Neuromuscular Spine And Joint Center

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on reviews of the 2023-2025 Room Temperature (RT) and Humidity logs, the policy and procedure manual, the patient test log, and interviews with the Laboratory Director (LD)/Technical Consultant (TC) and the Practice Manager (PM), the laboratory failed to monitor and document the RT and Humidity for 5 of the 31 days in July 2023. The findings include: 1) A review of the RT and Humidity logs revealed the laboratory failed to monitor and document the RT and Humidity on July 24, 2023, through July 28, 2023. 2) A review of the Procedure for Operating the AU480 Analyzer System ID 47467682 page 1 revealed, 2. Operation: Start Conditions 2.4 Measure and record.... 2.4.1 RT between 18 degrees Celsius... 2.4.2 Relative Humidity between 20-80 percent RH ... 3) A review of the July 2023 patient test logs revealed 53 patients were performed during this period when RT and Humidity were not monitored and documented. 4) The LD/TC and the PM confirmed the above findings during the exit conference on 03-04-2025 at 11:45 AM. 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 2 -- (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: Based on reviews of the Chemistry maintenance logs, and the policy and procedure manual, and interviews with Laboratory Director (LD)/Technical Consultant (TC) and the Practice Manager (PM), the laboratory failed to document the quarterly and every 6-month maintenance. The surveyor noted no documentation of 12 of the 12 quarterly maintenances from 2023-2025. The surveyor also noted that three of the four every 6- month maintenance were not performed and documented from 2023-2025. The findings include: 1. A review of the Chemistry Beckman Coulter (BC) AU-480 maintenance logs revealed no documentation of the quarterly and every 6-month maintenance on the Beckman Coulter (BC) AU-480 Maintenance Log. 2) A review of the policy and procedure manual under Procedure for Operating the AU480 Analyzer System ID 47467682 page 1-2 revealed, 3. Operation: Maintenance 3.5 Quarterly Maintenance 3.5.1 Clean Air.... 3.5.2 Inspect... 3.6 Every 6-month maintenance 3.6.1 Clean the cuvette... 3. The LD/TC and PM confirmed the above findings during the exit conference on 03-04-2025 at 11:45 AM. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the 2019-2021 CAP (College of American Pathologists) proficiency testing (PT) records, and an interview with the Collections Supervisor, the surveyor determined the laboratory failed to ensure proficiency testing samples for Urine Drug Testing (UDS6 surveys) were rotated between all personnel who performed patient testing. This was noted on five of five UDS6 surveys reviewed. The findings include: 1. A review of CAP PT attestation statements revealed Testing Personnel #1 had performed all the UDS testing on five of five of the 2019-2021 UDS6 PT surveys. Testing Personnel #2 had not participated in any UDS6 PT testing since she was trained on 2/11/2019. 2. During an interview and review of the PT records on 7/6/2021 at 2:35 PM, the Collections Supervisor confirmed the above noted findings. . 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 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 -- 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 a review of the 2021 CAP (College of American Pathologists) proficiency testing (PT) records, and an interview with the Collections Supervisor, the surveyor determined the laboratory failed to print and retain records for two of two PT surveys performed in February and March 2021. The findings include: 1. A review of CAP PT records revealed the following: A.) A review of the instrument printouts for the Urine Adulterants / Urine Creatinine (DAI-A) survey revealed the testing was performed on 2/24/2021, however the scores, attestation statement and documentation of results review were not available for the surveyor's review. B.) A review of the instrument printouts for the Urine Drug Testing (UDS6-A)survey revealed no documentation of results review with

Summary Statement of Deficiencies 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)