(4) The policy and procedure manual shall be current and available for inspection by the board or its designee.
Phar 15.04 Physical requirements. (1) The pharmacy shall have a designated area with entry restricted to designated personnel for preparing sterile pharmaceuticals. This area shall be a room structurally isolated from other areas, with restricted entry and access, and must be designed to avoid unnecessary traffic and airflow disturbances from occurring within the controlled facility. It shall only be used for preparation and documentation of sterile pharmaceuticals. It shall be of sufficient size to accommodate a laminar airflow hood and to provide for proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation and security. Additional drug inventory and bulk supplies shall be stored in an area separate from the designated area for preparing sterile pharmaceuticals.
(2) The pharmacy shall maintain an environment suitable for aseptic preparation of sterile pharmaceuticals and shall have all of the following:
(a) Appropriate environment control devices capable of maintaining at least class 100 conditions in the workplace where critical objects are exposed and critical activities are performed. Furthermore, these devices are capable of maintaining class 100 conditions during normal activity.
(b) Appropriate disposal containers as required by OSHA regulations for used needles, syringes, as well as for disposal of other items in compounding, and if applicable, for cytotoxic waste from the preparation of chemotherapy agents and infectious wastes. This should be disposed of in a timely manner.
(c) Appropriate environmental controls to include class II biological safety cabinetry when cytotoxic drug products are prepared.
(d) Temperature-controlled delivery containers as necessary.
(e) For hand-washing, a sink with hot and cold running water should be in close proximity.
(f) Administration devices as necessary.
(3) The pharmacy shall have sufficient reference materials related to sterile pharmaceuticals to meet the needs of the pharmacy staff.
(4) The designated area should be closed and disinfected at regular intervals with appropriate agents.
Phar 15.05 Records and reports. (1) In addition to state required record and reporting requirements, the following additional records and reports must be maintained for pharmacy prepared sterile pharmaceutical documentation:
(a) Training and competency evaluations.
(b) Documentation of refrigerator and freezer temperatures.
(c) Certification of laminar airflow hoods.
(2) The following minimum labeling requirements must be met for sterile pharmaceuticals prepared by a single patient when they are to be completely administered within 28 hours by including it on the label only:
(a) Identity of all solutions and ingredients and their corresponding amounts, concentration or volumes and the final preparation container in such a manner as to allow the locating of problematic final products.
(b) Identity of personnel involved in preparation.
(c) Date and time of pharmacy preparation where applicable.
(d) Final sterile pharmaceuticals expiration date, and storage requirements where applicable.
Phar 15.06 Delivery service. The pharmacist shall assure the appropriate environmental control of all products shipped.
Phar 15.07 Emergency kits. (1) When sterile pharmaceuticals are provided to home care patients, the dispensing pharmacy must supply the patient or their agent with emergency drugs, when authorized by the physician under protocol, if an emergency situation has been anticipated by either the physician, nurse or pharmacist.
(2) The dispensing pharmacy shall be responsible for providing written instructions on the storage and recordkeeping associated with the emergency kit.
Phar 15.08 Cytotoxic drugs. In addition to the minimum requirements for a pharmacy established by rule of the board, the following requirements are necessary for those pharmacies that prepare cytotoxic drugs:
(1) All cytotoxic drugs should be compounded in a vertical flow, class II, biological safety cabinet. In the event non-exposed surfaces become contaminated with cytotoxic agents, no other products other than cytotoxic agents should be compounded in this cabinet until such time as the cabinet is decontaminated utilizing appropriate techniques to eradicate the contaminant.
(2) Personnel shall be protected by a protective barrier or apparel which must include gloves, gowns and other applicable protective apparel as determined by OSHA.
(3) Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile pharmaceuticals.
(4) Pharmacy disposal and patient and caregiver education regarding disposal of cytotoxic waste shall comply with all applicable local, state and federal requirements.
(5) Written procedures for the handling of both major and minor spills of cytotoxic agents must be developed and must be included in the pharmacy policy and procedure manual.
(6) Prepared doses of cytotoxic drugs must be dispensed, labeled with proper precautions on the primary and shipping container and should be shipped in a manner to minimize the risk of accidental rupture of the primary container.
Phar 15.09 Labeling. In addition to the labeling requirements of s. 450.11 (4), Stats., the following must also be included as a part of the labeling of sterile pharmaceuticals:
(1) Control or lot number.
(2) Expiration date, to include time when applicable.
(3) Appropriate auxiliary labeling, including precautions.
(4) Storage requirements.
(5) Identification of the responsible pharmacist.
Phar 15.10 Patient training. A pharmacist is responsible for documenting the patient's training and competency in managing this type of therapy provided by the pharmacist to the patient if self-administered by the patient or a caregiver. A pharmacist is responsible for the provision of or supervision of the patient training process in any area that relates to drug compounding, administration, labeling, storage, stability or incompatibility. A pharmacist must be responsible for seeing that the patient's competency in the above areas is reassessed on an ongoing basis.
Phar 15.11 Quality assurance. (1) There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment and facilities. Appropriate samples of finished products shall be examined to assure that the pharmacy is capable of consistently preparing sterile pharmaceuticals meeting specifications.
(2) All class 100 clean rooms, horizontal and vertical laminar flow hoods shall be certified by an independent contractor according to federal standard 209 for operational efficiency. All biological safety cabinets shall be certified according to national sanitation foundations standard 49 or manufacturer's specifications. Certification shall take place before initial use or after relocation and at least annually. Appropriate records shall be maintained.
(3) There shall be written procedures requiring sampling for microbial contamination through a validation procedure, simulation of actual aseptic technique, as well as by using bacterial growth medium to culture environmental samples.
(4) If compounding of parenteral solutions is performed using non-sterile chemicals, extensive end-product sterility testing must be documented. If any parenteral solution fails such testing, procedures shall be in place to quarantine future products for sterility testing to assure end-product sterility prior to release of the products from quarantine. The compounding process must utilize components and techniques which assure a sterile and particulate free product.
(5) There shall be a written justification of the assigned expiration date for pharmacy prepared sterile pharmaceuticals.
(6) There shall be documentation of quality assurance audits, including infection control and sterile technique audits at least annually.
(7) There shall be procedures to assure consistent preparation of sterile pharmaceuticals.
Fiscal Estimate
1. The anticipated fiscal effect on the fiscal liability and revenues of any local unit of government of the proposed rule is: $0.00.
2. The projected anticipated state fiscal effect during the current biennium of the proposed rule is: $0.00.
3. The projected net annualized fiscal impact on state funds of the proposed rule is: $0.00.
Initial Regulatory Flexibility Analysis
These proposed rules will be reviewed by the Department through its Small Business Review Advisory Committee to determine whether there will be an economic impact on a substantial number of small businesses, as defined in s. 227.114 (1) (a), Stats.
Copies of Rule and Contact Person
Copies of this proposed rule are available without cost upon request to:
Pamela Haack, (608) 266-0495
Office of Administrative Rules
Dept. of Regulation & Licensing
1400 East Washington Ave., Room 171
P.O. Box 8935
Madison, WI 53708
Notice of Hearing
Wis. Technical College System Board
Notice is hereby given that pursuant to ss. 38.33 (3), and 227.11, Stats., and interpreting s. 38.33, Stats., the Wisconsin Technical College System Board will hold a public hearing, at the time and place indicated below, to consider the creation of ch. TCS 15, relating to faculty development grants.
Hearing Information
The public hearing is scheduled as follows:
June 30, 1998 WTCSB Board Room
Tuesday 310 Price Place
9:00 a.m. MADISON, WI
Analysis Prepared by the Technical College System Board
Statutory authority: s. 38.33 (3)
Statute interpreted: s. 38.33
The purpose of the rule is to establish grant application criteria, and policies and procedures to implement and administer grant funds to local technical college districts. Local technical college districts will use these grants primarily to expand the use of learning technologies and to promote the effective use of newly-emerging technologies. The grant funds will also be used to train new faculty members, upgrade the skills of current faculty, and improve the skills of those faculty members seeking to build a stronger academic environment. Fundamental to the overall success of a faculty development program are the efforts to:
a) Promote instructor awareness and expertise in a variety of newly-emerging technologies;
b) Integrate the use of new learning technologies into the curriculum and delivery of technical college instruction; and
c) Use newly-emerging technologies through sharing and collaboration among faculty and staff both within and across technical college districts.
Section 38.33, Stats., authorizes the Technical College System Board to establish, by administrative rule, specific grant award criteria, along with grant application policies and procedures, that enables a local technical college district board to request and receive available grant funds so that the district board may implement and administer a faculty development program at the district level.
The grant award criteria include:
a) The availability of adequate funds, including matching funds, to provide a faculty development program.
b) Whether a technical college district faculty development program promotes curriculum development and instructional assistance associated with learning technologies.
c) Whether the technical college district's in-service activities are included in the faculty development program.
d) Whether a technical college district's continuing projects meet or exceed its prior year planned outcomes.
Detailed application instructions and procedures for submitting grant proposals, which includes deadline dates, and reporting requirements, are contained in a manual that is prepared annually by the Technical College System Board and distributed to each technical college district.
Text of Rule
SECTION 1. Chapter TCS 15 (title) is created to read:
Chapter TCS 15
