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Based on observation, interview, and record review, the facility's Governing Body (GB) failed to ensure the hospital's operation was conducted in an effective, safe, and organized manner by failing:

1. To develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program, in which the governing body (GB) ensured the program reflected the different department/services; and the program focused on indicators in improving health outcomes. (Refer to A620, and A500).

2. To ensure nursing services and operations were provided in a safe and effective manner that would meet the patients' needs. (Refer to A168, A385, A395, A396, A405, A454, A457, A465, A951, A1100 and A1103).

3. To ensure food and dietetic services and operations were provided in a safe and effective manner that would meet the patients' needs. (Refer to A283, A618, A620,A622, A628, A630, A631, and A749).

4. To ensure provision of pharmacy services were provided in a safe and effective manner to meet the patients' needs. (Refer to A490, A500, A505).

The cumulative effect of these systemic problems resulted in failure of the governing body to ensure patients were receiving quality care in a safe and effective manner.

Based on observation, interview and record review, the facility failed for one sampled patient (Patient 110), who was observed in restraints, to ensure the physician's order for restraint use included the time the restraint order was written, and the reason for the restraint (medical/surgical management or violent self-destructive behavior). This failure had the potential to result in Patient 110 spending an extended time in restraints.

Findings:

On October 23, 2012, at 2:40 p.m., Patient 110 was observed in bed in his assigned room. Patient 110 had bilateral wrist restraints in place.

Patient 110's record was reviewed on October 23, 2012. Patient 110, a seventy-one year old male presented to the facility on October 22, 2012, with complaints of syncope (fainting) and a low glucose (blood sugar) reading.

A "Daily Safety /Behavioral Restraint Assessment & Physician Orders," form dated October 22, 2012, indicated the patient required a restraint for Medical/Surgical Management. The form contained instructions that indicated "Medical/Surgical Management is a 24 hour maximum or less..." The form was signed and dated by the physician, but there was no time documented.

A "Daily Safety /Behavioral Restraint Assessment & Physician Orders," form dated October 23, 2012, indicated soft wrist restraints and side rails were to be used. The reason for the restraint use, for example Medical/Surgical Management or Violent or Self-Destructive behaviors, was not identified. The form was signed and dated by the physician, but there was no time documented.

In an interview with RN 10, on October 23, 2012, at 3:20 p.m., RN 10 stated the restraint orders were good for 24 hours. RN 10 agreed there was no time written on either of the restraint orders.

The facility's policy and procedure titled "Restraint and Seclusion," with a revised/reviewed date of September 2012, indicated "Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, staff member, or other and must be discontinued at the earliest possible time." The policy indicated:

"Physician orders for restraint that is not used for the management of violent or self-destructive behavior shall remain in effect until the patient's behavior or situation is assessed to no longer requires restraint, or the indications for discontinuation approved by the restraint order are met, or the end of the calendar day following the order date when the restraint order does not contain indications for discontinuation."

The "Medical Staff General Rules and Regulations" dated July 1, 2012, were reviewed on October 24, 2012. Section 2.7 of the Rules and Regulations indicated all clinical entries in the patient's medical record would be accurately dated, timed and authenticated. In the section titled "Restraint Orders," the following was documented:

"Restraint Orders must include a verbal or written time-limited order pertaining to each use of restraint or seclusion; the type of restraint..."

Based on observation, interview, and record review, the facility failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program, in which the governing body (GB) ensured the program reflected the different department/services by failing to ensure:

1. Data reported by the General Manager of Food Services (GMFS) as part of the Quality Assurance Performance Improvement (QAPI) program accurately reflected department operations ( Refer to A283, A620); and,

2. The Pharmacy renal dosing monitoring of medications was performed and was captured in its quality data.(Refer to A500).

The cumulative effect of these systemic problems resulted in the failure of the facility's QAPI program to ensure high quality healthcare and a safe environment for all patients.

Based on staff interview and document review, the hospital failed to ensure the accuracy of the reported quality improvement data related to foodservices. This resulted in a lack of ability to identify opportunities for improvement and changes that would lead to improvement in sanitation/safe food handling practices which could result in food borne illness.

Findings:

During the survey from October 22, 2012 - October 24, 2012, deficient practices related to safe and sanitary food service operations (Cross Reference A620 and A749) were identified. This would be considered a high risk area impacting the provision of safe patient care.

On October 24, 2012, at 10:20 a.m., the Quality Assurance Performance Improvement (QAPI) activities in the foodservice department were discussed with the GMFS (General Manager of Food Services) and the Sodexo (contracted foodservice operator) Support Manager. The GMFS stated the current foodservice indicators included Dating/Labeling - Food Storage, and Cleaning and Sanitation. The data compiled for these indicators was retrieved from "Opening" and "Closing" logs completed by the management team (Chef, Lead Supervisors, Patient Service Manager, etc.) within the foodservice department, every day, once at the beginning of the day and again at the end of the day. The GMFS stated the logs were developed in response to previous audit/survey findings.

Review of the logs showed the following areas that were monitored:

"Label and dating checked - no outdated products."
"Dish room clean - floors/machine."
"Production area - can openers clean."

Review of the trended findings for Cleaning and Sanitation from June 2012, to September 2012, showed the following:

June............97% Compliance
July..............96% Compliance
August.........96% Compliance
September..96% Compliance

Review of the trended findings for Dating/Labeling - Food Storage from June 2012, to September 2012, showed the following:

June.............98% Compliance
July...............97% Compliance
August..........99% Compliance
September...99% Compliance

Review of the completed audits for the month of October, 2012, (October 1-22, 2012) showed no identified concerns related to the above delineated indicators. In a concurrent interview with the GMFS, she could not explain the discrepancy between the reported findings on the "Opening" and "Closing" logs and the identified survey findings that included outdated items dating back to April, 2012, opened and undated food items, unsanitary equipment, etc.

The GMFS acknowledged the data from the "Opening" and "Closing" logs was the sole information used to aggregate QAPI data and if that information did not accurately reflect the condition of the foodservice operation, then the QAPI data would be flawed and corrective action hindered.

Review of the facility policy titled, "Performance Improvement Overview," dated October 2010, showed the following: "Evaluation of Care - Care will be evaluated when performance expectation levels are not met in order to identify either opportunities to improve care or problems. Necessary information will be communicated among departments/services when problems or opportunities to improve patient care involve more than one department/service."

On October 24, 2012, at 11:30 a.m., in an interview with the Director of Quality Assurance, she stated quality improvement data was submitted to the performance improvement committee by the foodservice department on a quarterly basis. She stated the reliance was on each department to submit accurate information and acknowledged a concern with receiving data that did not accurately measure the identified focus indicators.

Based on observation, interview and record review the facility failed to ensure the Condition of Participation for Nursing Services was met by failing to ensure:

1. A reassessment of Patient 307's vital signs including oxygen saturation levels was implemented when the patient was lethargic and patients's heart rate decreased from 70 bpm to 44 bpm. (Refer to A395).

2. Pain assessments and reassessments were implemented prior to, and after the administration of pain medication for Patient 302. (Refer to A395).

3. Patient 110's blood pressure was reassessed, and the physician notified as the patient was the patient exhibited increased blood pressure and was at risk for a stroke. (Refer to A395).

4. The OB (obstetric) Nurse transported Patient 115, admitted for an elective cesarean section (surgical delivery of an infant) to the surgical suite and obtained the FHT (fetal heart tones) prior to the patient's abdominal preparation. ( Refer to A395).

5. Nursing staff completed the nutrition screening portion of the admission assessment in a timely manner for four patients (Patients 401, 402, 403, and 405). (Refer to A395).

6. Appropriate implementation of the fluid restriction process for one patient (Patient 402) was carried out. (Refer to A395).

7. Individualized care plans were implemented consistently for Patient 303, who had a history of congestive heart failure and was in contact isolation for MRSA (methicillin resistance staphylococcus aureus). (Refer to A396).

8. Patient 304 was assessed for her recently diagnosed blindness with care plans initiated and the need for referrals to community resources evaluated. (Refer to A396).

9. A medication for Patient 305 ordered by the physician was administered, resulting in the patient not receiving the medication for three days. (Refer to A405).

10. A physician's order was obtained and documented for Patient 305 for the administration of Benadryl (a medication used to counter act allergic reactions) and Narcan (a medication used to counter act the effects of a narcotic). (Refer to A405).


11. Nursing staff on the pediatric unit was knowledgeable and trained to perform a pediatric code. (Refer to A1103).

12. Emergency room nurses were qualified in emergency care by failing to triage Patient 111 according to written emergency policies and procedures, resulting in the potential delay in treatment for Patient 111. (Refer to A1112).

13. Staff interviewed were aware of the procedures used to ensure patients on legal holds did not leave the facility, resulting in the potential elopement of patients on psychiatric holds. (Refer to A1112).

The cumulative effects of these systemic problems resulted in the failure of the nursing department to ensure care was being provided in a safe and effective manner.


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

1. A reassessment of Patient 307's vital signs, including oxygen saturation levels was implemented when Patient 307 was lethargic and had a heart rate of 44;

2. Pain assessments and reassessments were implemented prior to, and after the administration of pain medication for Patient 301;

3. Patient 110's blood pressure was reassessed, and the physician notified as the patient was admitted to rule out a CVA;

4. An OB (obstetric) Nurse transported Patient 115, admitted for an elective cesarean section (surgical delivery of an infant) to the surgical suite and obtained FHT (fetal heart tones) prior to the patient's abdominal preparation;

5. Nursing staff completed the nutrition screening portion of the admission assessment in a timely manner for four patients (Patients 401, 402, 403, and 405);

6. Appropriate implementation of the fluid restriction process for one patient (Patient 402) was carried out; and,

7. Policy and procedures were followed for completion of MRSA screening and nasal swab on admission (Patient 208).

These failures potentially led to the death of Patient 307 and negatively impacted the provision of medical care for the remaining patients.

Findings:

1. A review of Patient 307's record was conducted on October 25, 2012. Patient 307 was admitted to the CDU (chemical dependency unit) on September 30, 2012, at 9:50 a.m., to undergo detoxification treatment from Methadone (synthetic opioid, used in treating opioid dependence) and Xanax (to treat anxiety).

On October 1, 2012, at midnight Patient 307 was found in bed, unresponsive. Emergency Services (911) was called, the paramedics responded and subsequently pronounced the patient deceased at 12:14 a.m., on October 2, 2012.

A review of the Nursing 24 Hour Patient Care Flowsheet indicated on October 1, 2012, at noon Patient 307's Pulse (heart rate) was 70, at 5 p.m. Patient 307's Pulse was 70. At 9 p.m., the patient was sleeping and her Pulse was 44 (average resting Pulse is from 60 - 70 beats per minute).

On October 25, 2012, at 11 a.m., an interview was conducted with the Registered Nurse (RN) 4 who was assigned the care for Patient 307, from 7 p.m. through 7 a.m., the night the patient died. RN 4 stated at 9 p.m., on October 1, 2012, the certified nursing assistant informed her that Patient 307's Blood Pressure was normal, her Pulse rate was 44 (26 bpm (beats per minute slower). A pulse rate less than 60 is considered abnormal. Patient 307's oxygen saturation level was 94. RN 4 stated that at 10 p.m., she looked at Patient 307 but did not do a reassessment of her Pulse rate, nor did she notify the physician of the earlier Pulse rate of 44 taken at 9 p.m.

RN 4 stated the patient had been lethargic and because of that her medications that evening had not been administered.

A review of the "Pre-Printed Physician Detoxification Orders" dated September 30, 2012, at 10:40 a.m., indicated to check Patient 307's oxygen saturation levels as needed if the patient showed symptoms of lethargy.

The record failed to show that the patient's oxygen saturation level was re-checked after October 1, 2012, at 9 p.m., when it was 94% (average resting oxygen saturation levels are from 95% - 98%).

An interview was conducted with RN 4 on October 25, 2012, at 11:30 a.m. RN 4 stated the certified nursing assistant, at midnight notified her of the Patient's condition and she and the Licensed Vocational Nurse (LVN) ran to the room. RN 4 stated she began CPR as the patient was not breathing and the LVN called 911.

RN 4 continued to state when the Paramedics arrived they did not attempt CPR and pronounced the patient dead on October 2, 2012, at 12:14 a.m.

A review of the facility policy, "Provision of Care, Treatment and Services (Reviewed: 10/11)," was conducted. The policy indicated a re-assessment of the patient should be conducted as new problems occur.

An interview was conducted with the Nurse Manager on October 25, 2012, at 1:30 p.m., who stated a reassessment of Patient 307's vital signs was not done.

2. A review of Patient 302's record was conducted on October 22, 2012. Patient 302 was admitted to the facility on October 21, 2012, with a blood clot in his right leg which occluded the blood flow. The patient had a right axillo-femoral bypass (a surgical intervention to remove the blood clot) on October 21, 2012, at 12:15 p.m.

A review of the nursing assessment and accompanying care plans dated October 21, 2012, from 7 p.m. to 7 a.m., following the patient's surgery, was conducted. The nursing staff failed to complete the section of the document which reflected the patient's acceptable level of pain, or recurrent pain, on a scale of 1 - 10, (with 10 being the highest level of pain), or, to implement a care plan with accompanying plans and goals based on the patient's pain.

A review of the facility policy, "Pain Assessment, Reassessment and Management (Reviewed: 10/2012)," was conducted. The policy indicated, "Management of the patient's pain is an interdisciplinary process and is to be included in the interdisciplinary plan of patient care."

A review of the Medication Administration Record indicated Patient 302 received Hydrocodone 10/325 milligrams (a narcotic pain medication) on October 21, 2012, one tablet at 10 p.m., and one tablet at 3 a.m. The record failed to show the patient's pain level prior to, or after receiving the medication at 10 p.m., or after receiving the medication at 3 a.m.

An interview was conducted with the Registered Nurse (RN) 7, on October 22, 2012, at 11 a.m. RN 7 stated when a patient received pain medication, the Pain Management Record must be completed, and the pain level documented before and after the pain medication was given. The Pain Management Record was not implemented for Patient 302.


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3. On October 23, 2012, at 2:40 p.m., Patient 110 was observed in bed in his assigned room. Patient 110 had bilateral wrist restraints in place.

Patient 110's record was reviewed on October 23, 2012. Patient 110, a seventy-one year old male presented to the facility on October 22, 2012, with complaints of syncope (fainting) and a low glucose (blood sugar) reading. The "Emergency Room (ER) Report," dated October 22, 2012, indicated the patient's diagnostic impression was "decreased level of consciousness, hypoglycemia and rule out cerebrovascular accident."

The documentation indicated Patient 110 was observed in the Emergency Room from 8:25 p.m., until his transfer to the floor at 4 a.m. Vital signs were taken every 30 minutes to one hour. The patient's blood pressures were as follows:

9 p.m., 152/88 mmHg (millimeters/mercury),
10 p.m., 174/95 mmHg,
11 p.m., 169/97 mmHg,
11:30 p.m., 169/97 mmHg,
12:30 a.m., 171/97 mmHg,
1:30 a.m., 184/93 mmHg,
2 a.m., 159/89 mmHg, and
3 a.m., 185/94 mmHg.

Systolic pressure (upper number) is the peak pressure in the arteries, which occurs when the ventricles are contracting. Diastolic pressure (lower number) is the minimum pressure in the arteries, which occurs near the beginning of the cardiac cycle when the ventricles are filled with blood. An example of normal measured values for a resting, healthy adult human is 120 mmHg and 80 mmHg (written as 120/80 mmHg).

According to the "Interdisciplinary Progress Notes," Patient 110 was transferred from the ER to the telemetry unit on October 23, 2012, at 4 a.m. The initial blood pressure reading for Patient 110 was 205/101 mmHg. At 5:20 a.m., the patient's blood pressure was rechecked and read 207/103 mmHg. There was no further documentation of Patient 110's blood pressure until 7 a.m., when the patient's blood pressure was 219/103 mm/Hg. At 6:45 a.m., it was documented a message was left for the patient's physician.

An interview was conducted with the Registered Nurse (RN) 10 on October 23, 2012, at 3:20 p.m. RN 10 reviewed the record and stated the night shift nurse informed her she was unable to contact the patient's physician. The RN stated the patient had oral medications but could not swallow them. RN 10 stated if she needed to notify the patient's physician, she would use any phone number available.

On October 25, 2012, at 9:30 a.m., during an interview with the Director of the Medical/ Surgical Unit, the director stated she would expect the staff to reassess Patient 110's blood pressure and notify the patient's physician immediately, as increased blood pressure could increase the effects of a stroke.

In an interview with RN 11, on October 25, 2012, at 10 a.m., RN 11 stated if a patient had an elevated blood pressure, she would evaluate medications given in the emergency room, look at orders for anti-hypertensive medications and call the physician if there was no treatment. RN 11 reviewed Patient 110's initial admission orders and stated there were no orders for blood pressure management for Patient 110.

A review of the facility policy, "Provision of Care, Treatment and Services," with a last revised/reviewed date of October 2010, was conducted on October 25, 2012. The policy indicated a re-assessment of the patient should be conducted as new problems occur.

4. On October 24, 2012, at 2:15 p.m., during a tour of the facility's surgical department, Patient 115 was observed laying on an operating table. According to the Director of Surgical Services, Patient 115 was to undergo elective primary cesarean section (surgical delivery of newborn). Patient 115 did not have an external fetal monitor in place.

In an interview with the Director of Surgical Services (DSS) on October 24, 2012, at 2:15 p.m., she stated the patient's baby was not being monitored and a labor and delivery nurse should be present in the room. The DSS stated a labor room nurse should be in operating room with the patient and she would notify the department.

On October 24, 2012, at 2:25 p.m., two Labor and Delivery Nurses entered the surgical department, donned surgical attire (gown, shoe covers, and a head cover) and entered the room where Patient 115 was lying on the surgical table.

On October 25, 2012, at 2 p.m., in an interview with the Director of Maternal Services, the Director stated if a non-laboring patient was sent to the operating room for surgery, the labor and delivery nurse should transport the patient and stay with the patient until the baby was delivered.

On October 25, 2012, Patient 115's record was reviewed. The record contained a "Patient Care Flow Sheet," with the following documentation at the following times:

At 8 a.m., on October 25, 2012, the record reflected, "Admit for PC/S (primary cesarean section) FHM (Fetal Heart Monitor) placed for NST (Non Stress test-screening test used to monitor cardiac activity of a fetus)." At 8:30 a.m., the record reflected, "FHM DCD (discontinued) NST Reactive (normal-presence of two or more fetal heart rate accelerations within a 20-minute period, with or without fetal movement discernible by the mother).

Operative documentation indicated the patient's fetal heart tones were in the 130's at 2:17 p.m., and the baby delivered at 2:36 p.m.

In an interview with OB RN 2, on October 25, 2012, at 2:30 p.m., the RN stated she had worked the day prior and was called to the OR (operating room) for Patient 115. The RN stated the patient's abdomen had already been prepped for surgery when the Labor Room nurses arrived. OB RN 2 stated, "It depended upon the patient, whether or not the OB department nurse took the patient to surgery or the OR staff transported the patient."

In an interview with the Director of Maternal Services on October 25, 2012, at 2:30 p.m., the director stated the standard of practice was to complete a NST and a Doppler (auscultation of fetal heart tones) just prior to delivery. The director stated the Doppler for fetal heart tones needed to be done before the patient's abdomen was scrubbed for surgery.

A document titled, Planning and Strategy Concerning OB Considering Possibilities for Our Future and the Health of our Patients, was reviewed on October 25, 2012. The document indicated NST would be completed upon the patient's arrival, and at specified times through out the day (if patient had not been taken to surgery). The OB Nurse was to transport the patient to the OR and obtain a Doppler for FHT prior to the patient's abdominal prep.



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5. On October 23, 2012, at 3:30 p.m., review of the facility policy titled, "Initial Patient Assessment and Reassessment and Plan of Care", dated October 2010, showed the following: "An RN (Registered Nurse) shall complete a nursing assessment within 8 hours after the patient's inpatient assessment ... All data collected shall be recorded in the nursing assessment record and shall be available to all those disciplines involved in the care of the patient. Portions of the initial assessment form include screening information related to other disciplines. Based on the outcome of the screening data, other disciplines will be contacted to perform a more comprehensive assessment of the patient as needed."

On October 24, 2012, at 10:45 a.m., review of the facility policy titled, "Nutrition Assessment and Reassessment", with a revision date of June 2011, showed the following, "All patients are screened by nursing, for nutritional risk within 24 hours of admission using pre-determined nutrition risk indicators."

Medical record review was conducted on October 23, 2012, beginning at 9:03 a.m. The nutrition screen portion of the nursing admission assessment was noted to be incomplete for Patients 401, 402, 403, and 405. As a result, critical information such as measured patients' heights and weights, which would be relied upon by other disciplines when completing further assessments, were not available.

In a concurrent interview with the CNM (Clinical Nutrition Manager), she acknowledged the absence of nutritional screening information as part of the initial nursing assessment. She stated the dietitians often have to obtain stated heights/weights or information from patients' driver licenses, which may or may not be current, in order to complete the nutrition assessments. She also acknowledged that the absence of a nutrition screen may result in nutrition consults not being forwarded to the dietitians for appropriate nutritional interventions.

6. On October 23, 2012, at 9:03 a.m., review of the medical record for Patient 402 showed the patient was admitted on October 20, 2012. On admission, Patient 402 was prescribed a 1500 milliliter (ml) fluid restriction. On October 23, 2012, at 9:38 a.m., observation of the patient showed that he was in bed, awake, with a full water pitcher with ice cubes at bedside. In a concurrent interview with Patient 402, he stated that he was aware he was on a fluid restriction, but did not verbalize the exact amount of fluids that he could consume per day. He stated he was offered fluid on his trays and by nursing staff.

On October 24, 2012, at 8:15 a.m., the policy on Fluid Restriction was requested. The policy was provided by the facility and was reviewed, but showed no reference to whether a water pitcher was permitted at bedside or not.

On October 24, 2012, at 11:20 a.m., in an interview with the Director of Patient Services, she acknowledged the absence of a facility policy regarding Fluid Restriction and allowance of water pitchers, but stated that it was an expectation that the water pitcher be removed from the room, should a patient be prescribed a fluid restriction.



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7. Patient 208 was admitted to the hospital on October 17, 2012, for an acute psychotic episode, and high blood pressure. He had a recent admission on September 30, 2012 for aspiration pneumonia and altered level of consciousness. Patient 208 was discharged on October 8, 2012, after being treated in the intensive care unit. Patient 208 was stabilized and discharged to a subacute unit. Patient 208 had been discharged from the general acute care facility within 30 days and met criteria for a Methicillin Resistant Staphylococcus aureus (MRSA) nasal swab. Patient 208 did not have a MRSA screening and nasal culture completed as required.

An interview was conducted with the Director of Infection Control, on October 22, 2012, at 11 a.m. The Director of Infection Control reviewed Patient 208's record, and stated the MRSA screening should have been done within 24 hrs after being admitted. The MRSA screening in the chart was blank. The Director of Infection Control checked lab results in the computer and verified the nasal swab was not done for this admission. The Director of Infection Control stated Patient 208 was positive for MRSA on a previous admission.

The facility's infection prevention policy and procedure titled, "Active Surveillance Cultures (ASC) - MRSA," was reviewed. The purpose of the procedure was to identify patients in high risk groups who may be colonized with Methicillin Resistant Staphylococcus aureus (MRSA), to isolate, in Contact Precaution, those patients whose surveillance cultures are positive for MRSA, and to prevent healthcare associated transmission of MRSA from patient to others. The screening criteria procedure in the policy indicated, "The following patients must be screened within 24 hours of admission...The patient has been previously discharged from the general acute care facility within 30 days prior to the current hospital admission..."

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

1. Individualized care plans were implemented consistently for Patient 303, who had a history of congestive heart failure and was in contact isolation for MRSA (methicillin resistance staphylococcus aureus); and,

2. Patient 304 was assessed for her recently diagnosed blindness with care plans initiated and the need for referrals to community resources evaluated.

These failures could potentially lead to inconsistencies with the provision of nursing care.

Findings:

A review of the facility policy, "Initial Patient Assessment and Reassessment and Plan of Care (Reviewed: 10/2012)," indicated, "Each patient admitted to the institution shall receive a complete head to toe assessment by a qualified individual so that a plan of care can be developed to best meet the needs of the patient...Any change in the patient's condition shall require an immediate reassessment with changes in the plan of care reflecting the change in condition."

1. On October 22, 2012, at 10 a.m., during a tour of the 6th floor medical/surgical unit, a sign posted outside room a patient's room indicated the patient was in contact isolation. An additional posted sign indicated the patient was on a fluid restriction of 1.2 liters per day. The patient was observed with a chest tube, which was draining brown fluid.

A review of the record for Patient 303 was conducted on October 22, 2012. Patient 303 was admitted to the facility on October 14, 2012, with diagnoses of congestive heart failure, chronic kidney disease, and a history of MRSA (Methicillin Resistant Staphylococcus aureus) infection of the nares.

A review of the patient's record failed to show a care plan was implemented which addressed Patient 303's fluid restriction on October 15, 16, and 19, 2012, night shifts (7 p.m. to 7 a.m.), and on October 19, 2012, day shift (7 a.m. to 7 p.m.).

Further record review failed to show a care plan was implemented on the day shift of October 19, 2012, which addressed Patient 303's need for contact isolation due to his MRSA.

A review of Patient 303's record and a concurrent interview were conducted with the Charge Nurse, (CN) 6, on October 22, 2012, at 2:30 p.m. CN 6 stated care plans for the patients are done each shift and care plans for Patient 303 addressing his fluid restriction and isolation were missing.

2. A tour and observation of the fifth floor medical/surgical unit was conducted on October 23, 2012, at 10 a.m. Patient 304 was in her room, awake and alert as she sat on the side of the bed. Two large signs were taped to the wall and one sign hung from the bedside table. The three signs indicated Patient 304 was blind.

On October 23, 2012, at 10:10 a.m.,Patient 304's family member was observed assisting Patient 304 and stated, "I had to tell the staff (Patient 304) was blind even when we put the sign on the wall behind the bed. A nurse handed her liquids and (Patient 304) spilled it all over herself, they (staff) didn't help her. Then I put a sign on the bedside table, now they see it. (Patient 304) just became blind in August, she needs help with everything."

Patient 304's family member continued to state she had been asking how to get referrals to community resources to help Patient 304 learn to be more independent, but no one had helped her with this request.

A review of Patient 304's record was conducted. Patient 304 was admitted to the facility on October 14, 2012, with diagnoses of pneumonia and blindness.

Further record review failed to show a care plan which addressed the patient's recent diagnosis of blindness and the potential needs she may have with activities of daily living, such as eating, dressing and personal hygiene had been implemented.

An interview was conducted with the Registered Nurse (RN) 8, on October 23, 2012, at 10:45 a.m. RN 8 stated if a patient has problems with vision a care plan would be implemented.

A review of the initial assessment completed by the Case Management Department was conducted. The assessment indicated Patient 304's current level of functioning with activities of daily living was independent and that no further services were needed.

An interview was conducted on October 23, 2012, at 11 a.m., with the Case Manager (CM) who worked on the fifth floor. The CM stated she does discharge planning and referrals as needed.

The CM further stated she did the initial case management assessment for Patient 304 and did not realize that the patient was newly blind and needed community referrals.

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

1. The physician was notified when a medication that Patient 305 was taking at home was ordered and was not administered for three days; and,

2. A physician's order was obtained and documented for Patient 305 for the administration of Benadryl (a medication used to counter act allergic reactions) and Narcan (a medication used to counter act the effects of a narcotic).

These failures could lead to errors with medication management.

Findings:

1. A review of Patient 305's record was conducted. Patient 305 was admitted to the facility on October 18, 2012, with shortness of breath. The patient's history included Myasthenia Gravis (a neurological disease which causes muscle weakness). Among the medications the patient took included CellCept (a drug to slow down one's immune system).

Further record review indicated there was a physician's order for CellCept 1000 mg (milligrams) twice a day, ordered on October 18, 2012.

It was also revealed that between 1:45 a.m. and 1:56 a.m. on October 19, 2012, the order was scanned to the Pharmacy system, processed by a night pharmacist from the Contract Pharmacy Services, and completed with the following entered comment:

"Non-Formulary, Home meds (medication)."

During an interview conducted on October 23, 2012, at 3 p.m., Pharmacist 501 stated CellCept was a non-formulary drug and could be continued from home if the medication was brought to the facility with the patient. Pharmacist 501 stated neither Pharmacy nor Nursing followed up with the availability of the medication for the patient.

Pharmacist 501 stated the night pharmacist from the contract pharmacy processed the order without placing the order, "on hold" in order for the facility pharmacist to follow up in the morning when the pharmacy was open.

Pharmacist 501 stated that once medication orders were processed and completed by the pharmacist, the order would not remain in the Pharmacy work queue unless the orders were put "on hold." As a result, the facility pharmacist was not able to follow up with either the nurse or the ordering physician in charge of the patient who did not receive the medication ordered to continue as the patient had done while at home for three days.

There was no documented evidence provided by Pharmacist 501 or the Director of Pharmacy (DOP) to indicate nursing staff had inquired about the missing home medication (CellCept) that was ordered to be continued in the facility or about the possibility for the patient's family member to bring the medication to the facility.

On October 23, 2012, at 11:15 a.m., Physician 1, Patient 305's physician, was interviewed. Physician 1 stated the physician should be notified when a medication is not available, and he stated he was not aware the CellCept was not available.

Review of the facility's policy and procedure titled, "Pharmacy Services Agreement" indicated the following:

"... pharmacists shall intervene on incomplete or questionable orders with appropriate Customer medical staff and shall make best efforts to resolve interventions during the shift..."

2. An interview was conducted with Patient 305 on October 23, 2012. Patient 305 stated when she was a patient in the Emergency Room she had a severe reaction to Dilaudid and "passed out." Patient 305 then stated the next thing she remembered was waking up in the intensive care unit.

A review of Patient 305's record was conducted on October 22, 2012. Patient 305 was admitted to the facility on October 18, 2012, via the emergency room (ER) with shortness of breath. The patient's history included Myasthenia Gravis (a neurological disease which causes muscle weakness and can affect respirations).

On October 19, 2012, at 1:05 a.m., while still in the ER, the record indicated Patient 305's admitting physician was notified the patient had complaints of a headache. The patient rated at a level of 10 out of a scale of 1 - 10, (with 10 being the highest level of pain). The physician ordered Dilaudid (narcotic pain medication) 2 milligrams (mg) to be administered via intravenous push (directly into the vein). At 1:10 a.m., after 1 mg was administered, the patient complained of itching and was given Benadryl 25 milligrams via intravenous push at 1:20 a.m.

The interdisciplinary nursing documentation on October 19, 2012, at 2:35 a.m., indicated the patient was unresponsive to shouts, or to painful stimuli such as nail bed pressure or sternal wall pressure. Patient 305 had no gag reflex at that time. Subsequently, Narcan 1 milligram was administered to the patient three times via intravenous push, at 2:53 a.m., at 2:58 a.m., and at 4:12 a.m. The patient was subsequently admitted to the intensive care unit for further treatment.

An interview was conducted with the ER Charge Nurse, (CN) 4 on October 23, 2012, at 1 p.m. who after reviewing Patient 305's record, stated a verbal physician's order was not documented by the nursing staff for the Benadryl or for two doses of the Narcan administered at 2:53 a.m., or at 2:58 a.m.

A review of the facility policy, "Telephone, Verbal and Written Orders for Medication (Reviewed: 10/2012)," indicated, "All verbal and/or telephone orders for medications shall include the following criteria: Date and time the order is prescribed verbally or via telephone, The name of the individual prescribing the drug..."

Based on interview and record review, the facility failed to ensure verbal physician's orders for Patients 300 and 303 were dated, timed and included the ordering physician's name. This failure could lead to errors with the provision of medical care.

Findings:

1. A review of Patient 300's record was conducted on October 22, 2012. Patient 300 was admitted to the Cardiac Care Unit on October 18, 2012, after suffering a drug overdose.

A review of the Physician's Order Sheet reflected the following orders;
"Transfer to the Tele (telemetry) floor, Dx; (Diagnosis) OD (Overdose) , Activity; BRP (Bathroom Privileges), Oxygen at 2 (two liters) via NC (nasal cannula) PRN (as needed) for SOB (shortness of breath), cont. (continue) all orders, Diet; advance as tolerated."

The Physician's Orders failed to show who took the order, which Physician gave the orders, and the date and time the order was taken. There was no indication that the nurse who took the Physician's Orders read the orders back to the physician to verify the accuracy of the orders.

An interview was conducted with the Registered Nurse (RN) 6 assigned to the care of Patient 300 on October 22, 2012, at 3:30 p.m. RN 6 stated after reviewing Patient 300's record, that the Physician's orders must include the name of the nurse that took the order, the Physician's name, the date, the time, and include verification that the orders if given via telephone were reviewed with the Physician to ensure the orders were written correctly.

2. A review of Patient 303's record was conducted on October 22, 2012. Patient 303 was admitted to the facility on October 14, 2012, with a diagnosis of congestive heart failure.

A review of the Physician's Order Sheet reflected the follow order, "May decrease PCA of Hydromorphone (narcotic pain medication dispensed by a pump) 1 mg/ml (milligram per milliliter) STAT (as soon as possible) to 0.3 mg IV/hour (intravenous) T.O. (telephone order)."

The Physician's Order failed to show the date and the time the order was taken by the nurse.

A review of the facility policy, "Telephone, Verbal and Written Orders for Medication (Reviewed: 10/2010)," was conducted. The policy indicated,"All verbal and/or telephone orders for medications shall include the following criteria, Date and time the order is prescribed verbally or via telephone..Repeat back the entire order to the prescriber, spelling the name of the drug or requesting the prescriber to spell the drug if the receiver does not know the spelling. Repeat the frequency and/or instruction for use in the non abbreviated format."

An interview was conducted with the Charge Nurse (CN) 6 on October 22, 2012, at 1:30 p.m., who stated when a telephone order was taken from a physician by a nurse the date and time must be documented as well as a, "Read Back" of the order to ensure the accuracy of the order.

Based on interview and record review, the facility failed to ensure physician authentication was completed for all verbal/telephone orders for Patients 107 and 305. These failures could lead to an inaccurate or incomplete physician order which may impact the provision of medical care for these patients.

Findings:

The facility policy, "Telephone, Verbal and Written Orders for Medication," with a last reviewed date of October 2010, was reviewed on October 23, 2012. Section 2.7 of the Rules and Regulations indicated all clinical entries in the patient's medical record would be accurately dated, timed and authenticated. The policy indicated verbal and telephone orders were allowed, but to reduce medication errors the use was discouraged. The policy indicated "The prescribing practitioner must sign the written record of the verbal/telephone order within 24 hours of giving the order."

The "Medical Staff General Rules and Regulations," dated July 1, 2012, were reviewed on October 24, 2012. In the section titled "All Orders," the following was documented:

"The responsible practitioner shall authenticate such orders for medications within 48 hours or on the next visit, whichever is sooner, with signature date and time of authentication."

1. A review of Patient 107's record was conducted on October 22, 2012. Patient 107 was admitted to the facility on October 10, 2012, with diagnoses that included diabetes mellitus and respiratory distress.

There was no physician authentication completed for verbal/telephone orders received by a RN from the physician on the following dates and times:

On October 17, 2012, 9 p.m., (five days prior to this review), a telephone order for a stat (immediate) chest X-ray was received from Physician A, and on October 18, 2012, at 12 p.m., (four days prior to this review), a verbal order to discontinue Lopressor (an anti-hypertensive), was received from Physician B.

Both of these orders were flagged by the medical records staff, to alert the physician that authentication was required.

An interview was conducted with ICU (Intensive Care Unit) RN 1, on October 22, 2012, at 2:45 p.m. The RN stated the orders had not been signed by the physicians. The RN stated Physician A visited Patient 107 twice daily, and would sign the orders tonight. The RN stated Physician B had not been in since the orders were written.

2. A review of Patient 305's record was conducted on October 22, 2012. Patient 305 was admitted to the facility on October 18, 2012, via the emergency room (ER) with shortness of breath. The patient's history included Myasthenia Gravis (a neurological disease which causes muscle weakness and can affect respirations).

On October 19, 2012, at 1:05 a.m., while still in the ER, the record indicated that Patient 305's admitting physician was notified that the patient had complaints of a headache she rated at a level of 10 out of a scale of 1 - 10, (with 10 being the highest level of pain). The physician ordered Dilaudid (narcotic pain medication) 2 milligrams (mg) to be administered via intravenous push (directly into a vein). At 1:10 a.m., after 1 mg was administered, the patient complained of itching and Benadryl 25 mg was administered by intravenous push at 1:20 a.m.

Further record review did not show that the physician authenticated the order for Dilaudid with his signature, or dated and timed the order.

An interview was conducted with the Nursing Director of the ER on October 24, 2012, at 10:45 a.m., who stated the physician signed his facility number on the Dilaudid order. This practice is not acceptable. The physician must sign his name and date and time the order.

Based on interview and record review, the facility failed to ensure an unfavorable drug reaction experienced by Patient 305 was clearly documented in the patient's record. This failure could lead to confusion surrounding the future medical care needs for this patient.

Findings:

An interview was conducted with Patient 305 on October 23, 2012. Patient 305 stated when she was a patient in the Emergency Room (ER) she had a severe reaction to Dilaudid (narcotic pain reliever) and "passed out." Patient 305 then stated the next thing she remembered was waking up in the intensive care unit.

A review of Patient 305's record was conducted on October 22, 2012. Patient 305 was admitted to the facility on October 18, 2012, via the emergency room with shortness of breath. The patient's history included Myasthenia Gravis (a neurological disease which causes muscle weakness and can affect respirations).

On October 19, 2012, at 1:05 a.m., while still in the emergency room, the record indicated that Patient 305's admitting physician was notified that the patient had complaints of a headache. The patient rated her pain at a level of 10 out of a scale of 1 - 10, (with 10 being the highest level of pain). The physician ordered Dilaudid (narcotic pain medication) 2 milligrams to be administered via intravenous push (directly into a vein). At 1:10 a.m., after 1 milligram was administered, the patient complained of itching and was given Benadryl 25 milligrams via intravenous push (medication to relieve itching and other allergic reactions).

The interdisciplinary nursing documentation on October 19, 2012, at 2:35 a.m., indicated the patient was unresponsive to shouts, or to painful stimuli such as nail bed pressure or sternal wall pressure. Patient 305 had no gag reflex at that time. Subsequently, Narcan 1 milligram (medication used to counter act the adverse effects of a narcotic), was administered to the patient three times, at 2:53 a.m., at 2:58 a.m. and at 4:12 a.m. The patient was subsequently admitted to the intensive care unit for further treatment.

Further record review failed to show an addendum by the bedside treating physician which addressed the unfavorable drug reaction experienced by Patient 305.

An interview was conducted with the ER Registered Nurse (RN) 3 on October 23, 2012, at 12 p.m., who after reviewing Patient 305's record stated the physician should document or dictate a note when a patient has a drug reaction and no note was located in the patient's record.

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. Ensure patient's home medications were safely stored in the pharmacy away from the patient care areas. (Refer to A500).

2. Control and maintain the proper temperature range in the OB (obstetrics) medication refrigerator and not exposing patients to vaccines exposed to freezing temperature. (Refer to A500).

3. Control and maintain the proper temperature of the OB freezer compartment by not monitoring the temperature. (Refer to A500).

4. Ensure chilled normal saline bags were available in the OR medication refrigerator for the treatment of malignant hyperthermia. (Refer to A500).

5. Ensure verification by the pharmacist of topical home controlled medications did not take place without the assurance of knowing what medication was being verified. (Refer to A500).

6. Ensure nursing unit inspection by the pharmacy was performed monthly. (Refer to A500).

7. Ensure Emergency Department medication orders were being reviewed by the pharmacist in accordance with the facility's policy and procedure. (Refer to A500).

8. Ensure Pharmacy's renal dosing monitoring of medications was performed and being captured in its quality data. (Refer to A500).

9. Ensure physician ordered medication was timely obtained and administered to the patient without undue delay (Refer to A500).

10. Ensure unusable medications were not available for patient use. (Refer to A505).

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 record review, the facility failed to control drugs and biologicals in order to provide patient safety by failing to:

1. Ensure patients home medications were safely stored in the pharmacy away from the patient care areas;

2. Control and maintain proper temperature range of the OB (obstetrics) medication refrigerator and not exposing patients to vaccines which were exposed to freezing temperature;

3. Control and maintain proper temperature of the OB freezer compartment by not monitoring the temperature;

4. Ensure chilled normal saline bags were available in the operating room's medication refrigerator for the treatment of Malignant Hyperthermia (potentially deadly condition in which a patient's heart rate and temperature rises during surgery);

5. Ensure verification by the pharmacist of topical home controlled medications did not take place without the assurance knowing exactly what the medication was;

6. Ensure nursing unit inspection by the pharmacy was performed monthly;

7. Ensure ED (Emergency Department) medication orders were being reviewed by the pharmacist in accordance with the facility's policy and procedure;

8. Ensure Pharmacy renal dosing monitoring of medications was performed and was captured in its quality data; and,

9. Ensure physician ordered medication was timely obtained and administered to the patient without undue delay.

Findings:

1. During inspection of the facility's Chemical Dependency Unit (CDU) medication room on October 22, 2012, at 11:30 a.m. with Pharmacist 500, it was noted that in the medication refrigerator there was one opened 10-ml (milliliter) multi-dose vial of Novolin Insulin N (Insulin to control blood sugar) with the expiration of January of 2012 that a patient brought with them to the facility in the same medication refrigerator along with other refrigerated medications.

During a concurrent interview, the CDU Nurse Manager stated the policy at the CDU for home medications brought in to the facility by patients was to separate non narcotic and narcotic medications. Non-narcotic medications were kept locked in the medication cabinets located in the CDU medication room until discharge. Narcotic medications were sent to the Pharmacy.

Review of the facility's policy and procedure titled, "Medication Storage -- Patient's Own" indicated the following:

"Upon receipt of the medications...The patient's non-narcotic, formulary, personal medication is then stored in the locked file cabinet in the medication room at the nurse's station...each individual narcotic medication is recorded...RN or LVN will place the bottles into Patient Medication Receipt envelope...is then delivered to the pharmacy by two staff members..."

During a concurrent interview, Pharmacist 500 stated she was not aware of non-narcotic medications that were kept in the medication room and that all home medications brought in should be checked in to the Pharmacy.

During an interview on October 23, 2012, at 2:20 p.m., the Director of the Pharmacy (DOP) did not indicate he was aware of patients' home medications kept in the CDU medication room without the knowledge of the Pharmacy.

2. During an interview with Pharmacy Staff 500, she stated medication refrigerators connected to the Pyxis MedStations (automated dispensing cabinets) were remotely monitored in the Pharmacy and that she was made aware this morning that the temperature of the OB (obstetric) medication refrigerator was out of range since approximately 2 p.m. the previous day.

Pharmacy Staff 500 stated the medication refrigerator temperature was adjusted at approximately 8 a.m. this morning. Pharmacy Staff 500 stated the out of range temperature was checked once every morning and that she did not report the temperature out of range identified this morning to the Director of Pharmacy (DOP) or any other pharmacists.

Review of the remote temperature monitoring report for OB medication refrigerator indicated that the temperature had been 28 degrees Fahrenheit (below freezing temperature) for approximately 18 hours.

During an inspection of the OB medication refrigerator on October 22, 2012, at 2:30 p.m., it was observed that there was a 10 milliliter vial of Novolin insulin N that was frozen.

The OB medication refrigerator was observed to be a dormitory-style that had the upper freezer compartment located within the refrigerator.

The following medications were stocked in the refrigerator at the time of observation of the OB medication refrigerator:

Six syringes of Fluarix 0.5 ml dose, influenza virus vaccines.
Twenty-three 0.5 ml dose Tdap syringes, (tetanus, diphtheria, and pertussis) vaccines.
One 10 ml vial of Novolin insulin N,
One 10 ml vial of Novolin insulin R,
One 10 ml vial of Humalog insulin,
One 10 ml vial of Lantus insulin,
Four 0.5 ml dose vials of Pneumovax, pneumococcal vaccines,
Three 0.5 ml dose vials of Engerix B 10 mcg, Hepatitis B vaccines, and,
Two 2 ml single dose vials of Gamastan S/D, immune globulin that provide passive immunity.

A review of the activity report indicated Patient 500 received the following medications exposed to freezing temperature:

One 0.5 ml dose of Tdap.
One dose of influenza virus vaccine.

During an interview on October 23, 2012, at 10:30 a.m., the Director of Pharmacy did not indicate he was aware of the out of range temperature of the OB medication refrigerator.

Review of the facility's policy and procedure titled, "Drug Distribution" indicated the following:

"Refrigerator temperature shall be between 2.2 degrees Celsius (36 degrees Fahrenheit-F) and 7.7 degrees C (46 degrees F.)"

The Center for Disease Control and Prevention (CDC) recommends the following for storage, handling and management of vaccines:

"...At least 2 staff members should be responsible for vaccine management...

Store vaccines in refrigerator and freezer units which can maintain the appropriate temperature range and are large enough to maintain the year's largest inventory without crowding. Stand alone units are preferred but household combination units with separate exterior doors and thermostats can be used. Dormitory-style refrigerators should not be used. A dormitory-style refrigerator is defined as a small combination freezer/refrigerator unit that is outfitted with one exterior door with an evaporator plate (cooling coil), which is usually located inside an icemaker compartment (freezer) within the refrigerator.

Vaccine exposed to temperatures outside the recommended range - either too warm or too cold - requires immediate corrective action! Vaccine providers should have a current emergency vaccine retrieval and storage plan..."

3. During inspection of the OB Nursing Unit's medication refrigerator on October 22, 2012, at 2:30 p.m., there were five boxes, each containing one Cervidil (drug used to induce labor) 10 milligram suppository stored in the freezer compartment of the dormitory-style medication refrigerator. It was also observed that there was no thermometer to monitor the proper temperature at which the frozen medications were to be stored.

During a concurrent interview, Pharmacy Staff 500 stated that no monitoring of the freezer compartment of the OB medication refrigerator took place.

During a concurrent interview, Pharmacist 500 acknowledged there was no log for the freezer compartment and no temperature monitoring of the freezer compartment of the OB medication refrigerator.

Review of the facility provided policy and procedure titled, "Drug Distribution" did not indicate the proper temperature range for freezer(s) located throughout the facility and there was no facility provided policies that addressed monitoring medication freezer temperatures.

Review of the facility's policy and procedure titled, "Drug Distribution" indicated the following:

"Refrigerator temperature shall be between 2.2 degrees Celsius (36 degrees Fahrenheit-F) and 7.7 degrees C (46 degrees F.)"

The Center for Disease Control and Prevention (CDC) recommends the following for storage and handling and management of vaccines:

"...At least 2 staff members should be responsible for vaccine management...

Store vaccines in refrigerator and freezer units which can maintain the appropriate temperature range and are large enough to maintain the year's largest inventory without crowding. Stand alone units are preferred but household combination units with separate exterior doors and thermostats can be used. Dormitory-style refrigerators should not be used. A dormitory-style refrigerator is defined as a small combination freezer/refrigerator unit that is outfitted with one exterior door with an evaporator plate (cooling coil), which is usually located inside an icemaker compartment (freezer) within the refrigerator.

Vaccine exposed to temperatures outside the recommended range - either too warm or too cold - requires immediate corrective action! Vaccine providers should have a current emergency vaccine retrieval and storage plan..."

4. During inspection of the OR (Operating Room) medication storage on October 22, 2012, at 3:45 p.m., it was observed that the facility did not have in the medication refrigerator any refrigerated injectable 1000-ml (milliliter) bags of normal saline (fluid supplement) for the treatment of Malignant Hyperthermia (MH).

According to Malignant Hyperthermia Association of the United States (MHAUS), a nationally recognized organization dedicated to MH,
"The MH crisis is a biochemical chain reaction response, " triggered " by commonly used general anesthetics and the paralyzing agent succinylcholine, within the skeletal muscles of susceptible individuals. The general signs of the MH crisis include tachycardia, a greatly increased body metabolism, muscle rigidity and/or fever that may exceed 110 degrees F. Severe complications include: cardiac arrest, brain damage, internal bleeding or failure of other body systems. Thus, death, primarily due to a secondary cardiovascular collapse, can result."

During a concurrent interview with the Director of Surgical Services, she stated there were no normal saline bags stored in the the medication refrigerator.

During a concurrent interview, Pharmacist 500 also confirmed that there was no normal saline bags in the medication refrigerator.

A review of the facility's policy and procedure titled, "Malignant Hyperthermia (MH) Cart" indicated the following:

"At least 3000 ml of normal saline for irrigation should be kept in the medication refrigerator at all times."

5. During inspection of the facility's Chemical Dependency Unit (CDU) medication room on October 22, 2012, at 11:30 a.m. with Pharmacist 500, it was noted that Patient 502's topical medication brought from home,Testosterone 2% cream was stored in the Pyxis MedStation (an automated dispensing cabinet) located in the CDU medication room.

An inspection of the jar which contained the medication revealed that the facility pharmacist's initials were present indicating the medication was inspected and verified to indicate the jar contained the medication described on the outpatient pharmacy label and was okay for the patient to use during the stay at the facility

During a concurrent interview, Pharmacist 500 stated that she would not be able to verify the cream contained in the jar because all creams looked the same and that she would not have approved for use for the patient.

During an interview on October 24, 2012, at 2:30 p.m., the Director of Pharmacy stated the verifying pharmacist inspected and approved the medication in "good faith" and acknowledged that it should not have been approved for use during the patient's stay at the facility.

Review of the facility's policy and procedure titled, "Medication Administration" indicated the following:

"Patient's own medication being utilized on the nursing unit...requires Pharmacy verification, documentation and logging by pharmacist."

6. Review of the monthly nursing unit inspection log on October 22, 2012, indicated the log was missing documentation of the nursing unit inspection performed by a pharmacist during the months after March, 2012, in the ICU (intensive care unit).

During an interview on October 24, 2012, at 3 p.m., Pharmacist 502 stated that she was on a maternity leave for five months and did not know who was responsible for her assigned Intensive Care Unit (ICU) monthly pharmacy inspection.

During a concurrent interview, the Director of Pharmacy did not indicate he was aware a monthly unit inspection for ICU was performed and who was responsible for the inspection for ICU.

Review of the facility's policy and procedure titled, "Inspection of Medication Storage Areas" indicated the following:

"To insure [sic.] safe medication prescription ordering, medication procurement, distribution, storage and controls...All drug storage areas within the organization shall be inspected at least every 30 days by the pharmacy."

7. During an interview on October 23, 2012, at 3 p.m., Pharmacist 501 stated all orders were reviewed either before medications were allowed access by the nursing staff in the case of non-emergent medication orders and or after medications were accessed and administered to patients in the case of medication orders that were considered emergent in nature.

Pharmacist 501 also stated that all medications stocked in the ED (Emergency Department) Pyxis MedStation (an automated dispensing cabinet) could be accessed without prior pharmacist approval.

A review of the Pyxis MedStation activity report in the ED for the past two days was conducted with Pharmacy Staff 500 and Pharmacist 501 on October 25, 2012. The report indicated out of eleven ED patients' orders sampled there were no orders for seven patients that were received by the Pharmacy as indicated by no scanned ED orders for these patients in the Pyxis Connect that captured all scanned orders for order processing and pharmacist review in the Pharmacy.

During an interview on October 25, 2012, at 10 a.m., Pharmacist 501 stated the problem was addressed before by educating ED staff to scan all orders and acknowledged that scanning ED orders was not consistently done. Pharmacist 501 acknowledged that the Pharmacy was not able to review all ED orders in retrospect.

A review of the facility's policy and procedure titled, "Medication Orders-Processing" indicated the following:

"...urgent/emergency situations, defined as a sudden, unexpected occurrence demanding immediate action in which any delay of the action may result in harm to the patient...A pharmacist will retrospectively review all medication orders dispensed and administered due to an "urgent/emergency situation" for appropriateness as soon as a pharmacist is available or the pharmacy opens."

8. During an interview on October 24, 2012, at 3 p.m. with the Director of Pharmacy (DOP) and Pharmacist 501, they both did not indicate that the clinical pharmacists were accessing laboratory reports to review and assess to adjust doses of patients medications based on their daily kidney functions as indicated in the policy and procedure.

Pharmacist 501 indicated the clinical pharmacists efforts with monitoring and adjusting medication doses based on patients' kidney functions were not being collected and captured on the Pharmacy clinical activity report data and the system needed to be improved to capture all clinical pharmacists' activities.

Review of the facility's policy and procedure titled, "Clinical Pharmacy Services" indicated the following:

"Clinical pharmacy services offered by the department include...renal dosing service..."

Review of the facility's policy and procedure titled, "Renal Dosing" indicated the following:

"To increase patient safety as well as optimize patient outcomes, it is the policy...that patients receiving medications that require dosage adjustment due to renal dysfunction shall have the pharmacist monitor and adjust those medications...The pharmacist must document the intervention in HCS under "Dose Recommendation" category, specifying the original order, the creatinine clearance calculated, and the dose/frequency change...Documented interventions will be reviewed periodically to ensure guidelines are followed appropriately."

Review of pharmacy clinical activity data revealed that renal dose monitoring was not part of the data captured.

Review of the facility's policy and procedure titled, "Documentation of Clinical Pharmacy Services" indicated the following:

"In accordance with the Clinical Pharmacy Services Policy and Medication Order Review Policy, all pharmaceutical care interventions (oral or written) made by pharmacists will be documented and reported."

9. A review of Patient 305's medical record on October 22, 2012, indicated that there was a physician order for CellCept (drug to slow down own immune system) 1000 milligrams twice a day on October 18, 2012.

It was also revealed that between 1:45 a.m., and 1:56 a.m., on October 19, 2012, the order was scanned to the Pharmacy system, processed by a night pharmacist from the Contract Pharmacy Services, and completed with the following entered comment:

"Non-Formulary, Home meds."

During an interview on October 23, 2012, at 3 p.m., Pharmacist 501 stated CellCept was a non-formulary drug and could be continued from home if the medication was brought to the facility with the patient. Pharmacist 501 stated that neither Pharmacy nor Nursing followed up for the availability of the medication for the patient.

Pharmacist 501 stated the night pharmacist from the contract pharmacy processed the order without placing the order "on hold" in order for the facility pharmacist to follow up with in the morning when the pharmacy was open.

Pharmacist 501 stated once medication orders were processed and completed by the pharmacist, the order would not remain in the Pharmacy work queue unless the orders were put "on hold," and as a result, the facility pharmacist was not able to follow up with either the nurse or the ordering physician in charge of the patient who did not receive the medication ordered to continue as the patient had done while at home for three days.

There was no documented evidence provided by Pharmacist 501 or the Director of Pharmacy, that the nursing staff had inquired about the missing home medication that was ordered to continue in the facility and about the possibility for the patient's family member to bring the medication to the facility.

A review of the facility's policy and procedure titled, "Pharmacy Services Agreement" indicated the following:

"... pharmacists shall intervene on incomplete or questionable orders with appropriate Customer medical staff and shall make best efforts to resolve interventions during the shift..."

Based on observation, interview, and document review, the facility failed to ensure unusable medications were not available for patient use. These failures could lead to errors with medication administration and the delivery of safe patient care.

Findings:

1. During inspection of the Pharmacy on October 22, 2012, at 10:45 a.m., one 250-ml (milliliter) IV (intravenous) bag containing fat emulsion 20% was observed with the plastic overwrap removed and the affixed pharmacy label noted the expiration date of October 21, 2012.

During concurrent interview, Pharmacist 500 acknowledged that, even though the bag itself was still good to use because it was returned to the pharmacy from the nursing unit unused, according to the attached pharmacy label it was expired.

During the same inspection, it was also observed that there was a 50-ml IV bag containing magnesium sulfate (injectable supplement) 2 grams that was removed from the plastic overwrap and had the partial pharmacy label that did not have the expiration date.

During a concurrent interview, Pharmacist 500 stated it was not possible to know when the plastic overwrap was removed and did not indicate knowledge of how long the bag should be good for once the plastic overwrap was removed. Pharmacist 500 stated it would need to be thrown away and not kept in the Pharmacy.

Review of the facility's policy and procedure titled, "Intravenous Solution Labeling" indicated the following:

"A label will be affixed to all IV solutions made by pharmacy personnel prior to delivery for administration. The labels will contain the following information...Expiration date..."

2. During inspection of the facility's Chemical Dependency Unit (CDU) medication room on October 22, 2012, at 11:30 a.m. with Pharmacist 500, it was noted that in the medication refrigerator there was one opened 10-milliliter multi-dose vial of Novolin Insulin N (Insulin to control blood sugar) with the expiration January, 2012, that a patient brought with them to the facility in the same medication refrigerator along with other refrigerated medications.

During a concurrent interview, Pharmacist 500 agreed that the patient's expired medications should not have been stored in the medication refrigerator.

Review of the facility's policy and procedure titled, "Drug Distribution" indicated the following;

"Medications shall not be kept in stock after the expiration date on the label...Multiple-dose containers/vials (with preservative) shall be discarded 30 days after opening."

Based on observation, interview, and record review, the facility failed to ensure that food and nutrition services met the needs of all patients as evidenced by failure to:

1. Provide organized food and nutrition services as evidenced by findings of unsafe food handling/equipment storage practices, develop policies and procedures for routine tasks performed within the food and nutrition services, and comprehensively analyze the patient menu to ensure it met the nutritional needs of the populations serviced by the facility (Cross Reference A620, A630, A749);

2. Ensure the adequacy of disaster food supplies for patients prescribed therapeutic diets, staff, and visitors (Cross Reference A620);

3. Ensure staff competency as related to emergency procedures and thermometer calibration (Cross Reference A622);

4. Ensure that nutrition assessments met the needs of the patients and that interdisciplinary nutritional care plans were in place (Cross Reference A628);

5. Ensure that performance improvement activities accurately reflected the operations within the foodservice department (Cross Reference A283);

6. Ensure safe and effective food storage/production practices integrated in the facility's Infection control surveillance system (Cross Reference A749); and,
7. Ensure that the current Diet Manual was accessible on the units (Cross Reference A631).

The cumulative effect of these systemic problems resulted in the inability of the facility's food and nutrition services to direct and staff in such a manner to ensure the nutritional needs of the patients were met in accordance with acceptable standards of practice. The system problems resulted in the facility's inability to meet the Condition of Participation for Food and Dietetic Services.

Based on observation, interview, and document review, the facility failed to ensure the General Manager of Food Services (GMFS):
1) Developed and monitored written procedures for foodservice operational processes.

2) Ensured the adequacy of disaster food supplies for all patients, staff, and visitors.

3) Ensured that data reported as part of the Quality Assurance Performance Improvement (QAPI) program accurately reflected department operations.

These failures may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status, inadequate food supplies in the case of a disaster, and lack of intervention in response to quality assurance measures inaccurately reported.

Findings:

On October 23, 2012, at 3:30 p.m., review of the facility policy titled, "Role of Food and Nutrition Services Director/Clinical Nutrition Manager", dated October 2010, showed, "The GM (General Manager) has responsibility for organizing, managing and supervising the Food and Nutrition Services Department. The GM's responsibilities include: Directing and coordinating the daily activities of the department with the assistance from the CNM (Clinical Nutrition Manager), dietitians, Executive Chef, and food service staff, to carry out the department's established policies. These policies include: Patient care programs... Production...Sanitation...Coordinating and integrating any interdepartmental policies with the appropriate department directors."

1a. From October 22, 2012, through October 24, 2012, during foodservice observations and review of approved hospital departmental policies and procedures in food and nutrition services, it was noted that policies did not exist for standard processes in foodservice operations such as: dishwashing procedures, and the process for dietitian communication with the physician with regards to recommended nutritional interventions, and were not monitored as related to cleanliness of equipment within the food and nutrition services department, covering, labeling, dating and retaining food items past expiration dates or manufacturer use-by dates:

On October 22, 2012, starting at 9:38 a.m., during a tour of the main kitchen, dishroom activities were observed. Cook 3 and Foodservice Worker 2 (FSW 2) were noted to remove dietary equipment from the end of the dishmachine and place some on drying racks, and other equipment was returned to the dirty side of the machine to be re-washed/sanitized. In an interview with both employees, Cook 3 stated that the equipment returned to be re-washed was "dirty" and needed to be washed again. FSW 2 stated that silverware was run through the dishmachine three times, plate covers were washed twice and patient trays were washed once. He stated that was the practice employed by dietary staff. Both Cook 3 and FSW 2 were noted to be using the same gloves to place equipment on the drying racks, and returning the "dirty" equipment to be re-washed.

On October 22, 2012, at 9:45 a.m., in an interview with the GMFS, she stated that staff "got into the habit" of washing equipment multiple times, but that was not departmental policy. The department policy regarding dishwashing practices was requested.

On October 23, 2012, at 12:30 p.m., an inservice training module regarding dishwashing procedures was provided. The GMFS stated she could not locate a departmental policy addressing dishwashing procedures in foodservices including how many times equipment should be washed, the correct temperatures for washing, rinsing, sanitizing that should be maintained, how/how often the dishmachine should be cleaned, etc.

A policy titled, "Emergency Dishwashing", dated October 2010, was provided to address washing of equipment in the event the dishmachine was inoperable. The procedures in the policy included, "Wash dishes in hot soapy water... Submerge clean dishes in sanitizing solution." There was no indication as to what temperature the "hot" water should be, nor the type or amount of sanitizer to be used. The policy was generic in nature and not specific to the facility operations.

The specifics related to proper manual dishwashing were delineated in another inservice module that was printed from the computer and not readily accessible to all foodservice employees.

b. Medical record review was conducted on October 23, 2012, and showed the following:

b1. Patient 405 was admitted on October 18, 2012, with a left foot burn (deep partial thickness). On October 19, 2012, the Registered Dietitian (RD) completed a nutrition assessment and recommended implementation of a nutrition protocol for wounds including multivitamins, Vitamin C, and zinc sulfate. The RD recommendations were documented on a form identified as a "Nutrition SBAR" (Situation/ Background/ Assessment/Recommendations). The form was hole punched and placed on top of the physician progress notes. Written on the form was the statement, "Not a permanent part of the Medical Record." As of October 23, 2012, the patient had been prescribed multivitamins, but there was no response to the request for Vitamin C and Zinc Sulfate for wound healing. The "Nutrition SBAR" dated October 19, 2012, was still on top of the physician notes.

b2. Patient 404 was admitted on October 10, 2012. The patient had multiple wounds including redness to the buttocks, right foot plantar ulcer, and right leg and bilateral heel wounds. On October 11, 2012, the RD completed a nutrition assessment and recommended the vitamin/mineral protocol for skin ulcer. The recommendation was again documented on a "Nutrition SBAR" and placed on top of the physician notes. As of October 23, 2012, the vitamin/mineral protocol for skin ulcer had not been implemented and there was no documentation whether the physician acknowledged the recommendation.

In a concurrent interview with the CNM, she stated that the RDs communicated their recommendations with the physicians via a "Medical Nutrition Therapy Recommendations" sticker that was placed directly on the physician orders, or the "Nutrition SBAR" that was hole punched and placed on top of the physician orders. She stated that there was no facility policy that formalized this procedure, only that it had been the established practice. She could not confirm whether physicians were aware that they had to respond to the "Nutrition SBAR" and that the process was discussed with medical staff. She did not know why the physicians had not responded to the wound care recommendations as documented by the RDs. She acknowledged that with an average length of stay of 3-5 days, the delay in response by the physicians may impact the quality of patient care provided.

c. On October 22, 2012, beginning at 9:38 a.m., during a tour of the main kitchen, accompanied by the GMFS and CNM, the following observations were made:

c1. In the dishroom area, 2 large fans placed close to the ceiling were noted to have covers layered with dust particles. The fans were blowing directly on clean kitchen equipment that was being retrieved from the dishmachine and/or being washed and sanitized by hand, and on equipment that was stored on a storage rack in the dishroom. Inspection of the foodservice cooking equipment that was stored on the storage rack showed a layer of dust that was clinging to the surface of the equipment. The light covers in the dishroom were also covered with dust.

In a concurrent interview with the GMFS, she acknowledged the dirty fan covers and the dust layer on the stored equipment/light covers.

On October 23, 2012, at 3:30 p.m., review of the facility policy titled, "Sanitation Program", dated October /2010, showed: "The Food Service Director monitors sanitizing schedules and procedures. Equipment, walls, floors and storage areas are routinely cleaned with the appropriate sanitizing compounds."

c2. In Refrigerator #6, an opened quart of buttermilk, dated as being opened on October 16, 2012, was imprinted with a manufacturer use by date of October 21, 2012. In the same refrigerator, a quart of Soy milk was dated as having been opened on October 12, 2012. In a concurrent interview with the GMFS, she stated the product could be retained until the imprinted manufacturer use-by date of February 15, 2013. One quart of honey-thickened Orange Juice was undated as to when it was opened, and another quart of the same product was dated as being opened on October 1, 2012. The GMFS stated that the orange juice could also be retained until the manufacturer use by date of December 23, 2012. Trays of uncovered, undated gelatin pans were also stored in this refrigerator.

On October 24, 2012, at 9:10 a.m., in a follow-up interview with the GMFS, she stated that after consulting the foodservice vendor representative, she was informed the Soy milk should be discarded within five days of opening the container, and the thickened Orange Juice should be discarded within ten days of being opened. Both products had exceeded that time frame at the time of the observation on October 22, 2012.

c3. Two trayline reach-in refrigerators were noted to be dirty with dried, splashed product on the walls of the refrigerators. Another trayline refrigerator had a pan of fruit cups that were not dated as to when they had been prepared.

c4. In a Reach-In refrigerator located adjacent to the trayline, spilled fresh milk was noted on the floor of the refrigerator. A 4-ounce container of 2% milk was imprinted with a manufacturer use-by date of October 16, 2012.

In the walk-In dairy refrigerator, one opened pint of half and half was noted with an imprinted manufacturer use-by date of October 14, 2012. One half-gallon of creamer was opened but not dated as to when it had been opened.

The GMFS acknowledged the spilled milk and the outdated/unlabeled beverage containers.

c5. On a counter in the kitchen, a slicer was noted covered with a plastic bag. The GMFS stated the slicer was stored as clean, but was not in use awaiting repair. Upon removal of the plastic bag, the slicer was noted with dried food particles clinging to the blade.

In the cook's area, the can opener was noted to be removed and was being cleaned. Upon completion of the cleaning task, FSW 1 placed the can opener back into the can opener holder. Observation of the can opener holder showed that it was dirty with dried black and red material clinging to it and in contact with the can opener. In a concurrent interview with FSW 1, she stated she routinely cleans the can opener but not the holder.

Adjacent to the cook's area, a blender was noted to be stored. Inside the blender was residual water with floating brown particles. The Chef and Cook 1 confirmed that the blender had not been in use that morning and should have been stored as clean.

c6. In the cold food preparation area, a sanitizer pail was noted stored on the counter. FSW 1 stated that she had filled the pail with sanitizer at approximately 8 a.m. The time of the observation was 10:40 a.m. FSW 1 stated that the concentration of the sanitizer should be between 200 and 400 parts per million (ppm). Upon testing the sanitizer with the test strip, the concentration of the sanitizer read approximately 100 ppm. FSW 1 stated she was supposed to change the sanitizer every two hours.

c7. In the dry storage room, one #10 can of sauerkraut was noted with a dented rim. Two #10 cans of jellied cranberry were noted with manufacturer use-by dates of September 22, 2012. Three 5-pound boxes of white cake mix were imprinted with manufacturer use by dates of April 24, 2012. The tops of the stored cans and cake mix boxes were noted to have a layer of dust. In a concurrent interview with the GMFS, she acknowledged the outdated and dusty products in the dry storage room.

On October 23, 2012, at 3:30 p.m., review of the facility policy titled, "Food Storage", revised May 2011, showed: "Bulk dry goods & canned goods will be labeled and discarded after 12 months or by Manufacturer's expiration date."

d. On October 22, 2012, beginning at 11:35 a.m., a tour of the kitchen at the Chemical Dependency Unit (CDU) was conducted in the presence of the Operations Manager (OM) and the Clinical Nutrition Manager (CNM.) The following observations were made:

d1. In the "Pepsi" Reach-In refrigerator, food items such as pudding, fruit, and dessert were noted to be stored. Inspection of the thermometer located in the refrigerator showed that there were gaps in the red line that was meant to be the temperature indicator, so an accurate temperature could not be discerned. The OM acknowledged that the thermometer needed to be changed.

d2. In the cook's area, Cook 2 was observed placing curly fries in a hot holding cabinet to be held until meal service began. In the hot holding cabinet, a pan of bratwurst sausage was noted. There was no internal thermometer or temperature gauge noted. The outside temperature sensor was noted to be missing. Staff could not confirm at what temperature the hot food was being held.

d3. In the walk-in refrigerator, the fan cover was noted to have dust build-up and dust was noted on the ceiling. In the walk-in freezer, dust build-up was also noted on the fan cover. The vent located above the cold preparation area was noted to be dirty with dust/dirt build-up. A stand-up fan in the kitchen was also noted with dust build-up on the fan cover. The OM acknowledged the dirty equipment and stated she would place a work order for the equipment to be cleaned.

2. On October 22, 2012, at 11:15 a.m., and on October 23, 2012, at 12:10 p.m., the disaster food supply, which consisted of bottles of nutritional supplements and saltine crackers was inspected. One hundred and fifty five cases of Ensure - Muscle Strength, and one hundred and eight-two cases of Ensure - Clinical Strength were noted for a total of 8088 bottles of nutritional supplement.

On October 24, 2012, at 9:10 a.m., the "Disaster Food Supply and Distribution" policy, dated October 2010, was reviewed with the General Manager of Food Services (GMFS.) The policy indicated disaster provisions were planned for 348 patients at the Medical Center and Recovery Center at the rate of six bottles of nutritional supplement per person per day for four days. There were no provisions planned for staff, visitors and volunteers. The policy also had no provisions for patients with prescribed therapeutic diets such as carbohydrate controlled and renal diets. Six bottles of Ensure Clinical Strength would deliver 78 grams of protein and 306 grams of carbohydrates, 18 grams more protein than was planned for the facility's renal diet, and 100 grams more carbohydrates than planned for the consistent carbohydrate diet.

The GMFS acknowledged the lack of provisions for patients prescribed carbohydrate controlled and renal diets. She stated that the policy is currently being revised to account for staff and visitors, but the revised policy has not been finalized and approved yet.

3. On October 24, 2012, at 10:20 a.m., the Quality Assurance Performance Improvement (QAPI) activities in the foodservice department were discussed with the GMFS and the contracted foodservice company Support Manager. The GMFS stated that the current foodservice indicators included Dating/Labeling - Food Storage, and Cleaning and Sanitation. The data compiled for these indicators was retrieved from "Opening" and "Closing" logs completed by the management team (Chef, Lead Supervisors, Patient Service Manager, etc.) within the foodservice department, every day, once at the beginning of the day and again at the end of the day. The GMFS stated the logs were developed in response to previous audit/survey findings.
Review of the logs showed the following areas that were monitored:

"Label and dating checked - no outdated products."

"Dish room clean - floors/machine."

"Production area - can openers clean."

Review of the trended findings for Cleaning and Sanitation from June 2012, to September 2012, showed the following:
June..............97% Compliance
July................96% Compliance
August...........96% Compliance
September....96% Compliance

Review of the trended findings for Dating/Labeling - Food Storage from June 2012, to September 2012, showed the following:

June.............98% Compliance
July...............97% Compliance
August..........99% Compliance
September...99% Compliance

Review of the completed audits for the month of October, 2012, (October 1-22, 2012) showed no identified concerns related to the above delineated indicators. In a concurrent interview with the GMFS, she could not explain the discrepancy between the reported findings on the "Opening" and "Closing" logs and the identified survey findings that included outdated items dating back to April, 2012, opened and undated food items, unsanitary equipment, etc. The GMFS stated the Chef had identified the dirty fans in the dishroom in an audit completed on September 25, 2012. The Chef documented that the problem was reported to Engineering and resolved as of September 27, 2012.

Review of the Engineering "Equipment Data Sheet" showed that a request to clean the fans in the dishroom was made on October 1, 2012, but the work order had not been completed until October 23, 2012.

The GMFS acknowledged that the data from the "Opening" and "Closing" logs was the sole information used to aggregate QAPI data and that if that information did not accurately reflect the condition of the foodservice operation, then the QAPI data would be flawed and corrective action hindered.

Review of the facility policy titled, "Performance Improvement Overview", dated October /2010, showed the following: "Evaluation of Care - Care will be evaluated when performance expectation levels are not met in order to identify either opportunitites to improve care or problems. Necessary information will be communicated among departments/services when problems or opportunities to improve patient care involve more than one department/service."

Based on observation, interview, and record review, the facility failed to ensure the competency of two cooks (Cook 1 and Cook 2) responsible for working with the grill and/or deep fat fryer at the main hospital kitchen, and at the chemical dependency unit (CDU) kitchen, as related to emergency response in the event of a fire in the cooking area, and one cook (Cook 4) as related to the thermometer calibration process. Failure to ensure staff competency in these tasks may result in an uncontrolled fire that may spread to other parts of the facility and endanger the lives of staff, patients and visitors, and inaccurate temperatures of patient food should the thermometer used be not properly calibrated.

Findings:

1. On October 22, 2012, at 10:28 a.m., in an interview with Cook 1, the Cook was asked what she would do in the case of a fire in the cooking area. The Cook stated she would use a fire extinguisher if she thought she could "take care of it" and call 300 (emergency number). When asked about the ansul system (dry chemical fire suppression system) located above the cooking area, she stated the nozzles represented a sprinkler system that automatically activated in the case of a fire. The General Manager of Foodservice (GMFS), present at the time of the interview, corrected the employee by pointing to a button located on the wall adjacent to the cooking area, with a sign indicating that the button was to be pushed to activate the ansul hood system.

2. On October 22, 2012, at 11:40 a.m., in an interview with Cook 2 at the CDU kitchen, the Cook was asked what she would do in the case of a fire in the cooking area. The Cook stated she would pull the fire alarm ring and call Code Red (emergency number). When asked about the ansul system (dry chemical fire suppression system) located above the cooking area, she stated the nozzles represented a sprinkler system that automatically activates in the case of a fire.

On October 24, 2012, at 9:10 a.m., in an interview with the GMFS, she confirmed that the ansul system did not automatically activate in the case of a fire and stated that the activation button for the ansul system was located on the wall adjacent to the cooking area.


3. On October 22, 2012, at 12:02 p.m., during an observation of the lunch trayline process, Cook 4 was taking temperatures of the hot food items. When asked if she knew how to calibrate the thermometer, Cook 4 stated that she used an ice/water mixture and that the temperature should register 0 degrees Fahrenheit (F).


The facility lacked a policy addressing thermometer calibration, but provided an inservice module titled, "Thermometers", which showed that when using the ice/water method for thermometer calibration, "Read the thermometer after 2 minutes - must read 32 degrees F/0 degrees C (Celsius)."

Based on interview, and record review, the facility failed to ensure interdisciplinary care plans were developed for two Patients (Patients 402 and 405) and the Registered Dietitian (RD) accurately assessed the nutritional needs of four patients (Patients 401, 402, 404 and 405.)

Findings:

1. On October 23, 2012, at 10:12 a.m., review of the medical record for Patient 401, showed she was admitted on October 20, 2012, with increased lower extremity edema (swelling caused by fluid in the body's tissues) and abdominal distension. The patient also had diagnoses of congestive heart failure (CHF - inability of the heart to provide sufficient pump action to distribute blood flow to meet the needs of the body) and chronic obstructive pulmonary disease (COPD - lung disease causing shortness of breath). On admission, the patient had a prescribed tubefeeding (feeding via a tube inserted into the stomach) of Glucerna 1.2 to run at 70 cc per hour for 12 hours as well as an oral diet. The patient was also receiving intravenous (via vein) (IV) hydration.

On October 21, 2012, the IV hydration rate was decreased due to the patient's CHF and an RD consult was requested with respect to the tubefeeding. The patient was not tolerating the oral diet very well. On October 22, 2012, the Registered Dietitian (RD) completed a nutrition assessment but made no changes with respect to the patient's prescribed tubefeeding (type or rate).

In a concurrent interview with the Clinical Nutrition Manager (CNM), she acknowledged the availability of other nutritional formulas such as Vital AF and Pivot 1.5 that would have provided the patient's required nutritional needs in a lower volume, and thus decreased the volume of fluid provided to the patient and lessened the potential of exacerbation related to CHF.

2. On October 23, 2012, at 9:03 a.m., review of the medical record for Patient 402, showed he was admitted on October 20, 2012, with a clotted AV fistula.
(An arteriovenous fistula "AV fistula" is the connection of a vein and an artery to allow access to the vascular system for hemodialysis, a procedure that performs the functions of the kidneys in people whose kidneys have failed.) The patient had a history of end stage renal disease (compromised renal function), diabetes mellitus (high blood sugar) and hypertension (high blood pressure). The patient was prescribed a renal diet and a fluid restriction.On October 22, 2012, the RD completed a nutritional assessment and estimated the patient's needs as: 1650-1980 calories (25-30 calories per kilogram (kg)) and 79-86 grams of protein (1.2-1.3 grams(gm) protein per kg). The RD based the estimated needs on a weight of 145 pounds that was obtained from the patient's driver's license. A documented weight of 159 pounds was noted in the medical record, obtained when the patient was admitted for day surgery on October 18, 2012.

In a concurrent interview with the Clinical Nutrition Manager (CNM), she stated that when the RD cannot find a documented patient weight in the nursing assessment, then the RD will resort to asking the patient for their weight. She acknowledged that a stated weight may not be as accurate as a measured weight and may cause inaccuracies in the RD assessments. Had the RD based her assessment on the weight of 159 pounds, then the patient's assessed nutritional needs would be higher - 1800-2160 calories and 86-108 grams protein.

Further review of the medical record showed that there was no care plan entry by the RD reflecting the established goals for the patient. The CNM stated that the care plan entry should be completed by the RD on the daily flowsheets in the sections pertinent to the patient's status.

Review of the facility policy titled, "Nutrition Assessment & Reassessment", revised June 2011, showed: "A Nutritional Plan of Care, as a component of the interdisciplinary patient Plan of Care is developed for each patient with identified nutrition-related problems. The Plan of Care is an interdisciplinary responsibility and communication system enabling Nursing, Nutrition, and other ancillary staff to coordinate care by establishing expected outcomes and interventions for each nutrition-related problem. The Plan of Care is routinely updated."

3. On October 23, 2012, at 2:56 p.m., review of the medical record for Patient 404, showed he was admitted on October 10, 2012, with a right chronic foot ulcer infection and other wounds of the right leg and bilateral heels. The patient had a history of diabetes mellitus, hypertension and chronic renal insufficiency. The patient's documented albumin (a measure of protein stores) was 2.7 grams/deciliter (normal range 3.5-5.0 grams/deciliter.)

On October 11, 2012, the Registered Dietitian (RD) completed a nutrition assessment and estimated the patient's needs as: 2315-2850 calories (25-30 calories per kilogram (kg_) and 95-115 grams of protein (1-1.2 grams protein per kg). The RD based the estimated needs on a weight of 220 pounds which was documented as being 105% of the patient's ideal body weight.

Review of the facility policy titled, "Nutrition Assessment and Reassessment, revised June 2011, showed: "Standardized assessment protocols, compiled by the Clinical Nutrition staff from current medical journal sources and the Clinical Diet Manual have been established for specific diseases and/or patient groups. These are utilized in formulating nutrition care plan recommendations."

In a concurrent interview with the Clinical Nutrition Manager (CNM), she stated that the RDs utilized a chart titled, "Evidence Based Guidelines for Nutritional Needs Related to Specific Diseases", as a resource when calculating the nutritional needs of patients. The CNM referred to the section of the chart titled, "Wound Healing", which showed the following nutrition recommendations:

Stage I, II 30-35 kcal (calories)/kg, 1.25-1.5 gram (gm) protein/kg
Stage III 30-35 kcal/kg, 1.25-2 gm protein/kg
Stage IV 35-40 kcal/kg, 1.5-2 gm protein/kg

The CNM stated that for Patient 404, with multiple wounds and a low albumin level, the recommendation of 30-35 kcal/kg and 1.25-1.5 gm protein/kg could have been considered consistent with the established resource chart. The patient was not overweight or obese and despite his chronic renal insufficiency status, protein needs are increased with the presence of a chronic wound and other wounds. The patient's needs were not re-calculated until October 18, 2012, eight days after admission, when the RD re-assessed the protein needs based on 1.2-1.5 gm protein/kg.

4. On October 23, 2012, at 1:42 p.m., review of the medical record for Patient 405, showed he was admitted on October 18, 2012, with a left foot burn (deep partial thickness). The patient had a history of diabetes (high blood sugar), hypertension (high blood pressure), and chronic renal insufficiency (beginning stages of compromised renal function). The patient's albumin was 2.7 grams/deciliter (normal range 3.5-5.0 grams/deciliter.)

On October 19, 2012, the Registered Dietitian (RD) completed a nutrition assessment and estimated the patient's needs as: 2200-2600 calories (25-30 calories per kg) and 90-105 grams of protein (1-1.2 grams protein per kg). The RD based the estimated needs on a weight of 194 pounds which was 121% of the patient's ideal body weight.

In a concurrent interview with the Clinical Nutrition Manager (CNM), she stated that the RDs utilized a chart titled, "Evidence Based Guidelines for Nutritional Needs Related to Specific Diseases", as a resource when calculating the nutritional needs of patients. The CNM referred to the section of the chart titled, "Wound Healing", which showed the following nutrition recommendations:

Stage I, II 30-35 kcal (calories)/kg, 1.25-1.5 gm (gram) protein/kg
Stage III 30-35 kcal/kg, 1.25-2 gm protein/kg
Stage IV 35-40 kcal/kg, 1.5-2 gm protein/kg

The CNM stated that for Patient 405, with a deep burn and a low albumin level, the recommendation of 1.25-1.5 gm protein/kg could have been considered for wound healing and to improve protein stores.

Further review of the record showed there was no care plan entry by the RD reflecting the established goals for the patient. The CNM stated the care plan entry should be completed by the RD on the daily flowsheets in the sections pertinent to the patient's status.

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

1) Standard menus were comprehensively analyzed for the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and the DRI (Dietary Reference Intake) of the Food and Nutrition Board of the National Research Council, that they met the RDAs for all nutrients.

2) Patient food items were prepared and served as planned and in accordance with prescribed orders.

These failures have the potential for the patients in the facility to not receive adequate nutrition and to not meet the estimated recommended dietary allowances for all nutrients.

Findings:

1. The DRI/RDA consists of nutrient based references whose purpose is to plan diets for individuals, focusing on optimizing health status, disease prevention and ensuring consumption of nutrients in adequate amounts. The provisions of the Dietary Reference Intakes, which include the Recommended Dietary Allowances (RDA's), Adequate intake, and Acceptable Macro and Micronutrient distribution ranges, developed by the Food and Nutrition Board under the auspice of the Institute of Medicine are used to evaluate nutritional adequacy of patient/resident menus.

On October 24, 2012, at 9:10 a.m., the facility's nutrient analysis for the hospital diets was reviewed. The analysis did not include an analysis of all vitamins/minerals/micronutrients that are specified in the RDA or DRI. Approximately seventeen nutrients were not analyzed including, but not limited to, Vitamins D, E, K, Magnesium, Folate, etc. The menu analysis was compared to the DRI for a 50 year-old male and showed that the average fiber content of the hospital menus was at 65% of the DRI for fiber for that reference sample.

In a concurrent interview with the General Manager of Food and Nutrition Services (GMFS), and the contracted foodservice company's Support Manager, they stated that the menus were analyzed by the Corporate Office and acknowledged the absence of analysis for all the nutrients outlined in the DRI tables. No explanation was provided as to why the menus only provided 65% of the DRI for fiber.

Review of the facility license showed that the facility designated 12 beds for perinatal services (services provided to women in weeks just before or just after birth). On October 22, 2012, at 1:45 p.m., in an interview with the Clinical Nutrition Manager (CNM), she stated the facility would follow the Diet Manual recommendations for the "Pregnancy and Lactation Diet" for obstetric patients.

On October 24, 2012, at 9:10 a.m., review of the Diet Manual recommendations for the "Pregnancy and Lactation Diet" showed the following: "Nutritional Recommendation for Pregnancy: To achieve desired weight gain, an addition of 300 calories per day over normal calorie needs is recommended. Lactation: To meet extra nutritional demands for milk production, an addition of 500 calories per day over normal calorie needs is recommended." The Diet Manual also recommended that Calcium, Vitamin D, Zinc, Magnesium, Vitamin B6 and folate status be addressed on an individual basis due to increased need during pregnancy.

The GMFS, CNM and contracted service's Support Manager confirmed the menus were not adjusted for pregnant or post-partum patients (no additional calories were provided on non-select menus), and the menus had not been analyzed to ensure that they met the needs of that population, specifically the increased need for nutrients such as folate and Vitamin D.

2a. On October 22, 2012, at 12:02 p.m., during an observation of the lunch trayline at the main hospital campus, whipped potatoes were noted to be served to patients using a #16 (two ounce) scoop and roast beef was served in three ounce portions.

Review of the "Trayline HACCP (Hazard Analysis Critical Control Point) Temperature Log" showed that whipped potatoes were to be served in a four ounce portion. There was no direction on that form as to the portion size for roast beef. In a concurrent interview with the General Manager of Food Service (GMFS), she stated that staff should serve portions in accordance with the recipe. Review of the recipe for "Open Faced Roast Beef Sandwich" that coincided with the lunch menu on October 22, 2012, showed that the roast beef should have been served in a two ounce portion.

In a concurrent interview with Cook 3, she stated that she was following a scoop size guide posted above the trayline service area which showed, "#16 - 1/4 cup or four oz (ounce) - Blue Scoop." The GMFS, present at the time of the observation, acknowledged that the posted scoop size guide was incorrect.

b. On October 23, 2012, at 11:34 a.m., during an observation of the lunch trayline at the CDU, roast beef was noted to be served as two pieces per sandwich. In a concurrent interview with Cook 5, she stated the "Trayline HACCP (Hazard Analysis Critical Control Point) Temperature Log" did not provide guidance as to the portion size for the meat on the beef sandwich. She stated, "It just says one sandwich." When asked how she determined that two slices should be placed on each sandwich, she stated that since the alternate meat on the menu that day (pork loin) was to be served in a three ounce portion, then she assumed the beef should be served in the same portion. Upon weighing the two beef slices, the weight was approximately two and one half ounces. Cook 5 made no reference accessing the recipe for guidance.

Review of the facility policy titled, "Portion Control", dated November 2010, showed the following: "Use of standardized recipes is an important factor in portion control, but a recipe can be depended on to yield the stated number of portions only if servings are of uniform size." Providing portions that are over or under the established portion sizes also impacts the nutritional value of the meals served to the patients and would not be consistent with the established nutritional analysis.

Based on observation and staff interview, the facility failed to ensure that one of four staff interviewed on the hospital units was aware of the purpose and location of the facility diet manual.

Findings:

On October 24, 2012, at 8:52 a.m., in an interview with Registered Nurse (RN) 12, a floor nurse on the 2nd floor, she stated she had been employed at the facility for approximately seven months. When asked how she would access the diet manual on the unit, the employee stated she was not familiar with what a diet manual was and was not sure where it was located.

On October 24, 2012, at 9 a.m., in an interview with the Clinical Nutrition Manager (CNM), she stated a Clinical Diet Manual was located on each nursing unit, and RN 12 would have received training on the location of the manual during orientation to the unit. The Clinical Diet Manual was observed on the nursing unit.

Based on observation, interview and record review, the facility failed to ensure that the infection control officer provided effective infection control oversight into food services when the dietary staff failed to:

1) Ensure that food items were not kept past documented discard dates, and that equipment used within the foodservice department was kept clean.

2) Ensure that food supplies on the chemical dependency unit (CDU) were appropriately maintained.

3) Ensure that expired infant formula was not maintained.

These processes have the potential of promoting food-borne illness if not appropriately implemented/monitored.

Findings:
1. On October 22, 2012, beginning at 9:38 a.m., during a tour of the main kitchen, accompanied by the General Manager of Foodservice (GMFS) and Clinical Nutrition Manager (CNM), the following observations were made:

a. In the dishroom area, 2 large fans placed close to the ceiling were noted to have covers layered with dust particles. The fans were blowing directly on clean kitchen equipment that was being retrieved from the dishmachine and/or being washed and sanitized by hand, and on equipment that was stored on a storage rack in the dishroom. Inspection of the foodservice cooking equipment that was stored on the storage rack showed a layer of dust that was clinging to the surface of the equipment. The light covers in the dishroom were also covered with dust.

In a concurrent interview with the GMFS, she acknowledged the dirty fan covers and the dust layer on the stored equipment/light covers.

On October 23, 2012, at 3:30 p.m., review of the facility policy titled, "Sanitation Program", dated October /2010, showed: "The Food Service Director monitors sanitizing schedules and procedures. Equipment, walls, floors and storage areas are routinely cleaned with the appropriate sanitizing compounds."

b. In Refrigerator #6, an opened quart of buttermilk, dated as being opened on October 16, 2012, was imprinted with a manufacturer use by date of October 21, 2012. In the same refrigerator, a quart of Soy milk was dated as having been opened on October 12, 2012. In a concurrent interview with the GMFS, she stated the product could be retained until the imprinted manufacturer use-by date of February 15, 2013. One quart of honey-thickened Orange Juice was undated as to when it was opened, and another quart of the same product was dated as being opened on October 1, 2012. The GMFS stated that the orange juice could also be retained until the manufacturer use by date of December 23, 2012. Trays of uncovered, undated gelatin pans were also stored in this refrigerator.

On October 24, 2012, at 9:10 a.m., in a follow-up interview with the GMFS, she stated that after consulting the foodservice vendor representative, she was informed the Soy milk should be discarded within five days of opening the container, and the thickened Orange Juice should be discarded within ten days of being opened. Both products had exceeded that time frame at the time of the observation on October 22, 2012.

c. Two trayline reach-in refrigerators were noted to be dirty with dried, splashed product on the walls of the refrigerators. Another trayline refrigerator had a pan of fruit cups that were not dated as to when they had been prepared.

d. In a Reach-In refrigerator located adjacent to the trayline, spilled fresh milk was noted on the floor of the refrigerator. A 4-ounce container of 2% milk was imprinted with a manufacturer use-by date of October 16, 2012.

In the walk-In dairy refrigerator, one opened pint of half and half was noted with an imprinted manufacturer use-by date of October 14, 2012. One half-gallon of creamer was opened but not dated as to when it had been opened.

The GMFS acknowledged the spilled milk and the outdated/unlabeled beverage containers.

e. On a counter in the kitchen, a slicer was noted covered with a plastic bag. The GMFS stated the slicer was stored as clean, but was not in use awaiting repair. Upon removal of the plastic bag, the slicer was noted with dried food particles clinging to the blade.

In the cook's area, the can opener was noted to be removed and was being cleaned. Upon completion of the cleaning task, FSW 1 placed the can opener back into the can opener holder. Observation of the can opener holder showed that it was dirty with dried black and red material clinging to it and in contact with the can opener. In a concurrent interview with FSW 1, she stated she routinely cleans the can opener but not the holder.

Adjacent to the cook's area, a blender was noted to be stored. Inside the blender was residual water with floating brown particles. The Chef and Cook 1 confirmed that the blender had not been in use that morning and should have been stored as clean.

f. In the cold food preparation area, a sanitizer pail was noted stored on the counter. FSW 1 stated that she had filled the pail with sanitizer at approximately 8 a.m. The time of the observation was 10:40 a.m. FSW 1 stated that the concentration of the sanitizer should be between 200 and 400 parts per million (ppm). Upon testing the sanitizer with the test strip, the concentration of the sanitizer read approximately 100 ppm. FSW 1 stated she was supposed to change the sanitizer every two hours.

g. In the dry storage room, one #10 can of sauerkraut was noted with a dented rim. Two #10 cans of jellied cranberry were noted with manufacturer use-by dates of September 22, 2012. Three 5-pound boxes of white cake mix were imprinted with manufacturer use by dates of April 24, 2012. The tops of the stored cans and cake mix boxes were noted to have a layer of dust. In a concurrent interview with the GMFS, she acknowledged the outdated and dusty products in the dry storage room.

On October 23, 2012, at 3:30 p.m., review of the facility policy titled, "Food Storage", revised May 2011, showed: "Bulk dry goods & canned goods will be labeled and discarded after 12 months or by Manufacturer's expiration date."

h. On October 22, 2012, beginning at 11:35 a.m., a tour of the kitchen at the Chemical Dependency Unit (CDU) was conducted in the presence of the Operations Manager (OM) and the Clinical Nutrition Manager (CNM.) The following observations were made:

i. In the "Pepsi" Reach-In refrigerator, food items such as pudding, fruit, and dessert were noted to be stored. Inspection of the thermometer located in the refrigerator showed that there were gaps in the red line that was meant to be the temperature indicator, so an accurate temperature could not be discerned. The OM acknowledged that the thermometer needed to be changed.

ii. In the cook's area, Cook 2 was observed placing curly fries in a hot holding cabinet to be held until meal service began. In the hot holding cabinet, a pan of bratwurst sausage was noted. There was no internal thermometer or temperature gauge noted. The outside temperature sensor was noted to be missing. Staff could not confirm at what temperature the hot food was being held.

iii. In the walk-in refrigerator, the fan cover was noted to have dust build-up and dust was noted on the ceiling. In the walk-in freezer, dust build-up was also noted on the fan cover. The vent located above the cold preparation area was noted to be dirty with dust/dirt build-up. A stand-up fan in the kitchen was also noted with dust build-up on the fan cover. The OM acknowledged the dirty equipment and stated she would place a work order for the equipment to be cleaned.


2. On October 23, 2012, 11:10 a.m., during an inspection of the nourishment refrigerator on the chemical dependency unit (CDU), two opened 8-ounce cartons of milk were noted in the refrigerator. The cartons were not dated as to when they were opened. An opened bag of chips and an opened bag of pretzels were noted stored in the nourishment room. Both bags were not secured, labeled, or dated. CDU staff explained that CDU patients had access to the nourishment area, and that patient families sometimes brought in food for the patients, but it was CDU staff's responsibility to monitor the process to ensure proper food handling was maintained.

3. On October 23, 2012, at 2:40 p.m., during an inspection of the nursery, two 40 mililliter (ml) bottles of Enfamil water were noted. The bottles were imprinted with a manufacturer use-by date of October 1, 2012. Two boxes containing six 2 ounce bottles of Enfamil Prosobee soy formula were also noted. The boxes were imprinted with a manufacturer use-by date of October 1, 2012.

On October 24, 2012, at 11 a.m., in an interview with the Director of Infection Prevention, she stated that she completed an "Infection Control Checklist" in the foodservice department in conjunction with the General Manager of Food Service (GMFS) and/or the Chef. She stated that the checklist had been completed weekly up until August 2012, when the facility decided to reduce the inspection rounds to monthly due to little or no findings reported on the surveillance form. She stated she relied on the GMFS to correct any identified deficient practice. She also confirmed that infection control surveillance was only conducted within the main kitchen. No infection control rounds were conducted at the CDU kitchen or other food storage locations.

Review of the last sanitation inspection report showed that it was completed on October 2, 2012, and there were "No Findings." The requirements were "met" for these standards:

"Expired products immediately separated from general storage and returned for credit or destroyed; no out-of-date products are used."

"A cleaning schedule is followed for all equipment, floors and related equipment."

"Refrigerated items are stored in covered containers with labels and dates."

"Cutting boards/meat slicers/can openers are clean, free of build-up, in good repair."

The Director of Infection Prevention could not explain the discrepancy in the reported findings on the completed "Infection Control Checklist" dated October 2, 2012, and the deficient practice identified during the survey from October 22 to 24, 2012. She was not aware of the expired infant formula in the nursery and the unlabeled/undated food items at the CDU.

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

1. The policies regarding maintenance of specific temperature and humidity levels in the Operating Rooms (OR) were consistent and when the temperature levels were out of range follow up by the nursing and/or engineering staff was implemented to ensure the correct temperature levels were maintained; and,
2. Surgical site marking was consistently documented by the nursing staff for Patients 302 and 306.

These failures may negatively impact the health and safety of surgical patients.

Findings:

1. A tour and observation of the facility's six OR's was conducted on October 24, 2012, at 2:15 p.m., with the Director of Surgical Services (DSS). Following the tour a review of the, "OR Suite Temperature and Humidity Out-of-Range Tracking Log," for the month of October, 2012, was conducted.

Documented on the bottom of the Log was noted, "The temperature is maintained at 60 degrees F (Fahrenheit) to 78 degrees F with the humidity from 20% to 60%...contact the Engineering Department if results are out of range."

As specified in the Log, the OR temperatures on October 12, 2012, (untimed) noted:
In OR # 2, the temperature was 58 degrees F, in OR # 4, the temperature was 59 degrees F and in OR #5 the temperature was 55 degrees F.

As specified in the Log, the OR temperatures on October 13, 2012, (untimed) noted:
In OR # 2, the temperature was 57 degrees F, in OR # 3, the temperature was 56 degrees F, in OR # 4, the temperature was 58 degrees F and in OR # 5, the temperature was 58 degrees F.

An interview was conducted with the Staff Engineer on October 25, 2012, at 9:45 a.m., who stated after someone from the Engineering Department readjusts the temperature levels there is no follow up or documented follow up to record the corrected temperatures. A concurrent interview was conducted with the DSS who also stated there was no documented follow up after the temperatures were adjusted.

A review of the Surgery Departments policy, "Surgical Services Safety, (Reviewed: 10/2012)," indicated, "Temperature of the operating room will be maintained at 68 to 73 degrees F (American Institute of Architects, 1996, 2001)."

A review of the Engineering Departments policy, "OR & PACU (Post Anesthesia Care Unit)Temp. (temperature) & Humidity (Reviewed: 10/2012)," indicated, "The temperature is maintained at 64 degrees Fahrenheit to 70 degrees Fahrenheit with the humidity from 40% to 60%."

An interview was conducted with the DSS on October 25, 2012, at 10 a.m. The DSS stated there were inconsistencies with the facility's policies regarding which recommended OR temperature and humidity levels to maintain.

2. A review of the facility policy, "Surgical Site Identification (Reviewed: 10/2010)," was conducted. The policy indicated, "The correct patient, procedure and site will be verified by the patient and/or family, the Circulation RN (Registered Nurse), Anesthesia and the surgeon, preoperatively, in the Holding Area and again immediately prior to the initiation of the surgical procedure...Verification of surgery and side/site will be documented in the following areas; Pre-op Checklist, Intra-operative Nursing Record, Invasive/Surgical Procedure Verification Time Out Checklist, Anesthesia Record, Surgeon's Post-op Note."

a. A review of Patient 302's record was conducted on October 22, 2012. Patient 302 was admitted to the facility on October 21, 2012, with a blood clot in an artery located in his right lower extremity. On October 21, 2012, at 12:40 p.m., Patient 302 underwent a right axillofemoral bypass (surgical removal of the blood clot).

A review of the Surgical Checklist was conducted. The section dated October 21, 2012, at 12:05 p.m.,which indicated "Pre-Op Orders," included a check list. One item on the check list, "Site Marked," was not completed.

An interview was conducted with the Director of Surgical Services on October 22, 2012, at 11:40 a.m., who stated with a right axillofemoral bypass the site of the procedure must be marked and documented on the Surgical Checklist.

b. A review of Patient 306's record was conducted on October 25, 2012. Patient 306 was admitted to the facility on October 13, 2012, with a right elbow fracture. The patient was subsequently scheduled for an open reduction, internal fixation of the right elbow (a surgical intervention).

A review of the Surgical Checklist dated October 14, 2012, at 11:50 a.m., was conducted. A section of the Surgical Checklist which indicated, "To be completed by Operating Nurse," included the following items, "ID Band checked with chart and (surgical) Site Marked." These areas were not checked.

An interview was conducted with the Director of Surgical Services on October 25, 2012, at 10:30 a.m., who stated during all phases of the preoperative surgical check process the areas on the Surgical Checklist which ask if the ID Band was checked, and was the Site marked, must be completed.

Based on observation, record review, and interview, the facility failed to ensure for one sampled patient (Patient 212) received a post anesthesia evaluation prior to being discharged home after surgery.

Findings:

On October 23, 2012, a tour of the same day surgery was conducted.

A record review for Patient 212 was done. On October 23, 2012, Patient 212 underwent laser vaporization of the prostate under general anesthesia. The Postoperative Evaluation was left blank. Review of the record indicated no post anesthesia assessment was done prior to the patient being discharged home.

An interview was conducted with the Director of Surgery, on October 23, 2012, at 1:45 p.m., The director stated a Postoperative Evaluation should have been completed for Patient 212 prior to discharging the patient home.

The facility's prevention policy and procedure titled, "Pre and Post Anesthesia Evaluation," was reviewed. The policy indicated, "For outpatients, the post anesthesia evaluation must be completed prior to the patient's discharge."

Based on observation, interview and record review it was determined the facility failed to ensure:

1. Emergency room nurses were qualified in emergency care by failing to ensure emergency room personnel followed written emergency policies and procedures for triaging one of one patients (Patient 111) with the signs and symptoms of CVA (Stroke). This failure resulted in a delay in Patient 111 receiving the required treatment. (Refer to A1112).


2. Three of five staff interviewed were aware of the procedures used to ensure patients on legal holds did not leave the facility, resulting in the potential elopement of patients on psychiatric holds. (Refer to A1112).


3. Staff on the pediatric unit was knowledgeable and trained to perform a pediatric code. This failure placed the pediatric patient's health and safety at risk for harm, and possible death. (Refer to A1103).


4. ED (Emergency Department) medication orders were being reviewed by the pharmacist in accordance with the facility's policy and procedure. (Refer to A500).

The cumulative effect of these systemic practices resulted in the facility 's failure to ensure patients were receiving quality care in a safe and effective manner.

Based on observation, and interview, the facility failed to ensure staff on the pediatric unit was knowledgeable and trained to perform a pediatric code. This failure placed the pediatric patients' health and safety at risk for harm, and possible death.

Findings:

On October 23, 2012, at 9:30 a.m., a tour of the second floor was conducted. The second floor was divided into two sections. Located behind two doors was an area designated for pediatric patients. There were 14 pediatric beds.

At 9:45 a.m., an interview was conducted with the Charge Nurse/RN of the pediatric floor. The Charge Nurse stated they had two crash carts on the unit (one for adults and the other for pediatrics). The two crash carts were observed to have adult defibrillators on top of the crash carts. The Charge Nurse/RN was unable to show or state how to convert the adult pads on the defibrillator for pediatric use.

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

1. Emergency room nurses were qualified in emergency care by failing to ensure emergency room staff followed written emergency policies and procedures for triaging one of one patients with the signs and symptoms of CVA; and,

2. Three of five staff interviewed knew the procedures used to ensure patients on legal holds did not leave the facility, resulting in the potential elopement of patients on psychiatric holds.

Findings:

1. On October 23, 2012, a review of Patient 111's record was conducted. The "Pre-Hospital Care Report," provided by the ambulance company indicated they were called and dispatched at 4:41 p.m. Time on the scene was 4:48 p.m., and time arrived at the hospital was 5:20 p.m. Patient 111 was only moving his left arm, according to the documentation on the report.

The "Emergency Department (ED) Record," indicated the patient presented to the ED on October 15, 2012, at 5:25 p.m., with an altered level of consciousness. Patient 111's ESI (Emergency Severity Index -used to categorize need in order of severity) was documented on this form as level two. (Level two is considered emergent and requires intervention as soon as possible.)

Upon his arrival to the facility's ED, at 5:19 p.m., the nurse documented on the "Emergency Department Flowsheet." The flowsheet indicated the patient's chief complaint was "R/O (rule out) stroke Right side facial droop and Right side weakness." There was no triage classification documented on the form. In the section to document "Interdisciplinary Documentation," the following was written on October 15, 2012:

5:19 p.m., Pt. (patient) arrived via EMS (Emergency Medical Services) with GCS(Glascow Coma Scale) of 8-10 (used to measure level of consciousness after head injury), R sided weakness with right sided facial droop. CVA (stroke) protocol initiated, head CT (x-ray)...

5:25 p.m., Pt. restless, pulling on all lines.

6:45 p.m., MD (physician) notified that patient had not been seen. CT negative for bleed.

7 p.m., Dr. A stated Dr. B would take patient. Patient had not been seen by physician.

7 p.m., RN approached Dr. B with Patient chart and update. Dr. B told RN (Registered Nurse) to call Dr. C.

7 p.m., Dr. C called and voice mail left.

7:12 p.m., Dr. C returned call and stated for RN to call him back after Dr. B assessed pt. RN noticed Dr. B entering patient room.

Additional documentation indicated the patient was assessed by the physician at 7:15 p.m., and risks and benefits of tPA (Tissue plasminogen activator-see definition below) administration were discussed with patient and spouse at 7:50 p.m. Consent was signed by the patient's spouse at 8:15 p.m., and the tPA administered at 8:28 p.m. (3 hours and 40 minutes after the initial call regarding the patient's stroke like symptoms).
(Tissue plasminogen activator was involved in the breakdown of blood clots. Because it works on the clotting system, tPA was used in clinical medicine to treat embolic or thrombotic stroke. Use was contraindicated in hemorrhagic stroke and head trauma).

On October 25, 2012, at 10:15 a.m., during an interview with ED RN 2, the RN stated if she had a patient with stroke like symptoms (one side weakness, facial droop) she would inform the physician and initiate stroke protocol. ED RN 2 stated the stroke protocol consisted of diagnostic testing (lab tests and X-rays).

In an interview with the Director of the ED on October 25, 2012, at 10:45 a.m., the Director stated she was present the day Patient 111 was brought into the ED. The Director stated the bedside nurse came to her after 6 p.m., and informed her the patient had not been seen by a physician. The ED Director stated Patient 111's chart should have been handed to the physician as a patient with Level 2 ESI should be seen immediately.

The Director stated it was the nurse's first full day at the facility. The Director stated all new ED staff, either new hires or agency (traveler or registry) nurses need three years of experience. The Director stated new nurses were given a partner for their first shift and instructed in ED protocols. The Director stated if a new nurse needed additional time, it was provided.

During the interview with the CNO, information from the "Boston Medical," was reviewed. Titled "Acute Stroke Protocol," the information was meant only as a reference tool and did not replace or overrule the treating physician's judgment or diagnosis. Guidelines for use of intravenous tPA in Acute Ischemic Stroke indicated the approved FDA use for less than 3.0 hours from initial symptoms.

The facility's policy and procedure titled "ESI Triage- General Guidelines," with a last reviewed date of October 2010, was reviewed on October 25, 2012. The policy indicated acuity levels and disposition would be assigned to patients on the Emergency Severity Index. "ESI Level Two Emergent," indicated the patient presented with a condition posing a potential threat to life, limb, or function and requires rapid medical intervention. The policy indicated when ESI Level two condition was identified, "the triage process stops...and immediate physician intervention requested."

The employee file for ED RN 10 was reviewed on October 25, 2012. The file indicated ED RN 10 was a traveling nurse, contracted to work at the facility through an agency. The file contained a "Department Orientation Checklist," "Environment of Care Orientation Checklist," "Infection Prevention & Control and Patient Safety Orientation Checklist," and a "Registry/Traveler Orientation Checklist, Licensed Nursing Staff." The file did not contain information to prove that RN 10 had three years of experience and had the training required to ensure competencies in ED protocols. There was no written record of the partnership provided for the first shift and instruction of the ED protocols.

During an interview with the Chief Nursing Officer (CNO) on October 25, 2012, at 11:30 a.m., the CNO stated the agency nurse's competencies were reviewed prior to the nurse working. The CNO stated as the agency nurse needed three years' experience, she would expect them to know which patients' need to be seen immediately and which ones can wait.

2. On October 22, 2012, at 10:15 a.m., during a tour of the Emergency Department, Security Guard 1 stated he was not at the front desk because he was relieving another employee who was watching a "5150," (legal hold) patient.

Patient 104's record was reviewed on October 22, 2012. According to the "Receiving Hospital Care Record, " Patient 104 was coming to the hospital with back pain and low blood sugar. It was also documented on the form that the Sheriff's Office would meet the patient at the hospital to place the patient on the "5150 hold."

Documentation in the Interdisciplinary Notes indicated the following entries on October 21, 2012, at the following times:

At 6:35 p.m., "Patient arrived and left out the front doors no 5150."

At 7 p.m., "Patient arrived and stated she wants help. Law enforcement at bedside patient agitated and yelling."

At 8:45 p.m., "security officer present for constant observation."

At 10:45 p.m., "security at bedside, safety maintained."

On October 22, 2102, "the nurse documented the patient was agitated, talking with security and threatening to leave."

At 10:35 a.m., on October 22, 2012, Patient 104 was transferred to a locked psychiatric facility for treatment.

Patient 104's record contained a document titled "Application for 72 Hour Detention for Evaluation and treatment." The form indicated the patient was placed on this hold on October 21, 2012, at 6:28 p.m.

On October 22, 2012, 10:45 a.m. ED RN 1 was interviewed. The nurse stated Patient 104 walked out of the ED yesterday, but she was not on a hold at that time. ED RN 10 stated she could not physically hold a patient in the ED and if a patient on a "5150" left the facility she would need to call the police.

The facility's policy and procedure titled "Psychiatric Patients-Security Procedures Relating to Patients on Involuntary Holds (8 Hour/5150 Holds), with a last reviewed date of October 2012, was reviewed on October 23, 2012. The policy indicated its purpose was to clarify and define the appropriate procedures to be undertaken when dealing with a patient who presents with a psychiatric/behavior condition which may result in the application of a 72 hour hold. The policy statement indicated the facility was not a 5150 designated facility and when patient were placed on, or retained on a "5150 hold," it was known as an application status and this allowed the individual to be detained until transferred to a 5150 designated facility or the application expires or was broken.

The policy indicated if a patient was brought to the hospital with a 5150 hold already written, the patient should be placed under constant surveillance and security should remain at the room for the protection of the patient and staff. Security interventions included "Patient may be appropriately restrained under facility restraint policy and patients may be physically restrained."

On October 23, 2012, at 11:30 a.m., Security Officer 1 was interviewed. The security officer stated he could not physically hold a patient who was placed on a 5150 hold. If the patient walked out, Security Officer 1 stated he would notify the local police department.

On October 23, 2012, at 11:45 a.m., ED RN 2 was interviewed. ED RN 2 stated she would attempt to contract with the patient for safety or convince them to stay, but she could not physically stop a patient from leaving the facility.

On October 23, 2012, at 4 p.m., during an interview with the CNO and Director of Quality, the CNO stated staff have been educated as to the resources that can be utilized for 5150 patients and she was not sure why staff did not explain the procedures that could be used to prevent a patient from leaving. The CNO stated restraints can be used with a physician order.

In an interview with the ED Director on October 25, 2012, at 10:15 a.m., the Director stated if a patient on a 5150 was attempting to leave, the physician should be called to the bedside. If the patient was combative or uncontrollable, staff can call local law enforcement (before they leave).

On October 25, 2012, at 10:15 a.m., an ED tour was conducted. Security Guard 2 was observed at the door to a restroom. SG 2 stated he was watching a 5150 patient, "making sure she doesn't go AWOL." SG 2 stated if the patient did leave, he would notify local law enforcement.

On October 25, 2012, the facility's inservice information presented to emergency department staff was reviewed. Titled "Nonviolent Crisis Intervention," the program focused on the safe management of disruptive and assaultive behavior. The information provided did not address 5150 patients.

The facility failed to ensure all staff were trained to follow policies and procedures for protecting "5150," patients from harm, by ensuring all staff knew the procedures used to ensure legally held patients did not leave the facility.