Hematology Oncology Specialists Of Cape Cod Pc

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Regional Cancer Care Associates laboratory on 03/03/2026 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD) on 03/03 /2026, the laboratory failed to indicate on the patient final test report the correct name of the laboratory where the test was performed as evidenced by the following: The surveyor reviewed nine (9) patient final test reports between March 2024 and January 2026 in the Electronic Medical Record (EMR) IKnow Med. The review revealed that the laboratory failed to indicate the correct name of the laboratory where the test was performed for seven (7) out of the nine (9) patient final test reports. The name of the laboratory on the patient's final test reports in the IKnow Med EMR was Hem Onc Specialists Cape Cod. The name of the laboratory on the CLIA certificate as of 09/04 /2024 is Regional Cancer Care Associates. NOTE: The laboratory changed ownership and name on 09/04/2024 but the laboratory did not update the new name of the laboratory in the IKnow Med EMR on the patient 's final test reports. The LD confirmed in an interview on 03/03/2026 at 12:47 P.M. that seven (7) out of nine (9) 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 -- patient final test reports did not indicate the correct name of the laboratory where the test was performed. The laboratory performs approximately 34,500 Hematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)