Arthritis Specialty Center

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory procedures, training and competency assessment records and an interview with the general supervisor on 1/11/2024, the laboratory failed to establish and follow written policies and procedures to assess employee competency. The findings include: 1. The CMS 209 identified three (3) testing personnel (TP) performing moderate and high complexity testing. 2. A review of laboratory procedures identified that the laboratory failed to establish policies or procedures to assess TP initial, semiannual and annual competency and competency of the general supervisor (GS) and technical supervisor (TS). 3. A review of training and competency assessment records identified that the laboratory failed to have an annual competency assessments for one (1) of one (1) TP in 2023. 4. A review of training and competency assessment records identified that the laboratory failed to have six month competency assessments for two (2) of two (2) TP in 2023. 5. A review of training and competency assessment records identified that the laboratory failed to have competency assessments for the GS and TS in 2022 and 2023. 6. An interview with the general supervisor on 1/11/2024 at 8:53 am confirmed the above findings. 7. The laboratory reports performing 166,075 moderate and high complexity tests annually. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) 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 laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on review of laboratory documents, a lack of a policy and procedure manual and an interview with the general supervisor (GS) on 1/11/2024, the Laboratory Director (LD) failed to ensure that there was a laboratory policies and procedures manual for testing personnel to follow. The findings include: 1. A review of the laboratory documents and a lack of a procedure manual identified that the LD failed to ensure a procedure manual that included but not limited to a competency, proficiency, quality assurance, specimen collection and rejection, quality control and critical values procedures were available for testing personnel to follow. 2. An interview with the GS on 1/11/2024 at 12:28 pm confirmed that the LD failed to ensure that the laboratory had a policy and procedure manual to follow. 3. The laboratory reports performing 166,075 moderate and high complexity tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a record review of the Beckman Coulter DxH 500 instrument verification, the Alcor miniiSED instrument verification and an interview with the laboratory manager on 3/21/2022, the laboratory director failed to ensure that the instrument verifications were adequate. The findings include: 1. A record review of the new instrument verification of the Beckman Coulter DxH 500, used for hematology testing, identified that the laboratory director failed to review and approve the verification results for accuracy, precision, reportable range and carryover to ensure that they were adequate before beginning patient testing on 11/1/2021. 2. A record review of the new instrument verification of the Alcor miniiSED, used for sedimentation rate testing, identified that the laboratory director failed to review and approve the verification results for accuracy, precision, reportable range and carryover to ensure that they were adequate before beginning patient testing on 3/20/2020. 3. Interviews with the laboratory manager on 3/21/2022 at 2:11 pm and 3:42 pm confirmed that the laboratory director failed to review and approve the verifications of the Beckman Coulter DxH 500 and Alcor miniiSED . 4. The laboratory reports performing 45,362 hematology tests annually. 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 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) desk review, the laboratory failed to successfully participate in proficiency testing for the analyte Rheumatoid Factor. Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. 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 -- This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review and the laboratory ' s graded PT results from the American Proficiency Institute (API) and College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance for two out of three consecutive testing events for Rheumatoid Factor. Findings: 1. A review of the API PT results from 2019 event 2 revealed the laboratory received a score of 0% for Rheumatoid Factor. 2. A review of the CAP PT results from 2020 event 1 revealed the laboratory received a score of 0% for Rheumatoid Factor. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) record review and an interview with the laboratory manager, the laboratory failed to enroll in PT for the Immunoglobulin G and Immunoglobulin A analytes since the last survey on July 11, 2016. Findings: 1. A PT record review from the American Proficiency Institute (API), revealed the laboratory failed to enroll in PT for the analytes Immunoglobulin G and Immunoglobulin A. 2. An interview on April 10, 2018 at 3:45 PM, with the laboratory manager, confirmed the laboratory was not enrolled in a CMS-approved PT program since the last survey. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, 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 2 -- laboratory failed to verify the accuracy of estimated sedimentation rate (ESR) at least twice annually since the last survey on July 11, 2016. Findings: 1. A record review revealed the laboratory failed to document the accuracy of ESR at least twice annually since the last survey. 2. An interview on April 10, 2018 at 4:20 PM, with the laboratory manager, confirmed the laboratory failed to document the accuracy of ESR at least twice annually. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to verify the accuracy and correct the test results entered manually for a patient reviewed on March 28, 2018. Findings: 1. A review of a patient record from March 28, 2018, revealed the laboratory had reported an albumin result of 3 and a total bilirubin result of 90.6. A review of the Vitros 350 chemistry analyzer printouts for the patient revealed an albumin of 3.6 and a total bilirubin result of 0.6. 2. An interview on April 10, 2018 at 4:30 PM, with the laboratory manager, confirmed the laboratory failed to verify the accuracy of patient test results entered into the patient's electronic medical record. -- 2 of 2 --