Ritu Bhambhani Llc (Dba Complete Pain Care)

Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the quality assessment (QA) plan, proficiency testing (PT) procedure and interview with the testing person (TP), the laboratory director (LD) failed to ensure that the established QA plan clearly defined which worksheets are uploaded into "Medialab" for review by the LD and the process for assessing the accuracy of non-regulated analytes which are not included in a formal PT program. Findings: 1. The "Purpose" section of the procedure labeled "QA 100.0 QA 100.0 Quality Assurance Plan MDCPC" states "Monitoring includes pre-analytic, analytic, and post-analytic testing phases. The plan describes a standardized quality control system that maximizes the quality of laboratory testing to produce accurate, reliable and timely results. This plan will enable personnel to establish written procedures to be followed as required by the Clinical Laboratory Improvement Amendments (CLIA)." The TP stated that all the QA records, e.g., maintenance records, PT records, Levy-Jennings graphs, temperature and humidity, pipette calibration, and other laboratory records are uploaded into "Medialab" on a monthly basis for the LD to review. The TP confirmed that the QA plan and other laboratory policies and procedures do not define which records are to be uploaded to LD for review. 2. The "Purpose" section of the procedure labeled "QA 102.0 QA 102.0 Proficiency Testing MDCPC" states "For those analytes (non-regulated analytes) which are not included in a formal proficiency testing program, the laboratory must provide a method to assess and verify the accuracy and reliability of their analytes." The TP explained that the staff at Catalyst Lab Solutions provides blind specimens to the lab three times a year. The specimen covers all the analytes tested at the lab. The specimens are 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 -- evaluated and the results sent back to the lab. The PT procedure does not identify who provides the specimens; how often they are provided; and how to maintain the results. 3. During the exit interview on 05/01/2024 at 12:30 PM, the TP confirmed that the QA and PT plans did include the information listed above. -- 2 of 2 --

Summary Statement of Deficiencies D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on review of documentation submitted from the initial survey completed on 02 /16/2021, review of the standard operating procedure manual (SOPM), and interview and email communication with the technical supervisor (TS), the laboratory failed to retain a copy of the SOPM for toxicology testing using liquid chromatography tandem mass spectrometry (LC/MS/MS) for at least two years after discontinuation. Findings: 1. The laboratory employed all new permanent staff beginning 10/01/2021. During the onsite survey on 12/07/2022, the TS stated that the previous SOPM was not available to the new staff and, therefore, a new SOPM was drafted and approved by the laboratory director. 2. The surveyor had a copy of the testing SOP titled "Complete Pain Care Standard Operating Procedure: Quantitative Determination of Drugs and Metabolites in Urine via LCMS/MS" that was approved by the laboratory director on 05/25/2021. In an email response received on 12/28/2022, the TS confirmed that this original SOP was not available to the laboratory. 3. In the email response received on 12/28/2022, the TS also confirmed that the original SOP detailing the laboratory's previous quality assessment policies and procedures was not available to the laboratory. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems 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 -- activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of documentation submitted from the initial survey completed on 02 /16/2021, review of laboratory records, and interview and email communication with the technical supervisor (TS), the laboratory failed to retain all records documenting analytic systems activities for at least two years for toxicology testing performed using liquid chromatography tandem mass spectrometry (LC/MS/MS). Findings: 1. The laboratory employed all new permanent staff beginning 10/01/2021. During the onsite survey on 12/07/2022, the TS stated that not all documentation of testing activities was available to the new staff. 2. On 12/26/2022 the current TS emailed documents that were located on the previous TS's laptop. 3. The email received on 12 /26/2022 included a document titled "QC PREP 04172021" which showed that the quality control (QC) reagents were prepared on 04/17/2021 and also expired on 04/17 /2021. A revised version of this document was received from the previous TS on 05/24 /2021 as part of the follow up to the initial survey and showed that the expiration date had been updated to 04/17/2022. The current TS stated in an email received on 12/28 /2022 that the updated version of "QC PREP 04172021" with the corrected expiration date was not available to the laboratory. 4. The email received on 12/26/2022 included documentation of laboratory director review of QC results from the LC/MS/MS screening and confirmation assays for 01/01/2021-02/02/2021 and 05/12/2021-08/10 /2021. There was no documentation of QC results review for 02/03/2021-05/11/2021 and 08/10/2021-10/01/2021. 5. The surveyor had a copy of the worksheet labeled "Maintenance Log WHITE MARSH APRIL 2021" (Log) that was received via email from the previous TS on 05/20/2021. The Log recorded the daily temperatures; the LC /MS/MS maintenance; lot numbers and expiration dates for the mobile phases, needle wash, hydrolysis buffer, and hydrolysis enzyme; column guard changes; and

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the validation summary, review of the procedure and interview with the testing person (TP) and technical supervisor (TS), the laboratory failed to establish written policies and procedures for specimen storage and preservation for testing on the liquid chromatography with tandem mass spectrometry (LC/MS/MS) instrument. Findings: 1. The "Stability Study" section on page 4 of the laboratory's "Analytical Method Validation Report (November 2019) LC/MS/MS Pain Panel" states that specimens are stable when stored for 5 days, but doesn't specify under what conditions the specimens were stored at. 2. The "Testing Information" chart listed on page 7 of the laboratory's confirmatory testing procedure stated that specimens are stable less than 5 days at ambient temperature, at least 14 days at refrigerated temperatures (2 to 8C), and greater than 14 days at frozen temperatures (-20 to -5C). The laboratory's stability studies did not establish a specimen's stability beyond 5 days and the procedure does not include a reference to another study that established specimen stability. 3. The "Acceptance Criteria" section on page 33 of the laboratory's confirmatory testing procedure states that specimens should be rejected if "collected more than 30 days prior and / or not refrigerated." This statement conflicts with the previous statement that specimens are stable less than 5 days at ambient temperature. 4. During the survey on 02/16/2021 at 10:00 AM, the TP stated that the laboratory stores each specimen in the refrigerator for 6 weeks in case they receive a request to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- re-test a specimen. The laboratory's confirmatory testing procedure does not include instructions for the length of storage time and temperature once the specimens are tested. 5. During the survey on 02/16/2021 at 10:03 AM, the TS confirmed that specimens should be stored frozen for up to 6 weeks after specimen receipt and that the laboratory only performed stability studies showing that specimens were stable up to 5 days. 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)