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Based on observation, interview and document review, the facility did not have an effective governing body that carried out the functions required of a governing body as follows:

1. The governing body failed to ensure that contracted services provided were evaluated and adhered to hospital-wide policies and procedures. This failure resulted in the hospital not creating and maintaining a personnel file for a contracted employee. (A083)

2. The governing body failed to ensure that contracted cleaning service personnel at the outpatient clinic were subject to the same hospital-wide quality assessment and performance improvement (QAPI) evaluation as other services provided directly by the hospital. This deficient practice had the potential for services performed under contract to be provided in an unsafe and ineffective manner. This increased the risk for contracted staff to transmit potentially infectious microorganisms to patients receiving services in the facility. (A084).

3. The governing body failed to ensure that the Quality Assessment Performance Improvement Program identified that nursing was not providing continuous cardiac monitoring for 12 out of 12 intensive care unit patients and overflow Emergency department patients on portable cardiac monitors. (A 263)

4. The governing body failed to ensure that nursing provided continuous cardiac monitoring for 12 out of 12 Intensive care unit patients and emergency department overflow patients on portable cardiac monitors. (A 397)

The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Governing Body and failure to provide care to their patients in a safe environment.

Based on administrative staff interview and facility record review, the facility failed to recognize that the Governing Body of the hospital was ultimately responsible for all services furnished in the hospital whether or not they are furnished under contract. Hospital Administrators were not knowledgeable and were not aware that the governing body was ultimately responsible for the oversight of all contracted services provided in the hospital including outpatient clinics located at offsite locations. The Governing Body must ensure that a contractor of services, furnishes services that permit the hospital to comply with all applicable conditions of participation, and standards for the contracted services. This deficient finding resulted in the hospital not creating and maintaining a personnel file for 1 of 1 contracted employees (Contracted Staff A) to ensure that contracted services provided were evaluated and that Contracted Staff A was adhering to hospital-wide policies and procedures pertaining to general hospital orientation requirements, competency/ job specific evaluations and health screening examinations prior to and after employment.

Findings:

A review on 3/14/11, of Contracted Staff A's personnel file, revealed that Contracted Staff A was hired by the hospital on 12/10/2008, and was contracted to provide cleaning services after 5:00 PM, at Outpatient Clinic A, which was located at another location from the hospital. The facility failed to establish or create a current, accurate, and comprehensive personnel file containing evidence that the employee was adhering to policies and procedures of hospital-wide requirements, such as attending orientation sessions that included infection control prevention practices, classes in prevention of accidents, disaster preparedness, annual job specific evaluations, pre-employment and health screening requirements, including tuberculosis screening.

On 3/14/11, at approximately 2:30 PM, during an interview with the Human Resource Director, when asked if the hospital established or created a personnel file for Contracted Staff A, she stated, "I did not. All I have on her is what I have in my hand, this Confidentiality Agreement form that she had signed back in 2008."

A review on 3/14/11, of the facility's Personnel Policies and Procedures manual, dated 1/01, on page E-45, titled, "USE OF OUTSIDE RESOURCES-CONTRACTED SERVICES", in section 3, it stipulated, "...Regular Staff: includes contracted staff services where individuals provide services on a regular basis ... ". Further review, in subsection (a), stipulated, "Human Resources will establish and maintain personnel-like files for compliance with The Joint Commission and State regulatory requirements."

On 3/14/11, a review of the hospital's Administrative Policy, (not dated), titled, "POLICY FORMULATION, REVISION AND APPROVAL PROCESS", documented in Section 1 and 2, "... Personnel and Administrative policies are developed with input, as appropriate, from the Board members, Administration, Medical Executive Committee, and department managers...".

On 3/14/11, at approximately 4:20 PM, during the Exit Conference, in response to the findings, the Chief Executive Officer (CEO) stated, "What does this mean. Does this mean the hospital must create personnel files on all vendors that deliver products to the hospital, or how about our gardeners. I just don't know, in this case, I don't know the spectrum of the hospital's responsibilities."

Based on administrative staff interview and hospital record review, the facility failed to ensure that contracted cleaning service personnel at Outpatient Clinic A was subject to the same hospital-wide quality assessment and performance improvement (QAPI) evaluation as other services provided directly by the hospital. The hospital failed to create a current, complete and accurate personnel file to ensure that 1 of 1 contracted employees (Contracted Staff A) was adhering to hospital policies and procedures of hospital wide requirements pertaining to the hospital's orientation process, competencies of job specific assignments, and health screening requirements prior to employment. This deficient practice had the potential to result in services being performed under a contract in an unsafe and ineffective manner including possible transmission of potentially infectious microorganisms.

Findings:

A review on 3/14/11, of Contracted Staff A's personnel file, revealed that Contracted Staff A was hired on 12/10/08 by the hospital, and was providing cleaning services, such as cleaning of all patient examination tables, countertops and bathrooms, at Outpatient Clinic A, located at a separated location from the hospital. The hospital failed to create or establish a current, complete and accurate personnel file to ensure that Contracted Staff A was adhering to hospital policies and procedures of hospital-wide requirements pertaining to orientation sessions, such as infection control requirements, competency of job specific requirements and health screening validation, such as tuberculosis screening, prior to employment.

On 3/14/11, at approximately 2:30 PM, during an interview with the Human Resource Director, when asked if the hospital established or created a personnel file for Contracted Staff A, she stated, "I did not. All I have on her is what I have in my hand, this Confidentiality Agreement form that she had signed back in 2008."

The hospital failed to provide documented evidence that personnel records were maintained and in-service training was conducted for Contracted Staff A, such as infection control prevention. There was no documented evidence that job related competencies were conducted to ensure that contracted services were being provided in a safe and effective manner.

There was no evidence that hospital's QAPI program evaluated services provided by Contracted Staff A. There was no documented evidence that hospital-wide procedures pertaining to safety and accident prevention in the workplace were being followed by Contracted Staff A. There was no evidence that Contracted Staff A was adhering to hospital-wide policies and procedure pertaining to annual job related evaluation, disaster preparedness and health examination requirements.

On 3/14/11, a review of Contracted Staff A's Business Contract Agreement, dated 12/10/08, titled, "ASSIGNMENTS, TRAINING AND POLICIES AND PROCEDURES", stipulated in section 2.1, "...Hospital shall retain sole responsibility for directing the services provided by said Company. Hospital shall retain professional and administrative responsibility for the services rendered by said Company..."

Therefore, the hospital failed to provide evidence that the hospital's QAPI program established a mechanism to evaluate the quality of contracted cleaning services provided by Contracted Staff A. The hospital failed to evaluate and ensure that contracted cleaning services, provided by Contracted Staff A, were provided in a safe and effective manner; when it failed to maintain a personnel file for Contracted Staff A, in order for oversight and quality assurance and performance improvement review to take place.

Based on observation and interview, the facility failed to ensure the posting of patient's rights information in the emergency department (ED) patient waiting area.

Findings:

During a tour of the ED patient waiting area on 3/7/11 at 11:45 AM, there was no posted patient rights information observed in the waiting area.

On 3/7/11 at 11:45 AM during an interview with the ED charge nurse, he acknowledged that the posted patient rights had been removed from the ED waiting area and that the facility was waiting for new patient rights to be posted.

Based on observation, interview and record review, the facility failed to ensure that consents for treatment for 1 of 54 sampled patients (Patient 69) were signed by the responsible party for Patient 69 who was not competent to sign. This failure had the potential to result in the patient undergoing treatment without having documented evidence of consents for medical treatment from the responsible party.

Findings:

During an observation of Patient 69 conducted on 3/8/11 at 10:16 AM, in his room, Patient 69 was noted to be sleeping on a low bed, head of bed elevated 45 degrees, side rails up, receiving intravenous fluids, oxygen via nasal cannula, and had an indwelling urinary catheter (a tubing inserted in the patient's urinary tract to drain urine from the bladder into a bag) that contained yellow urine and was hanging from his bed.

The medical record for Patient 69 was reviewed on 3/8/11, and indicated that the patient was a 67 year old, male, admitted to the facility on 3/7/11, with diagnoses of dehydration and Down syndrome.

The history and physical (H&P) dated 3/7/11, indicated that Patient 69 was brought in to the facility by his caretaker. The H&P also revealed that Patient 69 was not able to provide any kind of history about himself secondary to his Down syndrome (a genetic condition that causes delays in physical and intellectual development) and worsening dementia (a loss of brain function that occurs with certain diseases. It affects memory, thinking, language, judgement, and behavior). Upon physical examination, Patient 69 was described as anxious and confused.

The medical admitting orders dated 3/7/11 included orders for intravenous hydration, laboratory and radiological tests, oxygen therapy, antibiotic therapy, anxiety and pain medications, soft restraints and fall precautions.

Review of the facility's form titled, "Conditions of Admission", that included consent for medical and surgical procedures was noted not to be signed by the patient or the responsible party, but instead was left completely blank.

Review of the facility's forms titled, "Consent to Use and Disclose Protected Health Information" and the "Inpatient Information Form" that included the Patient's Rights information were noted not to be signed by the patient or the responsible party, but instead was left completely blank.

During an interview with Staff A conducted on 3/8/11 at 11:30 AM, confirmed that the above forms were left blank and stated that the admitting nurse was responsible to ensure that the consents for medical treatment and all other admitting forms were signed by either the patient or by the responsible party at the time of admission.

During an interview with the Admitting Manager (AM), conducted on 3/8/11 at 1:40 PM, the request was made for the facility's P&P (policy and procedure) regarding consents for medical treatment. The AM stated that the facility did not have a policy and procedure directing them on how to obtain consent for medical treatment from a patient that was incompetent to provide consent.

During an interview conducted on 3/8/11 at 2:50 PM, the Medical Records Director (MRD) stated that the expectation of the admitting nursing staff was to request legal documentation which indicated who was legally able to sign for the patient's medical treatment consents. The MRD further stated that if a driver or another person not legally able to sign consents, brings the patient to the facility, the expectation of the admitting staff is to call the patients residence to obtain documentation and consent for treatment from the person legally responsible for the patient.

Based on interview and record review, the facility failed to ensure that 1 of 54 sampled patients (Patient 63) was given information on advance directives upon admission. This failure had the potential for Patient 63's medical care decisions to not be complied with by the facility in the event the patient was unable to communicate for himself/herself.

Findings:

Record review revealed Patient 63 was a 40 year old female admitted to the facility on 2/27/11 with a diagnosis of status post full arrest. (Cardiac and respiratory arrest, when the heart goes into a non-life sustaining rhythm and you stop breathing).

Record review of the Advance Directives Data Sheet to be completed by Admitting or Nursing Staff, dated 2/27/11, revealed an incomplete document. There were no items selected to determine if Patient 63 had or did not have an advanced directive. The form listed the patient ' s son as the spokesperson (surrogate decision maker). The form was noted to be signed by the patient ' s mother and a witness.

During an interview on 3/8/11 at 9:15 AM, RN 4 stated that the Advance Directives Data Sheet was normally completed on admission. RN 4 stated that at the time of admission Patient 63 was unable to complete the form and her son was her spokespokerson and he should have been given the advance directive information. RN 4 further stated that she would feel comfortable with the patient ' s response today since she was more alert. RN 4 confirmed that Patient 63 ' s son should have been given advance directive information upon admission if Patient 63 was not alert at the time of admission.

Based on interview and document review, the facility failed to implement and maintain an ongoing data driven quality assessment and performance improvement (QAPI) program by failing to do the following:

1. The hospital failed to ensure that contracted cleaning service personnel at the outpatient clinic were subject to the same hospital-wide QAPI evaluation as other services provided directly by the hospital. This deficient practice had the potential for services performed under contract to be provided in an unsafe and ineffective manner. This increased the risk for contracted staff to transmit potentially infectious microorganisms to patients receiving services in the facility. (A084).

2. The hospital failed to ensure that the QAPI program collected data to measure, analyze and track the following: 1. safe holding temperatures for potentially hazardous foods in the cafe on the salad bar; and 2. Nutrition assessments and nutrition monitoring of patients in the neonatal intensive care unit. These failures resulted in the hospital's inability to identify and correct problems to ensure that the problems did not occur or did not occur again. (A267)

3. Failed to identify that nursing was not providing continuous cardiac monitoring for intensive care unit patients and emergency department overflow patients on portable cardiac monitors. (A397)

The cumulative effect of the facility's failure to implement and maintain an ongoing QAPI program resulted in the facility's failure to deliver care in compliance with the Condition of Participation for QAPI and failure to provide care to their patients in a safe environment.

Based on observation, interviews and record reviews the hospital failed to ensure that the QAPI program collected data to measure, analyze and track the following: 1. Safe holding temperatures for potentially hazardous foods in the cafe on the salad bar; and 2. Nutrition assessments and nutrition monitoring of patients in the neonatal intensive care unit. These failures resulted in the hospital's inability to identify and correct problems affecting the health and safety of patients in a universe of 171 licensed beds, to ensure that the problems did not occur or did not occur again.

Findings:

During the survey from 3/7/11 to 3/11/11, deficient practices were observed as it related to the following:

1. The DFNS (Director of Food and Nutrition Services) failed to ensure that cold, potentially hazardous food (PHF) held on the cafe salad bar was not at temperatures greater than 41 degrees Fahrenheit (F) and that those foods were monitored for time temperature control (Cross refer A-620)

During a tour of the food service department on 3/7/11 at 11:30 AM, the temperature of the macaroni salad on the cafe salad bar was noted to be 47.2 degrees F (fahrenheit). During a concurrent interview with the DFNS, he stated that the food on the salad bar was placed there between 10:30 AM and 10:45 AM and was left there until 6:30 PM when the cafe closed. This food was for the service of both lunch and dinner.

When asked how the temperature of the food was monitored for safety during this 8 hour period, the DFNS stated that the food service workers (FSW) record temperatures on a log when the food was first placed on the salad bar and then every 2 hours throughout the day until the food was removed from the salad bar at 6:30 PM.

A concurrent review of the salad bar log for 3/7/11 and interview with the DFNS revealed that at 11:30 AM, the temperatures were not recorded for 10:30 AM that day. The DFNS stated that the FSW responsible for filling out the temperature logs was on a break and that the next time the temperatures were due to be checked was 12:30 PM.

The temperature of the macaroni salad on the salad bar was again checked at 1:55 PM the same day and was noted to be 55.6 degrees F. The container of bacon bits was noted to be 53.6 degrees F.

A review of the Hospital's HACCP (Hazard Analysis Critical Control Point-a systematic preventive approach to food safety) Food Safety Program policy, page 8, dated 8/2009, states that for handling food during preparation, cooking, holding, cooling, reheating and serving, all potentially hazardous foods must meet the following temperature requirements during preparation, display, service and transportation. "Cold foods: hold foods at 40 degrees or below."

A review of the hospital's HACCP Daily Taste Panel Chart (temperature logs) for the Cafeteria Soup and Salad Area showed that the staff is instructed that for HACCP Temperature Requirements for Potentially Hazardous Foods, "Product temperature must be recorded (hospital's emphasis) on this log at 2 hour intervals during holding and serving.

A review of these logs dated 2/28/11 through 3/6/11 revealed that in 16 of 36 opportunities that temperatures were required to be recorded, they were not. A further review of these logs between 1/3/11 and 2/24/11 revealed that only 3 of 20 days of logs had been filled out as directed and many of the forms had been blank.

According to the 2009 USDA Food Code, "Bacterial growth and/or toxin production can occur if potentially hazardous food (PHF) remains in the temperature "Danger Zone" of 41?F to 135?F too long. Up to a point, the rate of growth increases with an increase in temperature within this zone." It further states, "Maintaining PHF foods under the cold temperature control requirements prescribed in this code (less than 41?F) will limit the growth of pathogens that may be present in or on the food and may help prevent foodborne illness."

A review of the hospital's policy titled, "Food and Nutrition Performance Improvement Plan" revised 1/2011, revealed that the purpose of the policy was for the department to participate, "in a hospital wide Perfomance Improvement (PI) program designed to monitor, evaluate and improve the quality and appropriateness of food and clinical nutrition services through a systematic process of planning and designing, measuring, collecting data for aggregation and analysis that identifies and promotes performance improvement. This process was structured to:

1. Identify opportunities to improve care and services provided, through continuous assessment of systems;
2. Implement solutions which will bring about desired change;
3. Facilitate a positive patient outcome;
4. Maintain a safe environment for personnel, patients and visitors."

During an interview with the Clinical Nutrition Manager (CNM) on 3/10/11 at 1:30 PM, she confirmed that she maintained the PI reports for the Food and Nutrition Services Department. She further stated that the PI program did not monitor the retail (cafe) temperature logs for completeness and/or accuracy.

2. The Clinical Nutrition Manager (CNM) failed to ensure the nutrition needs of patients in the neonatal (newborn) intensive care unit (NICU) were reviewed according to the hospital ' s policy and procedures. (Cross refer A-630)

During a concurrent record review of NICU patients and interview with RD 1 on 3/9/11 at 10:00 AM, RD 1 stated that she didn ' t document in the patient ' s medical record unless she received an order for a nutrition consultation from the physician. She stated that she seldom received these consults, usually one or two a year. She stated that the hospital did not have a separate policy for assessment of the NICU patients, therefore the staff guidance for the assessment of the NICU patients was consistent with the nutrition assessment policy for the general population of patients at the hospital.

A review of the patient census for NICU revealed that there were 12 patients in the unit. Of the 12 patients, 6 were receiving either total parenteral nutrition (nutrition given directly into the blood through a needle inserted through the skin into a vein) or tube feedings. One of the 6 patients had been there less than 4 days, the others had been there 4, 23, 24 or 35 days. There was no documented nutrition assessment in the medical records for these patients.

A review of the hospital's policy titled, "Nutrition Assessment", last reviewed 4/2010, revealed that, "The goal of the patient (nutritional) assessment is to determine what kind of care is required to meet a patient's need as well as his or her needs as they change in response to care. Processes and activities shall include collecting data; analyzing data; making care decisions, developing a care plan." It further stated, "All patients including children; adolescents; adults; and geriatric patients will have nutrition status assessed, when warranted by the patient's needs or conditions. Nutritional assessment is triggered by: ...Priority parameters (reference policy #204)."

A review of the hospital's policy #204 titled, "Prioritization", revised 2/2011, revealed, "All patient's admitted will be screened to determine the need for nutritional assessment." And "To ensure timely and appropriate identification of those patients for whom nutrition intervention is an integral part of their therapy during hospitalization." The guideline stated, "Priority I - HIGH RISK (will be) assessed within 24 hours of identification of need: Consults ordered by the physician or generated by nursing resulting from the initial nursing assessment completed on admission, TPN (total parenteral nutrition) and tube feeding (a method to provide nutrition to patients who cannot obtain nutrition by swallowing) within 24 hours of receipt of order."

A review of the hospital's policy titled, "Food and Nutrition Performance Improvement Plan" revised 1/2011, revealed that the department was to participate, "in a hospital wide Perfomance Improvement (PI) program designed to monitor, evaluate and improve the quality and appropriateness of food and clinical nutrition services through a systematic process of planning and designing, measuring, collecting data for aggregation and analysis that identifies and promotes performance improvement. This process is structured to:
1. Identify opportunities to improve care and services provided, through continuous assessment of systems;
2. Implement solutions which will bring about desired change;
3. Facilitate a positive patient outcome;
4. Maintain a safe environment for personnel, patients and visitors."

During an interview with the Clinical Nutrition Manager (CNM) on 3/10/11 at 1:30 PM, she confirmed that she maintains the PI reports for the Food and Nutrition Services Department. She further stated that the PI program did not monitor NICU patients nutrition care documentation to ensure the hospital's policies regarding nutriton care were being followed.

Based on observation, interview, and record review the facility failed to have a well organized nursing service to provide 24-hour nursing services to all patients by:

1. Failing to ensure that portable cardiac bedside monitoring was being conducted continuously, at all times, for all patients in overflow hallway beds in the emergency room. This deficient practice had the potential for substandard nursing care being provided potentially affecting the health and welfare of those patients requiring continuous cardiac monitoring. (A392)

2. Failing to ensure that patient care needs were met in accordance with accepted standards of nursing practice and hospital policy for 1 of 54 sampled patients (Patient 69) by failing to perform the correct urinary catheterization procedure as ordered by the physician. This failure had the potential to result in a urinary tract infection. (A395)

3. Failing to ensure that ICU (Intensive Care Unit) patients with orders for continuous telemetry monitoring were being provided continuous monitoring oversight by a trained monitor technician or other qualified person.

This failure resulted in the identification of immediate jeopardy in which there was a potential for life threatening cardiac arrhythmias (any problem with the rate or rhythm of the heartbeat) to occur without immediate identification to provide necessary interventions for 12 patients currently admitted to the ICU.

Immediate Jeopardy (IJ) was called on 3/7/11 at 4:48 PM in the presence of the survey team and facility administrators. An acceptable plan of correction was received and agreed upon by the survey team on 3/7/11 at 5:50 PM. The IJ was abated on 3/9/11 at 3:38 PM in the presence of the facility's administrative staff. (A397)

4. Failing to ensure drugs and biologicals were administered in accordance with the orders of the practitioner responsible for the patient's care for 1 of 54 sampled patients (Patient 69) by failing to administer Ativan 0.5 mg intravenously as prescribed. This failure resulted in the potential for the patient to become agitated and stressed. (A404)

5. Failing to ensure that orders for IV (intravenous) potassium included the concentration of the diluent to be infused over a four hour period for 1 of 54 sampled patients (Patient 66). This failure had the potential for a fatal medication error to occur. (A406)

The cumulative effect of these systemic problems resulted in the facility's failure to deliver patient care in a safe manner and in compliance with the Condition of Participation for Nursing Services.

Based on staff interview and hospital record review, the facility failed to ensure that portable cardiac bedside monitoring was being conducted continuously, at all times, for all patients in overflow hallway beds in the emergency room. This deficient practice had the potential for substandard nursing care being provided potentially affecting the health and welfare of those patients requiring continuous cardiac monitoring.

Findings:

On 3/8/11, at approximately 2:15 PM, an interview with the Emergency Room Charge Nurse (ERCN) was conducted. The ERCN was asked the following question: when overflow patients are placed in the hallway and required portable cardiac monitoring, how were the nurses able to continuously monitor their patients who were not being continously monitored by the telemetry technician at the central nurses' station, the ERCN stated, "Occasionally this happens and it is very hard to do."

On 3/8/11, at approximately 3:00 PM, an interview with ER Staff C was conducted. ER Staff C was asked the following question, when overflow patients in the hallway required portable cardiac monitoring how were the nurses able to continuously monitor their patients, ER Staff C stated, "The primary nurse will monitor her patient but it is very hard to do because she has other patients to care for."

A review, on 3/8/11, of the hospital's policy and procedure titled, "TELEMETRY MONITORING", dated 6/2010, stipulated in section 2, "...Continuous telemetry monitoring is conducted by a trained monitor technician or nurse upon notification of order..."

Based on observation, interview, and record review, the facility failed to meet the patient's care needs in accordance with accepted standards of nursing practice and hospital policy for 1 of 54 sampled patients (Patient 69) by failing to perform the correct urinary catheterization procedure as ordered by the physician. This failure had the potential to result in a urinary tract infection.

Findings:

During an observation of Patient 69 conducted on 3/8/11, at 10:16 AM, in his room, Patient 69 was noted to have an indwelling urinary catheter (A tubing inserted in the patient's urinary tract to drain urine from the bladder into a bag) with a drainage bag attached that contained yellow urine and was observed to be hanging from his bed.

The medical record for Patient 69 was reviewed on 3/8/11 and indicated that the patient was a 67 year old, male, admitted to the facility on 3/7/11 with diagnoses of dehydration.

The medical admitting orders dated 3/7/11 included orders for urinalysis and urine culture and sensitivity via an in and out catheterization (procedure performed with the use of an urinary catheter to obtain clean urine, but not intended to be left in the bladder as an indwelling catheter). There was no documented evidence of a physician's order for the insertion of an indwelling catheter.

During an interview with Staff A conducted on 3/8/11, at 11:30 AM, confirmed that a physician's order for an indwelling urinary catheter was not located in the patient's medical record and stated that a physician's order should be in place prior to nursing staff performing the procedure.

During an interview with the Director of Telemetry conducted on 3/8/11, at 11:35 AM, stated that a telephone call was made to the nurse who performed the urinary catheterization procedure and confirmed that the catheter was left in place because she got confused with the physician's order.

Review of the facility's patient care policy titled, "Urinary Tract Infection Prevention/Management", with a last revision date of 3/10, indicated that the purpose was to outline responsibilities relating to indwelling urinary catheters with the goal of decreasing urinary tract infections. It also indicated that a physician's order was required for placement, removal, or change of an indwelling urinary catheter, including straight catheterization.

Based on observation, interview, and record review, the facility failed to ensure that ICU (Intensive Care Unit) patients with orders for continuous telemetry monitoring were being provided continuous monitoring oversight by a trained monitor technician or other qualified person.

This failure resulted in the identification of immediate jeopardy in which there was a potential for life threatening cardiac arrhythmias (any problem with the rate or rhythm of the heartbeat) to occur without immediate identification to provide necessary interventions for 12 patients currently admitted to the ICU.

Immediate Jeopardy (IJ) was called on 3/7/11 at 4:48 PM in the presence of the survey team and facility administrators. An acceptable plan of correction was received and agreed upon by the survey team on 3/7/11 at 5:50 PM. The IJ was abated on 3/9/11 at 3:38 PM in the presence of the facility's administrative staff.

Findings:

Patients admitted to the ICU setting are commonly placed on a cardiac telemetry device. The device is attached to the patient ' s skin by adhesive electrodes that snap on to lead wires. In turn, the wires attach to a radio frequency device. The monitoring device sends the electrical activity of the heart to a computer screen where technicians monitor the activity.

An observation was made of the facility's ICU on 3/7/11 at 11:50 AM. Three rooms were observed with patients in them and no nurse inside the rooms observing the cardiac monitors. There was no staff member observed to continuously monitor the centralized monitors located at the nursing station.

During an interview with CN 1 (Charge Nurse), who was present during the observation, she stated that there was no assigned monitor technician at the central telemetry monitors located at the nursing station. She also stated that the expectation was that everyone (Registered Nurses) was in their room watching their monitors. CN 1 further stated that the facility had CNA's (Certified Nursing Assistants) who were also monitor technicians but no one sat specifically at the central telemetry monitors at all times.

During an interview with the CNO (Chief Nursing Officer) on 3/7/11 at 11:56 AM, she stated, everyone watches the central monitors at the nursing station but there is no one specifically assigned to continuously watch the telemetry monitors.

During an interview with the ICU Nurse Manager (NM) on 3/7/11 at 12:00 PM, NM 1 stated the monitor alarms were audible and that no one was required to be at the central monitors at the nursing station.

During record review on 3/7/11 of the ICU Nursing Unit Census sheet revealed that 12 patients (Patients 63, 64, and 89-98) were admitted to the ICU.

During record review on 3/7/11 of the ICU admission orders for all 12 patients revealed orders for continuous telemetry (a means of sending real-time tracing of the electrical activity in the heart to a view screen somewhere within the vicinity of the patients telemetry monitor).

During an interview with the Director of Telemetry on 3/7/11 at 12:53 PM, she stated that she had worked at the facility for 13 years and had not had a monitor technician in the ICU. The CNO, who was also present during the interview, indicated that other hospitals were not required to have a monitor technician.

During further interview with the CNO, she stated, "If I were bathing a patient, I wouldn't be able to see the monitor on the other patient. That's why we have alarms".

Review of the Patient Care Policy on 3/7/11 for Telemetry Monitoring (Policy No. T-104) revealed the following:

Policy: "1. Patients meeting the admission criteria for telemetry monitoring will be placed on the centralized telemetry monitoring system located within the care unit for continuous observation of their heart rhythm by a Monitor Technician."

Procedure: "2. Continuous telemetry monitoring is conducted by a trained Monitor Technician or nurse upon notification of order."

During an interview on 3/7/11 at 1:53 PM with the CNO, NM 1, Director of Nursing (DON), Director of ICU, Director of Education, and the Director of Quality, the CNO stated that the patients in ICU were being continuously monitored by the telemetry monitor. She stated again that if a nurse were giving a bath to one of her patients, she would not be able to watch the monitor continuously but the monitors had alarms that would sound if the patient had an abnormal rhythm.

During an interview with NM 1 on 3/7/11 at 2:05 PM, she stated that the yellow alarms on the monitor could indicate pvc's (premature ventricular contractions: an abnormal heartbeat or arrhythmia in which the ventricle of the heart contracts early without receiving a signal from the AV (atrio-ventricular) node. (The AV node is a part of the electrical control system of the heart that coordinates heart rate). NM 1 stated that the alarms had different sounds for different rhythms but the monitors did not interpret the different types of heart block. NM 1 further stated the nurse needed to interpret the block.

Heart block is a problem that occurs with the heart's electrical system. This system controls the rate and rhythm of heartbeats. The three types of heart block are first degree, second degree, and third degree. First degree is the least severe and third degree is the most severe.

Third degree heart block, also known as complete heart block, may be a medical emergency with potentially severe symptoms and a serious risk of cardiac arrest (sudden cardiac death). Third degree heart block limits the hearts ability to pump blood to the rest of the body. Third degree heart block requires prompt treatment because it may be fatal.

During an interview on 3/7/11 at 2:07 PM, the CNO stated that if the nurse was in one patient's room, they can set up the monitor in that room which would allow them to view their other patient.

During an interview on 3/7/11 at 2:10 PM, with RN 1, he stated that he had worked in the ICU for approximately 3 ? years and that the nurses were supposed to be able to set up the monitor to allow them to view both of their patients in one room but he had not done that in a long time and was unsure of how to set it up. RN 1 further stated that the ICU had no monitor technician to continuously monitor the telemetry monitors at the nursing station.

During an interview on 3/7/11 at 2:14 PM, CN 1 stated she had trouble setting up the new monitors. When asked how long the monitors had been on the unit, CN 1 replied she was unsure how long they had the monitors, probably 3 to 4 years. CN 1 confirmed that if she was in one patient's room, she would not be able to watch the monitor of her other patient.

During further interview with CN 1, she confirmed that if she was in one patient's room, she would not be able to provide continuous monitoring of the other patient assigned to her.

During an interview on 3/7/11 at 2:15 PM, RN 2 stated that the facility does not have a staff continually monitoring the telemetry monitors located at the nurses station. Additionally, RN 2 stated that she was unable to continuously monitor her two patients and that if she was busy in one patient's room, she would be unable to visualize the tracing of her other patient's cardiac monitor.

Document review on 3/7/11 of the Standards of Care for the ICU patient revealed the following: "Policy: 11. ...Staff RN will respond to alarms in immediate fashion and respond to physiologic changes in patient or device. The reason for the alarming will be evaluated".

During an interview on 3/7/11 at 2:20 PM, RN 3 stated, "We don't bring it up, my other patient's cardiac screen. I don't know how to do it, we never do it here." RN 3 further stated, "I don't know how to bring up my other patients cardiac monitor from room 3. My other patient assignment is in room 6."

During an interview on 3/7/11 at 2:25 PM, when informed that 4 of 6 ICU nurses assigned to work the AM shift on 3/7/11 were interviewed and were unable to demonstrate how to pull up their second patient on the telemetry monitor, the CNO replied that she was informed the ICU staff RN's were aware of how to set up the monitors to allow them to view their other patient if they were in one patient's room.

Review of general guidelines from the American College of Cardiology revealed that there must be adequate human surveillance of the monitors 24 hours a day by medical, nursing, or paramedical personnel (monitor watchers) trained and qualified in the ECG (electrocardiogram) recognition of clinically significant cardiac rhythm disturbances.

During an interview on 3/7/11 at 4:48 PM, in the presence of the CEO (Chief Executive Officer), CNO, and the Director of Risk Management, an immediate jeopardy (IJ) was called due to lack of continuous cardiac monitoring by a trained monitor technician or other qualified person for ICU patients admitted to the unit with orders for continuous telemetry monitoring.

On 3/7/11 at 5:50 PM, an acceptable plan of correction was received by the survey team, however the IJ was not abated at that time. The facility indicated that each shift in the ICU would have a competent staff member dedicated to continuously monitor ICU patients for cardiac arrhythmias (any problem with the rate or rhythm of the heartbeat). The ICU Nursing Director/designee would assure the process was fully implemented and adhered to.

On 3/8/11 at 3:25 PM, an observation was made on the ICU of NM 1 standing with her back towards the central monitor located at the nursing station. NM 1 was talking to another staff member who was also standing and observed to be not watching the central monitor as well. The chair located in front of the central monitors was observed to be empty.

During an interview on 3/8/11 at 3:25 PM, NM 1 indicated that the person monitoring the central monitor was on a break. The break log did not show the time that the person monitoring went on break. It was observed to be blank. NM 1 further stated she forgot to record the time the nurse went on break.

During further interview, NM 1 stated that the PM monitor technician called off and they were waiting for the staffer to call back with a replacement.

On 3/8/11 at 3:30 PM, RN 1 returned to the chair located in front of the central monitoring unit at the nursing station.

On 3/8/11 at 4:19 PM, the CEO requested to speak with the surveyors prior to exiting for the day. The CEO indicated that the facility was providing continuous cardiac monitoring with the machine (telemetry monitor). The CEO and the Director of Quality both indicated that the alarms go off with abnormal rhythms. At the end of this discussion, it was a team decision not to abate the IJ.

On 3/9/11 at 9:30 AM, an observation was made in the ICU of staff monitoring the central telemetry monitors located at the nursing station. CN 2 was able provide evidence of staff assigned to provide continuous cardiac monitoring for the previous shift and the next two shifts to come.

On 3/9/11 at 2:55 PM, an observation was made in the ICU. There was an assigned monitor technician sitting at the central telemetry monitor at the nursing station.

On 3/9/11 at 3:38 PM, the IJ was abated by the survey team with facility staff present. The facility was able to provide a schedule of monitor technicians assigned to the ICU through 3/19/11.

Based on observation, record review and interview, the facility failed to ensure drugs and biologicals were administered in accordance with the orders of the practitioner responsible for the patient's care for 1 of 54 sampled patients (Patient 69) by failing to administer Ativan 0.5 mg intravenously as prescribed. This failure resulted in the potential for the patient to become agitated and stressed.

Findings:

During an observation of Patient 69 conducted on 3/8/11, at 10:16 AM, in his room, Patient 69 was observed to have an indwelling urinary catheter (A tubing inserted in the patient's urinary tract to drain urine from the bladder into a bag) with a bag attached that contained yellow urine and was observed to be hanging from his bed.

The medical record for Patient 69 was reviewed on 3/8/11 and indicated that the patient was a 67 year old, male, admitted to the facility on 3/7/11 with diagnoses of dehydration.

The history and physical dated 3/7/11 indicated that Patient 69 was not able to provide any kind of history about himself secondary to his Down syndrome and worsening dementia. Upon physical examination, Patient 69 was described as anxious and confused. The plan of care included an urinalysis and urine culture and sensitivity.

The medical admitting orders dated 3/7/11 included orders for urinalysis and urine culture and sensitivity via an in and out catheterization (procedure performed with the use of a urinary catheter to obtain clean urine). Also, included was an order for Ativan (medication used to treat anxiety and agitation) 0.5 mg IVP, to be administered prior to the in and out catheterization procedure.

The Patient Assessment/Admission Profile indicated that a Foley catheter (an indwelling urinary catheter) was inserted on 3/7/11.

The Med/Surg/Tele Shift Assessment dated 3/7/11, under the "GU" (genito-urinary: pertaining to the genital and urinary organs) section, indicated that the urine source was a Foley catheter.

Review of the Medication Administration Records (MARs) dated 3/7/11, indicated no documented evidence that the prescribed Ativan was administered prior to the urinary catheterization procedure.

During an interview with Staff A conducted on 3/8/11, at 11:30 AM, confirmed that the order for Ativan 0.5 mg (milligrams) was not documented as given prior to the urinary catheterization procedure. Staff A was not able to explain why the prescribed medication was not administered, but stated that she would find out.

During an interview with the Director of Telemetry conducted on 3/8/11, at 11:35 AM, stated that a telephone call was made to the nurse who performed the urinary catheterization procedure and confirmed that the prescribed Ativan 0.5 mg IVP (IV [intravenous: within the vein] push or bolus: a syringe is connected to the IV access device and the medication is injected directly into an ongoing intravenous infusion) was not administered prior to the procedure.

Review of the facility's patient care policy titled, "Medication Ordering, Administration, and Monitoring", with a last revision date of 11/09, under the administration section, indicated that all drugs will be checked against order prior to administration to ensure correct: patient, drug, dosage, time and date of administration, route of administration, and indication. Also, the policy indicated that all administered drugs would be documented on the MAR.

Based on interview and record review, the facility failed to ensure that orders for IV (intravenous) potassium included the concentration of the diluent to be infused over a four hour period for 1 of 54 sampled patients (Patient 66). This failure had the potential for a fatal medication error to occur.

Findings:

Record review on 3/9/11 revealed Patient 66 was an 82 year old male admitted to the facility with a diagnosis of pneumonia.

A record review was conducted on 3/9/11 of the MAR (medication administration record) for Patient 66 covering the period from 2/25/11 at 7 AM through 2/26/11 at 6:59 AM revealed a standing ICU (intensive care unit) Electrolyte Protocol which showed the following scale:

If NPO (nothing by mouth), give KCL (K=potassium, CL=chloride) 40 meq (milliequivalent) IVPB (intravenous piggyback: a set up which allows a supplementary solution to run into the IV system) over 4 hours. There was no documented evidence found on the MAR that this medication (kcl) was to be diluted in a solution.

Record review on 3/9/11 of the facility's Pharmacy Policy and Procedure Manual on intravenous (within a vein) potassium, policy number 03B12, dated 5/2008 revealed the following: "II. Concentration of Solution: b. central line administration: maximum concentration of 100 meq/liter. 40 meq/100 ml (milliliter) aliquots (to divide, as a solution, into equal parts) may be used."

During an interview on 3/9/11 at 11:10 AM, NM 1 stated that all staff were trained and understand that the kcl comes in a water solution. NM 1 confirmed that the kcl should have included the diluent it comes in on the MAR.

Based on interview and record review, the facility failed to ensure that 1 of 54 sampled patients (Patient 83) medical records were protected to prevent loss. This failure resulted in the loss of Patient 83's February 2011 MAR (Medication Administration Record). Additionally, this failure had the potential for Patient 83's health care providers to not have the medical records necessary for use in making assessments of Patient 83's condition, decisions on the provision of care and in planning Patient 83's care.

During review of a medical record on 3/10/11 at 12:10 PM, it was noted that Patient 83 was admitted on 2/17/11 with a diagnosis of peripheral arteriosclerosis (thickening and loss of elasticity of arterial walls).

Record review on 3/10/11, at 12:10 PM, revealed no documented evidence of Patient 83's February 2011 MAR's.

During an interview on 3/10/11 at 12:10 PM, RN 5 verified the findings and stated that she could not find them.

During an interview on 3/10/11 at 12:30 PM, RN 8 stated that the MAR''s for February 2011 were "misplaced."

Based on record review, policy review and interviews, the facility failed to ensure medical records were dated, timed and authenticated in a time frame consistent with the hospital's policy and procedures for 4 of 54 sampled patients (Patients 75, 74, 65, and 66). This failure resulted in dictated documents by the physicians to not be authenticated (validated) in a timely manner which had the potential to result in reports being filed in the medical record lacking the physicians signature to indicate verification of the report for accuracy.

Findings:

1. On 3/9/11, a record review revealed a physician had dictated on 2/22/11 a "Medical Decision Making" for Patient 75 to be admitted to the facility for treatment.

The form written by the physician for Patient 75's "Medical Decision Making" on 2/22/11, was not authenticated by the physician until 2/28/11, 4 days after the patient was discharged hospital, and 6 days after the admission treatment plans had been dictated by the physician.

On 3/9/11, at 11:15 AM, the facility's director of education during an interview stated, "The medical record admission assessments should be completed within 24 hours, that would include the physician's signature, date, and time. If it hasn't been authenticated within the 24 hours then the records are incomplete."

On 3/9/11, a record review of the facility's policy dated 2010 (no month written) for medical record titled a "Timely Completion of the Medical Record" states:

3.3-2 "The patient's attending physician shall be responsible for directing and supervising the patient's overall medical care, for coordinating all consultations, for completing and recording the medical record a medical history and physical examination within twenty-four hours of admission, for the prompt and accurate completion of the medical record, for necessary special instructions, and for transmitting information regarding the patient's status to the patient, the referring physician, if any, and to the patient's family. The history and physical examination must be completed and recorded in the medical record prior to any surgery or invasive procedure."

9.3-2 "A medical record lacking any required element or required authentication, which includes signature, date and time of entry is considered incomplete."


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2. Review of Patient 74's medical record conducted on 3/09/11 indicated that Patient 74 was admitted to the facility on 3/03/11 with diagnosis that included acute pancreatitis.

Review of the "History and Physical Examination" conducted and dictated on 3/03/11 indicated no documented evidence that it had been authenticated by the physician to this day.

On 3/15/11, at 11:15 AM, the facility's director of education stated, "The medical record admission assessments should be completed within 24 hours, that would include the physician's signature, date, and time. If it hasn't been authenticated within the 24 hours then the records are incomplete."

A record review of the facility's policy for medical record titled a "Timely Completion of the Medical Record" states:

3.3-2 "The patient's attending physician shall be responsible for directing and supervising the patient's overall medical care, for coordinating all consultations, for completing and recording the medical record a medical history and physical examination within twenty-four hours of admission, for the prompt and accurate completion of the medical record, for necessary special instructions, and for transmitting information regarding the patient's status to the patient, the referring physician, if any, and to the patient's family. The history and physical examination must be completed and recorded in the medical record prior to any surgery or invasive procedure."

9.3-2 "A medical record lacking any required element or required authentication, which includes signature, date and time of entry is considered incomplete."



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4. Record review revealed Patient 66 was an 82 year old male admitted to the facility with a diagnosis of pneumonia.

Record review on 3/9/11 revealed the following dictated reports without physician signatures:

A. Endoscopy with PEG (percutaneous endoscopic gastrostomy: also known as a peg tube: procedure in which a feeding tube is place in the stomach for enteral [intestinal] feeding to occur) tube placement report by Physician B, dated 2/6/11 and dictated on 3/4/11.

B. GI (Gastrointestinal) Consultation, dated 2/7/11.

C. Esophagogastroduodenoscopy report, dated 2/7/11.

D. Consultation with Physician A (Otolaryngologist), dated 2/10/11.

E. Echocardiogram report, dated 2/14/11.

F. Tracheostomy procedure report, dated 2/28/11.


During an interview on 3/9/11 at 9:41 AM, RN 5 stated that the timeframe required for the physicians to sign dictated reports was 24 hours and confirmed that the above reports were not signed by the respective physicians.




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3. Record review on 3/8/11 at 10 AM, indicated that Patient 65 was admitted on 1/16/11 with diagnoses which included renal failure and pneumonia. Patient 65 had a bronchoscopy (a procedure in which a fiberoptic scope with a viewing device is inserted into the airways that allows the visual examination of the lower airways), a esophagogastroduodenoscopy (EGD) with a percutaneous gastrostomy tube placement (a feeding tube that is surgically inserted through the stomach). On 2/2/11, Patient 65 had a tracheostomy. Additionally, Patient 65 had an EEG (electroencephalogram - a recording of the electrical waves of activity that occur in the brain) and a tracheostomy (a surgical procedure to create an opening through the neck to provide and airway and to remove secretions from the lungs).

Record review on 3/8/11 at 10 AM, revealed that Patient 65's procedure reports for the EGD with PEG tube insertion, the bronchoscopy, the tracheostomy and the EEG was not signed, dated, or timed by the physicians' who performed the procedures.

During an interview on 3/9/11 at 10:05 AM, with RN 7, she confirmed the above findings and stated that the reports should have been signed, dated, and timed by the physicians who performed the procedures.

Based on staff interview and hospital record review, the facility failed to ensure that all orders were dated, timed and authenticated promptly by the ordering practitioner for 2 of 54 sampled patients (Patients 78 and 81). For Patient 78, the physicians' order, dated 3/7/11, were not dated, timed and authenticated. For Patient 81, the physical medicine order, dated 3/5/11, were not dated, timed and authenticated. These deficient findings had the potential for errors in transcription with the potential to affect patient safety.

Findings:

1. A review on 3/8/11, of Patient 78's medical record revealed that Patient 78 was admitted to the hospital on 3/7/11, with an admitting diagnosis of respiratory difficulty.

A review on 3/8/11, of Patient 78's physician's order sheet dated 3/7/11 at 4:55 PM, revealed the following order:
a. Please initiate UPA (unpressurized aerosol: a hand held breathing treatment) every 4 hours while awake and when necessary of 2.5 milligrams albuterol and 0.5 milligrams atrovent per respiratory protocol.

There was no documented evidence that the physician dated, timed and authenticated the order written on 3/7/11.

2. A review on 3/8/11, of Patient 81's medical record revealed that Patient 81 was admitted to the hospital on 2/20/11, with an admitting diagnosis of partial bowel obstruction.

A review on 3/8/11, of Patient 81's Physical Medicine orders dated 3/5/11 at 10:03 AM, showed that the ordering physician or ordering practitioner did not date, time or authenticated the initial orders as per hospital policy.

During an interview on 3/8/11, at the time of the observation, Staff Nurse D confirmed the findings of Patient's 78's physician's orders, dated 3/7/11, not being dated, timed or authenticated and Patient 81's physical medicine order not being dated, timed and authenticated.

2. A review of Patient 42's clinical record on 3/9/11 at approximately 12:22 PM revealed that all of the admission documents were verbally consented to and the staff initials indicated that all admission criteria were met.

During an interview on 3/9/11 at 12:30 PM, the Medical Records Manager was not able to provide a current policy and procedure for the conditions of admission to the facility.



28020

Based on interview and record review, the facility:

1. Failed to completely execute an informed consent for 1 of 54 sampled patients (Patient 65) prior to administering a blood transfusion. This failure had the potential for Patient 65 to not actively participate in decisions regarding medial care and to authorize or refuse a blood transfusion.

2. Failed to have a current policy and procedure for the condition of admission for patients admitted to the facility. This failure had the potential to result in the patient to not be informed about the conditions of admission.

Findings:

1. Record review on 3/8/11 at 10 AM, indicated that Patient 65 was admitted on 1/16/11 with diagnoses, which included renal failure and pneumonia. Additionally, Patient 65 received a blood transfusion.

Record review on 3/8/11 at 10 AM, of a "Consent to Blood Transfusion" dated 1/24/11 at 10:40 (AM or PM not documented), revealed the following:
1. The "physician or surgeons" name section was left blank.
2. The "special instructions" section was left blank.
3. The section addressing that the patient was provided a copy of the State Department of Health Services information pamphlet, "A Patient's Guide to Blood Transfusion" was left blank and had no date or physician signature.
4. The "Informed Consent" section indicating that the physician discussed risks, benefits, adverse reactions, alternative methods, potential problems ...with the patient or legal representative was left blank and the "procedure" section, stated "blood transfusion'' however, the date, time, physician signature, and a witness signature were left blank.

During an interview on 3/8/11 at 11:15 AM, with RN 7, she stated that the physician's name, who ordered the blood transfusion, should have been documented on the blood transfusion consent and that the consent should not have blank spaces. Additionally, she stated that only informed consent she could find for the blood transfusion was left blank and that the physician did not sign it.

Record review on 3/8/11 at 2 PM, of the facility's policy for "Informed Consent for Medical and Surgical Procedures" revealed the following:
"In keeping with the philosophy and mission of "facility's name", it is the policy of the hospital to encourage patients to actively participate in decisions regarding their medical care and to decide whether to authorize or refuse treatment and procedures ...physicians must give patients the information they need to make their decisions ..." The policy also indicated, "informed consent is required for those treatments or procedures which are complex or involve material risks that are not commonly understood. The patient's physician is responsible for providing the information the patient ...needs in order to make an informed decision ...complex treatments or procedures include all operations and invasive procedures, blood transfusions ..." Additionally, the policy indicated, "Special Requirements. In addition, informed consent will be obtained as required by law and consistent with the special legal requirements set forth in the California Hospital Association for, among others, the following procedures: blood transfusions ..."

Based on observation and interview, the facility failed to ensure its intravenous procedure preparation area complied with the United States Pharmacopeia 797 (USP) standards for Pharmaceutical Compounding-Sterile preparations, which sets practice standards to help ensure that compounded sterile preparations are of high quality.

Findings:

During an inspection of the pharmacy on 3/7/11 at approximately 10:20 AM, it was observed that the intravenous (IV) preparation area was separated into a clean and non-clean (buffer) area delineated by a 'red line'. The United States Pharmacopeia (USP) 797 addresses facilities in which sterile products are prepared according to the manufacturers' labeling and where manipulations are performed during the compounding of sterile products which increase the potential for microbial contamination of the prepared products. It delineates what training, procedures for transporting products is needed, how the preparation area should be designed, equipment type, and quality control program formalized in writing.

On 3/7/11 at 10:29 AM, Staff S was observed opening and walking through the door to the IV room carrying IV solutions across the red line that separates the clean and non-clean areas. Staff S distributed the solutions in the clean area, then cross the red line, opened and exited the door to the IV room into the corridor/hallway. Corrugated boxes containing pharmacy preparation supplies were transported across the red line. The dust from the corrugated boxes would disseminate in the IV room and contaminate the prepared products in a sterile compounding area.

In a concurrent interview on 3/7/11 at 10:29 AM, with the Director of Pharmacy (DOP), he acknowledged that Staff S should have observed procedures to ensure that the facility's intravenous preparation area complied with the United States Pharmacopeia 797 (USP) standards for Pharmaceutical Compounding-Sterile Preparations.

Based on observation, interview, and record review, the facility failed to ensure the following:
1. To ensure Patient 43's immunosuppressant medications (Cyclosporine and Rapamune) were scheduled at appropriate times to prevent documented interactions,

2. To ensure Patient 41's medication Levothyroid 0.05 mg was administered as ordered,

3. To ensure Patient 42's orders for Casodex (Bicalutamide) and methylprednisolone included all elements (dosage, route, and frequency) required for complete medication orders.

4. To ensure the Malignant Hyperthermia cart was maintained in accordance with the MHAUS (Malignant Hyperthermia Association of the United States) accepted standards of practice.

These failures had the potential to affect the health and safety of the patients.

Findings:

1. During the medication pass observation conducted on 3/8/11 at 9:05 AM, Cyclosporine was administered. The nurse reviewed the eMAR (electronic Medication Administration Record) and noted that Rapamune (Sirolimus) was scheduled to be administered at the same time as Cyclosporine to Patient 43. The nurse received information during the medication pass that the drugs administration times should be separated by four (4) hours.

Review of Patient 43's clinical record on 3/9/11 at approximately 11:58 AM revealed orders for Cyclosporine (Gengraf) 50 milligram (mg) PO (by mouth) AM (morning), 25 mg HS (bedtime) and Rapamune 2 mg PO daily dated 3/7/11 at 5:30 PM. The facility's medication schedule for a daily or morning dose would be administered at the same time.

A review of LexiComp online drug information documents that Sirolimus may enhance the adverse/toxic effect of Cyclosporine and Cyclosporine may increase the serum concentration of Sirolimus. Management of therapy consists of administering oral doses of sirolimus 4 hours after doses of cyclosporine. Monitor for toxic effects of sirolimus if used with cyclosporine.

During an interview with the director of pharmacy (DOP) on 3/9/11 he acknowledged that the instructions on the eMAR to nursing should have been to administer both drugs in the sequence and time specified.

2. During the medication observation pass conducted on 3/8/11, Patient 41 was administered Levothyroid 0.05 milligrams (mg) at 9:38 AM after breakfast. Patient 41's Medication Administration Record (MAR) reviewed on 3/9/11 at approximately 12:22 PM documented that Levothyroid's administration scheduled for 7 AM was actually administered 9:38 AM, a delay of 1 hour and 38 minutes. Levothyroid is more effective when administered before breakfast on an empty stomach. When asked why the medication was not administered in a timely manner, the nurse was unable to explain the delay.

3. A review of Patient 42's clinical record on 3/9/11 at 10:33 AM revealed that Casodex (Bicalutamide), a medication used for prostate cancer and methylprednisolone were ordered 3/3/11 at 2200 (10 PM) on a pre-printed form titled, "Orthopedic Post Operative Orders for Patient 42". This order would allow the medications to be continued during Patient 42's hospital stay. Since the orders were incomplete lacking the dose, frequency, and route, on 3/4/11, 3/6/11, and 3/8/11. The pharmacy affixed requests to the physician's orders for clarification to include dose and frequency.

On 3/9/11 between the 24 hour chart check and 8:55 AM the order for Casodex (Bicalutamide) was clarified to read, Bicalutamide 50 milligrams (mg) PO (by mouth) daily. According to LexiComp online drug information, Bicalutamide should be administered daily. The drug Bicalutamide was not administered to Patient 42 for 5 days. At 11:17 AM on 3/9/11 it was not administered. Methylprednisolone, although checked simultaneously with Bicalutamide on 3/3/11 at 2200 (10 PM) on a pre-printed form titled, "Orthopedic Post Operative Orders for Patient 42", was not clarified as a valid order to be continued or discontinued by the physician.

A review of the physician's progress notes did not reveal why the medication orders were not clarified in a timely manner.

When asked why Patient 42's medications orders were not clarified in a timely manner, especially for a medication that requires consistent dosing, the DOP reported that medication clarification requests are submitted to the physician for a decision to start or stop the medication.


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4. On 3/8/11 at 9 AM during a tour of the Surgical Services area, the Malignant Hyperthermia cart was observed. The Cart had numbers posted on each drawer but there was no contents list to describe the location or number of essential equipment or fluids required for treatment of Malignant Hyperthermia (MH).

During an interview with the Director of Surgery on 3/8/11 at 9:05 AM, she acknowledged that the Malignant Hyperthermia cart did not have a contents list that described the location or number of the essential equipment required for MH treatment.

Based on observation, interviews and record reviews, the hospital failed to have a director of food service who ensured the daily management of the food service operation and provided safe and high quality food services for patients, visitors and staff when it failed to:

1. Ensure potentially hazardous food (PHF) was held on the cafe salad bar at temperatures greater than 41 degrees Fahrenheit (F) without monitoring for time temperature control;

2. Ensure that the table mounted can opener had a smooth blade, free of cracks, breaks, chips, pits, imperfections.

3. Ensure the dishmachine room floor was clean and free of debris.

These findings had the potential to result in food borne illness in patients, visitors and staff.

Findings:

1. During a tour of the food service department on 3/7/11 at 11:30 AM, the temperature of the macaroni salad on the cafe salad bar was noted to be 47.2 degrees F (fahrenheit). During a concurrent interview with the Director of Food and Nutrition Services (DFNS) he stated that the food on the salad bar was placed there between 10:30 and 10:45 AM and was left there until 6:30 PM when the cafe closes. This food was for the service of both lunch and dinner.

When asked how the temperature of the food was monitored for safety during this 8 hour period, the DFNS stated that the food service workers (FSW) recorded temperatures on a log when the food was first placed on the salad bar and then every 2 hours throughout the day until the food was removed from the salad bar at 6:30 PM.

A concurrent review of the salad bar log for 3/7/11 and interview with the DFNS revealed that at 11:30 AM, the temperatures were not recorded for 10:30 AM that day. The DFNS stated that the FSW responsible for filling out the temperature logs was on a break and that the next time the temperatures were due to be checked was at 12:30 PM.

During a follow up observation on 3/7/11 at 1:55 PM, the temperature of the macaroni salad on the salad bar was noted to be 55.6 degrees F. The container of bacon bits was noted to be 53.6 degrees F.

A concurrent review of the salad bar temperature log for 3/7/11 at 2:00 PM revealed that temperatures were now recorded for 10:45 AM (previously not recorded) and 12:30 PM as follows: Macaroni salad at 10:45 AM was 39 degrees F, at 12:36 PM was 38 degrees F; Bacon Bits at 10:45 AM was 37 degrees F, at 12:36 PM was 36 degrees F.

The temperatures for all items on the salad bar were recorded on the log as between 36 and 39 degrees F for both 10:45 AM and 12:30 PM. During a concurrent interview, FSW 1 was asked how it was that the temperatures she recorded were all below 40 degrees F when the 2 temperatures for the macaroni salad that were observed at 11:30 AM and 1:55 PM were 47.2 and 55.6 degrees respectively, she stated that she did not know. She further demonstrated that the thermometer she used to measure the temperature was calibrated to read 30 degrees in a bath of ice water. She then stated that she may have read the thermometer wrong. She demonstrated that she was able to read the thermometer correctly.

During an interview with DFNS the same day at 2:15 PM, he stated that the refrigeration fan on the salad bar was not working. He didn't know how long the refrigeration fan had not been functioning properly because the temperatures of the food on the salad bar were not being recorded accurately.

A review of the Hospital's HACCP Food Safety Program policy, page 8, dated 8/2009, revealed that for handling food during preparation, cooking, holding, cooling, reheating and serving, all potentially hazardous foods must meet the following temperature requirements during preparation, display, service and transportation. "Cold foods: hold foods at 40 degrees or below."

It further revealed on page 11 of the same policy that, "Food left over on Self-Service bars, buffets or food lines after the meal service period may be reused only if the self-service stations are monitored consistently throughout the service by employees trained in food safety per (the contractor's) policy. It goes on to reveal, "On self-service stations NOT monitored: all cold potentially hazardous food must be discarded at the end of the meal period."

A review of the hospital's HACCP (Hazard Analysis Critical Control Point - a systematic preventive approach to food safety) Daily Taste Panel Chart (temperature logs) for the Cafeteria Soup and Salad Area showed that the staff is instructed that for HACCP Temperature Requirements for Potentially Hazardous Foods, "Product temperature must be recorded (hospital's emphasis) on this log at 2 hour intervals during holding and serving.

A review of these logs dated 2/28/11 through 3/6/11 revealed that in 16 of 36 opportunities, the required temperatures were not recorded. A further review of these logs between 1/3/11 and 2/24/11 revealed that only 3 of 20 days of logs had been filled out as instructed to do by the form and many of the forms had been left blank.

During an interview with the DFNS, he stated that it was his responsibility to ensure that these forms were being completed as directed and that the temperatures recorded were accurate. He could not explain why these forms were not being completed since the beginning of the year. He further could not explain the discrepancy between the observed temperature on the salad bar on 3/7/11 and the recorded temperatures.

According to the 2009 USDA Food Code, "Bacterial growth and/or toxin production can occur if potentially hazardous food (PHF) remains in the temperature "Danger Zone" of 41?F to 135?F too long. Up to a point, the rate of growth increases with an increase in temperature within this zone." It further states, "Maintaining PHF foods under the cold temperature control requirements prescribed in this code (less than 41?F) will limit the growth of pathogens that may be present in or on the food and may help prevent foodborne illness."

2. During a concurrent tour of the kitchen and interview on 3/7/11 at 11:20 AM, the table mounted can opener was observed to have the blade worn and had a rough, nicked surface area. It was further observed to have dried food particles on the blade and the gear. During a concurrent interview with the DFNS, he verified the observation and stated that the can opener should be cleaned after each use.

According to the 2009 USDA Food Code, "Multiuse food-contact surfaces shall be: (1) Smooth; (2) Free of breaks, open seams, cracks, chips, inclusions, pits, and similar imperfections; (3) Free of sharp internal angles, corners, and crevices." It further states, "Equipment food-contact surfaces and utensils shall be cleaned ...At any time during the operation when contamination may have occurred." And, "Deterioration of the surfaces of equipment such as pitting may inhibit adequate cleaning of the surfaces of equipment, so that food prepared on or in the equipment becomes contaminated."

During a concurrent interview with the DFNS, he further stated that he was responsible for ensuring that the food service staff maintained the cleanliness and sanitation of the can opener. He was unable to state why the can opener was not clean and the blade was not intact.

3. During a concurrent tour of the kitchen and interview on 3/7/11 at 11:00 AM, a floor drain in the dishmachine room was observed to have a build up of brown, black and rust colored substances and trash. The DFNS stated that the floor drains are supposed to be cleaned every night. He further stated that it didn't look like it had been cleaned daily.

According to the 2009 USDA Food Code, "Physical facilities shall be cleaned as often as necessary to keep them clean." It further stated that, "Cleaning of the physical facilities is an important measure in ensuring the protection and sanitary preparation of food. A regular cleaning schedule should be established and followed to maintain the facility in a clean and sanitary manner."

During a concurrent interview with the DFNS, he further stated that he was responsible for ensuring that the food service staff cleaned the drains in the dishmachine room daily. He was unable to state why the drain was not cleaned.

Based on record review and staff interviews the hospital failed to ensure the nutrition needs of 1 of 6 patients (Patient 21) reviewed for nutrition care were met in accordance with recognized dietary practices. And it failed to ensure the nutrition needs of patients in the neonatal intensive care unit (NICU) were reviewed for nutrition care according to the hospital's policy and procedures. These failures had the potential to result in patients at nutrition risk of not receiving the nutrition support needed for treatment of their medical condition.

Findings:

1. The record for Patient 21 was reviewed on 3/7/11 at 3:00 PM. Patient 21 was admitted to the hospital on 2/27/11 with diagnoses that included ventilator dependent (dependent on a breathing machine) related to a full cardiac arrest and possible diabetes (disease marked by high levels of sugar in the blood). The patient was dependent on a feeding tube for all nutrition needs.

A review of the initial nursing assessment of the patient, dated 2/27/11, revealed that upon admission the patient weighed 137 pounds.

A review of the nutrition assessment dated 3/1/11 revealed a recommendation by the registered dietitian (RD) for the tube feeding product, Optimental, to run at 70 cubic centimeters (cc) per hour to meet (the patient's) needs. Optimental at 70 cc per hour over 24 hours provided 1680 calories per day and 85 grams of protein. The patient's needs were estimated to be between 1550 and 1860 calories a day and 50 to 62 grams of protein a day. The assessment further noted that the patient's prealbumin level on 2/28/11 was 18 and within normal limits and suggested adequate protein stores. Prealbumin is an important marker for assessing protein deficiency.

Further review of the nutrition notes by the RD revealed follow up notes on 3/3/11 and 3/4/11. Both notes indicated the tube feeding continued to run at the goal rate of 70 cc per hour, met the patient's need and that there were no problems with the patient tolerating the tube feeding.

On 3/7/11, a third follow up nutrition note by the RD revealed that tube feeding continued to run at 70 cc per hour and the patient was tolerating it. The RD nutrition note revealed that the prealbumin was trending down from 18 on 3/1/11 (normal) to 12 on 3/7/11 (low). There was no evaluation of the patient's weight. The RD recommended to repeat the prealbumin level in "3+ days," and suggested to increase the tube feeding if no improvement was noted with the next prealbumin level.

A review of the patient's weights indicated that the weight on 2/28/11 was 137 pounds and was 132 pounds on 3/7/11. This represented a 5 pound, or 3.6% weight loss in 7 days.

A review of the patient's intake and output record indicated that the patient had an average intake of tube feeding of 841 cc's a day for the period 3/2/11 through 3/7/11. The physician order of 70 cc per hour should have provided the patient with 1680 cc's a day of tube feeding. According to this intake and output record, the patient received half of the tube feeding formula, half of the calories and half of the protein that was ordered for the patient to receive. The RD notes did not evaluate the weight loss experienced by the patient and the documentation that the patient received 50 % of the physician ordered tube feeding.

During a concurrent interview with the Clinical Nutrition Manager (CNM) who evaluated the patient, she stated that the weight loss should have been noted and evaluated to determine if the tube feeding was meeting the patient's need. She confirmed that a 5 pound weight loss in one week in conjunction with a concurrent drop in prealbumin level might indicate that the tube feeding the patient received may not have been adequate and that further evaluation should have been done by the RD.

A review of the hospital's policy titled, "Nutritional Assessment" last reviewed 4/2010, stated that, "The goal of the patient (nutritional) assessment is to determine what kind of care is required to meet a patient's need as well as his or her needs as they change in response to care. Processes and activities shall include collecting data; analyzing data; making care decisions, developing a care plan."

2. During a concurrent record review of NICU patients and interview with RD 1 on 3/9/11 at 10:00 AM, RD 1 stated that she doesn't document in the patient's medical record unless she receives an order for a nutrition consultation from the physician. She stated that she seldom receives these consults, usually one or two a year. She stated that the hospital does not have a separate policy for assessment of the NICU patients, therefore the staff guidance for the assessment of the NICU patients would be consistent with the nutrition assessment policy for the general population of patients at the hospital.

A review of the patient census for NICU revealed that there were 12 patients in the unit. Of the 12 patients, 6 were receiving either total parenteral nutrition (IV nutrition) or tube feedings. One of the 6 patients had been there less than 4 days, the others had been there 4, 23, 24 or 35 days. There was no documented nutrition assessment in the medical records for these patients.

A review of the hospital's policy titled, "Nutrition Assessment " last reviewed 4/2010, revealed that, "The goal of the patient (nutritional) assessment is to determine what kind of care is required to meet a patient's need as well as his or her needs as they change in response to care. Processes and activities shall include collecting data; analyzing data; making care decisions, developing a care plan." It further stated, "All patients including children; adolescents; adults; and geriatric patients will have (their) nutrition status assessed, when warranted by the patient's needs or conditions. Nutritional assessment is triggered by: ...Priority parameters (reference policy #204)."

A review of the hospital's policy #204 titled, "Prioritization" revised 2/2011, revealed that the purpose of the policy was, "All patient's admitted will be screened to determine the need for nutritional assessment." The policy was, "To ensure timely and appropriate identification of those patients for whom nutrition intervention is an integral part of their therapy during hospitalization." The guideline stated, "Priority I - HIGH RISK (will be) assessed within 24 hours of identification of need: Consults ordered by the physician or generated by nursing resulting from the initial nursing assessment completed on admission, TPN (total parenteral nutrition) and tube feeding within 24 hours of receipt of order."

Based on staff interviews and record review, the hospital failed to have a therapeutic diet manual that is specific to the diets that the hospital routinely orders, provides guidance to the medical, nursing and food service staff for the ordering and preparation of patient diets and is readily available to the medical and nursing staff.

Findings:

During an interview with the Clinical Nutrition Manager (CNM) on 3/9/11 at 12:20 PM, she stated that the hospital used the American Dietetics Association's (ADA) online Nutrition Care Manual (NCM) for their diet manual. She stated that the NCM did not provide information on the specific kinds of diets that the hospital provided to their patients, but instead provided information on many different diets for a specific diagnosis, whether or not the facility had those diets available for their patients.

A review of the hospital's Current Diet List for 3/8/11 revealed that 23 patients had physician orders for ADA (American Diabetes Association) diets with varying calorie amounts from 1200 through 2200 calories. A review of the hospital's NCM revealed no guidance for the medical, nursing or food service staff on what is provided by the food services department when a physician orders an ADA diet.

A further review of the hospital's Current Diet List for 3/8/11 revealed that 3 patients had physician orders for "cardiac convalescent" diets. A review of the hospital's NCM revealed no guidance for the medical, nursing or food service staff on what is provided by the food services department when a physician orders these diets.

A review of the hospital's policy titled, "Manual of Nutrition Care Management" revised 1/2009, revealed that the purpose of the policy was, "To standardize the following aspect of the nutrition care throughout the hospital: Communication of standards, diets, methods for ordering patient's diets and procedure for review, approval and distribution of the Manual of Nutrition Care Management." It further stated, "The Manual will serve as a guide to ordering diets, and served menus will be consistent with the requirements in the manual." For guidelines it stated, "A copy of the ADA Nutrition Care Manual (Diet Manual) is located on each nursing unit, in the nutritional services department, in the Emergency Department ..."

During an interview on 3/9/11 at 12:20 PM, on the 4th floor nursing station, LVN X was asked how to find the hospital's diet manual for the nursing unit. She was able to state that the diet manual was available online, but was unable to locate it on the hospital's computer system. She then asked the charge nurse for the unit, RN X, who also was unable to state where it was located.

At 12:25 PM, on the same nursing unit, LVN Y was asked if she was able to locate the hospital's diet manual and she stated that they used to have the manuals (hardcopies) in the cupboards. She did not know that the manual was now on the hospital's computer system and no hardcopy of the manuals were stored on the nursing units. Concurrently, MD X was interviewed regarding the hospital's diet manual and he stated he didn ' t know how to locate it.

Based on interview and observation, the facility failed to ensure maintenance of a sanitary hospital environment by failing to ensure that a meal tray, which had been in a patient's room that was on contact isolation, was not placed on the contact isolation cart. This failure had the potential for the transmission of infections and communicable diseases.

Findings:

During tour of Unit 3200, on 3/7/11 at 12:35 PM, an observation was made of a meal tray that was on top of an isolation cart in front of a contact isolation patient's room.

During an interview on 3/7/11 at 12:45 PM, with RN 6, she stated that the meal tray was dirty, had been used by a patient who was on contact isolation for MRSA (Methicillin-resistant staphylococcus aureus - a bacteria that is resistant to the antibiotic methicillin and has been known to cause illnesses) and C-DIFF (clostridium difficile - a bacteria that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon). Additionally, she stated that the meal tray "should not have been on top of the cart but the patient's wife put it there" and that the patient had eaten off of it.

During an interview on 3/14/11 at 2:30 PM, with the Infection Control Manager, she stated that meal trays, clean or dirty, should not be placed on the isolation carts and that staff have been re-educated.