Allcare Medical Clinic, Pllc

Summary Statement of Deficiencies D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of

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 the laboratory's proficiency testing (PT) records and staff interview, the laboratory's testing personnel (TP) and technical consultant (TC) failed to sign attestation statements for four of six PT events in 2020 and 2021. The findings include: 1. Review of the TC job description revealed delegation of PT oversight to the TC. 2. Review of the laboratory's 2020 and 2021 Hematology/Coagulation PT attestation statements revealed the following: 2020 event two----Not signed by TP. 2020 event three----Not signed by TP. 2021 event two-----Not signed by the TC; not signed by TP. 2021 event three----Not signed by the TC; not signed by TP. 3. Interview with the TC on 01.19.2022 at 3:30 pm confirmed four of six PT attestation statements were not signed by TP and TC in 2020 and 2021. 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 --

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: The laboratory failed to maintain satisfactory participation in two out of three proficiency testing (PT) events for the automated white blood cell (WBC) differential, resulting in the first unsuccessful PT occurrence for the automated WBC differential. (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 a desk review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2020 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the automated white blood cell (WBC) differential in two out of three PT events, resulting in the first unsuccessful PT occurrence for the automated WBC differential. The findings include: 1) Review of the CMS 155 revealed the following unsatisfactory PT scores for the automated WBC differential: 2020 event one=0% 2020 event three=0% 2) Review of the laboratory's proficiency testing performance evaluation reports revealed the following: 2020 event one: Unacceptable scores for sample numbers HEM-01, HEM-02, HEM-03, HEM-04 and HEM-05 for Granulocyte %, Lymphocytes % and Monocytes/Mids%, resulting in an overall score of 0% for the WBC differential. 2020 event three: WBC differential scored as 0% for "Failure to Participate," resulting in the first unsuccessful PT occurrence for the automated WBC differential. -- 2 of 2 --