Massey Fertility Services, Llc

Summary Statement of Deficiencies D0000 Based on a CLIA recertification survey performed on December 3, 2020, this facility was found to not be in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. 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 proficiency test (PT) document review and staff interview, the testing personnel (TP) failed to attest to the routine integration of the PT samples into the patient workload as required. Findings include: See D2009 for details. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on proficiency test (PT) document review and staff interview, the testing personnel (TP) failed to attest to the routine integration of the PT samples into the patient workload as required. Findings include: 1. Review of American Proficiency Institute (API) PT documents revealed Staff #2 (CMS 209) failed to sign the 2020 Core Chemistry attestation statement for Event Three. 2. An interview with Staff #2 (CMS 209) confirmed the aforementioned TP did not sign the 2020 Core Chemistry attestation statement for Event 3. REPEAT DEFICIENCY D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to maintain a copy of PT program documents as required. Findings include: 1. Review of American Proficiency Institute (API) PT forms revealed there were no PT documents available at the time of survey for the following: 2019 Event 2 and 2020 Event 2 -- Hematology/Coagulation. 2 An interview with Staff #2 (CMS 209) in the breakroom on 12/3/2020 at approximately 2:00 p.m. confirmed the aforementioned missing PT documents at the time of survey. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 19, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency test (PT) records and interview with the laboratory testing person (TP) , the lab director (LD) and the testing person failed to attest that PT samples were tested in the same manner as patient specimens. Findings include: 1. Review of the 2017 PT documents revealed the LD failed to sign 3 of 3 attestation statements for the specialty of Chemistry and 1 of 3 attestation statements (1st event) for the specialty of Hematology. 2. Review of the 2017 PT documents revealed the TP failed to sign the Hematology testing event # 1. 3. Interview with the TP (CMS 209 form) on 7/19/18 at approximately 1 PM in the front office confirmed the aforementioned missing signatures. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. 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 observation and staff interview, the laboratory director (LD) failed to provide a flame resistant cabinet or container for reagent storage. Findings include: 1. Observation during the lab tour at approximately 10:15 AM revealed the storage of Methyl Alcohol ( lot#8024 Exp. 1/24/20) under the sink cabinet, not contained in a flame resistant cabinet or container. 2. Interview with the TP (CMS 209 form) on 7/19 /18 at approximately 10:15 AM in the lab confirmed the lack of a flame resistant cabinet or container. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require