Information

  • Document No.

  • Conducted on

  • Department (Select one)

  • Prepared by

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)<br>

  • 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:<br>Patient Identification<br>Patient Sex<br>Patient's DOB<br>Name and address of the physician ordering the test (OUTPATIENT ONLY)<br>Test(s) requested<br>Last menstrual period (for gyn specimens ONLY)<br>Time and date of specimen collection (can be on the container)<br>

  • 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)<br>

  • 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)<br>

  • 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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