ONLY YOU CAN PREVENT PRE-ANALYTICAL MEDICAL ERRORS!

CLIA ’88: THE ROADMAP TO ERROR-FREE SPECIMEN PROCESSING
By Estelle Loxsom, BS, MT(ASCP)SH

“Accidents happen!” Yes, mishaps such as traffic accidents occur regularly, despite all the measures taken to stop them. However, the severity of these “accidents”
may be lessened if everyone would drive safely and obey traffic regulations. Medical errors are like traffic accidents: they are bound to occur eventually. Like traffic accidents, no one wants to be the victim of a medical error. Medical facilities certainly do not want to be the focus of the media that follows the more serious medical errors—this media frenzy seems to be more and more frequent lately. The clinical laboratory is not immune to these events, and in fact, is under a lot of scrutiny, because of the importance of laboratory results in the diagnostic process.

In spite of regulations and technical advancements in laboratory testing, current research shows that laboratory errors have not significantly decreased, and are still at unacceptably high levels. Why is this? Isn’t laboratory testing more automated, therefore less subject to human error? Haven’t laboratory computer systems streamlined the transfer of testing information to the final report, leaving less chance of transcription error? It could be that, while the testing phase has been under intense scrutiny, little attention is paid to what goes on before and after each specimen enters the laboratory for testing.

In fact, recent studies reveal that the majority of laboratory medical errors actually occur before (“pre-analytic” phase) and after (“post-analytic” phase) the specimens are tested. One study (Bonini, Plebani, et al)1 found that an astoundingly high percentage of errors
(from 31% to 75%, depending on the research source) took place in the “pre-analytic” phase. This study also states that the error rate may be much higher, because the data was based only on reported mistakes or complaints— no process was in place to estimate the true rate of pre-analytical errors.

These troubling statistics indicate that many labs may not be alerted to the importance of proper specimen collection and processing. What can you do to lower the frequency of pre-analytic errors in your lab? The CLIA ’88 regulations include components for the pre-analytic phase; let’s examine some of these guidelines to see how medical errors can be reduced through their use:

1. CLIA standard §493.1241: “the laboratory must have a written or electronic request for patient testing from an authorized person.” Documentation is required to show that orders come only from authorized health-care practitioners. More importantly, the patient’s safety is a concern.

DON’T rely solely on verbal orders or “standing orders”. If orders are assumed or given only verbally, miscommunication may cause the wrong test to be performed, or the specimen may be collected on the wrong patient or at the wrong time. Example: “Did Dr. Smith say to perform a glucose test on Mrs. Jones?” Yes, he did, but he wanted it collected while fasting. If you collect this specimen without regard to when the patient last ate, you may be causing a medical error. Let’s suppose this specimen yielded a glucose result of “225.” Is it possible that this may lead Dr. Smith to diagnose Mrs. Jones as a diabetic, when in truth, she had enjoyed a piece of cherry pie shortly before you drew her blood sample?
 

DO obtain a written order for every test request— orders may be initially received verbally (such as telephoned from the physician), but they should be verified carefully and followed by written orders from the authorized person as soon as possible (within 30 days).

2. §493.1241 (continued): “The laboratory must ensure the test requisition solicits …information” that is essential for testing. Essential information includes the ordering person’s name and address, and the person to contact concerning alert or “panic” values. The patient’s information should include the patient’s name (or unique identifier), sex, age or date of birth, specific tests, source of specimen, date and time of collection, last menstrual cycle (for pap smears), and any additional information to ensure timely testing, reporting, and interpretation of results. These requirements may seem too detailed, but they are essential for patient safety.
 

Don’t forget to collect and verify all essential ordering information. Suppose you receive a requisition to test “John Smith” for a Protime/INR from Dr. Kahn. A man stands up when you call out “John Smith” in the crowded waiting area, and you perform a Protime test on him in the phlebotomy area. You get a result of “Greater than 8.0 INR.” You should notify the physician of this panic value, but you then realize that there are three physicians with the name of “Dr. Kahn” on the registry. While trying to decide what to do about this dilemma, you announce your next patient, “Tom Smith.” No one in the waiting room responds. This scenario contained several errors that you could have avoided if you followed proper protocol:

Do obtain and verify essential patient information. This information must include complete ordering person’s name, address, and phone number so that the testing results can be given to the correct individual in a timely manner. (In this example, get Dr. Kahn’s complete name, address, and phone number.)
 

Do identify the patient adequately—do not assume that the person responding to the name you call, or the patient lying in the bed in front of you, matches the name on your request without verifying the information. Ask the person to give you their first and last name and ask for age, date of birth, phone number or other information to ensure you have the correct person. (“John Smith” may sound like “Tom Smith” to a person with hearing difficulties.) Patients are often moved to other beds or locations, so never rely solely on a location or an armband for identification—try to get verbal verification of name and date of birth.

3. §493.1241 (continued): “If the laboratory…enters test requisition or authorization information into a record system…the laboratory must ensure the information is transcribed or entered accurately.” Standardized or computerized requisitioning may help streamline the testing process, but many errors are caused by entering the wrong information into these systems.

Don’t hurry when entering or transcribing orders into an electronic system. A simple keystroke may select the wrong ordering physician, wrong test, or even wrong patient. Time is consumed when the error has to be corrected: finding the correct physician to
give the results, calling the patient back for a re-draw for the right test, and (worse yet) causing test results to go to the wrong patient’s record.

Do have a means for checking order entry. Proofreading your own and co-workers’ order entries may help prevent a medical error. Schedule regular audits of requisition accuracy to determine the error rate.

4. §493.1242 Standard: Specimen submission, handling, and referral. Each lab must establish and follow written directions for patient preparation, specimen collection, labeling, processing, storage, transportation, and acceptance. This involves not only having the written procedures, but also training the staff to follow them, and observing their actions to ensure they follow proper protocol.

Don’t overlook preparation protocols— if a patient isn’t fasting, glucose or lipid panel results may be falsely elevated. If dietary restrictions aren’t followed, occult blood testing may be falsely positive. If 24-hour urine specimens are not collected and stored correctly, they may yield false results.

Do provide written and verbal instructions to prepare patients appropriately. These instructions should be written so that staff and patients can be made aware of special collection or preparation needs. Staff should also instruct patients verbally to make sure the patients understand the directions.

Don’t collect specimens incorrectly— If a blood specimen collected in a lavender-top tube is submitted for electrolyte testing, it will yield “panic” results. Failure to mix a tube containing an additive may cause clots to form in the specimen. Drawing blood above an
active IV site may give erroneous test results. Collecting urine in a non-sterile container may yield a culture with falsely elevated bacterial growth.

Do follow directions when collecting specimens. There should be specific written instructions for proper specimen collection technique and containers. Make sure everyone involved in the specimen collection process is properly trained and periodically
observed for following proper protocol.

Don’t pre-label blood collection tubes. Example: Joanie likes to save time by labeling all the patients’ blood tubes before she begins the phlebotomy draws. This activity may save time, but Joanie may cause a medical error if she does not carefully match these
tubes up with the proper patients—this is a common cause of pre-analytic error.

Do label each tube immediately after drawing the specimen with complete information, including the source, if appropriate. Label each tube right away-- if you wait until you get to the lab to label specimens, they could be mixed in with other specimens and potentially be mislabeled. Each tube should contain the patient’s full name, secondary unique identifier (account or chart number), date of birth, and initials of the specimen collector. Include date and time of collection and specimen source because this is essential diagnostic information, especially when there are multiple specimens taken from one person.
 

Do follow specimen storage, preservation, transportation and processing guidelines. Mishandling of specimens may cause false test results. This could include improper centrifuging times or speeds, not separating serum or plasma from red cells, not storing or transporting at specified temperatures, improper slide preparation, and improper inoculation of culture media.

Do establish and follow written guidelines for accepting and rejecting specimens. Specimens that are hemolyzed or clotted are the most common specimen collection mishaps. Not only can they cause erroneous test results, but they also cause valuable loss of time because the specimen has to be re-collected. Have strict criteria for accepting or rejecting specimens. Document occurrences and notify the concerned
parties immediately.

5. §493.1249 Standard: Pre-analytic systems quality assessment. A lab can learn from its mistakes when implementing this standard. Establish a way to document errors that do occur, and then examine these errors for true cause to try to eliminate reoccurrences. But don’t wait for errors to occur: set up ways to audit the system to make sure everyone is following procedure. This type of quality assessment could help to prevent these types of medical “accidents.”

There are many do’s and don’ts in the pre-analytic process. Use CLIA ’88 as your guide to establish written protocol for this important phase of testing. If these procedures are established and are followed by everyone, medical errors can be avoided. The clinical
testing process may never be error-free but, like traffic accidents, it should get better if everyone does their part in observing the “rules of the road.”

References:
1. Pierangelo Bonini, Mario Plebani, Ferruccio Ceriotti, and Francesca Rubboli. “Errors in Laboratory Medicine.” Clinical Chemistry 48:5 (2002): 691-698.