Gago Center For Fertility

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation and interview with the general supervisor, the laboratory failed to ensure blood specimen collection tubes had not exceeded expiration dates for 90 of 106 total tubes in the phlebotomy room. Findings include: 1. The surveyor observed the following blood specimen collection tubes that had exceeded manufacturer expiration dates in the phlebotomy room on 8/12/25 at 12:58 pm: a. Nine green-top sodium heparin tubes with the expiration date of 3/31/22. b. Two serum red-top tubes with the expiration date of 3/31/25. c. 72 sodium citrate blue-top tubes with the expiration date of 9/30/24. d. Seven sodium citrate blue-top tubes with the expiration date of 12/31/24. 2. An interview on 8/12/25 at 12:58 pm with the general supervisor confirmed the tubes above had exceeded expiration dates. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the general supervisor, the laboratory failed to include the name and address of the laboratory performing sperm morphology testing for seven (Patients 1-7) of seven patient test reports reviewed. Findings include: 1. A review of the laboratory's test menu revealed the laboratory performs only sperm count and motility testing. 2. A review of patient test reports revealed all patients included results for "SPERM MORPHOLOGY KRUGER": a. Patient #1 had semen analysis performed on 07/31/25. b. Patient #2 had semen analysis performed on 04/17/25. c. Patient #3 had semen analysis performed on 11/21 /24. d. Patient #4 had semen analysis performed on 09/05/24. e. Patient #5 had semen analysis performed on 04/11/24. f. Patient #6 had semen analysis performed on 02/15 /24. g. Patient #7 had semen analysis performed on 10/05/23. 3. An interview on 8/12 /25 at 1:52 pm with the general supervisor revealed the laboratory sends its semen specimens to another laboratory for the morphology testing and confirmed it had not included the name and address of the laboratory reporting those results on the test reports. -- 2 of 2 --

Summary Statement of Deficiencies 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 procedure manual review and interview with the General Supervisor (GS), the Laboratory Director (LD) failed to approve, sign, and date 4 of 4 revised procedures in the "OSHA Manual." Findings include: 1. Review of the "OSHA Manual" revealed for 4 of 4 revised procedures, the LD did not approve, sign, and date the revisions for the following: a. Hazard Communication Program b. Exposure Control Plan c. Fire Prevention d. Emergency Action Plan 2. During the interview on 01/18/2022 at 10:02 am, the GS confirmed the LD did not approve, sign, and date the revised procedures from 7/27/2021. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the General Supervisor (GS), the laboratory failed to perform and document the function checks as required for the refrigerator and incubator for 2 months (February and June 2020) of 24 months reviewed. Findings include: 1. A record review revealed lack of documentation of the 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 -- refrigerator and incubator temperatures as follows: a. February 2020 - lack of documentation for the month i. Patient testing on 2/06/20, 2/13/20, and 2/27/2020 b. June - lack of documentation for the month i. Patient testing on 6/11/2020 2. An interview on 1/18/2022 at 11:07 am, the GS confirmed there was no documentation for the 2 months listed above. -- 2 of 2 --