Diamond Institute For Infertility & Menopause

Summary Statement of Deficiencies D5789 TEST RECORDS CFR(s): 493.1283(b) Records of patient testing including, if applicable, instrument printouts, must be retained. This STANDARD is not met as evidenced by: Based on surveyor review of Work Records (WR) and interview with the General Supervisor (GS), the laboratory failed to retain WR for Semen Count from 2/10/20 to the date of survey. The finding includes: 1) A review of eight patients WR revealed that one out of eight patients did not have a WR. 2) The GS confirmed on 6/22/21 at 11:00 am that records for all patient testing were not retained. 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 D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the lack of work records and interview with the General Supervisor (GS), the laboratory failed to document semen counts in duplicate from 8/27/17 to the date of survey. The GS confirmed on 8/27/19 at 10:45 am that the laboratory did not document patient semen counts in duplicate. 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 --