Rockville Gynecology Llc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 laboratory staff, the laboratory failed to ensure that all the testing personnel (TP) who tested patient samples performed the PT. Findings: 1. The laboratory had seven TP listed on the "Laboratory Personnel Report (CLIA)" (CMS-209) which was collected on the day of the survey who perform testing for Chlamydia trachomatis and Neisseria gonorrhoeae on the Cepheid GeneXpert system. 2. A review of microbiology PT attestation worksheets from six PT events from 2023 through 2025 showed that PT was performed by the same TP (TP #1) in six of six events. 3. During an interview on 07/25/2025 at 1:40 PM, the laboratory staff 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. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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: 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 -- Based on procedure manual review and interview with laboratory staff, the laboratory failed to ensure that the written procedure manual had one, consistent and accurate procedure which instructed testing personnel (TP) how to perform quality control (QC) on the Cepheid GeneXpert system. Findings: 1. The laboratory performs testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) on the Cepheid GeneXpert system. 2. Procedure manual review showed that there were two versions of the "Cepheid GeneXpert CT/NG Procedure" in the procedure manual. One version stated, "External controls are run (per IQCP) [Individualized Quality Control Plan]: Weekly" and the other version stated, "External negative [and positive] CT/NG control - run daily" There was one signature page showing that the laboratory director (LD) reviewed the procedure on 01/03/2025. 3. A review of the IQCP (signed by the LD on 03/08/2022) showed that QC for CT/NG were to be run "Weekly, for each new lot, for each new shipment, and each time a new operator performs test"; however a document titled, "Quality Control Procedure Review" (signed by the LD on 11/11 /2021) stated that "GeneXpert controls are to be run daily for Neisseria gonorrhoeae and Chlamydia trachomatis." 4. Further review showed that a document titled, "Quality Control Procedure Review" (signed by the LD on 11/11/2021) stated that "GeneXpert controls are to be run daily for Neisseria gonorrhoeae and Chlamydia trachomatis" and the "Quality Assurance" procedure listed "Run and record quality control" under "Daily" tasks. 5. During an interview on 07/25/2025 at 10:15 AM, TP #1 stated that QC is run monthly. A document/letter was found, signed on 10/19/2023 by the LD that stated that CT/NG controls were to be run "Once a month for each new lot for each new shipment." 6. Review of QC records from January through May 2024 and January through June 2025 showed that the laboratory was running QC monthly. 7. During an interview on 07/25/2025 at 1:40 PM, the laboratory staff confirmed that the procedure manual did not have one consistent procedure instructing the laboratory staff on how frequently to run QC on the Cepheid GeneXpert system. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies 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 procedure manual, manufacturer's "Instructions for Use," and record review and interview with the testing personnel (TP) and laboratory director (LD), the laboratory did not follow manufacturer's instructions for performing waived SARS- CoV-2 testing using the Cepheid GeneXpert System. Findings: 1. The "Instructions for Use" for the test, "Xpert Xpress SARS-CoV-2" was reviewed. Section "16.3 Running External Controls" states, "It is recommended that external controls be tested at the frequency noted below. Each time a new lot of Xpert Xpress SARS-CoV-2 kits is received. Each time a new shipment of Xpert Xpress SARS-CoV-2 kits is received even if it is the same lot previously received." 2. Record review showed that the laboratory's "Covid Monthly Control Log" was blank. A review of quality control (QC) records on the instrument from June, 2021 to present showed that no SARS- CoV-2 QC records were recorded. 3. Section "21 Conditions of Authorization for Laboratories" states, "Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." Procedure manual review showed that the laboratory did not have a procedure for how to report SARS-CoV-2 test results to the appropriate local health department. 4. This section also states, "All operators using your product must be appropriately trained in performing and interpreting the results of your product, use appropriate personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling." Record review showed that there was no documentation of initial training or competency assessments performed for 4 of 4 TP listed on the "Laboratory Personnel Report (CMS-209)." 5. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- Record review showed that the laboratory validated the instrument and testing system for the "4-Plex" test cartridge (Xpert Xpress SARS-CoV-2/Flu/RSV), however the lab is currently using the "Xpert Xpress SARS-Cov-2" cartridge. There was no documentation that the new cartridge had been validated before use. 6. During an interview on 10/18/2021 at 4:00 PM, the LD confirmed that the laboratory did not follow manufacturer's instructions for performing waived SARS-CoV-2 testing using the Cepheid GeneXpert System. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on laboratory record review and interview with the laboratory director (LD), the laboratory failed to retain all analytic systems records for at least 2 years. Findings: 1. Quality assurance (QA) record review showed that there were no QA records present at the time of the survey. 2. Record review showed that the laboratory did not have documentation that SARS-CoV-2 test results (both positive and negative) were reported to the appropriate health department. 3. During an interview on 10/18 /2021 at 4:00 PM, the LD confirmed that the laboratory failed to retain all analytic systems records for at least 2 years. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and electronic communication with the practice manager and interview with the laboratory director (LD), the laboratory did not ensure that a copy of all PT documents was maintained by the laboratory for a minimum of two years from the date of the PT testing event. Findings: 1. In an email received on 11/08/2021 the practice manager stated that the laboratory began testing with the BD Affirm VPIII Microbial Identification System on 11/30/2020 and with the Cepheid GeneXpert System on 02/03/2021. 2. A review of PT records showed that the laboratory had the results form and the attestation statement for "Q3 Nonchemistry 2021" "Chlamydia/GC/Strep Screen B." The results form was blank and the attestation statement was not signed by the LD or testing personnel. No other PT records were available at the time of the survey. 3. During an interview on 10/18/2021 at 4:00 PM, the LD confirmed that the laboratory did not retain all PT records for at least 2 years. 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 -- 2 of 12 -- 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 record review and interview with the laboratory director (LD) the laboratory failed to follow the written procedure manual for all tests, assays, and examinations performed by the laboratory (D5401); failed to provide the testing personnel with written preanalytical, analytical, and post analytical policies and procedures for testing with the BD Affirm Microbial Identification System and the Cepheid GeneXpert System (D5403); failed to define, monitor, and document laboratory refrigerator, room, and heat block temperature and room humidity to ensure proper reagent storage, and accurate and reliable test system operation and test result reporting (D5413); failed to ensure that reagents are not used when they have exceeded their expiration date, have deteriorated, or are of substandard quality (D5417); failed to ensure that the laboratory validated all analyzers to demonstrate that they can obtain performance specifications comparable to those established by the manufacturer before being used for patient testing (D5421); failed to ensure that maintenance is performed and documented as defined by the manufacturer and with at least the frequency specified by the manufacturer (D5429); failed to run 2 levels of QC each day of patient testing and failed to establish an Individualized Quality Control Plan (D5445); and failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283 (D5791). 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 record review and interview with the testing personnel (TP) and laboratory director (LD), the laboratory failed to follow the written procedure manual for all tests, assays, and examinations performed by the laboratory. Findings: 1. The procedure "Quality Assessment Program" under "Specimen Collection and Handling" states, "Samples that do not meet acceptable criteria for testing are rejected. Rejected sample documentation includes why a sample was rejected and is maintained on the Sample Rejection Log." During an interview on the day of the survey, TP stated that the laboratory did not have a "Sample Rejection Log." 2. The section titled "Patient Test Management/Record Keeping" states, "A daily specimen accession log is maintained in the lab." The laboratory used a spiral notebook where they wrote patient names but would cross the names off with pen when patient results were entered into the electronic record. The TP stated that the technical consultant was supposed to provide them with a patient log but had not. 3. The section titled, "Proficiency Testing" states, "PT results are reviewed and retained for a period of at least 2 years." Record review showed that proficiency testing records were incomplete. Cross-refer to D3037. 4. The laboratory did not have a policy for reporting all (including positive and negative) SARS-CoV-2 patient results to the -- 3 of 12 -- appropriate health department. 5. During an interview on 10/18/2021 at 4:00 PM, the LD confirmed that the written procedure manual did not accurately reflect the actual practice of the laboratory. 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)