HospitalInspections.org

Based on findings from document review and interview, the hospital did not address an untoward patient event completely. Specifically, the event was not thoroughly analyzed for its causes. Preventative actions and monitoring were not formally implemented to all applicable areas of hospital. The event was not shared with hospital quality council(s). Hospital Administration did not interact timely with the involved patient.

The hospital's failure to thoroughly investigate this untoward event could have put other patients safety at risk.

Findings include:

-- Per review of Root Cause Analysis (RCA) Meeting minutes dated 4/20/15, it indicated a patient had a tubal ligation (done with a hysteroscope). During the procedure a piece of bioburden (potentially infectious tissue) was discovered when grasper passed through the hysteroscope. Patient was exposed to bioburden.

The RCA meeting minutes further stated "The bioburden was taken to sterile processing and shown to the supervisor. Per the supervisor the staff member cleaned the scope prior to use and was unsure how the bioburden got there. She states she may have missed cleaning that channel." Under section titled "Actions" the meeting minutes state "All instrument lumens will be flushed by the scrub tech as part of post case breakdown of table. The lumens can be flushed with enzymatic foam, saline or sterile water."

The RCA did not identify lack of supervisor/nurse manager notification by involved operating room staff, lack of timely testing of the patient for blood born pathogens (BBP) or the hospital's inability to track patient scope usage.

The RCA did identify that the involved physician did not notify risk management staff, infection control staff or quality management staff. It also identified the hospital's lack of follow up with the patient. However no actions were documented to address these issues.

The one action identified in the RCA "All instrument lumens will be flushed by the scrub tech as part of post case breakdown of table. The lumens can be flushed with enzymatic foam, saline or sterile water" lacked an implementation plan.

-- Per interview of Staff #1 (sterile processing department manager) on 8/11/15 at 11:00 am, no new plan was implemented as a result of this RCA.

-- Per interview with Staff #2 (operating room performance improvement coordinator) on 8/11/15 at 11:30 am, operating room staff were educated via an email sent on 4/21/15 (11 days after the event). The email included recommended practices regarding flushing lumens of instruments at case end. No formal education, monitoring, or competencies were performed.

-- Per interview of Staff #3 (Director of Quality Management) on 8/13/15 at 11:00 am, after the RCA was completed it should have been forwarded to Quality Council(s). However, this did not occur. An email of the event was sent to a Hospital Administrator, but the email was not opened.

-- During interview with Staff #3 on 8/13/15 at 1:15 pm, the above findings were confirmed.

Based on findings from medical record review (MR), interview, and document review, in 1 of 7 MRs reviewed a patient (Patient A) was not provided timely follow up medical care for a potential blood borne pathogen (BBP) exposure and the hospital lacked a policy and procedure (P&P) regarding patient exposure to BBP.

The lack of a BBP P&P could lead to untimely exposure testing for patients as occurred in this event.

Findings include:

-- Per medical record (MR) review, Patient A had a gynecological surgical procedure on 4/10/15. During the procedure a grasper was inserted into the operative channel of a hysteroscope and a piece of black crusty blood-appearing substance (bioburden) came out of the channel and was released into the uterus. The bioburden was immediately grasped and all pieces were brought out, the uterus was rinsed considerably.

-- Per interview of Staff #4 (RN) on 8/11/15 at 1:05 pm, he/she asked the surgeon if the bioburden should be sent to pathology. The surgeon stated no, so the bioburden was not sent to pathology.

-- Per interview of Staff #5 (operating room nurse manager) on 8/11/15 at 2:15 pm, he/she found out about this event on 4/14/15 (four days after it occurred) when one of her staff spoke with Patient A during a routine post surgical follow up call. Staff #5 immediately called back the patient. Patient A told Staff #5 the surgeon would be ordering blood work within the next several months. The patient was under the impression that the bioburden was sent to pathology and would like to know the results.

-- Per interview of the Staff #6 (operation surgeon) on 8/12/15 at 9:50 am, he/she discussed the event with Patient A on 4/13/15. Staff #6 could not recall why he/she did not order the BBP testing. He/She felt the patient was a low risk exposure and testing would not be required. However, either the office nurse or the patient asked him/her to perform testing. Staff #6 stated he did not tell operating room staff not to send the bioburden to pathology.

-- Per review of an email sent on 4/21/15 (11 days after the event) by Staff #5 to her supervisor, administration and risk management, it indicated that after consultation with the hospital's Infection Disease Physician, the patient would be screened for BBP. Patient A was not tested for BBP until 4/16/15, 6 days after the exposure event occurred.

-- Per review of the hospital's P&Ps, they did not provide evidence that the hospital had an established procedure on how to handle patients exposed to BBP.

-- Per interview of Staff #3 on 8/13/15 at 1:15 pm, he/she confirmed the hospital lacked a P&P for patients exposed to BBP and that the patient was not tested timely for BBP.

Based on findings from medical record review (MR), interview, and document review, the facility failed to provide an aseptic surgical procedure to a patient and failed to follow hospital policy and procedure (P&P) to notify supervisory staff of the event.

These failures may have put patients at risk for hospital acquired infections.

Findings include:

-- Per medical record (MR) review, Patient A had a gynecological surgical procedure on 4/10/15. During the procedure a grasper was inserted into the operative channel of a hysteroscope and a piece of black crusty blood-appearing substance (bioburden) came out of the channel and was released into the uterus. The bioburden was immediately grasped and all pieces were brought out, the uterus was rinsed considerably.

-- Per interview of Staff #4 (RN) on 8/11/15 at 1:05 pm, after this event occurred he/she completed an incident report (Verge report). This was his/her only responsibility. The nurse manager and quality manager are suppose to take over after report completion.

-- Per interview of Staff #7 (RN - quality assurance) on 8/11/15 at 1:35 pm, he/she reviewed the Verge report on 4/11/15, notified his/her supervisor on 4/11/15 or 4/12/15. He/she set up a Root Cause Analysis (RCA) meeting for 4/20/15. It is supervisory staff's decision whether an event should be reported to administration.

-- Per interview of Staff #5 on 8/11/15 at 2:15 pm, staff are required to report anything out of the ordinary to him/her and to file a Verge report. Staff #1 did file a Verge report but did not report the event to him/her. Staff #5 also indicated that on 4/14/15 (his/her awareness of event) he/she sent an email to the Director of the Sterile Processing Department (SPD), Director of Perioperative Nursing, and the Vice President of Patient Care Services (VPPCS). He/she indicated that no one emailed followed up with him/her about this event.

-- Per interview of Staff #8 (VPPCS) on 8/12/15 at 10:15 am, he/she did not open the email sent by Staff #5.

-- Per interview of Staff #6 on 8/12/15 at 9:50 am, he/she was informed by Staff #4 that he/she would file a report regarding the bioburden. He/she thought this would take care of the hospital notification. He/she did not notify the medical director or surgical director. Staff #6 did discuss the event with the patient and indicated hospital staff would be contacting her.

-- Per review of P&Ps titled "Internal Incident Reporting "last revised 10/7/13, it stated "Notification of the occurrence will be provided to the applicable individuals.... If the event involves more that one department, all applicable managers will be notified... "

The above findings were shared with the hospital during exit conference on 8/13/15 at 3:30 pm.

Based on findings from interview the hospital lacked a policy and procedure (P&P) regarding patient specific tracking for endoscopes.

This lack of procedure could place patients at risk for infection.


Findings include:

-- Per review of the hospital's P&Ps, they did not provide evidence that the hospital had an established procedure for patient specific tracking of scope use as recommended by e.g., Food and Drug Administration (FDA), Association for Professionals in Infection Control and Epidemiolgy (APIC).

-- Per interview of Staff #1 on 8/11/15 at 11:05 am, the hospital does not have the capability to do patient specific tracking for surgical scopes and are unable to identify which patient a scope had been previously used on.