Reprocessing Observation Checklist

Form Approved

OMB No. 0920-1011

Exp. Date 03/31/2017

Reprocessing Observation Checklist

(Adapted from AAMI Dialysis Standards, 2012 Edition)

Reprocessing Documentation Review	Yes/No
Is there a written reuse policy identifying:
staff in charge of reprocessing program and training
procedures specific to reuse method in use;
Quality control and monitoring
Are all operating logs complete (daily reprocessing records, water treatment records, etc.)?
Are required chemical and microbiological analyses current and properly documented?
Are repair and service logs complete?
Is a written complaint and incident file established and maintained?
Is training documented for staff members who operate and monitor the reprocessing system?
Observation of reprocessing process
Steps of the process
Header cleaning/precleaning
Header cleaning manual or machine (name of machine)
Reprocessing machine (name)
Documentation of completion for all steps
Operator manual available for all machines
Monitoring log available (for the machines)
How often are preventive maintenance procedures performed? Most recent (date)
Water system
Designed and installed appropriately
Monitored appropriately (review log?)
Most recent water testing result (?) within limit (cultures, endotoxin testing, and chemical analysis)
Dialyzer is tested for concentration of germicide before use
Method used
Log of test results is available
Result is within limit for a randomly-picked dialyzer
Reprocessing area
Is the processing area clean and sanitary
Reprocessing materials, hemodialyzers awaiting reprocessing, and reprocessed hemodialyzers should be stored so as to minimize deterioration, contamination, or breakage
Are new, used, and reprocessed dialyzers clearly segregated?
Are reprocessed dialyzers protected from casual access

Public reporting burden of this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74 Atlanta, Georgia 30333; ATTN: PRA (0920-1011)

Do reprocessing personnel wear appropriate personal protective equipment when performing reprocessing steps
Are appropriate washing facilities, eyewash stations, respirators and other personnel safety devices in place?
Supplies
Are supplies used for reprocessing certified or labeled by the supplier for dialyzer reprocessing
Are there written specifications or are the supplies labeled by the supplier for dialyzer reprocessing?
Does the policy call for first-in, first-out inventory control?
Are all supplies within the dates specified for use? (check one or two items)
Hemodialyzer labeling
Are all reprocessed dialyzers in use during treatment labeled for the patient
Does the labeling uniquely identify the patient who is using the dialyzer?
Are dialyzers being labeled before their first use in a treatment?
Are the labels updated after each use?
Does the reuse label obscure pertinent information on the manufacturer’s label
Is the blood path visible
Do dialyzer labels contain the patient’s name, number of reuses and date of last reprocessing?
What method is used to alert the staff of patients with the same or similar last names?
Are the dialyzers checked before use to ensure that an appropriate amount of time has passed since reprocessing the dialyzer?
Observe reprocessing process
Note set up and take down of reprocessed dialyzers on the treatment floor. Are dialyzers handled and transported in a clean and sanitary manner?
How soon after the end of treatment is a dialyzer to be reprocessed?
What is the policy and procedure when a dialyzer is not reprocessed within the recommended 2 hours?
If dialyzers are refrigerated, check the temperature and time logs to verify that they match the policy
Watch the precleaning process to confirm that maximum pressures or other limits for the dialyzer set by the dialyzer manufacturer are adhered to.
What chemicals are used in the reprocessing of dialyzers?
If more than one chemical is used to clean and disinfect a dialyzer is there information that validates that each chemical is reduced to safe levels before introduction of the next chemical and has no adverse effect on the dialyzer performance and integrity?
Is there a maximum storage temperature for the germicide in use, and if so, how is compliance documented?
How is the expiration of diluted chemicals documented?
What steps are taken to assure that expired germicide is not used?
Header cleaning
Do you remove header caps?
Do you remove O-ring?
What safeguard is in place to ensure the original O-ring and header caps are kept with their respective dialyzer?
Are instruments or other material used in header cleaning, and if so, are they new or cleaned and disinfected between uses and has the user determined that the instrument or material does not damage the end of the dialyzer?
Are properly disinfected port caps used?
Is the outside of reprocessed dialyzers cleaned with a low-level germicide?
Examine a number of randomly selected reprocessed dialyzers to ensure that external surfaces are clean, the dialyzer has not been damaged, the dialyzer has been satisfactorily rinsed of blood, and the appearance is aesthetically acceptable and properly labeled.
What do you do with failed dialyzers?
What is the maximum storage time for reprocessed dialyzers?
What happens to a dialyzer that exceeds maximum storage time?
Preparation and testing before use
What is the contact time for the chemical germicide used?
How is the presence of chemical germicide verified and documented
Residual germicide measured by an appropriate test (name of test)
What is the maximum allowable time between rinsing and testing the dialyzer and beginning dialysis?
Are reprocessing records complete, legible, signed, and secure