Mccrary Rost Clinic - Gowrie

Summary Statement of Deficiencies 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 (PT) testing records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 9:20 am on 12/14 /2023, the laboratory failed to attest to the routine integration of PT samples in to the patient workload for five out of six PT events from 1/1/2022 - 12/14/2023. The findings include: 1. For 2022 testing event 1, the testing personnel and laboratory director (or designee) failed to sign the hematology/coagulation/urinalysis PT attestation statement. 2. For 2022 testing event 2, the laboratory director (or designee) failed to sign the hematology/coagulation/urinalysis PT attestation statement. 3. For 2022 testing event 3, the laboratory director (or designee) failed to sign the hematology/coagulation/urinalysis PT attestation statement. 4. For 2023 testing event 1, the laboratory director (or designee) failed to sign the hematology/coagulation /urinalysis PT attestation statement. 5. For 2023 testing event 2, the laboratory director (or designee) failed to sign the hematology/coagulation/urinalysis and microbiology PT attestation statements. 6. At the time of the survey, the laboratory did not attest to the routine integration of PT samples by not signing the above PT attestation statements. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on lack of quality assessment audits, review of the Quality Management Plan /Quality Assurance Plan and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 9:51 am on 12/14/23, the laboratory director failed to ensure the laboratory performed twice annual audits for four out of four time periods from 1/1/2022 - 12/13/2023. The findings include: 1. The Quality Management Plan/Quality Assurance Plan stated, ""McCrary-Rost clinic laboratories will be visited twice per year by a hospital lab employee and ensure quality using a quality assurance check off sheet". 2. At the time of the survey, the laboratory did not have documentation of any quality assurance checks. -- 2 of 2 --

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 review of proficiency records and reports, the laboratory failed to successfully participate in a proficiency testing program for the analyte, automated white blood cell differential, for two out of three consecutive testing events: 2022 event 3 and 2023 event 2 (refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) reports and records, the laboratory failed to achieve satisfactory performance for the analyte, automated white blood cell (WBC) differential, for two out of three consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 32% for 2022 testing event 3 and 24% for 2023 testing event 2. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --