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Based on review of medical staff by-laws, record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure a qualified medical provider was available on site within 30 minutes for 6 of 8 closed emergency department records (Patient #21, #22, #23, #24, #27, and #28) reviewed. Failure to have a qualified medical provider available on site within 30 minutes placed all patients presenting to the emergency department at risk for complications related to illness or injury and has the potential to cause a delay in assessment and treatment.

Findings include:

Review of the CAH's "Rules and Regulations" occurred on 08/27/18. This document, dated February 2018, stated, ". . . G. Emergency and Outpatient Services: . . . 4. . . . A licensed health care practitioner, qualified by training and experience in care of the emergency patient, will be on call at all times and available to respond to emergencies within thirty (30) minutes."

- Review of Patient #21's closed emergency room (ER) record occurred on 08/28/18. The record identified the patient presented to the emergency room on 04/25/18 at 3:34 a.m. and the CAH staff notified the medical provider at 3:38 a.m. The record identified the medical provider (Provider #1) arrived at 5:00 a.m. (1 hour, 26 minutes).

- Review of Patient #22's closed ER record occurred on 08/28/18. The record identified the patient presented to the emergency room on 04/25/18 at 4:37 a.m. and the CAH staff notified the medical provider (Provider #1) at 4:55 a.m. Nurses notes stated, "6:23 a.m. Pt [patient] still complaining of tooth ache. Awaiting provider. . . . 6:42. a.m. Pt decided to leave AMA form signed. Pt could not wait for the provider. Not seen by provider."

- Review of Patient #23's closed ER record occurred on 08/28/18. The record identified the patient presented to the emergency room on 06/26/18 at 5:55 p.m. The record failed to identify when the CAH staff notified the medical provider of the patient's arrival. The record identified the medical provider (Provider #1) arrived on the unit/bedside at 6:39 p.m. (44 minutes).

- Review of Patient #24's closed ER record occurred on 08/28/18. The record identified the patient presented to the emergency room on 06/27/18 at 8:09 a.m. The record failed to identify when the CAH staff notified the medical provider (Provider #1) of the patient's arrival. The record identified the medical provider arrived on the unit/bedside at 8:45 a.m. (36 minutes).

- Review of Patient #27's closed ER record occurred on 08/28/18. The record identified the patient presented to the emergency room on 07/02/18 at 8:57 a.m. and the CAH staff notified the medical provider (Provider #1) at 9:04 a.m. The medical record did not identify the time the medical provider arrived in the ER, however the first notation from the medical provider in the record occurred at 10:33 a.m., when the provider signed orders (1 hour, 30 minutes).

- Review of Patient #28's closed ER record occurred on 08/28/18. The record identified the patient presented to the emergency room on 07/04/18 at 10:15 a.m. The record failed to identify when the CAH staff notified the medical provider (Provider #1) of the patient's arrival. The record identified the medical provider arrived on the unit/bedside at 10:48 a.m. (33 minutes).

The documentation failed to demonstrate the qualified medical provider was available on site within the required 30 minutes.

During interview, the afternoon of 08/28/18, an administrative staff nurse (#1) confirmed the medical provider should be on-site within 30 minutes and staff should document when the provider arrives in the ER.

Based on observation, review of hospital policy, and staff interview, the Critical Access Hospital (CAH) failed to store medications in a manner that prevented unauthorized access for 2 of 5 (Pharmacy and Radiology Department) medication storage areas. Failure to store all medications securely may result in unauthorized access to medications.

Findings include:

PHARMACY

Review of the CAH's policy titled, "Proper Storage of Drugs and Chemicals" occurred on 08/29/18. This policy, dated 09/01/16, stated, ". . . Professional Nursing Staff (RN's [registered nurses] and LPN's [licensed practical nurses]), Providers and Pharmacy Staff are the only personnel able to access the locked cabinets, medication room and medication cart. . . ."

During interview on 08/29/18 at 1:30 p.m., an administrative staff member (#1) and a pharmacy technician (#2) stated the CAH limits access to the pharmacy to the pharmacy staff, director of nursing, assistant director of nursing, and the information technology staff.

During observation of the medication storage areas on 08/28/18 at 1:30 p.m., a maintenance staff member (#16) swiped his badge and entered the medication storage room that contained the Omnicell medication dispenser. The medication storage room contained an access door to the pharmacy that required scanning of a name badge to a security pad. Observation showed the maintenance staff member (#16) swiped his badge and opened the door allowing him access to the pharmacy department.


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RADIOLOGY

Review of the CAH's policy titled "Contrast Reaction Medications" occurred on 08/28/18. This policy, dated July 2018, stated, ". . . The contrast reaction medication box is located in the CT room. . . ."

Observation of the Radiology Department on 08/28/18 at 10:45 a.m. with the department's director (#12) showed an emergency kit (E-kit) located in the computed tomography (CT) scan room. The CT room and the E-kit lacked a locking system.

During interview on 08/28/18 at 2:40 p.m., the radiology director (#12) confirmed staff, including housekeeping and maintenance, had assess to the CT room and the E-kit.

Review of the E-kit medication list showed medications included DiphenhydrAMINE (Benadryl), Ephedrine (stimulant), Epinephrine (adrenalin), and similar medications administered for various contrast reactions during a CT scan.

The facility failed to ensure the storage of all drugs in a manner that prevents unauthorized access and/or tampering.

CLEANING OF EQUIPMENT

1. Based on observation, review of manufacturer's instructions, review of facility policy, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff followed manufacturer's instructions for the use of chemicals used for cleaning and disinfecting equipment for 1 of 1 operating room. Failure to follow manufacturer's instructions may result in transmission of organisms and pathogens from equipment to patients.

Findings include:

Review of facility policy titled, "Colonoscopy /Endoscopy", occurred on 08/29/18. This policy, dated 08/13/12, stated, ". . . Endoscopes must be manually cleaned, following manufacturer's instructions, prior to processing in the Steris system. . . ."

Observation in the surgical department on 08/28/18 at 10:30 a.m., identified a container of Steris valsure enzymatic cleaner next to the sink used to clean scopes. The manufacturer's instructions on the cleaner stated, ". . . Dilute one ounce of chemical per one gallon of water. . . ." The surgical technician (#17) stated staff use the cleanser to wash the endoscopes and colon scopes before disinfection. The surgical technician (#17) stated she fills the sink half full of water and adds 2 pumps of the Steris cleaner, and verified she does not measure the water or the amount of chemical. An administrative staff member (#1) present during the observation, obtained a water pitcher and measured the number of gallons it took to fill the sink approximately half full as identified by the surgical technician (#17). Observation identified it took 4 gallons to fill the sink 1/4 full, and six gallons to reach 1/2 full. One pump of chemical was measured using a medication cup and identified one pump was equal to one ounce. The surgical technician (#17) and the administrative staff member (#1) verified staff were not following the manufacturer instructions and staff were not using enough Steris chemical for the amount of water placed in the sink for precleaning of the scopes.


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MULTI-DOSE MEDICATION VIALS

2. Based on observation, professional reference review, policy/procedure review, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff followed professional standards of infection control for administration of medications in 1 of 1 Physical Therapy department. Failure to follow professional standards for withdrawing medication from a multi-dose bottle of medication placed patients receiving Iontophoresis (delivery of medication through the skin by electrical stimulation) at risk of contracting an infection from potential contamination of the medication.

Findings include:

Review of the policy/procedure titled "Opening of Multi-dose Vials" occurred on 08/29/18. This policy, dated 09/06/16, stated, ". . . 2. . . . For multi-dose vials disinfect the rubber septum on all vials prior to each entry, even after initially removing the cap of a new, unused vial. Always use a new sterile syringe and new needle/cannula when entering any vial. Never enter a vial with a syringe or needle/cannula that has been previously used."

The APIC (Association of Professionals in Infection Control and Epidemiology) Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Health Care (2016) stated, ". . . * Always use a new sterile syringe . . . when entering any vial. . . . access multidose vials away from the immediate patient care environment and always use a sterile syringe . . . each time the vial is accessed. . . ."

- Observation of the Physical Therapy department occurred on 08/27/18 at 3:45 p.m. with an administrative therapy staff member (#4). A locked cabinet in the therapy area contained two multi-dose bottles of dexamethasone, which the staff member (#4) stated therapy staff use for Iontophoresis treatments. Observation showed a puncture device in the rubber septum at the top of the bottles, with an open port at the top of the device. The staff member (#4) stated staff disinfect around the port and attach a new syringe to withdraw the medication.

During interview at 8:15 a.m. on 08/29/18, a pharmacy staff member (#3) stated the open port on the device in the multi-dose bottle can be a source of contamination for the medication.