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Based on document review and staff interview it was determined the facility failed to ensure there was an effective Governing Body that carried out the functions of maintaining necessary contractual agreements for the maintenance of biomedical equipment (See tag A 083).

Based on document review and staff interview it was determined the Governing Body of the hospital failed to ensure contracted services were provided for the periodic inspection and maintenance of the biomedical equipment. This failure has the potential to result in serious patient harm when electrical equipment used for patient care is not properly inspected and maintained.

Findings include:

1. Review of the current "ByLaws of the Governing Body of Welch Community Hospital" revealed members of the Governing Body include the Chief Executive Officer (CEO), Chief Operations Officer (COO), Chief Nursing Officer (CNO), the Chief Financial Officer (CFO) and the Director of Quality and Risk Management (DQRM). The ByLaws stated, in part: "The Governing Body will hold the CEO accountable for the application and implementation of established policies to the operation of the hospital..."

2. Review of the document entitled, "Master Agreement", with order number CMA 0506 2845 WEH13018 and order date 12/5/14, for "Medical Equipment Maintenance and Repairs" revealed the contractual agreement had an effective end date of 7/18/15.

3. Review of the Nursing Council meeting minutes, dated 7/27/15, revealed the CNO was in attendance and that the BioMedical contract had expired.

4. During an interview with the CEO on 11/16/15 at approximately 4:30 p.m., he stated he was aware the BioMedical provider's contract had expired and that there was no current contract with any qualified BioMedical inspection individual/company.

5. The expired BioMedical contract was discussed with the CNO and the COO during a joint interview on 11/17/15 at approximately 10:25 a.m. and they both concurred they were aware the hospital did not have a current contract with a qualified BioMedical individual or company.

Based on document review, observation and staff interview it was determined the hospital failed to ensure proper gloving technique when performing glucose monitoring, per facility policy. This failure has the potential for patient harm due to cross contamination.

Findings include:

1. Facility policy entitled, "Specific Use of Personal Protective Equipment", last reviewed 1/11, states, in part: "Employees shall wear gloves when it can be reasonably anticipated that the employee may have hand contact with blood."

2. An observation of the medical surgical unit was conducted on 11/17/15 at 10:50 a.m. Licensed Practical Nurse (LPN) #1 was observed donning one (1) glove on the right hand. She then grasped the patient's finger with the left, ungloved hand, cleansed it with an alcohol swab, used the right hand to perform the puncture then used her ungloved hand to place a cotton ball on the bleeding site.

3. An interview was conducted with LPN #1 on 11/17/15 at 10:56 a.m. at which time she stated, "I always use one (1) glove. I know I should use two (2) gloves."

Based on record review, document review and staff interview it was determined the hospital failed to document, per policy, the analysis of an incident in which there was equipment failure while a patient was under general anesthesia. This deficient practice involved one (1) of two (2) patients reviewed who had equipment fail while under general anesthesia (patient #11). This failure creates the potential for an adverse impact on the quality of care for all patients who undergo general anesthesia at the facility.

Findings include:

1. Review of the medical record for patient #11 revealed the patient was scheduled for a surgical procedure under general anesthesia on 7/30/15. Documentation in the anesthesia record revealed the patient was already sedated and intubated when a malfunction in the anesthesia machine was discovered. The patient was awakened from anesthesia and extubated. The surgical procedure was canceled and the patient was admitted to the hospital.

2. Review of the hospital policy entitled, "Incident Reporting", last revised 7/11, revealed it stated, in part: "The Incident Report is to be completed immediately after the incident by the individual who has the best knowledge of the incident...If a piece of equipment is involved, the name of the equipment, the manufacturer, ...and other related identification should be documented on the incident report...The supervisor has the responsibility to forward all incident reports...to the QA&I Coordinator...The Safety Committee will follow-up on all...safety incidents to formulate findings, make recommendations and to implement the action, follow-up, along with the Department Manager."

3. The Incident Report log for 2015 was reviewed and no documentation was found to indicate that an incident report had been completed for the above-stated event, as required by hospital policy.

4. Review of the Safety Committee meeting minutes for May through October 2015 revealed there was no documentation related to follow-up on any safety incidents during those time periods.

5. During a telephone interview with the Certified Registered Nurse Anesthetist (CRNA) on 11/17/15 at 3:15 p.m., she stated she recalled the case involving patient #11. She stated, "We put her to sleep, but canceled the case due to a malfunction on the (anesthesia machine) monitor." The CRNA stated she called the manufacturer and he advised her the problem was a battery and recommended canceling the case. She stated she thought she had completed an incident report about the event and "handed it to (the surgery supervisor)" but was not certain. The CRNA stated she had no further follow-up with patient #11 after she was moved from the surgery department.

6. The Incident Log was reviewed with the Director of Quality and Risk Management during an interview on 11/17/15 at approximately 3:30 p.m. and she agreed there was no record that an incident involving patient #11 had been reported, as per hospital policy.

Based on observation and staff interview it was determined the hospital failed to implement and maintain the biomedical equipment inspection and testing program to prevent, recognize and control defective patient care equipment within the facility and failed to ensure preventative maintenance and inspection was conducted by a reliable BioMedical company or individual.

These failures resulted in an Immediate Jeopardy (IJ) to the health and well-being of all operating room patients. The IJ was first called at 4:50 p.m. on 11/16/15. The hospital had continued non-compliance with biomedical equipment testing practices until 11/16/15 at 5:48 p.m. At that time, the hospital was informed that surgeries must cease until biomedical equipment within the operating room had been tested and recertified by a reliable BioMedical company or individual. The IJ was abated upon the cessation of surgeries.

Findings include:

1. During observation on 11/16/15 between 3:00 p.m. and 4:30 p.m., it was discovered that thirty-nine (39) of forty-three (43) pieces of biomedical equipment in surgery was found to be out of date for annual maintenance. Two (2) pieces of equipment expired in March 2015 and thirty- seven (37) pieces expired in September 2015.

2. The above findings were discussed with the Chief Executive Officer on 11/16/15 at approximately 4:30 p.m. and he agreed the biomedical equipment was out of date and at the time of the survey, the facility did not have a biomedical agreement or contract to have the equipment serviced.

Based on document review and staff interview it was determined the facility failed to ensure the designated Infection Control Director was qualified through education, training, experience or certification. This failure creates the potential for an adverse impact on the quality of infection control practices, which can negatively impact all patients.

Findings include:

1. The personnel file of the Infection Control Director was reviewed on 11/18/15. It revealed the director's hire date for her current position as 6/2014. No documentation was found of prior experience in infection control, training for the position, education since assuming the position or certification in infection control.

2. An interview was conducted with the Infection Control Director on 11/18/15 at 10:25 a.m. She confirmed she had no prior experience in infection control at the time she assumed the position, and also confirmed she had not received any training, ongoing education or certification in infection control since that time.

3. An interview was conducted with the Chief Nursing Officer on 11/18/15 at 11:25 a.m., at which time he concurred with the above findings.