For Blood / Biologics

A Myriad of Documents - Is there Control?
by Marianne A. Silva, MS, MT(ASCP)SBB, CQA(ASQ)

Document control is an issue for every laboratory. The words in the requirements seem so simple: control your documents. How can so much effort be involved in three words?

Many times the issue is not "did we perform the testing" but can we locate the documentation to support it?

Clinical laboratories struggle with documentation because, due to regulatory requirements, so much of the daily work life involves documenting something. We document the time of arrival, quality control of reagents, maintenance on equipment, inventory, laboratory test results and the reporting of test results to physicians. We generate procedures, document that staff are trained in those procedures, investigate unexpected events and evaluate the effectiveness of corrective action. We take a second look at the outcome of our daily work as we conduct audits and make an independent evaluation of the quality of work performed. Thereafter, a representative of a regulatory or accrediting organization reviews and evaluates the compilation of information. Documentation surrounds our work life.

Many times the issue is not "did we perform the testing" but can we locate the documentation to support it? Once we locate the appropriate document, is it organized and is the criteria for acceptability of test results available so an adequate assessment can be made? There are many opportunities to improve our system of documents and records, and regulatory and accrediting agencies have identified a number of these areas. The more common issues identified include documentation of training, equipment, supplies, process control, SOPs, recordkeeping and management of deviations with associated follow-up activities.

Training
Some form of training occurs in all facilities; the depth of documentation of the training event may vary, but there is usually some form of documentation that supports the fact that certain individuals have been trained. The question is usually "Who is trained in what activity?" Many facilities develop spreadsheets or tables to help track the information. This is certainly an option, but the table or spreadsheet can become quite large and unwieldy, particularly when the staff works in multiple areas of the laboratory.

Some facilities develop an audit to evaluate their training documentation program by identifying who performed a specific task, and then verifying that training documents exist to support that the individual was qualified and deemed competent to perform the task. This can be a time-consuming but enlightening endeavor. Unfortunately, this type of investigation usually reveals that staff has not completed training in regard to necessary procedures, or in regard to updates to procedures. A system to track training must be implemented that will ensure that staff who are responsible for the completion of specific tasks are trained in the task, and are informed of updates or revisions.

Generating the documentation to support that training occurred, that it was sufficient to support the completion of the task, and to have that information updated and available on an ongoing basis can be cumbersome.

Equipment Records
Many facilities outsource the calibration, maintenance and repair of equipment to another department or to an outside vendor. Experience has shown that some facilities have compiled a series of receipts and consider that to be documentation of preventive maintenance. Clearly, documentation must include what was done and an assessment of suitability for continued service. Review of the results of maintenance and repair records must occur in a timely manner such that corrective action can be initiated, if indicated. Documentation of the review, additional action or investigation of testing performed using that equipment is required if the unit was deemed to be "out of specification" at any time. When repairs or maintenance of equipment is performed by someone outside the department, the responsibility for ensuring the documentation is complete and the results acceptable belongs with the party initiating the request. Documentation of equipment calibration, maintenance and repair should be readily retrievable and allow an assessment of equipment performance over time.

Coordinating maintenance schedules, documentation of repair and follow up actions can be time-consuming in any laboratory, as the types of equipment and the functions they perform can be diverse. The development of a schedule that is consistent with manufacturer's recommendations as well as regulatory and accreditation requirements, and the outcome of each maintenance or repair event will provide the documentation necessary to evaluate your level of compliance with requirements and the stability of equipment performance.

Supplies, Suppliers
The importance of supplies and supplier qualification has become an increasing concern in recent months. While the requirement for supplier qualification and the monitoring of critical supplies has been included in regulatory and accreditation requirements for a number of years, we continue to encounter questions relating to the monitoring of supplies and suppliers. For example:

  • How is supply and reagent inventory documented?
  • Are lot numbers of supplies tracked?
  • What is known about the vendor?
  • Is information related to a supply or reagent available / accessible?
  • Once information is gathered about supplies and suppliers, how is it organized? Is it readily available for review and update?
  • If there is a recall, is sufficient information available to conduct an investigation of all the products and supplies associated with the process?

Developing a system that organizes information related to supplies and suppliers will allow any investigation to proceed systematically, limiting the potential for negative outcome and leading to timely corrective action.

Process Control
Providing staff with a clear set of work instructions is critical to process control. Work instructions need to be generated, validated, implemented, reviewed and updated such that they accurately reflect the work performed. As staff becomes familiar with any process, there is a temptation to independently modify the process to "save time" or "contribute to the process." If every staff member were to include their own personal revision, the potential for variation in outcome increases significantly. The modification of any process must occur in a systematic, controlled manner, followed by validation of the process to ensure that elements critical to the outcome have been considered.

A common concern is whether written procedures are available to address all activities performed. Written instructions should be comprehensive; they need to address the elements required to complete the task, specifications, action to take when results are not within the acceptable limits, reporting information, common "pitfalls" and what to do when challenges are encountered.

When well-written, comprehensive documents are available, staff will use the documents that have been prepared because they can find the information they need, when they need it. The likelihood of obtaining the desired outcome and your level of compliance with regulatory and accrediting agencies will improve when processes are completed in a controlled environment.

Standard Operating Procedures (SOPs)
Regulatory agencies refer to the need for an "SOP on SOPs," which implies that a standardized format for work instructions is a requirement. A number of facilities are struggling to find a format that is suitable for their organization. A recent encounter in one facility identified four different formats for Standard Operating Procedures that were "in use" at one time. Staff struggled to locate critical information, testing was delayed, reporting was delayed and the opportunity for error was increased. Critical elements to be considered when evaluating Standard Operating Procedures include:

  • Is there a defined format?
  • Who generates reviews and approves new procedures and those that require change?
    • How is that documented?
  • Read your procedures: do they accurately reflect current practice?
    • Do they say what you do?
    • Does the staff do what they say?
  • Are procedures available to staff at their workstation (whether in electronic or paper form) and are those that are available considered "the current version?"
  • How are documents distributed to the user?
    • Is the distribution of new or changed documents controlled?
    • Is there training or acknowledgement of receipt of the updated information?
    • How is access to the out-of-date version controlled?
  • Are procedures annually reviewed?
    • What is your method to track and document annual review?
  • What is the process when you want to change an SOP?
    • Who makes the change?
    • How is it reviewed?
    • Who approves the changes?
  • What is your process for record retention, requirements related to storage and how are records retrieved?

Standard Operating Procedures are "living documents" and will require revision. Updating procedures such that they accurately reflect current practice and address issues commonly encountered by staff will allow processes to be completed in a consistent, controlled manner.

Recordkeeping
Recordkeeping is only one aspect of document control. Information can be recorded either electronically or manually, but it remains a part of the "recordkeeping process." When recording information manually:

  • Is a form available? Where are copies of the current blank form? Are there instructions that describe the use, review and retention of the form?
  • How is the form to be completed, with "check boxes" written text or abbreviations? Is a legend available to indicate what the abbreviations mean?
  • When a document has been completed, is it legible, is it really complete and is a reviewer able to make an assessment as to what is an acceptable test result? Will the reviewer know what to do if an unacceptable result is identified?

These questions are integrally related to process control and verifying that work instructions are available for all processes, because the completion of a form is in itself, a process. The completion of a test will require recording something, somewhere. How the result is recorded and what happens to that record is all a part of "recordkeeping." Whatever steps can be taken to simplify the process, yet retain detailed content in any recordkeeping system, lead to improvement.

Surrounding staff with forms, papers and checklists may not be the answer. Alternatives must be explored such that documents can be completed in the manner designed and retrieved to allow additional evaluation of the information. Getting the work done is the first challenge, finding the record that documents the outcome is the second challenge. Making an assessment as to the content of the document and evaluating what was recorded occurs thereafter, but cannot occur unless the correct document is located and is found to be complete.

Management of Deviations and Follow Up Activities
Unexpected events occur even in the most controlled environment. Documentation of the unexpected event and evaluation of not only what happened, but why it happened can lead to revision of a process and the development of internal controls that will prevent the event from recurring.

Evaluation of an unexpected event begins with documentation of what happened. Identifying how often a particular unexpected event occurs and consideration of the surrounding circumstances will assist in identifying the true cause of the event.

A system of ongoing monitoring provides an opportunity for an independent assessment of the work performed, and an evaluation for trending. A system that allows not only the documentation of the event, but an evaluation of the root cause as well as follow up activities must be captured for review, evaluation and trending.

Summary
Controlling documents, all of them, whether related to training, equipment, SOPs or the most recent audit must be addressed in a manner that is systematic, comprehensive and something a reasonable person can perform successfully. This requires a system of organization and control of documents and records that allows you to retrieve and act on information in a timely manner.

Document control is more than generating good documents; it is the ability to compile, review and evaluate documents that are required to ensure the quality of products and services provided. Manual systems of controlling documents are only as effective as the individual managing the process. Adopting an electronic system for document control that has the potential to address SOPs, training, equipment, audits and management of deviations will enhance any organization's ability to comply with their SOPs and with regulatory requirements, and improve the quality of products and services provided. The question is, are your documents controlling you, or are you controlling your documents? Documentation will always be required; it is time to take control.

Marianne Silva is a Consultant with AABB Consulting Services Division providing consulting services in the regulatory aspects of transfusion medicine, quality systems, transfusion services and donor centers. Marianne has more than 30 years of experience in blood banking and has been the Compliance Officer for a licensed blood center and a university-based academic medical center with an active donor program and apheresis unit.

Marianne was a member of the AABB Standards Committee for the 20-22nd editions, and has served as Chair of the Committee for the 23rd and 24th editions. Marianne has been the liaison for the Canadian Standards Association in the development of Standards for blood banks and transfusion services in Canada and has also served on the Bacterial Contamination Task Force and the Circular of Information Task Force.

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FDA Link

Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application http://www.fda.gov/cder/guidance/5667fnl.htm