Reproductive Medicine Associates

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the Accession Log (AL), Test Records (TR) and interview with the Testing Personnel (TP), the laboratory failed to retain male patient TR for Semen Analysis tests from 1/1/20 to the date of the survey. The finding includes: 1. From a random sample of ten male patients found in the AL eight out of ten TR were not available for review. 2. TP stated TR were not filed by the males name. 3. TP stated he was unable to locate the TR without the accompanying female name. 4. TR requested were for a review of the semen analysis results obtained manually with the Makler Chamber. 5. The TP #1 listed on CMS form 209 confirmed on 2/18/20 at 1:40 pm all patient TR were not retained in the patients name. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of Personnel Records (PR) and interview with the Testing 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 -- Personnel (TP), the Laboratory Director failed to ensure that the education record for one of two testing personnel was available on the date of the survey. The TP #1 listed on CMS form 209 confirmed 2/18/20 at 1:30 pm that all education records were not available. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. 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 maintain copies of all PT records for testing performed with the American Associations of Bioanalysts (AAB) in the calendar year 2016. The findings include: 1. There were no work records for PT events in 2016. 2. The laboratory did not have attestation statements for PT events in 2016. 3. The laboratory did not have graded PT results for events in 2016. 4. The TP confirmed on 3/20/18 at 10:00 am that PT records were not maintained. 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 lack of personnel records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to evaluate and document the Competency Assessment (CA) of two out of two TP from 3/15/16 to the date of survey. The TP #1 listed on CMS form 209 confirmed on 3/20/18 at 10:20 am that CA was not performed. D6102 LABORATORY DIRECTOR RESPONSIBILITIES 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): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on lack of Personnel Records (PR) and interview with the Testing Personnel (TP), the Laboratory Director failed to ensure that two of two TP had appropriate education and training documented prior to patient testing from 3/15/16 to the date of survey. The TP #1 listed on CMS form 209 confirmed on 3/20/18 at 10:00 am that education and training was not documented. -- 2 of 2 --