Arthritis And Rheumatic Diseases Pc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Arthritis and Rheumatic Diseases, PC on October 17, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The inspection included an offsite interview and review of records with the practice manager on 10/18/23. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of hematology proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to record evaluation for eight (8) of 8 Complete Blood Count (CBC) analyte parameters scored/ reported as unsatisfactory on challenge sample #HD-2 by Medical Laboratory Evaluation (MLE) for 2022 Event M1. Findings include: 1. Review of three MLE 2022 PT events (M1- M3) revealed the following 8 analyte parameters reported as unacceptable on Event M1 challenge sample #HD-2: Lymphocyte Percent (%) reported as 42.5 outside acceptable range 8.6-15.6; Monocyte % reported as 17.6 outside acceptable range of 2.6-4.3; Granulocyte % reported as 39.9 outside acceptable range 80.8-88.2; White Blood Cell reported as 2.0 outside acceptable range 17.2-23.4; Red Blood Cell reported as 2.19 outside acceptable range 5.38-6.08; Hemoglobin reported as 5.8 outside acceptable range 17.1-19.8; Hematocrit reported as 15.4 outside acceptable range 48.2-54.4; Platelet reported as 69 outside acceptable range 409-683. 2. The inspector requested to review documentation that the laboratory evaluated the 8 unacceptable challenge results outlined above. Documentation was not available for review. 3. An interview with the practice manager on 10/17/23 at 1:30 PM confirmed the above findings. 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 -- D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of procedures, hematology quality control (QC) records, lack of documentation, and interviews, the laboratory failed to perform an evaluation of statistical analysis to identify possible shifts and trends for Complete Blood Count (CBC) testing on the Horiba ABX hematology instrument for twenty-one (21) of 21 months reviewed during timeframe of January 2022 to the date of the inspection on October 17, 2023. Findings include: 1. Review of the laboratory procedure manual revealed: Manufacturer's Quality Control and Peer Group Program protocol (dated 11 /22/19) that outlined, "The QC Program will improve the management of QC using Horiba instrument. The Horiba QC Peer program includes automatic QC data uploaded in real time, peer review statistics by instrument, proactive monitoring and auto notification based on Westgard violations, easily identify data that is out of specification on demand peer and Levey-Jennings reports". Quality Assurance Procedure (dated 3/2/21) that stated, "End of Month Report- after the last day of the month, log into Horiba QC website to print monthly QC reports, attach to the maintenance log, turn into lead tech for Lab Director's signature". 2. A review of 2022 and 2023 hematology Horiba instrument's Tri Level QC materials (levels 1-3) revealed no available documentation of statistical analysis for the parameters of CBC testing (White Blood Cell, Red Blood Cell, Hemoglobin, Hematocrit, Platelet, Lymphoctye, Monocyte, Granulocyte Neutrophil) during the timeframe of January 2022 to the date of the inspection 10/17/23. The inspector requested documentation. No records were available. The practice manager stated on 10/17/23 at 1:00 PM: "I would defer to our lead lab tech for this issue. I am not sure why the Levey Jennings charts are missing for those months." In a follow up interview on 10/18/23 at 4:55 PM, the practice manager stated, "I was able to contact Horiba and found that the QC data was uploaded. They helped me to access the reports." 3. The inspector reviewed QC Levey Jennings charts provided by the practice manager via an email scan on 10 /18/23. The ten reports provided did not include date of assays nor were the review /date attestation pages signed by the lab director. 4. An exit offsite interview with the practice manager on 10/18/23 at 5:15 PM confirmed the above findings -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Arthritis and Rheumatic Diseases PC on January 20, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, lack of documentation, and interviews, the laboratory technical consultant (TC) failed to document annual hematology competency assessments for Complete Blood Count (CBC) testing for four (4) of five (5) testing personnel (TP) in calendar years 2020 and 2021. Findings include: 1. Review of the CMS 209 form and personnel files revealed that the Laboratory Director (LD) qualified/served as the TC and identified 5 TP (A-E) as responsible for performing patient CBC testing during the twenty-six (26) months reviewed (timeframe October 2019 to 1/20/22). See Personnel Code Sheet. 2. Review of the following laboratory personnel files revealed 2020 and 2021 competency assessments for CBC testing: TP B - CBC Skills Check List performed/signed by TP A TP C - CBC Skills Check List performed/signed by TP B TP D - CBC Skills Check List performed/signed by TP B TP E - CBC Skills Check List performed/signed by TP B The inspector noted that TP A and B did not meet the qualification requirements for TC duties and requested to review competency assessment documentation evaluated by the director (as TC) for the 2020 and 2021 records outlined above. The documentation was not available for review. The office manager and assistant office 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 -- manager stated at approximately 11:00 AM on 1/20/22: "We were not aware that the lab director should be the person evaluating the competency assessments for the testing staff." 3. An exit interview with the office manager and assistant office manager on 1/20/22 at approximately 11:30 AM confirmed the above findings. D6052 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, lack of documentation, and interviews, the technical consultant (TC) failed to document annual hematology competency assessments that included evaluation of problem solving skills for five (5) of 5 testing personnel (TP) in calendar years 2020 and 2021. Findings include: 1. Review of the CMS 209 revealed that the lab director (LD) performs the duties of TC and 5 TP qualified/responsible for patient hematology testing during the review timeframe of October 2019 to 1/20/22. 2. Review of the 2020 and 2021 laboratory personnel files revealed no Horiba ABX hematology analyzer competency assessments that included the competency procedure of problem solving skills for TP A-E. (See Personnel Code Sheet.) The inspector noted the personnel files included a Complete Blood Count (CBC) Skills Check Sheet for each TP outlining direct observation of CBC testing and requested to review additional competency procedures documentation. No additional documentation was available for review. 3. An exit interview with the office manager and assistant office manager on 1/20/22 at approximately 11:30 AM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Arthritis and Rheumatic Diseases PC on September 25, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited as follows: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records, and interviews, the laboratory failed to rotate PT among the five (5) personnel who performed Complete Blood Count (CBC) and Rheumatoid Factor (RF) patient testing from August 2017 to September 2019. Findings include: 1. Review of the CMS 209 form revealed 5 testing personnel listed as having performed/reported patient CBC and RF testing during the twenty-four (24) months reviewed. 2.. Review of the laboratory's Medical Laboratory Evaluation (MLE) PT documentation (2017 Event 3, 2018 Events 1-3, 2019 Events 1-3) revealed that testing personnel A (TP A) signed the following CBC and RF performance attestation statements: 2017 M3, 2018 M1, 2018 M3, 2019 M1, 2018 M2, 2019 M3; TP A performed six (6) of seven (7) events reviewed. (See Personnel Code Sheet) 3. In an exit interview with the lab director, office manager, and TP A, at approximately 4:00 PM, the above findings were confirmed. 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 --