Rheumatology Associates Of N A

Summary Statement of Deficiencies 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 review of the accuracy verification records and an interview with the General Supervisor, the surveyor determined the laboratory missed performing one of two accuracy verifications for TSPOT TB in 2021. The findings include: 1. A review of Immunology records revealed the laboratory performed split testing with a reference lab to verify the accuracy of TSPOT TB (a non-regulated manual assay for the detection of effector T-cells in patients with latent tuberculosis). 2. A review of the accuracy verification records revealed the laboratory only verified the accuracy of TSPOT TB the second half of 2021 on 9/17/2021. 3. During an interview on 6/21 /2022 at 3:55 PM, the General Supervisor confirmed the laboratory had not performed TSPOT TB accuracy verification the first half of 2021. . D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. 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 review of the test menu and test platforms during the entrance tour, a review of personnel records and an interview with the General Supervisor, the Laboratory Director failed to specify in writing the duties of six of six testing personnel after orientation and training. The findings include: 1. During the entrance tour on 6/21/2022 at 12:00 PM, the General Supervisor listed the moderate/high- complexity lab menu and testing platforms, as follows: A) Hematology testing using the Sysmex XN-550 B) Chemistries and Rheumatoid Factor (RF) on the Beckman Coulter AU480 C) Vitamin D and Thyroid Panel on the Beckman Coulter Access 2. D) ANA (Anti-Nuclear Antibodies) Panels on the Athena Luminex Multilyte E) TSPOT TB (a manual assay for the detection of effector T-cells in patients with latent tuberculosis). F) Synovial Fluid Crystal Identification 2. A review of personnel records revealed competencies for the testing personnel did not include all six testing platforms. Since some competencies were missing (Refer to D6151), the surveyor was unable to clearly determine which tests each of the testing personnel were allowed to perform. 3. During an interview on 6/22/2022 at 9:10 AM, the above noted findings were reviewed with the General Supervisor who confirmed the duties for each of the six testing personnel. The surveyor then explained the Laboratory Director was required to specify in writing the duties, examinations and procedures each individual was authorized to perform upon completion of their training. . D6151 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(b)(3)(4) (3) The director or technical supervisor may delegate to the general supervisor the responsiblity for providing orientation to all testing personnel; and (4) Annually evaluating and documenting the performance of all testing personnel. This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with the General Supervisor, the General Supervisor failed to perform and document competency assessments for three of six testing personnel (TP) in 2020 - 2021. The findings include: 1. A review of personnel records revealed the following: A) TP #1: No annual competency assessment for TSPOT TB in 2020 or 2021 B) TP #2: No semi-annual competency assessment for Immunology/ANA (Anti-Nuclear Antibodies) Panels on the Athena Luminex Multilyte and Hematology testing on the Sysmex XN-550 in early 2021 C) TP #6 : No annual competency assessment for Hematology testing on the Sysmex XN- 550 in 2021 2. During an interview on 6/22/2022 at 9:10 AM, the above noted findings were reviewed and confirmed with the General Supervisor. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a lack of quality control records and an interview with the General Supervisor, the laboratory failed to document Chemistry/Endocrinology quality control (QC) shifts and trends over time for a two and a half year period from the previous survey on 9/21/2017 till the date of the current survey on 2/18/2020. The findings include: 1. A review of the QC records for the Beckman Coulter (B/C) AU480 and Access 2 analyzers revealed only the daily QC printouts were available for review. The laboratory had no records documenting the monitoring of QC shifts and trends over time. (Examples include printing Levi-Jennings charts periodically or submitting data to a QC company's Interlaboratory Quality Assurance Program [IQAP]). 2. During an interview on 2/19/2020 at approximately 4:00 PM, the General Supervisor explained she had not had time to print the Levi-Jennings charts for the Chemistry / Endocrinology tests; because she had missed a lot of work over the last two years, she had reviewed the QC "on the computer", then she documented her review with "QC reviewed" on the maintenance charts for each analyzer. 3. As the interview continued at approximately 4:15 PM, the surveyor explained electronic 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 -- review of QC was acceptable as long as the records for the survey period (9/21/2017-2 /18/2020) were available for the surveyor's review. In the Chemistry area, the surveyor and General Supervisor reviewed the Levi-Jennings QC records on the B/C Access 2 computer from 1/19/2020 thru 2/19/2020. However, when the surveyor requested QC from before 1/19/2020, the General Supervisor was unable to "pull up" any of the older records. The Supervisor also confirmed this was a new Access 2 analyzer installed in May 2018, so any records on the previous Access 2 were definitely lost. The General Supervisor was unable retrieve any Levi-Jennings QC records from the B/C AU480 Chemistry analyzer. Thus the above noted findings were confirmed. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --

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 a review of the CASPER reports (#153/#155) for proficiency testing participation and a telephone interview with the laboratory director, the surveyor determined the laboratory scored forty percent (40 %) and zero percent (0 %) for the WBC (White Blood Cell) Differential for testing Events #1 and #2 of 2019, respectfully. The failing scores of two consecutive testing events resulted in the laboratory's initial unsuccessful proficiency testing participation. The findings include: 1. The laboratory scored 40 % for the WBC Differential for Event #1, 2019 and 0 % for the WBC Differential for Event #2, 2019, two consecutive testing events. 2. In a telephone interview on 7/08/2019 at 3:37 PM, the Laboratory Director stated 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 -- an investigation was underway, including speaking with the manufacturer of the Hematology instrument. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER reports (#153/#155) for proficiency testing participation and a telephone interview with the laboratory director, the surveyor determined the laboratory scored forty percent (40 %) and zero percent (0 %) for the WBC (White Blood Cell) Differential for testing Events #1 and #2 of 2019, respectfully. The unsatisfactory (failing) scores for two consecutive testing events for the same analyte resulted in unsuccessful performance for the laboratory. 1. Refer to D2016. -- 2 of 2 --