Stanly County Health Department

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 desk review of 2021 and 2022 CAP (College of American Pathologists) proficiency testing results 12/1/22, the laboratory failed to successfully participate in proficiency testing for Bacteriology in two of three consecutive 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 2 -- 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 Casper reports 153D and 155D and desk review of 2021 and 2022 CAP proficiency testing results 12/1/22, the laboratory failed to achieve satisfactory performance for Bacteriology in two of three consecutive testing events, resulting in unsuccessful participation. Findings: 1. Desk review of Casper reports 153D and 155D and desk review of 2021 CAP proficiency testing results revealed the laboratory received a score of 60% for Bacteriology on the D5-C test event. 2. Desk review of Casper reports 153D and 155D and desk review of 2022 CAP proficiency testing results revealed the laboratory received a score of 60% for Bacteriology on the D5-B test 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 Casper reports 153D and 155D and desk review of 2021 and 2022 CAP proficiency testing results 12/1/22, 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 Casper reports 153D and 155D and desk review of 2021 and 2022 CAP proficiency testing results 12/1/22, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of Casper reports 153D and 155D and desk review of 2021 CAP proficiency testing results revealed the laboratory received a score of 60% for Bacteriology on the D5-C test event. 2. Desk review of Casper reports 153D and 155D and desk review of 2022 CAP proficiency testing results revealed the laboratory received a score of 60% for Bacteriology on the D5-B test event. -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedure, review of 2018, 2019, 2020 and 2021 CAP(College of American Pathologists) PT(proficiency testing) records and interview with TP(testing personnel) 5/26/21, the laboratory failed to document evaluation of all proficiency testing results received. Findings: The laboratory's "Proficiency Testing" policy and procedure states, "...9. Upon receiving Proficiency Testing Results all results: graded, ungraded, and any unacceptable will be reviewed using the Participant Summary report. 10. Any failed, missed or unacceptable result will be reviewed and documented following the Policy and Procedure for Missed or Failed Proficiency Testing." Review of 2018, 2019, 2020, and 2021 CAP PT records revealed the laboratory failed to document evaluation of all unacceptable PT results. Examples: 1. 2018 D5-C event: 1 of 5 Gram Stain morphology challenges incorrect with no evaluation documented; 2. 2019 D5-A event: 1 of 5 Gram Stain morphology challenges incorrect with no evaluation documented; 3. 2019 D5-C event: 3 of 5 Gram Stain morphology challenges incorrect with no evaluation documented; 4. 2020 D5-A event: 3 of 5 Gram Stain morphology challenges incorrect with no evaluation documented; 5. 2020 D5- B event: 3 of 5 Gram Stain morphology challenges incorrect with no evaluation documented; 6. 2020 D5- C event: 1 of 5 Gram Stain morphology challenges incorrect with no evaluation documented; 7. 2021 D5-A event: 1 of 5 Gram Stain morphology challenges incorrect with no evaluation documented. At approximately 11:55 a.m., TP #2 and TP #3 stated they are reviewing the summaries from CAP but the reviews were not documented. 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 -- They also confirmed the Missed and Failed PT investigation form is not being completed for any morphology challenge responses that are incorrect. Deficiency previously cited 8/1/18. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's QA(quality assessment) policies and procedures and review of QA records 5/26/21, the laboratory failed to follow written policies and procedures to monitor, assess, and correct problems identified with PT(proficiency testing) performance. Findings: The laboratory's "Quality Systems Assessment" policy and procedure states, "1. Select one or more systems each quarterly and evaluate components or processes for compliance...6. As a part of the Quality Systems Assessment, Proficiency test results will be reviewed to ensure that appropriate action has been taken for any missed or failed proficiency test results. This is to be documented on the Quality Systems Assessment Checklist." Review of the laboratory's QA records revealed the laboratory completed the "Quality Systems Assessment Checklist" on 12/27/18, 4/25/19, 1/3/20, and 5/24/21. Review of the "Quality Systems Assessment Checklist" revealed the QA program failed to identify and correct the problems in the laboratory for PT performance(See D5211). For example: A response of "Compliant" was given on the 12/27/18 checklist and a response of "Not applicable" was given on the 5/24/21 checklist for question, "Were incorrect results(graded and ungraded) investigated and

Summary Statement of Deficiencies 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 review of the laboratory's policies and procedures, review of personnel records, and interview with staff 8/1/18, the laboratory failed to follow established policies for evaluating the competency of all TP (testing personnel). The laboratory's "Personnel Competency Testing Assessment" policy (revised 8/17/16) states "... Procedure: 1. Competency testing will be performed on each test an individual is approved to perform by the lab director. 2. Personnel will be evaluated semiannually during the first year of testing and yearly thereafter. ..." Review of personnel records revealed there was no competency evaluation documented during 2016, 2017, or 2018 for 1 of 4 TP (TP #1) who perform moderate complexity testing. During interview at approximately 1:15 p.m., the nurse manager confirmed that the laboratory director had not evaluated the competency of TP #1 (the nurse practitioner) during 2016, 2017, and 2018. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of 2016, 2017, and 2018 CAP (College of American Pathologists) 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 -- proficiency testing records and interview with TP (testing personnel) 8/1/18, the laboratory failed to document evaluation of all proficiency testing results received. Review of 2016, 2017, and 2018 CAP proficiency testing records revealed the laboratory failed to document evaluation of all unacceptable proficiency testing results. Examples: 1. 2016 D5 B test event - 2 of 5 Gram stain morphology challenges incorrect with no evaluation documented; 2. 2016 D5 C test event - 2 of 5 Gram stain morphology challenges incorrect with no evaluation documented; 3. 2017 D5 A test event - 3 of 5 Gram stain morphology challenges incorrect with no evaluation documented; 4. 2017 D5 B test event - 2 of 5 Gram stain morphology challenges incorrect with no evaluation documented; 5. 2018 D5 A test event - 2 of 5 Gram stain morphology challenges incorrect with no evaluation documented. During interview at approximately 11:20 a.m., TP #2 stated the results were reviewed, but the reviews were just not documented. -- 2 of 2 --