Arthritis & Rheumatology Center Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on January 25, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 review of the College of American Pathologist (CAP) Proficiency Testing (PT) for the year 2020 and 2021, as well as staff interview, the laboratory did not perform testing of the PT samples in the same manner as patient samples. Findings: 1. Review of CAP documents for 2020 and 2021, for specialties Hematology, Chemistry, Microbiology, and Diagnostic Immunology, the laboratory performed PT testing of samples in duplicate and testing performed by two different Testing Personnel. 2, Interview with staff #2, and #3 (reference CMS 209 form), on January 25, 2022, at approximately 2pm, in the Laboratory Office, confirmed the aforementioned statement. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(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 -- 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 review of the College of American Pathologist (CAP) Proficiency Testing (PT) for the years 2020 and 2021, as well as staff interview, the laboratory did not test PT specimens by personnel who routinely perform the testing in the laboratory. Findings: 1. Review of the CAP documents for 2020 and 2021 for the Specialties of Hematology, Chemistry, Microbiology, and Diagnostic Immunology, PT test samples were not rotated to all personnel who routinely perform clinical testing in the laboratory. Staff # 4 (reference CMS 209 form), did not complete any PT testing. 2. Interview with staff # 2 and 3 (reference CMS 209 form) on January 25, 2022, at approximately 2:30 pm in the laboratory office, comfirmed the aforementioned statement. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the College of American Pathologist (CAP) Proficiency Testing (PT) provider for the year 2020 and 2021, and staff interview, the laboratory was not performing testing of the PT samples in the same manner as they test their patient samples. Findings: 1. Review of the CAP PT documents for 2020, and 2021 for Specialty Hematology, Chemistry, Microbiology, and Diagnostic Immunology, the laboratory was performing testing of all samples in duplicate, with testing being performed by two different Testing Personnel. 2. Review of the Attestation Statement forms for all events in 2020, and 2021, revealed that two different testing personnel were performing the PT samples in duplicate and not the same was as patient samples were tested. The Laboratory Director was signing the Attestation Statements confirming that the PT samples were being tested in the same manner as patient samples. 3. Interview with staff #two and three (CMS 209 form), on January 25, 2022, at approximately 2 pm, confirmed the above aforementioned statements. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on July 17, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to evaluate and verify PT activities as required. Findings include: 1. College of American Pathologists (CAP) PT document review revealed

Summary Statement of Deficiencies D0000 An Initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on January 5, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to implement an established safety procedure to ensure protection from physical, biochemical, and biohazardous materials. Findings include: 1. During the laboratory tour it was observed there was not a maintenance log for the eyewash equipment for 2016 and 2017. 2. An interview with Staff #2 (CMS 209) during the laboratory tour on 1/5/18 at approximately 1:30 p.m. confirmed the eyewash equipment was not maintained during 2016 and 2017. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to provide a policy and procedure for monitoring laboratory temperature and humdity. Findings include: 1. SOP document review revealed the laboratory had not written a policy and procedure for monitoring the temperature and humidity as required by the Horiba Micros 60 hematology analyzer. 2. An interview with the office manager on 1/5/18 at approximately 2:15 PM in an offuce area confirmed there was not a policy and procedure in the SOP for monitoring laboratory temperature and humidity. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 general laboratory systems document review and staff interview, the laboratory failed to document laboratory temperature and humidity as required by the manufacturer. Findings include: 1. General laboratory systems document review revealed the laboratory failed to document laboratory temperature and humidity for 2016 and 2017 as required for the Horiba Micros 60 hematology analyzer. 2. An interview with Staff #2 (CMS 209) in the laboratory on 1/5/18 at approximately 1:30 p.m. confirmed laboratory temperature and humidity were observed but not recorded for 2016 and 2017. . D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on testing personnel (TP) document review and staff interview, the technical supervisor/laboratory director (TS/LD) failed to evaluate and document the TP responsible for high complexity testing semi-annually during the first year. Findings include: 1. TP document review revealed the TS/LD did not perform a six-month competency on Staff #2 (CMS 209) in 2017. 2. An interview with Staff #2 (CMS 209) on 1/5/18 in an office area at approximately 2:15 p.m. confirmed a six-month competency was not performed for Staff #2 (CMS 209). D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the -- 2 of 3 -- performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on testing personnel (TP) document review and staff interview the TS/LD (Technical Supervisor/Laboratory Director) failed to perform an annual competency on high-complexity TP. Findings include: 1. TP document review revealed the TS/LD did not perform an annual competency on Staff#2 (CMS 209) in 2017. 2. An interview with Staff #2 (CMS 209) in an office area on 1/5/18 confirmed the TS/LD did not perform an annual competency on Staff #2 (CMS 209) in 2017. -- 3 of 3 --