Genesis Healthcare Partners Pc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on August 12, 2026, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (2026-1 and 2026-2), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the Prostate-Specific Antigen (PSA) analyte resulting in unsuccessful performances. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for two consecutive events (2026-1 and 2026-2) for the analyte Prostate-Specific Antigen (PSA) (specialty Chemistry): The findings include: 1. PSA 40% - 2026 first testing event; PSA 60% - 2026 second testing event. A review of the 2026 scores from American Proficiency Institute (API) confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and American Proficiency Institute (API) records for 2026-1 and 2026-2 events, the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful participation of the proficiency testing. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and American Proficiency Institute (API) records for 2026-1 and 2026-2 events, the laboratory director failed to ensure successful proficiency testing participation as required in this subpart. Refer to D2096. -- 2 of 2 --

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 Surveyor review of laboratory's patients tests records, proficiency testing records and interview with the laboratory director on October 31, 2025, at 12:10 p.m., the laboratory failed to enroll in the proficiency testing for chemistry. The findings include: 1. The laboratory used Fastpack system to test for PSA and testosterone. The laboratory participated in the API proficiency testing for the year 2023 and 2024. However, it did not enroll proficiency testing program for the year 2025. Therefore, the accuracy of the patients' test results rendered by the laboratory cannot be assured and may have harmed patient. 2. The laboratory director on October 31, 2025, at 12: 10 p.m., affirmed that the laboratory did not enroll into the proficiency program due to non-payment to the program. 3. The laboratory's testing declaration form, signed by the laboratory director on 10/31/2025, stated that the laboratory performed approximately 1,575 PSA and testosterone tests, annually. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing 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 -- program for the testing performed and that-- This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory patients' tests, proficiency testing records and interview with the laboratory director on October 31, 2025, at 12:10 p.m., the laboratory director failed to ensure that the laboratory enrolled into a proficiency testing program. The findings include: See D2000. -- 2 of 2 --