Harnett County Health Department

Summary Statement of Deficiencies 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 review of manufacturer's instructions and review of 2022, 2023, and 2024 Medonic hematology records 3/19/24, the laboratory failed to perform and document the monthly maintenance for the Medonic M-Series hematology analyzer as specified by the manufacturer for 26 of 26 months from January 2022 through February 2024. Findings: Review of the Medonic M-Series User's Manual revealed in "Section 8: Cleaning, Maintenance & Transport Section Overview Introduction This section contains information that is crucial for maintaining, transporting and storing the Medonic M-Series. ... 8.2 Monthly Cleaning Description This section describes the cleaning procedure to be used to secure the correct function of the instrument on a monthly basis. ..." The section described steps for performing the required monthly cleaning and clot prevention. Review of 2022, 2023, and 2024 Medonic hematology analyzer maintenance records revealed the laboratory failed to perform and document the manufacturer's specified monthly cleaning and clot prevention for the Medonic M- Series hematology analyzer for 12 of 12 months in 2022 and 2023, and for 2 months (January and February) in 2024. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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 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 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and the 2020 and 2021 AAB(American Association of Bioanalysts) proficiency testing results 7/27/21, the laboratory failed to successfully participate for Bacteriology on four of five consecutive test events. See the deficiency cited at D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 -- Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 and 2021 AAB(American Association of Bioanalysts) proficiency testing results 7/27/21, the laboratory failed to achieve satisfactory performance for Bacteriology on four of five consecutive test events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2020 AAB proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Genital culture samples, resulting in a score of 60% for Bacteriology on the 2020 Nonchemistry 1st event. 2. Desk review of CMS Casper report 155D and 2020 AAB proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Gram Stain Samples, resulting in a score of 60% for Bacteriology on the 2020 Nonchemistry 2nd event. 3. Desk review of CMS Casper report 155D and 2021 AAB proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Gram Stain Samples, resulting in a score of 60% for Bacteriology on the 2021 Nonchemistry 1st event. 4. Desk review of CMS Casper report 155D and 2021 AAB proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Gram Stain Samples, resulting in a score of 60% for Bacteriology on the 2021 Nonchemistry 2nd event. 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 and 2021 AAB(American Association of Bioanalysts) proficiency testing results 7/27/21, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at 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: Based on desk review of CMS(Centers for Medicare and Medicaid Services) Casper -- 2 of 3 -- reports 153D and 155D and desk review of 2020 and 2021 AAB(American Association of Bioanalysts) proficiency testing results 7/27/21, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2020 AAB proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Genital culture samples, resulting in a score of 60% for Bacteriology on the 2020 Nonchemistry 1st event. 2. Desk review of CMS Casper report 155D and 2020 AAB proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Gram Stain Samples, resulting in a score of 60% for Bacteriology on the 2020 Nonchemistry 2nd event. 3. Desk review of CMS Casper report 155D and 2021 AAB proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Gram Stain Samples, resulting in a score of 60% for Bacteriology on the 2021 Nonchemistry 1st event. 4. Desk review of CMS Casper report 155D and 2021 AAB proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Gram Stain Samples, resulting in a score of 60% for Bacteriology on the 2021 Nonchemistry 2nd event. 5. Desk review of CMS Casper report 153D and 155D revealed the laboratory failed to achieve satisfactory performance for Bacteriology on four of five consecutive proficiency testing events, resulting in non-initial unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper report number 153D and 155D and the 2020 AAB (American Association of Bioanalysts) proficiency testing results 7/20/20, the laboratory failed to successfully participate in proficiency testing for Bacteriology. See the deficiency cited at D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS(Centers for Medicare and Medicaid Services) Casper Reports 153D and 155D and desk review of 2020 AAB (American Association of Bioanalysts) proficiency testing results 7/20/20, the laboratory failed to achieve satisfactory performance for Bacteriology in two consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2020 AAB proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Genital culture samples, resulting in a score of 60% for Bacteriology on the 2020 Nonchemistry 1st event. 2. Desk review of CMS Casper report 155D and 2020 AAB proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Gram stain samples, resulting in a score of 60% for Bacteriology on the 2020 Nonchemistry 2nd event. 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 AAB(American Association of Bioanalysts) proficiency testing results 7/20/20, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at 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: Based on the desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 AAB(American Association of Bioanalysts) proficiency testing results 7/20/20, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2020 AAB proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Genital culture samples, resulting in a score of 60% for Bacteriology on the 2020 Nonchemistry 1st event. 2. Desk review of CMS Casper report 155D and 2020 AAB proficiency testing results revealed the laboratory provided unacceptable responses for -- 2 of 3 -- 2 of 5 Gram stain samples, resulting in a score of 60% for Bacteriology on the 2020 Nonchemistry 2nd event. -- 3 of 3 --