Reproductive Medicine Associates

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to evaluate coded results obtained from the American Association of Bioanalysts (AAB) for Andrology & Embryology event S2 2020. The findings include: 1. The laboratory did not evaluate Code ? (This score may not truly evaluate performance for this specimen which was not graded because of a lack of participant consensus) response from AAB for the following: a) Antisperm Antibody IgG+IgA sample 7 in Andrology & Embryology events S2 2020 . b) Sperm Cell ID and Sperm Viability sample 8 in Andrology & Embryology event S2 2020. 2. The TP on 9/29/22 at 1:20 pm that the laboratory failed to evaluate the above mentioned coded results. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with 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 -- the Testing Personnel (TP), the laboratory failed to verify the accuracy of Andrology & Embryology test results obtained from the American Association of Bioanalysts (AAB) for the S2 2020 event. The findings include: 1. The laboratory received a 100 but results were not graded. 2. There was no documented evidence the laboratory verified: a. Antisperm Antibody IgG+IgA b. Sperm Cell ID 3. The TP confirmed on 9 /29/22 at 1:20 pm accuracy of the PT results were not verified D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Staining Station and interview with the Testing Personnel (TP), the laboratory failed to label all Coplin staining jars used for Semen Morphology testing from 7/31/19 to the date of the survey. The TP confirmed on 9/29 /22 at 2:00 pm that all staining jars were not labeled. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 surveyor observation of Semen Morphology reagents and interview with the Testing Personnel (TP), the laboratory used expired Semen Morphology reagent from 8/9/22 to the date of survey. The findings include: 1. Hem 3 Stat Pack received 4/13 /21 expired 8/9/22. 2. Approximately 84 patients were tested with the expired reagent. 3. The TP confirmed on 9/29/22 at 1:30 PM that the laboratory used expired reagent. -- 2 of 2 --

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of the Final Report and interview with the Testing Personnel (TP), the laboratory failed to ensure that quality systems for the postanalytic phase of Hematology testing were monitored from 8/7/17 to the date of the survey. 1. The laboratory did not ensure positive patient identification. Cross Refer D 5805. 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 surveyor review of the Competency Assessment (CA) records, review of the personnel files and interview with the Testing Personnel (TP), the laboratory failed to perform a CA on the Technical Supervisor (TS) in the calendar year 2017 and 2018. The TP #1 listed on CMS form 209 confirmed on 7/31/19 at 10:00 am that a CA was not performed on the TS. D5789 TEST RECORDS 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 -- 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 the Test Records (TR) and interview with the Testing Personnel (TP), the laboratory failed to retain the number of White Blood Cells (WBC) counted used in the calculation of the WBC percentage for Semen tests from 8 /2/17 to the date of survey. The TP #1 listed on CMS form 209 confirmed on 7/31/19 at 11:00 am that records of all patient testing were not retained. 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 surveyor review of Final Reports (FR) and interview with the Testing Personnel (TP), the laboratory failed to ensure the FR included the requirements for positive patient Identification (ID) from March 2019 to the date of the survey. The finding includes: 1. A review of ten FR revealed that eight of ten patients' name, date of birth and last 4 digits of the social security number were not from the patient who provided the sample. 2. This was a repeat citation on which The