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Based on observation, document review and interview the facility failed to ensure that all medications used during life saving emergencies are readily available for use for all patients treated at the hospital (facility A) or at the hospital's after-hours clinic (facility B), resulting in the potential for a delay in treatment during a life threatening emergency. Findings include:

On 08/06/2013 at 1700 during observations at facility B with staff A (Hospital-Interim CEO), revealed in the "lab/medication" area, a box labeled as "Crash Box." Upon inspection of the box's contents, it was noted that it contained a syringe labeled Glucose 50% (25 grams) that had exceeded manufacturers expiration date of 1 March 2013. The box also contained a document signed with staff's initials indicating that the box had been checked for outdates. The document contained staffs' initials for checking the boxes contents for March, April, May, June, July and August 2013; however, the outdated medication remained in the box.

On 008/07/2013 at 0830 during an observation of the Radiology Department with staff A and M (X-Ray Technician), revealed a box in the Cat Scan room that was labeled as "emergency box." Upon inspection of the box's contents, it was noted that the box contained a box labeled Epinephrine which was also labeled with a manufacturers expiration date of 1 May 2013 indicating the the medication was outdated.

A review of the Hills & Dales policy titled "Expiration Dates: Monitoring 11.16", undated, reads "Expired Drug Monitoring, The expiration dates of all drugs and devices shall be checked during the monthly medication area inspections and all drugs and devices scheduled to expire during the next month shall be removed from stock. Administration: It shall be the responsibility of the Director of Pharmacy to ensure adherence to this policy and procedure." A further review of policy 11.16 reads "Policy, Expired drugs and devices shall not be available for patient use."

On both 08/06 and 08/07/2013, staff A was present and confirmed the outdated medications at the time of the tour. Staff A stated "staff are supposed to check monthly for outdates and either return the medication to pharmacy or inform them of the need to have the medication replaced." Staff A also confined the documentation on the document used for checking for outdates at the after hours clinic and the inconsistencies with the medication in the box being outdated since 1 March 2013. She stated "I really don't know why this is like this."

Based upon on-site observation and document review by Life Safety Code (LSC) surveyors on August 6, 2013, the facility does not comply with the applicable provisions of the 2000 Edition of the Life Safety Code.

See the K-tags ( 0054 & 0062) on the CMS-2567 dated 8/6/2013 for Life Safety Code deficiencies.

Based on observation, policy review and interview, the facility failed to ensure that medications are properly labeled and that outdated medications are not available for patient use for 3 of 6 inpatients (#1,
#3, #32) currently being treated at facility A, resulting in the potential for poor patient outcomes. Findings include:


On 08/062013 at 1230, observation in the medication room on the medical surgical unit revealed the following:
1. Eleven (11) bags of Lactated Ringers/5 % Dextrose 1000 ml, outdates 1 July 2013
2. Three (3) bags Dobutamine, outdates 1 May 2013
3. Three (3) 50 ml bags Sodium Chloride, outdates 1 July 2013
4. One (1) opened package Xopenex (respiratory medication) - not dated when opened. *
5. One (1) package Levalbuterol (respiratory medication) - not dated when opened. *
6. Three (3) packages Budesonide Inhalation Suspension 0.25 mg/ 2 ml (respiratory medication) - not dated when opened. *
* #4, #5, #6- all packages read "Once the foil package is opened, the vials should be used within two weeks.
7. One (1) vial Lantus Insulin opened 05/05/2013
8. One (1) vial Humulin N Insulin opened 02/11/2013
9. One (1) vial Humulin 70/30 Insulin opened 01/08/2013
10. One (1) vial Novolog Insulin opened 12/02/2012


On 08/06/2013 at 1330, observations in the medication cart located on the medical surgical unit revealed a brown bottle containing medication in the drawer for patient # 1. Upon review of the medication bottle, it was noted that the bottle contained two white pills. A review of the bottle's label identified the patient by name, name of the drug, strength of the drug and lot number. The bottle lacked an expiration date for the medication. Further review of the cart's drawers for both patient's #3 and #32, revealed medication bottles with no expiration dates on the labels.

A review of the Hills & Dales policy titled "Expiration Dates: Monitoring 11.16", undated, reads "Expired Drug Monitoring- The expiration dates of all drugs and devices shall be checked during the monthly medication area inspections and all drugs and devices scheduled to expire during the next month shall be removed from stock. Administration: It shall be the responsibility of the Director of Pharmacy to ensure adherence to this policy and procedure." A further review of policy 11.16 reads "Policy Expired drugs and devices shall not be available for patient use."

Review of the Hills & Dales policy titled "Labels 14.18", undated, reads "POLICY -All drugs stocked in the pharmacy, supplied to floor stock, or dispensed to patients shall clearly and accurately labeled. LABEL CONTENTS -All labels shall include at least: Patients full name and room number, the proprietary and/or nonproprietary name, drug strength, dosage form, lot number, expiration date, where applicable."

On 08/06/2013 at 1230 during the observation in the medical surgical medication room with Staff B and Staff J present, they confirmed the bags of outdated IV medications, and the opened and not dated respiratory medications. When queried about the opened vials of Insulin, staff J replied "per our policy they are good until the expiration date."

At 1300 on 08/06/2013 during an interview with staff K (Director of Pharmacy), he stated "Insulin is good until the expiration date on the vial per our policy."

A review of the Hills and Dales policy on 08/06/2013 at 1500 titled "Expiration Dates for Multidose Vials and Suspensions", (no policy number/undated) reads "Multidose vials to keep until the drug expires: Insulin, Flu Vaccine Pneumonia Vaccine."

On 08/07/2013 at 1130 during an interview with staff K, all findings regarding outdated medications, incomplete labeling of medications and inaccurate information in the Hills and Dales policy regarding multidose vials being good until expiration date were discussed. Staff K confirmed understanding that Pharmacy is responsible for all medications in the facility and voiced the need for better monitoring of outdates and a change in their policy to reflect correct information.

Based on observation, policy review and interview, facility B failed to ensure that medical devices used to monitor patients during a diabetic event were calibrated per policy, and that solutions used to perform the calibrations were not expired (per manufactures recommendations) resulting in a potential delay of treatment ; facility A failed to ensure that contrast dye used for computerized tomography (CT) scans are maintained and available for patient use resulting in a potential delay of treatment. Findings include:

On 08/06/2013 at 1730 during observations of facility B (After Hours Clinic) with staff A and staff Q, (Licensed Practical Nurse) revealed a Blood Glucose monitor located in the "lab/medication" area. When staff Q was queried as to how often the machine was calibrated, she presented documentation showing that calibrations/controls were completed on 03/22/2013, 03/25/2013, 04/19/2013, 04/21/2013, 05/03/2013, 06/14/2013, 06/21/2013 and 07/22/2013. When queried as to how often they are supposed to be done; staff Q replied "I think they are supposed to be done at least once a month." Further review of the solutions used to perform the calibration/control test, revealed no date as to when the solutions were opened. When staff Q was queried as to how long the solutions were good for once opened, she replied "I am not sure." A review of the manufacturer's guidelines for the Precision PCx Blood Glucose Monitor reads on page 12 "Control solutions good for 90 days once opened. Bottles should be dated when opened and discarded after 90 days."

On 08/07/2013 at 0800 a review of the Hills and Dales Off-site Clinics policy titled "Quality Control Standard for Precision-G System," review date 07/2013, reads, I. "Statement of Purpose: Nursing measures are taken each clinic day to perform Quality Control test using high and low glucose control solutions. II. Statement of Policy: daily Quality Control testing of the Precision-G monitor is necessary to verify its accuracy."

On 08/07/2013 at 1000 during an interview with staff N (Director of Laboratory), he confirmed the documentation findings and stated that "I thought that they had to do a control test before use; I was unaware that the policy stated daily."

On 08/07/2013 at 0900 during an observation with staff A and staff M in the CT scan room, revealed eight (8) bottles of Visipaque contrast dye labeled with a manufacturer's expiration date of 30 June 2013. When staff M was queried about the bottles of contrast she stated "we don't use that one very often, someone must have missed that it is outdated."

Based on document review and interview the facility failed to ensure the quality assurance program evaluated the plans of action for initiative actions. Findings include:

On 8/7/2013 at approximately 11:30 am a review of the quality program and review of monthly quality meeting minutes from the time period of January 2013 to July 2013 occurred. The documentation failed to have quantitative data to show the outcomes of action plans and initiatives.

On 8/7/2013 at approximately 11:45 an interview with the director of the quality program was conducted. When asked how information for performance was analyzed, she stated that it was brought to the facility's attention that a better method needed to be implemented and the hospital was in the process of designing a new "dashboard" to help collect/organize data. This new process would be implemented in September 2013. The director of quality agreed their analysis was not transparent that data was collected but plans of action were not in place.

Based on document review and interview the facility failed to conduct periodic evaluation of action plans put into place for the quality assurance program. Findings include:

On 8/7/2013 at approximately 11:30 am during document review of the quality assurance program it was determined plans of action were not reviewed to assess the effectiveness of plans implemented. Initiatives reviewed included patient fall reduction plans of action and patient call back plans of action.

On 8/7/2013 at approximately 11:45 am during an interview with the director of the quality assurance program it was asked how it was determined if the plans of action were effective or needed to be changed since the plans were always "ongoing". The director stated she was unaware there was a need to reevaluate plans of action, periodically.