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Based on interviews and a tour of the hospital conducted with Emergency Department Registered Nurse (EDRN) 1, the hospital failed to comply with the provisions of 42CFR489.20(q) when it failed to post signage in the treatment areas of the emergency department, specifying the rights of individuals presenting to the hospital for evaluation of an emergency medical condition. This could lead to violations of patient rights.

Findings:

A tour of the emergency department was conducted on 3/12/12 at approximately 9 AM. The treatment areas of the emergency department contained no signage specifying the rights of individuals presenting to the hospital for evaluation of an emergency medical condition, or indicating whether the hospital participates in the Medicaid program. When interviewed, EDRN 1 seemed unaware that signage in the treatment areas of the emergency department, specifying patient rights, was required.

Based on interview and record review the facility failed to ensure that 1 of 42 sampled patients (Patient 44) right to make an informed consent for blood transfusion was protected as evidenced by the patient (or their representative) not being fully informed of the risks and benefits of the blood transfusion. This failure had the potential for a transfusion to be performed to a patient that might not have consented to the transfusion if the patient had been fully informed of the risks, benefits and alternatives to the blood transfusion.

Findings:

Record review revealed Patient 44 was admitted to the facility on 3/10/12 with a diagnosis of acute (rapid onset) CHF (congestive heart failure: a condition in which the heart can't pump enough blood to meet the body's needs).

Record review of the Physician Orders, dated 3/11/12 at 1 PM revealed an order to transfuse 1 unit of PRBC (packed red blood cells).

Record review of the facility form titled, "Consent To Blood Transfusion" dated 3/11/12 for Patient 44 revealed an area on the form for Physician Certification. The statement indicated the following: "I have provided the patient with a copy of the state department of health services information sheet, A Patient's Guide to Blood Transfusion, concerning the advantages, disadvantages, risks and benefits of autologous (obtained from the same person) blood and of directed and non-directed homologous (similar in structure) blood from volunteers. ...". This area had a place for the physician's signature and the form was not signed.

During an interview on 3/12/12 at 10:40 AM, Registered Nurse (RN) 2 confirmed that Patient 44 received one unit of blood on 3/11/12. When asked who discusses the risks and benefits of the blood transfusion with the patient, RN 2 stated that the physician usually discusses the risks and benefits to the patient. After a concurrent review of the physicians progress notes for Patient 44 with RN 2, she confirmed that there was documentation in the physician notes recommending a transfusion. RN 2 confirmed that the physician did not sign the form titled, "Consent To Blood Transfusion" and also stated that there was no documentation found in the medical record showing that the physician discussed the risks and benefits with Patient 44.

Record review of the facility's policy and procedure titled, "Administration of Blood: Packed Cells/Whole Blood", dated 4/10, revealed the following: "Policy: Upon written order from a physician, the RN (Registered Nurse) shall administer blood to patients. In compliance with the Paul Gann Blood Safety Act, patients shall be provided information regarding blood transfusion options by the physician."

Record review of the facility's policy and procedure titled, "Blood Product, Identification for Administration", dated 4/10, revealed the following: "Procedure: 2. Informed Consent and patient consent shall be verified prior to blood administration."

Based on record reviews and staff interviews, the hospital's Quality Program failed to measure, analyze and track quality indicators related to dietitian recommendations being carried out by the physician. This failure resulted in the hospital's inability to identify when the dietitian's recommendations were not carried out and in it's inability to identify opportunities for improving the process to ensure that the nutritional needs of the patients were met in a timely manner.

Findings:

The medical record for Patient 22 was reviewed on 3/14/12. The patient was admitted to the hospital on 3/8/12 with diagnoses that included protein malnutrition, urinary tract infection and a stage IV pressure ulcer on the left hip (A stage IV pressure ulcer is a bed sore where there is full thickness tissue loss with exposed bone, tendon or muscle). There was an order for a tube feeding for Jevity, one can QID (four times a day). Jevity is a nutritional formula used for tube feeding. There were no other orders for tube feeding for the patient.

A review of the Nutrition Notes indicated an initial nutrition assessment was completed on 3/8/12 by Registered Dietitian 2 (RD 2). The note recommended Jevity continuous feeding at 20 milliliters (ml) per hour and increase as tolerated to 45 ml per hour to provide 1145 calories and 47.8 grams of protein. The note indicated that a follow-up reassessment would be required in 2 to 3 days.

The RD recommendations were not carried out. There was no documented evidence that the physician was informed of the RD recommendations.

A follow-up nutrition note dated 3/12/12 was reviewed. The note indicated that the patient was still on one can of Jevity four times a day and it was inadequate to meet the patient's needs. The RD note further indicated a recommendation to consider changing the tube feeding formula to Suplena to meet 100% of the patient's calorie needs and 92% of the patient's protein needs.

A review of the physician's orders indicated that the new tube feeding recommendations were not ordered. Again, there was no documented evidence that the physician was notified of the dietitian's recommendations. There was no documented evidence that the RD contacted the physician to ensure that the nutrition plan of care was initiated to meet the patient's needs.

The patient had been in the hospital for six days and the tube feeding did not meet the patient's nutrition needs, despite having a diagnosis of protein malnutrition and a deep wound that required additional nutrition to improve the healing process.

During an interview with the Director of Food and Nutrition Services (DFNS) on 3/15/12 at 10:00 AM, she stated that the department had not identified the RD recommendations not being carried out as a problem. Although the department was analyzing other performance indicators, they were not tracking this specific matter. She was unable to state how the hospital was able to ensure an improvement in the process of communicating nutrition recommendations to the physicians.

A review of the hospital's policy titled, "Performance Improvement", dated 1/12, revealed that the purpose of the policy was to establish procedures for the development and monitoring of the performance improvement program in the Food and Nutrition Services department. It further stated that the Food Service Director in conjunction with the Clinical Dietitians, initiates, coordinates, monitors and evaluates department services for appropriateness and effectiveness of nutrition care and food services.

The DFNS confirmed that tracking the data on the RD's recommendations that were being carried out would help to improve the chances that patients' nutritional needs would be met in a timely manner.

Based on interview and record review, the facility failed to ensure that there was written documentation of a QA (Quality Assurance) plan to evaluate the facility's patient acuity system for assignment of nursing staff on the ICU (Intensive Care Unit) and the DOU (Direct Observation Unit) to validate compliance with staffing ratios. This failure resulted in the ICU and DOU making patient assignments that were not based on an acuity system to ensure compliance with meeting patient care needs. This failure had the potential for the patients' care needs to not be met.


Findings:

Acuity: One of the parameters considered in patient classification systems that are designed to serve as guidelines for the allocation of the nursing staff and to justify staffing decisions.

A review of AFL (All Facility Letter) 07-26 addressed to all general acute care hospitals, dated 10/1/07 and effective 1/1/08 revealed the following: "...It is imperative that hospitals staff according to patient acuity. Hospitals must ensure that they are staffed to assure that the needs of the patients are met. It is far more important that hospitals pay attention to the patient classification system and the needs of the patient rather than the minimum staffing requirements. Hospitals are reminded that the regulations only reflect the minimum standards for staffing and that to be in compliance with the regulations refer to Section 70217(b).

Review of the Title 22, CA Code of Regulations, Section 70217(b), revealed the following: In addition to the requirements of subsection (a), the hospital shall implement a patient classification system as defined in Section 70053.2 above for determining nursing care needs of individual patients that reflects the assessment, made by a registered nurse, of patient requirements and provides shift-by-shift staffing based on those requirements.

Patient Classification System, Title 22, CA Code of Regulations, Section 70053.2 revealed the following:

(a) Patient classification system means a method for establishing staffing requirements by unit, patient, and shift that includes,
(1) A method to predict nursing care requirements of individual patients.
(2) An established method by which the amount of nursing care needed for each category of patient is validated for each unit and for each shift.
(4) A mechanism by which the accuracy of the nursing care validation method described in (a)(2) above can be tested. This method will address the amount of nursing care needed, by patient category and pattern of care delivery, on an annual basis, or more frequently, if warranted by the changes in patient populations, skill mix of the staff, or patient care delivery model.

Review of the facility's staffing assignments for the ICU and DOU from the period of 3/5/12 through 3/12/12 revealed no evidence that a patient classification system was used to validate adequacy of the staffing assignments for the ICU and the DOU.

During an interview on 3/12/12 at 9:25 AM, CN 1 (Charge Nurse) of the ICU and DOU units stated that she makes staffing assignments based on the patients' needs and also taking into consideration if the patient is on any vasopressors (an agent that causes the blood pressure to rise). CN 1 further stated that the maximum bed capacity on the DOU unit was 8 beds and they used 3 RN's on that unit. CN 1 added that the nurse to patient ratio was three to one (3 patients to one nurse) on the DOU. CN 1 confirmed that assignments were not based on a patient classification system.

During an interview on 3/12/12 at 2:23 PM, the Director of ICU/DOU confirmed that the ICU and DOU had no patient classification or acuity system. He stated that in the ICU, there either was one RN (Registered Nurse) with two patients or one RN with one patient if the patient was really sick. The Director of ICU/DOU failed to provide evidence that a patient classification system existed for the ICU and the DOU.

A review of the facility's policy and procedure titled, ICU Scope of Service revealed the following, "...Written policies and procedures are developed and maintained by the Director in consultation with other health care professional and Administration. Policies are approved by the Policy/Procedure Committee, which meets at least quarterly, and also by the Medical Executive Committee and the Governing Board. The Policies and procedures comply with the standards as defined by the State of California Licensing Regulations (Title 22) and the Healthcare Facilities Accreditation Program (HFAP).

Further review of this same policy revealed the following under the section titled, Staffing Plan: "....Staffing levels are established based on patient needs and staffing policies are established by the Title 22 requirements, as well as (facility named here) guidelines for acuity based staffing. The licensed nurse to patient ratio shall be 1:2 or fewer at all times in the intensive care unit. Staffing patterns are upgraded according to patient acuity. Criteria exist to determine the need for 1:1 staffing in the intensive care unit...".

A review of the facility's policy and procedure titled, DOU (Definitive Observation Unit) Scope of Service revealed the following under Staffing Plan: "... Staffing levels are established based on patient needs and staffing policies are established by the Title 22 requirements, as well as (facility named here) guidelines for acuity based staffing. The licensed nurse to patient ratio shall be 1:3 in the DOU".

During an interview on 3/15/12 at 10:23 AM, the PIM (Performance Improvement Manager) stated that QA (Quality Assurance) was not looking at the classification system on the ICU and DOU as one of their performance improvement indicators. The PIM added that she would have the CNO and the Director of ICU/DOU talk to the CDPH (CA Dept of Public Health) surveyor regarding this issue.

During an interview on 3/15/12 at 1:32 PM, the CNO (Chief Nursing Officer) confirmed that the ICU and the DOU did not have a patient classification system. The CNO also confirmed that the facility did not have a committee that met at least annually to validate the adequacy of staffing on the various units within the facility.

Based on staff interview and facility record review, the facility failed to ensure that a Registered Nurse supervised and evaluated the nursing care for 2 of 42 sampled patients (Patients 41 and 57) as evidenced by the following:

1. For Patient 41, the facility failed to reassess and evaluate the pain status after the administration of a pain medication . This deficient practice had the potential to affect the health and well being of Patient 41.

2. For Patient 57, the registered nurse did not reassess the patient after administering Ativan (a medication used for the treatment of anxiety) for complaints of difficulty breathing. This failure had the potential to result in Patient 57 being ineffectively treated and managed with the highest level of care.

Findings:

1. On 3/12/12, a review of Patient 41's medical record was conducted. The admitting face sheet revealed that Patient 41 was admitted to the facility on 3/11/12 with a spontaneous rupture of membranes and preterm labor. Further documentation revealed that Patient 41 underwent a cesarean section (surgical delivery of an infant) on 3/11/12, at 12:00 PM, with successful delivery of an infant baby boy.

On 3/12/12, a review of Patient 41's medical record was conducted. Patient 41's nursing progress notes, dated 3/12/12, documented that Toradol 30 milligram tablet PO (taken by mouth) for pain relief was administered on 3/12/12 (Toradol is a medication given for pain relief).

There was no documented evidence in Patient 41's medical record or from other facility sources that Patient 41 was reassessed for the effectiveness of pain relief after the Toradol administration on 3/12/12.

On 3/12/12, a review of the facility's policy and procedure titled, "PAIN MANAGEMENT" dated 10/11, stipulated, "...The facility shall do an initial assessment and reassessment of pain on all patients, which shall include patient perception of, quality, radiation, severity and time of pain, in order to effectively mange their pain ..." Section 1.5, stipulated, "Clinical approach includes an evaluation of the effectiveness of the pain intervention."

On 3/12/12, a review of the facility's policy and procedure titled, "MEDICATION ADMINISTRATION", dated 8/10, stipulated in Section (1) (g), "...The licensed staff shall be responsible for assuring that the "seven rights" of medication administration are employed at all times that includes 'Response of the Patient' , and in Section (8), "...Following medication administration, the Licensed Staff shall assess the patient for efficacy, adverse effects and/or toxicity."

Therefore, the facility failed to reassess Patient 41's pain status or check for any adverse reactions to the pain medication, Toradol, after its administration on 3/12/12 as per facility policy.

On 3/12/12, at approximately 10:30 AM, at the same time as the finding, the Director of Labor Delivery Recovery Post-partum (LDRP) Department confirmed the finding that the nursing staff did not reassess Patient 41's pain status, or check for any adverse reaction to the pain medication, "Toradol", after it's administration on 3/12/12.



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2. A record review on 3/15/12, at 9 AM, of Patient 57's medical record, indicated that the patient was admitted to the hospital on 2/4/11, with septic shock (a lethal drop in blood pressure due to bacteria in the blood stream), and complained of nausea and vomiting and soreness of the neck. On 2/11/11, the physician's diagnosed the patient with acute myeloid leukemia (cancer of the blood).

A record review on 3/15/12, at 9 AM, of Patient 57, indicated that on 2/12/11 at 8:45 PM, the patient reported to the nurse that she was "Having a hard time breathing." The nurse administered Ativan (for anxiety).

A record review on 3/15/12, at 9 AM, of Patient 57, revealed no reassessment was conducted to determine the patient's response to the Ativan or if it resolved her difficulty of breathing.

An interview and a concurrent record review, on 3/15/12, at 9:30 AM, with the hospital Chief Nurse Officer (CNO) and the Manager for Performance Improvement was conducted. After review of the medical record, the CNO and the Performance Improvement Manager were unable to find a nursing reassessment of the effectiveness of Ativan for Patient 57. There was no reassessment of Patient 57's complaint of difficulty breathing.

A record review, on 3/15/12, at 10 AM of the hospital policy titled, "Assessment/Reassessment of Patients-Interdisciplinary", revised 2/11, was reviewed. The policy indicated that, "The patient shall be reassessed: a. To determine response to medication, treatment, and nursing interventions. b. When there is a significant change in condition." , and "the patient's response to treatments, procedures and medications administered shall be documented in Meditech" (the electronic medical records system).

Based on interview and nursing assignment review, the facility failed to ensure that nursing assignments on the ICU (Intensive Care Unit) and DOU (Definitive Observation Unit) were based on a patient classification/acuity system in accordance with the needs of each patient admitted to those units. This failure had the potential for the patients' care needs to not be met once admitted to the ICU and/or the DOU.

Findings:

Acuity: One of the parameters considered in patient classification systems that are designed to serve as guidelines for allocation of nursing staff, to justify staffing decisions.

A review of AFL (All Facility Letter) 07-25 addressed to all general acute care hospitals, dated 10/1/07 and effective 1/1/08 revealed the following: "...It is imperative that hospitals staff according to patient acuity. Hospitals must ensure that they are staffed to assure that the needs of the patients are met. It is far more important that hospitals pay attention to the patient classification system and the needs of the patient rather than the minimum staffing requirements. Hospitals are reminded that the regulations only reflect the minimum standards for staffing and that to be in compliance with the regulations refer to Section 70217(b).

Review of the Title 22, CA Code of Regulations, Section 70217(b), revealed the following: In addition to the requirements of subsection (a), the hospital shall implement a patient classification system as defined in Section 70053.2 above for determining nursing care needs of individual patients that reflects the assessment, made by a registered nurse, of patient requirements and provides shift-by-shift staffing based on those requirements.

Patient Classification System, Title 22, CA Code of Regulations, Section 70053.2 revealed the following:

(a) Patient classification system means a method for establishing staffing requirements by unit, patient, and shift that includes,
(1) A method to predict nursing care requirements of individual patients.
(2) An established method by which the amount of nursing care needed for each category of patient is validated for each unit and for each shift.
(4) A mechanism by which the accuracy of the nursing care validation method described in (a)(2) above can be tested. This method will address the amount of nursing care needed, by patient category and pattern of care delivery, on an annual basis, or more frequently, if warranted by the changes in patient populations, skill mix of the staff, or patient care delivery model.

Review of the facility's staffing assignments for the ICU and DOU from the period of 3/5/12 through 3/12/12 revealed that there was no evidence that a patient classification system was used to validate the adequacy of the staffing assignments for the ICU and the DOU.

During an interview on 3/12/12 at 9:25 AM, CN 1 (Charge Nurse) of the ICU and DOU units stated that she makes staffing assignments based on the patients' needs and also taking into consideration if the patient is on any vasopressors (an agent that causes the blood pressure to rise). CN 1 further stated that the maximum bed capacity on the DOU unit was 8 beds and they used 3 RN's on that unit. CN 1 added that the nurse to patient ratio was three to one (3 patients to one nurse) on the DOU. CN 1 confirmed that assignments were not based on a patient classification system.

During an interview on 3/12/12 at 11:24 AM, the Director of ICU stated that in the ICU, every patient is a 1:2 (one nurse per two patients). He also stated that there was criteria for 1:1 (one nurse per one patient) assignments.

A review of the facility's ICU policy and procedure on 1:1 criteria revealed the following:

"1. The following physiological components to be considered for a 1:1 ratio:

1.1 Intra-aortic balloon patients
1.2 Impella Catheter System
1.3 Organ Procurement
1.4 Active GI bleeds with hemodynamic instability
1.5 Acute coagulation instability
1.6 Hemodynamic instability with 2 or more of the following:
1.6.1 Vasoactive drips requiring frequent titration
1.6.2 Hypoxia refractory to mechanical ventilation
1.6.3 Pulmonary Artery catheter with cardiac parameter every two hours or more frequent.

During an interview on 3/12/12 at 2:23 PM, the Director of ICU/DOU confirmed that the ICU and DOU had no patient classification or acuity system. He stated that in the ICU either there was one RN (Registered Nurse) with two patients or one RN with one patient if the patient was really sick. The Director of ICU/DOU was unable to provide evidence that a patient classification system existed for the ICU and the DOU.

A review of the facility's policy and procedure titled, ICU Scope of Service revealed the following, "...Written policies and procedures are developed and maintained by the Director in consultation with other health care professional and Administration. Policies are approved by the Policy/Procedure Committee, which meets at least quarterly, and also by the Medical Executive Committee and the Governing Board. The Policies and procedures comply with the standards as defined by the State of California Licensing Regulations (Title 22) and the Healthcare Facilities Accreditation Program (HFAP).

Further review of this same policy revealed the following under the section titled, Staffing Plan: "....Staffing levels are established based on patient needs and staffing policies are established by the Title 22 requirements, as well as (facility named here) guidelines for acuity based staffing. The licensed nurse to patient ratio shall be 1:2 or fewer at all times in the intensive care unit. Staffing patterns are upgraded according to patient acuity. Criteria exist to determine the need for 1:1 staffing in the intensive care unit...".

A review of the facility's policy and procedure titled, DOU (Definitive Observation Unit) Scope of Service revealed the following under Staffing Plan: "... Staffing levels are established based on patient needs and staffing policies are established by the Title 22 requirements, as well as (facility named here) guidelines for acuity based staffing. The licensed nurse to patient ratio shall be 1:3 in the DOU".

During an interview on 3/15/12 at 12:58 PM, the Director of ICU/DOU stated that in the ICU there is one RN to two patients and one RN to one patient if the patient is on a balloon pump (IABP, intra-aortic balloon pump is a mechanical device that increases myocardial [muscular tissue of the heart] oxygen perfusion while at the same time increasing cardiac [relating to the heart] output).

During an interview on 3/15/12 at 1:32 PM, the CNO (Chief Nursing Officer) confirmed that the ICU and the DOU did not have a patient classification system. The CNO also confirmed that the facility did not have a committee that met at least annually to validate the adequacy of staffing on the various units within the facility.

Based on interviews, a tour of the hospital and a review of 22 open and closed medical records, the hospital failed to ensure that medications had been administered in a safe manner to meet the needs for 1 of 22 patients (Patient 4) whose medical record was reviewed. This failure had the potential to lead to inappropriate medications being administered.

Findings:

A tour of the cardiac cath lab recovery area was conducted on 3/12/2012 at approximately 11:00 AM. Patient 2 was interviewed in the recovery area and the medical record was reviewed.

The record review revealed a physician order for "Morphine Sulfate 2 mg IV every 30 minutes x 2 doses PRN (as needed) and every 2 hours for Chest Pain". The intensity of pain, for the administration of Morphine Sulfate, a potent narcotic, was not specified in the physician order. RN K and RN D were interviewed regarding the narcotic orders. Both RN providers seemed unaware that a numerical assessment for pain intensity was required for the administration of Morphine. When interviewed, RN K stated that she assessed the pain level of the patient prior to deciding if medication should be administered.

Based on interview and record review, the hospital failed to ensure that the progress and response to medications were accurately recorded for 1 of 42 sampled patients (Patient 57) following the administration of Lidocaine (Used to numb and provide pain relief) and Ativan (a potent benzodiazepine used to treat agitation) after Patient 57 complained of having a "Hard time breathing." Additionally, the hospital failed to ensure that Patient 57 was notified regarding a change in condition. These failures resulted in the potential for Patient 57's quality of care needs not being met.

Findings:

A record review on 3/15/12, at 9 AM, of Patient 57's medical record, indicated that the patient was admitted to the hospital on 2/4/11, with septic shock (a lethal drop in blood pressure due to bacteria in the blood stream), complaints of nausea and vomiting and soreness of the neck. On 2/11/11, the physician's diagnosed the patient with acute myeloid leukemia (cancer of the blood).

A record review on 3/15/12, at 9 AM, of Patient 57, indicated that on 2/12/11 at 8:45 PM, the patient reported to the nurse that she was "Having a hard time breathing." The nurse administered Ativan (for anxiety).

A record review on 3/15/12, at 9 AM, of Patient 57, revealed no documented evidence of Patient 57's reassessment, to determine the patient's response to the Ativan or if it resolved her difficulty breathing.

A record review on 3/15/12, at 9 AM, of Patient 57's vital signs, taken by a Licensed Vocational Nurse (LVN) at 10:06 PM, included a heart rate of 114 (normal is 60 to 100) and a respiratory rate of 28 (normal is less than 22). There were no nursing assessments of the abnormal heart rate and respiratory rate that were documented and there was no documented evidence of notification of the physician that was found.

A record review on 3/15/12, at 9 AM, of Patient 57 indicated, that on 2/13/11 at 12:40 AM, the patient complained of the difficulty of swallowing and throat swelling. Lidocaine was administered at 2 AM, however there was no follow-up assessment to see if there was relief of difficulty swallowing and throat discomfort. Additionally, there was no documentation that the nurse practitioner, who ordered the Lidocaine, assessed Patient 57 after she complained of difficulty swallowing and throat swelling.

A record review on 3/15/12, at 9 AM, of Patient 57, indicated that on 2/13/11 at 6:39 AM the patient's heart rate was 125 (elevated). There was no nursing assessment of the increasingly abnormal vital signs, and there was no notification to the physician that was documented.

A record review on 3/15/12, at 9 AM of Patient 57 indicated that on 2/13/11, at 12 PM, the physician saw the patient and ordered that she be transferred to the Intensive Care Unit (ICU) for neck swelling and acute respiratory distress. Patient 57 was intubated (Insertion of a tube to ensure an airway) on 2/13/11 at approximately 12:15 PM. Patient 57 was noted as having stridor breath sounds (Breathing sounds which indicated an airway occlusion) and her airway was documented as "very narrowed".

An interview and a concurrent record review, on 3/15/12, at 9:30 AM, with the hospital Chief Nurse Officer (CNO) and the Manager for Performance Improvement were conducted. After review of the medical record, the CNO and the Performance Improvement Manager were unable to find a nursing reassessment of the effectiveness of Patient 57's response to the Ativan and Lidocaine. Additionally, there was no reassessment of Patient 57's complaint of difficulty breathing and there was no documentation of notification of the physician.

A record review, on 3/15/12, at 10 AM of the hospital policy titled, "Assessment/Reassessment of Patients-Interdisciplinary" revised 2/11 was reviewed. The policy indicated that, "The patient shall be reassessed: a. To determine response to medication, treatment, and nursing interventions. b. When there is a significant change in condition." , and "the patient's response to treatments, procedures and medications administered shall be documented in Meditech" (the electronic medical records system).

Based on interview and record review, the facility failed to ensure that all verbal orders were authenticated, dated and timed by the ordering practitioner within 48 hours per regulation and the facility policy for 1 of 42 sampled patients (Patient 43). For Patient 43, five physician telephone orders were not authenticated, dated and timed by the ordering physician. This failure resulted in the potential for errors in transcription and the increased potential to negatively affect patient care.

Findings:

A record review on 3/12/12, at 9:45 AM of Patient 43 indicated that the patient was admitted on 3/1/12, for abdominal pain and mesenteritis (inflammation of a tissue which is attached to the small intestine).

A record review on 3/12/12, at 9:45 AM of Patient 43's physician telephone orders dated 3/4/12 at 6:15 PM, 3/5/12 at 5 AM, 9 AM, and 11:30 AM, and on 3/9/12 at 2:45 PM were not authenticated (validated), dated and timed by the ordering physician.

An interview and a concurrent record review were conducted on 3/12/12 at 11:30 AM with the Intensive Care Unit (ICU) Director. He stated that the physician orders were supposed to be signed within 48 hours.

A record review of the facility's Medical Staff Bylaws, page 6 in the section titled, 3.0 Orders revealed the following: "Verbal orders shall be written on the Physician Order Sheet and signed by the person to whom dictated and shall be followed by the name of the practitioner dictating the order and shall be authenticated by the practitioner within forty-eight (48) hours."

Based on staff interview and facility record review, the facility failed to ensure that all pain medication orders written by the subscriber had clear, well defined pain scale ranges written on the order prior to its administration for 1 of 42 sampled patients (Patient 41). This deficient finding had the potential of unnecessary medication being administered affecting the health and safety of Patient 41.

Findings:

On 3/12/12, a review of Patient 41's medical record revealed that Patient 41 was admitted to the facility on 3/11/12 with spontaneous rupture of membranes and preterm labor. Further documentation revealed that Patient 41 underwent a successful cesarean section (surgical delivery of an infant) on 3/11/12 at 12:00 PM.

On 3/12/12, a review of Patient 41's medical record was conducted. The Medication Administration Record (MAR) dated 3/11/12 through 3/12/12 documented the following pain medication orders:

a. Toradol 30 milligrams NP, may repeat x 4, every 4 hours PRN (as needed).
b. Nubain 10 milligrams SQ (given subcutaneously).
c. Morphine Sulfate 2 milligrams IV (given intravenously) every 30 minutes.
d. Dilaudid 1 milligram IV (given intravenously) every 2 hour PRN pain.
e. Norco 10/325 milligrams 2 tablets by mouth every 4 hours PRN severe pain.

There was no documented evidence in the Physicians' Order Sheet or on the Medication Administration Record, dated 3/11/12 through 3/12/12, that a clear, well defined pain range scale (a pain scale from 0 to 10 designating on the scale when the patient's perception of pain was considered to be mild, moderate or severe) was included in the written pain medication orders prior to its administration.

There was no documented evidence that the pharmacist reviewed the physician's pain medication orders for appropriateness prior to its administration to minimize the potential occurrence of adverse events and to prevent the administration of unnecessary medications. The hospital pharmacy must ensure that medication orders are accurate and check for irregularities of written orders by the subscriber. According to the American Society of Health-Systems Pharmacists' (ASHP) professional standards requires a pharmacist to ensure the safety and effectiveness of drug therapy.

Therefore, the hospital pharmacy should have clarified the physician's order to make certain the drug was administered as intended or that the dose was appropriate and that a pain scale range was included on the written pain medication orders prior to administration. There was no evidence in Patient 41's medical record that a pharmacist clarified the orders which created an unsafe patient care environment.

On 3/12/12, a review of the facility's policy and procedure titled, "PAIN MANAGEMENT " dated 10/11, documented, "...pain scale shall be used to document and evaluate pain level" prior to administering pain medications.

On 3/12/12, at the time of the finding, the Director of Labor Delivery Recovery Post-Partum (LDRP) Department confirmed the finding that the pain medication orders written by the physician should have included pain scale ranges prior to its administration and therefore constitutes an invalid order.

Based on observation, interviews and a tour of the hospital, the hospital failed to ensure that outdated, mislabeled or otherwise unusable medications were discarded to ensure patient safety. This could lead to the unsafe use of fluids and electrolytes for patient use for a universe of 84 patients.

Findings:

A tour of the surgical areas was conducted on 3/12/12 at approximately 10:45 AM. The warming cabinet was inspected with Operating Room (OR) Tech 1, OR Tech 2 and the Interim OR Director. When the warming cabinet was opened, 12 one liter bags of Normal Saline and lactated ringers for intravenous infusions as well as 4 one liter Bottles of sodium chloride for irrigation were found. These bottles and IV solution bags contained no date or time indicating when these items were placed in the warming cabinet. The staff agreed these had to be discarded to ensure patient safety.

Based on interviews, a review of documents supplied by the hospital and a tour of the hospital, the hospital failed to implement policies and procedures to accurately reflect how the facility would ensure that the protective barrier integrity met the needs of its personnel and patients. This could lead to unnecessary radiation exposure for a universe of 84 patients.

Findings:

A tour of the hospital was conducted on 3/13/12 at approximately 11:00 AM. The radiology protective aprons in the surgical areas were inspected and the maintenance logs for the radiation protection integrity of the aprons were inspected. This revealed that the aprons had been inspected for radiation protection, however the log failed to provide information or a numbering system for each protective lead apron, to indicate which apron had been evaluated for integrity, or a mechanism to identify each apron. When interviewed, Operating Room (OR) Tech 1 and OR Tech 2 agreed that the log for radiation protection integrity for each of the aprons could not be determined from the information provided on the log.

Based on observation, interviews and record reviews, the hospital failed to ensure that the nutritional needs of the patients were met in accordance with recognized dietary practices and physician's orders as evidenced by a lack of an effective system to ensure:

1.) That the dietary staff prepared patient foods according to standardized recipes.

2.) That the nutritional needs were met for one of three patients (Patient 22) whose records were reviewed for nutrition care.

These failures to ensure patients' nutritional needs were met had the potential to further compromise the nutritional and medical status for a universe of 84 patients.

Findings:

1. During a trayline observation on 3/13/12 between 12:15 and 12:45 PM, it was observed that patients on a regular diet received the same food as those patients on a low salt diet.

During an interview with the Food Service Supervisor on 3/13/12 at 12:35 PM, she stated that all the food the hospital serves is low salt. She stated that the turkey and the gravy served were low salt.

During an interview with Cook 1 on 3/13/12 at 12:45 PM, he stated that the turkey he served was a precooked turkey breast. He stated that he sliced the turkey, placed it in the pan with a small amount of liquid and no other seasoning. He also stated that the potatoes were red potatoes cut, skin intact with no salt seasoning. The gravy was made from a packet of low sodium gravy mix that he just added water to. He stated that all the items were low sodium. He did not make two different types of gravies.

A review of the diet spreadsheets for all the therapeutics diet for lunch that day showed that those patients on a regular diet should receive 2 ounces of Poultry Gravy and patients on a Low Sodium, Cardiac, Diabetic and Renal diets should receive 2 ounces of Low Sodium Poultry Gravy.

A review of the hospital's recipe for Poultry Gravy (#0268707463) dated 2004, showed ingredients for the gravy as vegetable salad oil, fresh yellow onions, fresh carrots, fresh celery, low sodium chicken base, water dried thyme, dried rosemary, ground sage, cornstarch and flour. There was no other recipe for Low Sodium Poultry Gravy.

A review of the hospital's recipe for Seasoned Roast Turkey Breast (#0465713599) dated 2004 showed ingredients that included raw turkey breast, fresh garlic, vegetable salad oil and poultry seasoning.

A review of the hospital's recipe for Oven Roasted Garlic Potatoes (#8666) dated 2004 listed ingredients as fresh peeled chef potatoes, margarine and salt-free garlic and herb seasoning.

During an interview with the Director of Food and Nutrition Services (DFNS) on 3/13/12 at 12:50 PM, she stated that she didn't know when they stopped using the standardized recipes and started using convenience products. She further stated that the nutrition analysis of the menus was based on the standardized recipes and not the convenience items. She stated that patients on a regular diet received a salt packet on their tray and were able to add salt to the low salt items. She was unable to state how patients with dementia, who were not capable of adding salt to their food and who might be at greater risk for not eating food that wasn't seasoned, would add the salt to their food, or even know to ask for it.

A review of the hospital's policy titled, "Menus and Standardized Recipes" dated 1/12 revealed that the policy is that food prepared for the patient menu will be prepared using standardized recipes. It further stated that a standardized recipe will be used for regular diets with ingredient modification made for all non-regular diets. And that recipes will be approved in advance of preparation by the Food and Nutrition Services Director.

A review of the hospital's policy titled "Food Preparation", dated 1/12, revealed that foods are prepared with consideration for appearance, retention of nutrients, flavor and texture, which are incorporated into the preparation and handling procedures specified in the recipes.

2. The medical record for Patient 22 was reviewed on 3/14/12. The patient was admitted to the hospital on 3/8/12 with diagnoses that included protein malnutrition, urinary tract infection and a stage IV pressure ulcer on the left hip. (A stage IV pressure ulcer is a bed sore where there is full thickness tissue loss with exposed bone, tendon or muscle.)

A dietary consult was ordered on 3/8/12 regarding a tube feeding because the patient was unable to eat. In addition, there was an order for a tube feeding through a nasogastric tube (a feeding tube placed through a nostril into the stomach) for Jevity, one can QID (four times a day). Jevity is a nutritional formula used for tube feeding. There were no other orders for tube feeding for the patient.

A review of the Nursing Nutrition Screen, dated 3/8/12, indicated that the patient had malnutrition.

A review of the nutrition notes indicated an initial nutrition assessment was completed on 3/8/12 by Registered Dietitian 2 (RD 2). The note indicated that the patient's estimated nutrition needs were 924 to 1155 calories initially but gradually increase needs to 1386 to 1617 calories per day. The patient's protein needs were 37 to 46 grams of protein per day. The note further recommended Jevity continuous feeding at 20 milliliters (ml) per hour and to increase as tolerated to 45 ml per hour to provide 1145 calories and 47.8 grams of protein to the patient. The note indicated that a follow-up reassessment would be required in 2 to 3 days.

During an interview with RD 2 on 3/14/12 at 3:00 PM, she stated that she spoke with the nurse and told her what she recommended on 3/8/12. She further stated that the physician order for Jevity at one can four times a day provided 1060 calories and 44.3 grams of protein a day and did not meet the patient's nutrition needs. She further confirmed that the physician order for the recommended tube feeding was never initiated. She was unable to show that the physician was ever notified of her recommendations.

A follow-up nutrition note dated 3/12/12, four days after the RD assessment, was reviewed. The note indicated that the patient was still on one can of Jevity four times a day and it was inadequate to meet the patient's needs. The note stated that the patient's estimated nutrition needs were now 1386 to 1617 calories a day and 37 to 46 grams of protein a day and the tube feeding provided only 1060 calories and 44.3 grams of protein a day. The RD note further indicated a recommendation to consider changing the tube feeding formula to Suplena to meet 100% of the patient's calorie needs and 92% of the patient's protein needs.

During a further interview with RD 2, on 3/14/12 at 3:00 PM, she was unable to state why there had been no follow-up regarding the tube feeding recommendations to ensure that the nutrition needs of the patient were met.

A review of the physician's orders indicated that the new tube feeding recommendations were not ordered. There was no documented evidence that the physician was notified of the dietitian's recommendations.

A review of the hospital's policy titled, "Nutritional Care of Patient with Impaired Skin Integrity" dated 1/12 revealed that the purpose of the policy was to assure adequate nutritional support to patients with dermal ulcer or non-healing wounds to promote healing. It furthers stated that an RD will individually assess each patient for nutrition needs and recommendations will be implemented following physician order.

A review of the hospital's policy titled "Nutrition Prioritizing Guidelines", dated 1/12, revealed that patients with full thickness skin loss and patients with a diagnosis of malnutrition were identified as "High Priority".

A review of the hospital's policy titled, "Nutrition Therapy Reassessment", dated 1/12, revealed that high nutrition outcome risk patients are reassessed in 2 to 3 days.

The patient had been in the hospital for six days and the tube feeding still was not meeting the patient's nutrition needs, despite having a diagnosis of protein malnutrition and a deep wound that required additional nutrition to improve. There was no documented evidence that the physician was ever informed of the RD recommendations to increase or change the tube feeding to meet the needs of the patient. There was no evidence that the RD conducted a timely follow-up to ensure the nutrition recommendations were implemented.

Based on interview and record review the facility failed to:

1. Ensure that the ICP (Infection Control Preventionist) provided oversight of the DOU (Direct Observation Unit) by failing to ensure that an effective infection control surveillance system was developed and implemented and failing to monitor the cleaning practices of the housekeeping staff on the DOU to ensure that the sanitation techniques, of environmental surfaces, were effective in reducing the risk of the spread of infection in the facility. This failure had the potential to result in the spread of infection to patients, visitors and employees in the facility.

2. Maintain a sanitary environment to avoid sources and transmission of infections for a universe of 84 patients. A Registered Nurse (RN 1) was observed on the DOU (Direct Observation Unit) providing direct care to a contact isolation patient and was observed removing medical supplies from a cart without first removing her isolation gown. This deficient practice had the potential of spreading and transmitting infectious microorganisms to other patients and staff.

3. Ensure that there were infection control measures to prevent the development of food borne illness and cross contamination in the food service departments and nursing nutrition pantries. Also, the hospital failed to have a thorough infection control surveillance system that monitored the conditions and practices of the dietetics services staff and nursing staff. By not having these measures and a thorough surveillance system, potentially hazardous foods had been stored, prepared and distributed under unsafe and unsanitary conditions and there was potential for such continuation in the absence of identification and remediation in a hospital.

Findings:

1. During an interview on 3/14/12 at 10:07 AM, the ICP (Infection Control Preventionist) stated that no active surveillance was occurring in the DOU in regards to hospital acquired infections in that area. The ICP stated that infected patients were cohorted (a group of individuals sharing a common characteristic, as in an infectious disease process) on the unit.

During an interview on 3/15/12 at 10:23 AM, the PIM (Performance Improvement Manager) stated that there were no current QA (quality assurance: the systematic monitoring and evaluation of various aspects of a project, service, or facility to ensure that the standards of quality are being met) activities for infection control surveillance for the DOU (Definitive Observation Unit).

Record review of the facility's Infection Control Annual Summary for 2011 revealed that the facility's Infection Control Plan was to provide a systematic, coordinated and continuous approach that included:

1. Surveillance, data collection, analysis, and reporting.
2. Monitoring, evaluating, and reporting of the organization's compliance with Infection Control policies, procedures, and practices.

During an interview on 3/15/12 at 1:32 PM, the ICP stated that the facility's infection rates were not broken down by specific units within the hospital. The ICP also stated that she did not keep a log of all terminal cleanings (the cleaning of a patient room performed after an isolated patient is discharged to decrease the risk of the spread of diseases to the next patient admitted to the room) and did not provide oversight of the DOU to ensure that the Environmental Services Department was providing a sanitary environment in the DOU by following proper procedures for cleaning and disinfecting environmental surfaces and when performing terminal cleaning after an isolation patient had been discharged.



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2. During an observation on 3/13/12, at 9:15 AM, in the hospital's Definitive Observation Unit (DOU), a registered nurse (RN 1) was observed exiting Patient 47's room (a contact isolation patient). RN 1 had performed direct patient care, while wearing a hospital gown (Used to protect and prevent the spread of infection in a contact isolation patient room). RN 1 exited Patient 47's room while wearing the hospital gown. RN 1 proceeded to obtain medical supplies from a cart that was in the hallway and contained sterile supplies. RN 1 then reentered Patient 47's room and continued to provide direct patient care.

During an interview on 3/13/12, at 10 AM, with RN 1. She stated that the reason she exited Patient 47's room with the contact isolation gown and obtained medical supplies from the cart was "because I kept my distance and removed my gloves and sanitized. I reached over, being careful not to touch anything." Additionally, RN 1 stated regarding the hospital policy, "We are not to leave the patient's room if they are on contact isolation with a gown but it is a little challenging with this space."

A record review on 3/15/12, at 1:55 PM, of the hospital policy titled, "Precautions:Standard and Isolation", formulated on February 1997 and reviewed and revised on November 2009, revealed the following under Contact Precautions, "3.6 Gown ...Remove the gown before leaving the patient's environment...".


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3a. During a trayline (patient meal tray assembly) observation on 3/13/12 at 11:30 AM, the holding temperature of the sliced turkey was checked. The temperature registered 98 degrees Fahrenheit (F).

A review of the Trayline Temperature Log dated 3/13/12, for lunch, revealed that the temperature recorded for the turkey was written as 172 degrees F.

During a concurrent interview with Cook 1 who prepared the turkey and checked the temperature, he stated that the turkey was a precooked product. He stated that he sliced then heated the turkey to 165 degrees F. He stated that he placed the sliced turkey in the hot box for holding until he placed it on the steam table for serving. He stated that he checked the edge pieces of turkey and recorded that temperature. He further stated that he should have checked the temperature at the middle of the pan, but that he did not.

A review of the hospital's policy titled, "Food Temperatures" dated 1/12, revealed that the purpose of the policy was to control the spread of infection and disease. It further stated that foods must be held and served at appropriate temperatures to prevent food borne illness. Hot foods are held at a minimum temperature of 140 degrees F. Steam tables and food warmers are designed for holding hot food, not heating, therefore food must be at 140 degrees F or greater when placed in them.

During an interview with the Director of Food and Nutrition Services on 3/15/12 at 9:30 AM, she stated that she reviews the Trayline Temperature Logs for accuracy, but doesn't actually check the temperature of the food to ensure the recorded temperatures are accurate.

According to the 2009 FDA Food Code, bacterial growth and/or toxin production can occur if potentially hazardous food remains in the temperature "Danger Zone" (41 to 135 degrees F) too long. For this reason, it requires that hot potentially hazardous food be held at 135 degrees F or above.

3b. During the initial tour of the kitchen on 3/12/12 at 1:50 PM, the ice machine was observed. A clean paper towel swipe of the chute where the ice drops into the storage bin produced a moderate amount of brown residue on the paper towel. Also the deflector in the storage bin was noted to have a white build-up.

During a concurrent interview with Engineering Staff 1 (ES 1), she stated that the white build-up was lime scale. She stated that the ES cleaned and sanitized the ice machine every three months and de-limed the machine annually. She further stated that the last time that the machine was cleaned and sanitized was in December and it was due to be cleaned on 3/17/12.

The ES 1 was unable to provide documented evidence that the ice machine had been clean and sanitized by the ES since 8/11/11, seven months earlier.

A concurrent interview with the Director of Food and Nutrition Services (DFNS) revealed that the dietary staff was responsible for cleaning the ice storage bin of the ice machine. She stated that the dietary staff does not remove the deflector in order to clean the top of the bin. She stated that it was not the responsibility of the dietary staff to clean the chute.

A review of the posted form titled, "Scheduled Cleaning of Ice Bin" kept adjacent to the ice machine, revealed instructions to the dietary staff. The instructions stated, "Sanitize Ice Bin and Chute. Shut off machine, remove ice and sanitize bin and chute." The form indicated the last time this cleaning was done was on 2/20/12.

In a further interview with the DFNS, on 3/12/12 at 1:50 PM, she was unable to explain how her staff could clean and sanitize the ice chute without removing the deflector which blocked access to the chute. She further could not explain why the form stated that cleaning of the ice bin included cleaning and sanitizing of the chute, when she previously stated that the dietary staff did not clean the chute.

According to the 2009 FDA Food Code, equipment such as ice bins and enclosed components of equipment such as ice makers shall be cleaned at a frequency specified by the manufacturer or at a frequency necessary to preclude accumulation of soil or mold.

The accumulation of brown residue in the chute of the ice machine had the potential to cross contaminate the ice served to patients. This cross contamination has the potential to cause food borne illness in an already immune compromised patient population.

3c. During an observation of the nursing nutrition pantries on 3/13/12 between 3:30 and 4:00 PM, the following items were noted:

? In the ICU refrigerator, an open one liter bottle of Glucerna that was 2/3 full and was dated 3/6/12
? In the ICU refrigerator, an individual portion cup of gelatin was noted with an expiration date of 2/29/12
? In the East Nursing Station refrigerator, a container of food from outside of the facility was noted to be labeled with only the patient's name and room number. There was no date to record when the food was first used by the patient and subsequently stored in the nursing station refrigerator.

During an interview with the Clinical Nurse Educator on 3/13/12 at 3:50 PM, she stated that food brought in from outside the facility should be labeled, dated and should contain a patient sticker. She verified that the container in the East Nursing Station refrigerator was not labeled, dated and did not contain a patient sticker.

During a concurrent interview with Registered Nurse (RN) A, the Charge Nurse for the East Nurses Station, she stated that the container of food brought in from the outside belonged to a patient who was discharged on 3/7/12. She was unable explain why the food was still in the nutrition pantry refrigerator 6 days after the patient was discharged.

During an interview with the Director of Food and Nutrition Services (DFNS) on 3/13/12 at 3:30 PM, she stated that the dietary staff was responsible for ensuring that expired food was discarded on the day it expires. She stated that someone from dietary checked the refrigerators daily for expired food. She was unable to explain why a container of gelatin that had expired was not noted for 2 weeks.

During an interview with RN B, the charge nurse for ICU, on 3/13/12 at 3:35 PM, she stated that the opened one liter bottle of Glucerna, dated 3/6/12, should have been discarded. She did not know how long the bottle had been opened and stored in the refrigerator. She was unable to explain why the bottle was not discarded.

A review of the product information for Glucerna revealed instructions that once the product is opened, cover and refrigerate and use the complete product within 48 hours.

A review of the hospital's policy titled, "Refrigerators on Patient Care Units" dated 4/09, revealed that the purpose of the policy was to provide patients on the patient care units with safe and sanitary refrigerated food and beverage items. It stated that Nutrition Services will be responsible for discarding all outdated nourishment in the refrigerators. Food held in the refrigerator must be appropriately covered, clearly labeled with the patient's name, room number and dated. All food items not meeting this criteria will be discarded.

A review of the hospital's policy titled, "Outside Food for Hospitalized Patients" dated 1/12, revealed that for perishable food brought in but not eaten right away, it may be stored in the patient refrigerator and shall be labeled with the patient's name, room number and date of preparation. It also stated that the food shall be discarded two days after food is dated.

Outdated foods that are not labeled, dated and are not monitored for expiration dates have the potential to be served to patients and cause food borne illness.

3d. During the initial tour of the kitchen on 3/12/12 at 1:30 PM, the meat slicer was observed to have meat particle debris around the edge of the blade. The slicer was not observed to be in use.

During a concurrent interview with Food Service Worker (FSW) 1, she stated that the meat slicer should be cleaned and sanitized after each use. She further stated that the person who had been using it in the morning had already left for the day. She stated that that person should have cleaned and sanitized the slicer before she left.

A review of the hospital's policy titled, "Cleaning Procedures" dated 1/12, revealed that it is the policy of the hospital that food grinders and slicers will be cleaned after each use.

Food slicers that are not cleaned after each use create the potential for cross contamination during subsequent uses with old, potentially hazardous food particles left on the equipment. This cross contamination has the potential to cause food borne illness in an already immune compromised patient population.

3e. During the initial tour of the kitchen on 3/12/12 at 2:30 PM the following was observed in the walk-in refrigerator:

? Three cases of cooked turkey meat labeled "keep frozen" with no thaw date
? Four cases of bacon labeled "keep frozen" with no thaw date
? Four cases of liquid egg product labeled "keep frozen" with no thaw date.

During a concurrent interview with the Food Service Supervisor (FSS), she was unable explain how the staff knew the shelf life for these products. She stated that she was not aware that these products were labeled "keep frozen" and did not know the shelf life for the products once they are thawed.

A review of the product information for these products revealed that: for the turkey, the shelf life was 3-5 days after thawed; for the bacon, the shelf life was 7 days after thawed; and for the liquid egg product, the shelf life was 3-5 days after thawed.

Food stored and served to patients after their shelf-life had expired had the potential to cause food borne illness. A lack of system for monitoring the shelf-life of frozen foods once they were thawed contributed to this risk.

3f. During the initial tour of the kitchen on 3/12/12 at 2:35 PM, an open box of muffin mix was observed not sealed in the dry storage area. Also observed were two open bags of rice stored in a bulk dry food storage bin, unsealed. The rice bags were the same bags the rice was shipped in. No other outer containers were used for shipping.

During a concurrent interview with the Food Service Supervisor (FSS), she stated that the box of muffin mix should be sealed to prevent cross contamination and attracting pests.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS), she stated that she did not think storing the open rice bags in the bulk storage bins was a problem

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

During an interview with the Infection Preventionist (IP) on 3/14/12 at 10:05 AM, she stated that she didn't enter the kitchen to conduct infection control surveillance. She stated that she monitors for hand hygiene, proper hair restraints and standard precautions. She was unable to state how she monitored these without walking through the kitchen. She stated that she does not monitor trayline food temperatures, the interior of the ice machine, the cleanliness of the meat slicer, the shelf-life of food in the refrigerator or that food is properly sealed in the dry storage area. She stated that she conducts daily rounds of the nursing nourishment pantries and checks the refrigerator temperature logs. She also checks to be sure employee's food is not stored in patient refrigerators. She was unable to state how patient food could be stored in the patient refrigerator without a date for six days after the patient was discharged, or an open bottle of Glucerna could be stored in the patient refrigerator with a date that indicated it was seven days old. She was unable to state how she could effectively provide infection control surveillance in the dietary department without entering the kitchen.

Based on staff interview and facility record review, the facility failed to educate Patient 41, prior to being discharged from the hospital, on the effects of the medication Vicodin, prescribed for pain relief and it having the potential to be transmitted via breast milk to the infant during lactation with the possibility of causing possible side effects of neonatal depression at or after birth for 1 of 42 sampled patients (Patient 41). This deficient finding had the potential to affect the health and safety of the infant, at or after birth, from the lactating mother resulting in possible rehospitalization of the infant for reasons that could have been prevented.

Findings:

On 3/12/12, a review of Patient 41's medical record was conducted. The admitting face sheet revealed that Patient 41 was admitted to the facility on 3/11/12 with spontaneous rupture of membranes and preterm labor. Further documentation revealed that Patient 41 underwent a successful cesarean section (surgical delivery of an infant) on 3/11/12, at 12:00 PM.

On 3/12/12, a review of Patient 41's medical record revealed that Patient 41's physician had written an outpatient prescription, dated 3/11/12, to be filled after discharge for Vicodin, 2 tablets to be taken by mouth every 4 hours for pain relief, as needed.

On 3/12/12, a review of Patient 41's medical record revealed in the "Lactation Assessment Notes", dated 3/13/12 and timed at 8:00 AM, it documented that Patient 41 would be breastfeeding for a "short time" because her mom wants her to, and would be switching to bottle feeding.

There was no documented evidence in the medical record or from other facility sources that the "Lactation Consultant" had educated or instructed the patient of possible side effects of taking the pain medication Vicodin, and its possible adverse outcomes towards the infant after breastfeeding by the mother.

There was no documented evidence in the Physician's Progress Notes, dated 3/14/12, that Patient 41's physician had informed, educated, or instructed the patient of possible side effects of Vicodin, prescribed for pain relief, and its possible adverse outcome towards the infant from the lactating mother.

There was no documented evidence in Patient 41's Discharge Summary Instruction sheet, dated 3/14/12, that addressed precautionary information given to the mother while taking the medication Vicodin for pain relief, and its possible adverse effect on the infant, from the lactating mother.

According to Mosby's Nursing Drug Reference, 22nd Edition, dated 2009, stated, "Vicodin is a controlled substance scheduled III medication. It binds to opiate receptors in CNS to reduce Pain. Precautions include: Pregnancy, breastfeeding, respiratory depression, weakness and nausea and vomiting. FDA pregnancy category C. It is not known whether Vicodin is harmful to an unknown baby, but it could cause breathing problems in a newborn. Acetaminophen and hydrocodone can pass into breast milk and may harm a nursing baby."

The Hospital failed to ensure that Patient 41 was instructed on the possible adverse side effects of taking the medication Vicodin, after discharge, and its possible adverse effect on the infant after breast feeding by the mother.

On 3/15/12, at the time of the finding, the Director of Labor Delivery Recovery Post-Partum (LDRP) Department confirmed the finding that Vicodin had the possibility of causing adverse side effects on the infant after breastfeeding by the mother and that the facility had failed to educate Patient 41 of such information prior to discharge from the hospital.

Based on observation, interviews and a tour of the hospital, the hospital failed to ensure the provision of sterilization and disinfection procedures to meet the needs of its patients. This could lead to unsafe disinfection procedures for a universe of 84 patients.

Findings:

1. A tour of the surgical areas was conducted on 3/12/12 at approximately 10:00 AM. The instrument cleaning room was inspected and OR Tech 1 interviewed with the Interim OR Director. OR Tech 1 was unaware that specific dilutions for water and enzymatic cleaner-detergent were required. OR Tech 1 stated he added enzymatic cleaner to the sink and estimated the amount of product to the cleaning sink. He then stated that he added an estimated amount of water to the sink to clean the instruments. OR Tech 1 seemed unaware that the dilutions were specific for each product. OR Tech 1 seemed unaware that the soaking of instruments was to be left in the solutions for a specific amount of time, prior to washing and sterilizing the instruments.

2. The autoclave area was toured with the Interim OR Director and Central Services Tech 2 at approximately 10:30 AM on 3/12/12. The autoclaves in the operating rooms and the Central Supply areas were toured. The cleaning logs for the autoclaves in the surgical areas and in the Central Sterile Supply were requested. Central Services Tech 2 stated that he cleaned the autoclaves daily, weekly and monthly, according to the manufacturers recommendations, however, he kept no log for his cleaning of the autoclaves since 2007. Written documentation for the cleaning and maintenance of the autoclaves could not be produced on request.

3. The sub-sterile area of the cardiovascular operating room was inspected with the Interim OR Director, OR Tech 1 and OR Tech 2. The sub-sterile room was found to contain a refrigerator to be used to store human blood and blood products for use during heart and cardiovascular operative procedures. The refrigerator contained no warning sign or label of "Biohazard" to alert staff that human blood and blood products were in the refrigerator.

4. The GI endoscopy lab was toured and inspected on 3/14/12 at approximately 11:00 AM. Inspection of the GI endoscopy lab revealed no evidence of a temperature or humidity gauge. When interviewed GI RN 1 stated that electrocautery was used in the GI Lab for biopsies, when bleeding could not be otherwise controlled. Nationally recognized organizations such as the American Society for Healthcare Engineering of the American Hospital Association, for 9/20/10 require monitoring Temperature and Humidity in surgical areas and maintaining humidity in the 20-60% range. The Association of Operating Room Nurses, AORN, guidelines for 2011 also recommend a relative humidity of 20-60 % and monitoring of airflow in all surgical and sterile areas.

5. The GI endoscopy lab was toured and inspected on 3/14/12 at approximately 11:00 AM. Surgical Tech 1 and GI RN 1 were interviewed. Surgical Tech 1 demonstrated the method for cleaning of GI endoscopes. Surgical Tech 1 was unaware that specific dilutions for water and enzymatic cleaner-detergent were required. Surgical Tech 1 stated he added enzymatic cleaner to the sink and estimated the amount of product to the cleaning sink. He then stated that he added an estimated amount of water to the sink to clean the endoscope. Surgical Tech 1 seemed unaware that the dilutions were specific for each product. Surgical Tech 1 seemed unaware that the soaking of instruments was to be left in the solutions for a specific amount of time, prior to washing and sterilizing the endoscopes and instruments used during the endoscopy procedure.

6. The GI endoscopy procedure was observed for Patient 18. Following removal of the colonoscope, Surgical Tech 1 was observed to place the colonoscope in a container for transport to the cleaning area of the GI lab. Surgical Tech 1 was observed to then handle the siderail of the bed without removing his gloves or practicing hand hygiene. When this was pointed out to the staff in the GI lab, all agreed this was an unsafe practice.

Based on record reviews and staff interviews, the hospital's Quality Program failed to measure, analyze and track quality indicators related to dietitian recommendations being carried out by the physician. This failure resulted in the hospital's inability to identify when the dietitian's recommendations were not carried out and in it's inability to identify opportunities for improving the process to ensure that the nutritional needs of the patients were met in a timely manner.

Findings:

The medical record for Patient 22 was reviewed on 3/14/12. The patient was admitted to the hospital on 3/8/12 with diagnoses that included protein malnutrition, urinary tract infection and a stage IV pressure ulcer on the left hip (A stage IV pressure ulcer is a bed sore where there is full thickness tissue loss with exposed bone, tendon or muscle). There was an order for a tube feeding for Jevity, one can QID (four times a day). Jevity is a nutritional formula used for tube feeding. There were no other orders for tube feeding for the patient.

A review of the Nutrition Notes indicated an initial nutrition assessment was completed on 3/8/12 by Registered Dietitian 2 (RD 2). The note recommended Jevity continuous feeding at 20 milliliters (ml) per hour and increase as tolerated to 45 ml per hour to provide 1145 calories and 47.8 grams of protein. The note indicated that a follow-up reassessment would be required in 2 to 3 days.

The RD recommendations were not carried out. There was no documented evidence that the physician was informed of the RD recommendations.

A follow-up nutrition note dated 3/12/12 was reviewed. The note indicated that the patient was still on one can of Jevity four times a day and it was inadequate to meet the patient's needs. The RD note further indicated a recommendation to consider changing the tube feeding formula to Suplena to meet 100% of the patient's calorie needs and 92% of the patient's protein needs.

A review of the physician's orders indicated that the new tube feeding recommendations were not ordered. Again, there was no documented evidence that the physician was notified of the dietitian's recommendations. There was no documented evidence that the RD contacted the physician to ensure that the nutrition plan of care was initiated to meet the patient's needs.

The patient had been in the hospital for six days and the tube feeding did not meet the patient's nutrition needs, despite having a diagnosis of protein malnutrition and a deep wound that required additional nutrition to improve the healing process.

During an interview with the Director of Food and Nutrition Services (DFNS) on 3/15/12 at 10:00 AM, she stated that the department had not identified the RD recommendations not being carried out as a problem. Although the department was analyzing other performance indicators, they were not tracking this specific matter. She was unable to state how the hospital was able to ensure an improvement in the process of communicating nutrition recommendations to the physicians.

A review of the hospital's policy titled, "Performance Improvement", dated 1/12, revealed that the purpose of the policy was to establish procedures for the development and monitoring of the performance improvement program in the Food and Nutrition Services department. It further stated that the Food Service Director in conjunction with the Clinical Dietitians, initiates, coordinates, monitors and evaluates department services for appropriateness and effectiveness of nutrition care and food services.

The DFNS confirmed that tracking the data on the RD's recommendations that were being carried out would help to improve the chances that patients' nutritional needs would be met in a timely manner.

Based on record reviews and staff interviews, the hospital's Quality Program failed to measure, analyze and track quality indicators related to dietitian recommendations being carried out by the physician. This failure resulted in the hospital's inability to identify when the dietitian's recommendations were not carried out and in it's inability to identify opportunities for improving the process to ensure that the nutritional needs of the patients were met in a timely manner.

Findings:

The medical record for Patient 22 was reviewed on 3/14/12. The patient was admitted to the hospital on 3/8/12 with diagnoses that included protein malnutrition, urinary tract infection and a stage IV pressure ulcer on the left hip (A stage IV pressure ulcer is a bed sore where there is full thickness tissue loss with exposed bone, tendon or muscle). There was an order for a tube feeding for Jevity, one can QID (four times a day). Jevity is a nutritional formula used for tube feeding. There were no other orders for tube feeding for the patient.

A review of the Nutrition Notes indicated an initial nutrition assessment was completed on 3/8/12 by Registered Dietitian 2 (RD 2). The note recommended Jevity continuous feeding at 20 milliliters (ml) per hour and increase as tolerated to 45 ml per hour to provide 1145 calories and 47.8 grams of protein. The note indicated that a follow-up reassessment would be required in 2 to 3 days.

The RD recommendations were not carried out. There was no documented evidence that the physician was informed of the RD recommendations.

A follow-up nutrition note dated 3/12/12 was reviewed. The note indicated that the patient was still on one can of Jevity four times a day and it was inadequate to meet the patient's needs. The RD note further indicated a recommendation to consider changing the tube feeding formula to Suplena to meet 100% of the patient's calorie needs and 92% of the patient's protein needs.

A review of the physician's orders indicated that the new tube feeding recommendations were not ordered. Again, there was no documented evidence that the physician was notified of the dietitian's recommendations. There was no documented evidence that the RD contacted the physician to ensure that the nutrition plan of care was initiated to meet the patient's needs.

The patient had been in the hospital for six days and the tube feeding did not meet the patient's nutrition needs, despite having a diagnosis of protein malnutrition and a deep wound that required additional nutrition to improve the healing process.

During an interview with the Director of Food and Nutrition Services (DFNS) on 3/15/12 at 10:00 AM, she stated that the department had not identified the RD recommendations not being carried out as a problem. Although the department was analyzing other performance indicators, they were not tracking this specific matter. She was unable to state how the hospital was able to ensure an improvement in the process of communicating nutrition recommendations to the physicians.

A review of the hospital's policy titled, "Performance Improvement", dated 1/12, revealed that the purpose of the policy was to establish procedures for the development and monitoring of the performance improvement program in the Food and Nutrition Services department. It further stated that the Food Service Director in conjunction with the Clinical Dietitians, initiates, coordinates, monitors and evaluates department services for appropriateness and effectiveness of nutrition care and food services.

The DFNS confirmed that tracking the data on the RD's recommendations that were being carried out would help to improve the chances that patients' nutritional needs would be met in a timely manner.

Based on interview and record review, the facility failed to ensure that there was written documentation of a QA (Quality Assurance) plan to evaluate the facility's patient acuity system for assignment of nursing staff on the ICU (Intensive Care Unit) and the DOU (Direct Observation Unit) to validate compliance with staffing ratios. This failure resulted in the ICU and DOU making patient assignments that were not based on an acuity system to ensure compliance with meeting patient care needs. This failure had the potential for the patients' care needs to not be met.


Findings:

Acuity: One of the parameters considered in patient classification systems that are designed to serve as guidelines for the allocation of the nursing staff and to justify staffing decisions.

A review of AFL (All Facility Letter) 07-26 addressed to all general acute care hospitals, dated 10/1/07 and effective 1/1/08 revealed the following: "...It is imperative that hospitals staff according to patient acuity. Hospitals must ensure that they are staffed to assure that the needs of the patients are met. It is far more important that hospitals pay attention to the patient classification system and the needs of the patient rather than the minimum staffing requirements. Hospitals are reminded that the regulations only reflect the minimum standards for staffing and that to be in compliance with the regulations refer to Section 70217(b).

Review of the Title 22, CA Code of Regulations, Section 70217(b), revealed the following: In addition to the requirements of subsection (a), the hospital shall implement a patient classification system as defined in Section 70053.2 above for determining nursing care needs of individual patients that reflects the assessment, made by a registered nurse, of patient requirements and provides shift-by-shift staffing based on those requirements.

Patient Classification System, Title 22, CA Code of Regulations, Section 70053.2 revealed the following:

(a) Patient classification system means a method for establishing staffing requirements by unit, patient, and shift that includes,
(1) A method to predict nursing care requirements of individual patients.
(2) An established method by which the amount of nursing care needed for each category of patient is validated for each unit and for each shift.
(4) A mechanism by which the accuracy of the nursing care validation method described in (a)(2) above can be tested. This method will address the amount of nursing care needed, by patient category and pattern of care delivery, on an annual basis, or more frequently, if warranted by the changes in patient populations, skill mix of the staff, or patient care delivery model.

Review of the facility's staffing assignments for the ICU and DOU from the period of 3/5/12 through 3/12/12 revealed no evidence that a patient classification system was used to validate adequacy of the staffing assignments for the ICU and the DOU.

During an interview on 3/12/12 at 9:25 AM, CN 1 (Charge Nurse) of the ICU and DOU units stated that she makes staffing assignments based on the patients' needs and also taking into consideration if the patient is on any vasopressors (an agent that causes the blood pressure to rise). CN 1 further stated that the maximum bed capacity on the DOU unit was 8 beds and they used 3 RN's on that unit. CN 1 added that the nurse to patient ratio was three to one (3 patients to one nurse) on the DOU. CN 1 confirmed that assignments were not based on a patient classification system.

During an interview on 3/12/12 at 2:23 PM, the Director of ICU/DOU confirmed that the ICU and DOU had no patient classification or acuity system. He stated that in the ICU, there either was one RN (Registered Nurse) with two patients or one RN with one patient if the patient was really sick. The Director of ICU/DOU failed to provide evidence that a patient classification system existed for the ICU and the DOU.

A review of the facility's policy and procedure titled, ICU Scope of Service revealed the following, "...Written policies and procedures are developed and maintained by the Director in consultation with other health care professional and Administration. Policies are approved by the Policy/Procedure Committee, which meets at least quarterly, and also by the Medical Executive Committee and the Governing Board. The Policies and procedures comply with the standards as defined by the State of California Licensing Regulations (Title 22) and the Healthcare Facilities Accreditation Program (HFAP).

Further review of this same policy revealed the following under the section titled, Staffing Plan: "....Staffing levels are established based on patient needs and staffing policies are established by the Title 22 requirements, as well as (facility named here) guidelines for acuity based staffing. The licensed nurse to patient ratio shall be 1:2 or fewer at all times in the intensive care unit. Staffing patterns are upgraded according to patient acuity. Criteria exist to determine the need for 1:1 staffing in the intensive care unit...".

A review of the facility's policy and procedure titled, DOU (Definitive Observation Unit) Scope of Service revealed the following under Staffing Plan: "... Staffing levels are established based on patient needs and staffing policies are established by the Title 22 requirements, as well as (facility named here) guidelines for acuity based staffing. The licensed nurse to patient ratio shall be 1:3 in the DOU".

During an interview on 3/15/12 at 10:23 AM, the PIM (Performance Improvement Manager) stated that QA (Quality Assurance) was not looking at the classification system on the ICU and DOU as one of their performance improvement indicators. The PIM added that she would have the CNO and the Director of ICU/DOU talk to the CDPH (CA Dept of Public Health) surveyor regarding this issue.

During an interview on 3/15/12 at 1:32 PM, the CNO (Chief Nursing Officer) confirmed that the ICU and the DOU did not have a patient classification system. The CNO also confirmed that the facility did not have a committee that met at least annually to validate the adequacy of staffing on the various units within the facility.

Based on staff interview and facility record review, the facility failed to ensure that a Registered Nurse supervised and evaluated the nursing care for 2 of 42 sampled patients (Patients 41 and 57) as evidenced by the following:

1. For Patient 41, the facility failed to reassess and evaluate the pain status after the administration of a pain medication . This deficient practice had the potential to affect the health and well being of Patient 41.

2. For Patient 57, the registered nurse did not reassess the patient after administering Ativan (a medication used for the treatment of anxiety) for complaints of difficulty breathing. This failure had the potential to result in Patient 57 being ineffectively treated and managed with the highest level of care.

Findings:

1. On 3/12/12, a review of Patient 41's medical record was conducted. The admitting face sheet revealed that Patient 41 was admitted to the facility on 3/11/12 with a spontaneous rupture of membranes and preterm labor. Further documentation revealed that Patient 41 underwent a cesarean section (surgical delivery of an infant) on 3/11/12, at 12:00 PM, with successful delivery of an infant baby boy.

On 3/12/12, a review of Patient 41's medical record was conducted. Patient 41's nursing progress notes, dated 3/12/12, documented that Toradol 30 milligram tablet PO (taken by mouth) for pain relief was administered on 3/12/12 (Toradol is a medication given for pain relief).

There was no documented evidence in Patient 41's medical record or from other facility sources that Patient 41 was reassessed for the effectiveness of pain relief after the Toradol administration on 3/12/12.

On 3/12/12, a review of the facility's policy and procedure titled, "PAIN MANAGEMENT" dated 10/11, stipulated, "...The facility shall do an initial assessment and reassessment of pain on all patients, which shall include patient perception of, quality, radiation, severity and time of pain, in order to effectively mange their pain ..." Section 1.5, stipulated, "Clinical approach includes an evaluation of the effectiveness of the pain intervention."

On 3/12/12, a review of the facility's policy and procedure titled, "MEDICATION ADMINISTRATION", dated 8/10, stipulated in Section (1) (g), "...The licensed staff shall be responsible for assuring that the "seven rights" of medication administration are employed at all times that includes 'Response of the Patient' , and in Section (8), "...Following medication administration, the Licensed Staff shall assess the patient for efficacy, adverse effects and/or toxicity."

Therefore, the facility failed to reassess Patient 41's pain status or check for any adverse reactions to the pain medication, Toradol, after its administration on 3/12/12 as per facility policy.

On 3/12/12, at approximately 10:30 AM, at the same time as the finding, the Director of Labor Delivery Recovery Post-partum (LDRP) Department confirmed the finding that the nursing staff did not reassess Patient 41's pain status, or check for any adverse reaction to the pain medication, "Toradol", after it's administration on 3/12/12.



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2. A record review on 3/15/12, at 9 AM, of Patient 57's medical record, indicated that the patient was admitted to the hospital on 2/4/11, with septic shock (a lethal drop in blood pressure due to bacteria in the blood stream), and complained of nausea and vomiting and soreness of the neck. On 2/11/11, the physician's diagnosed the patient with acute myeloid leukemia (cancer of the blood).

A record review on 3/15/12, at 9 AM, of Patient 57, indicated that on 2/12/11 at 8:45 PM, the patient reported to the nurse that she was "Having a hard time breathing." The nurse administered Ativan (for anxiety).

A record review on 3/15/12, at 9 AM, of Patient 57, revealed no reassessment was conducted to determine the patient's response to the Ativan or if it resolved her difficulty of breathing.

An interview and a concurrent record review, on 3/15/12, at 9:30 AM, with the hospital Chief Nurse Officer (CNO) and the Manager for Performance Improvement was conducted. After review of the medical record, the CNO and the Performance Improvement Manager were unable to find a nursing reassessment of the effectiveness of Ativan for Patient 57. There was no reassessment of Patient 57's complaint of difficulty breathing.

A record review, on 3/15/12, at 10 AM of the hospital policy titled, "Assessment/Reassessment of Patients-Interdisciplinary", revised 2/11, was reviewed. The policy indicated that, "The patient shall be reassessed: a. To determine response to medication, treatment, and nursing interventions. b. When there is a significant change in condition." , and "the patient's response to treatments, procedures and medications administered shall be documented in Meditech" (the electronic medical records system).

Based on observation, interviews and record reviews, the hospital failed to ensure that the nutritional needs of the patients were met in accordance with recognized dietary practices and physician's orders as evidenced by a lack of an effective system to ensure:

1.) That the dietary staff prepared patient foods according to standardized recipes.

2.) That the nutritional needs were met for one of three patients (Patient 22) whose records were reviewed for nutrition care.

These failures to ensure patients' nutritional needs were met had the potential to further compromise the nutritional and medical status for a universe of 84 patients.

Findings:

1. During a trayline observation on 3/13/12 between 12:15 and 12:45 PM, it was observed that patients on a regular diet received the same food as those patients on a low salt diet.

During an interview with the Food Service Supervisor on 3/13/12 at 12:35 PM, she stated that all the food the hospital serves is low salt. She stated that the turkey and the gravy served were low salt.

During an interview with Cook 1 on 3/13/12 at 12:45 PM, he stated that the turkey he served was a precooked turkey breast. He stated that he sliced the turkey, placed it in the pan with a small amount of liquid and no other seasoning. He also stated that the potatoes were red potatoes cut, skin intact with no salt seasoning. The gravy was made from a packet of low sodium gravy mix that he just added water to. He stated that all the items were low sodium. He did not make two different types of gravies.

A review of the diet spreadsheets for all the therapeutics diet for lunch that day showed that those patients on a regular diet should receive 2 ounces of Poultry Gravy and patients on a Low Sodium, Cardiac, Diabetic and Renal diets should receive 2 ounces of Low Sodium Poultry Gravy.

A review of the hospital's recipe for Poultry Gravy (#0268707463) dated 2004, showed ingredients for the gravy as vegetable salad oil, fresh yellow onions, fresh carrots, fresh celery, low sodium chicken base, water dried thyme, dried rosemary, ground sage, cornstarch and flour. There was no other recipe for Low Sodium Poultry Gravy.

A review of the hospital's recipe for Seasoned Roast Turkey Breast (#0465713599) dated 2004 showed ingredients that included raw turkey breast, fresh garlic, vegetable salad oil and poultry seasoning.

A review of the hospital's recipe for Oven Roasted Garlic Potatoes (#8666) dated 2004 listed ingredients as fresh peeled chef potatoes, margarine and salt-free garlic and herb seasoning.

During an interview with the Director of Food and Nutrition Services (DFNS) on 3/13/12 at 12:50 PM, she stated that she didn't know when they stopped using the standardized recipes and started using convenience products. She further stated that the nutrition analysis of the menus was based on the standardized recipes and not the convenience items. She stated that patients on a regular diet received a salt packet on their tray and were able to add salt to the low salt items. She was unable to state how patients with dementia, who were not capable of adding salt to their food and who might be at greater risk for not eating food that wasn't seasoned, would add the salt to their food, or even know to ask for it.

A review of the hospital's policy titled, "Menus and Standardized Recipes" dated 1/12 revealed that the policy is that food prepared for the patient menu will be prepared using standardized recipes. It further stated that a standardized recipe will be used for regular diets with ingredient modification made for all non-regular diets. And that recipes will be approved in advance of preparation by the Food and Nutrition Services Director.

A review of the hospital's policy titled "Food Preparation", dated 1/12, revealed that foods are prepared with consideration for appearance, retention of nutrients, flavor and texture, which are incorporated into the preparation and handling procedures specified in the recipes.

2. The medical record for Patient 22 was reviewed on 3/14/12. The patient was admitted to the hospital on 3/8/12 with diagnoses that included protein malnutrition, urinary tract infection and a stage IV pressure ulcer on the left hip. (A stage IV pressure ulcer is a bed sore where there is full thickness tissue loss with exposed bone, tendon or muscle.)

A dietary consult was ordered on 3/8/12 regarding a tube feeding because the patient was unable to eat. In addition, there was an order for a tube feeding through a nasogastric tube (a feeding tube placed through a nostril into the stomach) for Jevity, one can QID (four times a day). Jevity is a nutritional formula used for tube feeding. There were no other orders for tube feeding for the patient.

A review of the Nursing Nutrition Screen, dated 3/8/12, indicated that the patient had malnutrition.

A review of the nutrition notes indicated an initial nutrition assessment was completed on 3/8/12 by Registered Dietitian 2 (RD 2). The note indicated that the patient's estimated nutrition needs were 924 to 1155 calories initially but gradually increase needs to 1386 to 1617 calories per day. The patient's protein needs were 37 to 46 grams of protein per day. The note further recommended Jevity continuous feeding at 20 milliliters (ml) per hour and to increase as tolerated to 45 ml per hour to provide 1145 calories and 47.8 grams of protein to the patient. The note indicated that a follow-up reassessment would be required in 2 to 3 days.

During an interview with RD 2 on 3/14/12 at 3:00 PM, she stated that she spoke with the nurse and told her what she recommended on 3/8/12. She further stated that the physician order for Jevity at one can four times a day provided 1060 calories and 44.3 grams of protein a day and did not meet the patient's nutrition needs. She further confirmed that the physician order for the recommended tube feeding was never initiated. She was unable to show that the physician was ever notified of her recommendations.

A follow-up nutrition note dated 3/12/12, four days after the RD assessment, was reviewed. The note indicated that the patient was still on one can of Jevity four times a day and it was inadequate to meet the patient's needs. The note stated that the patient's estimated nutrition needs were now 1386 to 1617 calories a day and 37 to 46 grams of protein a day and the tube feeding provided only 1060 calories and 44.3 grams of protein a day. The RD note further indicated a recommendation to consider changing the tube feeding formula to Suplena to meet 100% of the patient's calorie needs and 92% of the patient's protein needs.

During a further interview with RD 2, on 3/14/12 at 3:00 PM, she was unable to state why there had been no follow-up regarding the tube feeding recommendations to ensure that the nutrition needs of the patient were met.

A review of the physician's orders indicated that the new tube feeding recommendations were not ordered. There was no documented evidence that the physician was notified of the dietitian's recommendations.

A review of the hospital's policy titled, "Nutritional Care of Patient with Impaired Skin Integrity" dated 1/12 revealed that the purpose of the policy was to assure adequate nutritional support to patients with dermal ulcer or non-healing wounds to promote healing. It furthers stated that an RD will individually assess each patient for nutrition needs and recommendations will be implemented following physician order.

A review of the hospital's policy titled "Nutrition Prioritizing Guidelines", dated 1/12, revealed that patients with full thickness skin loss and patients with a diagnosis of malnutrition were identified as "High Priority".

A review of the hospital's policy titled, "Nutrition Therapy Reassessment", dated 1/12, revealed that high nutrition outcome risk patients are reassessed in 2 to 3 days.

The patient had been in the hospital for six days and the tube feeding still was not meeting the patient's nutrition needs, despite having a diagnosis of protein malnutrition and a deep wound that required additional nutrition to improve. There was no d

Based on interview and record review the facility failed to:

1. Ensure that the ICP (Infection Control Preventionist) provided oversight of the DOU (Direct Observation Unit) by failing to ensure that an effective infection control surveillance system was developed and implemented and failing to monitor the cleaning practices of the housekeeping staff on the DOU to ensure that the sanitation techniques, of environmental surfaces, were effective in reducing the risk of the spread of infection in the facility. This failure had the potential to result in the spread of infection to patients, visitors and employees in the facility.

2. Maintain a sanitary environment to avoid sources and transmission of infections for a universe of 84 patients. A Registered Nurse (RN 1) was observed on the DOU (Direct Observation Unit) providing direct care to a contact isolation patient and was observed removing medical supplies from a cart without first removing her isolation gown. This deficient practice had the potential of spreading and transmitting infectious microorganisms to other patients and staff.

3. Ensure that there were infection control measures to prevent the development of food borne illness and cross contamination in the food service departments and nursing nutrition pantries. Also, the hospital failed to have a thorough infection control surveillance system that monitored the conditions and practices of the dietetics services staff and nursing staff. By not having these measures and a thorough surveillance system, potentially hazardous foods had been stored, prepared and distributed under unsafe and unsanitary conditions and there was potential for such continuation in the absence of identification and remediation in a hospital.

Findings:

1. During an interview on 3/14/12 at 10:07 AM, the ICP (Infection Control Preventionist) stated that no active surveillance was occurring in the DOU in regards to hospital acquired infections in that area. The ICP stated that infected patients were cohorted (a group of individuals sharing a common characteristic, as in an infectious disease process) on the unit.

During an interview on 3/15/12 at 10:23 AM, the PIM (Performance Improvement Manager) stated that there were no current QA (quality assurance: the systematic monitoring and evaluation of various aspects of a project, service, or facility to ensure that the standards of quality are being met) activities for infection control surveillance for the DOU (Definitive Observation Unit).

Record review of the facility's Infection Control Annual Summary for 2011 revealed that the facility's Infection Control Plan was to provide a systematic, coordinated and continuous approach that included:

1. Surveillance, data collection, analysis, and reporting.
2. Monitoring, evaluating, and reporting of the organization's compliance with Infection Control policies, procedures, and practices.

During an interview on 3/15/12 at 1:32 PM, the ICP stated that the facility's infection rates were not broken down by specific units within the hospital. The ICP also stated that she did not keep a log of all terminal cleanings (the cleaning of a patient room performed after an isolated patient is discharged to decrease the risk of the spread of diseases to the next patient admitted to the room) and did not provide oversight of the DOU to ensure that the Environmental Services Department was providing a sanitary environment in the DOU by following proper procedures for cleaning and disinfecting environmental surfaces and when performing terminal cleaning after an isolation patient had been discharged.



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2. During an observation on 3/13/12, at 9:15 AM, in the hospital's Definitive Observation Unit (DOU), a registered nurse (RN 1) was observed exiting Patient 47's room (a contact isolation patient). RN 1 had performed direct patient care, while wearing a hospital gown (Used to protect and prevent the spread of infection in a contact isolation patient room). RN 1 exited Patient 47's room while wearing the hospital gown. RN 1 proceeded to obtain medical supplies from a cart that was in the hallway and contained sterile supplies. RN 1 then reentered Patient 47's room and continued to provide direct patient care.

During an interview on 3/13/12, at 10 AM, with RN 1. She stated that the reason she exited Patient 47's room with the contact isolation gown and obtained medical supplies from the cart was "because I kept my distance and removed my gloves and sanitized. I reached over, being careful not to touch anything." Additionally, RN 1 stated regarding the hospital policy, "We are not to leave the patient's room if they are on contact isolation with a gown but it is a little challenging with this space."

A record review on 3/15/12, at 1:55 PM, of the hospital policy titled, "Precautions:Standard and Isolation", formulated on February 1997 and reviewed and revised on November 2009, revealed the following under Contact Precautions, "3.6 Gown ...Remove the gown before leaving the patient's environment...".


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3a. During a trayline (patient meal tray assembly) observation on 3/13/12 at 11:30 AM, the holding temperature of the sliced turkey was checked. The temperature registered 98 degrees Fahrenheit (F).

A review of the Trayline Temperature Log dated 3/13/12, for lunch, revealed that the temperature recorded for the turkey was written as 172 degrees F.

During a concurrent interview with Cook 1 who prepared the turkey and checked the temperature, he stated that the turkey was a precooked product. He stated that he sliced then heated the turkey to 165 degrees F. He stated that he placed the sliced turkey in the hot box for holding until he placed it on the steam table for serving. He stated that he checked the edge pieces of turkey and recorded that temperature. He further stated that he should have checked the temperature at the middle of the pan, but that he did not.

A review of the hospital's policy titled, "Food Temperatures" dated 1/12, revealed that the purpose of the policy was to control the spread of infection and disease. It further stated that foods must be held and served at appropriate temperatures to prevent food borne illness. Hot foods are held at a minimum temperature of 140 degrees F. Steam tables and food warmers are designed for holding hot food, not heating, therefore food must be at 140 degrees F or greater when placed in them.

During an interview with the Director of Food and Nutrition Services on 3/15/12 at 9:30 AM, she stated that she reviews the Trayline Temperature Logs for accuracy, but doesn't actually check the temperature of the food to ensure the recorded temperatures are accurate.

According to the 2009 FDA Food Code, bacterial growth and/or toxin production can occur if potentially hazardous food remains in the temperature "Danger Zone" (41 to 135 degrees F) too long. For this reason, it requires that hot potentially hazardous food be held at 135 degrees F or above.

3b. During the initial tour of the kitchen on 3/12/12 at 1:50 PM, the ice machine was observed. A clean paper towel swipe of the chute where the ice drops into the storage bin produced a moderate amount of brown residue on the paper towel. Also the deflector in the storage bin was noted to have a white build-up.

During a concurrent interview with Engineering Staff 1 (ES 1), she stated that the white build-up was lime scale. She stated that the ES cleaned and sanitized the ice machine every three months and de-limed the machine annually. She further stated that the last time that the machine was cleaned and sanitized was in December and it was due to be cleaned on 3/17/12.

The ES 1 was unable to provide documented evidence that the ice machine had been clean and sanitized by the ES since 8/11/11, seven months earlier.

A concurrent interview with the Director of Food and Nutrition Services (DFNS) revealed that the dietary staff was responsible for cleaning the ice storage bin of the ice machine. She stated that the dietary staff does not remove the deflector in order to clean the top of the bin. She stated that it was not the responsib

Based on staff interview and facility record review, the facility failed to educate Patient 41, prior to being discharged from the hospital, on the effects of the medication Vicodin, prescribed for pain relief and it having the potential to be transmitted via breast milk to the infant during lactation with the possibility of causing possible side effects of neonatal depression at or after birth for 1 of 42 sampled patients (Patient 41). This deficient finding had the potential to affect the health and safety of the infant, at or after birth, from the lactating mother resulting in possible rehospitalization of the infant for reasons that could have been prevented.

Findings:

On 3/12/12, a review of Patient 41's medical record was conducted. The admitting face sheet revealed that Patient 41 was admitted to the facility on 3/11/12 with spontaneous rupture of membranes and preterm labor. Further documentation revealed that Patient 41 underwent a successful cesarean section (surgical delivery of an infant) on 3/11/12, at 12:00 PM.

On 3/12/12, a review of Patient 41's medical record revealed that Patient 41's physician had written an outpatient prescription, dated 3/11/12, to be filled after discharge for Vicodin, 2 tablets to be taken by mouth every 4 hours for pain relief, as needed.

On 3/12/12, a review of Patient 41's medical record revealed in the "Lactation Assessment Notes", dated 3/13/12 and timed at 8:00 AM, it documented that Patient 41 would be breastfeeding for a "short time" because her mom wants her to, and would be switching to bottle feeding.

There was no documented evidence in the medical record or from other facility sources that the "Lactation Consultant" had educated or instructed the patient of possible side effects of taking the pain medication Vicodin, and its possible adverse outcomes towards the infant after breastfeeding by the mother.

There was no documented evidence in the Physician's Progress Notes, dated 3/14/12, that Patient 41's physician had informed, educated, or instructed the patient of possible side effects of Vicodin, prescribed for pain relief, and its possible adverse outcome towards the infant from the lactating mother.

There was no documented evidence in Patient 41's Discharge Summary Instruction sheet, dated 3/14/12, that addressed precautionary information given to the mother while taking the medication Vicodin for pain relief, and its possible adverse effect on the infant, from the lactating mother.

According to Mosby's Nursing Drug Reference, 22nd Edition, dated 2009, stated, "Vicodin is a controlled substance scheduled III medication. It binds to opiate receptors in CNS to reduce Pain. Precautions include: Pregnancy, breastfeeding, respiratory depression, weakness and nausea and vomiting. FDA pregnancy category C. It is not known whether Vicodin is harmful to an unknown baby, but it could cause breathing problems in a newborn. Acetaminophen and hydrocodone can pass into breast milk and may harm a nursing baby."

The Hospital failed to ensure that Patient 41 was instructed on the possible adverse side effects of taking the medication Vicodin, after discharge, and its possible adverse effect on the infant after breast feeding by the mother.

On 3/15/12, at the time of the finding, the Director of Labor Delivery Recovery Post-Partum (LDRP) Department confirmed the finding that Vicodin had the possibility of causing adverse side effects on the infant after breastfeeding by the mother and that the facility had failed to educate Patient 41 of such information prior to discharge from the hospital.