Primary Pediatrics Of Mcdonough

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 25, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 the laboratory tour and staff interview, the laboratory failed to ensure the fire extinguisher was inspected, the last inspection date was November 2021. The Findings include: 1. Laboratory tour revealed that the fire extinguisher closest to the laboratory was last inspected in November 2021. It is required to check the fire extinguisher on an annual basis. 2. During an interview with the General Supervisor on April 25, 2023 at 4:45 PM, in the breakroom, confirmed the fire extinguishers were last inspected in November 2021. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. 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 -- This STANDARD is not met as evidenced by: Based on the tour of laboratory and staff interview, the laboratory failed to ensure two identifier's were present on the blood agar plates. Findings include: 1. During the laboratory tour, 9 out of 9 blood agar plates in the incubator was observed with only one identifer, during the survey. 2. During an interview with the Testing Personnel #1 CMS-209) on April 25, 2023 at 5:25 PM in the laboratory, confirmed the lack of two identifier's on the blood agar plates. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on laboratory policy and procedure manual (SOP) review and staff interview, the laboratory failed to perform competency for 3 out of 6 Testing Personnel (TP) for 2021, 2022, and thus far 2023. The Findings include: 1. Competency documents revealed the annual competencies were performed but not reviewed by the Laboratory Director for Testing Personnel #1, 2, and 6(CMS-209) for 2021 and 2022, and thus far 2023(January-April). 2. During an interview with the Testing Personnel #1 (CMS- 209) on April 25, 2023 at 2:45 PM, in the back office, confirmed that competencies were performed for the Testing Personnel (TP), but the competencies were not performed for 2021, 2022, and thus 2023 for Testing Personnel #1, 2, and 6 (CMS- 209). D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on laboratory policy and procedure manual (SOP) review and staff interview, the Laboratory Director (LD) failed to perform competency for 3 out of 6 Testing Personnel (TP) for 2021, 2022, and thus far 2023. The Findings include: 1. Competency documents revealed the annual competencies were performed but not reviewed by the Laboratory Director for Testing Personnel #1, 2, and 6(CMS-209) for 2021 and 2022, and thus far 2023(January-April). 2. During an interview with the Testing Personnel #1 (CMS-209) on April 25, 2023 at 2:45 PM, in the back office, confirmed that the Laboratory Director (LD) failed to perform competencies on 3 out of 6 Testing Personnel (TP): Testing Personnel #1, 2, and 6 (CMS-209). -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory failed to maintain satisfactory proficiency testing (PT) performance for automated white blood cell (WBC) differential analyte # 765 in 2020 events one and two resulting in the 1st unsuccessful occurance and in 2021 event one resulting in the second unsuccessful occurrence for WBC differential. 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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for automated white blood cell (WBC) differential analyte # 765 in 2020 events 1 and 2 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 -- resulting in the 1st unsuccessful occurrence and in 2021 event 1 resulting in the second unsuccessful occurrence for WBC differential. Findings include: Refer to D 2130 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 a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and review of the laboratory's 2020 and 2021 proficiency testing (PT) evaluation reports from the American Proficiency Institute (API) , the laboratory failed to maintain satisfactory performance in three proficiency testing events for the automated white blood cell (WBC) differential #765, resulting in the second unsuccessful PT occurrence for WBC differential. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory automated WBC differential scores: - 2020 event 1 0% / 2020 event two 73% (1st unacceptable occurance) - 2021 event 1 0% (2nd unacceptable occurance) 2. Review of the API 2021 event 1 evaluation report revealed unacceptable scores for Granulocytes % for sample number Hem-3 score of 0%; Lympocytes for the sample number Hem-3 score of 0% resulting in the 2nd unsuccessful PT occurance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in PT event 1 of 2021 resulting in the second unsuccessful occurrence for WBC Diff , analyte # 765. Findings include: Refer to D 6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and review of the laboratory's 2020 and 2021 proficiency testing (PT) evaluation reports from the American Proficiency Institute (API) , the laboratory director failed to ensure the laboratory maintained satisfactory performance in 2021 event 1 proficiency testing for the automated white blood cell (WBC) differential #765 resulting in the second unsuccessful PT occurrence for WBC differential. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory automated WBC differential scores: -2020 event 1 0%, 2020 event two 73% (1st unacceptable occurance) - 2021 event 1 0% (2nd unacceptable occurance) 2. Review of the API 2021 event 1 evaluation report revealed unacceptable scores for Granulocytes % for sample number Hem-3 score of 0%; Lympocytes for the sample number Hem-3 score of 0% resulting in the 2nd unsuccessful PT occurance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 6, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on personnel records and interview with the Laboratory Manager, determined that the laboratory failed to establish a written policy that assess the six criteria's for employee competency that include hematology and microbiology testing. The findings include: 1. The laboratory failed to have a written policy and procedure for competency that included the six criteria's for the testing personnel for 2019, 2020, and 2021. 2. An annual competency assessment was not performed for any of the staff for 2019, 2020, and 2021 for hematology and microbiology testing. 3. During an interview with the Laboratory Manager on May 6, 2021, at approximately 12:30 PM, confirmed that the laboratory did not have a policy that assess the six criteria's for the testing personnel in the laboratory. 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. 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 STANDARD is not met as evidenced by: Based on laboratory record review and interview with the Laboratory Manager, the laboratory failed to record and document temperatures for the incubator used for Microbiology testing. The Findings include: 1. Laboratory record review revealed that the testing personnel(TP) did not record and document temperatures for the incubator for 2019, 2020, and 2021 for the use of Microbiology testing. 2. During an interview with the Laboratory Manager on May 6, 2021 at approximately 12:40 PM, in an office confirmed that the laboratory did not record and document incubator temperatures for Microbiology testing for 2019, 2020, and 2021. 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 Hematology calibrations document review and interviews with the laboratory manager, the laboratory failed to perform instrument calibrations every six months as required in 2019 and 2020 for the Cell dyn Emerald Hematology Analyzer. Findings include: 1. The Cell Dyn Emerald hematology analyzer calibrations document review revealed the laboratory performed instrument calibrations as follows: None in 2019 and one in 2020 (06-10-2020). 2. An interview with the the laboratory manager in the review room at approximately 12:45 p.m. confirmed hematology analyzer calibrations were not performed during the aforementioned periods in 2019 and 2020. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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: Based on Quality Control (QC) data review and laboratory manager's interview, the laboratory director (LD) failed to review QC data for the Celldyn Emerald Hematology analyzer on a monthly basis as specified in the Quality Assurance (QA) manual. 1.) Quality Control data review revealed daily QC data and Levey Jennings graphs were not reviewed and signed by the lab director who is also the Technical Consultant(TC) from January 2019 to April 2021 on a monthly basis. 2.) An interview -- 2 of 3 -- with the laboratory manager on 05/06/2021 at approximately 12:35 pm in the review room confirmed the LD has not been reviewing QC data from this clinic from January 2019 to April 2021. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 25, 2021. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three consecutive events 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 -- (Events 1 and 2 of 2020), resulting in the first unsuccessful occurrence for Cell I.D. /WBC Diff #0765. The findings include: Refer to 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of 3 consecutive events (Events 1 and 2 of 2020), resulting in the first unsuccessful occurrence for Cell I.D./WBC Diff #0765. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Cell I.D./WBC Diff #0765 on Event 1 of 2020 with a score of 0% and Event 2 of 2020 with score of 73%. 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 3. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed Cell I.D./WBC Diff on Event 3 of 2019 and Events 1, 2 and 3 of 2020 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in four consecutive events (Events 1 and 2 of 2020), resulting in the first unsuccessful occurrence for Cell I.D./WBC Diff #0765 in the specialty of Hematology. The findings include: Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two out of three consecutive events (Events 1 and 2 of 2020), resulting in the first unsuccessful occurrence for Cell I.D./WBC Diff #0765 in the specialty of Hematology. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Cell I.D./WBC Diff #0765 on Event 1 of 2020 with a score of 0% and Event 2 of 2020 with score of 73%. 2. The criteria for acceptable performance for the specialty of Hematology is 80%. 3. Desk review of the laboratory's proficiency testing reports from the American Proficiency Institute (API) confirmed the laboratory failed analyte #0765 Cell I.D./WBC Diff for Event 1 and 2 2020 resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on October 3, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for automated white blood cell (WBC) differential analyte in 2016 events two and three and in 2018 events one and two resulting in the second unsuccessful occurrence for WBC differential. (Refer to D 2130). 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 -- 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 a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and review of the laboratory's 2016, 2017 and 2018 proficiency testing (PT) evaluation reports from the American Proficiency Institute (API) , the laboratory failed to maintain satisfactory performance in four of seven consecutive proficiency testing events for the automated white blood cell (WBC) differential resulting in the second unsuccessful PT occurrence for WBC differential. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory automated WBC differential scores: 2016 event two 67%, 2016 event three 53%, 2018 event one 73% and 2018 event two 73%. 2. Review of the API 2016 event two evaluation report revealed unacceptable scores for Granulocytes % for sample numbers HEM-06, HEM 07 and HEM 10, Lymphocytes % for sample number HEM-06 and Monocyte/Mid% for sample number HEM-10. 3. Review of the API 2016 event three evaluation report revealed unacceptable scores for Granulocytes % for sample numbers HEM-12, HEM 13 and HEM 15, Lymphocytes % for sample numbers HEM-11 and HEM 12 and Monocyte/Mid% for sample numbers HEM-12 and HEM-15. 4. Review of the API 2018 event one evaluation report revealed unacceptable scores for Granulocytes % for sample numbers HEM-03 and HEM 05 and Lymphocytes % for sample numbers HEM-03 and HEM 05. 5. Review of the API 2018 event two evaluation report revealed unacceptable scores for Granulocytes % for sample numbers HEM-06 and HEM 07 and Lymphocytes % for sample numbers HEM-06 and HEM 07. 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: The laboratory director failed to maintain compliance with successful white blood cell (WBC) differential proficiency testing (PT) for four of seven consecutive events , resulting in the second unsuccessful PT occurrence for WBC differential. (Refer to D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and review of the laboratory's 2016, 2017 and 2018 proficiency testing (PT) evaluation reports from the American Proficiency Institute (API) , the laboratory director failed to ensure the laboratory maintained satisfactory performance in four of seven consecutive proficiency testing events for the automated white blood cell (WBC) differential resulting in the second unsuccessful PT occurrence for WBC differential. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory automated WBC differential scores: 2016 event two 67%, 2016 event three 53%, 2018 event one 73% and 2018 event two 73%. 2. Review of the API 2016 event two evaluation report revealed unacceptable scores for Granulocytes % for sample numbers HEM-06, HEM 07 and HEM 10, Lymphocytes % for sample number HEM-06 and Monocyte/Mid% for sample number HEM-10. 3. Review of the API 2016 event three evaluation report revealed unacceptable scores for Granulocytes % for sample numbers HEM-12, HEM 13 and HEM 15, Lymphocytes % for sample numbers HEM-11 and HEM 12 and Monocyte/Mid% for sample numbers HEM-12 and HEM-15. 4. Review of the API 2018 event one evaluation report revealed unacceptable scores for Granulocytes % for sample numbers HEM-03 and HEM 05 and Lymphocytes % for sample numbers HEM-03 and HEM 05. 5. Review of the API 2018 event two evaluation report revealed unacceptable scores for Granulocytes % for sample numbers HEM-06 and HEM 07 and Lymphocytes % for sample numbers HEM-06 and HEM 07. -- 3 of 3 --