #3 a. The test requisition revealed a "Comprehensive Quantitative Analysis" panel was ordered. b. The tests indicated in the "Comprehensive Quantitative Analysis" panel signed by the ordering physician on 9 /25/19 included the following tests that were not on the final report: "Alcohol - ETG and ETS, Methylphenidate, Anticonvulsant - Gabapentin and Pregabalin, Barbiturates -- 2 of 5 -- - Secobarbital, Phenobarbital, and Butalbital, Benzodiazepine - 2-Hydroxyethyl, Desalkflyrazepam, Midazolam, Alpha-Hydroxymidazolam, and Chlordiazeproxide, Naloxone, Cathinones (Bath Salts) - MDPV, Methedrone, Methylone, and Pentedrone, Muscle Relaxant - Carisoprodol and Meprobamate, Nicotine Metabolite - Cotinine, Opiates - Norhydrocodone and Dihydrocod, Oxycodone - Noroxyeodone, Sleep aid - Zaleplon and Zolpidem, Synt. Marijuana (SPICE) - JWH-073 N- (5Hydroxybtyl, JWH-250 5-Hydroxypentyl, JWH-018 N-4Hydroxypentyl, and JWH- 018 Pentanoic Acid, N-Desmethyltapentadol, Trycyclic Antidepressant - Amtriptyline, Nortryptline, Doxepin, Desipramine, and Impramine." Patient #4 a. The test requisition revealed a "Comprehensive Quantitative Analysis" panel was ordered. b. The tests indicated in the "Comprehensive Quantitative Analysis" panel signed by the ordering physician on 10/07/19 included the following tests that were not on the final report: "Alcohol - ETG and ETS, Methylphenidate, Anticonvulsant - Gabapentin and Pregabalin, Barbiturates - Secobarbital, Phenobarbital, and Butalbital, Benzodiazepine - 2-Hydroxyethyl, Desalkflyrazepam, Midazolam, Alpha- Hydroxymidazolam, and Chlordiazeproxide, Naloxone, Cathinones (Bath Salts) - MDPV, Methedrone, Methylone, and Pentedrone, Muscle Relaxant - Carisoprodol and Meprobamate, Nicotine Metabolite - Cotinine, Opiates - Norhydrocodone and Dihydrocod, Oxycodone - Noroxyeodone, Sleep aid - Zaleplon and Zolpidem, Synt. Marijuana (SPICE) - JWH-073 N-(5Hydroxybtyl, JWH-250 5-Hydroxypentyl, JWH- 018 N-4Hydroxypentyl, and JWH-018 Pentanoic Acid, N-Desmethyltapentadol, Trycyclic Antidepressant - Amtriptyline, Nortryptline, Doxepin, Desipramine, and Impramine." Patient #5 a. The test requisition revealed a "Comprehensive Quantitative Analysis" panel was ordered. b. The tests indicated in the "Comprehensive Quantitative Analysis" panel signed by the ordering physician on 10 /11/19 included the following tests that were not on the final report: "Alcohol - ETG and ETS, Methylphenidate, Anticonvulsant - Gabapentin and Pregabalin, Barbiturates - Secobarbital, Phenobarbital, and Butalbital, Benzodiazepine - 2-Hydroxyethyl, Desalkflyrazepam, Midazolam, Alpha-Hydroxymidazolam, and Chlordiazeproxide, Naloxone, Cathinones (Bath Salts) - MDPV, Methedrone, Methylone, and Pentedrone, Muscle Relaxant - Carisoprodol and Meprobamate, Nicotine Metabolite - Cotinine, Opiates - Norhydrocodone and Dihydrocod, Oxycodone - Noroxyeodone, Sleep aid - Zaleplon and Zolpidem, Synt. Marijuana (SPICE) - JWH-073 N- (5Hydroxybtyl, JWH-250 5-Hydroxypentyl, JWH-018 N-4Hydroxypentyl, and JWH- 018 Pentanoic Acid, N-Desmethyltapentadol, Trycyclic Antidepressant - Amtriptyline, Nortryptline, Doxepin, Desipramine, and Impramine." Patient #6 a. The test requisition revealed a "Comprehensive Quantitative Analysis" panel was ordered. b. The tests indicated in the "Comprehensive Quantitative Analysis" panel signed by the ordering physician on 10/14/19 included the following tests that were not on the final report: "Alcohol - ETG and ETS, Methylphenidate, Anticonvulsant - Gabapentin and Pregabalin, Barbiturates - Secobarbital, Phenobarbital, and Butalbital, Benzodiazepine - 2-Hydroxyethyl, Desalkflyrazepam, Midazolam, Alpha- Hydroxymidazolam, and Chlordiazeproxide, Naloxone, Cathinones (Bath Salts) - MDPV, Methedrone, Methylone, and Pentedrone, Muscle Relaxant - Carisoprodol and Meprobamate, Nicotine Metabolite - Cotinine, Opiates - Norhydrocodone and Dihydrocod, Oxycodone - Noroxyeodone, Sleep aid - Zaleplon and Zolpidem, Synt. Marijuana (SPICE) - JWH-073 N-(5Hydroxybtyl, JWH-250 5-Hydroxypentyl, JWH- 018 N-4Hydroxypentyl, and JWH-018 Pentanoic Acid, N-Desmethyltapentadol, Trycyclic Antidepressant - Amtriptyline, Nortryptline, Doxepin, Desipramine, and Impramine." Patient #7 a. The test requisition revealed a "Comprehensive Quantitative Analysis" panel was ordered. b. The tests indicated in the "Comprehensive Quantitative Analysis" panel was not dated by the ordering physician but collected on 10/22/19 that included the following tests that were not on the final -- 3 of 5 -- report: "Alcohol - ETG and ETS, Methylphenidate, Anticonvulsant - Gabapentin and Pregabalin, Barbiturates - Secobarbital, Phenobarbital, and Butalbital, Benzodiazepine - 2-Hydroxyethyl, Desalkflyrazepam, Midazolam, Alpha-Hydroxymidazolam, and Chlordiazeproxide, Naloxone, Cathinones (Bath Salts) - MDPV, Methedrone, Methylone, and Pentedrone, Muscle Relaxant - Carisoprodol and Meprobamate, Nicotine Metabolite - Cotinine, Opiates - Norhydrocodone and Dihydrocod, Oxycodone - Noroxyeodone, Sleep aid - Zaleplon and Zolpidem, Synt. Marijuana (SPICE) - JWH-073 N-(5Hydroxybtyl, JWH-250 5-Hydroxypentyl, JWH-018 N- 4Hydroxypentyl, and JWH-018 Pentanoic Acid, N-Desmethyltapentadol, Trycyclic Antidepressant - Amtriptyline, Nortryptline, Doxepin, Desipramine, and Impramine." Patient #8 a. The test requisition revealed a "Comprehensive Quantitative Analysis" panel was ordered. b. The tests indicated in the "Comprehensive Quantitative Analysis" panel not dated by the ordering physician but collected on 10/25/19 included the following tests that were not on the final report: "Alcohol - ETG and ETS, Methylphenidate, Anticonvulsant - Gabapentin and Pregabalin, Barbiturates - Secobarbital, Phenobarbital, and Butalbital, Benzodiazepine - 2-Hydroxyethyl, Desalkflyrazepam, Midazolam, Alpha-Hydroxymidazolam, and Chlordiazeproxide, Naloxone, Cathinones (Bath Salts) - MDPV, Methedrone, Methylone, and Pentedrone, Muscle Relaxant - Carisoprodol and Meprobamate, Nicotine Metabolite - Cotinine, Opiates - Norhydrocodone and Dihydrocod, Oxycodone - Noroxyeodone, Sleep aid - Zaleplon and Zolpidem, Synt. Marijuana (SPICE) - JWH-073 N- (5Hydroxybtyl, JWH-250 5-Hydroxypentyl, JWH-018 N-4Hydroxypentyl, and JWH- 018 Pentanoic Acid, N-Desmethyltapentadol, Trycyclic Antidepressant - Amtriptyline, Nortryptline, Doxepin, Desipramine, and Impramine." 2. During the interview on 11/7/19 at approximately 3:15 pm, TS and GS2 acknowledged the discrepancies between the test requisitions and test reports. 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: The laboratory failed to meet applicable analytic system requirements in 493.1251 - 493.1283 and correctly identify problems specified in 493.1289. Findings include: 1. The laboratory failed to establish performance specifications for the laboratory information system (LIS). Refer to D5423 A. 2. The laboratory failed to establish and verify the performance specifications of analytic specificity for toxicology testing. Refer to D5423 B. 3. The laboratory failed to follow established performance specifications in the verification of Alprazolam and Hydromorphone testing. Refer to D5423 C. 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 -- 4 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: . A. Based on procedure review, document review, and interview with the Technical Supervisor (TS) and the General Supervisor #2 (GS2), the laboratory failed to establish performance specifications for the laboratory information system (LIS) for 7 ( April to November 2019) of 7 months testing patient specimens. Findings include: 1. Review of the laboratory procedure manual revealed a section labeled "Laboratory Information System" which stated the system is "validated with 2-5 specimens and monitored semiannually." 2. Document review revealed a lack of documentation for the validation of the LIS system and the semiannual review. 3. On 11/7/2019 when queried at 2:15 pm, GS2 was unable to provide the surveyor the documentation of the LIS system validation prior to reporting patient test results and the semiannually review. 4. During the interview on 11/7/219 at 2:15 pm, GS2 acknowledged the documentation for the validation of the LIS system was not available on the day of the survey. B. Based on record review and interview with the Technical Supervisor (TS) and General Supervisor #2 (GS2), the laboratory failed to establish and verify the performance specifications of analytic specificity for toxicology testing for 7 (April 2019 to November 2019) of 7 months reviewed. Findings include: 1. A review of the laboratory's "Prism Lab LLC Rochester Hills, MI Performance Validation Approval" book revealed a lack of documentation of an analytic specificity study for toxicology testing performed on the Sciex Triple Quad 5500 analyzer. 2. A review of the laboratory's procedure manual revealed a procedure titled "Initial Method Verification" did not include specifications for analytic specificity. 3. An interview on 11/7/19 at 1:42 pm with the TS and GS1 confirmed performance specifications of analytic specificity for toxicology testing were not available. C. Based on record review and interview with the Technical Supervisor and General Supervisor #2 (GS2), the laboratory failed to follow established performance specifications in the verification of Alprazolam and Hydromorphone testing for 7 (April 2019 to November 2019) of 7 months reviewed. Findings include; 1. A review of the laboratory's "Prism Lab LLC Rochester Hills, MI Performance Validation Approval" book revealed a section stating, "Review the Calibration curves for each primary transition to ensure that the R value of the regression is >0.9." 2. A review of the laboratory's "Prism Lab LLC Rochester Hills, MI Performance Validation Approval" book revealed the following analytes with the corresponding regression values: a. Alprazolam had a regression value of 0.84 b. Hydromorphone had a regression value of 0.89. 3. An interview on 11/7/19 at 1:17 pm with the TS and GS2 confirmed the laboratory did not adhere to the established performance specifications for the analytes listed above. 41759 -- 5 of 5 --