Continuing Education Volume 4 - Issue 1

As in most manufacturing processes, the quality of the end product is dependent upon the quality of the materials that go into its creation and the skill of those who create it. In healthcare the product is health. A key component of health is the information the physician receives on the patient’s well-being. Seventy percent of the objective information the physician receives on the patient’s status comes from the results of tests performed by the clinical laboratory on blood and other body fluids. A test result, therefore, is a product of health of their patients. With so much on the accuracy of the test result, laboratory processes have been extensively studied and perfected to eliminate sources of error. As a laboratory product, the equality of the test results is partially dependent on precise laboratory instrumentation and the skill of testing personnel. Sophisticated instrumentation and highly sensitive test methodologies are now available that have eliminated many of the sources of error that could alter results.

Studies show that of all the errors that can affect the quality of a test result, only 13% occur during the testing (analytical) phase. However, even the most sophisticated testing instrumentation and most highly skilled testing personnel can not extract an accurate result from a specimen that has not been collected and or processed properly. Because specimen collection and processing can never be fully automated, up to 56% of the errors that can alter test results occur during this “preanalytical” phase. As a result preanalytical errors cost the average 400 bed hospital $200,000 per year in recollections and medication and medication errors. When specimen collection and processing errors contribute to a low quality test result, the ultimate product the healthcare industry delivers, patient health, can be tragically flawed. Because phlebotomy will always be a manual procedure, it is critical to properly educate and supervise those with blood collection responsibilities to prevent the high number of possible errors from becoming actual errors that lead to negative patient outcomes. For the same reason, those properly trained to draw blood specimens must diligently adhere to the standards and their facility’s policies to ensure that testing personnel can extract an accurate result from the specimen. No degree of sophisticated instrumentation or expertise of testing personnel can obtain a result that reflects the patient’s actual health status from a specimen altered by improper collection and/ or processing. Some preanalytical errors can be detected by testing personnel, but most cannot. These undetected errors can contribute to erroneous results and cause physicians to misdiagnose, overmedicate, under medicate, and mismanage their patients. Therefore, those who draw specimens have significant influence on 70% of the objective information physicians receive on patient health status. The importance of specimen collection cannot be overstated.

Tips from the Trenches:

• Up to 56% of the errors that can alter test results occur during the specimen collection and processing phase of clinical testing.
• Only through a comprehensive training program that teaches every aspect of phlebotomy to those who undertake the procedure can facilities and individuals ensure their own safety, the safety of their patients, the integrity of their specimens, and the preservation of the quality of care they strive to deliver.

Identifying and Managing the Risks

Treating patients according to results that are inaccurate due to poor specimen collection is only one of the risks that patients may be subjected to by phlebotomy. Physical injuries inflicted during the collection process can have equally serious consequences. Nerve damage, arterial nicks, lymphedema, and other injuries can be caused by those who fail to perform blood collection procedures according to the standard of care. The risk of liability for such injuries, therefore, is substantial and must be managed. But the risks involved in drawing blood specimens are not limited to those that impact the health of the patient. One study showed phlebotomy to be the procedure most frequently associated with HIV exposure and that the risk of exposure is in part linked to the frequency with which healthcare professionals perform blood collection procedures. Twenty different diseases are known to be transmitted by blood exposure, putting those who collect and process specimens at risk of acquiring a bloodborne pathogen.

Proactive managers and supervisors can effectively manage all risks of phlebotomy by:

• Instituting a comprehensive phlebotomy training program
• Drafting safe phlebotomy procedures
• Implementing engineering and work practice controls
• Maintaining high standards of performance Soliciting input

Instituting a Comprehensive Phlebotomy Training Program

To minimize the risks of phlebotomy, healthcare professionals and their administrators are challenged to recognize phlebotomy for what it is- an invasive procedure with serious consequences when performed improperly- and to apply the same importance to training as they would for any other invasive procedure. Only through a comprehensive training program that teaches every aspect of phlebotomy to those who undertake the procedure can facilities and individuals ensure their own safety, the safety of their patients, the integrity of their specimens, and the preservation of the quality of care they strive to deliver.

What are the minimum training requirements for those who perform phlebotomy procedures? Unfortunately, no national standards or federal regulating agencies establish minimum phlebotomy training requirements. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires only that the “Hospital’s leaders define the qualifications and performance expectations for all staff positions” and that “an orientation process provides initial job training and information and assess the staff’s ability to fulfill specified responsibilities.”

Therefore, the burden of establishing a phlebotomy training program that fully addresses the risks of the procedure, that protects the patient and collector from injury, and that preserves the integrity of specimens and the quality of results extracted from those specimens belongs to employers and managers. Those who establish high standards and a comprehensive training protocol are those who most effectively manage the risk. California is the only state mandating license for all phlebotomists.

Because of the laboratory’s expertise in specimen collection and testing, every training program must be conducted by or in concert with a laboratory representative or a healthcare professional with a strong laboratory background. When teaching blood collection procedures to non-laboratory personnel, the training program should include rotations through the laboratory department to enhance a more thorough understanding of the importance of specimen collection and processing. Every healthcare facility with specimen collection personnel should establish an in house phlebotomy curriculum that effectively manages the risk to the patient and the collector and minimizes the employer’s vulnerability to phlebotomy- related lawsuits.

The list should include:

• Critical steps of the venipuncture procedure
• Proper capillary puncture procedures
• Physical risks associated with venipuncture
• Collection related analyze alterations
• Practices that increase risk of exposure

Even those healthcare personnel who only draw and transport specimens benefit by understanding how specimens must be processed to preserve the integrity of the specimen and ultimately the results.

Legislating Phlebotomy Certification

In 1999, California became the first state to enact legislation mandating that all phlebotomist be certified by a state-approved certification organization or licensed in a profession that includes phlebotomy in its official scope of practice (i.e., nurses, physicians, clinical laboratory scientists, etc.) The minimum training requirement for new phlebotomists in California now includes 40 hours of classroom instruction, 40 hours of practical instruction and a minimum of 50 supervised punctures. This legislation sets a precedent for all healthcare professionals performing venipuncture, regardless of their discipline. Other states are considering similar legislation.

Drafting Safe Phlebotomy Procedures

Infusing the provisions of two agencies into every policy and procedure per-training to blood specimen collection is critical to effectively managing the risks accompanying specimen collection procedures. The Clinical and Laboratory Standards Institute (formerly NCCLS) sets standards for specimen collection and handling to protect the patient from injury and negative outcomes, while the OSHA Bloodborne Pathogens Standard protects employees from accidental exposure to bloodborne pathogens.

Clinical and Laboratory Standards Institute

To manage the risk of patient injury and negative patient outcomes from the erroneous results derived from improperly performed procedures, it is critical that policies and procedures reflect the standards and guidelines established and maintained by the Clinical and Laboratory Standards Institute. These documents propose the specific details by which clinical laboratory procedures should be performed based on evidence in the literature and the expertise of nationally recognized authorities.

Facilities that use Clinical and Laboratory Standards Institute documents for blood collections procedures protect patient against baseless modifications to blood collection techniques that put the patient at risk of injury and/or negative outcomes due to results altered during the collection procedures. However, facilities can modify aspects of their procedures from those established by the Clinical and Laboratory Standards Institute to fit  circumstances that may be unique to their institution, providing internal research supports such modifications. Self-styled techniques or modifications not supported in Clinical and Laboratory Standards Institute documents or established through internal studies should be the employer to potential liability.

Homemade Phlebotomy

The following practices taught on some Internet tutorials deviate from Clinical and Laboratory Standards Institute standards and should not be attempted or included in a facility’s procedure manual:

• If the vein has collapsed, tap the flesh above the needle with index finger (multiple occurrences)
• Slap the site to make veins more prominent (multiple occurrences)
• It’s okay to perform an arterial puncture for routine lab work (multiple occurrences)
• A discard tube is still required before a coagulation tube for routine coagulation tests (multiple occurrences)
• Incorrect order of draw (multiple occurrences)
• Always use a winged collection set on children
• Draw above an IV are acceptable
• “Blind Sticking” is acceptable when no vein can be found
• Place the collection tray on the patient’s bed
• Tourniquet goes under the armpit

Engineering and Work Practice Controls

Managing the risks of accidental exposure and injury cannot be effectively accomplished without fully implementing the regulations of the OSHA Bloodborne Pathogens Standards. Revised in 2001, the Standards instruct employers to implement work practice controls (i.e., policies, procedures, and practices) and engineering controls (i.e., supplies, equipment, and devices) that protect employees from injury and illness. All employers whose employees have the potential to be exposed to bloodborne pathogens are subject to OSHA guidelines. Although the standard does not apply to students, educators are well advice to voluntary implement the guidelines for safety because the employers who hire their student will expect adherence.

The Bloodborne Pathogens Standards insist that:

• Gloves are worn during all phlebotomy procedure for diagnostic testing
• Hands are washed after gloves are removed
• Gowns or lab coats are worn whenever the risk of exposure exists
• Needles with safety features are used whenever performing a venipuncture
• Tube holder/needle assemblies are discarded as one unit immediately after use
• Food is never stored or consumed in areas in which specimens are processed, tested, or stored
• When safer devices that protect employees from bloodborne exposures become available, they must be considered annually and implemented
• Nonmanagerial  employees with direct patient contact must assist in the evaluation and selection of safety devices and safe practices
• Regular inspections must be conducted to ensure devices with safety features remain functional and are used properly
• Needles must not be bent, recapped, or removes unless no alternative to disposal is feasible or if such action I required by the procedure. Justification must exist in the facility’s exposure control plan supported by reliable evidence
• Sharp containers must be as close as feasible to the point of use

In the lab

If a specimen is diluted with IV fluids, it will likely go unnoticed by the tech performing the test. Only the most grossly diluted specimens arouse suspicion. Therefore, it is dangerous to assume that contaminated specimens will be detectable during specimen processing or laboratory testing. In the patient has a normal blood level, a grossly diluted specimen can evaluate or depress the test result to a level that would be viewed as life-threatening, prompting the physician to react with  life-saving measures that may actually be life-threatening. Conversely, diluted specimens can yield negative or normal results when the patient’s actual level is life-threateningly low or high resulting when intervention is crucial to the patient.

For example, let’s say Mr. De Jesus, a new patient, has his blood drawn for a metabolic profile, toxicology screen, hepatitis profile, and CBC. The collector draws the blood above an active IV site unaware of the risks and limitations. When the specimen is sent to the laboratory for processing and distribution, processors immediately send the CBC tube to hematology and set the serum tube aside for clotting to complete (10 to 30 minutes). Once clotted, it is centrifuged for 5 to 10 minutes to separate the serum for the remaining test.

The serum is removed and divided into three separate transfer tubes: one goes to the chemistry department for the metabolic profile, one to the toxicology lab for the toxicology screen, and the third to special chemistry for the hepatitis profile. Before the serum arrives in any of the other departments, the hematology technologist, having already tested the specimen, calls the physician with hemoglobin of 5.9, which was confirmed by repeat testing. The physician responds by adding a type and cross match to the orders.

While the toxicology and special chemistry departments test their respective aliquots of serum, the technologist in the chemistry department has complete the metabolic profile and is now reviewing the results. The potassium level is 7.9 a level incompatible with life and must be confirmed by repeat testing. Meanwhile, the toxicology lab has finished its testing and is reporting negative results on all metabolites. Mr. De Jesus is having his blood drawn again, this time for the type and cross match, a process that requires a special patient identification protocol that was not in place during the first draw.

Repeat testing of the potassium confirms the elevated level. The chemistry technologist notices that the glucose, sodium, and chloride levels also are significantly elevated. However, all other levels are well below normal or at the low end of the normal range. Because of the erratic results, the technologist calls the floor and discusses the result with the burse. Together they make the connection between the elevated analyses obtained and the fluids being infused D5W, KCL, and normal saline. Upon questioning, the collector admits that he drew the specimen above the IV.

It has been over an hour since the initial order was placed, and the physician has called the lab three times for the rest of the results. Mr. De Jesus is failing fast. The chemistry technologist investigates other tests ordered at the same time and alerts the hematologist department, toxicology lab, and special chemistry section that the prior specimen was diluted and the results should be invalidated. The hematologist and toxicologist collaborate and notify the physician of the erroneous results. The physician puts the type and cross match on hold and orders a flurry of incident reports filled out. Mr. De Jesus’s blood is collected a third time.

After processing, centrifugation and distribution, the results from the fresh specimen eventually show normal hemoglobin, potassium, glucose, sodium, and chloride levels. All liver enzymes previously at the low end of normal because of the dilution are elevated. The toxicology screen is positive for alcohol and barbiturates and the hepatitis panel is positive for hepatitis B; all were initially negative from being diluted by the IV fluids.

Poor judgment in a specimen collection site initiated a cascade of actions, reactions, and delays that could have been prevented. Two  additional collections, which would have been otherwise unnecessary; confirmatory testing ; repeat testing; delays in treatment; and a blizzard of paperwork all translate into an expensive waste of supplies, equipment, and human resources. And that’s not to mention the incalculable cost to Mr. Smith from the delay in treatment and diagnosis. Adding further to the total cost was the strain the incident placed on the relationships among the physician, the nursing department, and the laboratory.

References:

1. An interview with needle phobia expert, Dr. Hamilton. Phlebotomy Today 2003; August. www.phlebotomy.com/archives/0803.htm (accessed 7/01/04).
2. Needle Phobia page. http://www.needlephobia.com (accessed 08/03/03)
3. What phlebotomists must know about needle phobia. Phlebotomy Today 2003; August. www.phlebotomy.com/archives/0803.htm (accessed 7/01/04)
4. Learn about age specific competencies. South Deerfield, MA: Channing L. Bete Co., Inc., 2000
5. NCCLS. Procedures for the collection of diagnostic blood specimens by venipuncture. Approved Standard. H3-A5. Wayne, PA, 2003
6. NCCLS. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens. Approved Standards. H4-A5. Wayne, PA, 2004
7. Dale J. Preanalytic variables in laboratory testing. Lab Med 1998;29:540-545
8. Watson R, O’Kell R, Joyce J. Data regarding blood drawing sites in patients receiving intravenous fluids. Am J Clin Pathol 1983;79:119-121.
9. McCall R, Tankersley C. Phlebotomy essentials, 3rd ed. Baltimore, MD; Lippincott, Williams & Wilkins, 2003.
10. Hoeltke L. Phlebotomy: the clinical laboratory manual series. Albany, NY: Delmar, 1995.
11. Hoeltke L. The complete textbook of phlebotomy. Albany, NY: Delmar, 1994

Review Questions

1. Creating Phlebotomy positions in the 1970s allowed the higher paid laboratory technologists to concentrate on:

• blood  specimen collection
• phlebotomy supervision
• the testing phase of clinical laboratory work
• unionization

2. In the 1980s, patient satisfaction surveys began to show that the more employees a patient encountered:

• the more satisfied they were with their care
• the less satisfied they were with their care
• the more expensive it was to treat them
• the longer their length of stay became

3. As healthcare delivery systems expanded in the 1980s, it became increasingly obvious to administrators that:

• employing individuals who had only one skill was an inefficient use of human resources
• Phlebotomist were an integral art of the laboratory staff
• Cross-training phlebotomists was costly and inefficient
• Nursing assistants were over utilized

4. Efficiencies gained in the decentralization of the phlebotomists were lost by:

• the unionization of health care
• the growth of HMOs
• delays in testing and the cost of recollections
• increased salaries for cross-trained personnel

5. Up to ____% of the errors that can alter test results occurs during the “preanalytical” phase.

• 13
• 46
• 56
• 85

6. Procedures pertaining to blood specimen collection should be based on documents issues by:

• OSHA and the Clinical and Laboratory Standards Institute
• FDA and OSHA
• JCAHO and Clinical and Laboratory Standards Institute
• CAP and NSI

7. Which state became the first state to enact legislation mandating that all phlebotomists be certified?

• Louisiana
• New York
• Michigan
• California