105 CMR 302.050
Medical Records Abstraction
(A) Qualifications and Training. Abstractors shall have the qualifications and training, as
determined by the Commissioner, to accurately review and abstract records for the Congenital
Anomalies Registry and shall maintain confidentiality at all times. Individuals selected as
abstractors shall meet the minimum qualifications as defined by the Commissioner.
(B) Purpose. When a physician or his or her agent has made a report to the Congenital
Anomalies Registry but has not provided complete information that the commissioner requires
for reporting, trained abstractors shall be given access to those parts of a medical record as are
necessary to obtain information required to be reported and to verify the accuracy of reported
information.
(C) Access to Medical Records.
(1) When a reported diagnosis occurs in Massachusetts in the office of a physician or in a
licensed facility with a maternal-newborn service, neonatal intensive care unit, special care
nursery service, continuing care nursery service, pediatric service, pediatric intensive care
unit or with a medical specialty service as defined in 105 CMR 130.020 and when a
physician or his or her agent has not provided complete information that the Commissioner
requires for reporting, abstractors shall be given access to those parts of the medical record
which are necessary to obtain information required to be reported and to verify the accuracy
of reported information. Abstractors shall provide advance notice of an intention to inspect
records.
(2) Information from medical records of children and their parents relating to diagnostic
information regarding congenital anomalies diagnosed prenatally, at delivery and three years
of age or younger that is required to be reported to the Department is subject to abstraction
without patient consent.