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Tag No.: C0276
Based on observation, interview, and policy review, the provider failed to ensure the security and accountability for controlled Scheduled II medications morphine sulfate (MS, narcotic pain medication) in two of two observed ambulances (439 and 439A). Findings include:
1. Observation on 12/2/15 from 9:00 a.m. until 9:15 a.m. of ambulances 439 and 439A with the ambulance director revealed:
*Both ambulances had been unlocked.
*Inside both of the ambulances there was a locked cupboard.
*The keys to open those cupboards had been located inside of a plastic tackle box containing multiple medications.
*When the ambulance director opened the locked cupboard in ambulance 439 there was a large plastic container.
*Inside of that container there was three carpuject (device used to administer fluid medications) syringes filled with a liquid medication. That liquid medication was 10 milligrams (mg) of MS.
*When the ambulance director opened the locked cupboard in ambulance 439A there was a large plastic bag.
*Inside of that plastic bag were two syringes.
*Each of those two syringes contained 10 mg of MS.
Review of ambulance 439's controlled substance record revealed:
*The time, date, patient's name, and how many units of MS were used from the cupboard were documented on the form.
*On 11/21/15 was the last documentation to support any MS had been used from the cupboard.
*No documentation to support:
-How many syringes of MS had remained in the cupboard upon removal of one for a patient.
-When the pharmacy had replaced the MS syringes after being used by the paramedics.
Review of ambulance 439A's controlled substance record revealed:
*The same information as documented above.
*On 5/13/15 was the last documentation to support any MS had been used from the cupboard.
*No documentation to support how many carpuject syringes of MS had remained in the cupboard upon removal of one for a patient.
Interview on 12/2/15 at 9:20 a.m. with the ambulance director revealed:
*He was not aware Scheduled II medications were required to be double-locked.
*He agreed the emergency medical technicians and staff had access to the key that unlocked the cupboards.
*When MS was given to a patient the paramedics would have documented that information on a controlled substance record log.
*They would have informed the pharmacy department when a carpuject of MS would have been used.
*The pharmacy department would have replaced that used carpuject of MS with another one.
*The director of purchasing, who was a paramedic and was a part of the ambulance team, would have checked the MS syringes once a month to ensure an accurate count.
*He agreed the controlled substance record report had failed to support:
-The tracking of how many carpujects of MS had remained in the cupboard after one had been used.
-How many carpujects of MS had been in the cupboard after the pharmacy had replaced them.
*He agreed the MS could easily have been diverted (stolen) with the current process they had been using.
Review of the Drugs for 439A and 439 record utilized by the director of purchasing revealed:
*She had documented how many carpujects of MS were in each of the ambulances monthly.
*On 11/30/15 she had documented there was three carpujects of MS in each of the ambulances.
Interview on 12/2/15 at 9:30 a.m. with the director of purchasing revealed:
*She would have visually checked each ambulance monthly for how many carpujects of MS were in the cupboards.
*She would have documented her findings on the Drugs for 439A and 439 records.
*She would not have checked the controlled substance record report to verify her count.
*She confirmed she had checked the ambulances on 11/30/15.
*She had no documentation to support from 11/30/15 through 12/2/15 where one of the carpujects of MS from ambulance 439A had been used.
*She had stated "It could have been a miscount. Human error."
Interview on 12/2/15 at 10:10 a.m. with the licensed pharmacist revealed:
*He confirmed all Scheduled II medications should have been double-locked up.
*He would not have checked the ambulances to ensure the carpujects of MS had been double-locked.
*He would have replaced any carpujects of MS that had been used for both of the ambulances.
*He would have documented the date and how many he would have given the ambulances.
*He had no responsibility of the carpujects of MS after they left his department for security or accountability in the ambulances.
*He had no documentation to support between 11/30/15 through 12/2/15 there had been a carpuject of MS removed and used from ambulance 439A.
*His last documentation revealed on 11/21/15 one carpuject of MS was removed for "Patient: Ambulance."
*He agreed the process for accountability of the MS syringes would have allowed easy access for diversion.
Review of the provider's 5/21/13 Record Keeping for Controlled Substances policy revealed:
*Purpose: "To ensure accurate records of controlled substances are maintained and deter diversion."
*Procedure:
-"All class two-four medications are signed out in the controlled substance binder and a perpetual inventory is kept."
-"Inventory will be taken each Monday, for all controlled substances that have been accessed in the previous week, by the pharmacist and charge nurse."
The provider had no policy or procedure in place for the security of controlled Scheduled II medications in the ambulances.
Tag No.: C0278
Based on observation, interview, and policy review, the provider failed to:
*Ensure single-use supplies remained sealed until needed for three of three endotracheal tubes (to keep a patient's airway open during surgery) in one of two operating rooms (1).
*Ensure appropriate infection control technique had been followed during one of one observed dressing changes for one random patient (34). Findings include:
1. Observation on 12/1/15 at 1:15 p.m. of operating room 1 revealed a small cart. The top of that cart contained three opened packages of endotracheal tubes. Each package had been separated by towels. Those towels had not fully covered the opened packages, and the tubes were open and visible.
Interview at that time with surgical technician C revealed the certified registered nurse anesthetist (CRNA) had opened three sizes of endotracheal packages routinely. She stated he had wanted to be prepared for the next operation.
Interview on 12/2/15 at 1:30 p.m. with CRNA D regarding the opened endotracheal tubes in operating room 1 revealed:
*He had not opened the tube packages.
*CRNA B had kept his own cart in the operating room. He routinely opened the endotracheal tube packages in different sizes. That way they would have been immediately available when they were needed.
*CRNA D agreed the packages should not have been opened until they had been used.
*The operating rooms were not used daily.
*He had not known if unused packages had been disposed of after each operation.
Interview on 12/2/15 at 1:00 p.m. with the infection control nurse revealed her expectation was all supplies would remain sealed until they were used.
Review of the provider's December 2013 Asceptic Sterile Technique policy revealed "Consider items unsterile if a sterile table or articles are found open and left unattended."
Review of Patricia A. Potter et al., Fundamentals of Nursing, 8th Ed., Elsevier, St. Louis, Mo., 2013, revealed "Never use a sterile item if the packaging is open or soiled or shows evidence that the package had been wet."
2. Observation on 12/2/15 at 9:00 a.m. of registered nurse (RN) A during a dressing change for patient 34 revealed she:
*Entered patient 34's room and placed the dressing supplies on the sink.
*Washed her hands and applied gloves.
*Used those gloved hands to close the bathroom door.
*Picked up the dressing supplies and placed them on the bedside table.
No barrier had been applied to the table before placing the dressing supplies on the table. With the same gloves on RN A:
*Removed the old surgical dressing.
*Used a syringe from the table and flushed the surgical wound with that syringe.
*Used a measuring tape from the table and measured the leg with the surgical wound.
*Opened a gauze package.
*Removed her gloves and applied clean gloves.
With those gloves on she:
*Applied gauze to the surgical wound.
*Asked a nursing student to bring another package of gauze that was on the sink area.
*Opened that gauze package and applied the gauze to the surgical wound.
*Applied tape to the gauze.
Interview on 12/2/15 at 1:30 p.m. with the infection control nurse regarding RN A's technique with the above dressing change revealed she had agreed RN A should have:
*Changed gloves after touching areas of the room.
*Used a barrier between dressing supplies and the bedside table.
*Changed gloves before applying dressings to a wound.
Upon request the provider had been unable to locate a policy for dressing changes.
4. Review of Patricia A. Potter et al., Fundamentals of Nursing, 8th Ed., Elsevier, St. Louis, Mo., 2013, revealed on page 410:
*"Base efforts to minimize the onset and spread of infection on the principles of aseptic technique."
*Medical asepsis included procedures for reducing the number of disease-producing organisms present.
*Preventing the transfer of organisms using preventative measures included hand hygiene and barrier techniques.