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Based on observation, record review and interview, the facility failed to ensure blood collection tubes were not outdated. This failed practice had the potential to compromise the accuracy of blood test results, placing patients at risk for delayed, omitted, or inappropriate treatment. Findings:


Per one blood collection tube manufacturer (BD), the expiration date printed on each tube "indicates the shelf life of the product as determined by functional testing. To assure accurate draw and test reliability, tubes must be used by the expiration date".

Per Mosby's Manual of Diagnostic and Laboratory Tests, Second Edition, the rubber stoppers on blood collection tubes "are color-coded to distinguish whether the tube contains a specific anticoagulant" (substance that prevents blood clotting) or preservative, both of which have a limited shelf life. In addition, "selection of the color-coded tube is based on the requirements of the test". The manual identified blood collection tubes with lavender, gray, green, and blue stoppers as containing additives (anticoagulants or preservatives).

Per the manufacturer, both black top tubes and gold top tubes contain additives.

Observations during the initial facility tour at 10 am on 5/3/10 revealed the following blood collection tubes were outdated:

Exam Room 3
1 blue top tube, expiration date 2009;
1 black top tube, expiration date 04 2010;
1 green top tube, expiration date 2009;
2 gold top tubes, expiration date 01 2010; and
1 red top tube, expiration date 04 2010.


Exam Room 5
4 blue top tubes, expiration date 2009;
3 yellow top tubes, expiration date 01 2010;
2 black top tubes, expiration date 04 2010;
1 purple/lavender top tube, expiration date 2009;
1 green top tube, expiration date 04 2010; and
1 gray top tube, expiration date 2009.


Observation in the lab at 11 am on 5/4/10 revealed 3 black top tubes on the counter with an expiration date of 04 2010.


When the Surveyors asked who was responsible for checking blood collection tubes in the exam rooms for outdates, staff gave the following answers:

Registered Nurse, at 2:30 pm on 5/4/10 stated the lab was responsible;

Certified Nurse Aide, at 11 am on 5/5/10, stated the nurses were responsible; and

Lab Staff, at 11 am on 5/4/10, stated the nurses were responsible for checking for outdated tubes in the exam rooms.

As a result, the facility had no system in place to ensure blood collection tubes in the exam rooms were checked for outdates.

In addition, on 5/4/10 at 11 am Lab Staff confirmed the outdated black top tubes in the lab had been missed when they did "monthly checks".