HospitalInspections.org

Based on interview, review of QAPI plan documentation, and documentation for 2 of 2 contracted services reviewed (EKG [electrocardiogram] interpretation and SANE [Sexual Assault Nurse Examiner] exams), it was determined the hospital failed to ensure the governing body was responsible for all services furnished in the hospital under contract as required and in accordance with the hospital's QAPI plan. The governing body failed to ensure an assessment of the quality and appropriateness of all aspects of the clinical contracted services.

Findings include:

1. Review of the "Bay Area Hospital Performance Improvement Program," approved 03/02/2010 reflected "Scope & Applicability
This is an organization-wide plan. It applies to all departments, care, treatment, and service settings (including those services furnished under contract or agreement)...
Scope of Data Collection
At a minimum, the organization will collect data in the following areas...Evaluation of Contracts for services when necessary..."

During an interview with the Director of Quality Services/Safety Officer on 03/14/2012 at 1100, he/she reported that the "Bay Area Hospital Performance Improvement Program," approved 03/02/2010 was the hospital's QAPI plan for 2010-2012. Review of the QAPI plan lacked clear guidelines describing when the "Evaluation of Contracts for services" were considered "necessary" in order to ensure the services provided under contract were evaluated.

2. A list of services furnished to the hospital under contract was reviewed and included approximately 170 "Patient Care Services." EKG interpretation with a contract expiration date of 10/01/2012 and SANE (Sexual Assault Nurse Examiner) exams with a contract expiration date of 09/30/2015 were selected for review. Documentation contained within the list of contracted services lacked evidence of corresponding QAPI monitoring or an assessment of the services.

3. An interview was conducted with the Director of Quality Services/Safety Officer on 03/15/2012 at 0930. He/she revealed that there was no QAPI monitoring or assessment of the EKG interpretation or SANE exam services. Although the hospital's QAPI plan reflected "At a minimum, the organization will collect data in the following areas...Evaluation of Contracts for services when necessary...," there was no data collected or an evaluation of the EKG interpretation or SANE exam services in accordance with the QAPI plan.

The lack of monitoring and assessment of the patient care services furnished under contract failed to ensure that the contractor of services furnished services that permitted the hospital to comply with all applicable conditions of participation and standards for those services.

Based on interview, observations, review of e-mail documentation, and documentation for 2 of 3 causal analyses (RCA [Root Cause Analysis] Report event 11/07/2010 and RCA Report event 01/03/2011) reviewed, it was determined the hospital failed to ensure that the hospital's performance improvement activities effectively tracked adverse patient events to ensure that all parts of the hospital at similar risk were identified, and preventive actions implemented as required.

Findings include:

1. A document titled "RCA Report" was reviewed and reflected an event date of 11/07/2010. The report "Event Summary" reflected "...[male/female] presents to [the] [Emergency Room] with [a] chief complaint of decreased level of consciousness...MD [medical doctor] assessment reveals possible pneumonia...Thoracentisis [an invasive procedure involving the lungs] indicated...Thoracentisis initially done on left side instead of right."

The report "Findings" reflected "Initial prep for procedure done on left side. Patient consent did not specify right or left side...Transposition of right and left side with manner in which [the] patient [was] positioned for [the] procedure...Time out not done with initial procedure...Multiple interruptions for both MD/RN [registered nurse] during set up for procedure causing delay from time of set up to time procedure was actually performed."

The report "Actions" reflected "...Evaluate Time-out process for procedures that do not require sedation" and the corresponding "Status" reflected "...recognize need for further education in organization. Director of Surgical Services with advanced knowledge of time out process - working with CME [continuing medical education] to do education session on time outs"

E-mail documentation dated 06/24/2011 at 1003 from the Director of Peri-Operative Services to OR (operating room), anesthesia and surgery staff was reviewed and reflected plans for changing the time out process in the OR. Review of the documentation reflected "...Subject: Time Out Procedure in the OR...To insure we are doing all we can to protect our surgical patients, the OR would like to initiate the following changes to our Time Out process.
Starting today, you will notice a new process for the Surgical Pre-Incision Time Out procedure. The new process that needs to be performed with EVERY surgical case will look like this
-Just prior to handing the surgeon a scalpel/needle...the circulating nurse will call for the Time Out
-The Time Out will include 3 (and only 3) elements:
1. Correct PATIENT
2. Correct operative SIDE
3. Correct surgical SITE
-A VERBAL acknowledgement of the patient identification and surgical procedure MUST be obtained from the SURGEON
-A VERBAL acknowledgement of the patient identification and surgical procedure MUST also be obtained from the ANESTHESIA provider
-AFTER the verbal acknowledgements: the scalpel...will be passed to the surgeon from the scrub nurse."

An interview and review of the causal analysis report and the 06/24/2011 e-mail documentation was conducted with the Risk Manager/Patient Safety Officer on 03/15/2012 at 1130. He/she indicated that the adverse event associated with the causal analysis had occurred in the ED (emergency department). He/she further revealed that the documentation for the new "time out" process contained within the e-mail only addressed procedures in the OR and the education contained within the email was distributed to OR staff. The process changes and education did not include the ED where the event occurred. He/she revealed that similar procedures may be carried out within all patient care units and therefore were at similar risk. He/she further revealed that the new "time out" process education should have gone out to all patient care units in the hospital in order to address all areas at similar risk.

2. A document titled "RCA Report" was reviewed and reflected an event date of "Discovered" 01/03/2011. The report "Event Summary" reflected "...Patient found to have small bowel obstruction and acute renal failure. Patient to OR...Patient's weight obtained on admission and documented as 98 lbs on written Patient Admission Data form. Weight entered into [electronic medical record system] as 98 kilograms. Post-operatively Vancomycin [antibiotic medication] started...as well as Dilantin [anti-seizure medication] for suspected seizure activity. Dosing for both medications based on weight in kilograms. Patient became obtunded [reduced level of consciousness] after initial Dilantin dose and was transferred to the [critical care unit]. Lab values obtained showed Dilantin toxicity..."

The report "Findings" reflected "...Patient Admission Data form asks for weight in pounds. Information then transcribed electronically into [medical record system] which defaults to kilograms...Policy does not distinguish if weights should be in pounds or kilograms...Bed scales and hallway scales may be switched from kilograms to pounds..."

The report "Actions/Status" included "...'Lbs' cannot be turned off on bed scales and hallway scales...Stickers reminding that weights are to be in "Kg only" made and distributed to nursing units for bed scales and hallway scales 1/10/11."

An e-mail dated 01/10/2011 at 1235 from the Risk Manager/Patient Safety Officer to management and administrative staff was reviewed. The documentation included plans for placing stickers on the hospital scales in order to remind staff of the process change for obtaining patient weights. Review of the documentation reflected "...This week a Root Cause Analysis was performed and an opportunity to improve patient safety relating to medication dosing and administration was identified. Effective immediately kilograms (and grams for newborns) will be the standard unit of measure for all patient weights. The following changes are being made to assist with this process change...The sticker below will be routed to your department managers to be placed on all patient scales: 'All Weights are to be done in KGs only [sticker]"

A tour was conducted with the Quality Coordinator on 03/15/2012 at 1155 of the Intermediate Care Unit, Pediatric Unit, Orthopedic Unit, Bariatric/Medical Unit and the hallway near the Oncology/Medical Unit. During the tour, scales used to obtain patient weights were observed. Three of 6 scales observed did not have stickers in place indicating that weights were to be obtained in kilograms only as planned. A "Kg only" or "All Weights are to be done in KGs only" sticker was not observed on the scale located in the closet across from the nurses station on the Pediatric Unit, the newborn scale located in the treatment room on the Pediatric Unit or the upright scale on the Bariatric/Medical Unit. These observations were verified with the Quality Coordinator at the time of the tour.

An interview and review of the causal analysis documentation was conducted with the Risk Manager/Safety Officer on 03/15/2012 at 1215. He/she acknowledged that the causal analysis identified a plan for placing stickers on the scales used in the hospital for obtaining patient weights. He/she was informed that during a tour of several hospital units, there were 3 scales which did not have a "Kg only" sticker in place as planned. No further evidence indicating that the plan was fully implemented was received during the course of the survey which was completed on 03/15/2012 at 1240.

Based on interview, review of QAPI plan documentation, and documentation for 2 of 2 contracted services reviewed (EKG interpretation and SANE exams), it was determined the hospital failed to ensure that the hospital's governing body, medical staff, and administrative officials were responsible and accountable for ensuring that the hospital's ongoing program for quality improvement was defined, implemented, and maintained.

Findings:

Refer to tag A 083, Contracted Services, CFR 482.12(e)