Mettetal Family Medicine

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 9/22/2023, the laboratory failed to maintain satisfactory performance in two of two testing events (2023-Event 1 and 2023-Event 2) resulting in unsuccessful participation for WBC DIFFERENTIAL. Refer to D2130 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 -- 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 9 /22/2023, the laboratory has not successfully performed proficiency testing for WBC DIFFERENTIAL in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for WBC DIFFERENTIAL: WBC DIFFERENTIAL: Year 2023- 1st Event 47% Year 2023-2nd Event: 67% -- 2 of 2 --

Summary Statement of Deficiencies D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on interview with testing personnel #1 as listed on the Centers For Medicaid & Medicare Services (CMS) 209 form on the day of survey 3/26/19 at 3:00 pm, review of 2 CBC (complete blood count) final results completed on 3/26/19, 1 patient purple top tube, laboratory labeling policy, and the Medonic M series cumulative daily data report (May 2018 through March 2019), the laboratory failed to establish and follow written policies and procedures to ensure positive identification of the patient specimen from the time of collection through testing and reporting for CBC results. Findings include: 1. Observation of 1 of 1 patient specimen revealed only the patient name was written on the specimen tube. 2. Labeling policy states specimen will be labeled with the patient name, accession number and date. 3. Interview with TP #1 at 3:00 pm on 3/26/19 indicated that TP routinely enter the patient accession number, and patient's name in the Medonic M Series hematology analyzer. 4. Observation of 2 of 2 patient's CBC reports revealed the accession number printed but there was no name on the report. These patient reports were scanned into the patient's chart. 5. Observation of the CBC cumulative reports printed by the TP from the hematology analyzer since 5/2018 revealed that there was no name or accession number by the patient results. (Items printed on the report were: date, time, sequence number, 0000, results) 6. This process does not ensure positive identification of a patient's specimen from the time of collection through reporting of results. 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 --