Experience in using document control software to track SOPs

A colleague in Southern California reports that her facility has successfully employed a document control strategy that includes tracking their SOPs by title, number, and computer storage file number. The various distribution locations for these SOPs and the next review date for each is managed in an Excel spreadsheet. A list of SOPs is generated each month that details which SOPs are due for review within the upcoming month. This list is printed and distributed to the individual (i.e., supervisor) responsible to do the review. After the review, she updates the Excel spreadsheet with the completed review date. This aforementioned system was set up to handle only the blood bank, donor center, and a lab-wide Quality Program. There are approximately 600 SOPs covered by this program. She laments however, that they now need to get the same level of document control for their entire Department of Pathology, and they are concerned that manipulating numerous spreadsheets (one for each section of the lab) for probably at least double the number of SOPs, may be too massive of an undertaking. They have looked on the Internet and in ASQ professional journals for document control software but, they would really like to see if others in the blood banking community have had any experience with this type of software. To quote the inquiring colleague - "I never like to create the wheel if I can learn from others."

The following responses have been received.

ADDENDA Feb. 9, 2004

1. A colleague who is quite expert in blood bank computerization reports that the Southern Californian is wise to be concerned about the manual monster she is creating. He also comments that Electronic Document Management systems are designed to do just what the colleague from Southern California wants to do and much more, and suggests that she check out the products and services available at The Association for Information and Image Management. In particular, she could look into Document Imaging and Workflow management. Also, the AABB has an audioconference on February 11, on Electronic Records Management and 21CFR Part 11. He concludes, "Good Luck, you will be thrilled at capabilities of an ERM."
   
   
2. A colleague in Massachussetts reports that a laboratory in Salt Lake City uses MasterControl to manage their documents. She looked into that system, and felt that it seemed excellent but some might consider it to be expensive.
   
   
3. According to a colleague at a CBBS member institution, their blood center has been reviewing and evaluating various document control solutions, and they have found many vendors who offer sound products. An analytical process has been followed in order to evaluate the many offerings and find a solution that best meets their needs. She adds that with a regulated environment the blood banking community is faced with managing a wide variety of documents that contain a great deal of unstructured data. It is important to organize the documents so that the data contained in them can be easily tracked and organized as information in a meaningful manner. This type of organization and standardization can yield significant cost savings to an institution.

ADDENDA Feb. 10, 2004

4. A colleague in California who oversees compliance for a blood center reports that she has been investigating document control software for sometime. She has identified are several systems that she feels are reasonably good. One of her concerns, and thus one of the 'must haves' with any new system, was for the system to be compliant with FDA regulations/guidances. She thinks she has found two systems (there are probably others) that meet the FDA criteria.; they are MasterControl and EMC Documentum. Her center has had on-line and telephonic demonstrations of these two systems and they were quite impressed with many functions. Both of these systems are somewhat expensive, however when she looks at the time and cost necessary to review, revise, sign off, and track their many documents, the cost of one of these software systems would be well worth the investment, and her center has a budget approved for document control software for this fiscal year. She concludes "I am looking forward to the final selection and implementation of a system later this year."

ADDENDA Jan. 16, 2005

5. A transfusion medicine physician in Detroit wonders if colleagues have addressed the CAP requirement (GEN.20372) for document control in the laboratory, and implemented strategies to "reign in" documents in their laboratories. According to the checklist item the laboratory should have a document management or control system to assure that:
   1. All copies (paper and electronic) of policies and procedures are current;
   2. Personnel have read the policies/procedures relevant to their job activities;
   3. All policies/procedures have been authorized by the laboratory directory or designee before implementation;
   4. Policies and procedures are reviewed at least annually by the laboratory director or designee;
   5. Discontinued policies/procedures are kept in a separate file for a minimum of 2 years after the date of discontinuation (5 years for Transfusion Medicine).
   The Detroit physicians asks if colleagues would share information about programs for easy conversion of on-disc procedure manuals, forms, etc, to a web-based format for posting on an intranet site so these are accessible to all in the lab? Are any colleagues actually paperless as far as maintaining procedure manuals, documents, records, or all of the above? What challenges have been faced in making such a conversion?

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