Pioneer Central Medical Laboratory Llc

Summary Statement of Deficiencies 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: . A. Based on observation and interview with the Laboratory Director, the laboratory failed to utilize a uni-directional workflow for its open-system, SARS-CoV-2 molecular test system for 1 testing run observed. Findings include: 1. The surveyor observed the Laboratory Director perform SARS-CoV-2 testing for 5 specimens using its SeqOnce Biosciences reagents and the BioRad CFX C1000 thermocycler on 12/21 /22 at 9:51 am. The Laboratory Director entered the post-amplification area with the pre-amplification patient and quality control specimens to start the run on the thermocycler. Just as the Laboratory Director was about to set the pre-amplification samples in the thermocycler, he took the previous run's post-amplification samples to discard in the next room after putting the pre-amplification specimens back into the pre-amplification area. Once the post-amplification samples were disposed, the next run's pre-amplification samples were set into the thermocycler using the same gloves. 2. An interview on 12/21/22 at 1:44 pm with the Laboratory Director confirmed a unidirectional workflow had not been used for SARS-CoV-2 molecular testing. B. Based on observation and interview with the Laboratory Director, the laboratory failed to have separate areas for reagent preparation and specimen preparation for its open-system, SARS-CoV-2 molecular test system for 1 testing run observed. Findings include: 1. The surveyor observed the Laboratory Director perform SARS-CoV-2 testing for 5 specimens using its SeqOnce Biosciences reagents and the BioRad CFX C1000 thermocycler on 12/21/22 at 9:51 am. The Laboratory Director utilized the same biosafety cabinet for preparing the master mix reagents and to prepare and dispense patient specimens into the reaction wells. 2. An interview on 12/21/22 at 1: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- 44 pm with the Laboratory Director confirmed the laboratory utilizes the same biosafety cabinet for both reagent preparation and specimen preparation. 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, record review, and interview with the Laboratory Director, the laboratory failed to have the appropriate pipettes to dispense volumes less than 10 uL for its molecular SARS-CoV-2 testing for 1 testing run observed. Findings include: 1. The surveyor observed the Laboratory Director perform SARS-CoV-2 testing for five specimens using its SeqOnce Biosciences reagents and the BioRad CFX C1000 thermocycler on 12/21/22 at 9:51 am. The Laboratory Director used a Lichen pipette with a specified range of 20-200 uL to dispense the following components: a. Dye, 8 uL b. Patient sample, 5 uL c. Positive and Negative quality control, 5 uL 2. The surveyor toured the laboratory on 12/21/22 at 9:00 am and the following pipettes had been identified: a. Eppendorf Research Plus 1000 uL b. Eppendorf 200 uL c. Walter 100-1000 uL d. Walter 10-100 uL e. Lichen 20-200 uL 3. A review of the laboratory's Lichen Pipette Instructions for Use on 12/21/22 revealed a section stating, "The volume of the pipette is clearly shown through the handle grip window. The delivery volume is set by turning the thumb button clockwise or anticlockwise. When setting the volume, please make sure that: a. the desired delivery volume clicks into place. b. the digits are completely visible in the display window. c the selected volume is within the pipette's specified range." 4. An interview on 12/21/22 at 1:44 pm with the Laboratory Director confirmed the laboratory did not have the appropriate pipette to dispense volumes less than 10 uL. D5010 VIROLOGY CFR(s): 493.1205 If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1265, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observations, review of records, and interviews, the laboratory failed to utilize a uni-directional workflow for its open-system, SARS-CoV-2 molecular test system (Refer to D3005 A), failed to have separate areas for reagent preparation and specimen preparation for its open-system, SARS-CoV-2 molecular test system (Refer to D3005 B), failed to have the appropriate pipettes to dispense volumes less than 10 uL for its molecular SARS-CoV-2 testing (Refer to D3007), failed to establish a competency assessment policy (Refer to D5209), failed to follow its procedure for the performance of SARS-CoV-2 testing using the SeqOnce Biosciences reagents and the BioRad CFX C1000 thermocycler (Refer to D5401), failed to follow its policy to perform maintenance and function checks for its pipettes used in SARS-CoV-2 testing (Refer to D5433 A), failed perform and document control procedures at least each patient test run for its molecular SARS-CoV-2 test procedure (Refer to D5445), failed to test quality control materials used in its molecular SARS-CoV-2 test system in the -- 2 of 11 -- same manner as patient specimens (Refer to D5465), and failed to ensure SARS-CoV- 2 test results generated on the test report were accurate (Refer to D5801). 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 observations, review of records, and interviews, the laboratory failed to establish a competency assessment policy (Refer to D5209), the laboratory failed to verify the accuracy of its quantitative urine toxicology testing at least semiannually (Refer to D5217), failed to ensure reagents and solutions used in urine toxicology testing were not used beyond their expiration dates (Refer to D5417), and the laboratory failed to follow its policy to perform maintenance and function checks for its pipettes used in quantitative urine toxicology testing (Refer to D5433 A). 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 record review and interview with the Laboratory Director, the laboratory failed to establish a competency assessment policy for 2 (December 2020 to December 2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's personnel records revealed a lack of competency assessments for the Clinical Consultant and Testing Personnel #1, for the performance of molecular SARS-CoV-2 testing and urine toxicology testing, between August 2021 and December 2022. 2. The surveyor requested the laboratory's established competency assessment policy on 12/21/22 at 12:15 pm and it was not made available. 3. An interview on 12/21/22 at 12:20 pm with the Laboratory Director revealed the laboratory had not established a competency assessment policy. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to verify the accuracy of its quantitative urine toxicology testing at least semiannually for 12 of 68 total analytes listed on the laboratory's test menu. Findings include: 1. A review of the laboratory's proficiency testing and verification of accuracy records dated 4/25/22 revealed a document stating, "Split samples sent out to -- 3 of 11 -- ref lab. All results (pos/neg) match 100% 5/1/2022." 2. A review of the quantitative results from the split sample study revealed differences between the laboratory and the reference laboratory results had not been evaluated for its quantitative accuracy. The following analytes had not been evaluated: a. Ritalinic Acid b. Naloxone c. Naltrexone d. Sufentanil e. Norhydrocodone f. Tapentadol g. Hydroxyalprazolam h. Midazolam i. Triazolam j. MDEA k. Methcathinone l. Secobarbital 3. An interview on 12/21/22 at 1:35 pm with the Laboratory Director confirmed the laboratory had not assessed the quantitative results for the 4/25/22 split sample testing event for the analytes listed above. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Laboratory Director, the laboratory failed to follow its procedure for the performance of SARS-CoV-2 testing using the SeqOnce Biosciences reagents and the BioRad CFX C1000 thermocycler for 1 test run observed. Findings include: 1. The surveyor observed the Laboratory Director perform SARS-CoV-2 testing for 5 specimens using its SeqOnce Biosciences reagents and the BioRad CFX C1000 thermocycler on 12/21/22 at 9:51 am. The Laboratory Director used a Lichen pipette calibrated from 20-200 uL to dispense the following components: a. Dye, 8 uL b. Probes, 10 uL c. Master mix, 15 uL d. Patient sample, 5 uL e. Positive and Negative quality control, 5 uL 2. A review of the laboratory's Lichen Pipette Instructions for Use on 12/21/22 revealed a section stating, "The volume of the pipette is clearly shown through the handle grip window. The delivery volume is set by turning the thumb button clockwise or anticlockwise. When setting the volume, please make sure that: a. the desired delivery volume clicks into place. b. the digits are completely visible in the display window. c the selected volume is within the pipette's specified range." 3. A review of the laboratory's "SeqOnce Biosciences AzureSeq Direct One-Step Universal RT-qPCR Kit SARS-CoV-2 Instructions for Use" on 12/21/22 revealed a section stating, "All instruments must be maintained and operated according to manufacturer's instructions." 4. An interview on 12/21/22 at 9:51 am with the Laboratory Director confirmed the pipette used was not suitable for volumes less than 20 uL. 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 -- 4 of 11 -- 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of toxicology testing at least twice annually for 2 (August 2019 to August 2021) of 2 years of testing. Findings include: 1. A record review of the laboratory's test menu and list of drugs tested on the College of American Pathologist proficiency testing (PT) reports, the records revealed a lack of documentation of verification of accuracy testing for 13 toxicology analytes for 2 (August 2019 to August 2021) of 2 years of testing as follows: a. Norhydrocodone b. Noroxymorphone c. Naloxone d. Naltrexone e. Tapentadol f. Secobarbital g. Sufentanil h. Hydroxyalprazolam i. Midazolam. j. Triazolam k. Ritalinic Acid l. MDEA m. Methathinone 2. An interview on 8/03/2021 at 11:53 am, the LD confirmed the laboratory did not perform verification of accuracy testing for all analytes not included in the PT program for 2 years. D6151 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(b)(3)(4) (3) The director or technical supervisor may delegate to the general supervisor the responsiblity for providing orientation to all testing personnel; and (4) Annually evaluating and documenting the performance of all testing personnel. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the general Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- supervisor (GS) failed to evaluate the competency of 1 (#1) of 3 Testing Personnel (TP) at least annually after the first year. Findings include: 1. A record review of the competency documentations revealed a lack of documentation for the annual competency evaluations for 1 (TP#1) of 3 TP in 2020 and 2021. 2. An interview on 8 /03/2021 at 10:19 am, the LD confirmed the GS did not perform annual competency evaluation for TP#1 in 2020 and 2021. -- 2 of 2 --

Summary Statement of Deficiencies 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 laboratory director, the laboratory failed to enter test requisitions accurately for five (#1 - #5) of five patients reviewed. Findings include: 1. Record review of patients (#1-#5) test requisitions and final reports from December 2018 to May 2019 revealed the following discrepancies: Patient #1 a. The test requisition revealed a "Confirmation Panel" was ordered. b. The "Confirmation Panel" signed by the ordering physician on 12/28/18 included the following tests that were not on the final report: Pentazocine, Nalbuphine, Propoxyphene, Normeperidine, Butorphanol, Flunitrazepam. Flurozepam, LSD, Bath Salts, Methylone, and Fluoxetine. c. The final report included the following tests not indicated in the "Confirmation Panel": Gabapentin and Pregabalin. Patient #2 a. The test requisition revealed "Confirmation Panel" was ordered. b. The "Confirmation Panel" signed by the ordering physician on 02/05/19 included the following tests that were not on the final report: Pentazocine, Nalbuphine, Propoxyphene, Normeperidine, Butorphanol, Flunitrazepam. Flurozepam, LSD, Bath Salts, Methylone, and Fluoxetine. c. The final report included the following tests not indicated in the "Confirmation Panel": Gabapentin and Pregabalin. Patient #3 a. The test requisition revealed "Confirmation Panel" was ordered. b. The "Confirmation Panel" signed by the ordering physician on 03/19/19 included the following tests that were not on the final report: Pentazocine, Nalbuphine, Propoxyphene, Normeperidine, Butorphanol, Flunitrazepam. Flurozepam, LSD, Bath Salts, Methylone, and Fluoxetine. c. The final report included the following tests not indicated in the "Confirmation Panel": Zaleplon, Gabapentin, and Pregabalin Patient #4 a. The test requisition revealed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- "Confirmation Panel" was ordered. b. The "Confirmation Panel" signed by the ordering physician on 04/05/19 included the following tests that were not on the final report: Pentazocine, Nalbuphine, Propoxyphene, Normeperidine, Butorphanol, Flunitrazepam. Flurozepam, LSD, Bath Salts, Methylone, and Fluoxetine. c. The final report included the following tests not indicated in the "Confirmation Panel": Zaleplon, Gabapentin, and Pregabalin. Patient #5 a. The test requisition revealed "Confirmation Panel" was ordered. b. The "Confirmation Panel" signed by the ordering physician on 05/08/19 included the following tests that were not on the final report: Pentazocine, Nalbuphine, Propoxyphene, Normeperidine, Butorphanol, Flunitrazepam. Flurozepam, LSD, Bath Salts, Methylone, and Fluoxetine. c. The final report included the following tests not indicated in the "Confirmation Panel": Zaleplon, Gabapentin, and Pregabalin 2. During the interview on May 29, 2019 at approximately 1:00 PM, the laboratory director acknowledged there were discrepancies between the test requisitions and test reports. -- 2 of 2 --