Children's Clinic Of Fredericksburg, The

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency testing (PT) desk review was conducted for The Children's Clinic of Fredericksburg on May 22, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The survey concluded with an interview with the laboratory's technical consultant on May 22, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The following deficiencies are a result of the PT desk review of scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the following conditions of the CLIA program: D2016 - 42 CFR. 493.803 Condition: Successful Participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing- Laboratory Director. 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. 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 -- This CONDITION is not met as evidenced by: Based on an off-site desk review of the Center for Medicaid and Medicare Services (CMS) CASPER 0155 report, the laboratory's proficiency testing (PT) records and interview, the laboratory failed to attain a score of at least eighty percent of acceptable responses for Cell Identification (Cell ID)/White Blood Cell Differential (WBC Diff) on two consecutive hematology testing events, reviewed on May 22, 2025, resulting in an initial unsuccessful PT performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 Center for Medicaid and Medicare Services (CMS) CASPER 0155 report, the laboratory's proficiency testing (PT) records, and interview, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for Cell Identification (Cell ID)/White Blood Cell differential (WBC diff) for two (2) consecutive Complete Blood Count (CBC) hematology testing events resulting in an unsuccessful PT performance as reviewed on the date of the inquiry May 22, 2025. The findings include: 1. Review of the CMS CASPER 0155 report revealed the following 2 PT events with unsatisfactory scores: Hematology 2024 3rd Event - 0%, Failure to Participate for analyte 0765 Cell ID; Hematology 2025 1st Event - 20% for analyte 0770 WBC Differential. As of 12/28/2024 analyte # 0765 Cell ID was replaced with analyte # 0770 WBC Differential. 2. Desk review of the laboratory's America Proficiency Institute (API) PT records on May 22, 2025 revealed Cell ID/WBC differential scores of less than 80% for the following 2 consecutive hematology CBC events: API 2024 Hematology/Coagulation Event 3: White Blood Cell Differential scored 0%, Failure to Participate; API 2025 Hematology /Coagulation Event 1: White Blood Cell Differential scored 20%; resulting in an unsuccessful PT performance. 3. A telephone interview with the technical consultant on May 22, 2025 at 12:00 PM confirmed the above 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 an off-site desk review of the Center for Medicaid and Medicare Services CASPER 0155 report, the laboratory's proficiency testing (PT) records and interview, the laboratory director (LD) failed to provide overall management, direction and quality of the laboratory services provided. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on an off-site desk review of the Center for Medicaid and Medicare Services (CMS) CASPER 0155 report, the laboratory's proficiency testing (PT) records, and interview, the laboratory director (LD) failed to ensure the overall quality of the laboratory services provided. The LD failed to ensure successful participation in a Health and Human Services (HHS) approved proficiency testing program. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at The Children's Clinic of Fredericksburg on July 23, 2024 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 includes the Conditions under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems, D6000 -42 CFR. 493.1403 Laboratory Director, D6063 -42 CFR. 493.1421 Testing personnel qualifications. 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: A. Based on a review of proficiency testing (PT) documentation, lack of documentation, and an interview, the laboratory failed to retain attestation statements signed by the laboratory director (LD) and testing personnel (TP) for three (3) of 3 Hematology/Coagulation events; and failed to document evaluation review for two (2) of 3 Hematology/Coagulation events reviewed from January 2023 until the date of the survey on July 23, 2024. The findings include: 1. Review of the laboratory's American Proficiency Institute (API) hematology PT documentation, a total of 5 events (2023 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- Events 1-3 and 2024 Event 1-2), revealed the laboratory failed to retain signed result review documentation and attestation statements for the following three events: 2023 API Hematology/Coagulation-2nd Event-a lack of result review and attestation signatures by the LD and TP; 2024 API Hematology/Coagulation-1st Event-a lack of result review and attestation signatures by the LD and TP. 2024 API Hematology /Coagulation-2nd Event-a lack of attestation signature by the LD. Evaluation pending with PT agency. The surveyor requested to review the PT results reviews and attestation documentation for the events listed above. The laboratory provided no documentation for review. 2. In an exit interview with the Laboratory Director and Operations Administrator on July 23, 2024 at 1:00 PM, the above findings were confirmed. B. Based on a review of proficiency testing (PT) documentation, lack of documentation, and an interview, the laboratory failed to retain the hematology analyzer printed results for one (1) of five (5) Hematology/Coagulation events reviewed from January 2023 until the date of the survey on July 23, 2024. The findings include: 1. Review of the laboratory's American Proficiency Institute (API) hematology PT documentation, a total of 5 events (2023 Events 1-3, 2024 Event 1-2), revealed the laboratory failed to retain the Sysmex XP-300 hematology analyzer printed results for 2023 API Event 2. The surveyor requested to review the analyzer printed records for 2023 API Event 2. The laboratory provided no documentation for review. 2. In an exit interview with the Laboratory Director and Operations Administrator on July 23, 2024 at 1:00 PM, the above findings were confirmed. 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/procedures, instrument operation's manual, temperature logs, quality control documentation, patient reports, Centers for Medicare and Medicaid Services Statement of Deficiencies

Summary Statement of Deficiencies D0000 An unannounced, off-site, CLIA proficiency test desk review was conducted for The Children's Clinic of Fredericksburg on January 8, 2024 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: D2016 -42 CFR. 493.803 Successful Participation. 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's (API) proficiency testing (PT) records (2023 First Event and 2023 Third Event) and 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 -- interview, the laboratory failed to attain a score of at least eighty percent of acceptable responses for White Blood Cell count (WBC), Red Blood Cell count (RBC), Hemoglobin (HGB), Hematocrit (HCT), and WBC Differential (WBC diff) in two (2) out of three (3) Hematology testing events resulting in unsuccessful PT performance. See D2130. 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 percent (80%) of acceptable responses for White Blood Cell count (WBC), Red Blood Cell count (RBC), Hemoglobin (HGB), Hematocrit (HCT), and WBC Differential (WBC Diff) for two (2) of three (3) hematology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's American Proficiency Institute (API) PT records revealed WBC, RBC, HCT, HGB, PLT and WBC Diff scores of less than 80% for the following hematology events: 2023 Event 1 - WBC=0%; RBC=0%; HGB=0%; HCT=0%; and WBC diff=0%, Failure to participate; 2023 Event 3 - WBC=40%, RBC=40%, HGB=40%, HCT=40%, and WBC diff=67%, Unsuccessful; resulting in unsuccessful PT performance. 2. In a telephone interview with the Chief Operating Officer on January 8, 2023 at approximately 11:55 AM, the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at The Children's Clinic of Fredericksburg on December 14, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS-CoV-2 (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 and include the following Condition under 42 CFR part 493 CLIA Regulation: D5400 - 42 C.F.R. 493-1250 Condition: Analytic Systems, D6000 - 42 C.F.R. 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/procedures, instrument maintenance logs, instrument operation's manual, temperature logs, quality control documentation, patient reports, Centers for Medicare and Medicaid Services Statement of Deficiencies

Summary Statement of Deficiencies D0000 An announced off-site CLIA recertification survey was conducted for The Children's Clinic of Fredericksburg on February 10, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on January 15, 2021 and virtual record review conducted on February 5, 2021. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The Children's Clinic of Fredericksburg is performing SARS-CoV-2 (COVID-19) testing and is in compliance with the applicable COVID-19 reporting requirements. The specific deficiencies are 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), the laboratory's proficiency testing (PT) records and an interview, the laboratory failed to rotate PT among testing personnel performing Complete Blood Cell counts (CBCs) for three (3) of six (6) PT events from March 2019 until December 2020. Findings include: 1. Review of the CMS Form 209 revealed four (4) testing personnel (TP) performing patient CBC testing in 2019 and 2020. 2. Review of the laboratory's American Proficiency Institute (API) PT documentation from March 2019 to December 2020 (a total of 6 events) revealed TP A performed the following PT Events: 2020 API Hematology/Coagulation Event 1; 2020 API Hematology/Coagulation Event 2; 2020 API Hematology/Coagulation Event 3. 3 of 6 PT events were performed by TP A. (See Personnel Code Sheet.) 3. In an interview with the Operations Manager on February 10, 2021 at approximately 10: 45 AM, 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 3 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on the review of Quality Control (QC) package insert, temperature logs and interview, the laboratory failed to follow the manufacturer's storage requirements for Hematology quality control (QC) materials for nine days (9) from March 2019 until December 2020. Findings include: 1. Review of the Sysmex EightChek 3WP Extra Control package insert for storage requirements revealed the quality control materials are to be stored at 2-8 degrees Celsius. 2. Review of the refrigerator temperature logs revealed the following 9 days when the temperatures where outside the acceptable range for the storage of the QC materials: 07/11/2019 = 9 degrees Celsius (C) 08/26 /2019 = 9 C 09/02/2019 = 9 C 09/28/2019 = 9 C 09/29/2019 = 9 C 10/01/2019 = 9 C 10/02/2019 = 9 C 10/14/2019 = 9 C 10/17/2019 = 0 C 3. In an interview with the Operations Manager on February 10, 2021 at approximately 11:15 AM, the above 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: Based on a review of the Sysmex XP-300 instrument maintenance records, maintenance log, lack of documentation, and an interview, the laboratory failed to document performance of the Sysmex XP-300's weekly, monthly and quarterly maintenance as required during from March 2019 until December 2020. **Repeat Deficiency** Findings include: 1. Review of the laboratory's Sysmex XP-300 Instructions for Use and maintenance log revealed the following required maintenance procedures: Weekly-Clean SRV Tray; Monthly-Clean RBC and WBC Transducer, Clean Waste Chamber; Quarterly-Clean Sample Rotor Valve (SRV). 2. Review of the XP-300 hematology maintenance logs from March 2019 until December 2020 revealed the following weeks lacked documentation of weekly maintenance: 3/10 /2019, 3/17/2019, 3/24/2019, 3/31/2019, 5/5/2019, 5/12/2019, 6/2/2019, 7/7/2019, 9 /15/2019, 9/22/2019, 10/20/2019, 10/27/2019, 11/3/2019, 11/10/2019, 1/6/2020, 2/2 /2020, 2/23/2020, 3/2/2020, 3/9/2020, 5/10/2020 and 5/25/2020. The surveyor requested documentation of the performance of the weekly maintenance for the 21 weeks listed above. The laboratory provided no documentation of the weekly maintenance to review. 3. Review of the XP-300 maintenance logs from March 2019 until December 2020 revealed the following months lacked documentation of the monthly maintenance: 3/2019, 4/2019, 11/2019, 12/2019 and 10/2020. The surveyor -- 2 of 3 -- requested documentation of the performance of the monthly maintenance for the 5 months listed above. The laboratory provided no documentation of the monthly maintenance to review. 4. Review of the XP-300 maintenance logs from March 2019 until December 2020 revealed the following: 2/2019 quarterly maintenance documented; 5/2019 no quarterly maintenance documented; 8/2019 quarterly maintenance documented by service; 11/2019 quarterly maintenance documented; 2 /2020 no quarterly maintenance documented; 5/2020 no quarterly maintenance documented; 8/2020 no quarterly maintenance documented; 11/2020 no quarterly maintenance documented. The surveyor requested documentation of the performance of the quarterly maintenance for the 5 quarters with no maintenance listed above. The laboratory provided no documentation of the quarterly maintenance to review. 5. In an interview with the Operations Manager on February 10, 2021 at approximately 11:00 AM, the above findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at The Children's Clinic of Fredericksburg on March 19, 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: 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 validation records, manufacturer's validation protocol, patient test logs, and an interview with the Office Manager (OM), the laboratory failed to verify the normal values (reference ranges) for Complete Blood Count (CBC) testing prior to reporting eight hundred twenty-six (826) patient CBC panels from October 16, 2017 to the date of the survey, March 19, 2019. Findings include: 1. Review of hematology analyzer records revealed a new instrument installation, by a Sysmex service technical specialist, occurred on 9/26/17. The inspector noted that the validation documentation contained no verification of the CBC patient normal values by the laboratory for the new Sysmex XP300 (Serial Number B2259). The surveyor requested documentation of the normal range (reference range) verification. No normal value verification documentation was available for review. 2. Review of the Sysmex Automated Analyzer XP-300 Validation Protocol revealed the instruction: "It is the customers responsibility to perform additional studies, following 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 4 -- requirements of their accrediting agency. The following protocols are provided: Correlation Studies and Reference Range Verification." 3. Review of the patient test log from the laboratory's electronic medical record revealed that the laboratory had reported 826 CBC reports from 10/16/17 to the date of the survey on 3/19/19. 4. In an exit interview at approximately 1:00 PM, the OM confirmed the findings. 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: Based on a review of manufacturer's operations guide, maintenance logs, and interview with the Office Manager (OM), the laboratory failed to follow manufacturer's instructions for performing and documenting the performance of the Siemens XP-300 Hematology Analyzer's weekly, and monthly maintenance procedures from November 2017 to March 2019. Findings include: 1. Review of the laboratory's Sysmex XP-300 Instructions for Use and maintenance log revealed the following required maintenance procedures: Weekly-Clean SRV Tray; Monthly- Clean RBC and WBC Transducer, Clean Waste Chamber; Quarterly-Clean Sample Rotor Valve (SRV). 2. Review of the XP-300 maintenance logs from November 2017 to the date of the survey March 19, 2019 revealed the following weeks lacked documentation of weekly maintenance: 12/10/17, 3/8/18, 5/13/18, 6/17/18, 7/1/18, 7 /15/18, 8/3/18, 8/10/18, 8/17/18, 8/24/18, 8/31/18, 9/7/18, 9/14/18, 9/21/18, 9/28/18, 10/5/18, 10/19/18, 10/26/18, 11/2/18, 11/9/18, 11/16/18, 11/30/18, 12/7/18, 12/14/18, 12/21/18, 12/28/18, 1/4/19, 1/11/19, 1/18/19, 1/25/19, 2/1/19, 2/8/19, and 2/15/19. The surveyor requested documentation of the performance of the weekly maintenance for the weeks listed above. No documentation was available for review. 3. Review of the XP-300 maintenance logs from November 2017 to the date of the survey March 19, 2019 revealed the following months lacked documentation of monthly maintenance: January 2018 and January 2019. The surveyor requested documentation of the performance of the monthly maintenance. No documentation was available for review. 4. In an exit interview at approximately 1:00 PM, the OM confirmed the findings. 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 review of the laboratory's policy and procedure manual, Hematology Quality Control (QC) records and an interview with the Office Manager (OM), the laboratory failed to establish and follow a written policy for an ongoing mechanism to monitor, assess and correct "Accuracy bias codes" identified in the monthly Sysmex Insight QC reports for the XP 300 Hematology analyzer for twelve (12) of seventeen -- 2 of 4 -- (17) monthly reports from October 2017 to March 2019. Findings include: 1. Review of the laboratory's policy and procedure manual revealed a lack of a mechanism to monitor, assess and correct "Accuracy bias codes" identified in the monthly Sysmex Insight QC reports for XP 300 Hematology analyzer from October 2017 to March 2019. 2. Review of the Sysmex Insight Report revealed a section, "Interpreting the Period Report Flags", which stated "SDI values for the following parameter will flag if outside of the established SDI range. You will see the flag in the notes column of the report. This indicates that the analyzer should be monitored. Flagging at +/- 2 SDI range*: RBC, HGB, HCT, MCV, PLT, WBC, and RET. Flagging at +/- 2.5 SDI range*: MCH, MCHC, RDW, NEUT, LYMPH, MONO, EO, BASO, NRBC, IRF, MPV, IG, RET-He, and IPF. If a Accuracy bias flag persists for more than two reporting periods, the bias should be investigated." 3. Review of the monthly Sysmex Insight QC reports revealed the Laboratory Director (LD) reviewed seventeen (17) of seventeen monthly reports. The surveyor noted Accuracy bias codes for the following months and analytes: 10/16/17 to 11/17/17-Accuracy bias code PLT; 11/18/17 to 12/20 /17-Accuracy bias code PLT; 12/06/18 to 01/07/18-Accuracy bias code PLT; 01/08/18 to 02/09/18-Accuracy bias code PLT, WBC, MCV; 02/10/18 to 03/14/18-Accuracy bias code PLT, W-SMV, HCT, WBC, RDW-SD; 05/23/18 to 06/24/18-Accuracy bias codes PLT, MCV, RDW-CV; 06/25/18 to 07/27/18-Accuracy bias codes PLT, MPV, RDW-CV; 07/28/18 to 08/29/18-Accuracy bias codes PLT, MPV; 09/17/18 to 10/19 /18-Accuracy bias code HGB; 11/07/18 to 12/09/18-Accuracy bias codes PLT, MPV; 12/10/18 to 01/11/19-Accuracy bias code MPV; 01/12/19 to 02/13/19-Accuracy bias codes MCV, MCH. A total of 12 of 17 reports with Accuracy bias codes. The surveyor requested documentation of