Texas Diagnostic Laboratories, Llc

Summary Statement of Deficiencies D0000 An unannounced onsite complaint survey was performed in response to TX00408055, TX00406980, TX00406981, TX00407176, TX00407212, TX00407215, TX00407273, TX00407348, TX00407401, TX00410454 on 2/8/2022 and 2/9/2022. All allegations were substantiated. The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5200 - 42 C.F.R. 493.1230 Condition: General laboratory systems; 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; D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel; 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. D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on review of the laboratory records from 2021 and 2022, surveyor observations, and confirmed in interview, the laboratory failed to establish procedures to monitor for cross-contamination of patient specimens for two of two Covid PCR tests (BioGx Xfree Covid-19 Direct RT-PCR and LumiraDx FastLab Solutions SARS). Findings included: 1. Surveyor observations on 2/8/2022 at 1040 hours revealed the laboratory used a robot to uncap specimen tubes in the preamplification room. Afterwards, the rack with specimen tubes that are uncapped are brought to a table where laboratory personnel manually processed the specimens onto a specimen plate. Observations included laboratory personnel who walked in and out of the pre- amplification room with the same laboratory coats and worked in both the uncapping Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- and processing of specimens. 2. Review of the laboratory policies for both BioGx Xfree Covid-19 Direct RT-PCR and LumiraDx FastLab Solutions SARS revealed no documentation of procedures to monitor for cross-contamination of patient specimens. 3. Review of the laboratory CMS116 revealed the laboratory performed 25000 Covid tests annually. 4. An interview with the the director of laboratory operations on 2/9 /2022 at 1120 hours in the office confirmed the above findings. key: PCR: polymerase chain reaction RT-PCR: Reverse transcription PCR D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on review of records from 2021 and confirmed in interview, the laboratory failed to obtain and possess Pennsylvania (PA), Maryland (MD), and California (CA) State Licensure when specimens were received and tested from those three states as required. Findings included: 1. Random review of laboratory patient test records from 2021 revealed the laboratory collected and performed patient testing from the following three states: Pennsylvania, Maryland, and California. Refer to patient alias list. A random sampling of patients from PA, MD, and CA include: Requisition 1326904: MD Requisition 1326652: MD Requisition 1229655: PA Requisition 1229653: PA Requisition 1229655: PA sample ID 223220: CA sample ID 223221: CA sample ID 339596: CA 2. Surveyor requested documentation of the licenses to perform patient testing from the above states on 2/8/2022 at 1330 hours and again 2/09 /2022 at 1040 hours. The facility representative provided correspondence regarding their PA license, but no license was provided for any states. 3. An interview with the director of lab operations on 2/9/2022 at 1400 hours in the office confirmed the above findings. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The facility failed to have an effective mechanism by which to monitor and evaluate the overall quality of the general laboratory systems, to identify and correct problems in the following areas: competency assessments (refer to D5209) or verify the accuracy of specimen identity (refer to D5203) D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure -- 2 of 14 -- positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the laboratory and patient test records from 2021 and 2022, laboratory policies, and confirmed in interview, the laboratory failed to establish and follow procedures to ensure positive identification of patient specimens from collection, testing, and reporting of test results for one of ten patients reviewed for both Covid PCR tests (BioGx Xfree Covid-19 Direct RT-PCR and LumiraDx FastLab Solutions SARS). Findings included: 1. Review of the 2021 and 2022 patient final reports revealed one of ten patients that had conflicting specimen label and requisition name and date of birth. Both specimens (ID 392295 and 392290) had the same barcode label (1111-55075) with same patient names. 2. Review of the requisition for specimen ID 392295 included the picture of the specimen tube which revealed the specimen had a different name and date of birth as the requisition. 3. Review of the laboratory policies revealed no documentation of a policy to ensure positive identification of patient specimens for two of two Covid PCR tests (BioGx Xfree Covid-19 Direct RT-PCR and LumiraDx FastLab Solutions SARS). 4. Review of the laboratory CMS116 revealed the laboratory performed 25000 Covid tests annually. 5. An interview with the director of lab operations on 2/10/2022 at 1330 hours in the office confirmed the above findings. 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 review the laboratory's policies, review of laboratory's Centers for Medicare and Medicaid (CMS) Form 209, Laboratory Personnel Report, review of the laboratory's personnel records and staff interview, it was determined the laboratory failed to have documentation of competency assessment for 1 of 1 Technical Supervisor and 3 of 3 General Supervisors. Findings included: 1. Review the laboratory's policies revealed there was no policy for assessing competencies for the technical or general supervisor. 2. Review of the laboratory's CMS Form 209 (signed by Laboratory Director on 02/08/2022) revealed the laboratory identified 1 Technical Supervisor (TS) and 3 General Supervisors (GS). 3. Review of the laboratory's personnel records revealed there was no documentation of competency assessment for the TS, GS#1, GS#2 and GS#3, as listed on CMS Form 209. 4. In an interview on 02 /08/2022 at 1435 hours in the interview room the General Supervisor #1 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 -- 3 of 14 -- 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 manufacturer's instructions, review of the laboratory's preanalytical studies, review of the laboratory policy, and review of patient records, the laboratory failed to meet the requirements for preanalytic systems. Refer to D5311- I, II, III; 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 review of the manufacturer's instructions, review of laboratory and patient test records from 2021 and 2022, and confirmed in interview, the laboratory failed to establish the patient preparation; specimen collection; specimen storage and preservation and/or conditions for specimen transportation and processing of two of two specimen types (nasopharyngeal and oropharyngeal specimens) for the Covid PCR testing. Findings included: 1. Review of laboratory records from 2021 and 2022 revealed the laboratory performed Covid PCR testing using nasopharyngeal and oropharyngeal specimens in two types of viral transport media: Copan Universal Transport Media (UTM) and Beaver Viral Transport Media (VTM). 2. Review of the instructions for use for the BioGx Xfree Covid-19 Direct RT-PCR and LumiraDx FastLab Solutions SARS-CoV-2 RNA Star Complete revealed no documentation that the Beaver VTM was a compatible viral transport media for the test. BioGx Xfree Covid-19 Direct RT-PCR (500-003-XMP US Rev 04.4-11Oct2021) LumiraDx FastLab Solutions SARS-CoV-2 RNA Star Complete (SD-COM-ART-00023 Rev 16 Nov2021) A. BioGX Xfree Covid-19 3. Review of the laboratory policy for the BioGx Xfree Covid-19 Direct RT-PCR (SOP 002) revealed no documentation of the patient preparation; and specimen collection for the Beaver VTM. No preanalytical studies for either the nasopharyngeal and oropharyngeal specimens in Beaver VTM were available for review. Cross refer to D5423-A B. LumiraDx FastLab Solutions SARS 4. Review of the instructions for use for the LumiraDx FastLab Solutions SARS-CoV-2 RNA Star Complete (SD-COM-ART-00023 Rev 16 Nov2021) under limitations revealed "Samples must be collected, transported, and stored using appropriate procedures and conditions. Improper collection, transport, or storage of specimens may hinder the ability of this test to detect the target sequences." 5. Further review of the instructions for use for the LumiraDx FastLab Solutions SARS-CoV-2 RNA Star Complete (SD-COM-ART-00023 Rev 16 Nov2021) under Conditions of Authorization for the Laboratory revealed "authorized laboratories using LumiraDx SARS-CoV-2 RNA STAR Complete must use the product as outlined in the authorized labeling. Deviations from the authorized procedures, including the authorized instruments, authorized clinical specimen types, authorized control -- 4 of 14 -- materials, authorized other ancillary reagents and authorized materials required to use this product are not permitted." 6. Review of the laboratory policy for LumiraDx FastLab Solutions SARS-CoV-2 RNA Star Complete (SOP 007) revealed no documentation of the patient preparation; specimen collection; specimen storage and preservation and conditions for specimen transportation and processing for the Beaver VTM. No preanalytical studies for either the nasopharyngeal and oropharyngeal specimens in Beaver VTM were available for review. Cross refer to D5423-B 7. Review of the laboratory CMS116 revealed the laboratory performed 25000 Covid PCR tests annually. 8. An interview with the director of laboratory operations on 2/9 /2022 at 1000 in the office confirmed the above findings. II. Based on review of the laboratory and patient test records from 2022 and confirmed in interview, the laboratory failed to follow its policy for specimen acceptability for one of twenty specimens reviewed for Covid PCR testing using the LumiraDx FastLab Solutions SARS test kit. 1. Review of the validation report for LumiraDx PCR kit revealed specimen stability at room temperature (temperature range not defined) for 7 days. 2. Random review of patient test records from January 2022 revealed the laboratory received and performed patient testing for one of twenty specimens after the seven day stability. Patient requisition: 1433508, collected 1/6/2022, received 1/14/2022; elapsed time 8 days 3. An interview with the director of lab operations on 2/9/2022 at 1400 hours in the office confirmed the above findings. III. Based on surveyor observations, review of the laboratory records from 2021 and 2022, and confirmed in interview, the laboratory failed to ensure specimens were received per their preanalytical studies for two of two specimen types (nasopharyngeal and oropharyngeal specimens in Copan UTM and Beaver VTM for LumiraDx FastLab Soultions SARS). Findings included: 1. Surveyor observations on 2/8/2022 at 1000 hours in the specimen processing area revealed the laboratory received 50 nasopharyngeal and oropharyngeal specimens in two types of viral transport media: Copan Universal Transport Media (UTM) and Beaver Viral Transport Media (VTM) in various FedEx boxes; FedEx mailers; and regular brown box mailers and envelopes. Refer to patient alias list 2/8/2022. 2. Review of the validation report for LumiraDx PCR kit revealed specimen stability at room temperature (room temperature not defined) for 7 days. 3. Review of the laboratory records available revealed no mechanism to monitor the temperature of specimens received. No studies were performed to verify the FedEx boxes; FedEx mailers; and regular brown box mailers and envelopes kept specimens at room temperature (temperature range undefined) per the validation studies performed. 4. Review of the laboratory CMS116 revealed the laboratory performed 25000 Covid tests annually. 5. An interview with the the director of laboratory operations on 2/9/2022 at 1120 hours in the office confirmed the above findings. key: PCR: polymerase chain reaction RT-PCR: Reverse transcription PCR 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 manual and confirmed in interview, the laboratory failed to provide the appropriate specimen handling for nasopharyngeal and oropharyngeal specimens for two of two Covid PCR tests (BioGx Xfree Covid-19 -- 5 of 14 -- Direct RT-PCR and LumiraDx FastLab Solutions SARS). (specimen preservation, storage, transport) Findings included: 1. Review of the Collection Process Manual provided on 2/9/2022 revealed no documentation of the specimen storage and preservation; conditions for specimen transportation and specimen acceptability and rejection for two of two specimens types: nasopharyngeal and oropharyngeal specimens for two of two Covid PCR tests (BioGx Xfree Covid-19 Direct RT-PCR and LumiraDx FastLab Solutions SARS). 2. An interview with the director of lab operations on 2/9/2022 at 1340 hours in the office confirmed the above findings. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and staff interview, the laboratory's quality assurance program failed to detect problems in preanalytic systems. 1. The laboratory failed to establish criteria for specimen acceptability and rejection. (Refer to D5311-I, II, III) 2. The laboratory failed to establish a complete client service manual. (Refer to D5317) D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)