Section 392-5-33-5 - Records and Reporting1.Purchase and Destruction Records A certified midwife shall keep a log of injectable oxytocin and injectable vitamin K purchased by the midwife pursuant to this chapter. For each such purchase the log shall note:
B. The name and address of the retail pharmacy where the oxytocin or vitamin K was purchased;C. The name of the selling pharmacist;D. The quantity and dosage of oxytocin or vitamin K purchased;E. The expiration date of the oxytocin or vitamin K purchased; andF. A statement as to whether any quantity of the oxytocin or vitamin K remained unused upon the expiration date and, if any, the date and manner of destruction of the unused stock. Purchase and destruction records must be maintained separately from the administration records required by Section 5(2) of this chapter.
2.Administration Records A certified midwife shall keep a record of all noncontrolled drugs and substances administered by the certified midwife pursuant to this chapter. For each such administration the record shall contain:
A. The date of administration;B. The route of administration;C. A description of the place where the drug was administered (e.g., patient's home);D. The name, quantity and dosage of the noncontrolled drug or substance administered;E. The reason for administering the noncontrolled drug or substance to the patient;F. A notation of any adverse reaction to the noncontrolled drug or substance administered, including a complete description of the steps taken by the certified midwife to respond to the adverse reaction and the condition of the patient afterwards; andG. A notation of any medical emergency experienced by a patient to whom the noncontrolled drug or substance was administered, including a complete description of the steps taken by the certified midwife to respond to the emergency and the condition of the patient afterwards. Administration records must be maintained separately from the purchase and destruction records required by Section 5(1) of this chapter.
3.ReportingA. A certified midwife shall report any of the following in writing to the Department of Health and Human Services, the Maine Center for Disease Control and Prevention within 7 days of the event. The report shall be made on the form prescribed by that office: (1) The administration of oxytocin for intramuscular use;(2) Any time a patient experiences an adverse reaction to a noncontrolled drug or substance administered by the certified midwife, including oxytocin, with a complete description of the steps taken by the certified midwife to respond to the adverse reaction and the condition of the patient afterwards; and(3) Any medical emergency experienced by a patient to whom a noncontrolled drug or substance was administered by the certified midwife, including oxytocin, with a complete description of all steps taken by the certified midwife to respond to the emergency and the condition of the patient afterwards. [NOTE: The mailing address for the reports required by this subsection is Family Health Division, Maine Center for Disease Control and Prevention, 11 State House Station, Augusta, ME 04333-0011.]
B. A certified midwife shall provide the records of purchase, destruction and administration described in Section 5(1) and (2) to the board no later than September 1 of each year. Each annual report shall contain records of purchases, destruction and administrations that occurred during the preceding calendar year, provided that no record need be prepared for purchases, destruction or administrations that occurred prior to the effective date of this chapter.4.Retention and Production of Records A certified midwife shall retain the records of purchase, destruction and administration described in Section 5(1) and (2) of this chapter for a period of 5 years. A certified midwife shall produce the records to the board upon request.
02-392 C.M.R. ch. 5, § 33-5