Audit

Previous Audits

Has the last audit been reviewed?

Have all outstanding concerns been addressed?

Quality Management

The laboratory has a procedure for employees and patients to communicate concerns about quality and safety.

If any complaints have been noted, is there proper follow up?

The official CAP sign is posted within the laboratory?

If there are specimen collectors or phlebotomists in the department you are inspecting, have those individuals been trained on proper collection and is there supporting documentation for this training? (Select N/A if not applicable)

If the lab allows for mislabeled specimens to be relabeled, is there documentation of this change that includes a signature of the person relabeling the specimen?

All persons who package and ships infectious agents are trained.

If your area stores specimen collection devices (blood collection tubes, transport media, culture swabs) are not expired and stored per manufacturer recommendations. (Note: check to see if there are temp. requirements. If there are temp. requirements, is the temp monitored?)

Do all specimen requisitions have the following elements:
Patient Identification
Patient Sex
Patient's DOB
Name and address of the physician ordering the test (OUTPATIENT ONLY)
Test(s) requested
Last menstrual period (for gyn specimens ONLY)
Time and date of specimen collection (can be on the container)

All centrifuges have been checked within the last year.

Thermometers used in the refrigerators and/or freezers have been verified and checked in the last year.

The thermometers are not expired. (Some digital thermometers have an expiration date, please check all thermometers within your section)

Glassware used in the laboratory is cleaned appropriately and methods to ensure complete removal of detergents (if this is applicable to the lab there must be documentation of the cleaning)

If yes above, is there a log.

Enviroment

If instruments, reagents stored outside a refrigerator or freezer, and/or collection devices require a specified temp/humid range, the temperature and/or humidity is checked and documented daily.

Is the temp and humidity of the room within acceptable limits? (see above log)

Are all lights in working order?

Are all ceiling tiles undamaged? (No water marks, damaged, or missing tiles)

Exposure to bright sunlight is minimized

Safety

There is a comprehensive evacuation plan for the laboratory that includes accommodations for disabled persons.

All employees in the laboratory know where to locate the SDS. (Ask up to 3 employees, correct answers include online and books located within your lab)

All fire extinguishers have been inspected and are up to date (check the tag on the extinguishers)

All UV light sources have warning signs posted near the source.

Chemical waste is disposed of properly per policy

All sharps containers are below the required fill line

All employees are wearing their lab coats while in the laboratory at the time of the inspection.

All employees are wearing gloves while handling patient specimens at the time of the inspection.

All fire alarm stations are visible and unobstructed.

Heaters/fans in use? If so, are they approved by the QA Coordinator?

Waste containers properly labeled.

All flammable gas cylinders are secured.

Eyewash maintenance up to date?

Spill kits available and checked within the last year for effectiveness.

All hoods tested within the year.

Personal items are secured.

Employees know the process for reporting a security incident, chemical spill, Code red? (Ask 2 employees) Dial 811 or 77 (MHD campus)

Sharps containers filled below the indicator line or 3/4 capacity.

Accreditation items

All staff know the location of the collection manual online. (ask a few staff members)

All reagents are labeled appropriately. (an open date and expiration date should be on every container that is opened)

All reagents are not expired. (If an expiration date is not indicated by the manufacturer the lab must assign one based on stability of the product)

All secondary containers are properly labeled (secondary containers are defined as any container where a chemical and/or reagent is poured into from the manufacturer's container) (Proper labeling includes but is not limited to full name of the chemical/reagent, a warning label and the date of transfer)

The floors are clean.

Storage (boxes etc.) and equipment are no less that 18" from the bottom of a sprinkle head

Storage (boxes etc.) are 6" above the floor

Additional findings?

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Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things, workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to determine if the use of such checklist is permissible in your workplace or jurisdiction.