130 CMR, § 423.413

Current through Register 1531, September 27, 2024
Section 423.413 - Recordkeeping Requirements

Surgical centers must maintain a medical-record system promoting quality and confidential patient care in accordance with 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.

130 CMR, § 423.413

Amended by Mass Register Issue S1277, eff. 1/2/2015.