CLSI Announces New Guidelines, Terminology

The Clinical and Laboratory Standards Institute (CLSI) has recently released two new guidelines of importance to blood collection personnel, including changes in patient identification and terminology.
Accuracy in Patient and Sample Identification (GP33-A) is a new document that details proper patient identification well beyond what is included in its venipuncture and skin puncture standards (H3 & H4). The new guideline reinforces the importance of actively involving patients by asking them to state their name prior to drawing their blood, but goes a step further than prior documents by recommending inpatients as well as outpatients be asked to spell their last name. This new step, not previously recommended in other CLSI standards, strengthens patient identification requirements just months after The Joint Commission weakened its requirements.

Patients who cannot provide their information due to a cognitive impairment, language barrier, etc. should be asked to present some form of identification (e.g., driver's license, ID card, etc.) or be identified by a caregiver or family member. This provision reflects the requirements existing in CLSI's other sample collection standards.

The guideline also contains specific recommendations on labeling samples that includes standardizing the process facility-wide, establishing proper training protocols and competency assessments of staff who label samples, generating labels at the time of and/or site of collection, labeling all samples in the presence of the patient, and involving the patient in the sample labeling process whenever possible.

Additional sections in the guideline include instructions on how to validate a new system for patient identification, establish reports of incorrect patient ID incidents and audits, patient identification in point-of-care testing, and the use of barcode, radiofrequency identification technology, and biometrics. A robust appendix includes a sample Hospital Identification Band Policy, Inpatient and Outpatient Identification Procedures, Labeling Policy and Procedures, and a Policy for the Misidentified or Unidentified Patient.

The document introduces new terminology to replace the long-standing terms defining the three phases of laboratory testing. "Preanalytical" is now referred to as "preexamination"; the "analytical" phase becomes the "examination" phase; and "postanalytical" is being referred to as "postexamination." CLSI explains the necessity to incorporate these new terms in their documents in GP33-A:

"Clinical and Laboratory Standards Institute (CLSI) recognizes that medical conventions in the global metrological community have evolved differently in the United States, Europe, and elsewhere; that these differences are reflected in CLSI, International Organization for Standardization (ISO), and European Committee for Standardization (CEN) documents; and that legally required use of terms, regional usage, and different consensus timelines are all important considerations in the harmonization process. In light of this, CLSI’s consensus process for development and revision of standards focuses on harmonization of terms to facilitate the global application of standards.

"To align the use of terminology in this document with that of ISO, the terms preexamination, examination, and postexamination were adopted in place of preanalytical, analytical, and postanalytical, and the term sample replaces the term specimen where appropriate."

The term "sample" will refer to "one or more parts taken from a system, and intended to provide information on the system...." Therefore, in a blood collection context, a sample refers to the whole blood taken from the circulatory system by venipuncture, capillary puncture, or arterial puncture. A "specimen" is defined as "the discrete portion of a body fluid or tissue taken for examination, study or analysis of one or more quantities or characteristics, to determine the character of the whole." In the laboratory, a specimen would be an aliquot of serum or plasma, for example.

CLSI has also released a revision of its guideline on specimen handling. Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; reflects studies that have been published on analyte stability since the last revision was released in 2004. The update includes a nice chart summarizing analytes that are acceptable to test when centrifuged within 24 hours and 48 hours of collection. Also included is a passage on the effect of temperature and humidity on specimens, instruction on thawing serum or plasma, a comprehensive section on biobanking, and a statement that gel tubes without anticoagulants should be stored upright after collection and until centrifuged to prevent fibrin from attaching to the tube closure.

Hard copies and electronic versions of each document can be purchased from CLSI at www.clsi.org.

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This Month in Phlebotomy Today

Here’s what subscribers to Phlebotomy Today, the Center for Phlebotomy Education’s paid-subscription newsletter currently in its 11^th year of publication, are reading about this month:

• Feature Article: Patients Prefer Nurses over Physicians to Draw Their Blood
  
• Phlebotomy in the News: a round-up of articles on phlebotomy and phlebotomists who made Internet headlines in May including these stories:
• OSHA Requests Comment on its Bloodborne Pathogens Standard
• Healthcare Event Places Dozens at Risk for BBP Infection
• Phlebotomy Students Picket NC Business
• Hand Hygiene: There’s an App for That
• Study Exposes Risk-Prone Practices of HCWs
• Occupational Exposure a Daily Occurrence
• Patient Misidentification Figures Greatly in Patient Errors
• According to the Standards: Slapping the puncture site
• Tip of the Month: Ready or Not, Here I Come
• CE questions (institutional version only).

Buy this issue for only $9.95.

For subscription rates and to subscribe to Phlebotomy Today, click here. The current month’s issue will be emailed to you immediately upon subscribing.

Featured FAQ
Drawing multiple blood culture sets

Q: What's most important for blood culture collection: drawing each culture from a different site or assuring the proper volume is drawn?

A: According to most blood culture authorities, it’s considered more important to draw full volume blood cultures than to be concerned with spacing the draws apart. For adults, this means 20 mL per set divided between two bottles. Shorting the set can compromise the expediency of detecting and identifying organisms, which delays antibiotic therapy.

Allowing time to pass doesn't appear to be particularly necessary. Delaying the second set can affect the ability to harvest the causative organism of bacteremia. If the order was based on a fever spike, the population of the organism in the bloodstream peaked about 30 minutes before the fever spike. Any delay in collection decreases the chance of rapid bacterial detection and administration of antibiotics. So when blood cultures are ordered because of a fever spike, make sure they are collected as soon as possible. The bacteria are already on the decline in vivo.

Each month, PT-STAT! will publish one of the hundreds of phlebotomy FAQs in the growing database of questions and answers available in Phlebotomy Central, the members-only section of the Center for Phlebotomy Education's web site. For information on joining Phlebotomy Central, click here.

Survey Says
Transporting Samples for Coagulation Testing

Last month’s survey asked visitors to our website about the method of sample transport used in their facilities for blue-top citrate tubes drawn for routine coagulation testing.

When you draw blue-top citrate tubes for coag, how do you transport them to the laboratory; on ice, in a chilled container, or at room temperature?

On ice: 3.8%
In a chilled container: 13.4%
At room temperature: 82.8%

Sample Comments:

• “Our system is set up for us to send our coag specimens to our main lab via a pneumatic tube system within minutes after the draw. They are sent at ambient temperature. If we have a patient with a “unique” situation, we hand carry the tube to our first floor central location and have the sample transported by courier to the main lab.”
• “Routine coagulation tubes should not be on ice per recent clinical studies. Only special coagulation studies use ice, if indicated in the collection protocol. “
• “Coagulation tubes should always be kept at room temp until tested unless testing will be delayed and then they should be centrifuged and the plasma refrigerated or frozen.”
• “We’ve done in-house studies for PT and aPTT that have shown no change in results for stoppered tubes stored at room temperature for up to 24 hours.”

One of our survey respondents who indicated that routine coag samples are transported in a chilled container at his/her facility provided this additional comment: “I work for a major lab, our couriers pick up specimens 3x daily. We seem to have no problems with our PT/INR specimens.”

According to CLSI, blue-top citrate tubes for coagulation testing should be transported at room temperature. Transportation of whole blood samples on ice is not recommended for the majority of plasma-based coagulation assays because of the potential cold activation of Factor VII, loss of von Willebrand factor, and platelet disruption.(1) Extremes in temperature during transportation should also be avoided. Under ideal conditions, transport to the processing site or facility should occur within one hour of collection. For facilities using pneumatic tube systems, CLSI also recommends that coagulation samples be protected from physical vibrations and agitation that can cause protein denaturation and platelet activation through foaming of the sample.

Somewhat of a “gray-zone” exists in the body of evidence in the literature regarding the effects of refrigeration on aPTT samples. However, CLSI advises against refrigerated transport of aPTT samples (where “refrigeration” includes placing whole blood samples directly on ice or in an ice slurry) particularly if additional testing will be performed, since cold temperatures may lead to a spurious diagnosis of vWD or factor VIII deficiency. CLSI lists among the reasons for specimen rejection of  coag samples: 1) whole blood or plasma samples for PT testing that were refrigerated before testing, and  2) whole blood samples for vWF or factor VIII analysis that were refrigerated before processing.(1)

Reference
1.) CLSI. Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays: Approved Guideline-Fifth Edition. CLSI document H21-A5. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.

This month’s survey question:
Do you feel respected by other healthcare professions?

What Would You Do?

Each month, What Would You Do? presents a different case study, then asks readers to contribute their ideas as to how each situation would best be handled. The following month, selected responses will be chosen by the editor and published (sender will be identified by first name and state only). The most accurate, well written response will receive a free download from the Center for Phlebotomy Education’s Library of download articles. The exercise will conclude with a review of the selected submissions and a discussion of the standards pertinent to the case study.

After the litany of errors committed, 71 percent of PT-STAT! readers who responded to last month’s case study had one word for this phlebotomist: “Stop!”. But our readers’ reaction to bad technique didn’t end there. Thirty-six percent indicated they would request that another phlebotomist perform the draw, while 26 percent would also ask to speak to the phlebotomist’s supervisor.

Sample Comments:

• “I would stop her and ask for her supervisor…My concern would not at all be for the feelings of this phlebotomist. By her actions you can tell she’s been doing it a while and is quite comfortable with the wrong technique.”
• “I would have stopped her right then and there when she failed to ask me my NAME and DOB and chose to “ID the bed rail” instead of the PATIENT. I would have requested that someone else perform the draw. If this is any indication of how she starts out, she needs to be re-trained and learn the right practice skills…”
• “I wouldn’t have let her get past the “checking the ID on the bedrail” step! Once that was taken care of, any of the other behaviors would have me shouting “Stop!”  I would ask for this phlebotomist’s name, request another phlebotomist to do the draw, and ask for the number of the phlebotomy supervisor….”
• “I would stop her in her tracks, ask that she get another phlebotomist to come and draw my blood and ask to have her supervisor contact me so that I can explain what took place and let her handle it.”
• “…I would want to make sure that the supervisor was aware of these behaviors, to counsel the employee and make sure no other patients are drawn using these poor habits…I think the lab deserves the chance to help this employee learn better habits, but patient safety is the most important issue here.”

 For Dan in Missouri, this bad blood collection experience generated a deeper appreciation toward his own place of employment: “I would run like the wind back to my hospital where we use positive ID on wrists and ankles (babies), [and] use a new tourniquet to find a vein…”

Sixty-four percent of respondents stated they would engage the phlebotomist in conversation, pointing out the errors committed with 23 percent identifying themselves as a phlebotomist or phlebotomy instructor. Six percent of respondents stated that they would tell the phlebotomist she could possibly lose her job as a consequence for not following proper protocol. Due to the number of errors committed by this phlebotomist, it is clear that a thorough review of all pertinent CLSI, OSHA and facility policies is necessary, followed by re-training and a comprehensive reassessment of the employee. Anything less places patients at risk.

Dean from Indiana shared with us his approach to the situation to not only gain perspective on the competence of the phlebotomist but on the facility as a whole. He would be direct with the phlebotomist, giving her opportunity to answer for why proper protocol was not being followed. This open-ended question would give opportunity to see if the phlebotomist is truly competent to perform the procedure. If not satisfied with her response, Dean would request another phlebotomist. The professionalism of the second phlebotomist would determine whether the perceived incompetence was strictly one individual or an indicator of a larger problem, leading this reader to question the facility’s competence to perform his surgery and consider taking his business elsewhere.

Miles from Mississippi described his response this way: “First, refuse the venipuncture. Second, request a nurse supervisor to have an identification band placed on you, not the bed rail. Third, request the phlebotomy supervisor and/or Laboratory Administrative Director, if phlebotomy is centralized in the Laboratory, to your room. Explain to the phlebotomy supervisor/Laboratory Director the errors made when the phlebotomist attempted to draw your blood. Fourth, all interaction should be done in a manner that fosters an atmosphere of improved patient care.” 

For his succinct response and methodical approach, Miles will receive a free download from the Center’s library of articles.   

There are four major errors committed in this month's case study: 1) relying on an ID bracelet attached to the bedrail; 2) failing to survey all available sites for a median or cephalic vein before selecting the basilic vein, which lies close to nerves and the brachial artery; 3) removing the sheath with her teeth; and 4) repalpating the site after cleansing. Any one of these is reason to object to the way the procedure is being performed. All errors are clearly defined in the CLSI venipuncture standard (H3) except the "unsheathe by teeth" method of uncapping the needle. That's just plain uncouth.