Ardmore Family Practice, Pa

Summary Statement of Deficiencies D6052 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of personnel records, and interview with the TC (technical consultant) 2/23/23, the TC failed to ensure competency evaluations included an assessment of problem solving skills for 7 of 15 personnel performing moderate complexity testing (TP #1, #2, #3, #4, #5, #6, and the laboratory director). Review of the laboratory's "Competency Evaluations" policy revealed " ... Competency evaluations can be performed by the following methods and documented: 1) Direct observation of each test performed. 2) Blind sample testing of each test - proficiency testing surveys may be used. 3) Quality control review over a period of time for each test performed. 4) Preventive maintenance review. 5) Problem solving skills. 6) Recording of test results and controls. 7) Competency quizzes Failure or any problems identified during competency testing will be addressed either by re-training, additional monitoring, or possibly dismissal. " Review of personnel records revealed TP #1, #2, #3, #4, #5, #6, and the laboratory director were evaluated in September 2022. The competency evaluations were performed using an evaluation form which included a section to document evaluation of problem solving skills, but the section was not completed for any of the 7 personnel. During interview at approximately 10:15 a.m., the TC confirmed that evaluation of problem solving skills was not documented on the competency evaluations. 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: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 4/30/18 and desk review of 2017 API (American Proficiency Institute) proficiency testing results 5/1/18, the laboratory failed to achieve satisfactory performance for WBC (white blood cell) Differential on two of three consecutive testing events, resulting in unsuccessful participation. See the deficiency cited at D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 4/30/18 and desk review of 2017 API (American Proficiency Institute) proficiency testing results 5/1/18, the laboratory failed to achieve satisfactory performance for WBC (white blood cell) Differential on 2 of 3 consecutive testing events. Findings: Review of CMS Casper report 155D and review of 2017 API proficiency testing results revealed: 1. For the 2017 1st hematology testing event, the laboratory provided unacceptable responses for 5 of 5 monocytes % samples and received a score of 67% for WBC Differential. 2. For the 2017 3rd hematology testing event, the laboratory failed to participate and received a score of 0% for WBC Differential. -- 2 of 2 --