Maryland Pain And Wellness Ctr

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of monthly quality assurance (QA) reviews, reagent packing lists, and monthly maintenance forms, and interview with the technical consultant (TC), the laboratory failed to ensure that phencyclidine (PCP) toxicology reagents were not used beyond their expiration dates. Findings: 1. The laboratory documented the lot numbers of reagents that were in use in the monthly QA reviews. 2. The expiration dates for the reagent lot numbers were contained in the packing lists from the received reagents. 3. The packing list for PCP reagent lot 75191188 showed an expiration date of 07/31/2025. The 08/2025 QA review showed that lot 75191188 was used at the beginning of the month and the next lot, 75251349, was put into use on 08/20/2025. Maintenance logs showed that patient testing was performed on 08/04/2025 and 08/05 /2025, after the expiration date of lot 75191188 and before lot 75251349 was put into use. 4. The packing list for PCP reagent lot 75156792 showed an expiration date of 05 /31/2025. The 06/2025 QA review showed that lot 75156792 was used at the beginning of the month and the next lot, 75191188, was put into use on 06/26/2025. Maintenance logs showed that patient testing was performed on 06/02/2025, 06/03 /2025, 06/04/2025, 06/16/2025, and 06/25/2025, after the expiration date of lot 75156792 and before lot 75191188 was put into use. 5. During the survey on 10/27 /2025 at 1:45 PM, the TC confirmed that PCP reagents were used beyond their expiration date. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(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 3 -- (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: I. Based on review of the procedure manual, instrument maintenance records, and quality assurance (QA) reviews, and interview with the technical consultant (TC), the laboratory failed to ensure that maintenance activities were performed with the frequency specified by the manufacturer. Findings: 1. Section "IV. Instrument Maintenance" of the procedure manual stated: a. "To maintain instrument integrity it is important to follow the manufacturer's instruction for (daily, weekly, monthly, quarterly, annually, and preventative, etc.) maintenance. Each analyzer will have maintenance logs that will require some form of documentation for each day of use." b. "Preventative Maintenance will be performed by the Instrument Service Tech" and stated that preventative maintenance for the Chemistry AU480 instrument was to be "performed annually." 2. The monthly maintenance logs included multiple monthly and quarterly maintenance tasks. 3. Maintenance logs were reviewed from 01/2024-10 /2025 for a total of 22 months. 4. None of the monthly maintenance activities were documented in nine of 22 months (01/2024, 02/2024, 03/2024, 05/2024, 06/2024, 11 /2024, 04/2025, 06/2025, and 08/2025). The monthly QA reviews dated 06/28/2024, 11/17/2024, 1207/2024, 05/20/2025, and 09/01/2025 did make note that monthly maintenance had not been performed and requested that the testing personnel (TP) begin documenting that maintenance was performed. The monthly QA reviews were written by the TC and signed by the laboratory director. There was no documentation that the TP reviewed the notes made on the QA monthly reviews. 5. At least one but not all monthly maintenance activities were documented as performed in seven of 22 months (04/2024, 07/2024, 08/2024, 09/2024, 03/2025, 07/2025, and 10/2025). 6. There were three quarterly maintenance tasks: a. The task to "Inspect and if needed Replace the DI Water Filter and Sample Probe Filter" wasn't documented as performed from 11/2024-03/2025 or from 04/2025-10/2025. b. The task "Replace the wash solution roller pump tubing" was only documented as performed in 10/2024 and 06/2025. 7. There were no records that the annual preventive maintenance was performed in 2024. 8. During the exit interview on 10/27/2025 at 3:25 PM, the TC confirmed that maintenance activities were not performed with the frequency specified by the manufacturer. II. Based on review of the procedure manual, instrument maintenance records, and quality control (QC) records, and interview with the technical consultant (TC), the laboratory failed to ensure that daily maintenance activities were performed on days when patients were tested. Findings: 1. Section "IV. Instrument Maintenance" of the procedure manual stated "To maintain instrument integrity it is important to follow the manufacturer's instruction for (daily, weekly, monthly, quarterly, annually, and preventative, etc.) maintenance. Each analyzer will have maintenance logs that will require some form of documentation for each day of use." 2. Daily maintenance was documented on the monthly maintenance forms. 3. The monthly QA reviews included the monthly QC results. Two levels of QC were tested each day of patient testing. 4. The following dates were when QC was tested, but daily maintenance activities were not documented: 01/31/2024, 06/12/2024, 06/20 /2024, 08/15/2024, 02/05/2025, 03/11/2025, 03/31/2025, and 05/14/2025. 5. During the exit interview on 10/27/2025 at 3:25 PM, the TC confirmed that daily maintenance was not documented as performed on each day that QC was run for patient testing. D5781

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory staff did not test PT samples in the same manner as patient samples. Findings: 1. The laboratory currently has 2 testing personnel (TP) listed on the "Laboratory Personnel Report" (CMS-209). A review of the attestation worksheets from five PT events in 2022 and 2023 showed that TP #2 performed the PT for the second event of 2022 ("UDS-B-2022") and the first event of 2023 ("UDS- A-2023"). The remaining three PT events were performed by TP #1. 2. Review of the PT instrument printouts showed that for five of five PT events, the printouts stated, "Run by (TP #1)," documenting that TP #1 ran and resulted the PT. 3. During an interview on 12/13/2023 at 11:46 AM, the TC stated that each TP should log in with their credentials before running the analyzer. They confirmed that the TP listed on the instrument printout was not the TP who performed the PT. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 laboratory procedure manual and record review and interview with the technical consultant (TC), the laboratory did not ensure that the procedure for documenting unacceptable specimens accurately reflected the current practice in the laboratory. Findings: 1. The laboratory performs urine toxicology testing. The "Sample Collection, Accessioning, Rejection, and Referral Protocol" procedure states, "If a specimen has a recoverable deficiency, the specimen will be accessioned and tested; however, no results will be reported until the deficiency is corrected with documentation. The specimens are logged into the Tests In Question (TIQ) log." The procedure includes a table, listing in which cases a patient specimen should be documented on the TIQ log. 2. Record review showed that the procedure did not include an example of the TIQ log and there were no TIQ logs available for review at the time of the survey. 3. During an interview on 12/13/2023 at 12:30 PM, the TC stated that the testing personnel document rejected specimens on a rejection log, which is not included in the procedure manual. The TC confirmed that the procedure did not reflect the actual practice in the laboratory and that it needed to be updated. D5781

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the technical consultant (TC), the laboratory failed to maintain copies of the signed attestation statements for six of seven PT events reviewed. Findings: 1. The records for seven PT events from 2020-2022 for urine drug screening (UDS) were reviewed. 2. Records for six of the seven PT events reviewed did not include the attestation statement signed by the TP and laboratory director or designee documenting that the PT samples were tested in the same manner as patient specimens. 3. During the survey on 05/31/2022 at 2:30 pm, the TC confirmed that attestation statements were not printed, signed, and maintained for six of seven UDS PT events. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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)

Summary Statement of Deficiencies D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on record review and interview with the technical consultant (TC), the TC did not ensure that the verification of the toxicology analyzer was completed prior to testing and reporting patient test results. Findings: 1. A review of toxicology validation records showed that the method comparison which had been performed on the toxicology analyzer had not been evaluated and determined to be acceptable when the results were not in agreement. 2. During an interview on 5/4/18 at 12:30 PM, the TC confirmed that the verification of the toxicology analyzer was not completed prior to testing and reporting patient samples. 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 --