HospitalInspections.org

Based on observation, policy review, and interview, the provider failed to ensure medication safety was maintained for:
*Preparation of intravenous (IV) medications for one of three patients (1) observed for medication administration.
*One in-use vial of purified protein derivative (PPD).
*Seven of nine opened multiple-dose vials stored on the anesthesia cart.
*One vial of outdated lidocaine injection stored in the medical unit crash cart.
Findings include:

1. Observation on 9/27/11 at 11:00 a.m. of registered nurse (RN) A reconstituting an 800 milligram (mg) dose of IV ceftriaxone to have been administered to patient 1 revealed she:
*Added 4 milliliters (ml) of sodium chloride solution to a 1 gram (g) vial of ceftriaxone powder.
*Withdrew 1.8 ml of solution from the vial.
*Added the above 1.8 ml of solution to a 100 ml bag of sodium chloride solution.
*Placed a label with the name of the medication and the dose of 800 mg on the above bag.

Interview at the above time with RN A revealed she was not sure how much solution of ceftriaxone resulted when 4 ml of sodium chloride solution was added to the ceftriaxone powder.

Calculation at the above time by the surveyor and RN A revealed approximately 3.2 - 3.3 ml of the above reconstituted solution should have been withdrawn from the vial to make an 800 mg dose. When prompted by the surveyor, RN A obtained the ceftriaxone manufacturer's package insert to review the reconstitution directions.

Review of the ceftriaxone manufacturer's undated package insert revealed:
*For IV administration 9.6 ml of sodium chloride solution should have been added to the powder in the 1 g vial.
*The above amount of sodium chloride solution when added to the powder in the vial would have resulted in a solution of 100 mg of ceftriaxone/ml.

2. Observation on 9/27/11 at 10:25 a.m. of the medication room refrigerator revealed an in-use multiple-dose vial of purified protein derivative injection (PPD). The vial was dated as opened on 12/1/10.

Review of the PPD manufacturer's July 2006 package insert revealed opened vials of PPD should have been discarded thirty days after opening, because oxidation and degradation might have reduced the potency.

3. Observation on 9/28/11 at 10:00 a.m. of the operating room anesthesia cart revealed there were nine opened and in-use multiple dose vials of injectable medications. Of those medications seven were marked with a date when they had been opened.

Interview at the above time with the director of nursing (DON) revealed:
*The above multiple-dose vials should have been marked with a date of opening.
*Opened and in-use multiple-dose vials should have been discarded twenty-eight days after they had been first opened.

Review of the provider's policy for drug recall and outdated medications dated 11/20/08 revealed opened multiple-dose vials would expire and should have been discarded twenty-eight days from the handwritten date placed on the vial when opened.

4. Observation on 9/28/11 at 10:10 a.m. of the medical area crash cart revealed it contained one vial of lidocaine one percent injection with an expiration date of January 2011.

Review of the provider's policy for outdates on the crash cart/anesthesia cart revealed nursing personnel were responsible for ensuring medications in the carts were within their expiration dates. All carts were to have been checked for outdated medications on a monthly basis.

Based on observation, label review, policy review, testing, and interview, the provider failed to ensure:
*The common use linens were processed by a means that ensured disinfection.
*The cleaning procedure for isolation rooms was up-to-date with current recommendations for the inactivation of clostridium difficile (C. diff).
Findings include:

1. Observation, interview, testing, and label review on 9/27/11 starting at 9:50 a.m. with the support services manager, Ecolab sales representative, and maintenance manager revealed:
*The support services manager used Oxy Brite concentrated liquid oxygen bleach to disinfect the laundry.
*The Oxy Brite was a hydrogen peroxide aqueous solution and made no claim to disinfect. It did not have an environmental protection agency (EPA) registration number or any directions for use on the label.
*The support services manager had been told by the service agent that Oxy Brite would disinfect laundry. She was not aware Oxy Brite was not an acceptable product for disinfecting laundry.
*Phone interview on 9/27/11 at 9:55 a.m. with the Ecolab sales representative confirmed Oxy Brite was not a disinfectant.
*The facility was in the process of starting a new chemical called Bacstat liquid soft sanitizer. When the last of the current softener was used up they were going to start the Bacstat liquid soft sanitizer. Review of Bacstat label revealed it was an EPA registered laundry sanitizer. The old softener was replaced with Bacstat liquid soft sanitizer at 10:15 a.m. on 9/27/11.
*The laundry was also processed with hot water. The provider had not maintained a record of the water temperatures because, they had thought the Oxy Brite was an acceptable product. The water temperatures for washing were usually between 150 degrees Fahrenheit (F) and 160 degrees F.
*The wash machine filled with hot water of 177 degrees F and some cold water. The temperature on the display of the washer climbed to 155 degrees F and then dropped to 140 degrees F when the machine began to agitate.
*The support services manager was not aware if the infection control nurse had ever reviewed the chemicals used in the laundry process.

Interview on 9/27/11 at 10:51 a.m. with the infection control nurse and support services manager revealed:
*The infection control nurse and a consultant did rounds annually in the laundry department.
*The chemicals were reviewed and discussed at the department meeting and were approved based on the information provided by the support services manager.
*The infection control nurse was not aware the Oxy Brite was not an acceptable product for disinfecting laundry.

Interview on 9/27/11 at 3:45 p.m. with the director of nursing (DON) revealed:
*She was not aware the Oxy Brite was not an acceptable product for disinfecting laundry.
*She agreed the product had been reviewed and approved based on the information provided by the support services manager.

2. Review of the 5/31/11 isolation room cleaning policy and interview on 9/27/11 at 11:00 a.m. with the support services manager revealed:
*A chlorine solution of one tablespoon of bleach to one gallon of water was to be used to clean rooms and equipment that had been used for C. diff isolation.
*The policy had been developed as a result of a deficiency the provider had received during the last survey in 2008. She was not aware the Centers for Disease Control and Prevention (CDC) recommended a 1 to 10 ratio of bleach to water or 5000 parts per million (ppm) for the inactivation of C. diff.
*She was not aware the mixture of one tablespoon of bleach to one gallon of water was only 200 ppm.

Interview on 9/27/11 at 11:15 a.m. with the infection control nurse revealed:
*The policy had been developed as a result of a deficiency the provider had received during the last survey in 2008. The mixture for the bleach solution had been a recommendation from the South Dakota Department of Health, and she had not questioned its accuracy.
*She was not aware the CDC recommended a 1 to 10 ratio of bleach to water or 5000 parts per million (ppm) for the inactivation of C. diff.
*The provider followed CDC guidelines and worked in co-operation with a consultant from the Avera health systems network to develop and maintain polices.
*She had never received any information from the consultant indicating the mixture of bleach in the policy was not correct.
*The policy had been reviewed annually, but the mixture of bleach had never been questioned or verified that it was current with CDC guidelines.

Interview on 9/27/11 at 3:45 p.m. with the DON revealed she was not aware the CDC recommended a 1 to 10 ratio of bleach to water or 5000 parts per million (ppm) for the inactivation of C. diff.

Based on observation, policy review, and interview, the provider failed to ensure three of three solutions observed in a warming cabinet in the computed tomography (CT) room were maintained according to the manufacturers' specifications. Findings include:

1. Observation on 9/27/11 at 10:30 a.m. of a warming cabinet in the CT room revealed:
*Two types of contrast media were stored in the warmer:
- Ten 100 milliliter (ml) bottles of Isovue 300.
- Nine Optiray 320 single-use syringes.
*Twenty 10 ml sodium chloride flush syringes were stored in the warmer.
*There was no thermometer to establish the temperature within the warmer.
*The above solutions were not marked with a date when they had been placed in the warmer.

Testing by the surveyor at the above time with the surveyor's thermometer revealed the temperature was 99.7 degrees Fahrenheit (F).

Interview at the above time with the manager of the radiology service revealed:
*The provider did not have a policy or procedure for placing solutions in the warming cabinet.
*The warming cabinet had a light to indicate if the temperature was within the "normal" range.
*She did not know what the "normal" temperature was for the warming cabinet.
*The Isovue 300 bottles had been put in the warmer just recently.
*The Optiray syringes had been in the warmer for a while.
*She did not know the manufacturers' specifications for warming the above solutions.

Review of the manufacturer's Isovue package insert dated September 2005 revealed:
*It was desirable for the Isovue to be used at body temperature when injected.
*The storage temperature range was 68 degrees F to 77 degrees F.
*There were no directions for warming the solution.

Review of a letter received on 9/16/11 from the manufacturer of Isovue and addressed to a radiology manager at another medical center revealed:
*Isovue was stable if stored according to the conditions specified in the package insert (68 degrees F to 77 degrees F).
*Clinical experience indicated it was desirable for Isovue to be at body temperature (98.6 degrees F) when injected.
*Contrast warmer temperatures should not have exceeded 98.6 degrees F.
*Isovue should not have been kept in the warmer for any period of time longer than that reasonably needed to reach body temperature or to ensure warmed Isovue was readily available.
*The company advocated following the above protocol.
*The company had data to support allowing Isovue to remain in the warmer for up to a month when the temperature did not exceed 98.6 degrees F and there was at least 6 months remaining before the product's expiration date was reached.

Review of the manufacturer's Optiray package insert revised April 2010 revealed:
*Optiray syringes should have been stored at 77 degrees F.
*Excursions were permitted from 59 degrees F to 86 degrees F.
*Optiray could have been stored at temperatures up to 104 degrees F for up to one month in a contrast media warmer utilizing circulating warm air.

Review of the manufacturer's normal saline flush syringe package insert revealed:
*The storage temperature range was 68 degrees F to 77 degrees F.
*Excursions were permitted from 59 degrees F to 86 degrees F.
*There were no directions for warming the saline flush syringes.

Based on observation, interview, and policy review, the provider failed to ensure medical records were stored in a secure location and restricted to authorized personnel only for one of three medical record storage areas (outside warehouse). Findings include:

1. Observation and interview on 9/27/11 at 10:00 a.m. of the outside warehouse building with the director of medical records revealed numerous boxes of medical records were stacked on both sides of the area (photos 1 and 2). The director of medical records stated the boxes contained medical records from years past and death records. The key to the warehouse was kept on a hook inside the maintenance staffs' work area inside the hospital. She confirmed the key was accessible to all department staff members. As we left the warehouse she passed the key to an x-ray department staff member.

Interview on 9/28/11 at 1:45 p.m. with the administrator confirmed all medical records needed to be kept in a secured location and access restricted to authorized personnel only.

Review of the provider's Storage, Security, and Retention of Medical Records policy revised 8/1/11 revealed:
*All medical records would be housed in a physically secured area under the immediate control of the health information manager.
*Areas housing medical records would be restricted to authorized personnel.