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Based on observation, interview, and policy review, the provider failed to ensure three of three observed blanket warmers temperatures were set at a safe temperature. Findings include:

1. Observation on 5/2/11 from 3:30 p.m. through 3:45 p.m. of the obstetrics hall, surgical hall, and emergency room blanket warmers revealed:
*The temperature of the obstetrics and surgical halls blanket warmers were set at 150 degrees Fahrenheit (F).
*The temperature of the emergency room blanket warmer was set at 140 degrees F.

Interview on 5/2/11 at 3:30 p.m. with registered nurse A revealed:
*Nursing staff had not monitored the temperatures of the blanket warmers.
*Nursing staff only filled the blanket warmers with more blankets when they ran low.
*She believed maintenance was in charge of the blanket warmers as far as setting the temperatures and then monitoring those temperatures.
*She was not aware of a policy that guided the use of and monitoring of the blanket warmers.

Interview on 5/2/11 at 3:55 p.m. with the maintenance supervisor revealed:
*He had not monitored or set the temperatures of the blanket warmers.
*If the blanket warmers malfunctioned he would call the repair person under contract.
*He was not aware of a policy that guided the use of and monitoring of the blanket warmers.

Review of the provider's revised February 2010 policy on blanket warmers revealed the blanket warmers were to never be set above 120 degrees F.

Based on observation and interview, the provider failed to ensure medications in the operative area were properly secured. Findings include:

1. Observation on 5/2/11 at 3:15 p.m. of the operative area revealed:
*Opened vials of medication were found on top of the anesthesia cart in operating room 1. Those medications included:
-Succinylcholine.
-Versed.
-Atracurium.
-Zemuron.
-Potassium chloride.
-Flumazenil.
-Neostigmine.
*An unlocked cart next to the anesthesia cart in operating room 1 contained multiple vials of various non-narcotic medications that were used during procedures and operations.
*An unlocked drawer in the storage area between operating room 1 and operating room 2 contained multiple vials of various non-narcotic medications that were used during procedures and operations.

Interview on 5/2/11 at 3:20 p.m. with the operating room manager revealed:
*She agreed the anesthetic agents found on the anesthesia cart in operating room 1 were not properly secured.
*Other hospital department staff had access to the operative area after hours.

Observation on 5/3/11 at 8:00 a.m. of the operative area revealed:
*The main door to the operative area was unlocked, and no staff were present.
*In the storage area between operating room 1 and operating room 2 the locked cabinet that stored anesthesia drug supply and narcotics was unlocked.
*The anesthesia cart in operating room 1 had multiple anesthesia drugs unsecured on top of it.

Interview on 5/3/11 at 9:50 a.m. with nurse anesthetist B revealed:
*The medications found at 8:00 a.m. on the anesthesia cart were for that days case.
*The pharmacist had not come to the operative area to inspect the storage methods of medications.

Interview on 5/3/11 at 10:00 a.m. with the pharmacist revealed:
*He had no policy related to medication security or diversion.
*He had not inspected the methods of medication storage in the operative area.
*He had not checked the levels of medications stocked in the operating room.

Based on observation, record review, and interview, the provider failed to ensure medications were prepared and labeled according to professional standards in a way to prevent unusable drugs from being available for patient use in the pharmacy, medical unit, outpatient area, and operating room. Findings include:

1. Interview on 5/4/11 at 10:00 a.m. with the pharmacist revealed the pharmacy did not have a hazardous drug spill kit or a policy/procedure for preparing sterile hazardous drugs.

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations, effective 6/1/08, revealed there were:
*Additional requirements for preparation of sterile hazardous drugs.
*Requirements for the pharmacist to prepare policies and procedures to identify requirements for storage and handling of hazardous drugs to prevent contamination and personnel exposure.
*Requirements for each pharmacy to develop, maintain, implement, and adhere to written procedures for handling both major and minor spills of hazardous drugs.

Review of the American Society of Health System Pharmacists (ASHP) Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs, reviewed 1996, revealed there were guidelines for:
*Pharmacists to develop policies and procedures for handling cytotoxic and hazardous drugs.
*Preparing procedures and having materials available to clean up spills of hazardous drugs and to have personnel trained in their proper use.

2. Observation on 5/4/11 at 9:15 a.m. of the pharmacy revealed:
*There were three repackaged bottles of oral liquid medications with an assigned beyond-use expiration date that was the same as the original manufacturer's bottle. There was no date of packaging printed on the bottle.
*There were two repackaged bottles of oral liquid medications that did not have an assigned expiration date.

Interview on 5/4/11 at 9:15 a.m. with the pharmacist revealed he assigned beyond-use expiration dates of one year or less for repackaged unit-dose medications. He stated he used the manufacturer's assigned expiration date to establish a beyond-use date for repackaged oral solutions.

Review of the United States Pharmacopeia, 24th Rev., and The National Formulary, 19th Ed. (USP24/NF19) revealed the beyond-use expiration date for nonsterile dosage forms packaged into multiple-dose containers should have been the earliest date of:
* The expiration date on the manufacturer's container.
* One year from the date the drug was dispensed.

3. Observation on 5/4/11 at 8:50 a.m. of a cabinet in the medication room at the nurses station revealed:
*An opened package of Pulmacort Respules with no assigned beyond-use date.
*An opened package of Xopenex inhalation solution with no assigned beyond-use date.

Review of a sign on the door of the above medication cabinet revealed Pulmacort and Xopenex packages were to be marked with an opening date. The packages were to be used within two weeks of opening.

Review of the manufacturer's storage information for Pulmacort Respules dated June 2007 revealed the unused Respules should have been used within 2 weeks of opening.

Review of the manufacturer's storage information for Xopenex inhalation solution dated August 2009 revealed once the foil pouch was opened the vials should have been used within two weeks. Vials removed from the pouch, if not used immediately, should have been protected from light and used within one week.




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4. Observation on 5/2/11 at 3:15 p.m. of the operative area revealed:
*Opened multiple-dose vials of medication were found on top of the anesthesia cart in operating room 1. Those medications included:
-Succinylcholine.
-Versed.
-Atracurium.
-Zemuron.
-Potassium chloride.
-Flumazenil.
-Neostigmine.
*None of the opened multiple-dose vials were properly marked with the date, time, and initials of the person who had opened it in order to establish a beyond-use date.

Interview on 5/2/11 at 3:20 p.m. with the operating room manager revealed she believed the nurse anesthetist used those medications for multiple patients.

Interview on 5/3/11 at 9:50 a.m. with nurse anesthetist B revealed:
*He had used the above found medications as multiple-dose vials.
*He agreed the medications had not been properly labeled.

Review of the provider's September 2009 anesthesia policy on multiple-dose vials revealed the policy consisted of one short paragraph and did not fully describe the key aspects of the proper use of multiple-dose vials.

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 5/3/11 at 10:00 a.m. with the pharmacist revealed:
*He did not have a facility wide policy on multiple-dose vial use.
*He was not aware of the anesthesia policy described above.
*The only area of the hospital that still used multiple-dose vials was anesthesia.
*He agreed the multiple-dose vials found in the operative area were not properly labeled.

Based on interview, record review, and policy review, the provider failed to ensure:
*One of two sampled outpatient's (20) procedure records were accurately documented and contained a history and physical.
*One of two sampled patient's (22) emergency room transfer records had a completed and signed physician transfer certification (risks and benefits of transfer).
Findings include:

1. Review of patient 20's medical record from 3/14/11 revealed:
*The patient had an outpatient procedure (bone marrow aspiration) on the above date.
*The physician's procedure report indicated he had reviewed the patient's history and physical prior to the procedure.
*No history and physical could be found in the medical record for that patient by this surveyor or registered nurse (RN) C.
*No medications were documented for the above mentioned procedure.

Interview on 5/4/11 at 9:35 a.m. with RN C revealed:
*The history and physical reviewed by the physician should have been on the patient's medical record.
*She agreed it would have been impossible to perform the bone marrow aspiration without at least a local anesthetic.
*The nurse on patient 20's case must not have documented medications administered to the patient.
*After contacting an unidentified nurse she stated patient 20's physician always used a local anesthetic for that procedure.

Review of the provider's signed 11/25/08 medical staff rules on medical records revealed the history and physical and medications should have been attached and documented in the medical record.

Review of the provider's revised January 2011 policy on nursing process documentation revealed all pertinent nursing information would have been documented in the medical record.




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2. Review of patient 22's medical record from 8/6/10 revealed:
*The patient had an emergency room visit on the above date at 2:45 p.m. after a fall from a bicycle.
*The patient had been transferred to Avera McKennan Hospital at 6:00 p.m. that same day.
*The nursing emergency transfer checklist had indicated there had been a consent for transfer signed by patient 22's parents. However no signed physician's transfer certification or consent for transfer to Avera McKennan Hospital was found in the medical record for patient 22 by this surveyor, the nursing supervisor, or the medical records personnel.

Interview on 5/4/11 at 10:00 a.m. with the nursing supervisor confirmed the physician's transfer certification with signed consent for transfer by patient 22's parents should have been in the patient's medical record.

Review of the provider's revised October 2010 policy for patient transfer from the emergency department revealed:
*The patient or responsible party must have understood the reason for transfer and the possible consequences if the patient was not transferred.
*A patient consent/request for emergency transfer form should have been signed by the patient or a responsible party when able.