Mich. Admin. Code R. 338.3154

Current through Vol. 24-22, December 15, 2024

Section R. 338.3154 - Medication records in medical institutions

Rule 54.

(1) A patient's chart must constitute a record of medications ordered for, and actually administered to, a patient of medical institutions.

(2) Medication records are required for all controlled substances listed in schedules 2, 3, 4, and 5. At a minimum, these records must include all of the following information:

(a) The number of doses of controlled substances purchased.

(b) The number of doses dispensed to individual patients or distributed to nursing stations or both.

(c) The number of doses administered.

(d) The number of doses dispensed, but not administered, to the patient.

(3) If the controlled substance is not dispensed to an individual patient, all of the following provisions must be complied with:

(a) Medication records for those controlled substances listed in schedules 2, 3, 4, and 5 must be maintained.

(b) Distribution of a controlled substance to a nursing unit may not be more than 25 doses per container.

(c) A distribution record for each multiple of 25 doses must be used to account for delivery to a nursing unit. The record must include all of the following information:

(i) The name and dose of the controlled substance.

(ii) The quantity of the substance.

(iii) The date of delivery.

(iv) The location of the nursing unit.

(v) The name of the distributing pharmacy and address if it is a different location from the medical institution.

(vi) Name of distributing pharmacist.

(vii) The name of the individual on the nursing unit who receives the substance.

(d) A proof of use record must be maintained to account for all doses of an administered substance. The record must include all of the following:

(i) The name of the substance.

(ii) The dose administered.

(iii) The date and time a dose was administered.

(iv) The name of the patient.

(v) The signature of the individual who administered the dose.

(e) This subrule does not apply to automated devices.

(4) A controlled substance that is maintained at a nursing unit must be stored in a securely locked cabinet or medication cart that is accessible only to an individual who is responsible for the administration or distribution of the medication.

(5) If a controlled substance is dispensed from an automated device, documentation of all of the following must be maintained on-site in the pharmacy responsible for the automated device for 2 years for review by the department, an agency, or the board.

(a) The name and address of the pharmacy responsible for the operation of the automated device.

(b) The manufacturer name and model number of the automated device.

(c) The name and address of the facility where the automated device is located.

(d) The contents of the automated device.

(e) The quality assurance policy and procedure to determine continued appropriate use and performance of the automated device that includes all of the following quality assurance documentation for the use and performance of the automated device:

(i) Use of monitors that alert the user if the wrong medication is filled or removed for administration to a patient.

(ii) Use of security monitors that include an alert for unauthorized access, patients not in the system, system security breaches, and controlled substance audits.

(iii) Corrective measures to address issues and errors identified in the internal quality assurance program.

(f) The policy and procedure for system operation that includes all of the following:

(i) Safety.

(ii) Security systems and procedures that include prevention of unauthorized access or use and comply with federal and state regulations.

(iii) Accuracy.

(iv) Patient confidentiality.

(v) Access.

(vi) Type of controlled substances.

(vii) Data retention or archival.

(viii) Definitions.

(ix) Downtime procedures.

(x) Emergency procedures.

(xi) Operator inspections.

(xii) Installation requirements.

(xiii) Maintenance.

(xiv) Medication security.

(xv) Medication inventory.

(xvi) Staff education and training.

(xvii) System set-up and malfunction.

(xviii) List of medications qualifying for emergency dose removal without pharmacist prior review of the prescription or medication order.

(xix) The use of the automated device that includes a requirement that a pharmacist review a prescription or medication order before system profiling or removal of medication from the automated device for immediate patient administration, except in the following situations where a pharmacist shall review the orders and authorize further dispensing within 48 hours:

(A) The automated device is being used as an after-hours cabinet for medication dispensing in the absence of a pharmacist under R 338.486(4)(j).

(B) The system is being used in place of an emergency kit under R 338.486(4)(c).

(C) The system is being accessed to remove medication required to treat the emergent needs of a patient under R 338.486(4)(c). A sufficient quantity to meet the emergent needs of the patient may be removed until a pharmacist is available to review the medication order.

(g) The automated device must maintain transaction data that includes all activity regarding access to the contents of the automated device.

(h) The pharmacy responsible for the automated device shall maintain records related to access to the automated device. The records must be readily retrievable and must include all of the following information:

(i) The unique identity of the device.

(ii) Identification of the individual accessing the automated device.

(iii) The type of transaction.

(iv) The name, strength, dosage form, and quantity of the drug accessed.

(v) The name of the patient.

(vi) The identification of the pharmacist checking for the accuracy of the medications stocked or restocked in the automated device.

(vii) Any information the pharmacist considers necessary.

(i) For medication removed from the automated device for on-site patient administration, the automated device must document all of the following information:

(i) The name of the patient.

(ii) The date and time medication was removed from the automated device.

(iii) The name, initials, or other unique identifier of the individual removing the drug.

(iv) The name, strength, and dosage form of the drug. The documentation may be on paper or completed electronically.

(j) If the pharmacist delegates the stocking of the automated device, technologies must be in place and utilized to ensure that the correct drugs are stocked in their appropriate assignment utilizing bar-coding or another a board-approved error prevention technology.

(k) The automated device must provide a mechanism for securing and accounting for controlled substances removed from the automated device return bin. Controlled substances must not be returned directly to the automated device for immediate reissue or reuse. Controlled substances removed from the automated device may not be reused or reissued, except as indicated in R 338.486(7).

(l) The automated device must provide a mechanism for securing and accounting for wasted or discarded medications.

(6) An individual who is responsible for administering a controlled substance or a portion thereof shall record the quantity, disposition, and an explanation of the destruction of the controlled substance on the proper accountability record. If the institution has a policy that reflects current practice standards and delineates the method of destruction, an explanation would only be required if policy was not followed.

Mich. Admin. Code R. 338.3154

1979 AC; 1980 AACS; 1992 AACS; 2002 AACS; 2007 AACS; 2022 AACS; 2024 MR 10, Eff. 5/28/2024