York General Health Care Services

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory's list of tests performed, review of 2020 proficiency testing, and interview with general supervisor the laboratory failed to enroll in an approved proficiency testing program for moderate complexity Human Chorionic Gonadotropin (HCG), quantitative serum. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory had a yearly volume of twenty-sixty moderate complexity Human Chorionic Gonadotropin (HCG), quantitative serum tests for 2020. 2. Review of the laboratory's 2020 proficiency testing revealed the laboratory failed to enroll in an approved program for moderate complexity Human Chorionic Gonadotropin (HCG), quantitative serum. 3. Interview with general supervisor on 7/8/2021 at 11:04 AM confirmed the laboratory had not enrolled in an approved program for moderate complexity Human Chorionic Gonadotropin (HCG), quantitative serum for 2020. 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 achieve satisfactory scores for the immunohematolgy analyte Compatibility Testing for the third event 2017 and the second events 2018 (see D2173). This results in the unsuccessful performance in proficiency testing for this analyte. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory 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 -- performance. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing for 2017 and 2018, this laboratory had unsatisfactory performance for the analyte Compatibility Testing for the third event 2017 (score 80%) and the second event 2018 (score 60%). -- 2 of 2 --