Genetics & Ivf Institute-Endocrinology Laboratory

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at GIVFF, LLC on May 12, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies cited are as follows: D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a tour, review of the laboratory's policies and procedures, analyzer performance verification records, lack of documentation, and an interview, the laboratory failed to follow their established policy to perform and document calibration, quality control analysis and patient sample comparison/verification for two of two Roche Cobas Endocrinology analyzers after a physical move/installation to a new suite in February 2025 prior to reporting 1715 patient results as of the date of the inspection on May 12, 2026. The findings include: 1. During a tour of the laboratory on May 12, 2026 at 9:00 AM, the surveyor noted the laboratory had physically moved the two Roche Cobas analyzers (serial numbers 1122-08 and 1122- 11) from a first floor suite to a third floor suite location. The surveyor inquired of the move date. The technical consultant (TC) stated: "We moved the two instruments from the first floor in February 2025." The surveyor noted the analyzers were in use for Estradiol (E2), Progesterone (P4), Luteinizing Hormone (LH), and Beta Human 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 -- Chorionic Gonadotropin (BHCG) patient testing. 2. A review of the laboratory's policies and procedures revealed a "Quality Management Plan" with the statements, "10.2.7 Equipment which is moved from one location to another permanent location must be handled in the following manner....Upon arrival at the testing site, the instrument must be recalibrated, if required by the manufacturer, two-level QC must be performed together with representative patient samples (similar to lot-lot verification requirements, see 14.1) to verify the instrument functions properly prior to patient testing." 3. Review of the 2 Roche Cobas analyzers' performance verification documentation (serial numbers 1122-08 and 1122-11 ) revealed no laboratory director approved evaluation/verification of post-move calibration, quality control analysis, and comparison of analytes, E2, P4, LH, and BHCG, prior to patient testing, for the timeframe of the re-installation in the new laboratory location (2/2025) up to the date of the inspection on 05/12/2026. The surveyor requested to review the post-move performance verification records. The laboratory provided no documentation for review. 4. In an exit interview with the laboratory director, technical consultant and testing personnel at 1:30 PM on May 12, 2026, the findings were confirmed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of the laboratory's policies and procedures, analyzer calibration verification records, calibrator package inserts, lack of documentation and interview, the laboratory failed to follow their established policy to perform calibration verification for the two Roche Cobas Endocrinology analyzers every six months during the twenty-three (23) months reviewed from June 2024 through May 12, 2026. The findings include: 1. During a tour of the laboratory on May 12, 2026 at 9:00 AM, the surveyor noted two Roche Cobas Endocrinology Analyzers (serial numbers SN 1122-08 and 1122-11) in use for Estradiol (E2), Progesterone (P4), Luteinizing Hormone (LH), and Beta Human Chorionic Gonadotropin (BHCG) patient testing. 2. Review of the laboratory's policies and procedures revealed a Quality Management Policy with the statement, "15. Calibration Verification, 15.1 Calibration verification (analytical measurement range verification/linearity) will be performed at six-month intervals if calibration does not -- 2 of 3 -- span a sufficient part of the linear range with at least three calibrators." 3. Review of the Roche Cobas calibrator material package inserts revealed the following analytes with two or less routine calibrators: E2, P4, LH and BHCG. 4. Review of the laboratory's Roche Cobas calibration verification records from June 2024 through May 12, 2026 revealed calibration verification were performed for the analyzers (SN 1122-08 and 1122-11) for analytes E2, P4, LH and BHCG in 09/2024, 04/2025 and 04 /2026. The surveyor requested to review E2, P4, LH and BHCG calibration verification documentation performed in the timeframe of 10/2025. The laboratory provided no further documentation for review. 4. In an exit interview with the laboratory director, technical consultant and testing personnel at 1:30 PM on May 12, 2026, the findings were confirmed. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), available testing personnel (TP) records, laboratory policies and procedures, lack of documentation, and interviews, the laboratory director failed to ensure the performance of annual competency assessments as defined in the laboratory's policy for two of three TP in calendar year 2025. The findings include: 1. Review of the CMS-209 form and an interview with the Technical Consultant (TC) on May 12, 2026, at 9:30 AM revealed three Testing Personnel (TP #1-3) performed moderate complexity patient testing in the specialty of Endocrinology hematology in the calendar year 2025. 2. Review of available TP competency records revealed a lack of documentation of annual competency assessments for TP 2 and 3 in calendar year 2025. 3. Review of the laboratory's "Quality Management" policy revealed the following statements, "7.4 Competency Evaluations of Personnel, 7.4.1 A competency evaluation must be performed for each test a person performs. Evaluations will be performed six months after initial training is completed, and annually thereafter." 4. In an exit interview with the laboratory director, technical consultant and testing personnel at 1:30 PM on May 12, 2026, the findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An off-site CLIA proficiency testing (PT) desk review was conducted for GIVFF, LLC on October 1, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The survey concluded with an interview with the Technical Supervisor on October 1, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 CFR. 493.803 Condition: Successful Participation D6000 - 42 CFR. 493.1403 Condition: Laboratories performing moderate complexity testing- Laboratory Director 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: 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 a review of the Certification and Survey Provider Enhanced Reporting (CASPER 0155) report, the laboratory's proficiency testing (PT) records and interview, the laboratory failed to successfully participate in the Thyroid Stimulating Hormone (TSH) analyte for two consecutive PT testing events. The laboratory had unsatisfactory TSH scores for the first and second events of calendar year 2025. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in 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 a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, College of American Pathologists (CAP) PT records, and interview, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for Thyroid Stimulating Hormone (TSH) for two consecutive Endocrinology events in calendar year 2025 resulting in an initial unsuccessful PT performance as reviewed on the date of the inquiry on October 1, 2025. The findings include: 1. Review of the CASPER 0155 report revealed the following results: Chemistry 2025 - 1st Event - unsatisfactory score of 0% for analyte 0585 TSH; Chemistry 2025 - 2nd Event - unsatisfactory score of 0% for analyte 0585 TSH. 2. Desk review of the CAP 2025 PT records outlined above revealed unsatisfactory TSH scores of less than 80% for the following 2 consecutive Endocrinology events: 2025 CAP Event A: TSH scored 0% 2025 CAP Event B: TSH scored 0% resulting in an initial unsuccessful PT performance noted by CAP. 3. In an interview with the Technical Supervisor on October 1, 2025 at 11:00 AM, the above findings were confirmed. 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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER 0155) report, the laboratory's 2025 proficiency testing (PT) records and interview, the laboratory director (LD) failed to provide overall management and ensure the overall quality of the laboratory services provided. Refer to 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER 0155) report, the laboratory's 2025 proficiency testing (PT) records, and interview, the laboratory director (LD) failed to ensure the overall quality of the laboratory services provided. The LD failed to ensure successful participation in their Health and Human Services (HHS) approved PT program. Refer to D2107. -- 3 of 3 --