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Based on observation, interview and document review, the Governing Body did not fulfill its responsibilities in oversight of the Medical and Nursing staff with regards to orders for intravenous drip medications. The following deficient practices were identified:

1. The Governing Body did not ensure that the residents were being fully supervised by the faculty Medical Staff. The hospital's medical staff was not well-organized in terms of the interactions between resident physicians (have completed medical school but not yet completed a residency program) and attending physicians (fully trained and privileged physicians on the faculty). See A-338

2. They did not ensure that the Quality Assurance/Performance Improvement (QAPI) program was aware of these issues, or if they were not, why they were not aware. See A-263

3. They did not address services being provided by staff without qualifications or act to correct the situation. This includes nurses titrating (adjusting the medication dose) insulin (medication that regulates the blood sugar) drips and pressor (medications to increase blood pressure) I.V. (Intravenous) drips. They did not ensure that a policy, titled "ICU Insulin Infusion Order Form" approved on April 2010 by the Governing Body 2 years ago, for titration of insulin drips, was put in place and enforced. See A-490

4. They did not ensure that the Nursing Services were organized and that the delivery of nursing care was supervised. For Patients 43 and 45, Emergency Room RNs and Intensive Care Unit (ICU) Registered Nurses (RNs) were titrating Insulin Drips and Vasopressor Drips without proper guidance which resulted in an Immediate Jeopardy situation. See A-385

5. They did not ensure that the Nutrition Services Manager (NSM) was effective in the daily management of the dietary services, the NSM and the Clinical Nutrition Services (CNS) and dietary staff were competent in their respective duties, the disaster food plan was implemented to ensure the safety and well-being of the patients in the event of a disaster, and an effective infection control surveillance system for identifying unsafe food handling practices in the department was developed. See A-618

The cumulative effect of these systemic problems resulted in the possibility of patient harm in a universe of 272 patients.

Based on observation, interview and facility record review, the hospital's Quality Assessment and Performance Improvement Program failed to maintain an effective assessment of the hospital's organization, services and all hospital departments by failing to ensure that:

1. All Intensive Care Unit (ICU) Registered Nurses (RNs) administered intravenous (IV) vasopressor medications (medications to increase blood pressure) to patients in a safe manner and with proper guidance. As a result, RN 1 administered an IV vasopressor to Patient 45 and titrated the medication without proper guidance. This failure had the potential to adversely affect Patient 45's health and contributed to the unsafe administration of potent (powerful) medications and unsafe facility practice of IV administration of vasopressors. This deficient practice resulted in an Immediate Jeopardy situation. Refer to A-273 and A-405

2. All drugs were administered according to accepted standards of practice and in accordance with approved medical staff policies and procedures when the facility failed to ensure that all nurses in all critical care units were adjusting and titrating (adjusting the medication dosage) Insulin (medication that regulate the blood glucose) intravenous drips (to fall in drops) according to physicians' orders or from an established approved protocol. This deficient practice resulted in an Immediate Jeopardy situation which could have caused serious injury, harm, impairment or death to those patients on Insulin drips. Refer to A-273 and A-405

3. All medications were administered in accordance with the physician orders and the facility's policy and procedure when the following was observed:

a. During a medication pass observation conducted on November 7, 2012 at 9:20 AM, it was observed that RN 41 withdrew 0.8 ml from one-ml (milliliter) injectable vial of Heparin (a blood thinner) 5000 units/ml and administered to Patient 43.

b. During a medication pass observation conducted on November 8, 2012 at 4:15 PM, it was observed that Licensed Vocational Nurse (LVN) 41 accessed from the Pyxis MedStation (an Automatic Dispensing Cabinet, ADC) and administered to Patient 42, one tablet of Coumadin (a blood thinner) 2 mg (milligram). Refer to A-405

4. The facility maintained, at all times, the staffing ratio based on the acuity (complexity of care) of patient and level of care required during meal and break time in the Neonatal Intensive Care Unit (NICU) which resulted in inadequate staffing on November 7, 2012 between the hours of 11:00 AM through 1:00 PM and the hours of 2:00 PM through 3:00 PM. Refer to A-392

5. All Nursing Units maintained their nurse to patient ratios at all times (3 South). This failure had the potential for patients that received care and services in the hospital to not have their assessed needs met in a safe environment. On November 5, 2012, the 3 South Medical-Surgical (MS) Unit did not maintain the one nurse to five patients or less ratio during the registered nurses (RN) 30 minute meal breaks. Refer to A-392

6. Nursing services supervised and ensured that the RN 4 reassessed 1 of 58 sampled patients (Patient 44) when the patient's heart rate was 47 beats per minute (bpm; the normal heart rate ranges between 60 and 100 bpm). This failure had the potential for the patient to not receive medical treatment timely. Refer to A-395

7. Nursing services maintained a sanitary environment to avoid sources and transmission of infections and communicable diseases when it failed to ensure that the glucometer machine (a machine to measure the amount of sugar within an individuals blood) was disinfected after each patients use in the Emergency Department. This deficient practice had the potential for cross contamination of infectious microorganisms to all patients requiring blood glucose monitoring using the glucometer machine in the Emergency Department. Refer to A-749

8. The facility maintained infection control standards to reduce the risk of transmission of potentially pathogenic microorganisms as evidenced by:

a. Multiple clean specimen containers that contained formalin (solution of formaldehyde in water) observed in the dirty utility room.

b. In a GI procedure room, there were multiple endoscopes (a medical instrument consisting of a long tube inserted into the body, used for diagnostic examination and surgical procedures) hanging in a closet. The scopes were touching a towel at the bottom of the closet. Refer to A-724

9. All patient medical records were kept confidential and secured to prevent unauthorized individuals from accessing the records. A tour was conducted of the Medical Intensive Care Unit, with RN 2 and the Intensive Care Unit (ICU) Manager, on November 6, 2012 at 12 PM. The unit's patient nutrition room (an unlocked room), contained 12 patient medical records. The medical records were easily accessible and contained patient health information, including laboratory values. Refer to A-441

10. The Medical Staff insured that criteria were in place for determining the privileges to be granted to non-physician licensed practitioners for procedures not considered to be within their scope of practice. Refer to A-363

The cumulative effect of these systemic problems resulted in the hospital being unable to provide safe and effective patient care in a safe setting.

Based on interview and record review, the Quality Assurance (QA) program failed to:

1. Evaluate the system that allowed Registered Nurses (RN) to administer IV (intravenous) vasopressor medications to patients without established physician protocols creating the risk for substandard medication administration and poor health outcomes for patients receiving intravenous medications.

2. Evaluate the system that allowed critical care RNs to adjust and titrate IV insulin drips without established physician protocols with clear and defined parameters set for the titration of insulin according to the patient's blood glucose levels. This failure had the potential to adversely affect all patients on continuous IV insulin drips.

Findings:



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1. During an interview, on November 5, 2012, at 3:35 PM, with the Intensive Care Unit (ICU) Manager, she verified that the facility had no protocols for titrating the medications and that it was up to the RNs' discretion.

During an interview, on November 9, 2012, at 3:50 PM, with the Quality Medical Committee (QMC) Chair, he verified that there were no standard protocols to guide the nurses on titrating vasopressors. He stated that a protocol was developed in 2012 but that it never went through the proper channels (Policy committee, Governing Body or the medication committees) and that "It fell through the cracks." The QMC Chair also stated that "The physicians thought that the protocol had been implemented and that's why they were writing orders to follow the protocol and the nurses didn't say anything and were just titrating the medications on their own."



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2. There was no documented evidence that the hospital's Pharmacy Department or the Emergency Department had developed or implemented unit-specific approved protocols or guidelines for titrating Insulin drips on patients requiring Insulin management.

During an interview with RN 8, on November 5, 2012, at approximately 10:45 AM, when asked how he managed Patient 43's blood glucose levels utilizing the Insulin Drip, he stated, "I titrate the Insulin Drip slowly every hour to get the glucose level below 120 mg/dl."

When asked further if there was a hospital-wide protocol, titration guidelines or unit-specific Standard Orders that were available for use to manage patients on Insulin drips, he stated, "No, I just use my experience and clinical judgment in titrating insulin drips, I've done this before."

According to the Institute for Safe Medication Practices (ISMP), dated May, 2011, it stated, "The Safe Practice Recommendation: Standardized Protocols for titratable drips are invaluable to guide practitioners to safe use of medications which has an impact on patient safety."

There was no documented evidence that the Hospital-wide Quality Assurance and Performance Improvement Department had identified medication irregularities or a review was conducted to regularly monitor Insulin drip management of patients requiring titration without an established protocol or a physicians' order.

During an interview with the Director of Pharmacy on November 5, 2012, at approximately 12:45 PM, when asked if the hospital had developed hospital-wide protocols for managing and titrating Insulin drips on patients in the critical care units of the hospital, he stated, "No, we tried to institutionalize a protocol for Insulin Drip titration in 2010, but never finalized the process, it must have fallen between the cracks."

Based on interview and facility record review:

The Medical Staff failed to ensure that criteria were in place for determining staff privileges to be granted to non-physician licensed practitioners (RN [Registered Nurse] 1, RN 8, RT [Respiratory Technician] C) for procedures not considered to be within their scope of care.

The Hospital failed to ensure that policies and procedures were developed and approved by the Medical Staff and Governing Body to assure that management of Insulin dependent patients on Intravenous drips were according to accepted national standards of practice, and were in compliance with Federal and State Laws and regulations.

The Hospital failed to ensure that the Department of Pharmacy had recognized and identified possible medication irregularities to prevent adverse events from occurring to the patients when it failed to monitor all physician orders that were written: "Start Insulin drip per protocol" in light that a protocol was never developed or existed, for a universe of 272 patients by failing to ensure:

1. All Intensive Care Unit (ICU) Registered Nurses (RNs) administered intravenous (IV) vasopressor medications (Potent medications used to help increase blood pressure however if given incorrectly, it can cause too much of an increase in blood pressure or if not given in sufficient amount, it can also prevent a therapeutic blood pressure) to patients in a safe manner and with physician guidance.

2. Nursing staff in the Emergency Department were not routinely titrating (adjusting) insulin (a hormone, essential for the proper metabolism of blood sugar and for maintenance of the proper blood sugar level) drips (slow injection at a time via intravenously) on patients requiring glucose (an intermediate in metabolism of carbohydrates in the body during digestion) management without a set protocol or specific orders, a potential for unsafe use of the medication which can impact on patient's safety.

3. Respiratory therapists were inserting arterial lines (catheters inserted into arteries in the wrist often used to follow blood oxygen and pressure) without a policy to do so, a potential for consequences of patients developing serious complications.

Findings:

1. A review of Patient 45's medical record and a concurrent interview with RN 1, was conducted on November 5, 2012, at 2:50 PM. RN 1 stated that Patient 45 was admitted on November 3, 2012, with kidney failure and septic shock (a potentially lethal drop in blood pressure due to the presence of bacteria in the blood. It can cause a dramatic drop in blood pressure, preventing the delivery of blood to the organs which can lead to multiple organ failure and may cause rapid death, W. B. Saunders Company (1992). Miller-Keane Encyclopedia & Dictionary of Medicine, Nursing, & Allied Health, Fifth Edition).

A record review, on November 5, 2012, at 2:50 PM of Patient 45's physician orders revealed that on November 4, 2012, a physician ordered to "Start neosynephrine (a dangerous and powerful medication that is used to help increase blood pressure and should be administered in an ICU setting where the patient can be closely monitored) drip (given IV) to maintain a MAP (mean arterial blood pressure - an average blood pressure) of 65." On November 5, 2012, a physician ordered to "Continue with levophed (used to treat life-threatening low blood pressure and when given IV, it should be administered in a ICU setting where the patient can be closely monitored) drip to titrate or maintain MAP of 65." There were no specific orders written to guide the RNs on how much to titrate the medications or how often to titrate the neosynephrine or the levophed.

An interview was conducted on November 5, 2012, at 2:50 PM, with RN 1. When asked by the Surveyor how he titrated the IV vasopressors (Neosynephrine and Levophed), he stated, "It's up to me, a little here and there, depending on the blood pressure." RN 1 stated that the facility had no standardized protocols to help guide them on any titratable drips except for heparin (a blood thinner). RN 1 stated that nurses used their own nursing judgement and experience. When asked how the new nurses titrate the medications, RN 1 stated they just ask him or another experienced nurse and they would help them. RN 1 also stated that it would be good if they had standard protocols but there were none, they titrate the medications until they obtain the blood pressure parameters that the physician ordered.

During an interview, on November 5, 2012, at 3:35 PM, with the ICU Manager, she verified that the facility had no protocols for titrating the medications and that it was up to the RNs' discretion.

During an interview, on November 9, 2012, at 3:50 PM, with the QMC, he verified that there were no standard protocols to guide the nurses on titrating vasopressors. He stated that a protocol was developed in 2012 but that it never went through the proper channels (Policy committee, Governing Body or the medication committees) and "It fell through the cracks." The QMC Chair also stated that "The physicians thought that the protocol had been implemented and that's why they were writing orders to follow the protocol and the nurses didn't say anything and were just titrating the medications on their own."

2. A review on November 5, 2012 of Patient 43's medical record was conducted. The medical record revealed that Patient 43 was admitted to the Emergency Department on November 4, 2012, with admitting diagnoses that included dry mouth, jaw pain and nausea and vomiting for one week.

A review of Patient 43's blood glucose level, dated November 4, 2012, timed at 6:05 PM, revealed a level of "343 mg/dl" (Milligrams per deciliter of blood, levels under 120 mg/dl are considered acceptable blood glucose (sugar) levels) and a chloride (an element-salt, that is important for keeping acid and base in balance) level of "9" (normal ranges 100-110 mEq/l; low levels indicate diabetes as a cause).

A review of Patient 43's Emergency Room Physicians' Order sheet, dated November 4, 2012, and timed at 5:39 PM, revealed the following orders:

a. Normal Saline 2 liter bolus (Intravenous fluid)
b. 10 units of Insulin Intravenous (Insulin-a hormone to regulate sugar levels in the blood)
c. Insulin drip 10 units per hour.

A review of Patient 43's Admission Order Sheet, prior to admission to the Intensive Care Unit, dated November 5, 2012, revealed the following order:

a. Continue Insulin Drip per protocol

A review of patient 43's Medication and Fluids sheet, dated November 4, 2012 to November 5, 2012, documented the following entries by the Registered Nurse:

a. 10:40 PM: Insulin drip titrated to 2 units per hour
b. 1:55 AM: Insulin drip titrated to 3 units per hour
c. 6:15 AM: Insulin drip titrated to 5 units per hour

A review of Patient 43's Nursing Narrative Notes, dated November 5, 2012, and timed at 6:00 AM revealed that the patient's glucose level was below 200 mg/dl and the Anion Gap was 23 (Anion Gap is a measurement of acid-base levels, ranges from 8 to 16, high levels indicate metabolic acidosis or a diagnosis of Diabetic Ketoacidosis 'DKA'-a severe diabetic condition) and the insulin drip was titrated to 5 units per hour.

There was no documented evidence in the medical record or from other hospital sources that Patient 43's physician had written or given verbal or telephone orders to titrate the insulin drip as documented by the RN.

There was no documented evidence in the medical record or from other hospital sources that nurses were following established hospital-wide protocols, guidelines or physician standing orders in titrating Patient 43's Insulin drip from November 4 to November 5, 2012.

There was no documented evidence in the medical record that Patient 43's physician had written clear and well defined orders or parameters to titrate the Insulin drip according to the patient's blood glucose levels fluctuating up or down in order to achieve an acceptable target glucose level.

There was no documented evidence that the hospital's Pharmacy Department or the Emergency Department had developed or implement unit-specific approved protocols or guidelines for titrating Insulin drips on patients requiring Insulin management.

During an interview with RN 8, on November 5, 2012, at approximately 10:45 AM, when asked how he managed Patient 43's blood glucose levels utilizing the Insulin Drip, he stated, "I titrate the Insulin Drip slowly every hour to get the glucose level below 120 mg/dl".

When asked further if there was a hospital-wide protocol, titration guidelines or unit-specific Standard Orders that were available for use to manage patients on Insulin drips, he stated, "No, I just use my experience and clinical judgment in titrating insulin drips, I've done this before."

According to the Institute for Safe Medication Practices (ISMP), dated May, 2011, it stated, "The Safe Practice Recommendation: Standardized Protocols for titratable drips are invaluable to guide practitioners to safe use of medications which has an impact on patient safety."

There was no documented evidence that the Hospital-wide Quality Assurance and Performance Improvement Department had identified medication irregularities or a review was conducted to regularly monitor Insulin drip management of patients requiring titration without an established protocol or a physicians' order.

During an interview with the Director of Pharmacy on November 5, 2012, at approximately 12:45 PM, when asked if the hospital had developed hospital-wide protocols for managing and titrating Insulin drips on patients in the critical care units of the hospital, he stated, "No, we tried to institutionalize a protocol for Insulin Drip titration in 2010, but never finalized the process, it must have fallen between the cracks."

3. On November 9, 2012, a review of Respiratory Therapist C's (RT C) personnel file was conducted. RT C's file revealed as a Supervising Respiratory Care Practitioner he was deemed competent by the Respiratory Department and met all requirements in placement of arterial lines (monitoring device imbedded in the artery near the wrist area) in patients when ordered by a physician.

On November 9, 2012, a review of Respiratory Therapist C's personnel/education file revealed no documented evidence of his initial training or current competency in placement of Arterial Lines in those patients requiring arterial monitoring.

On November 9, 2012, a review of the facility's policy and procedure titled, "RADIAL ARTERY-PERCUTANEOUS ARTERIAL LINE PLACEMENT", dated April 2010, stipulated, "...Due to consequences of complications, competency validation will be performed initially and then annually..." In addition, "...To be deemed competent in placement of arterial lines, the Respiratory Care Practitioner must be observed and signed-off three times by one of the following: Intensivist, Hospitalist and Senior Surgical Resident..."

There was no documented evidence in Respiratory Therapist C's (RT C) personnel/education file that RT C was trained initially or had current competencies to perform percutaneous (through the skin) arterial line placement as per hospital policy dated April, 2010.

There was no documented evidence that the Respiratory Department or hospital-wide Quality Assurance and Performance Improvement Department were monitoring or reviewing RT C's educational training and requirements needed to perform specific specialized duties, such as percutaneous arterial line placements, and tracking outcomes after arterial line placements in those patients.

During an interview with the Assistant of Respiratory Care Department on November 9, 2012, at approximately 1:30 PM, he confirmed that RT C did not have evidence of initial training and no evidence of current competency to perform percutaneous arterial line placement as per hospital policy.

Based on observation, interview and facility record review, it was determined that the hospital failed to ensure that the Nursing Services were organized and that the delivery of nursing care was supervised. For Patients 43 and 45, Emergency Room Registered Nurses (RNs) and Intensive Care Unit (ICU) RNs were titrating Insulin Drips (adjustment of the dosage of insulin administration according to the blood glucose level, drop at a time, intravenously) and Vasopressor Drips (adjustment of the dose of vasopressor, potent medications used to help increase blood pressure however if given incorrectly, it can cause too much of an increase in blood pressure or if not given in sufficient amount, it can also prevent a therapeutic blood pressure) without physician guidance which resulted in an Immediate Jeopardy situation. The Nursing Services failed to ensure that:

1. All ICU RNs administered intravenous (IV) vasopressor medications to patients in a safe manner and with physician guidance. As a result, RN 1 administered an IV vasopressor to Patient 45 and titrated the medication without physician guidance. This failure had the potential to adversely affect Patient 45's health and contributed to the unsafe administration of potent (powerful) medications and unsafe facility practice of IV administration of vasopressors. This deficient practice resulted in an Immediate Jeopardy situation. Refer to A-405

2. All drugs were administered according to accepted standards of practice and in accordance with approved medical staff policies and procedures when it failed to ensure that all nurses in all critical care units were adjusting and titrating Insulin intravenous drips according to physicians' orders or from an established approved protocol. This deficient practice resulted in an Immediate Jeopardy situation which could have caused serious injury, harm, impairment or death to those patients on Insulin drips. Refer to A-405

3. All medications were administered in accordance with the physician orders and the facility's policy and procedure when the following was observed:

a. During a medication pass observation conducted on November 7, 2012 at 9:20 AM, it was observed that RN 41 withdrew 0.8 ml (milliliter) from one-ml injectable vial of Heparin (a blood thinner) 5000 units/ml and administered to Patient 29, a wrong dose.

b. During a medication pass observation conducted on November 8, 2012 at 4:15 PM, it was observed that LVN 41 accessed from the Pyxis MedStation (an Automatic Dispensing Cabinet, ADC) and administered to Patient 28 one tablet of Coumadin (a blood thinner) 2 mg (miligram), a wrong dose.

Refer to A-405

4. The staffing ratio, based on the acuity of the patient and level of care required was maintained, during meal and break time in the NICU (Neonatal Intensive Care Unit) which resulted to inadequate staffing on November 7, 2012 between the hours of 11:00 AM thru 1:00 PM and 2:00 PM thru 3:00 PM. Refer to A-392

5. All Nursing Units maintained their nurse to patient ratios at all times (3 South). This failure had the potential for patients that received care and services in the hospital to not have their assessed needs met in a safe environment. On November 5, 2012, the 3 South Medical-Surgical (MS) Unit did not maintain the one nurse to five patients or less ratios during the registered nurses' (RN) 30 minute meal breaks. Refer to A-392

6. Nursing services supervised and ensured that the RN reassessed 1 of 58 sampled patients (Patient 44) when the patient's heart rate was 47 beats per minute (bpm; the normal heart rate range is from 60 to 100 bpm). This failure had the potential for the patient to not receive medical treatment timely. (Refer to A-395)

7. Nursing services maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases when it failed to ensure that the glucometer machine was disinfected after each patients use in the Emergency Department. This deficient practice had the potential for cross contamination of infectious microorganisms to all patients requiring blood glucose monitoring by the glucometer machine in the Emergency Department. (Refer to A-749)

The cumulative effect of these systemic problems resulted in the Nursing Department's inability to ensure the provision of quality health care in a safe environment.

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

1. Maintain adequate number of staff based on the acuity (complexity of level of care) of the patient and level of care required during meal and break times in the Neonatal Intensive Care Unit (NICU) which resulted in inadequate staffing between the hours of 11:00 AM thru 1:00 PM and between 2:00 PM thru 3:00 PM, a potential for inadequate care as evidenced by not following the hospital policy of staffing based on acuity.

2. Maintain nurse to patient ratios at all times (3 South). This failure had the potential for patients that received care and services in the hospital to not have their assessed needs met in a safe environment.

Findings:

1. During an interview with Registered Nurse (RN) 16 on November 7, 2012 at 9:26 AM, RN 16 confirmed and stated that, "Staff relieved each other for breaks and lunches. It's a very common practice in the unit." RN 16 also stated that the Charge Nurse (CN) covers for breaks, but if the CN was busy or not available and there was no other available free nurse, another nurse assigned in the same Pod area (specific nursing area of responsibility) would be responsible for the patients of the nurse taking a break along with her assigned patients. RN 16 also stated that, "Regular break are 15 minutes, and the lunch break are 30 minutes."

During an interview with the Nurse Manager (NM) 1 on November 7, 2012 at 9:35 AM, NM 1 stated that the CN coordinates, and covers the breaks and lunches, as needed. NM 1 also stated that, "The CN are called for high risk and all cesarean-section (the removal of the fetus by surgical means) deliveries." NM 1 confirmed and stated that, "The podmate would cover for the other nurse. It does happen sometimes, not a common practice."

During an interview on November 7, 2012 at 9:41 AM, RN 17 stated that, "The CN makes the assignment in the morning on who to cover during meal/break time." RN 17, after reviewing the "Meal/break" schedule, confirmed that the nurses are covering for each other. RN 17 also stated, as per the schedule for November 7, 2012, it will give her a total of 5 patients (4 patients with acuity ratio of 1:3 and 1 patient with acuity ratio of 1:2) to take care for 30 minutes while covering the other RN (RN 22) during her lunch break. This was confirmed by NM 1.

During a review of the "NICU Assignment Sheet" form dated November 7, 2012 revealed a "Meal/Break relief" schedule. The assignment sheet indicated the following:

1. RN 16 was assigned to 2 patients with a ratio of 1:2.
2. RN 17 was assigned to 2 patients. One patient with a ratio of 1:2 and the other patient with a ratio of 1:3.
3. RN 18 was assigned to 3 patients with a ratio of 1:3.
4. RN 19 was assigned to 2 patients with a ratio of 1:2.
5. RN 20 was assigned to 2 patients with a ratio of 1:2.
6. RN 21 was assigned to 2 patients with a ratio of 1:2.
7. RN 22 was assigned to 3 patients with a ratio of 1:3.

The "Meal/Break relief" schedule revealed that RN 17 and RN 22 would relieve each other for lunch break. This would give each RN responsibility over five patients each time they relieved each other (a total of 1 hour duration), instead of the number of patients originally assigned to each RN per patient acuity.

RN 18 and RN 19 would relieve each other for lunch break. This would give each RN responsibility over five patients each time they relieved each other (a total of 1 hour duration), instead of the number of patients originally assigned to each RN per patient acuity.

RN 20 and RN 21 would relieve each other for lunch break. This would give each RN responsibility over four patients each time they relieved each other (a total of 1 hour duration), instead of the number of patients originally assigned to each RN per patient acuity.

During a concurrent interview with NM 1 and CN 1 on November 7, 2012 at 11:00 AM, both confirmed, after reviewing the November 7, 2012 meal/break coverage schedule, that the staffing did not meet the acuity ratio. NM 1 explained that a '1:1 ratio' means 1 patient to 1 RN, '1:2 ratio' means 2 patients to 1 RN, and '1:3 ratio' means 3 patients to 1 RN.

The facility policy and procedure titled "Assignments: Staffing Based on Acuity" with an effective date of December 16, 2004, was reviewed. The policy indicated:

A. Assignments are made upon assessment of patient needs and commensurate with qualifications of nursing personnel.

B. NICU staffing is determined according to acuity of patient and level of care required, utilizing the acuity guidelines.

C. NICU is staffed consistent with the approved Program Flex as follows:

1. The 1:1, 1:2, and 1:3 RN to Intensive Care infant ratio will be staffed according to the patient level of acuity.
2. Intensive Care infants shall have staff available at either a 1:1 or 1:2 RN to infant ratio as determined by their acuity.
3. Intermediate Care infants shall have a staff available at no more than a 1:3 RN to infant ratio as determined by their acuity.

Under "Guidelines for staffing", it indicated that, "It is the responsibility of the charge nurse to ensure proper assessment of acuity."

The NICU acuity for "Level of Care 1:2" included individual needs/level of care that required 1:2 ratio staffing:

1. Stable intubated infants with minimal ventilatory changes and maintenance blood gases.

2. Infants on nasal CPAP (Continuous Positive Airway Pressure - A ventilation modality using a device that continuously blows a gentle stream of air into the nose during sleep to keep the airway open), nasal cannula, or oxyhood (a device used to provide a consistent oxygen, at a controlled temperature and humidity for an infant needing supplemental oxygen).

3. Infants extubated less than 4 hours.

4. Peripheral IV (Intravenous) or PICC (Peripherally Inserted Central Catheter to obtain intravenous access) being titrated with feedings.

5. Multiple IV medications and maintenance drip.

6. Multiple documented apnea (temporary cessation of breathing)/bradycardia (slow heart rate, below acceptable parameters) requiring intervention.

7. Feedings, PO (oral) or gavage (feeding via a stomach tube or tube passed through the nares into the stomach).

8. Complex family dynamics requiring extensive discharge teaching or assistance; and/or extensive breast feeding teaching and support for mom and baby new to breast feeding.

9. Infants with drug withdrawal.

The NICU acuity for "Level of Care 1:3" included individual needs/level of care that required 1:3 ratio staffing:

1. Stable infant with heparin lock for IV medications.

2. Nasal cannula with oxygen maintenance less than 30% FIO2 (fraction of inspired oxygen).

3. Multiple oral medications.

4. Occasional apnea/bradycardia.

5. Requiring phototherapy.

6. Feedings, PO or gavage (feedings by mouth or through a tube).

7. Stable infants with drug withdrawal.

8. Stable small for gestational (the length of time from conception to birth) age or large for gestational age infant with normal blood glucose levels.

9. Stable growing and feeding premature (born prior to 37th weeks of gestation) infant.

A review of the policy and procedure titled, "Neonatal ICU Charge Nurse Role and Responsibilities" with effective date of June 2002, under "Complete or delegate the following responsibilities during the course of a shift" included, "Evaluate and implement staffing acuity changes."



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2. The 3 South Medical-Surgical (MS) Unit did not maintain the one nurse to five patients (or fewer) ratio during the registered nurses' (RN) 30 minute meal breaks.

On November 5, 2012 at 2:45 PM, an interview was conducted with Registered Nurse (RN) 8, who was the Charge Nurse (CN) for the 3 South Medical-Surgical (MS) Unit. RN 8 stated that there were 23 patients admitted to the unit and that there were five nurses on duty. RN 8 stated that the nurse to patient ratio for the MS unit was one nurse to five patients or less. When RN 8 was asked who relieved the unit's RNs for their 15 minute and 30 minute breaks, she stated that she did as the CN, because she did not have assigned patients. She also stated that if the RNs were "not busy" they relieved each other for their 15 minute and 30 minute breaks. RN 8 acknowledged that when the RNs relieved one another for their breaks the one nurse to five patient ratios was not maintained.

On November 5, 2012 at 2:55 PM, an interview was conducted with RN 9. RN 9 stated that she went to lunch for 30 minutes with the CN today, and that RN 10 was responsible for providing primary nursing care for her four patients while she was at lunch. She also stated that, "we only do that when the nurse is not busy." RN 9 acknowledged and confirmed that the ratio of one nurse to five patients or less on the MS unit should have been maintained at all times.

On November 5, 2012 at 3:05 PM, an interview was conducted with RN 10. RN 10 confirmed that she was responsible for providing primary nursing care for RN 9's four patients when she went on her 30 minute lunch break. She acknowledged that she had nine patients during that time. RN 10 acknowledged and confirmed that the nurse to patient ratios should have been maintained at all times. She also stated that when she went on her 30 minute meal break, RN 9 provided primary nursing care for her five patients.

On November 5, 2012 at 3:15 PM, an interview was conducted with RN 11 (3 South MS Unit Nurse Manager). RN 11 stated that the CN was responsible for providing primary nursing care for patients when the primary nurse went on their 15 minute and/or 30 minute breaks. She was not knowledgeable regarding how the CN scheduled the six nurses for their 15 and 30 minute breaks.

A review of the document "3 South Assignment/Bed Board," dated November 5, 2012, was conducted with RN 11. RN 11 acknowledged and confirmed that the document showed that there were two (of six) RNs, including the CN, scheduled for each 15 minute and 30 minute break time as follows:
a. 9:30 AM and 1:30 PM
b. 10 AM and 2 PM
c. 10:30 and 2 :30 PM

RN 11 acknowledged and confirmed that the document showed that when two nurses were scheduled at the same time for their 15 and/or 30 minute breaks the nurse to patient ratios were not maintained. She stated that the MS Unit staffing ratios of one RN to five patients or less should have been maintained at all times.

Based on observation, interview and record review, the hospital failed to ensure that the RN (RN 4)reassessed 1 of 58 sampled patients (Patient 44) when the patient's heart rate was 47 beats per minute (bpm; the normal heart rate range is from 60 to 100 bpm). This failure had the potential for the patient to not receive medical treatment timely resulting to a potential fatal outcome.

Findings:

On November 5, 2012 at 10 AM, an observation of the telemetry monitor at the nurses' station in the emergency department (ED) was conducted. The monitor indicated that the heart rate (HR) of the patient in bed #11 (Patient 44) was 47 bpm, the Emergency Department (ED) Assistant Manager confirmed the low HR. An interview was conducted with the ED Assistant Manager. When asked what the patient's HR parameter was set at, she reviewed the parameter on the monitor and revealed that the low parameter was set at 45 and the high parameter was set at 120 bpm. She stated that the alarm would not sound unless the HR dropped to 45 or less and/or 120 or higher. When asked what the patient parameters were based on, she stated that the nurse was able to set the parameters based on their assessment.

On November 5, 2012 at 10:10 AM, a review of Patient 44's medical record was conducted with the ED Assistant Manager. She confirmed that there was no physician order (PO) for the patient's HR parameter to be set at 45 bpm. She confirmed that there was no documented evidence to show that the patient was assessed as having had a HR below 50 bpm.

On November 5, 2012 at 2:30 PM, an interview and record review was conducted with RN 4. He did not recall setting the HR parameters for Patient 44. RN 4 stated that he should have reassessed the patient when the HR was 47 bpm. RN 4 reviewed Patient 44's ED record and verified that there was no documented evidence to show that the patient was reassessed when the HR dropped to 47 bpm.

Based on observation, interview and record review the facility failed to ensure the following, which resulted to an Immediate Jeopardy:

Immediate Jeopardy was called on November 5, 2012, at 1:32 PM, in the presence of the Administrator, Chief Operating Officer, Assistant Administrator, Chief Financial Officer, Chief Nursing Officer, Associate Administrator for Surgical Services, Director of Surgical Services and Director of Medicine.

Immediate Jeopardy was identified when it was discovered that Insulin (a hormone essential for the proper metabolism of the blood sugar) Drips (a slow injection of a solution a drop at a time, intravenously) and Vasopressor Drips (Potent medications used to help increase blood pressure) in the Emergency Department and in the Intensive Care Units were being titrated (incremental increases to a medication until an optimal therapeutic level is obtained and done according to physician's orders), by nurses without a physicians' order or an approved hospital-wide protocol. Refer to A-405

Immediate Jeopardy was abated on November 8, 2012 at 1:20 PM, in the presence of the Administrator, Assistant Administrators, Chief Executive Officer and Chief Nursing Officer after a Plan of Correction was accepted by the survey team on November 8, 2012, at 1:20 PM. The Plan of Correction included new Insulin and Infusion (the introduction of a liquid substance into the body via a vein) forms distributed to all critical care units. Staff education to all Critical Care Nurses, Medical staff and Pharmacy staff before the start of their shifts on how to utilize the new forms. Pharmacy staff were instructed not to accept any orders for Insulin/Cardiac infusions unless written on the new medication forms and daily aggregate monitoring data and surveillance would be accomplished by the Critical Care Pharmacist and Nurse managers on those Units.

The facility failed to ensure the following:

1. All Intensive Care Unit (ICU) Registered Nurses (RNs) administered intravenous (IV) vasopressor medications to patients in a safe manner and with physician guidance. As a result, RN 1 administered an IV vasopressor to Patient 45 and titrated the medication without physician guidance. This failure had the potential to adversely affect Patient 45's health and contributed to the unsafe administration of potent (powerful) medications and unsafe facility practice of IV administration of vasopressors. This deficient practice resulted in an Immediate Jeopardy situation.

2. All drugs were administered according to accepted standards of practice and in accordance with approved medical staff policies and procedures when it failed to ensure that all nurses in all critical care units were adjusting and titrating Insulin intravenous drips (incremental increases/decreases of insulin medication until an optimal therapeutic level is obtained and done according to physician's orders) according to physicians' orders or from an established approved protocol. As a result RN 8 titrated insulin drip without a physician's clear and defined orders or parameters to titrate the insulin drip according to the patient's (Patient 43) blood glucose level. This failure had the potential to adversely affect all patients on insulin drip administration. This deficient practice resulted in an Immediate Jeopardy situation which could have caused serious injury, harm, impairment or death to those patients on Insulin drips.

The Hospital failed to ensure that policies and procedures were developed and approved by the Medical Staff and Governing Body to assure that management of Insulin dependent patients on Intravenous drips were according to accepted national standards of practice, compliance with Federal and State Laws and regulations. Furthermore, the hospital failed to ensure that Insulin Infusion Protocol was approved by the medical staff.

3. All medications were administered in accordance with the physician orders and the facility's policy and procedure.

The Hospital failed to ensure that the Department of Pharmacy had recognized and identified possible medication irregularities to prevent adverse events to patients when it failed to monitor all physician orders that were written: "Start Insulin drip per protocol" in light that a protocol was never developed or existed.

Findings:

1. A record review of Patient 45's medical record and a concurrent interview with RN 1, was conducted on November 5, 2012, at 2:50 PM. RN 1 stated that Patient 45 was admitted on November 3, 2012, with kidney failure and septic shock (a potentially lethal drop in blood pressure due to the presence of bacteria in the blood. It can cause a dramatic drop in blood pressure, preventing the delivery of blood to the organs which can lead to multiple organ failure and may cause rapid death, W. B. Saunders Company (1992). Miller-Keane Encyclopedia & Dictionary of Medicine, Nursing, & Allied Health, Fifth Edition.)

A record review, on November 5, 2012, at 2:50 PM of Patient 45's physician orders revealed that on November 4, 2012, a physician ordered to, "Start neosynephrine (a dangerous and powerful medication that is used to help increase blood pressure and should be administered in an ICU setting where the patient can be closely monitored) drip (given IV) to maintain a MAP (mean arterial blood pressure - an average blood pressure) of 65." On November 5, 2012, a physician ordered to "Continue with levophed (used to treat life-threatening low blood pressure and when given IV, it should be administered in a ICU setting where the patient can be closely monitored) drip to titrate or maintain MAP of 65." There were no specific orders written to guide the RNs' on how much to titrate the medications or how often to titrate the neosynephrine or the levophed.

An interview was conducted on November 5, 2012, at 2:50 PM, with RN 1. When asked how he titrated the IV vasopressors (Neosynephrine and Levophed), he stated, "It's up to me, a little here and there, depending on the blood pressure." RN 1 stated that the facility had no standardized protocols to help guide them on any titratable drips except for heparin (a blood thinner). RN 1 stated that nurses use their own nursing judgement and experience. When asked how new nurses titrate the medications, RN 1 responded that they just ask him or another experienced nurse and they would help them. RN 1 also stated that it would be good if there were standard protocols but there were none, they titrate the medications until they obtain the blood pressure parameters that the physician ordered.

During an interview, on November 5, 2012, at 3:35 PM, with the ICU Manager, she verified that the facility had no protocols for titrating the medications and that it was up to the RNs' discretion.

During an interview, on November 9, 2012, at 3:50 PM, with the QMC Chair, he verified that there were no standard protocols to guide the nurses on titrating vasopressors. He stated that a protocol was developed in 2012 but that it never went through the proper channels (Policy committee, Governing Body or the medication committees) and that "It fell through the cracks." The QMC Chair also stated that "The physicians thought that the protocol had been implemented and that's why they were writing orders to follow the protocol and the nurses didn't say anything and were just titrating the medications on their own."



26502

2. A review on November 5, 2012 of Patient 43's medical record was conducted. The medical record revealed that Patient 43 was admitted to the Emergency Department on November 4, 2012, with admitting diagnoses that included dry mouth, jaw pain and nausea and vomiting for one week.

A review of Patient 43's blood glucose level, dated November 4, 2012, timed at 6:05 PM, revealed a level of "343 mg/dl" (Milligrams per deciliter of blood, levels under 120 mg/dl are considered acceptable blood glucose [sugar] levels) and a chloride (an element-salt, that is important for keeping acid and base in balance) level of "9" (normal ranges 100-110 mEq/l; low levels indicate diabetes as a cause).

A review of Patient 43's Emergency Room Physicians' Order sheet, dated November 4, 2012, and timed at 5:39 PM, revealed the following orders:

a. Normal Saline 2 liter bolus (Intravenous fluid)
b. 10 units of Insulin Intravenous (Insulin-a hormone to regulate sugar levels in the blood)
c. Insulin drip 10 units per hour.

A review of Patient 43's Admission Order Sheet, prior to admission to the Intensive Care Unit, dated November 5, 2012, revealed the following order:

a. Continue Insulin Drip per protocol

A review of patient 43's Medication and Fluids sheet, dated November 4, 2012 to November 5, 2012, documented the following entries by the Registered Nurse (RN 8):

a. 10:40 PM: Insulin drip titrated to 2 units per hour
b. 1:55 AM: Insulin drip titrated to 3 units per hour
c. 6:15 AM: Insulin drip titrated to 5 units per hour

A review of Patient 43's Nursing Narrative Notes, dated November 5, 2012, and timed at 6:00 AM revealed that the patient's glucose level was below 200 mg/dl and the Anion Gap was 23 (Anion Gap is a measurement of acid-base difference levels, normal range is from 8 to 16, high levels indicate metabolic acidosis or a diagnosis of Diabetic Ketoacidosis 'DKA' - a severe diabetic condition) and the insulin drip was titrated to 5 units per hour.

There was no documented evidence in the medical record or from other hospital sources that Patient 43's physician had written or given verbal or telephone orders to titrate the insulin drip as documented by the RN.

There was no documented evidence in the medical record or from other hospital sources that nurses were following established hospital-wide protocols, guidelines or physician standing orders in titrating Patient 43's Insulin drip on November 4 to November 5, 2012.

There was no documented evidence in the medical record that Patient 43's physician had written clear and well defined orders or parameters to titrate the Insulin drip according to the patients' blood glucose levels fluctuating up or down in order to achieve an acceptable target glucose level.

There was no documented evidence that the hospital's Pharmacy Department or the Emergency Department had developed or implemented unit-specific approved protocols or guidelines for titrating Insulin drips on patients requiring Insulin management.

During an interview with RN 8, on November 5, 2012, at approximately 10:45 AM, when asked how he managed Patient 43's blood glucose levels utilizing the Insulin Drip, he stated, "I titrate the Insulin Drip slowly every hour to get the glucose level below 120 mg/dl."

When asked further if there was a hospital-wide protocol, titration guidelines or unit-specific Standard Orders that were available for use to manage patients on Insulin drips, he stated, "No, I just use my experience and clinical judgment in titrating insulin drips, I've done this before."

According to the Institute for Safe Medication Practices (ISMP), dated May, 2011, it stated, "The Safe Practice Recommendation: Standardized Protocols for titratable drips are invaluable to guide practitioners to safe use of medications which has an impact on patient safety."

There was no documented evidence that the Hospital-wide Quality Assurance and Performance Improvement Department had identified medication irregularities or a review was conducted to regularly monitor Insulin drip management of patients requiring titration without an established protocol or a physicians' order.

During an interview with the Director of Pharmacy on November 5, 2012, at approximately 12:45 PM, when asked if the hospital had developed hospital-wide protocols for managing and titrating Insulin drips on patients in the critical care units of the hospital, he stated, "No, we tried to institutionalize a protocol for Insulin Drip titration in 2010, but never finalized the process, it must have fallen between the cracks."



25281


3a. During a medication pass observation conducted on November 7, 2012 at 9:20 AM, it was observed that RN 41 withdrew 0.8 ml from one-ml injectable vial of Heparin (a blood thinner) 5000 units/ml and administered it to Patient 29.

A review of the Patient 29's patient medical record indicated that there was a physician order to give the patient 5000 units of Heparin under the skin every 8 hours for DVT (deep vein thrombosis) on November 6, 2012.

0.8 ml of Heparin 5000 units/ml equated to 4000 units of Heparin.

During a concurrent interview, RN 41 observed the syringe that contained the medication she used from the Heparin vial and stated that the volume contained in the syringe was at "8" but did not specify the unit and that the volume contained in the syringe was less than 1 ml.

It was observed that RN 41 administered the medication contained in the syringe with the volume that RN 41 read as "8" to the patient.

During an interview on November 7, 2012 at 11:15 AM, RN 11 acknowledged that the dose would be questioned and prepared the right dose by using another vial of heparin to make sure there was no manufacturing error.

During an interview, the Chief Nursing Officer (CNO) stated that the facility confirmed with RN 41 that medication error had occurred which was communicated to the prescribing physician.

3b. During a medication pass observation conducted on November 8, 2012 at 4:15 PM, it was observed that Licensed Vocational Nurse (LVN) 41 accessed from the Pyxis MedStation (an Automatic Dispensing Cabinet, ADC) and administered to Patient 28 one tablet of Coumadin (a blood thinner) 2 mg.

A review of the patient's medical record indicated that there was a physician order to give to the patient 6 mg of Coumadin by mouth at 4 PM every day written on November 8, 2012.

During a concurrent interview, LVN 41 acknowledged that she should have given the patient three tablets of 2 mg Coumadin instead of one tablet.

A review of the facility's policy and procedure titled, "Medication Administration: General Guidelines and Safe Practices" effective date of January 1 1999, indicated the following:

"Staff are to follow the six rights during medication administration to verify accuracy of the following...right dose."

A review of the facility's policy and procedure titled, "Bedside Medication Verification (BMV) and Medication Administration" indicated the following:

"Prepare and administer medications as ordered after scanning is complete."

Based on observation, interview and record review, the facility failed to ensure that all patient medical records were kept confidential and secured to prevent unauthorized individuals from accessing the records. This failure had the potential for unauthorized individuals to access patient personal health information.

Findings:

A tour was conducted of the Medical Intensive Care Unit, with Registered Nurse (RN) 2 and the Intensive Care Unit (ICU) Manager, on November 6, 2012 at 12 PM. The unit's patient nutrition room (an unlocked room), contained 12 patient medical records. The medical records were easily accessible and contained patient health information, including laboratory values.

During an interview, on November 6, 2012 at 12 PM, RN 2 stated that the nutrition room was an unlocked room and that there was no method of monitoring who accessed the room. RN 2 stated that the dietary staff accessed the area to stock the room with food and that the house keeping staff accessed the room to clean it. RN 2 also stated that the patient records were kept in the nutrition room because the respiratory therapists used the room to store their patient records.

During an interview, on November 6, 2012 at 12 PM, the ICU Manager stated that the nutrition room was an unlocked area and any personnel can access the room. The ICU Manager also stated that the patient medical records were kept in the nutrition room because it was easily accessible to the respiratory therapists who work in an adjacent station near the nutrition room.

A record review, of the facility policy for "Patient Information Privacy & Security -HIPAA Compliance, revised on 2/14/12," was conducted on November 6, 2012 at 2:30 PM. The policy revealed the following: "...e. SAFEGUARDING PATIENT INFORMATION - Department staff will implement and adhere to appropriate administrative, technical, and physical safeguards which ensure protected health information (PHI) is not accessible by unauthorized individual and is protected from any intentional or unintentional use or disclosure in violation of Medical Center Privacy Policies...and/or the Federal privacy Regulations...Medical Charts are secured at all times. (Charts are not left on counters or in unsecured areas..."

Based on observation and interview, the hospital failed to ensure that discharge orders/instructions contained information regarding the discharge medications. In 2 of 17 charts reviewed (Patients 3, 4) the section on the Discharge order form for the listing of discharge medications had no medications (meds) listed and had handwritten across the section "see Rx (prescription)" or "see med reconciliation form." In the medical record for Patient 10 (an ED record), the final plan had a handwritten note "2. refill meds" with no indication in the record of what meds were refilled. This resulted in an inaccurate and incomplete medical record and the potential for confusion when the charts were reviewed. In a third instance there was the matter that another caregiver was permitted to contact the hospital to confirm the meds that the patient was prescribed and the hospital not needing to verify the accuracy of the information provided.

Findings:

1. Medical records were reviewed throughout the survey. The medical records for Patients 3 and 4 contained a pre-printed form for discharge instructions. The bottom half of the form contained a chart for filling out discharge medications. In both cases, the chart was blank except for a handwritten statement across the entire section referring the reader to either the discharge prescriptions or the medication reconciliation form.

2. The medical record for Patient 10 was an Emergency Department Record. His chief complaint was recorded as, "med refill." In the Emergency Treatment record History and Physical, it states that the patient was out of BP (blood pressure) med. The final plan of the record states that the patient was given Zithromax (a medication to treat bacterial infections) for bronchitis (inflammation of the airway), and "refill meds." On a form entitled 'Medication Reconciliation Form' there was a list of medications the patient was taking. No blood pressure medication was identified.

3. The Health Information Officer was present during the review and confirmed all of the above findings. She thought some of the issues with Medical Records were due to the fact that resident physicians were doing most of the documentation. When questioned regarding the policy of supervision by the attending staff she stated that the faculty was supposed to go over the chart each day as a check on what the resident physician had written. In addition, the nurses on each unit were supposed to flag unsigned verbal orders so that the physician would sign the order promptly. Lastly, the Health Information staff should have been identifying deficiencies in the medical record and contacting physicians to correct them. She did not know why some of the record deficiencies were being missed.

Based on observation and interview, the hospital failed to ensure that all verbal orders were authenticated by the ordering physician's signature within 48 hours. For 2 of 17 charts reviewed (Patients 6 and 13), there were verbal orders that had not authenticated, this led to the potential for incorrectly transcribed orders being missed by the physician and treatment provided to the patients, not intended by the physician, by the nursing staff.

Findings:

1. Medical Records were reviewed throughout the course of the survey. The record for Patient 14 contained a telephone order that was signed by the physician but did not have the date and time of the authenticating signature.

2. The record for Patient 13 contained a verbal order for acetaminophen (a medication to reduce elevated temperatures and pain), dated February 18, 2012 that was not signed by the physician by the time of survey (over 9 months later).

3. The Health Information Officer was present during the review and confirmed all of the above findings. She thought that some of the issues with Medical Records were due to the fact that resident physicians were doing most of the documentation. When asked on the policy of supervision by the attending staff she stated that the faculty was supposed to go over the chart each day as a check on what the resident physician had written. In addition, the nurses on each unit were supposed to flag unsigned verbal orders so that the physician would sign promptly. Lastly, the Health Information staff should have been identifying deficiencies in the medical record and contacting physicians to correct them. She did not know why some of the record deficiencies were being missed.

Based on observation, interview and record review, the facility failed to meet the Condition of Participation for provision of pharmacy services by failing to:

1. Keep accurate records of leftover overfill of 1-ml (milliliter) injectable morphine sulfate (narcotic pain medication), 10 mg/ml (miligram) vials, after compounding morphine sulfate 100 mg/100 ml IV (Intravenous)infusion bags. Refer to A-500

2. Set and maintain a proper medication temperature range resulting in two medication refrigerators maintained outside of the appropriate range without the Pharmacy being notified. Refer to A-500

3. Provide an emergency medication necessary to treat an unexpected event of extravasation (the escape of fluids into the surrounding tissue) from the infusion of chemotherapy. Refer to A-500

4. Conduct monthly random controlled substance audit and follow up of the identified discrepancies in a timely manner. Refer to A-500

5. All Intensive Care Unit (ICU) Registered Nurses (RNs) administered intravenous (IV) vasopressor medications (Potent medications used to help increase blood pressure however if given incorrectly, it can cause too much of an increase in blood pressure or if not given in sufficient amount, it can also prevent a therapeutic blood pressure) to patients in a safe manner and with physician guidance. As a result, RN 1 administered an IV vasopressor to Patient 45 and titrated (incremental increases to a medication until an optimal therapeutic level is obtained and done according to physician's orders), the medication without physician guidance. This failure had the potential to adversely affect Patient 45's health and contributed to the unsafe administration of potent (powerful) medications and unsafe facility practice of IV administration of vasopressors. This deficient practice resulted in an Immediate Jeopardy situation. Refer to A-405.

6. All drugs were administered according to accepted standards of practice and in accordance with approved medical staff policies and procedures when it failed to ensure that all nurses in all critical care units were adjusting and titrating Insulin intravenous drips according to physicians' orders or from an established approved protocol. This deficient practice resulted in an Immediate Jeopardy situation which could have caused serious injury, harm, impairment or death to those patients on Insulin drips. Refer to A-405.

The cumulative effect of these systemic problems resulted in the facility being unable to provide safe and effective pharmaceutical services.

Based on observation, interview and document review, the pharmacy failed to ensure drugs and biologicals were controlled in order to provide patient safety by failing to:

1. Keep accurate records of leftover overfill of 1-ml (milliliter) injectable morphine sulfate (narcotic pain medication), 10 mg/ml (miligram) vials, after compounding morphine sulfate 100 mg/100 ml IV (intravenous) infusion bags.

2. Set and maintain a proper medication temperature range resulting in two medication refrigerators maintained outside of the appropriate range without the Pharmacy being notified.

3. Provide an emergency medication necessary to treat an unexpected event of extravasation (the escape of fluids into the surrounding tissues) from the infusion of chemotherapy.

4. Conduct monthly random controlled substance audit and follow up of the identified discrepancies in a timely manner.

Findings:

1. During an inspection of the Pharmacy on November 5, 2012, at 11:30 AM, it was noted that there was a Pyxis CII Safe (an Automated Drug Cabinets where controlled substances were stored) in which there were two hundred sixty-eight (268) 1-ml injectable vials of morphine sulfate (MS)10 mg/ml and six multi-dose vials of MS 300 mg/20 ml that were not accounted for.

During a concurrent interview, the Assistant Director of Pharmacy (ADOP) stated that the Pharmacy maintained a perpetual inventory electronically.

During a concurrent interview, Pharmacist 41 stated that the unaccounted morphine sulfate vials were from the overfill that was left over after the Pharmacy made morphine sulfate 100 mg/100 ml IV infusion bags for patient's pain control. He stated that each vial of morphine sulfate would have a small amount of overfill and that only nine vials were used to make one 100 ml IV infusion bag of morphine sulfate 100 mg.

Pharmacist 41 stated that he instructed the verifying pharmacists to not waste and save the remaining leftover overfill vials and place them in the Pyxis CII Safe each day after making the MS IV bags. Pharmacist 41 stated that he would periodically count and deposit back to stock and acknowledged that he was not able to do so for a few months.

Pharmacist 41 also stated that he could not recall when the extra MS vials that were accumulated in the CII Safe and could not be sure all vials were fully accounted for.

During an interview on November 5, 2012 at 2 PM, the ADOP stated that, after requested review into the user activity of the CII safe, there were 477 MS IV bags that were made since January 1, 2012 until present and 283 extra leftover vials that were deposited back to stock in the CII Safe which meant there should have been 194 extra vials of MS from the overfill that were currently unaccounted for in the CII safe not 268 vials.

The ADOP further explained that some pharmacy technicians were sometimes able to use only eight 1-ml MS vials to make one 100-ml MS IV infusion bags but acknowledged that he could not tell exactly how many vials should have been in the CII Safe without the daily activity log by the pharmacist depositing the remaining vials back to CII Safe.

A review of the Pyxis CII Safe report for morphine sulfate (Controlled drug used for pain relief) indicated that two hundred eighty-six 1-ml vials were not accounted for.

A review of the facility's policy and procedure titled, "Controlled Substance Dispensing and Inventory -- CII Safe" effective date of February 1999, indicated the following:

"The pharmacist who fills narcotics should do the inventory on any items, which he or she is filling. If a discrepancy is found, please correct it before leaving the pharmacy. If the discrepancy can not be corrected for any reason, please inform the Associate Director of Pharmacy the next day."

2. During inspection of the medication room located in Oncology Infusion Clinic (Cancer Clinic)on November 5, 2012 at 3 PM, it was observed that there were one digital and one analog thermometer with the temperature reading of 29 degrees F and 31 degrees F, respectively.

It was also observed that there were injectable famotidine (used for treatment or prevention of stomach ulcers) vials and Insulin (for treatment of diabetes) vials.

A review of the Temperature/Humidity Graph for Family Health Clinic and Oncology Infusion Clinic medication refrigerators indicated that the minimum and maximum temperature range was set to 32 degrees F and 46 degrees F and that the medication refrigerator was outside the temperature range since October 13, 2012.

During a concurrent interview, the ADOP acknowledged that the temperature was out of range and that the lower temperature range needed to be adjusted to 36 degrees F.

During an interview with Biomed (Biomedical) Supervisor on November 8, 2012 at 9:40 AM, the Biomed Supervisor stated that about 2 months ago the facility started centrally monitoring the medication refrigerators located throughout the facility and in conjunction with the department heads the initial setup of minimum and maximum temperature range monitoring took place. He stated that he and a few others in his department were the only ones that could change the temperature range and have been doing so as they were instructed.

A review of the facility's policy and procedure titled, "Storage of Drugs and Biologicals" effective date of November 1998, indicated the following:

"Drugs shall be stored at appropriate temperatures. Refrigerator temperature shall be 2.2 C (36 degrees F) and 7.7 C (46 degrees F)."

A review of the facility's policy and procedure titled, "Central Plant -- Wireless Remote Temperature Monitoring of Refrigerators & Freezers" effective date of July 2, 2012, indicated the following:

"Temperatures are monitored by Central Plant and/or Facilities Management 24 hours per day 7 days per week.

The areas that are monitored include the following but are not limited to: Pharmacy...

The temperature environment for each device is set to the proper operating range based on the minimum (Low) and Maximum (High) temperature alarm range as defined by the product environmental requirements."

3. During inspection of the medication room located at Oncology Infusion Clinic on November 5, 2012 at 3 PM, it was noted that there was an emergency supply box labeled, "Extravasation Kit" intended for treatment of leakage of chemotherapeutic agents outside the blood vessel.

There was a note on the kit that indicated that one vial of sodium thiosulfate (drug to treat extravasation-infiltration of intravenous medicine from the vein into the tissue) was not included in the kit due to the manufacturer being unable to supply, dated April 23, 2012.

During an interview on November 7, 2012 at 2 PM, the DOP (Director of Pharmacy) stated that there were no other alternatives to sodium thiosulfate and did not indicate the Pharmacy researched into alternative treatment for cases and communicated to the clinic staff. The DOP also did not indicate the Pharmacy had looked into the availability of the medication.

The DOP further stated that the Pharmacy verified that sodium thiosulfate could be ordered from the manufacturer directly and the order would be delivered the next day.

A review of the facility document contained in the kit titled, "Management of Extravasation" (with no date) indicated sodium thiosulfate was to be administered by injection to the extravasation of cisplatin and mechlorethamine, chemotherapeutic agents (Anti-Cancer drugs).

During an interview on November 5, 2012 at 3:15 PM, the ADOP stated that above two agents were prepared by the Pharmacy for Infusion Clinic patients.

4. On November 8, 2012 at 1 PM, Controlled substance audit was reviewed with ADOP.

During a concurrent interview, the ADOP stated that the Pharmacy, on a monthly basis, reviewed twenty random medical records to monitor use of controlled substances throughout the facility.

A review of the Pharmacy's Audit of Controlled Substances (CS) document from June 2012 through August 2012, indicated that the Pharmacy did not perform the random CS Audit in September and October 2012.

A review of the Pharmacy's CS Audit for June, July, and August 2012 also indicated that there were identified CS discrepancies that were not communicated and followed up by the Pharmacy.

During a concurrent interview, ADOP acknowledged that the CS Audit was not done in September and October and indicated that discrepancies were identified during the months of June, July, and August but the Pharmacy did not follow up with investigations into the reason for the discrepancies.

For example, June CS Audit showed that one medical record reviewed nursing staff accessed Norco 5/325 mg (a narcotic pain medication) was accessed from the Pyxis MedStation (an Automatic Dispensing Cabinet, ADC) but no documentation was found on the MAR (Medication Administration Record).

There were five discrepancies in June, six in July, and eight in August according to the audit.

A review of the facility's policy and procedure titled, "Controlled Substances -- Random Audit" indicated the following:

"The pharmacist will select at random twenty (20) charts of patients who received controlled substances during the current month...

The pharmacist reviews all documents that reflect medication administration...

All discrepancies are documented on the Audit Documentation Form which is forwarded to the Associate Director of Pharmacy Services...

The Associate Director will review all completed Audit forms and will take appropriate action, including notifying the appropriate Department Head and Associate Administrator."

Based on observation, interview and record review, the facility failed to ensure that outdated, mislabeled or otherwise unusable drugs were not available for patient use. In the Medical Intensive Care Unit's medication refrigerator, a multi-dose bottle of neurontin (a medication to treat seizures) was labeled with a patient's name. There was no label recording the date the bottle was opened or the expiration date of the medication. The medication was available for patient use. This failure had the potential to increase the risk of adverse reactions to the patient.

Finding:

During a tour, with Registered Nurse (RN) 2, on November 6, 2012 at 11:40 AM, of the Medical Intensive Care Unit's medication room, a multi-dose bottle of neurontin 250 milligrams/5 milliliters (labeled with a patient's name) contained no expiration date, no open date and was stored in the medication refrigerator. RN 2 stated that she was unable to find the expiration date or the open date on the bottle.

A record review, on November 6, 2012 at 2:25 PM, of the facility policy for "Storage of Drugs and Biologicals" revealed: "...All medication areas shall be devoid of (without) outdated, discontinued, or recalled drugs...Multi-dose vials with preservatives will have the month, day, and year of opening written on the vial. The opened vial may be used for 28 days from the date of opening and will then be discarded..."

Based on observations, interviews and record reviews, the hospital condition of participation for food and dietetic services was not met as evidenced by:

?The hospital failed to ensure that the Nutrition Services Manager (NSM) was effective in the daily management of the dietary services. Cross refer A 620

?The hospital failed to ensure that the NSM, the Clinical Nutrition Supervisor (CNS) and dietary staff were competent in their respective duties. This was noted when they lacked the knowledge on the safe use of the dietary equipment used to thaw potentially hazardous foods (PHF) and when they lacked knowledge regarding the safe cooling of PHF. This lapse in competency resulted in unsafe food storage practices and had the potential to result in food borne illness in a susceptible patient population. Cross refer A 622

?The hospital failed to implement their disaster food plan in order to ensure the safety and well-being of the patients in the event of a disaster. This resulted when the hospital failed to maintain adequate supplies to carry-out their disaster food plan. This had the potential to result in inadequate nutrition during a disaster in a susceptible patient population. Cross refer A 701

?The hospital failed to develop an effective infection control surveillance system for identifying unsafe food handling practices in the dietary department. The lack of surveillance of these unsafe food handling practices had the potential to result in a food borne illness outbreak in a highly susceptible patient population. Cross refer A 749

The cumulative effect of these systemic problems resulted in the inability of the hospital's dietary department to direct and staff in such a manner to ensure that the nutritional needs of the patients were met in accordance with safe and acceptable standards of practice.

Based on observation, record reviews and staff interviews, the hospital failed to ensure that the Nutrition Services Manager (NSM) was effective in the daily management of the dietary services when:

Unsafe food handling practices were observed in the department. Cross refer A 749

?Management and staff of the department lacked competency in safe thawing and cooling of potentially hazardous food. Cross refer A 622

?The disaster food supplies were not adequate to ensure the disaster plan could be implemented. Cross refer A 701

These failures had the potential to result in food borne illness and/or inadequate nutrition during a disaster in a susceptible patient population in a hospital with a licensed bed capacity of 456.

Findings:

1. During the survey, unsafe food handling practices were observed as follows:

?A refrigerator used for thawing potentially hazardous (perilous/risky) foods (PHF) did not maintain the food at a safe temperature.

?Potentially hazardous foods were not being cooled in a safe manner.

?There was no system for monitoring the shelf life of some foods once it was removed from the freezer to thaw.

?Open bulk dry foods were not stored properly to prevent contamination.

Cross refer A 749

a. During observations in the kitchen on November 5, 2012 at 10:30 AM and November 6 at 10:55 AM, reach-in refrigerator J was noted to be maintained at 52 degrees Fahrenheit (F) at both times. During the second observation, two pans of Salisbury steak in the refrigerator were noted to be 44.6 and 42.6 degrees F.

According to the 2009 Food and Drug Administration (FDA) Food Code, refrigerated thawing of potentially hazardous food (PHF - foods that require time/temperature control for safety food) shall be under refrigeration that maintains the food temperature at 41 degrees F or less.

b. During interviews and record reviews on November 3, 5 and 6, 2012, it was ascertained that the patient food service consisted of a cook-chill system where the food was cooked, cooled and/or frozen and then reheated just prior to serving it to the patients. The system required safe cooling of PHF.

During the survey it was noted that PHFs were not being monitored for safe cooling to 41 degrees F or less within 4 hours when prepared from ingredients at room temperature. Also, the management and staff were not knowledgeable about this requirement.

According to the 2009 FDA Food Code, potentially hazardous food (time/temperature control for safety food) shall be cooled within 4 hours to 41 degrees F or less if prepared from ingredients at ambient (room) temperature, such as reconstituted foods and canned tuna.

c. During the observations and interviews on November 5, 2012 between 10:15 AM and 11:45 AM, several PHF that required date monitoring to ensure freshness and food safety were not dated. Items that had a limited shelf life when removed from the freezer to thaw in the refrigerator were not dated to ensure the shelf life was adhered to.

d. During the observations and interview on November 5, 2012 at 10:30 AM, the bulk dry items were observed stored in a bin still in the original packaging. These items should have been removed from the packaging that they were shipped in to prevent cross contamination. This would occur when the packaging was potentially contaminated by microbes, dust or chemicals introduced by products or equipment stored in close proximity or by persons delivering, stocking or opening packages or overwraps. Packaging must be appropriate for preventing the entry of microbes and other contaminants such as chemicals. These contaminants may be present on the outside of containers and may contaminate food if the packaging is inadequate or damaged or when the package is opened.

2. During the survey the NSM, the Clinical Nutrition Supervisor (CNS) and dietary staff were noted to lack competency in their respective duties. This was noted when they lacked knowledge on the safe use of the dietary equipment used to thaw potentially hazardous foods (PHF) and when they lacked knowledge regarding the safe cooling of PHF. This lapse in competency resulted in unsafe food storage practices and had the potential to result in food borne illness in a susceptible patient population. Cross refer A 622

3. During the survey the NSM failed to implement the disaster food plan in order to ensure the safety and well-being of the patients in the event of a disaster. This resulted when the hospital failed to maintain adequate supplies to carry-out their disaster food plan. This had the potential to result in an inadequate nutrition in a susceptible patient population. Cross refer A 701

Based on observation, interviews and record reviews, the hospital failed to ensure that the Nutrition Services Manager (NSM), the Clinical Nutrition Supervisor (CNS) and dietary staff were competent in their respective duties. This was noted when they lacked knowledge on the safe use of the dietary equipment used to thaw potentially hazardous foods (PHF) and when they lacked knowledge regarding the safe cooling of PHF. This lapse in competency resulted in unsafe food storage practices and had the potential to result in food borne illness in a susceptible patient population. Cross refer A 749

Findings:

1. According to the 2009 Food and Drug Administration (FDA) Food Code, refrigerated thawing of potentially hazardous food (PHF - foods that require time/temperature control for safety food) shall be under refrigeration that maintains the food temperature at 41 degrees F or less.

During observations in the kitchen on November 5, 2012 at 10:30 AM and November 6 at 10:55 AM, reach-in refrigerator J was noted to be maintained at 52 degrees Fahrenheit (F) at both times. During the second observation, two pans of Salisbury steak in the refrigerator were noted to be 44.6 and 42.6 degrees F. A third pan of frozen lasagna was noted to be frozen solid.

During an interview with the NSM and the CNS on November 6th at 11:00 AM, they stated that the refrigerator was called a "thaw box" and that the temperature in the thaw box could be maintained greater than 41 degrees F in order to thaw frozen foods rapidly. They were unable to explain how the Salisbury steak could be safely held in the thaw box at greater than 41 degrees F.

During an interview with the Cook on November 6th at 11:00 AM, he stated that the Salisbury steak had been placed in the thaw box the previous day by another cook. He stated that he had placed the lasagna in the thaw box that morning to thaw. He did not remove the Salisbury steak from the night before and did not check the temperature of the steak. He was unable to state how long the Salisbury steak had been held at greater than 41 degrees F.

A review of the Owner's Manual for the Even-Thaw thaw box, dated July 2001, revealed that it was designed to thaw product at safe temperatures by keeping the cabinet temperature from rising above 40 degrees F. It stated that this allows the product to thaw at temperatures that minimize bacterial growth. It further stated that after the product was thawed, the thaw box could be used as a holding cabinet at refrigerated temperatures. But if the unit was needed for thawing additional frozen product, all previously thawed product should be moved to another unit.

A review of the hospital's policy titled, "Infection Control/Food Handling" dated October 28, 2010, revealed that "Potentially Hazardous food (Time/Temperature Control for Safety Food) shall be thawed under refrigeration that maintains food temperatures of 41 F or less." This policy was consistent with the requirement of the 2009 FDA Food Code.

During an interview with the NSM on November 7, 2012 at 11:30 AM, he stated that he and the dietary staff had not read the owner's manual for the thaw box and that they did not know how it functioned.

2. During an interview with the NSM on November 5, 2012 at 9:40 AM, he stated that the nutrition services utilized a cook-chill system where patient food was cooked in advance (sometimes days in advance) then cooled or frozen until needed for meal service. The refrigerated and frozen foods were then plated and rethermed (heated to appropriate temperatures) in the nutrition pantries on each nursing unit before being served to the patients.

According to the 2009 FDA Food Code, potentially hazardous food (time/temperature control for safety food) shall be cooled within 4 hours to 41 degrees F or less if prepared from ingredients at ambient (room) temperature, such as reconstituted foods and canned tuna. It further states that if food is not cooled in accordance to this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness.

During a review of the hospital's Cooling Log dated November 3, 2012, bread dressing was noted to have a starting temperature of 61 - 62 degrees F at 5:30 AM and the temperature was not checked again until 10:20 AM. At 10:20 AM the temperatures were below 41 degrees F. There was no temperature recorded at 4 hours. The Cooling Log dated October 23, 2012 showed mashed potatoes were prepared with an initial temperature of 65 degrees F at 6:25 AM with no recorded temperature monitoring at 4 hours.

During an interview with Dietary Staff 1 on November 6, 2012 at 11:45 AM, she stated that she made the bread stuffing and mashed potatoes routinely. She stated that she had a total of 6 hours to bring the temperature of these items to 41 degrees F or less. She did not know that foods prepared from room temperature ingredients needed to be cooled to 41 degrees or less within 4 hours.

Further review of the hospital's Cooling Log revealed directions to the staff that included the 6 hour cooling timeframe. There was no direction to the staff that directed them to cool foods with ingredients at room temperature to 41 degrees or less in 4 hours.

During an interview with the NSM and the CNS on November 6, 2012 at 11:45 AM, they did not know that there was a different requirement for the cooling of PHF that were made using ingredients at room temperature versus cooked foods. They verified that the directions on the Cooling Logs were not accurate for PHF prepared from ingredients at room temperature.

A review of the employees files and posted certificates revealed that the NSM and the CNS both had successfully completed food safety certification courses. They were unable to explain why they did not know safe thawing and cooling practices in order to accurately direct and monitor the dietary staff.

Based on observation, interviews and record reviews, the hospital failed to implement their disaster food plan in order to ensure the safety and well-being of the patients in the event of a disaster. This resulted when the hospital failed to maintain adequate supplies to carry-out their disaster food plan. This had the potential to result in an inadequate provided nutrition during a disaster to a susceptible patient population for a hospital with a licensed bed capacity of 456.

Findings:

On November 5, 2012 at 1:30 PM, a concurrent observation of the disaster food supply, review of the hospital's disaster food plan and interview with the Nutrition Service Manager (NSM) was conducted. The Disaster Menu, undated, included using one package of instant breakfast (a high calorie, high protein nutrition drink) at breakfast for 3 days of the plan for all people except those patients whose diet prescription precluded its use. This would mainly include patients on a renal diet (a diet used for persons with kidney function impairment). The instant breakfast provided about 12 percent of the protein and 8 percent of the calories in the planned diet for three days. According to the plan, 72 cases of instant breakfast were required. The hospital had 22 cases.

During a concurrent interview with the NSM, he stated that they were rotating stock and had not replaced the instant breakfast yet. He was unable to state how they would provide the needed calories and protein to patients and staff if the disaster occurred without the planned menu items.

Based on observation and interview, the hospital failed to ensure 4 areas (Gastroenterology [GI] Laboratory, Outpatient Clinic A, Outpatient Clinic B and Outpatient Clinic C) maintain infection control standards to reduce the risk of transmission of potentially pathogenic microorganisms, as evidenced by: at the GI laboratory, multiple clean specimen containers were observed at the dirty utility room, multiple clean endoscopes were observed hanging in an open closet in the dirty utility room at the Outpatient Clinic A, clean supplies were stored in the dirty utility room at the Outpatient Clinic B, and there was an equipment decontamination area observed within the clean supply room. These resulted in a potential of transmission of infectious pathogens that can be detrimental to the patient, a universe of 272, and all staff at the Outpatient Clinics.

Findings:

1. On November 8, 2012 at 9:40 AM, a tour of the GI Laboratory was conducted with the Assistant Manager and the following were noted:

There were multiple clean specimen containers that contained formalin (solution of formaldehyde in water) observed in the dirty utility room. The Manager confirmed the finding and stated that the laboratory manager reported that it was okay to store the specimen containers in dirty utility room.

In a GI procedure room, there were multiple endoscopes (a medical instrument consisting of a long tube inserted into the body, used for diagnostic examination and surgical procedures) hanging in a closet. The scopes were touching a towel at the bottom of the closet, a potential for contamination. The Manager confirmed the finding.

2. On November 9, 2012 at 9:40 AM, a tour of Outpatient Clinic A was conducted with the Outpatient Nurse Manager and the Outpatient Operations Manager. There were multiple clean endoscopes observed hanging in an open closet in the dirty utility room used to decontaminate multi-use patient equipment. The Nurse Manager and the Outpatient Operations Manager confirmed the finding.

3. On November 9, 2012 at 11:35 AM, a tour of Outpatient Clinic B was conducted with the Outpatient Charge Nurse and the Outpatient Operations Manager. There were clean supplies stored in the decontamination room. The Charge Nurse and the Outpatient Operations Manager confirmed the finding.

4. On November 9, 2012 at 2:35 PM, a tour of Outpatient Clinic C was conducted with the Outpatient Charge Nurse and the Outpatient Operations Manager. There was an equipment decontamination area observed within the clean supply room. The Charge Nurse and the Outpatient Operations Manager confirmed the finding.

On November 9, 2012 at 4:20 PM, an interview was conducted with the hospital's Infection Control Nurse. She stated that Nursing Unit environmental care rounds were conducted every six months, which included the outpatient clinics. However, the ICN was not knowledgeable regarding the co-mingling of clean and dirty storage at the outpatient clinics or that the GI Laboratory stored clean specimen containers in the dirty utility room. These practices can result to potential transmission of infectious pathogens that can cause adverse effects to patients and staff.

Based on observations, interviews and record reviews, the hospital failed to develop an effective infection control surveillance system for identifying unsafe food handling practices in the dietary department when:

?A refrigerator used for thawing potentially hazardous foods did not maintain the food at a safe temperature.

?Potentially hazardous foods were not being cooled in a safe manner.

?There was no system for monitoring the shelf life of food once it was removed from the freezer to thaw.

?Open bulk dry foods were not stored properly to prevent contamination.

?Cooked frozen foods were stored beyond their shelf life.

?The ice machines throughout the hospital were cleaned with a sanitizer that was not food safe rated.

The lack of surveillance of these unsafe food handling practices had the potential to result in a food borne illness outbreak in a highly susceptible patient population in a hospital with a licensed bed capacity of 456.

Findings:

1. According to the 2009 Food and Drug Administration (FDA) Food Code, refrigerated thawing of potentially hazardous food (PHF - foods that require time/temperature control for safety food) shall be under refrigeration that maintains the food temperature at 41 degrees F or less.

During observations in the kitchen on November 5, 2012 at 10:30 AM and November 6 at 10:55 AM, reach-in refrigerator J was noted to be maintained at 52 degrees Fahrenheit (F) at both times. During the second observation, two pans of Salisbury steak in the refrigerator were noted to be 44.6 and 42.6 degrees F. A third pan of frozen lasagna was noted to be frozen solid.

During an interview with the Nutrition Services Manager (NSM) on November 6th at 11:00 AM, he stated that the refrigerator was called a "thaw box" and the temperature in the thaw box could be maintained greater than 41 degrees F in order to thaw frozen foods rapidly. He was unable to explain how the Salisbury steak could be safely held in the thaw box at greater than 41 degrees F.

During an interview with the Cook on November 6th at 11:00 AM, he stated that the Salisbury steak had been placed in the thaw box the previous day by another cook. He stated that he had placed the lasagna in the thaw box that morning to thaw. He did not remove the Salisbury steak from the night before and did not check the temperature of the steak. He was unable to state how long the Salisbury steak had been held at greater than 41 degrees F.

The Cook further stated that it was his usual practice to place a frozen food item in the thaw box, and then he kept pushing the "thaw button" to thaw food quickly. It was not unusual for the temperature of the thaw box to be greater than 41 degrees in order to rapidly thaw the frozen food.

During further interviews with the NSM and the Clinical Nutrition Supervisor (CNS) the same day at 11:15 AM, they stated that it was the purpose of the thaw box to reach temperatures greater than 41 degrees F in order to thaw frozen foods quickly. They further stated that the hospital used a centralized tracking system to monitor all the refrigerator temperatures in the building. The system was set up so that an alarm would alert the engineering staff when refrigerator temperatures fell outside preset ranges. They stated that an alarm would not go off until the temperature for the thaw box reached 53 degrees F. Therefore no alarm went off when the temperature of the thaw box was at 52 degrees F during the observations on two different days. No other refrigerator temperature monitoring was being conducted.

A review of the hospital's temperature monitoring "Performance Report" for the thaw box revealed that between November 4th at 11:30 AM and November 6th at 11:30 AM, the unit's temperature was recorded at greater than 40 degrees F more than 50% of the time. It further revealed that the temperature of the unit reached 53 degrees 10 times during this time period.

A review of the hospital's temperature monitoring "Alarm History and Corrective Action" report dated October 30 through November 6, 2012 did not indicate that the thaw box temperatures set off alarms during the timeframe November 4th through 6th.

A review of the Owner's Manual for the Even-Thaw thaw box, dated July 2001, revealed that it was designed to thaw product at safe temperatures by keeping the cabinet temperature from rising above 40 degrees F. It stated that this allows the product to thaw at temperatures that minimize bacterial growth. It further stated that after the product was thawed, the thaw box could be used as a holding cabinet at refrigerated temperatures. But if the unit was needed for thawing additional frozen product, all previously thawed product should be moved to another unit.

A review of the hospital's policy titled, "Infection Control/Food Handling" dated October 28, 2010, revealed that "Potentially Hazardous food (Time/Temperature Control for Safety Food) shall be thawed under refrigeration that maintains food temperatures of 41 F or less."

During an interview with the NSM on November 7, 2012 at 11:30 AM, he stated that he and the dietary staff had not read the owner's manual for the thaw box and they did not know how it functioned.

2. During an interview with the NSM on November 5, 2012 at 9:40 AM, he stated that the nutrition services department utilized a cook-chill system where patient food was cooked in advance (sometimes days in advance) then cooled or frozen until needed for meal service. The refrigerated and frozen foods were then plated and rethermed (heated to appropriate temperatures) in the nutrition pantries on each nursing unit before being served to the patients.

According to the 2009 FDA Food Code, potentially hazardous food (time/temperature control for safety food) shall be cooled within 4 hours to 41 degrees F or less if prepared from ingredients at ambient (room) temperature, such as reconstituted foods and canned tuna. It further states that if food is not cooled in accordance to this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness.

During a review of the hospital's Cooling Log dated November 3, 2012, bread dressing was noted to have a starting temperature of 61 - 62 degrees F at 5:30 AM and the temperature was not checked again until 10:20 AM. At 10:20 AM, the temperatures were below 41 degrees F. There was no temperature recorded at 4 hours.

Further review of the Cooling logs for October 1 through November 5, 2012 revealed that bread dressing and mashed potatoes were prepared using ingredients at room temperature then cooled. In 11 of 14 recordings of bread dressing, temperatures were not monitored within 4 hours. In 3 of 9 recordings of mashed potatoes, temperatures were not monitored within 4 hours.

During an interview with Dietary Staff 1 on November 6, 2012 at 11:45 AM, she stated that she made the bread stuffing and mashed potatoes routinely. She stated that she had a total of 6 hours to bring the temperature of these items to 41 degrees F or less. She did not know that foods prepared from room temperature ingredients needed to be cooled to 41 degrees or less within 4 hours.

Further review of the hospital's Cooling Log revealed directions to the staff that included the 6 hour cooling timeframe. There was no guidance to the staff that directed them to cool foods with ingredients at room temperature to 41 degrees or less in 4 hours or less.

During an interview with the NSM and the CNS on November 6, 2012 at 11:45 AM, they did not know that there was a different requirement for the cooling of PHF that were made using ingredients at room temperature versus cooked foods. They verified that the directions on the Cooling Logs were not accurate for PHF prepared from ingredients at room temperature.

A review of the hospital's policy titled, "Infection Control/Food Handling" dated October 28, 2010, revealed that "Potentially hazardous food (Time/Temperature control for Safety Food) shall be cooled within 4 hours to 41 F or less if prepared from ingredients at ambient temperature, such as reconstituted foods and canned tuna."

3. During a tour of the kitchen on November 5, 2012, between 10:15 and 11:45 AM, the following items were observed:

?Two half gallon cartons of a liquid egg product labeled keep frozen were observed thawed in the cook's refrigerator with no date marking. The manufacturer's instructions were written on the product to use within 3 days of thawing.

?Eleven cases of liquid egg labeled 'keep frozen' in the walk-in refrigerator with no date marking. The manufacturer's direction were written on the product to use within 3 - 4 days after thaw.

?Approximately four dozen six ounce milk-based nutritional supplements were observed in the walk-in refrigerator with no date marking. The manufacturer's instructions were written on the product to use within 14 days of thawing.

?Three cases of large boneless beef roasts were observed in the walk-in refrigerator with no use-by dates.

?Eight cases of uncooked bacon and two cases of deli meats were observed in the walk-in refrigerator with no use-by dates.

During a concurrent interview with the NSM, he stated that the staff was supposed to date perishable foods with a "use-by" date. Foods were to be discarded on their use-by date. He was unable to explain why the food observed did not have use-by dates written on them to monitor a safe shelf-life for these products. For the beef, he was unable to state what the shelf life was for the product. He was unable to state how the dietary staff could ensure these products were safe when served to the patients.

A review of the hospital's policy titled, "Infection Control/Food Handling" dated October 28, 2010 revealed that All foods shall be appropriately covered, labeled and dated.

4. During a tour of the kitchen and concurrent interview with the NSM on November 5, 2012 at 10:30 AM, a bulk dry storage bin was observed to contain an open large bag of cake flour that was not sealed. The NSM stated that the cake flour was shipped in the observed bag with no other outer covering. He verified that the bag was placed in a clean bulk storage container, but the bag was not clean and was not sealed. He was unable to state how the dietary staff could prevent the cross contamination of the flour with the bag.

According to the 2009 FDA Food Code, food shall be protected from cross contamination by storing food in packages, covered containers, or wrappings. Food that is inadequately packaged could become contaminated by microbes, dust or chemicals introduced by products or equipment stored in close proximity or by persons delivering, stocking or opening packages or overwraps. Packaging must be appropriate for preventing the entry of microbes and other contaminants such as chemicals. These contaminants may be present on the outside of containers and my contaminate food if the packaging is inadequate or damaged or when the package is opened.

5. During a tour of the kitchen on November 5, 2012 at 11:20 AM, in reach-in freezer "S", the following was observed:

?A pan of frozen spaghetti sauce dated use by October 30.

?A pan of frozen Asian chicken dated use by November 3.

?A pan of frozen meatloaf dated use by November 4.

These observations were confirmed by the NSM. He was unable to state why the items had not been discarded on the use by dates.

6. During an interview with the Environmental Services Assistant Manager (EVS-AM) on November 8, 2012 at 9:10 AM, he stated that his staff was responsible for cleaning and disinfecting the outside of and the drains for the ice machines throughout the hospital. He stated that his staff also cleaned the spouts that the ice dispenses through weekly. He stated that his staff used a product called Virex 256 that he stated "kills everything."

A review of the manufacturer's product information revealed that Virex 256 is not NSF rated for food safety (NSF is the organization that certifies products and writing standards for food, water and consumer goods). A cleaning and/or sanitizing product used in sanitizing food contact surfaces must be NSF rated.

During a phone call to the technical support department of the manufacturer for Virex 256 on November 8, 2012 at 10:30 AM, the representative stated that Virex 256 was not a food safe product.

During an interview with the Infection Control Nurse Epidemiologist on November 8, 2012 at 3:40 PM, she stated that she wasn't aware of the above food safety issues in the hospital. She was not aware that the thaw box temperature was allowed to reach 53 degrees F before the engineering staff was notified. She also wasn't aware that PHF was not being properly monitored for safe cool down. She didn't know that EVS staff was using a disinfectant that was not food safe to clean the ice machines. She confirmed that the above deficient practices created a potential for either cross contamination of the food/ice and/or were practices that had the potential to result in food borne illness,

Based on observation, interview and medical record review, the hospital failed to provide an appropriate and timely discharge plan evaluation that identified the biopsychosocial needs for 1 of 35 records reviewed (Patient 50). This failure had the potential to delay the discharge planning process for all patents that required a discharge plan evaluation, which may contribute to unsafe discharges from the hospital.

Findings:

Patient 50's medical record was reviewed. The patient was admitted to the hospital on September 4, 2012 with diagnoses that included danger to self, facial lacerations and possible fracture.

A review of the history and physical, dated September 4, 2012, revealed that the patient had a history of mental retardation and cerebral palsy.

A review of the Safe Discharge Plan, dated September 4, 2012, was conducted. The short-term goals included patient/caregiver knowledge of discharge plan. The interventions included case management: evaluation, discharge plan and utilization review. There were no revisions to the plan of care after September 4, 2012, to reflect the patient's developmental disability and care needs.

A review of the physician order (PO), dated October 15, 2012, was conducted and revealed an order for a "social worker consult to assist the case manager in placement issue for this patient."

A review of the Social Services documentation, dated October 24, 2012, which was completed 9 days after the PO, was conducted and revealed that there were multiple barriers to discharge that included a cervical collar. The evaluation did not address the patient's history of mental retardation and cerebral palsy.

On November 5, 2012 at 2:45 PM, an interview was conducted with Registered Nurse (RN) 1. RN 1 stated that Patient 50 was transferred to the medical-surgical unit on October 25, 2012. She stated that the patient had behaviors that required restraints and a sitter (a nurse assistant at the bedside that provided direct observation and care).

On November 6, 2012 at 2 PM, Patient 50 was observed lying in bed with a sitter in the room. The sitter stated that the restraints and cervical collar were discontinued. An interview was conducted with the patient's grandparents that confirmed that the patient had a history of mental retardation. They stated that the patient was unable to make his needs known and required assistance with feeding, total assistance with toileting and grooming. They stated that the patient had been hospitalized for two months and that they were anticipating discharge. They expressed concern regarding appropriate placement for the patient related to the patient's developmental disability and care needs. When asked if the hospital staff evaluated the patient for placement in an intermediate care facility for developmentally disabled individuals, the patient's grandparents stated "no."

On November 6, 2012 at 2:25 PM, an interview and record review was conducted with Social Worker (SW) 1. When asked about the patient's discharge plan, SW 1 stated that approximately ten mass referrals for placement were sent out daily.

A review of the most recent discharge plan documentation completed by a case manager, dated November 2, 2012, was conducted with SW 1 and showed that a mass referral was sent out for placement in a skilled nursing facility (SNF - facilities that accommodate chronically ill patients needing nursing care) or a board and care (B&C - facilities that accommodate individuals that can care for themselves; meals and supervision provided). The patient's "barriers to placement," included the need for restraints for safety and cervical spine precautions. The documentation also showed "Exhausted all (Insurance name here) contracted SNFs but no takers ... refused to take the patient because of his age, (insurance name here) aware."

SW 1 confirmed that the mass referral did not include the patient's history of mental retardation for potential placement in a home for individuals with developmental disabilities. The SW 1 acknowledged and stated that the patient's status was not updated to reflect that the patient no longer required a cervical collar and/or restraints. She stated that the patient ' s discharge plan should have been updated to reflect the patient's medical history and current needs. SW 1 acknowledged and confirmed that a SNF or a B&C was not appropriate placement for a patient with a developmental disability discharge need.

On November 8, 2012 at 11:35 AM, an interview and record review was conducted with the Social Services Manager (SSM). She reviewed the patient's medical record. The SSM confirmed that the Safe Discharge Plan of Care was updated to reflect the patient's current condition and identified needs. She also confirmed that there was a physician order for the SW Consult, dated October 15, 2012. She confirmed that the consult did not occur until October 24, 2012 (9 days after the physician order). The SSM stated that the consult should have been completed within 24 hours, per policy. The SSM also stated that when SW 1 conducted her evaluation she should have contacted Inland Regional Center (advocates for individuals with developmental disabilities) for assistance with appropriate placement options for the patient.

On November 8, 2012, a review to the hospital's policy and procedure titled, "Multidisciplinary Consult Requests," dated November 20, 2010, indicated that referrals will be responded to within 24 hours. In addition, during the Social Services assessment, the Social Worker will evaluate the patient/family needs and the necessity for follow-up and/or reassessment will be determined based on these needs. Guidelines for reassessments of patients include the following; change in medical condition; significant new information about a patient; at the request of the patient, family, and physician.

Based on interview and record review, the facility failed to ensure that Respiratory Therapists, determined by the facility to be qualified in placing percutaneous Arterial Line Monitoring devices into patients' Radial Artery, had documented evidence of training and competency to perform the procedure. This deficient finding had the potential to result in harm and injury affecting the health and safety of those patients undergoing the procedure.

Findings:

On November 9, 2012, a review of Respiratory Therapist C's (RT C) personnel file was conducted. RT C's file revealed that as a Supervising Respiratory Care Practitioner he was deemed competent by the Respiratory Department and met all requirements in placement of arterial lines (a monitoring device imbedded in the artery near the wrist area) in patients when ordered by a physician.

On November 9, 2012, a review of Respiratory Therapist C's personnel/education file revealed that there was no documented evidence of his initial training or current competency in the placement of Arterial Lines in those patients requiring arterial monitoring.

On November 9, 2012, a review of the facility's policy and procedure titled, "RADIAL ARTERY-PERCUTANEOUS ARTERIAL LINE PLACEMENT", dated April 2010 stipulated, "...Due to consequences of complications, competency validation will be performed initially and then annually...". In addition, "...To be deemed competent in placement of arterial lines, the Respiratory Care Practitioner must be observed and signed-off three times by one of the following: Intensivist, Hospitalist and Senior Surgical Resident..."

There was no documented evidence in Respiratory Therapist C's (RT C) personnel/education file that RT C was trained initially or had current competencies to perform percutaneous (through the skin) arterial line placement as per hospital policy dated April, 2010.

There was no documented evidence that the Respiratory Department or hospital-wide Quality Assurance and Performance Improvement Department were monitoring or reviewing RT C's educational training and requirements needed to perform specific specialized duties, such as percutaneous arterial line placements, and tracking outcomes after arterial line placements in those patients.

During an interview with the Assistant of Respiratory Care Department on November 9, 2012, at approximately 1:30 PM, he confirmed that RT C did not have evidence of initial training and no evidence of current competency to perform percutaneous arterial line placement as per hospital policy.