Gago Center For Fertility (Lansing)

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 review of laboratory procedure manual, review of competency records for testing personnel and interview with the General Supervisor, the laboratory failed to ensure written competency assessment policies were followed for testing performed in 2022 and 2023. Findings include: 1. Review of laboratory compentency assessments revealed that no documentation of competency assessments were found in 2023 for Testing Personnel #1 and Testing Personnel #2 and in 2022 for Testing Personnel #3. 2. An interview with General Supervisor on 06/04/2024 at 10:17 am, revealed that supporting documentation provided for Testing Personnel #1 for 2023, Testing Personnel #2 and Testing Personnel #3 from an affiliate location, not the laboratory. 3. A review of the laboratory's "Laboratory Personnel Training/Competence Checklist" policy revealed a section stating, "In order to establish and maintain accurate test performance in the Laboratory associated with Gago Center for Fertility all employees that perform laboratory functions are required to prove competency." 4. An interview with General Supervisor on 06/04/2024 at 10:23 am confirmed the competency assessments were not performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(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. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the laboratory failed to indicate the name and address of the laboratory location where the endocrinology testing was performed for 3 (L20-1107, L21-1416, and L22-192) of 14 patients audited. Findings include: 1. A record review for 3 (L20-1107, L21-1416, and L22-192) of 14 patient endocrinology audits revealed that no quality control was performed on those days of patient testing. 2. When queried on 7/21/2022 at 11:15 am, the GS confirmed the specimens had been sent to the main laboratory for testing due to a shortage of testing personnel. 3. A record review for 3 (L20-1107, L21-1416, and L22-192) of 14 patient audits, the endocrinology testing revealed the name and address of the main laboratory was not listed on the patient final laboratory test report. 4. An interview on 7/21/2022 at 11:15 am, the GS confirmed the testing facility name and address was not present on the patient final test report in the laboratory information system. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on record review and interview, the laboratory failed to enroll in a proficiency testing program for four (events 1st-3rd 2017 and 1st event 2018) of four events for the speciality of chemistry endocrinology beta human chorionic gonadotropin (BHcg) testing. Findings include: 1. On August 1, 2018 at 10:35 AM, record review revealed there was no documentation of proficiency testing for four (events 1st-3rd 2017 and 1st event 2018) of four events for the regulated analyte BHcg. 2. During the interview on August 1, 2018 at 10:35 AM, the general supervisor as listed on the CMS-209 confirmed the laboratory was not enrolled in a proficiency testing program for the BHcg testing. 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 2 -- This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to verify the accuracy of testing for 1) the hematology sperm count and motility and 2) the endocrinology estradiol, progesterone, follicle stimulating hormone (FSH), and the lutenizing hormone (LH) for one (2017) of two years of testing. Findings include: 1. On August 2, 2018 at 11:18 AM, record review revealed for one (2017) of two years of testing the laboratory did not have documentation to show the verification of accuracy was completed as least twice annually in 2017 for the hematology and endocrinology testing. 2. On August 2, 2018 at 11:18 AM when queried, the general supervisor as listed on the CMS-209 was not able to provide documentation to show the verification of accuracy was completed at least twice annually in 2017. 3. During the interview on August 2, 2018 at 11:18 AM, the general supervisor confirmed the verification of accuracy for the hematology and endocrinology testing was not performed and documented in 2017. -- 2 of 2 --