Virginia Endocrinology & Osteoporosis Center

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Virginia Endocrinology & Osteoporosis Center on January 23-24, 2025 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 and include the Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 personnel performing Complete Blood Count (CBC) patient testing in one of two years reviewed (2023 and 2024). Findings include: 1. Review of the CMS Form 209 revealed two testing personnel were identified as qualified and responsible for patient CBC testing during calendar years 2023 and 2024 up to the dates of the inspection on 1/23/25-1/24/25. 2. Review of the laboratory's 2024 American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) PT documentation, a total of three (3) events, revealed that testing personnel A signed attestations for performing: AAB-MLE 2024 Event 1 Hematology Module; AAB-MLE 2024 Event 2 Hematology Module; AAB-MLE 2024 Event 3 Hematology Module; TP A performed 3 of 3 hematology CBC PT events performed in 2024. (See Personnel Code Sheet.) 3. Interviews with the laboratory supervisor on 1/23/25 at 4:00 PM and on 1/24/25 at 11 AM 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 4 -- D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation, lack of documentation, and interviews, the laboratory failed to retain attestation statements signed by the laboratory director and testing personnel for one (1) of six (6) events reviewed. Findings include: 1. Review of the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) PT documentation (2023 Events 1-3, 2024 Events 1-3), a total of 6 events, revealed no signed attestation statements for the 2023 Chemistry/Endocrinology and Hematology modules' third event. 2. The inspector requested to review the attestation documentation for the AAB-MLE third event modules listed above. No documentation was available for review. 3. Interviews with the laboratory supervisor on 1/23/25 at 4:00 PM and on 1/24/25 at 11 AM confirmed the above findings. 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 test logs, proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to verify twice annual accuracy of a laboratory-developed test (LDT) for Hemoglobin A1C (HbA1c) from August 2023 to the dates of the inspection January 23-24, 2025. Cross Reference D5407, D5423. Findings include: 1. Review of test logs revealed seven hundred seventy- seven (777) HbA1c tests were resulted utilizing a LDT from 8/11/23 to 1/25/25. 2. Review of the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) PT documentation (2023 Events 1-3, 2024 Events 1-3), a total of 6 events, revealed no enrollment in a PT module for the LDT HbA1c test. The inspector requested to review PT or twice annual accuracy verification for the high complexity LDT HbA1c test. No records were available. 3. Interviews with the laboratory supervisor on 1/23/25 at 4:00 PM and on 1/24/25 at 11 AM confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. -- 2 of 4 -- This CONDITION is not met as evidenced by: Based on a review of policies and procedures, observation, manufacturer's operator manual, patient test logs, tour, performance verification documentation, and interviews, the laboratory failed to: 1. document laboratory director approval/review after a modification of the Tosoh G8 HPLC analyzer procedure during seventeen (17) of twenty-two (22) months reviewed - Cross Reference D5407; 2. document evaluation/verification of accuracy, precision, analytical sensitivity, and reportable range for a laboratory developed Hemoglobin A1c test prior to reporting seven hundred seventy-seven patient results from August 2023 to the dates of the inspection January 23-24, 2025 - Cross Reference D5423. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of policies and procedures, observation, manufacturer's operator manual, lack of documentation, and interviews, the laboratory failed to document the laboratory director's (LD) approval/review of a modification of the Tosoh G8 HPLC analyzer procedure for seventeen (17) of twenty-two (22) months reviewed (survey timeframe March 2023 through the dates of inspection January 23-24, 2025). Findings include: 1. Review of the laboratory's policy and procedure manual revealed a procedure for Hemoglobin A1C (HbA1c) testing on the Tosoh G8 HPLC analyzer that was approved by the LD on 8/7/23. The procedure stated under Intended Use: "The Tosoh Automated Glycohemoglobin Analyzer HPLC-723G8 is intended for the in vitro diagnostic use for quantitative measurement of % hemoglobin A1c (HbA1c) in venous whole blood specimens." 2. The inspector observed a nurse deliver a fingerstick sampled tube to the testing personnel and the loading of fingerstick sample onto the Tosoh G8 HPLC analyzer on 1/23/25 at 2 PM. The inspector inquired what sample types were accepted for HbA1c testing on the analyzer. The personnel stated, "We run venous whole blood and fingerstick whole blood samples. A lot of our patients want to know their result while here and it is faster for the nurses to do a fingerstick than to wait for the phlebotomist to draw a tube." 3. Review of the Tosoh G8 Operator's Manual revealed instructions (on page 4) under Section 1.5 Specimen Collection and Handling which stated, "Collect venous whole blood specimens in vacuum collection tubes containing K2-EDTA or K3-EDTA and mix thoroughly. The minimum volume required for analysis directly from collection tubes is 1 mL of whole blood. Venous whole blood samples as small as 50 uL may be used when appropriate sample cup and software options are selected." 4. The inspector requested to review documentation that the LD evaluated/approved/updated the procedure to include fingerstick whole blood sample type (outside of the manufacturer's intended use statement) prior to implementing the laboratory-developed test method in August 2023. The documentation was not provided. 5. Interviews with the laboratory supervisor on 1/23/25 at 4:00 PM and on 1/24/25 at 11 AM confirmed the above findings. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) -- 3 of 4 -- (b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (b)(2)(i) Accuracy. (b)(2)(ii) Precision. (b)(2)(iii) Analytical sensitivity. (b) (2)(iv) Analytical specificity to include interfering substances. (b)(2)(v) Reportable range of test results for the test system. (b)(2)(vi) Reference intervals (normal values). (b)(2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on a tour, review of policy and procedures, observation, manufacturer's user guide instructions, performance verification documentation, patient test logs, and interviews, the laboratory failed to document evaluation/verification of accuracy, precision, analytical sensitivity, and reportable range for their laboratory-developed test (LDT) of Hemoglobin A1c (HbA1c) prior to reporting seven hundred seventy- seven (777) patient results from August 2023 to the dates of the inspection January 23- 24, 2025. Findings include: 1. During an entrance tour of the laboratory on 1/23/25 at 1 PM, the inspector noted a new Tosoh G8 endocrinology analyzer in use for HbA1c testing. 2. Review of the laboratory's policy and procedure manual revealed a procedure for HbA1c on the Tosoh G8 HPLC analyzer that was approved by the LD on 8/7/23. The procedure stated under Intended Use: "The Tosoh Automated Glycohemoglobin Analyzer HPLC-723G8 is intended for the in vitro diagnostic use for quantitative measurement of % hemoglobin A1c (HbA1c) in venous whole blood specimens." 3. The inspector observed laboratory testing personnel loading a fingerstick sample on the Tosoh G8 HPLC analyzer on 1/23/25 at 2 PM. 4. Review of the Tosoh G8 Operator's Manual revealed instructions (on page 4) under Section 1.5 Specimen Collection and Handling which stated, "Collect venous whole blood specimens in vacuum collection tubes containing K2-EDTA or K3-EDTA and mix thoroughly." 5. Review of the laboratory's Tosoh instrument verification records revealed the analyzer installation, by a Tosoh field service technical specialist, occurred in August 2023. The inspector noted that the instrument verification of venous whole blood samples was approved by the LD and was placed in use on 8/11 /23. The inspector requested to review that performance specifications were established/approved for the LDT fingerstick method. The documentation was not available for review. 6. Review of test logs revealed 14,698 A1c tests were resulted from 8/11/23-1/25/25 on the new Tosoh G8 analyzer -noting that thirteen thousand nine hundred twenty one (13,921) A1c tests resulted from venous blood draw, 777 A1c tests resulted from the LDT fingerstick method. 777 of 14,696 A1c tests were resulted utilizing samples not approved under the manufacturer's intended use from 8 /11/23 to 1/25/25. 7. Interviews with the laboratory supervisor on 1/23/25 at 4:00 PM and on 1/24/25 at 11 AM confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Virginia Endocrinology on May 14, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview and initial virtual record review on 5/10/2021. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: 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 -- Based on a review of procedures, manufacturer package insert, chemistry analyzer calibration verification records, lack of documentation, and an interview, the laboratory failed to document the Beckman Coulter Access 2 analyzer's Thyroid Uptake (TU) calibration verification twice annually in calendar year 2020. Findings include: 1. Review of the laboratory's procedures revealed the following policies: Quality Assurance policy (title: Quality Assurance Program) that outlined the Access 2 immunoassay analyzer's calibration verification protocols: "If the test calibration procedures include three or more levels of calibration material (a low, mid, and high value) and is performed at least once every six months, then the requirements for calibration verification are met". Quality Control Policy (title: Quality Control Program) that outlined Access 2 immunoassay's control protocols for Thyroid Uptake: "run BioRad Liquichek Immunoassay Plus Control Level 1 and 3 each day". 2. Review of the Access 2 TU package insert revealed that the reagent included one level of calibrator. 3. Review of the laboratory's Access 2 TU calibration verification records, from August 2019 to the date of the survey on 5/14/21, revealed one calibration verification record performed on 5/13/21. The inspector requested to review additional documentation of TU calibration verification. The lead testing personnel stated: "We performed the verification in the spring of 2019 when we first set up the instrument. We overlooked performing a cal verification for this test analyte in 2020. I recently realized that we had not included it with our other chemistry calibration verifications in 2020 and I ordered a calibrator kit from Audit Micro Controls." 4. In an interview with the primary testing personnel on 5/14/21 at approximately 2:30 PM, the above findings were confirmed. -- 2 of 2 --