105 CMR, § 301.035 - Quality Assurance and Case Ascertainment

(A) For the purpose of assuring the accuracy and completeness of submitted data and to ensure that all cases of malignant disease and benign brain-related tumor disease are reported, each health care facility and health care provider shall allow authorized Cancer Registry staff or agents to inspect and copy such parts of patients' medical records, paper and electronic, as are necessary to assure accurate and complete reporting and to identify any missing required reports.

(B) Each health care facility, health care provider, and pharmacist licensed in accordance with M.G.L. c. 112, § 24, shall provide copies of the following records to the Cancer Registry upon request:

(1) Reports of all tissue analyses which have been performed for the purpose of determining the presence or absence of malignant disease and benign brain-related tumor disease;

(2) Reports (including X-rays) of radiological examinations performed for the purpose of determining the presence or absence of malignant disease and benign brain-related tumor disease;

(3) Reports of diagnoses of malignant disease and benign brain-related tumor disease, and notations of the reasons for such diagnoses, including both primary clinicians' reports and consultation reports;

(4) Pharmacy records for prescriptions relating to cancer treatment; and

(5) Those portions of medical records which contain the specific information required to be reported pursuant to 105 CMR 301.015.

(C) No health care facility nor health care provider shall be required by 105 CMR 301.035 to provide to the Cancer Registry any part of any patient's medical record other than those parts listed in 105 CMR 301.035(B)(1). A health care facility or health care provider may provide the Cancer Registry with copies of medical records from which parts other than those specified in 105 CMR 301.035(B)(1), have been deleted, masked, crossed out, or otherwise rendered illegible.

(D) Eachcopy of a medical record or part thereof obtained by the Cancer Registry pursuant to 105 CMR 301.035:

(1) Shall not be re-copied by the Cancer Registry;

(2) Shall be kept in a secure area with restricted access when not being used by the Cancer Registry;

(3) Shall be examined only by the Cancer Registry;

(4) Shall be destroyed promptly following verification of the corresponding reported data, or, if the reported data appears to be inaccurate, following clarification or correction of the reported data.

Notes

105 CMR, § 301.035

Amended by Mass Register Issue 1462, eff. 2/4/2022.