York Hospital Medical Services

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing reports from the laboratory. The facility was found to be out of compliance with the conditions of the CLIA program. The following: CONDITION and STANDARD level deficiencies were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation proficiency testing D2089- 42 C.F.R. 493.845 Standard: Laboratories performing Moderate Complexity testing: Routine Chemistiry 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 proficiency testing (PT) data report (Casper Report 155D) and 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 -- staff interview, the laboratory failed to successfully participate for the regulated analyte Phosphorus. Refer to D2096. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) (c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the CASPER Proficiency Testing (PT) data report (155), and staff interviews, the laboratory failed to successfully participate in PT for Routine Chemistry. Findings include: 1. Record review on 8/29/2025 of the CASPER 155 report revealed scores of 0% for 2025 PT Event 1 and 2025 PT Event 2 for the analyte Phosphorus. 2. Email correspondence with the laboratory's Director of Compliance on 9/3/2025 confirmed the findings above. 3. The laboratory performs 1,000 tests annually in the specialty of Chemistry. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 record review and staff interview with the Clinical Consultant (CC), the laboratory director (LD) failed to sign the attestation sheet for the College of American Pathologists (CAP) proficiency testing (PT) samples in the specialty of Chemistry. Findings include: 1. Record review on 1/7/2025 of the laboratory's PT attestation sheets for CAP Chemistry survey 1 2024 revealed the LD did not sign the attestation sheet. 2. Record review of tha laboratory PT procedure manual on 1/7/2025 revealed: "The Attestation Statement is sicned by the Laboratory Director or Designee." 2. Staff interview on 1/7/2025 at 10:00am with the CC confirmed the above findings. 3. The laboratory performs 1,000 tests annually in the specialty of Chemistry. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification 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 -- procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

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 review of the proficiency testing (PT) data report (Casper Report 155D) and PT graded results confirmed by the laboratory director the laboratory failed to successfully participate for the regulated analyte Hematology. Refer to D2123. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories 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 -- failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on surveyor review of the CASPER Proficiency Testing (PT) data report 155, CASPER Excused Nonparticipation Report 157, lack of PT records and documentation, and staff interviews, the laboratory failed to participate in a PT program under the specialty of Hematology. Findings include: 1. Record review on 12 /6/2022 of the CASPER 155 report revealed PT scores of 0% for "CELL I.D. OR WBC DIFF" for the following: a. Event 2 2022 0* b. Event 3 2022 0* 3. Staff interview with the laboratory director (LD) on 12/6/2022 at 9:00 AM confirmed the laboratory failed to submit results in PT for 2022 Event 2 and 2022 Event 3 for "CELL I.D. OR WBC DIFF". 4. The laboratory performs 3,678 tests annually in the specialty of hematology. -- 2 of 2 --