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• To ensure that treatments are performed utilizing an evaluable QA process.
• To ensure proficiency of staff who perform apheresis procedures.
• To ensure procedures are preformed utilizing safe and evaluable medical devices.

• To develop guidelines of quality assurance for apheresis procedures.

• The apheresis physician must have sufficient training and experience in clinical medicine to ensure that the apheresis client's health care needs are adequately met.
• There must be appropriate physician availability while therapeutic apheresis procedures are being done.
• Apheresis RN's must be currently certified as registered nurses in the relevant Province.
• Apheresis RN's must have current BCLS certificates.
• Documentation of ongoing competency of apheresis nurses must be available and up to date.
• Competency must be reviewed annually.
• Continuing education opportunities are made available to meet the needs of apheresis RN's
• RN's engage in self-evaluation practices and document evidence of ongoing professional growth on an annual basis.
• There are sufficient personnel with adequate documented training and experience available to meet the needs of the department

• There is adequate space available to safely perform apheresis procedures and allow for rapid access by emergency medical personnel.
• Fire/smoke detectors are present and functional.
• There is adequate ventilation in the space provided.
• Noise levels are at or below the decibels recommended by occupational health and safety guidelines.
• The temperature of the room is adequate to maintain comfort for both the client and the health care providers.
• There is a system in place to summon help in an emergency.

• All medical devices have been tested for electrical current leakage and documented as having adequate grounding.
• All cell separators have undergone preventive maintenance at least q6months.
• PM maintenance is documented and records of such retained for a period of not less than 5 years.
• Apheresis staff performs daily alarm checks.
• There is documentation of daily alarm checks.
• If a device does not pass alarm checks there is a documented mechanism to contact service technicians in a timely manner.
• Service requirements are documented.
• Machines are cleaned with virocidal solution after each use.
• There is a mechanism to monitor and document machine efficiency on a regular basis.
• Temperature controls for blood warmer devices are monitored on a regular basis.
• Documentation of temperature monitoring for blood warmer devices is available for review.
• All IV pumps are subject to regular preventive maintenance.
• All automated blood pressure devices are monitored for ongoing accuracy at least monthly.
• There is documentation of QC monitoring of automated BC devices.

• The apheresis unit should have a clear and easily interpreted organizational chart, which is accessible to all staff.
• There is a mission and vision statement for the healthcare institution overseeing apheresis procedures.
• Testing and competency records are kept and updated annually for all apheresis RN's.
• Preventive and ongoing maintenance records are maintained for all cell separators, as well as any additional medical devices, utilized by the apheresis unit staff.
• Supply documentation records are kept with regard to, record of receipt, lot numbers, expiration dates, and defective products.
• Practice guidelines of each type of therapeutic procedure are available.
• Practice guidelines for blood product ordering and handling are available.
• Practice guidelines for biohazardous waste disposal are available.
• S.O.P.'s of peripheral blood stem cell processing are available for the following:
• Client assessment
• Procedural
• Labeling
• Transportation to cryopreservation facility.
• Adverse events are reported and documented as per institutional guidelines.
• Serious adverse events are documented and reported to CAG.

• Validation is the establishment of evidence and records that assure a process, which when followed without deviation, will produce consistent results.