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Administrative Policy and Procedure Subject: Product Review and Standardization Committee Effective: February 23, 2000 Approved:

Signed by Maria Roloff, VP of HR, on 12/4/06 and original filed in Administration. Vice President of Human Resources PURPOSE:

Policy Number: 200.088 Page: 1 Of: 4 Revised: December 4, 2006 Signed by Al Stewart, Interim CFO, on 12/4/06. Interim Chief Financial Officer

The purpose of this policy is to outline the process by which new clinical products are introduced to Mission Health and to provide a mechanism for existing products to be reviewed and analyzed. This Administrative Policy of Mission Health, Inc. is applicable to Mission Hospitals and other locations where services of the hospital are being provided. POLICY: Mission Hospitals utilizes a Value Analysis Approach to product evaluation and selection. Multidisciplinary committees evaluate all requests for new disposable products and patient related equipment, and pursue all appropriate product alternatives with the objective of reducing operating expenses while simultaneously maintaining or improving quality. The focus should be on need versus want. The Product Review and Standardization Committee has the responsibility and authority to insure that medical/surgical and patient care products are selected for use in the hospital based on the criteria outlined below. All such products that are to be considered for use in any department or unit of the hospital must first be submitted for investigation and evaluation. The Product Review and Standardization Committee will be made up of the Supply Chain Advisory Committee (acting as a steering committee), and at least 6 Teams: Nursing, Surgical Services, Equipment Standards, Safety, Implants Review Committee, and Specialty/Clinical Support. Other teams may be added on an as needed basis. PRODUCT SELECTION AND EVALUATION CRITERIA: Products and equipment are carefully reviewed from many perspectives including, but not limited to: 1. 2. 3. Patient Safety. Quality. Improvement in patient care.

Product Review and Standardization Committee -- #200.088 Page: 2 Of: 4 ====================================================================== 4. 5. 6. 7. 8. 9. Price/cost. Relation of intrinsic value to cost. Manufacturer corporate stability. Ability of manufacturer to support their product and provide comprehensive in-service education to all shifts if necessary. Product history and references from other healthcare facilities. Revenue impact.

ROLE OF THE TEAMS: The individual Product Review teams have the following roles: 1. Product Review To establish a clear and simple definition of the function or purpose for which a product exists and to review acceptable alternatives with cost studies. Environmental Impact To consider products for possible purchase with regards to their overall packaging environmental impact, and recycling potential. Product Selection To reduce the possibilities for duplication, product dissatisfaction, waste and increased cost by channeling the selection process into one organized process. Infection Control To aid in the control of infections within the hospital by reviewing the following aspects of products/equipment. Infection risks to patients and personnel. Aseptic presentation and packaging of sterile products. Cleanability of refused products/equipment. Sterilization/disinfecting of reusable items. Proper disposal of items/products if not reusable Safety of reuse of disposable items. Standardization To provide quality care at a reasonable cost by reducing the number of different brands of essentially identical products. A. Education To insure patient safety and achieving savings from proper utilization and standardization. Cost Containment To reduce the number of items used to perform the same or related function, by reducing the materials that become obsolete and by reducing the quantity of items needed to maintain inventory, thereby reducing overall costs of patient care.

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Communication To establish a means to communication between the Medical Staff and Operations and to give them a common ground on which to discuss new products, and/or problems, including Safety Alerts and Product Recalls.

Product Review and Standardization Committee -- #200.088 Page: 3 Of: 4 ====================================================================== 6. Evaluate Processes Provide a means to discuss and evaluate the processes used in utilizing supplies to cut down on waste and increase efficiencies. Hospital- approved Alliances and GPO's will be a consideration in the evaluation and acceptance process. Substitutions Provide a means to discuss and develop a substitution list for the Hospital. These product substitutions will be used in back order and recall situations. Information Provide a means to gather required information for each new product that is utilized by the Hospital such as MSDS sheets, FDA approvals, and HCPCS codes.

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FUNCTION: 1. 2. Each committee will meet regularly, a minimum of quarterly. Minutes will be distributed at least one week after each meeting. The agenda will be sent to the committee members prior to each meeting. Written documentation of all committee minutes, trial evaluations and resulting dispositions will be kept in a master file in the Purchasing Dept. In order to utilize the committees time most effectively, products will be grouped by type/function, whenever possible. Further, all requests for new products should be submitted to Purchasing for completion and forwarded to the proper clinical committee. After a product has been reviewed it shall not be reviewed again for at least one year except under special circumstances, e.g. manufacturer recall.

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PROCESS: The attached flow diagram displays the process to be followed to introduce a new product and to change an existing product. All products must be presented to Product Review before being used clinically. All products must be submitted for review by completing a New Product/Implant Analysis Review Packet. A product will not be reviewed without this request. 1. 2. 3. The clinical committees will have a regularly scheduled meeting each month. The Product Review and Standardization Committee will meet the third Wednesday of each month. Minutes will be distributed at least one week after each meeting. The agenda will be sent to the committee members prior to each meeting. Written documentation of all committee minutes, trial evaluations and resulting dispositions will be kept in a master file in the Materials Management Department.

Product Review and Standardization Committee -- #200.088 Page: 4 Of: 4 ====================================================================== 4. In order to utilize the Committees time most effectively, products will be grouped by type/function, whenever possible. Further, all requests for new products should be submitted to Purchasing for completion and forwarding to the proper clinical committees. After a product has been reviewed, it will not be reviewed again for at least one year except under special circumstances (i.e., manufacturer recall). All products must be presented to Product Review and Standardization Committee before being used clinically. All products must be submitted for review by completing a Product Control and Data Sheet (see Attachment B). A product will not be reviewed without this request. The Product Review Process flow diagram (see Attachment A) displays the process to be followed to introduce a new product and to change an existing product.

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Attachment A -- Product Review and Standardization Committee -- #200.088 Page 1 of 1

Product Review Process


Need Identified Complete a New Product / Implant Analysis Packet (obtained on Intranet)

Submit to Materials Management

Assigned to Committee for Review

Product reviewed by Committee, from initial review to Clinical Trial, if needed.


No

Feedback to Submitter

Approved?
Yes

Product is added to Mission Formulary Database

Yes

Addition to Inventory Process Started

Add to Storeroom Stock?

No

Pricing finalized, contract loaded and template completed Feedback to Requestor

Attachment B -- Product Review and Standardization Committee -- #200.088 Page 1 of 2

PRODUCT CONTROL AND DATA SHEET


SECTION I TO BE COMPLETED BY REQUESTOR _____________________________________________________ Requestor Name and Department or Floor 1.

Date of Request

Name of Product _______________________________________________________________________ Manufactured By and Representative's Name Description of Product, Purpose and Use Has this product ever been evaluated by Mission Hospitals? If yes, when and results Yes No Unknown

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How did you become aware of this product? Other sources for same product performing same function Has this request been introduced to any other hospital committee at this date (Infection Control, Safety, etc.)? Yes No If yes, Committee name, date and action taken

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Does this product affect more than one department or service? Yes No Unknown If yes, identify areas and indicate whether this has been discussed with the department director

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Will this be a patient charge item? Yes No Unknown List Healthcare Common Procedure Coding System Codes

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Is this a: New Product Duplication Replacement ? A. Will this item be stocked on supply carts? Yes No Unknown B. Is product: Reusable Disposable ? If reusable, submit policy and procedure for cleaning/decontamination/sterilization. Was this evaluation requested by a Physician? Yes No If yes, Physician's name, date of request and reason for, if known

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Please explain problem/need that this product will resolve or fill

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Management approval for this evaluation: Director approval Date

Attachment B -- Product Review and Standardization Committee -- #200.088 Page 2 of 2

SECTION II TO BE COMPLETED BY RESOURCE MANAGEMENT/PURCHASING 1. 2. Has vendor supplied all product information needed for proper evaluation? Yes No

What supportive equipment, products or special storage facilities are needed and when will they be available? _____________________________________________________________________________ What cost will the hospital incur for this evaluation? Projected annual usage of new product and cost Annual usage and cost of product being replaced Additional cost or cost savings History of problems reported by other users or to FDA Or None reported Premier Compliance Program? Required MSDS obtained? Does product contain latex? Yes Yes Yes No No No

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SECTION III TO BE COMPLETED AT PRODUCT REVIEW AND STANDARDIZATION COMMITTEE MEETING 1. 2. Date product introduced to Committee Recommendation of Committee: Approval for trial Approval for immediate use Disapproval A. B. C. If approval for trial use and evaluation, will an inservice on this product be needed? Yes No Who will perform inservice? Inservice Coordinator Committee recommendation on length of trial period, From To Location

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Steering Committee Review (if needed)

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Final Approval/Decision