Dear Dr. NAACLS
In 2004, the Health Sciences Division at my college decided to update all of our clinical affiliation contracts, and went to a unified contract system. We had our affiliates sign new contracts and agreements. Since my phlebotomy Self-Study is coming due, and some portion of the previous term of approval was covered under the prior contracts, do we need to send the previous agreements as well?
Sincerely,
Concerned Program Director

Dear Concerned Program Director:
The Self-Study document is an in-depth review, reflecting the program at a particular moment in time. As such, NAACLS requires only the review of the current and active agreements. Agreements which have been superseded are not needed in the review.

Between reviews, it is the program director who is responsible for making sure that affiliation agreements are current and meet the NAACLS Standards. For new affiliates, NAACLS requires the program director to complete a checklist and sign off that the new affiliate and its agreement meet the NAACLS Standards. For new agreements with existing affiliates, we urge the program director to carefully review the affiliation agreement in light of the requirements of Standard 1. In both of these cases, NAACLS makes a full review of all affiliation agreements during the review process.

During the NAACLS review process, submitting the documents in an organized manner will greatly assist the reviewers as they attempt to understand your program. Particularly for programs with large numbers of affiliates, collecting and organizing all of the agreements, addenda and memoranda of understanding, and clinical facility fact sheets can be like swimming in a sea of paper. In fact, the same can be said for the reviewers attempting to understand the submission! For each affiliate, an approved program must submit a signed affiliation agreement and any memoranda of understanding, with accredited programs required to submit a sample in the Self-Study and have the remainder available for the site visit team. For each location, the program must submit a clinical facility fact sheet. Affiliates with multiple locations may be covered under an umbrella agreement, but fact sheets must be submitted for each location. It is often helpful to explain in the narrative which agreement covers which locations!

One way to organize this information is through the use of tabbed dividers in a notebook. In this system, Tab 1 would be "The Really Big Health System", with its agreement, any memoranda of understanding, and all clinical facility fact sheets. Tab 2 would be entitled "The Moderately big Health System", with its documents contained therein. Tabs 3 and following would each be a different affiliate, only including affiliations that are currently active!

I hope that I have not only answered your question, but also given you some tips on moving forward in your upcoming review process!
Sincerely,
Dr. NAACLS
 

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