I am sorry about this but the job is never done until the paperwork is done. So, this is how I organized my paper work for the Perfusion Department.  It is based on a Quality Management System that I picked up decades ago but I can not remember where.  It might have been from the American Association of Blood Banks.

There are ten core essentials to a QMS. Each core essential has its own policy or policies, processes and procedures.

  1. Authority structure. What authority are you working under? Who is in charge?
  2. Personnel, orientation, training and continuing education, students. Call schedules, evaluations, meeting attendance.
  3. Equipment. What is it? Where is it? Is it maintained? Recalls?
  4. Supplier and customer issues. How do you choose suppliers, supplies and equipment? How is new equipment evaluated and chosen?
  5. Clinical care process. How do you run the pump?
  6. Documentation and document control. What are you going to document? Who writes the documents? Who approves the documents? What standardized form do the documents take?
  7. Errors, accidents and adverse outcomes. What do you do if something goes wrong?
  8. Appraisals; quality control, competencies, self-assessments and external inspections. How well are you doing? How do others assess your performance?
  9. Quality Improvement. Can you do any better?
  10. Workplace safety and equipment. Are you and your patients safe in your working environment?

Policy Definition

A policy is a documented general principle that guides (directs) present and future decisions.

Example: “Perfusion License Policy: all perfusionists will be licensed or have a provisional license at the time of employment.”

Process Definition

A process is a set of related tasks, activities or procedures that accomplish a work goal, i.e., that transforms input into output products and services.

Example: CPB Process; contains the itemization of the many procedures used in the operation of the open heart pump, i.e., priming, DHCA, cardioplegia, ultrafiltration, sweep gas control, etc. When a trainee has shown competency in all of the procedures of the process, orientation for that process is completed.

Procedure Definition

A procedure is a set of tasks usually performed by one person according to instructions. Example:  Priming the CPB pump. When a trainee performs a procedure correctly, competency is documented.

Competency Definition

Competency is a record of personnel training for a process or procedure. Example: CPB orientation competency. When a trainee performs a procedure correctly, competency is documented.

When competency of all of the procedures needed to operate the open heart pump are documented, the trainee becomes competent in the CPB process.

Ancillary Document Definition

An ancillary document is descriptive of a Core Essential but not a policy, process or procedure.

Example: organizational chart.


Working Document Definition

A working document is a record of a process or procedure. Example: Perfusion flow sheet. Forms are blank records.

Eliminate other terms such as ‘guidelines’ or ‘protocol’ or ‘plan’ or give them specific definitions that do not conflict with the above definitions.

Numbering structure of a QMS

The first number in sequence indicates the specific Core Essential. The second number or letter indicates if it is an ancillary document or a policy. The third number indicates a process. The fourth indicates a procedure. The fifth sequential number indicates working document. A three number process or a four number procedure immediately followed by a C indicates a competency document.

Number Cascade

  1. Core Essential

1.A         Ancillary Documents – descriptive of Core Essential but not policy, process or procedure. Example: organizational chart

1.1          Policy    – A policy would cover one or more processes and/or procedures.

1.1.1      Process  – One or more processes would usually be under a policy.  Procedure – One or more procedures would usually be under a process. Working document

1.1.1C Competency document for a process.  Competency document for a procedure.

Filling In The Blanks

1.2.        Policy-   Some stand alone w/o any processes or procedures. Example: Policy on giving “breaks” during cases.

1.0.2      Process – Some aren’t covered by a policy. Procedure – Some aren’t covered by a policy or and process. Working document – Some may be generated w/o a written process or procedure.

Master list of documents:

A master list of documents shall be maintained and controlled by the Chief Perfusionist.  The list should include the following:

  1. Title of document
  2. Holder of document
  3. Current revision number
  4. Date of implementation

Standardized Format

All documents created for Perfusion Services should be in a standardized format that complies with hospital policy on documents and include the following items as applicable:

  1. Date written
  2. Purpose of document: what does it do? Is it a policy, process or procedure or some other document?
  3. Special Considerations: i.e., specifically qualified, competent people.
  4. Equipment: Is any equipment required? Is equipment safety documented?
  5. Exceptions: Example: “Emergent needs of the patient may supersede this procedure.”
  6. Description of the policy, process or procedure and instructions.
  7. Documentation: completion of required records.
  8. Quality Control: required with any patient related process or procedure. Ensure that the task is performed correctly; Examples; is there a checklist or record co-signer.
  9. Nonconformance: document any failure to comply with policy, process or procedure.
  10. Validation: required with any patient related process or procedure. Prove that it does what it is supposed to do.
  11. Review Period: Annually, semiannually
  12. Author: who wrote the document?
  13. Reviewer: who reviewed and approved the document?
  14. Storage: Where is the original kept.
  15. Archives: Unless a different time frame is mandated by an outside inspector or credentialing agency, policies, process and procedures related to patient care should be archived for twenty years after the date of retirement or replacement. All others should be archived for ten years.
  16. Document Development and Approval Process: Documents relating to patient care standards are developed according to the accepted hospital standards.
  17. References: Recent, if applicable.

Development and approval of documents:  New documents shall be written by competent personnel familiar with the subject being addressed and approved by the appropriate personnel prior to distribution.

Annual review: An annual review of all documents shall be carried out by the Chief Perfusionist or his designate.

Current and valid documents: Only documents currently approved and validated for use shall be utilized.

Archived documents: Obsolete documents shall be dated, marked “obsolete” and maintained for historical purposes.  Obsolete documents shall be maintained for a minimum of 5 years or in accordance with hospital policy or governmental law.


Facility records:  Records shall be completed and copied (if necessary) and placed with the patient chart or department files, as appropriate.

Copies of records:  A process shall be developed to ensure that copies of the original records are accurate, legible, complete and accessible.

Restricted access to patient records:  A process shall be developed that complies with hospital policy and governmental law to prevent unauthorized access to patient records or record copies.

Perfusion Services trace by record:  A processes shall be developed that records perfusion services personnel, equipment and disposable supplies utilized during any perfusion services application.

Computer Systems:

Documents, forms and record may be kept in computerized form if they are within substantial compliance to policy.


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Perfusion Theory is an educational platform for the Oxygen Pressure Field Theory (OPFT). August Krogh’s theoretical concept of the oxygen pressure field is explained and then applied to clinical applications in perfusion practice.

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