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Based on record review and staff interview, the medical staff failed to be accountable in updating the governing body regarding the NICU's current operational status and the quality of medical care being provided to it's patients. The failure to communicate the level of care being provided created a potential for harm to critically ill neonates who's care needs, in the absence of an in-house neonatologist, were more than the NICU personnel were qualified to manage.

Findings:

1. Per review of the Guidelines for Perinatal Care; 6th edition; co-authored by the American Academy of Pediatrics and the American College of Obstetrics and Gynecologists, a national authority setting the standard for levels of perinatal care, the designations of levels of care were Level I - basic, Level II - specialty (NICU), and Level III (NICU) - subspecialty.

* Level I neonatal care would have personnel and equipment to perform neonatal resuscitation, evaluate healthy infants and/or stabilize ill newborn infants until the necessary transfer to a higher level of care.

* Level II nurseries could provide care to moderately ill infants who were expected to recover rapidly. This level of neonatal care was further subdivided into Level IIA and Level IIB. Level IIA would have no capability to care for infants needing assisted ventilation unlike Level IIB who could provide care with assisted ventilation for a brief duration. At a hospital with a Level II nursery, a board-certified obstetrician-gynecologist with a subspecialty in maternal-fetal medicine should be chief of the obstetric service. In a Level IIB hospital and above, a board-certified pediatrician with subspecialty certification in neonatal-perinatal medicine should be chief of the neonatal care service.

The hospital staff also should include a radiologist and a clinical pathologist who would be available 24 hours per day. Specialized medical and surgical consultation should be available.

* Level III or a subspecialty NICU should care for severe high risk infants with complex and critical illnesses. A subspecialty NICU required it's personnel (neonatologist, neonatal nurses, neonatal respiratory therapists) to be continuously available to address neonatal emergencies.
This level of care was further subdivided into Levels IIIA, IIIB and IIIC. Infants with birth weights equal to or greater than 1000 grams and/or gestational age was greater than 28 weeks should be in a Level IIIA NICU. Level IIIA should have the capability for minor surgical procedures such as central line insertion or inguinal hernia repair. Infants with less than 1000 grams and/or gestational age was less than 28 weeks should be in a Level IIIB NICU. This level of nursery should be able to care for infants requiring high frequency ventilation and nitric oxide. Infants requiring surgical interventions with cardiopulmonary bypass due to serious congenital malformations should be in a Level IIIC NICU, the most advanced level of neonatal care.

Other neonatologists who practice in the subspecialty NICU should have qualifications similar to the chief of the service (board-certified pediatrician with subspecialty certification in neonatal-perinatal medicine). A neonatologist should be available for consultation 24 hours per day. A neonatologist should be in-house to manage neonatal emergencies.

On 6/2/10, review of the hospital's website indicated that since 7/8/05, the hospital's NICU was advertised as a community Level III (community) functional level.

On 6/2/10 review of the California Children's Services website revealed the levels of neonatal intensive care were interpreted by CCS as Level II - intermediate, Level III A &B - community, and Level III C - regional. California Children's Services pays the hospital to provide care for neonates and designates which level of care can be provided in a CCS participating hospital.

On 6/2/10, review of a memo of the same date by an Assistant Hospital Administrator revealed the following: On 9/14/09, the NICU Medical Director, a neonatologist, retired. On 9/15/09, a pediatrician who was board-eligible, not a board-certified neonatologist, became the Interim Medical Director for more than two months. On 11/21/09, a board-certified neonatologist assumed the role of the Medical Director.

Review of a notification letter from CCS addressed to the former NICU Medical Director, dated 11/20/08, revealed that the provisional approval for the hospital's NICU on a community level (Level III A&B) was changed to conditional approval as an intermediate (Level II) NICU for a period of four months due to staff qualification concerns, specifically the lack of neonatologists.

Review of the hospital's table of correspondence with CCS from 2005 to 6/2/10 showed the hospital failed to comply with CCS' requirements to only provide an intermediate (Level II) NICU. Record review for 5 of 30 infants cared for in the hospital's NICU, revealed that the NICU continued to care for infants requiring Level IIB to Level III A&B care (Patients 1, 2, 5, 4, 7).

On 6/2/10 review of the neonatologist's NICU schedule (3/10-5/10) and personnel record review revealed the hospital's NICU had one board-certified neonatologist alternating a weekly schedule with a pediatrician who was board-eligible, but not board certified, to be the neonatologist consultant. On 5/3/10, 5/30/10 and 5/31/10, there was no neonatologist coverage on the schedule for consultation. By the month of 6/10, the board-eligible pediatrician was on a leave of absence, leaving one board-certified neonatologist available for NICU consultation, but with no neonatologist in-house on a 7-day/24-hour basis to manage neonatal emergencies.

In an interview with the NICU Medical Director, on 6/3/10 at 1330 hours, he stated that coverage provided by pediatrician hospitalists had been helpful but his schedule remained tight being the sole board-certified neonatologist available for care and consultation.

2. During an observation tour of the NICU on 5/12/10 at 1120 hours, with the Medical Director of the NICU, the Director of Maternal Child, the Nurse Manager of NICU and RN 7, the call board at the nurses' station was observed. The call board listed all the physicians and NNPs working in the NICU. There was no information on the board to indicate who was the physician or NNP on-call or their contact numbers. When asked how staff would know whom to call in an emergency, RN 7 stated the name of the physician/NNP on-call was passed on at change of shift. When asked who was physician/NNP on-call at this time, the Director of Maternal Child and the Nurse Manager were unable to state. The Medical Director stated the call list was also on the hospital intranet. When asked, the Director of Maternal Child, the Nurse Manager of NICU and RN 7 stated they were not aware the call schedules were available on the intranet.

Based on interview, medical record review and review of facility documents, the hospital failed to ensure the QAPI program for the NICU addressed two adverse patient events by comprehensively analyzing their causes and implementing preventive actions which included feedback and inservicing for the nursing staff in a timely manner. This resulted in the potential for repeat incidents during weighin of infants. Additionally, this resulted in continued non compliance by nursing staff with the P&P regarding the collection, storage and handling of breast milk with the potential for error in administration to infants in the NICU for seven of 30 sampled patients (Patients 4, 6, 13, 16, 23, 25, and 28) .

Findings:

1. On 5/12/10, the California Department of Public Health initiated a complaint investigation which included the allegation a NICU baby was dropped from the scale onto the floor during weighing on 3/14/10.

During an interview with the CQO on 5/12/10 at 1150 hours, she provided an investigation report of the incident and confirmed Patient 2 was caught from an accidental slip off a scale on 3/14/10. A photograph of the scale involved showed two raised sides covering the length of the scale front and back. The ends of the scale were flat and open. The scale sat on top of a metal cart.

The medical record for Patient 2 was reviewed on 5/12/10 at 1515 hours. The patient was born prematurely at a gestional age of 26 and 4/7 weeks (full term pregnancy is 40 weeks) weighing 995 gms (approximately 2 pounds).

Review of the nurses' progress notes dated 3/14/10 at 2000 hours, showed documentation Patient 2 was bathed, weighed and redressed. "The bed linens were changed with the infant on scale #3, one hand on the infant and one hand tucking the sheet underneath the mattress, when the infant gave one big push and began falling to the floor. Was able to break part of the fall by grasping legs and buttocks. Upper back area actually touched floor."

During a follow up interview with the CQO on 5/12/10 at 1515 hours, she stated signs had now been placed on the two sided scale instructing staff not to use it for larger infants. The CQO stated a four sided scale was available and was to be used for those babies over 3000 gms (6.5 pounds) and/or more than eight weeks old. When asked to provide a P&P developed to address the proper use of scales for use with babies, the CQO stated there was no policy at that time.

The PI (Performance Improvement) notebook for the NICU was reviewed with the Director of Maternal Child Nursing on 6/3/10 at 0930 hours. In the area for reporting patient falls during the months of January, February and March, 2010, there were no reported falls. When asked regarding the fall of Patient 2 from a weighing scale on 3/4/10, the Director stated she was not sure if that incident was a "fall," that it was an event. When asked to define what else would constitute a fall when the patients in the NICU could neither ambulate nor sit up on their own, the Director then stated, "Yes, it was a fall." When asked, the Director stated the PI information from the NICU was compiled by the NICU Nurse Manager. The Director stated the Nurse Manager was aware there had been a fall in the NICU in March.

During an interview with the CQO on 6/3/10 at 1055 hours, the Department of Nursing PI information for the first quarter of 2010, was presented. Review of the discussion and action recommendations during the meeting dated 5/4/10, showed the committee reminded the NICU representative a fall in the NICU had been reported in March, 2010. Action taken showed the NICU PI report would be revised. The information of a fall in the NICU was added to the Department of Nursing PI Report.

A notebook containing documentation of NICU inservices was reviewed with the CQO on 6/3/10 at 1320 hours. Documentation showed nursing staff received formal inservicing on the use of scales for babies on 5/3/10 and 5/10/10. Included in the notebook was a memo dated 5/3/10, instructing staff to use the four sided scale for babies weighing more than 3 gms and/or more than eight weeks old. When asked why inservicing of staff was delayed for almost two months following the adverse event, she stated all staff were verbally reminded to use the four sided scale immediately following the event. The CQO stated, when the hospital received a formal complaint regarding the event in the beginning of May, 2010, they decided to take further action. At that time, she stated signs were placed on the two sided scale to remind staff not to use it for larger and older babies and inservicing of staff was initiated.

2. On 5/12/10, the California Department of Public Health initiated a complaint investigation which included the allegation that wrong breast milk was given to a NICU infant.

During an interview with the CQO on 5/12/10 at 1100 hours, she confirmed on 3/4/10, Patient 1 was fed breast milk not from the patient's mother.

On 5/12/10 the hospital's P&P, Collection, Storage and Handling of a Mother's Milk for Her Own Infant dated 2/12/09, was reviewed. The purpose of the policy was to provide guidelines for the collection, storage, and handling of breast milk to optimize nutritional and immunological protection while minimizing the chance of contamination or error. Documentation showed upon transfer of breast milk to feeding containers and before administration, two licensed personnel must verify proper identification, double checking the infant's name, date of birth and medical record number between the original container label and the infant band. This would be documented on the 24 hour nursing flow sheet. In addition, breast milk bottles would be accepted on admission/transfer from other hospitals provided they were properly labeled.

Patient 1's medical record was reviewed on 5/12/10 with the CQO. Review of the NICU 24 hour Nursing Flow Sheet dated 3/14/10, showed expressed breast milk was used for feedings. The CQO confirmed there was no documentation to show two licensed nurses double checked the label on the breast milk container against the ID band of Patient 1 before administration to the baby at 1800 hours.

A notebook containing documentation of NICU inservices was reviewed with the CQO on 6/3/10 at 1340 hours. Documentation showed nursing staff received formal inservicing on the collection, storage, and handling of expressed breast milk on 5/6, 5/10, 5/19 and 5/24/10. When asked why inservicing of staff was delayed for two months following the adverse event, she stated the information was given to the staff informally at first. The nurse involved was verbally counseled immediately. The CQO stated when the hospital received a formal complaint regarding the event in the beginning of May, 2010, they decided to take further action. Formal inservicing was presented to the staff at that time.

The PI (Performance Improvement) notebook for the NICU was reviewed with the Director of Maternal Child Nursing on 6/3/10 at 0930 hours. Review of the March 2010, PI findings showed an error in administration of breast milk. Actions taken were verbal counseling of the staff involved and reminder to all staff to follow the P&P for breast milk administration. There was no documentation to show plans to monitor staff for compliance.

Medical record reviews were initiated on 6/3/10, for NICU Patients 4, 6, 13, 16, 23, 25 and 28. The 24 hour Nursing Flow Sheets for the infants during the months of March, April, and May, 2010, were reviewed. Documentation did not show licensed nurses consistently followed the P&P by double checking the label on the breast milk container with the identification of the infant. See A405.

Based on observation, staff interview and record review, the medical staff failed to demonstrate responsibility to the governing body (GB) for the quality of medical care as shown in the operation of the Neonatal Intensive Care Unit (NICU).

Findings:

1. The medical staff failed in their responsibility to communicate and update the governing body regarding the capability of the NICU advertised as having a community level of care instead of the intermediate level of care designated by CCS. See A049, A288.

2. The medical staff failed to ensure that appointments of appropriate practitioners to the medical staff had been performed in a manner consistent with the hospital bylaws and standards of care. See tags A347, A353.

3. The medical staff failed to ensure patients safety in the NICU due to inconsistent and inadequate coverage by only one neonatologist. See tags A049, A347.

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.

Based on record review and staff interview, the medical staff failed to be accountable in updating the governing body regarding the NICU's current operational status and the quality of medical care being provided to its patients. In addition, the fall incident of Patient 2 failed to show an organized medical staff when a neonatal nurse practitioner was allowed to cover three hospital services with no immediate neonatologist back-up. The failure in organization and accountability could result in potential harm when the level of care being provided to critically ill neonates in the absence of an in-house neonatologist were greater than the NICU personnel were qualified to handle.

Findings:

1. Per review of Guidelines for Perinatal Care; 6th edition; co-authored by the American Academy of Pediatrics and the American College of Obstetrics and Gynecologists, a national authority setting the standard for perinatal care, designated levels of neonatal care as Levels I - basic, Level II - specialty and Level III - subspecialty. These levels of neonatal care were interpreted by California Children's Services (CCS) as intermediate, community and regional respectively.

* The Level I or basic neonatal care dealt with evaluation of healthy infants, neonatal resuscitation and/or stabilize ill newborn infants until the necessary transfer to a higher level of care.

* The Level II or specialty care nurseries could provide care to moderately ill infants with or without need for assisted ventilation for brief duration. At a hospital with a level II nursery, a board-certified pediatrician with subspecialty certification in neonatal-perinatal medicine should be chief of the neonatal care service.

* The Level III or subspecialty NICU should care for severe high risk infants with complex and critical illnesses. Other neonatologists who practice in the subspecialty NICU should have qualifications similar to the chief of the service (a board-certified pediatrician with subspecialty certification in neonatal-perinatal medicine). A neonatologist should be available for consultation 24 hours per day. A neonatologist should be in-house to manage neonatal emergencies.

On 6/2/10, review of the hospital's website indicated that since 7/8/05, the hospital's NICU had been advertised as providing a community level of care.

A memo written by an Assistant Hospital Administrator on 6/2/10 revealed on 9/14/09, the NICU Medical Director, a neonatologist, retired. On 9/15/09, a pediatrician who was board-eligible, not a board-certified neonatologist, became the Interim Medical Director for more than two months. On 11/21/09, a board-certified neonatologist assumed the role of the Medical Director.

On 6/2/10, review of a notification letter from CCS addressed to the former NICU Medical Director with a copy sent to the former CEO, dated 11/20/08, revealed that the provisional approval for the hospital's NICU on a community level was changed to conditional approval as an intermediate NICU for a period of four months.

On 6/2/10 review of the hospital's table of correspondence with CCS from 2005 to the present date showed that the hospital failed to comply with the CCS requirements downgrading the hospital's NICU to intermediate level. However, record review of 5 of 30 infants cared for in the NICU revealed that the NICU continued to care for infants requiring level IIB to level III care (Patients 1, 2, 4, 5, and 7).

2. Further review of the neonatologist's NICU schedule (3/10-5/10) and personnel record review, revealed the hospital's NICU had one board-certified neonatologist alternating a weekly schedule with a pediatrician who was board-eligible to be a neonatologist. On 5/3/10, 5/30/10 and 5/31/10, there were no neonatologist coverage on the schedule for consultation. By the month of 6/10, the board-eligible neonatologist was on vacation leaving one board-certified neonatologist available for NICU consultation but with no neonatologist in-house on a 7-day/24-hour basis to manage neonatal emergencies.

In an interview with the NICU Medical Director on 6/3/10 at 1330 hours, he stated that schedule coverage provided by pediatrician hospitalists had been helpful but his schedule remained tight being the sole board-certified neonatologist.

3. a. Per record review of Patient 2 on 6/2/10, the patient was a 995 gram product of a 26 and 4/7 week pregnancy who was on high frequency ventilation on and off from 8/10/09 until 12/8/09. On 11/30/09, the patient had a cardiac arrest when extubated and was placed on assisted ventilation until 12/30/09. On 3/14/10, past 2000 hours, Patient 2 had a fall incident while on a weighing scale. Per nurses notes, NNP2 was notified. NNP2 examined Patient 2 and ordered and reviewed skeletal x-rays to rule out fracture.

Per NNP1's notes on 3/15/10, Patient 2 sustained slight bruising to right eye, right forehead and right arm. Per NNP2's notes documented on 3/17/10, as a late entry, the Medical Director and board-eligible neonatologist were both notified after the fall incident of 3/14/10. Patient 2 had been "fussy and crying unable to determine if crying was from pain, wanting to be fed, held or changed." However, neither one of the neonatologists came to personally examine Patient 2.

On 3/14/10, a CT scan of the head was recommended by the Medical Director, upon discussion of the fall incident with NNP2, which was ordered on a "now" basis. The CT scan of the brain was not done until the following morning at 0932 hours. It showed no evidence of acute intracranial bleed but widening of the lateral and third ventricle of the brain remained as noted in previous studies.

On 6/3/10 at 0930 hours, the Interim CMO was asked why the neonatologist did not come in to examine Patient 2 on the night of the incident. Her response was, "I thought he did."

3. b. Additional documentation by NNP2 on 3/17/10 for the night of 3/14/10 showed she was the "sole clinician that night for Newborn Nursery, NICU and Labor and Delivery Unit for high risk deliveries and potential admissions. I felt it was appropriate to prioritize patient care according to their needs."

When the Interim Chief Medical Officer was interviewed on 6/3/10 at 0930 hours, she stated that she was not aware of the present operational status of the NICU while holding the temporary position for a couple of months.

The surveyor attempted twice to interview the NNP2 on 6/4/10 at 1000 hours by phone. No return call was received before the exit conference that afternoon.

4. During an observation tour of the NICU on 5/12/10 at 1120 hours, with the Medical Director of the NICU, the Director of Maternal Child, the Nurse Manager of NICU and RN 7, the call board at the nurses station was observed. The call board listed all the physicians and NPs working in the NICU. There was no information on the board to indicate who was the physician or NP on-call or their contact numbers. When asked how staff would know who to call in an emergency, RN 7 stated the name of the physician on-call was passed on at change of shift. When asked who was physician on-call at this time, the Director of Maternal Child and the Nurse Manager were unable to state. The Medical Director stated the call list was also on the hospital intranet. When asked, the Director of Maternal Child, the Nurse Manager of NICU and RN 7 stated they were not aware the call schedules were available on the intranet.

Based on staff interview and record review, the medical staff failed to enforce it's physician supervisory rules for two of two NNPs. This resulted in the potential for unqualified staff to be re-appointed to their advanced practice positions.

Findings:

On 6/3/10 review of Page 10 of the hospital's Nurse Practitioner Manual, 2009 revealed ongoing peer review would be conducted by the Clinical Supervising Physician by reviewing ten charts twice a year and contributing to the individual's annual performance evaluation.

On 6/3/10, review of the two NNP personnel files failed to show evidence that the supervising physicians reviewed 20 patient records cared for by the two NNPs as part of their annual evaluations.

On 6/3/10 at 1330 hours, when asked, the NICU Medical Director stated that he reviewed NNP's progress notes on a daily basis but was unaware of his responsibility to document those record reviews as part of the peer review process for re-appointment and performance evaluation of the NNP.

Based on observation, interview, medical record review and review of hospital P&P, the hospital failed to ensure the organized delivery of nursing services by failing to:

Findings:

1. Ensure nursing staff in the NICU evaluated the care needs of their patients in accordance with accepted standards of nursing practice and per hospital policy. See A395 and A405.

2. Ensure the nursing service implemented timely preventative actions to prevent future occurrences for two adverse events. See A288.

3. Ensure packets of breastmilk fortifier were stored in a NICU location where it would not be exposed to cross-contamination. The packets were found on the countertop by the sink where staff and visitors wash their hands, exposing these packets to contamination by the splashing water coming from the sink. See A749 #3.

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.

Based on interview, medical record review and review of facility documents, the hospital failed to ensure consistent adherance to the P&P for expressed breast milk administration for eight of 30 sampled patients (Patients 1, 4, 6, 13, 16, 23, 25, and 28). This resulted in Patient 1 receiving expressed breast milk from a mother not his own. This had the potential for Patient 1 and the other seven patients to be exposed to infectious diseases such as Hepatitis B and HIV. One of 30 sampled patients was able to push himself off a weighing scale while the nurse caring for him was attempting to complete another task, sustaining bruising to the head (Patient #2) The failure to take timely action to prevent recurrence placed all NICU patients at risk for falls.

Findings:

1. On 5/12/10, the California Department of Public Health initiated an onsite complaint investigation which included the allegation a NICU patient was dropped from the scale onto the floor during weighing on 3/14/10.

During an interview with the CQO on 5/12/10 at 1150 hours, she provided an investigation report of the incident and confirmed Patient 2 was caught from an accidental slip off a scale on 3/14/10. A photograph of the scale involved showed raised sides covering the length of the scale front and back. The ends of the scale were flat and open. The scale sat a top a metal cart.

The medical record for Patient 2 was reviewed on 5/12/10 at 1515 hours.
Review of the NICU Daily Progress Note by the NNP dated 3/15/10, showed Patient 2's age was 217 days and weighed 6973 gm (approximately 15 pounds).

Review of the nurses' progress notes dated 3/14/10 at 2000 hours, showed documentation Patient 2 was bathed, weighed and redressed. "The bed linens were changed with the infant on scale #3, one hand on the infant and one hand tucking the sheet underneath the mattress, when the infant gave one big push and began falling to the floor. Was unable to break part of the fall by grasping legs and buttocks. Upper back area actually touched floor."

Review of the NNP progress note, dated as a late entry on 3/17/10, showed an examination following the fall on 3/14/10. The documentation revealed Patient 2 had slight bruising to the right eye and the right lateral forehead, and a small 0.5 cm in length bruise to the right arm. A full body x-ray and a CT scan of the head were ordered. The patient's discharge, planned for the following day, would be delayed for one to two days.

During a follow up interview with the CQO on 5/12/10 at 1515 hours, she stated signs had now been placed on the two sided scale "not to be used for larger infants". The CQO stated a four sided scale was available and was to be used for those babies over 3000 gms and/or more than eight weeks old. Prior to this, nothing had been done formally to ensure the scale was not used on larger infants.

2. On 5/12/10, the hospital's P&P, Collection, Storage and Handling of a Mother's Milk for Her Own Infant dated 2/12/09, was reviewed. The purpose of the policy was to provide guidelines for the collection, storage, and handling of breast milk to optimize nutritional and immunological protection while minimizing the chance of contamination or error. Documentation showed upon transfer of breast milk to feeding containers and before administration, two licensed personnel must verify proper identification, double checking the infant's name, date of birth and medical record number between the original container label and the infant band. This would be documented on the 24 hour nursing flow sheet. In addition, breast milk bottles would be accepted on admission/transfer from other hospitals provided they were properly labeled.

a. On 5/12/10, the California Department of Public Health initiated a complaint investigation which included the allegation that wrong breast milk was given to a NICU infant.

During an interview with the CQO on 5/12/10 at 1100 hours, she confirmed Patient 1 was fed breast milk on 3/4/10 that was not from the patient's mother.

Review of the Investigation Report revealed Patient 1 had been transferred from an outside hospital on 2/17/10, along with several containers of breast milk. At the time of admission to the NICU, new hospital labels were applied to the containers of milk by the nurse. On 3/4/10 at approximately 1900 hours, it was noted the breast milk used at that feeding was from a different mother.

Patient 1's medical record was reviewed on 5/12/10 with the CQO. Review of the NICU 24 hour Nursing Flow Sheet dated 3/14/10, showed expressed breast milk was used for feedings. The CQO confirmed there was no documentation to show two licensed nurses double checked the label on the breast milk container against the ID band of Patient 1 before administration to the baby at 1800 hours.

b. The medical record for Patient 25 was reviewed on 6/3/10 at 1235 hours. Review of the NICU 24 hour Nursing Flow Sheets showed on 3/16/10 the patient was administered expressed breast milk via a bottle at 0700, 1300 and 1500 hours. There was no documented evidence two licensed nurses double checked the label on the breast milk container against the ID band of Patient 25 before administration to the baby.

c. The medical record for Patient 13 was reviewed on 6/3/10 at 1235 hours. Review of the NICU 24 hour Nursing Flow Sheets showed the following: 4/18/10 at 0800, 1100, 2000, 2300, 0200, and 0500 hours; 4/20/10 at 2100, 0000, 0300 and 0600 hours; 4/22/10 at 0800, 1100, 1400, 1700, and 0600 hours; and 4/25/10 at 2345, 0230, and 0530 hours did not show documentation two licensed nurses double checked the label on the breast milk container against the ID band of Patient 13 before administration to the baby.

d. The medical record for Patient 4 was reviewed on 6/3/10 at 0845 hours. Review of the NICU 24 hour Nursing Flow Sheets dated 5/8/10 and 5/9/10, showed the patient was administered expressed breast milk via stomach tube at 2000, 2300, and 0200 hours on both days. There was no documentation to show two licensed nurses double checked the label on the breast milk container against the ID band of Patient 4 before administration to the baby.


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e. Review of the medical record for Patient 23 began on 6/3/10, and showed on the NICU 24 hour Nursing Flow sheets documentation of feeding episodes. Feeding episodes reviewed included expressed breast milk requiring two signature verification by nursing staff. Feeding episodes dated 3/11/10, showed no co-signature verification for two feedings. Feeding episodes dated 3/15/10, showed no co-signature verification for one feeding. Feeding episodes dated 3/20/10, showed no co-signature verification for one feeding. Feeding episodes dated 4/4/10, showed no co-signature verification for seven feedings. Feeding episodes dated 4/16/10, showed no co-signature for four feedings. Feeding episodes dated 4/19/10, showed no co-signature by nursing staff for eight feedings.

f. Review of the medical record for Patient 6 began on 6/3/10, and showed on the NICU 24 hour Nursing Flow Sheets documentation of feeding episodes. Feeding episodes reviewed included expressed breast milk requiring two signatures by nursing staff. Feeding episodes dated 3/4/10, showed no cosignature verification for two feedings. Feeding episodes dated 3/9/10, showed no co-signature verification for two feedings. Feeding episodes dated 3/12/10, showed no co-signature verification for three feedings. Feeding episodes dated 5/10/10, showed no co-signature verification for one feeding.

g. Review of the medical record for Patient 28 began on 6/3/10, and showed on the NICU 24 hour Nursing Flow Sheets documentation of feeding episodes. Feeding episodes reviewed included expressed breast milk requiring two signatures by nursing staff. Feeding episodes dated 4/27/10, showed no co-signature verification for three feedings.

h. Review of the medical record for Patient 16 began on 6/3/10, and showed on the NICU 24 hour Nursing Flow Sheets documentation of feeding episodes. Feeding episodes reviewed included expressed breast milk requiring two signatures by nursing staff. Feeding episodes dated 5/2/10, showed no co-signature verification for three feedings.

Based on interview, medical record review and review of facility documents, the hospital failed to ensure nursing staff in the NICU followed the P&P for the handling and identification of expressed mother's breast milk prior to it's administration for eight of 30 sampled patients (Patients 1, 4, 6, 13, 16, 23, 25, 28). This resulted in Patient 1 receiving expressed breast milk from a mother not his own. This had the potential for Patient 1 and the seven other patients to be exposed to infectious diseases such as Hepatitis B and HIV.

Findings:

The hospital's P&P, Collection, Storage and Handling of a Mother's Milk for Her Own Infant dated 2/12/09, was reviewed. The purpose of the policy was to provide guidelines for the collection, storage, and handling of breast milk to optimize nutritional and immunological protection while minimizing the chance of contamination or error. Documentation showed upon transfer of breast milk to feeding containers and before administration, two licensed personnel must verify proper identification, double checking the infant's name, date of birth and medical record number between the original container label and the infant band. This would be documented on the 24 hour nursing flow sheet. In addition, breast milk bottles would be accepted on admission/transfer from other hospitals provided they are properly labeled.

On 5/12/10, the California Department of Public Health initiated a complaint investigation which included the allegation breast milk was given to the wrong infant in the NICU.

1. During an interview with the CQO on 5/12/10 at 1100 hours, she confirmed Patient 1 was fed breast milk on 3/4/10 that was not from the patient's mother.

Review of the Investigation Report revealed Patient 1 had been transferred from an outside hospital on 2/17/10, along with several containers of breast milk. New hospital labels were applied to the containers by the nurse at the time of admission to the NICU. On 3/4/10 at approximately 1900 hours, it was noted the breast milk used at this feeding was from a different mother.

Patient 1's medical record was reviewed on 5/12/10 with the CQO. Review of the NICU 24 hour Nursing Flow Sheet dated 3/14/10, showed expressed breast milk was used for feedings. The CQO confirmed there was no documentation to show two licensed nurses double checked the label on the breast milk container against the ID band of Patient 1 before administration to the baby at 1800 hours.

2. The medical record for Patient 25 was reviewed on 6/3/10 at 1235 hours. Review of the NICU 24 hour Nursing Flow Sheets showed, on 3/16/10, the patient was administered expressed breast milk via a bottle at 0700, 1300 and 1500 hours. There was no documented evidence two licensed nurses double checked the label on the breast milk container against the ID band of Patient 25 before administration to the baby.

3. The medical record for Patient 13 was reviewed on 6/3/10 at 1235 hours. Review of the NICU 24 hour Nursing Flow Sheets showed the following: 4/18/10 at 0800, 1100, 2000, 2300, 0200, and 0500 hours; 4/20/10 at 2100, 0000, 0300 and 0600 hours; 4/22/10 at 0800, 1100, 1400, 1700, and 0600 hours; and 4/25/10 at 2345, 0230, and 0530 hours did not show documentation two licensed nurses double checked the label on the breast milk container against the ID band of Patient 13 before administration to the baby.

4. The medical record for Patient 4 was reviewed on 6/3/10 at 0845 hours. Review of the NICU 24 hour Nursing Flow Sheets dated 5/8/10 and 5/9/10, showed the patient was administered expressed breast milk via stomach tube at 2000, 2300, and 0200 hours on both days. There was no documentation to show two licensed nurses double checked the label on the breast milk container against the ID band of Patient 4 before administration to the baby.


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5. Review of the medical record for Patient 23 began on 6/3/10, and showed on the NICU 24 hour Nursing Flow sheets documentation of feeding episodes. Feeding episodes reviewed included expressed breast milk requiring two signature verification by nursing staff. Feeding episodes dated 3/11/10, showed no co-signature verification for two feedings. Feeding episodes dated 3/15/10, showed no co-signature verification for one feeding. Feeding episodes dated 3/20/10, showed no co-signature verification for one feeding. Feeding episodes dated 4/4/10, showed no co-signature verification for seven feedings. Feeding episodes dated 4/16/10, showed no co-signature for four feedings. Feeding episodes dated 4/19/10, showed no co-signature by nursing staff for eight feedings.

6. Review of the medical record for Patient 6 began on 6/3/10, and showed on the NICU 24 hour Nursing Flow Sheets documentation of feeding episodes. Feeding episodes reviewed included expressed breast milk requiring two signatures by nursing staff. Feeding episodes dated 3/4/10, showed no co-signature verification for two feedings. Feeding episodes dated 3/9/10, showed no co-signature verification for two feedings. Feeding episodes dated 3/12/10, showed no co-signature verification for three feedings. Feeding episodes dated 5/10/10, showed no co-signature verification for one feeding.

7. Review of the medical record for Patient 28 began on 6/3/10, and showed on the NICU 24 hour Nursing Flow Sheets documentation of feeding episodes. Feeding episodes reviewed included expressed breast milk requiring two signatures by nursing staff. Feeding episodes dated 4/27/10, showed no co-signature verification for three feedings.

8. Review of the medical record for Patient 16 began on 6/3/10, and showed on the NICU 24 hour Nursing Flow Sheets documentation of feeding episodes. Feeding episodes reviewed included expressed breast milk requiring two signatures by nursing staff. Feeding episodes dated 5/2/10, showed no co-signature verification for three feedings.

Based on interview, medical record review and review of hospital P&P, the hospital failed to ensure the medical record for one of 30 sampled patients (Patient 1) contained information regarding the occurrence of the misadministration of breast milk to the patient from another mother not his own. There was no documentation to show if care was provided to the patient after the incident, follow up regarding the investigation of the infectious status of the source mother or a plan for follow up of the patient after discharge.

Findings:

The hospital's P&P Breast Milk Misadministration Policy dated 9/26/06, showed the purpose of the policy was to provide guidelines for action when an infant was fed human milk from a mother other than his/her own. Key points included: the physician would review the source mother's chart for maternal history; consent forms would be obtained for testing both the source mother and the recipient mother for the Hepatitis B Surface Antigen, HIV, and HTLV (Human T-lymphotropic virus - a virus that has been implicated in several kinds of diseases), the physician would obtain informed consents for the HIV test from the source mother and the recipients's mother if results were not available in the medical record; the physician would notify the primary physician of the recipient infant to provide follow up care as needed; and the incident would be discussed with both families in a timely and confidential manner. In addition, the following would be noted on the recipient infant's medical record: the date of the occurrence, laboratory studies sent, and that follow up laboratory tests on the infant might be needed; and action taken according to the recipient's physician's orders.

On 5/12/10, the California Department of Public Health initiated a complaint investigation which included the allegation that wrong breast milk was given to a NICU infant.

During an interview with the CQO on 5/12/10 at 1100 hours, she confirmed Patient 1 was fed breast milk on 3/4/10 that was not from the patient's mother.

Review of the Investigation Report revealed Patient 1 had been transferred from an outside hospital on 2/17/10, along with several containers of breast milk. New hospital labels were applied to the containers by the nurse at the time of admission to the NICU. On 3/4/10 at approximately 1900 hours, it was noted the breast milk used at that feeding was from a different mother.

On 5/12/10 at 1645 hours, the Chief Quality Officer was asked why the nurses' notes failed to show the misadministration of breast milk to Patient 1. The physician's progress notes and discharge history and physical for the patient dated 4/19/10 was reviewed. She then acknowledged she was unable to locate documentation to show the misadministration of breast milk and whether the event was ever discussed with the parents of Patient 1. She added the information should include the infectious status of the source mother or whether an updated infection status of the patient's mother was obtained, as per the hospital's P&P. The Chief Quality Officer said the source mother's history and infectious disease status had been reviewed by Patient 1's physician and Patient 1's parent informed; however, none of this information was recorded in the patient's medical record.

Based on record review and staff interview, the hospital failed to follow their P&P on prioritizing a CT scan of the brain ordered to be done on a "now" basis for one of 30 sampled patients (Patient 2). The failure to do so could result in a delay of life-saving medical or surgical diagnoses and interventions.

Findings:

On 6/4/10, review of the hospital's P&P on Ordering Radiological Sciences, letter g stated, "Stat" requests should be limited to true emergencies which would require an immediate radiologic study in order to proceed with patient care. Letter h stated, an "emergency request" should be the priority over routine examinations and would be expedited within three hours.

Per record review of Patient 2 on 6/2/10, Patient 2 had a fall incident while being weighed on an infant scale on 3/14/10 at approximately 2000 hours per the nurse's notes. NNP2, who was in-house, was informed and examined Patient 2. Upon discussion of the incident with the Medical Director, it was recommended that a CT scan of the brain was ordered "now." However, the CT scan of the brain for Patient 2 was done the following morning at 0932 hours. No other documentation was presented by the hospital as to why the CT scan was delayed.

On 6/8/10 at 1400 hours, the P&P on stat CT scan was received and discussed with CQO. It was acknowledged that the CT scan was delayed for more 12 hours.

Based on observation, interview, medical record review and review of hospital documents, the hospital failed to ensure P&Ps regarding the prevention and control of infections and communicable diseases were implemented in the NICU. The P&P for the handling and identification of expressed breast milk prior to it's administration was not implemented for eight of 30 sampled patients (Patients 1, 4, 6, 13, 16, 23, 25, 28). The P&P for the misadministration of breast milk was not implemented when no documentation was located in the Patient 1's medical record to show the patient's parents were aware of the incident, the source mother of the breast milk was tested and was free of communicable diseases, and a plan was in place for follow up of the patient. These failures had the potential for Patient 1 and the seven other patients to be exposed to infectious diseases such as Hepatitis B and HIV.

The hospital also failed to develop and maintain a system to identify employees who were found not to have current annual health screening requirements as evidenced by expired Tuberculin skin test status. The failure increased the potential for these fragile patients, other health care staff, and visitors to be at risk for communicable disease.

In addition, packets of breastmilk fortifier were exposed to contamination by splashing water when stored on a countertop in close proximity to the NICU sink.

Findings:

1. On 6/4/10, review of hospital policy titled: Medical Evaluation - County Workforce members, showed the policy to provide its workforce with a safe and healthy environment. Medical clearances and annual medical screenings would be provided and no person would be allowed to work inside the hospital without appropriate documentation of medical clearance or required medical evaluation.

Review of the hospital's list of employees and their annual date of compliance with annual physicals and medical examinations included tuberculin skin testing. If the employee was not current in the annual medical review requirements, 'NOT CLEARED' was documented to the right of the employee number.

Review of RCP 1's (Respiratory Care Practitioner) personnel file showed RCP 1's employment number was listed as 'NOT CLEARED.'

A tour of the NICU was conducted on 6/2/10 and 6/3/10. The staff stated the census was six. All babies were identified as having low birth weights and prematurity. RCP 1 was identified as the the respiratory care practitioner assigned to the NICU. He was observed interacting and caring for an infant. RCP 1 was not wearing a mask.

An interview with the Associate Administrator was conducted on 6/4/10 at 1300 hours. The Associate Administrator reported RCP 1's annual PPD and fit testing requirements had expired on 4/30/10.
An interview with the RCP supervisor was conducted on 6/4/10 at 1305 hours. The supervisor stated he reviewed the health notification memo and RCP 1 was not on it. He stated he reviewed the annual medical clearance listings as of 5/17/10 and RCP 1 was not listed as not being cleared. He admitted he was not aware RCP 1 was not cleared to work. When asked where RCP 1 worked in the hospital, he replied RCP 1 worked exclusively in NICU. The supervisor stated a letter would be issued not allowing RCP 1 to work until clearance was obtained.

Review of the hospital's respiratory care services monthly employee schedules for the months of May 2010 and June 2010 was conducted. RCP 1 was documented as having worked fourteen, twelve hour shifts, for the month of May 2010, and one twelve hour shift for the month of June 2010.

A document titled, Low Birthweight in Newborns) 2005, Children's Hospital Boston, showed babies with low birth weight were at increased risk for complications. The article showed the baby's tiny body was not strong and might have a harder time eating, gaining weight, and fighting infection. In addition, the document showed this population being prone to breathing problems such as respiratory distress syndrome (a respiratory disease of prematurity caused by immature lungs).


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2. The hospital's P&P, Collection, Storage and Handling of a Mother's Milk for Her Own Infant dated 2/12/09, showed the purpose of the policy was to provide guidelines for the collection, storage, and handling of breast milk to optimize nutritional and immunological protection while minimizing the chance of contamination or error. Upon transfer of breast milk to feeding containers and before administration, two licensed personnel must verify proper identification, double checking the infant's name, date of birth and medical record number between the original container label and the infant band.

The hospital's P&P Breast Milk Misadministration Policy dated 9/26/06, showed the purpose of the policy was to provide guidelines for action when an infant was fed human milk from a mother other than his/her own. Key points included: the physician will review the source mother's chart for maternal history; consent forms will be obtained for testing both the source mother and the recipient mother for blood borne; the physician will notify the primary physician of the recipient infant to provide follow up care as needed; and the incident will be discussed with both families in a timely and confidential manner. In addition, the following will be noted on the recipient infant's medical record: the date of the occurrence, laboratory studies sent, and that follow up laboratory tests on the infant may be needed; and action taken according to the recipient's physician's orders.

These policies and procedures to prevent and control infectious diseases were not implemented for eight of 30 sampled patients (Patients 1, 4, 6, 13, 16, 23, 25, 28). See A404.


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3. During a tour of the NICU on 6/3/10 at 1330 hours conducted with the NICU Medical Director, packets of breast milk fortifier were noted stored on the countertop by the sink where staff, including visitors, wash their hands. The location of the breast milk fortifier exposed these packets to contamination by the splashing water coming from the sink.