Arthritis And Rheumatology Consultants Pa

Summary Statement of Deficiencies D0000 . The Arthritis and Rheumatology Consultants PA laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on November 6, 2025. The following standard-level deficiencies were cited: 493.1236 Evaluation of proficiency testing performance 493.1253 Establishment and verificaiton of performance specifications . D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of six ungraded proficiency testing (PT) results for regulated and non-regulated analytes when the PT program did not obtain the agreement required for scoring in three of twelve proficiency testing events reviewed from 2024 and 2025. Findings are as follows: 1. The laboratory performed Chemistry and Immunology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 10:07 on 11/6/25. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. Two Chemistry PT results were not graded due to result variance in 2025. Four Immunology PT results were not graded by API due to lack of consensus in 2024. See below. 2024 - Immunology 2nd Event Analytes: Anti-dsDNA, Anti-sm Sample ID: ANA-07 2024 Immunology 3rd Event Analyte: Anti-dsDNA, Anti-RNP/Sm Sample IDs: ANA-14, ANA-12 2025 - Chemistry 3rd Event Analyte: Bilirubin, Total Sample IDs: CH-12, CH-13 4. 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 -- Evaluation of the ungraded results was not found in laboratory PT records. The laboratory was unable to provide this documentation upon request. 5. The laboratory was required to evaluate ungraded PT results as defined in the Proficiency Testing procedure found in LABDAQ software. 6. In an interview at 11:37 a.m on 11/6/25., the GS confirmed the above findings. . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to complete one of five required performance verification (PV) activities for two Hematology analyzers implemented by the laboratory in 2024. Findings are as follows: 1. The laboratory performed Erythrocyte Sedimentation Rate (ESR) testing under the Hematology specialty as confirmed by the General Supervisor (GS) during a tour of the survey at 10:07 on 11/6/25. 2. An Alcor iSED and and Alcor miniiSED were observed as present and available for use during the tour. The laboratory performed ESR testing on these analyzers beginning in October 2024. 3. The laboratory was required to perform reportable range verification when adding a new analyzer as defined in the Implementation of New Tests procedure found in the LABDAQ software. 4. Reportable range verification documentation was not included with the PV activities found in the Alcor Validation binder provided by the laboratory on the date of survey. The laboratory was unable to produce the missing documentation upon request. 5. In an interview at 2:28 p.m. on 11/6/25, the GS confirmed the above findings. 6. In an email received at 10:06 a.m. on 11/7/25, the GS indicated the laboratory performed the following testing on the Alcor Hematology analyzers: Year Instrument # of ESR tests 2024 miniiSED 136 2024 iSED 1719 2025 miniiSED 782 2025 iSED 11,199 . -- 2 of 2 --

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure 1 of 10 reference intervals were consistent between a Hematology procedure and a patient test report. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 9:10 a.m. on 11/16/21. 2. A Horiba Pentra 60 c+ hematology analyzer was observed as present and available for use during the tour. 3. Reference intervals listed in the Normal Ranges, Panic or Critical Values SOP, located in the Lab Policies and Procedures manual, for the following analyte was not consistent with those included on a patient test report reviewed on date of survey as indicated below. * Hemoglobin (HGB) Patient: Adult female, 68 years old, tested on 10/11/21 Analyte* Procedure Report HGB 11.5 - 18.0 11.5 - 16.0 4. In an interview at 12:50 p.m. on 11/16/21, TP1 confirmed the above finding. NOTE: This is a repeat citation from the 01/03/20 survey. . 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 D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to review and evaluate proficiency testing (PT) results from 1 of 10 PT events performed in 2019. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Testing Personnel 1 (TP1) during a tour of the laboratory on 01/03/20, at 10:10 a.m. 2. The laboratory performed PT using the American Proficiency Institute (API) PT provider. 3. Review and evaluation of API PT results was not performed by the laboratory for the 2019 event listed below. Specialty Event Hematology 2019-1 4. In an interview at 1:30 p.m. on 01/03/20, TP1 confirmed the above finding. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure 9 of 10 reference intervals were consistent between a Hematology procedure and a patient test report. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP1) 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 -- during a tour of the laboratory at 10:10 a.m. on 01/03/20. 2. A Horiba Pentra 60 c+ hematology analyzer was observed as present and available for use during the tour. 3. Reference intervals listed in the Normal and Panic Ranges chart, effective date 06/05 /19, for the following analytes were not consistent with those included on a patient test report reviewed on date of survey as indicated below. White Blood Cells (WBC) Red Blood Cells (RBC) Hematocrit (HCT) Mean Corpuscular Volume (MCV) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Ed Cell Distribution Width (RDW) Platelets (PLT) Patient #851 - adult female tested on 09/12/19 Analyte* Procedure Report WBC 3.5-10.8 4.0-10.0 RBC 3.8-5.2 3.80-5.80 HCT 36.0-49.0 37.0-47.0 MCV 81-100 80-100 MCH 27.0-35.0 27.0-32.0 MCHC 32.5-37.0 32.0-36.0 RDW 11.5-15.4 11.0-16.0 PLT 130-400 150- 500 4. In an interview at 2:50 p.m. on 01/03/20, TP1 confirmed the above finding. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Laboratory Director (LD) failed to ensure 1 of 11 testing personnel in 2018 and 2 of 13 testing personnel in 2019 were evaluated for test procedure competency. Findings are as follows: 1. The laboratory was cited for non-performance of annual competency evaluations during the previous survey conducted on 02/09/18. 2. Annual competency evaluations were not found on date of current survey for 1 of 11 testing personnel in 2018 records and 2 of 13 testing personnel in 2019 records. See D6046. 3. In an interview at 11:45 a.m. and 12:20 p.m. on 01/03/20, TP1 confirmed the above finding. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical consultant (TC) failed to ensure 1 of 11 testing personnel in 2018 and 2 of 13 testing personnel in 2019 were evaluated for test procedure competency. Findings are as follows: 1. The laboratory performed Chemistry and Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:10 a.m on 01/03/20. 2. Competency evaluations were required annually as established in the Employee -- 2 of 3 -- Training and Annual Competency for Testing Personnel procedure located in the Laboratory Policies and Procedures manual. 3. Annual competency evaluations were not found for testing personnel in 2018 and 2019 records as indicated below. 2018 Testing Personnel Missed evaluation MD9 Synovial crystal examination 2019 Testing Personnel Missed evaluation MD8 Synovial crystal examination TP4 Chemistry and Hematology 4. The laboratory was unable to provide the missing evaluations upon request. 5. In an interview at 11:45 a.m. and 12:20 p.m. on 01/03/20, TP1 confirmed the above finding. *This is a repeat citation from the previous survey on 02/09/18. See D6030* -- 3 of 3 --

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the technical consultant (TC) failed to assess all required elements in a 2017 competency evaluation for 1 of 3 testing personnel. Required competency evaluation elements per 493.1413(b)(8) include the following: 1) Direct observation of test performance, 2) Monitoring the recording and reporting of test results, 3) Review of intermediate test results or worksheets and testing records, 4) Direct observation of instrument maintenance, 5) Assessment of test performance with previously analyzed specimens, and 6) Assessment of problem solving skills. Findings are as follows: 1. The laboratory performed Diagnostic Immunology, Chemistry and Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 02/09/18 at 9:30 a.m. 2. Testing Personnel 3 (TP3) was included on the Laboratory Personnel Report (CLIA) Form CMS-209 as a part-time employee who performed testing in the Specialties listed above. 3. Requirements to assess testing personnel in all areas of testing annually were established in the Employee Training and Annual Competency for Testing Personnel procedure. 4. An evaluation in the Specialties of Diagnostic Immunology, Chemistry and Hematology for the elements listed below was not found in the 2017 competency assessment records for TP3. 2) Monitoring the recording and reporting of test results 3) Review of intermediate test results or worksheets and testing records 5) Assessment of test performance with previously analyzed specimens The laboratory was unable to provide the missing evaluations upon request. 5. In an interview on 02/09/18 at 11:13 a.m., TP1 confirmed the above finding. 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 --