Cancer Care Associates Of York

Summary Statement of Deficiencies D0000 An initial survey was conducted by the Pennsylvania State Agency at Cancer Care Associates of York on 11/14/2025. The laboratory was found out of compliance with the following condition: 493.1250 Condition: Analytic Systems. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Technical Consultant (TC), the laboratory failed to verify twice annually the accuracy of 1 of 1 chemistry test (Vitamin D 25-OH) performed from 4/28/2025 to 11/14/2025. Findings include: 1. On the day of survey, 11/14/2025 at 11:12 am, the laboratory could not provide documentation for the verification of accuracy performed at least twice annually for 1 of 1 chemistry test (Vitamin D 25-OH) performed from 4/28/2025 to 11/14/2025. 2. The TC revealed during interview, 11/14/2025, the laboratory performed 147 Vitamin D 25-OH tests from 4/28/2025 to 9/30/2025. 3. The TC (CMS 209 personnel #2, dated 11/06/2025) confirmed the findings above on 11/14/2025 at 1:30 pm. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing 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 5 -- This CONDITION is not met as evidenced by: Based on observation of the laboratory, lack of documentation and interview with the Technical Consultant (TC), the laboratory failed to meet applicable analytic systems requirements in 493.1251, 493.1252 and 493.1254 for 21 of 21 months from 1/25 /2024 to date of survey. Refer to D5407, D5413 and D5429. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's Chemistry procedure manuals, lack of documentation, and interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to ensure an approved policy for the Vitros 3400 chemistry analyzer and AIA Tosoh chemistry analyzer were available to all personnel from 1/25 /2024 to 11/14/2025. Findings include: 1. On the date of survey, 11/14/2025 at 12:04 pm, the LD failed to provide an approved policy for the Vitros 3400 chemistry analyzer and AIA Tosoh chemistry analyzer used for testing from 1/25/2024 to 11/14 /2025. 2. The TC (CMS 209 personnel #2, dated 11/06/2025) confirmed the findings above on 11/14/2025 at 1:30 pm. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory temperature records and interview with the Technical Consultant (TC), the laboratory failed to monitor freezer temperatures to ensure acceptable reagent storage temperatures were maintained for 21 of 21 months from 01/25/2024 to date of survey. Findings include: 1. On the day of survey, 11/14/2025 at 12:29 pm, during the tour of the laboratory, the surveyor observed the following reagents stored in the laboratory freezer: - Bio-Rad Liquichek Tumor Marker Control. Storage requirements -20C to -70C. - Vitros Na slides. Storage requirements less than or equal to -18C. - Vitros Mg slides. Storage requirements less than or equal to -18C. - Vitros Glu slides. Storage requirements less than or equal to -18C. - Vitros UREA & CREA slides. Storage requirements less than or equal to -18C. - Vitros FE slides. Storage requirements less than or equal to -18C. - Vitros LDHI slides. Storage requirements less than or equal to -18C. - Vitros Calibrator Kit 1. Storage requirements less than or equal to -18C. - Vitros -- 2 of 5 -- Performance Verifier II. Storage requirements less than or equal to -18C. - Vitros Calibrator Kit 4. Storage requirements less than or equal to -18C. 2. Review of the laboratory's temperature records revealed the laboratory's established freezer temperature range (less than or equal to -10 C) failed to ensure acceptable reagent storage temperatures were maintained for 21 of 21 months from 1/25/2024 to 11/14 /2025. 3. The TC (CMS 209 personnel #2, dated 11/06/2025) confirmed the findings above on 11/14/2025 at 1:30 pm. Repeat deficiency** D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory's verification of performance specifications records, lack of documentation, and interview with the Technical Consultant (TC), the laboratory failed to verify the required performance specifications for chemistry testing performed on 1 of 1 Tosoh chemistry analyzer and 2 of 2 Sysmex XN -530 hematology analyzers before reporting patient test results from 10/15/2024 to date of survey. Findings include: 1. On the day of the survey, 11/14/2025, at 11:22 am, review of the laboratory's verification of performance specifications records revealed the laboratory failed to perform a reference range/normal value study appropriate for the laboratory's patient population before reporting patient test results on the following chemistry and hematology analyzers from 10/15/2024 to 11/14/2025: - 1 of 1 AIA Tosoh chemistry analyzer (S/N 11813906) - 2 of 2 Sysmex XN-530 hematology analyzers (S/N 12566 and 12430). 2. The laboratory could not provide a policy that included the laboratory's criteria to ensure a reference range/normal value study was appropriate for the laboratory's patient population. 3. The TC revealed during interview, 11/14/2025, the laboratory performed 14,366 tests on the AIA Tosoh chemistry analyzer and 249,940 hematology tests on the Sysmex XN-530 hematology analyzers from 4/28/2025 to 9/30/2025. 4. The TC (CMS 209 personnel #2, dated 11/06/2025) confirmed the findings above on 11/14/2025 at 1:30 pm. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on lack of documentation, and interview with the Technical Consultant (TC), the laboratory failed to ensure maintenance/function checks were performed as defined by the manufacturer for 1 of 3 pipettes used for Chemistry testing in the laboratory from 1/25/2024 to 11/14/2025. Findings include: 1. On the day of the survey, 11/14/2025 at 12:15 pm, the laboratory failed to provide documentation of -- 3 of 5 -- maintenance/function checks performed for the following 1 of 3 pipettes used from 1 /25/2024 to 11/14/2025: - Pipette RU24480, Calibration due date 08/2024. 2. The TC (CMS 209 personnel #2, dated 11/06/2025) confirmed the findings above on 11/14 /2025 at 1:30 pm. B. Based on lack of documentation, and interview with the Technical Consultant (TC), the laboratory failed to ensure maintenance/function checks were performed as defined by the manufacturer for 3 of 3 traceable thermometers used to ensure acceptable reagent storage temperatures were maintained in the laboratory from 1/25/2024 to 11/14/2025. Findings include: 1. The laboratory failed to provide documentation of maintenance/function checks performed for the following 3 of 3 traceable thermometers used to monitor temperatures in the laboratory from 1/25/2024 to 11/14/2025: - McKesson freezer thermometer S/N 45753, Calibration due date 12/06/2024. - Traceable refrigerator thermometer "A", Calibration due date 02/2025. - Traceable room temperature thermometer "B", Calibration due date 02/2025. 2. The TC (CMS 209 personnel #2, dated 11/06/2025) confirmed the findings above on 11/14/2025 at 1:30 pm. Repeat deficiency** 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. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the Technical Consultant (TC), the laboratory failed to evaluate twice a year the relationship between test results using different instruments for 2 of 2 Sysmex XN-530 hematology analyzers used to perform complete blood cell count (CBC) examinations in 2025. Findings include: 1. On the day of the survey, 11/14/2025 at 11:35 am, the laboratory failed to provide documentation for the comparison of test results (CBC) between 2 of 2 Sysmex XN-530 hematology analyzers (S/N 12566 and S/N 12430) used to perform CBC examinations in 2025. 2. The TC (CMS 209 personnel #2, dated 11/06/2025) confirmed the findings above on 11/14/2025 at 1:30 pm. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Technical Consultant (TC), the TC failed to assess the competency of 1 of 27 Testing Personnel (TP) that performed chemistry testing in 2024. Findings include: 1. On the day of survey, 11/24 /2025 at 10:07 am, the laboratory failed to provide annual competency assessment records for 1 of 27 TP (CMS 209 TP#2, dated 11/06/2025) that performed chemistry testing in 2024. 2. The laboratory performed 340,618 chemistry examinations in 2024 (CMS 116, estimated annual volume, dated 11/05/2025). 3. The TC (CMS 209 -- 4 of 5 -- personnel #2, dated 11/06/2025) confirmed the findings above on 11/14/2025 at 1:30 pm. Repeat deficiency** -- 5 of 5 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 review of the American Association of Bioanalysts- Medical Laboratory Evaluation AAB-MLE) proficiency testing (PT) records, lack of documentation, and interview with the technical consultant (TC), the laboratory director (LD)/designee and testing personnel (TP) failed to sign 6 of 6 AAB-MLE PT attestation statements for chemistry and hematology testing performed in 2023. 1. The AAB-MLE PT instructions state, "be sure to keep the attestation statements printed from your online reporting form. We do not require this for grading. The attestation statements must be signed for each analyte by the analyst performing the procedure and kept in your files for inspection purposes. In addition to the analyts' signatures, the director or the director's designee must sign only once for each reporting form." 2. On the day of the survey, 01/25/2024 at 11:00 am, the laboratory failed to provide attestation statements signed by the LD/designee and TP for the following 6 of 6 AAB-MLE events in 2023 for hematology and chemistry testing: - Chemistry M1 - Chemistry M2 - Chemistry M3 - Nonchemistry M1 - Nonchemistry M2 - Nonchemistry M3. 3. The TC confirmed the findings above on 01/25/2024 at 01:30 pm. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, operator manuals, and interview with the technical consultant (TC), the laboratory failed to have a complete written procedure manual for chemistry testing performed on the Ortho Clinical Diagnostics Vitros that met the requirements of 493.1251 from 5/12/2022 to the date of the survey. Findings include: 1. On the day of the survey, 01/25/2024 at 11:30 am, review of the procedure manuals for chemistry testing revealed the operators manual was used when performing chemistry testing on the Ortho Clinical Diagnostics Vitros from 05 /12/2022 to 01/25/2024. 2. Review of the operators manual revealed that the test system instructions used failed to include the following requirements of 493.1251: - 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 - Step by step performance of the procedure including test calculations and interpretation of results - Preparation of slides, solution, calibrators, controls, reagents, stains, and other material used in testing. - Control procedures - Calibration and calibration verification procedures. - The reportable range for test results for the test system as established or verified in 493.1253. -

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A. Based on review of the Laboratory's competency policy, competency assessment records and interview with the Technical Consultant (TC), the laboratory failed to establish a competency assessment procedure to assess the competency of 1 of 1 Technical Consultant (TC) (on the CMS 209 form, listed as personnel #2) for their supervisory responsibilities from 01/23/2020 to 05/12/2022. Findings include: 1. On the day of survey, 05/12/2022 at 09:32 am, the TC could not provide a competency assessment policy that reviews how to assess the competency for 1 of 1 TC for their supervisory responsibilities in 2020 and 2021. 2. The TC could not provide competency assessment records for 1 of 1 TC for their supervisory responsibilities. 3. The TC confirmed the findings above on 05/12/2020 around 10:15 a.m. B. Based on review of Laboratory's competency policy and interview with the Technical Consultant (TC), the laboratory failed to establish a competency assessment procedure that includes the six point of CLIA to assess 22 of 22 Testing Personnel (TP) who performed Hematology, Routine Chemistry and Endocrinology examinations from 01 /23/2020 to 05/12/2022 . Findings include: 1. On the day of survey, 05/12/2022 at 09: 32 am, the TC could not provide a competency assessment procedure that includes the six points of CLIA for 22 of 22 TP who performed Complete Blood Count (CBC) (Sysmex analyzer), routine Chemistry (Vitros Ortho Clinical Diagnostic Analyzer), endocrinology (TOSOH), and Serum Human Gonadotropin (Hcg) kit examinations from 01/23/2020 to 05/12/2022. 2. The TC confirmed the findings above on 05/12 /2020 around 11:30 a.m. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the Ortho Clinical diagnostics analyzer validation records and interview with Technical consultant (TC), the laboratory failed to establish criteria for acceptable performance specifications for the Vitros Ortho Clinical diagnostics analyzer Validation used for routine chemistry specimens from November 16, 2020 to May 12, 2022. Findings Include: 1. On the day of survey, 05/12/2022 at 10:34 am, review of the Vitros Ortho Clinical diagnostics Validation records revealed, the validation performed on 11/16/2020 did not include criteria for acceptable precision, accuracy, and reportable range. 2. The laboratory analyzed 30,249 test were analyzed on the Vitros Ortho Clinical diagnostics analyzer. 3. TC confirmed the findings above on 05/12/2022 around 11:30 a.m. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on review of the Vitros Ortho Clinical Diagnostic analyzer validation records and interview with the Technical Consultant (TC), the Laboratory Director failed to approve the performance specifications of precision and accuracy for the chemistry analytes performed on the Vitros Ortho Clinical Diagnostic analyzer used from 11/16 /2020 to 05/12/2022. Finding Include: 1. On the day of survey, 05/12/2022 at 10:31 am. record review revealed that the LD did not approve and review the validation for the Vitros Ortho Clinical Diagnostic performed on 11/16/2020. 2. The TC confirmed the finding above on 05/12/2022 at 11:30 a.m. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory -- 2 of 4 -- director must-- (e)(4)(iv) Ensure that an approved