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Based on observation, interviews and record reviews, the Governing Body failed to be responsible for the conduct of the hospital because:

1. The Governing Board failed to ensure that all patient care, hospital process and service policies were considered and approved by the Governing Board before being published as facility policy, creating the risk of ineffective policies and the risk of the Governing Body not being aware of and therefore not enforcing published hospital policies.

The Governing Board Subcommittee minutes were reviewed on 1/13/12 at 2:45 PM with the Director of Medical Staff.

The facility policy, Humidity Control Systems, from the Engineering manual bore a Governing Board Approval date of 5/11. The minutes from the 5/31/11 Board Subcommittee were reviewed, and the table of contents of the Engineering manual was approved, but there was no evidence that the Humidity Control Systems policy was reviewed or approved on that date.

The facility policy, Skin Integrity, from the Nursing Administration manual, bore a Governing Board Approval date of 5/11. The minutes from the 5/31/11 Board Subcommittee were reviewed, and several policies from the Nursing Administration manual were approved on that date, but there was no evidence that the Skin Integrity policy was reviewed or approved on that date.

The facility policies, Infection Control Plan 2011 and Disinfection and Sterilization of Hospital Equipment Patient Care Items in the Infection Control manual bore the revision date 8/11, and the Governing Board Approval date of 9/11. However, the Board Subcommittee minutes for 9/26/11 indicated only that Infection Control Table of Contents was presented and approved, not the revision of any policies.

The facility policy, Grievance/Complaint Process in the Administration manual bore the Governing Board Approval date of 10/11, and the revised date of 12/11. The minutes from the 10/31/11 Board Subcommittee were reviewed, and the Administration manual table of contents was presented for review on that date, but no action based on the review was noted and there was no evidence that the specific policy was presented for approval. There was no evidence that a revision of the policy was approved by the Governing Board during December, 2011.

The facility policy, Emergency Preparedness, in the Food and Nutrition Manual bore the Governing Board Approval date of 9/11. The Board Subcommittee minutes from 9/26/11 did not include documentation that the policy was reviewed or approved.

The facility policy, Informed Consent, in the Administration manual bore the Governing Board Approval dates of 9/11 on one copy and 10/11 on another copy. The Subcommittee Board minutes from 9/26/11 and 10/31/11 were reviewed and showed that the table of contents of the Administrative manual was presented on 10/31/11, but that there was no informed consent policy review or approval in the minutes on either date.

During observations, interviews and review of facility documents, deficient practices were found related to Humidity Control Systems (see A-726), Skin Integrity (see A-287), disinfection of patient care items (see A-726 and A-729), addressing grievances (see A-118 and A-123), emergency preparedness (see A-701), and obtaining informed consent (see A-438) because the facility policies related to those hospital issues had not been fully implemented.

During an interview with the CEO on 1/13/12 at 1:35 PM, he was unable to explain why two similar consent policies bore approval dates one month apart. He also stated that he was surprised by the details of the disaster preparedness policy from the food and nutrition policy manual. He stated that he would not have approved the policy if he was aware of the details.

In an interview with the Director of Medical Staff on 1/13/12 at 2:45 PM, she concurred that there was no documentation in the minutes that the nutrition department's Disaster Preparedness policy, which was dated approved 9/11, or the Informed Consent policy, dated 9/11, went through the governing body for approval. The Grievance policy in use at the facility was marked with a revision date of 12/11. She stated there was documentation that the policy manual table of contents was on the roster to be approved by the Governing Body as part of the administrative manual on 10/31/11, but there was no evidence that a revision was approved 12/11. She concurred that there was no documentation that the Humidity Control Systems policy, in the engineering manual dated approved 5/11, was discussed or approved in the Governing Body meeting minutes. She stated that the Governing Board members did not receive the facility policies for review in advance of the Board Subcommittee meetings. She stated that noted policies might be made an agenda item and subject to review. However, most of the policies were not subject to individual review. She stated that the policies were available for review in the medical staff office, but that Board members rarely examined them. It had been a long time since any Board members had come to review the policies prior to approval. She stated that the MEC (medical executive committee, the committee representing the medical staff) met before the Board Subcommittee, and that the Board Subcommittee just approved what had gone through the MEC.

During a review of the Governing Board Bylaws adopted September 15, 2010, the duties of the Governing Board read in part, "To adopt and review Governing Board Bylaws and policies at least every three years and to review and approve Hospital policies, procedures and protocols related to the day to day operations of the Hospital at least every three years...".

2. The quality assurance program had not developed and implemented an effective, facility-wide program to ensure adverse events were minimized and the quality of healthcare provided was ensured for all patients because the PI program did not (see A-0263):

A. Use collected data to monitor the effectiveness and safety of services as evidenced by temperature and humidity data collected in the OR (see A-274) and data collected regarding patients was not used to ensure wound prevention and wound care (see A-274 and A-275).

B. Ensure that the scope of the program was adequate to ensure services such as emergency food preparedness per facility policy (see A-264).

C. Analyze adverse events such as patient grievances, new wounds and unanticipated deaths (see A-287).

D. Ensure that data regarding diet allergy documentation was being collected in such a way that it could form the basis for meaningful analysis (see A-285).

3. Nursing services were not organized to ensure high quality healthcare for all patients (see A-0385).

4. Pharmaceutical services provided did not ensure supervision of services and development and implementation of policies to minimize errors (see A-0490).

The cumulative effect of these deficient practices was that the Governing Body failed to ensure that the facility was providing high quality healthcare in a safe environment.

Based on interview and record review, the Governing Body failed to ensure the accountability of the medical staff as evidenced by policies, presented by the medical staff, that were not considered and approved by the Governing Body before their implementation in the facility.

Findings:

On 1/12/12, the facility staff were asked for the informed consent policy. Two different policies titled, Informed Consent, were provided. One of the presented policies had a Governing Body Approval date of 9/11, while the other had the approval date of 10/11.

During an interview with the CEO on 1/13/12 at 1:35 PM, he was unable to explain why two similar consent policies bore approval dates one month apart. He also stated that he was surprised by the details of the disaster preparedness policy from the food and nutrition policy manual. He stated that he would not have approved the policy if he was aware of the details.

The Governing Board Subcommittee minutes were reviewed on 1/13/12 with the Director of Medical Staff.

The facility policy, Humidity Control Systems, from the Engineering manual bore a Governing Board Approval date of 5/11. The minutes from the 5/31/11 Board Subcommittee were reviewed, and the table of contents of the Engineering manual was approved, but there was no evidence that the Humidity Control Systems policy was reviewed or approved on that date.

During observations, interviews and a review of facility documents, the facility had not implemented its policy on Humidity Control Systems (see A-726).

The facility policy, Skin Integrity, from the Nursing Administration manual, bore a Governing Board Approval date of 5/11. The minutes from the 5/31/11 Board Subcommittee were reviewed, and several policies from the Nursing Administration manual were approved on that date, but there was no evidence that the Skin Integrity policy was reviewed or approved on that date.

During observations, interviews and review of facility documents, the facility had not implemented its policy on Skin Integrity (see A-287).

The facility policies, Infection Control Plan 2011 and Disinfection and Sterilization of Hospital Equipment Patient Care Items in the Infection Control manual bore the revision date 8/11, and the Governing Board Approval date of 9/11. However, the Board Subcommittee minutes for 9/26/11 indicated only that Infection Control Table of Contents was presented and approved, not the revision of any policies.

During observations, interviews and record reviews, the facility had not fully implemented its infection control plan or the policy on disinfection of patient care items (see A-726 and A-729).

The facility policy, Grievance/Complaint Process in the Administration manual bore the Governing Board Approval date of 10/11, and the revised date of 12/11. The minutes from the 10/31/11 Board Subcommittee were reviewed, and the Administration manual table of contents was presented for review on that date, but no action based on the review was noted and there was no evidence that the specific policy was presented for approval.

During interviews and record reviews, the facility had not fully implemented its grievance policy (see A-118 and A-123).

The facility policy, Informed Consent, in the Administration manual bore the Governing Board Approval dates of 9/11 on one copy and 10/11 on another copy. The Subcommittee Board minutes from 9/26/11 and 10/31/11 were reviewed and showed that the table of contents of the Administrative manual was presented on 10/31/11, but that there was no informed consent policy review or approval in the minutes on either date.

According to interviews and record reviews, the facility had not fully implemented its informed consent policy (see A-438).

The facility policy, Disaster Preparedness, in the Food and Nutrition Manual bore the Governing Board Approval date of 9/11. The Board Subcommittee minutes from 9/26/11 did not include documentation that the policy was reviewed or approved.

In an interview with the Director of Medical Staff on 1/13/12 at 2:45 PM, she concurred that there was no evidence that the nutrition department's Disaster Preparedness policy, which was dated approved 9/11, or the Informed Consent policy, dated 9/11, went through the governing body for approval. The Grievance policy in use at the facility was marked with a revision date of 12/11. She stated there was documentation that the policy manual table of contents was on the roster to be approved by the Governing Body as part of the administrative manual on 10/31/11, but there was no evidence that a revision was approved 12/11. She concurred that there was no documentation that the Humidity Control Systems policy, in the engineering manual dated approved 5/11, was discussed or approved in the Governing Body meeting minutes. She stated that the Governing Board members did not receive the facility policies for review in advance of the Board Subcommittee meetings. She stated that noted policies might be made an agenda item and subject to review. However, most of the policies were not subject to individual review. She stated that the policies were available for review in the medical staff office, but that Board members rarely examined them. It had been a long time since any Board members had come to review the policies prior to approval. She stated that the MEC (medical executive committee, the committee representing the medical staff) met before the Board Subcommittee, and that the Board Subcommittee just approved what had gone through the MEC.

During a review of the Governing Board Bylaws adopted September 15, 2010, the duties of the Governing Board read in part, "To adopt and review Governing Board Bylaws and policies at least every three years and to review and approve Hospital policies, procedures and protocols related to the day to day operations of the Hospital at least every three years...".

Based on staff interview and facility record review, the hospital failed to ensure that the patient or patient's representative were informed of their rights for 2 of 34 sampled patients (Patients 65 and 61).

1. For Patient 65, the facility failed to ensure that the patient or patient's representative was informed of the right to formulate an Advance Directive in advance of furnishing or discontinuing care and had signed the appropriate documents.

2. For Patient 61, the facility failed to ensure that the patient or patient's representative was informed and had signed the Admission Patient's Rights documents.

These deficient findings resulted in the hospital not protecting and promoting Patient 65 and 61's rights.

Findings:

1. On 1/10/12, a review of Patient 65's medical record was conducted. The medical record revealed that Patient 65 was admitted to the facility on 1/7/12, with an admitting diagnosis of pneumonia. Patient 65 was placed on a ventilator for respiratory support and required a tracheostomy for an airway. Patient 65 was not able to follow simple commands.

On 1/10/12, a review of Patient 65's "Patient Right's Acknowledgement Form" dated 1/6/12, and timed at 8:01 PM, indicated that the patient was non-responsive and that the patient or patient's representative did not have a Healthcare Directive document or a Living Will document on admission. The Patient Right's Acknowledgement Form also indicated that the patient or patient's representative, on admission, did not receive educational materials and Healthcare Directive information as per hospital policy.

On 1/10/12, a review of patient 65's "An Important Message from Medicare about Your Rights" form, dated 1/6/12, indicated that the patient or patient's representative did not receive, on admission, the Medicare Right's notice.

There was no documented evidence in Patient 65's medical record or from other facility sources that an in-depth discussion had taken place between the facility and patient or patient's representative discussing, promoting and protecting Patient 65's rights as a hospitalized patient and the right to formulate and execute an Advance Directive in advance of furnishing care.

There was no documented evidence in Patient 65's Physician's Progress Notes, dated 1/9/12 through 1/13/12, documenting that the physician or the facility had a in-depth discussion with the patient or patient's representative regarding her rights as a hospitalized patient or had presented educational information or had a discussion educating the patient's representative/family regarding formulating and executing an Advance Directive of the patient's wishes and direction regarding healthcare decisions.

There was no documented evidence in Patient 65's medical record or from other facility sources that the facility's Social Service Department was actively involved in notifying Patient 65's representative or if appropriate, the patient's Durable Power Of Attorney For Healthcare or legal conservator/guardian regarding her rights as a hospitalized patient; her right to formulate and exercise an Advance Directive and to be informed and participate in the patient's plan of care, as of 1/13/12.

On 1/10/12, a review of the facility's policy and procedure titled, "SURROGATE DECISION-MAKING-PATIENTS WHO LACK CAPACITY TO CONSENT" dated 9/11, stipulated, " ...The hospital advocates for all patients to participate in their healthcare and the decisions affecting their care. Within 24 hours of admission, if a patient is unconscious or unable to effectively communicate, the hospital shall make all reasonable efforts to identify and communicate with the patient's representative or surrogate decision-maker ... "

On 1/10/12, a review of the facility's policy and procedure titled,
"ADVANCE DIRECTIVES" dated 9/11, stipulated, " ...In the event a patient does have an advance directive, but a copy is not available at the time of admission, the primary physician/supervising health care provider will discuss the contents of the advance directive and other special instructions with the appropriate responsible party of the patient's decisions and wishes and will be documented in the patient's medical record ... "

On 1/12/12, at approximately 10:30 AM, the Director of Case Management confirmed the finding that the facility failed to notify the patient's representative of Patient 65's rights as a hospitalized patient and the right to exercise and formulate an Advance Directive of the wishes and direction of health care decisions made by Patient 65.


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2. On 1/9/12, Patient 61's medical record was reviewed.
A review of the face sheet showed that the patient was admitted to the facility on 1/2/12 with diagnosis that included gastrointestinal bleed.

A review of the form "An Important Message from Medicare about Your Rights," dated 1/2/12, revealed that the document was not signed by the patient or the patient's responsible party (RP) within 2 days of admission.

On 1/13/12 at 1:05 PM, an interview was conducted with the Admission Department's Staff Person 1. She reviewed Patient 61's "An Important Message from Medicare About Your Rights," dated 1/2/12 and confirmed that the document was not signed by the patient or the patient's responsible party within 2 days of admission and/or prior to being discharged from the hospital. The Admission Department's Staff Person 1 stated that the patient should have been reassessed for the capacity to sign or the RP should have been contacted to sign the document prior to discharge.

Based on interview and record review, 1. for one of three grievances reviewed (the grievance regarding Patient 3), the facility failed to ensure that the grievance policy was implemented when there was no documentation provided that showed that the allegations were investigated, creating a failed grievance response for the complainant and 2. there was no documentation that the revised Grievance policy was reviewed and approved by the Governing Board, creating the risk of an ineffective response to any patient with a grievance. These failing also increased the risk of unrecognized poor facility practices that could result in substandard care for all patients.

Findings:

1. The complaint filed by Patient 3's mother, on 6/15/11, was reviewed. The complaint contained allegations that the patient's requests to see her physician were not honored, that the patient and her mother's requests for a chest x-ray were not responded to and that a nurse displayed unprofessional behavior. The complaint file was reviewed with the Chief Nursing Officer (CNO) on 1/10/12 at 12:00 PM. The file did not contain evidence of an investigation of the specific allegations.

During a concurrent interview with the CNO on 1/10/12 at 12:00 PM, she stated that there was no documentation for an investigation of the specific allegations because she felt that the larger concern presented by the complaint was a need for staff education about the patient's disease process.

The facility policy, Grievance/Complaint Process, revised 12/11, read in part, "The Grievance Committee will assure that the grievance is investigated."

2. In an interview with the Director of Medical Staff on 1/13/12 at 2:45 PM, she concurred that the Grievance policy in use at the facility was marked with a revision date of 12/11. She stated there was documentation that the policy manual table of contents was on the roster to be approved by the Governing Body as part of the administrative manual on 10/31/11, but there was no evidence that a revision was approved 12/11.

Based on interview and record review, for two of three grievances (related to Patients 2 and 3) reviewed, the facility failed to ensure that the written responses included the steps taken to investigate the complaints, the results of the investigations and the date the investigation was completed. This created the risk of unresolved grievances for Patients 2 and 3.

Findings:

The complaint files for complaints regarding the care of Patients 2 and 3 were reviewed on 1/10/12.

1. Patient 2's family member filed the complaint regarding her care during May and June 2011, especially the development of a pressure ulcer while in the facility. The response letter to the complainant did not contain specific information about the steps taken to investigate the complaint, the results of the investigation or the date that the investigation was completed. The response letter to the complainant contained generic statements, such as, "Our review processes, as in this case, include an in depth review by Administration, Performance Improvement, Risk Management, Department Directors, Clinical Staff involved and Medical staff as appropriate" and did not specify the outcome or actions taken as result of the investigation or the date of completion.

During an interview with the CNO on 1/10/12 at approximately 10:20 AM, she stated that staff training was done in response to the complaint regarding Patient 2.

2. Patient 3's family member filed the complaint regarding her care on 6/15/11. The complaint file was reviewed and indicated that the facility undertook staff training as a result of the complaint. The complainant response letter was reviewed and it did not contain specific information regarding the steps taken to investigate the complaint, but instead contained generic statements about the case being reviewed "as appropriate". There were no results of the investigation, such as the staff training or the date of completion of the investigation, stated in the letter.

The facility policy, Grievance/Complaint Process, revised 12/11, read in part, "If we are unable to resolve the issue on the spot, within seven (7) calendar days following the submission, the patient will be provided with a written notice of: The steps taken on behalf of the patient to investigate the grievance, The results of the investigation and grievance process, The date the investigation was completed".

During an interview with the CNO on 1/10/11 at 12:20 PM, she stated that the requirements for the complainant response letter had been brought to her attention previously, and she recognized there was room for improvement in the letters.

Based on staff interview and facility record review, the facility failed to ensure that the patient or patient's representative for 1 of 34 sampled patients (Patient 65) had the right to participate in the development and implementation of their plan of care. This deficient practice resulted in the facility not allowing Patient 65 or their representative the right to be involved and participate in the development and implementation of Patient 65's treatment plan, pain management plan and discharge plans.

Findings:

On 1/10/12, a review of Patient 65's medical record was conducted. The medical record revealed that Patient 65 was admitted to the facility on 1/7/12, with an admitting diagnosis of pneumonia. Patient 65 was placed on a ventilator for respiratory support and required a tracheostomy for an airway. Patient 65 was not able to follow simple commands.

On 1/10/12, a review of Patient 65's "Patient Right's Acknowledgement Form," dated 1/6/12, timed at 8:01 PM, indicated that the patient was non-responsive and that the patient or patient's representative did not have a Healthcare Directive document or a Living Will document on admission. In addition, the Patient's Rights Acknowledgement Form, dated 1/6/12, also indicated that the patient or patient's representative did not receive educational materials and Healthcare Directive information as per facility policy.

There was no documented evidence in Patient 65's medical record, nursing care plan or from other facility sources that the facility involved Patient 65's representative in the proactive development and implementation of the patient's treatment/nursing care plan, pain management plan and discharge plan.

There was no documented evidence in Patient 65's medical record or from other facility sources that the facility's Social Service Department was actively involved in notifying Patient 65's representative or if appropriate, the patient's Durable Power Of Attorney For Healthcare or legal conservator/guardian regarding her rights as a hospitalized patient, her right to formulate and exercise an Advance Directive and to be informed and participate in the patient's plan of care as of 1/13/12.

On 1/12/12, at approximately 10:30 AM, the Director of Case Management confirmed the finding that the facility failed to notify the patient's representative of Patient 65' s rights to be informed and to participate in their treatment plan, pain management plan and discharge plan.

Based on interview and record review, the quality assurance program failed to ensure the implementation of an effective, facility-wide quality assurance and performance improvement (PI) program because:

1. The PI program did not use collected data to monitor the effectiveness and safety of services as evidenced by temperature and humidity data collected in the OR (operating room) that showed repeatedly out of range readings that remained uncorrected, creating the increased risk of infection for patients using the OR (see A-274) and data regarding patients that was not used to ensure wound prevention and wound care, creating the increased risk of unrecognized or untreated wounds and a poor health outcome for all patients (see A-274 and A-275).

2. The PI program did not ensure that the scope of the program was adequate to ensure services such as emergency food preparedness per facility policy, creating the risk of unmet nutrition needs for all patients in the facility during an emergency (see A-264).

3. The PI program did not ensure the analysis of adverse events such as patient grievances, new wounds and unanticipated deaths, creating the risk of unresolved grievances for grieving patients and the risk of persistent poor practices and the risk of substandard care for all patients (see A-287).

4. The PI program did not ensure that data regarding diet allergy documentation was being collected in such a way that it could form the basis for meaningful analysis, creating the risk of persistent poor practices and the risk of substandard care for all the patients (see A-285).

The cumulative effect of these deficient practices is that the quality assurance program failed to implement a comprehensive, facility-wide program to ensure that high quality healthcare was provided in a safe environment.

Based on interview and record review, the facility failed to ensure the scope of the quality assurance program included all services and departments at the facility when:

1. The quality program was not aware that the hospital's emergency food supplies did not meet the needs of the patients in the event of disaster (cross refer A 620 and A 701).

2. The quality program was not aware that the nutrition needs of patients with a diagnosis of malnutrition were not met as a result of the recommendation from the registered dietitian were not communicated to the physician (cross refer A 630).

This lack of inclusion of these high risk, problem prone areas created the risk of unresolved quality problems and substandard healthcare for all patients using the facility due to inadequate surveillance.

Findings:


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A review of the hospital's Performance Improvement Plan, Year 2011, revealed that the values of the plan included a committment to an integarted healthcare delivery system that encompassed the entire spectrum of healthcare delivery. This continuum of care encompassed all aspects of an individual's healthcare. It further stated that the reporting systems for the organization-wide performance improvement of the hospital was designed to provide systematic communication of information and feedback to data collection, review and subsequent improvement of specific processes and outcomes. The plan further states that the priorities for the plan include high risk, problem prone areas.

1. During a review of the hospital's policy and procedure titled, "Emergency Operations Plan" for Food and Nutrition Services, dated 9/11, it was noted that the purpose of the policy was to provide basic dietetic needs during an emergency.

During a concurrent observation of the disaster food supplies in the dietary department and a review of the "7 Day Disaster Menu - Regular" posted in the dry storage room on 1/9/12 at 1:35 PM, it was noted that the hospital did not have adequate food stores to meet the patients' nutrition needs during a disaster.

During a concurrent interview with the DFNS (Director of Food and Nutritional Services), she stated that clearly there weren't adequate supplies to meet the plan. She further stated that the reason she did not have adequate disaster food on hand was because, since they were no longer able to store the food at the MOB (Medical Office Building), she did not have room to store the amount of disaster food. She stated that it had been over 6 months since she could store the food in the MOB building and the problem of where to store the disaster food had not been resolved.

During an interview with the Director of Quality on 1/12/12 at 9:30 AM, she stated that the quality committee was not aware that the disaster food supplies were not adequate to meet the needs of the patients in the event of a disaster. She stated that the problem with the lack of space for the disaster food supply should have been brought to the attention of the quality committee so that the problem could be resolved. She was unable to explain why is was not.

2. During the survey, it was noted that the hospital failed to meet the nutrition needs of 2 of 5 patients who were reviewed for nutrition care (Patients 23 and 24). The nutrition needs of Patients 23 and 24, both with a diagnosis of malnutrition, were not met when the nutrition recommendations from the registered dietitian (RD) were not communicated to the physician. (cross refer A630)

During an interview with the Director of Quality on 1/12/12 at 9:30 AM, she stated that the quality committee was not aware that there was a problem with the RD recommendations being communicated to the physician. She stated that the hospital was not tracking data on how often the RD recommendations were not communicated to the physician and resulted in appropriate nutrition care not being implemented. She did not know that this was a problem. She was unable to explain why this problem was not brought to the attention of the quality committee.

Based on staff interview and facility record review, the facility's Quality Assessment and Performance Improvement Department failed to incorporate quality indicator data when it:

1. Failed to monitor whether the nursing staff were notifying and consulting with the Wound Care Nurse when the patient's Braden Skin Risk Assessment score was 12 or below, as per facility policy for 1 of 34 sampled patients (Patient 63), and

2. Failed to monitor OR (Operating Room) climate data. These deficient practices had the potential for substandard wound care services being delivered affecting the length of stay of hospitalization and the health and safety of Patient 63, and created the increased risk of infection for patients obtaining services in the operating rooms.

Findings:

1. A review on 1/10/12, of Patient 63's medical record was conducted. The medical record revealed that Patient 63 was admitted to the facility on 1/4/12 with diagnoses that included sepsis (a profound systemic body infection) and renal failure (an abnormal kidney function). Patient 63 was admitted on a ventilator for respiratory support and had a tracheostomy tube (a tube in the throat) for an airway.

A review on 1/10/12, of Patient 63's "Intensive Care Admission Evaluation Form" dated 1/4/12, timed at 7:00 PM, included the following assessments:

a. IS PATIENT ON VENTILATOR: YES
b. RESPIRATORY ASSESSMENT COMMENT: ON VENTILATOR WITH TRACHEOSTOMY.
c. FRICTION & SHEAR RISK (causes for skin breakdown): POTENTIAL PROBLEM.
d. SKIN RISK ASSESSMENT SCORE: 12 POINTS.
e. WOUND ASSESSMENT LABEL: COCCYX (back bone area) DRY AND INTACT. PINK AND WELL APPROXIMATED. LENGTH; 5.0 cm. WIDTH 4.0 cm. Use DRIAD PASTE WITH COVERDERM (a dressing protecting skin breakdown areas).
f. INTEGUMENTARY ASSESSMENT WITHIN NORMAL LIMITS (skin condition assessment): NO

A review on 1/10/12, of the facility's policy and procedure titled, "SKIN INTEGRITY" dated 5/11, stipulated, " ...skin integrity from head to toe will be assessed upon admission by the Registered Nurse. The Registered Nurse will use the Braden Risk Skin Assessment Scale Tool when assessing the patient's skin. All open pressure ulcers as well as high risk patients with a Braden Scale of 12 or less shall require a wound care consultation referral ... "

A review on 1/10/12, of the facility's policy and procedure titled, "SKIN INTEGRITY" dated 5/11, stipulated, "...For inpatients, upon discovery of any pressure ulcer, nursing should complete the "Risk Identification Report" form utilizing the electronic module. This finding will be communicated to the patient's physician, charge nurse or manager of the unit and Risk Manager. The Wound Care Specialist should be consulted for further assessment of the wound and make recommendations as needed ... "

There was no documented evidence in Patient 63's medical record or from other facility sources that the Registered Nurse, after performing on admission an initial head-to-toe assessment on Patient 63, had filled out a "Risk Identification Report", according to facility policy, after it was discovered that Patient 63's Braden Skin Risk Assessment Scale (an assessment tool to evaluate skin condition) scored a "12" on 1/4/12.

There was no documented evidence in Patient 63's medical record or from other facility sources that the Registered Nurse responsible for the initial head-to-toe assessment upon admission, on 1/4/12, had notified the "Wound Care Nurse Specialist" when the Braden Skin Score reached 12, as per facility policy. In addition, the nursing staff subsequently failed to notify the Wound Care Specialist of Patient 63's skin assessment score of 12 throughout the patient's entire hospital stay (admitted 1/4/12, discharged 1/10/12).

During an interview on 1/10/12 at 1:30 PM, the Wound Care Nurse (WCN ) stated that she was off on vacation for 9 days, from 12/31/11 through 1/8/12.

On 1/13/12, a review of the facility's quality assessment and improvement report for the year 2011 under the title, "PERFORMANCE IMPROVEMENT DEPARTMENT QUALITY INDICATORS REPORT" was conducted. The Report, dated 2011, revealed that facility-wide quality indicators involving wound care monitoring required the use of a "Skin Integrity/Wound Care Audit Tool" for data gathering and analysis.

On 1/13/12, a review of the facility's "WOUND CARE MONITORING TOOL" dated 2011 was conducted. The wound care audit tool measured and tracked the following quality indicators:

a. Wound was present on admission.
b. Care plan initiated for patients at risk or with an active wound.
c. Photo documentation of wound, bruise, skin tear or other taken on admission or upon discovery.
d. Impaired skin integrity (condition) flow sheet.
e. Physician orders for wound/skin care received
f. Photo taken every 7 days and PRN.
g. Photo taken upon discharge.
h. Daily assessment of wound documented.
i. Repositioning every 2 hours.
j. Placed on Off Loading surface PRN
k. Wound culture completed.
l. Nutritional Referral made.
m. Patient/Family education provided.

There was no documented evidence in the "Wound Care Monitoring Audit tool" of 2011, that the Quality Assessment and Improvement Department was monitoring the nursing staff on whether the Wound Care Nurse had been notified upon discovery of a patient's Braden Risk Skin Assessment score of 12 or below, for further wound evaluation and management as per facility policy.

The facility's Quality Assessment and Performance Improvement program did not incorporate quality indicator data in monitoring whether the nursing staff were notifying the Wound Care Nurse when a patient's Braden Risk Assessment score was 12 or below.

On 1/13/12, at approximately 10:30 AM, the PIM (Performance Improvement Manager) confirmed the finding that her department was not tracking whether the nursing staff were consistently notifying the Wound Care Nurse when a patient's Braden Skin Risk Assessment score was 12 or below.



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2. The OR climate logs for January through June, 2011 and January 2012 were reviewed, and the logs read that the "humidity of the operating room must be maintained between 30-60%", and "report temperatures above 70 degree". There was also a space on the log to record problems and corrective actions. The temperature and humidity ranges fell outside of the target ranges on multiple dates during the months of January, February and June, 2011, and during January, 2012. Humidity as low as 19% was noted in January, 2012, and was below 30% for many consecutive days. Humidity was as high as 74% was noted in June, 2011, and was above 60% for many consecutive days. The portion of the log for noting problems and corrective actions was left blank.

During an interview with RN 1 on 1/11/12 at 10:15 AM, she stated that when temperature and humidity were out of range, she would call engineering. She stated that they were not always documenting the calls or what was done after the calls, or whether the problem was corrected.

The facility policy, Humidity Control Systems, reviewed 2/11, was seen and read in part, " The range required was 30-60%."

During an interview with the PIM (Performance Improvement Manager) on 1/12/12 at 9:45 AM, she stated that she was not aware of issues unless they were brought to her by a department chair.

The Performance Improvement Department Quality Indicators Report for 2011 was reviewed and did not include information about OR humidity problems.

The Performance Improvement Plan 2011 read in part, "Montclair Hospital Medical Center department-specific Performance Improvement process will be identified, assessed and coordinated with the Departmental Performance Improvement Representative in collaboration with their managers. Montclair Hospital Medical Center departmental review is accomplished through data collection and identification of any potential opportunities for improvement. Their PI activities will be reported quarterly to the Quality Council."

Based on staff interview and facility record review, the facility's Quality Assessment and Performance Improvement Department failed to incorporate quality indicator data in order to monitor the effectiveness and safety of services provided in the facility when it failed to monitor whether the nursing staff were notifying and consulting with the Wound Care Nurse (WCN) when the patient's Braden Skin Risk Assessment score was 12 or below, as per facility policy, for 1 of 34 sampled patients (Patient 63). This deficient practice had the potential for substandard wound care being delivered affecting the length of stay of hospitalization and the health and safety of the patient.

Findings:

A review on 1/10/12, of Patient 63's medical record was conducted. The medical record revealed that Patient 63 was admitted to the facility on 1/4/12 with diagnoses that included sepsis (a profound systemic body infection) and renal failure (an abnormal kidney function). Patient 63 was admitted on a ventilator for respiratory support and had a tracheostomy tube (a tube in the throat) for an airway.

A review on 1/10/12, of Patient 63's "Intensive Care Admission Evaluation Form" dated 1/4/12, timed at 7:00 PM, included the following assessments:

a. IS PATIENT ON VENTILATOR: YES
b. RESPIRATORY ASSESSMENT COMMENT: ON VENTILATOR WITH TRACHESTOMY.
c. FRICTION & SHEAR RISK (causes of skin breakdown) : POTENTIAL PROBLEM.
d. SKIN RISK ASSESSMENT SCORE: 12 POINTS.
e. WOUND ASSESSMENT LABEL: COCCYX (back bone area), DRY AND INTACT. PINK AND WELL APPROXIMATED. LENGTH; 5.0 cm. WIDTH 4.0 cm. Use DRIAD PASTE WITH COVERDERM (a dressing covering skin breakdown areas).
f. INTEGUMENTARY ASSESSMENT WITHIN NORMAL LIMITS (skin condition assessment): NO

A review on 1/10/12, of the facility's policy and procedure titled, "SKIN INTEGRITY" dated 5/11, stipulated, " ...skin integrity from head to toe will be assessed upon admission by the Registered Nurse. The Registered Nurse will use the Braden Risk Skin Assessment Scale Tool when assessing the patient's skin. All open pressure ulcers as well as high risk patients with a Braden Scale of 12 or less shall require a wound care consultation referral ... ".

A review on 1/10/12, of the facility's policy and procedure titled, "SKIN INTEGRITY" dated 5/11, stipulated, " ...For inpatients, upon discovery of any pressure ulcer, nursing should complete the "Risk Identification Report" form utilizing the electronic module. This finding will be communicated to the patient's physician, charge nurse or manager of the unit and Risk Manager. The Wound Care Specialist should be consulted for further assessment of the wound and make recommendations as needed ... "

There was no documented evidence in Patient 63's medical record or from other facility sources that the Registered Nurse, after performing on admission an initial head-to-toe assessment on Patient 63, had filled out an "Risk Identification Report", according to facility policy, after it was discovered that Patient 63's Braden Skin Risk Assessment Scale scored a "12" on 1/4/12.

There was no documented evidence in Patient 63's medical record or from other facility sources that the Registered Nurse responsible for the initial head-to-toe assessment upon admission, on 1/4/12, had notified the "Wound Care Nurse" when the Braden Skin Score reached 12, as per facility policy on admission. In addition, the nursing staff subsequently failed to notify the WCN of Patient 63's skin assessment score of 12 throughout the patient's entire hospital stay (admitted 1/4/12, discharged 1/10/12).

On 1/13/12, a review of the facility's quality assessment and improvement report for the year 2011 under the heading: "PERFORMANCE IMPROVEMENT DEPARTMENT QUALITY INDICATORS REPORT" was conducted. The Report, dated 2011, revealed that facility-wide quality indicators involving wound care monitoring required the use of a "Skin Integrity/Wound Care Audit Tool" for data gathering and analysis.

On 1/13/12, a review of the facility's document titled, "WOUND CARE MONITORING TOOL" dated 2011 was conducted. The wound care audit tool measured and tracked the following quality indicators:

a. Wound was present on admission.
b. Care plan initiated for patients at risk or with an active wound.
c. Photo documentation of wound, bruise, skin tear or other taken on admission or upon discovery.
d. Impaired skin integrity flow sheet.
e. Physician orders for wound/skin care received.
f. Photo taken every 7 days and PRN (as needed).
g. Photo taken upon discharge.
h. Daily assessment of wound documented.
i. Repositioning every 2 hours.
j. Placed on Off Loading surface PRN.
k. Wound culture completed.
l. Nutritional Referral made.
m. Patient/Family education provided.

There was no documented evidence in the "Wound Care Monitoring Audit tool " of 2011, that the Quality Assessment and Improvement Department was monitoring the nursing staff on whether the Wound Care Nurse were being notified upon discovery of a patient's Braden Risk Skin Assessment score of 12 or below, upon admission or during a patient's hospital stay, as per facility policy.

Therefore, the facility's Quality Assessment and Performance Improvement Department did not collect data on whether the nursing staff notified the WCN when a patient's Braden Skin Assessment score was 12 or below. This deficient practice lead to the department's inability to monitor the effectiveness and safety of services and quality of care provided at the hospital in order to attain opportunities for improvement or changes that will lead to improvement.

On 1/13/12, at approximately 10:30 AM, the Performance Improvement Manager confirmed the finding that her department was not tracking whether the nursing staff were consistently notifying the WCN when a patient's Braden Skin Risk Assessment score was 12 or below, on admission as per facility policy.

Based on record review and staff interviews, the hospital failed to accurately represent prevalence data. This occurred when two studies, to determine if food allergies and patient wounds were being communicated to the Food and Nutrition Services department, did not analyze the data based on only those patients with food allergies and/or wounds. The two studies were based on irrelevant cases (all assessed patients) instead of only the subset of patients who actually had food allergies and/or wounds. The studies were ineffective in determining the severity of the problem and therefore did not affect improvement in patient safety and quality of care.

Findings:

During a review of the "Performance Improvement 2011 Reporting Worksheet for Food and Nutrition," it was noted that the department was tracking data on food allergies being recorded in the medical record. The data collected to determine percent compliance was: for the numerator, the number of patients with food allergies but were recorded as NKFA (no known food allergies); the denominator was the total number of patients assessed by the registered dietitians.

Also noted was the indicator that the department was tracking was the number of patients who had wounds but there was no wound trigger in the nursing assessment (a wound trigger was the communication tool that nursing used to inform the registered dietitians of patients with wounds). The data collected to determine percent compliance was: for the numerator, the number of patients with wounds and no wound trigger; the denominator was the total number of patients assessed by the registered dietitians.

The Director of Food and Nutrition Services (DFNS) was interviewed on 1/13/12 at 9:15 AM. During the interview she was asked why the number of patients with food allergies that were listed as NKFA was compared to the total number of patients assessed, instead of only the number of patients with food allergies. She was unable to state why. She stated that the study of the prevalence of patients with food allergies that were not listed accurately should include only those patients with food allergies in the denominator. She also confirmed that based on the information collected she was unable to determine if nursing was reporting to dietary patients with food allergies. The patients with food allergies that were not communicated to dietary could be served foods that would cause an allergic reaction in these patiens.

The DFNS also stated that for the indicator for wounds, only patients with wounds should have been included in the denominator. She stated that she was going to stop the study because the numbers looked good, but she would now continue the study using only patients with food allergies and/or wounds in the study. She stated that this would more accurately depict the prevalences. She also confirmed that based on the information collected she was unable to determine if nursing was reporting to dietary patients with wounds who have increased nutrition needs and require dietitian intervention in a timely manner. The patients with wounds that were not communicated to dietary may be missed by the dietitian and not have their increased nutrition needs addressed in a timely manner.

A review of the hospital's Performance Inprovement Plan, Year 2011, revealed that it was the responsibility of the Quality Council to manage the plan, design, measurement, assessment and improvement processes and provide reports to the performance improvement committee, medical executive committee and the governing board.

During a concurrent interview with the Director of Quality, she stated that the two studies should have only looked at patients with food allergies or wounds, not all assessed patients. Both the Director of Quality and the DFNS were unable to state how the current studies accurately determined the prevalence of the errors. She further confirmed that the studies did not ensure that patient safety and quality care could be improved.

Based on interview and record review, the quality assurance program did not ensure that all of the facility adverse events were subject to analysis because: (1) not all unexpected deaths, such as the death of Patient 9, were being reviewed by medical personnel for appropriateness of care, creating the risk of persistent poor healthcare practices and the risk of substandard patient care for all patients, and (2) the process to ensure prevention, assessment and correct treatment of wounds had not been subject to quality assurance oversight and was not identifying all wounds, such as the wound of Patient 2, creating the risk of substandard wound assessment and treatment for all patients, and (3) for one patient, Patient 3, the performance improvement program did not ensure that the grievance allegations were reviewed and addressed, creating the risk of an unresolved grievance for Patient 3, and the risk of unrecognized poor healthcare practices affecting all patients in the facility.

Findings:

1. The facility did not ensure that all deaths were reported to the CNO (Chief Nursing Officer) for review per facility policy.

During a review of a code blue, that occurred on 6/21/11, of Patient 9, it was noted that the patient had been admitted on 6/20/11 and was scheduled for discharge, when she coded (had an arrest of lung or heart function, and an emergency response was called) and died. During the code a tension pneumothorax (a life threatening condition in which there is air in the chest that is not in the lungs) was detected but not relieved.

In an interview with the Director of Performance Improvement (PI) on 1/11/12 at 3:30 PM, she stated that she, or her assistant in the performance improvement department, reviewed all deaths. She stated that she did not have medical training, and that her assistant was not an RN or an MD. She stated that she then summarized the case to present to the medical staff. She stated that there had been a delay in reviewing the 2011 mortalities.

The facility policy, Patient Death (Including Determination of Brain Death), approved 10/11, was reviewed and read in part, "The Charge nurse (or his/her designee) will complete a Hospital Incident Report (RIR) and the Record of Death."

The facility policy, Risk Identification, approved 10/11, was reviewed and read in part, "The RIR" (incident report) "is submitted to the Chief Nurse Officer/Risk Manager (CNO) for review and further action by department manager, if necessary."

In an interview with the CNO on 1/12/12 at 2:30 PM, she stated that the charge nurse should create an incident report on each death, and she should receive the incident reports on all deaths, but that she did not receive them on all deaths. She stated that she was not sure if she received a report on Patient 9. She stated that she was unable to explain why the case had not been referred for review by the PI Department.

2. During a review of a list of the PI Department 2011 Departmental Quality Indicator projects on 1/11/12, use of the skin care/wound care audit tool was listed as the department quality indicator for the wound care department.

Patient 2's family member filed the complaint regarding her care during May and June 2011, especially the development of a pressure ulcer while in the facility and the family not being informed of the pressure ulcer. The pressure ulcer was detected upon admission to another facility.

During an interview with the CNO on 1/10/12 at approximately 10:20 AM, she stated that staff training was done in response to the complaint regarding Patient 2 in July 2011.

A review of Patient 2's medical record showed that the wound was not present on admission, that no care plan was initiated for it, that there was no physician order for wound care and there was no documentation of patient/family education that was provided.

During a review of the facility's wound care monitoring data for 2011, the data for May and June indicated that 100% of the patients who had wounds had them on admission, that care plans were initiated for 100%, that physician wound care orders were obtained for 100%, and that patient/family education was provided for 100%.

During an interview with the Director of PI on 1/12/12 at 9:25 AM, she stated that the WCN (Wound Care Nurse) reviewed all wound assessments. She stated that she was not sure who performed this task during the absence of the WCN. She stated that there was an audit tool to be performed by the nurses regarding wounds, which was to be given to the WCN. The wound data was then reported quarterly. She stated that the PI program had not identified issues with wound assessment being missed or done incorrectly. She was not aware if the wound audit tool was modified after missing an unstageable ulcer June, 2011. She stated there had been no sampling of patients to determine if the audit tool was effective or if it was being used correctly.

3. The complaint filed by Patient 3's mother on 6/15/11 was reviewed. The complaint contained allegations that the patient's requests to see her physician were not honored, that the patient and her mother's requests for a chest x-ray were not responded to and unprofessional behavior on the part of the nurse. The complaint file was reviewed with the CNO/Risk Manager on 1/10/11 at 12:00 PM, and did not contain evidence of an investigation of the specific allegations.

During a concurrent interview with the CNO/Risk Manager on 1/10/11 at 12:00 PM, she stated that there was no documentation of an investigation of the specific allegations because she felt that the larger concern presented by the complaint was a need for staff education about the patient's disease process.

The facility policy, "Grievance/Complaint Process" revised 12/11, read in part, "The Grievance Committee will assure that the grievance is investigated."

Based on observation, interview and record review, the facility failed to have a well organized nursing service with delineation of responsibilities for patient care by failing to:

1. Ensure that timely nursing services were provided for 1 of 34 sampled patients (Patient 67) after the patient expired in the Emergency Department. This failure resulted in the grieving family's needs to be unmet for approximately one hour and thirty-eight minutes. This failure created a potential to delay the grieving process for Patient 67's family. (A395).

2. Ensure that its Chief Nursing Officer (CNO) provided oversight of the Wound Care Specialist (WCS) who lacked certification in wound care management and was responsible for conducting initial wound consultations, staging and measuring of pressure ulcers, and providing education to staff nurses on wound management.

This failure resulted in inconsistent wound measurements being obtained by the wound care nurse and licensed nursing staff, no system in place to monitor the effectiveness of the Skin Audit Tool, and no validations were occurring between the Skin Audit Tool and the medical record to ensure accuracy of the tool put in place for previously identified issues related to wound identification. (A395).

3. Ensure there was adequate supervision of nursing care for 4 of 34 sampled patients (Patients 62, 63, 61 and 7) admitted with pressure sores with a score of 12 or below on the Braden Skin Risk Assessment Scale, were being assessed and evaluated by the Wound Care Nurse Specialist according to hospital policy. This deficient practice had the potential for substandard wound care being delivered to Patients 62 and 63 with the potential to result in extending the patient's length of stay in the hospital. (A395).

4. Ensure that a photograph was taken for 1 of 34 sampled patients (Patient 61) Stage 4 sacral pressure ulcer prior to discharge according to facility policy. (A395)

5. Ensure that Patient 7's wounds were assessed, reassessed and documented per facility policy. (A395).

6. Failed to develop a comprehensive individualized nursing care plan for 2 of 34 sampled patients (Patient 63 and 61) addressing wound care prevention and management of wound ulcers identified on and after admission. This deficient practice had the potential for substandard care to be delivered affecting the health and safety of Patients 63 and 61. (A396)

7. Ensure that the medication nurse administering medications for 1 of 34 sampled patients (Patient 64), had first explained the purpose and significant adverse reaction to the medication prior to its administration as per hospital policy. This deficient finding resulted in Patient 64 not having the opportunity to make decisions regarding his or her health care treatment. (A405).

The cumulative effect of these systemic problems resulted in the nursing department's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the facility failed to ensure that timely nursing services were provided for 1 of 34 sampled patients (Patient 67) after the patient expired in the Emergency Department. This failure resulted in the grieving family's needs to be unmet for approximately one hour and thirty-eight minutes. This failure created a potential to delay the grieving process for Patient 67's family.

Findings:

On 1/12/12, the medical record for Patient 67 was reviewed.

A review of the face sheet for Patient 67 revealed that on 9/18/11 at 5:19 AM, the 33 year old presented to the emergency department (ED) via ambulance in cardiac arrest (is the abrupt cessation of normal circulation of the blood due to failure of the heart to contract effectively during systole).

A review of the emergency department notes showed the following:

a. Patient 67 expired at 5:52 AM.

b. The emergency department's doctor, spoke with the patient's family. "Family was distraught and tearful." "Family waiting to see the PT (patient)." "They state understanding that they must wait until coroner gives permission (to view Patient 67) at 6:05 AM," (13 minutes after the time of death).

c. The ED staff contacted the coroner's office at 6:12 AM (20 minutes after time the of death).

d. The coroner's office called back for more information at 6:44 AM (52 minutes after the time of death).

e. The coroner's office gave the ED staff permission for the family to view Patient 67 at 7:02 AM (one hour and ten minutes after the time of death).

f. Patient 67's body was moved to the Gastrointestinal room and the family was at the patient's bedside at 7:40 AM (one hour and 48 minutes after the time of death; there was a 38 minute delay after the coroner's office gave clearance).

On 1/13/12 at 2:05 PM, an interview and record review was conducted with the ED Director (EDD). When asked the hospital's practice for meeting the needs of the family for the deceased patient, he stated, "The hospital's policy was to obtain the coroner's clearance before the family would be allowed to view the deceased." The EDD stated that this process may take up to 30 minutes, which was dependent on the circumstances of the patient's death.

The EDD reviewed Patient 67's ED record. The EDD confirmed that the documentation showed that the family waited for approximately one hour and forty-eight minutes to view the deceased. The EDD stated that he was not knowledgeable regarding what caused the delay in the family's viewing of Patient 67.

The EDD stated that there could have been multiple variables that could have delayed the family's viewing of the deceased, such as the influx of patients with more serious medical concerns, such as a suicidal patient that required the attention of the ED staff, and/or that the Coroner's Office did not call back to give their release timely.

A review of the "Daily Emergency Services control Register," dated 9/18/11, was conducted with the EDD. The register showed that a patient with suicidal ideation presented to the ED at 7:33 AM (after the coroner's clearance was received for Patient 67).

When asked if the ED was staffed according to the facility protocol during the date and time that Patient 67 expired, the EDD stated that on 9/18/11 between the hours of 3 AM and 7 AM, the ED was staffed according to the facility protocol with 3 Registered Nurses. He stated that if the ED staff was not able to meet the needs of Patient 67's family, the House Supervisor should have been notified to assist the grieving family. The EDD was unable to provide documented evidence to show that the House Supervisor was notified by the ED staff to assist in meeting the needs of the grieving family.

On 1/13/12 at 2:15 PM, the EDD confirmed that the coroner's release was obtained at 7:02 AM, and that the accommodations for the family to view the deceased was made at 7:40 AM. He stated that he was not knowledgeable regarding what caused the 38 minute delay once the coroner's office gave permission for the family to view the deceased.

A review of the hospital's policy and procedure titled, "Patient Death," dated 6/2011 was conducted with the EDD. The hospital's policy showed, "Upon death of a patient, appropriate procedures will be implemented in a dignified and caring fashion to meet the needs of the family/significant other; to comply with applicable local and state laws..."

The section of the hospital's policy titled, "Patient Deaths in the Emergency Room," was reviewed and showed the following:

"All patients that expire in the Emergency Department or that are pronounced dead on arrival are reported to the San Bernardino County Coroner. The Emergency Department Registered Nurse and/or Licensed Vocational Nurse will call the coroner as soon as the patient is pronounced. The time the Coroner is notified and case number is documented on the Emergency Room Record and the Record of Death."

On 1/13/12 at 2:25 PM, the EDD confirmed that the hospital's policy did not stipulate that the Coroner's Office clearance needed to be obtained prior to the patient family's view of the deceased.

On 1/13/12 at 2:30 PM, the EDD acknowledged and confirmed that the hospital did not identify and/or investigate the delay in meeting Patient 67's grieving family's needs.

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

1. Ensure that it provided oversight of the Wound Care Nurse (WCN), an RN (Registered Nurse), who lacked certification in wound care management and was responsible for conducting initial wound consultations, staging (a system developed to guide the clinical description of the depth of tissue destruction that occurs with pressure ulcers) and measuring (method of determining wound area by measuring the longest length and width and multiplying the two measurements for area in squared centimeters) pressure ulcers, and providing education to staff nurses on wound management.

This failure resulted in inconsistent wound measurements being obtained by the wound care nurse and licensed nursing staff, no system in place to monitor the effectiveness of the Skin Audit Tool which was to be utilized by nurses for all inpatient admissions and for QA (quality assurance) purposes, and no validations were occurring between the Skin Audit Tool and the medical record to verify accuracy of the tool put in place for previously identified issues related to wound identification.

2. Ensure there was adequate supervision of nursing care for 4 of 34 sampled patients (Patients 62, 63, 61 and 7) admitted with pressure sores and having a score of 12 or below on the Braden Skin Risk Assessment Scale were being assessed and evaluated by the Wound Care Nurse Specialist according to hospital policy. This deficient practice had the potential for substandard wound care being delivered to Patients 62 and 63 with the potential to result in extending the patient's length of stay in the hospital.

3. Ensure that a photograph was taken for 1 of 34 sampled patients (Patient 61) Stage 4 sacral pressure ulcer prior to discharge, creating the risk of a poor health outcome for Patient 61 due to potentially inadequately documented and treated wounds.

4. Ensure that timely nursing services were provided for 1 of 34 sampled patients (Patient 67) after the patient expired in the Emergency Department. This failure resulted in the grieving family's needs to be unmet for approximately one hour and thirty-eight minutes. This failure created a potential to delay the grieving process for Patient 67's family.

5. Ensure that Patient 7's wounds were assessed, reassessed and documented per facility policy, creating the risk of a poor health outcome for Patient 7 due to untreated wounds.

6. Ensure that the facility policy, Skin Integrity, was reviewed and approved by the Governing Board, creating the risk of ineffective wound care for all patients in the facility.

Findings:

1. During an interview on 1/10/12 at 9:40 AM, the WCN stated she had worked at the facility since April 2010. She stated that she was also the WCN at Facility A and worked between the two facility's. The WCN stated her role as the facility's WCN included performing wound consults, which included assessing the color, drainage and obtaining measurements of identified wounds, performed dressing changes, collaborating with the physician regarding treatment orders and providing education to patients, staff and new hires.

As the interview with the WCN continued, when asked who stages the pressure ulcers, the WCN stated that the facility did not want the RN's to stage the pressure ulcers due to inconsistencies in assessments and that only the WCN and the physician were allowed to stage the wounds. The WCN added that if a pressure ulcer was identified on admission, the unit secretary would let the charge nurse know, the order would go to administration, she would be paged, and that was how she (the WCN) was informed about wound consults that needed to be performed. The WCN stated that she worked monday through Friday and had a per diem nurse, RN 61, to assist her in overseeing the wound consults. The WCN stated that the timeframe she had to conduct the wound consults after the initial order was 24 to 48 hours.

The WCN further stated, during this same interview, that she had taken a test in February 2011, over 11 months ago, to receive her wound care certification, but she had not passed the exam yet. When asked when was she allowed to retake the test, she indicated that she was not sure and did not currently have a date scheduled to retake the test.

During an interview on 1/10/12 at 1:30 PM, the WCN stated that she was off on vacation for 9 days, from 12/31/11 through 1/8/12. She stated that she reported to the CNO and the Director of Wounds, who was at the corporate office.

During an interview on 1/11/12 at 9:50 AM with the CNO, she stated that RN 61 was assigned to work with the WCN one day per week. The CNO stated the WCN worked Monday through Friday doing wound consultations. The CNO stated that once the pressure ulcer was identified, the WCN was expected to see the patient within 24 to 48 hours. When asked if the WCN was certified, the CNO stated she was unsure.

During review of education/training on pressure ulcers received by the WCN, the following was noted:

a.) Lower Extremity Ulcers (one contact hour) on 4/7/11.

b.) Skin and Wound Management Course 2/21/11-2/24/11 (over 11 months ago) given by the Wound Care Institute at Facility A, where the WCN also worked.

c.) Legal Implications of Pressure Ulcers (one contact hour) on 9/30/10 at Facility A.

During an interview on 1/11/12 at 10:30 AM, the WCN stated that some RN's use the circumference (the area within a bounding line, perimeter or border) in measuring pressure ulcers. The WCN stated that her measurements included the length, width and depth of the wound using centimeters. The WCN confirmed that the differences in the measurements obtained made it difficult to determine if the wound was either healing or getting worse. The WCN added that it was very important to know the length, width and depth when determining treatment options.

A review of the facility policy and procedure titled, Skin Integrity, revealed the following, "C. Wound Assessment. The RN or LVN will document their assessment of each wound by including the following in their documentation but should not be limited to the following:

1. Location: Wound or ulcer location on body.
2. Size: (length x width x depth in cm-centimeter) length: longest head to toe measurement, width: longest hip to hip measurement, depth: deepest part of the wound.
3. Wound/Periwound Skin Color: describe the wound bed/periwound skin appearance.
4. Drainage: amount: small, medium, or heavy. Color/consistency.
5. Undermining/tunneling: Measure the extent/depth and using clock method for documentation.
6. Pain: Associated with the wound.
7. Infection: Symptoms present or not."

During an interview on 1/13/12 at 9:23 AM, the facility's WCN stated that the facility used a Skin Audit Tool (SAT). The WCN stated that the tool was included in the admission packet for all patients admitted to the facility. The WCN indicated that the tool was to be used by the nurses, was to be kept in the front of the medical record, and added that the tool was not part of the medical record. The WCN stated that the purpose of the tool was to aid in identifying breakdown on all patients admitted to the facility.

During this same interview, the WCN stated that the SAT's were reviewed after discharge and during the hospital stay. She indicated that the tool was being used for performance improvement and that every quarter she had to report how many patients were at risk. The WCN stated that patients who were at risk was determined by the Braden Scale (The purpose of the Braden scale is to help health professionals assess a patient's risk of developing a pressure ulcer). The WCN stated that if a patient scored less than 12 on the Braden scale, the nurse would need to put in a wound consult for the wound care nurse.

The instructions noted on the Skin Assessment Tool (SAT) were as follows:

To use the tool on admission or when breakdown was noted.
Use photo documentation form (one per affected area).
Keep audit tool in front of chart for concurrent auditing.
Complete audit tool on discharge and submit to Nursing Administration.

The SAT (Skin Audit Tool) included information obtained for concurrent (occurring at the same time) audits and retrospective (looking backward) audits.

The top portion of the SAT included the following information to be confirmed by the RN completing the audit tool:

Pictures of wounds taken in ER, on admission, or upon discovery of wound. Computerized skin wound assessment completed, care plan initiated for at risk patients or with existing wounds, wound consult initiated, physician notified of wound and orders obtained, wound culture obtained as appropriate, nutrition referral initiated, placed on pressure reduction support surface.

The bottom portion of the SAT included the following information to be confirmed by the RN completing the audit tool (retrospective audit):

Daily assessment of wound documented, documentation of measures taken to reduce risk for or progression of breakdown are documented, documentation of patient/family education, pictures taken on discharge, and documentation of discharge, and follow up on wound care plan.

A review of the Pressure Ulcer Prevention Guidelines, Addendum A, which was part of the Skin Integrity policy and procedure dated 5/2011 revealed the following: Braden Scale Score 10-12 was High Risk. The prevention action included referring to WCN via Meditech (computer program) and notifying the Physician.

When asked who the Skin Integrity Committee (SIC) consisted of, the WCN stated that it was herself, the Chief Nursing Officer (CNO), the Director of Medical/Surgical Telemetry (MST) Unit, and the charge nurses of the MST unit. The WCN indicated that the committee met weekly.

During further interview on 1/13/12 at 9:32 AM, the WCN stated that when evaluating the SAT, she only goes off what the nurses document on the tool. She confirmed that the SAT was not validated against the medical record for accuracy and that she expected the information that the nurses documented on the SAT to be accurate. The WCN stated it was the responsibility of the nurses to manage the patient and that it was not her responsibility as the wound care nurse to go behind all the Registered Nurses (RN) and look in the medical record. The WCN added that she only audits off the SAT only and expected that the RN's were documenting accurately. The WCN stated that the MST Manager was conducting her own audits of the patients after discharge. The WCN further stated that RN 61 was an RN who was asked to assist her (the WCN) one day per week to audit the medical records on Thursday. The WCN indicated that RN 61 had just started in December 2011 as was also a new graduate.

During an interview on 1/13/12 at 9:40 AM with RN 63, Nurse Manager of the MST unit, she stated that she does not conduct her own audits of the SAT. She added that it was determined that 100 percent of the SAT was not being completed as planned. She stated that the facility had no treatment nurse and that it was the primary nurses responsibility to assess wounds and change dressings. RN 63 stated that the wound care monitoring was based on the SAT only that was completed by the nurses. RN 63 confirmed that the information on the SAT was not being validated against the medical record for accuracy. She added that RN 61, who just started in December as a new graduate, was the nurse designated as the assistant to the WCN.

During an interview on 1/13/12 at 10 AM, the WCN acknowledged that there were inconsistencies in the system and there was a need to re-educate the nurses on how they measured wounds as well as review of the SAT against the medical record of all inpatients for accuracy and providing education to the nurses based on the outcome of the audits.

An interview was conducted on 1/12/12 at 9:15 AM with the Performance Improvement Manager (PIM). When asked if the facility had identified any issues relating to pressure ulcer identification and assessment, the PIM stated no issues were identified relating to pressure ulcers.

2a. Record review revealed that Patient 62 was a 55 year old female admitted to the facility on 11/15/11 with diagnoses that included dehydration and urosepsis (a toxic condition caused by the leakage of urine into bodily tissues).

A record review of the Adult Admission Assessment completed by RN 66 on 11/15/11 revealed the following assessments:
Integumentary Assessment Within Normal Limits: No
Skin Color: Normal
Skin Moisture: Dry
Integrity: Non intact
Skin Problem: Decubitus, Pressure, Scar
Current Treatment: Will consult wound care
Integumentary Assessment Comment: Multiple Decubitus

A record review of the Patient Notes documented by RN 66 on 11/15/11 at 5:30 PM, the day of admission, revealed that Patient 62 had a bilateral AKA (above knee amputation) with staples in both sides and had multiple decubitus on sacral (relating to the sacrum, which is a large triangular bone at the base of the lower spine).

A record review revealed the following Braden scale scores for Patient 62:
11/15/11 PM shift: 11 points
11/16/11 AM and PM shifts were 12 points.
11/17/11: AM and PM shifts were 12 points.
11/18/11: AM shift was 11 points.

During an interview on 1/13/12 at 9:23 AM, the facility's Wound Care Nurse (WCN) stated that patients who were a high risk for developing pressure ulcers was determined by the Braden Scale (The purpose of the Braden scale is to help health professionals assess a patient's risk of developing a pressure ulcer). The WCN stated if a patient scored less than 12 on the Braden scale, the nurse would need to put in a wound consult for the wound care nurse.

A record review of the photos taken on admission revealed the following pressure ulcers identified for Patient 62 on admission, 11/15/11:

1. Right trochanter pressure ulcer. STAGE not documented. Size (length x width x depth) cm: 3 x 8 cm. There was no documented evidence indicating which measurement was the length, width, or depth of the wound.
2. Coccyx (tailbone) pressure ulcer. STAGE not documented. Size cm: 8 cm length. There was no documented evidence showing the measurements of the width and depth of the wound.

A record review of the photos taken on 11/18/11, 3 days after admission revealed the following pressure ulcers for Patient 62:
1. Left hip pressure ulcer. STAGE IV was documented by the WCN, 3 days after admission. Size cm: 5 cm x 10 cm. Depth 6 cm. There was a box checked on this wound assessment form indicating that the wound was present on admission. The facility was unable to provide evidence that a photo of this wound taken on admission as per facility policy.
A record review of the photos taken on 11/21/11, 6 days after admission revealed the following pressure ulcers for Patient 62:
1. Left sacrum. No Stage documented. Size cm: 1 x 1 cm. A box was checked indicating this wound was present on admission. The facility was unable to provide evidence that a photo of this wound taken on admission as per facility policy.
2. Right trochanter pressure ulcer. No measurements documented.
3. Left hip pressure ulcer. Size cm: 5 x 10 cm x 6 cm. There was no documented evidence indicating which was the length, width or depth of the wound.
4. Coccyx pressure ulcer. Size cm: 8 cm. There was no documented evidence indicating if 8 cm was the length, width, or depth.
5. Left forearm pressure ulcer. No STAGE documented. Size cm: 5 x 7 cm. A box was checked indicating this wound was present on admission. The facility was unable to provide evidence that a photo of this wound taken on admission as per facility policy.

A record review of the Progress Notes dated 11/18/11 by the WCN revealed the following: Wound Consultation. "...Chronic Stage IV decubitus ulcers to coccyx, left trochanter and right hip. Wounds are foul odor and draining. Left forearm wrist covered with slough (a layer of dead tissue). Possible Stage III. 5 cm x 4 cm. ... All wounds present on admission and deep through muscle to bone structure. Care plan reviewed and updated. Coccyx - 8 x 10 cm x 7 cm. Right hip - 5 x 6 x 5 cm. Left trochanter - 5 x 10.

A request was made for all Wound/Skin Care Physician Orders since admission for Patient 62, the facility provided Wound/Skin Care Physician Orders for 11/29/11, 12/8/11 and 1/10/12.
A record review of the Wound/Skin Care Physician Orders, dated 11/29/11 at 4 PM, 14 days after admission, revealed wound care orders for:
a. Left forearm stage III pressure ulcer and
b. Coccyx/sacrum, left trochanter, and right hip stage IV pressure ulcers.

During an interview on 1/10/12 at 9:40 AM, the WCN stated that photos are taken of patient wounds on admission, when there is a change to the wound, on Mondays and upon discharge. The WCN further stated that she writes the wound orders in the progress notes and that she was overseen by the CNO and the Director of Wounds at the corporate office. The WCN acknowledged that there were inconsistencies with how the nurses measure wounds, how they describe the anatomical location of the wound, and with updating and individualizing the care plan to show current treatment and interventions implemented.

During an interview on 1/11/12 at 10:30 AM, the WCN stated that some RN's use the circumference (the area within a bounding line, perimeter or border) in measuring pressure ulcers. The WCN stated that her measurements included the length, width and depth of the wound using centimeters. The WCN confirmed that the differences in the measurements obtained made it difficult to determine if the wound was either healing or getting worse. The WCN added that it was very important to know the length, width and depth when determining treatment options.

A record review of the Professional Practice Minutes, dated 11/10/11, which included the CNO, WCN, PIM (Performance Improvement Manager), the Medical-Surgical Telemetry Unit (MST) Manager revealed a discussion regarding the Skin Integrity Packets/Audits. It was noted in the meeting minutes that RN 61, who was designated as the assistant to the WCN, was to assist nursing staff with pictures of wounds every Thursday. There was no documented evidence indicating that RN 61 was present at this meeting.

A review of the facility policy and procedure titled, Skin Integrity, revealed the following, "C. Wound Assessment. The RN or LVN will document their assessment of each wound by including the following in their documentation but should not be limited to the following:

1. Location: Wound or ulcer location on body.
2. Size: (length x width x depth in cm-centimeter) length: longest head to toe measurement, width: longest hip to hip measurement, depth: deepest part of the wound.
3. Wound/Periwound Skin Color: describe the wound bed/periwound skin appearance.
4. Drainage: amount: small, medium, or heavy. Color/consistency.
5. Undermining/tunneling: Measure the extent/depth and using clock method for documentation.
6. Pain: Associated with the wound.
7. Infection: Symptoms present or not."

A review of the facility's policy and procedure titled, Skin Integrity dated 5/2011 revealed the following: "A. Skin Integrity. The patient's skin integrity from head to toe will be assessed upon admission by RN. ...All compression stockings, dressings, wraps, and or antiembolic stockings will be removed and heels and legs will be assessed unless there is physician order not to remove such devices."

Further review of this same policy revealed the following, "B. Braden Scale. The RN or LVN will use the Braden Risk Assessment Scale Tool when assessing patient's skin. The Braden Scale is used on admission and each shift to evaluate the patient's risk of developing pressure ulcers. Patients with a Braden score of 18 or less are at risk of developing pressure ulcers. All open pressure ulcers as well as high risk patients with a Braden scale of 12 or less shall require a wound care consultation referral."



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2b. A review on 1/10/12, of Patient 63's medical record was conducted. The medical record revealed that Patient 63 was admitted to the facility on 1/4/12 with diagnoses that included sepsis (a profound systemic body infection) and renal failure (an abnormal kidney function). Patient 63 was admitted on a ventilator for respiratory support and had a tracheostomy tube (a tube in the throat) for an airway.

A review on 1/10/12, of Patient 63's "Intensive Care Admission Evaluation Form" dated 1/4/12, and timed at 7:00 PM, included the following assessments:

a. IS PATIENT ON VENTILATOR: YES
b. RESPIRATORY ASSESSMENT COMMENT: ON VENTILATOR WITH TRACHESTOMY.
c. FRICTION & SHEAR RISK (causes of skin breakdown): POTENTIAL PROBLEM.
d. SKIN RISK ASSESSMENT SCORE: 12 POINTS.
e. WOUND ASSESSMENT LABEL: COCCYX (back bone area): DRY AND INTACT. PINK AND WELL APPROXIMATED. LENGTH; 5.0 cm. WIDTH 4.0 cm. Use DRIAD PASTE WITH COVERDERM (a dressing covering skin breakdown areas).
f. INTEGUMENTARY ASSESSMENT WITHIN NORMAL LIMITS (skin condition assessment): NO

A review on 1/10/12, of the facility's policy and procedure titled, "SKIN INTEGRITY" dated 5/11, stipulated, " ...skin integrity from head to toe will be assessed upon admission by the Registered Nurse. The Registered Nurse will use the Braden Risk Assessment Scale Tool when assessing the patient's skin. All open pressure ulcers as well as high risk patients with a Braden Scale of 12 or less shall require a wound care consultation referral ... "

A review on 1/10/12, of the facility's policy and procedure titled, "SKIN INTEGRITY" dated 5/11, stipulated, " ...For inpatients, upon discovery of any pressure ulcer, nursing should complete the "Risk Identification Report" form utilizing the electronic module. This finding will be communicated to the patient's physician, charge nurse or manager of the unit and Risk Manager. The Wound Care Specialist should be consulted for further assessment of the wound and make recommendations as needed ... "

There was no documented evidence in Patient 63's medical record or from other facility sources that the Registered Nurse, after performing an initial head-to-toe assessment on admission, had filled out a "Risk Identification Report" according to facility policy, after it was discovered that Patient 63's "Braden Skin Risk Assessment Scale" scored a "12" on 1/4/12.

There was no documented evidence in Patient 63's medical record or from other facility sources that the Registered Nurse responsible for the initial head-to-toe assessment upon admission, had contacted the "Wound Care Nurse Specialist" for further evaluation and management, when the Braden Skin Assessment Score was 12 or below, as per facility policy and subsequently failed to notify the Wound Care Specialist throughout the patient's entire hospital stay.

A review on 1/10/12, of the facility's policy and procedure titled, "SKIN INTEGRITY" dated 5/11, stipulated, it is the responsibility of the nursing team to position the patient and ensure skin integrity is maintained. The following steps should be considered:
a. Prevent shear and friction injuries.
b. Limit the amount of time the head elevated 30 degrees or more unless patient's condition warrants head of bed to be elevated.
c. Monitor areas with devices for secondary sites of pressure ulcers. Nurse care team shall routinely check patient for any pressure points from medical devices like ears from oxygen tube, cheeks and nose from mask, telemetry wires or any tubes such as IV/ventilator tubing, Foley catheters, sequential device, rectal tube, etc.

On 1/10/12, a review of the facility's policy and procedure titled, "STANDARD OF CARE/PRACTICE: PRESSURE ULCER PREVENTION GUIDELINES" dated 5/11, stipulated, " ...Maintain the head of the bed at the lowest level of elevation that is consistent with medical condition and other restriction to manage friction and shear ... "

There was no documented evidence in Patient 63's medical record or from other facility sources that Registered Nurses caring for Patient 63 in the Intensive Care Unit, while on the ventilator, had considered or attempted to decrease the patient's head of the bed to less than 30 degrees to prevent friction or shearing as per facility pressure ulcer prevention guidelines.

Therefore, the facility failed to ensure that the nursing staff had referred Patient 63, who had a with a Braden Skin Assessment Score of 12 or less, to the Wound Care Nurse Specialist and considered all aspects of preventing skin breakdown of a ventilatory dependent patient as per facility policy throughout Patient 63's hospitalization.

On 1/12/12, at approximately 10:30 AM, the Wound Care Nurse Specialist confirmed that the Department did not receive a "Risk Identification Report" or a "referral" from the Department of Nursing regarding Patient 63's existing pressure ulcer that scored a "12" on the Braden Skin Assessment Scale on admission and throughout Patient 63's hospital stay, as required per facility policy and procedure.





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2c. On 1/9/12, Patient 61's medical record was reviewed.

A review of the face sheet showed that the patient was admitted to the facility on 1/2/12 with diagnosis that included gastrointestinal bleed.

A review of the Wound Assessment, dated 1/2/12, showed that Patient 61 was admitted with a Stage IV pressure ulcer (full tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present).

A review of the Nursing Assessments, dated 1/2/12 through 1/10/12, revealed that Patient 61's Braden Scale (evaluates the patient ' s risk of developing pressure ulcers) was a thirteen or less.

A review of the physicians order, dated 1/2/12, revealed an order for a wound consult.

On 1/9/11 at 2:00 PM, an interview and record review was conducted with the Medical-Surgical/Telemetry Unit's Charge Nurse (CN). She reviewed Patient 61's medical record to locate the wound consultation. The CN stated that the Wound Care Nurse was responsible for the staging of pressure ulcers. CN 2 stated that the physicians order, dated 1/2/12 for the wound consultation was not conducted as ordered.

On 1/10/12 at 9:45 AM, an interview was conducted with the Wound Care Nurse (WCN). The WCN stated that she conducts the wound consults within 24 to 48 hours after receiving the electronic physicians order. She stated that she was on vacation when the physicians order was written. The WCN stated that she had been on vacation the week of 1/2/12 and that 1/10/12 was her first day back to work in the facility. She stated that Patient 61's wound consult was conducted upon her return on 1/10/12 (8 days after the physicians order).

A review of the hospital's policy titled, "Skin Integrity," dated 5/11, was conducted and revealed the following:

The Purpose statement showed, "To provide guidelines for assessment of skin integrity, to determine risk of developing pressure ulcers, to develop a plan of care for prevention of pressure ulcers in those patients determined to be at risk and to provide guidelines for treatment."

The Assessment and Monitoring of Wounds section showed, "Staging of pressure ulcers should be deferred to Wound Care Nurses, Allied Healthcare Professionals, and Physicians."

Section B: Braden Scale showed, Patients with a Braden score of 18 or less are at risk of developing pressure ulcers. All open ulcers as well as high risk patients with a Braden scale of 12 or less shall require a wound care consultation referral.

3. On 1/9/12, Patient 61's medical record was reviewed.

A review of the face sheet showed that the patient was admitted to the facility on 1/2/12 with diagnosis that included gastrointestinal bleed.

A review of the Wound Assessment, dated 1/2/12, showed that Patient 61 was admitted with a Stage IV pressure ulcer (full tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present).

On 1/13/12 at 1:00 PM, an interview and record review was conducted with the Medical-Surgical/Telemetry Unit's Director. She confirmed that a photograph of Patient 61's sacral Stage 4 pressure ulcer was not taken per policy and that it should have been.

A review of the hospital's policy titled, "Skin Integrity," dated 5/11, was conducted and revealed the following:

The Purpose statement showed, "To provide guidelines for assessment of skin integrity, to determine risk of developing pressure ulcers, to develop a plan of care for prevention of pressure ulcers in those patients determined to be at risk and to provide guidelines for treatment."

The Assessment and Monitoring of Wounds section showed, "Staging of pressure ulcers should be deferred to Wound Care Nurses, Allied Healthcare Professionals, and Physicians."

D. The Photographing section of the policy showed, "Wounds should be photographed in the emergency department, upon admission, when transferred to another unit, and upon discharge from the hospital."

4. On 1/12/12, the medical record for Patient 67 was reviewed.

A review of the face sheet for Patient 67 revealed that on 9/18/11 at 5:19 AM, the 33 year old presented to the emergency department (ED) via ambulance in cardiac arrest (is the abrupt cessation of normal circulation of the blood due to failure of the heart to contract effectively during systole).

A review of the emergency department notes showed the following:

a. Patient 67 expired at 5:52 AM.

b. The emergency department's doctor, spoke with the patient's family. "Family was distraught and tearful." "Family waiting to see the PT (patient)." "They state understanding that they must wait until coroner gives permission (to view Patient 67) at 6:05 AM," (13 minutes after the time of death).

c. The ED staff contacted the coroner's office at 6:12 AM (20 minutes after time the of death).

d. The coroner's office called back for more information at 6:44 AM (52 minutes after the time of death).

e. The coroner's office gave the ED staff permission for the family to view Patient 67 at 7:02 AM (one hour and ten minutes after the time of death).

f. Patient 67's body was moved to the Gastrointestinal room and the family was at the patient's bedside at 7:40 AM (one hour and 48 minutes after the time of death; there was a 38 minute delay after the coroner's office gave clearance).

On 1/13/12 at 2:05 PM, an interview and record review was conducted with the ED Director (EDD). When asked the hospital's practice for meeting the needs of the family for the deceased patient, he stated, "The hospital's policy was to obtain the coroner's clearance before the family would be allowed to view the deceased." The EDD stated that this process may take up to 30 minutes, which was dependent on the circumstances of the patient's death.

The EDD reviewed Patient 67's ED record. The EDD confirmed that the documentation showed that the family waited for approximately one hour and forty-eight minutes to view the deceased. The EDD stated that he was not knowledgeable regarding what caused the delay in the family's viewing of Patient 67.

The EDD stated that there could have been multiple variables that could have delayed the family's viewing of the deceased, such as the influx of patients with more serious medical concerns, such as a suicidal patient that required the attention of the ED staff, and/or that the Coroner's Office did not call back to give their release timely.

A review of the "Daily Emergency Services control Register," dated 9/18/11, was conducted with the EDD. The register showed that a patient with suicidal ideation presented to the ED at 7:33 AM (after the coroner's clearance was received for Patient 67).

When asked if the ED was staffed according to the facility protocol during the date and time that Patient 67 expired, the EDD stated that on 9/18/11 between the hours of 3 AM and 7 AM, the ED was staffed according to the facility protocol with 3 Registered Nurses. He stated that if the ED staff was not able to meet the needs of Patient 67's family, the House Supervisor should have been notified to assist the grieving family. The EDD was unable to provide documented evidence to show that the House Supervisor was notified by the ED staff to assist in meeting the needs of the grieving family.

On 1/13/12 at 2:15 PM, the EDD confirmed that the coroner's release was obtained at 7:02 AM, and that the accommodations for the family to view the deceased was made at 7:40 AM. He stated that he was not knowledgeable regarding what caused the 38 minute delay once the coroner's office gave permission for the family to view the deceased.

A review of the hospital's policy and procedure titled, "Patient

Based on staff interview and facility record review, the facility failed to develop a comprehensive individualized nursing care plan for 2 of 34 sampled patients (Patient 63 and 61) addressing wound care prevention and management of wound ulcers identified on and after admission. This deficient practice had the potential for substandard care to be delivered affecting the health and safety of Patients 63 and 61.

Findings:

1. A review on 1/10/12, of Patient 63's medical record was conducted. The medical record revealed that Patient 63 was admitted to the facility on 1/4/12 with diagnoses that included sepsis (a profound systemic body infection) and renal failure (an abnormal kidney function). Patient 63 was admitted on a ventilator for respiratory support and had a tracheostomy tube (a tube in the throat) for an airway.

A review on 1/10/12, of Patient 63's "Intensive Care Admission Evaluation Form" dated 1/4/12 and timed at 7:00 PM, included the following assessments:

a. IS PATIENT ON VENTILATOR: YES
b. RESPIRATORY ASSESSMENT COMMENT: ON VENTILATOR WITH TRACHEOSTOMY.
c. FRICTION & SHEAR RISK (causes of skin breakdown): POTENTIAL PROBLEM.
d. SKIN RISK ASSESSMENT SCORE: 12 POINTS.
e. WOUND ASSESSMENT LABEL: COCCYX (back bone area), DRY AND INTACT. PINK AND WELL APPROXIMATED. LENGTH; 5.0 cm. WIDTH 4.0 cm. Use DRIAD PASTE WITH COVERDERM (a dressing covering skin breakdown areas).
f. INTEGUMENTARY ASSESSMENT WITHIN NORMAL LIMITS (skin condition assessment): NO

On 1/10/12, a review of Patient 63's coccyx wound photograph on the Wound Assessment Form, dated 1/4/12, timed at 5:05 PM, revealed the following coccyx ulcer wound measurements documented on the photograph:
a. Length of 5 centimeters.
b. Width of 5 centimeters.
c. Depth of 1 centimeter.

A review on 1/10/12, of Patient 63's Wound Assessment Form, dated 1/6/12, had described the patient's tracheostomy site as a new discovered wound site (# 2) had revealed the following measurement size and description:

a. Length is 2 centimeters.
b. Width is 2 centimeters.
c. Wound color is PINK, and periwound skin color is RED.

There is no documented evidence in Patient 63's medical record or from other facility sources that a comprehensive individualized nursing care plan was implemented addressing the patient's coccyx wound (#1) discovered on admission, and tracheostomy ulcer wound (#2), discovered on 1/6/12.

Therefore, the facility failed to implement a comprehensive, coordinated individualized nursing care plan addressing the patient's coccyx wound (#1) discovered on admission, and the tracheostomy ulcer wound (#2), discovered on 1/6/12.

On 1/12/12, at approximately 10:30 AM, the Wound Care Nurse Specialist confirmed the finding that the nursing staff did not implement and develop nursing care plans that were comprehensive and individualized addressing Patient 63's wound ulcers to the coccyx area and tracheostomy site.



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2. On 1/9/12, Patient 61's medical record was reviewed.

A review of the face showed that the patient was admitted to the facility on 1/2/12 with diagnosis that included gastrointestinal bleed.

A review of the Wound Assessment, dated 1/2/12, showed that Patient 61 was admitted with a Stage IV pressure ulcer (full tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present).

On 1/10/12 at 1:30 PM, an interview and electronic medical record was conducted with the Medical-Surgical/Telemetry Unit's Charge Nurse 2 (CN 2). A review of Patient 61's Altered Skin Problem plan of care, developed on 1/2/12 and current through 1/12/12 showed that the intervention included, "wound care per protocol." CN 2 stated that the patient's treatments and services interventions were implemented according to the hospital's skin care protocol. CN 2 confirmed that the altered skin plan of care was not individualized for the patient.

Based on observation, staff interview and facility record review, the hospital failed to ensure that the medication nurse administering medications for 1 of 34 sampled patients (Patient 64), had first explained the purpose and significant adverse reaction to the medication prior to its administration as per hospital policy. This deficient finding resulted in Patient 64 not having the opportunity to make decisions regarding his or her health care treatment.

Findings:

On 1/10/12, a review of Patient 64's medical record was conducted. The medical record revealed that Patient 64 was admitted to the hospital on 1/5/12, with an admitting diagnosis of acute respiratory failure. Patient 64 was on a ventilator for respiratory support and was awake and responsive.

On 1/9/12, a review of Patient 64's Physician's Order Sheet, dated 1/5/12, revealed a written medication order for Zosyn 2.25 grams to be given every 6 hours intravenously.

On 1/9/12, a review of Patient 64's Physician's Order Sheet, dated 1/7/12, revealed a written medication order for Reglan 10 milligrams to be given every 6 hours intravenously.

On 1/9/12, from 12:10 PM to 12:20 PM, it was observed during the medication pass inspection process for Patient 64 that Medication Nurse A failed to explain the purpose and possible adverse reactions or side effects of the medication Zosyn and Reglan, to the patient, prior to its administration, according to hospital policy.

On 1/9/12, a review of the facility's policy and procedure titled, "MEDICATION ADMINISTRATION" dated 9/11, stipulated,
" ...The individual administering a medication will advise the patient and/or family about the possibility of any clinically significant adverse reaction to the medication(s) or any other concerns regarding the administration of a medication. The discussion will be documented in the patient's medical record ... "

On 1/9/12, at approximately 12:30 PM, Medication Nurse A confirmed the finding that she failed to explain the purpose and educate Patient 64 of the possible side effects of the medication Zosyn and Reglan according to hospital policy prior to its administration, on 1/9/12.

Based on interview and record review, the facility failed to ensure that medical records entries were accurately written and documented for 3 of 34 sampled patients (Patients 62, 63 and 8) by failing to:

1. Completely document new orders upon transfer to a different unit within the facility for Patient 62.

2. Ensure that Patient 63's wound assessment form accurately documented the size and measurement of the patient's wound. The photograph of the wound, as part of the wound assessment form, did not match the measurement of the wound size documented on the upper section of the official wound assessment form. This deficient finding resulted in an inaccurate description of Patient 63's initial wound size affecting other care givers information needed in making assessments of the patient's condition, and making other decisions on the provision of care.

3. Include the date and time on the physician's confirmation of informed consent for a procedure for Patient 8.

These failures to maintain accurate and complete medical records had the potential to adversely affect patient care and/or the health and safety of these three patients.

Findings:

1. A record review revealed that Patient 62 was a 55 year old female admitted to the facility on 11/15/11 with diagnoses that included dehydration and urosepsis (a toxic condition caused by the leakage of urine into bodily tissues).

A record review of the Physician Orders, dated 11/28/11 at 2:40 PM, revealed the following order: "May transfer to telemetry with same orders".

During an interview on 1/9/12 at 2:45 PM, RN 64 (Charge Nurse on the Medical Surgical Telemetry Unit) stated that when patient's transfer between units, the nurse completes a Medication Reconciliation/Order Sheet and the physician signs it. RN 64 stated that Patient 62's chart was thinned and that she was currently trying to locate the Medication Reconciliation/Order Sheet because it was not in the Patient's active medical record. RN 64 stated that the orders should have been re-written when the patient transferred to the MST Unit.

During further interview with RN 64, she stated that she found the Medication Reconciliation/Order Sheet, dated 11/28/11 in Patient 62's thinned medical record which was not a part of the active medical record.

During an interview on 1/9/12 at 3 PM, RN 64, who was also the charge nurse confirmed that the Medication Reconciliation/Order Sheet was a physician order and that it should not have been thinned out of Patient 62's active medical record. RN 64 further stated that the unit secretary's usually thin the medical record.

During an interview on 1/9/12 at 3:15 PM, Unit Secretary 1 (US 1) stated that she normally thins physical therapy notes, medication administration records, EKG's, and laboratory results. She stated that she usually will leave 5 days of the most recent lab results in the medical record and stated she does not thin medication orders. US 1 stated that the Medication Reconciliation/Order Sheet, dated 11/28/11, was thinned by mistake and should have been kept in Patient 62's active medical record with the physician orders to transfer the patient to telemetry with the same orders, dated 11/28/11.

A review of the facility's policy titled, Admission/Intra-unit Transfer and Discharges, dated 10/2011 revealed the following: "B. Inter-Unit Transfer of Patients. A. Patients may be transferred upon written order from the attending physician between acute care units, the intensive care units, and the recovery room. B. The unit transferring the patient is responsible for: 1. Assuring the physician writes order for the transfer. ..."


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2. A review on 1/10/12, of Patient 63's medical record was conducted. The medical record revealed that Patient 63 was admitted to the facility on 1/4/12 with diagnoses that included sepsis (a profound systemic body infection) and renal failure (an abnormal kidney function). Patient 63 was admitted on a ventilator for respiratory support and had a tracheostomy tube (a tube in the throat) for an airway.

A review on 1/10/12, of Patient 63's "Intensive Care Admission Evaluation Form" dated 1/4/12 and timed at 7:00 PM, included the following assessments:

a. IS PATIENT ON VENTILATOR: YES
b. RESPIRATORY ASSESSMENT COMMENT: ON VENTILATOR WITH TRACHEOSTOMY.
c. FRICTION & SHEAR RISK: POTENTIAL PROBLEM.
d. SKIN RISK ASSESSMENT SCORE: 12 POINTS.
e. WOUND ASSESSMENT LABEL: COCCYX, DRY AND INTACT. PINK AND WELL APPROXIMATED. LENGTH; 5.0 cm. WIDTH 4.0 cm. Use DRIAD PASTE WITH COVERDERM.
f. INTEGUMENTARY ASSESSMENT WITHIN NORMAL LIMITS: NO

On 1/10/12, a review of Patient 63's Wound Assessment Form, dated 1/4/12, timed at 5:05 PM, revealed on the form that a stage III pressure ulcer to the coccyx area was discovered on admission and had the following measurements:
a. Length of 3 centimeters.
b. Width of 4 centimeters.
c. Depth of 1 centimeter.

On 1/10/12, a review of Patient 63's original coccyx ulcer wound photograph on the Wound Assessment Form, dated 1/4/12, and timed at 5:05 PM, revealed the following coccyx ulcer wound measurements documented on the photograph:
a. Length of 5 centimeters.
b. Width of 5 centimeters.
c. Depth of 1 centimeter.

In combination, the facility failed to identify conflicting coccyx ulcer wound size measurements from Patient 63's initial admission assessment form, original wound assessment form, and initial coccyx ulcer wound photograph taken on 1/4/12. Therefore, the facility failed to document in an accurate, complete and consistent manner the patient's correct coccyx ulcer wound size on the official Wound Assessment Form dated 1/4/12.

On 1/10/12, a review of the facility's policy and procedure titled, "GENERAL DOCUMENTATION GUIDELINES", dated 9/11, stipulated, "...The health record of patients shall be documented in an accurate, complete and consistent manner to facilitate patient care and promote continuity of care among providers. In the event that conflicting information is identified in the records, the supervisor shall be notified and corrections made ... ".

On 1/12/12, at approximately 10:30 AM, the Wound Care Nurse confirmed that the nursing staff did not document accurately the measurement size of Patient 63's coccyx ulcer wound on the official wound assessment form dated 1/4/12.


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3. During a review of the medical record of Patient 8 on 1/11/12, the informed consent for the surgery was seen. The consent form was signed by the patient on 1/11/12 at 6:40 AM. On the same form, the physician signed at the bottom of the page, but left the lines provided for recording time and date blank. A review of the record did not show a dated or timed note from the surgeon documenting informed consent prior to the surgery elsewhere in the record.

A review of the facility policy, Informed Consent, approved 10/11, the policy read in part, "Documenting the informed consent in the operative report is not acceptable since informed consent must be given and verified prior to surgery."

During a review of the record with RN 1 on 1/11/12 at 11 AM, she concurred that there was no way to know what time the consent form was signed by the physician.

Based on staff interview and facility record review, the facility failed to maintain that all medical record entries were dated and authenticated accurately for 1 of 34 sampled patients (Patient 63) by not identifying that Patient 63's coccyx and tracheostomy wound ulcer photographs were correctly dated and authenticated. This deficient practice resulted in other care providers not being able to identify the person responsible for providing or evaluating the service provided for further follow up care.

Findings:

A review on 1/10/12, of Patient 63's medical record was conducted. The medical record revealed that Patient 63 was admitted to the facility on 1/4/12 with diagnoses that included sepsis (a profound systemic body infection) and renal failure (an abnormal kidney function). Patient 63 was admitted on a ventilator for respiratory support and had a tracheostomy tube (a tube in the throat) for an airway.

A review on 1/10/12, of Patient 63's "Intensive Care Admission Evaluation Form" dated 1/4/12 and timed at 7:00 PM, included the following assessments:

a. IS PATIENT ON VENTILATOR: YES
b. RESPIRATORY ASSESSMENT COMMENT: ON VENTILATOR WITH TRACHEOSTOMY.
c. FRICTION & SHEAR RISK: POTENTIAL PROBLEM.
d. SKIN RISK ASSESSMENT SCORE: 12 POINTS.
e. WOUND ASSESSMENT LABEL: COCCYX, DRY AND INTACT. PINK AND WELL APPROXIMATED. LENGTH; 5.0 cm. WIDTH 4.0 cm. Use DRIAD PASTE WITH COVERDERM.
f. INTEGUMENTARY ASSESSMENT WITHIN NORMAL LIMITS: NO

On 1/10/12, a review of the facility's policy and procedure titled, "SKIN INTEGRITY", dated 5/11, stipulated, " ...Wounds should be photographed in the emergency room, upon admission, when transferred to another unit and upon discharge. Wound photographs should also be obtained upon discovery of new wounds, changes in condition of the wound and weekly ... ".

On 1/10/12, a review of Patient 63's coccyx wound photograph on the Wound Assessment Form, dated 1/4/12, timed at 5:05 PM, revealed the following coccyx ulcer wound measurements documented on the photograph:
a. Length of 5 centimeters.
b. Width of 5 centimeters.
c. Depth of 1 centimeter.

The coccyx wound photograph, dated 1/4/11, had no documented written evidence of the person responsible taking the photograph or authenticating the photograph as being complete, accurate and final.

On 1/10/12, a review of the facility's policy and procedure titled, "SKIN INTEGRITY" , dated 5/11, stipulated, " ...All photographs should be included in the medical record to support documentation to determine progression of wound healing or effectiveness of therapy. Labeling in the photograph shall include the following:
a. Patient's name or medical record.
b. Location or site of ulcer.
c. Date and time of photograph.
d. Nurse's initials.

On 1/12/12, at approximately 10:30 AM, the Wound Care Nurse (WCN) confirmed that a nursing staff member did not authenticate the photograph by writing his or her initials after taking the photograph on 1/4/12.

A review on 1/10/12, of Patient 63's Wound Assessment Form, dated 1/6/12, described the patient ' s tracheostomy site as a new discovered wound site (Number 2) and had revealed the following measurement size and description:

a. Length is 2 centimeters.
b. Width is 2 centimeters.
c. Wound color is PINK, and periwound skin color is RED.

The tracheostomy photograph of the patient's second wound site, discovered on 1/6/12, did not have the facility's staff member's signature or initial authenticating the photographs accuracy and completeness. It was also noted that the photograph had an incorrect date documented as being 6/1/12.

On 1/12/12, at approximately 10:30 AM, the WCN confirmed that a nursing staff member did not authenticate the photograph by writing his or her initials after taking the photograph which had an incorrect date documented as 6/1/12.

Based on interview and record review, the facility failed to ensure that the physician verbal orders for medications for 1 of 34 patients (Patient 1) was authenticated, creating the potential risk of a substandard health care outcome for the patient from a possible incorrect administration of the medication.

Findings:

During a review of the medical record of Patient 1 on 1/11/12 at approximately 11:00 AM, the following telephone orders for medication orders were seen without physician signatures:

1. On the Physician's Order Sheet, a telephone order for Aldomet 250 mg dated 1/8/12 at 6:30 PM.

2. On the Pre-op Orders/Cesarean Section Delivery Physician Orders form, a telephone order for Bicitra 30 ml PO 30 minutes prior to surgery dated 1/8/12, by DR 1.

3. On the Cesarean Section Post Operative Physician Orders form, a telephone orders for eleven different medications, including narcotic pain relievers, dated 1/9/12 at 15 minutes past midnight.

During a concurrent interview with the Director of Perinatal, she concurred that the physician should have signed the orders.

The Medical Staff Rules and Regulations (2009) read in part (page 6), "All verbal orders for medications shall be signed, dated and timed by the ordering practitioner within forty-eight (48) hours."

Based on interview and record review, the facility failed to ensure that the history and physical (H&P) examination documentation was promptly signed by the practitioner that performed the service for 1 of 34 sampled patients (Patient 61). This failure resulted in the patient's examination findings to not be authenticated by the physician to validate the accuracy of the content.

Findings:

On 1/9/12, Patient 61's medical record was reviewed.

A review of the face showed that the patient was admitted to the facility on 1/2/12 with diagnosis that included gastrointestinal bleed.

A review of the History and Physical (H&P), dated 1/2/12, revealed that the physician signature line was blank.

On 1/9/12 at 2:00 PM, an interview and record review was conducted with the Medical-Surgical/Telemetry Unit Charge Nurse. She reviewed Patient 61's H&P and verified that the physician that conducted the examination failed to sign the patient's H&P.

A review of the hospital's Medical Staff Rules and Regulations, dated March 2009, revealed the following:

"4. The attending practitioner shall promptly sign the history, physical examination and preoperative note, when they have been recorded."

Based on interview and record review, the facility failed to ensure that consultations were promptly signed by the practitioner that performed the services for 1 of 34 sampled patients (Patient 61). This failure resulted in the patient's examination findings to not be authenticated by the physicians to validate the accuracy of the content.

Findings:

On 1/9/12, Patient 61's medical record was reviewed.

A review of the face showed that the patient was admitted to the facility on 1/2/12 with diagnosis that included gastrointestinal bleed.

A review of the Gastroenterology Consultation, dated 1/3/12, revealed that the physician signature line was left blank.

A review of the Rule out Urinary Tract Infection Consultation, dated 1/4/12, revealed that the physician signature line was left blank.

A review of the Respiratory Failure Consultation, dated 1/7/12, revealed that the physician signature line was left blank.

On 1/9/12 at 2:00 PM, an interview and record review was conducted with the Medical-Surgical/Telemetry Unit Charge Nurse. She reviewed Patient 61's consultations and verified that the physicians that conducted the examinations failed to sign the patient's consultations.

A review of the hospital's Medical Staff Rules and Regulations, dated March 2009, revealed the following:

"7. Consultations shall document evidence of review of the patient's medical record by the consultant, pertinent findings on examination of the patient, the consultant's opinion and recommendations, and shall be promptly signed by the consultant."

Based on interview and record review, the facility failed to ensure that informed consents for treatment and/or services for 1 of 34 sampled patients (Patient 61) contained the hospital's full name. This failure caused the patient's responsible party to sign informed consents for treatment and/or services that did not contain the hospital's full name that indicated where the treatment and/or services were provided.

Findings:

On 1/10/12, Patient 61's medical record was reviewed.

A review of the face showed that the patient was admitted to the facility on 1/2/12 with diagnosis that included gastrointestinal bleed.

A review of the document titled, Consent to Blood Transfusion, dated 1/5/12, showed an acronym MMC in the lower left hand corner of the document. The informed consent did not contain the hospital's full name.

A review of the document titled, Peripherally Inserted Central Catheter Informed Consent, dated 1/8/12, showed an acronym MMC in the lower left hand corner of the document. The informed consent did not contain the hospital's full name.

On 1/12/12 at 3:00 PM, an interview was conducted with the Chief Nursing Officer. She reviewed the patient's informed consents and confirmed that the informed consents contained the acronym MMC and should have contained the hospital's full name.

Based on observations, interviews, record reviews, document reviews and policy and procedure reviews, the hospital's pharmaceutical services did not meet the needs of all of the patients.

1. Pharmaceutical services were not provided according to accepted professional principles. The content of medications orders did not clearly communicate pain management orders for Patient 44 to nursing staff. Refer to A 0500

2. The facility failed to remove Darvocet N-100(Propoxyphene NAP w/APAP 100 mg) medication as a selection for pain from an approved pre-printed order form titled, "Post Partum Physician Orders". Refer to A0500

3. The facility failed to ensure that unapproved abbreviations were NOT used during the prescribing of medications for Patients 42 and 49. Refer to A0500

4. The facility failed to ensure that graphical spheres used to monitor (record) the freezer temperatures were removed consistently every 7 days. Refer to A0491

5. The facility failed to ensure that a policy and procedure was developed and implemented to specify situations where it may be appropriate to administer a medication prior to pharmacist review. Refer to A500

6. The facility failed to comply with the regulatory requirement of having patient area medication storage inspected by a pharmacist at least every 30 days. Refer to A491

7. The facility failed to ensure that Patient 44 medication orders written for pain management included the intensity of pain being treated Refer to A500

8. The facility failed to accurately account for controlled and non-controlled substance use in the Automated Dispensing Cabinet distribution system. A491

9. The facility failed to document all elements of medication orders when written for Patients 25, 48 and 49. Refer to A500

10. The facility failed to ensure that duplicate drug orders were not prescribed for Patient 49. Refer to A500

11. The facility failed to maintain the contrast warmer at a consistent temperature. A491

12. The facility failed to have a documented system of response to a malignant hyperthermia code should it occur outside of the surgery department. Refer to A500

13. The facility failed to ensure that complete orders, including starting dose and titration parameters, were provided for Propofol administration to Patient 9. Refer to A500

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

Based on observation, document review and interview, the facility failed to (1) ensure that graphical spheres used to monitor (record) the freezer temperatures were removed consistently every 7 days, (2) comply with the regulatory requirement of having patient area medication storage inspected by a pharmacist at least every 30 days and (3) maintain the contrast media warmer within the temperatures specified by the manufacturer.

Findings:

1. According to the manufacturer's recommendation, the graphical spheres are designed to be used with the freezer to monitor its temperatures automatically on a daily basis. They should be replaced weekly. In this instance, these spheres were changed at different time periods, anywhere from 30 days to 90 days, thereby blurring the temperatures recorded.

During a tour of the pharmacy on 1/9/12 at approximately 9:15 AM with the Director of Pharmacy (DOP), the freezer containing antibiotics was inspected. A review of the graphical spheres used to monitor the freezer temperatures for the previous 6 months on 1/9/12 at 9:50 AM revealed that they were not consistently changed on a weekly basis. Some spheres were lightly shaded with a singular line while others were not. The DOP confirmed the finding.

2. A review of the Unit Inspection Completion Log and the facility's policy and procedure on 1/10/12 titled, "Inspection of Drug Storage Areas (Nursing Station Inspection)" documented on pages 2 and 3 that technicians inspect the units' floor stock and automated dispensing cabinet contents. Further review of inspection sheets for various patient care areas and concurrent interview with staff revealed that pharmacy technicians inspected the drugs storage areas in patient areas.

In a concurrent interview with the Director of Pharmacy (DOP), and after review of the regulation, he acknowledged that monthly unit inspections will be done by a pharmacist. The DOP confirmed that the facility's policy and practice of having technicians perform unit inspections was not in compliance with the regulation.

3. On 1/11/12 at 12:45 PM, an inspection of the warmer used to keep the contrast media warm (Isovue 300) for use during diagnostic procedures revealed that the temperature average of 37.1 degrees Centigrade (98.78 degrees Fahrenheit).

According to the manufacturer's specifications the temperature should be maintained consistently at 98.6 degrees Fahrenheit (37 degrees Centigrade). This will ensure that the contrast media is kept in its maximal effective state. Variance of the contrast media storage temperature from the manufacturer's recommended temperature will increase the risk of the media producing inaccurate imaging results of the patient. This may therefore also increase the risk of harm to the patient due to treatment modalities, suggested by the imaging results, that may not be valid for the patient's medical condition.

A review of the monitoring logs used to document temperatures on a daily basis revealed that the temperatures were not maintained consistently at the temperature specified by the manufacturer.

A review of the policy and procedure titled "Contrast Warmer" on 1/11/12 revealed that staff should follow manufacturer's instructions and that these instructions should be posted where visible to staff.

During an interview with the Radiology Director on 1/11/12, she acknowledged that the manufacturer's instructions to maintain a consistent temperature was not followed consistently.

Based on record review and interview, the facility failed to accurately account for controlled and non-controlled substance use that were stored in Automated Dispensing Cabinet (ADC).

Findings:

1. On 1/10/12 a review of the "All Discrepancy List" obtained from the Intensive Care Unit's (ICU) Automated Dispensing Cabinet (ADC) at 9:41 AM revealed a transaction history for Vicodin, a controlled substance.

On 1/6/12 at 7:30 PM, two registered nurses (RN) verified the count as zero (0) for Vicodin. The displayed inventory documented the count as 11 Vicodin tablets expected when the ADC was accessed to remove a prescribed dose of Vicodin, not zero (0) tablets. At 7:40 PM, 11 minutes later, the same RNs re-verified the actual count as 11 Vicodin tablets.

2. On 1/10/12 at approximately 10:00 AM, the ADC transactions were reviewed. The review revealed that an end count of three (3) IVPB of potassium 20 milliequivalent mEq/100 ml water, also referred to as a K-rider prior to a 'refill'.

During the refill procedure by pharmacy staff 1 (PS1), three (3) K-riders were found in the ADC instead of a displayed inventory of five (5) on 1/1/12 at 4:05 PM. The PS1 resolved the discrepancy by selecting 'AUTO-RESOLVED' from the options provided in the menu as an explanation of why the discrepancy occurred. The PS1 added Five (5) K-riders to the ADC inventory.

Injectable potassium chloride in any concentration is considered a high risk/alert medication, therefore tracking and monitoring the use of this albeit non-controlled (non-scheduled) drug is paramount to the integrity of pharmaceutical services.

In an interview with the DOP on 1/10/12 at approximately 10:00 AM he reported that a system is not in place to track drugs identified as high risk/alert stored in an ADC. He further acknowledged that accuracy and accountability of controlled and non-controlled substances in the ADCs is expected from users.

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

1. Ensure that 1 of 34 sampled patients (Patient 65) drug regimen was free from unnecessary drugs when the patients' prescribed pain medication orders containing Acetaminophen exceeded the potential maximum daily dose recommended for adults, creating the potential for possible significant adverse drug consequences and medication-related negative outcomes for Patient 65.

2. For Patient 6, a powerful sedative was administered without complete administration orders, creating the risk of a substandard health care outcome for that patient from a possible incorrect administration of the medication.

3. For Patient 25, transfer orders for TPN (total parenteral nutrition, nutrition fed directly into the bloodstream instead of the stomach) were not specific, creating the risk for incorrect administration. In addition, the discharge/transfer orders, including orders for medications, were not signed by the physician.

4. Ensure that (1) Darvocet N-100(Propoxyphene NAP w/APAP (acetaminophen)100 mg) medication as a selection for pain from an approved pre-printed order form titled, " Post Partum Physician Orders was removed from distribution,

5. Ensure the content of medications orders for Patient 44 were clearly communicated to nursing staff,

6. Ensure unapproved abbreviations were NOT used during the prescribing of medications for Patients 42 and 49,

7. Ensure a policy and procedure was developed and implemented to specify situations where it may be appropriate to administer a medication prior to pharmacist review.

8. Ensure Patient 44's medication orders written for pain management included the intensity of pain being treated

9. Ensure duplicate drug orders were not prescribed for Patient 49, and

10. Ensure a system was developed to respond to a malignant hyperthermia code should it occur outside of the surgery department.

11. Accurately account for controlled and non-controlled substance use that were stored in the Automated Dispensing Cabinet (ADC).

These failures created the risk of inaccurate medication administration leading to the potential for substandard health care outcomes.

Findings:

1. On 1/11/12, a review of Patient 65's medical record was conducted. The admitting face sheet of Patient 65 revealed that the patient was admitted to the facility on 1/7/12 with an admitting diagnosis of pneumonia. Patient 65 was placed on a ventilator for respiratory support and had a tracheostomy for an airway. Patient 65 was not responsive to simple commands.

On 1/11/12, Patient 65's medical record indicated in the physician ' s orders sheet, dated 1/7/12, the following orders:

a. Tylenol 650 milligrams 1 tablet via GT every 4 hours as necessary for mild pain.
b. Vicodin 2 tablets 5/500 milligrams via GT every 6 hours as necessary for severe pain.
c. Vicodin 1 tablet 5/500 milligrams via GT every 6 hours for pain management.

A review of Patient 65's medical record was conducted on 1/11/12 and showed in the physician's orders sheet, dated 1/7/12, that the potential maximum daily medication dosage for Acetaminophen, as prescribed, was found to be greater than 4 grams per day (9.6 grams), which exceeded the daily maximum dose recommended for an adult.

A review on 1/11/12, of the facility's Nursing Drug Handbook 2006, Elsevier and Saunders, pages 9-11, indicated that Acetaminophen's daily maximum daily dose for an adult is 4 grams per day.

On 1/11/12, a review of Patient 65's blood chemistry laboratory results, dated 1/9/12, revealed a blood chemistry level of "155" for Alkaline Phosphatase (normal levels 50-136 U/L, levels higher than 136 is indicative of liver function abnormality).

On 1/11/12, a review of Patient 65's Physician Progress Notes from 1/9/12 through 1/13/12 indicated no documented evidence that Patient 65's physician had conducted an assessment that the patient's clinical condition warranted Acetaminophen drug doses to exceed 4 grams daily; indicating that the benefits outweighs its risks.

On 1/11/12, a review of the facility's policy and procedure titled, "MEDICATION ADMINISTRATION AND SCOPE OF SERVICE" dated 9/11, stipulated, " ...The individual administering the medication will verify the normal dosage and maximum safe dosage. A pharmacist shall review the patient's drug therapy (current drug regimen) prior to dispensing new orders for drugs to the patient. The pharmacist will be responsible for monitoring the patient's drug regimen for potential interactions, dosage irregularities, duplicate therapy, unnecessary drugs and excessive doses ... "

Therefore, the hospital pharmacy failed to monitor Patient 65's drug regimen profile for possible dosage irregularities of all medications containing acetaminophen and the possiblity of exceeding its daily maximum dosage as ordered by the physician.

During an interview with the facility's Director of Pharmaceutical Services on 1/12/12, at approximately 1:30 PM, when asked if he completed a medication regimen drug review for Patient 65, he stated, "Yes." When asked if the monthly medication regimen review included the drug: Acetaminophen or the concomitant use of Acetaminophen in other products, he stated, "Yes."

In addition, when asked if he knew the potential maximum daily dose for Acetaminophen in an individual patient, he stated, "4 grams per day and it looks like this patient's acetaminophen order exceeded the acceptable daily dosage."



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2. During a tour of the ICU on 1/9/12 at 11 AM Patient 6's medical a record showed that he was receiving Propofol (a powerful sedative also known as Diprivan) IV (intravenously-administered by vein).

The order for the Propofol, dated 1/5/12 at 2 PM, read, "Diprivan drip PRN (as needed) for sedation". The order did not specify the starting dose and did not specify the degree of sedation desired or the criteria for monitoring the degree of sedation.

In a concurrent interview with RN 14, she stated that low dose Propofol is administered in the ICU, with the nurse titrating to a level of sedation based on the Glascow Coma Score (neurologic test) of the patient.

In an interview with RN 13 on 1/9/12 at 12 PM, she stated that the physician who ordered the medication should have specified the degree of sedation by giving the Glascow Coma Score that he wished to achieve. The nurse could then change the amount of medication being administered to achieve that level of sedation. She concurred that the medical record of Patient 6 did not show that the nurse had been determining the Glascow Coma Score, and stated that the reasons for the nurse changing the dose levels was unclear.

The facility policy, Propofol, approved 10/11, read in part, "The Glascow Coma Scale will be utilized as the method of assessing the patients level of sedation."



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3. The medical record for Patient 25 was reviewed on 1/11/12. The patient was transferred from a skilled nursing facility (SNF) to the hospital on 12/29/11 with diagnoses that included severe malnutrition due to multiple abdominal surgeries. On 12/30/11 the patient was started on TPN (total parenteral nutrition, nutrition fed directly into the bloodstream instead of the stomach). On 1/3/12, there was a physician order to "D/C (discharge) the patient back to SNF with TPN, continue SNF meds (medications)."

A review of the "Physician Discharge Orders, Instructions and Transfer Summary" form dated 1/3/12, indicated that "Medications: see attached Medication Reconciliation List." The form was signed by a nurse but did not have a Physician's signature. There was no documentation of the TPN order on the form. A review of the attached "Medication Reconciliation Form/Order Sheet" revealed that it did not include TPN.

A review of the hospital's policy titled, "Medication Administration" dated 9/11 showed that orders for medication must include a physician's signature.

During an interview with the Director of Case Management (DCM) on 1/11/12 at 3:30 PM, she stated that the Physician Discharge Orders, Instructions and Transfer Summary form is a physician order form and must be signed by the physician. She verified that this form for Patient 25 was not signed by a physician.

During an interview with the Director of Pharmacy on 1/11/12 at 3:00 PM, he stated that it was not the practice of the hospital to include specific TPN orders in the transfer orders. He stated that when a patient is transferred to SNF with an order for TPN, the accepting facility is responsible for determining the content of the TPN. He further stated that sometimes the accepting facility would call to ask about the content of the TPN. Or the accepting facility would be able to read the label on the TPN bottle that accompanied the patient during the transfer.

A review of the hospital's policy titled, "TPN (Total Parenteral Nutrition) Protocols, dated 9/11 revealed that all TPN orders must be ordered on a standardized TPN order form.





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4. Pre-printed orders are approved by a medical staff committee for use within the facility, and on an annual basis or when changes are needed. On 1/10/12 at 3:20 PM review of pre-printed order forms titled, "Post Partum Physician Orders" and "Cesarean Section Post Operative Physician Orders" revealed orders for Darvocet N 100 as options for mild and moderate pain.
A review of Patient 41's clinical record on 1/11/12 at approximately 2:30 PM with RN 41, the charge nurse, and the Director of Pharmacy (DOP) on the Labor and Delivery Unit revealed an order set for Darvocet N-100, a medication formerly used for pain.

The medication order set listed as an option, Darvocet N 100, 1 or 2 tabs (tablets) PO (by mouth) tabs q(every) 4 hours PRN (as needed) mild pain.

Following a review of the drug in November 2010, the FDA (Food and Drug Administration) and the manufacturer of Darvocet® (Propoxyphene and acetaminophen) and Darvon® withdrew both products from the U.S. market. Manufacturers of the generic version were asked to do the same.

The decision was the result of a recent safety study which demonstrated an increased risk of potentially serious and fatal cardiac rhythm abnormalities with propoxyphene. Prescribers were advised to no longer prescribe propoxyphene-containing products.

In a concurrent interview with the DOP and RN 41, they confirmed that drugs recalled from the U.S. market should be promptly removed from any prescription order communication.

5. A review of Patients 48 and 49 medical charts on 1/10/12 at 1:30 PM revealed orders that were written without all elements of a medication order present. All elements of a medication order include dose, strength, frequency, and route (method of administration).

Patient 48's order was written on 1/9/12 and timed 2 PM, noted at 4:40 PM
Patient 49's order was written 1/9/12 at 2 PM. Both orders were written as: "continue all home meds". The orders lacked the name of the drug, dose, route, and frequency, therefore, incomplete.

In a concurrent interview with the DOP on 1/10/12 at 1:30 PM, he acknowledged that medication orders are not complete if any or all elements are absent.

6. The ongoing use of unacceptable abbreviations frequently results in medication related errors.
A review of Patient 42's medical record on 1/10/12 at approximately 2:25 PM revealed an order written on 1/8/2012 at 9:54 AM for Levaquin 500 mg IVPB (IV piggyback) QD.
A review of Patient 49's medical record on 1/10/12 at approximately 2:05 PM revealed an order written on 1/10/2012 at 12:50 AM for Finasteride 5 mg po QD.
A review of the frequently used sheet list QD as a "Do not use this abbreviation" because it can be mistaken for q.i.d (four times daily) or q.o.d (every other day). The prescriber should write "daily" or "every day". The use of QD as a frequency for medication administration is an unacceptable abbreviation as determined by the medical staff and standards in the community. Such an abbreviation is likely to cause a medication error if interpreted incorrectly.

7. An interview with the Director of Pharmacy (DOP) on 1/9/12, at approximately 9:55 AM revealed that a policy and procedure had not been developed and implemented to ensure that medication orders are reviewed by a pharmacist prior to administration of drugs.

Pharmacy hours are 7 AM - 10 PM, Monday through Friday, 8 AM to 4:30 PM Saturdays, and Sundays.

Pharmacist review of medication orders prior to administration is a key step in medication safety. That process should only be bypassed (overridden) when the clinical status of the patient would be significantly compromised by any delay that would result from the review process, or when an independent practitioner directly controls the medication-use process. The override refers to the pharmacist review process, not the source of the medication. When the override process occurs, the caregiver is accountable to confirm the appropriateness of the drug, dose, route and frequency, as well as screen for allergies, potential drug interactions ..... and other contraindications to the drug being administered.

8. On 1/9/12 at approximately 1:05 PM medication orders sent to the pharmacy for processing were reviewed via the computer. An order was written on 1/6/12 at 12:50 AM for Morphine Sulfate 2 mg IV (intravenous) q (every) 4 hours PRN (as needed) pain. The order lacked the intensity of pain treated such as mild, moderate, or severe, or if a scale of zero to ten was adopted as part of the pain management process. Therefore, the content of the order was not clearly communicated to nursing staff for Patient 44. When asked, the DOP reported that intensity of pain should be communicated to nursing.

9. Patient 49 was admitted with diagnoses that included prostatitis. Patient 49's medical record reviewed on 1/10/12 at approximately 1:30 PM revealed a Medication Reconciliation Form/Order Sheet dated 1/9/12. Flomax 0.4 mg, 1 PO (by mouth) HS (at bedtime) for BPH (Benign Prostatic Hyperplasia) was ordered to be continued on admission/transfer. Further review of the record revealed an order for Finasteride (a drug used for Benign Prostatic Hyperplasia) 5 mg po (by mouth) QD written at 1/10/12 at 12:50 PM. The eMAR (electronic medication administration Record) document Flomax as part of the current drug regimen before Finasteride were ordered for BPH during the same admission.

When the nurse was asked why Flomax and Finasteride were ordered for the same indication, she reported that the physician would be called to clarify the order.

10. During a tour of the surgery department 1/12/12 at approximately 1:55 PM, inspection to the Malignant Hyperthermia (MH) cart and procedures for responding to the code within the facility revealed that the policy was directed towards the surgical staff, and not to other areas in the hospital, such as ICU (Intensive Care Unit) and Emergency Department (ED) in which neuromuscular blockers, i.e. Anectine are administered.

When asked how the Emergency Department (ED) responds to a MH code, the DOP and I were directed to the ED by the Surgery Director to ask the ED Director who is in charge of the ED and ICU. A staff nurse in the ED was asked how a MH code would be handled in the ED. She reported that in the event of a MH code, surgery staff would bring the MH cart from surgery to ED and assist the ED with the MH code. She was asked what happens when surgery staff is not available.

During an interview on 1/12/12 at approximately 2 PM, the ED/ICU Director reported that Corporate was in the process of developing a MH policy and procedure which would be hospital wide.

11a. On 1/10/12 a review of the "All Discrepancy List" obtained from the Intensive Care Unit's (ICU) Automated Dispensing Cabinet (ADC) at 9:41 AM revealed a transaction history for Vicodin, a controlled substance.

On 1/6/12 at 7:30 PM, two registered nurses (RN) verified the count as zero (0) for Vicodin. The displayed inventory documented the count as 11 Vicodin tablets expected when the ADC was accessed to remove a prescribed dose of Vicodin, not zero (0) tablets. At 7:40 PM, 11 minutes later, the same RNs re-verified the actual count as 11 Vicodin tablets.

11b. On 1/10/12 at approximately 10:00 AM, the ADC transactions were reviewed. The review revealed that an end count of three (3) IVPB of potassium 20 milliequivalent mEq/100 ml water, also referred to as a K-rider prior to a 'refill'.

During the refill procedure by pharmacy staff 1 (PS1), three (3) K-riders were found in the ADC instead of a displayed inventory of five (5) on 1/1/12 at 4:05 PM. The PS1 resolved the discrepancy by selecting 'AUTO-RESOLVED' from the options provided in the menu as an explanation of why the discrepancy occurred. The PS1 added Five (5) K-riders to the ADC inventory.

Injectable potassium chloride in any concentration is considered a high risk/alert medication, therefore tracking and monitoring the use of this albeit non-controlled (non-scheduled) drug is paramount to the integrity of pharmaceutical services.

In an interview with the DOP on 1/10/12 at approximately 10:00 AM he reported that a system is not in place to track drugs identified as high risk/alert stored in an ADC. He further acknowledged that accuracy and accountability of controlled and non-controlled substances in the ADCs is expected from users.

Based on interview and record review, the facility failed to ensure that one physician, DR 2, was being monitored for radiation exposure, creating the risk of unsafe radiation exposure for that physician.

Findings:

The facility radiation safety badge logs for 2011 were reviewed on 1/11/12. The logs did not include DR 2, a pain management physician.

During a review of the clinical privileges for DR 2 on 1/11/12, pain management privileges, including procedures requiring the use of fluoroscopy, were granted on 7/26/10.

A list of operations performed by DR 2 during 2011 was examined on 1/12/12 and showed more than 40 procedures using fluoroscopy.

During an interview with the Manager of Radiology, she stated that the medical staff office usually notified her if there was a new physician on staff who required a radiation safety badge but that it was overlooked in the case of DR 2. She stated that DR 2 had been using fluoroscopy while performing services in the facility and was required to wear a radiation safety badge.

The facility policy, Personnel Radiation Monitoring Devices, approved 10/11, read in part, "Radiation monitoring devices must be used by radiation workers who are considered occupationally exposed."

Based on record review and interview, the facility failed to (1) determine or assess the risk of the therapeutic class of antibiotics reported in the Biological Product Retrieval' transmission report, and (2) obtain the most current Clinical Laboratory Improvement Act (CLIA) certificate from the referral laboratory used by the facility.

Findings:

1. Review of the 'Biological Product Retrieval' transmission report on 1/13/2012 at approximately 11:55 AM received by the facility on 5/16/11 from the American Red Cross (ARC) regarding blood to be quarantine and disposed of according to federal guidelines revealed that a donor was identified who had been on an antibiotic regimen. The facility did not determine or assess the risk of the therapeutic class of antibiotics reported in the Biological Product Retrieval' transmission report.

Review of the documents provided to ARC that identified the disposition of the blood revealed that Patient 50 received a transfusion of Fresh Frozen Plasma (FFP) 3/9/11.

Review of Patient 50's medical record revealed an allergy to sulfa drugs. The documented date of the actual transfusion on the 'Blood or Blood Component Transfusion' record and nursing notes was 3/8/11.

In a concurrent interview and document review with the Laboratory Director on 1/13/12 at approximately she reported that a follow-up with ARC was not done.

2. During a tour of the laboratory department on 1/12/12 at approximately 3:19 PM, the laboratory permits and staff credentials were reviewed. When asked if tests were referred to another laboratory, the director reported that they were. However, the director was unable to provide a current Clinical Laboratory Improvement Amendment (CLIA) certificate.

The director reported that the referral laboratory usually send a copy of their CLIA certificate upon renewal, however, a renewal certificate was not sent to the facility to verify continued accreditation. The date of the last CLIA certificate renewal was 2/28/2011.
The director contacted the referral laboratory who provided the facility with the most current CLIA certificate dated 2/27/13 on 1/12/12.

Based on observation, record reviews and staff interviews, the hospital condition of participation was not met as evidenced when:

1. 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. (cross refer A 620 )

2. The disaster food plan for the hospital was inconsistent, it did not meet the needs of the patients and the dietary services did not maintain adequate supplies to meet the needs of the patients in the event of a disaster. (cross refer A 620 and A 701)

3. Safe food handling and storage practices were not followed for the cooling of cooked, potentially hazardous food; dietary staff were observed within food preparation areas without proper hair restraint; proper label, dating and storage guidelines were not followed; the can opener blades were not maintained to prevent cross-contamination; appropriate dietary staff did not know safe emergency dish washing procedures. (cross refer A 620)

4. The nutrition needs of 3 of 5 patients reviewed for nutrition care, with a diagnosis of malnutrition, were not met when the nutrition recommendations from the registered dietitian were not communicated to the physician and/or the nutrition assessment was not performed in a timely manner. (cross refer A 630)

5. The quality committee was not informed about the inadequate disaster food supplies, the issues with registered dietitian's nutrition recommendations not being communicated to the physician and the appropriate data analyzed for the prevalence of patients with food allergies and wounds and their communication to dietary. (cross refer A 264 and A 285)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure safe food handling and prevent the potential of food borne illnesses, to ensure the nutritional needs of the patients were met during a disaster, to ensure the nutritional needs of the patients were met according to the registered dietitian's recommendations and to prevent deficient practices identified during the survey to continue in a hospital with a licensed bed capacity of 102.

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 when:

1. The disaster food plan for the hospital was inconsistent; it did not meet the needs of the patients; and the dietary services did not maintain adequate supplies to meet the needs of the patients in the event of a disaster. (cross refer A 701)

2. Cooked, potentially hazardous food was not monitored for safe cool down temperatures to minimize pathogenic (disease causing) microorganism growth. (cross refer A 749)

3. The Director of Food and Nutrition services and other dietary staff were observed within food preparation areas without proper hair restraint on multiple days of the survey. (cross refer A 749)

4. Multiple food items were noted to not be covered or dated; or they had passed their expiration date; or they were improperly stored so as to impact the quality and/or the safety of the food. (cross refer A 749)

5. The table mounted can opener blades were not maintained in a manner that prevented canned goods from becoming contaminated during use. (cross refer A 749)

6. One dishwashing staff did not know the procedure from manual dishwashing in the event the dish machine did not function properly. (cross refer A 749)

This failure to ensure the daily management of the dietary services department created the potential to result in malnutrition of the patients during a disaster; the inability of the hospital to ensure that the patients were provided quality food; and the potential to cause food borne illness in a hospital with a licensed bed capacity of 102.

Findings:

1. During a review of the hospital's policy and procedure titled, "Emergency Operations Plan" for Food and Nutrition Services, dated 9/11, it was noted that the purpose of the policy was to provide basic dietetic needs during an emergency. It further stated that in addition to the 3-day extra food supply located within food and nutrition services, an additional 2-day supply of food (non-perishables) were located in the Medical Office Building (MOB).

During an interview with the Director of Food and Nutrition Services (DFNS) on 1/9/12 at 1:35 PM, she stated that it had been over 6 months since the emergency food was stored in the MOB. She further stated that she was in the process of transitioning the storage of the disaster food in the dietary department and that there were no other disaster foods stored in the facility. When asked about the current plan for food service during a disaster, she stated that the plan was to feed 306 people three meals a day. She stated that she calculated this number based on the number of licensed beds in the hospital, times three. She further presented a written "7 Day Disaster Menu - Regular Diet" dated 2011, and stated that it was the hospital's disaster menu.

During a concurrent observation of the disaster food supplies in the dietary department and a review of the "7 Day Disaster Menu - Regular" posted in the dry storage room on 1/9/12 at 1:35 PM, it was noted that "Milk 1 c (cup or 8 ounces) was on the menu for 14 meals. The hospital did not have any dry milk. A review of the disaster menu indicated that milk provided a significant portion of the protein component of the menus. Without milk, the menu provided very little protein. Seven of the meals on the menu utilized canned soup as an entrée when no other protein-rich foods were included. The nutrition information on the canned soups were noted to include between 1 and 3 grams of protein per serving. Peanut butter and jelly sandwich was listed as the entrée at lunch on day 4 of the menu. The hospital only had approximately 150 individual serving cups of peanut butter and no bulk peanut butter, which was inadequate to feed 306 people.

Further review showed that dry cereal was listed for breakfast on 6 of the 7 days of the menu, which would require 1,836 servings needed to feed 306 people. The hospital only had 288 servings of dry cereal on hand. A Basic Meal Plan was included in the policy which stated that pureed diets will use canned pureed meats and vegetables. The hospital did not have these items available.

Further review of the policy revealed that the available food supplies should feed approximately 550 people per day. The DFNS had stated that the plan was to feed 306 people. She was unable to explain the discrepancy.

During a concurrent interview with the DFNS, she stated that there weren't adequate supplies to meet the plan. She was unable to explain why the policy had been reviewed and approved by the Governing Board in September 2011 but was not accurate in terms of the number of people that would be served in a disaster and the location of the disaster food. She further stated that the reason she did not have adequate disaster food on hand was that, since they were no longer able to store the food at the MOB, she did not have room to store the amount of disaster food. She was unable to explain why it had been over 6 months and the problem of where to store the disaster food had not been resolved.

2. During the initial tour of the kitchen on 1/9/12 at 10:40 AM, an undated pan of previously cooked rice was observed in the walk-in refrigerator.

During a concurrent interview with Cook 1, she stated that the rice was leftover from the celebratory dinners given to patients who are new parents. She stated that the rice had been made the previous day, but verified that there was no date recorded to attest to the fact. Cook 1 stated that the rice should have been monitored for a safe cool down and temperatures written on the Cooling Log.

During a concurrent interview with the DFNS, she stated that all leftover food should be thrown out and not saved. She confirmed that previously cooked rice was a potentially hazardous food that required temperature monitoring of the cool down process.

According to the 2009 US Food and Drug Administration's Food Code (3-501.14 Cooling) safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (PHF) has been consistently identified as one of the leading contributing factors to foodborne illness. During slow cooling, PHF are subject to the growth of a variety of pathogenic microorganisms. If the food is not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness. The Food Code provision for cooling provides for cooling from 135°F to 41°F or 45°F in 6 hours, with cooling from 135°F to 70°F in 2 hours.
A review of the hospital's policy titled, "Food Preparation" undated, revealed that during the cooling of PHF the internal temperature was to be taken at the end of two hours and at the end of six hours and recorded on the Cooling Log.

A review of the Cooling Log for the previous week revealed that the rice was not on the log.

The DFNS and Cook 1 were unable to state how they could ensure that the rice had been safely cooled and was safe to feed patients if it wasn't recorded on the Cooling Log.


3. During the initial tour of the kitchen on 1/9/12 from 9:25 to 10:30 AM, it was observed that the DFNS had a hairnet on that was only partially covering her hair. She had a ponytail about twelve inches long that was not restrained in the hairnet At 10:30 AM, it was also observed that Engineering Staff 1 (ES 1) entered the kitchen in the vicinity of the ice machine with a hairnet that was only partially covering his hair, He also had a ponytail about ten inches long that was not restrained in a hairnet.

During an interview with the DFNS on 1/9/12 at 10:30 AM, she stated that both her hair and the hair of ES 1 should be fully restrained in a hairnet while present in the kitchen.

During subsequent observations on 1/10/12 at 11:25 AM, the DFNS again did not have her hair fully restrained in the hairnet. Concurrently, Food Service Worker 1 (FSW 1) entered the kitchen and walked through the kitchen and food preparation areas without a hairnet or restraint. On 1/11/12 at 1:50 PM, the DFNS walked through the kitchen and food preparation areas, from her office without a hair restraint.

A review of the hospital's policy titled, "Infection Control and Contamination Control, Food and Nutrition" dated 9/11, revealed that the policy was to create and maintain an environment that is physically and bacteriologically safe for the storage, preparation and serving of food. It further stated that hairnets or caps must be worn by all kitchen staff that handle or are near food.

4. During the initial tour of the kitchen on 1/9/12 at 9:25 AM in the walk-in refrigerator, the following was observed: a one gallon container of salad dressing labeled with an open date of 12/6/11 and a one gallon container of Caesar salad dressing labeled with an open date of 12/7/11. Both of these products had been opened for greater than one month at the time of the observation. Also observed was a one gallon container of lite ranch salad dressing that had been opened with no open date.

During a concurrent interview with the DFNS, she stated that the staff was supposed to date the containers with the date the product was opened. She further stated that she would have to refer to their policy for the shelf life of the opened salad dressings.

A review of the hospital's policy titled, "Food Labeling and Dating" dated 9/11, revealed that for salad dressings, the expiration date was 5 days after opening.

The same day at 9:45 AM, also observed in the cook's area were 10 large and 36 smaller plastic containers of various dry spices with no date. Inside the bottled labeled nutmeg, there was a plastic spoon. And in the dry storage room there was an additional 43 containers of dry spices with no date. Also noted in the dry storage area were 3 containers of Coji berries, not in their original containers that were not dated. Also observed were open containers of walnuts, maca root powder and vanilla powder, all not dated with an open or expiration date. In addition, an open bag of croutons was not sealed.

During a concurrent interview with the DFNS, she stated that the spices had a shelf life of 1 year. She was unable to state how her staff monitored the expiration date when the spice containers were not dated. She further stated that she did not know the shelf life of the Coji berries, maca root powder or the vanilla powder. She was unable to state how her staff was able to monitor the expiration dates for those products. She stated that the bag of croutons should have been sealed and the plastic spoon should not be stored in the bottle of nutmeg to avoid cross contamination of these products.

A review of the hospital's policy titled, "Food Labeling and Dating" dated 9/11, revealed that herbs and spices had a product shelf life of 1 year. The policy did not indicate the shelf life for Coji berries, walnuts, maca root powder or vanilla powder.

Again the same day, 1/9/12, at 10:40 AM, a pan of raw fish was observed in the walk-in refrigerator with an expiration date of 1/7/12. Also observed was a pan of sliced deli turkey meat, not in its original packaging, with no date. A pan of uncooked turkey bacon was only partially covered. A pan of hoisin sauce, not in the original container, was dated 11/29/11. A large, shallow pan of previously cooked chicken breasts was uncovered. And a one pound block of raw cheddar cheese was observed with mold.

During a concurrent interview with the DFNS, she confirmed the date on the pan of raw fish was the expiration date and that date was 2 days past. She stated that the fish should have been discarded on that date. She also confirmed that the sliced deli turkey meat did not have a date and should have been dated. She was unable to state the expiration date for the turkey or how her staff knew when it expired since it was not dated. She stated that the turkey bacon should have been completely covered to prevent cross contamination and it was not. She was unable to state the expiration date was for the hoisin sauce or how long it could remain safely stored. She stated the moldy cheese should have been discarded. She further stated that it was the cooks practice to leave cooked food uncovered during the cooling process and the pan of chicken breasts were being monitored for safe cooling. She was unable to state how the staff could protect the chicken breasts from cross contamination during the 2 hours in which they were cooling and were left uncovered.

A review of the hospital's policy titled, "Food Labeling and Dating" dated 9/11, revealed that all prepared foods or foods stored out of the original container must be covered and labeled as to its contents with the shelf life expiration date displayed. It also stated that food should be disposed of on the day of the expiration date. The policy indicated that for luncheon meat such as turkey, it had a discard date of 5 days after opened. The policy did not indicate the shelf life for hoisin sauce.


5. During the initial tour of the kitchen on 1/9/12 at 9:40 AM, the blades on two table mounted can openers in the cook's area and in the cold prep area were noted to be worn and nicked.

During a concurrent interview with the DFNS, she confirmed that the can opener blades were worn and nicked. She stated that the can openers were cleaned daily and she was not notified that the blades were worn or nicked.

A review of the hospital's policy titled, "Cleaning Procedures, Food and Nutrition" dated 9/11, revealed that the staff was directed to inspect the cutting blades of the can openers. If the blades were nicked the staff was directed to notify the supervisor since the blade may need to be replaced. It further directed the staff to keep blades sharp, and that dull blades produced shavings.

According to the 2009 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.


6. During an interview with FSW 2 on 1/9/12 at 1:20 PM, he stated that his job included washing dishes and he had been working in the dietary department for 3 years. When he was asked what he would do if the dish machine did not work and the dishes were needed for the next meal. He stated that he would scrub and wash the dishes in the scraping and staging area of the dish machine, the counter area adjacent to the dish machine where the dishes were placed in racks and placed in the dish machine. This area did not contain any sinks. FSW 2 was unable to state how he would sanitize the dishes.

During a concurrent interview with the DFNS, she stated that the policy was for the staff to use disposable dishes if the dish machine did not function properly. She stated that FSW 2 knew the proper procedure. She was unable to explain why he was not able to verbalize the proper procedure.

A review of the hospital's policy titled, "Emergency Operations Plan, Food and Nutrition" dated 9/11, revealed that if food service is unable to proceed in a normal manner, if needed, single service ware would be used. A supply of disposable dishes and utensils were kept on hand.

Based on record reviews and staff interviews, the hospital failed to meet the nutrition needs of 3 of 5 patients who were reviewed for nutrition care (Patients 23, 24 and 25). The nutrition needs of Patients 23 and 24, both with a diagnosis of malnutrition, were not met when the nutrition recommendations from the registered dietitian were not communicated to the physician. For Patient 25, the TPN for the patient was not assessed in a timely manner so that the nutrition needs of the patient with severe protein-calorie malnutrition were not met during the hospital stay. These failures had the potential to further compromise the nutrition status and cause an overall decline in the medical status of these patients.

Findings:

1. The medical record for Patient 23 was reviewed on 1/11/12. The patient was admitted to the hospital on 12/30/11 with a medical history that included chronic respiratory failure; ventilator (breathing machine) dependent; quadriplegia (condition of paralysis in which a person loses complete or partial use of all limbs and the torso); a large, deep pressure ulcer (bed sore) on the sacrum (base of the spine); diabetes (disease in which there are high levels of sugar in the blood).; and gastrostomy tube (feeding tube) dependent. The reasons for this admission included status post cardiac arrest (heart stopped beating).

A review of the physician orders showed that a tube feeding was ordered on 12/31/11 for Glucerna (a nutritional formula used in feeding tubes, specific for diabetes) at a rate of 45 cc (cubic centimeters) per hour.

A review of the nutrition notes showed that the initial nutrition assessment was completed on 1/1/12 by Registered Dietitian 1 (RD 1), two days after the patient was admitted, one day after the tube feeding was started. The assessment indicated that the nutrition needs of the patient were estimated to be 1900 - 2300 calories and 90 - 115 grams of protein. The assessment indicated that the current tube feeding order provided only 1080 calories and 45 grams of protein. RD 1 recommended to change the tube feeding to Pulmocare (another nutritional formula used in feeding tubes, specific for breathing problems) at 60cc per hour to provide 2160 calories and 90 grams of protein. The assessment also indicated that the patient's nutrition status was malnutrition.

During an interview with the Director of Food and Nutrition Services (DFNS) on 1/11/12 at 9:50 AM, she stated that it was the standard of practice for the RD to document their nutrition recommendations for the physician on a "Malnutrition Assessment" form and place the form in the physician orders section of the chart. If the physician agreed with the recommendations, he/she signed, dated and timed the form and the RD recommendations became a physician order. She stated that this practice had produced the best results in communicating the RD recommendations to the physicians.

A review of the medical record revealed that the tube feeding was not changed per RD 1's recommendations. Also, there was no evidence that RD 1 had placed a Malnutrition Assessment form in the medical record to alert the physician about her recommendations. RD 1 was not available for interview.

Further review of the nutrition notes revealed a follow-up note by RD 2 dated 1/4/12. According to the follow-up note, the patient was still on a tube feeding of Glucerna at 45 cc per hour, 5 days after admission. The tube feeding provided 1080 calories and 45 grams of protein and remained inadequate to meet the patient's needs. The nutrition problems listed in the follow-up note included increased need for protein, multivitamins, zinc and vitamin C for wound healing needs for the pressure ulcer on the patient's sacrum. Another problem listed was inadequate enteral (tube feeding) nutrition due to the current tube feeding order did not meet the caloric needs of the patient. RD 2 recommended increasing the rate of the current tube feeding to 80 cc per hour and adding extra protein twice a day to provide the patient with 2040 calories and 110 grams protein a day. RD 2 also recommended adding multivitamin, vitamin C and zinc to the tube feeding.

A review of the physician orders showed a Malnutrition Assessment form was placed in the orders section. It contained all the recommendations from the 1/4/12 RD note. It was signed by the physician on 1/4/12 and the RD recommendations were implemented. For the first time since the patient was admitted, 5 days after admission, the nutrition care provided, met the needs of the patient.

During a concurrent interview with the DFNS and RD 2 on 1/11/12 at 10:15 AM, neither one could explain why RD 1 did not communicate her recommendations to the physician. They were unable to state why it took 5 days for Patient 23 to receive the amount of tube feeding required to meet the assessed nutrition needs.

2. The medical record for Patient 24 was reviewed on 1/11/12. The patient was admitted to the hospital on 12/31/11 with diagnoses that included acute renal (kidney) failure and uncontrolled diabetes. According to the physician orders the patient was placed on a Renal (special diet for patients with failing kidneys) 1800 calorie ADA (diabetic) diet when admitted.

During an interview with the DFNS on 1/11/12 at 10:45 AM, she stated that when a renal diet is ordered, the default order is 60 gram protein, 2 gram sodium and 2 gram potassium restrictions.

A review of the Nutrition notes showed that the initial nutrition assessment was completed by RD 2 on 1/1/12. The nutrition assessment indicated that the estimated nutrition needs for the patient were 1700 - 2000 calories and 70 grams protein. The patient's nutrition status was listed as malnutrition; the nutrition problems included protein deficiency. RD 2's recommendation was to continue with the current Renal 1800 Calorie ADA diet; even though the diet was restricted in protein and did not meet the patient's estimated needs. The patient was listed as being at High nutrition risk.

A follow-up note was documented on 1/4/12 by RD 1. The note indicated that the patient had improved appetite, the diet order was unchanged and RD 1 recommended to continue the same diet, even though the diet provided only 60 grams of protein and the patient's estimated needs were 70 grams of protein. RD 1's note indicated that the patient was now at moderate nutrition risk instead of high risk.

A review of the physician orders dated 1/6/12 revealed that the patient was started on hemodialysis a (treatment for kidney failure using a machine to remove waste products from the blood, also removes some protein) on 1/6/12.

A second follow-up note was documented on 1/9/12 by RD 1. The note indicated that the patient had been started on hemodialysis on 1/6/12 and 1/7/12. It further stated that the patient was eating 75 - 100% of meals and that the protein in the diet will be increased due to starting on hemodialysis. RD 1 recommended to change the patient's diet to 80 gram protein and add a vitamin supplement. The note stated that the patient had an increased need for protein due to starting hemodialysis. RD 1 further indicated that the patient was now at high nutrition risk. Another follow-up visit was scheduled for 2 - 3 days.

During an interview with the Director of Food and Nutrition Services (DFNS) on 1/11/12 at 9:50 AM, she stated that it was the standard of practice for the RD to document their nutrition recommendations for the physician on a "Malnutrition Assessment" form and place the form in the physician orders section of the chart. If the physician agreed with the recommendations, he/she signed, dated and timed the form and the RD recommendations became a physician order. She stated that this practice had produced the best results in communicating the RD recommendations to the physicians.

A review of the medical record on 1/11/12 revealed no documented evidence that a Malnutrition Assessment form was completed with RD 1's recommendations from the 1/9/12 note. There was no physician order to change the patient's diet to include more protein or add a vitamin supplement. Patient 24's diet remained the default Renal 1800 calorie ADA diet which provided only 60 grams of protein a day.

During an interview with RD 1 on 1/11/12 at 11:15 AM, she was unable to state why a Malnutrition Assessment form was not completed and inserted in the physician's orders. She stated that she thought she had done it and it must have been an oversight. She verified that Patient 24 had not received adequate protein since admission on 12/31/11, 11 days earlier. She further verified that the patient had a deficit of 20 grams of protein a day since 1/6/12 when the patient was started on hemodialysis, 5 days earlier.

3. The medical record for Patient 25 was reviewed on 1/11/12. The patient was admitted to the hospital on 12/29/11 with diagnoses that included severe malnutrition secondary to multiple bowel surgeries, dehydration and a large open abdominal wound. On 12/29/11 there was a physician order to start TPN (total parenteral nutrition, nutrition fed directly into the bloodstream instead of the stomach) per pharmacy protocols and a mechanical soft diet (easy to chew). TPN was started on 12/30/11.

A review of the nutrition notes revealed the initial nutrition assessment for Patient 25 was completed on 12/30/11 by RD 1. The assessment indicated that the patient's BMI (body mass index, a measure of body fat) was "12.8 (emaciated) malnourished." The assessment did not include documentation that TPN had been ordered. It stated that the patient had refused to eat over 3 days, complained of vomiting and was not hungry. The nutrition needs of the patient were estimated to be 1000 - 1200 calories initially, gradually increased to 1700 - 1900 calories, and 50 grams of protein. Nutrition problems included severe calorie protein malnutrition and increased need for protein. RD 1 indicated that the patient was at high nutrition risk and was to follow-up in 2 - 3 days.

During an interview with RD 1 on 1/11/12 at 3:00 PM, she stated that when she documented the initial nutrition assessment of the patient, it was before the TPN had started. She was unable to state why the order for TPN the day before the assessment did not indicate a need to assess the patient for TPN.

Further review of the nutrition notes revealed that a follow-up note was not documented until 1/3/12, 4 days after the initial assessment. The note indicated that the patient was on TPN and was being transferred to a skilled nursing facility the same day. It further stated that the TPN provided 913 calories a day, below established needs for the patient. The patient had been at the hospital for 5 days and the nutrition needs of the patient had not been met during the stay despite a diagnosis of severe protein-calorie malnutrition.

Further review of the medical record revealed that the patient was transferred to a skilled nursing facility on 1/3/12 with physician orders to continue TPN.

During further interview with RD 1 she stated that RD 2 should have written a follow-up assessment of Patient 25 the day after the TPN started on 12/31/11. She was unable to state why that did not happen. RD 2 was unavailable for interview.

28135

Based on observations, record reviews and interviews, the hospital failed to maintain the environment in such a manner that the safety and well-being of the patients was assured when the disaster food plan for the hospital contained inconsistencies, did not meet the needs of the patients and the dietary services did not maintain adequate supplies to meet the needs of the patients in the event of a disaster. Also there was no evidence that disaster food plan was approved by the Governing Board. This failure created the potential to result in malnutrition of the patients during a disaster in a hospital with a licensed bed capacity of 102.
.
Findings:

During a review of the hospital's policy and procedure titled, "Emergency Operations Plan" for Food and Nutrition Services, dated 9/11, it was noted that the purpose of the policy was to provide basic dietetic needs during an emergency. It further stated that in addition to the 3-day extra food supply located within food and nutrition services, an additional 2-day supply of food (non-perishables) were located in the Medical Office Building (MOB).

During an interview with the Director of Food and Nutrition Services (DFNS) on 1/9/12 at 1:35 PM, she stated that it had been over 6 months since the emergency food was stored in the MOB. She further stated that she was in the process of transition to storage of the disaster food in the dietary department and that there were no other disaster foods stored in the facility. When asked about the current plan for food service during a disaster, she stated that the plan was to feed 306 people three meals a day. She stated that she calculated this number based on the number of licensed beds in the hospital, times three. She further presented a written "7 Day Disaster Menu - Regular Diet" dated 2011, and stated that it was the hospital's disaster menu.

During a concurrent observation of the disaster food supplies in the dietary department and a review of the "7 Day Disaster Menu - Regular" posted in the dry storage room on 1/9/12 at 1:35 PM, it was noted that "Milk 1 c (cup or 8 ounces) was on the menu for 14 meals. The hospital did not have any dry milk. A review of the disaster menu indicated that milk provided a significant portion of the protein component of the menus. Without milk, the menu provided very little protein. Seven of the meals on the menu utilized canned soup as an entrée when no other protein-rich foods were included. The nutrition information on the canned soups were noted to include between 1 and 3 grams of protein per serving. Peanut butter and jelly sandwich was listed as the entrée at lunch on day 4 of the menu. The hospital only had approximately 150 individual serving cups of peanut butter and no bulk peanut butter, in adequate to feed 306 people.

Further review showed that dry cereal was listed for breakfast on 6 of the 7 days of the menu, which would require 1.836 servings needed to feed 306 people. The hospital only had 288 servings of dry cereal on hand. A Basic Meal Plan was included in the policy which stated that pureed diets will use canned pureed meats and vegetables. The hospital did not have these items available.

Further review of the policy revealed that the available food supplies should feed approximately 550 people per day. The DFNS had stated that the plan was to feed 306 people.

During a concurrent interview with the DFNS she stated that clearly there weren't adequate supplies to meet the plan. She was unable to explain why the policy had been reviewed and approved by the Governing Board in September 2011 but was not accurate in terms of the number of people that would be served in a disaster and the location of the disaster food. She further stated that the reason she did not have adequate disaster food on hand was because, since they were no longer able to store the food at the MOB, she did not have room to store the amount of disaster food. She was unable to explain why it had been over 6 months and the problem of where to store the disaster food had not been resolved.

During an interview with the PIM (Performance Improvement Manager) on 1/12/12 at 9:30 AM, she stated that the quality committee was not aware that the disaster food supplies were not adequate to meet the needs of the patients in the event of a disaster. She stated that the problem with the lack of space for the disaster food supply should have been brought to the attention of the quality committee so that the problem could be resolved.

During an interview with the CEO on 1/11/12 at approximately 2:30 PM, he stated that the amount of emergency food stores available in the facility was enough for 40 people for three days. When asked to review the disaster preparedness policy, approved 9/11, from the food and nutrition manual, it read that the food stores should be sufficient for 550 people. The CEO stated that he was unaware of the amount of food required in the policy, and would not have approved it if he had been aware. He further stated that the plan included a reliance on "sister facilities" to provide food in the event of a disaster. He was unable to state how they would access this food in the event that the hospital needed to be self-sufficient, for example when the sister facilities suffered during the same disaster or the roads were inaccessible.

The facility policy, Disaster Preparedness, in the Food and Nutrition Manual bore the Governing Board Approval date of 9/11. The Board Subcommittee minutes from 9/26/11 did not include documentation that the policy was reviewed or approved.

In an interview with the Director of Medical Staff on 1/13/12 at 2:45 PM, she concurred that there was no evidence that the nutrition department's Disaster Preparedness policy, which was dated approved 9/11, went through the governing body for approval.

Based on observation, interview and record review, the facility failed to: 1. ensure that operating room climate conditions were controlled to inhibit the spread of infection, and failed to 2. ensure that the policy on operating room climate was approved by the governing body, creating the increased risk of infection for patients using the ORs in the facility.

Findings:

1. During a tour of the OR on 1/10/12 at 8:25 AM with RN 1, the gauge on the wall of OR 1 indicated a temperature of 63.7 degrees and humidity of 28%. OR 2 had a temperature of 68.9, humidity 25 %. The GI procedure room had a temperature of 67.9 degrees, and humidity of 27%

In a concurrent interview with RN 1, she stated that the facility goal humidity range was 27% to 60%.

During a tour of the operating rooms on 1/11/12, the temperature and humidity logs were requested. The logs for January through June, 2011 and January 2012 were reviewed, and the logs read that the " humidity of the operating room must be maintained between 30-60% " , and " report temperatures above 70 degree " . There was also a space on the log to record problems and corrective actions. The temperature and humidity ranges fell outside of the target ranges on multiple dates during the months of January, February and June, 2011, and during January, 2012. Humidity as low as 19% was noted in January, 2012, and was below 30% for many consecutive days. Humidity was as high as 74% was noted in June, 2011, and was above 60% for many consecutive days. The portion of the log for noting problems and corrective actions was left blank.

During an interview with the OR Mgr on 1/11/12 at 10:15 AM, she stated that when temperature and humidity were out of range, she would call engineering. She stated that they were not always documenting the calls or what was done after the calls, or if the problem was corrected.

The facility policy, Humidity Control Systems, reviewed 2/11, was seen and read in part, " The range required is 30-60%. "

2. The Governing Board Subcommittee minutes were reviewed on 1/13/12 with the Director of Medical Staff.

The facility policy, Humidity Control Systems, from the Engineering manual bore a Governing Board Approval date of 5/11. The minutes from the 5/31/11 Board Subcommittee were reviewed, and the table of contents of the Engineering manual was approved, but there was no evidence that the Humidity Control Systems policy was reviewed or approved on that date.

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

1. ensure that a policy for glucometer cleaning was implemented throughout the facility,

2. ensure infectious disease screening of physicians providing patient care in the facility, and

3. ensure the correct use of sterilizing chemicals, creating the increased risk of the spread of infection to patients in the facility.

4. ensure an effective infection control surveillance system was developed and implemented to ensure the safe food handling in the dietary department when there was :
A. Inadequate monitoring of cooked, potentially hazardous food for safe cool down temperatures to minimize pathogenic (disease causing) microorganism growth.
B. Ineffective monitoring of staff within food preparation areas without proper hair restraint.
C. Inadequate monitoring of food items that were not covered or dated, had passed their expiration date or were improperly stored so as to impact the safety of the food.
D. Table mounted can opener blades that were not maintained in a manner that prevented canned goods from becoming contaminated during use.
E. One dishwashing staff did not know the procedure from manual dishwashing in the event the dish machine did not function properly.
These failure had the potential to result in an outbreak of food borne illness in a hospital with a licensed bed capacity of 102 (cross refer A 620)

Findings:

1. During an interview with RN 10 in the ER, she was asked to demonstrate use of the glucometer as she would use it on a patient. She demonstrated the machine and then replaced it without cleaning. When asked about how often it was cleaned, she said she thought it was cleaned each shift.

During an interview with RN 11 in the ER, she was asked to demonstrate use of the glucometer as she would use it on a patient. She demonstrated the machine and then replaced it without cleaning. When prompted, she stated that it should be cleaned after each patient.

During an interview with the Mgr Inf Control on 1/13/12 at 12:25 AM, he stated that glucometers were to be cleaned each shift, or if used for an isolation patient, after each use. He stated that the facility followed Center for Disease Control guidelines for infection control practices, as well as some other national guidelines.

The facility policy, Disinfection and Sterilization of Hospital Equipment Patient Care Items, approved 9/11, was provided by the Mgr Inf Control, and read in part, "Reusable patient care equipment is cleaned after patient is discharged and/or prior to next patient use."

According to the Center for Disease Control information for healthcare providers provided through their online website, " Infection Prevention During Blood Glucose Monitoring and Insulin Administration " , if blood glucose monitoring devices must be shared, they must be cleaned and disinfected after every use per manufacturer ' s directions.

2. During a review of the credential file of MD 1 on 1/10/12 at 10:35 AM, there was no evidence of TB or hepatitis screening in the file.

In concurrent interview with the Dir Medical Staff, she concurred that there was no evidence of TB or hepatitis screening for MD 1 in his file.

During an interview with the Mgr Inf Control on 1/10/12 at 1:15 PM, he stated that there was no policy on infection screening for physicians, although there was for all other staff.

The facility policy, Pre-employment Health Screen (title handwritten by staff), revised 6/11, indicated that medical staff and non patient-care related employees were not required to have a tuberculosis screen, but were required to have immunization screening and vaccine acceptance or declination.

According to CDC's MMWR: Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC) dated December 26, 1997 indicated:

"Because of their contact with patients or infective material from patients, many health-care workers (HCWs) (e.g., physicians, nurses, emergency medical personnel, dental professions and students, medical and nursing students, laboratory technicians, hospital volunteers, and administrative staff) are at risk for exposure to and possible transmission of vaccine-preventable diseases. Maintenance of immunity is therefore an essential part of prevention and infection control programs for HCWs."

According to the CDC document, Guidelines for Preventing the Transmission ofMycobacterium Tuberculosis in Healthcare Settings, 2005., "All HCWs who have duties that involve face-to-face contact with patients with suspected or confirmed TB disease (including transport staff )
should be included in a TB screening program. The following are HCWs who should be included in a TB screening program: ...Physicians (Assistant, Attending, Fellow, Resident or Intern) ..."

According to a communication on 9/23/08 from the California TB Controllers, the California Occupational Health Branch recommends annual TB screening of HCWs in California. Health care facilities that want to perform less frequent screening must perform institutional and community risk assessments and must obtain the approval of the local health officer. These facilities must perform TB screening of HCWs at least every two years.

3. During an interview with the SP Tech on 1/10/12 at 8:25 AM, she stated that she used Medline Enzymatic cleaner in a dilution of 1-2 pumps with an unknown quantity of water.

The label on the Medline Enzymatic cleaner was reviewed and gave directions for a specific dilution of the enzymatic cleaner should be prepared for use, using measured portions of water and cleaner.

During a concurrent interview with the SP Tech, she stated that she would need to find a container to measure the water.



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4. The hospital failed to ensure an effective infection control surveillance system was developed and implemented to ensure the safe food handling in the dietary department which had the potential to result in an outbreak of food borne illness.

A. During the initial tour of the kitchen on 1/9/12 at 10:40 AM, a pan of previously cooked rice was observed in the walk-in refrigerator, undated.

During a concurrent interview with Cook 1, she stated that the rice was leftover from the celebratory dinners given to patients who are new parents. She stated that the rice had been made the previous day, but verified that there was no date. Cook 1 stated that the rice should have been monitored for safe cool down and temperature written on the Cooling Log.

During a concurrent interview with the DFNS, she stated that all leftover food should be thrown out and not saved. She confirmed that previously cooked rice was a potentially hazardous food that required temperature monitoring of the cool down process.

According to the 2009 US Food and Drug Administration's Food Code (3-501.14 Cooling) safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (PHF) has been consistently identified as one of the leading contributing factors to foodborne illness. During slow cooling, PHF are subject to the growth of a variety of pathogenic microorganisms. If the food is not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness. The Food Code provision for cooling provides for cooling from 135°F to 41°F or 45°F in 6 hours, with cooling from 135°F to 70°F in 2 hours.
A review of the hospital's policy titled, "Food Preparation" undated, revealed that during the cooling of PHF the internal temperature was to be taken at the end of two hours and at the end of six hours and recorded on the Cooling Log.

A review of the Cooling Log for the previous week revealed that the rice was not on the log.

The DFNS and Cook 1 were unable to state how they could ensure that the rice had been safely cooled and was safe to feed patients if it wasn't recorded on the Cooling Log.

During an interview with the Infection Control Preventionist (ICP) on 1/13/12 at 11:30 AM, he stated that he conducts formal infection control rounds in the dietary department quarterly. He stated that he does not monitor for previously cook potentially hazardous food and ensure that the cooling process for those foods have been monitored.

B. During the initial tour of the kitchen on 1/9/12 from 9:25 to 10:30 AM, it was observed that the DFNS had a hairnet on that was only partially covering her hair. She had a ponytail about twelve inches long that was not restrained in the hairnet At 10:30 AM, it was also observed that Engineering Staff 1 (ES 1) entered the kitchen in the vicinity of the ice machine with a hairnet that was only partially covering his hair, He also had a ponytail about ten inches long that was not restrained in a hairnet.

During an interview with the DFNS on 1/9/12 at 10:30 AM, she stated that both her hair and the hair of ES 1 should be fully restrained in a hairnet while present in the kitchen.

During subsequent observations on 1/10/12 at 11:25 AM, the DFNS again did not have her hair fully restrained in the hairnet. Concurrently, Food Service Worker 1 (FSW 1) entered the kitchen and walked through the kitchen and food preparation areas without a hairnet or restraint. On 1/11/12 at 1:50 PM, the DFNS walked through the kitchen and food preparation areas, from her office without a hair restraint.

A review of the hospital's policy titled, "Infection Control and Contamination Control, Food and Nutrition" dated 9/11, revealed that the policy was to create and maintain an environment that is physically and bacteriologically safe for the storage, preparation and serving of food. It further stated that hairnets or caps must be worn by all kitchen staff that handle or are near food.

During an interview with the ICP on 1/13/12 at 11:30 AM, he stated that he conducts formal infection control rounds in the dietary department quarterly. He further stated that one of items observed in the surveillance is that hairnet or caps are worn by the staff and hair is generally covered. He stated that staff that is in the kitchen but not preparing food was not required to wear a hair restraint and therefore was not counted. He was unable to state how food could be protected from cross contamination by hair if staff present in the kitchen did not have restrained hair.

C. During the initial tour of the kitchen on 1/9/12 at 9:25 AM in the walk-in refrigerator, the following was observed: a one gallon container of salad dressing labeled with an open date of 12/6/11 and a one gallon container of Caesar salad dressing labeled with an open date of 12/7/11. Both of these products had been opened for greater than one month at the time of the observation. Also observed was a one gallon container of lite ranch salad dressing that had been opened with no open date.

During a concurrent interview with the DFNS, she stated that the staff was supposed to date the containers with the date the product was opened. She further stated that she would have to refer to their policy for the shelf life of the opened salad dressings.

A review of the hospital's policy titled, "Food Labeling and Dating" dated 9/11, revealed that for salad dressings, the expiration date was 5 days after opening.

The same day at 9:45 AM, also observed in the cook's area was a bottled labeled nutmeg with a plastic spoon inside. In the dry storage room were 3 containers of Coji berries, not in their original containers that were not dated. Also observed were open containers of walnuts, maca root powder and vanilla powder, all not dated with an open or expiration date. In addition, an open bag of croutons was not sealed.

During a concurrent interview with the DFNS, she stated that she did not know the shelf life of the Coji berries, maca root powder or the vanilla powder. She was unable to state how her staff was able to monitor the expiration dates for those products. She stated that the bag of croutons should have been sealed and the plastic spoon should not be stored in the bottle of nutmeg to avoid cross contamination of these products.

A review of the hospital's policy titled, "Food Labeling and Dating" dated 9/11, revealed that herbs and spices had a product shelf life of 1 year. The policy did not indicate the shelf life for Coji berries, walnuts, maca root powder or vanilla powder.

Again the same day, 1/9/12, at 10:40 AM, a pan of raw fish was observed in the walk-in refrigerator with an expiration date of 1/7/12. Also observed was a pan of sliced deli turkey meat, not in its original packaging, with no date. A pan of uncooked turkey bacon was only partially covered. A pan of hoisin sauce, not in the original container, was dated 11/29/11. A large, shallow pan of previously cooked chicken breasts was uncovered. And a one pound block of raw cheddar cheese was observed with mold.

During a concurrent interview with the DFNS, she confirmed the date on the pan of raw fish was the expiration date and that date was 2 days past. She stated that the fish should have been discarded on that date. She also confirmed that the sliced deli turkey meat did not have a date and should have been dated. She was unable to state the expiration date for the turkey or how her staff knew when it expired since it was not dated. She stated that the turkey bacon should have been completely covered to prevent cross contamination and it was not. She was unable to state the expiration date was for the hoisin sauce or how long it could remain safely stored. She stated the moldy cheese should have been discarded. She further stated that it was the cooks practice to leave cooked food uncovered during the cooling process and the pan of chicken breasts were being monitored for safe cooling. She was unable to state how the staff could protect the chicken breasts from cross contamination during the 2 hours in which they were cooling and were left uncovered.

A review of the hospital's policy titled, "Food Labeling and Dating" dated 9/11, revealed that all prepared foods or foods stored out of the original container must be covered and labeled as to its contents with the shelf life expiration date displayed. It also stated that food should be disposed of on the day of the expiration date. The policy indicated that for luncheon meat such as turkey, it had a discard date of 5 days after opened. The policy did not indicate the shelf life for hoisin sauce.

During an interview with the ICP on 1/13/12 at 11:30 AM, he stated that he conducts formal infection control rounds in the dietary department quarterly. He stated that he monitors for expired products. He did not know the shelf life of the items found during the survey. He also was unable to state how to monitor the shelf life of foods removed from their original containers and were not dated.

D. During the initial tour of the kitchen on 1/9/12 at 9:40 AM, the blades on two table mounted can openers in the cook's area and in the cold prep area were noted to be worn and nicked.

During a concurrent interview with the DFNS, she confirmed that the can opener blades were worn and nicked. She stated that the can openers were cleaned daily and she was not notified that the blades were worn or nicked.

A review of the hospital's policy titled, "Cleaning Procedures, Food and Nutrition" dated 9/11, revealed that the staff was directed to inspect the cutting blades of the can openers. If the blades were nicked the staff was directed to notify the supervisor since the blade may need to be replaced. It further directed the staff to keep blades sharp, and that dull blades produced shavings.

According to the 2009 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.

During an interview with the ICP on 1/13/12 at 11:30 AM, he stated that he conducts formal infection control rounds in the dietary department quarterly. He stated that he did not observe the can opener blades for integrity of the blade.

E. During an interview with FSW 2 on 1/9/12 at 1:20 PM, he stated that his job included washing dishes and he had been working in the dietary department for 3 years. When he was asked what he would do if the dish machine did not work and the dishes were needed for the next meal. He stated that he would scrub and wash the dishes in the scraping and staging area of the dish machine, the counter area adjacent to the dish machine where the dishes were placed in racks and placed in the dish machine. This area did not contain any sinks. FSW 2 was unable to state how he would sanitize the dishes.

During a concurrent interview with the DFNS, she stated that the policy was for the staff to use disposable dishes if the dish machine did not function properly. She stated that FSW 2 knew the proper procedure. She was unable to explain why he was not able to verbalize the proper procedure.

A review of the hospital's policy titled, "Emergency Operations Plan, Food and Nutrition" dated 9/11, revealed that if food service is unable to proceed in a normal manner, if needed, single service ware would be used. A supply of disposable dishes and utensils were kept on hand.

During an interview with the ICP on 1/13/12 at 11:30 AM, he stated that he conducts formal infection control rounds in the dietary department quarterly. He stated that he was not aware that the dishwashing staff did not know how to manually wash dishes in a sanitary manner.

Based on interview and record review, the facility failed to implement a system for ensuring documentation of the return of radiopharmaceutical materials to the manufacturer, creating the risk of improper disposal of radiopharmaceutical materials and the risk of radiation exposure to facility patients and staff.

Findings:

During a review of the nuclear materials delivery logs on 1/11/12 at 11:55 AM, for some days the logs did not specify the amount of containers of material delivered or picked up.

In a concurrent interview with the Dir Security, she concurred that the log should indicate the number of bags of nuclear materials received and returned and that the log was missing some of this information.

The facility policy, Waste Disposal, approved 10/11, read in part, "At the present time, all spent unit dose containers are returned to the Radiopharmacy via licensed courier."

Based on interview and document review, the facility failed to ensure that for one patient in the ED, Patient 5, pain was assessed as the fifth vital sign, creating the risk of untreated pain for Patient 5.

Findings:

During a review, on 1/10/12 at 1:50 PM, of the medical record of Patient 5 in the ER, it was noted that the patient had vital signs taken at 11:53 AM, 12:53 PM, and 1:46 PM. However, there was no assessment of pain done at the 12:53 PM assessment interval. The grid in the electronic medical record had spaces to record other vital signs such as blood pressure and pulse, but not for a pain assessment.

During a concurrent interview with the Dir ER/ICU, he concurred that there was no pain assessment recorded for Patient 5 at the 12:53 PM time.

The facility policy, Pain Management, approved 9/11, read in part, "Assess for pain using a point scale (numeric, visual analog or text based) consistently as follows: Upon admission, After any pain-producing event, With each new report of pain, Routinely with vital signs and PRN (as needed)..."