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3865 JACKSON STREET

RIVERSIDE, CA 92503

MEDICAL STAFF - APPOINTMENTS

Tag No.: A0046

Based on interview and record review, the facility failed to ensure that only the Governing Body had authority to grant temporary privileges to the Medical Staff to provide care in the facility.

Findings:

A review of the Medical Staff Bylaws dated December, 2010, was conducted on May 14, 2012, at 10:45 a.m. The bylaws specified, "Upon receipt of a completed medical staff application for and supporting documentation from a physician, dentists, or podiatrist, authorized to practice in California, the chief executive officer or his or her designee, on the recommendation of either the applicable clinical department chairperson or the chief of staff, may grant temporary privileges to a member who appears to have qualifications, ability and judgment consistent with section 2.2-1."

An interview with the Director of Medical Staff Services was conducted on May 14, 2012, at 11:30 a.m. She acknowledged that the Medical Staff Bylaws specified that the Chief Executive Officer (CEO) had authority to grant temporary privileges to Medical Staff when a patient required care by a specialist that was not a member of the Medical Staff.

An interview with members of the Governing Body was conducted on May 17, 2012, at 11:30 a.m. The Governing Body acknowledged that the Medical Staff Bylaws allowed the CEO to grant temporary privileges for a provider after the department head had reviewed and confirmed the credentials of the provider. The Governing Body members further stated that the CEO was not a voting member of the Governing Body.

PATIENT RIGHTS: GRIEVANCES

Tag No.: A0118

Based on interview and record review, the facility failed to establish a prompt resolution of the patients' grievances according to facility policy for two of three reviewed grievances. This failure had the potential to result in missed opportunities to identify, investigate, and resolve patient care issues in a timely manner and identify opportunities for improvement within the hospital's operation.

Findings:

On May 16, 2012, at 10:20 a.m., the Risk Manager/Patient Relations Manager (RM) was interviewed. Three randomly picked grievances were reviewed with the RM. The RM stated the facility processed their grievances and completed the investigation within 30 days. If the investigation would require more than 30 days, the facility will notify the complainant. Once a grievance had been investigated, the facility would send a letter to the complainant confirming completion of the investigation.

1. The facility's grievance log was reviewed with the RM. In review of the log, it indicated Sample Complaint (SC) 2 was received by the facility by fax from an insurance company on April 23, 2012. During a concurrent interview with the RM, she stated the patient (Patient A) had also called the facility to verify whether the complaints, forwarded by the insurance company, had already been received by the facility. The RM stated the facility had already sent the insurance company and the patient a letter confirming completion of the investigation on April 30, 2012, and that no other letter will be sent out.

The letter addressed to Patient A, dated April 30, 2012, was reviewed with the RM. The RM stated the patient's grievance had been forwarded to the Quality Department for review and that the letter indicated that the grievance process had already been completed.

On May 16, 2012, at 11:35 a.m., the Quality Analyst (QLA) 2 and Assistant Director of Quality Services (ADQS) were interviewed. Both QLA 2 and ADQS stated Patient A's grievance was not received and was not processed for review. The ADQS stated the facility did not have a current tracking system that ensured investigation was completed when grievances were received from risk management/patient relations.

2. The facility's grievance log was reviewed with the RM. In review of the log, it indicated Sample Complaint (SC) 3 was received in person, which was forwarded by the case manager to risk management by email on April 24, 2012. The RM stated the facility had already completed the investigation and had sent the complainant a letter confirming completion of the investigation on May 14, 2012, and that no other letter will be sent out.

On May 16, 2012, at 11:35 a.m., the QLA 2 and ADQS were interviewed. The QLA 2 stated Patient B's grievance needed to be reviewed by another physician. The ADQS stated the grievance had already been reviewed by a physician (Physician 3) and determined the grievance needed to be forwarded for "second determination." The QLA 2 and ADQS stated a letter of request needed to be signed by the Medical Chief of Staff requesting the physician included in the complaint (Physician 4) to respond. The ADQS stated Physician 4 would have 14 days to respond to the request, and then further actions will be determined.

The facility policy titled, "Patient Complaints, Grievances, and Problems" dated January 2012, was reviewed. The policy indicated, "...All grievances will be responded to in writing. A letter, signed by Administration or designee, shall be given to the complainant within seven (7) business days following the investigation. Should the investigation require more time the response should address that the hospital is still working to resolve the complaint and that there will be follow up with another written response once the grievance is resolved. At no time shall resolution take longer than thirty (30) days."

PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS

Tag No.: A0147

Based on observation, interview, and record review, the facility failed to ensure all patient information was kept confidential, which resulted in the potential for unauthorized access of the patients' protected health information (Patient 16).

Findings:

On May 14, 2012, at 10:05 a.m., a tour of the second floor was conducted with the Director of Medical/Surgical (DMS). A paper document was observed in a common hallway, resting on the handrail, outside of Room 210.

A review of the document revealed that it was a "Diabetic Flow Sheet," belonging to Patient 16. Information contained on the document included name, date of birth, medical record number, results of blood glucose levels, medication, and dosage given.

In a concurrent interview with the DMS, she stated the flow sheet was part of Patient 16's medical record and should not have been taken out of the patient's chart and left in the hallway.

NURSING SERVICES

Tag No.: A0385

Based on observation, interview, and record review, the facility failed to ensure it provided an organized nursing service to all patients by failing to:

1. Ensure drugs were ordered, prepared, and administered in accordance with standards of practice, state laws and regulations, and facility policy. Intravenous (IV) vasoactive medication (used to increase the blood pressure) orders did not include the dose and specific instructions, including the maximum infusion rate parameter. Ambiguous IV vasoactive medication orders from the prescribing physician, were not clarified. Registered Nurse (RN's) were practicing outside of their scope of practice, by determining the infusion rate of the vasoactive medications given to the patients, without clarifying the order from the physician. The medication (Depakene - used for seizures) ordered by the physician wasn't administered to Patient 22, which resulted in a missed dose/medication error. Medication orders were not clarified to indicate the right route of administration for Patient 23. These failures had the potential to result in medication error, which could subsequently lead to harm, disability, and death of patients. (Refer to A0405)

2. Ensure the recommendation of the Registered Dietician (RD) to weigh the patient was implemented by the nursing staff (Refer to A0392);

3. Ensure vital sign assessments were completed as ordered by the physician for Patient 11 (Refer to A0392);

4. Ensure Physician orders for an air mattress and a wound care consult were implemented in a timely manner (Refer to A0392);

5. Provide ongoing assessments and interventions that ensured the transcutaneous bilirubin (TcB - A way to find out how much bilirubin was in the blood. Bilirubin is released into the blood when red blood cells break down) assessments were not repeated in 6-8 hours when the values were in the "High or High Intermediate zone," and an assessment was not completed every 12 hours for Patient 9 (Refer to A0395);

6. Provide ongoing assessments and interventions that ensured the peripherally inserted central catheter (PICC) line was assessed every twelve hours according to facility policy and procedure for Patient 12 (Refer to A0395);

7. Ensure nursing personnel communicated the RD's recommendation to the physician or practitioner for Patient 24 (Refer to A0395);

8. Ensure a Licensed Vocational Nurse (LVN 2) met the requirements as outlined in the job description, and to ensure the 90-Day as well as the annual evaluations were completed on time (Refer to A0397); and

9. Ensure an Obstetrical Technician (OB Tech) met the minimum requirements according to the facility's job description (Refer to A0397).

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.

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on observation, interview and record review, the facility failed for three of 46 sampled patients (Patients 2, 11 and 16) to provide nursing care by failing to:

1. Ensure that the recommendation from the Registered Dietician (RD), to weigh Patient 2, was implemented by the nursing staff;

2. Ensure vital sign assessments were completed, as ordered by the physician, for Patient 11; and

3. Ensure Physician orders for an air mattress and a wound care consult were implemented in a timely manner for Patient 16.

These failures had the potential to delay the overall delivery of care and treatment.

Findings:

1. During a facility tour on May 14, 2012, at 10 a.m., Patient 2 was observed lying on his hospital bed. The patient appeared thin, his face was gaunt. During a concurrent interview, Patient 2 stated he had lost weight lately because he had been homeless.

A review of Patient 2's record was conducted on May 14, 2012. Patient 2 was admitted to the facility on April 30, 2012, with a diagnosis of a urinary tract infection. Patient 2 has a history of quadriplegia (paralysis from the neck down). The patient's height and weight were documented at the time of admission as 5'10," and 132 pounds.

A review of the initial nutrition risk screening dated May 1, 2012, indicated Patient 2's nutrition risk was assessed at a "High Risk" level.

A review of the RD Clinical-Interdisciplinary Notes, dated May 2, 2012, at 12:32 p.m., indicated the RD goal for Patient 2 was to prevent weight loss and for the nursing staff to "Please weight (Patient 2) weekly."

A weight of 193.26 pounds was documented in Patient 2's record on May 2, 2012, at 1:41 p.m. An interview was conducted with the Licensed Vocational Nurse (LVN 1), on May 14, 2012, at 11:50 a.m., who stated that the weight was not correct, as Patient 2 appeared to weigh less than that.

A review of the RD Clinical-Interdisciplinary Notes, dated May 7, 2012, at 10:59 a.m., indicated Patient 2's ideal body weight is 153.6 (adjusted for patient's quadriplegia). Intervention suggestions noted, "Please weigh pt (patient) today and document wt (weight) in EMPOWER (computer program)." The patient goal was indicated as, "Prevent weight loss."

A review of the RD Clinical-Interdisciplinary Notes, dated May 10, 2012, at 1:31 p.m., indicated intervention suggestions as, "Please weight pt."

Further record review failed to show that the RD's recommendations to weight Patient 2 were followed, nor was the weight of 193.26 pounds verified for accuracy.

An interview was conducted with LVN 1 on May 14, 2012, at noon. LVN 1 stated the staff does not weight a patient unless there was a physician's order, or if the patient was receiving intravenous nutrition. LVN 1 stated there was not a physician's order to weigh Patient 2 and the RD did not instruct him to weigh Patient 2, so the patient was not weighed.

An interview was conducted with the Charge Nurse of the C-wing on May 14, 2012, at 12:15 p.m., who stated the Registered Dietician would notify us if they wanted a weight done on a patient.

A review of the facility policy, "Nutrition Screening, Assessment, And Follow-up (Revision Date: June 2011)," indicated, "Nutritional care will be provided through multidisciplinary nutrition screening, assessment, and re-assessment process among medical clinical nutrition, nursing, other patient care staff, and patients and patient care-givers."

An interview was conducted with RD 1 on May 14, 2012, at 12:30 p.m. RD 1 stated patient weights were not being done on the nursing units when requested by the dieticians.




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3. On May 14 and 15, 2012, the record for Patient 16 was reviewed. Patient 16 was admitted to the facility on April 13, 2012. The initial Braden Scale (Skin risk assessment for pressure ulcers), dated April 13, 2012, revealed Patient 16 had a score of 13, placing her at moderate risk for developing pressure ulcers.

A physician's order for an "air mattress." was ordered for Patient 16 on April 13, 2012.

The Nurse's Progress Notes revealed that the air mattress was placed on April 17, 2012 (4 days after the physician order).

On May 15, 2012, at 9:30 a.m., the Director of Medical/Surgical (DMS) was interviewed. The DMS stated the unit secretary notified the SPD (Sterile Processing Department) when there was a physician's order for an air mattress and the mattress was usually delivered in less than 24 hours. The DMS did not know why Patient 16's mattress was not placed until four days after the physician's order.

A physician's order for a, "wound care consult," was ordered for Patient 16 on May 5, 2012. The RN Wound Consult was completed on May 12, 2012, (seven days after the physician's order).

On May 14, 2012, at 10:50 a.m., the Wound Nurse (RN 2) was interviewed. RN 2 stated a "RN Wound Consult" can be ordered either by the nurse or by the physician. RN 2 stated she usually tried to see the patient within 24 to 48 hours after she received an order for a wound care consult.

RN 2 checked in the computer system and stated that on April 13, 2012, a nurse had ordered a wound care consult for Patient 16. RN 2 stated she was not aware of that order, but would have expected nursing to follow up on it when it had not been done in a timely manner. RN 2 stated the physician also ordered a wound care consult on May 5, 2012. RN 2 was not able to see Patient 16 until May 12, 2012.





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2. On May 14, 2012, the record for Patient 11 was reviewed. Patient 11 was admitted to the facility on May 11, 2012, at 5:26 p.m., with diagnoses including newborn infant.

At the time of Patient 11's admission, the maternal Group B Streptococcus (GBS - type of severe bacterial infection that can be passed to a baby during delivery) status was "unknown."

The "Physician Orders - Newborn Admission" dated May 11, 2012, at 5:40 p.m., indicated "Routine Vital Signs and Pain assessment Q4°" was checked.

The "Nursery BP (Blood Pressure) Graph" revealed heart rate, respiratory rate, and temperature were documented on:
a. May 11, 2012, at 7 p.m.;
b. May 12, 2012, at 2:30 a.m. (7 1/2 hours after the previous vital sign assessment);
c. May 12, 2012, at 8:15 a.m. (5 3/4 hours after the previous vital sign assessment);
d. May 12, 2012, at 2:30 p.m. (6 1/4 hours after the previous vital sign assessment);
e. May 12, 2012, at 8:15 p.m.;
f. May 13, 2012, at 12:15 a.m.;
g. May 13, 2012, at 4:15 a.m.;
h. May 13, 2012, at 8 a.m.;
i. May 13, 2012, at 2 p.m. (6 hours after the previous vital sign assessment);
j. May 13, 2012, at 8 p.m. (6 hours after the previous vital sign assessment);
k. May 14, 2012, at 2:30 a.m. (6 1/2 hours after the previous vital sign assessment); and
l. May 14, 2012, at 8:30 a.m. (6 hours after the previous vital sign assessment).

During an interview with the Director Women's Services (DWS) on May 14, 2012, at 2:45 p.m., she stated she did not know why Patient 11's vital signs were not done every four hours as ordered by the physician.

The facility policy and procedure titled "Group B Strep" revised September 2010, revealed "... Risk Factors - Group B Strep unknown ... Observe infant and check vital signs every four (4) hours or more often if indicated for signs or symptoms of sepsis. ..."

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

3. On May 15, 2012, Patient 24's record was reviewed. The patient was seen in the Emergency Department (ED) for chief complaints of nausea, vomiting, and dizziness. The patient was admitted in the Intensive Care Unit (ICU) on April 30, 2012, at 11:45 p.m.

The "Nursing Adult Initial Assess/Admit...Nutritional Screening" dated April 30, 2012, at 11:45 p.m., indicated a score of "13." The record further indicated, "...Nutritional screening score > 12 = Dietician referral."

The "Clinical-Interdisciplinary Notes" dated May 2, 2012, at 10:54 a.m. (completed by a Registered Dietitian [RD 3]), was reviewed. The record indicated, "...Intervention Suggestions - Consider initiate TF (tube feeding) with Glucerna 1.2 @ 30ml/hr (milliliter per hour), advance to goal of 55 ml/hr as tolerated. If pt (patient) able to wean from vent, consider SLP (Speech and Language Pathology) eval(uation) and possible to initiate po (oral) diet..."

The "Clinical-Interdisciplinary Notes" dated May 3, 2012, at 1:02 p.m. (completed by RD 8), was reviewed. The record indicated, "Initiate Glucerna 1.2 @ 15 ml/hr and increase 10 ml q6h (every 6 hours) as tolerated to goal 45 ml/hr while on current rate of propofol. If tolerated at 30 ml/hr, taper off TPN and continue increasing TF as tolerated to goa(l). If pt with poor tolerance and high residuals please initiate Reglan..."

The "Physician Order Sheet" dated May 3, 2012, at 2:08 p.m., indicated RD 8 obtained telephone orders from the physician of her recommendations.

On May 15, 2012, at 1:40 p.m., Patient 24's record was reviewed with the Clinical Nutrition Manager (CNM). The CNM stated Patient 24 was assessed and identified that the patient required an RD evaluation within 24 hours (due May 1, 2012). The patient was not seen by the RD until May 2, 2012 (approximately 35 hours). On May 2, 2012, RD 3 made recommendations. The CNM was unable to find documented evidence that RD 3's recommendation was communicated to the physician. The CNM stated the RDs communicated all recommendations to the nursing staff for physician follow-up.

In a concurrent interview, the Critical Care Director (CCD) stated nursing staff should be communicating the recommendations to the physicians or practitioners for appropriate intervention, then document the communication or interventions in the patient's record.




28294

Based on interview and record review, the facility failed to provide ongoing assessments and interventions for three of 46 sampled patients (Patients 9, 12, and 24):

1. For Patient 9, the transcutaneous bilirubin (TcB - A way to find out how much bilirubin was in the blood. Bilirubin is released into the blood when red blood cells break down.) assessments were not repeated in 6-8 hours when the values were in the "High or High Intermediate zone," and an assessment was not completed every 12 hours;

2. For Patient 12, the peripherally inserted central catheter (PICC) line was not assessed every twelve hours according to facility policy and procedure; and

3. For Patient 24, the facility failed to ensure nursing personnel communicated the RD's recommendation to the physician or practitioner.

These failures had the potential to result in a delay in care, treatment, and recovery of the patients.

Findings:

1. On May 14, 2012, the record for Patient 9 was reviewed. Patient 9 was admitted to the facility on May 10, 2012, with diagnoses including newborn infant.

The "Newborn Jaundice Record" form indicated "Plot total bilirubin at age drawn. Repeat bilirubin in 6-8 hours if value in High or High Intermediate zone."

The "Newborn Jaundice Record" revealed Patient 9 was born at 1:36 p.m., on May 10, 2012.
The transcutaneous bilirubin (TcB) measurements were performed on:
a. May 11, 2012, at 6:30 a.m., at 17 hours of age, with a result of 7.9 mg/dL (graphed in the "High Risk Zone").
b. May 11, 2012, at 6 p.m., at 28 hours of age, with a result of 9.0 mg/dL (graphed in the "High Intermediate Risk Zone").
c. May 12, 2012, at 5:30 a.m., at 39 and one half hours of age, a serum bilirubin was drawn with a result of 10.3 mg/dL (graphed in the "High Intermediate Risk Zone").
d. May 12, 2012, at 6 p.m., at 52 and one half hours of age, with a result of 10.2 mg/dL (graphed in the "Low Intermediate Risk Zone").
e. May 13, 2012, at 6:05 a.m., at 64 hours of age, a serum bilirubin was drawn with a result of 15.6 mg/dL (graphed in the "High Risk Zone").
f. May 14, 2012, at 5:10 a.m., at 88 hours of age, a serum bilirubin was drawn with a result of 10.3 mg/dL(graphed in the "Low Risk Zone").

There was no assessment or graph for May 13, 2012, at 5 p.m. to 6 p.m.

Double phototherapy (used when it is necessary to reduce an elevated serum bilirubin level as rapidly as possible or when the bilirubin level is rising) was initiated, per physician's order, for Patient 9 on May 13, 2012, at 9:50 a.m.

There were no "repeat bilirubin in 6-8 hours" when the values were in the "High or High Intermediate zone" on May 11, 2012, at 6:30 a.m., and 6 p.m.; May 12, 2012, at 5:30 a.m.; and May 13, 2012, at 6:05 a.m.

On May 14, 2012, at 2:15 p.m., an interview was conducted with RN 21. She stated TcB measurements were done every 12 hours after the newborn was 12 hours of age until discharge, and an assessment should have been done for Patient 9 on May 13, 2012, between 5 p.m. and 6 p.m.

The facility policy and procedure titled "Hyperbilirubinemia Management" revised February 2012, revealed "... Transcutaneous bilimeter (TcB) reading to be done between 0500-0600 (5:00 to 6:00 AM) and 1700-1800 (5:00 to 6:00 PM) and follow physician's orders. ..."

2. On May 15, 2012, the record for Patient 12 was reviewed. Patient 12 was admitted to the facility Neonatal Intensive Care Unit (NICU) on March 23, 2012, with diagnoses including prematurity (birth of a baby before the developing organs were mature enough to allow normal survival).

The facility document "Central Line Insertion Practices Adherence Monitoring" dated March 28, 2012, revealed a peripherally inserted central catheter (PICC) line was placed at 5:15 p.m., in Patient 12's upper extremity.

The "Central Line/PICC Bundle Check List" for Patient 12 revealed shift assessments were not done on March 31, April 1, 2, and 3, 2012, for the 7 p.m. to 7 a.m. shift.

During an interview with the Manager NICU, on May 15, 2012, at 9:25 a.m., she reviewed the record and was unable to find documentation of a shift assessment for Patient 12's PICC line on March 31, April 1, 2, and 3, 2012, for the 7 p.m. to 7 a.m. shift. She stated the "Central Line/PICC Bundle Check List" was utilized by the facility to assess central lines and PICC lines every 12 hours. The Manager NICU stated the 7 p.m. shift assessments should have been completed because the PICC line was in place.

The facility policy and procedure titled "Standardized Procedures for Percutanous Central Venous Catheter Insertion for Neonates" revised August 2011, revealed "... Documentation ... the Central Line/PICC bundle checklist to include the following: ... Hand hygiene. ... Disinfecting of catheter hubs before access. Physicians evaluation of need for PICC line. Arm circumference measurement every shift. Replacement of IV tubing. ..."

The facility policy and procedure titled "Admission Assessment/Reassessment" reviewed May 2010, revealed "... A reassessment will be done in the NICU flow sheet based on need and condition of patient...."

NURSING CARE PLAN

Tag No.: A0396

Based on observation, interview and record review, the facility failed to ensure comprehensive care plans were developed and individualized based on the patient's assessment for six of 46 sampled patients (Patients 2, 3, 16, 11, 12, and 13).

1. For Patient 2, the facility failed to initiate an individualized care plan addressing Patient 2's nutritional risks or the RD's recommendation for weekly weights was not implemented;

2. For Patient 3, the facility failed to initiate an individualized care plan addressing Patient 3's nutritional needs as related to her TPN (intravenous nutrition) was not implemented;

3. For Patient 16 The Interdisciplinary Care Plan for "Skin Integrity" was not initiated until April 19, 2012, (six days after the admission assessment , and the "wound care consult" was not included in the specific interventions;

4. For Patient 11, a care plan was not developed for the possible risk of infection due to the infant's possible exposure to Group B Streptococcus (GBS - type of severe bacterial infection that can be passed to a baby during delivery) when the mother's GBS status was unknown;

5. For Patient 12, a care plan was not developed for the possible risk of infection due to the use of a peripherally inserted central catheter (PICC) line; and

6. For Patient 13, a care plan was not developed for unknown GBS status with preterm premature rupture of membranes (PPROM - breaking of the amniotic sac prior to the 37th week of pregnancy and the beginning of labor).

These failures had the potential to result in confusion and inconsistency with the delivery of care.

Findings:

1. During a facility tour of the C-wing on May 14, 2012, at 10 a.m., Patient 2 was observed lying on the hospital bed. The patient appeared thin, his face was gaunt. During a concurrent interview, Patient 2 stated he has lost weight lately because he had been homeless.

A review of Patient 2's record was conducted. Patient 2 was admitted to the facility on April 30, 2012, with a diagnosis of a urinary tract infection. Patient 2 has a history of quadriplegia (paralysis from the neck down). The patient's height and weight were documented at the time of admission as 5'10", and 132 pounds.

A review of the initial nutrition risk screening dated May 1, 2012, indicated Patient 2's nutrition risk was assessed at a "High Risk" level.

A review of the RD's (Registered Dietician) Clinical-Interdisciplinary Notes, dated May 2, 2012, at 12:32 p.m., indicated the RD goal for Patient 2 was to prevent weight loss and for the nursing staff to "Please weight (Patient 2) weekly."

Further record review failed to show an individualized care plan addressing Patient 2's nutritional risks or the RD's recommendation for weekly weights was implemented.

2. During a facility tour of the C-wing on May 14, 2012, at 10:15 a.m., Patient 3 was observed lying on the hospital bed. Patient 3 was receiving intravenous (into a vein) nutrition (TPN). A concurrent interview was conducted with Patient 3 who stated she was receiving TPN because she had gallstones.

A review of Patient 3's record was conducted. Patient 3 was admitted to the facility on May 11, 2012, with diagnoses of gallstones and pancreatitis (inflammation of the pancreas). The patient was NPO (nothing by mouth) status.

Further record review failed to show an individualized care plan addressing Patient 3's nutritional status as related to her TPN was implemented.

An interview was conducted with RD 2 on May 14, 2012, at 12:30 p.m. RD 2 stated the Registered Nurses initiate the care plans and the RD enhanced them as indicated based upon the patient's needs.

A review of the facility policy, "Interdisciplinary Care Plan (Reviewed: 6/11)," was conducted. The purpose indicated, "To ensure that the planning of care and delivery of services is individualized to meet the patients needs, and provided in a interdisciplinary collaborative manner, as appropriate to each patient."


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3. On May 14, 2012, the record for Patient 16 was reviewed. Patient 16 was admitted to the facility on April 13, 2012. The initial Braden Scale (Skin risk assessment for pressure ulcers), dated April 13, 2012, revealed Patient 16 had a score of 13, placing her at moderate risk for developing pressure ulcers. The suggested interventions listed on the Braden Scale included, regular repositioning, heel off-loading, low pressure surface, and turn 30 degrees.

There was a physician's order, dated April 13, 2012, for an "air mattress."

There was a physician's order, dated May 5, 2012, for a "wound care consult."

The Interdisciplinary Care Plan for Patient 16 was reviewed, and indicated a problem of "Skin Integrity" was not initiated until April 19, 2012, (six days after the admission assessment and Braden scale assessment). In addition, the "wound care consult" was not included in the specific interventions.

On May 15, 2012, at 9:30 a.m., the Director of Medical/Surgical (DMS) was interviewed. The DMS stated the "Skin Integrity" care plan should have been initiated for Patient 16 upon admission on April 13, 2012, based on the Braden Scale of 13. The director also stated she would expect to see "wound care consult," added to the list of interventions as it applied to Patient 16.

The policy and procedure titled, "Skin and Wound Care," with a revision date of June 2011, was reviewed. The policy indicated, "Risk factors for skin impairment and pressure ulcers... Braden scale of eighteen (18) or less... Care Plan to include Alteration in Skin Integrity and updated every shift... Interventions should address prevention strategies and local wound care."



28294

4. On May 14, 2012, the record for Patient 11 was reviewed. Patient 11 was admitted to the facility on May 11, 2012, at 5:26 p.m., with diagnoses including newborn infant.

At the time of Patient 11's admission, the maternal GBS status was "unknown."

The "Physician Orders - Newborn Admission" dated May 11. 2012, at 5:40 p.m., indicated "Routine Vital Signs and Pain assessment Q4°" and "GBS policy as indicated" were checked.

The "Nursery Care Plans" dated May 11, 2012, at 6:18 p.m., and May 12, 2012, at 8:56 a.m., did not reveal that a care plan was initiated for Patient 11's possible risk of infection due to the infant's exposure to GBS when the maternal GBS status was unknown.

During an interview with the Director Women's Services (DWS), on May 14, 2012, at 2:45 p.m., she reviewed the record and was unable to find a care plan that was initiated for Patient 11's possible exposure to GBS and the risk of developing an infection due to this exposure.

5. On May 15, 2012, the record for Patient 12 was reviewed. Patient 12 was admitted to the facility Neonatal Intensive Care Unit (NICU) on March 23, 2012, with diagnoses including prematurity (birth of a baby before the developing organs were mature enough to allow normal survival).

The "Central Line Insertion Practices Adherence Monitoring" dated March 28, 2012, revealed a peripherally inserted central catheter (PICC) line was placed at 5:15 p.m., in Patient 12's upper extremity.

The microbiology reports revealed blood cultures were drawn from the PICC line and directly from a vein on April 3, 2012.

The "Medication Administration Record" dated April 3, 2012, at 7 a.m., through April 4, 2012, at 7 a.m., revealed Patient 12 was started on Vancomycin (an antibiotic) 10 milligrams every 18 hours via intravenous at 4 p.m.

The "Interdisciplinary Care Plan" revealed a care plan for "Actual or Potential risk of infection related to ..." was not initiated to include goals, target date, interventions, and plan of care updates.

During an interview with the Manager NICU on May 15, 2012, at 9:25 a.m., she reviewed the record and was unable to find documentation of a care plan being initiated for Patient 12's potential risk of infection. The Manager NICU stated the care plan for the actual or potential risk of infection should have been initiated because Patient 12 had a PICC line placed, blood cultures were drawn, antibiotics were started, and based on Patient 12's physical status.

6. On May 15, 2012, the record for Patient 13 was reviewed. Patient 13 was admitted to the facility on May 13, 2012, with diagnoses including preterm premature rupture of membranes (PPROM).

Upon admission, Patient 13's Group B Streptococcus (GBS - type of severe bacterial infection that can be passed to a baby during delivery) status was "unknown."

The "Perinatal Care Plan" dated May 14, 2012, at 7:19 a.m., revealed a care plan for "Infection - Additional Dx (diagnosis) or r/t (related to) premature rupture of membranes" was initiated. Interventions related to Patient 13's unknown GBS status to include prolonged rupture of membranes, antibiotic administration, and risk to the newborn were not included.

During an interview with the Director Women's Services (DWS) on May 15, 2012, at 11 a.m., she stated the computerized care plan did not allow for choices related to GBS such as preterm premature rupture of membranes, GBS status, treatment with antibiotics, and potential risk to the newborn.

The facility policy and procedure titled "Interdisciplinary Care Plan" reviewed June 2011, revealed "... The development of the plan of care, treatment and services is individualized and appropriate to the patient's needs, strengths, limitations, and goals. ..."

PATIENT CARE ASSIGNMENTS

Tag No.: A0397

Based on interview and record review, the facility failed:

1. To ensure a Licensed Vocational Nurse (LVN 2) met the requirements as outlined in the job description, and to ensure the 90-Day as well as the annual evaluations were completed on time; and

2. To ensure an Obstetrical Technician (OB Tech) met the minimum requirements according to the facility's job description.

These failures could potentially result in the inability of staff to meet the patient's medical needs.

Findings:

1a. On May 14, 2012, at 10:30 a.m., LVN 2 was interviewed. LVN 2 stated she was IV (Intra-venous) Certified, which allowed her to start IV's and hang IV fluids for the patients. LVN 2 stated she has worked at the facility for over 3 years.

On May 16, 2012, the employee file for LVN 2 was reviewed. LVN 2 was hired on December 10, 2008. The license for LVN 2 did not indicate that she was IV certified, and there was no additional documentation to show that LVN 2 had the certification that would allow her to start IV's.

The job description, signed by LVN 2, revealed a requirement for IV certification.

On May 16, 2012, at 3:30 p.m., the Director of Human Resources (DHR), was interviewed. The DHR stated that she thought LVN 2 was IV certified, but did not have any documentation to support that.

b. On May 16, 2012, the employee file for LVN 2 was reviewed with the DHR. LVN 2 was hired on December 10, 2008.

The 90 Day review for LVN 2, due on March 10, 2009, was done on July 28, 2010 (16 months past due). The Annual Review, due in December 2009, was done on July 21, 2010 (7 months past due).

On May 16, 2012, at 3:30 p.m., the DHR also stated that the 90 Day Review done in July 2010 was delinquent and the 2009 Annual Reviews done in July 2010, were also delinquent.



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2. On May 16, 2012, the employee file for Obstetrical Technician 1 (OB Tech 1) was reviewed.

The facility job description for "OB Technician" indicated "... Requirements ... One year experience as a surgical technician in an acute care setting. ..."

OB Tech 1's resume indicated she had five months of surgical technologist experience at one facility and three months of a surgical technologist internship at another facility for a total of 8 months of experience.

OB Tech 1's background check indicated for the three months of the surgical technologist internship, "Human Resources was unable to locate any record of the applicant's employment."

OB Tech 1 signed the "OB Technician" job description on January 17, 2012.

During an interview with the Director Human Resources (DHR), on May 16, 2012, at 3:50 p.m., she reviewed the employee file and was unable to find documentation of OB Tech 1's one year of experience as a surgical technician. The DHR stated the applicants' must meet the minimum requirements for the Job Description for which they were applying and the background check was used to confirm the applicant's application/resume. In addition, the DHR stated OB Tech 1 did not meet the minimum requirements for her job description.

The facility policy and procedure titled "Hiring Process" revised March 2012, revealed "... Human Resources will screen all applications and determine ability to satisfy requirements of the job description for the position for which they are applying. Those candidates meeting the initial screening qualifications will be forwarded to the appropriate Department Director/designee. ... During the initial interview, the candidates will be screened to determine if they meet the minimum qualifications of the job description. ..."

The policy and procedure titled, "Evaluation Process," revised May 2007, revealed "Employee Evaluation review shall be based on standards of competency completed annually on all employees and/or designated here: ... Within the first 90 days of employment... Annually... Evaluations are considered delinquent if they are not completed and returned to Human Resources within 30 days of the due date."

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on interview and record review, the facility failed to ensure drugs were ordered, prepared, and administered in accordance with standards of practice, state laws and regulations, and facility policy. The facility failed to:

1. Ensure intravenous (IV) vasoactive medication (used to increase the blood pressure) orders included the dose and specific instructions, including the maximum infusion rate parameter. The facility failed to clarify ambiguous IV vasoactive medication orders from the prescribing physician. The facility failed to identify that the (Registered Nurse) RNs were practicing outside of their scope of practice, by determining the infusion rate of the vasoactive medications given to the patients, without clarifying the order from the physician. These failures had the potential to result in medication error, which could subsequently lead to harm, disability, and death of patients;

2. Ensure the medication (Depakene - used for seizures) ordered by the physician was administered to Patient 22. This resulted in a missed dose/medication error; and

3. Ensure medication orders were clarified to indicate the right route of administration for Patient 23. This had the potential for medication administration error.

Findings:

1. According to the California Nursing Practice Act § 2725.1, "...Notwithstanding any other provision of law, a registered nurse may dispense drugs or devices upon an order by a licensed physician and surgeon if the nurse is functioning within a licensed clinic..."

According to the California Code of Regulations, Title 22, Division 5, § 70263(g), "No drugs shall be administered except by licensed personnel authorized to administer drugs and upon the order of a person lawfully authorized to prescribe or furnish..."

a. On May 14, 2012, Patient 22's record was reviewed. The patient was admitted through the facility's Emergency Department (ED), into the Intensive Care Unit (ICU).

Patient 22's ED "Medical Orders" dated May 13, 2012, at 8:57 p.m., included, "Dopamine (vasoactive medication; used to increase the blood pressure) 10 mcg/kg/min IVPB (intravenous piggy back [medication hooked with other medications]) Drip Titrate SBP > 100 (systolic blood pressure [the heart's arterial pressure; the top value of a blood pressure]), one time, intravenous, STAT (immediately)..." The order did not include the infusion rate for the medication.

The ED's "Clinical-Interdisciplinary Notes" indicated:

- On May 13, 2012, at 11:05 p.m., "...Dopamine drip at 13 mcg/kg/min..."

- On May 14, 2012, at 1:11 a.m., "...Dopamine drip continues to infuse..."

The "Physician Order Sheet" dated May 13, 2012, at 10 p.m., indicated, "Admit to inpatient status: ICU...Dopamine drip titrate to keep SBP above 90; Start Neosynephrin (vasoactive medication) drip if max out on Dopamine-titrate to keep SBP above 90..."

The order did not include:

- The rate of infusion for both Dopamine and Neo-synephrine;
- The concentration of both Dopamine and Neo-synephrine; and
- The maximum rate of Dopamine.

The Medication Administration Record (MAR) dated May 13 through May 14, 2012, was reviewed. The MAR indicated Dopamine 400 mg/250 ml IV titrate to keep SBP > 90.

The "Intensive Care Record" dated May 14, 2012, at 1:30 a.m., indicated Patient 22's SBP was 83 (mm/Hg) and the patient was receiving 15 mcg/kg/min. The record further indicated, "Received patient from emergency department with hypotensive problem...on Dopamine drip 15 mcg/kg/min..."

The Medication Administration Record (MAR) dated May 14 through May 15, 2012, was reviewed. The MAR indicated:

- Dopamine 400 mg/250 ml IV titrate to keep SBP > 90; and
- Neo-synephrine 80 mg/250 ml titrate to keep SBP >90.

The "Intensive Care Record" dated May 14, 2012, at 8 a.m., indicated Patient 22 was receiving 7 mcg/kg/min.

On May 14, 2012, at 10:50 a.m., RN 10 (an ICU nurse) was interviewed. RN 10 stated the rate of the dopamine was determined by the RNs. RN 10 stated, "Dopamine was usually started at 5 to 10 mcg/kg/min." RN 10 stated Patient 22 was started at 5 mcg/kg/min (in the ED).

On May 14, 2012, at 11:15 a.m., Patient 22's record was reviewed with the Critical Care Director (CCD). The CCD noted the difference in the SBP titration parameters between the ED and ICU Dopamine order. The CCD identified the missing components of the Dopamine and Neo-synephrine medication orders such as: concentration of the medication, rate of infusion (both Dopamine and Neo-synephrine), and the maximum rate parameter of the dopamine, in order to start the Neo-synephrine. The CCD stated the expectation was to write a complete medication order.

b. On May 14, 2012, Patient 23's record was reviewed. The patient was admitted to the ICU on May 1, 2012. The Physician Orders dated May 1, 2012, noted at 2:07 p.m., included, "Dopamine titrate to keep SBP > 90..." The order did not include the infusion rate for the medication.

The "Intensive Care Record" dated May 1, 2012, at 12:45 p.m., indicated Patient 23's SBP was 89 mm/Hg and the Dopamine was started at a rate of 7 mcg/kg/min. The record further indicated, "...at 1 p.m....Patient on Dopamine @ 7 mcg/kg/min..."

On May 15, 2012, at 2:10 p.m., RNs 11 and 12 (both ICU nurses) were interviewed. RN 11 and 12 stated the physicians gave Dopamine, Neo-synephrine, and any other vasoactive medication orders without a specific infusion rate. The physician would give orders for titrating parameters to maintain a certain SBP. The physicians do not include the maximum infusion rate when using multiple vasoactive medications. Both RNs stated they would determine the rate of infusion and the maximum titration infusion rates of the vasoactive medications.

In a concurrent interview with the CCD, she stated the facility did not have a current policy of vasoactive infusion rates, including the maximum range. The CCD stated it was the ICU RNs' practice to determine the infusion rate of Dopamine and its maximum rate, in order to start the Neo-synephrine. The CCD stated the RNs also determined the starting rate of the Neo-synephrine.

The facility policy titled, "Vasoactive Infusion, Care of Patient (Dopamine, Dobutamine, Nitroprusside, Inocor, Nitroglycerine, Neo-synephrine, Sandostatin)" dated April 2007, was reviewed. The policy did not include medication start and maximum dose range standards. The policy indicated, "...Validate physician's order and solution concentration...Calculate x factor appropriately to determine flow rates, as well as setting the pump in the appropriate dosing mode..."

On May 17, 2012, at 10:05 a.m., the Director of Pharmacy (DOP) was interviewed. He stated the vasoactive medications being ordered in the facility had already been identified to be incomplete, but action plans had not been successful. The DOP stated there was currently no set guideline for nursing to use in order to determine the infusion and maximum rates of the vasoactive medications. The DOP stated the vasoactive medication orders should include the concentration of the medication, the infusion start rate, and if required, the medication's maximum infusion rate when multiple vasoactive medications were ordered.

The policy titled, "Administration of Medications" dated May 2010, was reviewed and indicated:

"...Medications shall be administered only upon the order of an individual authorized to prescribe by the State of California..."

"...Whenever a question occurs regarding the appropriate use, administration...of medications, the licensed person administering the medication shall contact the Pharmacist and/or the prescribing Physician for information or clarification..."

"...Orders for medication shall include the name of the drug, the dosage, the frequency of administration...specific indications for same drug multiple doses or multiple drugs same indication..."

2. On May 14, 2012, Patient 22's record was reviewed. The patient was admitted through the facility's ED, into the ICU.

The "Physician Order Sheet" dated May 13, 2012, at 10 p.m., included, "Depakene 250 mg/5 ml GT (gastrostomy tube - feeding tube inserted through the stomach wall) BID (twice a day)."

On May 14, 2012, at 11:45 a.m., Patient 22's MAR was reviewed with RN 10. RN 10 stated she already had administered all the scheduled routine medications. RN 10 was unable to find the Depakene order in the MAR and stated, "The medication was missed..."

The facility policy titled, "Medication Administration Times" dated May 2010, was reviewed and indicated, "...Routine scheduled medications to be administered to the patient within a range of 30 minutes of the scheduled time; may be given within a time frame of 30 minutes before and/or 30 minutes after the scheduled time..."

3. On May 14, 2012, Patient 23's record was reviewed. The patient was admitted to the ICU on May 1, 2012, with diagnoses that included nausea, vomiting, acute renal failure. The patient was "NPO (nothing by mouth)."

Patient 23's MAR was reviewed and indicated, "Coumadin 3 mg oral daily...Zyprexa 2.5 mg oral every 12 hours..."

On May 14, 2012, at 2:30 p.m., Patient 23's MAR was reviewed with RN 13. RN 13 stated Patient 23 received medications by GT and there were no medications administered by mouth.

On May 14, 2012, at 2:40 p.m., the MAR was reviewed with the CCD. The CCD stated the Coumadin and Zyprexa orders should have been clarified to indicate the route of administration as GT, not oral.

The policy titled, "Medication Administration" dated September 2010, was reviewed and indicated, "Observe the 'Six Rights' when administering medications...Right Route..."

The policy titled, "Administration of Medications" dated May 2010, was reviewed and indicated, "...Whenever a question occurs regarding the appropriate use, administration...of medications, the licensed person administering the medication shall contact the Pharmacist and/or the prescribing Physician for information or clarification..."

CONTENT OF RECORD: ORDERS DATED & SIGNED

Tag No.: A0454

Based on interview and record review, the facility failed to ensure all physician orders were timed for three of 46 sampled patients, (Patients 1, 2 and 3). This failure could potentially result in confusion with the overall provision of medical care for these patients.

Findings:

1. A review of Patient 1's record was conducted. Patient 1 was admitted to the facility on May 9, 2012, for an elective surgical procedure.

Further record review reflected nine physician orders in which the time the orders were written was not noted.

2. A review of Patient 2's record was conducted. Patient 2 was admitted to the facility on April 30, 2012, with a diagnosis of a urinary tract infection.

Further record review reflected five physician orders in which the time the orders were written was not noted.

3. A review of Patient 3's record was conducted. Patient 3 was admitted to the facility on May 11, 2012, with a diagnosis of gallstones.

Further record review reflected five physician orders in which the time the orders were written was not noted.

An interview was conducted with the Registered Nurse, (RN 1) on May 14, 2012, at 11 a.m. RN 1 stated all physician orders must be dated and timed.

A review of the facility's Medical Staff Bylaws, General Rules and Regulations dated December 2010, within Section II, Medical Records, indicated, "All clinical entries in the patient's medical record shall be accurately dated and authenticated by written signature, identifiable initials or computer key. Medication orders must be dated and timed."

Standard-level Tag for Pharmaceutical Service

Tag No.: A0490

Based on observation, interview, and record review, the facility failed to ensure it provided pharmaceutical services that meet the needs of the patients by failing to:

1. Ensure the actual date of product expiration was included on the labels of the pharmacy compounded intravenous solutions (Refer to A0500);

2. Perform all pharmacy clinical monitoring of the medications that included monitoring of patients' kidney functions in accordance with the facility's policy and procedure (Refer to A0500);

3. Pair updated policy and procedures that listed of contents of the Adult Crash Carts with the actual content of the carts that matched the list (Refer to A0500);

4. Ensure single dose injectable vials were used only once to prevent potential issues with infection, medication error, and controlled substance accountability (Refer to A0500);

5. Ensure pharmacy had oversight of all controlled medication use from the Pyxis MedStations that included the Recovery (PACU) and Gastrointestinal (GI) Laboratories (Refer to A0500);

6. Ensure IV Laminar Flow Hoods (hoods used to protect while IV medications are being mixed) in the Pharmacy were inspected and prefilters for the hoods were cleaned and/or replaced as needed quarterly in accordance with the facility's policy and procedure (Refer to A0500);

7. Review annually, Pyxis medication use and Night Locker medication use in accordance with the facility's policy and procedures (Refer to A0500);

8. Ensure the Pharmacy had the control of the medications located in Radiology Department by not having access by way of keys and/or access codes (Refer to A0500);

9. Ensure the pharmacy department provided oversight by failing to ensure intravenous vasoactive medications (used to increase the blood pressure) included the dose and specific instructions including the maximum infusion rate parameter. The facility failed to clarify ambiguous intravenous (IV) vasoactive medication orders when received from the prescribing physician. The facility failed to control the dispensing of medications that allowed the Registered Nurses (RNs) to practice outside of their scope of practice, by determining the infusion rate of the vasoactive medications given to the patients, without clarifying the order from the physician (Refer to A0500);

10. Ensure the medication refrigerator in the newborn nursery was not used to store urine specimens, (Refer to A0500), and;

11. Ensure expired medications were unavailable for patient use. (Refer to A0505)


The cumulative effects of these systemic problems had the potential to result in medication errors which could subsequently lead to harm, disability, and death of patients.

DELIVERY OF DRUGS

Tag No.: A0500

Based on observation, interview, and document review, the facility failed to control medications in order to provide patient safety by failing to:

1. Ensure actual date of product expiration was included on the labels of the pharmacy compounded intravenous solutions;

2. Perform all pharmacy clinical monitoring of the medications that included monitoring of patients' kidney functions in accordance with the facility's policy and procedure;

3. Pair updated policy and procedures that listed of contents of the Adult Crash Carts with the actual content of the carts that matched the list;

4. Ensure single dose injectable vials were used only once to prevent potential issues with infection, medication error, and controlled substance accountability;

5. Ensure pharmacy had oversight of all controlled medication use from the Pyxis MedStations that included Recovery (PACU) and Gastrointestinal (GI) Laboratory;

6. Ensure IV Laminar Flow Hoods (IV hoods) in the Pharmacy were inspected and prefilters for the hoods were cleaned and/or replaced as needed quarterly in accordance with the facility's policy and procedure;

7. Review annually Pyxis medication use and Night Locker medication use in accordance with the facility's policy and procedures;

8. Ensure the Pharmacy had the control of the medications located in Radiology Department by not having access by way of keys and/or access codes;

9. Ensure the pharmacy department provided oversight by failing to ensure intravenous vasoactive medications (used to increase the blood pressure) included the dose and specific instructions including the maximum infusion rate parameter. The facility failed to clarify ambiguous intravenous (IV) vasoactive medication orders when received from the prescribing physician. The facility failed to control the dispensing of medications that allowed the Registered Nurses (RNs) to practice outside of their scope of practice, by determining the infusion rate of the vasoactive medications given to the patients, without clarifying the order from the physician; and

10. Ensure the medication refrigerator in the newborn nursery was not used to store urine specimens.

These failures had the potential to result in medication errors which could subsequently lead to harm, disability, and death of patients.

Findings:

1. Pharmacy was toured on May 14, 2012, starting at 10:30 a.m. It was noted that in the medication refrigerator, there were seventeen expired injectable intravenous (IV) bags in various volume containing potassium chloride (an injectable electrolyte supplement) which were labeled with expiration dates one day after the date they were prepared in the Pharmacy. These IV bags were inside the same medication refrigerator that contained refrigerated medications that were not expired.

It was also observed the labels had expiration dates written in pen that did not match the expiration dates (one day after IV bags were made) printed on the original IV labels.

During a concurrent interview, the Director of Pharmacy (DOP) explained the reason for expiration date one day after they were prepared was for the nurses to be aware not to use the IV bags after one day and for the pharmacy staff to make sure they were returned to the Pharmacy. The actual expiration date for the IV injectable bags, when they were added with potassium chloride, was nine days after preparation.

The DOP further explained there was no policy and procedure that described assigning a one day expiration date to all compounded IV medications and that the Pharmacy used a guideline titled, "Parkview Hospital IV Admixture Dilution and Stability Guideline 2012" for the actual expiration date of compounded IV bags.

Review of the facility's policy and procedure titled, "Expiration Dating of Medications" indicated,

"Compounded, repackaged and prepared dosage forms beyond the expiration date, shall be collected for disposal as appropriate ...Expired medications shall be segregated from the medications used for the storage of outdated medications. Expired medications shall be stored in a clearly marked area specific for the storage of outdated medications."

A review of the facility's policy and procedure titled, "Labeling of Medications" indicated for large and small volume parenterals and piggybacks,

"All admixture containers are affixed with a label containing the following informations ...expiration date of the parenteral admixture or product."

Review of the facility's policy and procedure titled, "Return of Medication to the Pharmacy" indicated, "All expired medication will be placed in the "Return to Pharmacy" box, and be appropriately labeled as EXPIRED medication."

2. During discussion of drug monitoring by the Pharmacy on May 16, 2012, at 11 a.m., it was noted that renal function (how well kidneys work) monitoring of all inpatients with serum creatinine (SCr: indicator of the kidney function) between 1 and 2 mcg/ml was to be conducted.

A review of the facility's High Risk Drug Monitoring binder did not indicate the pharmacy reviewed all patients with SCr between 1 and 2 mcg/ml.

During a concurrent interview, Pharmacist 2 acknowledged that the pharmacist on clinical shift was responsible for reviewing the report daily for SCr between 1 and 2 mcg/ml but stated that such monitoring was not performed daily.

During an interview, Pharmacist 1 stated that the renal function monitoring daily could not be performed because of the technological limitation of the current pharmacy computer system that could not generate the report currently even though the program was in place.

During an interview, DOP agreed that currently Renal Function Monitoring of patients with SCr between 1 and 2 mcg/ml was not done and that the policy was poorly written and needed to be revised.

Review of the facility's policy and procedure titled, "Renal Function Monitoring" indicated,
"The pharmacist shall review all medications of adult inpatients whose serum creatinine level is 1 to 2 mcg/ml. (Values>2 generally handled by nephrologist.)"

Review of the facility's policy and procedure titled, "Scope of Clinical Services Program" indicated for Renal Function Monitoring: "A Clinical Pharmacist will, on a daily basis, assess all patients who fall within the above clinical program as outlined in policy & procedure."

3. During a tour of the Nursing Stations on third and second floors on May 14, 2012, starting at 11 a.m., it was noted that one Adult Crash Cart located on third floor nursing station and one Adult Crash Cart located on second floor nursing station did not have an updated adult crash cart content list outside the carts that matched the actual contents.

During a concurrent interview, DOP stated that the policy and procedure with the new content list was updated but the binder on the nursing stations had a previous content list that did not match the actual content of the Adult Crash Carts.

Review of the facility's policy and procedure titled, "Crash Cart - Adult" revised in 2009, and in 2011, indicated that content list was not the same.

4. Review of Patient 34's medical record on May 14, 2012, at 3:30 p.m., indicated that there was a physician order written on the same day at 2:50 p.m. for fentanyl (narcotic pain medication) 50 mcg IV every 5 minutes as needed for pain with maximum dose of 150 mcg.

Review of the medical record also indicated that one dose of 50 mcg fentanyl IV was recorded as administered on May 14, 2012 at 3:15 p.m.

Review of the Pyxis MedStation report indicated that one dose of fentanyl 100 mcg/2 ml vial was accessed by RN 500. There was no documentation of wasting the remaining 50 mcg from the 100 mcg/2 ml vial on the report.

During an interview on May 14, 2012, at 3:45 p.m., 30 minutes after the first dose of 50 mcg fentanyl IV was given, RN 500 stated that they had the remainder of the dosage in a syringe in anticipation for possible need for second dose.

During a concurrent interview, RN 501, stated the wastage would be documented when the patient no longer needed the medications in PACU, when the patient got discharged, or transferred to inpatient unit.

During a concurrent interview, the DOP could not determine if the practice would pose a potential infection hazard and stated that there was definitely an accountability of controlled substance issue with the RN in possession of the medication.

Review of the facility's policy and procedure titled, "Automated Medication Dispensing System - Medication Administration" indicated,

"When any medication - partial or full dose - is removed from a tamper resistant package and is not used, it must be wasted. It will be documented at the station by using the "Waste" option under Procedures. Two nurses will be required to waste any controlled substances. Wastage is to be documented immediately."

According to CDC (Center for Disease Control and Prevention) on its website,

"The safest practice is to enter a single-dose or single-use vial only once so as to prevent inadvertent contamination of the vial and infection transmission. Single-dose or single-use vials should be used for a single patient and a single case/procedure/injection. Therefore, they should require only a single entry into the vial.However, in certain situations, healthcare personnel may believe that drawing the entire contents of the vial into a single syringe will not allow for safe and accurate titration of dosage (e.g., pediatric dosing during a surgical procedure). In these circumstances, healthcare personnel must consider the risk of repeated entry into a single-dose or single-use vial for that single patient/procedure."
In addition CDC in its position statement recommended,

"Healthcare providers should consult with pharmacy professionals and USP 797 standards when there is a need to subdivide contents of single-dose/single-use vials."

5. A review of the pharmacy monitoring of the use of medications from the Pyxis MedStations (Pyxis) located in nursing units was conducted on May 16, 2012, which included Override Reports, Discrepancy Reports, and Controlled Substance (CS) use in non-profiled Pyxis located in ED (Emergency Department).

Non-profiled is a term to indicate that access to all medications located in the Pyxis is allowed by authorized personnel before pharmacist review of new medication orders whereas profiled system is the term to indicate a pharmacist review of new medication orders was performed prior to authorized personnel having access only to those reviewed medications profiled for each patient in the Pyxis system.

During an interview on May 16, 2012, at 2:45 p.m., the Pharmacy Technician (RXT 1) stated there were three nursing units with non-profiled Pyxis: ED, PACU (Post Anesthesia Care Unit), and GI Laboratory (Lab).

RXT 1 stated CS use in ED was reviewed daily but acknowledged that CS use in other non-profiled units was not reviewed.

May 16, 2012, at 2:30 p.m., the DOP stated the Pharmacy should have an oversight of all CS use from the Pyxis in non-profiled areas as well.

6. On May 16, 2012, at 2:30 p.m. an interview with the DOP was conducted. The DOP stated the pre-filter for the IV Hoods in the IV Room were inspected quarterly.

A review of the IV Hood Cleaning Log indicated it was last cleaned in December 2011.

The DOP indicated that the prefilter was not inspected by the engineering department this year.

A review of the facility's policy and procedure titled, "Laminar Flow Hood" indicated,
"Laminar Flow Hood prefilters will be changed at least every three months or more frequently if necessary due to working conditions."

7. A review of the Pharmaceuticals and therapeutics (P&T) Committee meeting minutes for 2011, and 2012, did not indicate there was documented evidence of discussion of Night Locker and Pyxis medications review.

During an interview conducted on May 16, 2012, at 2:45 p.m., the DOP stated that Night Locker medications and Pyxis medications were reviewed annually and acknowledged that they were not reviewed last year or this year.

A review of the facility's policy and procedure titled, "Obtaining Medications after the Pharmacy is Closed" indicated, "The content of the night locker will be reviewed on an annual basis by the P&T (Pharmacy and Therapeutics) Committee for appropriateness."

A review of the facility's policy and procedure titled, "Automated Dispensing - Formulary Management" indicated patient safety medications defined as medications for use in non-routine emergency situations would be "reviewed and approved at least annually by the medical staff by the P&T Committee function."

8. The facility's Radiology Department (RD) was toured on May 14, 2012, at 10 a.m. It was noted there was a locked room with a numbered pad into which access code had to be entered to gain access to medications (contrast media and barium sulfates (diagnostic aids)) inside.

It was also noted that in the cabinet containing prescription injectable contrast agents in the MRI area of the RD had a lock that needed a key to gain access to medications.

During a concurrent interview, the DRD stated that the pharmacy staff did not have the access code to the room.

During a concurrent interview, the DOP stated the Pharmacy did not have either the access code or the key to access medications stored in the above areas and acknowledged that the Pharmacy should have the keys and access codes to medication storage areas.



25338

9. According to the California Nursing Practice Act § 2725.1, "...Notwithstanding any other provision of law, a registered nurse may dispense drugs or devices upon an order by a licensed physician and surgeon if the nurse is functioning within a licensed clinic..."

According to the California Code of Regulations, Title 22, Division 5, § 70263(g), "No drugs shall be administered except by licensed personnel authorized to administer drugs and upon the order of a person lawfully authorized to prescribe or furnish..."

a. On May 14, 2012, Patient 22's record was reviewed. The patient was admitted through the facility's Emergency Department (ED), into the Intensive Care Unit (ICU).

Patient 22's ED "Medical Orders" dated May 13, 2012, at 8:57 p.m., included, "Dopamine (vasoactive medication; used to increase the blood pressure) 10 mcg/kg/min IVPB (intravenous piggy back [medication hooked with other medications]) Drip Titrate SBP > 100 (systolic blood pressure [the heart's arterial pressure; the top value of a blood pressure]), one time, intravenous, STAT (immediately)..." The order did not include the infusion rate for the medication.

The ED's "Clinical-Interdisciplinary Notes" indicated:

- On May 13, 2012, at 11:05 p.m., "...Dopamine drip at 13 mcg/kg/min..."

- On May 14, 2012, at 1:11 a.m., "...Dopamine drip continues to infuse..."

The "Physician Order Sheet" dated May 13, 2012, at 10 p.m., indicated, "Admit to inpatient status: ICU...Dopamine drip titrate to keep SBP above 90; Start Neosynephrin (vasoactive medication) drip if max out on Dopamine-titrate to keep SBP above 90..."

The order did not include:

- The rate of infusion for both Dopamine and Neo-synephrine;
- The concentration of both Dopamine and Neo-synephrine; and
- The maximum rate of Dopamine.

The Medication Administration Record (MAR) dated May 13 through May 14, 2012, was reviewed. The MAR indicated Dopamine 400 mg/250 ml IV titrate to keep SBP > 90.

The "Intensive Care Record" dated May 14, 2012, at 1:30 a.m., indicated Patient 22's SBP was 83 (mm/Hg) and the patient was receiving 15 mcg/kg/min. The record further indicated, "Received patient from emergency department with hypotensive problem...on Dopamine drip 15 mcg/kg/min..."

The Medication Administration Record (MAR) dated May 14 through May 15, 2012, was reviewed. The MAR indicated:

- Dopamine 400 mg/250 ml IV titrate to keep SBP > 90; and
- Neo-synephrine 80 mg/250 ml titrate to keep SBP >90.

The "Intensive Care Record" dated May 14, 2012, at 8 a.m., indicated Patient 22 was receiving 7 mcg/kg/min.

On May 14, 2012, at 10:50 a.m., RN 10 (an ICU nurse) was interviewed. RN 10 stated the rate of the dopamine was determined by the RNs. RN 10 stated, "Dopamine was usually started at 5 to 10 mcg/kg/min." RN 10 stated Patient 22 was started at 5 mcg/kg/min (in the ED).

On May 14, 2012, at 11:15 a.m., Patient 22's record was reviewed with the Critical Care Director (CCD). The CCD noted the difference in the SBP titration parameters between the ED and ICU Dopamine order. The CCD identified the missing components of the Dopamine and Neo-synephrine medication orders such as: concentration of the medication, rate of infusion (both Dopamine and Neo-synephrine), and the maximum rate parameter of the dopamine, in order to start the Neo-synephrine. The CCD stated the expectation was to write a complete medication order.

b. On May 14, 2012, Patient 23's record was reviewed. The patient was admitted to the ICU on May 1, 2012. The Physician Orders dated May 1, 2012, noted at 2:07 p.m., included, "Dopamine titrate to keep SBP > 90..." The order did not include the infusion rate for the medication.

The "Intensive Care Record" dated May 1, 2012, at 12:45 p.m., indicated Patient 23's SBP was 89 mm/Hg and the Dopamine was started at a rate of 7 mcg/kg/min. The record further indicated, "...at 1 p.m....Patient on Dopamine @ 7 mcg/kg/min..."

On May 15, 2012, at 2:10 p.m., RNs 11 and 12 (both ICU nurses) were interviewed. RN 11 and 12 stated the physicians gave Dopamine, Neo-synephrine, and any other vasoactive medication orders without a specific infusion rate. The physician would give orders for titrating parameters to maintain a certain SBP. The physicians do not include the maximum infusion rate when using multiple vasoactive medications. Both RNs stated they would determine the rate of infusion and the maximum titration infusion rates of the vasoactive medications.

In a concurrent interview with the CCD, she stated the facility did not have a current policy of vasoactive infusion rates, including the maximum range. The CCD stated it was the ICU RNs' practice to determine the infusion rate of Dopamine and its maximum rate, in order to start the Neo-synephrine. The CCD stated the RNs also determined the starting rate of the Neo-synephrine.

The facility policy titled, "Vasoactive Infusion, Care of Patient (Dopamine, Dobutamine, Nitroprusside, Inocor, Nitroglycerine, Neo-synephrine, Sandostatin)" dated April 2007, was reviewed. The policy did not include medication start and maximum dose range standards. The policy indicated, "...Validate physician's order and solution concentration...Calculate x factor appropriately to determine flow rates, as well as setting the pump in the appropriate dosing mode..."

The policy titled, "Administration of Medications" dated May 2010, was reviewed and indicated:

"...Medications shall be administered only upon the order of an individual authorized to prescribe by the State of California..."

"...Whenever a question occurs regarding the appropriate use, administration...of medications, the licensed person administering the medication shall contact the Pharmacist and/or the prescribing Physician for information or clarification..."

"...Orders for medication shall include the name of the drug, the dosage, the frequency of administration...specific indications for same drug multiple doses or multiple drugs same indication..."

On May 17, 2012, at 1:35 p.m., Pharmacist 5 was interviewed. Pharmacist 5 stated the pharmacy department received vasoactive medications without specific drug concentration, infusion rates, and maximum rates. Pharmacist 5 stated the facility had two concentrations for Dopamine: 400 mg/ml and 800 mg/ml. Pharmacist 5 stated the pharmacy department does not clarify the Dopamine orders even if it did not have the infusion rate or maximum rate.

On May 17, 2012, at 10:05 a.m., the DOP was interviewed. He stated the vasoactive medications being ordered in the facility had already been identified to be incomplete, but action plans had not been successful. The DOP stated there was currently no set guideline for nursing to use in order to determine the infusion and maximum rates of the vasoactive medications. The DOP stated the vasoactive medication orders should include the concentration of the medication, the infusion start rate, and if required, the medication's maximum infusion rate when multiple vasoactive medications were ordered. The DOP stated pharmacy dispensed the vasoactive medications even if the order was incomplete.



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10. On May 14, 2012, at 10:10 a.m., a tour of the Newborn Nursery was conducted with the Director Women's Services (DWS).

In the Newborn Nursery, in a refrigerator labeled "Med Refrig," a red top laboratory tube with a yellow liquid inside, and labeled with a patient's name, was observed. The red top laboratory tube was inside a plastic bag labeled "Biohazard."

During a concurrent interview with the DWS, she stated the red top laboratory tube contained urine from a patient and should not have been placed in the refrigerator labeled "Med Refrig."

The facility policy and procedure titled "Medication Area Unit Inspections" reviewed May 2010, revealed "... Medications are stored separately from food and laboratory specimens, including refrigerated medications. ..."

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observation, interview and document review, the facility failed to ensure expired medications were unavailable for patient use.

Findings:
1. During a tour of the Pharmacy Night Locker on May 14, 2012 at 10:30 a.m., it was noted that there was an emergency medication supply kit labeled AMI Clot Box with the expiration date of 11/11 (November 2011).

During a concurrent interview, DOP agreed that the AMI Clot Box was expired and should have been removed from the Pharmacy Night Locker.

Review of the facility's policy and procedure titled, "Expiration Dating of Medications" indicated,

"Compounded, repackaged and prepared dosage forms beyond the expiration date, shall be collected for disposal as appropriate ...
Expired medications shall be segregated from the medications used for the storage of outdated medications.
Expired medications shall be stored in a clearly marked area specific for the storage of outdated medications."

Review of the facility's policy and procedure titled, "Labeling of Medications" indicated for large and small volume parenterals and piggybacks,

"All admixture containers are affixed with a label containing the following information ...expiration date of the parenteral admixture or product."



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2. On May 14, 2012, at 9:30 a.m., a tour of the Pediatric unit was conducted with the Director Women's Services (DWS) and the Manager Neonatal Intensive Care Unit (NICU).

In the Pediatric examination room the following a 30 gram tube of Lidocaine 2.5% and Prilocaine 2.5% cream with an expiration date of June 2011, was observed.

On May 15, 2012, at 8:35 a.m., a tour of the NICU was conducted with the Manager NICU. In a storage cabinet, a one 10 milliliter container of "Toot Sweet", with an expiration date of February 2012, was observed.

During concurrent interviews with the Manager NICU, she stated the items were expired and should have been discarded.

The facility policy and procedure titled "Expiration Dating of Medications" reviewed May 2010, revealed "... Outdated medications which have exceeded unusable as determined by its expiration date. ..."

ADEQUACY OF LABORATORY SERVICES

Tag No.: A0582

b. On May 14, 2012, at 9:50 a.m., during the tour of the Emergency Department (ED) medication room, approximately 50 serum laboratory test tubes (red top), available for patient use, had an expiration date of April 2012.

On May 14, 2012, at 3:30 p.m., the Laboratory Director was interviewed and stated the laboratory test tubes were not being used by the facility any longer. He stated the expired test tubes may lose the vacuum when used for blood drawing. The Director stated the facility did not have a policy on how to monitor and maintain the use of laboratory supplies.




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Based on interview and record review, the facility failed:

1. To provide a comparison of two or more testers on all specimens tested for ferning (testing for the presence of amniotic fluid) in Labor & Delivery (L&D) and record the results on the "Fern Test Quality Control" log per the facility policy and procedure for two unsampled patients (Patients 47 and 48); and to provide direction when two testers disagreed on the ferning results for one of 46 sampled patients (Patient 13). This failure had the potential to result in pregnant patients being diagnosed or not being diagnosed as having ruptured membranes.

2. To ensure laboratory supplies were not expired and available for patient use in all of the facility's patient care areas, which could negatively impact the results of laboratory results if used.



Findings:

1. On May 14, 2012, the "Fern Test Quality Control" log was reviewed.

The "Fern Test Quality Control" log revealed:
- On March 2, 2012, Patient 47 was seen at the facility and a fern test was performed. One nurse recorded the results as negative and there were no results from a second tester.
- On an unknown date, Patient 48 was seen at the facility and a fern test was performed. One nurse recorded the results as negative and there were no results from a second tester.
- On May 13, 2012, Patient 13 was seen at the facility and a fern test was performed. One nurse recorded the results as positive and the second nurse recorded the results as negative,

During an interview with the Director Women's Services (DWS) on May 15, 2012, at 1:40 p.m., she reviewed the "Fern Test Quality Control" log and was unable to find documentation of a second tester for Patient's 47 and 48. In addition, she stated there should always be at least two people checking the fern testing results. The DWS stated if two testers did not agree on the ferning results, a third tester could be used or another ferning test could be done. In addition, the DWS stated the facility policy and procedure did not address what should be done if the first two testers did not agree on the ferning results.

The facility policy and procedure titled, "Standardized Procedure for Fern Testing for Presence of Amniotic Fluid" revised August 2011, revealed "... Ferning of amniotic fluid on a microscope slide is caused by the presence of Sodium chloride and protein in amniotic fluid. ... There is no quality control material available for this microscopic test. Quality for this test is maintained by the following:... Comparison of readings between two or more of the testing personnel on all Specimens. The results will be recorded on a log sheet to be kept in the nursing station. ..."

2 a. On May 14, 2012, at 10:25 a.m., a tour of Labor & Delivery (L&D) was conducted with the Director Women's Services (DWS).

The following was observed:
- Three, "Specimen Collection Kit for Endocervical Specimens" one with an expiration date of December 31, 2011, and two with an expiration date of January 31, 2012.
- Two, "Culture Swab" one with and expiration date of September 2006, and one with an expiration date of August 2011.
- Fifteen, red top laboratory tubes with an expiration date of February 2011.

During a concurrent interview with the DWS, she stated the items were expired and should have been discarded.

On May 14, 2012, at 11:30 a.m., a tour of the Neonatal Intensive Care Unit (NICU) was conducted with the Manager NICU.

The following was observed:
- Three, "Culture Swab" two with an expiration date of March 2012, and one with an expiration date of April 2012.

During a concurrent interview with the Manager NICU, she stated the items were expired and should have been discarded.

On May 14, 2012, at 1:15 a.m., a tour of the Postpartum unit was conducted with the Director Women's Services (DWS).

The following was observed:
- Two bags of "Capiject Tubes" one with an expiration date of November 2011, and one with an expiration date of January 2012.

On May 15, 2012, at 2:10 p.m., an interview was conducted with the Director Materials Management (DMM). He stated the culture tubes were obtained from Materials Management and the laboratory tubes were obtained from the Laboratory. The DMM stated Materials Management was responsible for checking for outdates in the Post Partum and NICU storage rooms. The unit staff were responsible for checking for outdates on supplies that were located in any other areas.

ORGANIZATION

Tag No.: A0619

Based on observation, interview and record review, the facility failed to ensure expired food products were not available for patient consumption.

Findings:

On May 14, 2012, at 9:30 a.m., a tour of the Pediatric unit was conducted with the Director Women's Services (DWS) and the Manager Neonatal Intensive Care Unit (NICU).

In the nourishment room, the following was observed:

a. A frozen "Celeste Pepperoni Pizza" with an expiration date of March 10, 2012.
b. A frozen "Chicken Pasta Marinara" dinner with an expiration date of February 9, 2012.
c. In the refrigerator, three half pint cartons of "Tru Moo" one with an expiration date of May 8, and two with an expiration date of May 13, 2012.
d. In the refrigerator, one half pint carton of milk with an expiration date of May 7, 2012.
f. Two, eight ounce cans of vanilla "Pedia Sure" with an expiration date of February 1, 2012.
g. One, twelve ounce can of "Brisk Lemon Iced Tea" with an expiration date of March 12, 2012.
h. One can of "Low Sodium V 8 Vegetable Juice" with an expiration date of September 9, 2011.
i. Two containers of pureed peaches with an expiration date of September 10, 2011.

During a concurrent interview with the Manager NICU, she confirmed the items observed in the nourishment room were expired.

On May 14, 2012, at 11:30 a.m., and May 15, 2012, at 8:35 a.m., a tour of the NICU was conducted with the Manager NICU.

In the NICU storage room one carton of "Similac 20 cal/fl oz - Rice Starch" with an expiration date of April 1, 2012, was observed.

In the NICU in a cupboard an open, undated eight ounce box of "Rice Cereal" with an expiration date of April 26, 2012, was observed.

During concurrent interviews with the Manager NICU, she stated the NICU staff were responsible for checking for the formula outdates, and expired formula was to be discarded or returned. In addition, she stated the box of rice cereal should have been dated when opened and discarded when the rice cereal expired.

The facility policy and procedure titled "Expiration of Perishable Items" reviewed March 2010, revealed perishable items which did not already have an expiration date would be labeled and dated for expiration within 3 days of opening.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observation, staff interview and document review, the Director of Dietary (DOD) failed to ensure the daily management of the Food and Nutrition Department as evidenced by:

1. A lack of a system to ensure a thawed liquid egg product was used within its shelf life in accordance with manufacturer's instruction;
2. Expired nutrition supplements were available for use;
3. An undated frozen ham;
4. The wash temperature on the dishmachine was logged as not reaching manufacturer's wash temperature guidelines without corrective action (cross reference A-0622);
5. One cook did not know where the gas shut off valve was located in the kitchen (cross reference A-0714);
6. A lack of a specific therapeutic diet manual to include therapeutic diets ordered in the hospital (cross reference A-0631); and,
7. A failure to utilize the qualified dietitian to assess a patient's nutritional status within 24 hours after receiving a consult request by nursing for Patient 43 and Patient 44 in accordance with hospital policy. Failed to ensure that the qualified dietitian or other qualified credentialed individual had the function within the dietary department to complete a nutrition screening that involved assessing and prioritizing nutritional risk (Patients 43, 24, and 42). (cross-reference A-0621).

These failures regarding unsafe and unsanitary food handling and food equipment practices had the potential for placing the medically compromised patients at risk for a foodborne illness, and to have delayed nutrition recommendations to meet the nutritional needs of patients.

Findings:

1. On May 14, 2012, at 9:15 a.m., in the walk-in refrigerator was a full box of unopened cartons of a liquid egg product that was labeled "Keep Frozen Until Needed." There were also three individual cartons of the same liquid egg product on the rack, out of the box. The cartons of the liquid egg product were not dated as to when the thawing process began. The Director of Dietary Services, (DOD) stated, "we would keep for 5-7 days."

On the individual cartons of the liquid egg product were manufacturer's instruction that indicated "Thaw in Refrigerator (41 degrees F or below) for 2-3 days after thawing, use within 3 days."

2. On May 14, 2012, at 9:23 a.m., in the dry storage room in the kitchen, there were nine cans of a liquid nutrition supplement designed for patients with reduced kidney function that had an expiration date of December 1, 2011. The DOD stated, "They shouldn't be here."

During the same observation of the dry storage room, there were two cases of a liquid nutritional supplement designed for children with an expiration date of February 1, 2012. The DOD acknowledged that the nutritional supplements were expired and "shouldn't be here."

3. On May 14, 2012, at 9:34 a.m. in the walk-in freezer was an uncooked 14 pound frozen ham that was not dated. The DOD was unable to determine how long the ham had been in the freezer, and stated, "It appears very old and should not be here."

QUALIFIED DIETITIAN

Tag No.: A0621

Based on observation, interview and record review, the hospital failed to utilize the qualified dietitian to assess a patient's nutritional status within 24 hours after receiving a consult request from nursing for Patients 43 and Patient 24 in accordance with hospital policy. The hospital failed to ensure that the qualified dietitian or other qualified credentialed individual had the function within the dietary department to complete a nutrition screening that involved assessing and prioritizing nutritional risk (Patients 43, 24 and 42).

Findings:

On May 14, 2012, at 3:18 p.m., Patient 43's medical record was reviewed with the Clinical Nutrition Manager. Patient 43 was admitted to the hospital on May 12, 2012, with a chief complaint of pancreatitis according to the Patient Information sheet. According to the nursing adult initial assessment dated May 12, 2012, the dietitian received a nutrition consult request from nursing for Patient 43.

According to the hospital's policy and procedure entitled Nutrition Screening, Assessment, and Follow-up (last revised June 2011), the clinical dietitian would complete an assessment within twenty-four hours of receipt.

On May 13, 2012, the dietary department had a senior diet clerk, instead of a dietitian (RD), review Patient 43's medical record in order to prioritize, assign a nutrition assessment priority and determine a date in which the RD should complete a nutrition assessment.
Senior diet clerk 7 documented, Nutritional Risk Assessment-High Risk (Level 1) = Assessment within 24 hours, Comments - Due to diagnosis; noted albumin -1.5, RD Assessment Date: - May 12, 2012.

On May 14, 2012, RD 8 completed a nutrition assessment for Patient 43, which was 48 hours after receiving a nursing consult request for a dietitian to complete a nutrition assessment which should have been done 24 hours later in accordance with hospital policy.

In addition, according to hospital policy entitled Nutrition Screening, Assessment and Follow-up, "Patient determined as a Level 1 (high nutritional risk) as outlined by criteria of ...admitting diagnosis will be assessed by the clinical dietitian within twenty-four (24) hours of admission. A nutrition screen for patients considered a Level 1 (high nutritional risk) at a time of admission will not be completed as the patient will be assessed within twenty-four (24) hours of admission." According to the hospital's level of nutritional risk an admitting diagnosis of pancreatitis would have met the automatic dietitian assessment within 24 hours.

The Director of Dietary and the Clinical Nutrition Manager did not ensure that a dietitian completed a nutrition assessment within 24 hours in accordance with hospital policy, which delayed appropriate nutrition recommendations by one day for Patient 43.

On May 15, 2012, at 1:40 p.m., Patient 24's medical record was reviewed. The Clinical Nutrition Manager reviewed Patient 24's nursing adult initial assessment, dated April 30, 2012, in which a licensed nurse made a dietitian referral based on a nutritional screening score. According to hospital policy a dietitian should have completed the nutrition consult within 24 hours.

On May 1, 2012, the dietary department had a senior diet clerk (SDC 9) review Patient 44's medical record in which SDR 9 prioritized a nutrition risk level, and determined when an RD should complete a nutrition assessment for Patient 24, after the licensed nurse had already sent a referral for a dietitian to assess within 24 hours. An RD did not complete a nutrition assessment for Patient 24 until 48 hours later.

On May 15, 2012, at 9:23 a.m., Patient 42's medical record was reviewed. Patient 42 was admitted on April 21, 2012, with a diagnoses that included acute renal failure. On April 23, 2012, a senior diet clerk (SDC 10) completed a nutrition risk screening for Patient 42. SDC 10 documented, "Nutritional Risk Assessment- Low Risk (Level 3) = Assessment within 7 days, RD Assessment Date:-RD TO ASSESS ON 4/30/12 NOTED PT AGE, ANEMIA."

According to hospital policy entitled LEVELS OF NUTRITIONAL RISK AND NUTRITION CARE, acute renal failure should have been a Level 1: High Risk and a dietitian should have automatically nutritionally assessed the patient, without a nutrition screen. The Clinical Nutrition Manager verified that the senior diet clerk inaccurately assigned a low risk level, to the nutritionally high risk patient.

On May 16, 2012, at 11:40 a.m., the senior diet clerk job description developed by the hospital was reviewed. During a concurrent interview, the Director of Dietary stated the original intent of the job description was designed for a dietetic technician registered but the hospital could not find one in the job market. The Director of Dietary stated that they trained a few of their employed diet clerks to be senior diet clerks and allowed them to review patients medical records in order to assess a nutrition risk level and determine when the RD should complete a nutrition assessment.

A review of the hospital's job description for a Registered Dietitian indicated, "A Registered Dietitian is responsible for performing major clinical nutrition activities on all patient care units, including screening, assessing, and educating patients in accordance with established procedures. REQUIREMENTS: 1. Bachelor of Science degree in Nutrition/Dietetics. 2. Current Registered Dietitian status with the Commission of Dietetic Registration..."

COMPETENT DIETARY STAFF

Tag No.: A0622

Based on observation, interview and record review, one dietary employee responsible for dishwashing was not competent in that assigned duty.

Findings:

On May 14, 2012, at 9:50 a.m., the "Dishwashing/Warewashing Machine Temperature Log Type of Machine: Low Temperature" was reviewed from May 1, 2012 - May 14, 2012. The column entitled "Wash Temp" had a pre-printed number that indicated that the wash temperature should reach 140 degrees F. The logged temperature during May 1, 2012 - May 14, 2012, was logged as less than 140 degrees for the wash temperature 31 times. The column entitled "Action Plan" was blank during the same time period.

The dietary employee (DE 2) that had been operating the dishmachine stated that he was responsible to monitor and log the dishmachine temperatures. When DE 2 was asked at what wash temperature he would stop using the dishmachine and report a temperature to the dietary supervisor, he stated, "if it is less than 130 degrees F." DE 2 stated if the wash temperature was 130 degrees it was "fine."

According to the data plate that was affixed to the dishmachine, the wash temperature should have reached 140 degrees F in accordance with manufacture's guidelines.

During the same observation, the Director of Dietary (DOD) acknowledged that DE 2 should have known to report a wash temperature that was less than 140 degrees F to the dietary supervisor, or directly to her. The DOD acknowledged that she was unaware that the wash temperature cycle was logged as less than 140 degrees F 31 times during May 2012.

The hospital ' s policy and procedures entitled DISHES AND SILVERWARE CLEANING (last reviewed 2/2008) indicated, "Minimum acceptable temperatures for the dish machine are: Wash 140F... "

The wash solution temperature in mechanical warewashing equipment is critical to proper operation, and the manufacturer's instructions must be followed. (FDA Food Code 2009)

THERAPEUTIC DIETS

Tag No.: A0629

Based on observation, interview and record review, the hospital failed to ensure that oral nutrition supplements for Patients 41 and 42, were ordered by a practitioner responsible for the care of the patient.

Findings:

1. On May 14, 2012, at 2:43 p.m., Patient 41's medical record was reviewed. On May 11, 2012, Registered Dietitian (RD 2), completed a follow-up nutrition assessment for Patient 41. RD 2 documented that Patient 41's current diet order was for 2000 kcal [calories] ADA [American Diabetic Association], 1000 ml fluid restriction/day. RD 2 noted that Patient 41 was consuming less than 50% of meals. Under "INTERVENTION SUGGESTIONS," RD 5 documented, "1. Glucerna [an oral nutrition supplement for persons with diabetes] 1 can w/meals TID... " RD 2's RD follow-up plan included monitoring PO intake [food eaten by mouth] of meals and supplements, and scheduled the next RD follow-up for four days later for a nutritional high risk patient per RD 2.

The Clinical Nutrition Manager, RD reviewed Patient 41's medical record and stated that there was not a physician's order for Glucerna. The Clinical Nutrition Manager stated, "Dietitians will add supplements without orders." The Clinical Nutrition Manager stated that the hospital's dietitians will go down to the dietary office and add the supplements onto the patient's dietary kardex that is kept solely in the dietary office.

At that time, Patient 41's dietary kardex was observed in the dietary department. On May 11, 2012, RD 2 noted on Patient 41's dietary kardex to provide the patient with Glucerna 4 oz [ounces] at breakfast, lunch and dinner without a physician's order.

2. On May 15, 2012, at 9:23 a.m., Patient 42's medical record was reviewed. On April 23, 2012, RD 6 completed a nutrition assessment for Patient 42. RD 6 noted that the patient's diet order was for a renal diet. RD 6 documented under INTERVENTION SUGGESTIONS, "1) Continue current diet, 2) Provide Nepro [an oral nutrition supplement designed for people with kidney disease receiving dialysis which is a treatment to do the functions of a kidney] TID [three times a day] to supplement..."

The Clinical Nutrition Manager reviewed Patient 42's medical record and verified that there was not a physician's order to provide Patient 42 with Nepro TID. According to Patient 42's dietary kardex kept solely in the dietary department, RD 6 instructed the dietary staff to provide Patient 42 with Nepro TID. RD 6 had not been granted privileges by the hospital's physicians to provide the above direct patient care nutrition intervention.

On May 15, 2012, at 11:40 a.m., the Director of Dietary stated it was her expectation that the dietitians were providing nutrition recommendations to the physician, and then if the physician agreed with the recommendation the physician would write the order.

During the same interview with the Director of Dietary and the Clinical Nutrition Manager, both stated that the practice of the hospital's dietitians providing supplements to patients without physician orders had not been approved by the physician's at the hospital. The Director of Dietary confirmed that the hospital's dietitians had not been granted privileges to provide direct patient care by providing nutrition supplements without physician orders.

The hospital's policy, "Diet Orders" indicated diet orders are provided by the physician. The hospital's clinical dietitians cannot act as independent practitioners.

Patient 41 and 42's nutrition supplements were not prescribed by the practitioner responsible for diet orders in the facility.

THERAPEUTIC DIET MANUAL

Tag No.: A0631

Based on observation, interview and record review, the facility failed to have a facility specific therapeutic diet manual to include therapeutic diets ordered in the facility. This information was not readily accessible for hospital medical and nursing staff. This failure resulted in the potential for patients receiving an inappropriate therapeutic diet.

Findings:

On May 15, 2012, at 3:30 p.m., the Director of Dietary (DOD) who had direct oversight over the clinical dietitians, was asked to utilize the hospital's diet manual to demonstrate how the various therapeutic diets were defined by the physician's at the hospital. The DOD stated that she was unable to utilize the hospital's on-line diet manual to demonstrate how the therapeutic diets were implemented at the hospital because it was a generic manual, and not facility specific.

The DOD acknowledged that the facility's approved diet manual was not facility specific and was unable to be used as a tool for communication amongst the multidisciplinary health care team in describing how a therapeutic diet was ordered, defined and implemented at the facility.

The facility's policy and procedure entitled Manual of Nutrition Care Management (last reviewed 3/2010) indicated, "It is the policy of the Food and Nutrition Service Department to provide accurate diet modifications, as prescribed by the physician, in accordance with the approved Manual of Nutrition Care Management. The manual will serve as a guide to ordering diets, and the served menus will be consistent with the requirements in the manual."

The facility's policy entitled Diet Orders (last reviewed 2/2008) indicated, "...diet orders should conform to the terminology used in the Diet Manual, so that there will be uniformity of understanding by everyone concerned."

EMERGENCY POWER AND LIGHTING

Tag No.: A0702

Based on observation and interview, the facility failed to ensure emergency lighting was available in the Labor & Delivery (L&D) Operating Rooms (OR). This had the potential to result in no lighting being available during a surgical case if a power failure occurred.
Findings:
On May 14, 2012, at 3:20 p.m., a tour of L&D ORs was conducted with the Director Women's Services (DWS), RN 20, and Obstetrical (OB) Technician (Tech) 1.
In L&D OR 1 and OR 2, there was no battery operated emergency lighting.
During a concurrent interview with the DWS, RN 20, and OB Tech 1, they were unable to find emergency lighting in L&D OR 1 and OR 2. They stated if the lights went out they would just stand still and not continue the surgical case until the emergency power came on. In addition, they stated if the lights went out and the emergency power did not come on, they would "find a flash light." They again stated they would stop what they were doing until the lights came back on.
On May 14, 2012, at 4:15 p.m., a tour of L&D ORs was conducted with the Director of Plant Operations (DPO). He stated there was no battery operated emergency lighting in L&D OR 1 and OR 2. In addition, he stated if there was a power failure it would take 5 to 10 seconds before the emergency generator power came on and if the emergency generator did not come on, the ORs would be without lights and power.

FIRE CONTROL PLANS

Tag No.: A0714

Based on observation and interview, one cook did not know where the gas shut off valve was located in the kitchen, which potentially could lead to injuries in the event of a disaster.

Findings:

On May 14, 2012, at 9:46 A.M., Cook 1 pointed to an area in which he thought he could turn off the gas in the event of a disaster inside the kitchen. A concurrent interview was conducted with the Director of Dietary (DOD) who stated that the location in which Cook 1 pointed to was not where the gas shut off valve was located.

The DOD stated she would have expected Cook 1 to know where and how to turn off the gas shut off valve in the kitchen in the event of a disaster.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

3. On May 14, 2012, at 9:45 a.m., during the tour of the ED, a food refrigerator was inspected. The food refrigerator's thermometer read 12 °F (should be between 35-40 °F according to facility policy). The refrigerator contained three cartons of milk and a cup of apple sauce. The inside of the refrigerator was observed with sticky fluid spills. The freezer section could not be inspected due to ice build-up preventing the door to be opened. There was no documented evidence the refrigerator's temperature was being monitored and that the refrigerator was being maintained or checked.

During a concurrent interview with the Critical Care Director (CCD), the CCD was unable to say who monitored the refrigerator's temperature. She stated the nursing department used to do it, but thought the dietary department took over the monitoring.

4. On May 14, 2012, at 10:30 a.m., during the tour of the Intensive Care Unit (ICU) with the CCD and Quality Analyst (QLA) 1, the ice machine's catch basin was observed filled with stagnant water with grayish-green material floating, and the grills noted with scaling. The machine did not have any evidence of preventative maintenance. The ICU Director was unable to state when the ice machine was last cleaned or serviced/sanitized.




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

1. To ensure supplies for patient care use were not expired in Labor & Delivery (L&D) and the Postpartum units;

2. To ensure the emergency call light in the Pediatric shower was functioning;

3. To ensure the food refrigerator in the Emergency Department was maintained in a sanitary manner and kept at the recommended temperatures according to the facility's policy; and

4. To ensure the ice machine in the Intensive Care Unit was maintained in a sanitary manner.

These failures could negatively impact the medical care and safety of all patients.

Findings:

1. On May 14, 2012, at 1:15 p.m., a tour of the Postpartum unit was conducted with the Director Women's Services (DWS).

The following was observed:

-The storage closet in the examination room contained a 4-0 Vicryl suture with an expiration date of January 2011.
-The postpartum supply storage room contained, two 4.5 fluid ounce fleets enemas with expiration dates of September 2011.

A concurrent interview was conducted with the DWS, she stated the supplies were expired and should have been removed from the unit.

On May 14, 2012, at 11 a.m. and 3:20 p.m., a tour of L&D was conducted with the DWS.

The following was observed:

- In the L&D storage room, a box of "Plain Gut 0 CT-1 Taper" suture with an expiration date of July 2011.
- In Operating Room (OR) 1, a box of "Plain Gut 0 CT-1 Taper" suture with an expiration date of January 2011.
- In OR 2, a box of "0 Polysorb 3.5 metric" with an expiration date of January 2012.

A concurrent interview was conducted with the DWS, and she stated the supplies were expired and should have been removed from the unit.

During an interview with RN 20 on May 14, 2012, at 3:20 p.m., she stated it was the responsibility of the Obstetrical Technicians and the nursing staff to check for expiration dates, and if an outdated supply was found it should be discarded or returned for credit.

The facility policy and procedure titled "Bulk Stores - General Organization" revised June 2009, revealed "... All supply items should be reviewed monthly and upon issuance in respect to expiration dates. All expired items will be immediately removed ..."

2. On May 14, 2012, at 9:30 a.m., a tour of the Pediatric unit was conducted with the Director Women's Services (DWS) and the Manager Neonatal Intensive Care Unit (NICU).

In the Pediatric shower room, when the pull cord for the emergency call light was pulled it did not activate the emergency call light system.

During a concurrent interview with the Manager NICU, she attempted to pull the emergency call light cord in the Pediatric shower room and was unable to activate the emergency call light system. She stated the emergency call light system in the Pediatric shower room was not functioning.

The facility policy and procedure titled "Call Lights" revised June 2011, revealed "... Call lights are placed at each patient's bedside as well as in each bathroom as a patient safety mechanism for all patients. ..."

INFECTION CONTROL PROGRAM

Tag No.: A0749

3. On May 14, 2012, at 10:27 a.m., a utility engineer employee (UE 2), in the presence of the Director of Dietary (DOD) removed the external panel to the ice-machine located in the kitchen to show the internal tubings of the ice-making apparatus. The UE2 and the DOD observed a layer of a green substance on the internal part of the tubing, and neither person could identify what the substance was.

UE 2 stated that the only product that was used to clean the top part of the ice-making apparatus was a lime-away product. UE 2 verified three times that there were no other steps that were taken to clean the internal top-part of the ice-making apparatus. UE 2 stated that he had been assigned to clean the ice-machine's for the hospital, those located in the kitchen as well as on the nursing units, but had never received training on how to do it.

On May 14, 2012, UE 2 provided a work order document and stated that the date on the work order indicated the last time the internal top part of the ice-making apparatus was cleaned for the ice-machine located in the kitchen, which was dated July 14, 2011. According to the same work order, the previous time the ice-making apparatus was located in the kitchen was cleaned prior to July 14, 2011, was on August 10, 2010. UE 2 stated, "I try to get to the ice-machine's [to clean them] semi-annually but I m not always able to." UE 2 stated that there was not a tracking mechanism in place to tell him when the next cleaning schedule would be, only when the last one was completed per a work order. According to the ice-machine's manufacturer's guidelines for the ice-machine located in the kitchen, the cleaning and sanitizing maintenance should have been completed at least every six months, and local water conditions may require that cleaning be performed more often.

According to the ice-machine's manufacturer's guidelines for the ice-machine located in the kitchen, the ice-machine should have had two distinct functions completed which would have consisted of a cleaning step, and a sanitizing step. According to UE 2 he had only performed a cleaning step. UE 2 was unaware that the ice-machine required a sanitizing step. During the same interview on May 14, 2012, at 10:27 a.m., UE 2 stated that he was responsible for cleaning of the ice-machine ' s located on the nursing unit ' s. UE 2 stated that the system was the same, in which he use only a de-scale product and "tried to get to them all on a semi-annual basis " The ice-machine was not sanitized in accordance with manufacturer's guidelines.

On May 14, 2012, at 11:30 p.m., the ice-machine located next to the nursing station on the 1st floor at the medical unit was observed to have a heavy build-up of a white and brown residue on the chute in which ice would make direct contact. Certified nursing assistant (CNA 3) observed the ice-machine chute, and stated, "It looks like mold."

Build up of a white substance with discoloration was observed on the chute's of the ice-machines located on B wing identified as the mother/baby unit on May 14, 2012, at 2:15 p.m. An environmental services employee (EVS 4), in the presence of the DOD, stated that she was responsible to clean the exterior of the ice-machine, but was not allowed to put any cleaner on the chute of the ice-machine.

On May 15, 2012, at 2:15 p.m., the administrative assistant for the engineering department, in the presence of the Director of Engineering, verified that the only product used in the ice-machine ' s ice-making apparatus portion for the ice-machine's located near the nursing units was a SafeClean ice machine cleaner. According to the manufacturer's guidelines, there should have been another step completed following the cleaning of the ice-machine, which would be to sanitize the ice-machine.

According to the "Equipment Data" log from the hospital's department of engineering, the last time the ice-machine located at c-wing, floor 1, was cleaned was on January 18, 2011, and the document indicated that the next cleaning was scheduled for "January 1, 2013." According to the manufacturer's guidelines for the ice-machine's located in the nourishment rooms by the nursing units, "Cleaning should be performed at least every 6 months, more often if conditions dictate."

The hospital's policy and procedure entitled ICE MACHINES, under the department of infection control indicated, "...The Infection Control Coordinator is to be notified when conditions of the machines may affect patient outcomes." The same policy indicated, " Environmental Services is responsible for sanitizing all ice machines throughout the hospital. Ice machines are located in nourishment areas on the nursing units an din various patient care areas throughout the hospital." On May 15, 2012, at 2:15 p.m., EVS 4 stated she was not allowed to put the cleaner she had on the chute of the ice-machine.

On May 16, 2012 at 9:10 a.m. the hospital's designated infection control coordinator stated that he was unaware that the top internal components of the hospital's ice-machine's had not been sanitized.

On May 15, 2012, at 3:20 p.m., the Director of Environmental Services stated he expected the EVS staff to use a disinfectant cleaner in which he provided the product information. According to the manufacturer of the product via a phone call placed on May 16, 2012, at 11:23 a.m., the manufacturer stated the specified disinfectant product had not been registered and approved as a foodservice type product and would not recommend for the ice-machine chutes.

The hospital did not have a system in place to ensure that the ice-machine' hospital-wide were maintained in a clean and sanitized manner which placed the medically compromised patients at potential risk for an infection.




28294

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

1. To ensure the breast milk in the Neonatal Intensive Care Unit (NICU) was stored and maintained according to national standards, and the facility's policy, procedure, and temperature log were congruent with each other;

2. To ensure the mattress on an infant warmer was not torn and held together with multiple pieces of tape in place; and,

3. To ensure the infection control officer had a system in place in which would have identified that the facility's ice-machines were not sanitized in accordance with the manufacturer's guidelines.

These failures placed all patients at potential risk for an infection.


Findings:

1. On May 15, 2012, at 8:35 a.m., a tour of the NICU was conducted with the Director Women's Services (DWS) and Manager NICU.

The "NICU Temperature Log" for breast milk revealed the acceptable ranges for breast milk storage in the freezer was "up to 0°F (Fahrenheit)" and in the refrigerator was "36 - 42°F." The instructions revealed "... If the temperature falls out of the range then document actual temp. (temperature) and adjust refrigerator temp. control knob. Recheck temp. in 30 minutes and document in the space provided (in the comments). If the temp. is still out of acceptable range then check the food before transfer to another refrigerator, for medications contact pharmacy, then notify engineering department immediately. Document all actions taken to correct any temperatures that fall out of acceptable range. ..."

The "NICU Temperature Log" for breast milk storage dated May 2012, revealed:

a. On May 3, 2012, at 8:05 p.m., the refrigerator temperature was 46°F, and the "comments" indicated "temp adjusted." There was no indication a recheck of the temperature had been done, or engineering was notified.
b. On May 8, 2012, at 7:05 p.m., the refrigerator temperature was 32°F, and the "comments" indicated
"temp adjusted." There was no indication a recheck of the temperature had been done, or engineering was notified.
c. On May 15, 2012 (actual date was May 14, 2012), at 8 p.m., the refrigerator temperature was 44°F, and the "comments" indicated "temp adjusted." There was no indication a recheck of the temperature had been done, or engineering was notified.

During an interview with RN 22 on May 15, 2012, at 8:40 a.m., she stated the refrigerator temperature recorded for May 15, 2012, at 8 p.m., was actually May 14, 2012, at 8 p.m. In addition, she stated the nursing staff should have gone back and rechecked the temperature after they had adjusted the temperature to make sure the temperature was within range.

During an observation with RN 22 on May 15, 2012, at 8:45 a.m., in the NICU, she looked at the breast milk refrigerator thermometer which revealed the temperature of the refrigerator to be 44°F (out of temperature range).

During a concurrent interview with RN 22, she stated she would adjust the temperature of the refrigerator to be colder. In addition, RN 22 stated she did not know if the temperature of the refrigerator had been out of range since the previous reading of 44°F which was 12 hours and 45 minutes ago.

On May 15, 2012, at 1:30 p.m., a tour of the NICU was conducted with the Manager NICU and RN 22.

The "NICU Temperature Log" for breast milk dated May 2012, revealed on May 15, 2012, at 10:15 a.m., the temperature of the refrigerator was 50°F, and "breast milk taken out and put in step down refrigerator."

During a concurrent interview with the Manager NICU and RN 22, they stated a work order was placed with engineering on May 15, 2012, at 10:20 a.m. In addition, they stated on May 14, 2012, at 8 p.m., when the temperature was found to be out of range, the temperature was adjusted but the staff did not recheck and record another temperature after the temperature adjustment. The Manager NICU and RN 22 stated a work order should have been placed at this time and the house supervisor notified.

The facility policy and procedure titled "Breast Milk Storage in the NICU" revised April 2011, revealed "... Freezer temperature range should be 4 degrees F to 14 degrees F and refrigerator temperature range should be 36 degrees F to 46 degrees F. The temperature must be recorded in the breast milk log book."

During an interview with the Manager NICU, on May 15, 2012, at 1:35 p.m., she stated she "believed" the breast milk in the breast milk refrigerator was still "good" after 12 1/2 hours even if the temperature in the refrigerator was 44°F for 12 1/2 hours.

On May 15, 2012, at 1:35 p.m., the differences in the breast milk freezer and refrigerator temperature ranges between the facility policy and procedure and the breast milk "NICU Temperature Log" were reviewed with the Manager NICU. The Manager NICU stated she "believed" the facility policy temperature ranges were correct but she would need to check clinical references. In addition, the Manager NICU stated if the refrigerator temperature was out of range for 12 1/2 hours the breast milk would need to be "tossed."

On May 15, 2012, at 2 p.m., a tour of the Nursery was conducted with the Manager NICU.

An observation was made of the Nursery breast milk refrigerator which contained breast milk.

During a concurrent interview with the Manager NICU, she stated the breast milk in the Nursery breast milk refrigerator was the breast milk which had been moved from the NICU breast milk refrigerator.

During an interview with the Chief Nursing Officer (CNO), on May 15, 2012, at 5 p.m., he stated the breast milk would need to discarded and the parents notified.

The Academy of Breastfeeding Medicine Protocol #8: Human Milk Storage Information for Home Use for Full-Term Infants dated March 2010, revealed breast milk storage guidelines to include storing breast milk in the refrigerator at 39°F (Fahrenheit) and in the freezer at 0°F.

The Centers for Disease Control and Prevention (CDC) dated March 4, 2010, revealed breast milk storage guidelines, for use with healthy full term infants, to include storing breast milk in the refrigerator at 39°F and in a freezer compartment of a refrigerator with separate doors at 0°F.

2. On May 14, 2012, at 1 p.m., a tour of the Postpartum unit was conducted with the Director Women's Services (DWS).

In the examination room, there was an infant warmer with a mattress covered by a blanket. The mattress had a tear in one of the corners which was approximately three inches by three inches. The tear was taped with multiple pieces of tape.

On May 14, 2012, at 1:30 p.m., an interview was conducted with RN 21. She stated the infant warmer was used when laboratory tests were done, circumcisions were performed, and sometimes when a physician wanted to examine the infant. RN 21 stated nursing cleaned the infant warmer, to include the mattress, using sani-wipes, and the mattress could be cleaned with the tape affixed to the torn corner.

On May 15, 2012, at 11:15 p.m., a tour of the Postpartum unit was conducted with the DWS. The infant warmer mattress, in the examination room, remained available for use.

On May 16, 2012, at 9:10 a.m., an interview was conducted with the Infection Control Practitioner (ICP). He stated a surface could not be disinfected if the surface had tears, and it was not acceptable to tape a mattress. In addition, the ICP stated there was no specific education that had been done in regards to torn mattresses.