Hematology Oncology Assoc Of Fredericksburg

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Hematology Oncology Associates of Fredericksburg on July 12, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of package insert, and interviews, the laboratory failed to follow the manufacturer's instructions for one (1) of 1 expired Influenza A &B test kit stored in the laboratory on the date of the inspection, July 12, 2022. Findings include: 1. During a laboratory tour on 7/12/22 at approximately 10 AM, the inspector noted one (1) expired box of McKesson Consult Influenza A & B kit (Lot Number 449K41, Expiration 10/31/2021). No other lot numbers of the expired Influenza A & B test cassettes were stored in the laboratory. The inspector noted twenty-two (22) of twenty-five (25) test cassettes in the kit. 2. Review of the Influenza A & B package insert revealed manufacturers instructions: "Do not use test cassettes beyond the kit expiration date. Discard after expiration." The inspector inquired regarding the expired test kit. The Technical Supervisor (TS) stated at approximately 12 noon, "The staff should have noted that the kit is not in use on the box". 3. An exit interview with the Lab Director, Exam/Lab Manager, and TS on 7/12/22 at approximately 3:30 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 -- 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 a review of proficiency testing (PT) records and interviews, the laboratory failed to evaluate non-graded hematology and chemistry module PT results for two (2) of six (6) events reviewed for both Blood Cell Identification (BCI) and Cancer Antigen (CA) 19-9. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT notebooks, a total of 6 hematology and 6 core chemistry module events (2020 Event 3, 2021 Events 1-3, 2022 Events 1-2), revealed no documentation of an evaluation or verification of accuracy for the following non- graded responses: API Heme Module: 2020 Event 3- challenge sample BCI-11, one (1) of five (5) responses scored as "not graded"; 2021 Event 2- challenge sample BCI- 07, 1 of 5 responses scored as "not graded"; API Core Chemistry Module: 2020 Event 3 - CA 19-9 challenges TM-11, TM-12, 2 of 2 responses scored as "not graded"; 2021 Event 1 - CA 19-9 challenges TM-01, TM-02, 2 of 2 responses scored as "not graded"; The PT notebooks' review pages recorded signatures of review by the lab director (LD) and Technical Supervisor (TS) with written comment "100%" for the above outlined events. 2. An exit interview with the LD, Exam/Lab Manager, and TS on 7/12/22 at approximately 3:30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Hematology Oncology Associates of Fredericksburg on January 27 and 28, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: **REPEAT DEFICIENCY** Based on a review of the laboratory's policies and procedures, proficiency testing (PT) documentation, and an interview, the laboratory failed to follow their established policy and retain attestation statements signed by the laboratory director (LD) for one (1) of sixteen (16) events reviewed for calendar years 2018 and 2019. Findings include: 1. Review of the laboratory's policies and procedures revealed a policy, "Proficiency Testing", which stated "7. Upon completion of the testing, the Laboratory Director or his designee must review and sign the result reporting form. The Lab Director and all testing personnel must sign the Attestation Statement." 2. Review of the laboratory's American Proficiency Institute (API) 2018 and 2019 Core Chemistry Events 1,2 3; 2018 and 2019 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- Miscellaneous Chemistry Events 1, 2, 3; and 2018 and 2019 Hematology/Coagulation Events 1, 2, 3 PT documentation, a total of 16 events, revealed no attestation statement signed by the LD for the 2019 API Miscellaneous Chemistry Event 2. The surveyor requested to review the signed attestation for the 2019 API Miscellaneous Chemistry Event 2. The laboratory provided no documentation to review. 3. In an interview with the Technical Supervisor on January 27, 2020 at approximately 2:00 PM, the above findings were confirmed. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, proficiency testing (PT) records, and interview, the laboratory failed to follow their established policy and document remedial action taken for one (1) unsatisfactory scored Vitamin B12 analyte event out of six (6) events reviewed for calendar years 2018 and 2019. Findings include: 1. Review of the laboratory's policies and procedures revealed a policy, "Proficiency Testing", which stated, "12. c. Failures must be thoroughly investigated and

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Hematology Oncology Associates of Fredericksburg on March 15, 2018 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: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's chemistry proficiency testing (PT) documentation, and an interview, the laboratory failed to retain attestation statements signed by the laboratory director for two (2) of seven (7) events reviewed. Findings include: 1. Review of the laboratory's 2016 and 2017 American Proficiency Institute (API) chemistry PT documentation, a total of seven (7) events, revealed no laboratory director signed attestation statements for: 2016 Event 2 Chemistry Group 2 Module, 2017 Event 2 Chemistry Miscellaneous Module. The inspector requested to review the attestation documentation for the events listed above. No documentation was available for review. 2. In an exit interview with the lead laboratory technician on 3/15/18 at approximately 1:00 PM , it was confirmed that the laboratory failed to retain copies of 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 -- the API laboratory director signed attestation statements for the two (2) PT events outlined above in 2016 and 2017. 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: Based on a review of the laboratory's procedures, calibration verification records, analyzer's online test data, patient test logs, and interviews, the laboratory failed to perform twice annual calibration verification studies for sixteen (16) of sixteen (16) analytes according to the laboratory's written policy in calendar year 2017. Findings include: 1. Review of the procedure manual revealed a Quality Assurance (QA) policy to perform calibration verification for the Medica EasyRA chemistry testing once every six months. The policy states "Calibration Verification is required every 6 months on all analytes tested on the EasyRA analyzer". 2. Review of the laboratory's 2016 and 2017 EasyRA calibration verification records revealed that the verification studies were performed once (on 6/7/17) in calendar year 2017. The inspector noted that the laboratory calibration verification for the EasyRA was next performed nine (9) months later on 3/14/18. The inspector requested to review additional documentation of calibration verification performed in 2017. The documentation was not available for review. 3. Review of the EasyRA analyzer's online test data for analytes included for patient testing in 2017 and up to the date of the inspection, revealed the following sixteen (16) analytes: Albumin, Alkaline Phosphatase, Alanine Aminotranserase, Aspartate Aminotransferase, Blood Urea Nitrogen, Calcium, Choride, Carbon Dioxide, Creatinine, Glucose, Lactate Dehydronase (LDH), Magnesium, Potassium, Sodium, Total Bilirubin, Total Protein. 4. Review of the laboratory's Patient Test Count Log records revealed the following panels and tests were resulted during the three (3) month calibration verification lapse: Comprehensive Metabolic Panels: Three thousand two hundred sixty-nine (3,269), Magnesium: Three thousand eighteen (3,018), LDH: Four hundred twenty-four (424). 5. In an interview with the lead tech and at approximately 1:00 PM and a phone conversation with the technical consultant at approximately 1:30 PM on 3/15/17, it was confirmed that the -- 2 of 3 -- laboratory failed to perform linearity validation studies according to the laboratory's written QA policy for the sixteen (16) Medica EasyRA chemistry test reagents outlined above in calendar year 2017. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of policies and procedures, Quality Assurance (QA) documentation, and interviews, the laboratory failed to establish and follow a policy for the comparison of hematology Complete Blood Count (CBC) test results performed on the two (2) Diatron Abacus 5 instruments for twenty-four (24) of the twenty-four (24) months reviewed. Findings include: 1. During a laboratory tour at approximately 10:00 AM, the inspectors noted patient CBC samples were being assayed on two (2) Diatron Abacus 5 hematology instruments. The instruments were labeled as: Instrument 1, Serial Number (SN) 510477, Instrument 2, SN 510475. 2. Review of the laboratory's policies and procedures revealed no QA plan to evaluate a comparison of CBC test results assayed on the two (2) Abacus 5 instruments. 3. Review of the laboratory's QA documentation from March 2016 through the date of the survey on 3/16/18 revealed no documentation or evaluation of CBC result comparison records for the two (2) hematology instruments listed above. 4. In an interview with the lead tech and at approximately 1:00 PM and a phone conversation with the technical consultant at approximately 1:30 PM on 3/15/17, it was confirmed that the laboratory failed to establish and document a comparison of hematology test results performed on the two (2) Diatron Abacus 5 instruments (SN 510477 and SN 510475) in twenty-four (24) of twenty-four (24) months reviewed. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of the laboratory's procedures, Medica EasyRA calibration verification records and analyzer's online test data, Quality Assurance (QA) documentation, and interviews, the laboratory director failed to ensure that QA policies were established and or followed during the twenty-four (24) of twenty-four (24) months reviewed. Refer to D5439 and D5775. -- 3 of 3 --