130 CMR 423.413
Recordkeeping Requirements
Surgical centers must maintain a medical-record system promoting quality and confidential
patient care in accordance with Massachusetts Department of Public Health regulations at 105
CMR 140.000: Licensure of Clinics. This system must collect and retain data in a comprehensive
and efficient manner and permit the prompt retrieval of information. Accurate and complete
medical records must be maintained for each member receiving surgical services from the surgical
center. The data maintained in the member’s medical record must also be sufficient to justify any
further diagnostic procedures, treatments, recommendations for return visits, and referrals. The
medical record must be clear and legible, and readily accessible to health care practitioners and the
MassHealth agency. The medical record must be maintained by the surgical center for six years.
(A) Documentation. Payment for any service covered by MassHealth is conditioned upon its full
and complete documentation in the member’s medical record. Payment for maintaining the
member’s medical record is included in the fee for the facility component. Each medical record
must contain sufficient information to fully document the nature, extent, quality, and necessity of
the care furnished to the member for each date of service claimed for payment. If the information
in the member’s record is not sufficient to document the service for which payment is claimed by
the provider, the MassHealth agency will not pay for the service or, if payment has been made,
may consider such payment to be an overpayment subject to recovery as defined in the
MassHealth administrative and billing regulations in 130 CMR 450.000: Administrative and
Billing Regulations. The medical record requirements in 130 CMR 423.000 constitute the standard
against which the adequacy of records will be measured, as set forth in 130 CMR 450.000:
Administrative and Billing Regulations.
(B) Components. The medical record must include the following:
(1) patient identification, including name, date of birth, and the member’s MassHealth
identification number;
(2) medical history and dental history, as appropriate;
(3) findings of physical examination and preoperative diagnosis;
(4) results of any preoperative diagnostic studies (entered before surgery) if ordered,
including laboratory and radiologic reports. These results include dated and mounted X rays,
if applicable;
(5) operative record documenting clinical findings, techniques of the operation, intraoperative
medications administered, and type of surgical procedure;
(6) pathologist's reports on tissue removed in surgery, except those exempted by the
governing body;
(7) date of surgery;
(8) surgeon's name, address, and telephone number;
(9) allergies and adverse drug reactions;
(10) anesthesia record describing anesthetic agents used, dosages administered, and
documentation of start and end times of general or intravenous anesthesia;
(11) nursing notes (preoperative, intraoperative, and postoperative, including documentation
of any medical goods or supplies dispensed);
(12) patient's surgical consent, with documentation of it as properly executed informed
consent;
(13) postoperative diagnosis;
(14) discharge summary, including recommendations and referrals for additional treatment or
consultations, when applicable; and
(15) records pertaining to requests for laboratory, radiologic, and/or pathology information
requested in relation to the surgical procedure.
(C) Clinical Laboratory and Radiology Services. For clinical laboratory services and radiologic
services, additional information must be maintained in the member’s medical record in relation to
the payable surgical procedure, as well as a record of each specimen and laboratory test result for
at least six years from the date on which the results were reported to the prescriber. This record
must include the following components:
(1) name and any other means of identification of the patient from whom the specimen was
taken, including date of birth and MassHealth member identification number;
(2) site from which the specimen was obtained;
(3) name of the person who obtained the specimen;
(4) name of the person who ordered the laboratory test;
(5) name of the person who ordered the radiologic service;
(6) authorized requisition for the test;
(7) name and address of the surgical center where the specimen was obtained;
(8) date on which the specimen was collected by the prescriber or laboratory;
(9) date on which the specimen was received in the laboratory;
(10) condition of unsatisfactory specimens when received (for example, broken, leaked,
hemolyzed, turbid, or insufficient sample size);
(11) date on which the test was performed;
(12) test name and the results of the test, or the cross-reference to results and the date of
reporting;
(13) name and address of the person performing the examination of the specimen; and
(14) if applicable, the name and address of a second independent laboratory consulted to
examine the specimen, as well as documentation stating the necessity for further examination.
(D) Pharmacy Services. Surgical center pharmacies must maintain, for six years, a record for
each member of the drug and amount dispensed, the date, and the original prescription. Verbal
orders for the administration of all drugs and biologicals must be followed by a written order
signed by the prescriber at the completion of the surgical procedure.