Our Town Family Care, Llc

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 Services) CASPER reports and API (American Proficiency Institute) proficiency testing records, the surveyor determined the laboratory failed White Blood Cell (WBC) Differential testing for two consecutive testing events, Event #3, 2020 and Event #1, 2021. These failures resulted in an initial unsuccessful proficiency testing participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored sixty percent (60 %) for the WBC Differential for Event #3, 2020 [forty percent (40 %) for Granulocytes and Monocytes], and 67 % for Event #1, 2021 [60 % for Granulocytes and Monocytes]. These two consecutive failures resulted in an 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 -- initial unsuccessful proficiency testing participation. 2. A review of the API proficiency testing evaluations confirmed the above noted findings. 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 CASPER reports and API (American Proficiency Institute) proficiency testing records, the surveyor determined the laboratory failed to successfully perform in White Blood Cell (WBC) Differential testing for two consecutive testing events, Event #3, 2020 and Event #1, 2021. These failures resulted in an initial unsuccessful proficiency testing participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored sixty percent (60 %) for the WBC Differential for Event #3, 2020 [forty percent (40 %) for Granulocytes and Monocytes], and 67 % for Event #1, 2021 [60 % for Granulocytes and Monocytes]. These two consecutive failures resulted in an initial unsuccessful proficiency testing participation. 2. A review of the API proficiency testing evaluations confirmed the above noted findings -- 2 of 2 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of calibration records, a review of operations manual, and an interview with test personnel (TP) #1 and the office manager, the laboratory failed to perform and document calibrations on the Emerald Cell-Dyn at least once every six months, as required by the laboratory's policy, between March 2018 to March 2019. This affected one of five opportunities to perform the calibration. The findings include: 1) A review of the calibration records in March for the Cell-Dyn Hematology analyzer revealed data from one calibration performed on March 6, 2018 and the next was performed on June 10, 2019. The laboratory did not perform a calibration for a whole year. 2) During an interview on 11/04/2020 at 2:25 PM, when asked what was the calibration policy for the Emerald, TP#1 and the office manager stated it should be done every six months. At this time, the surveyor and the laboratory staff reviewed the operator's manual, which indicated the calibration should be performed every six months. The surveyor asked TP#1, why a calibration was not performed for a whole year between 3/06/2018 to 6/10/2019, TP#1 stated she was not sure, because she was not there at the time it occurred. 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 -- D5781

Summary Statement of Deficiencies D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the 2016-2017 American Proficiency Institute (API) proficiency testing records and an interview with the Clinical Consultant (CC), the laboratory director failed to ensure one of three proficiency testing events in 2017 was submitted to the proficiency testing program within the established timeframe. This affected one of six proficiency testing surveys reviewed. The findings include: 1. A review of the results from the 2017-Event #2 Hematology survey revealed a score of 0 % (percent) due to a failure to participate. 2. In an interview conducted on 3/27/2018 at 10:30 AM, the CC stated he and the Laboratory Director had entered the results together on the API website, however they failed to print a transmission worksheet for the 2017- Event #3 survey. The surveyor then asked why did the laboratory received a score of 0% if they submitted the results. The CC stated he did not know why the PT provider had not received their results, and the Laboratory Director had not realized there was a problem with the submission until they received the evaluation with a score of 0% from API. Thus the above noted findings were confirmed. Jeremy Westry, BS, MT (ASCP) Licensure and Certification Surveyor 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 --