QA/Compliance Position

[jasonviau]

I have requested that a new position be created in my Transfusion Service department for QA/Compliance. Not too surprisingly, I'm having some trouble getting it approved. I was hoping that someone would be willing to share info about their facility. Are you AABB accredited? Bed number and services provided? Do you have an individual (or individuals) whose primary responsibility is QA/Compliance, or is it included with other duties? How many techs, senior techs, supervisors? I am the lone supervisor of an AABB accredited Transfusion Service at a 299 bed, urban, Level II trauma center and teaching hospital. There are 8 technologists in my department to cover 24/7. All of the QA/Compliance stuff is currently falling on my shoulders along with the regular supervisory duties. Any info would be appreciated.

[Cliff]

Hi Jason,

Welcome to our forum.

I am the compliance officer of a Boston teaching hospital. We have two small donor centers and a 750 bed hospital. The transfusion service is very active, we transfuse about 37,000 rbc / year.

I have one part time person who works for me. In all we have about 100 staff which includes the supervisors and medical directors.

My position came about around 8 year ago when we had a less than favorable FDA inspection. Unfortunately this can be the impetus for positions like mine. It's a tough financial decision for a lab to make to support a full time compliance position.

Since you are meeting some resistance, maybe the request could be for a part time person? A full time compliance person in a lab your size could be more than you will need. Granted, it might feel like you need it now, but once things stabilize a little, they will have less to do. Just a thought.

Good luck and welcome again.

[Myella]

Hi Cliff,

We have a compliance officer in our lab that was also created about the same time yours did. It was also the corrective action due to our FDA deficiency for not meeting having a compliance officer in the blood bank or something. The problem is, that compliance officer's duties is now mainly overseeing the whole laboratory. I am a bench tech who is doing most of the blood bank QA whenever I am pulled from the bench. They hardly give me the time to do it, so our Quality Program is not in compliance if someone really takes a good look during an inspection.

We are also a teaching institution and a trauma center. Our size is probably almost the same and we have a small donor center. I think we transfused a little more than your facility. Do you also oversee the whole laboratory, in addition to the Blood Bank?

[QDeb]

I am a Quality Assurance Officer for a 6-facility hospital system. My sole job is Quality Assurance for Transfusion Services for the 6 hospitals. It is a huge job. I am resposnsible for maintaining the Quality System manual; Creating, performing, compiling and presenting audits/monitors and assessments (all aspects of transfusion - biomed, nursing, Transfusion Services, etc.); Compiling data, and many times doing a more involved analysis of the incident, on errors, complaints, and process problems (again for all aspets of transfusion-both in and outside of the transfusion services department); I chair the Executive Council for Transfusion Services; I create and review validation plans (equipment and policy/procedure); I fill out and submit BPDR's for FDA. Quarterly and annual reports (comparison of info over time) are developed as a system, as a system comparison between the facilities and as individual facilities. For nursing audits, they may also be broken down to individual nursing units. I am also part of root cause analysis team.

In this system (over 1500 beds) there is both a Level I and a Level II trauma center (274 beds) along with 4 other community based facilities. So I can relate to your size and scope.

I love my job. It is overwhelming at times. I never feel as though I am doing all that I should be doing to do the job justice. Having an individual to do what I do for a single facility could be very rewarding for both the individual and the faciltiy - not only could that individual keep up with everything much better than I can but he/she could perform assessments to evaluate every aspect of the quality system on a routine basis (I find it difficult to do more than 1-2 major assessments across the system). They could do a much better job of documenting corrective and preventative actions and their effectiveness. And, keep up with the policies, processes and procedures of the quality system. It is much better to be knowledgeable of the problems then be informed of them by an outside/external agency i.e. FDA, JCAHO, HCFA, CMS.

Good Luck!!!

[Cliff]

I am responsible for just the compliance of our donor centers and transfusion service. I also have one person who works 32 hours that reports to me. Even with this we always feel behind. Our clinical laboratories has a separate individual responsible for laboratory compliance. We do not report to one another but work closely together. Our department is not part of the clinical labs, but part of pathology instead.

Hi Cliff,

We have a compliance officer in our lab that was also created about the same time yours did. It was also the corrective action due to our FDA deficiency for not meeting having a compliance officer in the blood bank or something. The problem is, that compliance officer's duties is now mainly overseeing the whole laboratory. I am a bench tech who is doing most of the blood bank QA whenever I am pulled from the bench. They hardly give me the time to do it, so our Quality Program is not in compliance if someone really takes a good look during an inspection.

We are also a teaching institution and a trauma center. Our size is probably almost the same and we have a small donor center. I think we transfused a little more than your facility. Do you also oversee the whole laboratory, in addition to the Blood Bank?

[sgoertzen]

I am the Transfusion Service supervisor of a 250 bed pediatric hospital. We are AABB Accredited and CAP Accredited. Because we have an on-site blood irradiator and COBE washer (for washing rbc units), we are also FDA registered and have a state license for the manufacture of biologics, so we also get FDA and State inspected every other year. I am responsible for the clinical training and competency of 28 med techs who rotate through my department 24/7. I have 2 "lead" techs on the day shift who also rotate through hematology and chemistry, but whose primary department is transfusion. They do most of the training and they both help me quite a bit in maintaining my QA program, but I am responsible for all of the technical, personnel and QA oversight of my department. I don't have a QA/Compliance person.