Audit

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?

Records are stored and materials retained according to Policy 3.04 Quality Assessment Attachment 4.

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)

Are the departmental policies located on the Policy and Procedure website?

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?

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.

Refrigerator and freezer temperatures are recorded daily. (for those areas where the lab is not operational on the weekend, appropriate notation is on the temperature chart and the max and min for the non-operational days has been recorded and verified.

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)

If patient samples are stored in non frost-free freezers the temperature range is ad only.

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)

Enviroment

Are all lights in working order?

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

Temperature and humidity are controlled. 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.

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.

Use of liquid nitrogen used within the laboratory is documented.

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

All employees are wearing gloves while handling patient specimens

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.

All hoods tested within the year.

All Common Checklist

Proficiency Testing attestations are signed by performing personnel.

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)

There are start-up, operation, and shutdown of instruments and equipment.

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

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.