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Based on observation, interview and document review, the Critical Access Hospital (CAH) failed to monitor temperatures and provide preventive maintenance for the hydroculator heating units and Therabath (paraffin wax bath). This had the potential to effect all inpatients and outpatients receiving physical therapy and occupational therapy.


Findings include:


On 9/10/13, at 2:40 p.m., the physical therapy (PT) and occupation therapy (OT) departments were toured. Two hydroculators (wet hot pack heaters) lacked evidence of temperature monitoring or preventive maintenance.


The physical therapy manager (PT)-A, was interviewed on 9/10/13, at 2:40 p.m., and stated it was facility policy to check and record hydroculator temperatures daily. After further review PT-A stated the daily temperatures were not completed or recorded for either hydroculator. Water temperatures in the OT department hydroculator had not been monitored or documented either. PT-A was did not know what the manufacturer's guidance indicated was the correct temperature for hydroculators.


The hydroculator manufacturer instruction included caution statements indicating the thermostat was extremely sensitive and the slightest adjustment would alter the temperature several degrees. Further cautions indicated the water temperature should be checked with a thermometer after every adjustment and before using the hot packs. The water temperature required enough time to stabilize.


In the OT department, on 9/10/13, at approximately 3:00 p.m., the paraffin wax bath for extremities had melted wax in it. PT-A was unaware of monitoring/maintenance instructions for the paraffin wax bath. The manufacturer's maintenance for the Therabath directed the use of a laboratory quality thermometer to ensure the paraffin wax temperature was between 126-134 degrees Fahrenheit.

Based upon observation, interview and document review, the critical access hospital (CAH) did not maintain security of disposed medication in the medical/surgical medication room, the surgical suite and the biohazard room; after hours access to the pharmacy was not monitored; code locks were not changed for individual patient medication storage boxes; expired medication was noted in the outpatient rehabilitation clinic. The lack of security had the potential to affect all patients and visitors to the CAH.

Findings include:


During observation on 9/10/13, at 8:40 a.m., registered nurse (RN)-C asked RN-O to waste 1 mg of morphine sulfate (a narcotic used for pain) with her. RN-C and RN-O signed out the morphine for wasting in the McKesson medication unit. RN-C took the morphine into the locked medication/supply room and disposed of the Morphine filled carpuject vial directly into a sharps container. The morphine was not wasted into the toilet or sink prior to placing the vial into the sharps container. The wasting of the morphine was not actually witnessed by RN-O.


RN-C. interviewed on 9/10/13, at 2:40 p.m., stated that wasting medications needs to be done by two nurses. The second nurse is to, "Verify the amount wasted and where it goes." RN-C further stated, "If it's in a syringe we waste it down the sink, if it's in a vial we put it in the sharps container."


The sharps container was observed on 9/11/13, at 1:10 p.m. and the syringe containing the 1 mg of morphine sulfate was visible from the top and could easily have been removed from the sharps container. RN-H was working on the unit and verified the MS was in the sharps container. RN-H stated that the MS should have been wasted, not left in the syringe in the sharps container.


Review of the Medication Administration policy dated as being effective 06/14/05, and with no review date stated that all medication that have been contaminated are to be destroyed by crushing or washing down the sink. A narcotic or other controlled substance should be returned to the Return Bin in Acudose and recorded in Acudose. Narcotic waste must be witnessed by another nurse before destroying and documented in Acudose.


Review of the McKesson system for wasting of medications gave a choice of putting the medication in the sharps container to be wasted.


The pharmacist (Ph)-M, interviewed on 9/12/13, at approximately 8:30 a.m., stated that it was not their policy to waste a narcotic in the sharps container and the 1 mg of MS should not have been left in the sharps container. Ph-M further stated that she did not know the McKesson medication storage system gave staff a choice of medication destruction in the sharps container.


Interview with the DON on 9/11/13, at 2:05 p.m. stated the 1 mg of MS or any scheduled medications should not be put in the sharps container to be wasted.




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The surgery department was toured with RN-F at 1:30 p.m. on 9/10/13. In operating room (OR)-2, the crash cart was noted to be unlocked, as well as a cupboard that contained the malignant hyperthermia emergency kit. Although the surgery area was locked, several staff and vendors had access to the area without appropriate staff in attendance. There were no written policies or procedures regarding security of medications or access to the OR.


The crash cart medications included Epinephrine (often used for shock and cardiac arrest), Narcan (a narcotic used for pain control), Lidocaine (an anesthetic), Amiodarone (used to treat cardiac arrhythmia), Atropine (often used to regulate the heart), and Dopamine (improves nerve conduction).


RN-F, interviewed on 9/10/13, at 1:30 p.m., stated the crash cart and medication cupboards were not kept locked. The housekeepers would be in this area by themselves, as well as service and preventive maintenance personnel and maintenance staff.


Ph-R, interviewed on 9/11/13, at 9:30 a.m., stated that all crash carts should be locked. There were tabs with a numbering system to keep the carts secure between uses or monthly pharmacy checks. There were no tracking system for medications in the OR.


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An environmental tour of the CAH was completed with the environmental services director on 9/10/13, at 2:00 p.m.. The door to the BIOHAZARD ROOM was unlocked. Inside the biohazard room there were multiple sharps containers. The sharps containers were not closed or sealed and held vials of controlled medications that were not empty. One sharps container had many vials of propofol (medication used for induction and maintenance of general anesthesia, sedation of mechanically ventilated adults, and procedural sedation for conscious sedation). Three of the visible propofol vials had large amounts of fluid left in the bottom of the vials. There were 2 vials of lorazepam (antianxiety medication) with liquid left inside them. The biohazard room was not in an area that was constantly monitored.


The pharmacy policy for STORAGE OF DRUGS OUTSIDE OF THE PHARMACY dated as last revised 7/07, did not address the how to waste or secure the unused portions of medications.


The acting pharmacy director was interviewed on 9/11/13, at 9:00 a.m., and stated that wasting unused portions of medications including controlled substances could be achieved by leaving the unused medication in the syringe or vial and placing it in the sharps container.


The environmental services director, interviewed on 9/10/13, at 2:00 p.m., verified the unused medication visible in the sharps containers and that the biohazard room was not kept locked.



The acting pharmacy director and the pharmacy technician, interviewed on 9/10/13, at 10:00 a.m., stated the CAH charge nurse was responsible for the pharmacy key after hours. The pharmacy did not have camera security and there was no log for staff to document pharmacy access after hours. Pharmacy staff would know if the charge nurse left a note and duplicate of the medication order. The charge nurse did not have access to control medications. There was no current policy or procedure for after hours access of the pharmacy and no system to monitor who and how often a charge nurse enters the pharmacy after hours.


During observation of medication pass on 9/10/13, at 8:30 a.m. individual medications were stored in a steel box attached to the wall of each patient's room. There were six black buttons in a row on the top of each box. RN-A was observed to open the patients medication box by pressing the correct sequence of black buttons. RN-A was interviewed and stated that sequence of black buttons had been changed only one time that she could remember in the previous 2 years. RN-A did not know if the codes were changed when licensed nurse staff left employment.


The acting pharmacy director was interviewed on 9/11/13 at 9:30 a.m. and stated there was no policy or procedure for changing the code sequence for patient room medication boxes. She stated that the code sequence for the medication boxes had been changed approximately 3 months ago, but she did not know when the codes would again be changed or if the codes were changed when licensed staff left employment at the CAH.


During observation of the outpatient offsite rehabilitation clinic on 9/10/13, at 4:00 p.m. it was noted that a large bottle of dexamethasone (anti-inflammatory medication) labeled as 4 mg (milligrams) per 100 ml (milliliters) dated as expired on 11/13/12, was found in the refrigerator of the rehabilitation clinic.

Review of the CAH policy STORAGE OF DRUGS OUTSIDE OF THE PHARMACY dated as last reviewed 7/07, the policy identified the following: "...6. Pharmacy will check medication boxes monthly for outdated medications."

The pharmacy technician was interviewed on 9/11/13, at 9:45 a.m. and stated she was not aware that the outpatient rehabilitation clinic had any medications so she had not been checking the medication for outdates.

Based on interview, incident report review, and policy review the Critical Access Hospital (CAH) failed to ensure pharmacy policies addressed pharmacist involvement in reviewing medication errors and development of interventions to minimize further error incidents. In addition the pharmacist did not review medication errors or implement interventions to minimize reoccurrence for 3 of 3 mediation errors reviewed. This practices has the potential to affect all CAH patients.


Findings include:


The acting pharmacy director, interviewed on 9/10/13, at 9:00 a.m., stated she was not involved in review or analysis of medication errors or adverse drug events.


The Pharmacy and Therapeutics (P&T) committee (advisory group that serves as the organizational line of communication or liaison between the medical staff and the pharmacy department) meeting minutes from January 1, 2013 thru the last meeting dated 5/16/13, were reviewed. Meeting minutes from 5/16/13, and 9/10/13, lacked evidence of medication error review and analysis.


The P&T meeting minutes dated 1/15/13, indicated: "P&T Committee will review medication errors and make recommendations for improving problem areas."


Medication error reports from 6/1/13-9/10/13, were provided by the director of nursing (DON). Three medication errors had occurred; however, there was no evidence that the acting pharmacy director or any staff from the pharmacy had reviewed the medication errors.


Review of the CAH policy ADVERSE DRUG REACTION/MEDICATION ERRORS/NEAR MISS POLICY dated as last reviewed on 7/3/07, revealed that the policy did not address a systematic process for handling medication errors. The policy addressed a process for handling adverse drug events, but did not mention anything related to medication errors.


The DON, interviewed on 9/11/13, at 2:30 p.m., stated she reviewed all medication errors and that medication errors were reviewed at the P&T committee meetings. Since the previous the pharmacy director left in June, 2013, the pharmacist did not review medication errors. The P&T committee had not reviewed medication errors since the meeting held January 24, 2013.

Based on observation, interview and record review the facility did not ensure appropriate infection control techniques were utilized for 1 of 1 residents observed for intravenous (IV) access (P4) and 1 of 1 residents (P4) observed for blood glucose monitoring.


Findings include:


P4 had multiple diagnoses including ventricular tachycardia (v-tach) and congestive heart failure (CHF). During observation on 9/10/13, at 4:45 p.m., registered nurse (RN)-P was observed to remove P4's intravenous (IV) access with appropriate technique and glove use. Without changing gloves or cleansing hands, RN-P attempted to insert a new IV, but was unsuccessful. RN-P informed P4 that she would call the nurse anesthetist to come in and start the IV. RN-P removed the gloves and sanitized her hands on the way out the door. RN-P was interviewed on 9/10/13, at 5:15 p.m., and verified she did not change gloves between the removal of the infiltrated IV and the attempted start of a new IV access. NR-P further stated that normally she would change her gloves between the tasks but she doesn't always cleanse her hands between glove changes.


On 9/10/13 at 7:15 a.m. RN-D was observed to complete a blood glucose monitoring (BGM) test for P4 using appropriate technique. Upon completion of the test, RN-D returned the BGM machine, without cleaning it, to the charging unit at the nursing station. RN-D stated that, although the BGM machines were for community use, P4 was the only patient requiring BGM at that time. On 9/10/13, at 5:15 p.m. RN-Q was observed coming out of P4's room with the BGM machine. RN-Q immediately docked the machine in the charging unit. Interview with RN-Q on 9/10/13, at 5:20 p.m. verified she did not sanitize the BGM machine. She stated she, "Should clean the machine when I come out of the room with the white topped cleaner - and it should be wet for 3 minutes." RN-P was interviewed on 9/10/13, at 5:15 p.m. about the need for cleansing the BGM machine and stated she thought night shift cleaned it when they tested it. RN-P further stated, "I suppose we should maybe clean it between patients - but honestly nights does it."


Interview with RN-R on 9/10/13, at 3:00 p.m. verified the expectation and facility policy was to change gloves and wash hands between the removal of an IV and the attempt to start a new IV. RN-R also verified the facility policy for cleansing the BGM machines was to wipe the machine down prior to docking it for charge. She further indicated the staff were aware to use the white topped wipes and allow it to air dry for 3 minutes prior to use. On 9/11/13, at 10:00 a.m. the director of nursing (DON) verified the facility expectations and policies as stated by RN-R.


The facility policy for the BGM machine provided by the facility as current directed staff to "Disinfect the meter with a damp Sani-Wipe before proceeding to another patient or before docking the meter."


According to the Center for Disease Control (CDC), Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011, "Hand hygiene should be performed before and after palpating catheter insertion sites as well as before and after inserting, replacing, accessing, repairing, or dressing an intravascular catheter." The CDC also identified for the "Infection Prevention during Blood Glucose Monitoring and Insulin Administration" that "Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions."

Based on staff interview and review of the Critical Access Hospital (CAH) policies, the CAH failed to ensure that patient care policies and pharmacy policies were reviewed on an annual basis. This had the potential to affect all patients treated by the CAH.


Findings include:


Review of the CAH pharmacy policies related to receipt and distribution of drugs; handling and dispensation of drugs; drug storage; medication administration; storage of drugs outside of the pharmacy; adverse drug reaction/medication errors/near miss policy; and administration of drugs and biological's revealed that the policies had not been reviewed and revised at least annually by a group of professional personnel.


The acting pharmacy director was interviewed on 9/11/13, at 10:00 a.m. and stated that she was unsure when the CAH pharmacy polices had been last reviewed for accuracy and current standard of practice.


The registered nurse compliance officer (CO) was interviewed on 9/12/13, at 11:00 a.m. and confirmed the only policies reviewed by the group of professional personnel are those which are new, changed, or deleted. She confirmed that all of the pharmacy policies were not reviewed at least annually.



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On 9/11/13, at 1:00 p.m., the CO stated that each department head was responsible for reviewing their patient care policies, and indicating if there were any changes or revisions made to policies. Policies were brought forth to be reviewed only if there were additions, deletions or revisions.


The facility policy and procedure on review/revise of health care policies, reviewed 9/12, directed each department director to review and evaluate departmental policies at least annually, and all health care policies were to be reviewed by the CAH professional advisory committee annually.

Based on interview, the Critical Access Hospital (CAH) lacked an arrangement with an outside entity to review the quality and appropriateness of diagnoses and treatments furnished by the CAH's physicians. This had the potential to affect all patients receiving treatment at the CAH.


Findings include:


On 9/10/13, at 3:45 p.m., the compliance officer (CO) was interviewed and stated the facility physician's review patient charts. The CO further stated an outside agency is only utilized to review patient charts if a facility physician finds a concern with the attending physician's diagnoses or treatments.


The facility was unable to provide a policy and procedure on review of charts by an outside entity.