Chesapeake Women's Care

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) procedure and interview with the lead testing person (TP) and office manager (OM), the laboratory did not ensure that PT samples were tested in the same manner as patient specimens. Findings: 1. The laboratory's "Proficiency Testing" procedure stated "When testing is complete, write down results on a separate piece of paper, DO NOT DISCARD PAC [Probe Analysis Card] CARDS! Remove cards from processor, lay them on a paper towel for Lab Director to review and validate results." 2. In an interview on 06/05/2024 at 1:00 PM, the TP confirmed that the laboratory director did not review the PAC for patient testing prior to reporting results. 3. During the exit interview on 06/05/2024 at 1:30 PM, the lead TP and OM confirmed that PT samples were not tested the same as patient samples as the laboratory director reviewed the PAC for PT samples but not for patient samples prior to reporting the results. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must 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 -- attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the lead testing person (TP) and office manager (OM), the laboratory failed to attest to the routine integration of samples into the patient workload using the laboratory's routine methods for four of four PT events reviewed. Findings: 1. Records from four PT events from 2023-2024 were reviewed. 2. The laboratory did not have signed attestation forms in either a hardcopy or electronic format. 3. During the exit interview on 06/05/2024 at 1:30 PM, the lead TP and OM confirmed that the laboratory did not download the attestation forms for either hardcopy or electronic signatures. 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 procedure manual and competency records and interview with the lead testing person (TP) and office manager (OM), the laboratory failed to establish a written procedure for assessing competency of the testing personnel (TP). Findings: 1. The laboratory's procedure titled "Quality Assessment Worksheet 2023" stated that "Competency Assessment" was to be performed at "2 months for new hire and Annually after first year of employment. Annually for employees >2 years." 2. The laboratory used a form titled "Laboratory Personnel Evaluation" to document competency assessments, but there was no procedure describing how competency was to be performed including the six CLIA requirements for assessing competency of TP: 1) Direct observation of routine patient test performance, 2) Monitoring the recording and reporting of test results, 3) Review of intermediate test results or worksheets, quality control records, proficiency testing (PT) results, and preventive maintenance records, 4) Direct observations of performance of instrument maintenance and function checks, 5) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external PT samples, and 6) Assessment of problem solving skills. 3. During the exit interview on 06/05/2024 at 1: 30 PM, the lead TP and OM confirmed that the laboratory did not have an approved procedure for performing competency of the TP. 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 proficiency testing (PT) records and interview with the lead testing person (TP) and office manager (OM), the laboratory failed to document the -- 2 of 7 -- review and evaluation of PT results in four of four PT events. Findings: 1. Records from four PT events from 2023-2024 were reviewed. 2. The laboratory did not have a hardcopy or electronic record of the PT results that was signed by the laboratory director (LD) or designee indicating review of the PT results. 3. During the exit interview on 06/05/2024 at 1:30 PM, the lead TP and OM confirmed that the laboratory did not download the PT results for either hardcopy or electronic signatures of the LD or designee indicating their review and evaluation of the PT results. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of temperature records, review of the manufacturer's user manual, and interview with the lead testing person (TP) and office manager (OM), the laboratory failed to record the relative humidity in the laboratory where the Beckton Dickinson (BD) MicroProbe Processor was operated. Findings: 1. The laboratory tested the BD Affirm VPIII Microbial Identification Test using the BD MicroProbe Processor. 2. The instrument user's manual (document MA0106 2016-04 (08)) listed "Operating Specifications" for "Ambient Humidity" as "10-85%." 3. Temperature records for 2023 and 2024 were reviewed and there was no documentation of ambient humidity. 4. During the exit interview on 06/05/2023 at 1:45 PM, the lead TP and OM confirmed that the laboratory was not documenting ambient humidity in the room where the BD Affirm VPIII testing was performed. 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 review of patient test logs and interview with the lead testing person (TP) and office manager (OM), the laboratory failed to ensure that test kits for the Becton Dickinson (BD) Affirm VPIII assay were not used beyond their expiration dates. Findings: 1. The laboratory documented the lot number and expiration date of the BD Affirm VPIII test kits used for each patient tested on the "Affirm Test Log." 2. Each page of the Affirm Test Log documented results for 12 patients. 3. Patient logs from 04/03/2023 to 06/04/2024 were reviewed. 4. A single page listed patient results from 04/19/2024-05/02/2024 and documented that testing was performed with Affirm kit lot number 3146709 with expiration date 04/09/2024 for all 12 patients. 5. During the -- 3 of 7 -- exit interview on 06/05/2024 at 1:45 PM, the lead TP and OM confirmed that 12 patients listed on a single page of the Affirm Test Log were tested with expired BD Affirm VPIII test kits. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for use (IFU), the laboratory's procedure, the patient test log, and the quality control (QC) log and interview with the lead testing person (TP) and office manager (OM), the laboratory failed to perform external QC testing on new test kit lot numbers prior to testing patient specimens for five of eight test kit lot numbers reviewed. Findings: 1. The manufacturer's IFU (document 670160JAA(06) 2023-11) stated that "each reagent lot must be tested for adequate sample lysis and release of target nucleic acid." The laboratory used a tri- valent swab that included all three test organisms included in the assay. The manufacturer's IFU also stated that "If quality control (QC) testing with all three organisms, ensure that the results for the internal controls are both acceptable (i.e. , blue Positive Control bead and colorless Negative Control bead) and interpret results as follows: 1. If all three organism beads turn blue, all patient results can be reported." 2. The laboratory's "Quality Control Testing" procedure stated that the "External Control" should be performed "with a new box of Affirm BD VPIII is opened. Before patient testing or monthly." 3. The laboratory recorded each test kit lot number used for each patient specimen on the "Affirm Test Log" and each external QC result for each test kit lot number on the "External Quality Control Log Sheet." Both logs were reviewed for patient testing performed from 04/03/2023-06/05/2024. 4. Five of eight test kit lot numbers reviewed were tested with external QC after patient testing had begun with that test kit lot number: a. Lot number 3051325: QC was first performed on 09/22/2023 and patient testing began on 09/07/2023 b. Lot number 3135433: QC was first performed on 11/06/2023 and patient testing began on 10/10/2023 c. Lot number 3115101: QC was first performed in 12/2023 (the day was not recorded) and patient testing began on 11/16/2023 d. Lot number 3146709: QC was first performed on 01/05/2024 and patient testing began on 01/04/2023 e. Lot number 3262038: QC was first performed on 05/13/2024 and patient testing began on 04/19/2024 5. During the exit interview on 06/05/2024 at 1:45 PM, the lead TC and OM confirmed that external QC was not consistently performed on new test kit lot numbers prior to patient testing with those lot numbers. D5783

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 proficiency testing (PT) record review and interview with the testing supervisor, the laboratory did not ensure that all the testing personnel (TP) who tested patient samples performed the PT. Findings: 1. The laboratory currently has 8 TP listed on the "Laboratory Personnel Report" (CMS-209) who perform microbiology testing. 2. A review of microbiology PT attestation worksheets from 2021 and 2022 showed that PT was performed by the same TP in 3 of 6 events. 3. During an interview on 01/10/2023 at 12:00 PM, the testing supervisor confirmed that PT samples were not tested each year by all the staff who perform patient testing to ensure accurate and reliable patient test results. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on quality control (QC) record review and interview with the testing supervisor, the laboratory did not ensure that State requirements were followed when performing QC on the BD Affirm VPIII Microbial Identification System. Findings: 1. The laboratory performs microbiology testing using the BD Affirm VPIII Microbial 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 -- Identification System. 2. A review of QC records from January through December 2022 showed that QC for this analyzer was not run weekly from 01/28/2022 to 02/08 /2022; 03/16/2022 to 03/29/2022; 04/07/2022 to 04/25/2022; 05/03/2022 to 05/19 /2022; 05/24/2022 to 06/10/2022; 06/10/2022 to 06/23/2022; 07/01/2022 to 07/15 /2022; 07/15/2022 to 07/29/2022; 08/18/2022 to 08/31/2022; and 09/16/2022 to 09/29 /2022. 3. Code of Maryland Regulations- COMAR 10.10.06 Medical Laboratories- Quality Assurance, .06 Quality Control - Single-Use Test Devices, B. Standards, (6) Quality Control Tests, (b) Qualitative Test System states, "A licensee shall ensure that quality control testing for a qualitative test system is performed and documented using known positive and negative control materials before patient testing" "At least weekly for each lot of a single-use test device used for patient testing." 4. During an interview on 01/10/2023 at 12:00 PM, the testing supervisor confirmed that the laboratory was not in compliance with the State requirements to run QC at least weekly when performing patient testing. 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: Note: This is a repeat deficiency. The laboratory was cited during the re-certification survey on 02/22/2021 for not documenting the expiration dates of control materials used for performing microbiology testing to ensure that control materials are not used when they exceed their expiration date. The

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on procedure manual and quality assurance (QA) record review and interview with the clinical coordinator, the laboratory did not follow written procedures for performing chart reviews to ensure that patient results from testing on the Affirm VPIII were documented and entered accurately. Findings: 1. The procedure "Quality Assurance - Affirm Testing" states, "The Clinical Coordinator (Testing Supervisor) will insure that the Affirm Test result log is reviewed for accuracy and proper charting each month." "In general, 5-7 log entries will be reviewed for entry completion, results documented in the EHR, order (by provider) documented in EHR, and the scanned copy of results is present." It also states, "Reviewed entries will be listed on a form and the clinical coordinator will insure any necessary action (procedure reminders, entering missing results, error investigation, etc.) is taken and documented as such." 2. A review of QA logs from August, 2018 to June, 2019 showed that in August, 2018 1 of 26 patients checked as part of the QA review did not have a response for "Provider Order present?" documented. 3. In January, 2019 1 of 25 patients checked had "no" marked in the box labeled "All info entered?" but no

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) record review and interview with technical consultant (TC), the laboratory did not ensure that both a positive and a negative control were run each time external QC was run on the BD Affirm Microbial Identification System. Findings: 1. The laboratory uses a BD Affirm Microbial Identification System to test for Candida albicans, Trichomonas vaginalis, and Gardnerella vaginalis. A review of QC records from 2017 to 2018 showed that the laboratory was running a positive Candida albicans control on the BD Affirm but no negative external control. The laboratory did not run positive controls for Trichomonas vaginalis or Gardnerella vaginalis; 2. During an interview on 7/9/18 at 11:00 AM, the TC confirmed that a negative control and positive Trichomonas and Gardnerella controls were not being run, and stated that they were following the procedure manual from the company and were not aware that they needed to run the additional controls. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --