Information
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Document No.
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Conducted on
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Department (Select one)
- Blood Bank
- Donor Center
- Microbiology
- Center City Chemistry
- Center City Hematology
- Immunology
- Flow Cytometry
- Electron Microscopy
- Molecular Pathology
- Central Receiving
- Jefferson Infusion Center
- JHN
- MHD
- Navy Yard
- Surgical Pathology
- Cytopathology
- Phleb (833 Chestnut)
- Phleb (Main)
- Phleb (Infusion)
- Phleb (Pavilion)
- Computer Services (Informatics)
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Prepared by
- Alex Vuong
- Raquel Dennis
- Lisa Hall
- Liam Nisenfeld
- Molly Kelly
- Lisa Morano
- Celena King
- David Peterson
- Angel Borishek-Quaile
- Peggy Rapa
- Kathy Schroeder
- Irma Silva
- Thomas Speakman
- Micheline Thera
- Vicky Ward
- Aryana Treweek
- Nandita Patel
Previous Audits
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Has the last audit been reviewed?
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Have all outstanding concerns been addressed?
Quality Management
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The laboratory has a procedure for employees and patients to communicate concerns about quality and safety.
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If any complaints have been noted, is there proper follow up?
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The official CAP sign is posted within the laboratory?
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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>
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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?
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All persons who package and ships infectious agents are trained.
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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?)
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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>
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All centrifuges have been checked within the last year.
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Thermometers used in the refrigerators and/or freezers have been verified and checked in the last year.
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The thermometers are not expired. (Some digital thermometers have an expiration date, please check all thermometers within your section)
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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)
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If yes above, is there a log.
Enviroment
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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.
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Is the temp and humidity of the room within acceptable limits? (see above log)
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Are all lights in working order?
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Are all ceiling tiles undamaged? (No water marks, damaged, or missing tiles)<br>
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Exposure to bright sunlight is minimized
Safety
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There is a comprehensive evacuation plan for the laboratory that includes accommodations for disabled persons.
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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>
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All fire extinguishers have been inspected and are up to date (check the tag on the extinguishers)
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All UV light sources have warning signs posted near the source.
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Chemical waste is disposed of properly per policy
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All sharps containers are below the required fill line
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All employees are wearing their lab coats while in the laboratory at the time of the inspection.
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All employees are wearing gloves while handling patient specimens at the time of the inspection.
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All fire alarm stations are visible and unobstructed.
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Heaters/fans in use? If so, are they approved by the QA Coordinator?
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Waste containers properly labeled.
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All flammable gas cylinders are secured.
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Eyewash maintenance up to date?
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Spill kits available and checked within the last year for effectiveness.
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All hoods tested within the year.
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Personal items are secured.
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Employees know the process for reporting a security incident, chemical spill, Code red? (Ask 2 employees) Dial 811 or 77 (MHD campus)
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Sharps containers filled below the indicator line or 3/4 capacity.
Accreditation items
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All staff know the location of the collection manual online. (ask a few staff members)
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All reagents are labeled appropriately. (an open date and expiration date should be on every container that is opened)
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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)
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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)
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The floors are clean.
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Storage (boxes etc.) and equipment are no less that 18" from the bottom of a sprinkle head
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Storage (boxes etc.) are 6" above the floor
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Additional findings?
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