Ccrm Virginia Beach

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CCRM Virginia Beach on January 24, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and includes the Condition under 42 CFR part 493 CLIA Regulation: D5200 -42 CFR. 493.1230 General Laboratory Systems. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of proficiency testing (PT) records, quality assurance (QA) policies, lack of documentation, and interview, the laboratory failed to verify twice annual accuracy of patient sperm count testing by Makler Counting Chamber per procedure and quality assessment protocols in calendar years 2022 and 2023. See D5217 (repeat deficiency). 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of the andrology laboratory's proficiency testing (PT) records, quality assurance (QA) policies, lack of documentation, and an interview, the laboratory failed to verify twice annual accuracy of patient sperm count testing for twenty-four (24) of 24 months reviewed (timeframe February 2022 to the date of the inspection on 1/24/24). *REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's American Association of Bioanalysts (AAB) and Wisconsin State Laboratory of Hygiene (WSLH) PT documentation in calendar year 2022 to the date of survey on 1/24/24 (five events) revealed the following one performance score report for Sperm Count: 2023 WSLH Off Schedule Proficiency Testing Evaluation Sperm Count Module 3200: 50% Unsatisfactory (specimen SP3 graded as Pass, specimen SP4 graded as Fail/incorrect response). The inspector requested to review additional accuracy verification for sperm count by Makler Counting Chamber for calendar year 2022 and 2023. No additional records were available for review. 2. Review of the laboratory's procedures revealed that the facility utilized AAB Proficiency Testing for accuracy verification that outlined "for sperm count (Makler Counting Chamber), motility, sperm morphology, and embryo grading, IVF culture media, and microscopy twice annually -internal audit will be performed when results are not graded by AAB or unsatisfactory". 3. Review of the laboratory's procedures revealed protocols for quarterly quality assurance audit reviews which included /outlined proficiency testing review of results and

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at The New Hope Center for Reproductive Medicine on February 17, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of the laboratory's proficiency testing (PT) records, quality assurance (QA) policies, and an interview, the laboratory failed to verify twice annual accuracy of sperm motility testing in calendar year 2021. Findings include: 1. Review of the laboratory's American Association of Bioanalysts (AAB) PT documentation from 2020 to the date of survey on 2/17/22 (four events) revealed the following two (2) unsatisfactory performance scores for Sperm Motility: 2021 Embryology, Andrology, and Fetal Module 1: 50% (specimen 1 graded as incorrect response, Specimen 2 noted by AAB as not graded due to lack of participant consensus), 2021 Embryology, Andrology, and Fetal Module 2: 50% (Specimen 1 graded as incorrect response). The inspector requested to review additional accuracy verification for sperm motility testing for calendar year 2021. No additional records were available for review. 2. Review of the laboratory's procedures revealed that the facility utilized AAB Proficiency Testing for accuracy verification for sperm count, motility, sperm morphology, and embryo grading twice annually that outlined "internal audit will be performed when results are not graded by AAB or unsatisfactory". 3. An interview with the laboratory's lead embryologist on 2/17/22 at approximately 1:00 PM confirmed the above findings. 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 -- D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a tour of the laboratory, review of procedures, pipette calibration records, and an interview, the laboratory director (LD) failed to update an approved posted laboratory maintenance schedule/protocol for pipette calibration as reviewed on the date of the inspection, February 17, 2022. Findings include: 1. During a tour of the laboratory on 2/17/22 at approximately 10:30 AM, the inspector noted six (6) Gilson Pipetman single channel pipettes in use and racked/stored in the laboratory safety hood. The inspector noted calibration stickers by Rainin Technical Services dated for calendar year 2018. 2. Review of a posted IVF Laboratory Maintenance Schedule revealed protocols/procedure for annual pipette calibration and service. 3. Review of available pipette calibrations revealed Rainin service reports for the 6 pipettes outlined above dated in calendar year 2017-2018. No additional calibration records were available for review. The embryologist stated at approximately 12:00: "We no longer send the pipettes out for calibrations. I think that was discontinued in 2019." The inspector requested to review the IVF Laboratory Maintenance Schedule procedure changes approved by the LD. The embryologist stated at approximately 12: 10: "I will get the director to modify the written procedure posted in the lab to reflect the procedure change." 4. An interview with the laboratory's lead embryologist on 2/17 /22 at approximately 1:00 PM confirmed the above findings. D5785