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On the bleeding edge: Advances in technology, concerns about safety, and newly enacted legislation are thrusting blood collection procedures, and those who perform them, into a white-hot spotlight. (Cover Story - Phlebotomy).

Nearly every aspect of blood collection is making progress, if not headlines, as the healthcare industry focuses on blood collection procedures and those who perform them. Current hot topics include safety needles, conversions to plastic tubes, the order of draw, phlebotomy certification, tube holder reuse, and phlebotomy-related lawsuits.

Safety

Perhaps the most revolutionary development in the history of blood collection since disposable needles was the anxiously anticipated signing of the Needlestick Safety and Prevention Act in 1999. This measure mandated those employers who are subject to the provisions of the Bloodborne Pathogens Standard to put safer needles into the hands of those who collect blood specimens. The act not only changed forever the way blood collection procedures are performed, but impacted nearly every facet of blood specimen collection in the United States.

Phlebotomists

Because safer needles require one or more additional steps to activate a safety feature (there are currently no passive sharps for blood collection by venipuncture), those who draw blood specimens must adapt to new equipment -- no small task for the hundreds of thousands of phlebotomists and blood collectors from other healthcare professions who have grown comfortable with a technique standardized to conventional syringes and tube holders for more than 30 years. Even though the General Accounting Office estimates the legislation will prevent up to 69,000 accidental needlesticks annually, change -- for better or worse -- invariably meets with resistance. (1, 2)

Laboratory managers

Some employers were ahead of the curve when the legislation took effect and had implemented the safeguards in their facilities while they could afford the luxury of selecting and implementing on their own timetable. When the act became effective on April 18, 2001, however, most had 90 days to orchestrate the necessary steps to become compliant: organizing committees, selecting the products to be evaluated, evaluating the products, collating the results, selecting the safety device(s), and implementing them facilitywide. Not much time considering the magnitude of the task. Managers who were not proactive to the legislation were hard-pressed to comply before enforcement began, and many are still mired in the process.

Manufacturers

Anticipating the demand that legislation promised to bear upon the market, manufacturers have been gearing up for years. The U.S. Patent and Trademark Office issued more than 1,000 patents for safety products in the last 10 years. (3) The scramble to satisfy the mandated hunger for safer systems has only intensified since the legislation has become effective. With conventional needles on their way out, the playing field for the blood collection supply market has leveled, allowing innovative designs and companies to emerge and compete for dominance of an entirely new market on an even footing with those who have dominated the conventional needle market.

Currently, at least 11. companies offer safety products in four categories for facilities to evaluate: modified tube holders, modified needles, winged infusion sets, and skin puncture devices (see page 13). Many others provide products that facilitate needle concealment, incineration or disposal. But of all the types of blood collection supplies, no category has seen more new products in the last 12 months than that of winged-infusion (butterfly) sets. Long awaiting safety modification, winged infusion sets have been associated with an inordinately high rate of accidental needlesticks -- 18 percent of all those incurred by healthcare workers and 32 percent of those sustained by phlebotomists. (4,5) Shunned safety- and cost-conscious, the device, nevertheless, continues to be preferred by many for its maneuverability and for use on small and fragile veins.

Plastic tubes

Concern over exposure has spread to non-needle injuries as well. Since broken glass injuries have resulted in documented cases of HIV infection, facilities nationwide are looking hard at converting from glass collection tubes to plastic. (6) Besides the obvious benefits of reducing broken-glass exposures, managers are further enticed by the reduction in the cost of disposing of plastic specimen tubes over their glass counterparts.

Industry experts are quick to point out that broken glass injuries, although they occur less frequently than accidental needlesticks, pose a greater risk of transmitting bloodborne pathogens.

"Glass devices containing blood cause some of the most serious injuries to healthcare workers because broken-glass injuries usually involve a larger inoculum of source-patient blood to the laceration site than an injury from a blood-filled needle," says Jane Perry, M.A., director of communications for the International Health Care Worker Safety Center at the University of Virginia Health System. "The good news is that injuries from glass tubes are totally preventable by substituting plastic ones. But while progress is being made in replacing glass with plastic capillary tubes, more attention needs to be focused on the conversion from glass to plastic blood collection tubes."

Perry points out that the revisions to the Bloodborne Pathogens Standard targeting a reduction in exposures applies to safer blood collection tubes as well. "OSHA, in its commentary on the revised bloodborne pathogens standard, says that 'engineering controls' include all control measures that isolate or remove a hazard from the workplace, encompassing not only sharps with engineered sharps injury protections and needleless systems, but also other medical devices designed to reduce the risk of percutaneous exposure to bloodborne pathogens. OSHA cites plastic capillary tubes as one example; clearly, plastic blood collection tubes also fall into this category. This is a simple control measure that needs to be widely implemented."

Concern over exposure has spread to non-needle injuries as well. Since broken glass injuries have resulted in documented cases of HIV infection, facilities nationwide are looking hard at converting from glass collection tubes to plastic. (6)

Besides the obvious benefits of reducing broken-glass exposures, managers are further enticed by the reduction in the cost of disposing of plastic specimen tubes over their glass counterparts.

Plastic tubes and the order of draw

The industrywide conversion from glass to plastic tubes, however, is forcing the reconsideration of one of the most basic principles of blood specimen collection: the order of draw. Often referred to as "phlebotomy's best-kept secret," the order of draw has its origins in the literature as fur back as 1977 when additive carryover from one tube to the next was observed independently at two hospitals, St. Barnabas Medical Center in Livingston, NJ, and Hillcrest Medical Center in Tulsa, OK. (7) Subsequent observations of similar spurious results related to the order in which tubes are filled led the National Committee for Clinical Laboratory Standards (NCCLS) to institute an order of draw designed to prevent erroneous results due to additive carryover in their standard, Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture, published in 1991.8 In that document, the standards organization established two distinct orders of draw: one for syringes and one for vacuum-assisted draws. However, t he separate order for syringes was repealed when NCCLS revised the standard in 1998 due to the lack of supportive evidence that syringes required a separate order. According to the 1998 standard, the most current, NCCLS recommends the following order:

* First: Sterile tubes for cultures.

* Second: Nonadditive tube.

* Third: Sodium citrate tube.

* Fourth: Gel separator tube.

* Fifth: Heparin tube.

* Sixth: ETDA tube.

* Seventh: Oxalate-fluoride tube.

With so many facilities now converting from glass to plastic tubes, those who draw blood specimens must now consider the composition of the tube they are using. (9) Since plastic does not activate clotting like glass does, plastic tubes for serum testing, e.g., red-stoppered tubes, must contain a clot activator. The problem arises when drawing plastic red-stoppered tubes (which contain a clot activator) in the same place in the order of draw as red-stoppered tubes made of glass (without an additive). During tube exchange, if even minute amounts of the blood/clot activator mixture carries over into the next tube, which according to the current order of draw is the sodium citrate tube (blue top) for coagulation testing, the clot activator can alter the results and lead a physician to adjust the patient's anticoagulant therapy based on erroneous results.

Therefore, it stands to reason that facilities using plastic tubes should draw the red-stoppered tubes with the clot activator after the blue top if coagulation studies are also being drawn. If no blue top is drawn, the plastic red top can precede a heparin (green top) or EDTA (lavender top) tube without concern for carryover. (The current thinking is that any carryover of the clot activator into tubes other than blue tops is irrelevant since the minute amount of clot activator will be consumed by the excess heparin or EDTA and will not compromise their ability to anticoagulate the specimen.)

Tube holder reuse

One of the more controversial issues affecting the blood collection industry is the reuse of tube holders. This practice has come under increased scrutiny over the last several years for two reasons: contamination and safety. Studies show that a high percentage of tube holders are contaminated with blood even after one use. (10,11) Some facilities are reacting to these concerns by soaking their used tube holders in a dilute bleach solution daily instead of the costly practice of discarding them after each use. However, the Occupational Safety and Health Administration (OSHA) is sending strong signals that it is becoming increasingly intolerant of removing needles and, therefore, reusing tube holders for safety reasons.

Through compliance directive, inspectors are reminded that needle removal is prohibited unless employers can meet both of two conditions: 1) that needle removal is required for the procedure or that no feasible alternative is available and 2) that needle removal is performed by some method other than two-handed recapping.

As if to underscore the difficulty in justifying needle removal from tube holders, the latest directive, issued in January 2002, includes the following statement: "The practice of removing the needle from a used blood-drawing/phlebotomy device is rarely, if ever, required by a medical procedure. Because such devices involve the use of a double-ended needle, such removal clearly exposes employees to additional risk." (12) With this statement, OSHA clearly challenges employers to prove that no alternative is feasible. Employers that make this claim are required to back up such a policy with written justification supported by reliable evidence, a caveat many consider impossible to satisfy.

Another change in the language of the new directive, however, could easily be interpreted as OSHA's long awaited ban on needle removal and, hence, tube holder reuse. The prior directive, issued in 1999, stated "Needles are expected to be used and immediately discarded." However, the new directive states "Devices with needles must be used and immediately discarded after activation of the safety feature." Industry watchers see this change in the language from "needles" to "devices with needles" as significant step toward banning tube-holder reuse completely.

This firmer stance calls into question the legitimate use of an entire class of modified tube holders -- those that employ a release mechanism to allow the operator to drop the contaminated needle into a nearby sharps container one-handedly and automatic unthreading devices built into sharps containers. Since releasing the needle through these mechanical means constitutes removing the needle, laboratory managers who want to continue using them will have their work cut out to justify the practice in their exposure control plan.

Certification

No single act subjected phlebotomists to more scrutiny than that of the California phlebotomist who was caught rinsing and reusing contaminated butterfly needles on multiple patients. An inconceivable act that appalled the phlebotomy community on every level, the incident became the flashpoint for California to enact legislation mandating certification of all phlebotomists. Two other states also have certification legislation on the books, although their measures are less sweeping than California's. Louisiana requires certification for phlebotomists unless they are under the direct supervision of a physician or employed by a licensed clinical laboratory; Nevada mandates that all laboratory assistants obtain phlebotomy certification.

Although New York and Florida legislatures are considering certification measures, the lack of initiatives in other states suggests that the California incident is being considered an isolated one that couldn't happen elsewhere.(14)

The OSHA directive refers to a federal program change to which state adoption is not required. "A dangerous complacency," says Sheila Clover BS CPT(ASCP)(NCA)(NPA), executive director of Phlebotomy West, a phlebotomy advocacy group that lobbies for the profession.

Certification, however, goes beyond just making sure phlebotomists don't put patients at risk of injury and illness or subject them to negative outcomes of erroneous laboratory results caused by improper collection procedures. It's about establishing standards of performance. "Professional certification provides an excellent means to validate the phlebotomist's education and experience," says Chris Damon, executive director of American Medical Technologists (AMT). "Particularly with certifications that require passage of a national exam, certification provides a respected credential with real meaning to employers and peers alike."

Damon sees phlebotomy certification as becoming increasingly popular with both legislatures and employers. "With the growing regulatory focus on safety and error reduction in the lab and in healthcare generally, interest in phlebotomy certification is likely to grow," he says.

References

(1.) GAO estimates needlestick bill will prevent 69,090 exposures. Phlebotomy Today. 2001;2(2). www.phlebotomy.com accessed 2/18/02.

(2.) Perlman D., Takacs G. The 10 Stages of Change. Clin. Lab. Mgmt. Rev. May/ June 1993;208-216.

(3.) Safety designs proposed, but not produced. San Francisco Chronicle online edition. April 14,1998. www.sfgate.com accessed 6/9/98.

(4.) Jagger J., Hunt E. Brand-Elnaggar, Pearson, R. Rates of needle-stick injury caused by various devices in a university hospital. N Eng J Med. 1988:319(5):284-288

(5.) Jagger J. (1994) Risky procedure, risky devices, risky job. Advanced Exposure Prevention 1(1):4-9

(6.) Ernst D. Plastic collection tubes decrease risk of employee injury. AdvAdmin Lab 2001;33(5):44-59.

(7.) Sun N., Knauf R. Cross contamination solved by technique. ASCP Summary Report 1977:14(3):3.

(8.) National Committee for Clinical Laboratory Standards. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture. Approved Standard, H3-A3, Villanova, PA, 1991.

(9.) Jacobsen R. Addressing 'order of draw" in comparative calcium levels. MLO. 2001;33(12):6.

(10.) Rethinking the order of draw. Phlebotomy Today 2001;2(10.) www.phlebotomy.com accessed 2/18/02.

(11.) Howanitz R, Schifman R. Phlebotomists' safety practices. Arch Pathol Lab Med 1994;118:957-962.

(12.) Weinstein S., Hamrahi P., Avato J., Gantz N. Blood contamination of reusable needle holders. Am J Inf. Control 1991;19(2).

(13.) Occupational Safety and Health Administration Compliance Directive CPL 2-2.69. www.osha-slc.gov/OshDoc/Directive_data/CPL_2-2_69. html accessed 2/16/02

(14.) Phlebotomist education and certification a growing issue. Lab Med 2002;33(1):7.

RELATED ARTICLE: Modified Tube Holders

* Drop-it--Bio-Plexus 1-800-223-0010 www.bio-plexus.com

* Auto Drop--Kendall 1-800-962-9868 www.kendallhq.com

* Pronto--BD 1-800-237-2762 www.bd.com

* ProGuard II--Kendall 1-800-962-9888 www.kendallhq.com

* Saf-T Clik-MPS Acacia 1-800-486-6677 www.mpsacacia.com

* VanishPoint--Retractable Technologies 1-868-703-1010 www.vanishpoint.com

* Saf-T Holder--MPS Acacia 1-800-486-6677 www.vanishpoint.com

* Vanipuncture Needle Pro--Smis Portex 1-800-258-5361 www.simsportex.com

Modified Blood Collection Needles

* Eclipse--BD 1-800-237-2762 www.bd.com

* Punctur-Guard--Bio-Plexus 1-800-223-0010 www.bio-plexus.com

* Safe-Point VAC--NAMP (North American Medical Products Inc.) 1-800-4886267 www.nampic.com

Winged Infusion Sets

* Safety Blood Collection Set--Greiner Bio-One (New) 1-888-286-3683 www.vacuette.com

* Angel Wing--Kendall (New) 1-800-962-9688 www.kendallhq.com

* Wingset--Bio-Plexus (New) 1-800-223-0010 www.bio-plexus.com

* Vacu-B--Myco Medical (New) 1-600-454-6926 www.mycamedical.com

* Safety-Lok--BD 1-800-237-2762 www.bd.com

Skin puncture/incision devices

* Tenderlett/Tenderfoot--International Technidyne Corporation Inc. (Margate, United Kingdom and Kent, NJ, USA) 1-800-631-5945 www.itcmed.com

* Nicky--Helena Laboratories 1-800-231-5663 www.helena.com

* Quickheel--BD 1-800-237-2762 www.bd.com

* Monolettor/Monoject--Kendall 1-800-962-6888 www.kendallhq.com

Miscellaneous products

* AND--Post Medical 1-800-876-8678 www.postmedical.com

* Mobile Draw Station--MarketLab 1-800-237-3604 www.marketlabinc.com

* NeedleSafe II--Prime lime Plus 1-800-727-3865 www.primetimeplus.com

* Point-Lok--Sims Portex 1-800-258-5361 www.simsportex.com

* SharpX--Biomedical Disposal 1-888-363-9595 www.biodisposal.com

* Needlyzer--MedPro 1-659-225-5375 www.needlyzer.com
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Author:Ernst, Dennis J.
Publication:Medical Laboratory Observer
Article Type:Brief Article
Geographic Code:1USA
Date:Apr 1, 2002
Words:2627
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