Hematology Oncology Care Of Northern Virginia, Pc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Hematology Oncology Care of Northern Virginia, PC (Woodbridge) on August 22, 2023 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 and include the Condition under 42 CFR part 493 CLIA Regulation: D2000- 42 CFR. 493.801 Enrollment and Testing of Samples. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to enroll in a PT program for White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Hemoglobin (HGB), Hematocrit (HCT), Platelet Count (PLT), and Cell Identification (Cell ID) from January 2023 until March 2023. Findings include: 1. A review of the laboratory's PT records revealed a lack of documentation of PT testing enrollment for WBC, RBC, HGB, HCT, PLT, and Cell ID from January 2023 until March 2023. The surveyor requested to review documentation of the laboratory's enrollment in a PT program from January 2023 until March 2023. The laboratory provided proof of PT enrollment dated March 27, 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 -- 2023. The laboratory provided no proof of PT enrollment from January 2023 until March 27, 2023 for review. 2. During an interview with the Technical Consultant (TC) on August 22, 2023, at approximately 9:45 AM, the TC stated they realized the lab was not enrolled after their other location received the PT samples and they didn't receive Event 1's samples. Once they realized they were not enrolled, they immediately enrolled in PT but were too late to get samples submitted for Event 1. They have participated in Event 2 and received a score of 100% for WBC, RBC, HGB, HCT, PLT, and Cell ID. 3. In an exit interview with the TC on August 22, 2023, at approximately 12:00 PM, the findings were confirmed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on a review of the manufacturer's instructions for use, hematology analyzer maintenance records, lack of documentation, and an interview, the laboratory failed to document performance of the required annual instrument preventative maintenance in calendar year 2022 (record review timeframe from February 2022 until August 22, 2023). The findings include: 1. Review of the Beckman Coulter DxH 520 Instructions for Use revealed manufacturer's instructions to "Yearly-Lubricate the pistons." 2. Review of the laboratory's DxH 520 hematology analyzer's maintenance logs from February 2022 to the date of the inspection on August 22, 2023, revealed a lack of documentation of the performance of the required annual maintenance outlined above for calendar year 2022. The inspector requested to review documentation of the piston syringe maintenance in calendar year 2022. The laboratory provided no documentation to review. In an interview with the Technical Consultant (TC) on August 22, 2023, at approximately 11:00 AM, the TC stated they realized the October 2022 maintenance log was missing when they were completing their monthly review. They were unable to locate the log. 3. In an exit interview with the TC on August 22, 2023, at approximately 12:00 PM, the above findings were confirmed. B. Based on a review of the manufacturer's instructions for use, hematology analyzer maintenance records, lack of documentation, and an interview, the laboratory failed to document performance of the required monthly instrument preventative maintenance for six (6) of nineteen (19) months reviewed (record review timeframe from February 2022 until August 22, 2023). The findings include: 1. Review of the Beckman Coulter DxH 520 Instructions for Use revealed manufacturer's instructions to "Monthly or every 1,000 cycles-Perform Bleach Cycle" and "Monthly-Clean the WBC Bath Filter." 2. Review of the laboratory's DxH 520 hematology analyzer's maintenance logs from February 2022 to the date of the inspection on August 22, 2023 revealed a lack of documentation of the performance of the required monthly maintenance outlined above for the following months: October 2022, November 2022, December 2022, February 2023, March 2023 and April 2023. A total of 6 months. The inspector requested to review documentation of the monthly maintenance for the above listed months. The laboratory provided no documentation to review. 3. In an exit interview with the TC on August 22, 2023, at approximately 12:00 PM, the above findings were confirmed. C. Based on a review of the manufacturer's instructions for use, hematology analyzer maintenance records, hematology quality control records, lack of documentation, and an interview, the laboratory failed to document performance of -- 2 of 4 -- the required daily instrument preventative maintenance for eight (8) of 8 days of patient testing in October 2022 (record review timeframe from February 2022 until August 22, 2023). The findings include: 1. Review of the Beckman Coulter DxH 520 Instructions for Use revealed manufacturer's instructions to "Daily-Perform Shutdown, Perform Daily Checks-Verify that all results are within limits, Clean the instrument, Process Controls." 2. Review of the laboratory's DxH 520 hematology analyzer's quality control records and maintenance logs from February 2022 to the date of the inspection on August 22, 2023, revealed a lack of documentation of the performance of the required daily maintenance outlined above for the following patient testing days: 10/4/2022, 10/7/2022, 10/11/2022, 10/14/2022, 10/18/2022, 10/21 /2022, 10/25/2022 and 10/28/2022. A total of 8 days. The inspector requested to review documentation of the daily maintenance for the above listed days. The laboratory provided no documentation to review. In an interview with the Technical Consultant (TC) on August 22, 2023, at approximately 11:00 AM, the TC stated they realized the month of October 2022 maintenance log was missing when they were completing their monthly review. They were unable to locate the log. 3. Review of the laboratory's quality control records for the DxH 520 revealed three levels of QC were performed on 10/4/2022, 10/7/2022. 10/11/2022, 10/14/2022, 10/18/2022, 10/21 /2022, 10/25/2022 and 10/28/2022. 4. In an exit interview with the TC on August 22, 2023, at approximately 12:00 PM, the above findings were confirmed. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, Hematology instrument calibration records, lack of documentation, and an interview, the laboratory failed to perform Complete Blood Count (CBC) calibration procedures for patient testing on the Beckman Coulter DxH 520 Hematology analyzer every six months, according to their procedure, during calendar year 2022. The findings include: 1. Review of the laboratory's procedure manual revealed a Hematology Calibration policy that outlined to calibrate CBC testing at a frequency of every six months. The policy stated: "Calibration of all hematology analytes on the Beckman Coulter DxH 520 Instrument is performed at set up of the instrument, and at a frequency recommended by the manufacturer, which is every six (6) months, for individual testing and analyzer systems using the appropriate number and type of calibrators." 2. Review of the laboratory's 2022 Coulter DxH 520 calibration documentation revealed one calibration record dated 06/02/2022. 3. The inspector requested to review additional calibration records for the DxH 520 analyzer in calendar year 2022. The laboratory provided no additional 2022 calibration documentation for review. The laboratory provided 2023 DxH 520 calibration documentation dated 01/11/2023 and 07/24/2023 -- 3 of 4 -- 4. In an exit interview with the Technical Consultant (TC) on August 22, 2023, at approximately 12:00 PM, the findings were confirmed. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Hematology Oncology Care of Northern Virginia, PC on February 8, 2022 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: D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 a review of analyzer performance verification documentation, manufacturer's "DxH 520 Performance Verification Workbook" and interviews, the laboratory director (LD) failed to evaluate and verify the normal values (reference ranges) for Complete Blood Count (CBC) testing of a newly installed hematology analyzer from the installation date of September 28, 2021 to the date of the survey, February 8, 2022 while testing four hundred nineteen (419) patient specimens. Findings include: 1. During a tour of the laboratory on February 8, 2022 at approximately 9:15 AM, the inspector noted a Beckman Coulter DxH 520 Hematology Analyzer (Serial Number BE030119) installed by a Beckman Coulter Representative with an installation date of September 28, 2021. The Technical consultant stated the instrument was installed in September 2021 but the laboratory did not begin using the instrument until November 2021. 2. A review of the 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 -- laboratory's analyzer performance verification documentation for the new Beckman Coulter DxH 520 Hematology Analyzer (Serial Number BE030119 installed on September 28, 2021) revealed no documentation of the verification of the new instrument's patient normal value ranges prior to patient testing. The surveyor requested to review the verification of the new instruments's patient normal value ranges. The laboratory provided no documentation of the normal range verification to review. 3. Review of the "DxH 520 Performance Verification Workbook" revealed the instructions "The laboratory director and/or the Medical Laboratory consultant need to validate the normal range studies." 4. Review of patient CBC test reports revealed 419 patient specimens were tested on the DxH 520 analyzer from November 12, 2021 until February 8, 2022. 5. In an interview with the Technical Consultant on February 8, 2022 at approximately 11:45 AM, the above findings were confirmed. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports, and interviews, the laboratory failed to ensure the test report accurately indicated the laboratory name and address where testing was performed for four hundred nineteen (419) patient reports reviewed from November 12, 2021 until the date of the survey on February 8, 2022. Findings include: 1. During a tour of the laboratory on February 8, 2022 at approximately 9:15 AM, the inspector noted a Beckman Coulter DxH 520 Hematology Analyzer (Serial Number BE030119) installed by a Beckman Coulter Representative with an installation date of September 28, 2021. The Technical consultant stated the instrument was installed in September 2021 but the laboratory did not begin using the instrument for patient Complete Blood Count (CBC) testing until November 2021. 2. Review of patient test reports revealed from November 12, 2021 until the date of the survey on February 8, 2022, patient test reports did not contain the name and address of the laboratory where the testing was performed. 3. Review of patient CBC test reports revealed 419 patient specimens were tested on the DxH 520 analyzer from November 12, 2021 until February 8, 2022. 4. In an interview with the Technical Consultant on February 8, 2022 at approximately 11: 45 AM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced, off-cite CLIA proficiency testing (PT) desk review was conducted for Hematology Oncology Care of Northern Virginia on October 1, 2018 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: 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 2017 and to date 2018 proficiency testing (PT) records, a total of five (5) events, and interview, the laboratory failed to 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 -- attain a score of at least eighty (80) percent of acceptable responses for White Blood Cell Differential in two (2) of three (3) Hematology testing events resulting in unsuccessful PT performance. See 2130. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's proficiency testing (PT) records and interview, the laboratory failed to submit PT results within the specified time frame for Hematology Erythrocyte Count (RBC), Hematocrit (HCT), Hemoglobin (HGB), Leukocyte Count (WBC), Platelets (PLTs) and White Blood Cell (WBC) Differential in one (1) of five (5) Hematology testing events from 2017 and to date in 2018. Findings include: 1. Desk review of the laboratory's 2017 and to date 2018 American Proficiency Institute (API) PT records, a total of five (5) events, revealed RBC, HCT, HGB, WBC, PLTs and WBC Differential results of 0%-failure to participate for 2018 2nd Event resulting in an unsatisfactory PT performance. 2. In a telephone interview with the technical consultant on October 1, 2018 at 2:30 PM, the findings were confirmed for the PT event described above. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 proficiency testing (PT) records and interview, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for White Blood Cell (WBC) Differential in two (2) of three (3) Hematology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2017 and to date 2018 American Proficiency Institute (API) PT records, a total of five (5) events, revealed WBC Differential scores of less than eighty percent (80%) for the following Hematology events: 2017 3rd event - Differential score of 67%, Granulocytes 0%; 2018 2nd event - Differential score of 0%, Granulocytes 0% (failure to participate); resulting in an unsuccessful PT performance. 2. In a telephone interview with the technical consultant on October 1, 2018 at 2:30 PM, the findings were confirmed for the PT testing events as outlined above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Hematology Oncology Care of Northern Virginia on March 14, 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: D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, procedures and policies, and interviews, the laboratory failed to test twelve (12) of twenty-five (25) proficiency testing samples in the same manner as patients in three (3) of five (5) events reviewed. Findings include: 1. Review of the laboratory's 2016 and 2017 American Proficiency Institute (API) PT records revealed the laboratory tested the following hematology PT samples multiple times: 2016 Event 3: samples # 11, # 13 and # 14 were assayed in duplicate, sample # 12 was assayed in triplicate, 2017 Event 2: samples # 6, # 7 and # 8 were assayed in duplicate, samples # 9 and # 10 were assayed in triplicate, 2017 Event 3: samples # 11, # 13 and # 14 were assayed in duplicate. The inspector inquired, at approximately 11:00 AM, if the laboratory routinely assays patient samples in duplicate and triplicate as noted with the proficiency samples. The primary testing personnel stated "No, we do not routinely run patients more than once. We have run the proficiency samples more often because we wanted to make sure we ran them correctly". 2. Review of the laboratory's procedure manual revealed a PT policy that stated "PT samples are tested exactly like patient samples, the same number of times and using the same personnel and methods as for patient testing." 3. An exit interview with the primary testing personnel on 3/14/18 at approximately 1:00 PM 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 -- confirmed that the laboratory did not test twelve (12) of the twenty-five (25) reviewed PT samples in the same manner as patients for the 2016 and 2017 API events outlined above. 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 proficiency testing (PT) documentation and an interview, the laboratory failed to retain attestation statements signed by the testing personnel for two (2) of five (5) PT events reviewed. Findings include: 1. Review of the laboratory's 2016 and 2017 American Proficiency Institute (API) hematology PT documentation, a total of five (5) events, revealed no testing personnel signed attestation statements for: 2016 Event 3, 2017 Event 1. The inspector requested to review the signed attestation documentation for the events listed above. No documentation was available for review. 2. An exit interview with the primary testing personnel on 3/14/18 at approximately 1:00 PM it was confirmed that the laboratory failed to retain copies of the API testing personnel attestation statements for the two (2) PT events outlined above in 2016 and 2017. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 a review of the Medonic performance verification records, patient accession test logs, and an interview, the laboratory failed to evaluate and verify accuracy and precision studies for the Medonic M-Series hematology analyzer prior to reporting one thousand nine hundred twenty (1,920) patient Complete Blood Count (CBC) results from October 28, 2016 to the date of the survey on March 14, 2018. Findings include: 1. Review of the laboratory's Medonic M-Series (Serial Number 30037) hematology analyzer performance verification documentation revealed that the laboratory relocated the analyzer from another physical address on October 28, 2016. -- 2 of 3 -- The records did not include CBC accuracy and precision studies after the instrument was relocated and placed into use for patient CBC testing. The inspector requested to review documentation that the laboratory evaluated and verified the accuracy and precision performance criteria after the analyzer was relocated. No documentation was available for review. 2. Review of the accession test logs revealed that the laboratory had reported one thousand nine hundred twenty (1,920) patient CBC results from the date of the relocation on October 28, 2016 to the date of the survey on March 14, 2018. 3. An exit interview with the primary testing personnel at approximately 1:00 PM on 3/14/18 confirmed that the laboratory failed to document CBC accuracy and precision studies for the relocated Medonic-M (Serial Number 30037) analyzer prior to patient testing in October 2016. -- 3 of 3 --