Mary F Holley Md Pc

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid) CASPER reports and a review of the API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to successfully participate in two consecutive testing events for Hemoglobin (Hematology testing). These failures of Hemoglobin for Event #3, 2019 and Event #1, 2020 resulted in an initial unsuccessful proficiency testing for the laboratory. The findings include: 1. A review of the CASPER reports revealed the laboratory scored sixty percent (60 %) for Hemoglobin for Event #3, 2019 and Event #1, 2020. These consecutive failures of the same analyte constitutes an initial unsuccessful proficiency testing participation. 2. A 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 -- review of the API proficiency testing evaluations for the above mentioned events confirmed the sixty percent scores for the Hemoglobin for Event #3, 2019 and Event #1, 2020. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid) CASPER reports and a review of the API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to perform satisfactorily in Hemoglobin testing for Event #3, 2019 and Event #1, 2020. The laboratory scored sixty percent (60 %) for the two consecutive testing events for Hemoglobin (Hematology testing), resulting in unsuccessful proficiency testing participation. The findings include: Refer to D2016. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on a review of the laboratory's test menu, a review of proficiency testing records, and interviews with the Laboratory Director (LD) and Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure the accuracy in interpretation of vaginal wet preparations and sperm count analyses were performed at least twice annually. This affected the survey review period of 9/28/2016 - 2/20/2019. The findings include: 1. During the entrance tour of the laboratory at 11:00 AM on 2 /20/2019, TP #1 stated sperm counts and vaginal wet preparations were included in the laboratory's test menu, and were considered PPM (Provider Performed Microscopy) procedures. 2. A review of the proficiency testing records revealed the laboratory was enrolled in API (American Proficiency Institute) for 2016, 2017 and 2018. However, a review of proficiency testing records for Event #3, 2016 and three testing events in 2017 and 2018 revealed the above mentioned tests were not included in these records. Note: Because these analytes are considered CLIA non-regulated analytes, the laboratory may choose to verify the accuracy be another means, other than organized proficiency testing participation. 3. On 2/20/2019 at 1:20 - 1:42 PM, the surveyor inquired of TP #1 if the laboratory was enrolled in proficiency testing for vaginal wet preparations and sperm counts or verified the accuracy by some other method. TP #1 replied the laboratory was not enrolled in proficiency testing for these procedures and had not performed accuracy verifications by any other means. 4. At 4: 30 PM on 2/20/2019, the requirements to verify non-regulated analytes at least twice annually was discussed with the Laboratory Directory and TP #1. 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 --