Derbala Institute For Reproductive Immunology

Summary Statement of Deficiencies 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 record review and interview with the Technical Supervisor (TS) and General Supervisor (GS), the laboratory failed to follow its established competency assessment process to ensure competency policy was assessed and documented annually for 1 (TP1) of 5 testing personnel reviewed (TP1). Findings include: 1. Review of the CMS-209 form identified TP1 as Testing Personnel for high- complexity testing. 2. Review of the laboratory's Competency Assessment form revealed that competency re-evaluation is to be "performed after one year post-hire and annually thereafter." 3. Record review of competency assessment documentation for TP1 revealed competency assessments dated March 11, 2024, September 15, 2024, and March 17, 2025. Documentation of a competency assessment for TP1 for 2026 was requested; none was provided. 4. During an interview on September 10, 2026, at 4:15 PM, the TS and GS confirmed that a competency assessment had not been completed for TP1 in 2026. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) 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 -- Humidity. (b)(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 observation and interview with the Technical Supervisor (TS) and General Supervisor (GS), the laboratory failed to ensure 3 of 4 temperature-monitoring devices were calibrated. Findings include: 1. During a tour of the laboratory on September 10, 2026, at 10:25 AM, the surveyor observed three temperature-monitoring devices with expired calibration dates: a. In the Main Laboratory, a Traceable brand thermometer used to monitor the Panasonic refrigerator had a calibration due date of March 13, 2026. b. In the Main Laboratory, a Traceable brand thermometer used to monitor room temperatures had a calibration due date of March 13, 2026. c. In the Culture Room, a Traceable brand temperature-monitoring device used with the water bath had a calibration expiration date of February 2026. 2. During interviews on September 10, 2026, at 11:06 AM, the TS and GS confirmed the expired calibrations for the temperature-monitoring devices. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review, observations, and interviews, the laboratory failed to establish procedures to include specimen transportation (refer to D5403 A), failed to establish control procedures to include the laboratory's process for assessing staining control reactivity for flow cytometry testing using the BD FACSLyric instrumentation (refer to D5403 B), failed to establish procedures to include reference intervals for its immunophenotyping and natural killer cells functional assays (D5403 C), failed to ensure blood collection tubes had not exceeded expiration dates (refer to D5417), failed to establish performance specifications for its flow cytometry testing to include reference intervals (refer to D5423 A), failed to establish performance specifications for its flow cytometry testing to include the use of the Countess 3 automated cell counting system (refer to D5423 B), failed to establish accuracy and precision performance specifications for its flow cytometry testing (refer to D5423 C), failed to establish flow cytometry testing analytical specificity performance specifications including interfering substances for antibody cross reactivity (refer to D5423 D), and failed to perform and document positive and negative reactivity for its flow cytometry testing each time of use (refer to D5475). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 -- (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)