Northern Virginia Hematology Oncology Associates

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Northern Virginia Hematology Oncology Associates on July 16-17, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, Quality Assurance records, lack of documentation and interview, the laboratory failed to follow their established policy to perform "safety audits" annually in calendar year 2024 and 2025. Review timeframe August 2023 until July 2025. The findings include: 1. Review of the laboratory's Quality Assurance (QA) Policy revealed a "Quality Assurance Monitoring Schedule" with the statement "January QC and maintenance/action logs review. Calibration review if needed. Transcription audits. Safety/Infection Control QA Audit. Proficiency Testing Audit." 2. Review of the laboratory's QA records revealed a lack of documentation of the Safety/Infection Control QA Audit for calendar year 2024 and 2025. The surveyor requested to review documentation of the annual audits. The laboratory provided no documentation for review. 3. In an exit interview with the Technical Consultant, primary testing personnel and Office Manager on July 17, 2025 at 11:45 AM, the findings were confirmed. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) 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 -- (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on a review of daily Hematology quality control (QC) records, patient test records, lack of documentation, policies, manufacturer's user guide, and interview, the laboratory failed to perform daily Hematology QC procedures per their policy on one (1) day of seventeen (17) days in March 2024 and 1 of eighteen (18) days in April 2024 while reporting forty (40) Complete Blood Count (CBC) results. The findings include: 1. Review of the daily Sysmex XN 430 hematology QC records and patient CBC test logs from August 2023 to the date of the inspection, July 17, 2025, revealed the following two dates lacked documentation of QC procedures: 03/12/2024 - 20 patients reported; 04/09/2024 - 20 patients reported; A total of 40 patient CBC results were reported without QC verification. The surveyor requested to review QC results for the dates listed above. The laboratory provided no documentation for review. 2. Review of the laboratory's policies revealed a "Quality Control Policy and Guidelines" policy with the statement, "General Guidelines: 1. A minimum of 2 levels of QC will be run each day of testing for every non-waived procedure in the laboratory." 3. Review of the online Sysmex XN 430 User Guide revealed instructions in Section 2, "Quality control is performed in order to monitor an instrument's performance over time. XN-L Check tri level is the quality control material used to monitor the performance of the XN analyzer each day of operation. Quality control should be run according to licensing agency regulations." 4. In an exit interview with the Technical Consultant, primary testing personnel and Office Manager on July 17, 2025 at 11:45 AM, the findings were confirmed. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, quality control (QC) records, and interviews, the laboratory failed to follow their established policy to review Chemistry, Endocrinology and Hematology quality control statistics monthly during the twenty-three (23) months reviewed. Review timeframe: August 2023 through June 2025. The findings include: 1. Review of the laboratory's policies and procedures revealed a policy, "Quality Control Policy and Guidelines", with the statement "All QC results will be reviewed by the Technical Consultant or Laboratory Director on a monthly basis. This review will be documented by the completions of the QA Tracking sheet for Quality Control." 2. Review of the QA tracking sheet revealed documentation of QC review by the Technical Consultant (TC) quarterly for October 2023, January 2024, April 2024, July 2024, October 2024, January 2025, -- 2 of 4 -- April 2025 and July 2025. 3. In an interview on July 16, 2025 at 11:00 AM, the TC stated they review QC results and reports quarterly. 4. In an exit interview with the Technical Consultant, primary testing personnel and Office Manager on July 17, 2025 at 11:45 AM, the findings were confirmed. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: A. Based on a review of daily Hematology quality control (QC) records, patient test records, lack of documentation, policies, manufacturer's user guide, and interview, the laboratory director (LD) failed to ensure the policy for the performance of daily Hematology QC procedures was followed. Cross Reference D5447. B. Based on a review of the laboratory's policies and procedures, monthly quality control (QC) records, lack of documentation and interviews, the laboratory director (LD) failed to ensure the established quality assessment (QA) policy for monthly review of Chemistry, Endocrinology and Hematology QC and Levey Jennings (LJ) charts was followed. Cross Reference D5469. C. Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form, laboratory personnel files, laboratory's policies and procedures, lack of documentation, and an interview, the LD failed to ensure the laboratory followed their established policy to document hematology semi-annual competency assessments for new testing personnel. Cross Reference D6053. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory policies and procedures, personnel records, lack of documentation, and interview, the technical consultant (TC) failed to follow the laboratory's established policy to perform semi-annual competency assessments for one (1) of two (2) new laboratory testing personnel (TP). The findings include: 1. Review of the CMS 209 form revealed that the laboratory director (LD) identified four TP responsible for hematology testing. 2. A review of personnel records revealed TP# 1 and #2 were identified as new TP since the previous inspection in August 2023 (See Personnel Code Sheet). Further review revealed the 2 new TP's initial hematology training and semi-annual competency as: TP #1 - training February 2024, semi-annual competency documentation dated 7/2024; TP #2 - training May 2023, no semi-annual competency documentation. The surveyor requested to view semi-annual competency assessment records for TP #2 documented in calendar year 2023. The laboratory provided no documentation for review. 3. Review of the laboratory's policies and procedures revealed a policy, "Section 2-Staff -- 3 of 4 -- Training & Competency Testing, II. Competency Testing a. Will be performed by the technical consultant for each newly hired testing individual after successful completion of initial training for each test/instrument/test system, at 6 months of independent work and annually thereafter." 4. In an exit interview with the TC, primary testing personnel and Office Manager on July 17, 2025 at 11:45 AM, the findings were confirmed. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Northern Virginia Hematology Oncology Associates, PC on August 23, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 C.F.R. part 493 CLIA Regulations. Specific deficiencies cited are as follows and include the Conditions under 42 CFR part 493 CLIA Regulation: D5400-42 CFR. 493.1250 Condition: Analytic Systems; and D6000-42 CFR. 493.1403 Condition: Moderate Complexity Laboratory Director. 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. This CONDITION is not met as evidenced by: Based on a review of the laboratory's policies and procedures, 2021

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Northern Virginia Hematology Oncology Associates, PC on September 8, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on August 12, 2021 and virtual record review conducted on September 3, 2021. The laboratory was surveyed under 42 C.F.R. part 493 CLIA Regulations. The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems and D6000 - 42 C.F.R. 493.1403 Condition: Moderate complexity laboratory director. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, the CASPER 155 report and interview, the laboratory failed to participate in the first PT event of 2021 and received scores of "0" for Alanine Transaminase (ALT), Albumin (ALB), Alkaline Phosphotase (ALP), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL), Calcium (Ca), Chloride (Cl), Creatinine (Creat), Glucose (Gluc), Iron (Fe), Lactate Dehydrogenase (LDH), Magnesium (Mg), Potassium (K), Sodium (Na), Total Protein (TP), and Blood Urea Nitrogen (BUN). Findings include: 1. Review of the American Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- Proficiency Institute (API) PT records and the CASPER 155 report revealed API reported the 2021 1st event as: 0% "failure to participate" for Alanine Transaminase (ALT), Albumin (ALB), Alkaline Phosphotase (ALP), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL), Calcium (Ca), Chloride (Cl)., Creatinine (Creat), Glucose (Gluc), Iron (Fe), Lactate Dehydrogenase (LDH), Magnesium (Mg), Potassium (K), Sodium (Na), Total protein (TP), and Blood Urea Nitrogen (BUN). 2. In an interview with testing personnel A (TP A) on September 8, 2021 at approximately 10:30 AM, the testing personnel stated the laboratory forgot to enroll with API for 2021. 3. In an exit interview with testing personnel A (TP A) and office manager on September 8, 2021 at approximately 12:30 PM, the above findings were confirmed. D2100 ENDOCRINOLOGY CFR(s): 493.843(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, the CASPER 155 report and interview, the laboratory failed to participate in the first PT event of 2021 and received scores of "0" for thryoid stimulating hormone (TSH). Findings include: 1. Review of the American Proficiency Institute (API) PT records and the CASPER 155 report revealed API reported the 2021 1st event as: 0% "failure to participate" for TSH. 2. In an interview with the primary testing personnel on September 8, 2021 at approximately 10:30 AM, the Testing Personnel A (TP A) stated the laboratory forgot to enroll with API for 2021. 3. In an exit interview with the testing personnel A (TP A) and office manager on September 8, 2021 at approximately 12:30 PM, the above findings were confirmed. 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 proficiency testing (PT) records, policy and procedures, lack of documentation, and an interview, the laboratory failed to document evaluation taken for one (1) unacceptable prostatic specific antigen (PSA) score on American Proficiency Institute (API) 2020 Event 1. Findings include: 1. Review of the laboratory's API records (2019 Events 2 & 3, 2020 Events 1-3 and 2021 Events 1 & 2), a total of seven (7) events, revealed no evidence of remedial action taken for the unsatisfactory 2020 Event 1 PSA analyte score of 50%. 2. Review of the laboratory's procedures revealed a policy, "Procedure for Proficiency Testing", which stated -- 2 of 12 -- "REVIEW OF RETURNED SUMMARY SHEETS...4. Unacceptable results will be investigated and

Summary Statement of Deficiencies D0000 An unannounced off-site proficiency testing desk review of Northern Virginia Hematology Oncology Associates, PC was conducted on October 6, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was inspected under 42 CFR Part 493 CLIA regulations. Specific deficiencies cited are as follows: 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 an off-site desk review of the laboratory's American Proficiency Institute proficiency testing (PT) records and interview, the laboratory failed to attain a score of at least eighty percent of acceptable responses for Total Bilirubin in two 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 -- consecutive Chemistry testing events resulting in unsuccessful PT performance (reviewed: 2020 Second Event, 2020 Third Event). See D2097. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) results and interview, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable analyte responses for Total Bilirubin (TBil) on two (2) consecutive chemistry testing events reviewed (2020 Second Event and 2020 Third Event). Findings include: 1. Review of the laboratory's API Chemistry Core PT module results revealed a TBil analyte score of less than 80% for the following consecutive events: API Chemistry Core 2020 Event 2 TBil = 0%; API Chemistry Core 2020 Event 3 TBil = 40%; resulting in an unsuccessful TBil PT performance. 2. In a telephone interview with the primary testing personnel on October 6, 2020 at approximately 12:00 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Northern Virginia Hematology Oncology Associates on February 27, 2019 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: 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. This CONDITION is not met as evidenced by: ***REPEAT DEFICIENCY*** Based on a review of the policy and procedure manual, calibration verification records and interviews, the laboratory failed to perform calibration verifications for the Medica Easy RA and TOSOH A1A 900 twice annually for calendar year 2018 (Cross Reference D5439). 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 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 -- 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: ***REPEAT DEFICIENCY*** A. Based on a review of the policy and procedure manual, Medica Easy RA calibration verification records, analyzer's online test data, patient test logs, and interviews, the laboratory failed to perform twice annual calibration verification studies for the Medica Easy RA in calendar year 2018. Findings include: 1. Review of the laboratory's procedure manual revealed a Quality Assurance (QA) policy which states "Quantitative test systems require calibration verification be performed every 6 months..." 2. Review of the laboratory's 2017 and 2018 EasyRA calibration verification records revealed the calibration verification studies were performed on 7/12/17. No documentation was found for 2018 until the date of the survey. The surveyor requested documentation of calibration verifications for 2018. At approximately 12:30 PM, testing personnel A (TPA) stated he/she did not perform calibration verification for the analytes tested on the Easy RA. He/she stated that he/she had completed a calibration verification for the analytes on 2/22/19. 3. Review of the EasyRA analyzer's online test data revealed the following 17 analytes were analyzed on patient samples from 7/22/17 until the date of the survey: Albumin, Alkaline Phosphotase, Alanine Aminotranferase, Aspatate Aminotransferase, Blood Urea Nitrogen, Calcium, Chloride, Carbon Dioxide, Creatinine, Glucose, Iron, Lactate Dehydrogenase, Magnesium, Potassium, Sodium, Total Bilirubin, and Total Protein. 4. Review of the laboratory's Laboratory Information System (LIS), Medlinks, revealed two thousand fifteen (2,015) patients samples were tested on the Easy Medica from 7/12/17 until the date of the survey. 5. In an interview at approximately 2:00 PM, TP A confirmed the above listed findings. B. Based on a review of the laboratory's policy and procedure manuals, TOSOH A1A 900 calibration verification records, analyzer's online test data, patient test logs, and interviews, the laboratory failed to perform twice annual calibration verification studies on the TOSOH A1A 900 in calendar year 2018. Findings include: 1. Review of the laboratory's procedure manual revealed a Quality Assurance (QA) policy which states "Quantitative test systems require calibration verification be performed every 6 months..." 2. Review of the laboratory's 2017 and 2018 TOSOH A1A 900 analyzer verification records revealed the verification studies were performed on 7/12/17. No documentation was found for 2018 until the date of the survey. The surveyor requested documentation of calibration verifications for 2018. At approximately 12:30 PM, testing personnel A (TPA) stated he/she did not perform calibration verification for the analytes tested on the TOSOH A1A 900. He/she stated that he/she had completed a calibration verification for the analytes performed on the TOSOH A1A on 2/22/19. 3. Review of the TOSOH analyzer's online test data revealed 2 analytes, Ferritin and CEA, were analyzed on the TOSOH A1A 900 for patient samples from 7 -- 2 of 4 -- /22/17 until the date of the survey. 4. Review of the laboratory's Laboratory Information System (LIS), Medlinks, revealed two thousand one hundred forty-six (2,146) patients samples were tested on the TOSOH from 7/12/17 until the date of the survey. 5. In an interview at approximately 2:00 PM, TP A confirmed the above listed findings D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the laboratory's calibration verification records, policy and procedure manual, Quality Control records, Quality Assessment records and interviews, the laboratory director failed: to ensure calibration verifications were performed every 6 months (Cross Reference D5439-REPEAT DEFICIENCY); and to ensure monthly Levy Jennings graphs were printed and reviewed (Cross Reference D6020). D6020 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 program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the review of policy and procedure manual, Quality Control (QC) records, Quality Assessment (QA) records and interview, the laboratory director failed to ensure the staff followed the established QC policy to print out Levy Jennings graphs monthly for review for nineteen (19) of nineteen (19) months reviewed from July 2017 to date of the survey. Findings: 1. Review of the policy and procedure manual revealed a policy, Quality Control, which stated "Levy Jennings graphs will be printed and reviewed for shifts and trends and