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Based on observation and interview, the facility failed to meet the Conditions of Participation for Emergency Services by failing to ensure appropriate medications used for life-saving measures were immediately available (see Tag C-203).

An Immediate Jeopardy (IJ) was identified on 06/26/18 at 8:45 AM, during an inspection of the medication room, due to the presence of the medication Succinylcholine Chloride and the absence of the medication Dantrolene in the facility.

IJ was formally determined to exist on 06/26/18 at 11:45 AM under 42 CFR 485.618 Emergency Services at C200. The Facility Administrator, Chief Nursing Officer (CNO), Director of Pharmacy (Pharmacist), and Chief Medical Officer (CMO) were notified of the Immediate Jeopardy on 06/26/18 at 11:45 AM.

The Facility Administrator, CNO, Pharmacist and CMO were informed of the need for a Plan of Removal of the IJ on 06/26/18 at 11:45 AM.

The following is the official plan of correction for the Immediate Jeopardy at Oswego Community Hospital due to the presence of Succinylcholine in the facility and the absence of Dantrolene.

Steps that were taken by the facility to correct this situation include:

1. Upon being informed of this situation we immediately removed and discarded all Succinylcholine in the facility.

2. The Medical Director and the Chief Nursing Officer reviewed the needed medications for a rapid sequence intubation.

3. They determined that a suitable replacement is in stock, Etomidate.

4. As a matter of facility history the Medical Director is the only person authorized to do rapid sequence intubation. All additional Emergency Room practitioners (APRN /PA) are unwilling to do rapid sequence intubation and therefore they were never authorized. They are authorized to use the alternative tools to manage the difficult airway for example, Combitube, LMA.

The facility made two additional corrections to remove the immediacy of the IJ:

5. Entire staff informed of the change in protocol, and signage posted in the Medication Room.

6. The facility updated the "medication and do chart," included in the physical RSI kit.


The facility's Plan of Removal was validated by on-site surveyors and submitted on 06/26/18 at 3:45 PM to the Kansas State office for review.

The facility's Plan of Removal was approved on 06/26/18 at 4:51 PM, at which time the Facility Administrator and CNO were notified of the approval.

Based on observation, and interview, the facility failed to ensure it maintained a supply of medication to reverse a potential life-threatening side effect of another medication used by the facility during emergencies. Failure to anticipate the need for care of medication side-effects during medication administration had the potential to negatively impact all patients presenting to the facility for emergency care.

Findings include:

Observation of the facility's medication room on 06/26/18 at 8:30 AM, in the presence of the Chief Nursing Officer (CNO), revealed the presence of the facility's Rapid Sequence Intubation (RSI) kit (used when a patient requires immediate insertion of an endotracheal tube to maintain an airway and/or provide supplemental oxygen). In the kit were found five vials of Succinylcholine Chloride (used as a rapid-acting muscle relaxant on patients requiring rapid intubation to prevent the patient from struggling against the intubation process). When questioned, the CNO stated the facility did not stock the medication Dantrolene (used to counteract a possible side-effect of Succinylcholine Chloride called Malignant Hyperthermia, a life-threatening medical crisis which causes high fever and skeletal rigidity).

During a joint interview with the CNO, the Director of Pharmacy (Pharmacist), and the Chief Medical Officer (CMO) on 06/26/18 at 8:45 AM, it was agreed by all parties the facility did not have Dantrolene available.

Review of the facility's policy titled, "High Risk Medications," last revised 09/19/2012, revealed, "High risk medications" will be defined as those included in ISMP's (Institute for Safe Medication Practices) "List of High-Alert Medication." The attached ISMP list included succinylcholine. No information appeared on the policy related to the need for access to Dantrolene.

The facility was unable to provide a policy related to RSI, the use of Succinylcholine Chloride during RSI, or the need for the availability of Dantrolene in the Emergency Department. During the joint interview with the CNO, Pharmacist, and CMO on 06/26/18 at 8:45 AM, they were referred to the national standard of care as outlined in the Malignant Hyperthermia (MH) Association of the United States website recommendation, which states in part, " ...in a small percentage of cases MH appears to be triggered by succinylcholine alone ...Facilities that stock and have the potential to administer any triggering agent, including succinylcholine ...should have dantrolene immediately available (i.e., the ability to administer dantrolene within 10 minutes of the first sign of MH) in the event that a patient in that facility develops MH."

Based on observation, interview, and review of the facility's policy, the facility failed to ensure all malfunctioning equipment was identified and removed from service. This could lead to patients, visitors and staff using unsafe equipment, with potential negative outcomes for all patients receiving care at this facility.

Findings include:

An observation of the Inpatient/Swing Bed unit was conducted in the presence of the Chief Nursing Officer (CNO) on 06/25/18 at 8:45 AM. Room 2, Bed A (nearest the door) had a hand-written piece of paper taped to the headboard which read, "Do Not Use for Patients." When questioned, the CNO stated the bed was, "cantankerous," and could not further explain how the bed was malfunctioning. A hand-written piece of paper with "Do Not Use for Patients," was also found on Room 3, Bed A, and Room 5, Bed A, and, in each case, the CNO was unable to state the reason the signage.

During an interview with the CNO on 06/25/18 at 9:30 AM, the CNO stated facility expectation is for malfunctioning equipment to be labeled, removed from service, and for the Director of Maintenance to be notified. The CNO was unable to provide documentation showing the Director of Maintenance had been notified of the malfunctioning beds.

The Director of Maintenance was unavailable for interview during the survey.

Review of the facility's policy titled, "Defective Equipment," effective date 8/2008, revealed, "All hospital personnel will do the following: 1. Identify suspected defective equipment. 2. Tag equipment with a 'Defective Equipment' tag. 3. Remove the equipment from patient areas if possible. Notify the Plant Operations Department."

Based on observation, interview, and review of facility policy, it was determined the facility failed to ensure garbage was properly disposed. This failure has the potential to affect all patients and staff at the facility.

Findings include:

On 06/25/18 at 2:15 PM an observation outside the kitchen area of the hospital revealed a garbage dumpster used for collecting garbage at the facility was left open. Two (2) large bags of garbage were visible inside the dumpster.

On 06/26/18 at 8:15 AM an interview was conducted with the Dietary Director (DD). The DD stated garbage taken out of the kitchen area was placed in the dumpster outside the kitchen area and the lids of the dumpster were required to be closed.

On 06/26/18 at 8:20 AM an interview was conducted with Housekeeper (H)2. H2 stated the housekeeping department transports garbage to the dumpster outside the kitchen area and the dumpster lids were required to be closed.

A review of the facility policy, "Hazard Disposal and Waste Disposal," dated 08/2008, revealed the facility staff were required to maintain a sanitary and safe environment at the facility by ensuring trash receptacles were covered. The policy indicated, "If the trash receptacle is not in continuous use, it is covered by a lid." In addition, the policy indicated, "All garbage will be disposed of "3-4 times daily."

Based on interview, and review of hospital documentation, it was determined the facility failed to ensure laboratory services were provided under a current "Clinical Laboratory Improvement Act (CLIA)," certificate or waiver for all tests performed and meet the laboratory requirements specified in 42 CFR Part 493.

Findings include:

A review of the facility's "CLIA" certificate was conducted on 06/25/18. The review revealed the certificate's expiration date was 09/16/17.

On 06/25/18 at 1:30 PM, an interview with the Chief Nursing Officer, (CNO), revealed the hospital was aware of the "CLIA" certificate's expiration date prior to 09/16/17. The CNO stated the facility notified the state agency responsible for renewing the certificate and had been informed the facility would have to operate with an expired CLIA certificate due to the agency's inability to conduct a survey of the facility's laboratory before 09/16/17. The CNO stated the state agency informed the hospital's Laboratory Director, (LD), that a CLIA survey would be conducted within the next six (6) months. In addition, the CNO stated the state agency gave the facility an additional six (6) month grace period on 02/26/18.

On 06/25/18 at 2:30 PM, an interview with the LD revealed she was aware of the expiration of the "CLIA" certificate on 09/12/17 and attempted to get information related to the renewal of the certificate from the hospital's laboratory consultant on 09/12/17. The LD stated she was informed by the state agency that a "CLIA" survey would need to be conducted prior to the renewal of the facility's "CLIA" certification and she had not received any information from the consultant or the state agency related to when a "CLIA" survey would be conducted at the hospital.