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Based on observations, record reviews and interviews, the governing body failed to carry out its full and complete oversight of the hospital and failed to ensure the provision of quality health care in a safe environment by:

1. failing to ensure it developed, implemented and maintained an effective QAPI program, resulting in the potential for patient harm, refer to (A263, A267),

2. failing to ensure adequate staffing in the NICU and the Pediatric Unit was maintained, resulting in the potential for unsafe patient care and possible death, refer to (A385, A392, A395, A397),

3. failing to ensure the provision of safe and sanitary dietary services was implemented, resulting in the potential for patient harm, refer to (A84, A618, A620, A631, A701, A714).

The cumulative effect of these systemic practices resulted in the failure of the hospital to ensure patient care was provided in a safe environment.

Findings:

On May 26, 2011, at 11:10 a.m., an interview was conducted with the GBC. He stated he was not aware there were staffing problems in the NICU. He also stated, "I was not aware of the multiple staffing
complaints over the past two years. If the GB would have known about the staffing problem, we would have taken care of it." The GBC stated the GB is informed of issues in the facility by the Dashboard (a system used to evaluate the facility's QAPI). He stated, "If the GB knew there were so many staffing issues in the NICU, we would have fixed it or closed it [meaning the NICU]."

The GBC indicated he was not aware of the deficient practices identified in the dietary department during the survey. He further stated he had not reviewed quality performance reports from the contracted food and nutrition services. The GBC was unable to state how the facility ensured the contracted service was provided in a safe and effective manner and was in compliance with federal, state and local laws.

Based on record review and interview, the hospital governing body failed to ensure that services provided by the contracted food service department were provided in a safe and effective manner. The contracted food service failed to provide patients with safe, high quality food service and adequate food in the event of a disaster which had the potential to cause food borne illness and not being able to provide adequate nutrition to patients in the event of a disaster.

Findings:

During a survey conducted May 23, 2011, through May 26, 2011, deficient practices in the contracted food service department were observed as it related to the following:

The Food Service Director (FSD) failed to ensure the daily management of the dietary services to provide patients, staff and visitors with safe, high quality food service and adequate food in the event of a disaster (Cross refer A-620)

The Food Services did not customize their diet manual to be hospital specific and ensure it was approved by the medical staff prior to implementing it for use in conformance with physician's diet orders (Cross refer A-631)

The Food Service Director (FSD) failed to ensure the hospital disaster food plan and supplies were adequate to meet the needs of the patients in the event of a disaster (Cross refer A-701).

The hospital failed to ensure dietary staff and the Food Service Director (FSD) were knowledgeable of the hospitals policies and procedures for responding to a grease fire in the kitchen (Cross refer A-714)

The hospital failed to maintain supplies to ensure an acceptable level of safety when four CO2 tanks in the dietary department were not secured to prevent them from falling over (Cross refer A-724)

Review of the Food and Nutrition Services outsourcing agreement dated 2/23/09 stated, "The Contractor will assure that the Host Hospital food services department is in full compliance with federal, state and local regulations with which the Host Hospital must comply"

During an interview on May 26, 2011, at 11:10 a.m., the Governing Board Chairman stated he was not aware of the deficient practices identified during the survey. He further stated that he had not reviewed quality performance reports from the contracted food and nutrition services. He was unable to state how the hospital ensured the contracted service was provided in a safe and effective manner and was in compliance with federal, state and local regulations.

Based on observation, record review and interview, the hospital failed to implement and maintain an effective quality assessment and performance improvement program by:


1. failing to implement and monitor changes regarding unsafe staffing levels in the NICU and Pediatric Units, refer to A267, A392, A395, and A397.

2. failing to ensure temperatures and humidity were maintained according to the facility's policy and procedure in the NICU, and failure to ensure a labor room was used as it was intended and approved, refer to refer to A701 and A722.

3. failing to establish clear expectations for safety in dietetic services and contracted services, refer to A267 and A618.

The cumulative effect of these failed practices resulted in the failure of the facility to deliver statutory mandated compliance with the Federal regulations for the Condition of Participation QAPI, to ensure quality patient care in the facility.

Based on observations, interviews and record reviews the hospital failed to
measure, analyze and track quality indicators and aspects of performance that:

1. assess the process that ensured adequate staffing was maintained in all nursing service care areas including the NICU and Pediatric Units (cross refer to A392, A395, A397).

2. assess the process involved with food safety to effectively prevent cross contamination, food borne illness, ensure quality and the safety of patients staff and visitors. This resulted in the potential for the deficient practices from a contracted food services department identified during the survey to continue in a hospital with a licensed bed capacity of 156 beds (cross refer A84, A618, A620, A701, A714, A724).

Findings:

1. The hospital failed to ensure that there was adequate staff within the NICU to ensure a safe environment for the neonatal patients. On several ocassions, (refer to A 392, A 395, and A 397), there was only one nurse in the NICU, caring for three patients. The nurse would have no assistance in the event of an emergency.

The hospital also failed to ensure the nurse to patient care assigments in the pediatric unit were maintained at all times per facility policy and procedure. This failed practice could potentially cause a decline in the provision of medical care for this specialized population.

There was no evidence in the facility's Quality Improvement Projects that the staffing issues had been identified, analyzed or tracked.

On May 26, 2011 at 12:25 p.m., an interview was conducted with the CEO, CNO and DCQI. They acknowledged that staffing issues were identified by CDPH in the NICU during multiple visits. They indicated the issue was not included in the QAPI projects, because they were informed by the DMCC that the problem had been resolved.

The QAPI program did not implement any changes and did not track the staffing issues to ensure the issues were resolved.

2. Refer to A84, A620, A701, A714, A724.

During an interview with the Food Service Director (FSD) on May 23, 2011, at 3:30 p.m., he stated he was not aware of any documented food safety or food sanitation monitoring reported to the Quality Management program for the hospital.

During an interview with the Director of Clinical Quality Development on May 25, 2011, at 1:15 p.m., she stated the hospital identified the need to develop quality of measures for all their contracted services in January 2011. She further stated that the hospital quality committee is working through the list of contracts, but hasn't established a plan to measure the quality of the service provided by the contracted food service department. She further stated she was unaware of the deficient practices identified in the food service department during the survey.

A review of the hospital's Performance Improvement Plan (Improving Organizational Performance - IOP) effective December 10, 2010, revealed that under the plan, the organization (the hospital and clinics) provided a culture where care was delivered in a safe environment and quality care was measured, monitored and continuously improved. It further stated that the priority of data collection for performance improvement was based on focus on high risk, high volume or problem prone areas, it was to consider incidence, prevalence and severity of problems in these areas and was based on patient safety and quality of care.

Based on observations, interviews and record reviews the hospital failed to
measure, analyze and track quality indicators and aspects of performance that:

1. assess the process that ensured adequate staffing was maintained in all nursing service care areas including the NICU and Pediatric Units (cross refer to A392, A395, A397).There was no evidence in the facility's Quality Improvement Projects that the staffing issue had been identified, analyzed or tracked.

1. The hospital failed to ensure that there was adequate staff within the NICU to ensure a safe environment for the neonatal patients. On several ocassions, (refer to A 392, A 395, and A 397), there was only one nurse in the NICU, caring for three patients. The nurse would have no assistance in the event of an emergency.

The hospital also failed to ensure the nurse to patient care assignments in the pediatric unit was maintained at all times per facility policy and procedure. This failed practice could potentially cause a decline in the provision of medical care for this specialized population.

There was no evidence in the facility's Quality Improvement Projects that the staffing issue had been identified, analyzed or tracked.

On May 26, at 12:25 p.m., an interview was conducted with the CEO, CNO and DCQI. They acknowledged that staffing issues were identified by CDPH in the NICU during multiple visits. They indicated the issue was not included in the QAPI projects, because they were informed by the DMCC that the problem had been resolved.

Based on interview and record review, the facility's medical staff failed to implement policies adopted by the Governing Body, by failing to ensure the physician indicated the medical necessity and appropriate level of care for Patient 12's direct admission to the facility. This failed practice had the potential to result in the delay in treatment and care of the patient.

Findings:

On May 23, 2011, Patient 12's record was reviewed. Patient 12 was directly admitted to the facility on May 13, 2011.

The admitting physician's order, dated May 12, 2011, was reviewed. The orders did not indicate the medical necessity and appropriate level of care for the admission.

On May 23, 2011, at 3:45 p.m., Patient 12's record was reviewed with the CNO. The CNO stated the admitting orders should contain more information, which included the level of care the patient was being admitted to.

On May 26, 2011, the facility's "Medical Staff Bylaws" dated December 23, 2005, was reviewed. The document indicated, "The Medical Staff shall be governed by Medical Staff Bylaws...policies adopted by the Governing Board which set forth its organization and government..."

On May 26, 2011, the "Hospital Wide Administrative" policy titled, "Direct Admit or Transfer In From a Healthcare Facility," effective February 27, 2009, was reviewed. The policy indicated patients needed to be cleared for "medical necessity admission and appropriate level of care."

Based on observation, record review and interview, the facility failed to:

1. Ensure adequate nurse to patient care assignments in the Neonatal Intensive Care (NICU) and Pediatric Unit (Refer to A392, A395, A397).

On May 25, 2011, at 5:14 p.m., the facility's CNO, DCQI, and COO were notified of inadequate staffing in the NICU with Immediate Jeopardy declared. The Immediate Jeopardy was identified for the facility's failure to adequately staff the NICU. On multiple occasions, only one RN was left alone in the NICU to care for three vulnerable infants.

The team accepted a written plan of action for the Immediate Jeopardy situation, on May 25, 2011, at 7:30 p.m. The facility implemented the plan of action as follows:
a. The facility will ensure that a minimum of two nurses will be present in the NICU at all times.
b. The unassigned resource nurse will be added to the current staffing matrix at all times.
c. The unassigned resource nurse will attend high risk deliveries.
d. On-call staff will be utilized to maintain adequate nurse to patient care assignments.

After implementation of an acceptable plan of correction, the facility CEO; CNO; DCQI; and COO were notified the Immediate Jeopardy was removed on May 26, 2011, at 12:25 p.m.

2. Ensure the manager of the NICU and one RN failed to meet the competency requirements (Refer to A397).

3. Ensure an RN was available in the Arthritis Institute/ Bone and Joint Institute (Refer to A395, A397).

4. Ensure laboratory blood draws were done per the physicians' written orders (Refer to A392).

The cumulative effect of these systemic problems resulted in the failure of the facility to provide adequate nursing care and services, which had the potential to result in serious harm, injury, and/or death.

Based on observation, interview and record review, the facility:

1. Failed to ensure at least two competent licensed nurses were present, and the one nurse to two patients care assignment was maintained in the Neonatal Intensive Care Unit (NICU) at all times per facility policy and procedures. These failed practices left one nurse alone in the NICU with three patients (Patients 39, 40 and 41) which had the potential to result in a delay in treatment, a delay in staff response to a medical emergency, and harm or death to the neonatal patient.

2. Failed to ensure the nurse to patient care assignments, one nurse to four patients, in the pediatric unit was maintained at all times per facility policy and procedure. This failed practice could potentially cause a decline in the provision of medical care for this specialized population.

3. Failed to ensure a physician's order for a PT and PTT (blood tests to determine clotting time of the blood) were followed for Patient 35 prior to a cesarean section (surgical incision into the abdomen and uterine walls to deliver an infant). This failed practice had the potential to result in excessive bleeding during surgery which could cause anemia (low volume of blood), the need for blood transfusions, hypovolemic shock (failure to pump a sufficient volume of blood to vital organs) and death.

4. Failed to ensure a physician's order for "urine for GBS (group B streptococci) antigens" (a test to determine if an infant was infected with GBS during the delivery process) was followed after delivery of the patient (Patient 37). This failed practice had the potential to cause meningitis (inflammation of the membrane covering the brain and spinal cord), sepsis (deadly infection of the blood), or death.

Findings:

1. On May 25, 2011, at 2:05 p.m., an interview was conducted with RN 4. She stated that on May 24, 2011, at 3:30 p.m., there were three patients in the NICU with one staff nurse (RN 5) and one resource nurse (RN 4). RN 4 stated she had to leave the NICU:
a. At 4 p.m., to evaluate a patient in the postpartum unit;
b. At 4:24 p.m., to attend a cesarean section delivery; and
c. At 6:50 p.m., to attend a vaginal delivery where the infant had passed meconium (the first bowel movement) prior to delivery.

In addition, RN 4 stated she left the unit for approximately 15 to 20 minutes each time, and RN 5 was the only person left in the NICU with the three patients on May 24, 2011, at 4 p.m., 4:24 p.m., and 6:50 p.m.

On May 25, 2011, at 3:50 p.m., an interview was conducted with RN 5. She stated on May 25, 2011, at 9:30 a.m., there were three patients in the NICU with one staff nurse (RN 12) and one resource nurse (RN 5). RN 5 stated she had to leave the NICU at 10 a.m., to attend a cesarean section delivery. RN 5 stated RN 12 was the only person in the NICU with the three patients, and she returned to the NICU at 10:20 a.m. In addition, RN 5 stated that leaving one nurse in the NICU "has happened before."

On May 25, 2011, at 4:05 p.m., a subsequent interview was conducted with RN 4. She stated leaving one nurse in the NICU had been happening because the census was low and often times the resource nurse, who needed to attend deliveries and evaluate infants off of the unit, was given a patient care assignment in NICU.

The "JFK NICU Assignment Sheet" dated May 24, 2011, indicated:
a. The 7 a.m. to 7: 30 p.m. shift started with three staff nurses (RN 5, RN 12 and RN 13) and one resource nurse (RN 4) with five patients;
b. Two patients were discharged at 2:30 p.m.;
c. RN 12 was sent home at 3:15 p.m. and RN 13 was sent home at 3:30 p.m., leaving RN 5 and the resource nurse, RN 4, in NICU;
d. RN 4 left the NICU three times between 4 p.m., and 7:30 p.m., to evaluate a patient in postpartum and attend deliveries; and
e. RN 5 was the only person in the NICU caring for three patients (Patients 39, 40 and 41) when RN 4 left the NICU to evaluate a patient and attend deliveries.

The "JFK NICU Assignment Sheet" dated May 25, 2011, indicated:
a. The 7 a.m. to 7:30 p.m. shift started with one staff nurse (RN 12) and one resource nurse (RN 5) with three patients;
b. RN 5 left the NICU at 10 a.m., to attend a cesarean section delivery; and
c. RN 12 was the only person in the NICU caring for three patients (Patients 39, 40 and 41) when RN 5 left the NICU to attend the cesarean section delivery.

During an interview with the Director Maternal/Child Care (DMCC) on May 23, 2011, at 11:30 a.m., she stated the NICU resource nurse generally did not have a patient care assignment so the resource nurse could assist with transitioning infants immediately after delivery.

The "Staffing Matrix" (a list of nurse to patient care assignments) for NICU, 7 a.m. shift, dated May 25, 2011, indicated for three patients the NICU would have 24 hours (two RN's) of nursing care. The "Staffing Matrix" did not include a resource nurse.

The facility policy and procedures indicated staffing is planned to meet patient care needs and the nurse to patient care assignment for the NICU is one nurse to two patients at all times, to include meal breaks.

On May 25, 2011, at 5:14 p.m., the facility's CNO, DCQI, and COO were notified of inadequate staffing in the NICU with Immediate Jeopardy declared. The Immediate Jeopardy was identified for the facility's failure to adequately staff the NICU. One RN was left alone in the NICU to care for three vulnerable infants multiple times.

The team accepted a written plan of action for the Immediate Jeopardy situation, on May 25, 2011, at 7:30 p.m. The facility implemented the plan of action as follows:
a. The facility will ensure that a minimum of two nurses will be present in the NICU at all times.
b. The unassigned resource nurse will be added to the current staffing matrix at all times.
c. The unassigned resource nurse will attend high risk deliveries.
d. On-call staff will be utilized to maintain nurse to patient care assignments.

After implementation of an acceptable plan of correction, the facility CEO; CNO; DCQI; and COO were notified the Immediate Jeopardy was removed on May 26, 2011, at 12:25 p.m.

2. An interview was conducted on the pediatric unit with RN 10 on May 26, 2011, 9:30 a.m. RN 10 stated the nurse to patient care assignments on the pediatric unit is one nurse to four patients.

A review of the pediatric staffing assignment sheets was conducted with RN 10, who stated the nurse to patient care assignments was not maintained on the following days and shifts;

May 14, 2011, 7 a.m. to 7 p.m.,
May 19, 2011, 7 a.m. to 7 p.m.,
May 24, 2011, 7 a.m. to 7 p.m.,
May 22, 2011, nurse to patient care assignments not maintained during lunch relief.

A review of the facility policy and procedures indicate the nurse to patient care assignment is, one nurse for every four patients which must be maintained at all times, including lunch breaks.

3. On May 23, 2011, the record for Patient 35 was reviewed. Patient 35 was admitted to the facility on May 23, 2011, for a repeat cesarean section.

The "Physician Orders Cesarean Section Orders Labor & Delivery" (printed physician's orders) dated May 23, 2011, indicated "PT and PTT," and the orders were noted by RN 1.

A laboratory results report printed May 20, 2011, did not contain laboratory results for a PT and PTT.

The "Pre OP Surgical Check List" dated May 23, 2011, indicated a CBC (complete blood count) and "Other Lab" were checked as being completed. In the "O.R. Check" section of the form, "Yes" was checked next to the CBC and "Other Lab" sections as being completed and results in the record.

On May 23, 2011, at 3:50 p.m., an interview was conducted with RN 1. She stated she had admitted Patient 35 for a cesarean section and noted the physician's orders. RN 1 stated the PT and PTT were ordered by the physician but she did not have the laboratory draw the blood or complete the test. In addition, RN 1 stated she did not see the laboratory order for the PT and PTT, and physicians do not usually order a PT and PTT for cesarean section patients.

The facility policy and procedure titled, "Critical Tests and Critical Values/Results" dated June 17, 2010 indicated, "Objective: To ensure timely performance and reporting of Critical Tests. ... Definition: Critical Tests: Those which will always require rapid communication of the results, even if normal. ... Critical values/results list: ... Prothrombin Time (PT) ... PTT..."

RN 1 did not follow the physician's order for Patient 35 to have "Critical Tests" completed prior to surgery.

4. On May 23, 2011, the record for Patient 37 was reviewed. Patient 37 was delivered vaginally on May 23, 2011, at 8:02 a.m.

The "Physician Orders Newborn Group B Strep (infection of the newborn) Orders" dated May 23, 2011, indicated "Obtain blood culture, CRP (protein produced by the liver found in the blood when inflammation is present), CBC with manual differential STAT, and urine for GBS antigen."

A laboratory results report printed May 23, 2011, did not contain laboratory results for a "urine for GBS antigen."

On May 23, 2011, at 3:30 p.m., an interview was conducted with RN 2. She stated, "Although it is pre-printed on the 'Physician Orders Newborn Group B Strep Orders,' we do not do the urine GBS antigen as ordered by the physician. It was not ordered so it should have been crossed off the order sheet."

The facility policy and procedure titled, "Infection Control: Prevention and Treatment of Perinatal Group B Strep (GBS)" dated April 16, 2009, indicated "... Obtain CBC with differential cell count, and blood culture. ..."

Based on interview and record review, the facility:

1. Failed to ensure sufficient numbers of nursing staff were on duty in the Neonatal Intensive Care Unit (NICU) to safely care for and evaluate each patient, and to maintain, at all times, the nurse to patient care assignments for patients (Patient 39, 40, and 41) on May 24 and 25, 2011. This failed practice had the potential to result in delayed care, delayed response to an emergent medical condition which could result in harm or death to the neonatal patient.

2. Failed to ensure a Registered Nurse was onsite at all times when patients were present at the Arthritis Institute/Bone and Joint Institute outpatient clinics. This failed practice left the facility with no RN to provide assessments and to supervise the care provided to patients seen in the clinics.

3. Failed to ensure the registered nurse supervised and evaluated the nursing care by failing to report to the ordering physician the PTT results after initiating IV heparin infusion, in absence of a heparin protocol for Patient 11. This failed practice had the potential to result in under or over medication of the patient with heparin, which could worsen the patient's condition or cause excessive bleeding.

Findings:

1. On May 24 and 25, 2011, on the 7 a.m. shift, two staff nurses were left in the NICU to care for three critically ill infants.

The records for each patient were reviewed on May 25, 2011:
a. Patient 39 was delivered by cesarean section on May 18, 2011, with diagnoses of sepsis (infection in the body) and respiratory distress.
b. Patient 40 was delivered on May 23, 2011, with diagnoses of respiratory distress and rule out meconium aspiration (first stool breathed into lungs).
c. Patient 41 was delivered vaginally on May 20, 2011, with a diagnoses of 35 weeks (term pregnancy 40 weeks) gestation (number of weeks pregnant) and low birth weight with mild respiratory distress.

All three infants required intensive cardiac (heart) and respiratory (breathing pattern) monitoring in the Neonatal Intensive Care Unit (NICU).

The "JFK NICU Assignment Sheet" dated May 24, 2011, indicated:
a. The 7 a.m. to 7: 30 p.m. shift started with three staff nurses (RN 5, RN 12, and RN 13) and one resource nurse (RN 4) with five patients;
b. Two patients were discharged at 2:30 p.m.;
c. RN 12 was sent home at 3:15 p.m. and RN 13 was sent home at 3:30 p.m., leaving RN 5 and the resource nurse, RN 4, in NICU;
d. RN 4 left the NICU three times between 4 p.m., and 7:30 p.m., to evaluate a patient in postpartum and attend deliveries; and
e. RN 5 was the only person in the NICU caring for three patients (Patients 39, 40 and 41) when RN 4 left the NICU to evaluate a patient and attend deliveries.

The "JFK NICU Assignment Sheet" dated May 25, 2011, indicated:
a. The 7 a.m. to 7:30 p.m. shift started with one staff nurse (RN 12) and one resource nurse (RN 5) with three patients;
b. RN 5 left the NICU at 10 a.m., to attend a cesarean section delivery; and
c. RN 12 was the only person in the NICU caring for three patients (Patients 39, 40 and 41) when RN 5 left the NICU to attend the cesarean section delivery.

On May 25, 2011, at 2:05 p.m., an interview was conducted with RN 4. She stated that on May 24, 2011, at 3:30 p.m., there were three patients in the NICU with one staff nurse (RN 5) and one resource nurse (RN 4). RN 4 stated she had to leave the NICU:
a. At 4 p.m., to evaluate a patient in the postpartum unit;
b. At 4:24 p.m., to attend a cesarean section (surgical incision into the abdomen and uterine walls to deliver an infant) delivery; and
c. At 6:50 p.m., to attend a vaginal delivery where the infant had passed meconium (the first bowel movement) prior to delivery.

In addition, RN 4 stated she left the unit for approximately 15 to 20 minutes each time, and RN 5 was the only person left in the NICU with the three patients on May 24, 2011, at 4 p.m., 4:24 p.m., and 6:50 p.m.

On May 25, 2011, at 3:50 p.m., an interview was conducted with RN 5. She stated on May 25, 2011, at 9:30 a.m., there were three patients in the NICU with one staff nurse (RN 12) and one resource nurse (RN 5). RN 5 stated she had to leave the NICU at 10 a.m., to attend a cesarean section delivery. RN 5 stated RN 12 was the only person in the NICU with the three patients, and she returned to the NICU at 10:20 a.m. In addition, RN 5 stated that leaving one nurse in the NICU "has happened before."

On May 25, 2011, at 4:05 p.m., a subsequent interview was conducted with RN 4. She stated leaving one nurse in the NICU had been happening because the census was low and often times the resource nurse, who needed to attend deliveries and evaluate infants off of the unit, was given a patient care assignment in NICU.

The "Staffing Matrix (nurse to patient care assignments)" for NICU, 7 a.m. shift, dated May 25, 2011, indicated for three patients the NICU would have 24 hours (two RN's) of nursing care. The "Staffing Matrix" did not include a resource nurse.

The facility policy and procedures indicated staffing is planned to meet patient care needs, and the nurse to patient ration is one nurse to two patients at all times, including meal breaks.

2. On May 24, 2011, at 10:10 a.m., a tour was made to the Arthritis Institute/Bone and Joint Institute. The outpatient clinics were located offsite away from the main facility campus.

On May 24, 2011, at 11 a.m., the Front Desk Coordinator (FDC) and Director Cardiopulmonary (DCP) were interviewed. The FDC and DCP stated the RN (RN 3) on duty at the facility worked from 8 a.m. to 2 p.m., but the clinic hours of operation were 8 a.m. to 4:30 p.m. In addition, the FDC and DCP stated RN 3 was the only RN currently working at the clinics.

The "Timekeeper Punch Detail History" for RN 3 indicated she did not work at the clinics on the following days during the clinics' hours of operation:
a. March 24, 2011, 2:15 p.m. through 4:30 p.m.;
b. March 25, 2011, 8 a.m. through 4:30 p.m.;
c. March 28, 2011, 2 p.m. through 4:30 p.m.;
d. March 29, 2011, 2:15 p.m. through 4:30 p.m.;
e. March 30, 2011, 2 p.m. through 4:30 p.m.;
f. April 1, 2011, 8 a.m. through 4:30 p.m.;
g. April 4, 2011, 2:15 p.m. through 4:30 p.m.;
h. April 5, 2011, 2:15 p.m. through 4:30 p.m.;
i. April 6, 2011, 2:15 p.m. through 4:30 p.m.;
j. April 7, 2011, 2:45 p.m. through 4:30 p.m.;
k. April 8, 2011, 8 a.m. through 4:30 p.m.;
l. April 11, 2011, 2 p.m. through 4:30 p.m.;
m. April 12, 2011, 12:15 p.m. through 4:30 p.m.;
n. April 13, 2011, 2:15 p.m. through 4:30 p.m.;
o. April 14, 2011, 2:15 p.m. through 4:30 p.m.;
p. April 15, 2011, 2:15 p.m. through 4:30 p.m.;
q. April 18, 2011, 2 p.m. through 4:30 p.m.;
r. April 19, 2011, 2:15 p.m. through 4:30 p.m.;
s. April 20, 2011, 2:15 p.m. through 4:30 p.m.;
t. April 21, 2011, 2 p.m. through 4:30 p.m.;
u. April 22, 2011, 8 a.m. through 4:30 p.m.;
v. April 25, 2011, 2 p.m. through 4:30 p.m.;
w. April 26, 2011, 2:15 p.m. through 4:30 p.m.;
x. April 27, 2011, 8 a.m. through 4:30 p.m.;
y. April 28, 2011, 2:15 p.m. through 4:30 p.m.;
z. April 29, 2011, 8 a.m. through 4:30 p.m.;
aa. May 2, 2011, 2 p.m. through 4:30 p.m.;
bb. May 3, 2011, 2:15 p.m. through 4:30 p.m.;
cc. May 4, 2011, 12:30 p.m. through 4:30 p.m.;
dd. May 5, 2011, 2:15 p.m. through 4:30 p.m.;
ee. May 6, 2011, 8 a.m. through 4:30 p.m.;
ff. May 9, 2011, 2 p.m. through 4:30 p.m.;
gg. May 10, 2011, 2:15 p.m. through 4:30 p.m.;
hh. May 11, 2011, 12:45 p.m. through 4:30 p.m.;
ii. May 12, 2011, 2:15 p.m. through 4:30 p.m.;
jj. May 13, 2011, 8 a.m. through 4:30 p.m.;
kk. May 16, 2011, 2 p.m. through 4:30 p.m.;
ll. May 17, 2011, 2:30 p.m. through 4:30 p.m.;
mm. May 18, 2011, 2 p.m. through 4:30 p.m.;
nn. May 19, 2011, 8 a.m. through 4:30 p.m.;
oo. May 20, 2011, 8 a.m. through 4:30 p.m.; and
pp. May 23, 2011, 12:30 p.m. through 4:30 p.m.

On May 24, 2011, at 2:40 p.m., a subsequent interview was conducted with the DCP. He verified there was no RN scheduled to be onsite at the clinics from 2 p.m. to 4:30 p.m. daily, and when RN 3 was not available. The DCP also verified patients are seen in the clinics after 2 p.m. and on Fridays. The DCP stated there was another RN on staff, but he had been on a medical leave of absence since March 24, 2011.



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3. On May 23, 2011, Patient 11's record was reviewed. The patient was directly admitted to the facility with chief complaint of weakness on the right upper and lower side of the body, and dry mouth on May 13, 2011. The record indicated an impression of a CVA (stroke).

The physician's order dated May 13, 2011, at 6:59 p.m., included:

"STAT PT/PTT (blood test that measures how long it takes blood to clot)...Heparin (blood thinner) 1000 units/hr infusion...Check PTT (blood test to determine how long blood clotted-used to determine heparin therapy) 6 hours after start of infusion..."

The electronic MAR indicated the heparin IV infusion started at 9:23 p.m.

The PTT results (normal therapeutic range for heparin is 45-75 seconds) were as follows:

- May 13, 2011, at 6:10 p.m. - 26.1 seconds (before infusion)
- May 14, 2011, at 3:35 a.m. - 67.1 seconds (approximately six hours after the start of infusion)

The record did not indicate how to proceed with the IV heparin infusion when the PTT results were obtained. The electronic MAR indicated the patient received the same dose of heparin infusion until May 15, 2011.

On May 25, 2011, at 11:40 a.m., the CNO was interviewed. The CNO stated the facility used "Intravenous Heparin Protocol," to determine the IV heparin infusion rate. The CNO stated the ordering physician did not use the facility protocol, but wanted to be called with the PTT results to determine further dosing for the heparin infusion rate. In absence of a protocol, the ordering physician needed to be called to determine the heparin rate.

The facility policy titled, "Guidelines for I.V. Heparin Administration" effective July 27, 2009, was reviewed. The policy's purpose was to minimize the risk of thromboembolism (blood clots in the legs), minimize potential for bleeding complications and medication error, and improve outcomes.

The policy further indicated:

"Establishing a therapeutic range for monitoring heparin therapy...It is important that each facility determine it's own therapeutic range...and to adapt recommended dosage adjustments accordingly."

Based on interview and record review, the facility:

1. Failed to ensure sufficient numbers of nursing staff were on duty in the Neonatal Intensive Care Unit (NICU) to safely care for and evaluate each patient, and to maintain at all times the nurse to patient staffing care assignments for patients (Patient 39, 40, and 41) on May 24 and 25, 2011. This failed practice had the potential to result in delayed care, delayed response to an emergent medical condition which could result in harm or death to the neonatal patient;

2. Failed to ensure the manager of the NICU (neonatal intensive care unit) and pediatric departments met the competency requirements for the position;

3. Failed to ensure RN 6 met the competency requirements in order to work in the pediatric department.
Together this failed practices could lead to ineffective management and oversight in both the NICU and pediatric departments, in addition to potential problems with the delivery of care for these patients with highly specialized needs;

4. Failed to ensure a Registered Nurse was onsite at all times when patients were present at the Arthritis Institute/Bone and Joint Institute outpatient clinics. This failed practice left the facility with no RN to provide assessments and to supervise the care provided to patients seen in the clinics.

Findings:

1. On May 24 and 25, 2011, on the 7 a.m. shift, two staff nurses were left in the NICU to care for three critically ill infants.

The records for each patient were reviewed on May 25, 2011:
a. Patient 39 was delivered by cesarean section on May 18, 2011, with diagnoses of sepsis (infection in the body) and respiratory distress.
b. Patient 40 was delivered vaginally on May 23, 2011, with diagnoses of respiratory distress and rule out meconium aspiration (first stool breathed into lungs).
c. Patient 41 was delivered vaginally on May 20, 2011, with a diagnoses of 35 weeks late preterm newborn and low birth weight with mild respiratory distress.

All three infants required intensive cardiac (heart) and respiratory (breathing pattern) monitoring in the Neonatal Intensive Care Unit (NICU).

The "JFK NICU Assignment Sheet" dated May 24, 2011, indicated:
a. The 7 a.m. to 7: 30 p.m. shift started with three staff nurses and one resource nurse with five patients;
b. Two patients were discharged at 2:30 p.m.;
c. One nurse was sent home at 3:15 p.m. and one nurse was sent home at 3:30 p.m., leaving one staff nurse (RN 5) and one resource nurse (RN 4) in NICU;
d. RN 4 left the NICU three times between 4 p.m., and 7:30 p.m., to evaluate a patient in postpartum and attend deliveries; and
e. RN 5 was the only person in the NICU caring for three patients (Patients 39, 40 and 41) when RN 4 left the NICU to evaluate a patient and attend deliveries.

The "JFK NICU Assignment Sheet" dated May 25, 2011, indicated:
a. The 7 a.m. to 7:30 p.m. shift started with one staff nurse (RN 12) and one resource nurse (RN 5) with three patients;
b. RN 5 left the NICU at 10 a.m., to attend a cesarean section delivery; and
c. RN 12 was the only person in the NICU caring for three patients (Patients 39, 40 and 41) when RN 5 left the NICU to attend the cesarean section delivery.

On May 25, 2011, at 2:05 p.m., an interview was conducted with RN 4. She stated that on May 24, 2011, at 3:30 p.m., there were three patients in the NICU with one staff nurse (RN 5) and one resource nurse (RN 4). RN 4 stated she had to leave the NICU:
a. At 4 p.m., to evaluate a patient in the postpartum unit;
b. At 4:24 p.m., to attend a cesarean section (surgical incision into the abdomen and uterine walls to deliver an infant) delivery; and
c. At 6:50 p.m., to attend a vaginal delivery where the infant had passed meconium (the first bowel movement) prior to delivery.
In addition, RN 4 stated she left the unit for approximately 15 to 20 minutes each time, and RN 5 was the only person left in the NICU with the three patients at 4 p.m., 4:24 p.m., and 6:50 p.m.

On May 25, 2011, at 3:50 p.m., an interview was conducted with RN 5. She stated on May 25, 2011, at 9:30 a.m., there were three patients in the NICU with one staff nurse (RN 12) and one resource nurse (RN 5). RN 5 stated she had to leave the NICU at 10 a.m., to attend a cesarean section delivery. RN 5 stated RN 12 was the only person in the NICU with the three patients, and she returned to the NICU at 10:20 a.m. In addition, RN 5 stated that leaving one nurse in the NICU "has happened before."

On May 25, 2011, at 4:05 p.m., a subsequent interview was conducted with RN 4. She stated leaving one nurse in the NICU had been happening because the census was low and often times the resource nurse, who needed to attend deliveries and evaluate infants off of the unit, was given a patient care assignment in NICU.

The "Staffing Matrix" for NICU, 7 a.m. shift, dated May 25, 2011, indicated for three patients the NICU would have 24 hours (two RN's) of nursing care. The "Staffing Matrix" did not include a resource nurse.

The facility policy and procedures indicated staffing is planned to meet patient care needs The nurse to patient care assignment is one nurse to two patients at all times, including meal breaks.

2. An interview was conducted with RN 8 on May 23, 2011, at 11 a.m. RN 8 stated she was the manager of the pediatric and NICU departments.

A review of the undated facility job description, "Neonatal and Pediatric Service Clinical Manager/Clinical Nurse Manager - NICU," signed by RN 8 on July 13, 2009, indicated "The Clinical Manager demonstrates an ability to respond and provide direction in changing workload during crisis and emergency situations."

The required qualifications for the position, are, "BSN (Bachelor of Science degree in Nursing)...Certified in Neonatal Intensive Care Nursing from the NCC (national certification corporation)."

A review of RN 8's personnel file was conducted on May 24, 2011. There was no documentation found to indicate RN 8 was certified in neonatal intensive care nursing from the NCC, or was a BSN graduate from an accredited school of nursing.

An interview was conducted with RN 8 on May 25, 2011, at 11:30 a.m. RN 8 stated she did not have her BSN or certification in NICU from the NCC.

3. A tour of the pediatric unit was conducted on May 24, 2011, at 9 a.m. On the dry erase board located in the nurses station, the staffing schedule indicated RN 6 worked the night shift on May 23, 2011.

A review of the facility generated work schedule for the pediatric department indicated RN 6 worked four 12 hour night shifts on April 13, 23,and 24, 2011, and May 23, 2011, for a total of 50.5 hours.

A review of RN 6's personnel file indicated her job classification as RN II. The job description for the pediatrics department, "Registered Nurse (RN II)" (Revised 12/08), indicated "Mandatory Requirements: Current Competences: PALS (pediatric advanced life support) within 3 months of hire."

There was no documentation found to indicate RN 6 had current PALS certification.



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4. On May 24, 2011, at 10:10 a.m., a tour was made to the Arthritis Institute/Bone and Joint Institute. The outpatient clinics were located offsite away from the main facility campus.

On May 24, 2011, at 11 a.m., the Front Desk Coordinator (FDC) and Director Cardiopulmonary (DCP) were interviewed. The FDC and DCP stated the RN (RN 3) on duty at the facility worked from 8 a.m. to 2 p.m., but the clinic hours of operation were 8 a.m. to 4:30 p.m. In addition, the FDC and DCP stated RN 3 was the only RN currently working at the clinics.

The "Timekeeper Punch Detail History" for RN 3 indicated she did not work at the clinics on the following days during the clinics' hours of operation:
a. March 24, 2011, 2:15 p.m. through 4:30 p.m.;
b. March 25, 2011, 8 a.m. through 4:30 p.m.;
c. March 28, 2011, 2 p.m. through 4:30 p.m.;
d. March 29, 2011, 2:15 p.m. through 4:30 p.m.;
e. March 30, 2011, 2 p.m. through 4:30 p.m.;
f. April 1, 2011, 8 a.m. through 4:30 p.m.;
g. April 4, 2011, 2:15 p.m. through 4:30 p.m.;
h. April 5, 2011, 2:15 p.m. through 4:30 p.m.;
i. April 6, 2011, 2:15 p.m. through 4:30 p.m.;
j. April 7, 2011, 2:45 p.m. through 4:30 p.m.;
k. April 8, 2011, 8 a.m. through 4:30 p.m.;
l. April 11, 2011, 2 p.m. through 4:30 p.m.;
m. April 12, 2011, 12:15 p.m. through 4:30 p.m.;
n. April 13, 2011, 2:15 p.m. through 4:30 p.m.;
o. April 14, 2011, 2:15 p.m. through 4:30 p.m.;
p. April 15, 2011, 2:15 p.m. through 4:30 p.m.;
q. April 18, 2011, 2 p.m. through 4:30 p.m.;
r. April 19, 2011, 2:15 p.m. through 4:30 p.m.;
s. April 20, 2011, 2:15 p.m. through 4:30 p.m.;
t. April 21, 2011, 2 p.m. through 4:30 p.m.;
u. April 22, 2011, 8 a.m. through 4:30 p.m.;
v. April 25, 2011, 2 p.m. through 4:30 p.m.;
w. April 26, 2011, 2:15 p.m. through 4:30 p.m.;
x. April 27, 2011, 8 a.m. through 4:30 p.m.;
y. April 28, 2011, 2:15 p.m. through 4:30 p.m.;
z. April 29, 2011, 8 a.m. through 4:30 p.m.;
aa. May 2, 2011, 2 p.m. through 4:30 p.m.;
bb. May 3, 2011, 2:15 p.m. through 4:30 p.m.;
cc. May 4, 2011, 12:30 p.m. through 4:30 p.m.;
dd. May 5, 2011, 2:15 p.m. through 4:30 p.m.;
ee. May 6, 2011, 8 a.m. through 4:30 p.m.;
ff. May 9, 2011, 2 p.m. through 4:30 p.m.;
gg. May 10, 2011, 2:15 p.m. through 4:30 p.m.;
hh. May 11, 2011, 12:45 p.m. through 4:30 p.m.;
ii. May 12, 2011, 2:15 p.m. through 4:30 p.m.;
jj. May 13, 2011, 8 a.m. through 4:30 p.m.;
kk. May 16, 2011, 2 p.m. through 4:30 p.m.;
ll. May 17, 2011, 2:30 p.m. through 4:30 p.m.;
mm. May 18, 2011, 2 p.m. through 4:30 p.m.;
nn. May 19, 2011, 8 a.m. through 4:30 p.m.;
oo. May 20, 2011, 8 a.m. through 4:30 p.m.; and
pp. May 23, 2011, 12:30 p.m. through 4:30 p.m.

On May 24, 2011, at 2:40 p.m., a subsequent interview was conducted with the DCP. He verified there was no RN scheduled to be onsite at the clinics from 2 p.m. to 4:30 p.m. daily, and when RN 3 was not available. The DCP also verified patients are seen in the clinics after 2 p.m. and on Fridays. The DCP stated there was another RN on staff, but he had been on a medical leave of absence since March 24, 2011.

Based on observation, interview and record review, the facility:

1. Failed to control and distribute medications in accordance with applicable standards of practice when "sample" medications were distributed to patients and medications were stored in a refrigerator with biohazardous specimens at the Arthritis Institute/Bone and Joint Institute, an outpatient clinic. This failed practice placed patients at risk for receiving medications without complete instructions, being given medications that had expired and being administered medications that were contaminated.

2. Failed to ensure a medication refrigerator was monitored to ensure the temperatures were in an acceptable range. This failed practice had the potential for the medications efficacy to be less effective.

Findings:

1. On May 24, 2011, at 10:10 a.m., a tour of the Arthritis Institute/Bone and Joint Institute was conducted with the Director Cardiopulmonary (DCP) and COO.

A five drawer file cabinet in a supply room contained "sample" medications from distributors in drawers one and four, and medications supplied by the facility in drawers two and three.

"Sample" medications included Celebrex, Treximet, Advil, Colace, Diovan and respiratory inhalers to treat asthma. The Diovan had expired on April 2011. A "sample" medication, Victoza Liraglutide (r DNA) injection, was stored at the nurses' station in an unlocked refrigerator which had a pink "Biohazard" sign taped to the front of the refrigerator.

On May 24, 2011, at 11:15 a.m., an interview was conducted with LVN 1. He stated medications and specimens, such as aspirations of fluid from knees, were stored together at the nurses' station in the refrigerator which had a pink "Biohazard" sign taped to the front of the refrigerator.

On May 24, 2011, at 1:15 p.m., an interview was conducted with the DP and PCM. The DP stated he was aware the Arthritis Institute/Bone and Joint Institute had sample medications. He stated "sample" medications were not supposed to be used in the outpatient clinic. In addition, the DP stated the issue of "sample" medications had not been addressed at Pharmacy & Therapeutics Committee, the facility did not have a policy for "sample" medications, and the pharmacy did not check the "sample" medications as part of their monthly inventory.



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2. On May 23, 2011, at 11:15 a.m., the medication refrigerator in PCU-W was inspected with RN 7. The refrigerator had multiple medications which included insulins and antibiotics.

The May 2011 "Daily Refrigerator Temp (temperature) Checks" log was reviewed with RN 7. RN 7 stated the refrigerator temperature was monitored daily. The document indicated the acceptable refrigerator temperature range was 36 to 46 ?F. The log indicated the temperature was out of range 16 of 23 days (two consecutive day [34 and 35 ?F], 12 consecutive days [ranged between 29 to 35 ?F], and another two consecutive days [33 and 34 ?F]). All 16 days indicated the refrigerator was "adjusted," but did not have documented evidence the refrigerator was re-checked and was within 36 to 46 ?F.

The form also indicated, "...Submit a maintenance requisition if the temperature falls out of the shaded range (36 to 46 ?F) for 2 consecutive days.

During a concurrent interview with RN 7, she stated the nursing unit did not have any record that the maintenance department was notified of the out of range temperatures.

On May 24, 2011, the facility policy titled, "Pharmacy Monitoring of Medication Refrigerators" effective July 20, 2009, was reviewed. The policy indicated, "...All other medication refrigerators, in the immediate nursing units will have the temperatures monitored and recorded daily by the Nursing Department staff...No variances outside the acceptable temperature range. 36 Degrees Fahrenheit to 46 degrees Fahrenheit...Refer to Attachment (Daily Refrigerator Temp [temperature] Checks)..."

Based on observation and interview, the facility failed to ensure needles were not accessible to unauthorized personnel. This failed practice had the potential for unauthorized access to needles and misuse.

Findings:

1. On May 24, 2011, at 9:20 a.m., a tour was conducted in the Maternal/Child Health units with the DMCC and the COO. An observation of an unlocked room by the nurses' station revealed one milliliter syringes with 25 gauge needles in an unlocked cabinet.

In a concurrent interview with the DMCC, she stated the room was used by physicians to do infant examinations and by the nursing staff for infant blood draws. The DMCC stated she did not know why the needles were in the unlocked room.

2. On May 24, 2011 at 10:10 a.m., a tour of the Arthritis Institute/Bone and Joint Institute was conducted with the DCP. In examination room 105, in an unlocked cabinet, were 18 and 22 gauge, 1-1/2 inch needles.

In a concurrent interview with the DCP, he stated, "The property manager repairs locks. I need to call them to get it fixed because the facility does not do repairs in the outpatient facility."

Based on observation, interview and record review, the facility:

1. Failed to ensure patient safety by having expired laboratory tubes and specimen collection kits available for use. This failed practice had the potential to result in inaccurate test results.

2. Failed to remove expired medications from stock at the Arthritis Institute/Bone and Joint Institute. This failed practice had the potential to result in patients being given medications that were expired, which could lead to the use of ineffective medications.


Findings:

1. On May 23, 2011, at 11:30 a.m., a tour of the Maternal/Child Health units was conducted with Manager 1 and the COO.

a. In Labor & Delivery, in the medication room cabinet, the following were found:
i. 21 purple top Vacutainer tubes (a tube in which most of the air has been removed and used to collect blood specimens), expired 2009 and 2010, and
ii. 24 red top Vacutainer tubes, expired 2009 and 2010.

The COO and Manager 1 verified the items were expired.

b. In the Postpartum Unit, in the medication room refrigerator, there was an UTM-RT Specimen Collection Kit for viruses, chlamydia, mycoplasma and ureaplasma with an expiration date of December 2009.

In a concurrent interview with Manager 1, she stated she did not know why the specimen kit was in the refrigerator.

A facility policy and procedure titled, "Central Supply - General Organization" with a revised date of February 16, 2005, indicated, "... All supply items should be reviewed weekly and upon issuance in respect to expiration dates. All expired items will be immediately removed from the storage location and placed in a holding area until proper disposition can be made. ..."

2. On May 24, 2011, at 10:10 a.m., a tour of the Arthritis Institute/Bone and Joint Institute was conducted with the DCP, the COO and LVN 1. The following medications were found:
a. Gebauer's Ethyl Chloride spray, opened on February 3, 2011.
In a concurrent interview with LVN 1, he stated the Gebauer's Ethyl Chloride spray was "good for three to six months once it was opened."
b. Diovan, a "sample" medication, expired April 2011.
c. Influenza Virus Vaccine, 11 doses, expired March 2011.
d. Influenza A (H1N1) 2009, Monovalent Vaccine 5 milliliters, opened November 1, 2010 and expired March 29, 2011.

On May 24, 2011, at 1:15 p.m., an interview was conducted with the Director of Pharmacy (DP). He stated multi-dose vials such as Gebauer's Ethyl Chloride spray were good for 28 days once they were opened. The DP stated the pharmacy department inspected the supplies and medications at the Arthritis Institute/Bone and Joint Institute once every 30 days. In addition, the DP stated he did not know how the influenza or the H1N1 vaccines got in the refrigerator at the outpatient clinics.

The facility policy and procedure titled "Expiration Dates" dated July 24, 2009, indicated "... Opened multi-dose items will have an expiration date of 28 days or less. ..."

The facility policy and procedure titled "Pharmaceutical Waste Program and Management" revised April 6, 2009, indicated, "Return unused or intact expired medications to the pharmacy."

Based on observation, staff interviews and record reviews, the hospital condition of participation was not met as evidenced by:

The hospital Food Service Director (FSD) failed to ensure the daily management of the dietary services to provide patients, staff and visitors with safe, high quality food service and adequate food in the event of a disaster (Cross refer A-620)

The hospital failed to customize their diet manual to be hospital specific and ensure it was approved by the medical staff prior to implementing it for use in conformance with physician's diet orders (Cross refer A-631)

The hospital failed to ensure that the overall hospital environment was developed and maintained in such a manner that the safety and well-being of the patients a were assured when the Food Service Director (FSD) failed to ensure the hospital disaster food plan and supplies were adequate to meet the needs of the patients in the event of a disaster (Cross refer A-701).

The hospital failed to ensure dietary staff and the Food Service Director (FSD) were knowledgeable of the hospitals policies and procedures for responding to a grease fire in the kitchen (Cross refer A-714)

The hospital failed to maintain supplies to ensure an acceptable level of safety when four CO2 tanks in the dietary department were not secured to prevent them from falling over (Cross refer A-724)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure safe food handling to prevent the potential for food borne illness; the potential to result in patients at nutrition risk not receiving accurate therapeutic diets as prescribed by the physician; the potential to result in patients becoming malnourished in the event of a disaster; potential to compromise the safety of patients, visitors and staff in the event of a fire or compromised compressed gas tanks.

Based on observations, staff interviews and document reviews the hospital Food Service Director (FSD) failed to ensure the daily management of the dietary services to provide patients, staff and visitors with safe, high quality food service and adequate food in the event of a disaster when he:

1. failed to ensure that the dietary staff monitored the safe cool down of previously cooked, potentially hazardous food;

2. failed to ensure that the dietary staff monitored the time and temperature of potentially hazardous foods on display on a salad bar in the cafeteria;

3. failed to ensure that the dietary staff effectively monitored refrigeration and freezer temperature logs for accuracy and compliance with procedures to rectify temperatures when out of range;

4. failed to ensure dish machine temperatures were being monitored and were adequate for effective sanitation of dishes;

5. failed to ensure foods were discarded by their "use by," discard or expiration dates;

6. failed to ensure foods were stored in approved containers;

7. failed to ensure opened or prepared food was covered, dated and labeled to maintain food safety and quality;

8. failed to ensure that the table mounted can opener was clean and free of dried food to prevent cross contamination;

9. failed to ensure that holding temperatures for hot food were maintained at greater than or equal to 140 degrees Fahrenheit;

10. failed to ensure CO2 tanks were stored so that they were secure and prevented from falling (Cross refer A-724);

11. failed to ensure the hospital disaster food plan and supplies were adequate to meet the needs of the patients in the event of a disaster (Cross refer A-701);

12. failed to ensure dietary staff and the Food Service Director (FSD) were knowledgeable of the hospitals policies and procedures for responding to a grease fire in the kitchen (Cross refer A-714).

Findings:

1. During a inspection of the dietary department on May 23, 2011, at 12:10 p.m., the following was noted in the walk-in refrigerator: a 12 inch by 10 inch by 4 inch deep pan full of previously cooked bacon, sausage links and sausage patties, undated; a 12 inch by 10 inch by 6 inch deep pan full of previously cooked Spanish Rice dated May 22, 2011; and a tray of previously cooked chicken breasts, undated. Also in the walk-in freezer there was a 2 inch by 10 inch by 6 inch deep pan full of previously cooked white beans, undated.

According to the 2009 USDA Food Code, cooked potentially hazardous food (time/temperature control for safety food) shall be cooled within two hours from 135?F to 70?F and within a total of 6 hours from 135?F to 41?F or less. It further states that if food is not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause food borne illness.

A review of the hospital's policy titled, "Food Handling Guidelines" dated November 2009, revealed, "All foods being cooled must be identified with (a food service contractor's) label. Complete all information on the label including date and time food began cooling." The FSD provided a blank temperature log titled, "HACCP Food Cooling Temperature Log" undated that revealed instructions to the staff that, "Temperatures should be checked every hour and documented until the food is below 41 degrees." It further instructed the staff that when cooling food, once it falls below 140 degrees, food must reach 71 degrees with two hours, and 41 degrees within an additional 4 hours. It further instructs the staff that an item must be discarded if it does not meet these two requirements.

During a concurrent interview with the Food Service Director (FSD) and the Chef, they stated that there was no system in place to monitor the safe cool down of the identified foods. Both the Chef and the FSD confirmed that these foods were previously cooked and potentially hazardous. They further stated that the cool down process for these foods should be monitored to ensure they reached safe temperatures in the timeframes required to prevent the growth of harmful microorganisms that cause food born illness. The FSD was unable to state how he was able to ensure these foods were cooled in accordance to the Code requirements without monitoring time and temperature.

2. During an inspection of the cafeteria on May, 23, 2011, at 3:45 p.m., tuna salad and chicken salad were noted on display on the salad bar. During a concurrent interview with the Grill Cook 1 he stated that the tuna salad and the chicken salad were placed on the salad bar in the morning before the cafeteria opens and remained there until close after dinner and was replenished as needed throughout the day. He further stated that there was no system for monitoring or recording the temperature of the potentially hazardous food on display on the salad bar.

A review of the hospital's policy titled, "Food Handling Guidelines" dated November 2009, revealed staff guidance that for cold food holding, it should be held cold for service at a temperature of 41 degrees or less and that internal temperatures were to be recorded every two hours.

During a concurrent interview with the FSD, he was unable to state why the temperatures for the potentially hazardous cold food held on the salad bar were not being monitored to ensure they remained within the safe holding temperature guidelines required by the policy.

3. During an inspection of the kitchen on May 23, 2011, between 11:00 a.m., and 12:00 p.m., the temperature log for Freezer B was observed to have 33 of 90 temperatures recorded documented at greater than 0 degrees Fahrenheit (F). A review of the staff guidance for the document titled Refrigerator/Freezer Temperature Log dated May 2011, for Freezer B stated, "If temperature is at or below 0 degrees F, no corrective action is needed. If temperature is between 1 degree F and 5 degrees F, recheck in 30 minutes. If two consecutive temperatures are between 1 degree F and 5 degrees F, notify supervisor to contact maintenance for repair. Circle or highlight any deviant readings. Action should be taken....."

A review of the form revealed that off the 33 entries greater than 0 degrees F, all but 2 were documented to be greater than 5 degrees. The deviant readings were documented to be from 5 - 14.8 degrees F. Sixteen of the 23 days were documented to have two consecutive readings greater than 0 degrees F. None of the entries indicated that corrective action had been taken.

During a concurrent interview with the FSD, he stated that he was unaware that Freezer B was not working properly. He further stated that the staff should be documenting a corrective action taken when the temperatures were greater than 0 degrees F.

During an inspection of the patient nourishment area in the ACE nursing station on May 25, 2011, at 2:45 p.m., the Refrigerator/Freezer Temperature Log for the Refrigerator/Freezer was noted to have 12 documented temperatures greater than 41 degrees F (between 42 - 44 degrees F). A review of the staff guidance for the document titled Refrigerator/Freezer Temperature Log dated May 2011 stated, " If temperature is at or below 41 degrees F (refrig) / 0 degrees F (freezer), no corrective action is needed. If temperature is between 42 and 46 degrees F (refrig) / 1 degree F and 5 degrees F (freezer), recheck in 30 minutes. If two consecutive temperatures are between 42 and 46 degrees F (refrig) / 1 degree F and 5 degrees F (freezer), notify supervisor to contact maintenance for repair. Circle or highlight any deviant readings. Action should be taken. There was no documented evidence that corrective action had been taken for the refrigerator temperatures greater than 41 degrees F.

The temperature of an eight ounce container of milk stored in the refrigerator used for patients was noted to be 42.6 degrees F. The temperature was confirmed by the CNO. It was not known how long the milk that was stored in the refrigerator for patient use was greater than 41 degrees F. Milk should be store so that the temperature is less than or equal to 41 degrees F to maintain food safety.

During a concurrent interview with the CNO, he stated that the dietary services department was responsible for monitoring the temperature of the refrigerators in the nursing units nourishment areas.

During an interview at 2:50 p.m. with the FSD, he confirmed that it was the responsibility of the dietary services department to monitor the temperatures of the patient refrigerators in the nursing station nourishment area. He stated that corrective action should have been documented on the form per the directions noted on the form. He confirmed that there was no corrective action documented and was unable to state why. He further stated that the system for ensuring the policy was followed was not effective.

A review of the hospital's policy titled, "Storage Times and Temperatures," revised March 2005, revealed, "Temperatures of food storage areas and cold food vendors and action is taken to maintain temperatures within ranges recommended by licensing and surveying agencies: Refrigerated Storage 34 - 41 degrees F."

A review of the hospital's policy titled, "Food and Supply Storage Procedures" revised June 2009 revealed, "Milk will be refrigerated immediately upon receipt. As with all refrigerated storage, temperatures must be maintained at 41 degrees F or below." It further stated the policy indicated, "All food and non-food and supplies used in food preparation shall be stored in such a manner as to maintain safety and wholesomeness of the food for human consumption."

4. During an observation of the hospital's dishwashing procedures on May 24, 2011, at 1:00 p.m., it was noted that the dish machine uses water temperatures greater than or equal to 180 degrees F to sanitized patient dishes.

During a concurrent interview with FSW 1, he stated that the final rinse temperature was monitored at the beginning of each meal's dishewashing to ensure that the dish machine was working properly. He stated the temperatures were monitored using the dishmachine's gauges. He further stated that the temperatures were recorded on the Dishmachine Temperature Log.

A review of the Dishmachine Temperature Log dated May 2011 showed that no temperatures had been recorded for six of the last nine dinner's dishwashing. The log further directed the staff to record the temperature of the dishmachine twice during each meal service using a maximum holding thermometer (a Loly Pop Thermometer), not the dishmachine's gauges.

During a concurrent interview with the FSD, he stated that the dietary staff is frequently reminded to record the temperatures of the dishmachine during meal service. He further stated that it was the responsibility of the supervisors to ensure the temperature logs were complete. He was unable to explain why there were many missing entries on the log for the dinner meal. He further stated that the supervisors only worked until 5:00 p.m. and were not present during the dinner meal service dishwashing to ensure that the evening dietary staff documented the temperatures. He confirmed that if the temperatures on the dishmachine are not monitored and they don't reach a final rinse temperature of 180 degrees F, the dishes would not be properly sanitized and could cause the spread of infections.

5. During an inspection of the kitchen on May 23, 2011, between 11:00 a.m. and 12:30 p.m., the following expired products were noted in the refrigerators: an opened pint sized container of strawberry yogurt, expiration date May 9, 2011; an opened gallon sized container of sweet pickle relish, discard date January 20, 2011; a pan of chopped vegetables (onions and sweet peppers), discard date May 21, 2011, a container of prepared sun dried tomatoes soaked in oil, dated October 21st; a container of bacon bits, expiration date May 21, 2011; an open container of feta cheese, expiration date May 20, 2011; an open gallon sized container of balsamic salad dressing with an open date of March 14, 2011; and a package of flour tortillas, discard date April 28, 2011.

A review of the facility's policy titled, "Food and Supply Storage Procedures" revised June 2009, revealed , "All food and non-food and supplies used in food preparation shall be stored in such a manner as to maintain safety and wholesomeness of the food for human consumption. "It further stated that foods past the "use-by" date should be discarded.

A review of the hospital's policy titled, "Storage Times and Temperatures," revised March 2005, revealed that once opened or prepared, products have a limited shelf-life. And that the storage time of opened salad dressing was 30 days after opening.

During a concurrent interview with the DFS and the Chef, they stated that it was the Chef's responsibility to ensure all food was discarded at the end of its expiration or discard dates. The Chef further stated that he checked daily for outdated product to discard. He was unable to explain how product dated as far back as October 21, 2011, and January 20, 2011, had not been discarded. The DFS stated he was responsible for the oversight of the Chef to ensure expired products were discarded and not served to the patients in order to ensure food quality and safety.

6. During an inspection of the walk-in refrigerator in the kitchen on May 23, 2011 at 12:00 p.m., a plastic container labeled by the manufacturer as chili powder was observed to be relabeled by the dietary staff as "ginger." The container was not dated with a prepared date or a discard date.

During a concurrent interview with the FSD, he stated that the container had been improperly reused to store chopped ginger packed in oil. He confirmed that the container was not dated. He was unable to state how long the product had been stored in the walk-in refrigerator and if it was still safe to consume.

During an inspection of the cafeteria on May 23, 2011 at 5:45 p.m., an open can of vanilla pudding was observed in the prep refrigerator. The container was not dated with an open date or discard date.

During a concurrent interview with the FSD, he stated that the pudding should not be stored in the can once it is opened. He confirmed that the container was not dated. He was unable to state how the dietary staff could ensure the safety of the ginger and the pudding.

A review of the hospital's policy titled, "Food and Supply Storage Procedures" revised June 2009 revealed, "Unused portions of canned fruits and vegetables must be transferred to clean, approved storage containers. Do not store in open cans....Label and date container."

7. During an inspection of the kitchen on May 23, 201, between 11:00 a.m. and 12:40 p.m., the following items were observed:
Freezer F; an open box of onion rings was stored not sealed, not dated;

Refrigerator 4, an open gallon sized container of potato salad was stored not sealed and not dated, a flat of 30 shelled eggs was stored removed from its original box, not dated, a container of ranch dressing was stored not sealed, a five gallon container of pickles was stored not sealed with the lid ajar,

Freezer B, multiple individual serving sized portions of formed puree items were stored not sealed and removed from the original packaging, not dated,

in the dry storage room, bins containing rice and beans were stored not sealed with the lids ajar,

in the walk-in refrigerator, multiple opened, gallon-sized containers of salad dressings were stored, not dated; in the walk-in refrigerator, an open box of pepperoni slices was stored, not dated, chicken pieces were being thawed, not dated, approximately five pounds of ground turkey for stuffed peppers was being thawed, not dated, an open bag of Italian sausage chunks was stored, not dated, an open 24 ounce can of hollandaise sauce mix, crusted with a brown/green oily substance, not dated, four pans of flavored prepared gelatin were stored, uncovered, not dated and adjacent to a container of chopped onions with a strong odor;

in the walk-in freezer, two quart sized cartons of a liquid egg product were labeled
"Do Not Freeze " were stored frozen, not dated, and also in the walk-in freezer, multiple meat and vegetarian products were removed from the original packaging and not labeled with an expiration date.

During the observation, upon entering the walk-in refrigerator, Cook 1 was observed with a roll of food dating labels, placing labels on opened food items that had not been previous labeled. Further observation revealed, two ladder carts containing multiple different food items were covered with plastic bags and were labeled "May 23, 2011, discard by May 26, 2011." The food items contained in the food carts all were labeled with various dates of preparation or open and discard dates, many not consistent with the date on the outside of the carts.

A review of the hospital's policy titled, "Food and Supply Storage Procedures" revised June 2009, revealed that, "All food and non-food and supplies used in food preparation shall be stored in such a manner as to maintain safety and wholesomeness of the food for human consumption." It further stated the procedure is to, "Cover, label and date unused portions and open packages."

During concurrent interviews with the FSD and the Chef, they stated that all the observed items should be sealed and labeled with the date opened or prepared and a discard date. The FSD stated that all food service workers were responsible for covering, labeling and dating of opened and prepared food items. He further stated that the Chef is responsible for the oversight of the staff to ensure the policy is adhered to. And that the FSD was ultimately responsible for the oversight of the Chef. He confirmed that without properly sealing and dating of opened and prepared food items, the safety and quality of the food could not be established.

8. During a inspection of the dietary department on May 23, 2011, at 4:15 p.m., the table mounted can opener blade tip was observed to have a dried red colored food substance and vanilla pudding residue. During a concurrent interview with Cook 1, he confirmed the food residue and stated that the can opener is washed daily in the dishmachine.

During a concurrent interview with the FSD, he confirmed the presence of the two different food items on the can opener blade. He was unable to explain how the dietary services staff was able to prevent cross contamination of canned products when multiple different products were opened in one day and the can opener was only washed once a day.

According to the 2009 USDA Food Code, equipment food-contact surfaces and utensils shall be clean to sight and touch. It further stated that the objective of cleaning focuses on the need to remove organic matter from food-contact surfaces so that sanitization can occur and to remove soil from nonfood contact surfaces so that pathogenic microorganisms will not be allowed to accumulate and insects and rodents will not be attracted.

9. During an observation of the cafeteria hot food holding temperatures on May 23, 2011, at 4:00 p.m., the chicken breasts were noted to be 118.6 degrees F, the salmon was noted to be 137 degrees F, and the chicken pieces were noted to be 129.6 degrees F. During a concurrent interview with the FSD, he confirmed the temperatures and stated that the hot food should be held at greater than or equal to 140 degrees F. He instructed Grill Cook 1 to reheat the chicken breasts, the salmon and the chicken pieces to at least 140 degrees F. He further stated that Grill Cook 1 should check the temperature of the hot food before it is served to be sure that the holding temperature was maintained at a minimum of 140 degrees F.

During an observation of the trayline (patient meal tray assembly) in the kitchen on May 24, 2011, at 11:15 a.m., Salisbury steak was noted to be held for service at 117 - 132 degrees F. Two patient meals were served using the Salisbury steak before the inadequate temperature was noted by the dietary staff. During a concurrent interview with the Chef, he confirmed the inadequate temperature and stated that the minimum holding temperature for the Salisbury steak should be 140 degrees F to ensure food safety. The pan of Salisbury steaks was pulled from the trayline for reheating, but the two servings were not reheated. It was not known how long the Salisbury steak was held at temperatures less than 140 degrees F.

A review of the final cooking temperature log for the Salisbury steaks showed that it was cooked to a final cooking temperature of 172 degrees F, but the time that temperature was achieved was not noted,

A review of the hospital's policy titled, "Food Handling Guidelines" dated November 2009, revealed, "Foods should be held hot for service at a temperature of 140 degrees F or higher. "It further instructed, "Record temperatures every two hours."

10. During an inspection of the kitchen on May 23, 2011, at 11 a.m., four CO2 tanks were observed in the soda storage closet that were not secured to prevent them from falling over. Chains were observed attached to the wall but were only draped over two of the tanks. During a concurrent interview with the DFS, he stated that the chains were there to secure the tanks to the wall so they would not fall over. He confirmed that the tanks were not secured to the wall. He was unable to explain why the tanks were not secured to the wall. He further stated that the staff should know to secure the tanks to the wall and it was the supervisors responsibility to ensure the tanks are secured. He further stated that he oversees the work of the supervisors but was not aware the tanks were not secured.

The hospital's policy titled, "Oxygen Supply, Monitoring and Compressed Gas Safety" effective date August 19, 2009, was reviewed which stated that the purpose of the policy was to provide instruction and guidelines on the safe transportation, storage and usage of liquid (bulk) and compressed oxygen and other compressed gasses. The directions for Compressed Gas and Oxygen Use: Cylinders must be secured at all times so they cannot fall.

11. The hospital's disaster policy for food service was requested on May 23, 2011, at 4 p.m. The FSD stated that the policy was located in the food services policy and procedure manual locked in his office. He stated that to his knowledge that was the only copy of the hospital's plan for food service during a disaster. He was unable to state how the plan would be easily accessible and readily available for staff guidance in the event of a disaster. A copy of the plan was requested for review.

During an observation of the hospital's disaster food supplies in the trailer adjacent to the hospital on May 23, 2011, at 4:15 p.m., the FSD stated that the Chef was responsible for maintaining the inventory of the disaster food and he had already left for the day.

A review of the hospital's policy number H015 titled, "Disaster Menus" revised March 2009, revealed instructions on "Considerations for Disaster Planning." The policy also contained four different disaster menu plans. Each plan had a separate menu for different scenarios (i.e., utilities available or not, safe water available or not, deliveries available or not). The plan did not include the number of meals planned for or the inventory required to prepare those meals.

During an interview with the FSD on May 24, 2011 at 9:30 a.m., he stated that he didn't know why the plan contained different menus plans. He also confirmed that the plan did not specify the number of meals that would be required and to determine the inventory needed. But he stated that the plan was based on feeding 400 meals three times a day. He further stated that the disaster inventory did not include any shelf-stable puree meat or entrees in the event of a disaster where utilities were not available.

During a follow-up observation of the disaster food supply on May 24, 2011, at 10 a.m., with the FSD and the Chef, many missing items were noted. There was no tuna in the disaster supply when the plan required five cases of tuna. There were three cans of tuna in the dry storage room. The Chef stated that the tuna from the disaster supply was used two weeks prior and had not been replaced. The plan required two cases of peanut butter but, the hospital had one case. The plan required four cases each of chili con carne, beef stew, and beef ravioli, the hospital had two cases of chili con carne, four cases of beef stew and one case of beef ravioli. The Chef was unable to state why the inventory did not meet the needs of the plan. Further observation revealed that all the cases of canned goods in the disaster food supply inventory were labeled with an expiration date of August 10, 2010, nine and a half months prior. The Chef stated that he had intended to rotate the canned items into the regular inventory, but had not done so.

The FSD stated that the Chef conducts an inventory count every Thursday and should know exactly the amount of items for the disaster food plan that the hospital has on hand. It was observed that the storage area for the disaster food supply contained many other boxes stored in front of the disaster food supply that needed to be moved in order to count the boxes. During a further interview with the Chef, he stated that he does not actually count the individual items for the weekly inventory. He stated he just counted the number of boxes, not noting what each box contains. He also stated the disaster food supply and the regular inventory did not contain shelf-stable puree entrees for use in the event of a disaster in which utilities were not available to modify the consistency of the regular entrees. The Chef stated the hospital had four physician orders for puree diets for lunch on May 24,2011. He further stated the dietary department would not be able to feed those patients entrees if the disaster was to occur at that time and no utilities were available.

Based on staff interviews and record reviews the hospital failed to customize their diet manual to be hospital specific and ensure it was approved by the medical staff prior to implementing it for use in conformance with physician's diet orders. This failed practice had the potential to result in patients at nutrition risk not receiving accurate therapeutic diets as prescribed by the physician.

Findings:

During an interview with the Clinical Nutrition Manager (CNM) on May 24, 2011, at 3:30 p.m., she stated the diet manual used in this hospital was a general diet manual used for all the accounts for the contracted service. She further stated an updated version of the diet manual had been uploaded to the hospital's intranet two weeks prior and the previous version was no longer available. She further stated that the updated version had not been approved by the medical staff.

A review of the Active Diet Order Summary list for May 24, 2011, revealed 12 patients had physician orders for diabetic diets. The CNM stated the hospital served a consistent carbohydrate diet when the physician ordered a diabetic diet. A review of the hospital's diet manual titled, "Manual of Clinical Nutrition Management" dated 2011, revealed a consistent carbohydrate diet is not one of the diets described in the manual. The CNM was not able to state how a physician or the dietary staff would be able to use the hospital's diet manual to provide guidance on how to prepare or what foods are allowed and not allowed on a consistent carbohydrate diet.

A review of the Approval Form for the Manual of Clinical Nutrition Management revealed that, "The Manual, with appropriate revisions, has been reviewed and approved by the medical staff and dietitians." The form is last dated "July 30, 2010." The CNM confirmed the updated version was dated 2011 and had not been approved by the medical staff.

Based on observation, interview and document review the facility failed to provide a safe environment properly constructed, equipped and maintained to protect the health and safety of patients as evidenced by the failure to:

1. Ensure emergency light was provided in accordance with NFPA 99 and NFPA 101. This was evidenced by no emergency lights in four of five operating rooms, and by the failure of three emergency lights during testing. This affected all surgeries and two of two off site clinics. This could result in a possible patient injury during a surgery or could delay evacuation in the clinic buildings (refer to LSC K046).

2. Maintain their complete fire alarm system. This was evidenced by alarm devices that failed, by two areas with no alarm annunciator, by expired fire alarm panel batteries and by incomplete fire alarm system testing records for the Outpatient Rehabilitation clinic. This affected 14 of 14 smoke compartments in the main hospital, and two of two outpatient clinics. This could result in a failure of the alarms system or a delay in notification, in the event of a fire (refer to LSC K052).

3. Maintain their automatic sprinkler system in accordance with NFPA 13 and NFPA 25. This was evidenced by missing or displaced escutcheon rings, by sprinkler heads covered in paint or dust, by leaks at the main drain valve in two locations, by no complete supply of spare sprinklers and a wrench, and by incomplete documents for quarterly testing of the sprinkler system. This affected 14 of 14 smoke compartments at the main hospital, and one of two outpatient clinics. This could result in a delay in extinguishing a fire (refer to LSC K062).


The cumulative effect of these systemic problems resulted in the facility's failure to provide a safe environment for the protection of the health and safety of all patients receiving care at the facility, staff and visitors.

Based on observation, staff interviews and document reviews, the hospital failed to ensure:

1. the overall hospital environment was developed and maintained in such a manner that the safety and well-being of the patients a were assured when the Director of Food Services failed to ensure the hospital disaster food plan and supplies were adequate to meet the needs of the patients in the event of a disaster.

2. the temperature and humidity in the NICU was maintained within the ranges according to the facility's policy and procedure (temperature should be within 75 to 80 ?F, and the relative humidity should be within 30 to 60%). This failed practice had the potential to result in uncomfortable environment and placed the newborns at risk for infection.

Findings:

1. The hospital's disaster policy for food service was requested on May 23, 2011, at 4 p.m. The Food Service Director (FSD) stated that the policy was located in the food services policy and procedure manual locked in his office. He stated that to his knowledge that was the only copy of the hospital's plan for food service during a disaster. He was unable to state how the plan would be easily accessible and readily available for staff guidance in the event of a disaster. A copy of the plan was requested for review.

During an observation of the hospital's disaster food supplies in the trailer adjacent to the hospital on May 23, 2011, at 4:15 p.m., the FSD stated that the Chef was responsible for maintaining the inventory of the disaster food and he had already left for the day.

A review of the hospital's policy number H015 titled, "Disaster Menus" revised March 2009, revealed instructions on "Considerations for Disaster Planning." The policy also contained 4 different disaster menu plans with each plan having a separate menu for different scenarios (i.e. utilities available or not, safe water available or not, deliveries available or not). The plan did not include the number of meals planned for or the inventory required to prepare those meals.

During an interview with the FSD on May 24, 2011 at 9:30 a.m., he stated that he didn't know why the plan contained different menus plans. He also confirmed that the plan did not specify the number of meals that would be required and would then determine the inventory needed. But he stated that the plan was based on feeding 400 meals three times a day. He further stated that the disaster inventory did not include any shelf-stable puree meat or entrees in the event of a disaster that would not allow for the use of utilities.

During a follow-up observation of the disaster food supply on May 24, 2011, at 10 a.m., with the FSD and the Chef, many missing items were noted. There was no tuna in the disaster supply when the plan required five cases of tuna. There were three cans of tuna in the dry storage room. The Chef stated that the tuna from the disaster supply was used two weeks prior and had not been replaced. The plan required two cases of peanut butter but the hospital had one case. The plan required four cases each of chili con carne, beef stew, and beef ravioli, the hospital had two cases of chili con carne, four cases of beef stew and one case of beef ravioli. The Chef was unable to state why the inventory did not meet the needs of the plan. Further observation revealed that all the cases of canned goods in the disaster food supply inventory were labeled with an expiration date of August 10, 2010, nine and a half months prior. The Chef stated that he had intended to rotate the canned items into the regular inventory, but had not done so.

The FSD stated that the Chef conducts an inventory count every Thursday and should know exactly the amount of items for the disaster food plan that the hospital has on hand. An observation of the area where the disaster food supply was stored. The area was blocked by many boxes that were stored in front of the disaster food supply and needed to be moved in order to count the boxes. During an interview with the Chef, he stated he does not actually count the individual items for the weekly inventory. He stated he just counted the number of boxes, not noting what each box contains. He also stated the disaster food supply and the regular inventory did not contain shelf-stable puree entrees for use in the event of a disaster in which utilities were not available to modify the consistency of the regular entrees. The Chef stated the hospital had four physician orders for puree diets for lunch on May 24, 2011. He further stated the dietary department would not be able to feed those patients entrees if the disaster was to occur at that time and no utilities were available.





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2. The facility policy titled, "Temperature and Humidity Monitoring" effective April 21, 2011, was reviewed. The policy indicated, in the "Intensive Care Newborn Nursery," the temperature should be within 75 to 80 ?F, and the relative humidity should be within 30 to 60%.

The policy further indicated, "...The Mechanic makes adjustments and records actions. If the reading(s) are out of range, the Mechanic returns one hour after adjustments are made to check system. Facilities will adjust the system until both Temp (temperature) and Humidity are within normal ranges..."

On May 23, 2011, at 12:40 p.m., an observation of the NICU was conducted. The unit had seven patients. The unit's thermometer registered a temperature of 73.8 ?F.

On May 23, 2011, at 2:50 p.m., the NICU had four patients, the unit's thermometer registered a temperature of 73.4 ?F, and the relative humidity registered 29%.

On May 23, 2011, at 12:40 p.m., the CNO was interviewed. The CNO stated the facility was working with the original architect of the facility in resolving the humidity and temperature being out of range. He stated the facility currently had "no resolution." The maintenance department continued to adjust when it was out of range.

On May 26, 2011, the facility's May 2011 "Temperature and Humidity Monitoring Log" for NICU was reviewed. The document indicated the following:

- Twenty-four of 25 days, the temperature was out range (ranged 69 to 73 ?F), and
- Six of 25 days, the relative humidity was out of range (ranged 15 to 28 %).

There was no documented evidence that actions were taken when the temperatures and relative humidity were out of acceptable ranges, according to facility policy.

On May 26, 2011, at 1:20 p.m., the temperature and relative humidity log was reviewed with the Director of Facilities. The director stated the maintenance staff should have documented any action taken when the temperature and relative humidity were out of range.

According to National Association of Neonatal Nurses (NANN), the recommended environmental temperature should be between 72 to 76 ?F, and the relative humidity should be between 30 to 60 %.

NANN further indicated the following:

"...Thermal care (affected by the environment's humidity and temperature) is central to reducing morbidity and mortality among preterm and high-risk infants..."

"...Hypothermia (abnormally low body temperature) occurring during the adaptation to extrauterine life (birth of the infant) presents increased demands for oxygen during a period when oxygen delivery may be compromised..."

Based on observations, staff interviews and document review, the hospital failed to ensure dietary staff and the Food Service Director (FSD) were knowledgeable of the hospitals policies and procedures for responding to a grease fire in the kitchen. This failure practice had the potential to result in compromising the safety of staff, visitors and patients in the event of a grease fire on the stove in the kitchen.

Findings:

During an interview in the kitchen with Cook 1 on 5/23/11 at 4:00 PM, he stated in case of a grease fire on the stove, he would call 911, and use the red fire extinguisher on the fire. He further stated that the Ansul Fire Suppression System installed over the stove would be activated in case of a fire in the oven. Upon further questioning to determine what was the hospital ' s policy on responding to a fire, he stated that either he would call 911 or he would direct a coworker to call 911.

During a concurrent interview with the FSD, he stated it was the hospital's policy to call 911 in the event of a fire. He further stated the red fire extinguisher was not to be used in the event of a grease fire as Cook 1 had stated. He stated the silver fire extinguisher should be used. He also stated the Ansul Fire Suppression System installed over the stove could be activated by pulling the handle located adjacent to the stove area to extinguish a grease fire on top of the stove. He confirmed that Cook 1 was unable to correctly state what to do in the event of a grease fire on the stove.

A review of the hospital's policy titled, "Code Red Response" effective June 9, 2009, revealed the procedure, "If you discover a fire is to follow the R.A.C.E. format of (R) remove persons from immediate danger, (A) activate the Fire Alarm System by pulling the handle on the nearest Fire Pull Station. Dial 44. (C) Confine the fire. Close all patient room and office doors and windows (E) Extinguish the fire using fire extinguishers in the department or other fire prevention equipment as deemed appropriate. Evacuate if necessary." It further states that, "the operator will call the Indio Fire Department unless instructed not to do so by someone on the scene of the Code Red."

A review of the hospital's policy titled, "Fire Management Plan" effective May 27, 2009, revealed, "each supervisor is responsible for the degree to which their employees have gained knowledge and skills necessary to perform safely and effectively in their particular position." It further stated that, " the employee is responsible for being completely familiar with the fire safety program and their specific responsibilities: Participating in fire drills and practice sessions as required; Attending fire training classes when assigned; Knowing the fire alarm code and how to report a fire; the location of and how to operate the fire alarm boxes and fire extinguishers; And, being knowledgeable with evacuation procedures."

The FSD was unable to verify that Cook 1 had attended any fire drills or completed training in fire safety for his working area.

Based on observation, interview and record review, the facility failed to ensure the labor room was used only for it's intended services. This failed practice decreased the number of beds available for laboring patients and had the potential to place infants at risk.

Findings:

On May 23, 2011, at 11:30 a.m., a tour of the Maternal/Child Health unit was conducted with the DMCC, COO, and Manager 1. In Labor & Delivery, Room 706 was observed as a room for recovering infants after cesarean sections (surgical incision into the abdomen and uterine walls to deliver an infant). Room 706 contained three infant heat warmers, three infant cribs, one overbed table, two rolling carts of supplies, one covered hamper, and a sink with foot pedals.

Review of the facility floor plan indicated room 706 was a "labor room."

On May 23, 2011, at 11:30 a.m., an interview was conducted with RN 8. She stated when infants were delivered by cesarean section, the mother was recovered in the PACU, and the NICU resource nurse attended the cesarean section delivery and the infant was taken to room 706 for transition (recovery of the infant after delivery).

On May 23, 2011, at 3:50 p.m., an interview was conducted with Manager 1. She stated, two to three infants could be transitioned at one time in Room 706. In addition, Manager 1 stated if transitioning the infant was done in the nursery, the nurse transitioning the infant would be alone, there would be a staffing issue, and the transitioning process in the nursery would require two nurses versus one nurse when transitioning the infant was done in Room 706.

On May 25, 2011, at 11 a.m., an interview was conducted with Facilities Staff 1. He stated Room 706 in Labor & Delivery was supposed to be a labor room.

In a concurrent interview with the COO, he stated the facility did not have a waiver to use Room 706 for anything other than a labor room.

Title 22 California Code of Regulations, Article 7, Number 70805 indicated, "Spaces approved for specific uses at the time of licensure shall not be converted to other uses without written approval of the Department."

Based on observation, interview and facility document review, the facility failed to ensure:

1. the pediatric resuscitation cart had an up to date contents list available. This failed practice could potentially have serious or fatal results in the event of a pediatric emergency such as a cardiac arrest.

2. the facility failed to maintain supplies to ensure an acceptable level of safety when four CO2 tanks in the dietary department were not secured to prevent them from falling over.


Findings:

1. An observation of the pediatric resuscitation cart, (also called a Broselow cart, a system which supplies information and equipment for pediatric emergencies based on the child's height and weight) was conducted with RN 8 on May 23, 2011, at 11 a.m. The pediatric resuscitation cart consisted of nine drawers, each color coded to correspond to the weight and height of the patient. Each drawer contained medical equipment, such as endotracheal tubes, syringes and oxygen masks. There was no documentation found to indicate the contents of each drawer in the Broselow cart.

An interview was conducted with RN 8 on May 23, 2011, at 11:15 a.m., who stated, "There should be a contents list for each drawer..., materials management stocks the drawers."

An interview was conducted with materials management staff 1 on May 23, 2011, at 1 p.m., who stated, "When we stock the crash (resuscitation) cart, a copy of what is in the cart goes to our supervisor, and a copy goes onto the cart which the registered nurse puts in the crash cart notebook."

An interview was conducted with the facility Educator on May 23, 2011, at 3:10 p.m. The Educator stated every crash cart needed to have an accompanying list of contents which would indicate what it has, expiration date, and what items need to be pulled out.




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2. During an inspection of the kitchen on May 23, 2011, at 11 a.m., four CO2 tanks were observed in the soda storage closet that were not secured to prevent them from falling over. Chains were observed attached to the wall but were only draped over two of the tanks. During a concurrent interview with the FSD, he stated the chains were there to secure the tanks to the wall so they would not fall over. He stated the tanks were not secured to the wall. He was unable to explain why the tanks were not secured to the wall. The FSD further stated the staff should know to secure the tanks to the wall and it was the supervisors responsibility to ensure the tanks are secured.

The hospital's policy titled, "Oxygen Supply, Monitoring and Compressed Gas Safety" effective date August 19, 2009, was reviewed which stated the purpose of the policy was to provide instruction and guidelines on the safe transportation, storage and usage of liquid (bulk) and compressed oxygen and other compressed gasses. The directions for Compressed Gas and Oxygen Use: Cylinders must be secured at all times so they cannot fall.

Based on interview and record review, the facility failed to ensure:

1. Isolation precautions were initiated in a timely manner for one of 43 sampled patients;

2. Biohazard medical waste was maintained in a secured area;

3. Implement the hospital policy on immunization and screening of healthcare personnel, by failing to ensure that TB Screening results and annual influenza documentation was obtained for ten out of ten physician credential files; and

4. That a mattress in the Nuclear Medicine room was free from perforations, which has an increased potential for infections due to the inability for proper disinfection between patients.


These failed practices could potentially lead to the spread of infection.

Findings:

1. A review of Patient 20's record was conducted on May 24, 2011, at 2 p.m. Patient 20 was admitted to the facility on May 19, 2011, with diagnoses of seizures and diabetes.

A review of the patient's laboratory results indicated the initial results of a urine specimen on May 21, 2011, at 9:53 a.m.,as well as the final result on May 22, 2011, at 5:23 p.m., indicated, "Escherichia coli...Extended Spectrum Beta Lactamase Producer...(also known as ESBL, a bacteria which produces enzymes making it highly resistant to antibiotic treatment). Results called to (staff nurse)... May 21, 2011 09:52:41. Read back complete."

The facility policy and procedure, "Isolation Precautions," (Revised April 6, 2009), indicated contact precautions are transmission based precautions, "...for patients documented or suspected to be infected with highly transmissible or epidemiologically important pathogens for which additional precautions beyond standard precautions are needed to prevent transmission."

Further review of patient 20's record, indicated, isolation/contact precautions were first initiated on May 23, 2011, at 9 a.m., two days after staff was notified of the critical value laboratory result.

A telephone interview was conducted with the ICP on May 26, 2011, at 10:30 a.m. The ICP stated, "With ESBL, the patient has to be put in contact isolation. ESBL is considered a critical value."

2. An observation of the biohazard medical waste disposal area located directly outside the facility was conducted on May 24, 2011, at 10:30 a.m. One large unlocked metal rolling cart, accessible to the public was located outside a locked area labeled as biohazardous waste.

Located on the metal rolling cart was one red biohazard medical waste bin, which contained syringes, needles and vials, some partially filled with liquid medication. The red biohazard bin was one quarter full.

A concurrent interview was conducted with the Trash Technician who stated, any container which contained needles was to be kept in the locked area.

A concurrent interview was conducted with the EVS supervisor who stated,"Narcotic addicts can walk in here and get the syringes and needles."

A review of the facility policy and procedure, "Biohazardous and Sharps Waste," (Effective Mach 19, 2009), indicated, "Environmental Service staff will collect the biohazardous and sharps waste containers as often as needed from the soiled utility rooms and transport the containers directly to the Biohazardous Waste Accumulation area near the loading dock."

An interview was conducted with the ICP on May 26, 2011, at 11 a.m., who stated the biohazard plastic red box should have been put inside the biohazard garage.



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3. On May 24, 2011, at 9:40 a.m., an observation of a red biohazard container stored in the public corridor near the L&D desk was observed. The biohazard container stored used sharp instruments, syringes with medications and Epidural kit supplies. Upon further observation, the container lid could be easily removed and the contents accessible.

On May 24, 2011, at 9:45 a.m., an interview was conducted with the EVS director. She stated Housekeeping picked up the containers daily and as needed. She had no explanation as to the reason the Biohazard container was being stored in the public corridor.

The facility policy and procedure entitled Biohazardous and Sharps Waste dated March 19, 2009, was reviewed and indicated, procedures for the segregation and disposal of biohazardous and sharps waste. The policy further indicated Sharps waste included, empty syringes (with or without needles) needles, ...blades... And, biohazard waste containers will be red with tight fitting lids. Sharps containers located in areas accessible to the public will be locked in a secure enclosure to prevent removal from the area.

4. On May 24, 2011, at 9:35 a.m., an observation was conducted of a Dirty Utility Room door in the public corridor in L&D area. The door's latch plate was observed stuffed with paper and taped over to prevent the door from closing securely. Inside the Dirty Utility Room was observed a red bin with multiple placenta, dirty instruments, three large trash barrels, and two biohazard barrels. At that time, in an interview with Manager 1, he stated, "The door should not have been taped."

On May 26, 2011, at 10:15 a.m., an interview was conducted with ICP. She stated, "The Dirty Utility Rooms are locked and must have a code to enter. Every unit has a specific code. The door is suppose to be kept locked, because it may have chemicals. A little one could get into it. It could be a public concern."

5. On May 24, 2011, at 9 a.m., ten physician credential files were reviewed. Ten of ten credential files did not contain TB screening results or annual influenza documentation.

On May 24, 2011, at 10:10 a.m. the facility's Policy and Procedure titled, "Preventive Immunization and Screening of Healthcare Personnel," was reviewed. The policy specified that the immunization program included all healthcare personnel (including physicians) and that the program was based on CDC standards to reduce the risk of transmission of infectious disease (including tuberculosis and influenza).

An interview with the director of medical staff administration was conducted on May 24, 2011, at 1 p.m. She stated that the annual TB screening results and influenza documentation has not been obtained for the ten physicians on staff at the hospital because the Medical Staff felt that the Policy was a guideline and not mandatory.

6. The Nuclear Medicine room was inspected on May 23, 2011, at 2 p.m. A mattress on the table that slides into the Nuclear Medicine Scanner was observed to have a 2x2 inch perforation with foam exposure that would allow fluids to enter the foam center and possibly leak out at a later time and prevents disinfection of the mattress between patients.

An interview with the Nuclear Medicine technician was conducted on May 23, 2011, at 2:20 p.m. He stated that he could not ensure adequate disinfection of the mattress due to the perforation with foam exposure. He stated that the mattress needed to be replaced.

Based on interview and record review, the facility failed to ensure a discharge planning evaluation was completed, which included an evaluation of post-hospital services needs. This failed practice had the potential to result in the patient not to have the essential equipment and/or services needed after hospitalization for one of 43 patients (Patient 14).

Findings:

On May 24, 2011, Patient 14's record was reviewed. The patient was seen in the ED with a chief complaint of respiratory failure on May 20, 2011. The patient was admitted to an inpatient nursing care unit.

A physician's order dated May 24, 2011, at 1:30 p.m., indicated the patient was going to be discharged home "today."

The electronic record section titled, "Discharge Needs" was reviewed. The section included the following assessment categories: Anticipated discharge location, home environment, patient activities expected post discharge, home treatments, professional skilled services (anticipated need), anticipated devices/equipment, special services and community resources, social history, psychosocial assessment, functional assessment, cultural/spiritual assessment, and family history. All sections were blank.

The undated "Interdisciplinary Plan of Care" was reviewed. The document had a section titled, "Discharge Planning #1," which would have indicated a problem or concern, intervention, and expected outcome. The form was blank.

On May 24, 2011, at 4 p.m., Patient 14's record was reviewed with CM 1. CM 1 stated discharge planning started when a patient was admitted. CM 1 stated the expectation was either the admitting nurse or the case manager would document in the "Discharge Needs" section, and initiate a plan of care for discharge planning. CM 1 stated the case managers can modify the "Discharge Needs" assessment section as information was obtained, if the admitting nurse filled-out the section initially. CM 1 stated if the information could not be obtained from the patient, an attempt would be made to obtain it from the patient's responsible party. The record did not have documented evidence that the facility made attempts to complete the "Discharge Needs" section.

On May 26, 2011, the facility policy titled, "Documentation - Interdisciplinary Plan of Care" effective January 5, 2011, was reviewed. The policy indicated, "Purpose: To ensure that care, treatment, and rehabilitation are planned and appropriate to the patient's needs and severity of illness. To identify individualized patient care goals and interventions to achieve those goals in a collaborative, interdisciplinary manner."

The policy further indicated the following:

"The RN initiated the Interdisciplinary Plan of care after completion of the initial assessment..."

"Assessment, planning and evaluation are interdisciplinary and based upon actual or potential problems, anticipated length of stay, assessed needs...patient care standards, cultural issues, available resources and will be consistent with other therapies and/or disciplines..."

"Discharge planning is initiated upon admission to the inpatient area and will address the continuum of care and referrals..."

Based on record review and interview, the facility failed to ensure a Consent to Surgery / Special Procedures / Anesthesia (with physician certification) form was dated and timed by the RNs at the time a telephone consent was obtained. And, the form was not signed, dated and timed by the ordering physician for an invasive procedure.

This failed practice had the potential for wrong procedure, the patient and representative not being provided information of risks, benefits, and potential for injury or death.

Findings:

On May 23, 2011, at 12:41 p.m., a review of Patient 22's record was conducted. The patient was admitted to the facility on May 21, 2011 with diagnosis that included; fever and altered level of consciousness (any state of awareness that differs from the normal awareness of a conscious person). On May 21, 2011, at 12:15 p.m., the physician wrote orders for, "...Schedule PICC line (peripherally inserted central catheter for intravenous delivery of fluids/antibiotics) in AM."

At that time, a review of the "Consent to Surgery/Special Procedures/Anesthesia (with Physician Certification)," form was reviewed. The consent had no documented diagnoses, the name of the practitioner that was performing the procedure, dates and times next to the licensed staffs' signatures, or the ordering physician's signature.

A review of the "PICC line Insertion Nursing Documentation Record," indicated the PICC line was inserted on May 23, 2011, two days after the physician wrote orders for PICC line insertion in the AM.

On May 23, 2011, at 12:52 p.m., an interview was conducted with RN 11. She stated she witnessed the telephone consent, but she did not sign or date the document. RN 11 stated, "Can I do it now [meaning, sign the telephone consent form]."

The facility's policy and procedure entitled, "Consent Documentation For Surgery, Anesthesia And / or Invasive Procedure," effective March 19, 2009, indicated the consents needed to be completed when a procedure was ordered by a physician. The policy further indicated a telephone consent would be witnessed by two licensed nurses by listening on the phone. The consents needed to contain their names, signatures, time and date the consent was obtained. The consent must include the physician's name who was performing the procedure.

Based on interview, medical record and document review, the facility failed to ensure that physicians documented a complete recovery from general anesthesia evaluation note for patients that had surgery with general anesthesia prior to discharge, for eight of eight medical records reviewed.

These failed practices had the potential for post anesthesia complications including death.

Findings:

On May 23, 2011, at 10 a.m., eight medical records of patients that underwent surgery with general anesthesia were reviewed. A review of Patient charts #1 to 8, was conducted. All eight records contained a document titled, "Anesthesia Record." The post anesthesia documentation included blood pressure, pulse, respirations, O2 Saturation, temperature and total fluid summary. A second form titled, "Pre and Post Anesthesia Evaluation" was reviewed. Under the section "Post Anesthesia Evaluation" documentation, it indicated "vital signs stable" and "no apparent complications." There was no documentation in the eight post anesthesia notes of the patient's mental status, pain, or nausea and vomiting.

The operating room director was interviewed on May 23, 2011, at 2:30 p.m. He stated that the anesthesiologists were not documenting in the post anesthesia note the patients' post general anesthesia evaluation data such as mental status, pain, nausea and vomiting.