Section 392-2-4-A-3 - Operation of Drug or Vaccine Administration Clinics; One-Time Approval by Board for a Drug Administration Clinic1.Site Suitability A drug or vaccine administration clinic must be located in a sanitary, well-maintained, adequately equipped space that is appropriately sized for the expected patient volume and facilitates interaction among clinic staff and patients.
2.Written Plan of Operation The pharmacist holding a certificate of administration or pharmacy that operates a drug or vaccine administration clinic shall develop a written plan of operation prior to conducting the clinic, and shall ensure that the plan is complied with during operation. The plan may cover multiple pharmacies under common ownership, provided that each such pharmacy adheres to the plan. A drug administration clinic may not be conducted until the written plan of operation has been approved by the board pursuant to subsection 5 of this Section. The plan must, at a minimum:
A. Require that any non-health care personnel who assist at the clinic have no contact whatsoever with drugs, vaccines, needles or syringes;B. Include a specific protocol for prevention of administration errors (e.g., administration of incorrect drug or incorrect dose to patient; administration of drug to wrong patient);C. Include procedures for the orderly management and flow of patients through the clinic both pre- and post-administration;D. Include a specific protocol for performing the following procedures (1) Verification (Section 2(1));(2) Assessment (Section 2(2));(3) Provision of drug or vaccine information and discussion of possible adverse reactions (Section 2(3));(4) Obtaining written informed consent (Section 2(4)); and(5) Issuance of certificate of vaccination (Section 2(5));E. Incorporate the protocol for observing patients following administration required by Section 1(5) of this chapter. Clinic staff shall strongly recommend that all patients remain in the immediate vicinity of the drug orvaccination site for the post-administration observation period specified in the treatment protocol. To facilitate patient compliance, the operator of the clinic shall make a comfortable sitting area available in the immediate vicinity of the administration site. The sitting area must be of adequate size and must be suitably equipped to accommodate the flow of patients for the full duration of the post-administration observation period;F. Include a protocol for the safe storage and transportation of drugs and vaccines to ensure that the drug or vaccine remains viable until the point of administration;G. Include procedures to ensure that an adequate number of epinephrine and diphenhydramine syringes and other emergency medical supplies will be available for use in case a patient has an adverse reaction to the drug or vaccine administered; and H. Include a protocol for infection control. Standard precautions to minimize the risks of spreading disease during drug or vaccine administration must be in place. The protocol must include, at a minimum, the following provisions: (1)Handwashing. Hands must be washed thoroughly with soap and water or cleansed with an alcohol-based waterless antiseptic between patients, before vaccine preparation or any time hands become soiled;(2)Gloving. Gloves are not required to be worn when administering drugs or vaccines unless the person administering the vaccine is likely to come into contact with potentially infectious body fluids or has open lesions on the hands. It is important to remember that gloves cannot prevent needlestick injuries;(3)Needlestick Injuries. Needlestick injuries must be reported immediately to a lead person, with appropriate care and follow-up given. Safety needles or needle-free injection devices should be used if available to reduce the risk of injury;(4)Equipment Disposal. Used needles may not be detached from syringes, recapped or cut before disposal. All used syringe/needle devices must be placed in puncture-proof containers to prevent accidental needlesticks and reuse. Empty or expired vaccine vials are considered medical waste and are subject to Chapter 900 of the rules of the Department of Environmental Protection, "Biomedical Waste Management Rules;" and(5)Drug or Vaccine Preparation. Proper drug or vaccine handling and preparation is critical in maintaining the integrity of the drug or vaccine during transfer from the manufacturer's vial to the syringe and ultimately to the patient.3.Clinic Personnel At the conclusion of a drug or vaccine administration clinic the pharmacist holding a certificate of administration or pharmacy that conducted the clinic shall attach to the written plan of operation for that clinic a list that identifies, by name and position:
A. The lead person or persons who were responsible for operation of the clinic; and B. All pharmacists holding a certificate of administration, pharmacy technicians, student interns, other health care personnel and non-health care personnel who staffed or assisted at the clinic.4.Retention of Records Records received or created by a pharmacy or pharmacist pursuant to this chapter are subject to the record retention and production requirements of Chapter 24 of the board's rules.
5.One-Time Approval of Written Plan of Operation for a Drug Administration Clinic The written plan of operation described in subsection 2 of this Section must be submitted to the board for approval no less than 30 days prior to initial operation of a drug administration clinic pursuant to the plan. The duration of approval is indefinite, provided that in the event of any change to the plan, or any change in operation of a clinic that is not documented by or is inconsistent with the approved plan, the entire written plan of operation must be re-submitted to the board for approval. This section does not apply to a vaccine administration clinic.
02-392 C.M.R. ch. 2, § 4-A-3