The following is the text of an E-mail sent to the Wisconsin Division of Quality Assurance from the CMS Region V Office in Chicago, August 2002 - see also CMS Letter S&C 02-43 (exit DHS; PDF), 9/12/02:
The Centers for Disease Control and Prevention (CDC) issued a July 5, 2002, letter to Dr. Sean Tunis, Medical Director of CMS, revising its recommendations on the multiple use of single-use intravenous medication vials used in ESRD facilities.
The Survey Procedures and Interpretive Guidelines for ESRD facilities state that facilities should institute the current recommendations of the CDC relative to infection control and prevention.
The current (April 27, 2001) guidelines from the CDC say "intravenous medication vials labeled for single use, including erythropoietin, should not be punctured more than once."
We have been aware that for several months the CDC has been reconsidering its position on the repeated use of single-use vials.
Therefore, we had asked Regions and States to hold these intravenous-medication-vial citations in abeyance because we expected a revised guideline from the CDC.
We have just received the revised CDC recommendation. The revised recommendation changes the CDC practice guidelines for ESRD facilities. Therefore, we are also changing the guidance to Regions and States regarding this issue.
Effective immediately, ESRD facilities will be expected to follow the revised CDC recommendations for injectable medications administered by ESRD facilities.
The CDC has stated that failure to comply with the following recommendations poses a significant health and safety risk to patients.
Therefore, we expect that either facilities will continue the practice of single use of single-use vials or facilities will follow the following recommendations:
1. All doses must be drawn-up by a licensed professional whose scope of practice includes administration of parenteral medications and knowledge of aseptic technique.
2. All doses from a given vial should be drawn-up and administered within a 4-hour period.
3. Only one vial of a given concentration of the medication should be opened and used by the administering professional at any given time. A second vial of the same medication must not be opened until the previous vial is discarded.
4. Any opened vials or filled syringes (with epoetin alpha, iron, or vitamin D) must be discarded if not used within 4 hours of first puncture of the vial.
Vials must be labeled to document the time of first entry and maintained at a temperature of 2-8 degrees Celsius (or 36-46 degrees Fahrenheit) during non-use.
5. Residual amounts of these medications (either in the vial or syringes) must never be pooled with medication from another vial or syringe.
If a patient requires more medication that is in a single, drawn syringe, then medication from a separate vial should be drawn into a separate syringe for administration.
6. Each facility must have in place a process monitoring (quality assurance) program which ensures compliance with these policies and procedures.
These policies must include: a) recording data on infections in treated dialysis patients; and b) unannounced practice audits involving quality assurance staff observing performance of re-use techniques.
ESRD facilities will now need to be monitored based upon these revised CDC guidelines. The CDC has stated that these procedures must be followed strictly to ensure patient health and safety. Not following these guidelines is a serious threat to patient health and safety.