HospitalInspections.org

Based on observation, interview and document review, the Governing Body did not fulfill its responsibilities in the conduct of the hospital as an institution. The following deficient practices were identified:

1. The hospital failed to ensure that the rights of patients were protected and promoted. (Refer to A-115).

2. The hospital's Quality Assessment and Performance Improvement Program failed to maintain an effective assessment of the hospital's organization, services and all hospital departments. (Refer to A-263).

3. The hospital failed to ensure the quality of patient medical care through enforcement of the facility medical staff bylaws. (Refer to A-338).

4. The hospital failed to ensure that the Nursing Services were organized and that the delivery of nursing care was supervised. (Refer to A-385).

5. The facility failed to meet the Condition of Participation for provision of pharmacy services. (Refer to A-490).

6. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases in all areas of the hospital including all off-site locations operating under the hospital's provider number. (Refer to A-747).

7. The hospital failed to ensure that a Registered Nurse (RN) was physically present at all times at 2 of 4 outpatient facilities (2 urgent care clinics) which provided nursing services to patients. This failure had the potential to contribute to the lack of proper oversight of Licensed Vocational Nurses (LVNs - require RN oversight) who worked at the urgent care clinics. This failure also had the potential to contribute to inadequate patient care and the potential for patients to not have their care needs met. (Refer to A-1076).

The cumulative effect of these systemic problems resulted in the possibility of patient harm in a universe of 191 patients.

Based on interview and record review, the hospital failed to ensure the rights of the patients were protected and promoted because:

1. Three of 6 grievances reviewed were not investigated (Refer to A-0119).

2. Letters sent to two complainants did not provide all required information about the steps taken to respond to the grievance, the resolution, and the date completed (Refer to A-123).

3. The adherence to Hospital policy governing consent for medical treatment for 6 of 51 sampled patients ( Patient's 1, 11, 49, 61, 64 and 43). This failure had the potential for the patients not to receive information needed in order to make informed decisions regarding his/her care. (Refer to A-131)

4. The hospital did not follow its policy for notification of one patient who received a blood transfusion with potentially infected blood (Refer to A-144).

5. That 4 of 51 sampled patients (Patient 43, 65, 61 and 11) had least restrictive interventions determined to be ineffective before being placed in restraint. This failure had the potential for a patient to be placed in an unnecessary restraint. (Refer to A-164)

6. For 1 of 51 sampled patients (Patient 11), the physician signed an order for restraints but did not document the clinical need, method of restraint, or the alternatives tried (Refer to A-169).

The cumulative effect of these systemic failures meant the hospital did not protect and promote the rights of all of the patients receiving care in the hospital for a universe of 191 patients.

Based on interview and record review, the hospital did not ensure that 2 of 6 grievances reviewed (for Patients 7 and 8) were investigated, creating the risk of persistent poor practices and substandard healthcare for a universe of 191 patients using the hospital.

Findings:

The hospital policy title, "Grievance Policy" (effective November, 2007), read in part, "The Grievance Committee will assure that the grievance is investigated. Investigation is to occur in a timely manner."

1. The grievance of Patient 8 was randomly selected and seen in the hospital computer system on November 29, 2012, and included allegations that on April 18, 2012 that she knew that the physician was busy with a critical patient but believed her discharge paperwork might be ready. When she sent her son to the nursing station to inquire about discharge, he was verbally abused by the Emergency Department (ED) staff.

The grievance was discussed with Quality Staff 2 on November 29, 2012 at approximately 10 AM. She reviewed the documentation in the computer and stated that there should have been an investigation, but that documentation of an investigation was not made.

During an interview with the ED Manager on November 30, 2012 at 8:50 AM, she stated that she recalled filling out paperwork regarding the complaint about staff yelling at a child, but did not keep a copy. She stated that no one in the ED keeps track of complaints.

The response letter to Patient 8 was reviewed and did not include information about the steps taken to investigate the grievance about verbal abuse. The letter did not explain why nursing staff was not available to give her information about her discharge. Instead, the letter included the statements, "The emergency room is an extremely busy area and it is not safe for anyone involved for a young child to walk around the area unattended. In the future, it would be best that your son not accompany you to the emergency room if possible."

2. The grievance of Patient 7's grandmother from May 3, 2012 was randomly selected on November 29, 2012 and was viewed in the hospital's computer. The grievance contained allegations that Patient 7 was seen twice in the ED and discharged with medications, but was subsequently admitted to another hospital with a diagnosis of pneumonia.

The grievance was discussed with Quality Staff 2 on November 29, 2012 at 10 AM. She reviewed the documentation in the computer and stated that there should have been an investigation, but that documentation of an investigation was not made. She stated that the Emergency Department Director (ED Dir) attempted to contact the complainant by phone, but was unable to reach her. She stated that the complaint had been attributed to Medical Doctor (MD) 2, the ED physician who saw the patient.

The response letter to Patient 7's grandmother was reviewed and stated, "I forwarded your concerns to [Dr. Name] who is the Medical Director of the Emergency department, and he informed me that as of the date of this letter he did attempt to contact you and left a message with his phone number." There was no attempt to investigate the concerns described, such as review of the medical record or interviewing staff.

Based on interview and record review, for 2 of 6 grievances reviewed, the hospital did not provide complainants with a written notice of its decisions that included the steps taken to investigate the grievance and the results of the grievance process and the date of completion, creating the risk of unresolved grievances for those complainants.

Findings:

The hospital policy title, Grievance Policy (effective November, 2007), read in part, "Within five (5) business days following the Grievance Committee decision, 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; The results of the investigation and the subsequent decision of the Committee; The name and number of a hospital contact person should further information be required."

The response letter, dated May 10, 2012, to Patient 7's grandmother was reviewed and did not include the results of the investigation, or the date it was completed. The response letter, dated April 26, 2012, to Patient 8 did not include the steps taken on behalf of the patient to investigate the grievance, or the date the investigation was completed.

Based on Hospital policy review, clinical record review and staff interviews the facility failed to ensure the adherence to Hospital policy governing consent for medical treatment for 7 of 51 sampled patients (Patients 1, 5, 11, 49, 61, 64 and 43). This failure had the potential for the patients to not receive information needed in order to make informed decisions regarding his/her care.

Findings:

During a review, on November 29, 2012, of the Hospital policy PCS-900005, dated March 2001, entitled, "Informed Consent/Informed Decision Making" the policy required, " Evidence of informed consent in the hospital medical record...the record must contain a fully completed consent form".

During a review, on November 29, 2012, of the Hospital Medical Staff Bylaws, dated August 2012, the bylaw required "Evidence of informed consent in the hospital medical record", and "...the record must contain a fully completed consent for, in which the patient has acknowledged that an informed consent was provided by the physician" and "...the record must contain a fully completed consent form".

1. A review of the clinical record for Patient 49, on November 27, 2012 noted that the patient was admitted on November 4, 2012 with a diagnosis of cholelithiasis (stones in the gall bladder). The record noted that the patient underwent a medical procedure, a cholangiogram (an x-ray with the use of fluorescent fluids to view the bile duct structure) to check tube placement and resolution of obstruction on November 19, 2012. The Consent to Surgery or Special Procedure form was noted that the Physician Certification portion of the form was not completed with a date, time and signature of the physician.

During an interview with the Registered Nurse (RN) 3 on November 27, 2012 at 10:45 AM, she confirmed that the medical procedure was performed and that the Physician Certification portion of the form was not completed with a date, time and signature of the physician.

2. A review of the clinical record for Patient 61, on November 27, 2012 noted that the patient was admitted on November 7, 2012 with a diagnosis of congestive heart failure (a condition in which the heart cannot pump enough blood to the rest of the body) and pneumonia (lung infection). The record noted that the patient underwent a medical procedure, a vena cava filter placement (a type of blood vessel filter) on November 14, 2012. The Consent to Surgery or Special Procedure form was noted that the Physician Certification portion of the form was not completed with a date, time and signature of the physician.

During an interview with RN 4 on November 27, 2012 at 3:15 PM, she confirmed that the medical procedure was performed and that the Physician Certification portion of the form was not completed with a date, time and signature of the physician.

3. A review of the clinical record for Patient 64, on November 30, 2012 noted that the patient was admitted on November 21, 2012 with a diagnosis of malignant neoplasm of the rectum (colon cancer). The record noted that the patient underwent a medical procedure, an exploratory laparotomy, excision of retro-sigmoid tumor, lower anterior anastomosis (abdominal surgery) on November 29, 2012. The Consent to Surgery or Special Procedure form was noted that the Physician Certification portion of the form was not completed with a date, time and signature of the physician.

During an interview with RN 5 on November 30, 2012 at 11:10 AM, she confirmed that the medical procedure was performed and that the Physician Certification portion of the form was not completed with a date, time and signature of the physician.



26502

4. A review on November 28, 2012, of Patient 11's medical record was conducted. Patient 11 was admitted to the hospital on October 19, 2012, with admitting diagnoses that included respiratory failure and cancer of the colon. Patient 11 was ventilator dependent.

According to the State Operations Manual, Appendix A, revised date, December 22, 2011, Section 482.24 (2) (c) (v), it stipulated, "All records must document a properly executed informed consent form that reflects the patient's consent process except in emergencies."

An informed consent form, in order to be properly executed, must be consistent with hospital policy. A properly executed informed consent form contains the following minimum elements:
a. Name of the hospital where the procedure or other type of medical treatment is to take place;
b. Name of the specific procedure, or other type of medical treatment for which consent is being given;
c. Name of the responsible practitioner who is performing the procedure or administering the medical treatment;
d. Statement that the procedure or treatment, including the anticipated benefits, material risks, and alternative therapies, was explained to the patient or the patient's legal representative
e. Signature of the patient or the patient's legal representative.
f. Name of the practitioner who conducted the informed consent discussion with the patient or the patient's representative.
g. Date, time, and signature of the person witnessing the patient or the patient's legal representative signing the consent form.
h. Indication or listing of the material risks of the procedure or treatment that were discussed with the patient or patient's representative.
i. Statement, if applicable, that physicians other that the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery.

The hospital failed to ensure that Patient 11's informed consent forms were dated, timed and authenticated (signed) by the responsible practitioners for the following procedures:
a. Esophagogastroscopy ('EGD' - an examination procedure to inspect the esophagus and stomach through a special scope, 'endoscope') performed on November 21, 2012.
b. Thoracentesis of the Right Chest (a surgical procedure that punctures the chest wall to remove fluid from the chest cavity) on November 20, 2012.
c. Transvenous Temporary Pacemaker Insertion (an application of an electrical current between electrodes placed on the skin to stimulate the heart to beat) on November 19, 2012.
d. Permanent Pacemaker Insertion (an electrical device surgically implanted in the body to control the beating of the heart by a series of rhythmic electrical discharges) on November 15, 2012

There was no documented evidence in the medical record or from other facility sources that the "Physician's Certification" forms of the above mentioned procedures were discussed by Patient 11's responsible practitioners or physician to the patient or to patient's legal representative, discussing the risks and benefits of the procedures; adverse reactions to be expected by the procedures; alternatives to the above identified procedures; anticipated results of not having the procedures; potential problems that may occur during recuperation of the above mentioned procedure or any research or economic interest the physician may have regarding the procedures.

The Physician's Certification forms for Patient 11 were found to be incomplete, blank, not filled out, not dated, not timed and not authenticated (signed) by the responsible practitioner.

The hospital's "Medical Staff Bylaws", dated August 2012, stipulated, "Evidence of informed consent in the hospital medical record...the record must contain a fully completed consent for, in which the patient has acknowledged that an informed consent was provided by the physician" and "...the record must contain a fully completed consent form..."

During an interview with the Intensive Care Unit (ICU) manager on November 28, 2012, at 11:45 AM, she confirmed the finding that Patient 11's physician did not date, time or sign the physician's certification form for Patient 11's mentioned procedures as per hospital policy.



25179

5. A review of Patient 43's record was conducted on November 27, 2012 and showed that the patient was admitted to the facility on November 19, 2012 with a diagnosis of a syncopal episode (a dizzy spell). Patient 43's family member signed a consent for a lumbar puncture (spinal tap) on November 22, 2012 at 1:55 PM. The "Physician Certification" section for the physician listed the following to document:

The procedure was discussed.
The risks and benefits of the procedure.
Any reactions that may be expected to occur.
Any alternative methods of treatment.
The anticipated results of not having the procedure.
The potential problems that may occur during recuperation and
any research or economic interest the physician may have regarding the treatment.

The physician did not document that the patient or the patient's family member received the information needed to give informed consent.

In an interview on November 27, 2012 with Registered Nurse (RN) 10, RN 10 acknowledged that the patient's physician should give the patient or patient's family information about the proposed procedure to be performed on the patient before an informed consent could be given for the procedure.



26881

6. The Medical Staff Bylaws (August, 2012) on page 96 read in part, "There must be documentation that the risks, benefits and alternatives (R,B&A) of the planned procedure have been explained and the patient agrees to proceed."

The record of Patient 1 was reviewed on November 28, 2012 and contained a form titled, Consent to Surgery or Special Procedure. The form was signed by the patient on October 1, 2012. The form was signed by the surgeon on October 5, 2012, but there was no time provided to verify that an informed consent discussion occurred prior the surgery on October 5, 2012.

During an interview with the Medical Director on November 30, 2012 at approximately 2:30 PM, he stated that it was important that the physician document the informed consent discussion.



31467

7. During a review of the closed clinical record for Patient 5, the outpatient surgery center consent form dated November 26, 2012 was reviewed and the area designated for the surgeon's signature was left blank. This indicated a lack of documented evidence that the surgeon counseled the patient regarding the risks and benefits of the operation before surgery was performed.

During a concurrent interview with Registered Nurse (RN) 11 on November 26, 2012 at 3:40 PM, she confirmed the absence of the surgeon's signature on the form and agreed that it should have been signed before surgery.

During a review, on November 29, 2012, of the Hospital policy PCS-900005, dated March 2001, entitled "Informed Consent/Informed Decision Making" the policy requires "Evidence of informed consent in the hospital medical record...the record must contain a fully completed consent form".

During a review, on November 29, 2012, of the Hospital Medical Staff Bylaws, dated August 2012, the Bylaws require "Evidence of informed consent in the hospital medical record...the record must contain a fully completed consent for, in which the patient has acknowledged that an informed consent was provided by the physician" and "...the record must contain a fully completed consent form".

During a review of Patient 28's medical record on November 27, 2012 at 10:10 AM, with the nurse on the L&D (labor and delivery) unit, it was noted that two consent forms titled, "Consent to Surgery or Special Procedure" were not signed by the same primary surgeon for the following completed procedures:

On November 25, 2012 at 2:20 PM a consent form for a 'Repeat Cesarean Section' was signed by Patient 28, and witnessed by the registered nurse. The form was not signed by the surgeon.

On November 26, 2012 at 7:35 AM, a consent form for a 'blood transfusion' was signed by Patient 28, and witnessed by the registered nurse, however, it was not signed by the surgeon.

In a concurrent interview with the Labor and Delivery Nurse Manager, she reported that this particular surgeon usually signed the consents.

Based on interview and record review, the hospital did not ensure the safety of patients receiving blood transfusions because it did not follow its policy to notify one of one blood transfusion recipients (Patient 12) reviewed of the possibility of hepatitis C exposure (a viral infection affects the liver), creating the risk of a poor health outcome for the patient.

Findings:

The hospital policy titled, "Lookback Procedure for HCV (Hepatitis C Virus)" (October, 2011), described the process for notifying patients who received blood transfusions from donors who later tested positive for hepatitis C about their risk of infection and thus enabled them to seek medical advice and testing. The policy read in part, "Consignees must promptly notify the patient in one of two ways: a. Notify the patient directly, and, concurrently notify either a) the physician of record or b) the physician that ordered the blood product, and ask the physician to immediately notify the patient.", and "If the physician is unavailable, declines to made the notification, or later informs the hospital that he or she was unable to notify the patient (or patient's legal representative), notification responsibility reverts to the hospital or transfusion service, who must then promptly attempt to notify the patient (or patient's legal representative)."

During a tour of the laboratory on November 28, 2012 at 1 PM, the Lead Tech of the blood bank was asked for an example of a patient who was identified as having received blood that was possibly infected. He produced a letter addressed to Medical Doctor (MD) 4 dated October 21, 2012, in which the physician was informed about the possible hepatitis C exposure of Patient 12, and referenced a form that was being sent to MD 4 with the letter for completion. The pre-printed form referenced in the letter to MD 4 was found, and it contained an item for "current status" with the possible responses "alive", "deceased", "unknown" and "other". The response "unknown" was checked, and it was signed by MD 5. There was no indication that any effort was made by either MD 4 or MD 5 to contact the patient regarding his possible exposure to hepatitis C via a blood transfusion.

During a concurrent interview with the Lead Tech BB, he stated that he was not sure what efforts were made by the doctor to contact the patient, and that no additional efforts had been made by the hospital to contact the patient. He stated that the issue of contacting the patient had not been referred to the hospital administration.

During an interview with the Director of Pathology (Dir Path) on November 27, 2012 at 1:15 PM, he stated that no further steps were taken by the hospital to contact a patient if the physician was unable to contact him. He stated that he did not know what efforts the physician may have made to contact the patient.

During an interview with the Med Dir on November 30, 2012 at approximately 2:30 PM, he stated that it was important for the patient with the possible infection exposure via the blood transfusion be contacted, and that both the physician and hospital should try to contact him.

Based on interview and record review the facility failed to ensure that 4 of 51 sampled patients (Patients 43, 65, 61 and 11) had less restrictive interventions determined to be ineffective prior to being placed in restraint. This failure had the potential for a patient to be placed in an unnecessary restraint.

Findings:

1. A review of Patient 43's record was conducted on November 27, 2012 and showed that the patient was admitted to the facility on November 19, 2012 with a diagnosis of a syncopal episode (a dizzy spell).

A review of a document titled "Physician Orders: Non-Violent Restraint" and dated November 20, 2012, showed that Patient 43 had the following check boxes to choose the clinical indications for restraint. The following two choices were checked: Patient pulling on tube and line. Patient attempting to get out of bed. Under the section to check off the type of restraint, soft restraint, right upper extremity, left upper extremity and both upper extremities was checked. There was a section of the physician order that had check boxes to choose alternatives to restraint attempted. Medication review/modification, Reality orientation, Modification of Environment, Increased Observation and Distraction techniques were checked.

There was no documentation of the patient's response to the alternatives tried or why the alternatives had been determined to be ineffective in the patient's medical record.

The Physician Orders: Non-Violent Restraint dated November 23, 2012 showed that "Soft Restraint, Both upper extremities, Mittens and Both hands" were checked and that the alternatives attempted were "Reality Orientation, Increased Observation, Modification of Environment, Potential physiological causes investigated /corrected and Distraction techniques."

There was no documentation in the medical record of the patient's response to the alternatives tried or why they had been determined to be ineffective.

There were restraint orders dated November 24, 2012, November 25, 2012 and November 26, 2012. The sections for checking off alternatives attempted was completed for the patient but there was no documentation in the medical record of the patient's response to the alternatives tried or why they had been determined to be ineffective.

In an interview on November 27, 2012 at 11: 35 AM with Registered Nurse (RN) 10, RN 10 acknowledged that there was no documentation of the patient's response to the alternatives tried or why they had been determined to be ineffective.

A review of a facility policy and procedure titled "Restraints/Seclusion, Use of" and dated February 2012 showed the following: "The use of restraint or seclusion is based on the assessed needs of the patient and should only occur after alternatives have been attempted or considered. Alternatives attempted or considered prior to the use of restraints must be documented. The patient's response to alternatives attempted are also to be documented."

2. A review on November 27, 2012 of Patient 65's record showed that the patient was admitted to the facility on November 20, 2012 with diagnoses that included acute respiratory failure (having difficulty breathing), schizophrenia (is a mental disorder that makes it hard to: Tell the difference between what is real and not real; Think clearly; Have normal emotional responses; Act normally in social situations) and dementia (confusion).

A review of a document titled "Physician Orders: Non-Violent Restraint" and dated November 24, 2012, showed that Patient 65 had the following check boxes to choose the clinical indications for restraint. The following two choices were checked: Patient pulling on tube and line. Under the section to check off the type of restraint, soft restraint, right upper extremity, left upper extremity and both upper extremities was checked. There was a section of the physician order that had check boxes to choose alternatives to restraint attempted. "Reality orientation" and "Increased Observation" were checked.

There was no documentation in the medical record of the patient's response to the alternatives tried or why they had been determined to be ineffective.

The Physician Orders: Non -Violent Restraint dated November 25, 2012 at 7:00 AM showed that the clinical indications for restraint was "Patient Pulling on: Tube and Line" and Patient attempting to get out of bed" were checked off. "Soft Restraint, Both upper extremities and Four side rails" was checked and that the alternatives attempted were "Reality Orientation, Increased Observation, Modification of Environment, Medication Review/modification, Distraction techniques."

There was no documentation in the medical record of the patient's response to the alternatives tried or why they had been determined to be ineffective.

A review of the Nursing Flow Sheet dated November 25, 2012 at 5:55 PM showed that "Pt. (Patient) found on the floor pt. yelling again pt. denies pain, assessed body and head, no visible injury noted, pt. alert, pt denies any discomfort. At 6:00 PM the nurse documented "Assisted back to bed with assistance, vs (vital signs) checked...pt. still denies pain, replaced wrist restraints bilateral, explained to pt. why re-applied restraints..." At 6:26 PM the nurse documented "...(Physician name) notified that pt. fell, gave orders for roll belt restraints via telephone..."

The Physician Orders: Non-Violent Restraint dated November 25, 2012 at 6:26 PM showed that the clinical indications for restraint was "Patient Pulling on: Line" and Patient attempting to get out of bed " were checked off. "Restraint roll and Four side rails" was checked and that the alternatives attempted were "Reality Orientation, Increased Observation, Modification of Environment, Medication Review/modification and Distraction techniques."

A review of a nursing documentation form titled "Patient Restraint Documentation/Non-Violent Patient Restraint" dated November 25, 2012 showed that there was no soft restraint on wrists from 1:00 PM to 6:30 PM. The nurse documented in the Nursing Flow Sheet that the soft wrist restraints were re-applied.

There was no new physician order for the soft wrist restraints.

There was no documentation in the medical record of the patient's response to the alternatives tried or why they had been determined to be ineffective.

In an interview on November 27, 2012 at 4:00 PM with Quality/Risk Management staff person, she acknowledged that the restraint documentation did not explain the alternatives attempted and why they were ineffective. She acknowledged that a fall was not a medical indication for a restraint.

A review of a facility policy and procedure titled "Restraints/Seclusion, Use of" and dated February 2012 showed the following: "The use of restraint or seclusion is based on the assessed needs of the patient and should only occur after alternatives have been attempted or considered. Alternatives attempted or considered prior to the use of restraints must be documented. The patient's response to alternatives attempted are also to be documented." And "If restraints are removed prior to the expiration of the order (24 hours) and it is necessary to re-initiate restraints, a new restraint order is necessary.

The nurse had re-applied the soft wrist restraints without obtaining a new order for them.



28066

3. A review of the clinical record for Patient 61, on November 27, 2012 noted that the patient was admitted on November 7, 2012 with a diagnosis of congestive heart failure (a condition in which the heart cannot pump enough blood to the rest of the body) and pneumonia (lung infection). The record noted that the patient's right arm was placed in a soft restraint (a device designed to safely fit around the wrist of a patient to prevent excessive movement of the patient's body part) on November 25, 2012 when the patient was pulling on the input and output lines.

Further review of the clinical record, the Non-Violent Restraint form, noted that no documentation of less restrictive interventions had been attempted and less restrictive alternatives had been determined to be ineffective to protect the patient and prevent him from pulling on the input and output lines.

During an interview with RN 4 on November 27, 2012 at 3:15 PM, she confirmed that the Non-Violent Restraint form had not documented less restrictive interventions and less restrictive alternatives had been tried and that the attempts had been ineffective prior to initiating the use of the right arm wrist restraint.




26502

4. A review on November 28, 2012, of Patient 11's medical record was conducted. Patient 11 was admitted to the hospital on October 19, 2012, with admitting diagnoses that included respiratory failure and cancer of the colon. Patient 11 was ventilator dependent.

A review on November 28, 2012 of Patient 11's medical record under the heading, "PHYSICIAN ORDERS: NON-VIOLENT RESTRAINT FORM", dated November 24, 2012, revealed the following sections checked off as being attempted, with the heading, "Section 2: ALTERNATIVES ATTEMPTED."
a. Medication review/modification
b. Potential physiological causes investigated/corrected
c. Reality Orientation
d. Modification of Environment
e. Increased Observation

On November 28, 2012, a review of Patient 11's "PATIENT RESTRAINT DOCUMENTATION NON-VIOLENT PATIENT RESTRAINT FORM", dated November 24, 2012, documented, "Documentation should reflect assessment at least every 2 hours and as needed." Further documentation revealed that the lone nursing entry under the heading: 'RESPONSE TO ALTERNATIVES ATTEMPTED, COMMENTS': ...moving hands towards the tube of the ventilator when hands released for range of motion exercises and turning..."

There was no documented evidence in Patient 11's medical record or from other hospital sources on precisely how these alternative measures were accomplished. There was no evidence of a methodology attempted to precisely explain how these attempted alternatives were deemed unsuccessful.

On November 28, 2012, the Director of the Intensive Care Unit (ICU) Department confirmed the finding that the registered nurse did not document the methodology of precisely how the alternative measures were accomplished and were deemed unsuccessful.

Based on observation, interview and record review, for one patient in restraints (Patient 11), the hospital did not ensure that the physician provided an order for continued restraint use, creating the increased risk of unnecessary restraints for that patient.

Findings:

A review of a hospital policy and procedure titled "Restraints/Seclusion, Use of" and dated February 2012 showed the following: "Before a restraint or seclusion is initiated, a LIP (Licensed Independent Practitioner-a physician or Doctor of Osteopathy and Advanced Practice Nurses or Physician Assistants functioning under the rules of the medical staff) shall be called to obtain an order for restraint."

During a tour of the ICU on 11/29/12 at 12 PM, Patient 11 was seen to have restraints attached to both wrists.

The record of Patient 11 was reviewed and contained a form titled Physician Orders: Non-Violent Restraint dated 11/28/12. At the top, the form read in bold type, " All 4 Sections Must Be Completed - PRN Orders are NOT Permitted " . The form contained sections in which the clinical indications for restraints, alternative attempted, and type of restraint were to be documented. However, these three sections were left blank. The fourth section contained a physician signature and the date 11/28/12.

During a concurrent interview with the CCU RN Mgr, she stated that the form should have been completed.

During an interview on 11/30/12 at approximately 2:30 PM with the Med Dir, he stated that the physician must fill in the reason for restraint on the form.

Based on interview and record review, the Quality Assurance (QA) program did not evaluate the system for using pre-printed intravenous medication order forms and allowing nurses to select starting doses and titration rates, creating the risk of substandard medication administration and poor health outcomes for patients receiving intravenous medications via those order sets, and the QA program did not obtain valid data regarding Emergency Department (ED) pain management, creating the risk of unmet pain needs for patients using the ED.

Findings:

1. During an interview with the Director of Quality Assurance/Risk Management (Dir QA/RM) on 11/28/12 at approximately 3 PM, she stated that there had been no discussion of the nurses titrating pressors during the quality committee. She stated that she wished they had discussed the nursing administration of intravenous pressors and the order sets.

2. On 11/29/12 at 2:30 PM, the Dir QA/RM provided printed quality information in a document titled, Clinical Care Monthly Operating Review. The document included data that was collected on patient satisfaction with ED pain management according to two measures-Timely pain control by nursing staff, and Medicine helped with pain. The data showed that data was collected from 83 and 78 patients respectively during a 3 month period. On another page of the same document, the ED patients seen was quantified as 18, 151 during the same 3 month period.

During a concurrent interview with the Dir QA/RM, she was asked if the data represented a sample of the ED patient population. She stated that surveys were mailed to nearly all patients using the ED (but not, for example, forensic patients). She stated that approximately 18,000 patients were seen in the ED during that period, but only 83 responded to the mailed survey. She stated that no other method was being tried to obtain information about patient satisfaction with ED pain management, and no analysis had been done to determine how to improve the response rate.

Based on observation, interview and record review, the hospital failed to ensure the quality of patient medical care through enforcement of the facility medical staff bylaws.

1. The hospital did not ensure the validity of the data used for periodic reappraisal of one of the medical staff (see A-340).

2. The hospital did not ensure that physicians supplied complete orders for intravenous blood pressure medications (See A-353).

3. The hospital did not ensure that physicians documented having an informed consent discussion with patients before surgery (See A-131).

4. The hospital did not ensure that the medical records and physician orders were complete (See A-450).

The cumulative result of these deficient practices meant that the hospital did not organize the medical staff to operate under the medical staff bylaws in order to provide quality patient medical care to a universe of 191 patients in the hospital.

Based on interview and record review, the hospital did not ensure the validity of the data used for periodic reappraisal of the medical staff, creating the risk of substandard care being provided by the medical staff.

Findings:

The Medical Staff Bylaws (August, 2012), on pages 15-16, read in part, "Each recommendation concerning the reappointment of a Medical Staff member and the clinical privileges to be granted upon reappointment shall be based upon such member's professional competence and clinical judgment in the treatment of patients, quality assurance profile evaluated by peers, ethics and conduct ...general attitude towards patients, the hospital and the public."

During a review of medical staff files with the Director of Medical Staff (Dir Med Staff) on 11/27/12 at 2 PM, the credential file of MD 2, an ED physician, was reviewed. The performance data in the file included a document with columns for evaluating performance during years 1 and 2. The year 2 column included "0" complaints, "0" mortality and "10,992" patients seen. The file contained another performance data sheet titled, QM DV Provider Profile, that listed the number of patients that MD 2 admitted to the hospital, procedures performed on inpatients, and procedures performed on outpatients.

In a concurrent interview with the Dir Med Staff, she stated that the data did not appear correct. She stated that MD 2 was an ED physician and did not admit patients to the hospital. She stated that the QA department provided the data, and analyzed and validated the physician data, and that she would ask the QA department to explain the data.

During an interview with Quality Staff 2 on 11/28/12 at 9 AM, she stated that the Medical Staff office was responsible for validating the data on the provider profiles. She looked at a report in the credential file for MD 2 and stated that all ED physicians were given a "0" for mortality, and that she did not know when the rule was implemented, or by whom. She also stated that some of the data in MD 2's credential file did not appear correct, and that it appeared there had been errors in coding data. She stated that she did pass on all data about grievances, even unsubstantiated ones, to the Medical Staff office for inclusion in the provider profile.

The grievance of Patient 7's grandmother from 5/3/12 was randomly selected on 11/29/12 and was viewed in the hospital's computer. The grievance contained allegations that Patient 7 was seen twice in the ED and discharged with medications, but was subsequently admitted to another hospital with a diagnosis of pneumonia.

The grievance was discussed with Quality Staff 2 on 11/29/12 at approximately 10 AM. She stated that the complaint had been attributed to MD 2, the ED physician who saw the patient. She stated that she did not know why the grievance did not appear on the summary data in MD 2's credential file.

Based on interview and record review, the medical staff did not ensure that physicians supplied complete orders for intravenous medications intended to increase patient blood pressure, creating the risk of substandard medication administration and poor health outcomes for patients for whom incomplete orders were written.

Findings:

The hospital policy titled, Medication Administration of IV Medications by RN's (April 1983), read in part, "intravenous medications may be given only on the order of the attending physician.", and "It is the responsibility of the physician to specify the nature and volume of the diluent and the rate of delivery when IV medication orders are written."

The Medical Staff Bylaws (August, 2012), read in part (page 96), "All written documentation within a medical record including but not limited to nursing notes, progress notes, consultation records, physician orders, treatment orders, medication orders, history and physicals, etc., shall be legible, accurate and timely."

During a review of the pre-printed medication orders for intravenous pressors, the orders did not contain complete information about the starting rate or the titration instructions for the medications.

During an interview with MD 3, an anesthesiologist, in the Post Anesthesia Care Unit (PACU) on 11/28/12 at 11:35 AM, he stated that he did use the pre-printed form for ordering IV pressors. He stated that he thought the nurses were acquainted with the starting dose of the medications, and that it was more effective to let the nurses use their judgment about the frequency of titrating the medications.

In an interview with the ED Manager on 11/28/12 at 11:45 AM, she stated that the nurses follow the Yellow Medication Guideline for drips in the ED. When asked about the Emergency Room Coronary Care Unit (ER CCU) Dosing Guidelines referred to in the Yellow Book Medication Guideline, she was not sure what it meant. She stated that she used her judgment regarding the starting dose for the drips.

Based on interview and hospital record review, it was determined that the hospital failed to ensure that the Nursing Services were organized and that the delivery of nursing care was supervised.

The Nursing Services failed to ensure that:

1. All Intensive Care Unit (ICU) Registered Nurses (RN's) administered intravenous (IV) vasopressor medications (a potent medication used to help increase blood pressure, if given incorrectly, can contribute to adverse patient outcomes) to patients in a safe manner and with physician guidance. As a result, RN 1 administered levophed, (an IV vasopressor) to Patient 50 and titrated (incremental adjustments of the administered dose of vasopressor) the medication without physician guidance and RN 2 administered and titrated levophed to Patient 51 without physician guidance. This failure had the potential to adversely affect the health of Patients 50 and 51 as well as all ICU patients who received IV vasopressors. This failure also contributed to the unsafe administration of potent (powerful) medications and unsafe facility practice of IV administration of vasopressors. This deficient practice resulted in an Immediate Jeopardy situation.

The facility failed to ensure that for Patient 55, a patient on IV vasodilators (a medication that dilates blood vessels and lowers blood pressure), the ICU RN administered the medications in a safe manner and with physician guidance. This failure had the potential to adversely affect any ICU patient who received vasodilators. (Refer to A-405)

2. A current, comprehensive and individualized nursing care plan for 2 of 51 sampled patients in a universe of 191 patients (Patient 45 and 65) was maintained. This deficient practice had the potential for substandard nursing care needs and interventions being provided to the patients. (Refer to A-396)

3. ICU patients with orders for continuous heart monitoring were being provided continuous monitoring by the assigned nurse.

This failure had the potential to result in life threatening cardiac arrhythmias (any problem with the rate or rhythm of the heartbeat) to occur without immediate identification to provide necessary interventions for patients admitted to the ICU. (Refer to A-397)

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, for one Emergency Department (ED) patient, Patient 13, the patient's vital signs, including pain level, were not reassessed per hospital policy, creating the risk of a poor health outcome for the patient.

Findings:

A review of a hospital policy titled "Pain Assessment and Management" and dated March 2011 showed the following: "Pain is assessed on an ongoing basis with a minimum of once per shift and after every pain control intervention." The policy continued, "Pain control will be addressed upon discharge."

The medical record of Patient 13 was selected at random from a stack of recent ED discharges. The record showed that the patient was triaged at 6:24 PM on November 26, 2012, and subsequently found to have facial injuries including missing teeth, a laceration and a fractured jawbone. The patient was deaf. Morphine was ordered at 6:40 PM and administered at 8:09 PM, nearly 1 ? hours later. The patient left the ED at 10:41 PM. There was no assessment of pain or other vital signs seen in the record from 6:24 PM until discharge, that portion of the medical record was blank. There was no assessment of pain from the time the morphine was ordered at 6:40 PM until it was given at 8:09 PM, and there was no reassessment after the morphine was given, nor prior to discharge.

During an interview with the ED Manager (Mgr) and ED Educator on November 27, 2012 at 10:30 AM, they concurred that the documentation on vital signs had not been completed in error. They stated that the vital signs should have been completed each 2 hours, after pain medications, and prior to discharge.

Based on staff interview and facility record review, the facility failed to maintain a current, comprehensive and individualized nursing care plan for 2 of 51 sampled patients in a universe of 191 patients (Patient 45 and 65). This deficient practice had the potential for substandard nursing care needs and interventions not being provided to the patients.

Findings:

1. A review was conducted on November 27, 2012, of Patient 45's medical record revealed that Patient 45 was admitted to the hospital on November 22, 2012, with an admitting diagnosis of hypovolemia (diminished blood volume).

A review on November 27, 2012, of Patient 45's medical record revealed in the Physicians' Order Sheet, dated November 26, 2012, timed at 9:15 AM the following dietary orders (G-Tube orders) for her nutritional needs:

a. Start G-Tube (a feeding tube inserted into the stomach for so that liquid nutritional formula feedings could be administered) feedings, Jevity 1.2 or equivalent, at 40 cc(cubic centimeter) /hr by pump.

b. Check for residual every 4 hours times 3, if residual is greater than 100 cc; hold feedings for 1 hour and restart again.

c. Tomorrow (November 27, 2012) increase rate to 60 cc/hr if tolerated well.

A review of Patient 45's "MULTIDISCIPLINARY PLAN OF CARE", dated November 23, 2012, revealed the following documented assessed patient problems in the care plan (I.):

a. INADEQUATE NUTRITIONAL INTAKE

b. DIFFICULTY CHEWING, SWALLOWING, INCREASE GLUCOSE, DECREASE LDL (low density lipoprotein - a type of cholesterol), HDL (high density lipoprotein) - a type of cholesterol), UNDERWEIGHT, NAUSEA/VOMITING, CONSTIPATION, STAGE 2 ulcer.

II. EXPECTED OUTCOMES/GOALS:

a. WEIGHT MAINTENANCE OR GAIN

b. IMPROVED INTAKE BY MOUTH TO 90%-100%

c. ACHIEVE ADEQUATE FLUID INTAKE

III. INTERVENTIONS/APPROACHES:

a. PROVIDE NUTRITIONAL SUPPLEMENTS

b. MONITOR MEALS

There was no documented evidence in Patient 45's nursing care plan, for nutritional services, that reflected the physician's dietary instructions written on November 26, 2012 at 9:15 AM, regarding his orders to:

a. Start G-Tube feedings, Jevity 1.2 or equivalent, at 40 cc/hr by pump.

b. Check for residual every 4 hours times 3, if residual is greater than 100 cc; hold feedings for 1 hour and restart again.

c. Increase increase rate to 60 cc/hr if tolerated well.

On November 27, 2012, a review of the hospital's policy and procedures titled, "FOOD & NUTRITION SERVICES" dated July, 2012, stipulated in Policy Statement Section (4): "Multidisciplinary Care Plan (Nutrition Section) shall be filled out by the Registered/Qualified Dietician upon completion of the nutrition assessment and include all current nutrition interventions and goals as appropriate."

On November 27, 2012, a review of the hospital's policy and procedures titled, "DOCUMENTATION; PLAN OF CARE, MULTIDISCIPLINARY, GUIDELINES FOR USE" dated revision, April, 2012, stipulated, "...The Registered Nurse is responsible to monitor all aspects of patient care and insure that all identified problems are being addressed by all necessary disciplines. These sections should be reviewed by the nurse daily along with the entire plan of care. Problems should be added and resolved as necessary when the needs of the patient changes. The Plan of Care must be initiated, reviewed, revised or resolved every 24 hours by the Registered Nurse..."

Care Plans must be comprehensive, individualized, and have specific objectives, measurable goals and interventions and must be time specific.

There was no documented evidence in Patient 45's medical record that the Multidisciplinary Plan of Care for nutritional services was updated, revised and was comprehensive, reflecting the physician's dietary written orders dated November 26, 2012, at 9:15 AM, as per hospital policy.

During an interview with the Clinical Dietician on November 27, 2012, at approximately 11:45 AM, she confirmed the finding that Patient 45's Multidisciplinary Plan of Care should have been updated and revised to reflect the physician's dietary order written on November 26, 2012 at 9:15 AM.



25179

2. A review on November 27, 2012 of Patient 65's record showed that the patient was admitted to the facility on November 20, 2012 with diagnoses that included acute respiratory failure (having difficulty breathing), schizophrenia (is a mental disorder that makes it hard to: Tell the difference between what is real and not real; Think clearly; Have normal emotional responses; Act normally in social situations) and dementia (confusion).

A review of the Nursing Flow Sheet dated November 25, 2012 at 5:55 PM showed that "Pt. (Patient) found on the floor pt. yelling again pt. denies pain, assessed body and head, no visible injury noted, pt. alert, pt denies any discomfort. At 6:00 PM the nurse documented "Assisted back to bed with assistance, vs (vital signs) checked...pt. still denies pain, replaced wrist restraints bilateral, explained to pt. why re-applied restraints..." At 6:26 PM the nurse documented "...(Physician name) notified that pt. fell, gave orders for roll belt restraints via telephone..."

The Physician Orders: Non-Violent Restraint dated November 25, 2012 at 6:26 PM showed that the clinical indications for restraint was "Patient Pulling on: Line" and Patient attempting to get out of bed " were checked off. "Restraint roll and Four side rails" was checked and that the alternatives attempted were "Reality Orientation, Increased Observation, Modification of Environment, Medication Review/modification and Distraction techniques."

A review of Patient 65's Multidisciplinary Plan of Care showed a "Patient Problem" entry for "Potential for injuries R/T (related to) Fall Risk." The goal for the plan of care was "Pt. (patient) will remain free from injury during hospitalization." The interventions included:
"Monitor orientation to time/place/comprehension ability.
Initiate fall precautions.
Fall risk assessment every 12 hours.
Physical Therapy consult as ordered.
Assess home health needs."

There was no care plan initiated for the patient's actual fall on November 25, 2012.

In an interview on November 27, 2012 at 4:00 PM with Quality/Risk Management staff member, she acknowledged that there should have been a care plan initiated for the patient's actual fall.

On November 27, 2012, a review of the hospital's policy and procedures titled, "DOCUMENTATION; PLAN OF CARE, MULTIDISCIPLINARY, GUIDELINES FOR USE" dated revision, April, 2012, stipulated, "...The Registered Nurse is responsible to monitor all aspects of patient care and insure that all identified problems are being addressed by all necessary disciplines. These sections should be reviewed by the nurse daily along with the entire plan of care. Problems should be added and resolved as necessary when the needs of the patient changes. The Plan of Care must be initiated, reviewed, revised or resolved every 24 hours by the Registered Nurse..."

Based on observation and interview, the facility failed to ensure that Intensive Care Unit (ICU) patients with orders for continuous heart monitoring were being provided continuous monitoring by the assigned nurse.

This failure had the potential to result in life threatening cardiac arrhythmias (any problem with the rate or rhythm of the heartbeat) to occur without immediate identification to provide necessary interventions for patients admitted to the ICU.

Findings:

During a tour of ICU side 1 on November 28, 2012 at approximately 1:15 PM, it was observed that there were nurses in patient rooms and nurses at the desk in view of the patient cardiac monitors.

In an interview with the Critical Care Unit (CCU) Director on November 28, 2012 at 1:15 PM, the CCU Director stated that the patient cardiac monitors were watched by the nurses. When asked how the patients are continuously monitored if a nurse who has an assignment of two patients gets tied up in one of the patient's room. The CCU Director stated that there were Ward Clerks that were trained to watch the monitors that could monitor the patients. The CCU Director then stated that there were no Ward Clerks on duty on the day of the tour and interview. When asked how the patients were continuously monitored when the nurse is tied up in one of the patient's room and there were no Ward Clerks on duty, the CCU Director stated that the monitor in the patient's room can pull up another patients' cardiac monitoring so that the nurse can view the two patients cardiac rhythm from the one patient's room. The CCU Director then demonstrated how it was accomplished.

In an interview with Registered Nurse (RN) 13 on November 28, 2012 at 1:40 PM, RN 13, was asked how he would monitor his second patient if he was tied up in the first patient's room. He responded that he would ask another nurse at the station to watch the monitor. When asked how the second patient would be monitored if the other nurse at the station was in a patient room, RN 13 responded that he would get a nurse from a neighboring station to watch the monitors. When asked about being able to monitor both patients from the patient room that he was in, RN 13 stated, "I didn't know we could do that."

Based on interview and record review, the hospital failed to ensure that all Intensive Care Unit (ICU) Registered Nurses (RNs) administered intravenous (IV) vasopressor medications (Potent medications used to help increase blood pressure, if given incorrectly, it can adversely affect a patient's outcome) to patients in a safe manner and with physician guidance. As a result, two RNs (RN 1 & RN 2) administered IV vasopressors to Patient 50 and Patient 51 and titrated (incremental increases to a medication until an optimal therapeutic level is obtained and done according to physician's orders) the medication without physician guidance. This failure had the potential to adversely affect Patient 50, Patient 51 and adversely affect all ICU patients who received vasopressors and contributed to the unsafe administration of potent (powerful) medications and unsafe facility practice of IV administration of vasopressors.

The facility failed to ensure that for Patient 55, a patient on IV vasodilators (medication that dilates arteries and lowers blood pressure), the ICU RN administered the medications in a safe manner and with physician guidance. This failure had the potential to adversely affect any ICU patient who received vasodilators.

Findings:

1. A record review of Patient 50's medical record and a concurrent interview with RN 1 was conducted on November 28, 2012 at 9:55 AM. RN 1 stated that Patient 50 was admitted on November 26, 2012 because of abdominal pain which was due to a perforated bowel (ruptured bowel). During the course of Patient 50's hospitalization, the patient required abdominal surgery and also developed hypotension (low blood pressure) which required the use of levophed (a powerful vasopressor) to help maintain Patient 50's systolic blood pressure (SBP) greater than 90 (an average blood pressure is 120/80, with the top number being the systolic blood pressure).

A record review of Patient 50's physician orders dated November 27, 2012 at 1:30 AM and a concurrent interview with RN 1 was conducted on November 28, 2012, at 9:55 AM. The order read to continue levophed to keep SBP greater than 90. There were no additional orders instructing the RN on what the initial dose was, there were no orders instructing the RN how to titrate the medication and there were no additional orders informing the RN about a maximum dose to administer to the patient. RN 1 stated that every RN titrated the medication depending on the patient's response and that there were no standard protocols to instruct them on how much to titrate the medication. RN 1 stated that she usually titrated about 1 to 2 micrograms per minute but that each nurse titrated based on their own judgment and experience. RN 1 also stated that the hospital had a document titled, "Emergency & Critical Care Medication Dosing Guidelines", however the guidance did not include vasopressor titrating parameters and other than having a range, there was no initial (starting) dose listed for the levophed. RN 1 stated that the RN's do not always use the guidelines and that the initial dose depended on a patient's condition and sensitivity to the levophed and that they titrated the medications (vasopressors) until they achieved the parameters that the physician ordered.

2. A record review of Patient 51's medical record and a concurrent interview was conducted on November 28, 2012 at 10:30 AM with RN 2. She stated that Patient 51 was admitted on November 18, 2012 with the diagnoses which included respiratory failure and upper gastrointestinal bleeding.

On November 28, 2012 at 10:30 AM, a record review of Patient 51's Physician orders dated November 18, 2012 at 10:20 AM was conducted. The orders included to start "levophed drip (IV) titrate MAP (Mean Arterial Pressure - the average blood pressure) the physician ordered greater than 60". No additional orders were written to direct the RN's on how to start the initial dose, how to titrate the medication and there was no maximum dose that was ordered.

During an interview with RN 2, on November 28, 2012 at 10:30 AM, she stated that she titrated the medication at about 0.5 to 1 microgram per minute but that it depended on the patient's response to the medication and RN 2's assessment of the patient. RN 2 stated that each nurse titrated the medications based on their own experience and their patient's condition and that there was no standing protocols for titrating medications.

During an interview, on November 28, 2012, at 2:20 PM, with the ICU Director, she verified that the facility had no protocols for titrating the medications and that the "nurses titrate based on their experience, judgment, patient's numbers (for example their blood pressure) and the RN's critical thinking skills."

During an interview, on November 28, 2012, at 3 PM, with the Vice President of Medical Affairs, he stated that he agreed that orders needed to be complete and that there should be an initial dose and not a range. He did not agree that there should be interval doses for titrating the medications.

Immediate Jeopardy (IJ) was called on November 28, 2012 at 3:45 PM in the presence of the survey team and facility administration, due to the facility's failure to ensure safe practices in the following area:

The facility failed to ensure that physicians' orders were complete for nurses starting and titrating vasoactive IV (intravenous: within the vein) medications used to control blood pressure. There were no orders indicating the starting doses or parameters established for titration of the medication.

This failure resulted in the identification of an IJ in which there was a potential for harm due to starting doses and titrations being left up to the nurses' discretion and experience to determine the dosage starting ranges and/or titration.

An acceptable plan of correction was received and agreed upon by the survey team on November 28, 2012 at 7:20 PM. The facility's plan included revised titratable medication orders, education regarding the changes made to physicians and nurses on the new orders as well as the requirement for complete medication orders.

On November 29, 2012 at 11:20 AM, the IJ was abated by the survey team with facility staff present.




26502

2. A review of Patient 55's medical record was conducted on November 28, 2012. Patient 55 was admitted to the hospital with a diagnosis of chest pain on exertion and underwent an elective surgical Coronary Artery Bypass Graft (CABG) procedure on November 28, 2012 (an operation to open blocked arteries in the heart). Patient 55 was subsequently admitted to the Intensive Care Unit (ICU) after the surgical procedure and remained on a ventilator (respirator) during the post surgical recovery phase until hemodynamically stable (normal functional status of the cardiovascular system is attained after a stress response to the heart).

A review of Patient 55's "ADULT CARDIAC SURGERY IMMEDIATE POST-OP ORDER Sheet" dated November 28, 2012, revealed in Section (9), the following pre-printed medication standing orders (order set):

a. Nitroglycerin (Tridil) 100 milligrams in 250 milliliters of 5% Dextrose and water: titrate to maintain Systolic Blood Pressure ('SBP' - pressure of blood exerted against the arterial wall) less than 130 mm/Hg. (Nitroglycerin is a medication to lower high blood pressure levels in the body. Normal blood pressure is considered 120/80 mm/Hg. 'millimeters of mercury' -a unit of measurement for blood pressure)

b. Nitroprusside (Nipride) 100 milligrams in 250 millimeters of 5% Dextrose and water if the maximum dose of 100 micrograms/minute of Nitroglycerin is required. (Nitroprusside is a medication used to lower high blood pressure levels in the body. Normal blood pressure is considered 120/80 mm/Hg. 'millimeters of mercury' -a unit of measurement for blood pressure)

c. May wean Nitroprusside and Nitroglycerin to maintain SBP at 130 mm/Hg.

A review of Patient 55's "CRITICAL CARE/INTERMEDIATE CARE FLOW SHEET" dated November 28, 2012, revealed the following documentation of the Systolic Blood Pressure and infusion rates of Nitroprusside and Nitroglycerin Intravenous infusion as documented by RN 6 (Registered Nurse 6).

a. At approximately 12:45 PM the SBP was recorded as 138 mm/Hg.
b. At approximately 1:00 PM the SBP was recorded as being 130 mm/Hg.
c. At approximately 1:15 PM the SBP was recorded as being 132 mm/Hg.
d. At 1:00 PM the RN 6 initiated/started the Nitroglycerin Intravenous medication infusion drip at 100 micrograms per minute and initiated the Nitroprusside intravenous medication infusion drip at 5 micrograms per minute. Between the hours of 12:45 PM and 2:00 PM, Patient 55 received a total of 30 cc ('cubic centimeter' -a unit of measurement for liquids) of the medication Nitroglycerin, and a total of 9.2 cc of the medication Nitroprusside during that time frame.

A review of the hospital's policy and procedure titled, "INTRAVENOUS MEDICATION GUIDELINES, 2012-2013, AKA: THE YELLOW BOOK " documented under the heading: NITROGLYCERIN: Infusion time; 10 to 200 mcg/min. Maximum dose in ICU is 100 mcg/min. No other information was provided.

A review of the hospital's policy and procedure titled, "INTRAVENOUS MEDICATION GUIDELINES, 2012-2013, PARENTERAL MEDICATION COMPOUNDING GUIDELINES, AKA: THE YELLOW BOOK " it documented under the heading: Nitroprusside: Infusion time; 0.5 to 4 mcg/min. Maximum dose in ICU 4 mcg/min. No other information was provided.

There was no documented evidence in the hospital's "Intravenous Medication 'Yellow Book' " that instructed or directed nurses to "start" the infusion medications at a specific start rate with a specific dose. The guidelines in the "Yellow Book" emphasized a dosage range and not a specific starting rate. Therefore, the medication infusion "start rate and dosage" was left to the nurses' judgment and clinical experience. In addition, there were no instructions or directions given to the nurses on how to incrementally titrate the infusion drip flow rate safely according to a targeted goal level during a specific time frame.

There was no documented evidence in the medical record that Patient 55's physician had written or given a verbal order in the ICU Physicians' Order Sheet, dated November 28, 2012, ordering RN 6 to initiate or to start the Nitroglycerin Medication infusion drip at 100 mcg/min. as documented in the ICU Flow Sheet.

On November 28, 2012, a review was conducted of the hospital's policy and procedure titled, "MEDICATION ADMINISTRATION OF INTRAVENOUS MEDICATIONS BY REGISTERED NURSES" dated April, 2010. It stipulated, "...Intravenous medication may be given only on the order of the attending physician. It is the responsibility of the physician to specify the nature and volume of the diluents and the rate of delivery when Intravenous orders are written ..."

There was no documented evidence in the hospital's policy and procedure titled, "INTRAVENOUS MEDICATION GUIDELINES, 2012-2013, PARENTERAL MEDICATION COMPOUNDING GUIDELINES, AKA: THE YELLOW BOOK" directing registered nurses specifically to initiate or start Nitroglycerin Medication Infusion drips at 100 mcg/min. There was no documented evidence of a standing order (established order set) directing registered nurses to incrementally decrease or increase the rate of infusion at pre-set time intervals according to a targeted goal level.

There was no documented evidence in the medical record that Patient 55's physician had written an order or had given a verbal order in the Physicians' Order Sheet, dated November 28, 2012, for RN 6 to initiate or start Nitroprusside Medication Infusion drip at 5 mcg/min. as documented in the ICU Flow Sheet.

There was no documented evidence in the hospital's policy and procedure titled, "INTRAVENOUS MEDICATION GUIDELINES, 2012-2013, PARENTERAL MEDICATION COMPOUNDING GUIDELINES, AKA: THE YELLOW BOOK " directing registered nurses to initiate or start Nitroprusside Medication Infusion drips at 5 mcg/min. or any evidence of a standing order for Registered Nurses to incrementally decrease or increase the rate of infusion at preset time intervals according to a targeted goal level.

On November 28, 2012, a review was conducted of the hospital's policy and procedure titled, "MEDICATION ADMINISTRATION OF INTRAVENOUS MEDICATIONS BY REGISTERED NURSES " dated April, 2010. It stipulated, "...Intravenous medication may be given only on the order of the attending physician. It is the responsibility of the physician to specify the nature and volume of the diluents and the rate of delivery when Intravenous orders are written ..."

There was no documented evidence that the hospital's Pharmacy Department or the Intensive Care Unit had developed or implement unit-specific approved protocols or specific guidelines for registered nurses administrating antihypertensive medication infusion drips at a "specific start rate and dose."

During an interview with the CCU/ICU Manager on Nonmember 28, 2012, at approximately 1:45 PM, she stated, "My open heart nurses are very experienced and use sound clinical judgement, according to their training and experience when starting and titrating drips. Many factors affect their judgement when assessing the patient."

The Hospital failed to ensure that policies and procedures were reviewed, developed and approved by the Medical Staff and Governing Body to assure that management of patients requiring antihypertensive medication Intravenous drips ordered by physicians specifically addressing the starting infusion rate, dose and titration sequence according to accepted national standards of practice and not allowing nurses to make that judgment or determination.

The Hospital failed to ensure that the Department of Pharmacy had recognized and identified possible medication irregularities in the hospital's established guidelines when it did not specify a specific standardized starting rate and titratable parameters according to a targeted goal ordered by the physician.

There was no documented evidence the Hospital-wide Quality Assurance and Performance Improvement Department had identified medication irregularities or a review was conducted to regularly monitor antihypertensive medication infusion drips or titratable medication infusion drips without a clear and specific standardized start rate on those patients requiring vasodilation continuous drip medication management.

On November 28, 2012, RN 8 (Registered Nurse answering questions by the surveyor) confirmed the finding that there were no specific orders written by the physician addressing a specific starting rate of the infusion drips and how to incrementally titrate the drips according to specific time frames.

3. A review of Patient 44's medical record was conducted on November 26, 2012. Patient 44 was admitted on November 26, 2012 at 6:20 AM, with a chief complaint of a swollen tongue. Patient 44's condition deteriorated due to an obstructive airway as a result of an allergic reaction to an ingested prescribed medication. Patient 44 was emergently intubated (a soft plastic tube placed in the lung and connected to a mechanical ventilator to assist with breathing) in the Emergency Room and was placed on a ventilator (Respirator). Patient 44 was being held in the Emergency Department until an Intensive Care Bed was available and was admitted to the unit with a diagnosis of respiratory failure and angioedema (allergic reaction causing swelling).
On November 26, 2012, a review of Patient 44's CCU Admission Orders (Coronary Care Unit orders) revealed that Patient 44 was converted at 10:00 AM from an Emergency Department Outpatient status to a CCU Inpatient status at 1000 AM, on November 26, 2012.

On November 26, 2012, a review of Patient 44's "Emergency Department Care Record" dated November 26, 2012 and timed at 10:15 AM documented that Patient 44 was intubated and placed on a ventilator. In addition, the Emergency Departments' (ED) patient care record revealed the following documentation:

a. 10:25 AM: Propofol ( 'Diprivan' -medication used to induce sedation or light anesthesia with patients on a ventilator to minimize agitation and avoid pulling out of the breathing tube) IV drip started at 15 mcg/min.
b. 10:30 AM: Propofol IV drip increased to 35 mcg/min.
c. 10:35 AM: Propofol IV drip increased to 45 mcg/min.
d. 10:37 AM: Propofol IV drip increased to 55 mcg/min.
e. 10:50 AM: Propofol IV drip increased to 75 mcg/min.

There was no documented evidence in the Emergency Department Physicians' Orders sheet dated November 26, 2012 at 11:45 AM (time of record review) documenting that Patient 44's physician had given a verbal order or had written an order for RN 9 to start Propofol (Diprivan) IV drip at 15 mcg/min.

On November 28, 2012, a review was conducted of the hospital's policy and procedure titled, "MEDICATION ADMINISTRATION OF INTRAVENOUS MEDICATIONS BY REGISTERED NURSES", dated April, 2010. It stipulated, "...Intravenous medication may be given only on the order of the attending physician. It is the responsibility of the physician to specify the nature and volume of the diluents and the rate of delivery when Intravenous orders are written ..."

On November 26, 2012, A review was conducted of the hospital's policy and procedure titled, "INTRAVENOUS MEDICATION GUIDELINES, 2012-2013, PARENTERAL MEDICATION COMPOUNDING GUIDELINES, AKA: THE YELLOW BOOK " it documented under the heading: PROPOFOL (DIPRIVAN); Infusion time: Initial Dose is 0.5 to 1.5 mg/Kg bolus slowly over 3 to 5 min. Titrate continuous infusion up to 25 to a Maximum of 75 mcg/min. or 20 mcg/min to 60 mcg/min in patient over 60 years of age. No other directions or information was documented.

There was no documented evidence that the hospital's policy infusion guidelines for Propofol had addressed a specific start rate and dose for initiating the medication. The Propofol infusion guidelines provided an initiation range, without a specific start rate order. Therefore, RN 9 needed to use her judgment based on her clinical experience at what precise starting dose Propofol medication IV drip was to be initiated.

During an interview with the Emergency Department's (ED) Manager, on November 26, 2012, at approximately 10:30 AM, she stated, "Our ED nurses are very experienced and use their best judgement when to start medication drips and when to titrate them according to the patient's assessment."

There was no documented evidence in the hospital's Propofol policy guidelines found in the Patient 44's medical record addressing what specific targeted goal level was to be attained along with the frequency of assessment by registered nurses in the Emergency Department.

There was no documented evidence that the hospital's policy guidelines for continuous Propofol infusion addressed a targeted level of sedation, such as following the Richmond Agitation Sedation Scale (RASS) for maintenance or titrating the medication to keep the patient at a targeted level of sedation while on a ventilator. ( 'RASS' -a agitation sedation scale assessment tool scoring a patients' response to physical stimulation. Such as, +4= for being combative; 0=as being alert and calm; and -5= being in deep sedation and having no response, unarguable to physical stimulation).

There was no documented evidence of a RASS score being recorded with the infusion rate adjustment along with the nursing assessment prior to titration of the drip on November 26, 2012.

On November 26. 2012, a review of the hospital's policy and procedure titled, "TARGET LEVEL OF SEDATION PROTOCOL" dated June 27, 2012 was conducted. The following components of the protocol were required to be documented when administering Propofol (Diprivan) Intravenous medication continuous drip for sedation while on the ventilator:

a. Section (3): Titrate to response when using Propofol. Use 1000 mg/100 milliliters. Continuous Infusion Rate: 25 to 75 mcg/kg/min.
b. Section (4): Targeted Level of Sedation: Keep patient at a specific score on the Richmond Agitation Sedation Scale (RASS). Such as (-1 to -4).
c. Section (5): Assessment: Assess patient on RASS at specific minute intervals and adjust infusion rate as needed until target Level (score) of sedation is achieved. Reassess at specific minute intervals to maintain desired level (score).
d. Section (7): Flow Sheet: Record RASS score and infusion rate on flow sheet every one hour.

There was no documented evidence in Patient 44's medical record that RN 9 had utilized the hospital-wide sedation protocol while caring for Patient 44 on a Propofol drip in the Emergency Department on November 26, 2012, as per hospital policy.

There was no documented evidence that the hospital's Pharmacy Department or the Emergency Department had developed or implement unit-specific approved protocols or specific guidelines for registered nurses administrating Propofol continuous infusion drips for sedation for ED patients on a ventilator. There was no evidence that hospital policy had directed specifically at what "specific start rate and dose" nurses must follow.

The Hospital failed to ensure that policies and procedures were reviewed, developed and approved by the Medical Staff and Governing Body to assure that management of patients requiring antihypertensive medication Intravenous continuous drips ordered by physicians specifically addressing the starting infusion rate, dose and titration sequence according to accepted national standards of practice and not allowing nurses to make that judgment or determination.

There was no documented evidence the Hospital-wide Quality Assurance and Performance Improvement Department had identified medication irregularities or a review was conducted to regularly monitor Propofol infusion management in patients in the Emergency Department on ventilators or monitoring titratable medication infusion drips without a clear and specific standardized start rate or standing orders for nurses to incrementally adjust the dose rates per a specific targeted sedation goal.

On November 26, 2012, at approximately 11:55 AM, the manager of the Emergency Department confirmed that RN 9 did not utilize the hospital-wide sedation protocol while managing Patient 44 while on a Propofol drip in the Emergency Room.
4. A review on November 28, 2012, of Patient 11's medical record was conducted. Patient 11 was admitted to the hospital on October 19, 2012 with admitting diagnoses that included respiratory failure and cancer of the colon. Patient 11 was ventilator dependent.

A review of Patient 11's Medication Administration Record (MAR) and Physicians' Order sheet, dated November 27, 2012, documented the following pain medication orders:
a. Hydromorphone hydrochloride (Dilaudid) 2 mg/1 ml Injection and 0.5 mg/0.25 ml Intravenous Q 4 hours PRN, Pain. Monitor Respiration Function. ('Dilaudid' is a medication given for severe pain. 'PRN' is term which means 'when necessary'. 'Q' means to 'give').
b. Hydrocodone-APAP 10, 10 mg Tablet, 10 mg/1 Tablet Oral Q 6 hours PRN for Pain. (Hydrocodone is a medication given for pain control).
c. Fentanyl 50 mcg 1 ml Injection, 25 mcg/1.5 ml Intravenous Q 4 hours PRN for Pain. (Fentanyl is a medication given for severe pain relief).
d. Meperidine hydrochloride (Demerol) 25 mg/1 ml Injection, 10 mg/0.4 ml Intravenous Q 6 hours PRN Pain. (Demerol is a medication given for pain control).

There was no documented evidence in the Physicians' Order Sheet or on the Medication Administration Record, dated November 27, 2012, that indicated that a clear, well defined pain range (a pain scale from 0 to 10 designating on the scale when the patient's perception of pain was considered to be mild, moderate or severe) was included in the written pain medication orders prior to its administration.

There was no documented evidence that the hospital pharmacist reviewed the physicians' pain medication orders for appropriateness prior to its administration to minimize the potential occurrence of adverse events and preventing the administration of unnecessary medications. The hospital pharmacy must ensure that medication orders are accurate and check for irregularities of orders written by the subscriber.

According to the American Society of Health-Systems Pharmacists' (ASHP) professional standards requires a pharmacist to ensure the safety and effectiveness of drug therapy. A pharmacist should have clarified the physicians' order to make certain the drug was administered as intended or that the dose was appropriate. There is no evidence in patient 11's medical record that a pharmacist clarified the pain medication orders for Patient 11 written by the subscriber which did not include pain scale parameters on when to specifically administer the pain medications according to the patients' pain intensity scale.

On November 28, 2012, a review of the facility's policy and procedure titled, "PAIN ASSESSMENT AND MANAGEMENT " dated as revised on April, 2012, documented, " ...RN's will be educated to 0-10 pain measurement scale during orientation and annually. Pain Assessment Tool shall be used to document and evaluate pain level " prior to administering pain medications by the RN. "

The facility failed to ensure that nurses were not using their own judgement in determining what pain medications to administer without a clear, well defined pain intensity scale written by the physician. This practice had the potential of unnecessary medications being administered to Patient 11 resulting in overdosing.

During an interview with the ICU Manager on November 28, 2012, at approximately 10:50 AM, she confirmed the finding that the physician should have written parameters of when the pain medications were to be administered according to the pain intensity of the patient.

Based on interview and record review, the hospital did not ensure that the medical records were complete because times and dates were omitted from some physician orders and statements for 1 of 51 sampled patients (Patient 1), creating the risk of substandard healthcare for those patients.

Findings:

The Medical Staff Bylaws (August, 2012), read in part (pages 95 and 96), "All orders for treatment shall be in writing, timed and dated" and "The attending Practitioner shall be held responsible for the preparation of a complete medical record of each patient.

The medical record of Patient 1 was reviewed on November 27, 2012 and contained a Physicians Orders page dated October 5, 2012 which contained two sets of orders, each encased by a thick black line and signed by the physician. There was no time on the orders. The first set of orders included, "D/C IV" (discontinue intravenous catheter), "D/C home" (discharge home). The second group of orders contained neither date nor time, and included, "Hold D/C," "Admit Overnight if feels better tomorrow ok to D/C home".

During an interview with Quality Staff 1 on November 30, 2012 at 2:15 PM, he stated that the physicians were to write a time on the medical record entries, and it was a recognized problem with ongoing efforts to improve physician compliance.

Based on interview and hospital record review, the hospital failed to ensure that informed consent forms for procedures and treatments, specified by the medical staff, were being completed by the responsible practitioner for 1 of 51 sampled patients (Patient 11) in a universe of 191 patients. This deficient practice had the potential to result in Patient 11 not being able to exercise her rights to make an informed decision regarding her care and treatment.

Findings:

A review on November 28, 2012, of Patient 11's medical record was conducted. Patient 11 was admitted to the hospital on October 19, 2012, with admitting diagnoses that included respiratory failure and cancer of the colon. Patient 11 was ventilator dependent.

According to the State Operations Manual, Appendix A, revised date, December 22, 2011, Section 482.24 (2) (c) (v), it stipulated, "All records must document a properly executed informed consent form that reflects the patient's consent process except in emergencies."

An informed consent form, in order to be properly executed, must be consistent with hospital policy. A properly executed informed consent form contains the following minimum elements:

a. Name of the hospital where the procedure or other type of medical treatment is to take place;
b. Name of the specific procedure, or other type of medical treatment for which consent is being given;
c. Name of the responsible practitioner who is performing the procedure or administering the medical treatment;
d. Statement that the procedure or treatment, including the anticipated benefits, material risks, and alternative therapies, was explained to the patient or the patient's legal representative;
e. Signature of the patient or the patient's legal representative;
f. Name of the practitioner who conducted the informed consent discussion with the patient or the patient's representative;
g. Date, time and signature of the person witnessing the patient or the patient's legal representative signing the consent form;
h. Indication or listing of the material risks of the procedure or treatment that were discussed with the patient or patient's representative;
g. A statement, if applicable, that physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery.

The hospital failed to ensure that Patient 11's informed consent forms were dated, timed and authenticated (signed) by the practitioner for the following procedures:

a. Esophagogastroscopy (EGD - an examination procedure to inspect the esophagus and stomach through a special scope, ('endoscope') performed on November 21, 2012.
b. Thoracentesis of the Right Chest (a surgical procedure that punctures the chest wall to remove fluid) on November 20, 2012.
c. Transvenous Temporary Pacemaker Insertion (an application of an electrical current between electrodes placed on the skin to stimulate the heart to beat) on November 19, 2012.
d. Permanent Pacemaker Insertion (an electrical device surgically implanted in the body to control the beating of the heart by a series of rhythmic electrical discharges) on November 15, 2012.

There was no documented evidence in the medical record or from other facility sources that the "Physician's Certification" forms of the above mentioned procedures were discussed by Patient 11's responsible physician to the patient or to patient's legal representative, discussing the risks and benefits of the procedures; adverse reactions to be expected by the procedures; alternatives to the above identified procedures; anticipated results of not having the procedures; potential problems that may occur during recuperation of the above mentioned procedure or any research or economic interest the physician may have regarding the procedures.

The Physician's Certification forms for Patient 11 were found to be incomplete, blank, not filled out, not dated, not timed and not authenticated (signed) by the responsible practitioner.

The hospital's "Medical Staff Bylaws", dated August 2012, stipulated, "Evidence of informed consent in the hospital medical record...the record must contain a fully completed consent for, in which the patient has acknowledged that an informed consent was provided by the physician" and "...the record must contain a fully completed consent form..."

During an interview with the Intensive Care Unit (ICU) Manager on November 28, 2012, at 11:45 AM, she confirmed the finding that Patient 11's physician did not date, time or sign the physician's certification form for Patient 11's mentioned procedures as per hospital policy.

Based on interview and record review, the facility failed to ensure the completeness of the Emergency Department's (ED) patient pain assessments for 2 of 51 sampled patients (Patients 17 and 18) as evidenced by missing documentation of a pain assessment when the patient's vital signs were taken and the pain assessment upon discharge was missing. This lack of patient pain assessment increased the risk of a poor health outcome and premature discharge of ED patients.

Findings:

During a review of the clinical record for Patient 17 the ED Patient Care Record was reviewed. The vital signs taken on November 26, 2012 at 3:02 PM, included three blood pressure readings, but lacked evidence of a pain assessment at that time.

During a review of the clinical record for Patient 18 the ED Patient Care Record was reviewed. The vital signs taken on November 26, 2012 at 5:45 PM, lacked documented evidence of a pain assessment upon discharge from the Emergency Department.

During an interview with the ED Director DG, on November 27, 2012, at 11:10 AM, she reviewed the clinical record for both Patient 17 & 18 and confirmed that the medical records lacked documented evidence of a pain assessment for the times stated above. She agreed that a pain assessment should have been assessed and documented in each patient's chart.

A review of a hospital policy titled, "Pain Assessment and Management", dated March 2011, showed the following: "Pain is assessed on an ongoing basis with a minimum of once per shift and after every pain control intervention." The policy continued, "Pain control will be addressed upon discharge."

Based on observations, record reviews, interviews, document reviews, and policy and procedure reviews, the hospital did not provide pharmaceutical services that met the needs of all of the patients.

1. Pharmaceutical services were not provided according to accepted professional principles. (Refer to A0131, A0491, A0500, A0501, A0749)

2. The facility failed to store a red container labeled as 'hazardous' separate from non-hazardous material (blanket and towel) in Patient 26's room. (Refer to A0749)

3. The facility failed to ensure that the facility's intravenous preparation area complied with the United States Pharmacopeia (USP) Chapter 797 Compounding-Sterile preparation, which set practice standards to ensure the safety and final quality of all products compounded under sterile conditions. (Refer to A0501)

4. The facility failed to ensure timely administration of respiratory treatment with the medications Albuterol and Atrovent to Patient 29. (Refer to A0500)

5. The facility failed to ensure that pharmacy technicians were assigned duties that were in compliance with state regulations to assure quality pharmaceutical services. (Refer to A0500)

6. The facility failed to designate the area of the Urgent Care Automated Dispensing Cabinets (ADCs) to the location in which they were physically housed. (Refer to A0491)

7. The facility failed to ensure that the attending physician authenticated consents for procedures such as a blood transfusion and a repeat Cesarean section for Patient 28. (Refer to A0131)

8. The facility failed to clearly communicate orders for Patient 29 to nursing staff. (Refer to A0500)

The cumulative effect 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 designate each Automated Dispensing Cabinet (ADC) assigned to off-site Urgent Care facilities to the location in which they are physically housed.

Findings:

During tours on November 26, 2012 at 1:35 PM and 2:20 PM of the Urgent Care facilities located in Fontana and Highland respectively, ADCs were observed in each facility. A review of the ADCs inventory and reports showed that the area the ADCs were to be stored was designated as ED (Emergency Department).

When asked, the Physician Assistant (PA) reported that the urgent care facilities were affiliated with the Emergency Department on the main campus, therefore, the ED designations were assigned to the ADCs.

During an interview with the Director of Pharmacy on November 27, 2012 at approximately 2:55 PM, he acknowledged that each ADCs should be accurately stored in the recorded assigned physical locations.

Based on interview and record review, the hospital failed to ensure that the Department of Pharmacy developed and implemented guidelines, protocols, policies and procedures to ensure patient safety in accordance with applicable standards of practice that were consistent with Federal and State Law for 4 of 51 sampled patients (Patients 11, 29, 44 and 55) in a universe of 191 patients when it failed to:

1. Develop and implement approved guidelines and protocols instructing Registered Nurses to precisely start/initiate, titrate and adjust anti-hypertensive (vasodilators) continuous medication drip rates and dosages according to an established targeted goal or by a physician order.

2. Develop and implement approved guidelines and protocols instructing Registered Nurses to precisely start/initiate, titrate and adjust continuous Propofol medication drips and dosages according to an established targeted goal using the RASS (Richmond Agitation Sedation Scale) or by a physician order.

3. Ensure that physician orders for pain medications were ordered with appropriate pain intensity scales or parameters indicating what medication was to be administered according to the patients' pain perception to prevent unnecessary medication administration or overdosage.

4. Ensure that post-operative pain medication orders were outlined in a manner that clearly indicated which medication was to be given in which circumstance, creating the increased risk of incorrect medication administration.

5. Ensure that drug distribution and inspection of medications stored on patient care units, that pharmacists were assigned and specific patient care areas were in compliance with state regulations.

6. Ensure that medication orders were clarified for nursing to ensure they were complete and not subject to interpretation prior to administration.

7. Ensure that all physician orders were standardized and contained all of the necessary elements of a complete physicians order. This failure increased the risk of medication errors and a poor health outcome for all facility patients.

These deficient practices had the potential to result in substandard care or adverse outcomes to those patients requiring safe and effective pharmaceutical services.

Findings:

1. A review of Patient 55's medical record was conducted on November 28, 2012. Patient 55 was admitted to the hospital with a diagnosis of chest pain on exertion and underwent an elective surgical Coronary Artery Bypass Graft (CABG) procedure on November 28, 2012 (an operation to open blocked arteries in the heart).

Patient 55 was subsequently admitted to the Intensive Care Unit (ICU) after the surgical procedure and remained on a ventilator (respirator) during the post surgical recovery phase until hemodynamically stable (normal functional status of the cardiovascular system is attained after a stress response to the heart).

Further review of Patient 55's medical record under the title: "ADULT CARDIAC SURGERY IMMEDIATE POST-OP ORDER Sheet" , dated November 28, 2012, revealed in Section (9), the following pre-printed medication standing orders (order set):

a. Nitroglycerin (Tridil) 100 milligrams in 250 milliliters of 5% Dextrose and water: titrate to maintain Systolic Blood Pressure (SBP -pressure of blood exerted against the arterial wall) less than 130 mm/Hg. (Nitroglycerin is a medication to lower high blood pressure levels in the body. Normal blood pressure is considered 120/80 mm/Hg. 'millimeters of mercury' -a unit of measurement for blood pressure).

b. Nitroprusside (Nipride) 100 milligrams in 250 milliliters of 5% Dextrose and water if the maximum dose of 100 micrograms/minute of Nitroglycerin is required. (Nitroprusside is a medication used to lower high blood pressure levels in the body).

c. May wean Nitroprusside and Nitroglycerin to maintain SBP at 130 mm/Hg.

A review of Patient 55's medical record, under the heading: "CRITICAL CARE/INTERMEDIATE CARE FLOW SHEET", dated November 28, 2012, revealed the following documentation of the Systolic Blood Pressure and infusion rates of Nitroprusside and Nitroglycerin Intravenous infusion as documented by RN 6 (Registered Nurse 6).

a. At approximately 12:45 PM the SBP was recorded as 138 mm/Hg.
b. At approximately 1:00 PM the SBP was recorded as being 130 mm/Hg.
c. At approximately 1:15 PM the SBP was recorded as being 132 mm/Hg.
d. At 1:00 PM, RN 6 initiated/started the Nitroglycerin Intravenous medication infusion drip at 100 micrograms per minute and initiated the Nitroprusside intravenous medication infusion drip at 5 micrograms per minute. Between the hours of 12:45 PM and 2:00 PM, Patient 55 received a total of 30 cc ('cubic centimeter' -a unit of measurement for liquids) of the medication Nitroglycerin, and a total of 9.2 cc of the medication Nitroprusside during that time frame.

A review of the hospital's policy and procedure titled, "INTRAVENOUS MEDICATION GUIDELINES, 2012-2013, AKA: THE YELLOW BOOK" documented under the heading: NITROGLYCERIN: Infusion time; 10 to 200 mcg/min. Maximum dose in ICU is 100 mcg/min. ('mcg'-micrograms, a unit of measurement-1000th part of a milligram). No other directions or information was provided.

A review of the hospital's policy and procedure titled, "INTRAVENOUS MEDICATION GUIDELINES, 2012-2013, PARENTERAL MEDICATION COMPOUNDING GUIDELINES, AKA: THE YELLOW BOOK" it documented under the heading: Nitroprusside: Infusion time; 0.5 to 4 mcg/min. Maximum dose in ICU 4 mcg/min. No other directions or information was provided.

There was no documented evidence in the hospital's "Intravenous Medication Yellow Book" that instructed or directed nurses to "start" the infusion medications at a specific start rate with a specific dose. The guidelines in the "Yellow Book" emphasized a dosage range and not a specific starting rate. Therefore, the medication infusion "start rate and dosage" was left to the nurses' judgment and clinical experience. In addition, there were no instructions or directions given to the nurses on how to incrementally titrate the infusion drip flow rate safely according to a targeted goal level during a specific time frame.

There was no documented evidence in the medical record that Patient 55's physician had written or given a verbal order in the ICU Physicians' Order Sheet, dated November 28, 2012, ordering RN 6 to initiate or to start the Nitroglycerin Medication infusion drip at 100 mcg/min. as documented in the ICU Flow Sheet.

On November 28, 2012, a review was conducted of the hospital's policy and procedure titled, "MEDICATION ADMINISTRATION OF INTRAVENOUS MEDICATIONS BY REGISTERED NURSES" dated April, 2010. It stipulated, " ...Intravenous medication may be given only on the order of the attending physician. It is the responsibility of the physician to specify the nature and volume of the diluents and the rate of delivery when Intravenous orders are written ... "

There was no documented evidence in the hospital's policy and procedure titled, "INTRAVENOUS MEDICATION GUIDELINES, 2012-2013, PARENTERAL MEDICATION COMPOUNDING GUIDELINES, AKA: THE YELLOW BOOK " directing registered nurses specifically to initiate or start Nitroglycerin Medication Infusion drips at 100 mcg/min. There was no documented evidence of a standing order (established order set) directing registered nurses to incrementally decrease or increase the rate of infusion at pre-set time intervals according to a targeted goal level.

There was no documented evidence in the medical record that Patient 55's physician had written an order or had given a verbal order in the Physicians' Order Sheet, dated November 28, 2012, for RN 6 to initiate or start Nitroprusside Medication Infusion drip at 5 mcg/min. as documented in the ICU Flow Sheet.

There was no documented evidence in the hospital's policy and procedure titled, "INTRAVENOUS MEDICATION GUIDELINES, 2012-2013, PARENTERAL MEDICATION COMPOUNDING GUIDELINES, AKA: THE YELLOW BOOK " directing registered nurses to initiate or start Nitroprusside Medication Infusion drips at 5 mcg/min. or any evidence of a standing order for Registered Nurses to incrementally decrease or increase the rate of infusion at preset time intervals according to a targeted goal level.

On November 28, 2012, a review was conducted of the hospital's policy and procedure titled, "MEDICATION ADMINISTRATION OF INTRAVENOUS MEDICATIONS BY REGISTERED NURSES " dated April, 2010. It stipulated, " ...Intravenous medication may be given only on the order of the attending physician. It is the responsibility of the physician to specify the nature and volume of the diluents and the rate of delivery when Intravenous orders are written ... "

There was no documented evidence that the hospital's Pharmacy Department or the Intensive Care Unit (ICU) had developed or implemented unit-specific approved protocols or specific guidelines for registered nurses administrating antihypertensive medication infusion drips at a "specific start rate and dose."

During an interview with the (Coronary Care Unit) CCU/ICU Manager on November 28, 2012, at approximately 1:45 PM, she stated, "My open heart nurses are very experienced and use sound clinical judgement, according to their training and experience when starting and titrating drips. Many factors affect their judgement when assessing the patient, they know at what rate to start the drip and how to titrate them"

The Hospital failed to ensure that policies and procedures were reviewed, developed and approved by the Medical Staff and Governing Body to assure that management of patients requiring antihypertensive medication Intravenous drips ordered by physicians specifically addressing the starting infusion rate, dose and titration sequence according to accepted national standards of practice and not allowing nurses to make that judgment or determination.

The Hospital failed to ensure that the Department of Pharmacy had recognized and identified possible medication irregularities in the hospital's established guidelines when it did not specify a specific standardized starting rate and titratable parameters according to a targeted goal ordered by the physician.

There was no documented evidence the Hospital-wide Quality Assurance and Performance Improvement Department had identified medication irregularities or a review was conducted to regularly monitor antihypertensive medication infusion drips or titratable medication infusion drips without a clear and specific standardized start rate on those patients requiring vasodilation continuous drip medication management.

On November 28, 2012, RN 8 (Registered Nurse answering questions by the surveyor) confirmed the finding that there were no specific orders written by the physician addressing a specific starting rate of the infusion drips and how to incrementally titrate the drips according to specific time frames.

2. A review of Patient 44's medical record was conducted on November 26, 2012. Patient 44 was seen and admitted to the Emergency Department on November 26, 2012 at 6:20 AM, with a chief complaint of a swollen tongue. Patient 44's condition deteriorated due to an obstructive airway as a result of an allergic reaction to an ingested prescribed medication. Patient 44 was emergently intubated (a soft plastic tube placed in the lung and connected to a mechanical ventilator to assist with breathing) in the Emergency Room and was placed on a ventilator (Respirator). Patient 44 was being held in the Emergency Department until an Intensive Care Bed was available and was admitted to the unit with a diagnosis of respiratory failure and angioedema (allergic reaction causing swelling).
On November 26, 2012, a review of Patient 44's CCU Admission Orders (Coronary Care Unit orders) revealed that Patient 44 was converted at 10:00 AM from an Emergency Department Outpatient status to a CCU Inpatient status at 10:00 AM, on November 26, 2012.

On November 26, 2012, a review of Patient 44's "Emergency Department Care Record" dated November 26, 2012 and timed at 10:15 AM documented that Patient 44 was intubated and placed on a ventilator. In addition, the Emergency Departments' (ED) Patient Care Record revealed the following documentation:

a. 10:25 AM: Propofol ( 'Diprivan' -medication used to induce sedation or light anesthesia with patients on a ventilator to minimize agitation and prevent pulling out of the breathing tube) IV drip started at 15 mcg/min.
b. 10:30 AM: Propofol IV drip increased to 35 mcg/min.
c. 10:35 AM: Propofol IV drip increased to 45 mcg/min.
d. 10:37 AM: Propofol IV drip increased to 55 mcg/min.
e. 10:50 AM: Propofol IV drip increased to 75 mcg/min.

There was no documented evidence in the Emergency Department Physicians' Orders sheet dated November 26, 2012 at 11:45 AM (time of record review) documenting that Patient 44's physician had given a verbal order or had written an order for RN 9 to start Propofol (Diprivan) IV drip at 15 mcg/min.

On November 28, 2012, a review was conducted of the hospital's policy and procedure titled, "MEDICATION ADMINISTRATION OF INTRAVENOUS MEDICATIONS BY REGISTERED NURSES ", dated April, 2010. It stipulated, " ...Intravenous medication may be given only on the order of the attending physician. It is the responsibility of the physician to specify the nature and volume of the diluents and the rate of delivery when Intravenous orders are written ... "

On November 26, 2012, A review was conducted of the hospital's policy and procedure titled, "INTRAVENOUS MEDICATION GUIDELINES, 2012-2013, PARENTERAL MEDICATION COMPOUNDING GUIDELINES, AKA: THE YELLOW BOOK " it documented under the heading: PROPOFOL (DIPRIVAN); Infusion time: Initial Dose is 0.5 to 1.5 mg/Kg bolus slowly over 3 to 5 min. Titrate continuous infusion up to 25 to a Maximum of 75 mcg/min. or 20 mcg/min to 60 mcg/min in patient over 60 years of age. No other directions or information was provided.

There was no documented evidence that the hospital's policy infusion guidelines for Propofol had addressed a specific start rate and dose for initiating the medication. The hospital-wide Propofol infusion guidelines provided an initiation range, without a specific start rate order. Therefore, RN 9 needed to use her judgment based on her clinical experience at what precise starting dose Propofol medication IV drip was to be started/initiated.

During an interview with the Emergency Department's (ED) Manager, on November 26, 2012, at approximately 10:30 AM, she stated, "Our ED nurses are very experienced and use their best judgement when to start medication drips and when to titrate them according to the patient's assessment."

There was no documented evidence in the hospital-wide Propofol policy guidelines located in Patient 44's medical record addressing what specific targeted goal level was to be attained along with the frequency of assessments to be conducted by registered nurses in the Emergency Department.

There was no documented evidence that the hospital-wide policy guidelines for continuous Propofol infusion addressed a targeted level of sedation, such as following the Richmond Agitation Sedation Scale (RASS) for maintenance or titrating the medication to keep the patient at a desired targeted level of sedation while on a ventilator. (RASS -an agitation sedation scale assessment tool scoring a patients' response to physical stimulation. Such as, +4= for being combative; 0=as being alert and calm; and -5= being in deep sedation and having no response, un-arousable to physical stimulation).

There was no documented evidence of a RASS score being recorded with the infusion rate adjustment along with the nursing assessment prior to titration of the drip on November 26, 2012.

On November 26. 2012, a review of the hospital-wide policy and procedure titled, "TARGET LEVEL OF SEDATION PROTOCOL" dated June 27, 2012 was conducted. The following components of the protocol were required to be documented when administering Propofol (Diprivan) Intravenous medication continuous drip for sedation while on the ventilator:

a. Section (3): Titrate to response when using Propofol. Use 1000 mg/100 milliliters. Continuous Infusion Rate: 25 to 75 mcg/kg/min.

b. Section (4): Targeted Level of Sedation: Keep patient at a specific score on the Richmond Agitation Sedation Scale (RASS). Such as (-1 to -4).

c. Section (5): Assessment: Assess patient on RASS at specific minute intervals and adjust infusion rate as needed until target Level (score) of sedation is achieved. Reassess at specific minute intervals to maintain desired level (score).

d. Section (7): Flow Sheet: Record RASS score and infusion rate on flow sheet every one hour.

There was no documented evidence in Patient 44's medical record that RN 9 had utilized the "Hospital-wide Sedation Protocol Flow Sheet" while caring for Patient 44 on a Propofol drip in the Emergency Department on November 26, 2012, as per hospital policy.

There was no documented evidence that the hospital's Pharmacy Department or the Emergency Department had developed or implemented unit-specific approved protocols or specific guidelines for registered nurses administrating Propofol continuous infusion drips for sedation for ED patients on a ventilator. There was no evidence that hospital policy had directed specifically at what "specific start rate and dose" nurses must follow.

The Hospital failed to ensure that policies and procedures were reviewed, developed and approved by the Medical Staff and Governing Body to assure that management of patients requiring continuous intravenous antihypertensive medication drips, ordered by physicians, specifically addressed the starting infusion rate, dose and titration sequence according to nationally accepted standards of practice and not allowing nurses to make that judgment or determination.

There was no documented evidence that the Hospital-wide Quality Assurance and Performance Improvement Department had identified medication irregularities or a review was conducted to regularly monitor Propofol infusion management in patients in the Emergency Department on ventilators or monitoring titratable medication infusion drips without a clear and specific standardized start rate or standing orders for nurses to incrementally adjust the dose rates per a specific targeted sedation goal.

On November 26, 2012, at approximately 11:55 AM, the manager of the Emergency Department confirmed that RN 9 did not utilize the hospital-wide sedation protocol while managing Patient 44 while on a Propofol drip in the Emergency Room.
3. A review on November 28, 2012, of Patient 11's medical record was conducted. Patient 11 was admitted to the hospital on October 19, 2012 with admitting diagnoses that included respiratory failure and cancer of the colon. Patient 11 was ventilatory dependent.

A review of Patient 11's Medication Administration Record (MAR) and Physicians' Order sheet, dated November 27, 2012, documented the following pain medication orders:

a. Hydromorphone hydrochloride (Dilaudid) 2 mg/1 ml Injection and 0.5 mg/0.25 ml Intravenous (within the vein) Q (every) 4 hours PRN (as needed), Pain. Monitor Respiration Function. (Dilaudid is a medication given for severe pain).

b. Hydrocodone-APAP 10, 10 mg Tablet, 10 mg/1 Tablet Oral Q 6 hours PRN for Pain. (Hydrocodone is a medication given for pain control).

c. Fentanyl 50 mcg (microgram)/1 ml Injection, 25 mcg/1.5 ml Intravenous Q 4 hours PRN for Pain. (Fentanyl is a medication given for severe pain relief).

d. Meperidine hydrochloride (Demerol) 25 mg/1 ml Injection, 10 mg/0.4 ml Intravenous Q 6 hours PRN Pain. (Demerol is a medication given for pain control).

There was no documented evidence in the Physicians' Order Sheet or on the Medication Administration Record, dated November 27, 2012, that indicated that a clear, well defined pain range (a pain scale from 0 to 10 designating on the scale when the patient's perception of pain was considered to be mild, moderate or severe) was included in the written pain medication orders prior to its administration.

There was no documented evidence that the hospital pharmacist reviewed the physicians' pain medication orders for appropriateness prior to its administration to minimize the potential occurrence of adverse events and preventing the administration of unnecessary medications. The hospital pharmacy must ensure that medication orders are accurate and check for irregularities of orders written by the subscriber.

According to the American Society of Health-Systems Pharmacists' (ASHP) professional standards requires a pharmacist to ensure the safety and effectiveness of drug therapy. A pharmacist should have clarified the physicians' order to make certain the drug was administered as intended or that the dose was appropriate. There was no evidence in patient 11's medical record that a pharmacist clarified the pain medication orders for Patient 11 written by the subscriber which did not include pain scale parameters on when to specifically administer the pain medications according to the patients' pain intensity scale.

On November 28, 2012, a review of the facility's policy and procedure titled, "PAIN ASSESSMENT AND MANAGEMENT " dated as revised on April, 2012, documented, " ...RNs will be educated to 0-10 pain measurement scale during orientation and annually. Pain Assessment Tool shall be used to document and evaluate pain level " prior to administering pain medications by the RN. "

The facility failed to ensure that nurses were not using their own judgement in determining what pain medications to administer without a clear, well defined pain intensity scale written by the physician. This practice had the potential of unnecessary medications being administered to Patient 11 resulting in overdosing.

During an interview with the ICU Manager on November 28, 2012, at approximately 10:50 AM, she confirmed the finding that the physician should have written parameters of when the pain medications were to be administered according to the pain intensity of the patient.



26881

4. The hospital pain medication order sheet was reviewed and contained a list of several medications for each category of pain.

In an interview with RN 12 in the recovery area on November 26, 2012, at 3:10 PM, she stated that she used nursing judgment when deciding which pain medication from the list to give the patient.


16333

5. On 11/30/12 at approximately 1:40 PM, the Director of Pharmacy (DOP) and the Pharmacy Manager (PM) were interviewed regarding drug distribution and inspection of medications stored on patient care units. The DOP and PM reported that designated pharmacists were assigned specific patient care areas, however, medications stored on the nursing units and other areas of the hospital were inspected by a pharmacy technician on a monthly basis, after which the pharmacist signs the inspection sheet.

Current regulation stipulates as follows, "Drugs maintained on the nursing unit shall be inspected at least monthly by a pharmacist" and "the supply shall be inspected by a pharmacist at periodic intervals specified in written policies. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years."

The Board of Pharmacy (BOP) delineated the scope of practice for a Pharmacy Technician to that of non-discretionary tasks. Hence, the facility failed to assure that pharmacy staff assigned duties to be in compliance with state regulations.

6. Review of Patient 29's chart on 11/29/12 at approximately 8:50 AM revealed a physician's order written in the chart that read, "11/28/12 at 3:40 PM - Resume prior diet and meds (medications)". The order as written using "Resume" instead of including each element of each medication order, such as "drug, dose, route, frequency, is one of the major causes of medication errors. The ongoing use of unacceptable expressions used instead of complete elements of a medication order frequently result in Medication Errors.

Underlying factors contributing to many of these errors are illegible or confusing handwriting by clinicians and the failure of health care providers to communicate clearly with one another. Medication safety and the identification, prevention and timely reporting of medication errors are of primary importance to the facility in determining where affected systems may be modified to prevent recurrence.

In a concurrent interview with the nurse manager on 11/29/12, at approximately 8:50 AM, she confirmed that an order such as 'Resume ...' was unacceptable and conflicts with the standards of acceptable practice and the facility's policies and procedures. The physician has essentially relinquished his/her authority as a prescriber of medication to the nurse.

Interview with the pharmacy staff on 11/29/12, the pharmacist acknowledged that the medication orders were not clarified for nursing to ensure they were complete and not subject to interpretation prior to administration.



31467

7. During a review of the pre-printed medication orders for intravenous vasopressors (medications to maintain patient blood pressure in a safe range), the orders did not contain complete information about the starting rate or the titration instructions for the medications.

During an interview with MD 3 on 11/28/12, at 11:30 AM he stated that he used the pre-printed form for ordering IV pressors, MD 3 stated that he expected the nurses to be able to assess the patient, give the medication at a starting dose per her/his expertise and then reassess the patient's medication needs and to adjust the patient medication dose to keep the patient's post anesthesia blood pressure in a safe range.

During an interview with the ED Mgr on 11/28/12 at 11:45 AM, when questioned regarding similar blood pressure medications given in the ED, she produced what she called "the yellow book" which contained Medication Guidelines for medication drips given in the Emergency Room. The Medication Guidelines indicated a range of possible starting doses for each medication. When asked about the Medication Guidelines, the ED Mgr stated that she used her judgment regarding the starting dose for the patient medication drips.

The hospital policy Medication Administration Admin of IV Medications by RN's dated April 1983, indicated "intravenous medications may be given only on the order of the attending physician." Also, "it is the responsibility of the physician to specify the nature and volume of the diluent and the rate of delivery when IV (intravenous: within the vein) medication orders are written".

Based on observation, document review, and interview, the facility failed to ensure that the facility's intravenous preparation area complied with the United States Pharmacopeia (USP) Chapter 797 Compounding-Sterile preparation, which set practice standards to ensure the safety and final quality of all products compounded under sterile conditions..

Findings:

The United States Pharmacopeia (USP) 797 addresses facilities in which sterile products are prepared according to the manufacturers' labeling and where manipulations are performed during the compounding of sterile products which increase the potential for microbial contamination of the prepared products. It delineates what training, procedures for transporting products is needed, how the preparation area should be designed, equipment type, and quality control program formalized in writing.

During an inspection of the facility's pharmacy on 11/27/12 at approximately 1:30 PM, it was observed that the intravenous (IV) preparation area (space) was not separated into a clean and non-clean (buffer, ante) areas. The expiration dates of IV solutions compounded in the preparation area (space) configuration would not comply with USP 797 practice standards.

In a concurrent interview with the Director of Pharmacy (DOP), and Pharmacy Manager (PM) on 11/27/12 at approximately 1:35 PM, they acknowledged that the facility's intravenous preparation area did not comply with the United States Pharmacopeia 797 (USP) standards for Pharmaceutical Compounding of Sterile Preparations. It was also noted that a USP 797 implementation project did not come to fruition due to competing financial priorities.

Based on observation and interview, the facility failed to ensure that outdated drugs and materials were removed from patient care areas including the in the O.R. (operating room). This failure increased the risk of a poor health outcome for a universe of 191 patients.

Findings:

During an initial tour of Labor and Delivery on November 26, 2012 at 1:55 PM, four (4) one-liter bags of Lactated Ringers solution and two (2) one-liter bags of 0.9% Normal Saline were noted to be expired. Two packages of surgifoam were also expired and available for use in the Labor and Delivery O.R.

During a concurrent interview with Registered Nurse (RN) 11, she confirmed that the items were expired and should be removed from the O.R.

A record review of the facility policy and procedure titled, "STR Rounding Checklist Find and Fix", dated September 24, 2012, on page 2 under "Patient Care" it stated in part, "No expired supplies (medications, Point of Care testing solutions);..."

Based on interview and record review, the hospital did not follow its policy to notify one of one blood transfusion recipients reviewed (Patient 12) of the possibility of hepatitis C exposure (HCV - a viral infection affects the liver), creating the risk of a poor health outcome for that patient.

Findings:

The hospital policy titled, "Lookback Procedure for HCV" (October, 2011), described the process for notifying patients who received blood transfusions from donors who later tested positive for hepatitis C about their risk of infection and thus enabled them to seek medical advice and testing. The policy read in part, "Consignees must promptly notify the patient in one of two ways: a. Notify the patient directly, and, concurrently notify either a) the physician of record or b) the physician that ordered the blood product, and ask the physician to immediately notify the patient" and "If the physician is unavailable, declines to make the notification, or later informs the hospital that he or she was unable to notify the patient (or patient's legal representative), notification responsibility reverts to the hospital or transfusion service, who must then promptly attempt to notify the patient (or patient's legal representative)."

During a tour of the laboratory on November 28, 2012 at 1 PM, the Lead Tech of the blood bank was asked for an example of a patient who was identified as having received blood that was possibly infected. He produced a letter addressed to Medical Doctor (MD) 4 dated October 21, 2012, in which the physician was informed about the possible hepatitis C exposure of a Patient 12, and referenced a form that was being sent to MD 4 with the letter for completion. The pre-printed form referenced in the letter to MD 4 was found, and it contained an item for "current status" with the possible responses "alive", "deceased", unknown" and "other". The response "unknown" was checked, and it was signed by MD 5. There was no indication that any effort was made by either MD 4 or MD 5 to contact the patient regarding his possible exposure to hepatitis C via a blood transfusion.

During a concurrent interview with the Lead Tech of the blood bank, he stated that he was not sure what efforts were made by the doctor to contact the patient, and that no additional efforts had been made by the hospital to contact the patient. He stated that the issue of contacting the patient had not been referred to the hospital administration.

During an interview with the Director of Pathology (Dir Path) on November 27, 2012 at 1:15 PM, he stated that no further steps were taken by the hospital to contact a patient if the physician was unable to contact him. He stated that he did not know what efforts the physician may have made to contact the patient.

During an interview with the Medical Director (Med Dir) on November 30, 2012 at approximately 2:30 PM, he stated that it was important for the patient with the possible infection exposure via the blood transfusion be contacted, and that both the physician and hospital should try to contact him.

Based on observation, staff interview and facility record review, the hospital failed to ensure that dietary staff followed established policies and procedures for maintaining safety practices for food handling in a universe of 191 patients when it failed to label and date all food items in the dietary refrigerator designated for patient use only. This deficient practice had the potential for certain food items to pass its freshness threshold and risk of spoilage.

Findings:

During the dietary tour of the kitchen, on November 27, 2012, at approximately 10:30 AM, it was observed in reach-in Refrigerator 3: one plate containing multiple tomato slices and lettuce, covered in transparent plastic wrap and one plate containing multiple slices of cheddar cheese, covered in transparent plastic wrap, were not labeled and dated as per posted instructions by the Dietary Department on the front door of reach-in Refrigerator 3.

A review of the hospital's Dietary Department's policy and procedure titled, "SCOPE OF SERVICES-FOOD AND NUTRITION SERVICES", dated August, 21, 2012, it stipulated in Section (1) (A), "...Food and Nutrition Services purchase, receive, store, prepare and serve foods in accordance with all regulatory agencies ..."

Therefore, the facility failed to ensure that those food items that required date monitoring to ensure freshness and food safety were dated and labeled. Items that had a limited shelf life in the refrigerator were not dated to ensure the shelf life was adhered to.

During an interview with the Director of Food and Nutritional Services, on November 27, 2012, at approximately 10:45 AM, she confirmed that the food items in Refrigerator 3 were not labeled and dated as per instructions posted on the front door of the refrigerator and department policy.

Based on observation, record review, and staff interview, it was determined that the hospital failed to be maintained to ensure the safety of the patients.

This was evidenced by the following:

1. The facility failed to ensure their corridor doors closed and latched. This was evidenced by six doors equipped with Roller Latches, eleven doors that failed to latch, three doors that were impeded from closing, and one door equipped with two locking mechanisms. (Refer to A710)

2. The facility failed to ensure that the fire alarm system could be heard in all areas in accordance with NFPA 101. This was evidenced by observation of the fire alarm system during alarm testing, by staff interviews, and by fire drill records indicating that the fire alarm system could not be heard. (Refer to A710)

3. The facility failed to ensure that all patient areas were protected by smoke detectors in accordance with National Fire Protection Association (NFPA) 101. This was evidenced on November 28, 2012, at 11:29 AM, by the absence of smoke detectors in an Intensive Care Unit (ICU). (Refer to A710)

4. The facility did not have a system that minimized the duration and frequency of instrument sterilizer failures, creating the risk of substandard instrument sterilization, and the increased risk of infection for patients undergoing surgery in the hospital. (Refer to A724)

5. The facility did not monitor and maintain the temperature and humidity in the sub-sterile areas and in the sterile processing area in accordance with hospital policy, creating the increased risk of infection for patients receiving supplies stored in an uncontrolled environment. (Refer to A726)

The cumulative effect of these systemic problems identified during the survey resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, record review and facility staff interview, the hospital failed to maintain their corridor doors and the fire alarm system to meet the provisions of the 2000 edition of the Life Safety Code 101 of the National Fire Protection Association. This was evidenced by corridor doors equipped with roller latches (no latching mechanism), by corridor doors that were obstructed from closing or that failed to latch, by no audible alarms provided in three areas, and by no smoke detectors provided in one patient care area. This affected five of six floors and could result in a delay to contain smoke and fire to a room or in a delay in notification in the event of a fire. This affected a universe of 191 patients, and 1 of 2 smoke compartments in the Outpatient Surgery Clinic. This increased the risk of injury to patients without the ability to protect themselves from smoke and fire.

Findings:

During the facility tour, and facility staff interviews from November 26, 2012, through November 30, 2012, the hospital was found out of compliance with the 2000 edition of the Life Safety Code 101 of the National Fire Protection Association.

1. During the facility tour from November 26, 2012, through November 30, 2012, there were corridor doors that failed to close and latch. This could allow the spread of smoke and fire, in the event of a fire.

2. There were three areas where an audible fire alarm could not be heard to notify the occupants of smoke and fire.

Ancillary - November 28, 2012:

At 11:59 a.m., the fire alarm system was not audible in the North side of the Clinical Lab and near the System Manager Office (near the Refrigerators). The fire alarm system could not be heard while the alarm was sounding.

At 2:40 p.m., the fire system was not audible in the Post Anesthesia Care Unit (PACU), near the nursing station, while the doors were closed.

Ancillary - November 29, 2012

At 9:54 a.m., the fire alarm system could not be heard in the Central Supply Storage and Decontamination Rooms while the fire alarm was sounding.

During an interview at 10:07 AM, Central Supply Staff 7a said that she could not hear the fire alarm system at all, in the area near the machines.

During record review at 10:08 AM, there was a remark on the fire alarm drill for Central Supply, dated March 29, 2012, that said that the fire alarm system could not be heard in the Central Supply area and the paging system was also hard to hear.

3. During the facility tour on November 28, 2012, at 11:29 AM, there were no smoke detectors in the smoke compartment Critical Care Unit (CCU), Side 7, in the E/W Tower. The CCU census was six during the survey.

Based on observation, interview and record review, the hospital did not have a system that minimized the duration and frequency of instrument sterilizer failures, creating the risk of substandard instrument sterilization, and the increased risk of infection for patients undergoing surgery in the hospital.

Findings:

During a tour of the hospital on 11/26/12, two sterilizers in the sub-sterile areas adjacent to the operating rooms had "out of order" signs on them.

During an interview with the Lead Tech on 11/27/12 at 8:30 AM, she stated that there were 9 steam sterilizers, and that 4 or 5 were now broken. She stated that OR (operating room) sterilizers 2 and 3 were broken.

During an interview with the Sterile Processing Manager (SP Mgr) on 11/27/12 at 8:40 AM, he stated that the two sterilizers in outpatient surgery had been broken for 2 weeks.

The hospital's daily documentation from November 1 through 28, 2012, for OR sterilizer 2 was reviewed. The SP department documents showed OR sterilizer 2 was out of service on 18 of 28 days reviewed-November 3, 4, 5, 6, 7, 13, 14, 17, 18, 20, 21, 22, 23, 24, 25, 26, 27, and 28.

The equipment maintenance company records for OR sterilizer 2 were also reviewed, and showed that the sterilizer was out of service on 7 days during the same period-November 21, 23, 24, 25, 26, 27 and 28. There was a discrepancy of 11 days in November between the documentation of the SP department and the equipment maintenance company about when OR sterilizer 2 was working.

The hospital's daily documentation from November 1 through 28, 2012, for OR sterilizer 3 was reviewed. The SP department documents showed OR sterilizer 3 was out of service on 12 of 28 days reviewed-November 13, 14, 15, 16, 17, 18, 19, 20, 21, 26, 27, and 28.

The equipment maintenance company records for OR sterilizer 3 were also reviewed, and showed that the sterilizer was out of service on 14 days during the same period-November 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 25, 26, 27, and 28.

The discrepancy between the documentation from the equipment maintenance company and the hospital records was discussed with the SP Mgr and the Maintenance Company Manager on 11/29/12 at 4:05 PM.

The SP Mgr stated that the sterilizers were not on the list of equipment for which a service call had been placed, and that the staff must have forgotten to write down on the log calls made regarding the sterilizers. He stated that on the days that the equipment maintenance company documents showed the sterilizers were working, when the SP department documentation did not, he thought the "out of order" sign might have been left on the equipment in error.

In a concurrent interview with the equipment maintenance supervisor, he reviewed the documentation and stated that he was not sure why the sterilizer 3 had not been returned to service more quickly. He stated that the technician repairing the machine had not provided adequate documentation about why there was a delay. He stated that he had not conducted any study of sterilization malfunction or down times.

Based on observation, interview and record review, the facility did not monitor and maintain the temperature and humidity in the sub-sterile areas and in the sterile processing area in accordance with hospital policy, creating the increased risk of infection for patients receiving supplies stored in an uncontrolled environment.

Findings:

1A. During a tour of the sub-sterile area outside of ORs 7 and 8, there was a steam sterilizer and cabinets containing sterile items. One stored item was observed to be the Medtronic Mosaic Ultra tissue valve (a heart valve made of pig tissue). The instructions on the side of the box indicated that the item was to be stored at 41 to 77 degrees Fahrenheit. A Surgery Department Temperature Monitor posted in the room indicated: "(Normal Temp Range: 41 degrees F to 98.6 degrees F)".

During an interview with the Scheduler Coordinator on 11/26/12 at 11 AM, she stated that the temperature and humidity were checked in the room in the morning by the engineering department, and that no one was rechecking the room after the sterilizer was run. She stated that it was okay for the room to be 98.5 degrees Fahrenheit, and that 41 to 98.6 degrees Fahrenheit was the correct ambient temperature. After observing the temperature range on the tissue valve box, she stated that implants were to be stored at 59-73 degrees Fahrenheit, and that the 41 to 98.6 degrees designation on the monitoring sheet had been printed in error.

1B. During a tour of a sub-sterile area outside ORs 9 and 10 on 11/26/12 at 11:40 AM, no temperature and humidity gauge was seen. In a concurrent interview, the Sr Dir Peri-Op stated that the area had a temporary temperature and humidity sensor that was being monitored daily.

The log for the anterooms to ORs 9 and 10 were reviewed and showed lines for entering daily temperature and humidity data in the two ante-rooms, sterile supply, etc. The instruction below the data grid read, "If temperature and/or humidity are out of range, do not start surgery room. Notify the charge nurse and engineering immediately." A second instruction on the page read, "normal range T" 68-73, Hum: 30-60%). The data that was handwritten on the page included 7 days when the facility was open, and two days (10/27-28/12) when no data was recorded. For both anteroom 9 and 10, for 4 of the 7 days logged in October, the temperature was above the target range. For the month of November, Ante Room 9 was above 73 degrees for 16 out of 23 days, and for anteroom 10, 13 of 23 days logged .

The OR Mgr was interviewed on 11/26/12 at 11:50 AM and she stated that she checked the temperature and humidity on days when she was working, and left it for others to do on the weekend. She stated that if the temperature was greater than 76 degrees Fahrenheit she called engineering. She stated that she did not document calling engineering or rechecking the temperature subsequently.

2. During a tour of the sterile processing area on 11/27/12 at 9:40 AM, a log of the area temperature and humidity was seen titled Decontamination Temperature and Humidity Log., with the goal temperature range of 60 to 65 degrees F, and humidity ranges from 30 to 60%. The log showed that the temperature was elevated above the There was the instruction to call engineering if the observed values fell outside those ranges. The log showed temperatures above the goal range on 13 of 25 days recorded in November. The documentation showed that engineering had been notified only twice.

In a concurrent interview with the Lead Tech, she stated that she was not sure why there was no notation of engineering being notified of the elevated temperatures.

In an interview with the SP Mgr on 11/27/12 at 9:45 AM, he stated that there was no other log on which the calls to engineering regarding elevated temperatures would have been noted.

Based on observation, interview, and record review, the hospital did not ensure that the infection control policies were implemented and enforced. Infection control practices were not adhered to by physicians, nursing staff, and other personnel, citing 11 of 14 departments and/or services (Emergency Department [ED], Surgical Department [OR], Labor & Delivery Department [L&D], Dietary Services [Kitchen] and General Acute Care areas). The following deficient infection control practices were observed:

1. Several live and dead insects with in a patient care area (4th floor - Telemetry unit).

2. The privacy curtains in patient rooms/cubicles were not cleaned as per hospital policy (4th floor - Telemetry unit; 5th floor - Medical/Surgical unit; Side 4 - Medical Critical Care Unit).

3. Within the Emergency Department (ED) and 2 of 4 outpatient clinics (Wound Care Clinic and an Urgent Care Clinic) there were biohazard rooms that contained clean and dirty patient supplies and materials which could become contaminated and used for patient care.

4. The dietary departments' industrial can openers were observes to have a reddish, liquid substance on the blade.

5. The hospital did not dispose of expired supplies according to policy within the operating room (OR).

6. There was no method for timing surgical scrubs at the surgical scrub sinks (Labor and Delivery Department).

7. The facility did not ensure that staff used a cleaning chemical according to the manufacturer's directions (General Acute Care areas).

8. Biologic indicators used for ensuring sterilization of surgical instruments were not used as indicated in the Sterile Processing area .

9. Surgical instruments were not sterilized appropriately before being made available for patient use. (OR)

These failures had the potential to jeopardize the health of patients and contributed to an unsanitary hospital environment.
Cross Refer: Tag A0749

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure the provision of an effective infection control program and contributed to an unsanitary environment for a universe of 191 patients.

Based on observation, interview, and record review, the hospital did not ensure that the infection control policies were implemented and enforced. Infection control practices were not adhered to by physicians, nursing staff, and other personnel, citing 11 of 14 departments and/or services (Emergency Department [ED], Surgical Department [OR], Labor and Delivery Department [L&D], Dietary Services [Kitchen] and General Acute Care areas). The following deficient infection control practices were observed:


1. Several live and dead insects in the patient care area (4th floor - Telemetry unit).

2. The privacy curtains in patient rooms/cubicles were not cleaned as per hospital policy (4th floor - Telemetry unit; 5th floor - Medical/Surgical unit; Side 4 - Medical Critical Care Unit).

3. The Emergency Department (ED) and 2 of 4 outpatient clinics (Wound Care Clinic and an Urgent Care Clinic) biohazard rooms contained clean and dirty patient supplies and materials which could become contaminated and used for patient care.

4. The dietary departments' industrial can openers were observes to have a reddish, liquid substance on the blade.

5. The hospital did not dispose of expired supplies according to policy (OR).

6. No method for timing surgical scrubs at the surgical scrub sinks (Labor and Delivery Department).

7. Did not ensure that staff used a cleaning chemical according to the manufacturer's directions (General Acute Care areas).

8. Biologic indicators used for ensuring sterilization of surgical instruments was not used correctly (Sterile Processing area) .

9. Surgical instruments were not sterilized appropriately before being made available for patient use. (OR)

These failures had the potential to jeopardize the health of patients and contributed to an unsanitary hospital environment.

Findings:

1. During an observation on November 27, 2012 at 10:05 AM, accompanied by multiple staff members present at on the 4th floor Telemetry unit, near room 424, an insect was observed crawling on the floor. No staff member removed or destroyed the insect.

During an interview on November 27, 2012 at 10:05 AM, RN 14 (Registered Nurse) stated that "that's only a cricket, it ' s bad luck to kill a cricket " and "I don't kill crickets".

During an interview on November 27, 2012 at 10:25 AM, on the 4th floor Telemetry unit, with Housekeeper 1, he stated "I have seen bugs every once in a while" .

During another observation on November 27, 2012 at about 10:35 AM, with RN 3 present, an ant was observed crawling on the counter top of the nurse's station where the staff worked.

During an additional observation on November 27, 2012 at about 2:00 PM, with RN 13 present, 2 dead insects and 1 live insect were observed crawling on the floor near room 424. RN 13 removed the insects from the floor.

A record review on November 29, 2012 of the Hospital pest control service report, dated November 21, 2012,noted that preventive treatment was rendered for pests.

2. During an observation, on November 27, 2012, at 9:35 AM on the 4th floor, on the Definitive Observation Unit/Telemetry (DOU, a part of a hospital that provides the second-highest level of care), with RN 10 present, Housekeeper 1 was observed to clean a patient room that had been used as an isolation room. Per RN 10, she stated that the patient that had been in the room had "C-Diff" (Clostridium difficile, a bacteria that causes severe diarrhea and other intestinal disease). The patient room was observed to have a privacy/ cubicle curtain (curtains that separate patient care spaces) hanging from the ceiling .

During an interview, on November 27, 2012, at about 10:25 AM, with Housekeeper 1, at the DOU/Telemetry unit, he stated that he does not clean or change the privacy/ cubicle curtains, including patient rooms used for isolation (a room designed to minimize the spread of contagious germs). He stated that the curtains are "special curtains" that do not need to be cleaned in between patient use. Housekeeper 1 further stated that the curtains are cleaned or changed "only when stains are seen on the curtains".

During an interview, on November 27, 2012, at about 2:50 PM, with Housekeeper 2, at the 4th floor Medical/Surgical unit, she stated that the privacy/ cubicle curtains do not need to be cleaned or changed in between patient use of room. She stated that the curtains are "special curtains" that are treated with a type of chemical so that the curtains do not need to be cleaned in between patient use. Housekeeper 2 further stated that she was told not to spray the curtains with the disinfectant cleaner.

During an interview, on November 28, 2012, at 1:35 PM, with Housekeeper 3, at the Intensive Care Unit, Side 4, she stated that the privacy/ cubicle curtains do not need to be cleaned or changed in between patient use of the room. Housekeeper 3 stated that the curtains were taken down from the ceiling hangers and changed every 6 months. She stated that if the curtains had a stain on them, she would spray the curtains with the disinfectant cleaner. Housekeeper 3 further stated that the privacy/ cubicle curtains and the curtains hanging on the windows were treated with a special formula that does not require cleaning in between patient use.

A record review was done, on November 30, 2012, of Hospital policies, PAC00100 Environmental Services, titled, "Isolation Room Discharge", dated May 2000, and PAC00200 Environmental Services, titled, "Patient Room discharge/transfer", dated May 2000. The policies noted the procedure to be followed when the patient rooms are cleaned after patient use: "wet wipe side of cubicle curtains that is used to pull open and closed with detergent/disinfectants solution (DDS) and damp cleaning cloth". The policies further noted that "cubicle and window curtains changed if visibly soiled".

A record review was done, on November 30, 2012, of the Environmental Services (EVS) staff daily assignment sheet (a form used by the housekeeping staff listing the patient rooms to be cleaned daily and upon the patient ' s discharge from the hospital), noted " Discharge cleaning [of patient rooms] consists of ...wet wipe side of cubicle curtains that is used to pull open and closed " .

During an interview, on November 30, 2012, at 9:45 AM with the EVS Supervisor she stated that the privacy/ cubicle curtains are treated with a special antimicrobial solution and the housekeeping staff are to clean the curtains based on visible inspection. The EVS Supervisor reviewed the Hospital policies, PAC00100, PAC00200 and the Environmental Services staff daily assignment sheet. The EVS Supervisor confirmed that the procedure to be followed by the housekeeping staff when the patient rooms are cleaned after patient use is to include wet wipe side of cubicle curtains that is used to pull open and closed with detergent/disinfectants solution (DDS) and damp cleaning cloth. The EVS Supervisor stated that she thought the housekeeping staff were cleaning the privacy/ cubicle curtains.



28020


3a. An observation was conducted of one of the hospital's Urgent Care Clinics, on November 26, 2012 at 1:20 PM. A room labeled "Biohazard Storage Room," contained dirty materials and cleaning supplies. The Lead Physician Assistant stated that the cleaning supplies were used to clean the facility.

During an interview with the Director of Quality, on November 26, 2012 at 1:20 PM, she stated that she agreed that the clean supplies should not be kept in the biohazard room. The Lead Physician Assistant stated, "It makes sense, clean and dirty shouldn't mix."

3b. An observation was conducted on November 26, 2012 at 3:30 PM, of the Outpatient Wound Clinic's soiled utility room. The room contained biohazard carts with soiled materials, cleaning supplies which according to the Program Director were used to clean the clinic, marketing and educational materials which were given to patient's, family and also used for marketing. The soiled utility room also contained clean patient disposable gowns which according to the Program Director were used for patients when needed.

3c. An observation was conducted on November 26, 2012 at 11:05 AM, of the hospital ED. Next to the bed of a patient exam area, a sharps container (a container designed for the disposal of sharp objects such as needles and syringes) which was ? full, was left open and exposed to the environment and easily accessible to any individual. The sharps container contained multiple dirty syringes with red material, used clamps and various other biohazard materials. The ED Charge Nurse stated that the sharps container was not supposed to be left open.

3d. An observation was conducted on November 27, 2012 at 9 AM, of the hospital's ED biohazard room. The room contained soiled materials, a specimen container labeled with a patient's name and an admit date of November 26, 2012. The ED Manager stated that the specimen was not supposed to be left on the counter top and that it should have been disposed of. The biohazard room also contained clean supplies such as patient commode basins, hemoccult slides (used for patient testing), various other clean supplies used for patient care and a container with dentures (labeled with a patient's name and dated November 24, 2012 - The ED Manager stated that the patient had expired and the facility saved the dentures in case the patient's family wanted them).



16333

3e. During the medication observation pass on November 27, 2012 at 8:44 AM, a red hazardous container was observed in Patient 26's room. There were linens, such as a blanket and a towel, that were stored on top of the container.


26502

4. During the initial tour of the kitchen area on November 26, 2012, at 10:15 AM, it was observed that 1 of 2 dietary departments' industrial can openers, positioned on the edge of one of the preparation food tables in the kitchen, was noted to have a reddish, liquid substance on its blade.

During an interview with the Director of Food and Nutritional Services, on November 26, 2012, at 11:00 AM, she confirmed the finding that 1 of 2 industrial can openers had a reddish, liquid substance on its blade.




26881

5. During a tour of Operating Room (OR) 7 on 11/26/12 at 10:20 AM, a cart contained Cavilon Barrier Film (a fast-drying, non-sticky, alcohol-free liquid barrier film that forms a breathable, transparent coating on the skin) with the expiration date 8/12, and the perfusionist cart (an equipment cart containing supplies used when patients are set up and connected to the heart-lung machine in hospital that takes over functions of patient's heart and lungs during surgery or respiratory failure) contained a pressure infusion bag with the expiration date 5/12, and a cardiovascular procedure kit with the expiration date 4/12.

The Senior Director of Perioperative (Sr Dir Peri-Op) Department, in a concurrent interview, stated that the carts should not have expired items. She stated that she had not been reviewing the contents of the perfusionist's carts.

6. During a tour of the labor and delivery (L&D) department on November 26, 2012 at 1:45 PM, there was no clock visible by the scrub sinks outside the operating rooms. The shelves adjacent to the scrub sinks contained pre-packaged surgical scrub preparations that recommended specific minimum scrub times.

During a concurrent interview with the L&D RN Mgr (Registered Nurse Manager), she stated that she was not sure how the surgeons timed their surgical scrubs.

7. During an observation on November 29, 2012 at 11:30 AM, EVS 1 was observed cleaning a vacant room in the ICU (Intensive Care Unit). She applied a solution with a cloth, and the solution appeared to dry quickly.

In a concurrent interview with EVS 1, she stated that she used an all purpose cleaner called "23". She stated that the cleaner dried in a few seconds, and that there was no required wet contact time. She stated that there was no need to re-wet the surface if the cleaner dried in seconds.

During an observation on November 30, 2012 at 10:13 AM, EVS 2 applied fluid via a damp mop to the floor of patient room 508. The floor appeared to dry in 3 minutes.

During an interview with Quality Staff 1 on November 30, 2012 at 10:16 AM, he stated the floor in room 508 appeared dry.

During an observation on November 30, 2012 at 10:20 AM, EVS 2 applied fluid via a damp mop to the floor of patient room 509. A handwritten sign, " reverse isolation " hung outside the door to the room. After cleaning the floor, EVS 2 left the room and removed her protective paper garments. The floor appeared to dry in under 4 minutes.

During an interview with the Registered Nurse Manager (RN Mgr) on November 30, 2012 at 10:24 AM, she observed the floor of room 509 and stated it appeared dry.

In an interview with EVS 2 on November 30, 2012 at 10:25 AM, she stated that she used the chemical disinfectant 23 on the floor. She stated that the chemical was to be on the floor for 10 minutes, but she was not sure what to do if it dried before that time.

The manufactor's label for the cleaner was reviewed and showed that for the majority of viruses and bacteria, a contact time of 10 minutes was required.

During an interview with Infection Control Staff 1 on November 30, 2012, she stated that she had never seen the chemical disinfectant, 23, dry in less than 10 minutes.

8. The hospital policy titled, Biological Monitoring - Steam Rapid Readout (effective 9/94) read in part, "Each day that a Biological Indicator Steam Pack [used for sterilization monitoring assuring that medical devices have been adequately sterilized] is incubated, crush, tap and incubate one non-processed Attest vial to use as a positive control. Write a "C" (for "Control") and a date on the label. The positive control should be from the same lot number as the processed Attest vial in the incubator." and "The positive (unprocessed control indicator will result in a red light on the Auto-reader. Processed BI vial results are not valid until the positive control results are obtained first."

During a tour of the sterile processing area on November 26, 2012 at 4 PM, the incubator for the biologic test vials used to ensure the capability of the sterilizers to kill organisms was observed. The incubator had two areas, one marked with a blue strip and the number, 1291, and the other marked with a brown strip and the number 1292. Each area of the incubator had several wells in which to place vials for incubation, and each well had an adjacent " - " and " + " sign that could light up to indicate if bacteria was growing in the vial. The wells in the blue, 1291, area had 4 brown-topped vials with the number 1292 on them incubating. One of the vials was marked with a "C" on top (for control), while the others were marked 1, 4, and 5, respectively. The results panel on the incubator showed that all of the results were " - " , indicating no growth of bacteria. However, when lifted out of the incubator, the control vial was a yellow color, while the others were purple. The labels on the vials showed that the control vial was from lot 09DB, while the other vials were from lots 05DP, 09DB and 09DJ. Only one of the three sample vials was from the same lot as the control.

During an interview with the Manager of Sterile Processing (Mgr SP) on November 26, 2012 at 4 PM, he stated that the lot number of the control vial should match the test vials that were incubating with it. He stated that he was not sure about the difference between the 1291 and 1292 vials, but thought the blue top vials were to be used for the flash sterilizers and placed in the blue striped area of the incubator, and the brown topped vials were to be placed in the brown-striped area of the incubator.

During a review of the manufacturer's data, the blue top 1291 tubes were to be used for 1 hour rapid readout tests, while the brown top tubes were used for three hour tests.

During a second interview with the Mgr SP, on November 27, 2012 at 8:30 AM, he stated that he had received the wrong vials, and that he would get the blue top vials to check the flash sterilization cycles. When asked about what procedure should be followed when the machine indicator for a vial did not match the observed color change, he stated that another set of vials should be incubated. When asked if there was evidence that this occurred, he checked the sterilizer documentation and was unable to find any documentation that a second control was processed. He stated that the problem with the machine reading " - " for a control that had undergone a color change should have been brought to his attention.

On November 27, 2012 at 8:30 AM, the incubators were again observed, and a new set of brown top vials had been placed in the brown striped incubators wells, with the date November 27, 2012 written on them. The control, marked with a "C" on top, had the lot number 09DB, while the other three vials had the lot numbers 09DJ, 09DB and 09DB. Only two of the vials were from the same lot as the control.



31467

9. During a tour of the Operating Room (O.R.) main sub-sterile core area, four of twenty instrument packs observed contained instruments that were noted to be in the closed position while packaged in their sterilizer packs. When the sterile packaged instruments were opened, it was apparent that the inside edges of the instruments had not been exposed to proper sterilization.

During a concurrent interview, RN 11 confirmed that the instruments were sterilized in the closed position and should be removed from the O.R. area and sterilized in the open position.

During an interview with the Dir SP, he confirmed that the instruments should be sterilized in the open position and demonstrated a new procedure which the facility plans to implement in the near future.

Based on interview and record review, for one surgical patient (Patient 14), who had surgery at the hospital on November 26, 2012, the record did not contain documentation of a surgical time-out to identify and confirm the correct patient, the correct surgical site and side as well as the necessary equipment prior to commencing with the surgery, creating the increased risk of a poor surgical outcome for the patient.

Findings:

The hospital policy titled, "Universal Protocol (marking of operative/procedural site & "time out"/surgical/procedural pause)", read in part, ""Time out" must be conducted in the location where the procedure will be done, just before starting the procedure..." and "The Pre-operative/Pre-procedural checklist and Operative/Procedural record will be utilized to document the Universal Protocol procedures."

The medical record of Patient 14 was randomly selected for review on November 26, 2012, after the patient had been discharged from outpatient surgery. The record contained a pre-printed form titled, "Nursing Operative Record". One section of the form contained a checkbox with the statement, "Surgical Pause" to confirm correct patient, procedure, site by surgical/procedural team. The check-box next to "Verbal agreement was made by every team member" was not checked, and documentation of a "time-out" was not seen elsewhere on the form.

During an interview with the Senior Director of Peri-Operation (Sr Dir Peri-Op) on November 26, 2012 at 3:10 PM, she reviewed the medical record of Patient 14 and stated that the time out was not documented and should have been documented. She stated that Patient 14 had been discharged after a procedure.

Based on interview and record review, for 2 of 10 surgical patient records reviewed (Patients 14 and 1), the hospital did not ensure that a post-anesthesia evaluation was completed, creating the increased risk of a poor post-anesthesia outcome for the patients.

Findings:

The Medical Staff Anesthesia Division Rules and Regulations (022312) read in part, "A Post Anesthesia Note: (PACU [Post Anesthesia Care Unit] note number 2) shall be completed within 48 hours of a general, regional or monitored anesthetic. Elements to be assessed include: a. Vital signs within 20% of preoperative values, b. Mental Status, c. Presence or Absence of Medical Problems".

The record of Patient 14 was randomly selected as a post-discharge surgery patient. The Anesthesia Pre-op Evaluation record dated November 26, 2012 showed that gynecologic procedures were to be performed under general anesthesia. The "Anesthesia Postoperative Assessment" section of the pre-printed form contained boxes for the anesthesiologist to check, included boxes to indicate whether vitals were within 20% of the pre-op values, whether complications were noted, whether the patient was awake and alert. However, none of the boxes had been selected. The "Anesthesia Postoperative Assessment" also included a line for "other comments", which was left blank. The form was signed by the anesthesia provider and the time and date filled in.

During an interview with the Senior Director of Peri-Operation (Sr Dir Peri-Op) on November 26, 2012 at 3:10 PM, she reviewed the post-anesthesia assessment and stated that the patient had already been discharged, and the section should have been completed.

2. The Anesthesia Procedure Note for Patient 1 was reviewed, and showed that the patient received a procedure and that the pre-printed anesthesia sheet had a section for "Anesthesia Postoperative Assessment ". However, the anesthesiologist had checked only the box, "awake and alert". The form was signed by the anesthesiologist.

During an interview with Quality Staff 1 on November 30, 2012 at 2 PM, he reviewed Patient 1's post-anesthesia assessment and stated that the post-anesthesia assessment should include documentation of stability of the patients vital signs, and that had been omitted.

Based on observation, interview and record review, the hospital failed to ensure that a Registered Nurse (RN) was physically present at all times at 2 of 4 outpatient facilities (2 urgent care clinics) which provided nursing services to patients. This failure had the potential to contribute to the lack of proper oversight of Licensed Vocational Nurses (LVNs - require RN oversight) who worked at the urgent care clinics. This failure also had the potential to contribute to inadequate patient care and the potential for patients to not have their care needs met.

Findings:

A tour was conducted on November 26, 2012 during various times, at two of the hospital's Outpatient Urgent Care Clinics. The Director of Quality and the Lead Physician Assistant of the clinic provided the tour. There were several patients waiting in the front lobby. Some patients had been seen in exam rooms. The Urgent Care Clinic was staffed by two LVNs however, the Lead Physician Assistant stated that a RN Manager was always available if needed and that if a LVN needed to administer an intravenous (IV) push medication (a medication that is injected directly into a vein) that a Physician Assistant could administer it (under the scope of practice, LVNs cannot administer IV push medications).

During an interview, with the Director of Quality, on November 26, 2012 at 2:30 PM, she stated that there was no RN physically present at the Urgent Care Clinics however she stated that a RN Manager was available 24/7 by telephone. The Director of Quality asked if it was necessary to have a RN present at all times. The the Director was shown "All Facilities Letter (AFL) 12-30" (a notification to the hospitals, from the California Department of Public Health, informing the hospitals of "Nurse staffing in Outpatient supplemental Service and Licensed Primary Care Clinics." The document read, "...There must be supervisory and staff personnel for each hospital department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for bedside care of any patient. The Centers for Medicare and Medicaid services (CMS) further clarified that the specific intent of this regulation is to ensure that an RN is physically present at all outpatient facilities which provide nursing services." The Director of Quality read the AFL and stated that she understood that the AFL did instruct that a RN must be physically present at all times.

A record review was conducted on November 26, 2012 at 2:30 PM, of a facility policy titled, "Scope of Service, Urgent Care Center, effective 2/17/09." The policy's "Scope and Complexity of Patient's Care Needs," indicated that patients who were seen at the clinic included patients which present with the following: chest pain, cardiac arrhythmia's (abnormal heart rhythms), asthma, seizures, fractures and allergic reactions (all which could potentially require the services of an RN).

An interview was conducted on November 26, 2012 at 2:45 PM, with the RN Manager of one of the Outpatient Urgent Clinics. She stated that although she was not physically present at all times at the clinic, she was available on call when needed.

A record review, on November 30, 2012, of the staffing schedule for the two Urgent Care Clinics was conducted. The staffing schedule did not have an RN scheduled to work every day and were staffed by LVNs.

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