In 2008, it was approved for COMTEX to proceed with the project.

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1 Case Study Title: Author: Designing and Building a New Packroom Facility to Centralize Hospital Groups Sterile Surgical Linen Pack Processing Jim Sprout, PrePak Business Manager BACKGROUND The primary hospital systems in Columbus, Ohio are the OhioHealth and the Mount Carmel Health Care Systems. In 2004, these two competing hospital groups came together to cooperatively build a central laundry to serve both entities. This new laundry is called COMTEX and has been successful in providing world class quality and service to all member facilities since its opening. In 2005, COMTEX and their member hospitals from OhioHealth and from Mount Carmel Health, partnered with Standard Textile and its PrePak Surgical Division, to investigate the financial and other impacts of building a central packroom, at COMTEX, to make sterile surgical linen packs for all member hospitals. In 2008, it was approved for COMTEX to proceed with the project. OBJECTIVE The objective of the project was to design and build an expansion to the existing central off-site laundry facility that could serve as a sterile surgical pack production facility. The primary design goals included the following: The facility should meet all requirements from AORN and from ANSI/AAMI for sterile pack processing facilities.

2 The facility should enable the work to be accomplished in the most productive way possible. The facility should enable quality assurance programs to be implemented fully. The facility should be large enough to allow complete service to all member hospitals, plus some growth. STRATEGY: The strategy was for COMTEX management to involve PrePak staff (engineering, business and clinical expertise) in most meetings and activities to allow PrePak s experience and recommendations to be considered in all major decisions. Korda Engineering was selected by COMTEX to build the facility, and PrePak was invited to participate in meetings with COMTEX and Korda. PrePak s experience of twenty years in building and managing packrooms positioned PrePak to provide input in areas including the following: PrePak defined the rooms needed as being a packroom, a sterilization room, a distribution room, with ancillary rooms including manager s office, locker rooms, and supply closet. PrePak scaled the rooms based on charts indicating the correlation of room size to number of workers and work output. PrePak provided direction on regulatory requirements and the impact on the required HVAC systems, lighting levels, surface materials, doors, hand washing, and other design features. PrePak provided recommendations in equipment selection, including steam sterilizers, light tables, carts and bins, and bag sealers. COORDINATION: The challenge was to coordinate the activities in five major segments of this project. The major project areas included these:

3 Product The specific products were trialed and approved by each hospital. Usage and inventory rates were determined. The product was manufactured and delivered. Facility The building was designed and built. Equipment was installed and validated. Operations Policies and Procedures needed to be documented. Supplies were tested, ordered, and received. Staff had to be hired and trained. Finally, the operation was implemented and validated. Clinical Support Each hospital s O.R. staff conducted trials and approved each product and each pack design. General training had to be completed. The actual conversion was scheduled, promoted, and managed. I.T. Computer hardware and software requirements had to be determined. The system had to be developed, tested, installed, and validated. Attachment A is an example of a document used to schedule and coordinate the activities under each of these five project segments. LAYOUT: The workflow in a medical device facility is critical, both for productivity and for quality assurance reasons. The size, shape, and relative location of rooms are critical, as is the placement of equipment. Attachment B is a layout provided by PrePak to assist COMTEX in this endeavor. RESULT: The facility was completed on schedule, and is a world-class, state-of-the-art facility. The program was successfully implemented. The benefits generated for COMTEX, their member hospitals, and their community, include the following.

4 Surgical Supply Costs The program provides packs at costs equal to, or lower than, the packs previously used, with an overall total cost significantly reduced from prior systems. When fully implemented, the system-wide cost savings are estimated at $400,000 per year. Environmental Impact The conversion of disposable products to reusable products significantly reduces the environmental impact of performing surgery, in areas including trash generation (by 97% reducing 521,000 pounds), energy use (by 71% saving 18,800,00 mega joules enough to power 524 households), water use (by 72% saving 6,900,000 gallons of water enough for 74 households), and the production of harmful contaminants such as CO2 (reduced 700,000 pounds), SO2 (reduced 20,000 pounds), and phosphates (reduced 833 pounds). Jobs This program has created already fifteen career level positions in the immediate community. Service These sterile packs are delivered daily throughout each hospital, to various multiple delivery locations, and the delivery includes shelf rotation and organization. Quality Assurance The program is managed under a strict quality assurance program developed in FDA-audited facilities.

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8 ATTACHMENT A COMTEX TIMELINE FOR PACKROOM IMPLEMENTATION STANDARD TEXTILE COMTEX Oct. Nov. Dec. Jan. Feb. March April May TEAM EFFORT PRODUCT ComTex sign ComPel order Order bar codes Make and ship bar codes Order RFID Make and ship RFID Order fabric Make and ship fabric ComTex sign towel order Make and ship towels Make and ship ComPel order All ComPel and Towels delivered Oct. Nov. Dec. Jan. Feb. March April May FACILITY Complete building shell Packroom shell completed Sterilizers installed Validate sterilizer operation Build/Buy tables and shelves Evaluate HVAC performance Buy patching and sewing machines Install/test sling drop system Position equipment/hook-up OPERATIONS Hire Q.A. Manager/SPD PrePak Train new Manager Policy Manual/Forms/Standards Supply list and specs determined Supply sources determined Supply orders all placed Supplies all received Hire Packroom workers Train Packroom Workers Hire/train sterilization workers Hire/train delivery reps Implement cleaning/dress codes Make packs for testing Make packs for actual use Oct. Nov. Dec. Jan. Feb. March April May Oct. Nov. Dec. Jan. Feb. March April May CLINICAL SUPPORT Verify equipment dimensions MCE data collection MCE workshop MCE implementation Doctors data collection Doctors workshop Doctors implementation MCW data collection MCW workshop MCW implementation Grant data collection Grant workshop Grant implementation St. Ann data collection St. Ann workshop St. Ann implementation New Albany data collection New Albany workshop New Albany implementation Riverside data collection Riverside workshop Riverside implementation I.T. Determine hardware needs Determine programming needs Programming software Test programs Order hardware not PCs Order PCs for bar code/rfid Receive hardware not PCs Receive PCs Install hardware Install software Test on site On-site customization Oct. Nov. Dec. Jan. Feb. March April May

9 70'-0" DROP AREA TOWEL PACKS QA TESTING 160'-0" VIEWING CORRIDOR GOWN PACKS SHEETS & DRAPES WRAPPER INSPECT & STACK SEW & MEND COOL DOWN STERILIZER 1 STERILIZER 2 STERILIZER 3 LARGE PACKS SUPPLIES SUPPLIES STERILIZATION ROOM HOLDING ROOM PACKROOM SUPPLIES STERILIZER 4 STORAGE OFFICE MEN S WOMEN S UNIFORMS CONVEYER ATTACHMENT B