November 2010

Editor:
Fredrick L. Kiechle, MD, PhD

Q. We are reviewing our phlebotomy procedures for syncope/fainting episodes, and I would like to know the current recommendations for addressing these patients. Is the use of ammonia capsules (inhalers) no longer recommended? Should these patients always be evaluated by a medical professional, that is, an RN or MD, before leaving the phlebotomy area? We are reviewing our phlebotomy procedures for syncope/fainting episodes, and I would like to know the current recommendations for addressing these patients. Is the use of ammonia capsules (inhalers) no longer recommended? Should these patients always be evaluated by a medical professional, that is, an RN or MD, before leaving the phlebotomy area?

A. According to the CLSI standard,¹ the procedure for a patient who has fainted or is unexpectedly nonresponsive is as follows:

1. Notify the designated first-aid trained personnel.
2. Where practical, lay the patient flat or lower his or her head and arms, if the patient is sitting.
3. Loosen tight clothing.
4. The use of ammonia inhalants may be associated with adverse effects and is not recommended.

McCall and Tankersley² state that a patient who feels faint or has a history of fainting should be asked to lie down for the procedure. Blood collection personnel should watch their patients for signs of fainting and be prepared to protect the patient from falling. If a patient feels faint or shows symptoms during a blood draw, they recommend following these steps:

1. 1. Release the tourniquet and remove and discard the needle as quickly as possible.
2. 2. Apply pressure to the site while having the patient lower the head and breathe deeply.
3. 3. Talk to the patient.
4. 4. Physically support the patient.
5. 5. Ask permission and explain what you are doing if it is necessary to loosen a tight collar or tie.
6. 6. Apply a cold compress or washcloth to the patient’s forehead and back of the neck.
7. 7. Have someone stay with the patient until recovery is complete.
8. 8. Call first-aid personnel if the patient does not respond.
9. 9. Document the incident according to facility protocol.

When the patient has regained consciousness, he or she must remain in the phlebotomy area for at least 15 minutes and be instructed not to operate a vehicle for at least 30 minutes.

References

1. Procedures for the collection of diagnostic blood specimens by venipuncture; approved standard—6th edition. CLSI document H3-A6, Vol. 27, No. 26. Wayne, Pa.: CLSI. 2007.

2. McCall RE, Tankersley CM. Phlebotomy Essentials. 4th ed. Philadelphia, Pa.: Lippincott, Williams and Wilkins; 2008.

Rebecca Rosser, MS, MBA, CLS, MT(ASCP)DLM
Education and Development Consultant
Director, Phlebotomy Program
Kaiser Permanente
SCPMG Regional Reference Laboratories
North Hollywood, Calif.

Q. What do you mean by waived or nonwaived testing? Please provide examples.

A. The federal Clinical Laboratory Improvement Amendments of 1988 created three laboratory testing categories: waived, moderate complexity, and high complexity. The classification has since been changed to waived and nonwaived categories.

The nonwaived categories have more stringent requirements, which include personnel standards for who can perform a test, training and competency assessment for all personnel, method validation studies before introducing a test, quality assessment programs including quality control, calibration, and external QC or proficiency testing, as well as physical testing site conditions, performance manuals, safety programs, and documentation of all required activities.

All waived test products are designed and developed to allow untrained operators to achieve test results equivalent to those achieved by health care professionals. Waived testing is more simply defined and has only the technical requirement that users “follow manufacturer’s instructions” for any test they perform. CLIA defines waived tests as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Waived testing is assumed to be easier to perform and have less chance for error.

Manufacturers have developed and refined waived testing so that it largely complies with that definition and the assumptions. However, the underlying test systems are still relatively sophisticated and depend on the operator following the steps and conditions set out by the manufacturers and approved by the Food and Drug Administration. The FDA determines the criteria for tests being simple, with a low risk of error, and approves manufacturers’ applications for test system waiver. Tests that the FDA has not waived are considered nonwaived.

Nonwaived product examples include any blood-based test requiring centrifugation of whole blood to serum or plasma (deemed sample processing)—for example, serum or plasma hCG testing. Waived product examples include home and physician’s office blood glucose testing and home and physician’s office urine hCG testing.

For a complete list of waived tests sorted by analyte name, visit the FDA’s Web site at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm. To determine which tests are categorized as waived or nonwaived (that is, moderate or high complexity), refer to the lists of tests online at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/search.cfm.

You can also contact the local survey agency at your state health department for categorization information about tests you may be performing in your laboratory.

James Nichols, PhD
Medical Director of Chemistry
Baystate Health
Springfield, Mass.

Consultant, CAP Point of Care
Testing Committee

David Ledden, PhD
Siemens Healthcare Diagnostics
Liaison, CAP Point of Care
Testing Committee