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Based on observation, interview, record review, and manufacturer's recommendations, the provider failed to ensure the Sodasorb (soda lime carbon dioxide absorbent) in the anesthesia gas machine in one of one operating room (OR) was maintained in a safe operating condition. Findings include:

1. Observation of the OR on 4/12/11 at 10:15 a.m. revealed an anesthesia gas machine. Two canisters of Sodasorb were installed on the machine. One of the canisters of Sodasorb had an expiration date of January 2010. The other one had expired in March 2010.

Interview at that time with the director of patient care services and quality assurance (QA) director confirmed those findings. Further interview revealed that anesthesia gas machine had just been inspected by a biomedical engineering specialist from the provider's referral hospital "two to three weeks ago." The QA director stated the Sodasorb canisters had been replaced at that time.

Review of The Sodasorb Manual of Carbon Dioxide Absorption, W.R. Grace & Co.-Conn., Cambridge, MA, 1993, Library of Congress Catalog Card No. 92-0700220, Second Printing, Pp. 38 and 42, revealed:
*"The efficient absorption of carbon dioxide is of critical importance in operating apparatus used for administering anesthetic gases and oxygen, and for determining the metabolic rate through measurement of the respiratory exchange. For this reason, U.S. Pharmacopeia-National Formulary standards are provided in this section for soda lime carbon dioxide absorbent."
*"Storage within the anesthesia machine - Carbon monoxide (CO) has been found to build up in unused anesthesia units. If Sodasorb absorbent is left in the machine, the absorber unit should be sealed and airtight. Change Sodasorb absorbent which has been in an idle absorber unit for more than 48 hours."
*"To avoid any under capacity for absorption, use only fresh Sodasorb absorbent for each charge."

2. Observation on 4/13/11 at 8:30 a.m. revealed there were seven Sodasorb canisters in the OR cleaning room with an expiration date of March 2010. Observation of the anesthesia gas machine revealed the expired Sodasorb was still in the machine. The anesthesia machine had two gas tanks, one blue and one yellow, attached to the back of it.

Interview at that time with the QA director revealed she was not sure what gases were contained in those tanks. She stated she would ask the maintenance director.

Review of a biomedical engineering service report completed and signed on 3/16/11 by a specialist from the provider's referral hospital revealed he had completed the annual preventative maintenance on the anesthesia machine. He had also replaced the Sodasorb canisters at that time.

Interview on 4/13/11 at 8:55 a.m. with the QA director revealed:
*The above anesthesia gas machine had been purchased in July 2010.
*The provider had not used the anesthesia gas machine since it had been purchased.
*The blue tank held nitrous oxide gas, and the yellow one held medical air.
*Most of the anesthesia used by the provider was monitored intravenous sedation.
*The last time an anesthesia gas machine had been used by the provider was in the 1990's.
*She had not been aware Sodasorb should not have been left in the anesthesia machine for more than 48 hours.

Based upon observation, policy review, and interview, the provider failed to ensure opened multiple-dose vials located in three of three areas (nursing station medication room, emergency room, and operating room [OR]) were:
*Marked with an opening date to establish a beyond-use date.
*Removed from use after beyond-use dates were exceeded.

1. Observation on 4/11/11 at 4:00 p.m. of the nursing station medication room revealed two opened multiple-dose vials with hand printed opening dates:
*Humulin N insulin with an opening date of 2/16/11.
*Tuberculin purified protein derivative injection with an opening date of 2/9/11.

Observation on 4/11/11 at 4:15 p.m. of the emergency room revealed two opened multiple-dose vials with hand printed opening dates:
*Lidocaine injection with an opening date of 11/29/10.
*Heparin injection with an opening date of 2/19/11.

Review of the provider's multi-dose vial policy issued 6/1/00 revealed:
*The expiration date of multi-dose vials was to be the expiration date printed on the vial by the manufacturer.
*Tuberculin purified protein derivative injection was to be removed from use after 30 days.

Review of the provider's referral hospital policy for multi-dose vials revised January 2011 revealed all multi-dose vials used within the hospital were to be discarded within one month of their initial usage. (United States Pharmacopeia [USP] 797 - 28 day expiration requirement.)

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations, effective 6/1/08, revealed the beyond-use date for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives was 28 days, unless otherwise specified by the manufacturer.

Interview on 4/11/11 at 3:45 p.m. with the consultant pharmacist revealed she had thought multiple-dose vials should have been removed from use 28 or 30 days after opening. The pharmacist stated she received her information from the policy of the provider's referral hospital.

Interview on 4/13/11 at 9:50 a.m. with the director of patient care services revealed the only policy prepared by the provider for multiple-dose vials was the above policy dated 6/1/00. She stated the policy for multiple-dose containers and other pharmacy policies were in the process of being reviewed.




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2. Observation on 4/12/11 at 10:15 a.m. of the OR revealed two opened multiple-dose vials not marked with an opening date.
*Lidocaine injection.
*Glycopyrrolate injection.

Based on record review, policy review, and interview, the provider failed to ensure three of six policy manuals reviewed (pharmacy, operating room [OR], and transitional care) were reviewed annually according to the provider's policy. Findings include:

1. Review of the provider's pharmacy policy manual revealed it was last reviewed on 1/20/09.



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2. Review of the provider's surgery manual of policies and procedures revealed it was last reviewed on 6/3/08.



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3. Review of the transitional care unit policy and procedure manual for the swing bed care area revealed it had last been reviewed on 12/14/06.

4. Interview with the director of patient care services at 8:15 a.m. on 4/13/11 revealed she was aware that policy and procedure manuals had not been reviewed in quite some time. She stated she planned to appoint a committee of nurses to review those policies soon.

Review of the provider's 6/23/09 policy on policies and procedures revealed:
*All policies and procedures should have been reviewed periodically, annually at a minimum.
*A standard approval form was recommended to document annual review of each policy of a manual.
*Policies that involved more than one department were developed in collaboration with all appropriate department managers.
*The policy manuals would be maintained by the primary department manager.