Arthritis And Rehab Medicine, Pllc

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 surveyor observation and interview with testing personnel (TP) #1, 02/26 /25, the laboratory failed to ensure expired calibration reagent was not available for use. Findings: At approximately 1:15 p.m. surveyor observed one bottle of "Buprenorphine 0 ng/mL Calibrator" reagent, Lot #74893999, with an expiration date of 11/30/24, available for use on the bottom shelf of the laboratory refrigerator. Interview with TP #1 at approximately 1:45 p.m. confirmed the calibration reagent was expired. They stated they had not used it for patient testing and the reagent was only used for troubleshooting if necessary. The calibration reagent was disposed of at time of survey. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on review of laboratory policy, 2023 and 2024 testing personnel (TP) competency records, and interviews with laboratory director (LD) and TP #1, 02/26 /25, the technical consultant (TC) failed to perform direct observations of patient test performance for 1 of 1 TP in 2023 and 2024. Findings: Review of laboratory policy, 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 -- "Quality Assurance Program" revealed "5. External Proficiency testing...PT is used as competency assessment of personnel as noted.". Review of TP #1 competency records for 2023 and 2024 revealed a printed copy of the competency assessments. The copies of the assessments were signed by the TC. The competency record states "Performs patient testing on specimens submitted to the laboratory for analysis by adhering to the laboratory's quality control policies, documents all quality control activities, instrument and procedural calibrations and maintenance performed in accordance with the clinical laboratory's approval policies and procedures identified by the direct observation by the supervisor." This assessment is checked "Yes". During interview with LD at approximately 1:45 p.m., the LD stated the TC has not been on-site for over 2 years and that record review and competency assessments are sent electronically for the TC to review and sign off on. Interview with TP #1 at approximately 2:20 p.m. confirmed the TC had not been on-site to perform direct observations of routine patient test performance. They stated the competency assessment form is sent electronically for the TC to sign and return to the laboratory. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) (b)(8)(iv) Direct observation of performance of instrument maintenance and function checks; This STANDARD is not met as evidenced by: Based on review of laboratory policy, 2023 and 2024 testing personnel (TP) competency records, and interviews with laboratory director (LD) and TP #1, 02/26 /25, the technical consultant (TC) failed to perform direct observations of instrument maintenance and function checks for 1 of 1 TP in 2023 and 2024. Findings: Review of laboratory policy, "Quality Assurance Program" revealed "5. External Proficiency testing...PT is used as competency assessment of personnel as noted.". Review of TP #1 competency records for 2023 and 2024 revealed a printed copy of the competency assessments. The copies of the assessments were signed by the TC. The competency records state "Performs patient testing on specimens submitted to the laboratory for analysis by adhering to the laboratory's quality control policies, documents all quality control activities, instrument and procedural calibrations and maintenance performed in accordance with the clinical laboratory's approval policies and procedures for instrumentation utilized identified by the direct observation by the supervisor." This assessment is checked "Yes". During interview with LD at approximately 1:45 p.m., the LD stated the TC has not been on-site for over 2 years and that record review and competency assessments are sent electronically for the TC to review and sign off on. Interview with TP #1 at approximately 2:20 p.m. confirmed the TC had not been on- site to perform direct observations of instrument maintenance and function checks. They stated the competency assessment form is sent electronically for the TC to sign and return to the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on review of 2021 laboratory policy and procedure manual, laboratory records, lack of documentation for 2021 verification of accuracy and interview with testing personnel (TP) #1 4/5/22, the laboratory failed to verify the accuracy of the testing performed on the Indiko Plus screening analyzer 2 of 2 times in 2021. Findings: Review of laboratory procedure manual revealed the procedure "Proficiency Testing Procedures" states "To satisfy CLIA regulations and accrediting organization criteria we are enrolled in the approved external Proficiency Testing programs for all regulated analytes and authorize that our PT results be forwarded to our accrediting agency if needed. In addition we perform split-sample analysis with other CLIA certified laboratories as an external validation of all non-regulated analytes not included in our approved proficiency testing program menus." Review of 2021 laboratory records revealed the laboratory tested patient samples on the Indiko Plus screening analyzer January of 2021 thru December of 2021, a period of approximately 12 months. Review of 2021 verification of accuracy records revealed no documentation the laboratory had performed a verification of accuracy for all analytes tested in 2021. Interview with TP#1 at approximately 3:30 p.m. confirmed the laboratory failed to perform a verification of accuracy 2 of 2 times in 2021 for the testing performed on the Indiko Plus screening analyzer due to machine problems. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) 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 -- (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 laboratory policy and procedure manual, 2020 proficiency testing (PT) records, and interview with testing personnel (TP) #1 4/5/22, the laboratory failed to retain documentation of the processing, reporting, and review of PT samples and results for the first and second toxicology events in 2020. Findings: Review of laboratory procedure manual revealed the procedure "Proficiency Testing Procedures" states "All records of external PT testing are kept for at least two years. This includes information about the PT specimens (date received, condition when received), the personnel who performed the analysis, the attestation form signed by the person doing the testing and the laboratory director and designee. The attestation form provides that the PT sample was treated and tested as a patient specimen in our laboratory, results submitted to the PT program, and the date the results from the PT programs are reviewed." Review of 2020 PT records revealed that the laboratory participated and was scored in the first and second toxicology events in 2020. Review of 2020 PT records revealed no documentation of the processing, reporting and review of results of the first and second toxicology events in 2020. Interview with TP#1 at approximately 3:00 p.m. confirmed the laboratory failed to document the first and second toxicology events in 2020 but that it was performed. 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)