How to keep those inspection jitters down.
In 1982, days after I started as blood bank supervisor at our 440-bed teaching hospital, the pathologist mentioned that an American Association of Blood Banks inspection would be coming up in six weeks. There were good reasons to panic. I was still learning my way around unfamiliar policies, procedures, and people. The blood bank had lacked a full-time supervisor for two months before i came aboard, and some necessary, though not really crucial, record keeping--maintenance logs, for example--had been overlooked.
Luckily, this wasn't my first supervisory position or inspection. A seven-step survival plan had seen me unscathed through some tough inspections in the past, including one surprise visit. It worked again when the AABB arrived; the blood bank was hit with only a few deficiencies, none of them major.
The same inspection preparation guidelines can work for any section of the laboratory, even though some of the details that follow relate directly to the blood bank. Here are the seven steps for surviving an inspection:
1. Know the inspecting agency's requirements. Lab requirements vary from agency to agency and also from year to year. The College of American Pathologists, the Joint Commission on Accreditation of Hospitals, the Food and Drug Administration, the AABB, and certain states with standards of their own may issue different requirements for the same test. The safest course is to be familiar with the entire spectrum of provisions and comply with the strictest in every case. For example, at the time th CAP last inspected us, it required monthly centrifuge calibration, while the AABB called only for periodic calibration. Sticking to the CAP's monthly schedule covered the blood bank for both agencies.
An agency will commonly include a checklist of its requirements in a preinspection package of material. If you're facing an inspection and haven't seen the checklist, scout around for it. The laboratory director or manager probably has a copy.
Read the checklist carefully. Should any point seen ambiguous, contact the agency for clarification before the inspector arrives. A preliminary phone call could have saved us a headache during last year's CAP inspection. We felt we were complying with the intent if not the actual letter of a checklist question on reagent labeling, but the inspector gave us a deficiency.
The checklist asked if labels on all reagents bear the contents and dates of receipt, preparation and/or use, and expiration. The problem is that we use large quantities of reagents--100 vials of anti-IgG serum each month, for example--and these vials are already labeled for contents and expiration date. To satisfy the rest of the labeling requirement, we relied on our log for entire lots of vials; there we entered dates of receipt and use of a particular lot number. After the inspector cited the blood bank for failing to date every single vial, we protested this would entail hiring an extra technologist. The deficiency was eventually disallowed.
2. Inspect your area. And don't be charitable. Itemize deficiencies, beginning with those that must be corrected to pass--documentation of confirmation typing on blood units received from other sources, for example, and monitoring refrigerator temperatures. Then note deficiencies that fall into the categories of what the agency recommends but does not require, and what the agency is merely interested in. To organize inspection preparation ever further, classify deficiencies under technical, quality control, and documentation headings.
This gives the laboratory work lists. The idea is to tackle the most important chores first and save the minor problems for later in case time runs short.
3. Review policy and procedure manuals. Keep separate manuals for policies and procedures. They're easier to maintain and refer to than one huge volume covering both areas. Organization is especially important, bolth for the inspector who must quickly scan the manual and for the technologists who must use it every day. Although a table of contents is not required, inspectors like to see one. They are interested most in checking that the manual is comprehensive, and they sometimes don't venture past a table of contents.
Our four-inch-thick lab procedure manual is divided into a number of sections for easy access. These include: specimen receipt and requirements, routine procedures, special procedures, donor blood processing, Stat procedures, neonatal and obstetrical procedures, types of transfusions, quality assurance, and transfusion reactions.
Make sure you have a written procedure for every test performed in the section and keep the information up to date. I thought I was staying current on our six routine procedures, three Stat tests, and 25 or so special requests--that it, until the day an inspector read each step in the manual while watching a technologist perform a test. The spin times on the page and at the bench did not agree, he pointed out. To my chagrin, I realized that I forgot to record new spin time instructions in the manual after recent calibration studies.
This incident highlights a valuable lesson at a time when many laboratories are streamlining procedures to meet the challenge of DRGs: It is imperative to note all changes in the manual as they occur. Otherwise, the lab will face a mammoth job of revision when its next inspection rolls around.
Whenever you adopt a methodology from the literature, take care to cite the source correctly in the procedure manual, and keep a copy of the original reference on hand. The AABB requires references for each test. For example, if you prepare your own low-ionic-strength solution, the inspector may want to see where you got the formula. Referencing is a good general policy to follow, because it quickly tells a newcomer to the lab why you do what you do.
4. Check all policies, general and specific. Prior to that first AABB inspection, I reviewed the blood bank's criteria for rejecting specimens and its requirements for issuing blood and accepting returns from the floor and operating room. Make sure everyone on the staff is up on such policies. Keeping the off-hours shifts informed is especially important in the blood bank, since our heaviest workload falls on weekend evenings and nights when technologists are largely on their own. You want the new 11-to-7 weekend technologist to know right from the start that blood can't be accepted for reissue if returned after 30 minutes from issue time.
If an irate resident refuses to sign a specimen's certification label, even experienced blood bank staff members welcome the backup provided by a properly referenced written policy. The section will prevail in that kind of dispute because the medical director initials all of our policies once a year.
Review your manual for omissions--policies the section should have but doesn't--and for possible consolidations that would extend the same general policy to a number of situations. For example, whether there's a positive direct antiglobulin test or an incompatible crossmatch, we call the clinician, notify him of the problem, document the call, and transcribe the results on a special antibody sheet. These opening steps are almost reflex actions because they are standardized. Then technologists can turn to specific problem-solving protocols.
5. Know where records are, and review them. Our staff has easy access to the three clearly labeled file cabinets that hold the blood bank's records. The policy, procedure, quality control, and laboratory manuals are kept out on a bench in the same area. Technologists are encouraged to pull whatever they need from the files and to put it back in the right place when they are finished.
Familiarity with section records is especially important when it comes to quality assurance. You may know the refrigerator alarm system is tested monthly and works just fine, but don't expect an inspector to accept your word in place of proper documentation. We post quality control charts on each refrigerator and note the date and time of each test, the actual temperature at which the alarm sounds, the operator's response time, and the initials of the technologist performing the test. A walk through the section quickly reveals which units are due for a check.
Continuing education should also be documented. While the laboratory maintains a central CE list, I find that it's helpful to keep my own record of the section's internal and outside educational activities. It's the fastest way to see which of our 18 technologists had an opportunity last and who's due next.
Errors and corrective actions also merit a separate file. We developed a form that notes the error, the patient, the individual responsible, and the corrective action. This type of documentation is especially useful in pinpointing patterns and identifying persistent problems with one staff member or, perhaps, a nursing station.
It's enough to show an inspector the policy on errors. If you volunteer to trot out the documentation, you may earn a bad mark for having too many errors, even though many of them are minor.
Finally, we document instrument malfunctions in an out-of-control-range log. It lists each problem, the date, corrective action taken, and reinspection prior to use. Inspections aside, the log comes in handy when dealing with service representatives who insist they fixed the problem. It also helps convince administrators that it's time to retire a troublesome instrument.
6. Review the list of deficiencies. Determine which problems can easily be corrected and which cannot. Developing a documentation system for the daily inventory of blood and components is more complicated than adding a procedural reference. Don't let the size of the task or the lack of time before the inspection overwhelm you.
Enlist technologists in the effort. Assign the duties that can be delegated--locating those missing references and designing the blood inventory log, for example. At the very least, start the required logs and documentation before the inspector arrives. This indicates you know what is needed and will continue to comply from now on.
The best plan, of course, is to start cleaning house before an inspection is announced. And the worst thing you can do is fail to clean up a documented problem left over from the last inspection.
7. Don't be nervous. No laboratory is perfect, not even the inspector's. Remember, inspections are meant to help laboratories through the medium of constructive criticism from an outside observer. They can even support your position if you want to purchase a new instrument or you feel that workload recording data warrant bringing an additional technologist. Administrators somehow pay more attention when an inspecting agency says the laboratory needs more staff, centrifuges, refrigerators, or continuing education.
One of the deficiencies recorded during our first AABB inspection helped us acquire a new fresh frozen thawing bath. Since then, we have been inspected by the JCAH, the CAP, and the AABB again and have come through fairly well.
Our section is ready for an inspection. Is yours?
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|Author:||Martin, Deborah N.|
|Publication:||Medical Laboratory Observer|
|Date:||Sep 1, 1984|
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