Internal auditing made (practically!) painless.

If you feel intimidated at the mere thought of trying to develop an internal auditing system for your laboratory, read on to learn how one lab did it successfully. The author offers tips for setting up your own system with a minimum of pain.

Edith Bunker, wife of the well-known TV character Archie Bunker, once said, "If it ain't broke, don't fix it." At times this is sound logic indeed, but in the world of laboratory medicine, we are better served by the maxim, "Fix it before it gets broke."

We at Roger Williams Medical Center Blood Bank recently established a comprehensive quality assurance (QA) program that enables our blood bank staff to "fix" things before they "break." In other words, we can detect at least some potential errors before they occur. Our QA program includes our daily quality control procedures; a daily or weekly review of all blood bank records; the validation of all new instrumentation; monthly, quarterly, and annual preventive maintenance on all equipment; an error/accident/incident reporting system; and a blood utilization tracking system.

Another important QA program component is our auditing system, through which we audit all of our blood bank systems on a periodic, rotating basis. The auditing program allows us to continually evaluate our performance as well as our risk for potential error. Two recent events brought home the importance and value of this simple, logical program.

Identifying the problems

The first incident involved the purchase of a new blood warmer. The blood bank develops and supervises the necessary quality control and preventive maintenance programs as part of the validation program for new operating-room fluid warmers. When I reviewed the vendor's literature for suggestions on quality control and preventive maintenance, I could not find any clear information. I called the company and was told by a staff member not to worry about the instrument because it would not malfunction and therefore would not require any periodic checks. Somehow, I didn't think a patient in the operating room would appreciate that information if the blood warmer overheated and he or she received a unit or more of hemolyzed cells.

The second incident involved the purchase of a new refrigerator for our blood bank. As we prepared for receipt of the refrigerator, I remembered that the alarm system - which connects to a main panel at the hospital's switchboard - needed to be hooked up to the new refrigerator. I reviewed our preventive maintenance records to determine when the alarm system was last checked, but I found no such records. Further investigation revealed that a yearly preventive maintenance check on the blood bank alarm system had never been established. Again, my concern was for the patient who might inadvertently receive blood that had been stored out of range if the refrigerator alarm had malfunctioned and had failed to alert the staff.

Because preventive maintenance for the blood warmer and the refrigerator alarm system affects the quality of the blood bank products our patients receive, it seemed crucial to ensure that preventive maintenance procedures be developed and, more importantly, routinely performed. We knew from experience that we needed to incorporate a review of preventive maintenance activities into a comprehensive auditing program to ensure that those activities would not be forgotten or delayed.

How did we develop an internal auditing system? How can you, too, develop a workable auditing system that meets your laboratory's need to internally review what you do, how well you do it, and how to recognize potential problems?

Blood bank background

We are a modest-size transfusion service in a modest-size general hospital located in Providence, RI. We provide approximately 4,000 red blood cell units, 2,000 random and pheresis platelet units, and 1,700 fresh-frozen plasma units to our patients every year. In addition to servicing a largely elderly population on the medical floors, we also provide products for the hospital's active surgery and oncology departments as well as the state's only bone marrow transplant unit.

In 1993, we underwent a major transition in blood banking when the 15th edition of the American Association of Blood Banks' Standards for Blood Banks and Transfusion Services required us to "establish a program of quality assurance," to be known as the quality program.[1] This quality program evolved to include (as of January 1998) 10 "quality system essentials" (QSEs). QSEs, as defined by AABB, are "necessary items of a quality system which enable an organization to work efficiently and identifies the parties responsible for provisions for key quality functions."[2] These 10 necessary items include organization, personnel, equipment, supplier issues, process control, documents/records, error management, assessments, process improvement, and facilities/safety.[2] This comprehensive quality program required that we develop auditing techniques to review our processes in a far more comprehensive manner than ever before. Before the development of comprehensive lab system auditing, we waited until something "broke," treated it as a single occurrence unrelated to other lab processes, "fixed" the problem, and then soon forgot about it. In the process of developing our full quality program, we have had to take a good look at our lab systems and our auditing process for those systems. Gone are the days when reactive response rather than proactive planning was the norm.

Defining an audit

An audit, as defined by the American Society for Quality, is "a planned, independent, and documented assessment to determine whether agreed-upon requirements are being met."[3] In simpler terms, an audit is a written series of simple, direct questions, which when answered and reviewed, tell you, as your lab's internal assessor, if your lab is performing its procedures, activities, and policies correctly and on time. Audits are valuable: If written with the intent to review thoroughly all the crucial systems within your lab, they allow you to recognize quickly the areas you need to improve; discern the relationships between systems inside and outside your lab; and, as required, meet the needs of accrediting and regulatory agencies that may externally assess your internal assessment activities.

While there are many types of audits, this article will focus on one specific type, the process quality audit. The American Society for Quality defines a process quality audit as one that "is performed to verify that processes are working within established limits. It examines an activity to verify that the inputs, actions, and outputs are in accordance with defined requirements."[3] Because our audits focus primarily on blood bank processes, rather than, for example, products (blood components), this definition worked well for us. Depending on what type of activities you focus on in your laboratory, other audit types may be more suitable. I would advise looking through publication catalogs specific to your laboratory type to help you define what audit types would be best for your situation.

Setting up an audit program

If you are ready to set up an audit program in your facility, the following suggestions may be helpful. All of them are based on what we did in our blood bank.

1. Do not reinvent the wheel. We relied on AABB, our main accrediting organization, to tell us what systems within the blood bank we needed to audit. AABB forwarded us a list of important systems, which included personnel, equipment, process control, record keeping, compatibility testing, and lab safety, to name a few. We used these systems to determine how many separate audits we needed to develop with the appropriate audit forms. In other words, we wrote audit forms for equipment auditing as distinct from facilities and safety auditing.

We also borrowed from an earlier version of AABB's suggested "Quality Plan," which was broken down first into systems, then distinct critical control points, and finally key elements. These have been helpful when I write audit forms because I rewrite the key elements as questions requiring scored responses [ILLUSTRATION FOR FIGURE 1 OMITTED]. An example of a key element is, "System in place to ensure all staff are certified annually as competent to perform duties," which is found under the critical control point "Personnel Selection/Training/Education," under System A, "Quality Program." I reworded this key element to read, "Is there a system in place to ensure that all staff members are annually certified as competent to perform duties?" This question is part of an audit checklist form for our personnel training and education activities. (In this particular AABB system, there are 8 key elements dealing with personnel and education issues; by rewording these elements, I automatically had 8 checklist questions to build into a training/education audit form.)

When I perform this audit, it prompts me to update our personnel files to ensure that all staff members are maintaining their state certification and to check that recent training records are complete and have been filed for each staff member.

2. Look for previously developed audit formats as a guide to building your own. The College of American Pathologists inspection checklist is one model: It is a series of "yes" and "no" questions, already outlined into systems particular to either hematology, chemistry, serology, or transfusion medicine, to name a few. For example, the CAP inspection checklist for diagnostic immunology and syphilis serology is divided into the following systems: proficiency testing, quality control, procedures and test systems, personnel, physical facilities, and laboratory safety. Under each of these systems is a series of "yes-no-N/A" questions that a CAP inspector would use to audit your serology lab. Your internal audit of immunology-serology could be built from these same questions, worded a little differently to meet the unique needs of your own lab. While your particular CAP checklist may not include activities from all the systems in your lab, you can easily write more questions as you see fit, using procedure manuals, QC logs, hospital policy manuals, and employee management manuals.

3. Talk to other lab managers and ask to see copies of their audit forms. While everyone approaches auditing from a unique perspective, the likelihood is that someone has developed an audit format that makes sense to you. You can then use this format as a guide to write your own questions. I did not need to research published reference materials on audit formats, but perhaps you may find a few that would be helpful.

4. Write a separate audit form for each system with questions that apply to the activities within that system. You must decide what is most critical for the safe and effective delivery of your services and focus on the necessary daily activities.

For example, one of our audit forms the most comprehensive of all - is a transfusion service audit, which is intended as a tool to review all the activities involved in ordering, preparing, delivering, and administering blood products [ILLUSTRATION FOR FIGURE 2 OMITTED]. These activities are addressed in the key elements from 2 AABB systems, "Compatibility Testing" and "Blood Administration."

Initially, I review carbon copies of our transfusion report records that go to the nursing unit with each blood product. Each record includes the number of the unit to be transfused; the signatures of the technician releasing the unit and the person to whom the unit is dispensed; patient vital signs; patient identifiers; and the times associated with each step, from dispensing through transfusing. The nursing units return the carbon copy of the transfusion report record to us (which should be completely filled in) after a transfusion is completed. I take a random group of these carbon copies on a quarterly basis, review them as a group, and answer the questions on the transfusion service audit form, such as, "Were the patients correctly identified?" and "Were vital signs before and after the transfusion recorded?"

Sometimes, in addition to reviewing the records, I arrive unannounced at one of the nursing units and observe a transfusion from start to finish. Some of the transfusionists do not appreciate my observing their blood administration activities, but I do see occasional deviations from the Nursing Blood Administration Protocol (the nursing department's procedure for transfusing blood products) that need to be rectified through re-education by the nursing education department.

Equipment is another blood bank system we address through periodic auditing. Here again, I chose a particular system from AABB's QSEs, although I could have drawn from the CAP inspection checklist for transfusion medicine. The CAP checklist covers the same basic systems as AABB and includes a section entitled "Instruments and Equipment." I reworded some of the key elements under "Equipment" as questions such as, "Do storage refrigerators, freezers, and platelet incubators have systems to monitor the temperature continuously?" Our equipment audit is less complicated than a transfusion service audit - which includes procedural steps that occur outside the walls of the blood bank - but the periodic audit of equipment, like any audit, reminds us to pay attention to details before problems arise.

It is important to develop auditing questions that reflect the full scope of your laboratory's activities, not just questions that will automatically net you positive answers every time you audit. The point of the audit is to be thorough. If you appreciate an audit as a tool for identifying potential or newly developed problem areas, you will gain the opportunity to improve your systems, hence patient care.

When we first develop our audit forms, we include the basics, but we don't consider them final drafts. With each audit, we refine the questions, sometimes adding more questions that are based on the findings from previous audits. All of our audit forms evolve to meet our changing needs. I recommend doing a dry-run audit using your draft audit form, with the assumption that you will change the type of questions, their arrangement, etc., frequently.

Completing the audit form

Most of our internal auditing consists of reviewing the records of completed work. My auditing method is to pick up a randomly selected group of records that relate to the blood bank system I want to audit, find a quiet place to work, and begin reviewing the records against the appropriate audit checklist form. I answer all the questions on the checklist, write comments underneath as needed, and fill in the "Total applicable points" and "Total possible points," using the key as a guide. Applicable points are added together and become a percentage of the total possible points. For example, an audit of 8 questions is worth 24 total possible points. If all questions net 2 as a scored response, the total applicable points would be 16, hence a 67% score. Again, we borrowed this format and scoring system directly from AABB so the time-consuming job of creating our own wasn't necessary.

What is an acceptable score for an. audit? Each blood bank needs to set criteria that maintain standards high enough to provide safe products and services to its patients. In our blood bank, we respond immediately to all scores of 1 or 0 with corrective action and reevaluate after that action has been implemented. We expect a minimum percentage of 85%, which means scores of 2 are frequently reviewed, particularly if a previous audit of the same system had a higher final percentage. We look for downward trends that need to be addressed before our work is compromised.

To date, the one exception to this evaluation process is our transfusion service audit. Because this particular audit form reviews a variety of systems both inside and outside the blood bank, its results are summarized in written form as part of a separate quarterly report to the medical director. The quarterly report is forwarded to our clinical nurse managers for their review as needed.

Taking corrective action

Our final step - before forwarding the audit to our medical director for his review is to make corrective action recommendations. For example, a recent audit of our nursing staff's blood administration practices indicated that on several occasions, units of red blood cells (RBCs) were not transfused within 4 hours after release from the blood bank to the floor. Because our blood administration protocol requires that RBC transfusions be done within 4 hours of delivery to the nursing unit, we needed to educate our transfusionists about the time limitations. We noted the problem in the separate quarterly report mentioned above and formally discussed it with the blood bank's medical director. Then we decided that the nursing education department staff would hold inservice sessions with nurses on all 3 shifts to discuss and review the storage and administration requirements for each type of blood product. Once this was accomplished, I noted it on the audit form as a completed corrective action.

Now each time I audit returned transfusion report records, I review the time frames between the release and completion of each transfusion - including RBC transfusions - to ensure that all transfusionists are adhering to the appropriate time frames. We take our systems seriously, and we expect all hospital departments involved in the transfusion of blood products to do likewise. Because our corrective action measures may affect the activities of other departments, it is imperative that we continually monitor the effects of corrective action measures taken outside as well as inside the blood bank.

Scheduling the audit

How often do we audit? Because no regulatory agency dictates a particular auditing schedule for us, I have set up a yearly auditing program with annual audits scheduled for some systems and quarterly or monthly audits for others. I took advantage of a software calendar program and plugged in monthly audits for the 10 QSE systems on a rotating basis: equipment in January, component processing in February, and storage and distribution in March, for example. The unique transfusion service audit is done at least quarterly, and sometimes monthly if a trend appears to be developing that needs monitoring. To resolve the problems with the new blood warmer and the alarm system that I discussed in the beginning of this article, I added a review of these preventive maintenance procedures into our January equipment audit. I check in quarterly with the operating room and annually with the alarm company staff to ensure that their respective preventive maintenance activities are acceptable and performed on schedule.

Conclusion

For some of us, the transition from the review of simple, daily quality control procedures to periodic reviews of entire lab systems may be overwhelming. The development of an auditing program, as part of a larger quality assurance program, is achievable and can be done by those willing to spend the time to investigate what needs to be audited and then build the documents for the auditing process. We are not the biggest or the fanciest blood bank east of the Mississippi, but we do have a comprehensive quality assurance program in place. Our program includes several types of internal audit forms designed to evaluate virtually everything we do in the lab itself and what related staff members do outside the blood bank, which directly affects our work.

A process that at one time seemed to be an overwhelming task has become a sensible, logical part of our comprehensive quality assurance program. Because our laboratory reviews our products and services before problems develop, I leave at the end of each day knowing that we have done our best to provide our patients with safe blood products. Everything we do in our lab is done, to the best of our combined abilities, for the safety and well-being of our patients. Everything - for us - includes paying attention to the quality assurance details addressed through our auditing activities. By paying attention to these details, we hope to avoid potential errors. As a patient, Edith Bunker would be proud of us.

References

1. American Association of Blood Banks. Standards for Blood Banks and Transfusion Services. 15th ed. Bethesda, MD: American Association of Blood Banks; 1993:1.

2. American Association of Blood Banks. Accreditation Information Manual. 2nd ed. American Association of Blood Banks; 1998: Section 9-14.

3. Smith JL. The Quality Audit Handbook. Milwaukee, WI: ASQ Quality Press; 1997:4.

Karen McHugh, CQA(ASQ), MEd, was a technical specialist at the Roger Williams Medical Center Blood Bank, Providence, RI. She is now the laboratory manager at Lexigen Pharmaceuticals, Lexington, MA.