(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
FACULTY DEVELOPMENT GRANTS
TCS 15.01 Purpose. This chapter establishes criteria, policies and procedures to implement s. 38.33, Stats., relating to district board faculty development programs.
Note: Forms used in administering this rule are available from the Wisconsin Technical College System Board, 310 Price Place, P.O. Box 7874, Madison, Wisconsin 53707-7874.
TCS 15.01 Definitions. In this chapter:
(1) “Board” means the technical college system board.
(2) “Director” means the person appointed by the board according to s. 38.04 (2), Stats.
(3) “District” means a technical college district established according to ss. 38.04 (1) and 38.06, Stats.
(4) “District board” means the district board in charge of the technical college of a district.
(5) “District director” means the person employed by a district board under s. 38.12 (3), Stats.
(6) “Program” means the faculty development program established by the district board under s. 38.33, Stats.
TCS 15.03 General. (1) Only technical college districts are eligible to apply for grant funds under this chapter.
(2) The board shall prepare an application manual and may update it as needed. The manual shall contain the application instructions, procedures and requirements for funding and submitting grant proposals.
TCS 15.04 Grant applications. (1) Annually, during a time established by the board, districts may submit proposals for a grant to assist in the funding of a faculty development program under s. 38.33 (1), Stats.
(2) The grant proposal shall be in writing, signed by the district director or designee, and be in such form as the board requires.
(3) Each district is limited to a single grant application.
(4) Each grant proposal shall include:
(a) A description of the proposed faculty development program, which includes:
1. The planned development of the district's program.
2. Any current activities being conducted by the district relating to the faculty development program.
(b) A plan, which includes:
1. The goals and objectives of the program for meeting the instructional technology needs of the district.
2. A description and explanation of conditions that lead to development of the goals and objectives.
3. A detailed budget.
TCS 15.05 Grant award criteria. The board shall consider all of the following when granting an award:
(1) The availability of financial resources to successfully provide the program as proposed in the grant proposal.
(2) The extent to which the district's program promotes the use and integration of technology curriculum development and instructional delivery.
(3) The extent to which the district's program is conducted through in-service activities.
(4) Whether a district's continuing project has met or exceeded its prior year planned outcomes.
