Chesterfield Pediatrics Pc

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Chesterfield Pediatrics on 04/04/23 by the Virginia Department of Health's Office of Licensure and Certification. The surveyor performed a focused SARS-CoV-2 Test Reports survey on 04/04/23. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D3000 - 42 C.F.R. 493-1100 Condition: Reporting of SARS-CoV-2 Test Reports. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a tour of the facility, record review and interviews, the lab failed to report twenty two (22) SARS-CoV-2 (COVID-19) positive test results for 90 of 90 testing dates from 01/01/23 up to date of survey on 04/03/23. Findings include: 1. A tour of the facility and interview with the primary testing personnel and technical consultant on 04/04/23 at 09:45 AM revealed the facility utilized one Quidel Sofia reader to perform to COVID-19 patient testing. During the same interview, the inspector requested to review a log sheet or mechanism in which the facility tracks COVID-19 testing and reporting of positive results to the State agency. The primary testing stated 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 -- "We do not have log sheets and we report results directly into our electronic medical records. We have not been reporting positive results." Patient testing data was retrieved from the electronic medical records "Procedure code count by Plan" data query. 2. Twenty two (22) positive results were not reported as required during the period of review (90 testing dates). 3. The laboratory performed 342 COVID-19 tests during the period of review. 4. An exit interview with the primary testing personnel and technical consultant on 04/04/23 at approximately 11:45 AM 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 the review of manufacturer operator's manual, maintenance records, lack of documentation and interview, the lab failed to follow manufacturer's instructions of performing weekly maintenance for the Cell-Dyn Emerald hematology analyzer for 12 of 91 weeks from 07/01/21 up to date of survey on 04/04/23. Findings include: 1. Review of the Cell-Dyn Emerald operator's manual (Revision date March 2019) revealed the following statement, "Section 9, Weekly Maintenance, Bleach Cleaning- Bleach cleaning the system with a bleach solution is performed weekly and as needed if instrument use conditions cause frequent rejection of measured or quality control material out of range issues." 2. Review of the Cell-Dyn Emerald analyzer event log and daily logs for lab procedures that indicated performance of maintenance procedures from 07/01/21 up to date of survey on 04/04/23 revealed a lack of documentation of the performance of the weekly bleach cleaning procedures for the following weeks: August 23-27, 2021, September 27 - October 1, 2021, November 29- December 3, 2021, January 24-28, 2022, February 21-25, 2022, May 30- June 3, 2022, June 20-24, 2022, July 25-29, 2022, August 15-19, 2022, September 6-9, 2022, December 12-16, 2022 and December 26-30, 2022, Total of 12 weeks. 3. An exit interview with the testing personnel and technical consultant on 04/04/23 at 11:45 AM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Chesterfield Pediatrics on 04/04/23 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: D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a tour of the facility, record review and interviews, the lab failed to report twenty two (22) SARS-CoV-2 (COVID-19) positive test results for 90 of 90 testing dates from 01/01/23 up to date of survey on 04/03/23. Findings include: 1. A tour of the facility and interview with the primary testing personnel and technical consultant on 04/04/23 at 09:45 AM revealed the facility utilized one Quidel Sofia reader to perform to COVID-19 patient testing. During the same interview, the inspector requested to review a log sheet or mechanism in which the facility tracks COVID-19 testing and reporting of positive results to the State agency. The primary testing stated "We do not have log sheets and we report results directly into our electronic medical records. We have not been reporting positive results." Patient testing data was retrieved from the electronic medical records "Procedure code count by Plan" data 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 -- query. 2. Twenty two (22) positive results were not reported as required during the period of review (90 testing dates). 3. The laboratory performed 342 COVID-19 tests during the period of review. 4. An exit interview with the primary testing personnel and technical consultant on 04/04/23 at approximately 11:45 AM 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 the review of manufacturer operator's manual, maintenance records, lack of documentation and interview, the lab failed to follow manufacturer's instructions of performing weekly maintenance for the Cell-Dyn Emerald hematology analyzer for 12 of 91 weeks from 07/01/21 up to date of survey on 04/04/23. Findings include: 1. Review of the Cell-Dyn Emerald operator's manual (Revision date March 2019) revealed the following statement, "Section 9, Weekly Maintenance, Bleach Cleaning- Bleach cleaning the system with a bleach solution is performed weekly and as needed if instrument use conditions cause frequent rejection of measured or quality control material out of range issues." 2. Review of the Cell-Dyn Emerald analyzer event log and daily logs for lab procedures that indicated performance of maintenance procedures from 07/01/21 up to date of survey on 04/04/23 revealed a lack of documentation of the performance of the weekly bleach cleaning procedures for the following weeks: August 23-27, 2021, September 27 - October 1, 2021, November 29- December 3, 2021, January 24-28, 2022, February 21-25, 2022, May 30- June 3, 2022, June 20-24, 2022, July 25-29, 2022, August 15-19, 2022, September 6-9, 2022, December 12-16, 2022 and December 26-30, 2022, Total of 12 weeks. 3. An exit interview with the testing personnel and technical consultant on 04/04/23 at 11:45 AM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at the Chesterfield Pediatrics on May 11, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory conducted on May 5, 2021 with off-site record review of documentation and a follow- up phone conference on May 10, 2021. Specific deficiencies cited are as follows: The laboratory is performing COVID-19 testing and in compliance with the applicable COVID-19 reporting requirements. 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 the review of maintenance logs, manufacturer's operation manual, lack of documentation and interview with the primary testing personnel and technical consultant, the lab failed to perform the semi-annual maintenance on the Abbott Cell Dyn Emerald hematology analyzer in the calendar years of 2019 and 2020. Findings include: 1. Review of the maintenance logs for the Abbott Cell Dyn Emerald analyzer from January 2019 through January 2021 revealed lack of documentation of the performance of the semiannual maintenance (piston syringe lubrication). The inspector requested to review documentation of the above-specified maintenance on May 11, 2021 at approximately 12:30 PM with the primary testing personnel and technical consultant. The documentation was not available for review. 2. Review of the Abbott Emerald Operations Manual revealed manufacturer's instructions 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 -- "perform Lubricating Syringe Pistons maintenance procedure twice annually". 3. An exit interview on May 11, 2021 at 1 PM with the primary testing personnel and technical consultant confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of Chesterfield Pediatrics was conducted on May 6, 2019 by a Medical Facilities Inspector of 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 the review of proficiency testing (PT) scores for the third event in 2018 and the first event in 2019, the CASPER 0153D Unsuccessful PT report and communication with the technical consultant, the laboratory failed to achieved 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 -- satisfactory performance of at least 80% for two consecutive events for the White Blood Cell Differential (WBC Diff) parameter, resulting in unsuccessful performance (Cross Reference 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 the review the American Proficiency Institute (API) proficiency testing (PT) scores for the second and third events in 2018, the CASPER 0153D Unsuccessful PT report and communication with the technical consultant, the laboratory failed to achieve satisfactory performance of at least 80% for two consecutive events for the White Blood Cell Differential (WBC Diff) parameter, resulting in unsuccessful performance. Findings include: 1. Review of the API hematology PT scores and the CASPER 0153D Unsuccessful PT report revealed the following scores: 2018 3rd event WBC Diff- 33% 2019 1st event WBC Diff- 67% The laboratory received an unsuccessful API PT score for the above listed analyte. 2. An email communication with the technical consultant at approximately 7:30 AM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Chesterfield Pediatrics on February 6, 2019 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: **Repeat Deficiency. Based on the review of proficiency testing (PT) records, quality control (QC) records, and interviews with the primary testing personnel (TP) and lab director, the lab failed to maintain PT records for six (6) of the 6 PT events reviewed for 2017 and 2018. Findings include: 1. The inspector requested to review the American Proficiency Institute (API) hematology PT records for 2017 and 2018 calendar year events. The primary TP presented API results for the 2nd event in 2018. In an interview with the primary TP at approximately 9:45 AM, she/he stated that they were a new TP and that she/he did not know where the other records were located. 2. During the review of QC records, the inspector located the results for the 2017 Event 3 and 2018 Event 3; however, there was no documentation of review by staff or 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 10 -- lab director. The laboratory did not have the following hematology PT records: 2017 Event 1- Attestation statement, original and submitted PT results, API results. 2017 Event 2- Attestation statement, original and submitted PT results, API results. 2017 Event 3- Attestation statement and original and submitted PT results. 2018 Event 1- Attestation statement, original and submitted PT results, API results. 2018 Event 2- Attestation statement and original and submitted PT results. 2018 Event 3- Attestation statement and original and submitted PT results. 3. An interview with the lab director at approximately 3:45 PM confirmed the above-specified findings. 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 the review of proficiency testing PT) scores for the second and third events in 2018, the CASPER 0153D Unsuccessful PT report and an interview with the lab director, the laboratory failed to achieve satisfactory performance of at least 80% for two consecutive events for the Red Blood Cell Count (RBC) and Hematocrit (HCT) parameters, resulting in unsuccessful performance (Cross Reference D2130). D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the review the American Proficiency Institute (API) proficiency testing (PT) scores for the third events in 2018, the CASPER 0155D Individual Laboratory Profile report and an interview with the lab director, the laboratory failed to achieve an overall score of at least 80% for the third Hematology PT event in 2018. Findings include: 1. Review of the API hematology PT scores and the CASPER 0155D Individual Laboratory Profile report revealed that the laboratory received an overall score of 65% for the 3rd event in 2018. White Blood Cell (WBC) Differential (Diff)- 33% Red Blood Cell (RBC) count- 0% Hematocrit (HCT)- 60% The individual scores -- 2 of 10 -- above resulted in the overall unsatisfactory performance for the above listed event. 2. An interview with the lab director at approximately 3:45 PM confirmed the above- specified findings. 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 the review the American Proficiency Institute (API) proficiency testing (PT) scores for the second and third events in 2018, the CASPER 0153D Unsuccessful PT report and an interview with the lab director, the laboratory failed to achieve satisfactory performance of at least 80% for two consecutive events for the Red Blood Cell Count (RBC) and Hematocrit (HCT) parameters, resulting in unsuccessful performance. Findings include: 1. Review of the API hematology PT scores and the CASPER 0153D Unsuccessful PT report revealed the following scores: 2018 2nd event RBC - 60% HCT- 60% 2018 3rd event RBC - 0% HCT- 60% The laboratory has received an unsuccessful API PT score for the above listed analytes. 2. An interview with the lab director at approximately 3:45 PM confirmed the findings. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) records, and interview, the laboratory failed to retain the "Cell Dyn 18 Plus control " manufacturer's assay information inserts documenting Complete Blood Cell (CBC) count QC acceptable ranges for seven (7) of nine (9) lot numbers utilized from March 1, 2017 and up to the date of survey on February 6, 2019. Findings include: 1. Review of the laboratory's end of the lot instrument printouts from March 1, 2017 and up to the date of survey on February 6, 2019 revealed the laboratory received and utilized 9 lot numbers of the "Cell Dyn 18 Plus control ". The following QC lot numbers had no documentation of acceptable ranges or manufacturer's package inserts: 6354, 7184, 7268, 8071, 8155, 8239 and 8323. 2. An interview with the lab director at approximately 3:45 PM confirmed the findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. -- 3 of 10 -- This CONDITION is not met as evidenced by: **Repeat Deficiencies** Based on the review of policy and procedures (P&P), operator's manual, calibration records, quality control (QC) records, instrument data log, electronic medical records (EMR) and an interview with the laboratory director, the laboratory failed to 1) follow the established policy and manufacturer's instructions for performing the calibration in 2017 and 2018 (Cross Reference D5437); and 2) follow the established policy for performing QC procedures each day of patient testing (Cross Reference D5447). 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: ** Repeat Deficiency.** Based on the review of policy and procedures (P&P), operator's manual, calibration records, and an interview with the laboratory director, the laboratory failed to follow the established policy and manufacturer's instructions for performing the calibration verification procedures on the Abbott Cell Dyn Emerald hematology analyzer every six months in 2017 and 2018. Findings include: 1. Review of the P&P "Plan of Action for Quality Assurance policy", signed by the lab director in 2016 and 2018 (not date provided) revealed the following statement: " 5. Calibration of Emerald will be done semi-annually or after quality control data indicates as documented in cell-dyne manual. Calibration is also done following any maintenance." Review of the manufacturer operator's manual for the Abbott Cell Dyn Emerald analyzer revealed the following statements: "Section 6- When to Calibrate- Criteria should be established for calibration verification. Calibration verification criteria include: When indicated by Quality Control data, after major maintenance and service procedures, at least every 6 months and as directed by the regulatory agencies governing the laboratory." 2. Review of calibration verification documents revealed procedures performed on September 14, 2017 and July 17, 2018. There was no other calibration documentation available for review. 3. An interview with the lab director at approximately 3:45 PM confirmed the findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different -- 4 of 10 -- concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: ** Repeat Deficiency** Based on the review of policy and procedures (P&P), quality control (QC) records, instrument data log, electronic medical records (EMR) and interview with the laboratory director, the laboratory failed to follow the established policy for performing QC procedures each day of patient testing on May 1 and 3, 2018 and October 2-16, 2017, while reporting a total of thirteen (13) patients. Dates of record review included March 1, 2017 and up to the date of survey on February 6, 2019. Findings include: 1. Review of the P&P "Plan of Action for Quality Assurance policy", signed by the lab director in 2018 (no date provided) revealed the following statement: "2. Cell-dyne Emerald will have quality control done each morning of operation. If controls are not within prescribed limits, Emerald is shut down until maintenance is performed and controls are re-run in accepted limits." 2. Review of the daily QC records from March 1, 2017 and up to the date of survey on February 6, 2019 revealed the following dates in which there was no documentation of daily QC procedure according to the established policy: October 2-17, 2017 and May 1 and 3, 2018. 3. Review of the instrument data log and EMR patient data revealed the following patients resulted that did not have documentation of daily QC procedures: October 4, 2017- Accession number 2468, 1607, and 4871, October 5, 2017- Accession number 6309 and 268, October 6, 2017- Accession number 1171, October 12, 2017- Accession number 901, 2671 and 1113, October 16, 2017- Accession number 5395 and 5914, May 1, 2018- Accession number 5122 and May 3, 2018- Accession number 5217. Total of 13 patients. 4. An interview with the laboratory director at approximately 3:45 PM confirmed the above-specified 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: **Repeat Deficiency** Based on the review of policy and procedures (P&P), quality control (QC) records, calibration records, and an interview with the laboratory director, the current quality assurance policy failed to identify and address failures in the analytic phase for the hematology specialty at the date of survey. Findings include: 1. Review of the P&P "Plan of Action for Quality Assurance policy", signed by the lab director in 2016 and 2018 (not date provided) revealed the following statements: "2. Cell-dyne Emerald will have quality control done each morning of operation. If controls are not within prescribed limits, Emerald is shut down until maintenance is performed and controls are re-run in accepted limits." "3. Monthly quality control report will be uploaded to abbott eqc the first week of the month. Results will be reviewed by the lab director when received." "5. Calibration of Emerald will be done semi-annually or after quality control data indicates as documented in cell-dyne manual. Calibration is also done following any maintenance." 2. The laboratory did not have documentation of performing the daily Cell Dyn 18 Plus QC procedures on October 2-17, 2017 and May 1 and 3, 2018 (Cross Reference D5447). 3. There was no documentation of the Abbott Cell Dyn -- 5 of 10 -- eQC reports for the following lot numbers: 6354, 7100, 7184, 7268, 7352, 8071, 8155, 8239 and 8323. Each lot number includes low, normal and high range values. 4. The laboratory did not follow the established policy for performing the semi-annual calibration for the hematology instrument in 2017 and 2018 (Cross Reference D5437). 5. An interview with the lab director at approximately 3:45 PM confirmed the 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 the review of policy and procedures (P&P), proficiency testing (TP) records, quality control (QC) records, instrument data log, electronic medical records (EMR), calibration verification records, the Laboratory Personnel Report Form (CLIA) (CMS- 209 Form), and interviews with the primary TP and lab director, the lab director failed to 1) follow the established policy for reviewing PT results (Cross Reference D6018); 2) follow the established policy for performing and documenting