HospitalInspections.org

Based on observation and record review, the hospital failed to post information at an outpatient clinic, informing patients of their rights.

Findings:

On 9/25/12 at 9:15 a.m. during an observation of the hospital outpatient clinic "Valley Specialty Center", it was noted the only Patient Rights posting was located in a remote hallway. The Patient Rights posting did not include a copy in the English language. In addition, the Patient Rights notice was not posted in the clinic's entry for patients using the ramp access.

The above tour was conducted in the presence of the ambulatory director.

Review of the hospital's "Rights and Responsibilities of Patients" policy and procedures dated 7/7/09, indicated the facilities department "posts Patient Rights...in English, Spanish, and Vietnamese in designated areas as required by appropriate codes."

Based on observation and interview, the hospital failed to protect patient rights to receive care in a safe setting.

Findings:

1. On 9/24/12 at 10:40 a.m., during the tour of the "MIC" unit, an opened room containing "hazardous materials" was left unlocked. During the observation, the "MIC" unit director stated the room should have been locked.

Review of the hospital's "medical waste" policy and procedures dated 3/12, indicated hazardous waste should "be secured so as to deny access to unauthorized persons".

2. On 9/24/12 at 11:50 a.m., next to Room 4CO21 an unattended laboratory cart containing needles and glass vials was left in a hallway where patients and visitors had access.

The hospital did not have a policy and procedure addressing proper storage of laboratory carts.

Based on observation and record review, the hospital failed to maintain patient rights for confidentiality of records when confidential information was in view and accessible to the public.

Findings:

1. On 9/24/12 at 9:40 a.m., during the tour of the transitional care unit, Patient 8's medical record was left open unattended on the counter at the nurse's station. The record disclosed Patient 8's name, medical record number, date of birth, and vital signs.

2. On 9/24/12 at 12 p.m., during the tour of the "four medical unit", Patient 15's medical record was left open and unattended by a hospital physician on the counter of the nurse's station. The record disclosed Patient 15's name, medical record, date of birth, and physician progress notes.

3. On 9/24/12 at 2:10 p.m., during the tour of the MICC B unit, a chart rack containing patient medical records was located in the main hallway, easily accessible to visitors or patients. At the time of the observation the chart rack contained medical records for Patients 18 and 19.

4. During an observation on 9/27/12 at 10:00 a.m. at the 4 Surgical nurse's station, a list of patient names, medical record numbers, and indications of need for a sitter (supervised care) was noted on the counter. The list was visible to the public.

During a concurrent interview with the charge nurse, she stated the list should not have been placed where it was visible to the public. She further stated the patient names and other information should be covered.

Review of the hospital's "security of protected health information" policy and procedures dated 3/23/09, indicated the hospital would "protect monitors/documents/faxes from public view".

Based on staff interview and record review, the hospital failed to set priorities for its performance improvement activities which focused on high risk areas that might affect health outcomes, patient safety, and quality of care. The hospital failed to ensure the Infusion Center Pharmacy (where chemotherapeutic medications were prepared and dispensed for inpatients and outpatients) had quality improvement data to show it employed mechanisms to track and monitor the effectiveness, safety of services, and quality of care related to chemotherapeutic product preparation and dispensing. As a result, there were no weaknesses and deficiencies identified and actions implemented to improve performance. The pharmacy performed about 1,000 chemotherapeutic products per month.

Findings:

On 9/26/12 at 10 a.m., a visit to the Infusion Center Pharmacy was conducted with the director of pharmacy (DOP). He said the pharmacy prepared and dispensed chemotherapeutic products for the hospital's inpatients and outpatients.

During an interview on 9/26/12 at 11:15 a.m. in the presence of the DOP, the pharmacy supervisor (Pharm 1) described the process for quality improvement monitoring at the Infusion Center Pharmacy. He said he had only been auditing to ensure there was a "Production Label" for each of the chemo product preparations since 5/12. The production label was a label that specified the amount of a chemo medication and base solution to be compounded for each chemo preparation. The audit was a plan of correction from a serious medication error related to the incorrect dispensing of a chemotherapeutic medication. Other than the production label auditing, Pharm 1 could not provide evidence of quality improvement data that showed an ongoing monitoring for effectiveness, safety of services, and quality of care related to pharmacy services at the Infusion Center. Pharm 1 said the pharmacy staff prepared and dispensed about 1,000 chemotherapeutic orders per month.

Based on interview and record review, the hospital's quality assurance and performance improvement program failed to collect data and identify opportunities for improvement as it related to deficient practices observed throughout the survey in the Food and Nutrition Services Department when:
1. Data collected related to labeling and dating of food for safe storage did not accurately measure deficient practices observed during the survey (cross-reference A-620).

2. There was no data collection to study whether the clinical dietitian's nutrition assessments were consistent with recommended and/or implemented nutrition plans of care (cross-reference A-630).

This failure to accurately collect and/or analyze data as it related to the nutrition care of the patients prevented the hospital from identifying opportunities for improvement. It further allowed the deficient practices to continue without remediation.

Findings:

1. Review of the food and nutrition department's quality improvement program on 9/27/12 with the FSM at 11:00 a.m., showed there was one quality measure in the food service operation for label and dating. Review of last year's Storage and Labeling Report showed the department was at 98 to 100 percent for the last 6 months (February to July 2012). The storage and labeling inspection was to inspect at least 5 items for expiration, opened and dated, stored on appropriate shelf, and other issues identified.

Deficient practice was found in labeling and dating and identifying the products stored in the department when on tour with the DNFS 9/24/12. The FSM acknowledged this quality program was not accurately measuring the indicator.

2. A review of the food and nutrition department's quality improvement program on 9/27/12 with RD 2 at 11:15 a.m., showed that no data was being collected as it related to how the nutrition needs of the patients were being met. She stated that the studies being evaluated addressed whether department policies were being followed, such as timeliness of assessments and reassessments, completeness of the nutrition assessment and care plans and adherence to documentation requirements.

A review of the medical record for Patient 5 on 9/26/12 revealed the documentation requirements were met and the notes were timely, yet appropriate nutrition interventions were not recommended or initiated as they related to the stated nutrition goals. Patient 5 also was not interviewed for possible interventions that may have prevented an undesirable weight loss, despite being admitted to the hospital for more than one week.

RD 2 acknowledged the department's studies only addressed adherence to policy and procedures. They did not identify opportunities to improve nutrition care provided to the patients as it related to how the hospital met the patient's nutritional needs.

Based on medical record review and document review, for 5 of 17 patient records surveyed, the hospital failed to ensure that an appropriate medical history and physical examination (H&P) was completed within 30 days prior to surgery.

Findings: See A952.

Based on interview and record review, the hospital failed to ensure nursing personnel had current Advance Cardiac Life Support (ACLS) certification according to hospital policies and procedures. The failure resulted in a registered nurse (RN A) providing specialized care without evidence of current ACLS certification for approximately 18 months.

Findings:

On 9/25/12 at 10:15 a.m., during review of personnel records it was noted RN A's ACLS certification expired in March 2011.

On the above same day and time in an interview with RN A's manager, she stated ACLS certification was required for RN A's employment position. The manager was not able to provide a copy of RN A's current ACLS certification.

During an interview with the interim chief nursing officer (CNO) on 9/26/12 at 2:45 p.m., she stated the hospital's "Registered Nurse and Licensed Vocational Nurse Licenses" policy and procedures (P&P) dated 04/10 applied to requirements for registered nurse ACLS certification. The P&P indicate "verification showing the licensee's name, type of license, license number, license status, expiration date, issue date and any actions associated with the license is maintained on file".

Based on interview and document review, the hospital failed to ensure the registered nurse supervised and evaluated the nursing care of two patients (4 and 5). Patient 4's shellfish allergy was not entered into the hospital computer system as an allergy alert. Patient 5 had an physician order for one-on-one supervision during meals due to risk for choking and he did not receive the supervision. This failure had the potential of compromising the patients' care.

Findings:

1. On 9/26/12 at 11:40 a.m., Patient 4's medical record was reviewed. Patient 4 was admitted 9/22/12 with diagnoses of diabetes mellitus, obesity, and sleep apnea.

The Clinical Record History and Physical dated 9/22/12 documented in the allergies section "shellfish" and signed by the attending physician.

The Physician Order Adult Medicine Inpatient Admission Orders dated 9/22/12 indicated, under allergies, "shellfish. "

Review of Patient 4's allergies computer information on 9/26/12 with the Surg 3 Nurse Manager showed there was no shellfish allergy listed in the computer system.

The nurse manger concurrently stated she did not know how the allergies were to be entered into the computer system.

Admission of Adult policy reviewed 4/12, documented the registered nurse would "enter admission information, including.. .allergies ...into Invision computer system."

2. During meal time observations on 9/25/12 at 12:30 p.m. on the Rehab unit patio, Patient 5 was served his lunch by a nurse who then walked away from the patient. The patient sat by himself at his table.

The medical record for Patient 5 was reviewed on 9/26/12. Review of the physician orders dated 9/24/12 showed an order for a dysphagia diet for swallowing difficulty with "1:1 supervision".

During an interview with the nurse manager for the unit on 9/25/12 at 9:30 a.m., she stated 1:1 (one-on-one) supervision meant a nurse was supposed to sit down with the patient to closely observe the patient while he ate. She stated that he should not be left alone during meals without direct visual observation.

A 1:1 supervision policy was requested and the nurse manager stated they did not have one.

Based on interview and record review, the hospital failed to obtain competencies for nursing staff to ensure the safe administration of sedative medications where nurses adjust doses and monitor the effects of the medications based on their subjective clinical interpretation of the range orders.

Findings:

Review of the clinical record for Patient 67 who was admitted to the Neurosurgery Intensive Care unit (ICU) on 9/15/12 revealed he was prescribed Propofol (medication for sedation) and Fentanyl (opiated medication for pain control and sedation) under the PRN (as needed) intravenous (IV) infusions protocol. Propofol was to be administered at a rate of 0 to 100 mcg/kg/min via IV infusion to maintain Ramsay scale (sedation level scale) of 2 to 4 while Fentanyl was to be administered at a rate of 0 to 100 mcg/hour via IV infusion to maintain intracranial pressure (ICP) less than 20 millimeters of mercury (mmHg) according to his Neurosurgery ICU inpatient admission orders.

Neither the Propofol nor the Fentanyl medication had a starting dose included in the order. Also missing from the orders were the parameters instructing the nurse how to titrate (increase or decrease) the doses for both Propofol and Fentanyl. The physician orders of Propofol and Fentanyl for Patient 67 did not provide clear instructions to nursing staff. and did not promote safe medications use; resulting in subjective interpretation by the individual titrating and administering the medications.

On 9/27/12 at 2:20 p.m., when registered nurse 3 (RN 3) was asked to provide documentation to demonstrate the ICU nurses were competent to adjust the doses and to monitor for safe and effective treatment with these two medications, she stated they were not currently evaluating nurses for competency with use of Propofol and or Fentanyl. In an interview with Pharm 4 and RN 3 on 9/24/12 at 2:42 p.m.., they both acknowledged the two medication orders as written did not provide adequate instruction on the titration of the Propofol and Fentanyl doses, and did not promote titration consistency.

Based on staff interview and medical record review, the hospital failed to ensure medications were prepared and administered as ordered by the physician or in accordance with the hospital's established policy and procedures, when:

1. A review of three medical records of patients who were administered pain medications via the PCA (patient controlled analgesia, a pain management method via an infusion pump that permits patients to manage their pain by self-administering small amounts of narcotics at frequent intervals by pushing a button upon patient demand) revealed staff failed to document double checking for PCA administration consistently, as required per policy, for one patient (Patient 74). Also, staff failed to document required patient assessment hourly after each increase in pump setting as ordered for Patient 74; and,

2. Staff failed to recheck blood sugar (BS) within 15 minutes following the administration of D50W (50% dextrose in water, a sugar solution to treat severely low BS) as ordered for one of three patients (Patient 73). The failure demonstrated the lack of timely assessment and monitoring for the patient's condition and medication effectiveness after the event; and,

3. Controlled substance (CS) medications were not wasted immediately at the time of removal from the Pyxis (an automated medication dispensing cabinet), as per hospital expectation and per hospital policy, for five of 42 CS wastage transactions (over a 3-day period) reviewed. This failure had the potential for CS drug loss and/or diversion as well as medication administration errors (inadvertent administration).

Findings:

1. On 9/25/12 at 11:55 a.m., a review of Patient 74's medical record was conducted at the Pediatric Unit with multiple staff including the clinical nurse specialist (CNS). Patient 74 was admitted to the hospital for appendicitis (inflammation of the appendix) and since 9/22/12 required Dilaudid (a potent narcotic for pain) via the PCA. The CNS said, per hospital policy, double checking by two nurses was required at the initiation of the PCA, at start of shift, and at dose changes (changes in pump setting) for patients on PCAs. Documentation of double checking was required on the flowsheet.

A review of the PCA flowsheets for Patient 74 during the same visit revealed on 9/23/12 at 6:15 p.m., there was an order to reduce the demand dose from 0.1 milligram (mg) to 0.05 mg. The order was carried out shortly after but there was only one nurse's initials on the flowsheet. Similarly, on 9/24/12 at 4 p.m., the physician ordered to increase the basal rate (amount deliver per hour) from 0.05 mg to 0.07 mg. The flowsheet showed the order was carried out but there was only one set of nursing initials. Also, the nursing initials were missing at the start of shift on 9/25/12 at 8 a.m. The CNS verified there should have been two sets of nurses' initials at the indicated times.

The hospital policy and procedures "Medication Ordering and Administration", dated 11/1/10, indicated: "When the following medications are delivered intravenously via infusion pumps (insulin,..., and narcotics), the IV pump setting and solution are to be double checked by 2 RNs at set-up, change of order; and hand-off and change of shift." The policy indicated documentation was required on the "medication administration record (MAR) or other appropriate location before administering to the patient."

2. Included in the Pediatric PCA orders for Patient 74 was: "Patient Assessment: Assess and document respiratory rate and O2 sat (oxygen saturation) Q 1 hr (every 1 hour) x 4 with the initiation of the PCA and after each increase in pump setting..." The PCA flowsheets showed dose increase was ordered three times during the course of therapy from 9/22/12 to 9/25/12. However, there was no documented evidence the respiratory rate and O2 sat were monitored hourly x 4 following each dose increase. The CNS acknowledged this finding. She commented the flowsheet was not constructed as such to allow documentation of hourly assessment and monitoring.

3. Patient 73 was admitted to the hospital for chest pain. On 9/26/12 at 5:15 p.m., a review of her medical record with a nurse manager (NM 1) revealed the patient had a physician order for insulin coverage via sliding scale (a set of instructions for administering insulin dosages based on specific BS readings). Part of the sliding scale order was to give 50 ml of D50W intravenously (directly into a vein) and "repeat glucose in 15 min" when BS fell below 70 mg/dL (unit of measurement).

A nursing note, dated 9/5/12, indicated the patient called the unit nurse and complained of being "dizzy and weak" and stated "I think my sugar is low" at 3:55 a.m. Upon checking, the BS was 51 mg/dL; a dose of D50W was given. The record showed the next BS was rechecked at 6 a.m., more than two hours later. NM 1 said the BS should have been checked 15 minutes after the D50W administration as ordered. She confirmed the nursing staff failed to assess the patient timely following the hypoglycemic event.

4. On 9/24/12 at 1:15 p.m., a visit to the emergency department (ED) was conducted with the director of pharmacy (DOP) and the ED nurse manager (NM 2). When questioned about the wastage of CS medication dosages that were less than the amount available in the Pyxis, NM 2 said she expected the nurses to calculate the amount needed and waste the extra portion with another nurse "in real time". In other words, she said CS wastage should happen at the time of Pyxis removal. She said she did not want any excess medications "hanging around" posing a potential for loss.

During the same ED visit, the DOP provided the 24-hour Pyxis usage report of Dilaudid (a potent narcotic for pain) 2 mg/ml vials. The report indicated a patient (Patient 69) had a physician order on 9/23/12 for Dilaudid 0.5 mg to be given once. The patient's nurse obtained a vial of Dilaudid 2 mg at 9:13 p.m., but did not waste the remaining portion with another nurse until 11:10 p.m., almost two hours later. NM 2 could not explain why it would take that long to waste the unused portion.

On 9/25/12, the DOP was asked to provide the last 3-day Pyxis report for Dilaudid use in the ED. The report revealed 5 out of 42 Dilaudid wastage transactions did not happen at the time of removal. The time lapses between removal and documentation of wastage ranged from 4 minutes up to 2 hours. This information was verified with the DOP on 9/25/12 at 1:15 p.m.

The hospital policy and procedures "Controlled Substances", dated 5/19/10, indicated the following under "Ordering": "Licensed Personnel removes appropriate amount of controlled substance... Administers all doses of controlled substances at the time of removal from the locked cabinet or Pyxis System.
"If the dose is not or cannot be administered at the time of removal, immediately returns the dose to inventory or waste the dose."

Based on observation and interview, the hospital failed to have a system in place to access medical records stored at an outpatient clinic.

Findings:

On 9/25/12 at 3:40 p.m., during the tour of the medical record department at East Valley Clinic, a staff member stated the clinic was in the process of scanning the medical records into the computer system linked with the main hospital. When asked how the main hospital staff would access unscanned medical records after clinic business hours, the staff member was not able to articulate how the medical records would be attained.

On 9/27/12 at 8 a.m., during an interview with the chief nursing officer, she stated the hospital did not have a system in place to access the unprocessed medical records from the outpatient clinic after clinic business hours.

Based on interview and record review, the hospital failed to ensure licensed staff timed, dated, and signed an admission assessment for one (47) sampled patients, and failed to enforce its policies and rules intended to ensure that all medical record entries are legible for 3 out of 17 history and physical records surveyed.

Findings:

1. On 9/26/12 at 9:00 a.m., the clinical record for Patient 47 was reviewed in the company of the quality improvement manager.

The record indicated Patient 47 was admitted to the hospital with a breathing tube in the patient's airway, and sedated. The Hospital Admission Assessment form documented assessments for demographics, orientation, psychosocial, past medical history, communication, activities of daily living, nutrition & screening, and social history. The assessment record failed to include a signature and title, and date and time the assessment was made.

The quality improvement manager reviewed the record and stated she was unable to find the signature documentation.



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2. On 9/25/12, review of the records for Patients 36, 39, and 44 demonstrated the preoperative history and physical examinations contained entries were illegible. In interview with the MSC on 9/26/12 at 11 a.m., it was confirmed that the entries were illegible.

Review of the 2012 hospital medical staff rules and regulations on 9/26/12 demonstrated the requirement that the attending practitioner is responsible for timely completion of a "comprehensive and legible" medical record for each patient.

Based on interview and record review, the hospital failed to ensure physicians' verbal orders were authenticated within 48 hours for one patient (47) medical record reviewed. Findings:

On 9/26/12 at 9:00 a.m., twelve random medical records were reviewed in the company of the interim Health Information Management Director and the Quality Improvement Manager.

For Patient 47, documentation on a Diagnostic Imaging Order indicated a physicians verbal order for a chest X-ray was taken on 7/9/12 at 3:50 a.m. More than two and one-half months after the verbal order was taken, Patient 47's medical record had a blank space where the MD signature was required. The Health Information Management Director stated nurses were responsible for having physicians sign their verbal orders.

Based on interview and record review, the hospital failed to document accurate allergy information. This failure has the potential to cause significant harm to patients receiving medications to which they are allergic.

Findings:

Review of the clinical record with Pharm 3 and RN 5 in the Critical Care Unit (CCU) on 9/26/12 revealed that Patient 66 was transferred to the CCU from the Adult medicine unit on 9/22/12 with admitting diagnoses which included cardio artery disease, shortness of breath, and pericardial effusion. Further review of Patient 66's Adult Medicine Inpatient admission orders dated on 9/17/12 indicated that she was allergic to penicillin, while her admission orders to the Adult Intensive Care Unit (ICU) admission dated on 9/22/12 revealed that she had no known drug allergy.

When Pharm 3 was asked about the conflicting allergy information on the two separate physician orders, she stated the pharmacy computer system would have the most updated allergy information for this patient. On 9/26/12 at 2:49 p.m., review of Patient 66's electronic record with Pharm 3 and RN 5 showed she had a documented allergy to Penicillin.

During an interview with the RP 1 on 9/27/12 at 8:50 a.m., she was asked about the discrepancy found regarding Patient 66's allergy information between the two admitting orders. RP 1 stated Patient 66 did not have any drug allergy when she interviewed her. The "No Known Drug Allergy (NKDA)" had also been verified with Patient 66's family and both of their statements were consistent. However, RP 1 acknowledged she did not attempt to reconcile with any of the patient's prior allergy records. She further stated if there were a discrepancy identified between the her record and the electronic record, she would expect to be contacted for verification.

Review of the hospital policy "Admission of the Adult Patient", it read "Enter admission information, including height, weight, allergies and isolation code into the Invision computer system."

During interview with the Director of Pharmacy (DOP) on 9/27/12 at 11:15 am, he acknowledged the allergy profile for Patient 66 should have been verified and updated by hospital staff to NKDA during the subsequent admission orders review process.

Based on staff interview and record review, the hospital failed to ensure patients' weights were accurately recorded in the medical record and obtained in a timely manner for two sampled patients (1 and 2). The facility also failed to monitor the safe and effective administration of sedative medications for one sampled patient (67).

Findings:

1. Review of the clinical record for Patient 67 who was admitted to the Neurosurgery Intensive Care unit (ICU) on 9/15/12 revealed that he was prescribed Propofol (medication for sedation) and Fentanyl (opiated medication for pain control and sedation) under the PRN (as needed) intravenous (IV) infusions protocol. Propofol was to be administered at a rate of 0 to 100 mcg/kg/min via IV infusion to maintain Ramsay scale (sedation assessment scale) of 2 to 4 while Fentanyl was to be administered at a rate of 0 to 100 mcg/hour via IV infusion to maintain intracranial pressure (ICP) less than 20 mmHg according to his Neurosurgery ICU inpatient admission orders.

Review of Patient 67's ICU flowsheet indicated the Propofol was initiated on 9/15/12 at 10:00 p.m. at the rate of 10 mcg/kg/min with a documented Ramsay score of 6 (no response to stimulus). Further review of the flowsheet revealed that sedation assessment using the Ramsay scale was not performed the next day and was missing on the flowsheet between the hours of 9:00 a.m. to 3:00 p.m. on 9/16/12, while Propofol was infusing at the rate of 10 mcg/kg/min during that time.

In the interview with registered nurse 3 (RN 3) on 9/24/12 at 2:42 p.m., she acknowledged the sedation assessment should have been monitored during those hours to ensure the appropriate sedation goal was achieved.

Review of the hospital policy and procedure "Assessment parameters for the Patient Receiving IV Sedation", under process of utilizing the Ramsay scale, it read, "A. The patient will be assessed at least every 2 hours ... Review of another hospital policy entitled "Standards of Care in the Adult Intensive Care Units", under documentation standard, read, "A. Vital signs and your assessment parameters will be documented at least every two hours."



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2. Patient 1 was admitted to the Behavior unit (BAP) on 7/24/12 with diagnoses of schizophrenia paranoid. Medical diagnoses included back pain, hypertension and chronic renal failure. Emergency Psychiatric Services (EPS) dated 7/24/12, listed the patient's height as 175 centimeters (cm) and weight 140 pounds in a section stated "Approximate." Acute Psychiatric services inpatient psychiatric admission nursing assessment dated 7/24/12 documented height at 153 (no unit of measure designation), and with a check mark where there was space for patient weight. The Acute psychiatric services daily nursing flowsheet dated 7/24/12 recorded weight at 153 (no unit of measure designation).

A Nutrition Services note dated 7/29/12 documented Patient 1's estimated height 5 feet 5 inches, and weight 160 pounds.

A Nutritional Services note dated 8/8/12 documented admission weight 160 pounds.

A Nutritional Services note dated 8/21/12 documented current weight "na" (not available).

A Nutrition Services note stated "current weight" 150 pounds with admission weight 140 pounds. The assessment was for "patient with good oral intake and increase 10 pounds."

Patient 1 did not have an accurate weight taken from admission for two months.

Present during the record review on 9/25/12 at 9:30 a.m., were RD 1, Nurse Manager BAP, and the Interim Director of Nursing. The Interim director of Nursing acknowledged the medical record lacked accuracy and clarification of the discrepancies. He acknowledged patients on long term admissions should be weighed regularly to ensure medical care was appropriate and changes in status would be promptly addressed by medical personnel.

3. Patient 2 was admitted 8/10/12 with diagnoses of Schizoaffective Disorder.

An Emergency Psychiatric services (EPS) face sheet dated 8/9/12, documented "unable" for height and weight.

Nutrition Services Notes dated 8/13/12 showed height "Est (estimated) 6 feet, and weight 158 pounds. Status is underweight."

Nutrition Services notes dated 8/21/12 showed "current weight 158 pounds on 8/13 and patient needs more calories and high protein."

Nutrition Services Notes dated 8/28/12, 9/5/12, and 9/11/12, requested nursing staff to update current weight.

Review of the Clinical Workload report dated 9/26/12 showed the patient's height at 72.0 inches and weight at 158.0 pounds. In addition, clinical notes documented the 8/3/12 height was 5 feet 1 inch (61 inches).

There was no determination of Patient 2's accurate height when several entries ranging from from 72 inches to 5 feet 1 inches appeared in various parts of the medical record.

At the time of review, RD 1 stated the patient needed ongoing weight to ensure his nutritional needs were being met.

Based on observation, interview and record review, the facility failed to document and monitor temperatures for intravenous (IV) contrast agents stored in a warmer.

Findings:

On 9/26/12 at 2:12 p.m., during an inspection of the Radiology Department with Pharm 3 and RN 4, a warmer containing intravenous (IV) contrast agents was found inside the Angio 1 procedure room. The IV contrast agents in the warmer included Visipaque and Omnipaque (contrast agents).

Review of the current month (September 2012) temperature log for this warmer revealed that temperature monitoring was not consistently carried out by staff and was missing on the following dates: 9/1/12, 9/2/12, 9/3/12, 9/6/12, 9/7/12, 9/8/12, 9/9/12, 9/15/12, 9/16/12, 9/22/12, and 9/23/12.

Further review of the temperature log revealed the temperature of the warmer was consistently at 38 degrees Celsius for the past two weeks which is above the maximum temperature of 37 degrees Celsius listed on the manufacturer's packet insert for these two IV contrast agents.

During interview with RN 4 on 9/26/12 at 2:18 p.m., she acknowledged the temperatures for the warmer should have been monitored on those days to ensure acceptable storage conditions were met.

Review of the hospital policy "Iodinated IV Contrast Storage", under Policy Action, it read, "The temperature of the warmers shall be maintained at temperature not to exceed 37 degree Celsius ...If the temperature falls out of the stated guidelines corrective measures need to occur..."

Based on observation, staff interview, and record review, the hospital failed to ensure drugs were controlled and distributed according to hospital policy and procedures and standards of practice, when:

1. The hospital failed to ensure medications available for Pyxis overrides were consistent with the hospital policy and procedures.

2. Also, certain medications (such as morphine PCA) approved by the hospital for override might prove to be unsafe if given prior to a pharmacist review for appropriateness.

3. The hospital failed to ensure safe and effective administration of sedative medications.

These failures had potential to result in unsafe medication use practices, and to cause an adverse drug reaction which could have resulted in harm to the patients.

Findings:

1. Pyxis is a computerized medication dispensing machine. Override takes place when an authorized user obtains medication(s) from the Pyxis before the pharmacist has a chance to review the physician order for appropriateness, i.e., dose, duration, allergies, drug-interactions, etc.

The hospital's 6/11 Pyxis override policy allowed overrides when "significant harm could result from the delay caused by the pharmacist's review; the potential harm would outweigh the benefit of the pharmacist's review." The policy included a list of medications that were approved for override.

On 9/26/12, the director of pharmacy (DOP) provided the Pyxis override report for a 7-day period from 9/18/12 to 9/25/12. A review of the report with the DOP at 5:15 p.m. revealed numerous overridden medications, such as quetiapine, aripiprazole (medications for psychosis), propranolol (for high blood pressure), multivitamins, etc., were not listed on the approved override list. In other words, the overridden medications did not match those on the approved override list. The DOP said, "It's an oversight".

A Pyxis Medstation at the EPS (Emergency Psychiatric Services) was observed on 9/27/12 at 9:05 a.m. with the DOP and several EPS nursing staff. There were seven medications that were available for overrides which were not on the approved override list. The DOP acknowledged this deficiency.

2. In the "Guidelines on the Safe Use of Automated Dispensing Devices" 2010, the American Society of Health-System Pharmacists (ASHP- a nationally recognized organization) wrote the following in regards to overrides: "Override access to medications should be limited to cases in which the drug product has been approved by a multidisciplinary committee of physicians, pharmacists, and nurses as having a clinically urgent need for the medication that outweighs the potential risk of medication error."

Included in the hospital approved override list were medications such as morphine PCA (patient controlled analgesia, an interactive method given via an infusion pump that permits the patient to self-administer small amount of narcotic for pain upon demand). The hospital considered narcotic given via an infusion pump (such as PCA) as a high-risk medication (those that bear a heightened risk of causing significant patient harm when they are used in error).

During an interview with several pharmacy leadership staff on 9/27/12 at 10:30 a.m., the DOP and the pharmacy supervisor (Pharm 1) agreed that orders for morphine PCA should be thoroughly reviewed with respect to pertinent patient and clinical information by the pharmacist before the first dose was administered to the patient. They agreed morphine PCA should not be an override-able medication.



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3. Review of the clinical record for Patient 67 who was admitted to the Neurosurgery Intensive Care unit (ICU) on 9/15/12 indicated he was prescribed Propofol (medication for sedation) and Fentanyl (opiated medication for pain control and sedation) under the PRN (as needed) intravenous (IV) infusions protocol. Propofol was to be administered at a rate of 0 to 100 mcg/kg/min via IV infusion to maintain Ramsay scale (sedation scale) of 2 to 4, while the Fentanyl was to be administered at a rate of 0 to 100 mcg/hour via IV infusion to maintain intracranial pressure (ICP) less than 20 mmHg according to his Neurosurgery ICU inpatient admission orders.

Neither the Propofol nor the Fentanyl medication had a starting dose included in the order. Also missing from the orders were the parameters instructing the nurse on how to titrate (increase or decrease) the doses for both Propofol and Fentanyl. The physician orders of Propofol and Fentanyl for Patient 67 did not provide clear instruction to the nursing staff and did not promote safe medications use. Futhermore, dosage range orders do not ensure that the physician's orders are complete, and do not provide a clear direction to the clinical staff on how to execute those orders, resulting in subjective interpretation by the individual titrating and administering the medications.

In the interview with Pharm 4 and RN 3 on 9/24/12 at 2:42 p.m., they acknowledged the two medication orders as written did not provide adequate instruction on the titration of the Propofol and Fentanyl doses, and did not promote titration consistency.

Based on observation and record review, the hospital failed to keep drugs in a secure and locked area.

Findings:

1. On 9/24/12 at 9:40 a.m., during the tour of the transitional care unit, an unattended medication cart next to Room 4M109, was left unlocked. The medication cart contained insulin (a medication that lowers blood sugar), needles, and syringes.

2. On 9/24/12 at 12 p.m., during the tour of the "four medical unit", an unattended medication cart between Rooms 4E053 and 4E051 was left unlocked. The medication cart contained medications (levothyroxine and gluconate) and needles.

Review of the hospital's "Medication Administration" policy and procedure dated 5/10 indicated "medicine carts are locked whenever unattended by licensed nursing staff."

Based on observation, interview and record review, the hospital failed to have a current written description for outpatient clinics that addressed the expected reporting time for stat (immediate) laboratory test results. Findings:

On 9/25/12 at 3:30 p.m., a physician ordered stat laboratory testing for Patient 25.

On 9/26/12 at 1 p.m., review of Patient 25's stat laboratory results indicated the results were not available until 6:27 p.m. on 9/25/12, approximately three hours after being ordered.

On 9/27/12 at 8:20 a.m., during an interview with the director of laboratory services, she stated after the outpatient courier dropped off the stat specimen at the main hospital, staff left the specimen unattended for approximately 50 minutes, which delayed the laboratory results. The laboratory director further stated the expected result time for stat orders at the outpatient clinics was between one to two hours, but the hospital did not have a current policy and procedure in place addressing stat laboratory orders at the outpatient clinics.

Based on observation, interview, and document review, the hospital failed to ensure Food and Nutrition Services met the needs of all patients as evidence by the failure to:

1. Provide organized and effective food and dietetic services (cross-reference A-619).

2. Ensure the Food and Dietetic Service Director developed and monitored written procedures according to standards of practice for operational processes at the hospital (cross-reference A-620).

3. Ensure the nutritional needs of patients were met in accordance with recognized dietary practices. The menus were not analyzed to ensure they met the Recommended Daily Dietary (RDA) allowance, or the Dietary Reference Intake (DRI) adopted by the Food and Nutrition Board of the National Research Council of the National Academy of Sciences, and appropriate nutrition interventions were not initiated to maintain the nutritional status of patients (cross-reference A-630).

4. Ensure the therapeutic puree diets and tube feedings prescribed by the practitioners responsible for the care patients provided the prescribed diet/tube feeding and planned protein portions (cross-reference A-629).

5. Ensure an effective Infection Prevention program for identifying unsafe food handling practices that involved cool down of potentially hazardous food (cross-reference A-749).

6. Ensure the safety of the patients during a disaster with a comprehensive and effective disaster food plan (cross-reference A-701).

The cumulative effect of these systemic problems resulted in the inability for the hospital's food and nutrition service to direct and staff in such a manner to ensure that the nutritional need of the patients were met in accordance with practitioners orders and acceptable standards of practice.

Based on food storage, production and servie observations, and dietary document review, the hospital failed to ensure an effective, organized food and dietetic services department. The lack of organization and oversight of the dietary department resulted in deficient practices in multiple areas related to safe food practice, service, sanitation, and storage.

Findings:

During several interviews witht he director of nutrition and food service (DNFS) from 9/24/12 to 9/27/12, there were observations that reflected lack of oversight of food service iperations. During the interviews conducted with the DNFS, she indicated that while she bore the ultimate responsibility for the food service operation, she managed the day-to-day food service operation through the food service manager. She stated she was also responsible for the management of the Clinical Dietitian staff which required approximately 30 percent, or more, of her time.

Review of the food service manager's credentials showed he was a Certified Dietary Manager, was qualified and was responsible for the large patient food service for the hospital with a 527 bed license, cafeteria food service, and a small cafe food service.

As a result of the DNFS' responsibilities for both food service and clinical nutrition management of the clinical dietitian, she was not fully aware of the issues that affected the safe food handling practices of the food service operation.

As a result of this management organizational structure, the DNFS was not fully aware of the issues affecting safe food handling practices. For example, although there was a cool down procedure (safe practice to ensure minimal growth or pathogenic microorganism in food prepared ahead of service or to be reserved after heating), there was no consistent monitoring of the process t ensure food was prepared and maintained in a safe manner. Food storage practices revealed deficient practices such as expired produce maintained for service to patients, and lack of knowledge of product expiration and following manufacturers' directions for preishable products (cross-reference A-0749).

Based on food storage, food production and service observations, staff interview, and document review, the hospital failed to ensure the Director of Nutrition and Food Service (DNFS) developed and monitored written procedures according to standards of practice for operational processes at the hospital. Failure to develop and monitor standardized procedures may result in patients being exposed to foodborne illness and cross-contamination which may further compromise medical status.

The hospital failed to ensure a comprehensive and detailed hospital food disaster plan. Failure to ensure adequate planning for disaster food for patients, staff, and visitors may result in lack of availability of adequate food supply in the event of a disaster, compromising the medical status of patients.

Findings:

During several interviews with the Director of Nutrition and Food Services (DNFS), from 9/24/12 to 9/27/12, observations were made that reflected lack of oversight of food service operations. During the interviews conducted with the DNFS, she indicated that while she bore the ultimate responsibility of foodservice operations, she managed the day-to-day foodservice operations through the use of a food service manager (FSM). She stated she was also responsible for the management of the Clinical Dietitian staff. During the kitchen tour on 9/24/12 starting at 9:30 a.m., the DFNS was unable to state the practice of food service staff on the cooling of hot food to be held, or maintaining the kitchen ice machine sanitary for holding food. She referred all findings to the FSM who was not at the hospital that day.

As a result of this management organizational structure, the DNFS was not fully aware of the issues affecting safe food handling practices. For example, although there was a cool down procedure (safe practice to ensure minimal growth of pathogenic microorganism in food prepared ahead of service or to be reserved after heating) there was no consistent monitoring of the process to ensure food was prepared and maintained in a safe manner. Food storage practices revealed deficient practices such as expired produces maintained for service to patients and lack of knowledge of product expiration, and following manufacturers' directions for perishable products (cross-reference A-0749).

1. During random review of selected departmental policies and procedures related to identified deficient practices in dietetic services, it was noted policies did not consistently provide sufficient procedural guidance that reflected current standards of practice, or the department had not developed procedural guidance for all functions.

a. The dietary department handwashing policy dated 7/12 included a step to turn off the water using back of hands, elbow or paper towel. Review of the policy with infection control practitioner on 9/26/12 at 2:00 p.m., she stated she had not reviewed the policies from the Dietary Department and the policy did not reflect safe practice when the staff turned off the water with back of hand or elbow thus decontaminating clean areas.

b. Policy for Hazard Analysis and Critical Control Point Cooling Temperatures stated all foods returned to the kitchen from the cafeteria for reserving would be cooled. One step included was to lower [temperature] from 140 degrees Fahrenheit (F) to 40 degrees F in less than 4 hours. Review of FDA Food Code 2009 does not include this cooling step for foods cooled from 135 degrees F.

c. Documentation reviewed 9/24/12 did not reflect safe cooling, and staff did not follow written policies and procedures.

d. On 9/26/12 at 9:25 a.m., the Cafe had a frozen yogurt machine and the FSM stated there was no policy developed to ensure the machine was cleaned and sanitized. He stated that he did not know how the Cafe staff cleaned and sanitized the frozen yogurt machine. This equipment is high risk for pathogenic microbial growth if not maintained sanitary.

e. During the Cafeteria observation on 9/24/12 at 11:00 a.m., a chlorine bleach solution for equipment and counter sanitation was used. The DS stated the kitchen used a quaternary ammonia solution and the Cafeteria used the bleach. The FSM was not able to provide a policy defining the concentration of the bleach solution or the quaternary sanitizing solutions.

f. During an interview with food service worker 4 (FSW 4) on 9/24/12 at 10:15 a.m., he stated if the automatic dishwasher did not reach the proper temperature to effectively sanitize the dishes, he added a cup of bleach to the rinse tank. A review of the hospital's policy titled, "Dishwashing Procedure" dated 7/12 confirmed this procedure. During an interview with the FSM on 9/27/12 at 10:00 a.m., he was unable to state the source for this procedure that would ensure it was an effective means of sanitizing dishes. He further stated that adding the bleach was not their current policy. He was unable to produce the current policy that provided staff guidance regarding emergency dishwashing procedures when the dish machine did not work.

g. Review of the Cafe on 9/26/12 at 9:25 a.m., had a two compartment ware washing sink. The FSM stated that he did not know how the staff he supervised washed, rinsed and sanitized in this sink to ensure the multiuse utensils were clean and sanitized. He stated on 9/27/12 at 10:00 a.m. that there was no policy directing staff as to the correct washing procedures, and was just writing a policy.

h. On 9/25/12 at 11:30 a.m., Cook 2 was observed calibrating a food thermometer using ice water with inadequate ice. He was unaware that more ice was required to effectively calibrate the thermometer. The hospital's policy stated the thermometer was to be placed in a cup of ice water and did not specify that crushed ice should be used and enough ice should be used to create a slushy mixture. According to the Santa Clara County Department of Environmental Health, 4/08, using the Ice Point Method requires crushed ice using enough ice to create a slushy mixture.

2. Review of the dietary department quality improvement program on 9/27/12 with FSM at 11:00 a.m., showed there was one quality measure in the food service operation for label and dating. Review of the last year's Storage and Labeling Report showed the department was at 98 to 100 percent for the last 6 months (February to July 2012). The storage and labeling inspection was to inspect at least 5 items for expiration, opened and dated, stored on appropriate shelf, and other issues identified.

Deficient practice was found in label and dating and identifying the products stored in the department when on tour with the DNFS 9/24/12. The FSM acknowledged this quality program was not accurately measuring the indicator.

3. On 9/24/2012 starting at 9:30 a.m., the following were observations with concurrent staff interviews:

a. Egg salad and tuna salad were in the walk in refrigerator. FSW 1 stated she made the egg and tuna salads and placed there in the refrigerator for use later. DNFS stated there was no policy to monitor the temperature from 70 degrees F to 41 degrees F. She was unaware of the standard of practice to monitor food in the danger zone when made at room temperature as defined in the FDA (Food and Drug Administration) Food Code 2009.

b. The walk in refrigerator stocked thawing fruit juice from frozen. DSK stated the cases of juice were put in to thaw each day. He stated the cases were not dated. The manufacturer document titled "shelf life matrix" stated the food service juice and drinks could be used thawed in 14 days. The DNFS confirmed there was no system to ensure the fruit juice was used within the 14 days.

c. Observed to be expired between 9/10/12 to 9/14/12 were 6 loaves of 100 percent wheat bread, 8 packages of sourdough rolls, 6 loaves of raisin bread, 6 loaves of white bread, 5 loaves of multigrain bread, 3 packages of English muffins, 7 packages of hamburger buns, and 2 loaves of rye bread. Cook 1 stated the bread man was responsible to replace the expired products and he had just delivered the new bread. The DNFS acknowledged there was a system problem with maintaining the fresh bread stock.

The following items were identified as outdated: one container open prunes dated 9/20, cottage cheese opened 9/20, sour cream expired 9/9/12, an open package of parmesan cheese opened 9/14 and unidentified white product dated 9/12. DNFS acknowledged the products that are opened are kept for three days and discarded.

The following items did not have identification of the product or date when opened: one package shredded carrots, two large containers cut melon, two egg salad sandwiches, an individual potion of prunes, an individual portion of hard boiled eggs, individual portions of sliced cheese, a container of dry milk powder, a container of orange drink mix and 2 pans of unidentified produce with no date. DNFS acknowledged the products should be dated when opened and content identified.

d. One cafeteria electric can opener blades were black with crusted food debris. The DS could not state when the can opener blades had been cleaned.

e. One fan in the cafeteria directed air onto a food preparation counter and was noted to be covered with dust. The DS verified the dust and could not state when the fan had been cleaned.

4. Refrigerator #3 contained three 5 gallon containers of peeled potatoes and several containers of cut melon product. The storeroom clerk (DSK) was asked when the products expire. There was no expiration date visible on the product container. DSK stated 9/24/12 at 9:30 a.m. that he had not talked to the manufacturer and he just used the products. There was no product information provided before the survey exit on 9/27/12. The DNFS stated the product should provide an expiration date for the fresh prepared potatoes and cut melon.

5. On 9/25/12 at 2:30 p.m., the dry storage holding room contained 11 cases of canned puree meats with received dates ranging from 6/1/09 to 8/22/11. One case was found in the cook's area dated 2/21/11. There were no expiration dates. Many other canned products did not contain an expiration date or a received date. During an interview with the FSM on 9/25/12 at 2:30 p.m. he stated the policy was to discard canned products one year after received, and the DSK monitored those dates. He verified that many of the canned products did not have a received or expiration date. He was unable to state how the staff monitored the shelf life of the canned foods. During a concurrent interview with DSK, he stated, "I honestly don't know what date it is." He stated he did not know if the pureed meat was expired or not.

6. On 9/24/12 at 10:45 a.m., the dry storage room contained six 20 pound boxes of dried beans that were left open, and uncovered. RD 2 stated the beans should be covered to avoid contamination by pests.

7. On 9/24/12 at 11:00 a.m., the cafeteria walk-in refrigerator contained 3 cases of portioned cookie dough labeled, "Store frozen, do not refrigerate". During an interview with the DS on 9/24/12 at 11:00 a.m., she stated the cookies should be stored in the freezer. She was unable to explain why they were stored in the refrigerator.

8. On 9/24/12 starting at 9:30 a.m., the rack holding approximately 15 to 20 clean cutting boards had a buildup of dried food debris and grime on the tracks and the front face grill. The DNFS could not state when this equipment was cleaned or a schedule for cleaning.

9. On 9/27/12 at 9:25 a.m., there was one wet blue cloth on the Cafe handwashing sink counter. FSW 2 identified the rag as just used for washing the cafe tables and FSW 2 was putting it away in the bucket of sanitizer but had put it down on the sink. The FSM stated this was not the place to put contaminated rags, and they should be stored in the sanitizer bucket.

10. On 9/25/12 at 10:15 a.m., the hospital's disaster food plan (dated 2/2011) was reviewed with the DNFS and the FSM. The plan adequate food and water was maintained on-site to supply patients, staff and potential visitors, estimated for a period of seven days. The attached disaster plan menus for days 1 - 2 required the use of perishable foods such as sandwich meats, fresh fruit, yogurt and milk. During a concurrent interview, the DNFS and the FSM stated that the kitchen refrigerators were connected to back-up power in the event of a loss of electricity. During a follow-up interview with ES 1 on 9/25/12 at 1:20 p.m., he stated the kitchen refrigerators were not on back-up power and would not be functional during a power failure.

The menu for days 3 - 4 included cooked cereal, rice, potatoes, pasta and ground meat, but the plan did not include how these items would be cooked without utilities. There was no menu for days 5 -7.

Further review of the disaster plan menus for days 1 - 4, revealed most items did not have a portion size. There was no guidance to the staff on how much milk, cereal, sandwich meat or juice to serve each person during a disaster. During a concurrent interview with RD 2, she stated the hospital did not have a nutritional analysis of the menus to determine if the menus met the needs of the patients during a disaster.

The plan did not include an inventory list or guidance to staff to ensure that adequate supplies of food for the menus were on-site at all times. During an interview with the FSM on 9/25/12 at 10:30 a.m., he stated he did not have an inventory list that showed he had adequate food on-site to meet the needs of the disaster menu.

During a concurrent interview with the DNFS, she stated the disaster plan was to feed 524 people. She was unable to explain how the hospital would be able to feed patients, staff and potential visitors when they had 574 licensed beds. During an interview with the Emergency Management Coordinator on 9/25/12 at 1:45 p.m., she stated, with the current patient census, the average number of staff working in the hospital during the day was approximately 1200. She further stated, if in a disaster all the beds were full, more staff would be required to care for the increase. She was not aware the disaster food plan did not consider the staff.



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11. On 9/24/12 at 9:40 a.m., during observation of the transitional care unit, the patient refrigerator contained an opened milk container not dated when opened, and one orange juice container with an expiration date of 9/19/12.

12. On 9/24/12 at 11:10 a.m., during an observation of the "four surgical unit", the patient refrigerator contained two open orange juice containers not dated when opened, and multiple small fruit juice containers without expiration dates.

Based on staff interview and document review, the hospital failed to ensure the therapeutic puree diets prescribed by the practitioners responsible for the care patients provided the prescribed diet and planned protein portions. For one patient (Patient 5) the physician's order for a tube feeding was not followed. These failures had the potential for the patients' nutrition needs not being met.

Findings:

1. On 9/25/12 starting at 11:30 a.m., Cook 2 was serving preformed puree pork product. This product was prepared and bought from a commercial company. Three puree diets observed were each served one preformed, packaged, portion of puree pork.

Review of the menu showed the regular meal provided a 3 ounce portion of pork chop. This would provide 21 grams of protein. Review of the puree product manufacturer's information showed the observed portion served provided 14 grams of protein.

Interview with the FSM on 9/27/12 at 10:00 a.m. stated the puree meat should be the same protein content as the regular diets meat portion.

2. The medical record for Patient 5 was reviewed on 9/26/12. The physician's orders dated 9/18/12 included a sliding scale tube feeding (feeding directly into the stomach through a tube). The order included one can of tube feeding formula if the patient ate less than 75% of his meal, and two cans of formula if he ate less than 50% of his meal.

A review of the nursing notes for 9/22/12 indicated the patient ate 80% of both breakfast and lunch and he was given one can of tube feeding formula at each meal. On 9/24/12 he ate 50% of lunch and he was not given the formula. On 9/25 he ate 90% of breakfast and was given one can of formula.

During an interview with the nurse manager for Patient 5 on 9/26/12 at 9:50 a.m., she verified the tube feeding was not given according to the physician order. She was unable to explain why the order was not being followed.

Based on staff interview and document review, the hospital failed to ensure the nutritional needs of patients were met in accordance with recognized dietary practices, when:

1. The menus were not analyzed to ensure they met the Recommended Daily Dietary (RDA) allowance or the Dietary Reference Intake (DRI) adopted by the Food and Nutrition Board of the National Research Council of the National Academy of Sciences.

2. One patient (Patient 5) had estimated nutrition needs greater than his ordered diet and the registered dietitian (RD) failed to recommend interventions to ensure his needs were met.

3. Dietary Staff did not follow standardized recipes to ensure the nutrition needs of the patients were met.

Lack of nutrient analysis of patient menus, failure to follow recipes and inadequate nutrition interventions could potentially place patients at risk of not receiving required nutrients thereby compromising medical care.

Findings:

1. On 9/27/12, at 11:00 a.m., the DNFS provided the nutrition analysis they had just completed running of the data base they used.

Review of the nutriment analyses provides showed there was no analysis for all diets provided by the hospital, no analysis of all age and gender categories outlined in the RDA, no analysis of how the menus met the diet requirement as outlined in the diet manual, and the analysis did not contain all of the nutrients provided in the RDA.

The DNFS acknowledged during a concurrent interview, the nutrients included in the hospital's menu analysis were the only ones that printed and could not confirm if other nutrient analysis was available. She stated the diet had not been analyzed in reference to the RDA and DRI requirements.

2. The medical record for Patient 5 was reviewed on 9/26/12. A Medical Nutrition Therapy note by RD 3, dated 9/19/12, indicated the patient had a physician's order for a puree consistency diet which provided 1800 calories a day. It also indicated the patient's estimated nutrition needs were 2000 to 2500 calories, and 70 to 85 grams of protein a day. These needs were based on a body weight of 127 pounds and a BMI (body mass index) of 19 (low). The assessment indicated the patient had a low body weight and weight gain was the goal. The note did not contain any recommendations to remedy the discrepancy between the patient's estimated nutrition need and the nutritional value of the diet ordered.

During an interview with RD 3 on 9/26/12 at 9:30 a.m., she stated the patient's weight (127 pounds) was a reported weight from the transferring hospital and not an actual weight.

A follow-up note by RD 3 dated 9/25/12 indicated Patient 5's weight on 9/22/12 was 139 pounds, 12 pounds greater than on the previous assessment. The patient's calorie and protein needs were not re-evaluated based on the new weight. The patient was eating between 50 and 100% of his meals.

RD 3 stated that she had not interviewed the patient to determine if he had special food preferences or if he would drink a supplement that could help meet his increased nutrition needs. She was unable to explain why this had not happened even though the patient was admitted to the hospital 8 days prior.

During a concurrent interview with the nurse manager for Patient 5, she stated the patient's current weight was 136 pounds. He had lost 3 pounds in 4 days.

3. On 9/25/12 starting at 11:30 a.m., Cook 2 was preparing chicken quesadilla. He stated that he put in a handful of cheese and one slotted spoon of chicken.

Review of the production recipe for chicken quesadilla stated "place 2 ounces cheese on."

Based on staff interviews and record reviews, the hospital failed to maintain the environment in such a manner that the safety and well-being of the patients was assured when the disaster food plan for the hospital contained inconsistencies, did not meet the needs of the patients and the dietary services did not maintain adequate supplies to meet the needs of the patients in the event of a disaster. This failure created the potential to result in malnutrition of the patients during a disaster.

Findings:

On 9/25/12 at 10:15 a.m., the hospital's disaster food plan (dated 2/2011) was reviewed with the DNFS and the FSM. The plan stated that adequate food and water was maintained on-site to supply patients, staff and potential visits, estimated for a period of seven days. The attached disaster plan menus for days 1 - 2 required the use of perishable foods such as sandwich meats fresh fruit, yogurt and milk. During a concurrent interview, the DNFS and the FSM stated that the kitchen refrigerators were connected to back-up power in the event of a loss of electricity. During a follow-up interview with ES 1 on 9/25/12 at 1:20 p.m., he stated the kitchen refrigerators were not on back-up power and would not be functional during a power failure.

The menu for days 3 - 4 included cooked cereal, rice, potatoes, pasta and ground meat but the plan does not include how these items would be cooked without utilities. There was no menu for days 5 -7.

Further review of the disaster plan menus for days 1 - 4, revealed that most items did not have a portion size. There was no guidance to the staff on how much milk, cereal, sandwich meat or juice to serve each person during a disaster. During a concurrent interview with RD 2, she stated the hospital did not have a nutritional analysis of the menus to determine if the menus met the needs of the patients during a disaster.

The plan did not include an inventory list or guidance to the staff to ensure that adequate supplies of food for the menus were on-site at all times. During an interview with the FSM on 9/25/12 at 10:30 a.m., he stated he did not have an inventory list that showed he had adequate food on-site to meet the needs of the disaster menu.

During a concurrent interview with the DNFS, she stated that the disaster plan was to feed 524 people. She was unable to explain how the hospital would be able to feed patients, staff and potential visitors when they had 574 licensed beds. During an interview with the Emergency Management Coordinator on 9/25/12 at 1:45 p.m., she stated that with the current patient census, the average number of staff working in the hospital during the day was approximately 1200. She further stated that, if in a disaster all the beds were full, more staff would be required to care for the increase. She was not aware that the disaster food plan did not consider the staff.

Based on observation, interview, and record review, the hospital failed to ensure: (1) preventive maintenance (PM) was performed according to the hospital policy and procedures to ensure an acceptable level of safety and quality for one of three IV (intravenous, directly into a vein) infusion pumps (a device used to deliver IV medications) observed, (2) the refrigeration monitoring system was fully implemented for the food service operation and the walk in refrigerator, and (3) freezer condenser grills were maintained clean.

Findings:

1. During a medication pass observation at the MSSU (Medical Short Stay Unit) on 9/26/12 at 9:15 a.m., a licensed nurse gave a medication via an IV pump for Patient 72. The sticker on the IV pump indicated it was last serviced in 1/12 and was due for PM in 7/12.

During an interview on 9/26/12 at 9:50 a.m. in the presence of the MSSU Manager and the pharmacy director, a Bio-medical staff (Staff 1) confirmed the IV pump used for Patient 72 had passed the PM date. He said IV infusion pumps were scheduled for PM every six months per hospital policy. He said because the pumps "moved" from place to place within the hospital, the bio-medical department had difficulty tracking all the IV infusion pumps to ensure they had PM done timely.



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2. On 9/27/12 records for the Temptrak system were reviewed with the Director of Support Services, Food Service Manager (FSM) and Maintenance coordinator at 10:00 a.m. The Temptrak system was used to monitor refrigerator and freezer temperatures and alert staff if the temperatures were out of safe temperature range. On 9/15/12 at 4:14 p.m.. the Temptrak document showed the kitchen sandwich refrigerator was above 56 degrees Fahrenheit (F). The kitchen review of the elevated temperature was documented on 9/16/12 at 5:34 a.m., and indicated, "ok now." Review of the graph provided by the maintenance coordinator showed the temperature was above the allowable level of 41 degrees F from 4:14 p.m. to 6:45 p.m.

The Maintenance Coordinator explained the system for the pharmacy and clinic refrigerators is on a call system to alert staff of refrigerator temperatures that exceed the range set at 41 degrees F. He explained the alert system was not implemented in the Dietary Department. The Engineering Coordinator stated that the system for the kitchen would ring the engineer (ES2) on his desk phone. He confirmed the system would not alert the Director of the Department or the Manager if temperatures were out of range and the food storage could be compromised.

The FSM stated the cooks monitored the temperatures two times per day at 5:30 a.m., and 7:00 p.m., but did not have access to the graph to show how long the refrigerator was out of range. He stated there was no comprehensive policy for the food service staff to evaluate the safety of the refrigerators and freezers on an ongoing or retrospective view of the temperatures from this system .

3. On 9/24/12 starting at 9:30 a.m., there were 8 refrigerator condenser grill fronts observed that had heavy buildup of dust and grime covering the whole grill face.

The DNFS stated these grills were cleaned by the engineering department.

On 9/27/12 at 11:00 a.m. ES 2 confirmed that the dietary department staff was to clean the grills on the condensers.

Based on observation, staff interviews and document review, the hospital's Infection Prevention coordinator failed to develop an effective system for:

1. Identifying unsafe food handling practices that involved cool down of potentially hazardous food.

2. Identifying that the preventative maintenance for all hospital ice machines were cleaned and sanitized in accordance with the manufacturer's directions and time frames. Failure to sanitize ice machines in a timely manner places patient at risk of infection.

3. Identifying that raw fish in sushi was not served in a hospital with a highly susceptible population, who were at greater risk from food borne illness from raw fish.

4. Identifying safe practices for washing utensils when utensils in the cafeteria were washed in the designated handwashing sink. Washing utensils in a designated handwashing sink puts patient at risk of cross-contamination and food borne illness.

5. Identifying safe practices for the cleaning and sanitizing of the frozen yogurt machine in the Cafe. Equipment not maintained in a sanitary manner put patients at risk of food borne illness.

6. Identifying safe practices and policies for staff handwashing in the Dietary Department.

7. Identifying safe practices and policies for proper sanitation of dishes in the dish machine, and when the dish machine temperatures are too low to effectively sanitize dishes.

8. Identifying safe practices for food service staff hair restraints in the dietary services department

9. Identify monitoring procedures and compliance of cold food at the tray line and cafeteria salad bar.

10. Identifying safe practices and policies for patient food brought from outside the hospital and stored in the nursing station pantries.

Findings:

1. On 9/24/12 starting at 9:30 a.m., accompanied by the Director of Nutrition and Food Service (DNFS) the following were observed:

a. One pan of roast beef dated 9/23 was observed in the walk in refrigerator. Review of the Roast Beef Temperature Chart stated Cook II will take the temperatures of the Roast Beef after it rests for 30 minutes and again in 2 hours after placement in freezer, and record and take temperature in 4 hours.

There were no documented temperatures of a roast beef on 9/23/12. The DNFS could not state why cooling temperatures of the roast beef identified in the refrigerator were not documented on the Temperature Chart.

b. Two pans of beef stew dated 9/26 were identified in the walk in refrigerator. Review of the Leftovers Temperature Log Dated Sept. 17, 2012, showed the beef stew temperature was taken on 9/24 at 5:30 a.m. Cook 1 stated the food leftovers from the dinner patient serving line were placed in the walk in refrigerator and the temperatures were taken the following morning.

Review of the policy dated 7/20/12 for Cooling temperature indicated "All food items returned to the kitchen from the cafeteria will be evaluated by Cook II... Food items will be transferred into shallow pans to chill and dated and labeled. Lower from 140 degrees F to 70 degrees F in less than two hours; lower from 70 degrees to 40 degrees in less than four hours."

This policy directs staff to cool food through the danger zone where pathogenic microorganisms will grow to ensure the food is safe to reheat and serve. The policy does not direct the kitchen staff to cool the leftovers from the patient serving line.

On 9/27/12 at 11:00 a.m., the FSN stated food placed in the refrigerator after the dinner. The serving line ends around 6:00 p.m. He stated the dietary staff goes home by 7:00 p.m., and did not know how the procedure to monitor the cooking temperatures would be accomplished. He stated the staff went home, the temperatures were taken the following morning. This practice allowed the potential growth of pathogenic microorganisms for over 11 hours.
2. On 9/24/12 at 9:30 a.m., accompanied by the DNFS, the bin ice machine in the kitchen was observed. There was significant white scale covering the front interior deflector panel. The DFNS stated concurrently that this ice was "non-potable" (not clean for consumption). She stated this ice was used to bank the food in the cafeteria food bar, and for placing around milk being held on the patient service line each meal. She did not know if, or when, the ice machine operating equipment or the bin had been cleaned.

Review of ice machine cleaning/sanitizing was started on 9/25/12 at 1:20 p.m. with ES 1 who stated the ice machines were cleaned/sanitized on an annual basis.

Review of the Ice Machine PM (preventive maintenance) form showed the kitchen ice machine was last cleaned 2/7/11. Review of the approximately 36 ice machines on the form showed that 22 ice machines had dates of last cleaning from 3/22/11 to 10/1/11. There were approximately 9 other ice machines with cleaning cycles of 12 months. There was one ice machine identified as X-ray room 1m015 that did not have any dates cleaned.

Review of the Ice machine manuals for the two main brands of ice machines listed the manufacturers' cleaning schedule was every 6 months. ES2 who stated he was the staff who cleaned the ice machines and that he was on a semiannual cleaning schedule but could not provide any information that validated the approximately 36 ice machines were cleaned and sanitized every 6 months.

Review of the summary for PM Procedures report dated 9/30/11, indicated "...clean and service ice machines, test switches, and inspect for mold semiannually."

There was no PM or policy with procedures specific to the cleaning and sanitizing per the manufacturer's manual to ensure the refrigeration mechanics followed the procedures as outlined.

3. On 9/24/12 starting at 11:00 a.m., there were contained sushi products for sale, including spicy tuna roll and salmon roll. The staff could not state if the ingredients were raw fish. On 9/27/12 at 10:00 a.m., the FSM provided product information for the sushi, but this did not identify if the tuna or salmon were raw.

The FDA Food Code 2009 specifies that highly susceptible population (means persons who are more likely than other people in the general population to experience foodborne disease because they are: immunocompromised; preschool age children, or older adults; and obtaining food at a facility that provides services such as custodial care, health care, or assisted living, such as a child or adult day care center, kidney dialysis center, hospital or nursing home, or nutritional or socialization services such as a senior center) are not served products such as raw fish, or raw sprouts.

The FSM stated he did not purchase a sashimi (plain raw fish) product, but did not know if the products he bought contained raw fish.

4. Review of the Cafe on 9/26/12 at 9:25 a.m., had a two compartment ware washing sink. The FSM stated that he did not know how the staff he supervised washed, rinsed and sanitized in this sink to ensure the multiuse utensils were clean and sanitized. He stated on 9/27/12 at 10:00 a.m. that there was not policy directing staff as to the correct washing procedures and was just writing a policy.

5. On 9/26/12 at 9:25 a.m., the Cafe had a frozen yogurt machine and the FSM stated there was no policy developed to ensure the machine was cleaned and sanitized. He stated he did not know how the Cafe staff cleaned and sanitized the frozen yogurt machine. This equipment is high risk for pathogenic microbial growth is not maintained sanitary.

6. On 9/24/12 at 10:00 a.m., FSW 4 was observed loading dirty dishes in the dish machine, then unloading clean dishes without washing his hands.

On 9/25/12 at 11:30 a.m., Cook 3 was observed on trayline (patient meal tray assembly). Cook 3 was observed washing his hands after touching contaminated equipment. After washing his hands, he was noted to turn off the water with his forearms.

The dietary department handwashing policy reviewed 7/12 included a step to turn off the water using back of hands, elbow or paper towel. Review of the policy was conducted with the infection control practitioner (ICP) on 7/26/12 at 2:00 p.m. ICP stated she had not reviewed the policies from the Dietary Department and stated the policy did not reflect safe practice when the staff turned off the water with back of hand or elbow thus recontaminating clean areas.

7. During an interview with FSW 4 in the dish room on 9/24/12 at 10:00 a.m., he stated the final rinse temperature for the dish machine needed to be 170 to 180 degrees Fahrenheit (F) to ensure the dishes were sanitized.

A review of the Dishroom Temperature Log dated September 2012 showed that the staff was directed to record the final rinse temperatures of the dish machine at breakfast, lunch and dinner daily. It further directed the staff that the final rinse temperature should be 180 degrees F and to notify the supervisor of low temperatures immediately. Three dinner temperatures were missing. In 9 of the 67 entries for the final rinse temperature, temperatures were less than 180. The low temperatures ranged from 160 to 177. There was no indication on the form that any action was taken based on these low temperatures.

During further interview with FSW 4, he stated if the final rinse temperature was less than 170 degrees, he added one cup of bleach to the rinse tank to sanitize the dishes.

A review of the hospital's policy, "Dishwashing Procedure" dated 7/12 confirmed this procedure.

During an interview with the FSM on 9/27/12 at 10:00 a.m., he was unable to state the source for this procedure that would ensure it was an effective means of sanitizing dishes. He further stated adding the bleach was not their current policy. He was unable to produce the current policy that provided staff guidance regarding emergency dishwashing procedures when the dish machine did not work.

8. During an observation in the dish room on 9/24/12 at 10:00 a.m., FSW 4 was observed with a hairnet only covering about 50 percent of his hair. Again, during trayline observation on 9/25/12 at 11:15 a.m., FSW 4 was observed with a hairnet partially covering his hair. The observations were concurrently verified by the DNFS. She stated his hairnet should cover all his hair to prevent it from contaminating the food.

A review of the hospital's policy, "Uniforms" dated 7/12, revealed that food service personnel shall wear hairnets to confine hair in food production and service areas.

9. During an observation in the cafeteria on 9/24/12 at 11:20 a.m., the temperature of the potatoes registered 112 degrees F.

A review of the Cafeteria Temperature Log dated 9/24/12 revealed staff guidance for the temperature of the hot food to be greater than 145. It further guides the staff to take hot food temperatures at 11:00 a.m.

During a concurrent interview with FSW 6, he stated he had not taken the temperature of the food, even though the cafeteria had been open for 20 minutes and he had been serving the hot food.

A review of the hospital's policy, "Cafeteria/Coffee Shop - Temperatures of Food" dated 7/12 revealed temperatures of food held on the hot cart will be recorded twice per meal. It stated acceptable temperatures are entrees, starches and vegetable, 145 degrees F.

A review of the temperature logs for 8/20/12 through 9/24/12 showed 94 out of 210 required temperature recordings were blank.

Further review of the Cafeteria/Coffee Shop - Temperatures of Food policy indicated the temperature of the salad bar was to be recorded every two to four hours during operating hours. Also, temperatures greater than 41 degrees were to be reported to the supervisor.

During a concurrent interview with the DS she stated that they do not monitor the temperature of the salad bar to ensure cold food is held at 41 degrees or below.

10. During trayline observation at 12:00 p.m. the temperature of a tuna sandwich registered 52.5 degrees F. The sandwich was stored unrefrigerated on a cart.

During a concurrent interview with DNFS, she stated the staff does not monitor the temperature of the cold food during trayline or when it is removed from the refrigerator at the beginning of trayline. She was unable to state how they could ensure the tuna sandwich was not in the food danger zone (41 - 135 degrees F) when temperatures were not monitored.

According to the 2009 Food Code, potentially hazardous food (time/temperature control for safety food) shall be maintained at 135 degrees F or above or 41 degrees F or less.

11. During an observation of the Rehab 2 nursing station pantry on 9/25/12 at 9:10 a.m., the refrigerator and freezer were noted to contain numerous foods brought in from outside for the patients. Many items were labeled with only a patient name and no date. Some items were not labeled. One open ziplock bag contained a partially eaten popsicle. Also noted were nourishments prepared by the dietary services department with expiration dates including five sandwiches expired 9/25, and two sandwiches with fruit expired 9/22.

During a concurrent interview with the Rehab Nurse Manager, she stated all food brought in from outside should be labeled with a patient name, room number and a date. She did not know how long the food could be stored in the refrigerator.

A review of the hospital's policy, "Food from Home" dated 7/12 indicated food from home MUST be covered, labeled, dated and stored in the refrigerator. It further stated leftovers will be discarded after one day.

A review of the hospital's policy titled, "Nursing Division Nourishment Rotation/Sanitation" dated 7/12 revealed nursing was responsible for discarding old stock on the expiration date.

Foods served that have not been properly stored have the potential to cause food borne illness.

12. On 9/26/12 at 2:00 p.m., the Infection Control Preventionist (IPM) stated she was responsible for the hospital wide infection program. She stated she participated in an annual environmental rounds dated December 2011 which included the dietary department. The review included items such as handwashing procedures were followed, hairnets were worn and hair was generally covered, food was held at proper temperature, no out of date products were used, refrigerated items were stored covered, with label and date, cleaning schedule was followed, handwashing facilities were used for no other purpose. This report identified issues with clean kitchen and equipment, label and dating, and following cleaning schedule.

The IPM stated during the above interview she does not review dietary policies unless the DNFS sends them to her. She acknowledged the annual review was not frequent enough and did not include food safe handling procedures like the cooling of food, or staff practices with glove use. She stated she did not review the county inspection reports and have input into the corrections. She acknowledged she had limited knowledge of the kitchen specific infection control areas, such as the requirement of cooling food time frames and staff application and practices.

She was not aware that the cafeteria sold product that contained raw fish.

Based on medical record review and document review, in 5 out of 17 patient records surveyed, the hospital failed to ensure that an appropriate medical history and physical examination (H&P) was completed within 30 days prior to surgery.

Findings:

On 9/25/12 and 9/26/12, review of 17 preoperative patient records demonstrated that the record of Patient 30 contained a preoperative H&P performed 50 days prior to the date of surgery. The record of Patient 31 contained a comprehensive preoperative H&P performed 52 days prior to the date of surgery, but the repeat H&P 4 days prior to surgery was absent documentation of a physical examination except for examination of the lungs and the extremities. The record of Patient 33 was absent documentation of social history and contained an incomplete review of systems and an incomplete physical examination. The record of Patient 44 contained a preoperative H&P performed 57 days prior to the date of surgery. The record of Patient 45 contained a preoperative H&P performed 69 days prior to the date of surgery.

Review of the medical staff rules and regulations on 9/26/12 demonstrated that the preoperative H&P should include date of admission, chief complaint, admitting diagnosis, present illness, past history, allergies, current medications, current conditions, family history, social history, review of systems, physical examination (include pelvic, breast and rectal exams or reason why deferred and for diabetic patients include fundoscopic eye exam and peripheral pulses), treatment plan, impression, and a statement regarding the risks, benefits, options, and potential complications of the procedure. Review of the medical staff bylaws on 9/26/12 demonstrated that the requirement for preoperative H&P may be satisfied by a complete H&P that has been performed within 30 days prior to admission and updated within 24 hours prior to surgery.