Reagent, Materials, and Proper Labeling Review

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The page below is a sample from the LabCE course Inspection Preparation, Process, and Corrective Action. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Reagent, Materials, and Proper Labeling Review

As a part of the mock inspection, a detailed physical overview of all areas associated with the laboratory should take place. This detailed survey will be inclusive of all staff members on all shifts.
This process will include the following:
  1. Check all reagents, quality control materials, kits, swabs, collection tubes, etc., for expiration dates. In storage areas, be diligent about checking the bottom layer or supplies behind the front-facing items. This will verify that stock is appropriately stored and rotated per the expiration date.
  2. Verify that all appropriate items have been labeled with received, open, prepared, and expiration dates as required by institutional policy and procedure and good laboratory practice. Also, verify that all items, as appropriate, are logged into the materials management system, as required.
  3. Verify and issue reminders that all containers must be closed tightly with each use. Urine dipstick containers may be subject to hasty closing with caps left off or not tightly capped.
  4. Verify that all test kits contain all integral components that are intended to be included in each kit. Components of kits are not to be interchanged.
  5. Check all package inserts for manufacturer's requirements for modified expiration dates of quality control and testing materials. Verify that all open items have modified expiration dates marked, if applicable.
  6. Verify by comparison that the package inserts on file, and those being used as an operating procedure, are the most recent versions and are signed and dated by the laboratory director if they are being used as an operating procedure.
  7. Note sharps disposal containers. Verify that none are overfilled, that locations allow for the containers to be secured so they cannot tip or fall, and that containers are at eye level for the safety of users.
  8. Verify that all small equipment, such as microscopes and centrifuges, have appropriate biomedical examinations and performance checks completed and that these have been documented. This is often with a sticker on each piece of equipment.
As part of this process, including all point-of-care testing sites and remote locations both within and external to the main location. Small point-of-care instruments such as glucose meters are particularly vulnerable to having outdated reagents or improperly-stored supplies. It is wise to carefully inspect each item to verify that the manufacturer's instructions are being followed.
Immediately perform any corrective action and disposal. Following these steps, issue reminders and, if appropriate, retrain staff for items requiring corrective action. Follow up with ongoing checks that maintenance of corrective action steps is being implemented continuously.