Durham Women's Clinic

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 2024 AAB (American Association of Bioanalysts) MLE (Medical Laboratory Evaluation) proficiency testing results 1/8/25, the laboratory failed to successfully participate in proficiency testing for Bacteriology on two 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 2 -- (e) 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 2024 AAB MLE proficiency testing results 1/8/25, the laboratory failed to achieve satisfactory performance for Bacteriology on two consecutive test events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper reports 153D and 155D and desk review of 2024 AAB MLE proficiency testing results revealed the laboratory received an overall score of 0% for Bacteriology on the 2024 AAB MLE Nonchemistry M2 test event. 2. Desk review of CMS Casper reports 153D and 155D and desk review of 2024 AAB MLE proficiency testing results revealed the laboratory received an overall score of 0% for Bacteriology on the 2024 AAB MLE Nonchemistry M3 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 AAB MLE proficiency testing results 1/8/25, 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) (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 desk review of CMS Casper reports 153D and 155D and desk review of AAB MLE proficiency testing results 1/8/25, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. See the deficiency cited at D2028. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation and testing personnel interview 10/20/22, the laboratory failed to dispose of expired potassium hydroxide (KOH) reagent that had exceeded their expiration date. Findings: Surveyor observed the following two bottles of KOH reagent that had exceeded their expiration dates and were available for use. 1. One bottle of KOH reagent, Troy Biologicals Lot # 17312 expiration date 11/8/19, on the counter top beside microscope. 2. One bottle of KOH reagent, HealthLink Lot #9301 expiration date 10/28/21, in the cupboard above microscope. During observation TP confirmed the two bottles of KOH reagent had exceeded their expiration dates. The TP promptly disposed of the reagents to ensure they would not be available for use. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel records, review of 2020, 2021 and 2022 testing personnel (TP) competency records and interview with laboratory director (LD) 10/20 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 -- /22, the technical consultant (laboratory director) failed to perform the yearly competency assessments for all TP. Findings: Review of personnel records revealed TP #3 and TP #4 have a high school diploma and do not meet the qualifications to serve as technical consultant and evaluate the competency of TP. Review of 2020, 2021 and 2022 TP competency records revealed the following: 1. TP #3 evaluated the competency of TP #4 in 2020, 2021 and 2022, TP #6 in 2021, TP #7 in 2022 and TP #10 in 2021 and 2022. 2. TP #4 evaluated the competency of TP #2 in 2022, TP #3 in 2021 and TP #8 in 2021 and 2022. Interview with LD at approximately 12:30 p.m. confirmed the TP #3 and TP #4 have high school diplomas. The LD stated they were not aware that only someone who qualifies as a technical consultant could evaluate the competency of TP. -- 2 of 2 --

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 2020 and 2021 MLE(Medical Laboratory Evaluation) proficiency testing results 7/27/21, the laboratory failed to successfully participate in proficiency testing for Bacteriology in two of three consecutive testing 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(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 and 2021 MLE(Medical Laboratory Evaluation) proficiency testing results 7/27/21, the laboratory failed to achieve satisfactory performance for Bacteriology in two of three consecutive events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2020 MLE proficiency testing results revealed the laboratory failed to participate and received an overall score of 0% for Bacteriology on the 2020 MLE 3rd event. 2. Desk review of CMS Casper report 155D and 2021 MLE proficiency testing results revealed the laboratory failed to participate and received an overall score of 0% for Bacteriology on the 2021 MLE 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 MLE(Medical Laboratory Evaluation) 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 reports 153D and 155D and desk review of 2020 and 2021 MLE(Medical Laboratory Evaluation) 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 MLE proficiency testing results revealed the laboratory failed to participate and received an overall score of 0% for Bacteriology on the 2020 MLE 3rd event. 2. Desk review of CMS Casper report 155D and 2021 MLE proficiency testing results revealed the laboratory failed to participate and received an overall score of 0% for Bacteriology on the 2021 MLE 2nd event. -- 2 of 2 --

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 testing personnel (TP) competency records and interview with laboratory director (LD) 9/25/19, the laboratory failed to establish competency procedures that meet the regulations as stated in section 493.1413(b)(8) of the 42 CFR Part 493 Requirements for Laboratories. Section 493.1413(b)(8) states: "The procedures for evaluation of the competency of the staff (testing personnel) must include, but are not limited to... Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; Monitoring the recording and reporting of test results; Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; Direct observation of performance of instrument maintenance and function checks; Assessment of test performance through testing of previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and Assessment of problem solving skills; Findings: Review of TP competency records revealed a form entitled "Competency Assessment for Testing Personnel - Affirm Testing". The form is a checklist of tasks that testing personnel must be able to do. The checklist fails to establish a competency policy or procedure, it does not indicate how the evaluations are conducted and documented, and does not include the criteria used for the evaluation. The checklist also fails to include the required procedures for evaluation of the competency of staff as required in section 493.1413(b)(8) of the 42 CFR Part 493 Requirements for Laboratories. During exit interview with LD at approximately 2:00 p.m. the LD stated she was unaware that there was a problem with the competency assessments and that these Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- were used by the previous laboratory director so she assumed they were sufficient and met the regulations. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency testing (PT) records and interview with office manager and laboratory director (LD) 9/25/19, the laboratory failed to verify the accuracy of the testing performed on the BD MicroProbe Processor. Findings: The laboratory performs testing for Candida species, Gardnerella vaginalis, and Trichomonas vaginalis using the BD Affirm VPIII microbial identification test on the BD MicroProbe Processor. Review of laboratory PT records revealed the laboratory had copies of Medical Laboratory Evaluation (MLE) PT records from their "sister" facility located at a separate address. The records failed to document PT or verification of accuracy for the testing performed at the facility surveyed. Interview with office manager and LD at approximately 12:00 p.m. confirmed the PT records were copies of PT performed at their "sister" facility. The office manager stated they were told by MLE that they would not have to enroll for this site if they were already enrolled at another site for the same testing. 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)