BLOOD SAFETY: WIN, LOSE, or DRAW

CONTINUING EDUCATION

To earn CEUs, see current test at

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 under the CE Tests tab.

This month's CE test includes all articles in the cover story section.

LEARNING OBJECTIVES

Upon completion of this article, the
reader will be able to:

1. identify factors related to blood splattering during phlebotomy;
2. recognize definitions of blood splash and regulations pertaining to these issues;
3. describe an online registry of patients with antibodies for use by transfusion services;
4. describe new threats to the national blood supply; and
5. identify existing technologies and donor screening protocols for preparing safe blood supplies.

Survey sheds new light on blood-splash exposures

Have you ever experienced blood splash beyond your gloves during phlebotomy procedures? If so, you are not alone. In fact, you are part of the “soiled majority,” based on a recent study that found over 74% of blood-collection personnel surveyed reported one or more instances of blood splash or spatter occurring beyond their hands.

In their first collaboration, DenLine Uniforms of Quincy, IL, in conjunction with the Center for Phlebotomy Education of Corydon, IN, conducted a national survey of healthcare professionals who perform blood specimen collection as part of their assigned responsibilities in the workplace. The objectives of this study were twofold: 1) to determine if during phlebotomy procedures blood from a patient splashes beyond the hand area of the collector, and 2) to learn the causal factors of splatter beyond the wrists, and the affect of engineering and work practice controls to eliminate these factors.

Nearly one-fourth of the participants cited blood spatter or drips occurring during needle insertion
or removal as a factor …

Blood-splash estimates
Participants were asked to estimate the number of times they recall blood from a patient splashing beyond their hand area during phlebotomy procedures and coming in contact with either their skin, or the lab coat or personal clothing they were wearing. Of the 180 survey participants, 134 reported one or more such experiences (74.4%). Those who reported splatter beyond the hand area averaged 6.9 occurrences per person.

Causal factors
What accounts for the splashing and spattering of patient blood during phlebotomy procedures? Movement on the part of the patient during the draw was reported as the most common reason for the exposure (36.6%). Examples of such movements cited by respondents were combative/non-cooperative patients, unexpected movement (e.g., flailing or jerking by the patient), and patient trauma.

The second most common reason given for splatter was mishaps during the handling or transferring of the patient's blood sample (34%), such as dropped tubes, spills and leaks during syringe transfers, or loss of control over the device.

Respectively, procedure/technique issues and equipment/device failures claimed the third and fourth spots on the survey's compiled list of frequently mentioned factors. Technique-related causes included

• collector distraction;
• pulling the needle out too soon;
• pulling the plunger out of the syringe;
• failure to back the tube off the hub before removing the needle;
• incomplete release of the tourniquet; and
• rushing during emergency situations.

Equipment failures were described by respondents as broken or cracked tubes, defective tube holders, malfunctioning syringes, and faulty butterfly collection sets and adapters. Nearly one-fourth of the participants cited blood spatter or drips occurring during needle insertion or removal as a factor, while attributes unique to the patient (i.e., vein size, clotting issues, coagulation therapy) were mentioned by one-fifth of those reporting as a cause for blood splash during sample collection.

Rounding out the list of frequent mentions were finger-stick issues (9.0%), splashes occurring during safety-device activation and sample capping (8.2%), and touching other surfaces where blood is present, such as the tops of tube stoppers or blood-culture bottles (5.2%).

Use of protective lab coats or jackets
In response to the survey question “Do you currently wear a protective lab coat or jacket when drawing blood?” overwhelmingly, the respondents answered yes (81.1%). For those reporting the use of lab coats or jackets as personal protective equipment during blood-collection procedures, the majority indicated the type of coat worn to be fluid resistant (64.4%), followed by polyester/cotton (28.1%), with others not sure of the fabric type or composition (7.5%).

Incident reporting
The survey found the reporting and documentation practices of occurrences are not universal. Approximately 69% of participants indicated that their employer keeps a record of blood-splash events, along with the causal factors, while more than 31% of those surveyed stated no such records are maintained. When asked to describe their personal reporting practice when blood goes beyond their hands, 56.1% indicated they always report, 31.1% stated they most always or sometimes report, with 12.8% never reporting such incidents.

Why the variation in reporting? This is partially explained when the individual's own interpretation of what needs to be reported is revealed. Some respondents indicated that they only report if blood contacts the skin, eyes, mouth, or other mucous membranes. Other respondents deemed the event as reportable only when blood comes into contact with non-intact skin (i.e., an open cut or wound) the eyes, mouth or other mucous membranes. A third of the respondents felt there was no need to report the event if adequate protection was provided by their lab coat — the lab coat had served its intended purpose.

Other reasons stated for not always reporting included no employer reporting policy in place (19.8%), and the individual's perception of the risk, essentially seeing “no harm done” (17.3%). Some respondents felt reporting was unnecessary if the area soiled was cleansed immediately using soap, water, disinfectant wipes, and the like (14.8%). Others used the quantity of blood as the benchmark, not reporting the incident if they considered it a “small amount of blood” (7.4%).

Additional barriers to reporting expressed by survey participants included concern over the amount of time it takes, as well as the personal ramifications of making a report. Among the explanations given for not always reporting blood-splash occurrences were

• being too busy;
• the amount of paperwork required;
• embarrassment; fear of getting in trouble;
• being made to feel incompetent by their manager, and
• the employer always thinking the phlebotomist is at fault (as opposed to equipment failure).

OSHA compliance
Based on the findings of this study, there is now compelling data that employees not only have the potential for blood splash beyond the hand area while performing phlebotomy procedures, but most have already experienced it.1

Can blood splash be reasonably anticipated during blood-collection procedures in your facility? Ultimately, it is up to your employer to make that determination. According to Occupational Safety and Health Administration's (OSHA's) Compliance Directive, the manual which the agency provides to its inspectors to help interpret and enforce the standard:

The employer must evaluate the task and the type of exposure expected and, based on the determination, select the “appropriate” personal protective clothing in accordance with paragraph (d)(3)(i). For example, laboratory coats or gowns with long sleeves must be used for procedures in which exposure of the forearm to blood or OPIM [other potentially infectious material] is reasonably anticipated to occur.2

OSHA 29 CFR 1910.1030(d)-2 requires the employer to institute engineering and work practice controls to eliminate routes of exposure.3 Due to the various and often-unpredictable causal factors identified by this survey, many of the circumstances described will remain OSHA compliance issues. For the 81.1% who reportedly wear a protective lab coat or jacket during blood-collection procedures, their employers may have long since determined that gloves alone are not enough.

Survey respondents
Of the 180 questionnaires received, 67.8% of the participants identified themselves as phlebotomists; phlebotomy managers or supervisors; or phlebotomy educators; 10% as medical/clinical technologists, 9.4% as medical/clinical technicians; with the remaining 12.8% of respondents divided among various disciplines and job titles, including medical assistants, laboratory management, and nursing. The average number of years of phlebotomy experience reported by survey participants was 14.3 years.

In terms of where they work, the majority of respondents indicated employment by a hospital (67.2%), followed by a medical clinic/physician's office (20%), an independent laboratory (7.2%), or “other” (5.6%). Geographically, 42.8% of the survey participants were from the Midwest, 22.8% from the Northeast, 13.9% the Southwest, 11.7% the Southeast, and 8.9% from the Northwest.

Methods
The self-administered survey was announced in the September 2008 issue of PT-Stat!, the Center for Phlebotomy Education's free monthly e-newsletter, and was also accessible via the sponsor's website at www.denline-uniforms.com.

References

1. Exposure to blood beyond the hands and reporting practices among those who draw blood; 2008 Survey Report; DenLine Uniforms Inc. Quincy, IL.
2. US Department of Labor and Occupational Safety and Health Administration (OSHA). Enforcement Procedures for Occupational Exposure to Blood borne Pathogens. CPL 2 3.69. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=DIRECTIVES&p_id=2570. Accessed May 27, 2009.
3. Occupational Safety and Health Administration. (1991) Occupational exposure to blood borne pathogens: Final rule. 29 CFR 1910.1030. Federal Register, 56, 64003-64282. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051.Accessed May 27, 2009.

Lisa O. Ballance is the director of Online Education with the Center for Phlebotomy Education, located in Corydon, IN.

 

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Keeping the U.S. blood supply safe

 

New threats to the U.S. blood supply have surfaced. News reports in May 2010 indicate that public-health officials report their newest battle against several infectious threats to the nation's blood supply, including Chikungunya, a virus from Africa, and babesiosis, a parasitic infection linked to at least 10 deaths through blood transfusions beginning in 2006.1 Laboratory diagnosis of arboviral infections like Chikungunya is generally arrived at by testing serum or cerebrospinal fluid to detect virus-specific IgM and neutralizing antibodies.2 Babesiosis is usually diagnosed by examining blood specimens microscopically and finding Babesia parasites inside red blood cells; however, some species look identical and a reference laboratory may be required to confirm diagnosis through blood-smear examination or serologic or molecular methods.3

While testing for hepatitis C and HIV has been performed for years, the only new tests on donated blood in recent years include West Nile virus and Chagas, a tropical parasitic disease. More pathogens show up as more people travel globally, and “bugs” continue to grow ever more resistant to antibiotics. Last year, researchers identified 68 emerging infectious agents with the potential to threaten the blood supply.1

We need to take a more proactive
approach to emerging infections. …
We learned from HIV that we have to react
aggressively to every next potential threat.

The Centers for Disease Control and Prevention (CDC) recently reported the first outbreak of dengue fever in the U.S. outside the Texas-Mexico border region since 1945. Dengue, a debilitating mosquito-borne disease, kills 25,000 people a year worldwide and has been increasingly found in travelers returning from the Caribbean, South America, and Asia. The American Red Cross currently is using an investigational test to screen blood for dengue in Puerto Rico where dengue is highly prevalent, but the test is not yet approved for wide use.1 Dengue can be diagnosed by isolation of the virus, by serological tests, or by molecular methods, depending upon the acute (more than five days of symptoms) and/or early convalescent stages phase (more than five days of symptoms).4

Developing new screening tests is often difficult, and then the process of getting government approval can take years. The U.S. Food and Drug Administration (FDA) regulates blood operations, so blood-supply officials are urging the U.S. government to adopt “pathogen-reduction” technology that can kill a wide range of contaminants in donated blood. In Europe, Asia, and other countries, a method being used destroys most pathogens with a combination of chemicals and ultraviolet light; however, the FDA cited possible side effects when it declined to approve the technology several years ago. Currently, the FDA continues to evaluate the process. An FDA spokeswoman says the agency's position is that pathogen-reduction “could potentially protect blood from known and unknown infectious agents.”1

According to Richard Benjamin, chief medical officer at the American Red Cross, all of this means “the U.S. blood system is becoming more vulnerable to new pathogens. We need to take a more proactive approach to emerging infections.”1

Michael Busch, director of the Blood Systems Research Institute in San Francisco and a member of a federally funded group studying whether the retrovirus XMRV, which some studies show linked to chronic fatigue syndrome, poses a threat to the blood supply told The Wall Street Journal, “We learned from HIV that we have to react aggressively to every next potential threat.”1

Paul Ness, director of transfusion medicine at Johns Hopkins University in Baltimore, MD, says pathogen-reduction technologies raise concerns because the combination of UV light and chemicals used to inactivate viruses may cause adverse reactions in the recipient. Chemicals used in such processes may result in other types of toxic effects, he says. But he says there may be ways to lessen the damage, so a combination of blood testing and pathogen reduction could be used by blood centers to reduce infectious risks and risks of harm to the immune system from white blood cells.

In an interview with The Wall Street Journal, Louis Katz, executive vice president of medical affairs for the Mississippi Valley Regional Blood Center, says that pathogen-reduction technology could be the “Holy Grail” for blood safety because it has been shown to kill or inactivate most viruses and bacteria along with potentially harmful white blood cells that naturally occur in donated blood. The leukocytes (white cells) can carry hidden viruses and can react badly with the recipient's immune system. Current testing and questionnaires meant to weed out potentially infected donors are not enough to guarantee safety, he says, especially if there is a potential threat on the scale of HIV.1

Existing test systems and technologies
A system sold in 11 countries kills most contaminants in platelets and plasma using a combination of chemicals and UV light. This system also inactivates white blood cells. This was the system that the FDA declined to approve for use in the U.S. after a 2003 clinical trial showed a slight risk of a respiratory injury from blood treated with the system. The FDA does not accept European data, which the corporation's chief medical officer (CMO) cites: In more than 75,000 transfusions in Europe, there has not been any increased incidence of lung injuries with the system's treated platelets. The CMO says his company is discussing requirements for the size of a new clinical trial with the FDA, as well as preparing an alternative clinical study approach. The company says it is now developing a version of the technology to use for red blood cells.1

Other companies operating outside of the U.S. provide different technologies to kill pathogens in donated blood, including those that add a mix of vitamin B and various chemicals to the blood or using solvents and dyes to kill pathogens in different blood components. Many blood centers and the American Red Cross have been using filtering systems for the last 10 years or so to reduce the number of white blood cells; however, some of them still remain in blood.1

Rejection rates
According to the latest figures available, about 16 million units of whole blood and red blood cells were donated in the U.S. in 2006. The increase in prohibitions has reduced the pool of eligible donors. In 2006, out of 12.4 million people presenting to donate blood, nearly 2.6 million were turned away during screening; and 1.2% of donor blood was thrown out that year.1

Without tests for the many new risks, blood centers have continued to add new prohibitions for people wanting to give blood as a way to keep out potentially harmful donations. Donors must answer nearly 50 questions — up from 20 questions in the 1970s. — most of which are required by the FDA and by the AABB to determine disease exposures from travel; risky sexual behaviors; medical conditions; and medication and drug use.1

Donors are rejected if they have traveled to regions where malaria is present or lived in Europe since 1980, which may put them at risk of carrying variant Creutzfeldt-Jakob, or the human version of mad-cow disease. Would-be donors who have ever taken the psoriasis drug Tegison (removed from the market because of its risk of causing birth defects) are rejected. Blood found to carry disease after testing is discarded.

Hemovigilance
Other new risks from blood transfusion have emerged in recent years, including lung injury and deadly reactions caused by white blood cells and antibodies in donor blood. The CDC this year began a “hemovigilance” program to encourage hospitals to track such events more closely. The hemovigilance program provides standard criteria and definitions to participating facilities to report adverse events related to blood transfusions that will result in aggregate data suitable for trend analyses and benchmarking in order to improve outcomes in the use of blood products, according to the CDC. Visit www.cdc.gov/nhsn/bio.html for details. The CDC will be conducting training on the National Healthcare Safety Network's Hemovigilance Module with AABB on Oct. 7, 2010, in Baltimore before the official start of the AABB annual meeting. For more information on this training opportunity e-mail [email protected].

 

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First HIPAA-compliant, online antibody registry in U.S. assists hospitals in preventing life-threatening blood-transfusion reactions

By Deb Turpin

In June 2008, the first antibody registry in the United States was launched for the Community Blood Center of Greater Kansas City (MO). The online registry is a resource for area transfusion services, which contains names of patients with their known alloantibodies and antibodies identified. Containing more than 6,000 patient records, the registry is a lifesaving medical and technological advancement for transfusion services and patients. By reducing the amount of time needed to test blood, the registry allows blood transfusions to take place quickly; tracks patient records despite changes in hospital, healthcare provider, or insurance carrier; and provides an efficient alternative to traditional paper.

Currently, 72 hospitals in Kansas and Missouri
have access to the Antibody Registry.

“On the registry's first day of activity, a hospital blood bank discovered a transfusion patient had a complex antibody profile. Ordinarily, several hours would be spent identifying the antibody, but the Antibody Registry provided the Community Blood Center with crucial information in a timely manner,” says Vicki Schwickerath, manager of hospital relations at the Community Blood Center. “The hospital saved vital time, and the patient avoided a potentially life-threatening incompatibility.”

During the first year of use, the Antibody Registry was accessed more than 3,100 times. Sixty-eight hospitals viewed records, and 13 of these hospitals had the ability to enter their own patient antibodies for further documentation. Hospitals report that they have reaped the benefits of a centralized database, available 24 hours a day, which can access crucial information with the click of a mouse.

Additional benefits of the registry include

• prevention of delayed transfusion reactions;
• decreased amount of required blood samples;
• decreased turnaround time for workups;
• reduced risk of hemolytic transfusion reactions;
• faster cross matches;
• less reliance on patients' memory of prior treatments; and
• instant access to records from other facilities.

The Community Blood Center credits the Antibody Registry with savings in time and money as well as lives. A partnering hospital states that the Antibody Registry cuts down on calls that have to be made to Community Blood Center to check on a patient. Currently, 72 hospitals in Kansas and Missouri have access to the Antibody Registry. Each week, approximately 120 blood bankers at these hospitals access the Antibody Registry and view 20 to 30 patient records on average.

The password-protected and encrypted system meets HIPAA and HITECH standards with multitiered security levels. Sensitive patient information is protected through varied levels of access, while all user activity is time stamped and recorded. A double-entry system reduces the possibility of data-entry error. The Community Blood Center's staff is able to add patient information and participating hospitals view the records and add notes via a Web browser. The Blood Center's staff assigns privileges to select individuals and posts important medical memos, recall information, hospital services, and pricing information in one central location. The user-friendly interface allows authorized users to quickly locate and retrieve a patient's test records from any participating blood bank or transfusion service.

Deb Turpin is CEO of River City Studio in Kansas City, MO, which offers the Web-based Antibody Registry application to blood centers around the United States. Visit www.antibodyregistry.com for more information.