Blood Bank computer modifications with no notice

[mcgouc]

Does anyone else have this problem and what do you do about it?  I work in a hospital for a corporation where multiple hospitals use the same computer system.   Local hospital BB employees do not have access to see, much less change, the truth tables in this computer.  However, corporate makes changes in the BB computer system with no notice (or discussion of the change).  The other day we were performing the second ABORh on a patient and there was a new reaction column (that we don't use on recheck types) added to the result field.  When we entered correct results for the test with a NT in the new column, there was a warning "no pattern match".  A few minutes later, these reactions worked.  I did various tests to ensure calculations were correct.  About 6 hours later, after I had left for the day, corporate emailed me that they had changed this test and we needed to validate it immediately.  Last week I was on vacation and it would have been 6 days before I saw that email which was the first notice I had received about the change, forget having input.   Recently, second shift couldn't issue uncrossmatched packed cells (even O negs) because somebody somewhere accidentally changed something.  When I demanded an explanation of what happened,  they couldn't track when and who made the change.  I know the way these changes are made do not meet any regulations.  My Lab Director shrugs his shoulders.  I have talked and talked to the computer people and demanded explanations and am told they are trying to get BB under more control, but nothing changes.  We do not have a lab IT person so I am trying to do all of my other duties while working a bench and handling these problems.   I document all of these as deviations, but that goes nowhere in this facility.   I finally modified my validation policy to include a section on validating changes made by corporate with no notice.    Any ideas on how to handle this problem?

[Dansket]

You have a right, without fear of retaliation, to contact your laboratory's accrediting agency(ies) regarding this issue.

[cthherbal ☆]

If you are AABB Accredited there is a standard requiring validation of changes to the LIS for Transfusion Service activities. I have a policy specific to this with verbiage right out of the standard. Is it possible to bring this to the attention of Risk Management, Quality, or Transfusion Committee? If you can't get any support, I would contact AABB, etc. as DANSKET suggested.

[Dr. Pepper]

I'm guessing that someone, maybe a supervisor at one of the other hospitals, has the access to do so or the ear of the IT people who make background dictionary changes (I shudder to think that a non-lab person is just doing this on their own). If IT says they are unable to determine why, who and when changes were made, they are either lying, or the department is careening down the road totally out of control.If changes are made (or being considered) it's just common courtesy to let other users know. Who "in corporate" emailed you? Are they aware that every agency under the sun requires validation before changes are made?

If you have truely exhausted all your avenues of communication, including going up the food chain in your hospital, then you can blow the whistle, as Dan mentions, to CAP, AABB, your state DOH etc. If your lab manager, lab/BB medical director, lab and hospital compliance officers, lab administrator, head of IT, transfusion committee all shrug their shoulders, you have my deepest sympathies. Good luck, and keep us posted.

[tbostock]

They need to follow an established Change Control format. All Blood Bank Supervisors need to review changes, validate them, and inform staff of changes BEFORE it is implemented.

I'm hoping your Medical Director involved in this will help?

[goodchild]

Pointing out the blood bank requirements is one thing but there also regulations governing change control documentation for hospital information systems. I don't have any references myself because it's not my field.

I just remember our IS department had a hammer come down on them after an inspection a few years ago and now getting even a canned comment added to the LIS requires the sacrifice of a fattened lamb, a completed TPS report with coversheet and seventeen signatures.

[L106]

Along with everyone else's appropriate comments............Surely your computer system has a "Training" or "Test" system, right?  What the heck does whoever is making these changes think the "Training/Test" system is for??

 

As Teri said....You make the change in the Training/Test system, validate the change, train the users, THEN implement the change.

[mcgouc]

 Thanks to everyone for your advice.   I am going to ask the corporate employees in charge of the reviews and changes for a root cause analysis as to why computer changes keep occurring with little or no notification and validation. If the only response is for me to be counseled (another tech at another facility has already been told she was too harsh in telling her manager she would report to FDA if this continues), I will escalate the complaint.   Corporate has a change control program - they just do not follow it.  We are supposed to submit a change report, a standards committee reviews it, it is loaded into "test" and a production notice is sent to affected sites that it will go into live on a certain date - usually about a week.  When I went into the "test" system to validate the ABORh recheck the other day (even though it was in live already), there was a third version in test.  The A,B column was added, but the reverse testing reactions had been removed.   We perform electronic crossmatches so I guess I should be thankful they didn't load what is in test into the live system with no notice.    My Medical Director has not been at work since I completed this validation.  (Plus, I had to perform another validation Friday of a change that went into effect today that I had known nothing about before Friday morning.)   I never worked in a place where an employee says he can't do something and my first thought is that they changed the computer again.  

[tricore]

I am an IT analyst, primarily Blood Bank. If you have a change control procedure and the company is not following it you have serious problems. If you do not have a change control SOP you have serious problems. This is CMPs and regulatory.

Was the BB SOP changed and made to accommodate the new column?

IT should NEVER make changes as was done in your system without consultation with all of the users who will be affected by the change.

We never make requested changes without receiving a System Change Request which must be signed by a manager or director. We have a ticketing system where all changes are recorded.The request is built and validated in the TEST system. If it is something that will affect all sites it is discussed in the Transfusion Management Workgroup before the change is requested. The exception is adding new bone/tissue codes or comment codes. These are usually built at the resquest of one site. If the other sites do not want or need to use it, it is not a problem.

Sometimes I validate and sometimes the requestor validates. Not until then is it moved to the production system. If it affects all sites a notice goes out to all sites.

If procedure changes are needed the item is not moved into production unitl the SOPs have been changed.

There is nothing worse than to log in, perform a test and find out the rules have been changed.

[David Saikin]

If all else fails, the FDA has policies on Medical Devices of which your BBIS is considered one.  These include change control policies and processes.  Every other accrediting agency can slap your wrist - the Feds can take you jail when they walk out.  They are a powerful tool to use . . . if all else fails. 

[Likewine99]

Like tricore, I am and IT person and my primary function is Blood Bank.  I am a "corporate employee" and maintain the BB system for 8 and soon to be 11 separate BBs within our system.

 

Everyone who has posted here is absolutely correct, your institution must have a highly structured, well defined change control process and a method to communicate changes to your end users.  All changes need to be thoroughly tested and the appropriate documentation generated and maintained for your accrediting agencies.  

 

We do not have "standard" build but it is tailored to each site, our BBs do not have standard testing methodologies (yet).

 

Would it be possible to talk to someone in your Corporate Compliance department.  Your IT dept is violating all kinds of rules and regulations by just moving things into production w/o thorough validation and end user training?

 

This presents a risk to pt safety which should get the ear of the compliance people.  At the bare minimum you need to talk to the manager of the IT team.  Being part of a corporation leads me to believe that there are other hospitals in your group and your IT people are probably making these changes w/o proper validation at other sites within your system.

 

Yes, IT change control is long and involved and not always a quick process, but knowing that your testing results affect a patient should never be taken lightly, especially by someone working in lab IT.