HospitalInspections.org

Based on interviews and record reviews, the hospital failed to ensure that the Director of Food and Nutrition Services (DFNS) met all the qualifications for a dietetic services supervisor under the State of California Health and Safety Code (CA HSC) section 1265.4(b). These qualifications were not met when the DFNS failed to receive at least six hours of in-service training on the specific California dietary service requirement contained in Title 22 of the California Code of Regulations prior to assuming full time duties as a dietetic services supervisor at the health facility.

Findings:

According to the California Health and Safety Code (CA HSC) 1265.4(b), the dietetic services supervisor shall have completed at least one of the following educational requirements:

(1) A baccalaureate degree with major studies in food and nutrition, dietetics, or food management and has one year of experience in the dietetic service of a licensed health facility.
(2) A graduate of a dietetic technician training program approved by the American Dietetic Association, accredited by the Commission on Accreditation for Dietetics Education, or currently registered by the Commission on Dietetic Registration.
(3) A graduate of a dietetic assistant training program approved by the American Dietetic Association.
(4) Is a graduate of a dietetic services training program approved by the Dietary Managers Association and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least
six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.
(5) Is a graduate of a college degree program with major studies in food and nutrition, dietetics, food management, culinary arts, or hotel and restaurant management and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers
Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services
supervisor at the health facility.
(6) A graduate of a state approved program that provides 90 or more hours of classroom instruction in dietetic service supervision, or 90 hours or more of combined classroom instruction and instructor led interactive Web-based instruction in dietetic service
supervision.
(7) Received training experience in food service supervision and management in the military equivalent in content to paragraph (2), (3), or (6).

During a review of the employee file for the Director of Food and Nutrition Services (DFNS) on 3/28/12 at 1:00 PM, it was noted that the DFNS had documentation that he graduated from a dietetic services training program approved by the Dietary Managers Association. It also showed that he had received his Certified Dietary Manager credential from the Dietary Managers Association on 10/25/08.

During an interview with the DFNS on 3/29/12 at 2:45 PM, he stated that he had not completed the six hours of in-service training on the specific California dietary service requirement contained in Title 22 of the California Code of Regulations. He further stated that he did not meet any of the other requirement for the pathways of becoming a qualified dietary service supervisor outlined in the CA HSC 1265.4(b).

Based on observation, interview and record review, the Board of Governors failed to be responsible for the conduct of the hospital because:

1. Not all policies that were distributed in the facility were reviewed and approved by the GB (Governing Body), creating the risk of substandard healthcare and an unsafe environment for patients using the facility.

Findings:

The policy, Processing Instruments, dated effective 11/11, was seen on 3/27/12.

During interviews with the GB Executive Assistant (Exec Asst) on 3/29/12 at 3:30 PM and on 3/30/12 at approximately 10 AM, she stated that the Processing Instruments policy was reviewed by the policy committee during the 11/11 meeting. The policy was to be sent to the T and S Committee but the committee did not have a quorum during its 11/17/11 and 11/23/11 meetings, and the policy was not presented at the subsequent meeting on 3/29/12. She stated that after approval by the T and S Committee, the policy should have been presented by the Quality Department for review by the GB, and that the GB or its Director was to approve the policy prior to implementation. She stated that the Processing Instruments policy should not have been distributed as an approved policy in the facility.

2. Quality assurance assessments had not been performed on all contracted service providers, creating the risk of substandard contracted services and substandard healthcare (see A-084).

3. The Board of Governors did not ensure the implementation of a facility-wide, comprehensive, proactive and data-based quality improvement organization, because:

A. Quality data regarding operating room humidity and post-surgical infection surveillance data were incompletely analyzed and tracked.

B. Medical errors that had been brought to the QI department, such as underreporting of medication errors and incomplete orders for Propofol, were not subject to analysis to determine their causes.

C. Prompt action was not taken regarding staff concerns regarding underreporting of medication errors.

D. Corrective actions for incomplete orders for Propofol, were not reassessed to determine their success (see A-263)

4. The Board of Governors failed to ensure a facility that was equipped and maintained to ensure high quality healthcare and a safe environment because there was no emergency power in the GI (gastrointestinal) Laboratory, creating the risk of a poor health outcome for any patient using the room during a power outage and the operating room humidity was repeatedly out of range for over a year, creating the increased risk of infection or fire for patients receiving services in that area (see A-700).

During an interview with the CEO on 3/30/12 at 11:15 AM, he affirmed that some of the problems, such as incomplete Propofol orders, that had previously been brought to the attention of the facility, had not been resolved. He stated that previous staff had not carried out all actions to address the problems as expected, and he had received inaccurate progress reports from previous management staff. He stated that new staff had been hired, but had not yet had time to rectify the problems.

The cumulative effect of these failings meant the facility was unable to ensure high quality healthcare and a safe environment for all patients using the facility.

Based on interview and record review, the facility had not implemented quality assurance for 3 of 3 contracted services reviewed, creating the risk of substandard services being provided, resulting in the risk of substandard healthcare or an unsafe environment for all of the patients.

Findings:

The files of the three randomly selected contracted service providers, Amicas, Inc, Desert Sierra Cancer Surveillance and GE Medical Systems IT-Centricity Perinatal were viewed on 3/26/12. The files did not contain evidence of quality assurance review supporting renewal of the contracts.

During an interview with the Dir QI on 3/26/11 at approximately 10 AM, he stated that he had begun the process of quality assurance (QA) of contracted service providers, and was looking into hiring someone to assist with QI of IT contract service providers, but the facility had not performed QI of the three selected providers yet.

The facility policy, Contracts (revision date 10/09), read in part, "The contract would include a written agreement which, as appropriate, would include the following: ...Verification that the agency shall participate in quality improvement activities ....Verification that the agency shall comply with hospital policies and procedures.", and "Contracts are to be re-evaluated and re-approved on annual basis."

Based interview and record review, the facility failed to ensure that the physician signed medical restraint orders within 24 hours of applying to 2 of 36 sampled patients (Patients 44 and 50). This failure had the potential to result in the physicians not performing face to face assessments as required every 24 hours to ensure the necessity of the restraints.

Findings:

1. A review on 3/26/12 of Patient 44's record showed a T.O. (telephone order) for a restraint that was dated 3/16/12 at 8:00 PM that was not authenticated by the physician.

In an interview on 3/27/12 at approximately 10:00 AM with Director 1, she acknowledged that physician orders should be authenticated within 24 to 48 hours.

A review of a facility policy and procedure titled "Restraints-Medical/Surgical" and with a revision date of 5/11 showed on page 6 under section 5. Physician Evaluation/Reevaluation, "Face-to-face reevaluations will occur no less than once each calendar day to determine clinical justification of restraint use."



25882

2. Record review revealed that Patient 50 was a 58 year old female admitted to the facility with a diagnosis of exacerbation of chronic obstructive pulmonary disease (a worsening of COPD symptoms: shortness of breath, cough and sputum production).

A review on 3/27/12 of Patient 50's medical record showed the following T.O.'s for non-behavioral restraints that were not authenticated by the physician:

T.O. dated 3/23/12 at 8:30 AM.
T.O. dated 3/19/12 at 7:30 AM.

During an interview on 3/27/12 at 10:15 AM, the Director of Inpatient Services confirmed that the T.O. were not authenticated by the physician.

Based on staff interview and facility record review, the facility failed to determine that less restrictive restraint interventions were deemed ineffective prior to administering bilateral soft wrist restraints and that other alternatives were considered or attempted and the rationale for not using alternatives were documented in the medical record for 1 of 36 sampled patients (Patient 61). This deficient practice had the potential for affecting Patient 61's safety and well being and right to be free from restraints.

Findings:

A review on 3/26/12, of Patient 61's medical record, revealed that Patient 61 was admitted to the facility on 3/25/12, with an admitting diagnosis of delirium tremors and alcohol withdrawal. (Seizure like movements of the body due to alcohol being withheld) and was admitted to the Intensive Care Unit and subsequently placed on a ventilator (breathing machine) for respiratory support.

There was no documented evidence in Patient 61's medical record that the facility conducted a comprehensive assessment of the patient to determine that the risks associated with the use of restraints outweighed the risk of using the restraint. There was no documented evidence in Patient 61's medical record that a discussion took place indicating that facility staff considered and determined least restrictive interventions. There was no documentation that least restrictive interventions were deemed ineffective and that other alternatives were considered or attempted, and that the rationale for not using other alternatives was discussed.

There was no documented evidence in Patient 61's medical record that facility staff considered the patient's safety needs affecting restraint use by not assessing the patient's overall condition, needs, strengths, weaknesses, and preferences after weighing factors such as patient's condition (ventilator dependent: a machine that maintains a flow of air into and out of the lungs of a patient who is unable to breathe normally), behaviors, history, and environmental factors.

There was no documented evidence in Patient 61's medical record that facility staff developed and maintained a comprehensive and individualized nursing care plan for "restraints" after restraining the patient on 3/25/12.

A review on 3/26/12, of the facility's policy and procedure titled, "RESTRAINTS", dated 5/11, stipulated in section 5, "...A restraint can only be used if needed to improve the patient's well being and less restrictive interventions have been determined to be ineffective ... "In section C (1) (d), it stipulated a comprehensive patient assessment must determine that the risks associated with the use of the restraints are outweighed by the risks of not using them and alternative interventions should be considered prior to the use of a restraint. In addition, the facility's restraint policy dated 5/11, revealed in section C (1) (G), "..Identify and attempt to alleviate current causes for behaviors requiring restraints prior to application may include:
a. Fever.
b. Decreased perfusion to the heart or brain.
c. Sepsis
d. Medication use.
and considered alternatives prior to application of restraints may include:
a. Pain management.
b. Placement of patient's room near nurses' station.
c. Frequent contact with patient.
d. Toilet every two hours.
e. Provide sitter or family members in attendance.

The Medical Staff General Rules and Regulations last revised 8/2/10, page 10, read in part, " In the case of a medical surgical patient, a restraint can only be used if needed to improve the patient's well being and less restrictive interventions have been determined to be ineffective. Orders must include the maximum amount of time restraints may be used, the type of restraint and the reason for the restraint. "

On 3/26/12, at approximately 11:55 AM, an interview with the Director of Inpatient Services confirmed the finding that there was no documented evidence in Patient 61's medical record that facility staff had determined that less restrictive interventions were initiated prior to
the use of bilateral soft wrist restraints that were applied on 3/25/12.

Based on interview and record review the facility failed to ensure that the use of physical restraints for 1 of 36 sampled patients (Patient 44) was not used on a PRN (as needed) basis. The patient's restraints were removed for a 6 hour period and replaced without obtaining a physician order to re-initiate the restraint. This failure had the potential to result in the patient being placed in a restraint without a medical indication for the use of the restraint.

Findings:

During a review on 3/26/12 of Patient 44's medical record, the medical record showed that the patient was admitted on 3/12/12 with diagnoses that included hepatic (related to the liver) encephalopathy (an abnormal condition of the function of the brain related to elevated blood ammonia levels) and seizures.

A review of the physician order for restraints dated 3/15/12 at 8:00 PM showed an order for non-behavioral restraints that included soft right wrist and soft left wrist restraints with indications as "Impulsive observed disconnecting and/or removing therapeutic device", "Observed trying to climb out of bed when instructed not to do so" and "Unsteady. Will not ask for assistance."

A review of the Restraint Flowsheet dated 3/15/12, showed that the standard for non-behavioral restraints was for monitoring the patient every two hours. There were boxes for the nursing staff to assess the patient in restraints timed for every two hours. The boxes for 8:00 AM, 10:00 AM and 12:00 PM were filled in, indicating that Patient 44 was in restraints and the nurse was monitoring the patient at two hour intervals. The boxes for 2:00 PM, 4:00 PM, and 6:00 PM (a six hour period) were blank, indicating that the patient was not in restraints. The boxes for 8:00 PM through the following day at 6:00 AM were filled in, indicating that the patient was placed back into restraints.

There was no physician order to place the patient back into restraints after they had been removed. There was no documentation that a trial release of restraints was attempted.

In an interview with RN 5 on 3/27/12 at 9:30 AM, she acknowledged that when restraints are removed from the patient that another physician order should be obtained.

In a review of a facility policy and procedure titled "Restraints-Medical/Surgical and with a revision date of 5/11 showed the following:

"Trial release attempts, as appropriate, will be performed throughout restraint use to determine patient's readiness for discontinuation. It is not required to obtain another physician order for reapplying the restraint after unsuccessful trial release attempts. However, once the restraint has been discontinued, a new order must be received."

Based on observation, interview and record review, the facility failed to ensure the implementation of a facility-wide, comprehensive, proactive and data-based quality improvement organization because:

1. The QI program did not ensure that quality indicator data was analyzed and tracked because: 1. operating room humidity data showed the OR climate was not maintained within facility parameters, creating the risk of a poor health outcome for patients using the OR when the humidity was not maintained per policy, and 2. post-surgical infection surveillance data was incompletely collected, creating the risk of unrecognized infection hazards that could affect all patients using the operating rooms (see A-274).

2. The QI program did not routinely analyze medical errors because it failed to provide analysis of errors that had been brought to the QI department, such as: 1. the underreporting of medication errors, 2. incomplete orders for Propofol, creating the risk of persistent poor medical practices and substandard care for all patients (see A-287).

3. The QI program did not take action for improving performance because it failed to act on errors that had been brought to the QI department, such as the underreporting of medication errors, creating the risk of persistent poor medical practices and substandard care for all patients (see A-289).

4. The QI program failed to measure its success after implementing corrective actions for incomplete orders for Propofol, creating the risk of persistent poor Propofol ordering and administration practices, and the risk of substandard health outcomes for patients receiving Propofol (see A-290).

5. The hospital failed to implement and maintain an effective and ongoing, hospital-wide Quality Assessment and Performance Improvement program related to improving health outcomes of patients and prevention and reduction of medical errors; as well as other aspects of performance that assess processes of care, hospital service and operations for all patients presenting at the hospital's outpatient departments. This deficient practice had the potential of compromising quality of care being provided to patients and not monitoring the effectiveness and safety of services provided at the facility's outpatient departments. (see A-0264).


The cumulative effect of these findings meant the QI program did not ensure the delivery of high quality healthcare in a safe environment.

Based on staff interview and hospital record review, the hospital failed to implement and maintain an effective and ongoing, hospital-wide Quality Assessment and Performance Improvement program related to improving health outcomes of patients and prevention and reduction of medical errors; as well as other aspects of performance that assess processes of care, hospital service and operations for all patients presenting at the hospital's outpatient departments. This deficient practice had the potential of compromising quality of care being provided to patients and not monitoring the effectiveness and safety of services provided at the facility's outpatient departments.

Findings:

On 3/29/12, at approximately 10:30 AM, an interview with the facility's Director of Quality Improvement and Compliance Department was conducted. When asked if the hospital had an ongoing, hospital-wide, quality assessment and performance improvement program for the hospital's outpatient Women's Clinic, the outpatient MRI (Magnetic Resonance Imaging) Department and the CT (Computerized Tomography) Department, he stated, "No, but I know I will make it my priority now."

On 3/29/12, a review of the hospital's Quality Improvement/Risk Management Departments' scope of service policy and procedure was conducted. The goals of the Quality Improvement Program, dated 10/2011, documented the following:
a. Systematically apply a methodology and process for continuous quality improvement.
b. Ensure an integrated, coordinated and collaborative approach to patient care, as appropriate.
c. To plan a systematic, organization-wide approach to performance improvement, which is collaborative and interdisciplinary. It is necessary to use a variety of information sources to formulate plans about a new service, extend an existing service, or redesign a process or system.
d. Each department is responsible for preparing supplemental policies and procedures specific to that departments' identified problems.


On 3/29/11, at approximately 11:00 AM, during an interview with the facility ' s Director of Quality Improvement and Compliance Department, when asked to review the hospital's current QAPI (Quality Assessment and Performance Improvement) activities, including quality improvement indicators involving all hospital inpatient and outpatient departments and services; or any data documenting other aspects of performance that assess processes of care, hospital outpatient services and operations; or any evidence that the Governing Body was involved in addressing priorities for improving quality of care, he stated, " At present I am not following any quality indicators from any outpatient departments of the hospital (Women ' s clinic, MRI and CT Outpatient Centers) on my dashboard; but I will make it a priority from now on. "

There was no documented evidence that implementation of an on-going, organized, hospital-wide, Quality Management program was being conducted at the hospital ' s outpatient centers (Women ' s Clinic, MRI and CT Departments) for the year 2011 to 3/29/2012.

The hospital was unable to provide current and on-going Quality Assessment and Performance Improvement activities reports or any data that were considered important in maintaining clinical quality assessment activities from all outpatient departments (Women ' s Clinic, MRI and CT Departments) of the hospital from 2011 through 3/29/2012.

There was no documented evidence that the QA Department collaborated and reviewed information addressing opportunities of improvement for all hospital outpatient departments (Women ' s Clinic, MRI and CT Departments) which involved the hospital's Safety Committee, Risk Management Committee and Utilization/Case Management Committees from the year 2011 through 3/29/2012.

There was no documented evidence that the QA Department promoted a facility-wide communication, education and coordination to improve hospital-wide systems and processes and to improve the department and/or organizational performances of all hospital outpatient departments (Women ' s Clinic, MRI and CT Departments) from the year 2011 through 3/29/2012.

There was no documented evidence that the hospital's Governing Body and Quality Council committee members reviewed the hospital's Quality Management Program activities involving all outpatient departments (Women ' s Clinic, MRI and CT Departments) from the year 2011 through 3/29/2012 on a consistent basis (quarterly).

On 3/29/12, at approximately 11:00 AM, during an interview with the facility ' s Director of Quality Improvement and Compliance Department confirmed the finding that the Quality Improvement and Compliance Department did not provide oversight and monitoring of all the outpatient departments (Women ' s Outpatient Clinic, MRI and CT Outpatient Departments) under the hospital ' s license.

Based on observation, interviews and record reviews, the hospital failed to measure, analyze and track quality indicators related to deficient practices identified in the dietary department related to safe food handling practices, ensuring the provision of timely and appropriate nutrition care of the patients, ensuring disaster food supplies were sufficient to meet the needs of the patients and staff during a disaster and physician ordered diets were accurately prepared and distributed to the patients. The result of this lack of monitoring resulted in the continuation of deficient practices and substandard nutrition care.

Findings:

During the survey deficient practices were identified related to:
? safe food handling and storage (cross refer A 749)
? timeliness of the provision of nutrition care to the patients (cross refer A 630)
? disaster food supplies not adequate to meet the needs of the patients and staff in a disaster (cross refer A 701)
? physician's diet orders were not being followed or implemented according to recognized dietary practices (cross refer A 630)

During a review of the hospital's Quality Improvement Indicator Plan for Nutritional Service, 2012, it showed that the rationale for selecting the indicators included high risk, high volume and problem prone issues. The department had two quality indicators that did not address the deficient practices identified during the survey.

During an interview with the Director of Food and Nutrition Services on 3/29/12 at 1:40 PM, he stated they had not identified the deficient practices observed during the survey and they were not monitoring these problems. He stated that the indicators that the department was monitoring were the same ones they were monitoring last year.

During an interview with the Director of Quality on 3/29/12 at 10:25 AM, he stated that the quality committee was not aware of the deficient practices identified in the dietary department.

Based on interview and record review, the QA program did not ensure that quality indicator data was analyzed and tracked because: 1. Operating room humidity data showed the OR climate was not maintained within facility parameters, creating the risk of a poor health outcome for patients using the OR when the humidity was not maintained per policy, and 2. Post-surgical infection surveillance data was incompletely collected, creating the risk of unrecognized infection hazards that could affect all patients using the operating rooms.

Findings:

1. During a review of the Main Operating Room Temperature and Humidity Log for the period 1/11 through 3/25/12, the log read, "Maintain room humidity between: 30% and 60%, but the recorded values varied from that range on numerous dates. On 3/9 and 3/10, the humidity was 26 or below in 4 of the 5 ORs in use on those dates. For OR 1, the humidity was below the facility policy's lower limit on 8 of 24 days recorded in March, 2012. The humidity fell either above (high of 72%) or below (low of 18%) the facility's policy in the ORs on some dates during every month from 1/11 through 3/12 (see 1-726).

During an interview with the Dir QI on 3/29/12 at 11:40 AM, he stated that he was not aware of the problem with OR humidity, and that he was not sure why the problem had not come to the attention of the QI department.

2. During an interview with the Dir IC on 3/29/12 at 9:35 AM, she stated that the surgeons were supposed to send back forms regarding post-operative infections, but that in fact the forms were only being returned 50-60% of the time. She stated that the return rate had been reported to the surgical services committee, but that no method to enforce return of the surveys had been implemented.

In an interview with the Dir QI on 3/29/12 at 11:40 AM, he stated that he was not aware the post-operative infection surveillance data was incomplete. He concurred that it was the role of the QI program to work with department chairs to ensure the effectiveness of data collection and analysis.

During a review of the facility policy, Quality Improvement Plan Attachment A, dated November, 2011, the document read in part, "Important processes and activities are measured, assessed and improved systematically throughout VVCH. Data is collected on key indicators of performance identified by services, programs, and the medical staff."

Based on interview and record review, the QI program failed to provide analysis of errors that had been brought to the QI department, such as: 1. the underreporting of medication errors, 2. incomplete orders for Propofol, creating the risk of persistent poor medical practices and substandard care for all patients.

Findings:

1. During an interview with the Dir Pharm on 3/30/12 at 10:35 AM, he stated that he found that medication errors were being underreported. He stated that two thirds of the potential medication errors were being caught by the pharmacy, when they should be caught earlier, by other staff members, including the nursing staff. He stated that the facility policy was for an incident report to be filed when a reversal agent was needed to correct over-medication, but that the staff members were not completing the incident reports. He stated that he had presented this information to the MEC, the QI Department, and the CNO, but that he had not seen an analysis of the problem or other response to the problem by the QI Department.

In an interview with the Dir QI on 3/30/12 at 11 AM, he stated that underreporting of medication errors had come to the attention of the QI department the prior month, but that no analysis of the problem had occurred yet.

During a review of the facility policy, Quality Improvement Plan Attachment A, dated November, 2011, the document read in part, " QIC responsibilities are at a minimum: ...Referring priority problems to appropriate departments, services or committees for in-depth assessment ... "

2. During a tour of the ICU on 3/26/12, the medical records of Patients D and E were reviewed. Patient D's record contained an order dated 3/22/12 at 7:55 that read, "Diprivan titrate to sedation". Patient E's record contained an order dated 3/16/12 that read, "Propofol for sedation max 59 mil/kg/min". There was no rate of infusion or parameters describing the desired level of sedation included in the orders. There were no clarifications of the orders seen.

During an interview with the CNO on 3/30/12 at 10 AM, he stated that the Propofol orders were incomplete and should have been clarified by the nursing staff prior to implementation.

The facility policy, Medication Orders (revision date 8/11) read in part, "Elements of a complete medication order: ...c. Medication name and strength d. Medication frequency of administration" and "When a question arises concerning a medication order, the pharmacist will contact the patient's nurse and either the nurse or pharmacist may contact the prescribing physician."

During an interview with the Dir QI on 3/30/12 at 9:05 AM, he concurred that incomplete Propofol orders were an issue noted during a 6/2011 survey, and described in a document received by the facility in February, 2012. He stated that the nursing staff was to have been checking Propofol orders for completeness. He stated that he was not sure why the medical staff had not gotten the message regarding the need for complete Propofol orders. He stated that there had been no analysis of the incomplete Propofol orders issue yet.

During a review of the facility policy, Quality Improvement Plan Attachment A, dated November, 2011, the document read in part, "QIC responsibilities are at a minimum: ...Referring priority problems to appropriate departments, services or committees for in-depth assessment ... "

Based on interview and record review, the QI program did not take action for improving performance because it failed to act on errors that had been brought to the QI department, such as the underreporting of medication errors, creating the risk of persistent poor medical practices and substandard care for all patients.

Findings:

During an interview with the Dir Pharm on 3/30/12 at 10:35 AM, he stated that he found that medication errors were being underreported. He stated that two thirds of the potential medication errors were being caught by the pharmacy, when they should be caught earlier, by other staff members, including the nursing staff. He stated that the facility policy was for an incident report to be filed when a reversal agent was needed to correct over-medication, but that the staff members were not completing the incident reports. He stated that he had presented this information to the MEC, the QI Department, and the CNO, but that he had not seen an analysis of the problem or other response to the problem by the QI Department.

In an interview with the Dir QI on 3/30/12 at 11 AM, he stated that underreporting of medication errors had come to the attention of the QI department the prior month, but that no analysis of the problem had occurred yet.

During a review of the facility policy, Quality Improvement Plan Attachment A, dated November, 2011, the document read in part, " QIC responsibilities are at a minimum: ...Referring priority problems to appropriate departments, services or committees for in-depth assessment and corrective action .... "

Based on interview and record review, the facility failed to measure its success after implementing corrective actions for incomplete orders for Propofol, creating the risk of persistent poor Propofol ordering and administration practices, and the risk of substandard health outcomes for patients receiving Propofol.

Findings:

During a tour of the ICU on 3/26/12, the medical records of Patients D and E were reviewed. Patient D's record contained an order dated 3/22/12 at 7:55 that read, "Diprivan titrate to sedation". Patient E's record contained an order dated 3/16/12 that read, "Propofol for sedation max 59 mil/kg/min". There was no rate of infusion or parameters describing the desired level of sedation included in the orders. There were no clarifications of the orders seen.

During an interview with the CNO on 3/30/12 at 10 AM, he stated that the Propofol orders were incomplete and should have been clarified by the nursing staff prior to implementation.

During an interview with the Dir QI on 3/30/12 at 9:05 AM, he concurred that incomplete Propofol orders were an issue noted during a 6/2011 survey, and described in a document received by the facility in February, 2012. When asked why the problems was again found in the facility, he stated that the nursing staff was to have been checking Propofol orders for completeness and that he was not sure why the medical staff had not gotten the message regarding the need for complete Propofol orders. He stated that a packet with information regarding the need for complete Propofol orders had been distributed to the CMS and to some other medical staff members.

During a review of QIC documents on 3/28/12, no evidence of assessment of the success of the actions regarding Propofol orders was seen.

During a review of the facility policy, Quality Improvement Plan Attachment A, dated November, 2011, the document read in part, "VVCH measures and assesses the effectiveness of efforts to improve performance and patient safety."

Based on interview and document review, the Medical Staff did not ensure that, for one physician, DR 1, the facility reappraisal was completed prior to his reappointment to the medical staff, creating the risk of substandard patient care for patients in his care.

Findings:

During a review of the credential file of DR 1 on 3/29/12 at 4:30 PM, the file contained a Reappointment Profile and Evaluation form. The first page had been completed, but the second page, which was "an evaluation to be completed by Division/Department Chairperson" was not completed. The page contained pre-printed questions about the physician's on-call and ethical behavior, compliance with bylaws and policies, cooperativeness with others, skills, discipline, malpractice history and health. The third page of the form contained pre-printed questions about whether reappointment was recommended, which were left blank. The otherwise blank third page was signed by the department chair on 8/12/10, by the MEC on 8/18/10, and by the Board of Directors on 8/25/10.

During an interview with the Med Staff Coordinator on 3/28/12 at 2:15 PM, she reviewed the credential file of DR 1 and concurred that the Reappointment Profile and Evaluation form should have been filled out.

The Medical Staff Bylaws (revision 1/25/2012) were reviewed and read in part in section 5.5-326, " The Department Chairperson shall evaluate all matters deemed relevant, including information concerning the applicant ' s provision of services within the scope of privileges granted, the individual ' s clinical and/or technical skill as indicated by the results of Quality Assurance activities, compliance with Bylaws, Rules/Regulations, the Division Chairperson recommendations, and shall submit to the Credentials Committee recommendations as to appointment ... "

Based on observation, interview and record review, the Medical Staff did not enforce its bylaws because: 1. For one physician, DR 3, proctoring was not completed in the time frame required, 2. For one physician, DR 4, A. his pre-operative history and physical examinations were incomplete, B. a physical exam dated for the day of surgery had been performed on an earlier date and C. there was no documented follow-up of concerns about incomplete history and physical examination documentation, and 3. The facility failed to ensure that all physician's orders were clear and complete and followed facility policy when initiating orders for Propofol (an intravenous anesthetic medication) for 3 of 36 sampled patients (Patients D, E, and 61). This deficient practice had the potential to result in creating a risk of incorrect treatment, poor health outcome, and substandard healthcare for patients under the care of the Medical Staff.

Findings:

1. The credential file of DR 3 was reviewed on 3/28/12, and no evidence of proctoring was found in the file.

In an interview with the Med Staff Coordinator 2 on 3/28/12 at 2:15 PM, she reviewed the credential file of DR 3 and was unable to locate evidence of proctoring. She stated that proctoring was to be done within 6 months of appointment according to the rules and regulations, and should have been done by January, 2011.

During an interview with the Chief MS on 3/29/12 at 11 AM, he stated that he was not sure why proctoring had not been completed on DR 3.

The Medical Staff Bylaws (last revised 1/25/2012), page 28, was reviewed and read in part, "All initial appointees to the Medical Staff and Allied Health Practitioner Staff granted new independent clinical privileges shall be assigned to the appropriate department where performance of an appropriate number of cases shall be observed during a period as specified in the department Rules and Regulations. "

2A. During a tour of the ambulatory surgery area on 3/26/12, the record of Patient F was reviewed. The record contained a pre-printed pre-operative history and physical examination form titled Short History. The history portion of the Short History form dated 3/26/12 and signed by DR 4 was blank, but the physical examination portion of the form had information filled in. The remainder of the record was reviewed, and nursing notes indicated that the patient had a significant medical history, including lymphoma (a type of cancer), back problems, previous surgeries and was on six medications, which were not listed on the Short History form.

On 3/28/12, the medical records of DR 4's ambulatory surgery Patients A and B, who had surgery on 3/26/12, were reviewed, and also showed incomplete Short History forms prior to surgery.

In an interview with Surg RN 2 on 3/26/12 at 9:50 AM, she reviewed Patient F's Short History and stated that the form should have the present illness and vital signs filled in.

In an interview with the Dir Surg on 3/27/12 at 11:15 AM, she stated that the Short History form for ambulatory surgery patients should be complete, including the patient's medical and surgical history. She reviewed the medical record of Patients A, B and F and concurred that the Short History form for those patients was missing information.

The Medical Staff Rules and Regulations (revised 8/2/10) read in part, "The short history and physical form must include at a minimum: chief complaint, present illness, allergies, past history, vital signs, diagnosis, and an examination to include HEENT, chest and lungs, heart, abdomen and neurological status."

B. During a tour of the ambulatory surgery area on 3/26/12, the record of Patient F was reviewed. The history portion of the Short History form dated 3/26/12 and signed by DR 4 was blank, but the physical examination portion of the form had information filled in.

During an interview with Patient F on 3/26/12 at 10 AM, he stated that DR 4 had performed a physical examination in his office, approximately 2 weeks prior, but had not seen him on 3/26/12.

In an interview with Surg RN 2 on 3/26/12 at 9:50 AM, she stated that the form was sent from the surgeon ' s office on the day of surgery, and she thought that the patients had been seen there that day prior to coming to the hospital.

The Medical Staff Rules and Regulations (revised 8/2/10) read in part, "If a patient is hospitalized for less than 24 hours, physicians may use the preprinted short history & physical form. The physician must document an update when the outpatient service or procedure is rendered." and in the Medical Staff Bylaws (revised 1/25/2012), "The updated examination of the patient including any changes in the patient's condition must be completed and documented by a physician."

C. In an interview with the Dir Surg on 3/27/12 at 11:15 AM, she stated that the Short History form for ambulatory surgery patients should be complete, including the patient's medical and surgical history. She reviewed the medical record of Patients A, B and F and concurred that the Short History for those patients was missing information. She stated that DR 4 had been counseled previously about the quality of his history and physical examination documentation with temporary improvement, but that the improvement was not sustained.

During a review of DR 4's medical staff files on 3/29/12, no documentation of specific follow-up with the physician regarding the incomplete history and physical examinations was seen.

During an interview with the Chief MS on 3/29/12 at 11 AM, he stated that the Chief of Surgery should have spoken to DR 4, and that should have been documented.

3. During a tour of the ICU on 3/26/12, the medical records of Patients D and E were reviewed. Patient D's record contained an order dated 3/22/12 at 7:55 that read, "Diprivan titrate to sedation". Patient E's record contained an order dated 3/16/12 that read, "Propofol for sedation max 59 mil/kg/min". There was no rate of infusion or parameters describing the desired level of sedation included in the orders. There were no clarifications of the orders seen. There was no pre-printed Orders for Propofol form in the medical record for Patients D and E.

The facility's Pre-printed Orders for Propofol form was reviewed and included detailed instructions for titration, vital signs and sedation level monitoring parameters, and instructions on when to order additional tests or contact the physician.

During an interview with the CNO on 3/30/12 at 10 AM, he stated that the Propofol orders were incomplete and should have been clarified by the nursing staff prior to implementation.

During an interview with the Dir QA on 3/30/12 at 9:05 AM, he stated that he was not sure why the medical staff had not gotten the message regarding the need for complete Propofol orders. He said that he had begun distribution of policies to the medical staff as a reminder of actions that were expected.

During an interview with the Chief MS on 3/29/12 at 11 AM, he stated that a booklet had been prepared by the QI Department regarding issues involving the Medical Staff, and had already been distributed to some members of the Medical Staff. He stated that he was not familiar with the issue of incomplete Propofol orders, and thought that the Medical Staff might not be filling out the pre-printed order form because they were unable to locate it.

The facility policy, Medication Orders (revision date 8/11) read in part, "Elements of a complete medication order: ...c. Medication name and strength d. Medication frequency of administration "

The facility policy, High Alert Medications (revision date 9/09), read in part, "Propofol (Diprivan) shall only be administered in the ED and ICU per the hospital's propofol protocol for critical care and in surgery."

The Medical Staff Bylaws (revised 1/25/12), read in part, "...the ongoing responsibilities of each member of the Medical Staff include: ...Abiding by the Medical Staff Bylaws, Rules and Regulations, and Medical Staff policies; and by applicable Hospital rules, regulations or policies approved by the Medical Executive Committee and Governing Board."



26502


3. On 3/26/12, a review of Patient 61's medical record was conducted. The admitting face sheet revealed that Patient 61 was admitted to the facility on 3/25/12, with an admitting diagnosis of delirium tremors and alcohol withdrawal. (Seizure like movements of the body due to alcohol being withheld); was admitted to the Intensive Care Unit and subsequently placed on a ventilator (breathing machine) for respiratory support.

On 3/26/12, a review of Patient 61's physicians' order sheet dated 3/25/12 and timed at 11:30 PM, revealed an order for the following:
a. Continue all drips as per Emergency Department orders.
b. Diprivan (Propofol) Drip 10-50 micrograms/kilograms/minute IV (Intravenous).

There was no documented evidence on the Physicians' Order sheet dated 3/25/12, that a specific rate was to be maintained according to the Ramsay Sedation Scale or functional parameters were to be followed that was specified on the order sheet. There was no written order for attempting "weaning trials" or an order to ???"attempt to decrease Propofol" with appropriate dosing change orders as guidelines.

Therefore, there was no functional parameter (boundaries) on the Propofol Drip orders for maintaining sedation according to the Ramsay Sedation Scale, or specific dose changes when weaning off or attempts to decrease propofol that were initiated on the Physicians' Order sheet, dated 3/25/12, and timed at 11:30 PM.

On 3/26/12, a review of Patient 61's pre-printed Propofol (Diprivan) Order sheet (no date) revealed that the order sheet was incomplete, not filled out, and left blank. There was no indication that the physician had authenticated the order, timed or dated the order sheet. The pre-printed order sheet for Patient 61 had only the admitting diagnosis, allergies and the status of "NPO" (nothing by mouth) written on the form and entered into the medical record.

During a review of the facility's pre-printed Propofol order set, several sets of parameters were provided and the physician was to choose the appropriate parameters for the patient. For example, the order set required that the physician choose the Ramsey Scale (used to assess the level of sedation) score that would indicate the desired degree of sedation for the patient, but no criteria, such as a desired Ramsey Scale score was supplied for Patient 61.

The pre-printed Propofol (Diprivan) Order sheet (not dated), for Patient 61, had the following components not ordered, checked off and not selected by the physician prior to initiating the Propofol Drip on 3/25/12:

1. VITAL SIGNS: (baseline assessment, cardiac monitoring, neurological assessment, blood pressure pulse and respirations every 5 minutes while titrating drip, then every 30 minutes times 2 then very hour thereafter and assess sedation level within 5 minutes of every rate adjustment). This section was found incomplete, not filled out and left blank by the physician.

2. MEDICATIONS: (Intravenous infusion of Propofol Drip, for ventilation control, titrate for Ramsey Sedation score of 4 to 5, increase or decrease by 5 micrograms/kilogram/minute until level of sedation reaches a Ramsay score of 4 to 5 (Ramsay score level 4=Brisk response to tapping and loud auditory stimulus or Level 5=Sluggish response to stimulus) and maintenance infusion of 5 micrograms/kilogram/minute to maintain sedation for Ramsay score of 4 to 5. In addition, the nurse must call the physician to increase the dose if patient remains agitated after 50 micrograms/kilogram/minute was reached. This section was found incomplete, not filled out and left blank by the physician.

3. NURSING ORDERS: (Titration orders for titrating off the Propofol Drip according to the Ramsay Sedation Scale was found incomplete, not filled out and left blank by the physician.

On 3/26/12, during a review of the Medical Staff General Rules and Regulations, revised 8/2/10 page 7, documented, "...The physicians's order must be written clearly, legibly and completely, transcribed accurately, dated and timed..."

On 3/26/12, at approximately 10:45 AM, the Director of Inpatient Services confirmed the finding that Patient 61's Propofol orders were not accurate and incomplete.

Based on observation, interview, and record review the facility failed to have a well organized nursing service to provide 24-hour nursing services to all patients by failing to:


1. Ensure that proper resuscitative and monitoring equipment were immediately available in the Radiology Department (X-ray Department), CT Department (Computerized Tomography-specialized x-ray machine), and MRI Department (Magnetic Resonance Imaging-specialized x-ray machine) by failing to provide Pediatric emergency resuscitative equipment readily available. (Emergency resuscitative equipment for Non-adult patients). This deficient finding had the potential to affect the health and safety of non-adult patients experiencing an emergency resuscitative event while undergoing procedures in the Radiology Department, CT Department and MRI Departments.

The facility further failed to ensure that nursing evaluated the nursing care for 4 of 36 sampled patients, Patient 44, 46, 47 and 48, by not thoroughly assessing the patients' pressure sores. This failure had the potential to result in the patients' pressure sores becoming worse. (Refer to A-0395)

2. Ensure that nursing staff develops, and keeps current, an individualized nursing care plan for (5 of 36 sampled patients) (Patients 43, 44, 46, 47 and 48). This deficient practice had the potential to affect the health and safety and the care being delivered to patients. (Refer to A-0396)

3. Ensure that the hospital's Special Procedure Nurse, working in the Radiology Department, had a completed competency validation evaluation in the employees' personnel file prior to receiving patient care assignments demonstrating competency with qualifications to perform only those duties and responsibilities for which competency had been validated. This deficient practice had the potential to affect the health and safety of patients being monitored and receiving services in the Radiology Department. (Refer to A-0397)

4. Ensure the following:


A. Signed orders were the basis for initiation of intravenous fluid in the ambulatory care unit.


B. That orders for Propofol (an intravenous anesthetic agent) were complete for Patients D and E, creating the risk of poor health outcomes from medication dosing errors.


C. The hospital failed to ensure that clear parameters were set for the administration of propofol, a powerful anesthetic, for 3 of 6 patients (Patients 49, 50 and 51 admitted to the intensive care unit (ICU). This failure had the potential to result in an adverse reaction. (Refer to A-0404)


5. Ensure that all physician's orders for 2 of 36 sampled patients, were clear and complete and followed facility policy based on the following:

A. For Patient 61, the facility failed to ensure that all physician orders were clear and complete when initiating orders for Propofol.

B. For Patient 62, Nursing Services and Pharmacy Services failed to clarify an order for Lactulose when the dose ordered was inaccurate.

These deficient practices had the potential to result in creating a risk of incorrect treatment, poor health outcome, and substandard healthcare for patients under the care of the Medical Staff. (Refer to A-0406)

The cumulative effect of these systemic problems resulted in the facility's failure to deliver patient care in a safe manner and in compliance with the Condition of Participation for Nursing Services.

Based on observation, interview and record review the facility failed to ensure that proper resuscitative and monitoring equipment were immediately available in the Radiology Department (X-ray Department), CT Department (Computerized Tomography-specialized x-ray machine), and MRI Department (Magnetic Resonance Imaging-specialized x-ray machine) by failing to provide Pediatric emergency resuscitative equipment, readily available. (Emergency resuscitative equipment for Non-adult patients). This deficient finding had the potential to affect the health and safety of non-adult patients experiencing an emergency resuscitative event while undergoing procedures in the Radiology Department, CT Department and MRI Departments.

The facility further failed to ensure that nursing evaluated the nursing care for 6 of 36 sampled patients as follows:
1. For Patients 44, 46, 47 and 48, by not thoroughly assessing the patients' pressure sores. This failure had the potential to result in the patients' pressure sores becoming worse.
2. The nutrition care of Patient 22, admitted with a recent history of weight loss and chronic constipation was delayed when:
a.) A dietary consult was not ordered according to the hospital's policy and
b.) A nurse entered a diet into the computer without a physician order that was inconsistent with the physician's diet order.

3. The meal percentages were not recorded for Patient 21 during her 14 day stay at the hospital preventing the nutrition assessment and reassessment from being accurate and delaying appropriate nutrition interventions.

Findings:

1. On 2/28/12, during environmental rounds and tour of the Radiology, CT and MRI Departments, it was observed that Pediatric Resuscitative Emergency Equipment were not available on the Adult Crash Cart (a cart where emergency medications and equipment is stored) in each department.

On 3/28/12, a review of the facility's policy and procedure titled, "IMAGING SERVICES; SCOPE OF CARE AND SERVICE " dated 9/2009, stipulated, "...Types of patients served in the imaging services department: All ages of patients from newborn to senior citizen ... ".

On 2/28/12, at approximately 9:30 AM to 10:45 AM, an observation of the Adult Crash Carts in the Radiology, CT and MRI Outpatient Departments revealed no physical evidence of Emergency Pediatric Resuscitative equipment was noted. The following emergency pediatric resuscitative equipment were missing:

a. Pediatric cardiac monitor with defibrillation paddles (special size paddles capable of delivering electric shock to the patient's heart) and a backboard.
b. Pediatric intubation tray (a tray with emergency equipment to provide artificial oxygenation).
c. Pediatric oxygenation masks of different sizes and uses.
d. Pediatric Interosseus Equipment (specialized equipment used to penetrate the bone of the patient instead of the vein to provide rapid fluid administration in critical patients).
e. Pediatric Broselow/Hinkle quick-glance information guidance sheet used during pediatric emergency resuscitative events.

On 3/28/12, at the time of the findings the Director of Radiology Services and Director of Ancillary Services agreed that Pediatric emergency resuscitative equipment was lacking in the Radiology Department, CT and MRI Outpatient Departments.




25179

2. A review on 3/26/12 of Patient 44's medical record showed that the patient was admitted to the facility on 3/12/12 with diagnoses that included hepatic encephalopathy (an abnormal condition of the function of the brain related to elevated blood ammonia levels due due a problem with the liver) and seizures.

A review of Patient 44's ICU (Intensive Care Unit) Nursing Flowsheet and Decubitus Flow- sheet dated 3/16/12 showed that the patient developed redness and excoriation (an injury to the surface of the skin caused by scratching, or a chemical or thermal burn-a Stage 2 pressure sore) to the buttocks and the area between the legs. There was no documentation of the stage of the pressure sore (damage to the skin or underlying structures as a result of tissue compression and inadequate perfusion), the measurement of the pressure sore area, whether there was drainage from the pressure sore or what the surrounding skin looked like.

A review of the Decubitus Flowsheet dated 3/17/12 showed the nurses documented an excoriation to the sacrum (area just above the buttocks) and scrotal area. There was no documentation of the stage of the pressure sore, the measurement of the pressure sore area, whether there was drainage from the pressure sore or what the surrounding skin looked like.

A review of the Decubitus Flowsheet dated 3/26/12 showed that the nurse documented that the pressure sore was a Stage 2, that the area was starting to heal and that it was painful. There was no documentation of the measurement of the pressure sore or what the surrounding skin looked like.

There were two pictures taken of Patient 44's pressure sore. One was not dated and the area shown in the picture was not identified. The second picture was dated 3/25/12, 9 days after the patient developed the pressure sore.

In an interview on 3/27/12 at 9:25 AM with RN 5, she acknowledged that the patient's pressure sore was not completely assessed per the facility policy and procedure.

A review of a facility policy and procedure titled "Integumentary, Pressure Ulcer Treatment", dated with a revision date of 2/12, showed that "It is the policy of ...(name of facility) to regularly assess patient's skin integrity and to promote tissue healing." In the same policy under the Assessment section: "1. Assess pressure ulcer by using one or more of the following wound assessment tools every shift, upon the patient's complaint of pain or discomfort, change in patient's condition, and/or upon discharge. 2. The initial skin integrity assessment must be performed by two RNs and documented accordingly." Under the Photographing wounds section: "1. All wounds shall be measured (length x width x depth) and photographed with a standardized measurement tool next to the wound in the picture...a. On admission b. With first documentation if skin breakdown develops after admission c. With documentation of progression or significant change in wound condition d. Weekly..."

3. A review on 3/26/12 of Patient 46's medical record showed that the patient was admitted on 3/19/12 with diagnoses that included infected decubitus (pressure sore) and anemia.

Review of Patient 46's admission notes showed that there was an incomplete assessment of the patient's pressure sores. There was no description of the wounds and no measurement of the pressure sores.

A review of the nursing flowsheet dated 3/19/12 at 7:30 PM showed under the skin section "multiple decubs (decubitus)" There was no description or measurement of the pressure sores.

In an interview on 3/27/12 at 11:30 AM with RN 6, she acknowledged that there should have been an assessment of the patient's pressure sores.

A review of a facility policy and procedure titled "Integumentary, Pressure Ulcer Treatment" dated with a revision date of 2/12 showed that "It is the policy of ...(name of facility) to regularly assess patient's skin integrity and to promote tissue healing." In the same policy under the Assessment section: "1. Assess pressure ulcer by using one or more of the following wound assessment tools every shift, upon the patient's complaint of pain or discomfort, change in patient's condition, and/or upon discharge. 2. The initial skin integrity assessment must be performed by two RNs and documented accordingly." Under the Photographing wounds section: "1. All wounds shall be measured (length x width x depth) and photographed with a standardized measurement tool next to the wound in the picture...a. On admission b. With first documentation if skin breakdown develops after admission c. With documentation of progression or significant change in wound condition d. Weekly..."

4. A review on 3/27/12 of Patient 47's medical record showed that the patient was admitted to the facility on 3/6/12 with diagnoses that included altered level of consciousness and head trauma (injury).

In a review of the physician history and physical dated 3/6/12, the physician documented under history of present illness that Patient 47 had "some decubitus ulcer (pressure sore) in the left leg and left arm." Under the physical examination section the physician documented that Patient 47 had a decubitus ulcer in the "left arm, left leg and one in the back."

A review of the emergency room (ED) nursing notes, dated 3/6/12 at 4:00 PM, showed that the patient had a "3-4 cm (centimeter) Stage 1 pressure ulcer (Redness to the skin caused by unrelieved pressure to the area) to L (left) hip and R (right) great toe (big toe)."

A review of the Adult Multidisciplinary Initial Assessment dated 3/6/12 at 11:00 PM showed the following documentation: "wound location: L side of face, leg, hip, etc. (etcetera) Bruising: bilateral (both) arms. Other: L eyes, L leg, L hip, bil (bilateral) arm bruises."

There was no consistent assessment of Patient 47's wounds and pressure sores so that the medical team could have an effective treatment plan.

In an interview on 3/28/12 at 3:05 PM with RN 7, she acknowledged that the wound assessments were inconsistent and that the the ED nurse and the floor nurse should do the skin assessment together so that it is accurate.

A review of a facility policy and procedure titled "Integumentary, Pressure Ulcer Treatment" dated with a revision date of 2/12 showed that "It is the policy of ...(name of facility) to regularly assess patient's skin integrity and to promote tissue healing." In the same policy under the Assessment section: "1. Assess pressure ulcer by using one or more of the following wound assessment tools every shift, upon the patient's complaint of pain or discomfort, change in patient's condition, and/or upon discharge. 2. The initial skin integrity assessment must be performed by two RNs and documented accordingly." Under the Photographing wounds section: "1. All wounds shall be measured (length x width x depth) and photographed with a standardized measurement tool next to the wound in the picture...a. On admission b. With first documentation if skin breakdown develops after admission c. With documentation of progression or significant change in wound condition d. Weekly..."

5. A review on 3/27/12 of Patient 48's medical record showed that the patient was admitted to the facility on 3/16/12 with diagnoses that included stroke, pneumonia and congestive heart failure (the heart does not pump blood strongly and fluid backs up into the lungs).

A review of the Adult Multidisciplinary Initial Assessment dated 3/16/12 at 11:30 PM showed that the nurse documented under the skin assessment that Patient 48 had "Redness on buttocks." The redness area on buttocks was not assessed as a pressure sore. (Stage 1 pressure sore-redness of the skin caused by unrelieved pressure). There were no measurements of the area.

A review of the nursing flowsheet dated 3/17/12, showed that the nurse documented that the skin was intact, warm and dry. There was no mention of redness on the buttocks.

The nursing flowsheet dated 3/20/12 and 3/21/12 documented that the skin was intact, warm and dry. There was no mention of redness on the buttocks.

The nursing flowsheet dated 3/25/12 showed that there was redness on the coccyx (area above the buttocks) area. This was not assessed as a pressure sore. There were no measurements of the area.

The nursing flowsheets for 3/26/12 documented that the skin was warm, dry and intact.

Review of a photograph (undated) showed a picture of Patient 48's buttocks. The photograph was of a Stage 2 pressure sore (a pressure sore which is a break in the skin).

In an interview on 3/27/12 at 10:25 AM with RN 9, she stated that she took the picture of Patient 48's pressure sore on 3/21/12 when she saw that the skin on the patient's buttocks was excoriated (open wound). She confirmed that she did not document a description of the patient's pressure sore on the buttocks when the picture was taken.

A review of a facility policy and procedure titled "Integumentary, Pressure Ulcer Treatment", dated with a revision date of 2/12, showed that "It is the policy of ...(name of facility) to regularly assess patient's skin integrity and to promote tissue healing." In the same policy under the Assessment section: "1. Assess pressure ulcer by using one or more of the following wound assessment tools every shift, upon the patient's complaint of pain or discomfort, change in patient's condition, and/or upon discharge. 2. The initial skin integrity assessment must be performed by two RNs and documented accordingly." Under the Photographing wounds section: "1. All wounds shall be measured (length x width x depth) and photographed with a standardized measurement tool next to the wound in the picture...a. On admission b. With first documentation if skin breakdown develops after admission c. With documentation of progression or significant change in wound condition d. Weekly..."




28135

6. A review of the medical record for Patient 22 revealed that the patient was admitted to the hospital on 3/26/12 with diagnoses that included chronic constipation secondary to narcotic overuse. The nursing nutrition screen of the patient, dated 3/26/12, showed a recent unintentional weight loss greater then ten pounds during the last 30 days. There was no dietary consult ordered.

A review of the hospital's policy titled, "Nutrition Screening and Assessment" dated 6/11, revealed that nursing staff was responsible for completing the initial nutrition screening assessment. It further stated that upon identification of nutritional risks, nursing staff was to enter a dietary referral/consult into the computer system. The Registered Dietitian (RD) responded to these referrals/consults within 24 hours to initiate the nutritional plan of care.

During an interview with RN 7, charge nurse for Patient 22, on 3/28/12 at 11:00 AM, she stated that a dietary referral should have been made on 3/26/12. She verified that no referral had been made.

Further review of the medical record for Patient 22 revealed a physician order for a High Fiber Cardiac Diet on 3/26/12. A review of the computer entry for Patient 22's diet order dated 3/27/12, revealed the patient's diet order was for a Soft, High Fiber, Cardiac Diet.

During an interview with RN 7 on 3/28/12 at 11:00 AM, she stated that the "soft" component of the diet order was added by a nurse without a physician's order. She further stated that diet orders should only be changed with an order from the physician.

During an interview with the RD on 3/28/12 at 11:05 AM, she stated that patients on a soft diet cannot receive high fiber foods due to the diet restrictions. So Patient 22 was not getting high fiber foods.

A review of the hospital's policy titled, "Diet Orders, Changes and Deletions" dated 6/11 revealed that diet changes must be in a written order from the patient's physician.

As of 3/28/12 at 11:00 AM, the nutrition care of Patient 22 was not evaluated by the RD which caused a delay in the patient receiving the diet ordered by the physician and appropriate for the patient. Also the recent severe weight loss was not evaluated by the RD because the dietary referral was not made by nursing.

7. A review of the medical record for Patient 21 revealed that the patient was brought to the hospital on 3/13/12 with complaints of altered level of consciousness and not eating for two days. The patient was admitted to the hospital the same day with diagnoses that included altered level of consciousness and dehydration. A review of the physician orders for 3/14/12 showed a pureed high protein diet with Ensure (a liquid nutritional supplement) three times a day was ordered according to the registered dietitian's (RD) recommendations.

A review of the medical record revealed that the patient's meal intake was not recorded. A review of the "diet" section of the daily "Routine Care Checklists" since the patient was admitted showed no documentation in the "amount" area of that section to indicate the amount of meals eaten.

During an interview with the RD on 3/27/12 at 2:30 PM, she stated that she had to ask a nursing assistant how much the patient was eating. She stated that there was no documentation in the patient's medical record that indicated the percentage of meals that the patient ate. She confirmed that the nursing assistants don ' t always have the same patients day after day. She confirmed that their reports of meal consumption would be from the current day not over time. She was unable to state how she could evaluate the patient's meal consumption since the last nutrition assessment, 7 days earlier

During an observation of the patient's bedside table on 3/27/12 at 3:10 PM, two unopened bottles of Ensure were noted on the table. The patient did not respond to questions.

During an interview with RN 12, charge nurse for Patient 21, on 3/27/12 at 3:20 PM, she stated that there was no documentation of meal percentages or the amount of Ensure the patient was drinking. She further stated the nursing assistants should be documenting the meal percentages and the nurses should be documenting the amount of Ensure the patient drank. During an interview with RN 13, Patient 21's nurse, on 3/27/12 at 3:30, she stated that Patient 21 had refused to eat for 2 days. She stated that she informed the physician, but stated that she didn't have time to inform the RD.

The hospital's policy titled, "Nutrition Screening and Assessment" dated 6/11, was reviewed. The policy indicated that patient assessments and reassessments will address information pertinent to the patient's current nutrition status and/or response to nutritional therapy including diet tolerance. It further indicated that it will address appropriateness of the diet order relative to the patient's tolerance, medical condition and estimated nutritional goals.

A further interview with the RD on 3/27/12 at 3:30 PM revealed that she must rely on reports from the nursing assistants for meal intake information for patients. She confirmed that this doesn't give her information on how the patient has been eating beyond the current day. She acknowledged that this communication did not provide accurate information on how Patient 21 was eating over the course of her hospital stay. She agreed that if she had known how little the patient was eating, she could have implemented more aggressive nutrition interventions sooner.

Throughout the survey, a hospital policy was requested for documenting the amount patients eat during their stay. The hospital was unable to produce a policy.

Based on staff interview and facility record review, the facility failed to ensure that nursing staff develops, and keeps current, an individualized nursing care plan for 5 of 36 sampled patients (Patients 43, 44, 46, 47 and 48). This deficient practice had the potential to affect the health and safety and the care being delivered to the patients.

Findings:

1. On 3/29/12, a review of Patient 43's medical record was conducted. The Admitting Face Sheet revealed that Patient 43 was admitted to the facility on 3/21/12, with an admitting diagnosis of acute cholecystitis (a condition where there is an infection in the patient's gall bladder). Patient 43 underwent surgery for removal of the gall bladder on 3/23/12.

On 3/29/12, a review of Patient 43's Multidisciplinary Patient Plan of Care form initiated on 3/21/12, revealed the following problems addressed by the nursing staff:

a. COPING/STRESS TOLERANCE: (Initiated on 3/21/12): There was no documented evidence that the section was completed with documented individualized interventions/approaches that included offering appropriate reassurance and support, social service and discharge planning and pastoral support. In addition, there was no documented evidence that Patient 43 was assessed for anxiety or depression prior to undergoing surgery on 3/23/12, as offered as an option in the pre-printed nursing care plan.

b. NEUROMUSCULAR: (not initiated): There was no documented evidence that the section was completed with nursing assessment of impaired physical mobility post surgery such as achieving optimal mobility, participate with rehabilitative services, repositioning , encourage participation in Activities of Daily Living, ambulation and receiving home management instructions prior to and after surgery as offered as an option in the pre-printed care plan.

c. NUTRITION/METABOLISM/HYDRATION: (Initiated on 3/23/12). There was no documented evidence that the nursing staff had completed the section. The section titled, " EXPECTED OUTCOMES/GOALS " was not filled out, incomplete and left blank. The section titled, " INTERVENTIONS/APPROACHES " was not filled out, incomplete and left blank.

d. ALTERED NUTRITION/METABOLIC STATUS: (Initiated on 3/23/12). There was no documented evidence that the nursing staff had completed the section. The section titled, " EXPECTED OUTCOMES/GOALS " was not filled out, incomplete and left blank. The section titled, " INTERVENTIONS/APPROACHES " was not filled out, incomplete and left blank.

On 3/29/12, a review of the facility's policy and procedure titled, "NURSING DOCUMENTATION PROCESS" dated 3/2009, stipulated in section 10, " ...The initial plan of care is developed from the initial nursing assessment form. The plan of care is initiated within 24 hours of admission to the inpatient areas ... "

On 3/29/12, a review of the facility's policy and procedure titled, "NURSING DOCUMENTATION PROCESS " dated 3/2009, stipulated in section 11, "...The Interdisciplinary Care Plan is the central place where all disciplines may have access to and contribute to plans for the patient's stay. Interdisciplinary Team will have a problem labeled, the date the problem and plan was initiated, patient oriented and measurable goal(s), and the specific interventions planned for the patient ..."

Therefore, the facility failed to ensure that Patient 43's nursing care plan was comprehensive, coordinated and individualized to meet the medical and nursing goals and needs of the patient.

On 3/29/12, at approximately 2:30 PM, the Director of Inpatient Services confirmed the finding that an individualized, comprehensive and coordinated nursing care plan was not developed and implemented for Patient 43.



25179


2. A review on 3/26/12 of Patient 44's medical record showed that the patient was admitted to the facility on 3/12/12 with diagnoses that included hepatic (related to the liver) encephalopathy and seizures.


A review of the nurses notes dated 3/16/12 at 12:00 AM documented "...buttocks, anal area becoming red, irritated, will take picture next BM (bowel movement)."


A review of the Multidisciplinary Patient Plan of Care dated 3/13/12, indicated that there was no skin care plan developed when Patient 44 developed the Stage 1 pressure sore (redness of the skin with no break in the skin caused by unrelieved pressure to an area of the body, friction against the bed sheets or frequent urine or bowel movements that need cleansing. Can lead to a break in the skin or a deeper pressure sore).


Review of another Multidisciplinary Patient Plan of Care with a beginning date of 3/12/12 showed that there was no pressure ulcer care plan developed until 3/26/12, 10 days after the patient developed the Stage 1 pressure sore. The plan did not specifically say where the pressure sore was or the specific treatment applied. The care plan was not individualized for the patient.


In an interview with RN 5 on 3/27/12 at 9:28 AM, RN 5 stated that the patient was transferred from ICU (intensive care unit) to the medical floor on 3/18/12 and that the care plan should have been initiated when Patient 44 developed the redness and irritation to the buttocks.


On 3/29/12, a review of the facility's policy and procedure titled, "NURSING DOCUMENTATION PROCESS " dated 3/2009, showed in section 11, "...The Interdisciplinary Care Plan is the central place where all disciplines may have access to and contribute to plans for the patient's stay. Interdisciplinary Team will have a problem labeled, the date the problem and plan was initiated, patient oriented and measurable goal(s), and the specific interventions planned for the patient ..."

3. A review on 3/26/12 of Patient 46's medical record showed that the patient was admitted to the facility on 3/19/12 with diagnoses that included infected decubitus (pressure sores), anemia and a urinary tract infection (bladder infection).

A review of the Multidisciplinary Patient Plan of Care showed a skin care plan was initiated on 3/19/12. The problem was preprinted on the care plan form and showed as "potential for actual impaired skin integrity (a break in the skin, pressure sores)". The problem was not individualized for Patient 46 who was admitted with infected pressure sores.

Further review of the care plan under the integumentary (skin) section labeled problems, the following was checked off by the nurse:

Decreased mobility/friction/heat
Altered nutritional status
Open wound
Other (the nurse wrote in) Multiple decubitus.

There was no care plan documentation of where the wounds were and the treatment for them. There were preprinted interventions that the nurse checked off that included pressure sore prevention interventions but no individualized interventions to treat the pressure sores.

In an interview with RN 6 on 3/27/12 at 11:30 AM, RN 6 acknowledged that the care plan for Patient 46 was not individualized to the patient's condition.

On 3/29/12, a review of the facility's policy and procedure titled, "NURSING DOCUMENTATION PROCESS " dated 3/2009, showed in section 11, "...The Interdisciplinary Care Plan is the central place where all disciplines may have access to and contribute to plans for the patient's stay. Interdisciplinary Team will have a problem labeled, the date the problem and plan was initiated, patient oriented and measurable goal(s), and the specific interventions planned for the patient ..."


4. A review on 3/27/12 of Patient 47's medical record showed that the patient was admitted to the facility on 3/6/12 with diagnoses that included altered level of consciousness and head trauma (injury).


In a review of the physician history and physical dated 3/6/12, the physician documented under history of present illness that Patient 47 had "some decubitus ulcer (pressure sore) in the left leg and left arm." Under the physical examination section the physician documented that Patient 47 had a decubitus ulcer in the "left arm, left leg and one in the back."


A review of the document titled Multidisciplinary Patient Plan of Care showed a skin care plan was initiated on 3/6/12. The problem was preprinted on the care plan form and showed as "potential for actual impaired skin integrity (a break in the skin, pressure sores)". The problem was not individualized for Patient 47 who was admitted with pressure sores.

Further review of the care plan under the integumentary (skin) section labeled problems the following was checked off by the nurse:

Actual impaired skin integrity
Incontinence (lack of control of bowel or bladder)

There was no care plan documentation of where the wounds were and the treatment for them. There were preprinted interventions that the nurse checked off that included pressure sore prevention interventions but no individualized interventions to treat the pressure sores.

On 3/29/12, a review of the facility's policy and procedure titled, "NURSING DOCUMENTATION PROCESS " dated 3/2009, showed in section 11, "...The Interdisciplinary Care Plan is the central place where all disciplines may have access to and contribute to plans for the patient's stay. Interdisciplinary Team will have a problem labeled, the date the problem and plan was initiated, patient oriented and measurable goal(s), and the specific interventions planned for the patient ..."


5. A review on 3/27/12 of Patient 48's medical record showed that the patient was admitted to the facility on 3/16/12 with diagnoses that included stroke, pneumonia and congestive heart failure (the heart does not pump blood strongly and fluid backs up into the lungs).


A review of the Adult Multidisciplinary Initial Assessment dated 3/16/12 at 11:30 PM showed that the nurse documented under the skin assessment that Patient 48 had "Redness on buttocks." (Stage 1 pressure sore)


A review of the nursing flowsheet dated 3/17/12, reflected the nurse documented under the skin section that the skin was warm dry and intact. At 5:00 PM the nurse narrative notes show that "Patient had a BM (bowel movement)...Pictures taken, repositioned for comfort.


A review of the undated photo in the chart shows a picture of a buttocks with a Stage 2 pressure sore (broken skin, an ulcer).


As of 3/27/12, there was no care plan for the prevention or treatment of the patient's pressure sore.


In an interview on 3/27/12 at with RN 9, RN 9 stated that she took the picture on 3/21/12 and acknowledged that there was no care plan developed for Patient 48's pressure sore.


On 3/29/12, a review of the facility's policy and procedure titled, "NURSING DOCUMENTATION PROCESS " dated 3/2009, showed in section 11, "...The Interdisciplinary Care Plan is the central place where all disciplines may have access to and contribute to plans for the patient's stay. Interdisciplinary Team will have a problem labeled, the date the problem and plan was initiated, patient oriented and measurable goal(s), and the specific interventions planned for the patient ..."

Based on staff interview and facility record review, the facility failed to ensure that the hospital's Special Procedure Nurse, working in the Radiology Department, had a completed competency validation evaluation in the employees' personnel file prior to receiving patient care assignments demonstrating competency with qualifications to perform only those duties and responsibilities for which competency had been validated. This deficient practice had the potential to affect the health and safety of patients being monitored and receiving services in the Radiology Department.

Findings:

On 3/29/12, a review of Radiology Nurse A's personnel file was conducted. The personnel file revealed that Radiology Nurse A did not have a completed Competency Assessment Evaluation Form filled out, evaluated, and validated by the Director of Radiology Services and Chief Nursing Officer as per facility policy prior to accepting patient care assignments in the Radiology Department on 11/30/11.
On 3/29/12, a review of the Radiology Services Department's Competency Assessment Form, dated 11/30/11 revealed that the purpose of the Competency Assessment Form was to:
a. Evaluate the employee's past performance.
b. Communicate the ways to maintain or improve performance.
c. Validate job competencies.

On 3/29/12, a review of the Radiology Services Department's Job Description for a "Special Procedure Nurse" , dated 11/30/11 indicated, "The nurse shall prepare, instruct and monitor patients during various procedures. Work environment includes varying and unpredictable situations, exposure to unpleasant elements, such as accidents, injuries and illnesses and emergency and crisis situations."

There was no indication in the Competency Assessment Form, dated 11/30/11, that the Department of Nursing Services and Radiology Department had evaluated Radiology Nurse A for essential job specific functions and competencies in the Radiology Department prior to being assigned patient care duties on 11/30/11.

There was no indication in the Competency Assessment Form, dated 11/30/11, that Radiology Nurse A had met the qualifications, education and experience to meet the complexity and special needs of individual patients in the Radiology Department.

On 2/29/12, at approximately 9:30 AM, the Director of Radiology Services and Chief Nursing Officer confirmed the finding that Radiology Nurse A did not have a validated competency evaluation that was reviewed and accepted by the Director of Radiology Services and Chief Nursing Officer prior to accepting patient care assignments on 11/30/11.

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

1. Signed orders were the basis for initiation of intravenous fluid in the ambulatory care unit.

2. That orders for Propofol (an intravenous anesthetic agent) were complete for Patients D and E, creating the risk of poor health outcomes from medication dosing errors.

3. The hospital failed to ensure that clear parameters were set for the administration of propofol, a powerful anesthetic, for 3 of 6 patients (Patients 49, 50 and 51) admitted to the intensive care unit (ICU). This failure had the potential to result in an adverse reaction.

Findings:

1. During a tour of the ambulatory surgery preoperative area on 3/26/12, the medical record of Patient F was reviewed, and no pre-operative orders for intravenous fluid were seen.

Surg RN 2 was interviewed on 3/26/12 at 9:50 AM and she stated that there were standing orders for all patients to get lactated ringers intravenous fluid per policy. When asked for the policy, she showed a paper titled "IV Info" hanging on the wall that contained physician preferences for different intravenous fluids, and different intravenous fluids to be used by patient age, condition or intended surgery. The fluids included lactated ringers, lactated ringers with dextrose, water with dextrose and normal saline. There were no infusion rates listed. There was no date of review or approval from the facility.

During an interview with the Dir Pharm on 3/29/12 at 4:20 PM, he stated that a signed physician order was required for the administration of intravenous fluids, and that the "IV Info" posted on the wall was not an acceptable order.

In an interview with the CNO on 3/30/12 at 10 AM, he viewed a copy of the "IV Info" and stated that the orders were unacceptable and incomplete. He stated that intravenous fluid orders required a rate and a physician's signature. He stated that he was unaware of the practice of implementing intravenous fluids per "IV Info" in the ambulatory surgery department.

2. During a tour of the ICU on 3/26/12, the medical records of Patients D and E were reviewed. Patient D's record contained an order dated 3/22/12 at 7:55 that read, "Diprivan titrate to sedation". Patient E's record contained an order dated 3/16/12 that read, "Propofol for sedation max 59 mil/kg/min". There was no rate of infusion or parameters describing the desired level of sedation included in the orders. There were no clarifications of the orders seen.

In an interview with ICU RN 1 on 3/26/12 at 11:30, she stated that Propofol was to be titrated by the nurse, using the Ramsay score, to a specific level of sedation. She stated that the orders for Patients D and E did not provide the RN with the desired sedation level for titration. She further stated that she did not see copies of the pre-printed Propofol order set or Ramsay scores in the medical record.

During an interview with the CNO on 3/30/12 at 10 AM, he stated that the Propofol orders were incomplete and should have been clarified by the nursing staff prior to implementation.

The facility policy, High Alert Medications (revision date 9/09), included Propofol on a list of high alert medications and read in part, "Propofol (Diprivan) shall only be administered in the ED and ICU per the hospital's propofol protocol for critical care and in surgery."



25882


3a. Ramsey Sedation Scale: used to assess the level of sedation of a hospitalized patient). The scores are assessed as follows:
1- Anxious or restless or both.
2- Cooperative, orientated and tranquil
3- Responding to commands.
4- Brisk response to stimulus.
5- Sluggish response to stimulus.
6- No response to stimulus.

Record review revealed Patient 49 was a 74 year old male admitted to the facility on 8/1/37 with a diagnosis of ALOC (altered level of consciousness: not oriented).

Record review of the Physician Orders dated 3/24/12 at 1:50 AM revealed the following telephone order: " Propofol gtt (drip) titrate to sedation. There was no documented evidence found indicating that the propofol drip was to be titrated according to the ramsey sedation scale.

A record review of the Preprinted Order Sheet for Propofol (Diprivan) found in the medical record for Patient 49 was noted to be blank and only contained a label with Patient 49 ' s patient information on it. There was no date documented on the form.

The Propofol (Diprivan) Pre-printed Orders sheet contained the following guidelines to be followed during the administration of Propofol:

Vital Signs: Vital signs every 5 minutes while titrating Propofol then every 30 minutes times 2 then every hour thereafter. Assess sedation level within 5 minutes of every rate adjustment and then every hour.

Medications: Intravenous infusion of Propofol (Diprivan) 1000 mg (milligrams) in 100 ml (milliliters) for ventilation control, titrate for Ramsay sedation score of 4 to 5.

Ramsey Sedation Scale as preprinted on the bottom of the Preprinted order set:

Level 1: Anxious, agitated, restless
Level 2: Cooperative, oriented, tranquil
Level 3: Drowsy and responds only to commands.
Level 4: Brisk response to glabella tap or loud auditory stimulus.
Level 5: Asleep sluggish response to stimulus.
Level 6: No response to firm nail bed pressure or other noxious stimuli.

Record review of the facility form titled, " Controlled Substance/Narcotic IV (intravenous: within the vein) Administration Record " , written for Patient 49 revealed the following guidelines:

Name of Medication: Propofol
1. Vitals every 15 minutes and document on critical care flow sheet.

Record review of the Critical Care Flowsheet for Patient 49, dated 3/24/12 showed no documented evidence of the Ramsey sedation score for Patient 49 who was on a Propofol drip. There was no documentation of vital signs every 15 minutes as the, " Controlled Substance/Narcotic IV (intravenous: within the vein) Administration Record " suggested. Additionally, there was no evidence that the vital signs were recorded every 5 minutes during titrations (adjustments) of the drip as the Preprinted Propofol (Diprivan) Order sheet suggested.

During an interview on 3/26/12 at 2:58 PM, RN 1 confirmed that there was no monitoring of the vital signs for Patient 49 as the , " Controlled Substance/Narcotic IV (intravenous: within the vein) Administration Record " suggested. RN 2 also confirmed that there was no documentation of the vital signs every 5 minutes when the propofol drip was titrated on 3/24/12. Additionally, RN 2 confirmed that there was no documentation of the ramsey sedation score for Patient 49 and added that there was no place on the form designated for the ramsey sedation score. RN 2 acknowledged that the two forms had different guidelines for the monitoring of the patient ' s vital signs while receiving intravenous propofol.

During an interview on 3/26/12 at 3:10 PM, RN 3 who was a charge nurse confirmed that the Preprinted Propofol Order sheet was not completed and lacked a date. RN 3 stated that the physician should have completed the order and signed it. RN 3 also confirmed that the ramsey sedation score was not documented on the Critical Care Flowsheet and acknowledged that there was no designated place on the form to document the score.

3b. Record review revealed Patient 50 was a 58 year old female admitted to the facility on 3/14/12 with a diagnosis of exacerbation (the worsening of) of chronic obstructive pulmonary disease (a condition characterized by difficulty or discomfort in breathing).

A review of the Propofol (Diprivan) Preprinted Orders found in Patient 50 ' s medical record revealed a blank order sheet which only contained the patient ' s identifying information and diagnosis.

Record review of Physician Orders, dated 3/24/12 at 8 PM revealed the following order: " Diprivan (Propofol) gtt (drip) titrate for comfort on the ventilator " .

Record review of Physician Orders, dated 3/22/12 at 12:18 PM, revealed the following order: " May start low dose diprivan gtt " .

Record review of Physician Orders, dated 3/16/12 at 1:40 AM revealed the following orders: Propofol for sedation. Max (maximum) 50 mcg/kg/min (micrograms per kilogram per minute) " .

Record review of the Critical Care Flowsheet for Patient 50, dated 3/16/12 showed no documented evidence of the Ramsey sedation score for Patient 50 who was on a Propofol drip. There was no documentation of vital signs every 15 minutes as the, " Controlled Substance/Narcotic IV (intravenous: within the vein) Administration Record " suggested. Additionally, there was no evidence that the vital signs were recorded every 5 minutes during titrations (adjustments) of the drip as the Preprinted Propofol (Diprivan) Order sheet suggested.

Record review of the Critical Care Flowsheet for Patient 50, dated 3/19/12 showed no documented evidence of the Ramsey sedation score for Patient 50 who was on a Propofol drip. There was no documented evidence that the vital signs were recorded every 5 minutes when the Propofol drip was titrated as specified on the Preprinted Propofol Order sheet.

Record review of the Critical Care Flowsheet for Patient 50, dated 3/18/12 showed no documented evidence of the Ramsey sedation score for Patient 50 who was on a Propofol drip.

During an interview on 3/27/12 at 9:55 AM, RN 4 confirmed that the Preprinted Propofol Order sheet found in Patient 50 ' s medical record was blank and was not completed by the physician. RN 4 confirmed that the order sheet should have been completed on 3/16/12, 3/18/12, 3/19/12, 3/22/12 and 3/24/12, every time there was a new order. RN 4 confirmed there was only one preprinted Propofol Order sheet in the medical record for Patient 50 and it was not completed by the physician.

During further interview, RN 4 stated that when an order is written as ventilator management for comfort, that means that the patient is not bucking the vent (biting the tubes), vital signs are stable, and the patient is not grimacing. RN 4 confirmed that there was no designated area on the Critical Care Flowsheet to record the patients ramsey sedation score.

3c. Record review Patient 51 was a 24 year old female admitted to the facility on 3/22/12 with a diagnosis of cardiac arrest (the sudden loss of heart function).

Record review of the Physician Orders, dated 3/22/12 at 7:55 AM revealed the following Propofol order: " Diprovan (Propofol) 5-30 mcg (micrograms) IV (intravenous: within the vein). Titrate for sedation.

Record review of the Propofol Pre-Printed Order sheet, dated 3/26/12 at 3 PM, for Patient 51 revealed the following checked orders on the form:

Vital Signs: ECG Continuous monitoring.
Medications: Intravenous infusion of Propofol (Diprivan) 1000mg in 100 ml, for ventilation control, titrate for Ramsay sedation score of 4 to 5.

During an interview on 3/27/12 at 11 AM, RN 2 confirmed that the ramsey sedation score was not documented on the Critical Care Flowsheet for Patient 51 who was receiving Propofol. RN 2 acknowledged that there was no designated place on the flowsheet to enter the ramsey sedation score. RN 2 also confirmed that there was no consistency on when the nurses were documenting vital signs. RN 2 acknowledged that one form had guidelines to record vital signs every 15 minutes while receiving propofol and the other form had guidelines to record vital signs every 5 minutes when the drip was titrated.

Based on observation, staff interview and facility record review, the facility failed to ensure that all physician's orders for 2 of 36 sampled patients, were clear and complete and followed facility policy based on the following:
1. For Patient 61, the facility failed to ensure that all physician orders were clear and complete when initiating orders for Propofol.
2. For Patient 62, Nursing Services and Pharmacy Services failed to clarify an order for Lactulose when the dose ordered was inaccurate.
These deficient practices had the potential to result in creating a risk of incorrect treatment, poor health outcome, and substandard healthcare for patients under the care of the Medical Staff.

Findings:

1. On 3/26/12, a review of Patient 61's medical record was conducted. The admitting face sheet revealed that Patient 61 was admitted to the facility on 3/25/12, with an admitting diagnosis of delirium tremors and alcohol withdrawal. (Seizure like movements of the body due to alcohol being withheld); was admitted to the Intensive Care Unit and subsequently placed on a ventilator (breathing machine) for respiratory support.

On 3/26/12, a review of Patient 61's physicians' order sheet dated 3/25/12 and timed at 11:30 PM, revealed an order for the following:
a. Continued all drips as per Emergency Department orders.
b. Diprovan (Propofol) Drip 10-50 micrograms/kilograms/minute IV (Intravenous).

There was no documented evidence on the Physicians' Order sheet dated 3/25/12, that a specific rate was to be maintained according to the Ramsay Sedation Scale or functional parameters were to be followed that was specified on the order sheet. There was no written order for attempting " weaning trials " or an order to ???"attempt to decrease Propofol" with appropriate dosing change orders as guidelines.

Therefore, there was no functional parameter (boundaries) on the Propofol Drip orders for maintaining sedation according to the Ramsay Sedation Scale, or specific dose changes when weaning off or attempts to decrease propofol that were initiated on the Physicians' Order sheet, dated 3/25/12, and timed at 11:30 PM.

On 3/26/12, a review of Patient 61's pre-printed Propofol (Diprivan) Order sheet (no date) revealed that the order sheet was incomplete, not filled out, and left blank. There was no indication that the physician had authenticated the order, timed or dated the order sheet. The pre-printed order sheet for Patient 61 had only the admitting diagnosis, allergies and the status of " NPO " (nothing by mouth) written on the form and entered into the medical record.

During a review of the facility's pre-printed Propofol order set, several sets of parameters were provided and the physician was to choose the appropriate parameters for the patient. For example, the order set required that the physician choose the Ramsey Scale (used to assess the level of sedation) score that would indicate the desired degree of sedation for the patient, but no criteria, such as a desired Ramsey Scale score was supplied for Patient 61.

The pre-printed Propofol (Diprivan) Order sheet (not dated), for Patient 61, had the following components not ordered, checked off and not selected by the physician prior to initiating the Propofol Drip on 3/25/12:
1. VITAL SIGNS: (baseline assessment, cardiac monitoring, neurological assessment, blood pressure pulse and respirations every 5 minutes while titrating drip, then every 30 minutes times 2 then very hour thereafter and assess sedation level within 5 minutes of every rate adjustment. This section was found incomplete, not filled out and left blank by the physician.

2. MEDICATIONS: (Intravenous infusion of Propofol Drip, for ventilation control, titrate for Ramsey Sedation score of 4 to 5, increase or decrease by 5 micrograms/kilogram/minute until level of sedation reaches a Ramsay score of 4 to 5 (Ramsay score level 4=Brisk response to tapping and loud auditory stimulus or Level 5=Sluggish response to stimulus) and maintenance infusion of 5 micrograms/kilogram/minute to maintain sedation for Ramsay score of 4 to 5. In addition, the nurse must call the physician to increase the dose if patient remains agitated after 50 micrograms/kilogram/minute was reached. This section was found incomplete, not filled out and left blank by the physician.

3. NURSING ORDERS: (Titration orders for titrating off the Propofol Drip according to the Ramsay Sedation Scale was found incomplete, not filled out and left blank by the physician.
On 3/26/12, during a review of the Medical Staff General Rules and Regulations, revised 8/2/10 page 7, documented, " ...The physicians's order must be written clearly, legibly and completely, transcribed accurately, dated and timed..."
On 3/26/12, at approximately 10:45 AM, the Director of Inpatient Services confirmed the finding that Patient 61's Propofol orders were not accurate, incomplete and invalid.




25179

2. During a medication administration observation on 3/29/12 at 2:00 PM it was observed that RN 10 prepared lactulose (laxative) 20 g. (grams) in 30 cc (cubic centimeters) and administered it to Patient 62.

A review of the medication administration record showed that the medication the patient was to receive was lactulose 20 g. in 30 cc three times a day.

A review of the physician orders dated 3/26/12 showed an order for lactulose 20 mg.(milligrams) in 30 cc three times a day.

In an interview on 3/29/12 at 2:10 PM with DICU (Director of Intensive Care Unit and Medical/Surgical), she stated that the lactulose order should have been clarified with the ordering physician due to the discrepancy in the medication dose.

In an interview on 3/29/12 at 2:25 PM with Pharm 2, he stated that the lactulose order should have been clarified with the physician. Pharm 2 further stated that the pharmacist usually calls the patient's nurse and asks the nurse to call the patient's physician to get the order clarified. He stated that sometimes the call to the nurse is logged into a call log.

At 2:27 PM the Director of the Pharmacy confirmed that there was nothing in the pharmacy call log about Patient 62's lactulose order.

Based on interview and record review, the facility failed to ensure appropriate documentation in the medical record for 2 of 36 sampled patients (Patients 59 and 43) who presented to the facility's mobile unit for an MRI (Magnetic Resonance Imaging: a noninvasive radiological test that uses magnetic waves to create detailed images of body structures and is used to diagnose disorders). This failure resulted in no documented evidence of the patients' presentation to the mobile unit before and after the MRI was performed. This failure had the potential to result in an untoward event with no documented evidence showing events that lead up to or occurred after an adverse outcome.

Findings:

1. Record review revealed Patient 59 was a 14 year old male pediatric outpatient who received an MRI on 3/8/12. The documented reason for the visit was scoliosis (lateral curving of the spine).

Record review of the Physician Orders dated 3/8/12 revealed the following orders:

MRI chest spine without dye.
MRI neck spine without dye.
MRI lumbar spine without dye.

Record review of the MRI Screening Questionnaire revealed no date to indicate when the questionnaire was completed and no signature by the imaging technician that reviewed it.

During an interview on 3/28/12 at 1:59 PM, the Director of Imaging (DOI) confirmed that the MRI Screening Questionnaire did not have a date or a signature of the technician that reviewed the questionnaire. The DOI further stated that there was notation in the medical record for Patient 59 by the imaging technician of the procedure performed.

The DOI acknowledged that patients who were seen in the mobile unit for an MRI should have documentation to indicate how the patient presented to the unit (as an outpatient, inpatient, by gurney, wheelchair, walkin, alert/oriented, altered level of consciousness, etc.) and how they tolerated the test.

On 3/28/12, at approximately 1:20 PM, an interview with Radiology Technician A was conducted. When asked how she documented how the patients presented to the MRI Department (as an outpatient, inpatient, by gurney, wheelchair or walk-in, etc.) and how the patient tolerated the MRI procedure describing the patient's medical condition and status, she stated, "I did not document my patient's overall condition before or during the MRI procedure that I performed, I just performed the procedure ordered by the physician for that patient."



26502

2. On 2/29/12, a review of Patient 60's medical record was conducted. The admitting face sheet revealed that Patient 60 was admitted to the facility on 2/10/12 with an admitting diagnosis of sepsis (systemic body infection) and gallstones (stone-like material in gallbladder).

On 2/29/12, a review of Patient 60's physicians' order sheet, dated 2/12/12, revealed an order for an abdominal MRI (Magnetic Resonance Imaging-a specialized x-ray machine) with contrast was ordered and was to be scheduled with the Radiology Department.

On 2/29/12, a review of the facility's Radiology Department log, dated 2/12/12, revealed that Patient 60 had an MRI of the abdomen with contrast that was performed at the outpatient MRI center located across the street from the hospital.

There was no documented evidence in the medical record or from other facility sources that documentation of the patient's status and condition was noted during the 45 minute MRI procedure performed on 2/12/12.

There was no documented evidence in the medical record or from other facility sources that documentation was noted describing the patient's progress, response to services provided and care provided during the 45 minute MRI procedure on 2/12/12.

Therefore, the facility failed to ensure that documentation was entered into the medical record regarding an observation and evaluation of Patient 60's medical condition and status during the 45 minute MRI procedure on 2/12/12.

On 3/29/12, at the time of the finding, the Director of Radiology Services confirmed the finding that there was no documentation in the medical record that Patient 60's medical condition and status was being monitored and documented in the medical record.

Based on record review and interview the facility failed to ensure medical records were dated, timed and authenticated in a time frame consistent with the hospital's policy and procedures for 3 of 36 sampled patients (Patients 42, 43 and 57). This failure resulted in dictated documents by the physicians to not be authenticated (validated) in a timely manner which had the potential to result in reports being filed in the medical record lacking the physicians signature to indicate verification of the report for accuracy.

Findings:

1. Record review revealed Patient 42 was a 54 year old female who was admitted to the facility on 3/22/12 with a diagnosis of degenerative disc disease (the gradual deterioration of the disc between the vertebrae).

Record review of the Doctor's Progress Notes, dated 3/23/12 for Patient 42 revealed documented notes not timed by the physician.

During an interview on 3/26/12 at 11:40 AM, RN 2, who was the Director of Inpatient Services confirmed that the physician did not time his progress notes for Patient 42.

2. Record review revealed Patient 57 was a 80 year old female admitted to the facility with a diagnosis of respiratory failure (any condition that affects breathing function or the lungs).

Record review of the dictated Emergency Room (ER) Report for Patient 57, dated 2/8/12, revealed no authentication by the physician.

During an interview on 3/28/12 at 3:44 PM, the Health Information Management Supervisor (HIMS) stated that the ER physicians have not been signed on yet to authenticate their orders as the facility just started the process of electronic signing of dictated reports. The HIMS further stated that they have no mechanism to track inpatient records that are missing physician signatures until after the patient is discharged.



26502

3. On 3/ 29/12, a review of Patient 43's medical record was conducted. The Admitting Face Sheet revealed that Patient 43 was admitted to the facility on 3/21/12, with an admitting diagnosis of acute cholecystitis (a condition where there is an infection in the patient's gall bladder). Subsequently, Patient 43 underwent surgical removal of her gall bladder on 3/23/12.

On 3/29/12, a review of Patient 43's medical record contents from 3/21/12 through 3/26/12 revealed entries in the Physician's Progress Notes dated: "3/22/12, 3/25/12 and 3/26/12" were not timed by the author.

On 3/29/12, at approximately 11:45 AM, the Director of Inpatient Services confirmed the finding that Patient 43's physician did not time his progress notes on 3/22/12, 3/25/12 and 3/26/12.

On 3/29/12, a review of the facility's policy and procedures titled, "AUTHOR AUTHENTICATION" dated and revised on 12/11, stipulated in section (A), "All entries into the medical record will be dated and timed by the primary source of documented information. " And in section (B), "The portions of the medical record that are the responsibility of the medical practitioner are dated, timed and authenticated only by the individual practitioner making the entry."

Based on interview and record review, the facility failed to ensure that all verbal/telephone orders were authenticated (signed), dated and timed by the ordering practitioner within 48 hours per regulation and facility policy for 8 of 36 sampled patients (Patients 48, 45, 46, 44, 47, 57, 43 and 60). These failures resulted in the potential for errors in transcription with the potential to affect patient safety.

Findings:

1. A review on 3/27/12 of Patient 48's medical record showed that there were physician telephone orders (T.O.) dated 3/20/12, and 3/17/12 that were not authenticated by the physician.

2. A review on 3/26/12 of Patient 45's medical record showed the following:

T.O. dated 3/1/12 at 10:30 PM was not signed by the physician.
T.O. dated 3/1/12 at 12:30 PM was not signed by the physician.
T.O. dated 3/2/12 at 8:35 AM was not signed by the physician.
T.O. dated 3/14/12 at 4:35 AM was not signed by the physician.
Verbal order (V.O.) dated 3/15/12 at 1:30 AM was not signed by the physician.
T.O. dated 3/15/12 at 4:30 AM was not signed by the physician.
T.O. dated 3/18/12 at 12:00 PM was not signed by the physician.
T.O. dated 3/20/12 at 12:05 AM was not signed by the physician.
T.O. dated 3/21/12 had no time and was not signed by the physician.
T.O. dated 3/23/12 at 2:50 AM was not signed by the physician.

3. A review on 3/26/12 of Patient 46's record showed one T.O. without a date or time that was not authenticated by the physician. There was a physician order dated 3/20/12 at 3:15 PM written by a physical therapist that did not indicate whether it was a T.O. or a V.O. and the physician did not authenticate the order.

4. A review on 3/26/12 of Patient 44's record showed a T.O. dated 3/22/12 at 10:40 PM, a T.O. dated 3/21/12 at 2:20 PM, a T.O. dated 3/20/12 at 11:05 AM, an undated T.O. timed for 8:45 AM, a T.O. for a restraint that was dated 3/16/12 at 8:00 PM and a T.O. dated 3/20/12 at 10:45 AM that were not authenticated by the physician.

5. A review on 3/27/12 of Patient 47's record showed a T.O. dated 3/18/12 at 3:35 PM that
was not signed by the physician.

In an interview on 3/27/12 at approximately 10:00 AM with Director 1, she acknowledged that physician orders should be authenticated within 48 hours.

Review of the facility medical staff general rules and regulations showed that "Verbal orders for medication must be dated and timed by licensed personnel lawfully authorized to receive the order and authenticated, dated and timed by the ordering or attending physician within 48 hours."



25882

6. A review of Patient 57's medical record showed that the patient was admitted to the facility on 2/8/12 and discharged on 3/25/12. The following telephone order was found in the medical record and did not contain a physicians signature:

Administration of Insulin Per Sliding Scale Orders for Adults, dated 2/8/12 at 4:15 PM.

During an interview on 3/28/12 at 3:44 PM, the Health Information Management Supervisor confirmed that the telephone order was not signed by the physician and stated that they should be signed within 48 hours.

Based on interview and record review, the facility failed to ensure that each patient had a complete and accurate medical history and physical examination in the medical record prior to surgery, creating the risk of a poor surgical outcome for those patients.

Findings:

1. During a tour of the ambulatory surgery area on 3/26/12, the record of Patient F was reviewed. The record contained a pre-printed pre-operative history and physical examination form titled Short History. The history portion of the Short History form, dated 3/26/12 and signed by DR 4, was blank, but the physical examination portion of the form had information filled in. The remainder of the record was reviewed, and nursing notes indicated that the patient had a significant medical history, including lymphoma (a type of cancer), back problems, previous surgeries and was on six medications, which were not listed on the Short History form.

On 3/28/12, the medical records of DR 4's ambulatory surgery Patients A and B, who had surgery on 3/26/12, were reviewed, and also showed incomplete Short History forms prior to surgery.

In an interview with Surg RN 2 on 3/26/12 at 9:50 AM, she reviewed Patient F's Short History and stated that the form should have the present illness and vital signs filled in.

In an interview with the Dir Surg on 3/27/12 at 11:15 AM, she stated that the Short History form for ambulatory surgery patients should be complete, including the patient ' s medical and surgical history. She reviewed the medical record of Patients A, B and F and concurred that the Short History form for those patients was missing information.

In an interview with the CNO on 3/30/12 at 10 AM, he stated that the nurse should have discussed the incomplete history and physical exam documentation with the physician prior to surgery.

The Medical Staff Rules and Regulations (revised 8/2/10) read in part, "The short history and physical form must include at a minimum: chief complaint, present illness, allergies, past history, vital signs, diagnosis, and an examination to include HEENT, chest and lungs, heart, abdomen and neurological status."

2. During a tour of the ambulatory surgery area on 3/26/12, the record of Patient F was reviewed. The history portion of the Short History form dated 3/26/12 and signed by DR 4 was blank, but the physical examination portion of the form had information filled in.

During an interview with Patient F on 3/26/12 at 10 AM, he stated that DR 4 had performed a physical examination in his office, approximately 2 weeks prior, but had not seen him on 3/26/12.

In an interview with Surg RN 2 on 3/26/12 at 9:50 AM, she stated that the form was sent from the surgeon's office on the day of surgery, and she thought that the patients had been seen there that day prior to coming to the hospital.

The Medical Staff Rules and Regulations (revised 8/2/10) read in part, "The short history and physical form must include at a minimum: chief complaint, present illness, allergies, past history, vital signs, diagnosis, and an examination to include HEENT, chest and lungs, heart, abdomen and neurological status."

The Medical Staff Rules and Regulations (revised 8/2/10) read in part, "If a patient is hospitalized for less than 24 hours, physicians may use the preprinted short history & physical form. The physician must document an update when the outpatient service or procedure is rendered." and in the Medical Staff Bylaws (revised 1/25/2012), "The updated examination of the patient including any changes in the patient's condition must be completed and documented by a physician."

Based on interview and record review, the facility failed to ensure that pre-anesthesia assessments were completed and documented per facility policy, creating the risk of a poor health outcome for all patients receiving anesthesia without the benefit of a documented pre-anesthesia assessment, due to a possible undiscovered medical condition.

Findings:

The medical records of Patient A, B and C were reviewed on 3/28/12, and showed that each had an outpatient surgery on 3/26/12. The record contained an Anesthesia Record form which included, on the front, a section for recording the ASA class (American Society of Anesthesiologists class, a system for rating the patient's fitness for surgery), height, weight, allergies, time of food intake, diagnosis and procedure. On the back, there was space for recording a pre-anesthetic note, medical and surgical history, medications, and substance use. There was no space designated on the back or front of the form to document the anesthesiologist's physical examination of the patient, and no notations about a heart or lung exam were seen on the anesthesia record of Patients A, B, or C. The back of the Anesthesia Record had been left blank for Patients A and B-no medications were listed, and no surgical history had been completed on the Anesthesia Record.

In an interview with the Dir Anesth on 3/27/12 at 2:45 PM, he concurred that there was no anesthesiologist's heart or lung examination and no surgical history or medications listed on the Anesthesia Record for Patients A or B. He stated the documentation was not being completed because the pre-printed space provided on the paper on the reverse side of the Anesthesia Record form was difficult to write on. He stated that he had been trying to get the forms changed for months.

In an interview with the Dir MR on 3/29/12 at approximately 12 PM, he stated that he was in the middle of revising forms and had not heard that the Anesthesia Record needed to be changed.

Based on interview and record review, the hospital failed to ensure that the pharmaceutical services monitor drug therapy.

1. The pharmacist failed to ensure that all physician's orders were clear and complete and followed facility policy when initiating orders for Propofol (an intravenous anesthetic medication) for 3 of 36 sampled patients (Patients D, E, and 61). This deficient practice had the potential to result in creating a risk of incorrect treatment, poor health outcome, and substandard healthcare for patients under the care of the Medical Staff. (see A-0353)

2. The pharmacist failed to ensure the correct temperatures were maintained in the pharmacy refrigerator and freezer, creating the risk of substandard medication quality and a poor health outcome for patients treated with those medications. (see A-0491).

3. The pharmacist failed to ensure that all pain medication orders written by the subscriber had clear, well defined pain scale ranges ordered prior to its administration for 1 of 36 sampled patients (Patient 43). This deficient finding had the potential of unnecessary medication being administered affecting the health and safety of Patient 43. (see A-0500).

4. The pharmacist failed to ensure that medications were properly labeled because syringes of incompletely labeled medications were found in an anesthesia cart in the surgical suite, creating the risk of incorrect medication administration and a poor health outcome for patients given incompletely labeled medications. (see A-0500).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of pharmaceutical services in a safe environment.

Based on interview and record review, the facility failed to ensure the correct temperatures were maintained in the pharmacy refrigerator and freezer, creating the risk of substandard medication quality and a poor health outcome for patients treated with those medications.

Findings:

1. During a tour of the pharmacy on 3/27/12 at 3:30 PM, the pharmacy refrigerator was observed and was stopped with medications requiring refrigeration. The door of the refrigerator had a graphic log of the temperature that included several days in March with a temperature of 35 degrees. There was no notation on the log that the temperature had been adjusted or rechecked.

In a concurrent interview with the Dir Pharm, he reviewed the log and stated that 35 degrees was a little too low.

2. During a tour of the pharmacy on 3/27/12 at 3:30 PM, the freezer temperature log was seen, and indicated that the freezer temperature daily was below 32 degrees. The freezer was opened, and no thermometer could be located.

In a concurrent interview with the Pharm Tech, she looked for the thermometer and could not find it. She was unable to explain how the temperature was being monitored.

The facility policy, Refrigerators and Freezers (revision date 9/11), read in part, "The temperature of each medication refrigerator will be maintained at 36 degrees to 46 degrees Fahrenheit at all times.", and "All freezer temperatures will be maintained at 10 degrees Fahrenheit or less", and "The temperature for each freezer will be checked daily and documented on a Freezer Temperature Log."

Based on interview and record review, the pharmacy was not providing oversight of the use of the high risk medication Propofol per facility policy, creating the risk of incorrect medication use and poor health outcomes for patients who were given Propofol.

Findings:

During a tour of the ICU on 3/26/12, the medical records of Patients D and E were reviewed. Patient D's record contained an order dated 3/22/12 at 7:55 that read, "Diprivan titrate to sedation". Patient E's record contained an order dated 3/16/12 that read, "Propofol for sedation max 50 mil/kg/min". There was no initial or subsequent rate of infusion specified, or parameters describing the desired level of sedation, included in the orders. There were no clarifications of the orders seen.

During an interview with the CNO on 3/30/12 at 10 AM, he stated that the Propofol orders were incomplete and should have been clarified by the nursing staff prior to implementation.

During an interview with Pharm 1 on 3/27/12 at 11 AM, she stated that the pharmacy was not always receiving the pre-printed order sheet for Propofol orders.

During interviews with the Dir Pharm on 3/29/12 at 3:05 PM and on 3/30/12 at 9:05 AM, he reviewed the Propofol orders for Patients D and E and stated the orders were incomplete and incorrect. He stated that the physicians should be filling out the pre-printed Propofol order forms to ensure correct medication usage. He stated that the Propofol order sheet was the Propofol protocol for the facility. He stated that no surveillance was being performed to ensure use of the pre-printed order form or completeness of Propofol orders. He reviewed his utilization reports and stated that he was not doing medication utilization evaluations on Propofol. He stated that the issue of correct Propofol usage had not been brought before the T and S Committee.

The facility policy, High Alert Medications (revision date 9/09) read in part, "Propofol (Diprivan) shall only be administered in the ED and ICU per the hospital's propofol protocol ... "

The facility policy, Medication Orders (revision date 8/11) read in part, "Elements of a complete medication order: ...c. Medication name and strength d. Medication frequency of administration" and "When a question arises concerning a medication order, the pharmacist will contact the patient ' s nurse and either the nurse or pharmacist may contact the prescribing physician." and "Medications will not be dispensed by Pharmacy until clarified"

The facility policy, Medication Use Evaluation and Peer Review (revision date 5/11), read in part, "The Pharmacy Department will evaluate medication usage on the following: 1. High-risk medications ..."

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 ordered prior to its administration for 1 of 36 sampled patients (Patient 43). This deficient finding had the potential of unnecessary medication being administered affecting the health and safety of Patient 43.

The facility further failed to ensure that medications were properly labeled because syringes of incompletely labeled medications were found in an anesthesia cart in the surgical suite, creating the risk of incorrect medication administration and a poor health outcome for patients given incompletely labeled medications.

Findings:
1. On 3/29/12, a review of Patient 43's medical record was conducted. The Admitting Face Sheet revealed that Patient 43 was admitted to the facility on 3/21/12, with an admitting diagnosis of acute cholecystitis (a condition where there is an infection in the patient's gall bladder). Patient 43 underwent surgery for removal of the gall bladder on 3/23/12.

On 3/29/12, a review of Patient 43's physicians' order sheet, dated 3/21/12, revealed an order for:
a. Dilaudid 1 milligram IVP (given through the vein) every 4 hours, PRN (taken as necessary) Pain.

On 3/29/12, a review of Patient 43's physicians' order sheet, dated 3/24/12, revealed an order for:
a. Dilaudid 2 milligrams IV (given through the vein) every 4 hours, PRN (taken as necessary) PRN.
b. Tylenol 650 milligrams PO (a pill taken by mouth) every 4 hours, PRN (taken as necessary).

On 3/19/12, a review of Patient 43's medical record was conducted. The Medication Administration Record (MAR) dated 3/25/12 through 3/16/12 documented the following pain medication orders:
a. Dilaudid 1 milligram IVP every 3 hours PRN Pain.
b. Dilaudid 2 milligrams IVP every 4 hours PRN
c. Tylenol 650 milligrams PO every 4 hours PRN

There was no documented evidence on the physicians' order sheet dated 3/21/12 and 3/24/12 that documented the physician had written a clear, well defined pain scale range, prior to administration of the pain medications Dilaudid and Tylenol. (An example of pain scale ranging would be to give Dilaudid or Tylenol medication for mild pain '1 through 4' , moderate pain '5 through 7' , and severe pain '8 through 10' on the pain scale 0 through 10, 10 being the highest or most severe pain perceived by the patient).

There was no documented evidence in the Physicians' Order Sheet or on the Medication Administration Record, dated 3/25/12 through 3/26/12, to reflect that a clear, well defined pain range (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 medication administration.

There was no documented evidence that the pharmacist reviewed the physicians' pain medication orders for appropriateness prior to its administration to minimize the potential occurrence of adverse events and preventing the administration of unnecessary medications. The hospital pharmacy must ensure that medication orders are accurate and check for irregularities of orders written 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. A pharmacist should have clarified the physician's order to make certain the drug was administered as intended or that the dose was appropriate. There is no evidence in patient 43's medical record that a pharmacist clarified the orders which created an unsafe patient care environment.

On 3/29/12, 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 3/29/12, a the time of the finding, the Director Inpatient Services confirmed the finding that the pain medication orders written by the physician should have included pain scale ranges prior to its administration and constitutes an invalid order.




26881


2. During a tour of the OR on 3/26/12 at 3 PM, the bottom drawer of the anesthesia cart contained a blue towel wrapped around several liquid-containing syringes. They included: a syringe with 3 cc of fluid labeled "epinephrine", an unlabeled syringe with 11 cc of milky white fluid, and a syringe with less than 1 cc of fluid labeled "versed".

During a concurrent interview with Surg RN 1, she stated that the she thought the anesthesiologist left the medications in the cart, and that they should have been discarded.

During an interview with the Dir Pharm on 3/27/12 at 11 AM, he stated that the medication labels for medications drawn up in syringes must be filled out completely with the medication name, strength, and date.

The facility policy, Safe Medication Practices in Perioperative Practice Settings (revision date 10/11) read in part, "Label all medications, medication containers (e.g. syringes, medicine cups, basins), or other solutions on and off the sterile field even if there is only one medication involved." and "Include the name and strength of the medication on the label."

Based on interview and record review, the facility failed to ensure that one physician, DR 2, who was using fluoroscopy (a test using x-rays) was being monitored for radiation exposure per facility policy, creating the risk of inadequate radiation monitoring during cases involving DR 2.

Findings:

During an interview with the Dir Rad on 3/27/12 at 3:10 PM, he supplied the names of medical staff who were using fluoroscopy during procedures, including DR 2.

The radiation safety badge log for January through March, 2012 were reviewed, and did not contain the name of DR 2. There was no evidence that DR 2 wore a radiation safety badge during those months.

The fluoroscopy log for 2012 was reviewed, and showed that DR 2 performed procedures using fluoroscopy on 1/16, 2/27, and 3/12/12.

In an interview with the Dir Rad on 3/27/12 at 3:30 PM, he stated that DR 2 probably did not have a radiation safety badge, and that Medical Staff should have notified the radiology department to order a badge.

The facility policy, Monthly Radiation Exposure Monitoring (Dosimeter) (revision date 5/09) read in part, "All personnel will wear a film badge whenever x-ray/fluoroscopy is used for patient procedures or while caring for patients who have received radioactive materials in therapeutic amounts.", and "On a monthly basis obtain new film badge and return exposed film badge to supervisor."

Based on observations, interviews and record reviews, the hospital's condition of participation for food and dietetic services was not met when:

? The Director of Food and Nutrition Services failed to ensure the daily operation of the dietary services when food was not properly stored, equipment was not effectively cleaned and maintained, the cool down process for cooked potentially hazardous food was not monitored, staff didn't practice safe hand hygiene and an air gap was not properly maintained (cross refer A 620)

? The Director of Food and Nutrition Services did not meet the qualifications for a dietetic services supervisor (cross refer A 023)

? Therapeutic diets were served to patients without a physician order (cross refer A 629)

? Dietary services failed to ensure that the nutrition needs of the patients were met in accordance to recognized national standards when they failed to have a nutrition analysis of their menus, they failed to have a consistent definition of diets routinely ordered, patients on pureed diets received gravy with chunks of vegetables, nutrition assessment and interventions were not carried out in a timely manner (cross refer A 630)

? The hospital failed to have a diet manual that provided staff guidance on the diets routinely ordered at the hospital (cross refer A 631)

? The disaster food supplies were inadequate to meet the needs of the disaster plan to feed patients and staff in the event of a disaster (cross refer A 701)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure safe food handling to prevent the potential for food borne illness; to ensure the safety of the patients and staff; and to ensure nutrition needs of the patients were met in accordance with recognized dietary practices and national standards.

Based on observation, document reviews and staff interviews, the hospital failed to ensure that the Director of Food and Nutrition Services was effective in the daily management of the dietary services. The Director of Food and Nutrition Services failed to assure that established policies and procedures were developed and followed and ensure safe food handling practices were followed and appropriate nutrition care was provided when:

1. The shelf life for potentially hazardous foods was not appropriately monitored. (cross refer A749)
2. Previously cooked potentially hazardous food was not monitored for safe cool down. (cross refer A749)
3. The ice machine was not maintained in a sanitary manner (cross refer A749)
4. Food Service staff did not observe proper hand washing techniques (cross refer A749)
5. Hand sanitizer dispenser was located where there was a potential for food contamination (cross refer A749)
6. The can opener blade was worn in a way that created the potential for cross contamination (cross refer A749)
7. The air gap in a floor drain was not maintained (cross refer A749)
8. Patient coffee mugs were stored upside down on a metal shelf that was not an easily cleanable surface (cross refer A749)
9. Foods were stored without a system to monitor the shelf life to ensure the quality of the food was maintained.
10. There was no nutrition analysis of the menus (cross refer A 630)
11. The hospital's diet manual did not provide guidance to the hospital staff on the diets the hospital routine provides to patient (cross refer A 631)
12. The Director of Food and Nutrition Services failed to meet the qualifications of a dietary services supervisor as outlined in the California Health and Safety Code (cross refer A 023)
13. The competency of the registered dietitian was not being effectively evaluated (cross refer A 622)

These failures had the potential to cause food borne illness, result in poor quality food, and an inability to ensure that the nutrition needs of the patients were met.


Findings:

1. During the initial tour of the kitchen on 3/26/12 at 2:45 PM, in the walk-in refrigerator, two stainless steel containers of previously cooked pot pie filling dated 3/22/12 and expire 3/29/12 were observed.

During a concurrent interview with the Food Service Supervisor (FSS), he stated that the pot pie filling was cooked on 3/22/12. He stated that chicken pot pie was on the patient menu every Thursday. He further stated that the filling had a seven day shelf life after being cooked.

A review of the hospital's policy titled, "Standards for Handling Leftovers" dated 6/11 revealed that the policy was that all production food items that are stored in the refrigerator should be used within three days.

A review of the hospital's policy titled, "Food Storage" dated 6/11, also showed that prepared foods were to be dated out and to be used within three days.

Also observed was an open, one gallon container of fat-free vinaigrette salad dressing, dated 12/21/11.

During a concurrent interview with the FSS, he stated that the date on the container was the date it was opened. He was unable to state what the policy was for the shelf life of the salad dressing once it was opened.

Also observed were 11 four ounce containers of Healthshakes (a dairy based nutritional supplement), with no date. The containers listed instructions that the product should be kept frozen and must be used by 14 days after thawing.

During a concurrent interview with FSS he stated that the staff was directed to date the tray that the Healthshakes are stored on in the refrigerator in order to know when the shakes expired. He confirmed that there was no date for the Healthshakes observed. He was unable to state how long the shakes had been thawed.

On the same day at 3:00 PM, in the cook's area freezer, two open bags of frozen french fries with no dates, an open bag of frozen sweet potato fries with no dates, an open bag of frozen meatballs with no date, a bag of frozen chicken gravy labeled with the expiration date of 3/17/12, a bag of frozen biscuits labeled with an expiration date of 3/8/12, an open bag of pie crust dated 3/1/12 with no use by or expiration date and an open box of puree eggs dated 10/6/11, not sealed with ice crystals formed on the product were observed.

Also in the cook's area refrigerator, 3 flats of eggs (30 eggs per flat) in their shell were observed removed from their original box and not dated.

During a concurrent interview with the FSS, he stated that the bags of frozen french fries, sweet potato fries and meatballs should be dated with an open and a use by date. He was unable to explain why the chicken gravy and the biscuits were stored for nine days and eighteen days, respectively, after their expirations dates. He was unable to state how long the pie crust could be stored once it is open and he stated that it should have an expiration date listed on it. He further stated that the frozen puree eggs should be discarded due to the ice crystals formed on the eggs. He was unable to state what the expiration date was for the frozen eggs once they were opened. He was unable to state how his staff was able to know the expiration date for the eggs in their shells when they had been removed from their original box and not dated.

During an interview with the Director of Food and Nutrition Services (DFNS) on 3/26/12 at 3:00 PM he confirmed all of the above findings. He stated that it was the policy to date all opened products with an open date and an expiration date.

Further review of the hospital's Food Storage policy revealed that all foods held in the refrigerators will be appropriately covered, clearly labeled and dated. It also stated that canned foods are to be dated out to be used within seven days.

For foods that are not properly labeled with a date opened or an expirations date, the dietary staff has no guidance regarding the wholesomeness of the foods. Food stored beyond their expiration dates are at risk of being served to patients. Expired food have the potential to cause food borne illness in a patient population that is already medically compromised.

2. During the initial tour of the kitchen on 3/26/12 at 2:45 PM, in the walk-in refrigerator, two stainless steel containers of previously cooked pot pie filling dated 3/22/12 and expire 3/29/12 were observed.

During an interview with the Cook on 3/27/12 at 10:35 AM, she stated that the pot pie filling was cooked for lunch on 3/22/12. She stated that when there was left over pot pie filling mix and it was stored for later use and safe cooling of the food should be monitored and recorded on the "Hot Food Cooling Log". She stated that she left for the day on 3/22/12, before the pot pie filling was stored, and it was the responsibility of the PM cook to monitor the temperature during cooling. She verified that there was no entry for the pot pie filling on 3/22/12.

A review of the "Hot Food Cooling Log" dated 1/31/12 through 3/27/12 showed there was no documented temperature monitoring of the pot pie filling on 3/22/12. According to the directions on the logs, hot food must be cooled to 70 degrees Fahrenheit (F) in 2 hours and below 41 degrees F in the next 4 hours.

According to the 2009 FDA Food Code, cooked, potentially hazardous food shall be cooled within 2 hours from 135 degrees (F) to 70 degrees (F), and within a total of 6 hours from 135 degrees (F) to 41 degrees (F). It further states that if food is not cooled in accordance to this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness.

When there is a lack of documented monitoring of the cooling of potentially hazardous foods, there is no way to ensure that the food was safely cooled within the timeframes required. Therefore there is no way to ensure the food is safe and will not cause food borne illness.

3. During the tour of the kitchen on 3/26/12 at 3:40 PM, the ice machine was observed. A clean paper towel swipe of the water trough portion of the ice maker revealed a brown and black crusty residue. Also observed was a moderate buildup of a brown residue along the edge of the water trough.

During a concurrent interview with Engineering Staff 1 (ES 1), he stated that the ice machine was about 6 - 7 month old. He stated that the ice machine was cleaned by the ES monthly and the last time he had cleaned it was 2/27/12. He was unable to state why there was such an accumulation of residue in one month.

During a concurrent interview with food service worker 1 (FSW 1), he stated that it was his responsibility to clean the ice storage bin component of the ice machine every Friday evening. He stated that the process he uses to clean the bin is to turn the machine off, remove the ice, splash hot water inside the bin, the splash sanitizer in the bin and allow it to dry. He stated the sanitizer he used was Quat 146, a quaternary sanitizer.

During the observation of the ice machine, with the front cover removed, there was no barrier between the ice bin and the ice maker. The splashing of water and sanitizer inside the bin could potentially cause sanitizer to remain in the ice machine once the machine is turned back on after FSW 1 cleaned it. This could result in ice being formed from the sanitizer, instead of just water.

A review of the manufacturer's guidelines for Ice Machine Cleaning and Sanitizing Instruction, date 11/08, instructed that a solution of 100 to 200 parts per million choline solution is used to sanitize the ice machine using EPA/FDA approved sodium hypochloride food equipment sanitizer, not a quaternary based sanitizer that FSW 1 stated he used.

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.

4. During an interview with FSW 2 on 3/26/12 at 3:15 PM, he stated that he had worked as a dishwasher at the hospital for 2 years. During the interview, he stated that when he transitioned from handling dirty dishes to handling clean dishes he changed his gloves. He did not state that he washed his hands before handling clean dishes after handling dirty dishes. He further demonstrated how he changed his gloves between dirty and clean handling. He did not wash his hands.

Also during a trayline (patient meal tray assembly) observation on 3/27/12 at 12:20 and 12:30 PM, Cook 1 was observed twice changing her gloves after contaminating them and used hand sanitizer before applying clean gloves instead of hand washing.

During an interview with the Food Service Supervisor (FSS) on 3/27/12 at 1:00 PM, he stated that Cook 1 should have washed her hands before applying clean gloves.

A review of the hospital's policy titled, "Dish and Silverware Cleaning" dated 6/11 revealed that it was the policy during silverware washing to wash your hands after holding soiled utensils and before handling sanitized ones.

A review of the hospital's nutritional service's policy titled, "Infection Control Safety Plan" dated 6/11 revealed that employees must wash hands after handling dirty dishes, trash or any waste product. It also stated that disposable gloves are used to prevent cross-contamination and the transmission of disease carrying organisms. It further stated that, "Gloves are not a substitute for hand washing. Change gloves in any situation in which you would wash your hands. Wear gloves on clean hands."

According to the 2009 FDA Food Code, food employees shall clean their hands and exposed portions of their arms as specified in the code immediately before engaging in food preparation including working with food, clean equipment and utensils. It further states that a hand antiseptic used as a topical application shall be applied only to hands that are cleaned according to the code. According to the code, proper hand washing shall include rinse under clean warm running water, applying soap, rubbing vigorously for 10 - 15 seconds, rinse under clean running warm water and thorough drying.

5. During the initial tour of the kitchen on 3/26/12 at 3:30 PM, a hand sanitizer dispenser was noted attached to the wall over a food prep table. The sanitizer dispensed automatically when a napkin was placed under the dispenser.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS) he stated that there was the potential for the hand sanitizer to automatically dispense in food being prepared on the table. He stated that he would have the dispenser removed immediately due to this risk. He was unable to explain why the cross-contamination potential had not been addressed before.

A review of the hospital's policy titled, "Food Storage" dated 6/11 stated that pesticides, cleaning compounds and other toxic substances will not be stored in the kitchen area or in the storeroom for food and/or preparation equipment and utensils.

6. During the initial tour of the kitchen with the Director of Food and Nutrition Services (DFNS) on 3/26/12 at 2:15 PM, a table mounted can opener was noted in the cold prep area. The can opener blade was observed to have a blade that was nicked and not smooth to the touch. The observation was confirmed by the DFNS.

A review of the hospital's policy titled, "Cleaning of Appliances and Equipment" dated 6/11 revealed that the kitchen can opener will be cleaned and sanitized daily and the blade will be checked and replaced as needed.

According to the 2009 FDA Food Code, cutting or piercing part of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is open. It further stated that multiuse food contact surfaces shall be smooth and free of crevices. Surfaces which have imperfections such as cracks, chips or pits allow microorganisms to attach and form biofilms that can release pathogens in the food. Biofilms are highly resistant to cleaning and sanitizing efforts.

7. During the initial tour of the kitchen on 3/26/12 at 3:10 PM with the Director of Food and Nutrition Services (DFNS) the floor drain under the steamer in the cooks area, had a pipe draining into it where no air gap was being maintained. The DFNS confirmed that there was no air gap. He further stated that an air gap should be maintained to prevent the backflow of waste water in the event of a negative pressure problem. He stated that he had not noticed that there was no air gap.

According to the 2009 Food Code, the presence of air gaps prevents the back flow of waste water during times of negative pressure, preventing contaminated water from being drawn into the system. The standard of practice is to ensure that all food storage equipment contain air gaps.

8. During an observation of the kitchen on 3/27/12 at 10:40 AM, a metal cupboard in the trayline area was noted to have peeling paint and rust on the shelf where coffee mugs were stored upside down. The shelf was covered with a clear plastic film but was not smooth to the touch.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS), he confirmed that the surface of the shelf was rough and not easily cleanable. He confirmed that the coffee mugs stored upside down on the shelf posed a cross contamination risk when patients drank their beverage from them.

According to the 2009 FDA Food Code, materials that are used in the construction of utensils and food contact surfaces of equipment may not allow the migration of deleterious substances...under normal use and shall be durable, corrosion-resistant, finished to have a smooth, easily cleanable surface and resistant to pitting, chipping and decomposition.

9. During the initial tour of the kitchen on 3/26/12 between 2:45 and 3:00 PM, the following was noted:
16 spice containers, opened with no date
Bay leaf container dated 2/25/10
Parsley flakes container dated 7/10/10
Thyme container dated 12/13/10
Ground sage container dated 2/10/11
Ground red pepper container dated 2/10/11

During a concurrent interview with the Director of Food and Nutrition Services (DFNS), he stated that all spice containers should be dated when they are opened and they have a shelf life of 6 months after they are opened. He further stated that the cook who opens the spice is responsible for dating it. He was unable to state why there were so many containers that were not dated. He further was unable to explain how his staff could determine the shelf life of the spices when there was no open date.

Also noted during the observation in the walk-in freezer was:
An open box of frozen corn on the cob that was not sealed
An open box of frozen baby carrots that was not sealed
A bag of frozen broccoli, removed from the original container, not dated
A bag of frozen Italian green beans, removed from the original box, not dated
A bag of frozen waffles, removed from the original box, not dated

During a concurrent interview with the DFNS, he stated the items that were not sealed should have been to prevent freezer burn and cross contamination. He also stated that the items removed from their original boxes should have dated with a use by date.

A review if the hospital's policy titled, "Purchasing, Receiving and Storage" dated 6/11 revealed that all refrigerated foods are covered, labeled, dated and stored with proper circulation of air around food.

During a follow-up interview with the DFNS on 3/29/12 at 2:00 PM, he stated that the hospital did not have a policy that guides the staff on the shelf life of spices. He stated that they should have one to ensure the quality of the spices was maintained.

10. During an interview with the Director of Food and Nutrition Services (DFNS) and the Registered Dietitian (RD) on 3/29/12 at 1:40 PM, they stated that they did not have a nutrition analysis of the menus. The RD stated that she reviews and approves the menus annually, but was unable to state how she determines the menus meet the needs of the patients without a nutrition analysis. Based on what she could recall, the regular diet provided approximately 2200 to 2400 calories and 95 to 100 grams of protein a day. She was unable to provide documentation of this. Further she was unable to determine if the various therapeutic diets that the hospital provides meet the DRI's or RDA's for all nutrients: vitamins, minerals, fats, carbohydrates, dietary fiber, for example. She did not know how much fiber and protein were in the diets when high fiber and high protein diets were ordered.

A review of the hospital's policy titled, "Diet Manual" dated 6/11 revealed that all served menus were consistent with the requirements in the diet manual. It further stated that all standard diets in the manual have been established within the framework of the dietary allowances recommended by the Food and Nutrition Board of the National Research Council (2000 version) and the Basic Four Food Groups and are planned to meet the increased nutritional requirements of disease and injury.

The RD was unable to determine how the menus met these guidelines without a nutrition analysis.

11. During trayline (patient meal tray assembly) observations on 3/27/12 between 11:30 AM and 12:30 PM, the staff prepared meals for patients with diet orders that included high protein, high fiber and diabetic.

During an interview with the Registered Dietitian (RD) on 3/27/12 at 2:30 PM, she was queried about how the dietary staff was able to determine the definition of the above diets. She stated that the hospital had no clear definition of high protein and high fiber diets. She further stated that the diabetic diets followed a written pattern in the diet office. She was unable to state how the medical staff was able to determine the definition of the diet orders. She further stated that the hospital used the American Dietetic Association's online Nutrition Care Manual (NCM) for their diet manual. She stated that the NCM did not provide guidance to the dietary, nursing or medical staff on the specific diets that the hospital provided such as the ones listed above. The RD stated that one of the physicians at the hospital routinely orders a high protein diet and the hospital does not have a definition of how much protein is in the diet.

A review of the NCM online showed that it did not provide specific guidance to the hospital staff regarding their diets.

A review of the hospital's policy titled' "Diet Manual" dated 6/11 revealed that it was the policy to have a guide that directs Nutrition Services in the proper planning, preparation and execution of daily meals. It further stated that the diet manual utilized was the Manual of Clinical Dietetics from the American Dietetic Association, not the Nutrition Care Manual.

The RD was unable to state why the policy was inconsistent with the hospital's practice.

12. During a review of the employee file for the Director of Food and Nutrition Services (DFNS) on 3/28/12 at 1:00 PM, it was noted that the DFNS had documentation that he graduated from a dietetic services training program approved by the Dietary Managers Association. It also showed that he had received his Certified Dietary Manager credential from the Dietary Managers Association on 10/25/08.

During an interview with the DFNS on 3/29/12 at 2:45 PM, he stated that he had not completed the six hours of in-service training on the specific California dietary service requirement contained in Title 22 of the California Code of Regulations. He further stated that he did not meet any of the other requirement for the pathways of becoming a qualified dietary service supervisor outlined in the CA HSC 1265.4(b).

13. During a review of the employee file for the RD on 3/28/12 at 1:05 PM, the annual performance evaluation and competency assessment dated 11/22/11 was reviewed. The Job Specific Essential Functions/Competencies section contained six areas of competency evaluated for the job of Clinical Dietitian: Completes consults in a timely fashion; Acts as a liaison between hospital and Nutritional Services staff; Completes reports in a timely fashion; Maintains credentialing; Strives to educate patients and staff on benefits of good nutrition, and; Performs other duties as assigned. All six areas of assessment were marked with a five score indicating she knows how to perform responsibility, performs correctly every time and is adaptable, and is considered an expert. The form was completed by the Director of Food and Nutrition Service (DFNS). There was no evaluation of the accuracy of her nutrition assessments and reassessments, especially as it related to the various diagnoses and age specific patients the hospital regularly admits. There was no evaluation of menu or diet manual development and approval. The clinical dietetics skills were not evaluated.

During a concurrent interview with the DFNS, he stated that he completed the RD evaluation. He stated that he thought that a physician also evaluated her performance/competency. He was unable to state what makes him qualified to evaluate her competence for clinical dietitian skills since he has no education or background in that area.

During an interview with the Director of Ancillary Services on 3/28/12 at 4:00 PM, she stated that the RD competencies should not be evaluated by the DFNS, as he was not qualified. She stated that there was no evaluation done by a physician and that the only evaluation was done by the DFNS.

Based on interviews and record reviews, the hospital failed to ensure the registered dietitian (RD) displayed appropriate competence when:

1. The patient menus were approved annually by the RD without a nutrition analysis of the menus
2. The RD failed to establish a diet manual that provided guidance to the staff (medical, nursing and dietary) on the specific diets the hospital provided
3. The RD failed to establish defined diets for high protein and high fibers diets routinely ordered at the hospital
4. The RD failed to establish, in conjunction with nursing, a system for determining the percentage of meals patients ate in order to evaluate their nutrition risk level or status
5. The competency of the RD was assessed by the Director of Food and Nutrition Services (DFNS) who was not qualified by education or experience to evaluate the competency of the RD.

This deficient practice resulted in and had the potential to result in the hospital failing to ensure the nutrition needs of the patients were met in accordance with recognized standard of practice.

Findings:

1. During an interview with the RD on 3/29/12 at 1:40 PM, she stated that the hospital did not have a nutrition analysis of the menus. The RD stated that she reviews and approves the menus annually, but was unable to state how she determines the menus meet the needs of the patients without a nutrition analysis. Further she was unable to determine if the various therapeutic diets that the hospital provides meet the DRI's or RDA's for all nutrients: vitamins, minerals, fats, carbohydrates, dietary fiber, for example. She did not know how much fiber and protein were in the diets when high fiber and high protein diets were ordered.

2. A review of the hospital's policy titled, "Diet Manual" dated 6/11 revealed that all served menus were consistent with the requirements in the diet manual. It further stated that all standard diets in the manual have been established within the framework of the dietary allowances recommended by the Food and Nutrition Board of the National Research Council (2000 version) and the Basic Four Food Groups and are planned to meet the increased nutritional requirements of disease and injury.

During an interview with the RD on 3/29/12 at 1:40 PM, she stated that the hospital used the American Dietetic Association's online Nutrition Care Manual (NCM) for their diet manual. She stated that the NCM did not provide guidance to the dietary, nursing or medical staff on the specific diets that the hospital provided, such as high protein and high fiber diets.

4. During a review of the nutrition care of the patients throughout the survey, there was no documentation in the medical records of the meal intakes for patients that were eating.

During an interview with the RD on 3/27/12 at 3:00 PM, she stated that she determined a patient's nutritional intake by querying the nursing assistant who may have cared for the patient only for that day. The RD confirmed that this does not allow for a nutrition assessment based on nutrition intake over time.

Throughout the survey, a hospital policy was requested for documenting the amount patients eat during their stay. The hospital was unable to produce a policy.

5. During a review of the employee file for the RD on 3/28/12 at 1:05 PM, the annual performance evaluation and competency assessment dated 11/22/11 was reviewed. The Job Specific Essential Functions/Competencies section contained six areas of competency evaluated for the job of Clinical Dietitian: Completes consults in a timely fashion; Acts as a liaison between hospital and Nutritional Services staff; Completes reports in a timely fashion; Maintains credentialing; Strives to educate patients and staff on benefits of good nutrition, and; Performs other duties as assigned. All six areas of assessment were marked with a five score indicating she knows how to perform responsibility, performs correctly every time and is adaptable, and is considered an expert. The form was completed by the Director of Food and Nutrition Service (DFNS). There was no evaluation of the accuracy of her nutrition assessments and reassessments, especially as it related to the various diagnoses and age specific patients the hospital regularly admits. There was no evaluation of menu or diet manual development and approval. The clinical dietetics skills were not evaluated.

During a concurrent interview with the DFNS, he stated that he completed the RD evaluation. He stated that he thought that a physician also evaluated her performance/competency. He was unable to state what makes him qualified to evaluate her competence for clinical dietitian skills since he has no education or background in that area.

During an interview with the Director of Ancillary Services on 3/28/12 at 4:00 PM, she stated that the RD competencies should not be evaluated by the DFNS, as he was not qualified. She stated that there was no evaluation done by a physician and that the only evaluation was done by the DFNS.

Based on observation, interviews and record reviews, the hospitals failed to ensure patient therapeutic diet orders were prescribed by the practitioner responsible for the care of the patient when a nurse ordered a soft diet for a patient (Patient 22) without a physician order. This practice resulted in a diet order inconsistent with the physician's diet order and the potential for the physician to be uninformed about the diet his patient is receiving.

Findings:

During trayline (patient meal tray assembly) observation on 3/27/12 between 11:30 AM and 12:30 PM, the menu for Patient 22 was reviewed. The patient's menu stated soft, high fiber, cardiac diet. The meal tray contained a plain lettuce salad, two portions of canned peaches, chicken with gravy, potatoes and asparagus.

During an interview with the Registered Dietitian (RD) on 3/28/12 at 10:30 AM, she stated that "soft" and "high fiber" diet orders were inconsistent. She stated that soft diets cannot have fresh fruit and must rely on canned fruit which contains much less fiber. She also stated that the salad on a soft diet contains only lettuce which doesn't provide much fiber. She stated that the extra canned fruit and the salad were the components of the meal that provided the high fiber. She confirmed that these did not provide much fiber.

During a review of Patient 22's medical record, it was noted that there was no physician order for the soft diet. The only diet order from the physician was for a high fiber cardiac diet. The patient had a diagnosis of chronic constipation.

During a review of the computer communication from nursing to nutritional service for diet orders, it was noted that the "soft" component of the diet order had been entered in the computer without a physician order.

During an interview with RN 7, charge nurse for the patient on 3/28/12 at 11:00 AM, she stated that the patient should be on a high fiber cardiac diet and the order cannot be changed without a physician's order. She was unable to explain how the order was changed without this order.

A review of the hospital's policy titled, "Diet Orders, Changes and Deletions" dated 6/11 revealed that diet changes must be in a written order from the patient's physician.

Based on observation, record review and interviews, the hospital failed to ensure the nutrition needs of the patients were met in accordance with recognized dietary practices and in accordance with the orders of the practitioners responsible for the care of the patients when:

1. There was no nutrition analysis of the menus to ensure they met the Recommended Dietary Allowances (RDA) or Dietary Reference Intake (DRI).

2. The hospital failed to have defined high protein and high fiber diets that would provide guidance to the medical staff in ordering diets for their patients and the dietary staff in the meal preparation.

3. All patients on regular diets received the same low salt, low fat food as the patients whose diets were restricted in those nutrients, such as a cardiac diet.

4. Patients on a pureed diet received foods different from the menu and they received gravy that contained whole pieces of vegetables, inconsistent with a pureed consistency diet.

5. One patient reviewed (Patient 22) received a soft diet that was not ordered by the physician. The soft diet order resulted in the patient not receiving the physician ordered high fiber diet for a diagnosis of chronic constipation

6. The nutrition needs of one patient (Patient 21) were not met when the nutrition assessment and reassessments were not completed and nutrition interventions were not initiated in a timely manner.

The result of these deficient practices was that the hospital could not ensure that the nutrition needs of the patients were being met, patients on a pureed diet were at risk for choking on pieces of vegetable and patients were at risk for further compromise of their nutritional and medical status.

Findings:

1. During an interview with the Director of Food and Nutrition Services (DFNS) and the Registered Dietitian (RD) on 3/29/12 at 1:40 PM, they stated that they did not have a nutrition analysis of the menus. The RD stated that she reviews and approves the menus annually, but was unable to state how she determines that the menus meet the needs of the patients without a nutrition analysis. Based on what she could recall, the regular diet provided approximately 2200 to 2400 calories and 95 to 100 grams of protein a day. She was unable to provide documentation of this. Further she was unable to determine if the various therapeutic diets that the hospital provides meet the DRI's or RDA's for all nutrients: vitamins, minerals, fats, carbohydrates, dietary fiber, for example. She did not know how much fiber and protein were in the diets when high fiber and high protein diets were ordered.

A review of the hospital's policy titled, "Diet Manual" dated 6/11 revealed that all served menus were consistent with the requirements in the diet manual. It further stated that all standard diets in the manual have been established within the framework of the dietary allowances recommended by the Food and Nutrition Board of the National Research Council (2000 version) and the Basic Four Food Groups and are planned to meet the increased nutritional requirements of disease and injury.

The RD was unable to determine how the menus met these guidelines without a nutrition analysis.

2. During trayline (patient meal tray assembly) observation and review of patient menus on 3/27/12 between 11:30 AM and 12:30 PM, the menu for Patient 22 was reviewed. The patient's menu stated "Soft, High Fiber, Cardiac Diet." Also noted was a menu with a diet listed as "High Protein, Regular, 50 gram Protein Diet," and one listed as "Pureed, High Protein Diet."

During an interview with the Registered Dietitian (RD) on 3/27/12 at 3:00 PM, she stated that the hospital had one physician who often ordered high protein diets for his patients. She further stated that the hospital had no defined guidelines for a high protein diet. She stated that even though the regular diet provided 95 to 100 grams of protein a day, she determined that a high protein diet could be less than this depending on the patient's weight. She stated that there was no guidance in the diet manual that the hospital used for high protein diets.

During a follow-up interview with the RD on 3/28/12 at 10:45 AM, she stated that the hospital does not have a defined high fiber diet.

When the hospital has no defined guidance for meal preparation for the standard diets, there is not a system to ensure that the nutrition needs of the patient are being met with the diets that are provided.

3. During trayline (patient meal tray assembly) observation and review of patient menus on 3/27/12 between 11:30 AM and 12:30 PM, it was noted that patients on a regular diet received the same entree, potatoes and soup as patients on a low salt or cardiac diet (low salt/low fat diet).

A review of the hospital's menus for Regular and Cardiac Diets for Tuesday Lunch showed that for Regular Diets, patients received Cream of Tomato Soup, Oven Roasted Chicken with Mushroom Gravy and Parsley New Potatoes and the patients on Cardiac Diets get Low Sodium Cream of Tomato Soup, Low Sodium Chicken with Mushroom Gravy and Low Sodium New Potatoes.

During an interview with Director of Food and Nutrition Services (DFNS) on 3/27/12 at 12:35 PM, he stated that all the food the kitchen makes is low sodium. He stated that patients that are on a regular diet can add salt to their food because they receive a salt packet on their trays. He 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, "Scope of Service, Nutritional Services" dated 6/11, revealed that it was the policy of the hospital to provide attractive, palatable meals to inpatients and outpatients that were appropriate for age and therapeutic needs. It further stated that the regular menu was modified by the dietitian for special diets. It does not specify that regular diets will be provided low sodium foods and that seasoning of the food would require adding salt to the food.

4. During trayline (patient meal tray assembly) observation and review of patient menus on 3/27/12 between 11:30 AM and 12:30 PM, it was noted that three patients on pureed diets received the mushroom gravy on their chicken. The mushroom gravy had pieces of vegetables in it that were not pureed consistency. Also observed was that the patients on a pureed diet received green beans instead of the asparagus, which was on the menu.

During an interview with the Food Service Supervisor on 3/27/12 at 12:40 PM, he stated that there should not be chunks of vegetables in the pureed gravy. He was unable to explain why the patient's on pureed diets received gravy with chunks of vegetable. He further stated that the vegetables could cause choking in a patient who was on a pureed diet.

A review of the American Dietetic Association's Online Nutrition Care Manual, 2012, stated that for pureed diets, the purpose of the diet was to provide foods that can be successfully and safely swallowed. It further stated that all foods on this diet should be smooth and free of lumps.

During an interview with the Registered Dietitian (RD) on 3/27/12 at 1:00 PM, she stated that the patients on the pureed diet received green beans because they were a prepackaged, molded product and the hospital didn't have the asparagus in this form. She further stated that asparagus might be too difficult to puree. She was unable to explain why puree asparagus was on the menu if it wasn't being served.

A review of the hospital's policy titled, "Puree Diet" dated 6/11, revealed that the dietitian was responsible for developing the menu. It further stated that the puree menu is based on the soft menu. Review of the soft and the pureed menus revealed that the vegetable served was asparagus.

5. During trayline (patient meal tray assembly) observation on 3/27/12 between 11:30 AM and 12:30 PM, the menu for Patient 22 was reviewed. The patient's menu stated soft, high fiber, cardiac diet. The meal tray contained a plain lettuce salad, two portions of canned peaches, chicken with gravy, potatoes and asparagus.

During an interview with the Registered Dietitian (RD) on 3/28/12 at 10:30 AM, she stated that "soft" and "high fiber" diet orders were inconsistent. She stated that soft diets cannot have fresh fruit and must rely on canned fruit which contains much less fiber. She also stated that the salad on a soft diet contains only lettuce which doesn't provide much fiber. She stated that the extra canned fruit and the salad were the components of the meal that provided the high fiber. She confirmed that these did not provide much fiber.

During a review of Patient 22's medical record, it was noted that there was no physician order for the soft diet. The only diet order from the physician was for a high fiber cardiac diet. The patient had a diagnosis of chronic constipation.

During a review of the computer communication from nursing to nutritional service for diet orders, it was noted that the "soft" component of the diet order had been entered in the computer without a physician order.

During an interview with RN 7, charge nurse for the patient on 3/28/12 at 11:00 AM, she stated that the patient should be on a high fiber cardiac diet and the order cannot be changed without a physician's order. She was unable to explain how the order was changed without this order.

A review of the hospital's policy titled, "Diet Orders, Changes and Deletions" dated 6/11 revealed that diet changes must be in a written order from the patient's physician.

6. A review of the medical record for Patient 21 revealed that the patient was brought to the hospital on 3/13/12 with complaints of altered level of consciousness and was not eating for two days. The patient was admitted to the hospital the same day with diagnoses that included altered level of consciousness and dehydration.

A review of the physician orders dated 3/13/12 showed an order for a High Protein Diet.

A review of the nutrition notes dated 3/14/12 by the Registered Dietitian (RD) showed that the patient had poor food intake for 2 days prior to coming into the hospital. It further stated that the patient continued with poor intake since being admitted. The RD recommended a pureed high protein diet with Ensure (a liquid nutritional supplement) three times a day. The RD note stated that nutrition appears inadequate at this time. It further indicated that the RD would follow-up in 5 to 7 days.

A review of the physician orders for 3/14/12 showed both the pureed diet and the Ensure was ordered according to the RD recommendations.

A follow-up RD note dated 3/20/12 was reviewed. The note indicated that the patient was eating 50 to 70 % of meals and that the patient had improved intake.

During an interview with the RD on 3/27/12 at 2:30 PM, she stated that she spoke to a nursing assistant on 3/20/12 who told her the patient was eating this amount. She stated that there was no documentation in the patient's medical record that indicated the percentage of meals that the patient ate. She confirmed that the nursing assistants don ' t always take care of the same patients from day to day. She stated that their reports of meal consumption would be from the current day not over the last 6 days since the last nutrition assessment.

Further review of the RD note dated 3/20/12 showed that the RD's nutrition plan was to continue the same plan of care and follow up in 7 days.

A review of the medical record revealed that the patient's meal intake was not recorded. A review of the "diet" section of the daily "Routine Care Checklists" since the patient was admitted showed no documentation in the "amount (eaten)" area of that section. A review of "Nursing Flowsheets" since the patient was admitted showed a section of the charting where nutrition was assessed as very poor, probably inadequate, adequate or no apparent problem. In only 10 of the 28 times this area was completed, was the patients nutrition indicated to be adequate. There was no documentation of percent meal intakes or the amount of Ensure the patient was drinking.

During an observation of the patient's bedside table on 3/27/12 at 3:10 PM, two unopened bottles of Ensure were noted on the table. The patient did not respond to questions.

During an interview with RN 12, charge nurse for Patient 21, on 3/27/12 at 3:20 PM, she stated that there was no documentation of meal percentages or the amount of Ensure the patient was drinking. She further stated the nursing assistants should be documenting the meal percentages and the nurses should be documenting the amount of Ensure that the patient drank. A hospital policy was requested for documenting the amount patients eat during their stay. The hospital was unable to produce a policy.

During an interview with RN 13, Patient 21's nurse, on 3/27/12 at 3:30, she stated that Patient 21 had refused to eat for 2 days. She stated that she informed the physician, but stated that she didn't have time to inform the RD.

The hospital's policy titled, "Nutrition Screening and Assessment" dated 6/11, was reviewed. The policy stated that patient assessments and reassessments will address information pertinent to the patient's current nutrition status and/or response to nutritional therapy including diet tolerance. It further stated that it will address appropriateness of the diet order relative to the patient's tolerance, medical condition and estimated nutritional goals.

On 3/27/12, Patient 21 had been in the hospital for 14 days. Her intake had been inadequate for most of those days. The patient was unable to meet her nutrition needs with the current nutrition plan of care. There was inadequate evaluation and assessment of the effectiveness of the nutrition plan of care the hospital put in place for Patient 21.

Based on food production observations, dietary management staff interviews and dietary document reviews the hospital failed to ensure that their diet manual provided guidance to the medical, nursing and dietary staff on the specific diets prepared in the hospital. A lack of a diet manual that was inclusive of all the specific diets prepared by the hospital had the potential to result in a lack of guidance for the dietary staff to prepare meals and for the medical staff when ordering diets for their patients.

Findings:

During trayline (patient meal tray assembly) observations on 3/27/12 between 11:30 AM and 12:30 PM, the staff prepared meals for patients with diet orders that included high protein, high fiber and diabetic diets.

During an interview with the Registered Dietitian (RD) on 3/27/12 at 2:30 PM, she was queried about how the dietary staff was able to determine the definition of the above diets. She stated that the hospital had no clear definition of high protein and high fiber diets. She further stated that the diabetic diets followed a written pattern in the diet office. She was unable to state how the medical staff was able to determine the definition of the diet orders. She further stated that the hospital used the American Dietetic Association's online Nutrition Care Manual (NCM) for their diet manual. She stated that the NCM did not provide guidance to the dietary, nursing or medical staff on the specific diets that the hospital provided such as the ones listed above. The RD stated that one of the physicians at the hospital routinely orders a high protein diet and the hospital does not have a definition of how much protein is in the diet.

A review of the NCM online showed that it did not provide specific guidance to the hospital staff regarding their diets.

A review of the hospital's policy titled' "Diet Manual" dated 6/11 revealed that it was the policy to have a guide that directs Nutrition Services in the proper planning, preparation and execution of daily meals. It further stated that the diet manual utilized was the Manual of Clinical Dietetics from the American Dietetic Association, not the Nutrition Care Manual.

The RD was unable to state why the policy was inconsistent with the hospital's practice.

Based on observation, document review and interview, the facility failed to ensure it was arranged and maintained to ensure high quality healthcare in a safe environment to protect the health and safety of patients in accordance with NFPA 101, Life Safety Code (LSC) and NFPA 99 Health Care Facilities. This was evidenced by the failure to:

1a. Provide emergency lighting in all required areas of the hospital. (LSC K046)

1b. Provide emergency power in all required areas of the hospital. (LSC K147)

2. Provide documentation of for maintenance of the exit signs. ( LSC K047)

3. Provide a remote annunciator for the emergency generator. (LSC K144)

4. Provide documentation for the maintenance and testing of the fire alarm system. (LSC K 052)

5. Provide documentation for the maintenance of the dampers. (LSC K067)

6. Provide documentation for the maintenance of the fire pump. (LSC K130)

7. Provide emergency power to the room or to individual pieces of equipment used in the GI Laboratory, creating the risk of a poor health outcome for any patient using the room during a power outage (see A-702).

8. Ensure the operating room humidity was not repeatedly out of range for over a year, creating the increased risk of infection or fire for patients receiving services in that area (see A-726).

9. Ensure that the crash cart located in the North ICU (Intensive Care Unit) was checked every shift.

The facility further failed to ensure that the pediatric unit crash cart was checked daily and failed to ensure the pediatric crash cart had a back board available for emergency use.

The facility failed to ensure an apnea monitor had a current inspection by the biomed department and should not have been available for use.

These failures had the potential to result in faulty equipment or inadequate supplies in the event of an emergency. (see A-0724)

On 3/28/12, at 10:09 AM, an Immediate Jeopardy was identified by the LSC surveyor in the GI Lab. The lab had no emergency lighting or power. The CEO (Chief Executive Officer), Director of Ancillary Services, CNO (Chief Nursing Officer), Director of Quality and Risk Management Compliance Officer, were notified of the immediate jeopardy.

On 3/29/12, at 8:44 AM, the Immediate Jeopardy was abated after receiving an acceptable plan of correction. The CEO and Director of Ancillary Services provided a plan to discontinue use of the GI lab until emergency power was provided.

The cumulative effect of these systemic problems resulted in the failure to demonstrate the ability to ensure the provision of quality health care in a safe environment. This affected six of six smoke compartments on the first floor, two of two smoke compartments on the second floor, and the basement. This could result in a lighting failure in the GI Lab, a failure of the emergency power system in the event of a power outage in the GI Lab, the potential spread of fire, and a delay in evacuation for the patients and staff.

Findings:

During the facility tour from March 26, 2012 through March 29, 2012, the back-up emergency power system, emergency lighting, fire alarm system and sprinkler system were observed.

1. On March 27, 2012, at 9:30 a.m., there were no emergency lights or backup power in the GI lab. There were no red outlets, backed up by the generator, in the GI Lab. There were no emergency lights visible in the room.

During an interview on March 28, 2012, GI Lab Staff 1 confirmed there was no emergency lighting in the lab area.

On March 28, 2012, at 2:10 p.m., one emergency light failed when tested with the test button.

During record review, on March 27, 2012, there was no documentation for testing and maintenance of the emergency lights. (See K46 and K147 of the LSC survey)

2. During record review on March 27, 2012, records indicated that not all exit lights were tested monthly as required. Records indicated that exit signs failed in the North building, second floor, for six of seven months, from 9/2011 through 3/2012. There were no exit sign testing records for 12/2011, for areas on the first floor and basement.

On March 28, 2012, at 10:35 a.m., the exit sign in the hallway outside the emergency room had no date the sign was installed or when it was to be replaced.
At 10:38 a.m., the exit sign by AV 42, was a 10 year sign. The replacement date indicated replace before 5/2004.

At 10:45 a.m., the exit sign by Utilization review had no date of install or replacement.

At 3:11 p.m., 3 of 3 exit signs outside the kitchen, in the egress corridor, indicated replacement due by 1/2011.

At 10:56 a.m., in BHU (Behavioral Health Unit) the floor level exit sign near the scanning room had a broken face plate. The sign was no longer legible. (See K47 of the LSC survey)

3. During the facility tour from March 26, 2012 through March 29, 2012, there was no remote alarm annunciator, for the generator, located in an area that is constantly manned by staff. During an interview on March 30, 2012, at 9:17 a.m., Facilities Staff 1 reported that there was no remote annunciator for the emergency generator. The facility has a diesel generator. (See K144 of the LSC survey)

4. On March 26, 2012, the "Fire Alarm Inspection Report," dated June 14, 2011, was reviewed from 10:59 a.m. to 11:59 a.m.

Page 4 of the report indicated the Control Panel Central Processing Unit, Control Function(s) failed, in Engineering on the first floor.

At 11:04 a.m., during an interview, Facilities Staff 1 stated parts had been ordered to repair the unit. He reported the repairs had not been completed.

The report indicated that Lamps/LED test - failed light bulbs are missing, in Labor and Delivery 1st floor, inside telephone room by surgery.

There was no record that the lamps were replaced.

Page 8 noted, Alarm Initiating Devices - 54 duct detectors, 51 were tested. (See K52 of the LSC survey)

5. The facility failed to maintain and test all fire and smoke dampers. On March 29, 2012, at 1:45 p.m., the Fire Damper Report dated June 5, 2007 was reviewed. The report indicated dampers that were not inspected, damper motors that failed, and dampers that were held open with wood, on the first floor, second floor and in the basement. There was no current report for damper inspection in 2011.

On March 30, 2012, at 9:30 a.m., Facilities Staff 1 stated there was no documentation showing repairs had been completed on the dampers that failed. (See K67 of the LSC survey)

6. The facility failed to maintain the Fire Pump in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water Based Fire Protection Systems, 1998 edition. This was evidenced by ongoing leaks at the fire pump, and by no records for weekly testing.

During record review on March 26, 2012, at 11:48 a.m., the vendor Service Request form, dated December 7, 2011, was reviewed. The report noted "Fire Pump Leaking, took apart gland and cleaned corrosion reinstalled OS&Y still leaking but not overflowing on outside drive. Pump needs a repack."

On March 27, 2012, at 8:49 a.m., the Inspection, Testing, and Maintenance cover sheet dated April 19, 2011, indicated "Fire Performance Test," system failed, parts on order.

One weekly report "Fire Pump Preventative Maintenance" was dated 6/24/2011. There were no other weekly testing records provided during 2011 and no current testing records in 2012.

At 11:07 a.m., a Service Request report dated 2/22/12, noted fire pump leaking - ovulation relief valve on the fire pump is leaking, tried to adjust it on my last visit but I found that it is just broken and needs to be replaced.

On March 28, 2012, at 2:55 p.m., the fire pump area was observed. There was water leaking/dripping in one area. (See K130 in the LSC survey)

7. There was no emergency power to the room or to individual pieces of equipment used in the GI Laboratory, creating the risk of a poor health outcome for any patient using the room during a power outage (see A-702).

8. The operating room humidity was repeatedly out of range for over a year, creating the increased risk of infection or fire for patients receiving services in that area (see A-726).

9. The facility failed to ensure that the crash cart located in the North ICU (Intensive Care Unit) was checked every shift.

The facility further failed to ensure that the pediatric unit crash cart was checked daily and failed to ensure the pediatric crash cart had a back board available for emergency use.

The facility failed to ensure an apnea monitor had a current inspection by the biomed department and should not have been available for use.

These failures had the potential to result in faulty equipment or inadequate supplies in the event of an emergency. (see A-724)




26881

Based on observations, record reviews and staff interviews, the hospital failed to ensure the overall environment was developed and maintained in such a manner that assured the safety and well-being of the patients when the Director of Food and Nutrition Services failed to maintain adequate disaster food supplies to meet the needs of the patients in the event of a disaster. Also the hospital's disaster food plan was not readily available to the staff for guidance in the event of a disaster. This failure had the potential to result in malnutrition in patients and staff in the event of a disaster.

Findings:

During an observation and concurrent review of the hospital's disaster food plan and supplies on 3/27/12 at 8:30 AM, the following was noted:

? The plan required 1,000 ounces of peanut butter, there was 800 ounces.
? The plan required 12 number 10 cans of beef stew, there were only 8 cans.
? The plan required 12 number 10 cans of chili beans, there were only 11 cans.
? The plan required six 48 ounce cans of chicken, there were none.
? The plan required 24 cans of pureed vegetables, there were only 12 cans.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS) he stated that the Food Services Supervisor (FSS) monitors the disaster supply inventory quarterly. He further stated that his dietary staff sometimes used food from the disaster inventory for regular production and didn't replace it. He was unable to state how he would be able to implement his disaster food plan without many of the protein-rich foods the plan calls for. He acknowledged that a quarterly inventory was not adequate to ensure that there was inventory to meet the needs of the disaster plan to feed the patients and staff.

During further query with the DFNS, same date and time, he stated that the disaster food plan was kept in the Food and Nutrition Service's policy and procedure manual. He showed how the manual remained located in his office. He stated that his office remained locked when he was not present. He was unable to state how staff responding during a disaster would have access to the plan. He acknowledged that it was not easily accessible to ensure staff was able to implement the plan during the likely confusion a disaster might cause.

Based on interview and record review, the facility failed to ensure the availability of emergency power for the GI laboratory, creating the risk of a poor health outcome for all patients receiving care in that area due to the inability to provide treatment and monitoring in the event of a power outage.

Findings:

During a tour of the GI laboratory on 3/26/12 at 10:15 AM, no red plugs indicating an emergency power source were seen.

In a concurrent interview with the GI Tech, he stated that he did not believe that the GI Laboratory had emergency backup power.

In an interview with the Dir Surg Serv on 3/26/12 at 2:40 PM, she stated that there was no backup power in the GI laboratory.

In an interview with the Dir Fac on 3/28/12 at 10 AM, he stated that there was no backup power in the GI laboratory. He stated that there was no backup battery that powered the scope monitor in the event of a power failure.

During an interview with the Dir Anesth on 3/27/12 at 2:45 PM, he stated that anesthesia services were provided in the GI laboratory, and that he was not aware that backup power was not available in that room.

The facility policy, Emergency Power Distribution, revised 9/09, read in part, "The generator provides emergency power to designated areas and equipment as specified below and as applicable to the hospital: ...Critical Branch: i. Critical care areas that utilize anesthetizing gases, tasks illumination, selected receptacles, and fixed equipment. ii. The isolated power systems in special environments (Operating Rooms) ... "

On 3/28/12, at 10:09 AM, an Immediate Jeopardy was identified in the GI Lab. The lab had no emergency lighting or power. The CEO (Chief Executive Officer), Director of Ancillary Services, CNO (Chief Nursing Officer), Director of Quality and Risk Management Compliance Officer, were notified of the immediate jeopardy.

On 3/29/12, at 8:44 AM, the Immediate Jeopardy was abated after receiving an acceptable plan of correction. The CEO and Director of Ancillary Services provided a plan to discontinue use of the GI lab until emergency power was provided.

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

1. Ensure that the crash cart located in the North ICU (Intensive Care Unit) was checked every shift.

2. Ensure that the pediatric unit crash cart was checked daily and failed to ensure the pediatric crash cart had a back board available for emergency use.

3. Ensure an apnea monitor had a current inspection by the biomed department and should not have been available for use.

4. Maintain the walk-in freezer in the dietary department in safe working order when drops of water had frozen on food boxes and the floor of the freezer. Also, ice had formed around the seal of the freezer door, preventing it from closing and ensuring the freezer was functioning properly;

5. Maintain an air gap between the drain pipe and the floor drain under the steamer in the kitchen.

The emergency equipment failures had the potential to result in faulty equipment or inadequate supplies in the event of an emergency.

The freezer failure had the potential to affect the quality and safety of the patient food stored in the walk-in freezer. It also had the potential to result in slip and fall injuries occurring with the dietary staff. The air gap failure had the potential to allow backflow of waste water into the steamer in the event of negative water pressure and contaminate food cooked in the steamer

Findings:

1. An observation was made of the crash cart on the North ICU on 3/28/12 at 10:30 AM.

A review of the North ICU Crash Cart Check List revealed the following dates for the month of March in which the crash cart was not checked: 3/3, 3/4, 3/6, 3/10, 3/12, 3/13, 3/15, 3/16, 3/17, 3/18 and 3/25.

During an interview on 3/28/12 at 10:32 AM, CN 1 stated that checking the crash cart was a charge nurse responsibility and should be done every shift. CN 1 confirmed the crash cart was not checked when there are no patients on the unit.

During an interview on 3/28/12 at 10:35 AM, RN 2 confirmed that there were several days on the crash cart log where it was not checked. She confirmed that when no patients were on the unit, they probably don't check the crash cart although they should have.



25179

2. During a tour of the Pediatric unit on 3/29/12 at 10:00 AM with the DICU (Director of the Intensive Care Unit), it was observed that the pediatric crash cart checklist had blank areas on some days of the month.

The blank days were as follows:

March 3 during the PM
March 4 AM and PM
March 5 AM and PM (there was a notation that the unit was closed)

February 7 during the PM
February 8 during the PM
February 21 during the PM
February 22 AM and PM (there was a notation that the unit was closed)

January 20 during the PM
January 21 AM and PM (there was a notation that the unit was closed)
January 23 during the AM

In an interview on 3/29/12 at 10:05 AM with the DICU, she stated that the crash cart should be checked twice daily.

A review of the instructions on the Crash Cart Checklist showed the following:

"Crash cart to be checked at the beginning of each shift and after the cart is used.
If you are closed on Weekends and Holidays, please write closed on the appropriate day."

In a further discussion with the DICU she acknowledged that the Pediatric unit crash cart should be checked daily even if closed as the unit could receive a patient at any time.

3. On a tour of the Pediatric Unit on 3/29/12 at 10:00 AM it was observed that the pediatric crash cart did not have a back board on it. The back board is used during chest compressions in cardio-pulmonary resuscitation to provide a firm surface on top of a bed and under the patient.

In a concurrent interview with the Director of ICU, she acknowledged that the crash cart should have a back board.

4. During an initial tour of the Pediatric Unit on 3/26/12 at 9:50 AM it was observed that there was a apnea monitor with a biomed sticker that had a inspection due date of 8/11.

In a concurrent interview with the Director of Maternal Child Health, she acknowledged that the apnea monitor should have been inspected by the biomed department and should not be available for use.


28135


5. During the initial tour of the kitchen on 3/26/12 at 2:50 PM, the walk-in freezer was noted to have frozen water drips hanging from the ceiling, frozen water drips on boxes of food and puddles of ice on the floor. Also noted was an accumulation of ice around the seal of the door to the freezer, along the bottom right corner.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS), he confirmed that the ice on the floor was a safety issue for his staff. He also stated that the ice on the boxes of food compromised the integrity of the food container and could affect the quality of the food inside the box. He stated that his staff had not informed him of the ice build-up. He stated that the dietary staff was responsible for informing the Engineering Department when equipment wasn't functioning properly.

During a concurrent interview with the Engineering Staff 1 (ES1), he stated that the seal around the freezer door had been repaired 2 to 3 weeks ago. He was unable to explain why there was still ice build-up around the seal. He stated that the Engineering Department was not informed of the ice build-up inside the freezer. He confirmed that the ice build-up on the floor of the freezer could result in the dietary staff slipping and falling. Also, the accumulation of ice in the freezer indicated that it may not be functioning properly which could affect the safety and quality of the food stored inside.

6. During the initial tour of the kitchen on 3/26/12 at 3:10 PM with the Director of Food and Nutrition Services (DFNS) the floor drain under the steamer in the cooks area, had a pipe draining into it where no air gap was being maintained. The DFNS confirmed that there was no air gap. He further stated that an air gap should be maintained to prevent the backflow of waste water in the event of a negative pressure problem. He stated that he had not noticed that there was no air gap.

According to the 2009 Food Code, the presence of air gaps prevents the back flow of waste water during times of negative pressure, preventing contaminated water from being drawn into the system. The standard of practice is to ensure that all food storage equipment contain air gaps.

Based on observation, interview and record review, the facility failed to ensure that operating room humidity was maintained within facility policy, creating the increased risk of infection and fire for all patients using the operating rooms when the humidity was inadequately controlled.

Findings:

During a review of the Main Operating Room Temperature and Humidity Log for the period 1/11 through 3/25/12, the log read, "Maintain room humidity between: 30% and 60%", but the recorded values varied from that range on numerous dates. On 3/9 and 3/10, the humidity was 26% or below in 4 of the 5 ORs in use on those dates. For OR 1, the humidity was below the facility policy's lower limit on 8 of 24 days recorded in March, 2012. The humidity fell either above (high of 72%) or below (low of 18%) the facility's policy in the ORs on some dates during every month from 1/11 through 3/12.

During an interview with the Dir Surg on 3/27/12 at 2:40 PM, she stated that OR temperature and humidity were monitored by the facilities department, and they advised her if it was out of range. Then they made adjustments and let her know if it improved. She stated the pattern of OR climate falling out of control had been going on for over one year. She stated that in the past Infection Control and the QI Department had been advised of the issue.

In an interview with the Dir Facilities on 3/27/12 at 10:15 AM, he stated that when the OR humidity was less than 30%, an adjustment was to be made to the system, but that no work orders were created to document the process, and he was not sure if a follow-up assessment of the humidity was done. He stated that he was not aware that there was a problem with the OR humidity, and was not sure if the issue had been forwarded to the hospital administration.

The facility policy, Humidity Control (revision date 5/09), read in part, "The humidity will be maintained 30-60% by the Facilities Management Department."

Based on observations, interview and record review, the infection control department had not developed and implemented a system for recognizing and controlling infections because: 1. post-op infection surveys were not being routinely completed for all patients, and 2. The humidity was not being controlled in the operating rooms, creating the increased risk of infection for all surgical patients. Also, 3. the hospital failed to ensure that there were infection control measures in place to prevent the development of food borne illness and cross contamination in the food service departments. Also, the hospital failed to have a thorough infection control surveillance system that monitored the conditions and practices of the dietetics services 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.


Findings:

1. During an interview with the Dir IC on 3/29/12 at 9:35 AM, she stated that the surgeons were supposed to send back forms regarding post-operative infections, but that in fact the forms were only being returned 50-60% of the time. She stated that the return rate had been reported to the surgical services committee, but that no method to enforce return of the surveys had been implemented.

The facility policy, Infection Prevention Plan (revision date 8/09), read in part, "Primary goals ...Conduct ongoing, comprehensive surveillance, analysis and reporting of community and healthcare-associated infections."

2. During a review of the Main Operating Room Temperature and Humidity Log for the period 1/11 through 3/25/12, the log read, "Maintain room humidity between: 30% and 60%, but the recorded values varied from that range on numerous dates. On 3/9 and 3/10, the humidity was 26 or below in 4 of the 5 ORs in use on those dates. For OR 1, the humidity was below the facility policy's lower limit on 8 of 24 days recorded in March, 2012. The humidity fell either above (high of 72%) or below (low of 18%) the facility's policy in the ORs on some dates during every month from 1/11 through 3/12.

During an interview with the Dir IC on 3/29/12 at 9:35 AM, she stated that she was not aware of any recent problem with OR humidity. She stated that departments were to do environment of care (EOC) rounds 2x/year, but that departments were not using an individualized routine to check for infection control hazards in their areas. She said that EOC rounds would include universal issues such as handwashing.

The facility policy, Infection Prevention Plan (revision date 8/09), read in part, "Risk Assessment ...The Infection Preventionist uses historical and surveillance data, study findings, discussions with the various committee chairpersons, infectious disease physicians, San Bernardino County Public Health, and marketing and organization leadership to develop the assessment."



28135

3 a. During the initial tour of the kitchen on 3/26/12 at 2:45 PM, in the walk-in refrigerator, two stainless steel containers of previously cooked pot pie filling dated 3/22/12 and expire 3/29/12 were observed.

During a concurrent interview with the Food Service Supervisor (FSS), he stated that the pot pie filling was cooked on 3/22/12. He stated that chicken pot pie was on the patient menu every Thursday. He further stated that the filling had a seven day shelf life after being cooked.

A review of the hospital's policy titled, "Standards for Handling Leftovers" dated 6/11 revealed that the policy was the all production food items that are stored in the refrigerator should be used within three days.

A review of the hospital's policy titled, "Food Storage" dated 6/11, also showed that prepared foods were to be dated out to be used within three days.

Also observed was an open, one gallon container of fat-free vinaigrette salad dressing, dated 12/21/11.

During a concurrent interview with the FSS, he stated that the date on the container was the date it was opened. He was unable to state what the policy was for the shelf life of the salad dressing once it was opened.

Also observed were 11 four ounce containers of Healthshakes (a dairy based nutritional supplement), with no date. The containers listed instructions that the product should be kept frozen and must be used by 14 days after thawing.

During a concurrent interview with FSS he stated that the staff was directed to date the tray that the Healthshakes are stored on in the refrigerator in order to know when the shakes expired. He confirmed that there was no date for the Healthshakes observed. He was unable to state how long the shakes had been thawed.

On the same day at 3:00 PM, in the cook's area freezer, two open bags of frozen french fries with no dates, an open bag of frozen sweet potato fries with no dates, an open bag of frozen meatballs with no date, a bag of frozen chicken gravy labeled with the expiration date of 3/17/12, a bag of frozen biscuits labeled with an expiration date of 3/8/12, an open bag of pie crust dated 3/1/12 with no use by or expiration date and an open box of puree eggs dated 10/6/11, not sealed with ice crystals formed on the product were observed.

Also in the cook's area refrigerator, 3 flats of eggs (30 eggs per flat) in their shell were observed removed from their original box and not dated.

During a concurrent interview with the FSS, he stated that the bags of frozen french fries, sweet potato fries and meatballs should be dated with an open and a use by date. He was unable to explain why the chicken gravy and the biscuits were stored for nine days and eighteen days, respectively, after their expirations dates. He was unable to state how long the pie crust could be stored once it is open and he stated that it should have an expiration date listed on it. He further stated that the frozen puree eggs should be discarded due to the ice crystals formed on the eggs. He was unable to state what the expiration date was for the frozen eggs once they were opened. He was unable to state how his staff was able to know the expiration date for the eggs in their shells when they had been removed from their original box and not dated.

During an interview with the Director of Food and Nutrition Services (DFNS) on 3/26/12 at 3:00 PM he confirmed all of the above findings. He stated that it was the policy to date all opened products with an open date and an expiration date.

Further review of the hospital's Food Storage policy revealed that all foods held in the refrigerators will be appropriately covered, clearly labeled and dated. It also reflected that canned foods are to be dated out to be used within seven days.

For foods that are not properly labeled with a date opened or an expirations date, the dietary staff has no guidance regarding the wholesomeness of the foods. Food stored beyond their expiration dates are at risk of being served to patients. Expired food have the potential to cause food borne illness in a patient population that is already medically compromised.

3b. During the initial tour of the kitchen on 3/26/12 at 2:45 PM, in the walk-in refrigerator, two stainless steel containers of previously cooked pot pie filling dated 3/22/12 and expire 3/29/12 were observed.

During an interview with the Cook on 3/27/12 at 10:35 AM, she stated that the pot pie filling was cooked for lunch on 3/22/12. She stated that when there was left over pot pie filling mix and it was stored for later use and safe cooling of the food should be monitored and recorded on the "Hot Food Cooling Log". She stated that she left for the day on 3/22/12, before the pot pie filling was stored, and it was the responsibility of the PM cook to monitor the temperature during cooling. She verified that there was no entry for the pot pie filling on 3/22/12.

A review of the "Hot Food Cooling Log" dated 1/31/12 through 3/27/12 showed there was no documented temperature monitoring of the pot pie filling on 3/22/12. According to the directions on the logs, hot food must be cooled to 70 degrees Fahrenheit (F) in 2 hours and below 41 degrees F in the next 4 hours.

According to the 2009 FDA Food Code, cooked, potentially hazardous food shall be cooled within 2 hours from 135 degrees (F) to 70 degrees (F), and within a total of 6 hours from 135 degrees (F) to 41 degrees (F). It further states that if food is not cooled in accordance to this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness.

When there is a lack of documented monitoring of the cooling of potentially hazardous foods, there is no way to ensure that the food was safely cooled within the timeframes required. Therefore there is no way to ensure the food is safe and will not cause food borne illness.

3c. During the tour of the kitchen on 3/26/12 at 3:40 PM, the ice machine was observed. A clean paper towel swipe of the water trough portion of the ice maker revealed a brown and black crusty residue. Also observed was a moderate buildup of a brown residue along the edge of the water trough.

During a concurrent interview with Engineering Staff 1 (ES 1), he stated that the ice machine was about 6 - 7 month old. He stated that the ice machine was cleaned by the ES monthly and the last time he had cleaned it was 2/27/12. He was unable to state why there was such an accumulation of residue in one month.

During a concurrent interview with food service worker 1 (FSW 1), he stated that it was his responsibility to clean the ice storage bin component of the ice machine every Friday evening. He stated that the process he uses to clean the bin is to turn the machine off, remove the ice, splash hot water inside the bin, then splash sanitizer in the bin and allow it to dry. He stated the sanitizer he used was Quat 146, a quaternary sanitizer.

During the observation of the ice machine, with the front cover removed, there was no barrier between the ice bin and the ice maker. The splashing of water and sanitizer inside the bin could potentially cause sanitizer to remain in the ice machine once the machine is turned back on after FSW 1 cleaned it. This could result in ice being formed from the sanitizer, instead of just water.

A review of the manufacturer's guidelines for Ice Machine Cleaning and Sanitizing Instruction, date 11/08, instructed that a solution of 100 to 200 parts per million choline solution is used to sanitize the ice machine using EPA/FDA approved sodium hypochloride food equipment sanitizer, not a quaternary based sanitizer that FSW 1 stated he used.

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.

3d. During an interview with FSW 2 on 3/26/12 at 3:15 PM, he stated that he had worked as a dishwasher at the hospital for 2 years. During the interview, he stated that when he transitioned from handling dirty dishes to handling clean dishes he changed his gloves. He did not state that he washed his hands before handling clean dishes after handling dirty dishes. He further demonstrated how he changed his gloves between dirty and clean handling. He did not wash his hands.

Also during a trayline (patient meal tray assembly) observation on 3/27/12 at 12:20 and 12:30 PM, Cook 1 was observed twice changing her gloves after contaminating them and used hand sanitizer before applying clean gloves instead of hand washing.

During an interview with the Food Service Supervisor (FSS) on 3/27/12 at 1:00 PM, he stated that Cook 1 should have washed her hands before applying clean gloves.

A review of the hospital's policy titled, "Dish and Silverware Cleaning" dated 6/11 revealed that it was the policy during silverware washing to wash your hands after holding soiled utensils and before handling sanitized ones.

A review of the hospital's nutritional service's policy titled, "Infection Control Safety Plan" dated 6/11 revealed that employees must wash hands after handling dirty dishes, trash or any waste product. It also stated that disposable gloves are used to prevent cross-contamination and the transmission of disease carrying organisms. It further stated that, "Gloves are not a substitute for hand washing. Change gloves in any situation in which you would wash your hands. Wear gloves on clean hands."

According to the 2009 FDA Food Code, food employees shall clean their hands and exposed portions of their arms as specified in the code immediately before engaging in food preparation including working with food, clean equipment and utensils. It further states that a hand antiseptic used as a topical application shall be applied only to hands that are cleaned according to the code. According to the code, proper hand washing shall include rinse under clean warm running water, applying soap, rubbing vigorously for 10 - 15 seconds, rinse under clean running warm water and thorough drying.

3e. During the initial tour of the kitchen on 3/26/12 at 3:30 PM, a hand sanitizer dispenser was noted attached to the wall over a food prep table. The sanitizer dispensed automatically when a napkin was placed under the dispenser.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS) he stated that there was the potential for the hand sanitizer to automatically dispense in food being prepared on the table. He stated that he would have the dispenser removed immediately due to this risk. He was unable to explain why the cross-contamination potential had not been addressed before.

A review of the hospital's policy titled, "Food Storage" dated 6/11 stated that pesticides, cleaning compounds and other toxic substances will not be stored in the kitchen area or in the storeroom for food and/or preparation equipment and utensils.

3f. During the initial tour of the kitchen with the Director of Food and Nutrition Services (DFNS) on 3/26/12 at 2:15 PM, a table mounted can opener was noted in the cold prep area. The can opener blade was observed to have a blade that was nicked and not smooth to the touch. The observation was confirmed by the DFNS.

A review of the hospital's policy titled, "Cleaning of Appliances and Equipment" dated 6/11 revealed that the kitchen can opener will be cleaned and sanitized daily and the blade will be checked and replaced as needed.

According to the 2009 FDA Food Code, cutting or piercing part of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is open. It further stated that multiuse food contact surfaces shall be smooth and free of crevices. Surfaces which have imperfections such as cracks, chips or pits allow microorganisms to attach and form biofilms that can release pathogens in the food. Biofilms are highly resistant to cleaning and sanitizing efforts.

3g. During the initial tour of the kitchen on 3/26/12 at 3:10 PM with the Director of Food and Nutrition Services (DFNS) the floor drain under the steamer in the cooks area, had a pipe draining into it where no air gap was being maintained. The DFNS confirmed that there was no air gap. He further stated that an air gap should be maintained to prevent the backflow of waste water in the event of a negative pressure problem. He stated that he had not noticed that there was no air gap.

According to the 2009 Food Code, the presence of air gaps prevents the back flow of waste water during times of negative pressure, preventing contaminated water from being drawn into the system. The standard of practice is to ensure that all food storage equipment contain air gaps.

3h. During an observation of the kitchen on 3/27/12 at 10:40 AM, a metal cupboard in the trayline area was noted to have peeling paint and rust on the shelf where coffee mugs were stored upside down. The shelf was covered with a clear plastic film but was not smooth to the touch.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS), he confirmed that the surface of the shelf was rough and not easily cleanable. He confirmed that the coffee mugs stored upside down on the shelf posed a cross contamination risk when patients drank their beverage from them.

According to the 2009 FDA Food Code, materials that are used in the construction of utensils and food contact surfaces of equipment may not allow the migration of deleterious substances...under normal use and shall be durable, corrosion-resistant, finished to have a smooth, easily cleanable surface and resistant to pitting, chipping and decomposition.

3i. During an interview with the Director of Infection Prevention on 3/29/12 at 9:50 AM, she stated that as part of the Environment of Care rounds, two times a year she observes the kitchen for hand hygiene, expired foods, cleanliness, drains properly functioning and hair restraints. She stated that she has not in-serviced the dietary staff on appropriate hand hygiene in the kitchen. She further stated that she did not know that hand sanitizer could not be a substitute for hand washing in the kitchen. She further stated that she did not have a checklist of items monitored. She had no documented surveillance of infection control in the dietary department. She further stated that the dietary department did not attend the Infection Prevention meetings. There was no other infection control surveillance in the dietary department. She further stated that she was not aware of the problems found in the dietary department during the survey.

Based on interview and record review the facility failed to ensure that for 2 of 3 death records reviewed that the deaths were reported to the organ procurement organization (OPO) in a timely manner. This had the potential for the OPO not being able to retrieve suitable tissue or organs for transplant.

Findings:

1. A review on 3/28/12 of three death records showed that Patient 53 died on 1/23/12 at 6:38 AM. The OPO was not notified of the death until 1/23/12 at 11:30 AM, almost 5 hours after the patient's death occurred.

2. A review on 3/28/12 of Patient 54's record showed that the patient died on 11/12/11 at 11:58 AM. The OPO was not notified of the death until 11/12/11 at 1:25 PM, one and a half hours after the patient's death occurred.

In an interview on 3/28/12 at approximately 11:00 AM with the Director of QI/RM/Compliance, he acknowledged that the deaths should have been reported within one hour.

A review of a facility policy and procedure titled Organ and Tissue Donation and with a revision date of 9/10 shows the following:

"For imminent death, report within one hour as soon as patient shows one or more clinical signs of cessation of brain and brain stem functions.

For cardiac death, report as soon as possible, preferably within one hour."

Based on observation, interview and record review, the facility failed to: 1. Ensure that high level disinfectants used to process GI scopes were used per manufacturer's directions, creating the increased risk of infection in patients requiring GI scopes, and
2. Discard outdated supplies found in the GI laboratory, creating an increased risk of infection for patients receiving medical supplies in that area, 3. Ensure surgical instruments were not stored in an area that was not climate-controlled, creating the risk of loss of sterility and the increased risk of infection in patients requiring those instruments, and 4. Ensure a valid discharge order from a physician was on the medical record prior to discharging one surgical patient, Patient C, creating the risk of premature discharge and a poor post-surgical outcome for that patient.
.
Findings:

1. During a tour of the GI Lab on 3/26/12 at 10:15 AM, a label on the scope processor indicated the high level disinfectant was last changed 2/1/12.

In a concomitant interview with the GI Tech, he stated that the disinfectant chemical, Cidex OPA, could be used for 90 days after it was placed in the machine.

The bottle of Cidex OPA was examined, and the manufacturer's directions indicated that the chemical was to be used for a maximum of 14 days after the initial use.

The facility policy, High Level Disinfection of Endoscopes (review date 6/11) read in part, "An EPA registered sterilant/disinfectant shall be used on all endoscopes per manufacturer's instructions."

2. During a tour of the GI Laboratory on 3/26/12 at 10:15 AM, in the GI cart were found two Boston Scientific biliary system locking devices. One device package read "use before 3/12" and the other read "use before 1/12".

During a concurrent interview with the GI Tech, he stated that it was his responsibility to check the area for outdated items monthly.

The facility policy, Supplies-Shelf Life Control (revision date 9/08) read in part, "All items expiring in the next 30-day period are removed from stores and from floor stockrooms, then stamped "DO NOT USE" and moved to a separate storage area for return."

3. During a tour of the flash sterilization room on 3/27/12 with the Surg RN 1, the room was noted to be very warm, and the door was opened to cool it. After 7 minutes with the door opened, the temperature gauge on the wall read 80 degrees Fahrenheit. A metal cabinet was seen in the room, and the drawers contained sterile packs of surgical instruments, including sinuscopes, hysteroscopes, and cystoscopies. The surgical packs did not have dates on them to indicate when sterility expired.

The facility policy, Scope of Service - Surgical Services Department (revision date 5/09), read in part, "The AORN, ASPAN AAMI, the CDC and CDPH standards are references used in the formulation and review of policies, procedures and standards of practice in the Surgical Services Department ..."

The AORN Journal, May, 2008, contained the recommendation that sterile instruments should be stored at 75 degrees Fahrenheit, in an environment with at least 4 exchanges per hour.

4. The medical record of Patient C, who had an outpatient surgery on 3/26/12, was reviewed on 3/28/12, and the Post Anesthesia Record contained a physician signature, but the section for discharge orders was left blank.

During an interview with the CNO on 3/30/12 at 9:30 AM, he reviewed the Post Anesthesia record of Patient C and concurred that the section for a discharge order had been left blank.

The facility policy, Discharge Policy (revision date 3/09) read in part, "A physician's written order is required for an authorized hospital discharge."

Based on interview and record review, the facility failed to ensure that 4 of 36 patients, Patients A, B, F and 58, had a complete and accurate medical history and physical examination in the medical record prior to surgery, creating the risk of a poor surgical outcome for those patients.

Findings:

1. During a tour of the ambulatory surgery area on 3/26/12, the record of Patient F was reviewed. The history portion of the Short History form for history and physical examination dated 3/26/12 and signed by DR 4 was blank, but the physical examination section had exam findings written. A review of other documentation in the medical record indicated that Patient F had cancer and back trouble, a history of surgeries, and was taking 6 medications-information that did not appear on the Short History form.

During an interview with Patient F on 3/26/12 at 10 AM, he stated that DR 4 had performed a physical examination in his office, approximately 2 weeks prior, but had not seen him on 3/26/12.

On 3/28/12 the medical records of Patients A and B for 3/26/12 were reviewed, and each contained a Short History form completed by DR 4 in anticipation of surgery on 3/26/12. The section for past history, allergies and acute illness on each form were left blank, despite evidence elsewhere in the record that the patients had other medical conditions, previous surgeries and were taking medications for medical conditions.

In an interview with Surg RN 2 on 3/26/12 at 9:50 AM, she stated that the forms should have the present illness and vital signs filled in.

In an interview with the Dir Surg on 3/27/12 at 11:15 AM, she stated that the Short History form for ambulatory surgery patients should be complete, including the patients ' medical and surgical history. She reviewed the medical record of Patients A and B and concurred that the Short History for those patients was missing information.

In an interview with the CNO on 3/30/12 at 10 AM, he stated that the nurse should have discussed the incomplete history and physical exam documentation with the physician prior to surgery.

The facility policy, Pre-operative Testing Assessment Criteria for Inpatient/Outpatient Procedures (revision 6/11) read in part, " The Short H & P form must include at a minimum: a) Chief complaint, b) Present illness, c) Allergies, d) Past history, e) Vital signs, f) Diagnosis ...h) An exam to include HEENT, chest and lungs, heart abdomen and neurological status " .



25179

2. A review on 3/28/12 of Patient 58's medical record showed that the patient was admitted on 3/26/12 for a Caesarian Section on 3/26/12.

There was a history and physical exam in the chart, but it was not current. It was dated 9/26/11. There was no updated history and physical in the record.

In an interview on 3/28/12 at 11:50 AM with the Director of Maternal Child Health, she acknowledged that the physician should have completed a current history and physical prior to the patient having surgery.

A review of the Medical Staff General Rules and Regulations shows the following:

"1. A comprehensive History & Physical examination is required for patients that are hospitalized for more than 24 hours.

2. Physicians may use a comprehensive History & Physical that was performed within 30 days prior to the inpatient admission; however, the physician must document an update within 24 hours of the inpatient admission......

4. When performing surgery or any potentially hazardous diagnostic procedure and the History & Physical is not recorded in the chart, the procedure will be cancelled..."

Based on interview and record review, the facility failed to ensure that pre-anesthesia assessments were completed and documented per facility policy for 4 of 36 sampled patients, Patients A, B, C and 58, creating the risk of a poor health outcome for all patients receiving anesthesia without the benefit of a documented pre-anesthesia assessment, due to a possible undiscovered medical condition.

Findings:

1. The medical records of Patient A, B and C were reviewed on 3/28/12, and showed that each had an outpatient surgery on 3/26/12. The record contained an Anesthesia Record form which included, on the front, a section for recording the ASA class (American Society of Anesthesiologists class, a system for rating the patient's fitness for surgery), height, weight, allergies, time of food intake, diagnosis and procedure. On the back, there was space for recording a pre-anesthetic note, medical and surgical history, medications, and substance use. There was no space designated on the back or front of the form to document the anesthesiologist's physical examination of the patient, and no notations about a heart or lung exam were seen on the anesthesia record of Patients A, B, or C. The back of the Anesthesia Record had been left blank for Patients A and B-no medications or drug history were listed, and no surgical history had been completed.

The Anesthesia Record of Patients A and B were reviewed with the Surg RN Mgr on 3/27/12 at 11:15 AM. She stated that the pre-anesthetic assessment section on the back of the Anesthesia Record was left blank for those patients.

In an interview with the Dir Anesth on 3/27/12 at 2:45 PM, he stated that there was no anesthesiologist's heart or lung examination documented for Patients A or B and the documentation of previous surgeries and complications and drug history was not being completed because the paper on the reverse side of the Anesthesia Record form was made of paper that did not allow ink to adhere and therefore was difficult to write on.

The facility policy, Pre and Post Anesthesia Evaluations, ASA Classifications (revision date 8/09) read in part, "A pre-anesthesia assessment is performed for each patient before anesthesia induction.", and "This entry should also include the patient's previous drug history, other anesthetic experiences, and any potential anesthetic problems."





25179

2. A review on 3/28/12 of Patient 58's medical record showed that the patient was admitted on 3/26/12 for a Caesarian Section on 3/26/12.

There was no anesthesia pre-operative assessment by the anesthesiologist in the patient's record.

In an interview on 3/28/12 at 11:50 AM with the Director of Maternal Child Health, she acknowledged that there should be a pre-operative anesthesia assessment in the record that was completed before the patient went to surgery.

The facility policy, Pre and Post Anesthesia Evaluations, ASA Classifications (revision date 8/09) read in part, "A pre-anesthesia assessment is performed for each patient before anesthesia induction.", and "This entry should also include the patient's previous drug history, other anesthetic experiences, and any potential anesthetic problems."

Based on interview and record review, the ED did not ensure the availability of staffing to meet patient needs per facility policy because: 1. one patient using the ED, Patient G, did not have assessments of pain completed at each time her vital signs were recorded, and was not reassessed every 2 hours, creating the risk of untreated pain and a poor health outcome for Patient G, and 2. the ED failed to ensure that staff was available to provide immediate triage of patients presenting in the ED, creating the risk of a delay in recognizing an emergency medical condition.
.
Findings:

1. During a tour of the ED on 3/28/12 at 3:30 PM, the record of Patient G was viewed and showed that she had cancer and was in chemotherapy, and was sent to the ED for a blood transfusion. The record showed that she was triaged in the ED at 7:50 PM, and had initial vital signs collected at 7:52 PM, including a pain score of 6/10. The Mental Assessment section of her ED record indicated that the pain was in the back, and present for 3 hours. There was no pain goal established--that section of the record was left blank, and there was no evidence that the patient was offered treatment for her pain. Patient G's vital signs were next collected at 11:35 PM, almost 4 hours later, and included a pain level of 2/10. Her vital signs were collected 7 times, but the pain level was not documented during 3 of those 7 assessments.

During an interview with the Int Dir ED, at 3:30 PM on 3/28/12, she reviewed the record of Patient G and stated that the patient should have had a pain level assessment with each set of vital signs.

The facility policy, Emergency Department Assessment (revision date 5/09), read in part, "Minimum standard for reassessment is every two hours."

The facility policy, Pain Management, Assessment and Reassessment (revision date 9/11), read in part, "Reassessment of pain will occur: i. With each set of routine vital signs ... "

2. During a tour of the ED on 3/26/12, a sign requested that patients complete an intake form and present it to a clerk at the desk, or ring a bell if the clerk was not present.
The intake form was seen and contained spaces for the arrival time, name, gender, and reason for visit. The form contained the advice, "Please inform hospital personnel if you are experiencing chest pain."

During an interview with the ED Clerk on 3/26/12 at 11:25 AM, she stated that a patient presenting with jaw pain would wait briefly at her desk while she put together paperwork, then would be sent to triage and told to drop his or her paperwork there, and if the triage nurse was busy, was to take a seat in the waiting room and wait to be called. The ED clerk concurred that she did not have medical training.

In an interview with the CMS on 3/29/12 at 11 AM, he stated that he was not aware that patients were not being observed by a triage nurse immediately upon arrival in the ED.

The facility policy, Intake and Triage of ED Patients (effective 12/11), read in part, "The RN assigned to triage shall be immediately available at all times to triage patients when they arrive to the ED."