critical materials receipt and instructions for use

[Mabel Adams]

Does anyone have a really slick system for incoming reagents etc. (critical materials) to meet the AABB standard to inspect and accept them? Also, to make sure that the manufacturer's instructions on file are the most current? Every way that I can think of doing it seems to be labor-intensive, cumbersome and prone to oversiights.

Since Ortho doesn't seem to be sending us notices that they are updating their instructions like I recall that they said they would when they quit putting them in every package, it seems like we need to have a better system for catching revised instructions.

[jgabbard]

We use an excel spreadsheet that is accessible to all of our blood bank techs. Each reagent has a tab on the spreadsheet. We record the date of kit insert for each lot number/shipment we receive and save/implement a copy when they change.

I've attached a blank copy of the spreadsheet if you want to look at it.

[JOANBALONE]

Hi jgabbard,

How do you keep track of "dates in use/finish"?

JB

[Eagle Eye]

It seems like a good way to track reagents. How many techs are handeling this spreadsheet? How do you ensure the tacking of the document? what if someone changes previously made enteries in error.

We use an excel spreadsheet that is accessible to all of our blood bank techs. Each reagent has a tab on the spreadsheet. We record the date of kit insert for each lot number/shipment we receive and save/implement a copy when they change.

I've attached a blank copy of the spreadsheet if you want to look at it.

[Mabel Adams]

Jgabbard, do you use any Ortho reagents? Since their instructions don't come in the box we would need a system for checking the instruction version number on the product when it arrives and printing off the new instructions when they change. Does anyone have a good way of handling this issue?

[L106]

I wrestled with this, too. We enter our reagent receipt info into our Blood Bank computer. This captures all the necessary info except there is no documentation whether there has been any change in the manufacturer's package inserts.

I decided to handle this check myself (since if there is a change in the package insert, I have to make sure all staff are informed.) I designed a very basic form that includes the follow information: Name of Reagent, Lot #, Date Received, Date of Pkg Insert, Any Change?, Comments, My Initials.

I have a binder with a sheet for every reagent. We routinely receive reagent shipments on Thursday, so typically on Friday I document the new reagents we received and fill out the forms. (I was surprised that it usually takes me only 10 minutes.) (If there are any significant changes, I post a memo for the staff to read and sign-off.)

[jgabbard]

How do you keep track of "dates in use/finish"?

JB

When a new bottle is opened we are supposed to check the speadsheet and update the information. The same goes for when discarding a bottle.

Unfortunately that doesn't always happen.

[jgabbard]

It seems like a good way to track reagents. How many techs are handeling this spreadsheet? How do you ensure the tacking of the document? what if someone changes previously made enteries in error.

Only the blood bank techs have access to the file, there are 6 of us right now. We don't have a way to ensure that people don't delete items in error, don't fill it out, etc. We do print it periodically to have a hard copy incase of downtime/data loss.

[jgabbard]

Jgabbard, do you use any Ortho reagents? Since their instructions don't come in the box we would need a system for checking the instruction version number on the product when it arrives and printing off the new instructions when they change. Does anyone have a good way of handling this issue?

We don't use Ortho, all of the reagents that we use come with a kit insert.

[AMcCord]

Hi jgabbard,

How do you keep track of "dates in use/finish"?

JB

I use a crude method that seems to work pretty well. I have a package of self-stick labels that I preprint with info like reagent name, date received, lot #, OD, date opened, tech. There is a line for each piece of info. When we receive a new shipment, a label is filled out except for date opened and tech. A label is wrapped around one vial of each new reagent shipment with a rubber band or placed in the clam shell of kits. I have trays that hold reagents in use by reagent type. When I add new reagents to the tray slots, the vial with the new lot/shipment sticker goes to the head of the line for that batch of reagent vials. The techs here know that when they find a reagent with a sticker it's a new lot which requires QC prior to use and they know they have to complete the sticker with the open date/initials. The sticker goes on a piece of paper in a clipboard designated for that purpose. I periodically go through the stickers and update my Excel reagent spreadsheets. It's simple to use and I get excellent compliance.

[Deny Morlino]

When a new lot is received a new lot verification of performance occurs. I must review all of these documents and sign them as reviewed. There is a comment stating that the technical supervisor's signature indicates that the package insert has been checked for updates / changes. This puts the "burden" on my shoulders, but this way I am assured that the t's are crossed and the i's dotted on this issue.

When we receive a new lot of reagents, it is tagged with an orange sticker from a "dating" gun (sort of like the guns the supermarkets used in the past to place prices on items). This color indicated that the item has been received, but a new lot verification and QC need to be performed prior to the lot's use. Once the new lot verification has been performed, a blue sticker (3/4" Avery round stickers) is placed on all items in the lot indicating that the new lot verification has occurred. When the lot goes into use a green sticker (same as the blue stickers) is placed over the blue sticker on the entire lot and a date placed on each item as the bottle or rack of cards, etc is placed into use. This is the system we have used here for over 20 years and it works well for us. The lot changes are documented in the workbook as appropriate to allow tracking of reagent change down to the specific specimen a lot was started upon. The change of lot number is documented in red ink in the workbook to make it easier to find.

[Mabel Adams]

If you have defined any supplies besides reagents as "critical materials" do you keep track of them the same way as reagents? They don't all have lot numbers and they don't have instructions for use, but we would be hard pressed to do our work without pipet tips or tubes etc. If you have a separate form or idea for these items please post.

[Laurie Underwood]

We also use a similar spreadsheet as jgabbard. When we receive a new lot # in, we record it on the spreadsheet and place a "New Lot" sticker on the box, so when we start to use it, the tech will record the in use date on the spreadsheet. We do use some Ortho reagents. We have the Ortho site to look up package inserts under "Favorites" on all of our Blood Bank computers, to make for easy access when receiving in rgts. We record insert date and see if the insert has been updated.

[Thad Czuba]

We have about 40 Technologists that enter all supplies in One log book, with about 40 tabs. Each reagent or Critical material has a page and is logged in, inspected and direction circular reviewed or placed for new review by QA-Coordinator for changes.

Has worked well for over 15 years.

Placed into use is logged on daily QC sheet.

"NEW VIAL" Log is used whenever a new vial is opened on a bench.

Will share our SOP on request. Also includes the ORTHO Instruction. We are currently revising and updating this SOP, so it will be improving soon.

[webersl]

We use ortho, immucor and biotest. We use an excel spread much like the one already presented, but we do not separate reagents onto different tabs (because can sort, or use filters or "find") and ours has a column to type the mfg insert revision number into. When receiving in Ortho, techs have to look it up on the ortho website each time and compare the rev number on the website to the last rev number given. (Or they can use "find" to type in the new rev # and see if it was already the log or not.) When a tech hovers over the rev change Y/N spot, there is a caption that tells them that they need to notify the supervisor of any change. There are columns for havign notified supervisor and comments, if the rev number has changed. There is a column for me to comment when/how staff were notified of changes. It is working out much better than previous paper log system. I will admit that I have better than average Excel skills, so we are able to bend Excel to our will more easily, perhaps, than others. To avoid accidental changes, Excel does have a feature where cells can be "locked" so that no one can change them. I haven't done this, but I could start "locking" the previous entries every so often. Also, IT can help you set it up so that the file is protected so that only you have the authority to completely delete the file.

[kirkaw]

I use a spreadsheet system too, but it's paper and stays in a notebook. On the spreadsheet, we record the date of receipt, lot #, expiration and date put in use. The notebook is managed by all staff since supplies come in on different days and new reagents may be pulled on all/any shifts.

I have been reviewing the spreadsheets and have noticed that for the past 3 months, we have been slack about filling out when supplies are put in use. Is this an AABB requirement? CAP? JCAHO?

Thanks

[JOANBALONE]

I use a spreadsheet system too, but it's paper and stays in a notebook. On the spreadsheet, we record the date of receipt, lot #, expiration and date put in use. The notebook is managed by all staff since supplies come in on different days and new reagents may be pulled on all/any shifts.

I have been reviewing the spreadsheets and have noticed that for the past 3 months, we have been slack about filling out when supplies are put in use. Is this an AABB requirement? CAP? JCAHO?

Thanks

It is a CAP requirement for sure. I am wondering what people consider "date in use"?

JB

[crldehart]

Jgabbard, do you use any Ortho reagents? Since their instructions don't come in the box we would need a system for checking the instruction version number on the product when it arrives and printing off the new instructions when they change. Does anyone have a good way of handling this issue?

We maintain a log for receipt, open dates with lot numbers and date of package insert. For the Ortho products, there is an "e" number (electronic) for the Instructions for use on line, or a "J" number. We record this number. If it changes, the material is quarantined until the electronic instructions can be printed from the Ortho web site. We sometimes have to open cases to get the number from the individual sleeves of Gel cards. Immucor package inserts also have an ID/bar code number which we handle the same way. A bright green card is taped or rubber-banded to each unit to be opened(set, kit, vial). Whenever the product is opened, the open date in written on the card and left for day shift to record on the log. works well.After the new instructions are reviewed, a notation is made in the log, stating whether any procedural changes were needed

[EDibble]

We use HCLL for our BB IS, and when a new reagent comes in, all this information is entered in the reagent inventory section. We use Immucor reagents, each of which comes with a product insert. We check the product insert revision date on each one to see if it is different than the previous one. If so, we generate the necessary paperwork, if not, we are all set.

This is only done by day shift BB techs.

When a new lot of reagent is opened, a comment is added to the reagent in question in this inventory saying when it was put into use.

It is nice that we have this functionality built into our system already!

:D:D

[CGLENN]

We use HCLL for our BB IS, and when a new reagent comes in, all this information is entered in the reagent inventory section. We use Immucor reagents, each of which comes with a product insert. We check the product insert revision date on each one to see if it is different than the previous one. If so, we generate the necessary paperwork, if not, we are all set.

This is only done by day shift BB techs.

When a new lot of reagent is opened, a comment is added to the reagent in question in this inventory saying when it was put into use.

It is nice that we have this functionality built into our system already!

:D:D

We have HCLL also, but when I tried to go back and retrieve information on reagents that were no longer in use (outdated), I found that we are only set up to retrieve records on those that are still active in the system.  How do you manage to pull them out?

[tkakin]

Jgabbard, do you use any Ortho reagents? Since their instructions don't come in the box we would need a system for checking the instruction version number on the product when it arrives and printing off the new instructions when they change. Does anyone have a good way of handling this issue?

Hi Mabel,

We go to the Ortho web site to check the package insert version on each new shipment.  I put the latest version on thereagent list, so it can be compared.

[tkakin]

I wanted to also mention that we have it on the favorites bar for technical documents instruction for use,

so it is easy to get to.