The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

KAISER FOUNDATION HOSPITAL-SANTA CLARA 700 LAWRENCE EXPRESSWAY SANTA CLARA, CA 95051 Jan. 10, 2020
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on interview and record review, the facility failed to ensure the quality assessment and performance improvement (QAPI) committees had identified, analyzed, and/or develop action plans for its performance improvement activities which focused on high risk areas that might affect health outcomes, patient safety, and quality of care when:

1. Labor and delivery (L&D)'s staffing committee did not develop, implement, and evaluate/monitor the effectiveness of action plans regarding L&D staffing concerns.

2. Labor and delivery (L&D)'s staffing committee did not report the concerns identified, to the hospital's QAPI committee which resulted in missed opportunities for the hospital's QAPI committee to improve.

These failures had the potential place patient safety at risk.

Findings:

During interviews, twenty (20) of 21 registered nurses (RNs) expressed their concerns regarding patient safety related to staff shortages, overtime, and missing meals and/or breaks. (Refer to A392)

During an interview and record review with the interim chief nurse executive (ICNE) on 1/9/2020 at 2 p.m., she stated three committees were initiated in the Labor and Delivery (L&D) unit: Communication Committee, C-section logistics committee, and "Staffing &[and] scheduling committee" (Staffing Committee).

Review of the hospital's "LABOR/DELIVERY: 2019 Communication Plan", indicated the goal was to continue building an interdependent, transparent culture and communication for all of patient care services in the hospital that builds on the hospital's nursing vision and professional practice by ensuring routine opportunities for bi-directional communication. It indicated the Staffing &Scheduling Committee started in June, 2019.

During a concurrent interview and record review on 1/10/2020 at 9:45 a.m. with the ICNE, Maternal Child Health Services Director (DMCH), and the nurse manager (NM), the meeting minutes of "Staffing & Scheduling Committee" were reviewed.

Review of one page of Goal Planning Worksheet of the committee, included three meetings which were held on 6/13/19, 6/26/19, and 7/17/19. Topics in the first meeting, dated 6/13/19, included standard guidelines for scheduling, errors on schedule, and vacation planning approval. During the second meeting, dated 6/26/19, the committee discussed including 1-on-1 coverage for pick- ups, number of grid posted visible to staff, the broadcast process (to find staff available for the shifts) and recruitment updates.

Review of the committee's minute, dated 7/17/19, indicated the committee discussed "cancellation (how cancellation impact ability to maintain goal of 18 registered nurses on each shift).. posting of staff grid... trades... broadcast... phone courtesy, ANM [assistant nurse manager]"coverage. The NM confirmed that the minute did not include action plans, evaluation or follow-up from the previous meetings. The NM stated she followed-up, discussed, answered all questions in the staff meeting.

During the concurrent interview and review of the committee's minute of 8/2019 Staff Meeting in the L&D, indicated there was no documented evidence that during the staff meeting, all questions regarding staffing issues were discussed. The ICNE confirmed.

The NM stated she did not have a 9/12/19 committee meeting minute.

Review of the committee's minute, dated 10/10/19, indicated the committee discussed "deleting pre-approved vacations... trades... pick-ups... ANM... broadcast...standby [to make someone available in case of staff shortages]" The action plan was to discuss with the scheduling team and the ANM.

Review of the committee's minute, dated 11/22/19, indicated the committee discussed "schedule continues to be wrong, 1:1 Trades ...remains an issue, schedule ... inconsistency with noting RN's name..." There were no follow-ups from the previous meeting and the issues were remained same.

Review of the committee's 12/12/10 minute, indicated the topics included "vacant RN positions...vacant obstetric technician (OBT) position...scrub technicians... pre-confirming...cancellation... scheduling... paperwork... vacation binder...recruitment"

During a concurrent interview, the NM stated the minutes did not include action plans or follow-ups for the repeated issues. She stated staff did not bring issues regarding missing breaks and/or meal times and concerns about nurse to patient ratios in the committee. The NM stated she was aware about those issues from Assignment Despite Objection (ADO) forms, which were submitted by the staff but those were not discussed in the committee.

Review of the hospital's quarterly PERFORMANCE IMPROVEMENT RESOURCE MANAGEMENT (PIRM), Maternal Child Health (MCH) report, dated 8/5/19 and 12/2/19, indicated there no documented evidence the QAPI committee reviewed and discussed staffing issues in L&D.

During an interview on 1/9/2020 at 5:02 p.m., the Area Quality Leader (AQL) stated the QAPI committee and the staffing committee were not connected because the staffing issues were operational issues.

Review of Hospital Quality and Patient Safety Program Description, Annual Work Plan and Evaluation, dated 3/5/19, indicated the purpose of this plan is to provide the mechanism for improving hospital quality and safety and to ensure that the hospital Board of Directors' Quality and Health Improvement Committee (QHIC), senior leaders, medical staff, and hospital staff demonstrate a consistent and collaborative approach to deliver safe, effective, efficient, equitable, patient centered, and timely care with a quality assurance and performance improvement (QAPI) framework. It indicated other professional staff committees, departmental committees, and specifically focused committees and work group had been given, by leadership, the responsibility to develop, implement, and monitor performance effectiveness for the services and processes within their scope. These committees and work group report up through the quality structure. It further indicated to permeate responsibility and mutual accountability for patient safety throughout the organization, the hospital will continue to implement activities broadly aimed at becoming a highly reliable organization by achieving the six strategic themes: safe care, safe culture, safe staff, safe patients, safe place, and safe systems.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview and record review, the hospital failed to comply with the Conditions of Participation for Nursing Services as evidenced by:

1. Failure to maintain sufficient staffing levels to meet patients' needs on the labor and delivery (L&D) unit. (Refer to A392)

2. Failure to follow Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) guidelines for RN to patient ratios. (Refer to A392)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on interview and record review, the hospital failed to the maintain sufficient staffing levels to meet patients' needs on the labor and delivery (L&D) unit when:

1. Twenty (20) of 21 L&D registered nurses (RNs) interviewed expressed patient safety concerns related to staff shortages, overtime, and missing meals and/or breaks.

2. Triage nurses (RNs that assess patients and determine their level of need for medical assistance) and/or charge nurses were pulled from their duties to fill in for obstetric technician (OB tech, a medical assistant specialized to assist physicians and nurses of a L&D unit) shortages.

3. RN to patient ratios for patients in active labor were not followed per AWHONN (Association of Women's Health, Obstetric and Neonatal Nurses) guidelines.

These failures posed risks for patient safety.

Findings:

1. Review of the Activity/Pay Code Reports from 9/1/2019 to 9/30/19, indicated frequent incidences of when staff missed meals and/or breaks per shift as followed: 20 times for Day, 17 times for Evening, and 17 times for Night.

Review of the Activity/Pay Code Reports from 10/1/2019 to 10/31/19, indicated frequent incidences of when staff missed meals and/or breaks per shift as followed: 90 times for Day, 54 times for Evening, and 64 times for Night.

Review of the Activity/Pay Code Reports from 11/1/2019 to 11/30/19, indicated frequent incidences of when staff missed meals and/or breaks per shift as followed: 60 times for Day, 57 times for Evening, and 88 times for Night.

Review of the Activity/Pay Code Reports from 12/1/2019 to 12/31/19, indicated frequent incidences of when staff missed meals and/or breaks per shift as followed: 32 times for Day, 41 times for Evening, and 65 times for Night.

Review of the OB tech schedules indicated six out of nine OB techs were unavailable (i.e., sick, family and medical leave, or vacation) from 11/24/19 to 12/16/19; and five out of nine OB techs were unavailable from 12/17/19 to 12/27/19. In some instances, there were entire shifts within a 24-hour period that lacked an OB tech coverage.

During an interview on 1/5/2020 at 11:27 a.m., registered nurse 1(RN 1) stated staff shortages on the L&D unit was chronic. She stated, "Yesterday we were on redirect because we did not have enough staff or rooms." She stated this was her 4th double-shift (16 hours in a day) in a row. She stated there were only three OB techs available. She stated at times nurses including triage nurses, were pulled to act as OB techs, which delayed patients' treatments.

During an interview on 1/5/2020 at 11:44 a.m., RN 2 stated, "staff is working overtime instead of the hospital calling in nurses...If we don't have a bed to put a patient in or a nurse to take care of the patient they stay in triage (room). They are getting care out of ratio." RN 2 stated the shift started with 3 break nurses; but, the break nurses were pulled to take other assignments.

During an interview on 1/5/2020 at 12:02 p.m., RN 3 stated, "We are definitely short staffed... I worked a 16-hour shift yesterday ... They did not have anyone to scrub (A person that assists in surgical procedures. Some duties include setting up the operating room prior to a procedure and working with the doctor during surgery) as a tech. Break nurses are pulled. The majority of the time we do not have enough staff." RN 3 stated she felt frustrated with patient safety concerns and was burned out.

During an interview with the nurse manager (NM) on 1/5/2020 at 12:19 p.m., she stated there was a shortage of OB techs; but, she did not hear about RNs missing breaks or situations where RNs were out-of-ratio to patients.

During an interview with the maternal child health services director (DMCH) on 1/5/2020 at 12:19 p.m., he stated "OB techs are a challenge. When there is no tech ... then, a trained nurse is assigned."

During an interview on 1/5/2020 at 2:47 p.m., RN 5 stated, "people are not getting their breaks and we are short staffed." RN 5 stated she felt tired, overwhelmed, especially if she worked double shifts, and could not focus on patient care when she missed breaks. She stated sometimes she had assigned two patients who were in active labor and were supposed to have one nurse each, because the unit was short staffed, and could not get help. She stated she escalated the issues to the management.

During an interview on 1/5/2020 at 3:26 p.m., RN 6 stated, "yesterday I had two patients that should not have been put together. We were short staffed." She stated she felt it was unsafe and staffing at night was bad.

During an interview on 1/5/2020 at 3:55 p.m., RN 7 stated they were short staffed and the assignment was too heavy. She stated it was so busy and was unsafe. She stated one day she was assigned two patients, who should be one-on-one and she filed an Assignment Despite Objection (ADO, a tool to report unsafe working conditions when a manager or supervisor orders staff to perform a task that, in staff's professional judgment, is unsafe or potentially unsafe) form.

During an interview on 1/5/2020 at 4:14 p.m., RN 8 stated, "we are short staffed... We stay alot of overtime" and she felt burned out. She stated she missed breaks because break nurses were pulled to take other assignments and no staff were available. She stated staff complained to the management but they did not listen. She stated she filled out an ADO form when she was assigned two patients, who were supposed to have one nurse.





During an interview on 1/6/2020 at 6:45 a.m., RN 21 stated every day she felt the OB techs were short and RNs were pulled to act as OB techs. She stated staff shortages had been an issue.

During an interview on 1/6/2020 at 7:09 a.m., RN 18 stated a charge nurse worked as an OB tech the previous night and nurses could not get what they needed help from the charge nurse. She stated if there was an emergency cesarean delivery (C-section, a surgical procedure used to deliver a baby through incisions in the abdomen and uterus), it would be hard to open an operating room due to staffing shortages. She stated most of time, there was no break nurses available, staff were short, and she felt tired. She stated it was dangerous for patients.

During an interview on 1/6/2020 at 7:32 a.m., RN 20 sated understaffing was the serious issue. At night, there were not enough staff and there was a safety concern for patients. RNs were pulled out to work as OB techs or scrub nurses and a charge nurse was assigned to patients. She stated it was hard to make up an emergency operating team when emergency situations occurred. She stated she had to monitor screens while she took a break because there were no break nurses. She stated she felt frustrated and it was unsafe.

During an interview on 1/6/2020 at 8:15 a.m., RN 19 stated they were very short staffed and the staffing office did not properly call nurses. RN 19 stated staff filed ADOs for staff shortages, missing breaks/meals, and patient ratio, brought those issues in the staff meetings, but the L&D management did not respond.

During an interview on 1/6/2020 at 11:34 a.m., RN 16 stated she e-mailed the manager multiple times regarding understaffing, missing breaks, and the shortage of OB techs but, did not get responses.

During an interview on 1/6/2020 at 3:04 p.m. with RN 14, when asked about overtime, she responded, "It always happens. People have to stay over...We just need more people." She stated there was staffing issue and there were more issues at night because they started their shifts with less staff. She stated staff did not receive calls properly from a staffing office when they needed additional staff and it was very scary working with insufficient staff. She stated she filed ADOs but did not receive any response from the management.

During an interview on 1/7/2020 at 8:05 a.m., RN 22 stated nurses filed ADOs regarding staff shortage, missing breaks and meals but the L&D management did not respond. For staff shortage, the management was saying they posted job openings and that was it. She stated many travelers left, some staff were on their maternity leaves, OB techs were short, the management was aware, but there was no plan to replace them. When a charge nurse was pulled for a scrub nurse (a RN who assist in surgical procedures by setting up the room before the operation, working with the doctor during surgery and preparing the patient for the move to the recovery room) and when nurses needed help, there was no resource to ask. RN 22 stated nurses worked lots of overtime, missed their breaks, and her mind was fuzzy when she missed breaks.

During an interview on 1/7/2020 at 10:17 a.m., RN 23 stated staff shortages had been an issue and the management gave lots of empty promises. She stated it was completely unsafe.

During an interview on 1/7/2020 at 11:43 a.m., RN 17 stated the hospital's L&D had high acuity obstetric (OB) patients, worked as an OB emergency room , and had to prepare any emergency situations. Due to staff shortages, it did not allow staff do things right and it was unsafe. RN 17 stated staff missed their breaks and felt tired and burned out and it was unsafe for patient's care. She stated staff talked to the L&D management but they did not listen.

During an interview on 1/7/2020 at 3:49 p.m., RN 4 stated they were short staffed, lacked OB techs, many staff missed their breaks, RN-to-patient ratio changed all the times, and the management repeatedly said they were working on it. She stated it had been a year and half. She stated in the meeting, the management said not to call in sick. She stated staff felt exhausted.

During an interview on 1/7/2020 at 4:50 p.m., RN 24 stated nurses worked lots of overtime and breaks often got missed due to understaffing. She stated she reported by submitting ADOs but the management did not respond. She stated it was unsafe.

During an interview on 1/9/2020 at 3:52 p.m. RN 25 stated many nurses brought concerns regarding staff shortages to the management and they had empty promises. Staff could not react to the emergency situations when staff were short and it was unsafe.

During an interview on 1/10/2020 at 9:15 a.m., RN 27 stated at night, there should be more staff because it was unpredictable. She expressed staff shortages at night.

During an interview on 1/8/2020 at 8:15 a.m., the ICNE stated the hospital scheduled 18 RNs per shift including 12 core RNs, 3 break nurses, 2 triage nurses, and 1 charge nurse. She stated when OB techs were not available, RNs replaced their positions, but they did not schedule additional RNs.

2. During an interview on 1/5/2020 at 8:50 a.m., RN 26 stated one RN was assigned to one patient who was in active labor and they considered active labor when the patient's cervix (which is the bottom portion of the uterus, opens when a woman has a baby, through a process called cervical dilation. During labor, the cervix opens to accommodate the passage of baby's head into the vagina, which is around 10 centimeters [cm, unit of length]) was 6 or 7 cm dilated.

During an interview on 1/5/2020 at 10:25 a.m., the nurse manager (NM) stated when the patient's cervix was dilated more than 6 cm, the patient was considered in active labor and one nurse was assigned to the patient.

During an interview with the NM on 1/5/2020 at 12:19 p.m., she stated the hospital follows Association of Women's Health, Obstetric and Neonatal Nurses(AWHONN) guidelines.

Review of "Current Chalkboard [a printed screenshot of the computer screen to show patients' status and assigned staff]", dated 12/12/19 at 7:12 p.m., indicated a RN was assigned to two patients, Patients 35 and 36. Patient 35's cervix was dilated to 5 cm with "IND-Elective [Induction elective], Miso [Misoprostol, an induction agent], pit [Pitocin, an IV medication used to stimulate labor]" and Patient 36's cervix was dilated to 6 cm.

Review of Current Chalkboard, dated 12/29/19 at 11 p.m., RN 16 was assigned to two patients, Patients 33 and 34. It indicated Patient 33 had "srom" (spontaneous rupture of membrane, a rupture of the amniotic sac [the fluid-filled sac that contains and protects a fetus in the womb]) and "pit" (pitocin, an intravenous medication used to stimulate labor). Patient 34's cervix was 6 cm dilated with "srom, vb [vaginal bleeding], pit, gdma1[gestational diabetes A1, a type of glucose intolerance with onset or first recognition during pregnancy], epid [epidurals, medication for pain relief], chorio [chorioamnionitis, an inflammation of the fetal membranes due to a bacterial infection]"

During record review and concurrent interview on 1/7/2020 at 10:25 a.m., the NM reviewed Current Chalkboards, dated 12/12/19 at 7:12 p.m. and 12/29/19 at 11 p.m., and stated because all patients were stable, it was okay that one nurse had two patients. She stated patient to nurse ratios varied because the L&D was "so fluid" and the ratio was determined by the nurses' experiences and other factors.

During an interview on 1/9/2020 at 8:45 a.m. with RN 16, who provided care to Patients 33 and 34, stated Patient 34 was progressing with chorioamnionitis and supposed to have one RN assigned. The management thought it was okay that one nurse took care of two patients including one in active labor, but it was unsafe practice for patients. RN 16 stated anything could happen to the patients.

Review of Current Chalkboard, dated 12/19/19 at 9:03 p.m., indicated RN 28 was assigned to two patients, Patients 37 and 38. It indicated Patient 37's cervix was 10 cm dilated and Patient 38 was on monitoring for abdominal pain.

Review of Current Chalkboard, dated 12/19/19 at 10:02 p.m., indicated RN 28 was continuously assigned to Patients 37 and 38.

Review of Current Chalkboard, dated 12/19/19 at 11:01 p.m., indicated RN 28 endorsed two patients to other RNs.

During record review and concurrent interview on 1/7/2020 at 10:25 a.m., the NM stated RN 28 endorsed two patients to other RNs at 10 p.m. on 12/19/19 and both Current Chalkboards, at 10:02 p.m. and 11:01 p.m., were not updated to reflect actual RNs assigned. The NM did not explain on 12/19/19 at 9:03 p.m., the reason RN 28 had two patients including Patient 37, who was in active labor.

Review of Current Chalkboard, dated 12/29/19 at 2:16 a.m., indicated RN 16 was assigned to two patients, Patient 5 and 27. It indicated Patient 5's cervix was 8 cm dilated and Patient 27's cervix was 7 cm dilated. It indicated Patient 27 had "ind-ama [induction advanced maternal age], s/pcb [status post cook balloon (mechanical dilation of the cervical canal prior to labor induction)], pit [pitocin], epid [epidural], tamiflu [an antiviral medicine for treatment of flu]"

Review of Current Chalkboard, dated 12/29/19 at 3:31 a.m., both Patients 5 and 27 had progressed labor to 8 cm cervical dilation and RN 16 had continuously assigned to both patients.

During an interview on 1/7/2020 at 10:25 a.m., the NM stated both patients should have been one (nurse) on one (patient). She stated for staffing ratios, there were not clear guidelines and staff had different interpretations because the L&D was "so fluid."

Review of the website of AWHONN (www.awhonn.org) indicted "based on the cumulative body of evidence about normal labor progress, 6 centimeters rather than 4 centimeters dilation should be considered the beginning of the active phase of the first stage of labor . . . AWHONN supports the new recommendations, including the use of 6 centimeters dilation to define the beginning of the active phase of the first stage of labor..."

Review of AWHONN (Association of Women's Health, Obstetric and Neonatal Nurses) Guidelines for Professional Registered Nurse staffing for Perinatal units indicated 1 nurse to 1 woman for women choosing to labor with minimal to no pharmacological pain relief or medical intervention. Generally, this recommendation applies beginning with the active phase of the first stage of labor. However, some women in this category may require more intensive nursing care earlier in labor, depending on the woman's level of comfort an overall maternal-fetal status. It recommends continuous labor support, 1 nurse to 1 woman in labor to promote shorter labor, decrease use of analgesia and anesthesia, decreased risk of operative vaginal birth or cesarean birth, decreased need for oxytocin, and increased patient satisfaction.