Associated Medical Specialists, Pa Dba

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 06/06/2023 and concluded on 06/06/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation, laboratory policy review, and interview, the laboratory failed to have a system to evaluate the relationship between test results gathered from 2 of 2 hematology analyzers operated at the laboratory to ensure each analyzer produced consistent results. Findings included: A review of a laboratory policy titled, "Hematology Analyzer Procedure," reviewed and signed by the Laboratory Director (LD) on 09/26/2022, revealed there was not a written procedure for the required twice- yearly evaluation of test results between the two hematology analyzers. During a tour of the laboratory on 06/06/2023 at 9:00 AM, the surveyor observed two complete blood count (CBC) analyzers in use. In an interview on 06/07/2023 at 2:30 PM, the Technical Consultant/Clinical Team Coordinator stated the required twice-yearly evaluations had not been performed. 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: During an proficiency testing desk review performed on 03/03/2022, based on review of CASPER report 155D and graded reports from American Proficiency Institute (API), it was determined that the laboratory failed to successfully participate in proficiency testing for the specialty of hematology, the analyte WBC Diff, red blood cell count (RBC), hemoglobin (Hgb), hematocrit (Hct), white blood cell count (WBC), and platelet (Plt) for two consecutive proficiency testing events reviewed (2020, Event 2 and 2021, Event 1). See D2121 and D2130. D2121 HEMATOLOGY 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 -- CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: During a proficiency testing desk review performed on 03/03/2022, based on review of the CASPER report 155D and laboratory proficiency testing records (graded copies from API), it was determined that the laboratory failed to attain a score of at least 80 percent in proficiency testing for the specialty of hematology, the analyte WBC Diff, red blood cell count (RBC), hemoglobin (Hgb), hematocrit (Hct), white blood cell count (WBC), and platelet (Plt) for two consecutive proficiency testing events reviewed (2020, Event 2 and 2021, Event 1). The findings include: 1. Review of CASPER report 155D revealed the following RBC proficiency scores for your laboratory: a. 2020, Event 2: Hematology: 0%, WBC Diff: 0%, RBC: 0%, Hgb: 0%, Hct: 0%, WBC: 0% and Plt: 0%. b. 2021, Event 1: Hematology: 0%, WBC Diff: 0%, RBC: 0%, Hgb: 0%, Hct: 0%, WBC: 0% and Plt: 0%. 2. The scores were confirmed upon review of the graded API results. Scores less than 80% for these analytes indicate failure or unsatisfactory performance. A failure of the analytes for two consecutive or two out of three testing events is scored as unsuccessful. A failure of the analyte for three consecutive or three out of four/five events is scored as a repeat unsuccessful. 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: During the proficiency test desk review performed on 03/03/2022, based on review of CASPER report 155D and graded API results, it was determined that the laboratory failed to achieve satisfactory performance forthe specialty of hematology, the analyte WBC Diff, red blood cell count (RBC), hemoglobin (Hgb), hematocrit (Hct), white blood cell count (WBC), and platelet (Plt) for two consecutive proficiency testing events reviewed (2020, Event 2 and 2021, Event 1), resulting in unsuccessful proficiency testing performance. See D2121. -- 2 of 2 --