Central Carolina Ob-Gyn

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted 06/20/24. Based on the survey findings, Immediate Jeopardy was identified and the laboratory was notified 06/20/24 at approximately 2:30 p.m. The following condition level deficiencies were identified during the survey. D2000 - 493.801 Enrollment and testing of samples D5400 - 493.1250 Analytic Systems D6000 - 493.1403 Laboratories performing moderate complexity testing; laboratory director On 06/20/24, the laboratory ceased testing on the GeneXpert Dx analyzer; therefore, Immediate Jeopardy was removed. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor observation, manufacturers' instructions and interview with testing personnel (TP) #1, 06/20/24, the laboratory failed to ensure the OSOM BV (bacterial vaginosis) Blue Test test vessels and the OSOM Trichomonas Rapid Test sample buffer had not exceeded their expiration dates. Findings: At approximately 10:30 a.m. surveyor observed on the laboratory counter the following testing vessels and reagents that had expired and were available for use: 1. OSOM BV Blue Test - Lot #23CC02 - 27 test vessels - expiration 02/29/24. 2. OSOM Trichomonas Rapid Test - 2 bottles of trichomonas sample buffer - Lot # 221453 - expiration 05/31/24 and 1 bottle of trichomonas sample buffer - Lot #221311 - expiration 02/29/24. Review of package insert for OSOM BV Blue Test revealed "WARNINGS AND PRECAUTIONS....Do not use after the expiration date printed on the kit.". Review of package insert for OSOM Trichomonas Rapid Test revealed "WARNINGS AND PRECAUTIONS....Do not use after the expiration date printed on the kit.". Interview with TP #1 at approximately 10:30 a.m. confirmed the test vessels and bottles of buffer had Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- exceeded their expiration dates. She stated they just use the testing as a back up, and they have not been used recently. The test kits, vessels and bottles of buffer were disposed of at time of survey. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of laboratory policy, absence of 2023 and 2024 proficiency testing (PT) records, review of CMS (Centers for Medicare & Medicaid Services) Form 116, and interview with practice manager 06/20/24, the laboratory failed to enroll in PT for the subspecialty of bacteriology for the Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing since 2022, a period of approximately 18 months. Approximately 1,944 tests are performed each year. Findings: Review of laboratory policy "Quality Assessment" revealed "6. Proficiency Testing...This laboratory will enroll in formal proficiency testing appropriate to the test menu...". Review of laboratory records revealed no documentation of enrollment or participation in PT for 2023 and 2024 for the CT and NG bacteriology testing performed. Review of CMS Form 116 revealed the laboratory performs approximately 1,944 CT and NG bacteriology tests per year. Interview with practice manager at approximately 11:00 a. m. confirmed the laboratory had not enrolled in a PT program for the CT and NG testing for 2023 and 2024. They stated they were not aware of the requirement to enroll in PT. 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 policy, review of 2022 College of American Pathologists (CAP) PT records and lack of documentation 06/20/24, the laboratory failed to verify the accuracy of the Amniotic Fluid Crystallization Test (FERN) and Potassium Hydroxide (KOH)/Wet Prep testing twice annually since October of 2022, a period of approximately 20 months. Review of laboratory policy "Quality Assessment" revealed ""6. Proficiency Testing...This laboratory will enroll in formal proficiency testing appropriate to the test menu...". Review of CAP PT records revealed no documentation of enrollment in PT for the FERN and KOH/Wet Prep testing in 2023 or 2024. There were also no records available to indicate that the -- 2 of 9 -- laboratory performed any activity to verify the accuracy of the FERN and KOH/Wet Prep testing since the last CAP PT event in October of 2022. This deficiency was previously cited 02/23/21. 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. This CONDITION is not met as evidenced by: Based on review of Form CMS-116, review of laboratory policy, review of laboratory procedure manual, review of form CMS-116 processed 05/24/23, review of manufacturer's storage temperatures and specifications, review of 2022, 2023 and 2024 temperature and humidity charts, surveyor observation, interview with TP #1, review of GeneXpert Dx operator's manual, review of 2023 and 2024 maintenance logs, review of 2023 and 2024 quality control (QC) records, and review of Individualized Quality Control Plan (IQCP) 6/20/24, the laboratory failed to monitor and evaluate the overall quality of the analytic system, identify problems and implement corrections. Findings: 1. The laboratory procedure manual failed to include a procedure for FERN testing and a procedure or system used for entering test results in the patient record (see D5403). 2. The current laboratory director failed to sign and date their approval of the laboratory procedure manual (see D5407). 3. The laboratory failed to document refrigerator temperature, room temperature and humidity each day of patient testing (see D5413). 4. The laboratory failed to ensure control reagents that exceeded their expiration date were not available for use (see D5417). 5. The laboratory failed to perform and document all monthly and quarterly maintenance as required on the GeneXpert Dx analyzer (see D5429). 6. The laboratory failed to perform QC each day of patient testing on the GeneXpert Dx analyzer (see D5449). 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of 2019 and 2020 CAP (College of American Pathologists) proficiency testing records, review of patient logs, and interview with TP (testing personnel) #1 on 2/23/21, the laboratory failed to ensure that proficiency testing samples for 1 of 1 event in 2019 and 1 of 1 event in 2020 were tested with the laboratory's routine patient workload by personnel who normally perform patient testing. Findings: 1. Review of proficiency testing records for the 2019 CAP HC7-C test event and the 2020 CAP HC7-C test event revealed that 5 of 5 samples for both events were tested by TP #1. The laboratory has 9 TP who perform patient GeneXpert testing for Chlamydia trachomatis and Neisseria gonorrhea. During interview 2/23/21 at approximately 1:20 p.m., TP #1 confirmed that she tested 5 of 5 proficiency samples for both events (2019 CAP HC7-C, 2020 CAP HC7-C). 2. Review of 2019 and 2020 patient logs revealed that proficiency samples were not recorded on the GeneXpert patient logs in the same manner as patients are recorded. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on review of 2019 and 2020 CAP (College of American Pathologists) proficiency testing records and interview with TP (testing personnel) #1 on 2/23/21, the laboratory director and TP failed to sign the attestation statement to attest to integration of proficiency samples into the laboratory's routine patient workload for 1 of 1 event in 2019 and 1 of 1 event in 2020. Findings: 1. Review of records for the 2019 CAP HC7-C test event revealed the attestation statement was not signed by the laboratory director to attest to integration of the proficiency samples into the laboratory's routine patient workload. 2. Review of records for the 2020 CAP HC7-C test event revealed the attestation statement was not signed by the laboratory director or the TP to attest to integration of the proficiency samples into the laboratory's routine patient workload. During interview 2/23/21 at approximately 1:20 p.m., TP #1 confirmed that the attestation statements had not been signed. 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 the CMS (Centers for Medicare and Medicaid Services) 209 personnel form, the absence of records, the deficiency cited at D6004, and interview with TP (testing personnel) #1 2 /23/21, the laboratory failed to ensure their competency evaluation policy was followed. Findings: Review of the laboratory's "QUALITY ASSESSMENT" policy revealed "... 5. Personnel Competency ... At least annually, the laboratory director and /or technical consultant will review the performance of each employee working in the laboratory to assure employee competency. ..." 1. Review of the CMS-209 personnel form completed for the survey revealed the laboratory has 7 providers who perform vaginal wet preps and fern tests. There was no documentation of competency evaluation available for 7 of 7 providers. During interview 2/23/21 at approximately 2: 00 p.m., TP #1 stated they were not aware the providers were required to have competency evaluations performed by the laboratory director. 2. Review of personnel records revealed the laboratory director evaluated the competency of TP #1 and TP #1 evaluated the competency of the other 8 TP (TP #2, #3, #4, #5, #6, #7, #8, #9). See the deficiency cited at D6004. 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 the laboratory's policies and procedures, review of 2019, 2020, and 2021 CAP (College of American Pathologists) proficiency testing records, the absence of verification records, and interview with TP (testing personnel) #1 2/23/21, the laboratory failed to enroll in proficiency testing or establish a system to verify the accuracy of the wet/KOH (potassium hydroxide) preps and fern tests at least twice a -- 2 of 7 -- year. Review of the laboratory's "QUALITY ASSESSMENT" procedure revealed "... 6. Proficiency Testing This laboratory will enroll in formal proficiency testing appropriate to the test menu ..." Review of 2019, 2020, and 2021 CAP proficiency testing records revealed the laboratory was not enrolled in proficiency testing for wet /KOH preps and fern tests in 2019, 2020, or 2021. There were also no records available to indicate that the laboratory performed any activity to verify the accuracy of the wet/KOH preps and fern tests in 2019, 2020, or 2021. During interview 2/23/21 at approximately 10:30 a.m., TP #1 confirmed that the laboratory was not enrolled in proficiency testing and had not performed any activity to verify the accuracy of the wet/KOH preps and fern tests in 2019, 2020, or 2021. She stated they were unaware it was required. 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)