Pioneer Lab Houston Lp

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of the laboratory's records, a random review of patient's test reports from July 2024, and staff interview, the laboratory failed to include the correct address of the testing facility on three of three patient's test reports reviewed. Findings include: 1. A review of the laboratory's records revealed the laboratory moved in April 2024. 2. A random review of patient's test reports from July 2024 revealed the laboratory failed to include the correct address of the testing facility on the following 3 patient's initial screening test reports: Patient ID: A03151 Test Date: 7/31/24 Patient ID: A03095 Test Date: 7/31/24 Patient ID: A03152 Test Date: 7/31/24 3. Further review of the patient's initial screening test reports revealed the reports listed the previous address instead of the current address for the laboratory. 4. In an interview on 8/2/24 at 11:25 a.m. in the laboratory, after review of the records, the compliance consultant confirmed the above findings. 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 D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS 209 form, the laboratory's personnel records, and staff interview, it was revealed that the laboratory failed to have documentation of a competency assessment for one general supervisor in 2021. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified 1 general supervisor. 2. A review of the laboratory's personnel records revealed the laboratory failed to have documentation of a competency assessment for the general supervisor in 2021. 3. An interview with the compliance specialist on 8/2/22 at 10:45 a.m.. in room number one, after review of the records, confirmed the above findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. 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 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's policy, the College of American Pathologists (CAP) proficiency testing records from 2021 to 2022, and confirmed in an interview found the laboratory failed to document the review of two of five proficiency testing events: CAP ID3-C 2021 Influenza A, Influenza B, RSV, and CAP COV2-A 2022 SARS-CoV-2. Molecular. The findings were: 1. Review of the laboratory's policy titled Proficiency Testing Guidelines (Reference #1650-17) under Evaluation Reports revealed "4. The evaluation report and Summary Review of CAP SURVEY results will then be reviewed and signed by the Medical Director of Laboratory or designee and testing personnel in a timely manner." 2. Review of the CAP proficiency testing records from 2021 to 2022 revealed two of five proficiency testing events were not reviewed and signed by the medical director of laboratory or designee and testing personnel. CAP ID3-C 2021 Influenza A, Influenza B, RSV CAP COV2-A 2022 SARS-CoV-2. Molecular. 3. An interview with the technical consultant on 8/2/22 at 2: 30 pm in room number one confirmed the above findings. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) proficiency testing (PT) instructions, the laboratory's CAP proficiency testing records from 2022, and staff interview, it was revealed that the laboratory failed to have documentation of evaluating proficiency testing results returned as 'Code 26: Educational challenge' for two PT events reviewed in 2022. Findings include: 1. A review of the CAP testing instructions revealed "Code 26: Educational challenge: Review participant summary for comparative results and document performance accordingly. Evaluation criteria are not established for educational challenges. Laboratories should determine their own evaluation criteria approved by their laboratory director for self-evaluation. Response to the CAP is not required." 2. A review of the CAP proficiency testing records from 2022 revealed the following two events that had analytes flagged with Code 26: Educational challenge and there was no documentation of the self- evaluation per CAP requirements: - UDC-A 2022 Forensic Urine Drug Test Confirmatory Fentanyl UDC-10 See note [26] NorFentanyl UDC-10 See note [26] - UDC-B 2022 Forensic Urine Drug Test Confirmatory Fentanyl UDC-17 See note [26] NorFentanyl UDC-17 See note [26] 3. An interview with the compliance specialist on 8/2/22 at 11:40 a.m. in room number one, after review of the records, confirmed the above findings. ***NOTE: This is a repeat deficiency found during the survey performed on 9/2/21. 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: -- 2 of 5 -- Based on the review of the CAP proficiency testing records in 2021, the CAP proficiency testing (PT) instructions, the laboratory's PT records, and confirmed in an interview found the laboratory failed to verify 1 of 2 events of accuracy assessments of COVID test in 2021. The findings were: 1. Review of the CAP proficiency testing records in 2021 for the COVID test revealed not graded "See note [33]" for one of two events in 2021. CAP COV2-B 2021 SARS-CoV-2, Molecular 2. Review of CAP proficiency testing instruction (Rev 1/2021) under Actions Laboratories Should Take when a PT Result is Not Graded revealed "Code 33: Exception Reason Code Description: Specimen determined to be unsatisfactory after contacting the CAP. Action Required: Document that the laboratory has contacted the CAP and no replacement specimens were available. Perform and document alternative assessment (ie. split samples) for the period that commercial PT was not tested to the same level and extent that would have been tested." 3. Review of the laboratory's PT records titled Proficiency Survey Investigation Form for Survey COV2-B (Survey date: 12/21 /21) revealed under

Summary Statement of Deficiencies D0000 A recertification survey was performed on 9/1/21 and 9/2/21 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists proficiency testing (PT) instructions, review of the laboratory's CAP's proficiency testing records from 2019 and 2020, and confirmed in interview, the laboratory failed to have documentation of evaluating proficiency testing results returned as 'educational challenge' by the proficiency testing agency for three of six PT events reviewed. The findings were: 1. A review of the CAP testing instructions (2020) revealed Code 26: Educational challenge: Review participant summary for comparative results and document performance accordingly. Evaluation criteria are not established for educational challenges. Laboratories should determine their own evaluation criteria approved by their laboratory director for self-evaluation. Response to the CAP is not required." 2. Review of the CAP surveys from 2019 and 2020 revealed the following three of six surveys with no documentation of the self-evaluation per CAP instructions. UDC-C 2020 Forensic Urine Drug Test Confirmatory Fentanyl UDC-21 See note [26] UDC- 22 See note [26] UDC-23 See note [26] UDC-24 See note [26] UDC-25 See note [26] Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- UDC-26 See note [26] UDC-27 See note [26] UDC-28 See note [26] NorFentanyl UDC-21 See note [26] UDC-22 See note [26] UDC-23 See note [26] UDC-24 See note [26] UDC-25 See note [26] UDC-26 See note [26] UDC-27 See note [26] UDC- 28 See note [26] UDC-B 2020 Forensic Urine Drug Test Confirmatory Fentanyl UDC- 20 See note [26] NorFentanyl UDC-20 See note [26] UDC-A 2020 Forensic Urine Drug Test Confirmatory Fentanyl UDC-04 See note [26] NorFentanyl UDC-04 See note [26] Fentanyl UDC-01 See note [26] UDC-02 See note [26] UDC-03 See note [26] UDC-04 See note [26] UDC-05 See note [26] UDC-06 See note [26] UDC-07 See note [26] UDC-08 See note [26] NorFentanyl UDC-01 See note [26] UDC-02 See note [26] UDC-03 See note [26] UDC-04 See note [26] UDC-05 See note [26] UDC- 06 See note [26] UDC-07 See note [26] UDC-08 See note [26] 3. An interview with the compliance specialist on 9/1/21 at 1422 hours via phone confirmed the above findings. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of manufacturer's instructions, the laboratory's policy, the laboratory's stability study, patient test results, and confirmed in an interview revealed the laboratory failed to meet the requirements for preanalytic systems. Refer to D5311- I, II, and D5317. 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 the review of the manufacturer's instructions, laboratory's policies, the laboratory's records from 2019 to 2021, and confirmed in an interview revealed the laboratory failed to establish the specimen storage and preservation; specimen transportation; and acceptability criteria for one of one EUA approved test (Applied BiosystemsTaqPath COVID-19 Combo Kit) for the qualitative detection of SARS- CoV-2. The findings were: 1. Review of the laboratory's policy TaqPath COVID-19 Combo Kit approved by the laboratory director on February 1, 2021 under Samples and Controls revealed "Specimens can be stored at 4C for up to 72 hours after collection." 2. Review of TaqPath COVID-19 Combo Kit verification studies revealed no verification of preanalytical specimen stability studies to verify the stability claims -- 2 of 9 -- per the laboratory protocol. No documentation of the specimen storage and preservation; specimen transportation; and acceptability were available for review. Cross refer to D5421-B 3. An interview with the technical supervisor #2 on 9/1/21 at 10:00 am in the office confirmed the above findings. II. Based on the review of the laboratory's policies, the laboratory's records from 2021, and confirmed in an interview revealed the laboratory failed to establish the specimen storage and preservation; specimen transportation; and acceptability criteria for one of one non- EUA approved test (FluV19 RT-PCR (RUO) multiplex kit) for SARS-CoV-2. The findings were: 1. Review of the instructions for use for FluV19 RT-PCR (RUO) multiplex kit (Reference: G210221. Revision 210329.v1) revealed under Specimen Collection, Transport, and Storage Requirements "Sample collection and handling shall be performed per lab procedure, 'specimen collection, handling, transport, and submission'." 2. Review of the laboratory's validation report for FluV19 RT-PCR (RUO) multiplex kit revealed under Specimen Collection, Transport, and Storage Requirements "..., store specimens at 2-8C and ship overnight to the laboratory on ice pack. If a specimen is frozen at -70C or lower, ship overnight to the laboratory on dry ice." 3. Review of the laboratory establishment studies for the FluV19 RT-PCR (RUO) multiplex kit revealed no establishment of the preanalytical specimen stability. No documentation of the specimen storage and preservation; specimen transportation; and acceptability were available for review. Cross refer to D5423 4. An interview with the technical supervisor #2 on 9/1/21 at 10:00 am in the office confirmed the above findings. She stated that she used the package insert for the VTM (viral transport media) as the stability but acknowledged that no establishment studies were performed. Key: EUA=Emergency Use Authrozation RUO - Research use only 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 review of the laboratory's client service manuals, the laboratory's records, patient test records from May to August 2021, collection kit package insert, and confirmed in an interview, the laboratory failed to document a client service manual for two of three tests (TaqPath COVID-19 Combo Kit and FluV19 RT-PCR (RUO) multiplex kit) to the labortory's clients. The findings were: 1. Review of the laboratory's records from 2021 revealed the laboratory utilized Beaver Collection Kit (Manufacturing License(s): SSSYJXSCB 20161010) as the VTM (viral transport media) for both Covid testing performed. TaqPath COVID-19 Combo Kit (Publication#: MAN0019181, Revision: J.0) FluV19 RT-PCR (RUO) multiplex kit (Reference: G210221. Revision 210329.v1) 2. Review of the laboratory records available revealed no documentation of a client service manual to include the conditions for specimen transporation, specimen processing, and specimen acceptability and rejection for the above tests. (Refer to 5311-I, II). 3. Random review of patient requisitions and corresponding test records from May to August 2021 revealed the laboratory received nasophayngeal swabs collected in Beaver VTM from outside facilities for 12 of 12 patient records reviewed. TaqPath COVID-19 Combo Kit 5/13/21 Patient ID: 0002712 5/13/21 Patient ID: 0003103 5/13/21 Patient ID: 0003104 6/28/21 Patient ID: 0001454 6/28/21 Patient ID: 0003168 6/28/21 Patient ID: 0003564 FluV19 RT-PCR (RUO) multiplex kit 7/28/21 Patient ID: 0001729 7/28 -- 3 of 9 -- /21 Patient ID: 0003193 7/28/21 Patient ID: 0004468 8/23/21 Patient ID: 0006509 8 /23/21 Patient ID: 0006512 8/23/21 Patient ID: 0006554 6. An interview with the technical supervisor #2 on 9/1/21 at 10:00 am in the office confirmed the above findings. She confirmed nothing was provided to their clients. Key:VTM=Viral transport media D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on the review of the manufacturer's instructions, laboratory policies, TaqPath COVID-19 Combo Kit validation records, and confirmed in an interview revealed the laboratory failed to document complete verification studies for 1 of 1 EUA approved test (TaqPath COVID-19 Combo Kit ) for 2 of 2 instruments (Applied Biosystems QuantStudio 12K Flex Real-Time PCR system (SN#285882151) and 7500 Fast Real- Time PCR system (SN# 275015205)). A. accuracy and precision studies B. preanalytical studies The findings were: A. accuracy study 1. Review of the laboratory's Method Validation policy (Reference# 1650-24) revealed under III. Procedure: Accuracy, "3. Sample must agree with known value within manufacturer stated limits or within 5 to 10% if patient sample used. Constituents with extremely low numerical values must agree within 10 to 15%." 2. Review of the laboratory verification studies for the TaqPath COVID-19 Combo Kit revealed the raw data of accuracy and precision. No documentation of the assessment of accuracy nor precision were available for review for 2 of 2 instruments (Applied Biosystems QuantStudio 12K Flex Real-Time PCR system (SN#285882151) and 7500 Fast Real- Time PCR system (SN# 275015205)). B. preanalytical study 3. Review of the instructions for use TaqPath (Trademark) COVID-19 RNase P Combo Kit (Number MAN0024969 Revision B.0 25 August 2021) under samples and controls revealed "store patient samples according to CDC guidelines." 4. Review of the Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19) under Storing and Shipping Respiratory Specimens revealed "Store respiratory specimens at 2-8C for up to 72 hours after collection. If a delay in testing or shipping is expected, store specimens at -70C or below." 5. Review of the laboratory's policy TaqPath COVID-19 Combo Kit approved by the laboratory director on February 1, 2021 under Samples and Controls revealed "Specimens can be stored at 4C for up to 72 hours after collection." 6. Review of TaqPath COVID-19 Combo Kit verification studies revealed no verification of the preanalytical specimen stability to verify the stability claims per the laboratory protocol for 2 of 2 instruments (Applied Biosystems QuantStudio 12K Flex Real- Time PCR system (SN#285882151) and 7500 Fast Real-Time PCR system (SN# 275015205)). 7. An interview with the technical supervisor #2 on 9/2/21 at 1:00 pm in the office confirmed the above findings. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE -- 4 of 9 -- 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 the review of the manufacturer's instructions, the laboratory's policy, laboratory establishment studies, and confirmed in an interview revealed the laboratory failed to document complete establishment studies for 1 of 1 non-EUA approved test (FluV19 RT-PCR (RUO) multiplex kit). A. Accuracy B. Interfering Substances C. Pre-analytical studies The findings were: 1. Review of FluV19 RT- PCR (RUO) multiplex kit package insert (Reference: G210221; Revision:210329 v1) revealed under Intended Use "This kit is a laboratory developed test (LDT)...". A. Accuracy 2. Review of the laboratory's Method Validation policy (Reference# 1650- 24) revealed under III. Procedure: Accuracy, "3. Sample must agree with known value within manufacturer stated limits or within 5 to 10% if patient sample used. Constituents with extremely low numerical values must agree within 10 to 15%." 3. Review of the accuracy study for FluV19 RT-PCR (RUO) multiplex kit (Reference: G210221; Revision: 210329.v1) revealed the cq values of the runs did not agree with expected cq values within 10-15% for two of three samples reviewed. Sample: SC2 Mid Titer Target: SARS2 Expected Values (cq): 29.87 10% range: 26.88-32.86 15% range: 25.39-34.35 Three of eight cq values of the run out of the limits: 35.58, 34.45, and 35.23 Sample: SC2 Low Titer Target: SARS Expected Values (cq): 27.82 10% range: 25.04-30.60 15% range: 23.64-32.00 Eight of eight cq values of the run: 32.67, 33.13, 33.24, 32.28, 33.07, 33.39, 33.24, and 33.39 B. Interfering Substances 3. Review of the laboratory's policy revealed no policy established for interfering substances for FluV19 RT-PCR (RUO) multiplex kit (Reference: G210221; Revision: 210329.v1). 4. Review of laboratory establishment studies for FluV19 RT-PCR (RUO) multiplex kit revealed no documentation of the interfering substances study. C. Pre-analytical 5. Review of the laboratory's policy available revealed no policy to establish the pre-analytical criteria for FluV19 RT-PCR (RUO) multiplex kit (Reference: G210221; Revision: 210329.v1). 6. Review of the laboratory's validation report for FluV19 RT-PCR (RUO) multiplex kit revealed under Specimen Collection, Transport, and Storage Requirements "..., store specimens at 2-8C and ship overnight to the laboratory on ice pack. If a specimen is frozen at -70C or lower, ship overnight to the laboratory on dry ice." 7. Review of the laboratory establishment studies for the FluV19 RT-PCR (RUO) multiplex kit revealed no establishment of the preanalytical specimen stability. 8. An interview with the technical supervisor #2 on 9/2/21 at 2:30 pm in the office confirmed the above findings. Key: RUO= Research use only cq= Quantitation Cycle D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) -- 5 of 9 -- 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: I. Based on the review of the manufacturer's instructions, laboratory's records from July 2021 to August 2021, and confirmed in an interview revealed the laboratory failed to establish and document performance specifications for their QC materials for one of one LDT on the Applied Biosystems QuantStudio 12K Flex Real-Time PCR system and 7500 Fast Real-Time PCR system: FluV19 RT-PCR (RUO) multiplex kit. The findings were: 1. Review of FluV19 RT-PCR (RUO) multiplex kit package insert (Reference: G210221; Revision:210329 v1) revealed under Intended Use "This kit is a laboratory developed test (LDT)...". 2. Review of the laboratory's records from July- August 2021 revealed the laboratory used the following reagents: GRD Control FluV19 PCR Kit Ref: G210221 Lot#: 210429-C Exp: 2022/04 3, Review of the laboratory establishment records available for FluV19 Multiplex kit revealed no documentation of the performance specification for the above control. 4. An interview with the technical supervisor#2 on 9/2/21 at 1:40 pm in the office confirmed the started date of FluV19 multiplex kit was 7/27/21. 5. Random review of patient test records revealed four patients tests were performed using FluV19 multiplex kit. 7/29 /21 MRN#: 0001729 7/29/29 MRN#: 0003193 7/29/21 MRN#: 0004468 8/24/21 MRN#: 0006509 8/24/21 MRN#: 0006512 8/24/21 MRN#: 0006554 6. An interview with the technical supervisor #2 on 9/2/21 at 1:40 pm in the office confirmed the above findings. Key: QC=Quality Control LDT=Laboratory Developed Test RUO=Research Use Only II. Based on the review of laboratory records, extraction worksheets and patient test records from 2021, and confirmed in an interview revealed the laboratory failed to include a mechanism to detect cross-contamination of patient specimens or a blank control for two of two Covid tests on the Applied Biosystems QuantStudio 12K Flex Real-Time PCR system and 7500 Fast Real-Time PCR system. The findings were: 1. Review of the laboratory's records from 2021 revealed the laboratory performed Covid testing using the following two test kits: TaqPath COVID- 19 Combo Kit (Publication#: MAN0019181, Revision: J.0) FluV19 RT-PCR (RUO) multiplex kit (Reference: G210221. Revision 210329.v1) 2. Review of the test records from 2021 revealed the laboratory performed the above testing on both the Applied Biosystems QuantStudio 12K Flex Real-Time PCR system (SN#285882151) and 7500 Fast Real-Time PCR system (SN# 275015205). 3. Random review of the labortory's extraction worksheets from May 2021 to August 2021 revelaed no documentation of a blank control or a mechanism to detect cross-contamination of patient specimens for four of four days reviewed. 5/13/21 6/28/21 7/28/21 8/23/21 4. Random review of patient runs for each day reviewed above included the following 12 patients. 5/13/21 Patient ID: 0002712 5/13/21 Patient ID: 0003103 5/13/21 Patient ID: 0003104 6/28/21 Patient ID: 0001454 6/28/21 Patient ID: 0003168 6/28/21 Patient ID: 0003564 7/28/21 Patient ID: 0001729 7/28/21 Patient ID: 0003193 7/28 /21 Patient ID: 0004468 8/23/21 Patient ID: 0006509 8/23/21 Patient ID: 0006512 8 /23/21 Patient ID: 0006554 5. An interview with the technical supervisor #2 on 9/2/21 at 1:40 pm in the office confirmed the above findings. She was unaware she needed to include an NTC for each run. Key: NTC=Non templet Control PC=Positive Control NC=Negative Control D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) -- 6 of 9 -- (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, random review of quality control records from 03/2021 to 04/2021, and confirmed in interview, the laboratory failed to establish control procedures that could identify shifts and trends for two of six (DAU1 and DAU2) external quality control toxicology testing on the Shimadzu 8040 LC-MS /MS analyzer. Findings included: 1. Review of the laboratory records from 03/2021 to 04/2021 revealed the laboratory used the following six quality controls: WQCS- Blank: negative control certified drug free urine WQCS-1-Low: in-house prepared quality control WQCS-2-Mid: in-house prepared quality control WQCS-3-High: in- house prepared quality control Drugs of Abuse (DAU1 and DAU2): positive external controls 2. Review of the laboratory policy General Policies and Procedures (CMP- 001, effective 09/20/2017) under Control Procedures revealed "Levey Jennings are to be reviewed monthly for each test by general supervisor. Shifts and trends are to be addressed." 3. Random review of quality control records from 03/2021 and 04/2021 revealed the following trends for the following seven of twenty-five analytes for either the low and/or high external quality controls (DAU1 and DAU2) with no documentation of the laboratory addressing the shifts and trends per their lab policy. DAU1 (Low) Benzoylecgonine - range 136-204 3/01/21: 201 3/04/21: 203 3/09/21: 197 3/15/21: 190 3/19/21: 198 3/25/21: 195 3/26/21: 197 3/31/21: 199 DAU2 (High) Benzoylecgonine - range 353-529 3/01/21: 417 3/04/21: 431 3/09/21: 383 3/15/21: 410 3/19/21: 405 3/25/21: 397 3/26/21: 387 3/31/21: 418 DAU1 (Low) Carisoprodol - range 293-439 3/01/21: 421 3/04/21: 436 3/09/21: 420 3/15/21: 426 3/19/21: 427 3/25 /21: 418 3/26/21: 399 3/31/21: 409 DAU2 (High) Carisoprodol - range 3062-4594 3 /01/21: 4297 3/04/21: 4430 3/09/21: 4516 3/15/21: 4178 3/19/21: 4524 3/25/21: 4351 3/26/21: 4081 3/31/21: 4144 DAU2 (High) Clomipramine- range 3204-4806 3/19/21: 4568 3/25/21: 4665 3/26/21: 4511 3/31/21: 4615 DAU2 (High) Codeine - range 3032 - 4548 3/01/21: 3169 3/04/21: 3061 3/09/21: 3211 3/15/21: 3281 3/19/21: 3260 3/25 /21: 3233 3/26/21: 3177 3/31/21: 3177 DAU1 (Low) Cyclobenzaprine - range 262- 392 3/01/21: 373 3/04/21: 381 3/09/21: 360 3/15/21: 363 3/19/21: 351 3/25/21: 377 3 /26/21: 381 3/31/21: 380 DAU2 (High) Desipramine - range 2938 - 4406 3/01/21: 4377 3/04/21: 4073 3/09/21: 4310 3/15/21: 4091 3/19/21: 4211 3/25/21: 4048 3/26 /21: 4343 3/31/21: 4330 DAU1 (Low) Mitragynine - Range 63-94 3/01/21: 92 3/04 /21: 93 3/09/21: 93 3/15/21: 89 3/19/21: 90 3/25/21: 93 3/26/21: 89 3/31/21: 90 DAU1 (Low) Benzoylecgonine - range 136-204 4/06/21: 200 4/09/21: 202 4/14/21: 197 4/16/21: 199 4/21/21: 195 4/23/21: 197 4/27/21: 201 4/29/21: 201 DAU2 (High) Benzoylecgonine - range 353-529 4/06/21: 423 4/09/21: 399 4/14/21: 386 4/21/21: 378 4/23/21: 368 4/27/21: 384 4/29/21: 389 DAU1 (Low) Carisoprodol - range 293- 439 4/06/21: 425 4/09/21: 428 4/14/21: 432 4/16/21: 431 4/21/21: 395 4/23/21: 422 4 /27/21: 429 4/29/21: 426 DAU2 (High) Cyclobenzaprine - range 2791-4187 4/06/21: 3892 4/09/21: 3912 4/14/21: 3983 4/16/21: 4038 4/21/21: 4048 4/23/21: 3889 4/27 /21: 3890 4/29/21: 3825 DAU1 (Low) Cyclobenzaprine - range 262-392 4/06/21: 350 -- 7 of 9 -- 4/09/21: 370 4/14/21: 389 4/16/21: 375 4/21/21: 378 4/23/21: 389 4/27/21: 372 4/29 /21: 383 4. Review of the laboratory CMS-116 signed by the laboratory director on 8 /30/21 revealed the laboratory performed 209,044 toxicology tests annually. 5. An interview with the compliance specialist on 9/2/21 at 1300 hours in the office confirmed the above findings. D5783

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5022 - 42 C.F.R. 493.1213 Condition: Toxicology; D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. 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 review of the laboratory's records and confirmed in interview, it was revealed the laboratory failed to meet the requirements for the subspecialty of toxicology. The findings were: 1. The laboratory failed to have documentation of performing complete preanalytical establishment studies (refer to D5311). 2. The laboratory failed to have documentation of establishing acceptable quality control ranges (refer to D5469). 3. The laboratory failed to include the units of measurement for toxicology patient reports on the Shimadzu 8040 toxicology analyzer (refer to D5805). D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's records and confirmed in interview, it was revealed the laboratory failed to meet pre-analytic system requirements as evidenced by: 1. 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 Shimadzu 8040 toxicology analyzer. Refer to D5311 2. The laboratory failed to accurately transcribe collection of time of specimens into the laboratory information systems. Refer to D5309. 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 review of the laboratory patient requisitions and final reports and confirmed in interview, the laboratory failed to ensure the laboratory accurately transcribed time of collection of specimens into the laboratory information systems. Findings were: 1. Random review of patient requisitions with the corresponding final reports from August 2018 - October 2018 revealed 10 of 10 patient final reports with the date and time of collection transcribed onto the laboratory information system that did not match the information on the patient requisitions. 47454 date/time of collection on requisition: 8/03/18 1003 hours date/time of collection on final report: 8/03/18 0747 hours 47639 date/time of collection on requisition: 8/29/18 1448 hours date/time of collection on final report: 8/29/18 1030 hours 47705 date/time of collection on requisition: 9/4/18 1719 hours date/time of collection on final report: 9/4/18 0952 hours 47721 date/time of collection on requisition: 9/13/18 0900 hours date/time of collection on final report: 9/13/18 0745 hours 47737 date/time of collection on requisition: 9/12/18 2120 hours date/time of collection on final report: 9/12/18 0950 hours 47849 date/time of collection on requisition: 10/02/18 2000 hours date/time of collection on final report: 10/02/18 0941 hours 47922 date/time of collection on requisition: 10/18/18 1439 hours date/time of collection on final report: 10/18/18 0815 hours 47957 date/time of collection on requisition: 10/19/18 1510 hours date/time of collection on final report: 10/19/18 1009 hours 48006 date/time of collection on requisition: 10/23/18 0900 hours date/time of collection on final report: 10/23/18 0908 hours 47856 date/time of collection on requisition: 10/04/18 1016 hours date/time of collection on final report: 10/04/18 0954 hours 2. An interview with the general supervisor on 11/9/18 at 1010 hours in the office 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 -- 2 of 10 -- 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 Shimadzu 8040 toxicology analyzer. Findings were: 1. Review of the laboratory records revealed the laboratory performed toxicology testing on the Shimadzu 8040 toxicology analyzer for the following 69 analytes. lorazepam Fluoxetine Norpropoxyphene Venlafaxine O- Desmethylvenlafaxine Levetiracetam Cyclobenzaprine Chlordiazepoxide Clomipramine Desmethylclomipramine Traxodone Zaleplon Zolpidem Zopiclone Norfluoxetine Nortriptyline Peroxetine Pentazocine Phenobarbital Pregabalin 6- Acetylmorphine 7-Aminoclonazepam Alprazolam Amphetamine aOH-Alprazolam Benzolecgonine Buprenorphine Carisoprodol Codeine EDDP Fentanyl Hydrocodone Hydromorphone MDMA Meperidine Meprobamate Methadone Methamphetamine Morphine Norbuprenorphine Nordiazepam Norfentanyl Norhydrocodone Normeperidine Noroxycodone O-demethyltramadol Oxazepam oxycodone Oxymorphone PCP Propoxyphene Tapentadol Temazepam THC-COOH Tramadol Amitriptyline Butalbital Citalopram Desipramine Desmethylcitalopram Desmethyldoxepin Doxepin Gabapentin Imipramine Ritalinic Acid Sertraline MDPV Mitagynine Naloxone 2. Review of the laboratory Specimen Submission, Handling and Referral under specimen storage and preservative revealed "refrigerate for three days or freeze indefinitely." 3. Review of the laboratory stability studies available revealed the laboratory performed refrigerated storage stability for 13 of 69 analytes at day 1 and day 7. Norpropoxyphene Chlordiazepoxide Clomipramine Cyclobenzaprine Levetiracetam O-desmethylvenlafaxine Traxodone Venlafaxine Zalepon Zolpidem Zopiclone Desmethylclomipramine Norchlordiazepoxide 4. Review of the refrigerated storage stability revealed no documentation of the Day 2 or Day 3 for the above 13 of 69 analytes. 5. Review of the refrigerated storage stability revealed no documentation of the refrigerated stability for 56 of 69 analytes. lorazepam Fluoxetine Ritalinic Acid Norfluoxetine Nortriptyline Peroxetine Pentazocine Phenobarbital Pregabalin 6- Acetylmorphine 7-Aminoclonazepam Alprazolam Amphetamine aOH-Alprazolam Benzolecgonine Buprenorphine Carisoprodol Codeine EDDP Fentanyl Hydrocodone Hydromorphone MDMA Meperidine Meprobamate Methadone Methamphetamine Morphine Norbuprenorphine Nordiazepam Norfentanyl Norhydrocodone Normeperidine Noroxycodone O-demethyltramadol Oxazepam oxycodone Oxymorphone PCP Propoxyphene Tapentadol Temazepam THC-COOH Tramadol Amitriptyline Butalbital Citalopram Desipramine Desmethylcitalopram Desmethyldoxepin Doxepin Gabapentin Imipramine Ritalinic Acid Sertraline MDPV Mitagynine Naloxone 6. Random review of the laboratory patient final reports from August to October 2018 revealed the laboratory performed urine confirmatory testing with an elapsed time greater than 3 days: Accn # 47638: collection date 08/30/2018; run date: 09/07/2018, elapsed time 8 days 47639: collection date 08/29/2019; run date: 09/07/2019, elapsed time 9 days 47642: collection date 08/30/2018; run date: 09 /07/2018, elapsed time 8 days 47667: collection date 09/05/2018; run date 09/13 /2018, elapsed time 8 days 47668: collection date 09/04/2018; run date 09/13/2018, elapsed time 9 days 47745: collection date 09/17/2018; run date 09/28/2018, elapsed time 11 days 47739: collection date 09/15/2018; run date 09/25/2018, elapsed time 10 days 47752: collection date 09/19/2018; run date 09/28/2018, elapsed time 9 days -- 3 of 10 -- 47774: collection date 09/27/2018; run date 10/08/2018, elapsed time 11 days 47781: collection date 09/25/2018; run date10/08/2018, elapsed time 13 days 7. An interview with the general supervisor on 11/8/18 at 1030 hours in the office confirmed the above findings. He was unaware the laboratory needed to perform stability testing for each day the laboratory received specimen. 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 record review and confirmed in interview, the laboratory failed to have written instructions available to the laboratory's clients that included information on specimen conditions for transportation. Findings included: 1. Review of laboratory policy Specimen Submission, Handling, and Referral (approved 10/17/14) revealed no documentation of the "refrigerated," "frozen," or "room temperature" acceptable temperature range. 2. An interview with the general supervisor on 11/8/18 at 1030 hours in the office confirmed the above findings. 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 laboratory records, 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 standards and stock solutions used for the laboratory-developed tests for urine toxicology confirmatory testing on the Shimadzu 8040 toxicology analyzer. Findings were: 1. Review of the the laboratory worksheet used to prepare stock solutions revealed "stable up to 6 months when stored @ -20C." 2. A tour of the laboratory on 11/8/18 at 1310 hours revealed standards and stock solutions stored frozen in the laboratory freezer. IS [internal standard] Stock lot 07272018 (in use: 08/09/18, exp 1 /27/19) Reagent Standard stock lot # MAS06222018 (prep 6/22/18, exp 12/22/18, in use 7/5/18) Reagent Standard stock lot # MAS 09102018 (prep 9/10/18, exp 3/10/19, in use 10/5/18) 3. Review of the laboratory establishment studies revealed no documentation of the stability studies for the above standards and stock solutions. 4. Random review of the August - October 2018 toxicology patient log sheets and -- 4 of 10 -- quality control records revealed the laboratory performed patient testing using the above standards and stock solutions. Date accession # 08/29/18 47639 08/03/18 47454 09/12/18 47717 09/04/18 47705 09/13/18 47721 09/12/18 47737 10/24/18 48007 10 /02/18 47849 5. An interview with the general supervisor on 11/8/18 at 1400 hours in the office confirmed the above findings. He was unaware the laboratory was required to perform the stability studies for the reagent stocks and standards. 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 Shimadzu 8040 toxicology analyzer . Findings were: 1. Review of the package insert for the Affirm DAU 1 & 2 (catalog number: IR960 DAU, kit lot 1003e) revealed "laboratories should establish their own statistical values for precision and expected range." 2. Review of the package insert for the DAU HC2 Urine Toxicology control (Product Number 50701) revealed "laboratories should establish their own statistical values for precision and expected range." 3. Review of the package insert for the Benzodiazepines Plus 400 ng /mL urine Toxicology Control (Product Number 12091) revealed "laboratories should establish their own statistical values for precision and expected ranges; these values should fall within +/- 15% of the target value." 4. Review of the laboratory 2018 toxicology records revealed the laboratory performed toxicology testing on the Shimadzu 8040 toxicology analyzer for the following 65 analytes used the corresponding target value +/- 20% for the Affirm DAU 1 & 2 quality control material. DAU-1 low control (lot#131807e, exp 7/13/19) Lorazepam (acceptable range: 256 - 384 ng/mL) Fluoxetine (acceptable range: 320 - 480 ng/mL) Norpropoxyphene (acceptable range: 320 - 480 ng/mL) Butalbital (acceptable range: 640 - 960 ng/mL) Venlafaxine (acceptable range: 320 - 480 ng/mL) O- Desmethylvenlafaxine (acceptable range: 64 - 96 ng/mL) Levetiracetam (acceptable range: 320 - 480 ng/mL) Cyclobenzaprine (acceptable range: 320 - 480 ng/mL) Codeine (acceptable range: 320 - 480 ng/mL) Clomipramine (acceptable range: 320 - 480 ng/mL) Desmethylclomipramine (acceptable range: 320 - 480 ng/mL) Traxodone (acceptable range: 320 - 480 ng/mL) Zaleplon (acceptable range: 32 - 48 ng/mL) Zolpidem (acceptable range: 320 - 480 ng/mL) Norfluoxetine (acceptable range: 320 - 480 ng/mL) Nortriptyline (acceptable range: 320 - 480 ng/mL) Peroxetine (acceptable range: 320 - 480 ng/mL) Pentazocine (acceptable range: 96 - 144 ng/mL) Phenobarbital (acceptable range: 640 - 960 ng/mL) Pregabalin (acceptable range: 960 -- 5 of 10 -- - 1440 ng/mL) 6-Acetylmorphine (acceptable range: 10 - 15 ng/mL) 7- Aminoclonazepam (acceptable range: 256 - 384 ng/mL) Alprazolam (acceptable range: 256 - 384 ng/mL) Amphetamine (acceptable range: 320 - 480 ng/mL) aOH- Alprazolam (acceptable range: 256 - 384 ng/mL) Benzolecgonine (acceptable range: 160 - 240 ng/mL) Buprenorphine (acceptable range: 32 - 48 ng/mL) Carisoprodol (acceptable range: 320 - 480 ng/mL) EDDP (acceptable range: 320 - 480 ng/mL) Fentanyl (acceptable range: 32 - 48 ng/mL) Hydrocodone (acceptable range: 320 - 480 ng/mL) Hydromorphone (acceptable range: 320 - 480 ng/mL) MDMA (acceptable range: 320 - 480 ng/mL) Meperidine (acceptable range: 160 - 240 ng/mL) Meprobamate (acceptable range: 320 - 480 ng/mL) Methadone (acceptable range: 320 - 480 ng/mL) Methamphetamine (acceptable range: 320 - 480 ng/mL) Morphine (acceptable range: 320 - 480 ng/mL) Norbuprenorphine (acceptable range: 160 - 240 ng/mL) Nordiazepam (acceptable range: 256 - 384 ng/mL) Norfentanyl (acceptable range: 26 - 38 ng/mL) Norhydrocodone (acceptable range: 320 - 480 ng/mL) Normeperidine (acceptable range: 160 - 240 ng/mL) Noroxycodone (acceptable range: 160 - 240 ng/mL) O-demethyltramadol (acceptable range: 320 - 480 ng/mL) Oxazepam (acceptable range: 256 - 384 ng/mL) oxycodone (acceptable range: 160 - 240 ng/mL) Oxymorphone (acceptable range: 320 - 480 ng/mL) PCP (acceptable range: 32 - 48 ng/mL) Propoxyphene (acceptable range: 320 - 480 ng/mL) Tapentadol (acceptable range: 160 - 240 ng/mL) Temazepam (acceptable range: 256 - 384 ng/mL) THC-COOH (acceptable range: 192 - 288 ng/mL) Tramadol (acceptable range: 320 - 480 ng/mL) Amitriptyline (acceptable range: 320 - 480 ng/mL) Citalopram (acceptable range: 320 - 480 ng/mL) Desipramine (acceptable range: 320 - 480 ng /mL) Desmethylcitalopram (acceptable range: 320 - 480 ng/mL) Desmethyldoxepin (acceptable range: 320 - 480 ng/mL) Doxepin (acceptable range: 320 - 480 ng/mL) Gabapentin (acceptable range: 960 - 1440 ng/mL) Imipramine (acceptable range: 320 - 480 ng/mL) Ritalinic Acid (acceptable range: 320 - 480 ng/mL) Sertraline (acceptable range: 320 - 480 ng/mL) MDPV (acceptable range: 320 - 480 ng/mL) Mitragynine (acceptable range: 64 - 96 ng/mL) Naloxone (acceptable range: 320 - 480 ng/mL) DAU-2 high control (lot#131807e, exp 7/13/19) lorazepam (acceptable range: 2560 - 3840 ng/mL) Fluoxetine (acceptable range: 3200 - 4800 ng/mL) Norpropoxyphene (acceptable range: 3200 - 4800 ng/mL) Venlafaxine (acceptable range: 3200 - 4800 ng/mL) Butalbital (acceptable range: 6400 - 9600 ng/mL) O- Desmethylvenlafaxine (acceptable range: 640 - 960 ng/mL) Levetiracetam (acceptable range: 3200 - 4800 ng/mL) Cyclobenzaprine (acceptable range: 3200 - 4800 ng/mL) Clomipramine (acceptable range: 3200 - 4800 ng/mL) Desmethylclomipramine (acceptable range: 3200 - 4800 ng/mL) Traxodone (acceptable range: 3200 - 4800 ng /mL) Zaleplon (acceptable range: 320 - 480 ng/mL) Zolpidem (acceptable range: 3200 - 4800 ng/mL) Norfluoxetine (acceptable range: 2560 - 3840 ng/mL) Nortriptyline (acceptable range: 2560 - 3840 ng/mL) Peroxetine (acceptable range: 2560 - 3840 ng /mL) Pentazocine (acceptable range: 960 - 1440 ng/mL) Phenobarbital (acceptable range: 6400 - 9600 ng/mL) Pregabalin (acceptable range: 9600 - 14400 ng/mL 6- Acetylmorphine (acceptable range: 256 - 384 ng/mL) 7-Aminoclonazepam (acceptable range: 2560 - 3840 ng/mL) Alprazolam (acceptable range: 2560 - 3840 ng /mL) Amphetamine (acceptable range: 3200 - 4800 ng/mL) aOH-Alprazolam (acceptable range: 2560 - 3840 ng/mL) Benzolecgonine (acceptable range: 1600 - 2400 ng/mL) Buprenorphine (acceptable range: 320 - 480 ng/mL) Carisoprodol (acceptable range: 3200 - 4800 ng/mL) Codeine (acceptable range: 3200 - 4800 ng /mL) EDDP (acceptable range: 3200 - 4800 ng/mL) Fentanyl (acceptable range: 256 - 384 ng/mL) Hydrocodone (acceptable range: 3200 - 4800 ng/mL) Hydromorphone (acceptable range: 3200 - 4800 ng/mL) MDMA (acceptable range: 3200 - 4800 ng /mL) Meperidine (acceptable range: 1600 - 2400 ng/mL) Meprobamate (acceptable range: 3200 - 4800 ng/mL) Methadone (acceptable range: 3200 - 4800 ng/mL) -- 6 of 10 -- Methamphetamine (acceptable range: 3200 - 4800 ng/mL) Morphine (acceptable range: 3200 - 4800 ng/mL) Norbuprenorphine (acceptable range: 1600 - 2400 ng/mL) Nordiazepam (acceptable range: 2560 - 3840 ng/mL) Norfentanyl (acceptable range: 256 - 384 ng/mL) Norhydrocodone (acceptable range: 3200 - 4800 ng/mL) Normeperidine (acceptable range: 1600 - 2400 ng/mL) Noroxycodone (acceptable range: 1600 - 2400 ng/mL) O-demethyltramadol (acceptable range: 640 - 960 ng/mL) Oxazepam (acceptable range: 2560 - 3840 ng/mL) oxycodone (acceptable range: 1600 - 2400 ng/mL) Oxymorphone (acceptable range: 3200 - 4800 ng/mL) PCP (acceptable range: 320 - 480 ng/mL) Propoxyphene (acceptable range: 3200 - 4800 ng/mL) Tapentadol (acceptable range: 1600 - 2400 ng/mL) Temazepam (acceptable range: 2560 - 3840 ng/mL) THC-COOH (acceptable range: 1920 - 2880 ng/mL) Tramadol (acceptable range: 3200 - 4800 ng/mL) Amitriptyline (acceptable range: 3200 - 4800 ng/mL) Citalopram (acceptable range: 3200 - 4800 ng/mL) Desipramine (acceptable range: 3200 - 4800 ng/mL) Desmethylcitalopram (acceptable range: 3200 - 4800 ng /mL) Desmethyldoxepin (acceptable range: 3200 - 4800 ng/mL) Doxepin (acceptable range: 3200 - 4800 ng/mL) Gabapentin (acceptable range: 9600 - 14400 ng/mL) Imipramine (acceptable range: 3200 - 4800 ng/mL) Ritalinic Acid (acceptable range: 3200 - 4800 ng/mL) Sertraline (acceptable range: 3200 - 4800 ng/mL) MDPV (acceptable range: 3200 - 4800 ng/mL) Mitragynine (acceptable range: 640 - 960 ng /mL) Naloxone (acceptable range: 3200 - 4800 ng/mL) 5. Review of the laboratory 2018 toxicology records revealed the laboratory performed toxicology testing on the Shimadzu 8040 toxicology analyzer for the following 18 analytes used the corresponding target value +/- 20% for the DAU HC 2 Urine Toxicology control. 6- MAM (acceptable range: 400 - 600 ng/mL) Amphetamine (acceptable range: 400 - 600 ng/mL) aOH-Alprazolam (acceptable range: 240 - 360 ng/mL) Benzoylecgonine (acceptable range: 120 - 180 ng/mL) Butalbital (acceptable range: 240 - 360 ng/mL) Codeine (acceptable range: 1600 - 2400 ng/mL) EDDP (acceptable range: 240 - 360 ng/mL) Loracepam (acceptable range: 240 - 360 ng/mL) MDMA (acceptable range: 400 600 ng/mL) Methadone (acceptable range: 240 - 360 ng/mL) Methamphetamine (acceptable range: 400 - 600 ng/mL) Morphine (acceptable range: 1600 - 2400 ng /mL) Nordiazepam (acceptable range: 240 - 360 ng/mL) Nortriptyline (acceptable range: 240 - 360 ng/mL) Oxazepam (acceptable range: 240 - 360 ng/mL) PCP (acceptable range: 20 - 30 ng/mL) Phenobarbital (acceptable range: 240 - 360 ng/mL) Temazepam (acceptable range: 240 - 360 ng/mL) 6. Review of the laboratory 2018 toxicology records revealed the laboratory performed toxicology testing on the Shimadzu 8040 toxicology analyzer for the analyte Norchlordiazepoxide using the corresponding target value +/- 20% for the Benzodiazepines Plus 400 ng/mL Urine toxicology Control. Benzodiazepine (lot # A8684, exp 03/20) Norchlordiazepoxide (acceptable range: 320 - 480 ng/mL) 7. Review of the laboratory records available revealed no documentation of the laboratory establishing its own acceptable range for the above quality controls. 8. Random review of the laboratory patient records from August 2018 to October 2018 revealed the laboratory performed patient testing on days when the laboratory used the above quality controls. Date accession # 08/29/18 47639 08/03/18 47454 09/12/18 47717 09/04/18 47705 09/13/18 47721 09/12/18 47737 10/24/18 48007 10/02/18 47849 9. An interview with the general supervisor on 11/8/18 at 1505 hours in the office confirmed the above findings. He was unaware the laboratory should establish its own acceptable quality control ranges. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from -- 7 of 10 -- the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the laboratory establishment records, patient final reports, and confirmed in interview, the laboratory failed to have an adequate system in place to ensure the accuracy and reliability of data sent to the Laboratory Information System (LIS) from the Shimadzu 8040 toxicology analyzer Findings include: 1. Review of the Shimadzu 8040 establishment studies revealed the limit of detection and/or limit of quantitation for the following analytes: Fluoxitine limit of detection 65.23 ng/mL Morphine limit of quantitation 5208 ng/mL Norfentanyl limit of quantitation 410 ng /mL 2. Random review of patient final reports from August 2018 to October 2018 revealed 6 of 11 patient reports with values documented outside of the limit of detection and/or limit of quantitation for the above analytes. 08/29/18: 47636, Fluoxitine 0 08/03/18: 47454, Fluoxitine 23 09/04/18: 47705, Fluoxitine 25 09/12/18: 47737, Morphine 23801 10/24/18: 48807, Morphine 14518 10/02/18: 47849, Norfentanyl 2816 3. An interview with the general supervisor on 11/8/18 at 1450 hours in the office confirmed the above findings. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: A. Based on a review of patient test reports and interview of facility personnel, it was revealed that the laboratory failed to include a disclaimer on test reports for the laboratory developed tests on the Shimadzu 8040 toxicology analyzer testing not FDA- cleared. Findings were: 1. A review of the FDA (Federal Drug Administration) website revealed the Shimadzu 8040 analyzer was not listed on the FDA website. Tests on the Shimadzu 8040 analyzer are non-FDA approved, therefore the complexity is high and is a Laboratory Developed Test. 2. Review of test reports revealed the laboratory tested for the following 69 drug analytes on the Shimadzu 8040 analyzer : lorazepam Fluoxetine Norpropoxyphene Venlafaxine O- Desmethylvenlafaxine Levetiracetam Cyclobenzaprine Chlordiazepoxide Clomipramine Desmethylclomipramine Traxodone Zaleplon Zolpidem Zopiclone Norfluoxetine Nortriptyline Peroxetine Pentazocine Phenobarbital Pregabalin 6- Acetylmorphine 7-Aminoclonazepam Alprazolam Amphetamine aOH-Alprazolam Benzolecgonine Buprenorphine Carisoprodol Codeine EDDP Fentanyl Hydrocodone Hydromorphone MDMA Meperidine Meprobamate Methadone Methamphetamine -- 8 of 10 -- Morphine Norbuprenorphine Nordiazepam Norfentanyl Norhydrocodone Normeperidine Noroxycodone O-demethyltramadol Oxazepam oxycodone Oxymorphone PCP Propoxyphene Tapentadol Temazepam THC-COOH Tramadol Amitriptyline Butalbital Citalopram Desipramine Desmethylcitalopram Desmethyldoxepin Doxepin Gabapentin Imipramine Ritalinic Acid Sertraline MDPV Mitagynine Naloxone 3. Random review of 8 patient final reports from August 2018 to October 2018 revealed 8 of 8 test reports did not include the statement "The performance characteristics of this test were determined by (Laboratory Name). It has not been cleared or approved by the U.S. Food and Drug Administration". Date accession # 08/29/18 47639 08/03/18 47454 09/12/18 47717 09/04/18 47705 09/13/18 47721 09/12/18 47737 10/24/18 48007 10/02/18 47849 4. An interview with the general supervisor on 11/9/18 at 1000 hours in the office confirmed the above findings. He acknowledged that the lab reports did not include the required verbiage. B. Based on review of the laboratory patient test reports and confirmed in interview, the laboratory failed to include the units of measurement for 8 of 8 toxicology patient reports on the Shimadzu 8040 toxicology analyzer. Findings were: 1. Random review of 8 patient final reports from August 2018 to October 2018 revealed 8 of 8 test reports did not include the units of measurement for 69 of the 69 analytes performed on the Shimadzu 8040 toxicology analyzer Date accession # 08/29/18 47639 08/03/18 47454 09/12/18 47717 09/04/18 47705 09/13/18 47721 09/12/18 47737 10/24/18 48007 10/02/18 47849 2. An interview with the general supervisor on 11/9/18 at 1000 hours in the office confirmed the above findings. He acknowledged that the lab reports did not include the units of measurement. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the laboratory's records and staff interview, it was revealed the laboratory director failed to provide overall management for the laboratory. (Refer to D6082, D6086, D6093) 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 a review of laboratory preanalytic systems and analytic systems, the laboratory director failed to ensure that testing systems developed and used for each of the tests performed in the laboratory provided quality laboratory services for all aspects of test performance. (refer to D5311, D5469, D5805) D6086 LABORATORY DIRECTOR RESPONSIBILITIES -- 9 of 10 -- 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 a review of the laboratory's test system records and interview of facility personnel, the laboratory director failed to ensure the laboratory documented complete establishment of standards, calibrators, and stock solutions for its test systems before reporting patient test results. (Refer to D5423) 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 quality control records and interview, the laboratory director failed to ensure that the quality control programs were established to identify failures in quality as they occurred. Please see D5469. -- 10 of 10 --