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Based on observation, interview and policy review, the facility failed to ensure that medications and supplies used in life saving procedures in the emergency department and in the crash cart on the medical /surgical unit are monitored for outdates. Findings include:

On 06/24/2014 at 1000 during observations in the emergency department (ED) the medication refrigerator contained four (4) 10 ml vials of Succinylcholine that outdated 06/01/2014. The drug cupboard also contained two (2) packages of Xopenex Inhalation solution. The packages were both opened and contained a combined total of twelve (12) vials. The outside of the packages contained a place for putting the date when staff opened them; however, both packages lacked documentation of the date when opened. The manufacturer's package insert reads, "Once the foil pouch is opened, the vials should be used within two weeks."

On 06/24/2014 at 1015 during an interview with staff B when queried about who checks the medication refrigerator for outdates she stated, "we alternate it between pharmacy and nursing." When queried about the inhalation solution packages not being dated when opened staff B stated, "I have not noticed that on the package, Respiratory (Department) usually gets these meds (medications) out and administers them."

On 06/24/2014 at 1645 during review of the facility's policy titled, "Inspection of Medications Policy No: RX 016 Reviewed 6/10/13 reads, "It shall be the responsibility of the pharmacist and the nurses to care for medications and associated supplies at the nursing and emergency stations. A. These are to be inspected monthly by pharmacists or designee and nursing staff (alternating months). 1. Expiration dates.... B. After inspection completed, medications are replaced as needed and all expired medications (or those expiring prior to the next inspection) are to be returned to pharmacy."


27408

On 06/24/14 at 1020 during observations on the Medical/Surgical floor, the "crash cart" contained the following supplies that were beyond the manufacturer's expiration date:
? 4 Intravenous (IV) start kits (outdated on 04/14)
? 4 Tongue depressors (outdated on 05/13)
? 1 Suction connecting tubing (outdated on 03/14)
? 2 size 6.5 Endo-Tracheal tubes (outdated on 04/14)

On 06/24/14 at 1025 during an interview with Staff C, when queried about who checks the crash cart for outdated supplies and medications she stated, "mostly nursing, but pharmacy does some checks too."

On 06/25/14 at 1000 during review of the facility's policy titled, "Crash Cart Checks, Policy No: (none listed) last reviewed on 10/11" read, "Once a month, the cart will be opened and checked for (expired) supplies inside or after being used."

Based upon on-site observation and document review by Life Safety Code (LSC) surveyors on 6/24/14, the facility does not comply with the applicable provisions of the 2000 Edition of the Life Safety Code.

See the K-tags on the CMS-2567 dated 6/24/14 for Life Safety Code findings:
Building 1
K 0018
K-0025
K-0029
K-0050

Based on observation, policy and procedure review and interview the Governing Body failed to ensure that staff follow policy and procedure when preparing intravenous (IV) medications resulting in the potential for patient harm. Findings include:

On 06/25/2014 at 0915 during a tour of the hospital's pharmacy, staff I was observed under a laminar flow hood (LFH) mixing a small 100 ml bag of IV medication. Staff I was noted to not be wearing any protective sterile clothing.

On 06/25/2014 at 0925 while waiting in the pharmacy office for the pharmacist to complete the mixing, a review was conducted of the facility's policy titled, "Aseptic Technique, Policy NO.: (area blank)", Reviewed: 03/27/13, "I. Purpose: To provide guidelines in aseptic technique for persons functioning in the sterile products (IV) room. II. Policy: Personnel working in the sterile products room will follow careful aseptic technique. III. Procedure: A. Before preparing sterile products, the following is done: 1. Personnel preparing sterile products (donned in this order): a. Shoe covers (discarded after each wearing). b. Gown (may be reused provided it is not soiled and does not leave the buffer area). c. Hair cover (discarded after each wearing). d. Mask (discarded after each wearing). e. before putting on gloves, do a 30 second wash of hands, nails, wrist, and forearms with warm water, brush, and antimicrobial skin cleaner. f. Gloves (discarded after each wearing: must be cleaned during use with 70% isopropyl alcohol spray). D. Sterile products are prepared according to accepted aseptic technique."

On 06/25/2014 at 0930 review of another pharmacy policy titled, "Pharmacy Infection Control, Policy NO: RX 039" Reviewed: 6/11/13, reads in section "III. Laminar Flow Hood, C. Aseptic Technique will be used in the preparation of all IV's."

On 06/25/2014 at 1000 during an interview and review of the above policy with staff I (Pharmacist), he confirmed that he was not wearing any of the above protective clothing/items (gloves, gown, shoe covering or hair cover). When staff I was queried if he was aware that he was required to wear the protective equipment under the laminar flow hood he replied, "I only come here about five (5) times a month and was not aware that the policy said to wear all of that."

Based on observation, document review and interview the facility failed to ensure that accurate records were maintained regarding the receipt and disposition of all outdated scheduled drugs resulting in the potential for drug diversion and patient harm. Findings include:

On 06/25/2014 at 0930 during tour of the pharmacy an inquiry was made regarding what was done with outdated controlled substances. Staff I (Pharmacist) stated, "they are kept locked up here in the bottom drawer of the file cabinet." Staff H (Pharmacy Technician) stated, they just picked up so the only thing in the drawer is the Tylenol #3's that were just put in there yesterday." Query was made as to who picks up the controlled substances staff H replied, "someone from (Vendor A) comes and that person and a pharmacist go over the medications and packaged them up in a secured sealed box and then they are mailed from here by the hospital."

At 0940 during review of the documentation maintained by the facility's pharmacy department titled, "Scheduled II Expired Inventory Log" and "Scheduled III-V Expired Inventory Log" (logs used to identify what staff put in the file drawer) and the "Inventory Report by Vendor" revealed the following:
Vendor A was last at the facility to package the controlled substances for disposal on 06/19/2014. Per the vendor report the facility sent back "Demerol Injection (25 MG/ML) quantity 9, Demerol (50 MG/ML) quantity 10". A review of the hospital's "Scheduled II Expired Inventory Log" revealed that neither of the drugs had been documented on the log as being placed into the drawer for disposal. Further review of the hospital log showed an entry for "6-18-14 Percocet 5-325 mg quantity 9" that would expire on "07/2014." Review of Vendor A's "Inventory Report by Vendor" dated 06/19/2014 did not list the medication (Percocet) as being packaged for return.

On 06/25/2014 at 0950 during an interview with staff I (Pharmacist) documentation of both the hospital's inventory logs and the vendor's return report were reviewed. When staff I was queried about the discrepancies with the documentation he stated, "I know that they need to do a better job with this, I can see where the documentation on the records does not add up." When queried if he understands that the facility needs to be able to account for the disposition of controlled substances from entrance to the facility until the time that they exit the facility staff I replied, "yes, I am aware of this."

On 06/25/2014 at 1100, a review of the facility's policy titled, "Disposition of Returned Medicines Policy NO: RX 008 Reviewed 3/14/13" revealed that it does not include the process/procedure for the storage and/or disposal of controlled substances within the pharmacy area.

Based on record review, interview and policy review, the facility failed to ensure that the Organ Procurement Organization (OPO) was contacted within a "timely manner" for two of four (#18 & #21) death records reviewed. Findings include:

On 06/24/2014 at 1330 during review of the medical record for patient #18 revealed that the patient was brought to the emergency department (ED) by emergency medical services (EMS) with cardio-pulmonary resuscitation being performed, arriving at 1412. The patient was later pronounced deceased in the facility's ED on 03/12/2014 at 1425. The medical record documentation showed an entry on 03/12/2014 at 1600 that read, "Attempted to call Gift of Life at 18004824881 no answer. Notified supervisor-double checked phone number-correct number." The record lacked documentation of any further attempts to contact the OPO. The record also showed evidence that the attempt to call the OPO at 1600 was outside of the, "one hour" time frame identified in the agreement between the hospital and the OPO.

Review of the medical record for patient #21 at 1345 revealed that the patient was pronounced deceased in the facility's ED on 12/31/2013 at 2305. The documentation revealed that the Registered Nurse did not notify the OPO of the patient's death. The OPO was not notified of the death until 01/02/2014 when the risk manager made the call.

On 06/24/2014 at 1430 during an interview with staff E when queried about the untimeliness of the phone calls staff E (Manager of OPO Program) stated, "we've had staff education where the Gift of Life representative came in and spoke in January of this year. I am not sure if the staff get busy and just forget to call or what. I was not here at that time so it is hard for me to speak to."
Staff E also produced a document for patient #21 titled, "Eye/Tissue Donor Worksheet" that contained areas for date, time, staff name and OPO representative spoken to, all of the areas were blank.
When staff E was queried for the "Eye/Tissue Donor Worksheet" for patient #18, she stated, "I can't find it."

On 06/24/2014 at 1500 review of the policy titled "Anatomical Donation Policy NO: (area blank)" Approved 10/24/12 reads "Procedure: A. Organ Donation a. Notify Gift of Life IMMEDIATELY of all 'imminent deaths'". Review of the "Agreement Between Vendor B, Vendor C and Facility A dated and signed by the hospital's President on September 24, 2010 read in the section titled "Definitions 1.2 'Timely Referral' is defined as a telephone call to Vendor B by appropriate hospital staff within one hour of when a DONOR HOSPITAL health care provider identifies a patient that meets the DONOR HOSPITAL's definition of 'Clinical Triggers' for organ donation..."