HospitalInspections.org

Based on staff interview, clinical record and administrative document review, the Governing Body failed to be responsible for the conduct of the hospital as an institution as evidenced by:

1. The Governing Body failed to ensure that the medical staff was accountable to the governing body for the quality of care provided to two patients (Patient's 12 and 17) out of 51 reviewed. On two separate occasions three physicians (MD's 4, 5, and 6) failed to abide by the Medical Staff Rules and Regulations. MD's 4, 5, and 6 failed to seek consultations and to abide by the Medical Staff Rules and Regulations. "THE RULES AND REGULATIONS OF THE MEDICAL STAFF" of the hospital dated March 2011, "GENERAL CONDUCT OF CARE - In the case of emergency, regardless of a practitioner's department or staff status, the practitioner attending the patient shall be expected to do all in his power to save the life of the patient, including calling appropriate consultation in accordance with known standards of practice for complex cases for which the attending needs advice. MD's 4 failed to seek consultation which resulted in death for Patient 12; MDs 5 and 6 failed to seek consultation which resulted in death for Patient 17. MD's 4, 5, and 6 failed to be accountable to the governing body for the quality of care delivered on both occasions which directly impacted the quality of care delivered to both patients and resulted in their deaths. (A 49)

2. The hospital's governing body, medical staff and administration failed to be responsible and accountable by ensuring clear expectations for safety were established when a total of three physicians (MD's 4, 5, and 6) did not make appropriate judgements regarding seeking consultations on two separate occasions resulting in two patients (Patients 12 and 17) receiving substandard care which resulted in death for both patients. (A 314)

3. The hospital failed to assume full responsibility for the medical staff when the three physicians (MD's 4,5 and 6) were in violation of the medical staff rules, regulations and bylaws and as a result Patients 12 and 17 received substandard care resulting in death for both patients. (A 353)

4. The hospital failed to ensure that services performed under a contract were provided in a safe and effective manner when the hospital failed to have a mechanism in place to evaluate the competency (ability) of personnel involved in a contracted pharmacy compounding service (Pharmedium). (A 084)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Coverage: Governing Body.

Based on staff interview, clinical record and administrative document review, the Governing Body failed to ensure the medical staff was accountable to the governing body for the quality of care provided to two patients (Patients 12 and 17) out of 51 reviewed. On two separate occasions respectively, three physicians (MD's 4, 5, and 6) failed to abide by the Medical Staff Rules and Regulations when they failed to seek consultations. These failures negatively impacted the quality of care delivered to Patient's 12 and 17.

Findings:

1. THE RULES AND REGULATIONS OF THE MEDICAL STAFF of the hospital dated March 2011 were reviewed on 5/16/11 at 3:30 p.m. It indicated on Page 8 "GENERAL CONDUCT OF CARE - In the case of emergency, regardless of a practitioner's department or staff status, the practitioner attending the patient shall be expected to do all in his power to save the life of the patient, including calling appropriate consultation in accordance with known advanced directives. For the purpose of this section, an emergency is defined as A CONDITION IN WHICH THE LIFE OF THE PATIENT IS IN IMMEDIATE DANGER...and in which delay in administering treatment would increase the danger...14. Consultation with a member of the Consulting or Active medical staff is required in the following situations: a.) Where the diagnosis is obscure after ordinary diagnostic procedures have been completed; b.) When guidance in the choice of multiple therapeutic measures is desired or advisable; c.) In unusually complicated situations where specific skills of other practitioners may be needed; d.) In instances in which the patient exhibits severe psychiatric symptoms or suicidal tendencies and the patient is not under a psychiatrist's care; e.) When the patient (or family) requests a consultation; f.) Complex cases for which the attending needs advice."

The BYLAWS GOVERNING THE MEDICAL STAFF of the hospital dated January 2011 were reviewed on 5/17/11 at 3:30 p.m. It indicated on page 6 "2.5 BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP EXCEPT FOR HONORARY AND RETIRED STAFF, THE ONGOING RESPONSIBILITIES OF EACH MEMBER OF THE MEDICAL STAFF INCLUDE: a.) providing patients with the quality of care meeting the professional standards of the medical staff of this hospital; b.) abiding by the medical staff Bylaws, Rules and Regulations."

The policy Number AS.16 latest revision 12/13/10 was reviewed on 5/17/11 at 3:30 p m. The Rapid Response Team-hospital main Campus policy reflected, "Policy: The Rapid Response Team (RRT) will be assigned each shift and consist of a Respiratory Therapist, Pharmacist, phlebotomist, and ICU (Intensive Care Unit) competent/Advanced Cardiac Life Support (ACLS) certified Registered Nurse (RN). The RRT will be using a standard assessment process with ACLS Standardized Procedure. SP.100 guidelines and Treatment of Opoid and/or Benzodiazepine (medications used for pain and relaxation) Standardized Procedure, SP 112 for treatment. The RRT functions under the authority of the ICU Medical director in collaboration with the Primary Care Physician or alternate physician specified in Section IV. Procedure: Licensed Nurse, physician or family member may request the RRT for evaluation of the questionable clinical condition of a patient such as (but not limited to): A. Acute Care areas: 1. Temperature less than or equal to 36 degrees centigrade or greater than or equal to 38 degrees centigrade 2. Pulse less than 50 or greater than 100 bpm (beats per minute) 3. Pain: new or significantly increased 4. Respiratory rate less than 6 or greater than 20 breaths per minute 5. SAO 2 (oxygen saturation) less than 90% and /or increasing O2 requirements 6. Systolic blood pressure less than 90 mm Hg (millimeters of mercury) or mean arterial pressure less than 65 mm Hg 7. Change in level of consciousness. 8. Urine output less than 0.5 ml/kg/hour (millimeters/kilogram) for 2 hours. 9. Delayed capillary refill/mottled skin (small blood vessels) 10. Any patient you are seriously concerned about but does not meet criteria... IV. Physician Responsibilities A. On acute care units, critical care physician will be notified if the severity of illness is perceived to warrant urgent critical care evaluation with a simultaneous call to the managing physician. If there is a delayed response from the physician greater than 15 minutes from the initial request, the RRT RN will consult with an alternate physician in the following order: 1. Critical Care Physician 2. Hospitalist 3. Emergency Department physician 4. Head of Department involved 5. Chief of Staff B. The ED physician shall maintain responsibility for the patient while in the Emergency Department (ED) or until hand-off to Intensivist is complete. C. The Intensivist shall respond either in person or by phone on notification by RRT RN. D. The RRT/Intensivist/managing physician/RN shall collaborate on course of treatment with the ultimate goal to be expedited access to care and transport the proper level of care."

The "Medscape" website Protocol for managing obstetric hemorrhage (heavy bleeding) stated "Organization a. Call experienced staff in. b. Alert blood bank and hematologist. c. Designate a nurse to record VS (vital signs), urine output, and fluids/drugs administered d. Place operating room on standby".

MD 2 and MD 3 were interviewed concurrently on 5/18/11 at 3:00 p.m. Both stated they were familiar with the care issues surrounding the case involving Patient 17 and MD 5. Patient 17 had vaginal bleeding after delivery of a baby early in the afternoon of 12/17/10. She was being managed in the operating room by MD 5 and MD 6. Both stated MD 5 failed to seek a consult from a more experienced colleague on 12/17/10 while treating Patient 17. Both stated MD 5 and MD 6 failed to request assistance in managing Patient 17. Both stated Patient 17 did not receive quality care directly related to judgement errors made by MD's 5 and 6 while managing Patient 17 which resulted in the death of Patient 17.

MD 5 was interviewed on 5/19/11 at 12:30 p.m. He stated he was the physician attending Patient 17 on 12/17/10. MD 5 confirmed he did not request a consult with a more senior physician to assist him immediately once the situation became clear assistance was needed in the treatment of Patient 17. MD 5 stated he did not request the rapid response team to enter the operating room to assist in treating Patient 17 immediately when the situation became clear the rapid response team was needed. MD 5 stated a second physician was allowed into the operating room to assist only after he was prompted by a nurse to ask for assistance. MD 5 stated he should have sought a consult with a more experienced physician sooner to assist in the care of Patient 17. He stated he made judgement errors which directly impacted the quality of care of Patient 17 in a negative fashion which resulted in her death.

CEO (Chief Executive Officer) was interviewed on 5/19/11 at 1:30 p. m. The CEO stated he was familiar with the details of the cases corresponding to Patients 17 and 12 respectively. He stated as the CEO he had frequent interactions with both the Board of Directors and the Medical Staff leadership. He stated the hospital failed to provide quality care in both cases because the physicians involved did not seek appropriate consultations as called for in the medical staff rules and regulations.

MD 1 was interviewed on 5/19/11 at 1:45 p. m. MD 1 stated he was familiar with the cases of Patients 17 and 12. He stated he was aware the peer review process had been engaged to assess the practitioners performances in both cases. He stated judgement errors had been made in managing both patients. He stated the quality of care the patients received in both cases had been negatively impacted by the judgement errors which resulted in inappropriate care and the deaths of both patients.

2. THE RULES AND REGULATIONS OF THE MEDICAL STAFF of the hospital dated March 2011 were reviewed on 5/16/11 at 3:30 p.m. It indicated on Page 8 "GENERAL CONDUCT OF CARE - In the case of emergency, regardless of a practitioner's department or staff status, the practitioner attending the patient shall be expected to do all in his power to save the life of the patient, including calling appropriate consultation in accordance with known advanced directives. For the purpose of this section, an emergency is defined as A CONDITION IN WHICH THE LIFE OF THE PATIENT IS IN IMMEDIATE DANGER...and in which delay in administering treatment would increase the danger...14. Consultation with a member of the Consulting or Active medical staff is required in the following situations: a.) Where the diagnosis is obscure after ordinary diagnostic procedures have been completed; b.) When guidance in the choice of multiple therapeutic measures is desired or advisable; c.) In unusually complicated situations where specific skills of other practitioners may be needed; d.) In instances in which the patient exhibits severe psychiatric symptoms or suicidal tendencies and the patient is not under a psychiatrist's care; e.) When the patient (or family) requests a consultation; f.) Complex cases for which the attending needs advice."

The BYLAWS GOVERNING THE MEDICAL STAFF of the hospital dated January 2011 were reviewed on 5/17/11 at 3:30 p.m. It indicated on page 6 "2.5 BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP EXCEPT FOR HONORARY AND RETIRED STAFF, THE ONGOING RESPONSIBILITIES OF EACH MEMBER OF THE MEDICAL STAFF INCLUDE: a.) providing patients with the quality of care meeting the professional standards of the medical staff of this hospital; b.) abiding by the medical staff Bylaws, Rules and Regulations."

The policy Number AS.16 latest revision 12/13/10 was reviewed on 5/17/11 at 3:30 p m. The Rapid Response Team-hospital main Campus policy reflected, "Policy: The Rapid Response Team (RRT) will be assigned each shift and consist of a Respiratory Therapist, Pharmacist, phlebotomist, and ICU (Intensive Care Unit) competent/Advanced Cardiac Life Support (ACLS) certified Registered Nurse (RN). The RRT will be using a standard assessment process with ACLS Standardized Procedure. SP.100 guidelines and Treatment of Opoid and/or Benzodiazepine (medications used for pain and relaxation) Standardized Procedure, SP 112 for treatment. The RRT functions under the authority of the ICU Medical director in collaboration with the Primary Care Physician or alternate physician specified in Section IV. Procedure: Licensed Nurse, physician or family member may request the RRT for evaluation of the questionable clinical condition of a patient such as (but not limited to): A. Acute Care areas: 1. Temperature less than or equal to 36 degrees centigrade or greater than or equal to 38 degrees centigrade 2. Pulse less than 50 or greater than 100 bpm (beats per minute) 3. Pain: new or significantly increased 4. Respiratory rate less than 6 or greater than 20 breaths per minute 5. SAO 2 (oxygen saturation) less than 90% and /or increasing O2 requirements 6. Systolic blood pressure less than 90 mm Hg (millimeters of mercury) or mean arterial pressure less than 65 mm Hg 7. Change in level of consciousness. 8. Urine output less than 0.5 ml/kg/hour (millimeters/kilogram) for 2 hours. 9. Delayed capillary refill/mottled skin (small blood vessels) 10. Any patient you are seriously concerned about but does not meet criteria... IV. Physician Responsibilities A. On acute care units, critical care physician will be notified if the severity of illness is perceived to warrant urgent critical care evaluation with a simultaneous call to the managing physician. If there is a delayed response from the physician greater than 15 minutes from the initial request, the RRT RN will consult with an alternate physician in the following order: 1. Critical Care Physician 2. Hospitalist 3. Emergency Department physician 4. Head of Department involved 5. Chief of Staff B. The ED physician shall maintain responsibility for the patient while in the Emergency Department (ED) or until hand-off to Intensivist is complete. C. The Intensivist shall respond either in person or by phone on notification by RRT RN. D. The RRT/Intensivist/managing physician/RN shall collaborate on course of treatment with the ultimate goal to be expedited access to care and transport the proper level of care."

The "Medscape" website Protocol for managing hypoglycemia reviewed on 5/17/11 indicated "treatment and disposition of hypoglycemia are guided by the history and the clinical picture. Serum glucose should be measured immediately, and frequently. Clinical appearance alone is unreliable and may not reflect the seriousness of the situation." Staff failed to recognize the patient was hypoglycemic (low blood sugar).

MD 4 was interviewed on 5/18/11 at 10:30 a.m. MD 4 stated she was the attending physician for Patient 12 when she was called on 4/18 /11 at or around 2:30 a.m. MD 4 stated she was informed that Patient 12 had a change in her level of consciousness. MD 4 stated she responded in a timely fashion and evaluated the patient's clinical status. MD 4 stated she did not consider hypoglycemia as the cause for Patient 12's change in the level of consciousness. MD 4 stated she did not order a blood glucose test. MD 4 stated she did not request assistance from the Rapid Response Team. MD 4 stated in retrospect she had made a judgement error. MD 4 stated the judgement error had negatively impacted the care received by Patient 12 which resulted in her death. MD 4 agreed this situation represented a serious and substantive quality of care issue.

CEO (Chief Executive Officer) was interviewed on 5/19/11 at 1:30 p.m. He stated he was familiar with the details of the cases corresponding to Patients 17 and 12 respectively. He stated as the CEO he had frequent interactions with both the Board of Directors and the Medical Staff leadership. He stated the hospital failed to provide quality care in both cases because the physicians involved did not seek appropriate consultations as called for in the medical staff rules and regulations.
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MD 1 was interviewed on 5/19/11 at 1:45 p.m. he stated he was familiar with the cases of Patients 17 and 12. He stated he was aware the peer review process had been engaged to assess the practitioners performances in both cases. He stated judgement errors had been made in managing both patients. He stated the quality of care the patients received in both cases had been negatively impacted by the judgement errors which resulted in inappropriate care which resulted in patient deaths.

Based on staff interview and clinical record review, the hospital failed to ensure that services performed under a contract were provided in a safe and effective manner when it failed to have a mechanism in place to evaluate the competency (ability) of personnel involved in a contracted pharmacy compounding service (Pharmedium). Also, the hospital failed to include the contracted service in the hospital's Quality Assessment and Performance Improvement program (QAPI).
Findings:
On 5/17/11 at 1:50 p.m., an interview the Director of Pharmacy (DPH) indicated the hospital's pharmacy had competency records for their own personnel that compound drugs in a sterile (clean) environment. They did not have competency records for the employees of the contracted pharmacy that provided similarly prepared drugs for the hospital's patients. The DPH stated he had contacted the contractor but they had refused to provide competencies on their individual personnel. On 5/17/11 a review of hospital records failed to provide an indication the contractor's services and the contractor's employee compounding competencies were evaluated by the same hospital-wide QAPI evaluation as other services provided directly by the hospital.

Based on observation, staff interview, administrative and clinical record review, the facility did not allow active participation in the development, implementation, revision and reevaluation of the plan of care (a written plan of care outlining individual patient's mental and physical needs for recovery) for 6 of 51 sampled patients (Patients 17, 23, 24, and 25). The plan of care was created to meet the individual patient's needs and was a patient's right to participate in the creation, implementation and reevaluation of all aspects of care. Not having informed the Patient or designated representatives of the right to participate in the plan of care process was a violation of Patient's Rights.

Findings:

1. On 12/27/10 at 1:00 p.m., the Medical Records for Patient 17 had been reviewed. The clinical record and the electronic medical records did not contain a plan of care or information that the Patient or their representative was provided an opportunity to participate in the development of a plan of care.

On 12/27/10 at 1:13 p.m., during an interview in the Medical Records department for Patient 17, RM 2 ( Risk Manager 2) stated,"...all of the information is in the chart...if it is not there...then there is no care plan."

2. On 5/18/11 at 3:40 p.m., during an observation on 3 South, RN 13 was unable to provide a copy of the individualized plan of care for Patient 23 who was admitted on 4/30/11. (15 days earlier) The plan of care was requested at 3:50 p.m. and was unable to be provided at 4:18 p.m.

On 5/18/11 at 3:45 p.m., during an interview on 3 South, RN 13 indicated that he was unable to identify who was involved with the care plan. He was unable to determine the time frame for reevaluation of the care plan or any specific information provided by Patient 23 or his designated representative.

3. On 5/19/11 at 10:30 a.m., during a interview on 3 West, RN 12 indicated that all of the documentation (physician orders, progress notes, etc.) for Patient 24 (admitted on 5/19/11 at 3:15 a.m.) was in the medical record and that if was not there than it was not done.

On 5/19/11 at 10:25 am., during a clinical and electronic record review there was no documentation or discussion of a plan of care for, or with Patient 24 or any designated representatives.

7. On 5/19/11 at 4:05 p.m., during a interview on 3 West, RN 12 indicated that all of the information for Patient 25 was in the record." Patient 25 was admitted on 5/11/11, 8 days prior to the interview.

On 5/19/11 at 4:00 p.m., during a clinical and electronic medical record review of Patient 25, there was no documentation of a plan of care.

The facility policy and procedure titled, "Registered Nursing Standards of; Competent Performance , Nursing Practice Professional Performance, and Care" dated 12/13/10, indicated, "Policy: ...Staff members...within nursing departments will be held accountable to maintain the professional standards of competent performance, nursing practice...Procedure: III. Standards of Competent Performance (State of California, 2007)...B. Formulates a care plan in collaboration with the client...which ensures direct and indirect nursing services provide...safety, comfort, hygiene and protection...for restorative measures...F. ...initiating action to improve health care or change decisions...which are against the clients interest and wishes...giving the client the opportunity to make informed decisions about health care before it is provided". _____________________________

Based on observation, staff interview, clinical record and administrative document review, the facility placed 4 of 51 sampled patients (12, 17, and 23) at risk of harm when patient treatments were conducted without clarification of physician orders by staff members. The failure to seek clarification and follow established policies and procedures resulted in 2 patient deaths (Patient 12 and 17), use of excessive restraint application on Patient 23. The excessive restrain application occurred without physician orders. Patient 13 sustained a bowel perforation during an elective procedure which used a tube with a scope for viewing internally from the mouth to the bile duct and pancreas. (Endoscopic Retrograde Cholangiopancreatography) These failures resulted in substandard care.

Findings:

1. During the clinical record review on 12/27/10 it was noted the History and Physical was absent from the record. History's and Physicals are mandated to be in the clinical record prior to any procedure.

During an interview on 3/16/11 at 9:15 a.m., RN 13 stated Patient 17 developed excessive bleeding after the baby was delivered. RN 13 stated the amount of bleeding was not known. The status of Physician privileges for Physician 5 was not known at the time of the delivery or checked prior to the delivery of the baby.

During the 12/27/10 clinical record review, Patient 17's amount of blood loss was not documented in the clinical or electronic medical record. Blood transfusions were administered without the implementation of the massive transfusion protocol, which required physician orders, blood lab tests to be conducted and blood products to be given. There was a breakdown in communication when Physician 5 gave orders without waiting for staff to respond to the ordered medications and interventions.

2. On 5/18/11 at 2:55 p.m., during an observation on 3 South, Patient 23 was observed in bed in a upright position with both wrists tied to the bed and the room was darkened. A sitter (health care person who was assigned to watch a patient) was in a chair outside the room in the hallway. Patient 23's eyes were closed and did not attempt to move from 2:55 p.m. to 4:15 p.m. and remained in restraints the entire time.

On 5/18/11 at 3:50 p.m. during an interview, RN 14 indicated that Patient 23 was "lethargic" (not active, slow to respond), "is a 1:1" (1 staff member assigned to 1 Patient) and "he is not always like that (resting with eyes closed) when he wakes up...will pull at his tubes."

During a clinical record review on 5/17/11, the physician's signature on the restraint order was dated 4/31/11; time 8000 (as documented)(date and time was not clarified by nursing staff). No additional information, clarifications, renewals, or orders for restraints were present in record. The record also contained an administrative form approved 4/13/10, titled, "The Criteria/Order for Initiation of Restraints dated: 4/30/11 at 7:30 p.m., indicated, " I. Soft Limb Restraints" which had a check mark in each box for "left upper extremity and right upper extremity."

On 5/18/11 at 3:20 p.m., during an interview in the conference room, RN 15 stated, "...the Day nurse called the physician. The physician requested leathers...(Patient 23) was more agitated...the nurse misinterpreted the order and did not clarify...so made a mistake and put patient in 4 point leather restraints...since then he has been placed in soft restraints (order date 5/18/11 at 7:05 p.m.) and has a sitter for safety."

The facility policy, titled "Restraint/Seclusion of Patients, dated 6/29/10 indicated, " Philosophy: ...Staff will work to prevent, reduce and where possible, eliminate the need ...of restraint...staff will consistently attempt less restrictive interventions whenever possible. II. General Provisions: B. Initiation: each episode of restraint or seclusion requires a new order... Restraint shall be initiated:...2. By a registered nurse is necessary to protect the patient, staff members or others from harm...F. Assessment and Monitoring G. Discontinuation: ...be discontinued by the registered nurse once...behaviors are no longer present and safety may be assured through less restrictive means. H. Care Plan: The restrained ...patient's written care plan shall be modified to address appropriate interventions implemented to assure ...patient's safety and encourage the prompt discontinuation of restraint."

3. On 5/3/11 at 11:00 a.m., during an interview, RN 11 stated Patient 12 had a hemicolectomy (partial removal of the colon) with Whipple (removal of part of the duodenum, and the head of the pancreas). Patient 12 was placed on a TPN (method of feeding directly into the blood) due to Patient 12's decreased appetite and to stabilize blood glucose post Whipple procedure.

On 5/5/11 at 11:00 a.m., during an interview, RN 11 indicated Patient 12's TPN was discontinued "somewhere between 9:30 p.m. and 10:00 p.m." per the Family Nurse Practitioner's (FNP) order. RN 11 stated the TPN had not been tapered and had been running at 40 ml/hour all day long. No other infusions were started for Patient 12 at this time. The finger stick blood sugar (FSBS, a test to measure the sugar or glucose in the body) was 134 at 9:00 p.m.

Patient 12's Adult Parenteral Nutrition Order Set found in the clinical record, dated 4/2/11 at 6:35 a.m. indicated, "If a patient is receiving central (in a large blood vessel) TPN and administration of TPN is suddenly interrupted, infuse Dextrose 10% at same TPN rate and call physician for further orders. (Policy CP.01)"

The facility policy and procedure titled "IV Therapy Administration of Peripheral and Central Hyperalimentation Solutions " dated 8/24/09, indicated ...V. Discontinuation of TPN/PPN, A. Non-emergent situation: (i.e., discharge), 1. TPN may be discontinued after decreasing the infusion rate by 50% for one to two hours. ...B. Sudden Discontinuance of TPN: 1. If infusion of TPN must be stopped suddenly, an infusion of Dextrose 10% at the same infusion rate is sufficient."
On 5/5/11 at 11:00 a.m., during an interview, RN 11 stated she made the decision not to draw the morning labs (Patient 12 had been getting a renal panel every morning which would have shown her glucose level) or do the morning FSBS (finger stick blood sugar, a test to measure the sugar or glucose in the blood) because MD 4's Do Not Resuscitate (DNR) order included the statement "death is imminent."
The facility policy and procedure titled, "Do Not Resuscitate" dated 6/26/10, indicated "V. A DNR order does not negate previous orders not related to CPR. ...IV. When a DNR order is written by a physician, all previous orders not directly related to CPR stand as written and subsequent orders are not superseded. ...VI. If a patient's DNR order does not specify the category of medical intervention (Comfort Measures Only, Limited Additional Interventions, Full Treatment), then the patient will be treated as DNR with Full Treatment."

Based on observation, staff interview and administative document review the facility failed to maintain the confidentiality of Protected Health Information for 19 of 51 patients. This lack of confidentiality occurred when a unit report form that contained information on 19 patients, (Patient 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, and 50) had been left on top of a mobile computer keyboard in a public hallway. The lack of confidentilaity violated the Patient's Right to have their Protected Health Information maintained in a secure manner.

Findings:

1. On 5/17/11 at 3:25 p.m, during an observation, a nurse stood up and walked away from a mobile computer in a public hallway. The unit patient report form was laying face up on top of the computer keyboard.

On 5/17/11 at 3:30 p.m., during an interview, the 3W RN 15 indicated that the nurse should not have left the Unit Report Form with confidential patient information in the public hallway.

On 5/17/11 at 3:26 p.m, a patient report form was reviewed and contained the following information for Patient 31: Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, transfer status, past medical history, abnormal lab results, pending treatment interventions, and physical concerns.

2. On 5/17/11 at 3:27 p.m, a patient report form was reviewed and contained the following information for Patient 32: Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, past medical history, physical complaints and abnormal lab results.

3. On 5/17/11 at 3:29 p.m, a patient report form was reviewed and contained the following information for Patient 33: Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, of the past medical history.

4. On 5/17/11 at 3:35 p.m, a patient report form was reviewed and contained the following information for Patient 34: Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, date of procedure, request for consultation, transfer, medications, medical treatment and abnormal lab values.

5. On 5/17/11 at 3:40 p.m., a patient report form for Patient 35 was reviewed and contained the following information : Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, transfer status, and reason for admission.

6. On 5/17/11 at 3:45 p.m., a patient report form for Patient 36 was reviewed and contained the following information : Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, heart rhythmn, oxygen, transfer status, location of intravenous and medications.

7. On 5/17/11 at 3:50 p.m., a patient report form for Patient 37 was reviewed and contained the following information : Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, treatments, transfer status, and isolation status.

8. On 5/17/11 at 3:55 p.m., a patient report form for Patient 38 was reviewed and contained the following information : Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, transfer status, and treatments, infection status, recent medical history and diagnosis, physical status, and treatments.

9. On 5/17/11 at 4:00 p.m., a patient report form for Patient 39 was reviewed and contained the following information : Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, transfer status, and treatments, recent medical history and diagnosis, physical status and support systems.

10. On 5/17/11 at 4:05 p.m., a patient report form for Patient 40 was reviewed and contained the following information : Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, laboratory results, planned tests. and frequent lab test results.

11. On 5/17/11 at 4:10 p.m., a patient report form for Patient 41 was reviewed and contained the following information : Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, lab values, and medical concerns.

12. On 5/17/11 at 4:15 p.m., a patient report form for Patient 42 was reviewed and contained the following information : Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, lab values, and medical concerns and medications.

13. On 5/17/11 at 4:20 p.m., a patient report form for Patient 43 was reviewed and contained the following information : Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, medical treatments, past medical history, and planned treatments.

14. On 5/17/11 at 4:25 p.m., a patient report form for Patient 44 was reviewed and contained the following information : "Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, medical treatments, transfer status, and medications.

15. On 5/17/11 at 4:30 p.m., a patient report form for Patient 45 was reviewed and contained the following information : "Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, lab values, medical treatment and planned interventions.

16. On 5/17/11 at 4:35 p.m., a patient report form for Patient 46 was reviewed and contained the following information : "Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, recent medical history, medical treatments, lab values and medications.

17. On 5/17/11 at 4:40 p.m., a patient report form for Patient 47 was reviewed and contained the following information : "Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, recent medical history and concerns.

18. On 5/17/11 at 4:45 p.m., a patient report form for Patient 48 was reviewed and contained the following information : "Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, lab values, medical concerns and planned tests.

19. On 5/17/11 at 4:50 p.m., a patient report form for Patient 50 was reviewed and contained the following information : Room Number, Patient name, admit date, age, MD, diagnosis, brief physical assessment notes, code status, comments, medication treatments.

The facility policy and procedure titled, "Patient Privacy and Disclosure of Patient Information," dated 9/25/06 was reviewed. "Purpose: ...outlines patient privacy requirements ..use of protected health information in accordance with the Federal HIPPA and the State of California privacy related laws and regulations." "Process: II. Disclosures of PHI-
A. ...disclosures...as permitted or required by this policy...shall obtain a valid authorization by the patient... III. E. Prior to disclosing patient information...staff shall verify the identity...authority to access the information."

Based on staff interview, clinical record and administrative document review, the hospital's governing body, medical staff and administration failed to be responsible and accountable for ensuring clear expectations for safety were established when a total of three physicians (MD's 4, 5, and 6) failed to make appropriate judgements regarding seeking consultations on two separate occasions resulting in two patients receiving substandard care. These failures negatively impacted the quality of care delivered to 2 of 51 (Patient's 12 and 17) which resulted in death of both patients.

Findings:

1. THE RULES AND REGULATIONS OF THE MEDICAL STAFF of the hospital dated March 2011 were reviewed on 5/16/11 at 3:30 p.m. It indicated on Page 8 "GENERAL CONDUCT OF CARE - In the case of emergency, regardless of a practitioner's department or staff status, the practitioner attending the patient shall be expected to do all in his power to save the life of the patient, including calling appropriate consultation in accordance with known advanced directives. For the purpose of this section, an emergency is defined as A CONDITION IN WHICH THE LIFE OF THE PATIENT IS IN IMMEDIATE DANGER...and in which delay in administering treatment would increase the danger...14. Consultation with a member of the Consulting or Active medical staff is required in the following situations: a.) Where the diagnosis is obscure after ordinary diagnostic procedures have been completed; b.) When guidance in the choice of multiple therapeutic measures is desired or advisable; c.) In unusually complicated situations where specific skills of other practitioners may be needed; d.) In instances in which the patient exhibits severe psychiatric symptoms or suicidal tendencies and the patient is not under a psychiatrist's care; e.) When the patient (or family) requests a consultation; f.) Complex cases for which the attending needs advice."

The BYLAWS GOVERNING THE MEDICAL STAFF of the hospital dated January 2011 were reviewed on 5/17/11 at 3:30 p.m. It indicated on page 6 "2.5 BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP EXCEPT FOR HONORARY AND RETIRED STAFF, THE ONGOING RESPONSIBILITIES OF EACH MEMBER OF THE MEDICAL STAFF INCLUDE: a.) providing patients with the quality of care meeting the professional standards of the medical staff of this hospital; b.) abiding by the medical staff Bylaws, Rules and Regulations."

The policy Number AS.16 latest revision 12/13/10 was reviewed on 5/17/11 at 3:30 p m. The Rapid Response Team-hospital main Campus policy reflected, "Policy: The Rapid Response Team (RRT) will be assigned each shift and consist of a Respiratory Therapist, Pharmacist, phlebotomist, and ICU (Intensive Care Unit) competent/Advanced Cardiac Life Support (ACLS) certified Registered Nurse (RN). The RRT will be using a standard assessment process with ACLS Standardized Procedure. SP.100 guidelines and Treatment of Opoid and/or Benzodiazepine (medications used for pain and relaxation) Standardized Procedure, SP 112 for treatment. The RRT functions under the authority of the ICU Medical director in collaboration with the Primary Care Physician or alternate physician specified in Section IV. Procedure: Licensed Nurse, physician or family member may request the RRT for evaluation of the questionable clinical condition of a patient such as (but not limited to): A. Acute Care areas: 1. Temperature less than or equal to 36 degrees centigrade or greater than or equal to 38 degrees centigrade 2. Pulse less than 50 or greater than 100 bpm (beats per minute) 3. Pain: new or significantly increased 4. Respiratory rate less than 6 or greater than 20 breaths per minute 5. SAO 2 (oxygen saturation) less than 90% and /or increasing O2 requirements 6. Systolic blood pressure less than 90 mm Hg (millimeters of mercury) or mean arterial pressure less than 65 mm Hg 7. Change in level of consciousness. 8. Urine output less than 0.5 ml/kg/hour (millimeters/kilogram) for 2 hours. 9. Delayed capillary refill/mottled skin (small blood vessels) 10. Any patient you are seriously concerned about but does not meet criteria... IV. Physician Responsibilities A. On acute care units, critical care physician will be notified if the severity of illness is perceived to warrant urgent critical care evaluation with a simultaneous call to the managing physician. If there is a delayed response from the physician greater than 15 minutes from the initial request, the RRT RN will consult with an alternate physician in the following order: 1. Critical Care Physician 2. Hospitalist 3. Emergency Department physician 4. Head of Department involved 5. Chief of Staff B. The ED physician shall maintain responsibility for the patient while in the Emergency Department (ED) or until hand-off to Intensivist is complete. C. The Intensivist shall respond either in person or by phone on notification by RRT RN. D. The RRT/Intensivist/managing physician/RN shall collaborate on course of treatment with the ultimate goal to be expedited access to care and transport the proper level of care."

The "Medscape" website Protocol for managing obstetric hemorrhage (heavy bleeding) stated "Organization a. Call experienced staff in. b. Alert blood bank and hematologist. c. Designate a nurse to record VS (vital signs), urine output, and fluids/drugs administered d. Place operating room on standby"

MD 2 and 3 were interviewed together on 5/18/11 at 3:00 p.m. Both stated they were familiar with the care issues surrounding the case involving Patient 17 and MD 5. Patient 17 had vaginal bleeding after delivery of a baby early in the afternoon of 12/17/10. She was being managed in the operating room by MD5 and MD6. Both stated MD 5 failed to seek a consult from a more experienced colleague on 12/17/10 while treating Patient 17. MD 2 and MD 3 stated MD 5 and MD 6 failed to request assistance in managing Patient 17 when the situation became clear assistance was required. Both stated Patient 17 did not receive quality care directly related to judgement errors made by MD's 5 and 6 while managing Patient 17 which resulted in the death of Patient 17.

MD 5 was interviewed on 5/19/11 at 12:30 p.m. MD 5 stated he was the physician attending Patient 17 on 12/17/10. MD 5 stated he did not request a consult with a more senior physician to assist him immediately when the situation became clear assistance was needed in the treatment of Patient 17. He stated he did not request the rapid response team to enter the operating room to assist in treating Patient 17 immediately when the situation required the rapid response team involvement. He stated a second physician was allowed into the operating room to assist only after he was prompted by a nurse to ask for assistance. MD 5 stated he should have sought a consult with a more experienced physician sooner to assist in the care of Patient 17. He stated he made judgement errors which directly impacted the quality of care of Patient 17 in a negative fashion which resulted in her death.

CEO (Chief Executive Officer) was interviewed on 5/19/11 at 1:30 p. m. The CEO stated he was familiar with the details of the cases corresponding to Patients 17 and 12 respectively. The CEO stated he had frequent interactions with both the Board of Directors and the Medical Staff leadership. He stated the hospital failed to provide quality care in both cases because the physicians involved did not seek appropriate consultations as called for in the medical staff rules and regulations.

MD 1 was interviewed on 5/19/11 at 1:45 p. m. MD 1 stated he was familiar with the cases of Patients 17 and 12. He stated he was aware the peer review process had been engaged to assess the practitioners performances in both cases. He stated judgement errors had been made in managing both patients. He stated the quality of care the patients received in both cases had been negatively impacted by the judgement errors which resulted in inappropriate care and the deaths of both patients.


2. THE RULES AND REGULATIONS OF THE MEDICAL STAFF of the hospital dated March 2011 were reviewed on 5/16/11 at 3:30 p.m. It indicated on Page 8 "GENERAL CONDUCT OF CARE - In the case of emergency, regardless of a practitioner's department or staff status, the practitioner attending the patient shall be expected to do all in his power to save the life of the patient, including calling appropriate consultation in accordance with known advanced directives. For the purpose of this section, an emergency is defined as A CONDITION IN WHICH THE LIFE OF THE PATIENT IS IN IMMEDIATE DANGER...and in which delay in administering treatment would increase the danger...14. Consultation with a member of the Consulting or Active medical staff is required in the following situations: a.) Where the diagnosis is obscure after ordinary diagnostic procedures have been completed; b.) When guidance in the choice of multiple therapeutic measures is desired or advisable; c.) In unusually complicated situations where specific skills of other practitioners may be needed; d.) In instances in which the patient exhibits severe psychiatric symptoms or suicidal tendencies and the patient is not under a psychiatrist's care; e.) When the patient (or family) requests a consultation; f.) Complex cases for which the attending needs advice."

The BYLAWS GOVERNING THE MEDICAL STAFF of the hospital dated January 2011 were reviewed on 5/17/11 at 3:30 p.m. It indicated on page 6 "2.5 BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP EXCEPT FOR HONORARY AND RETIRED STAFF, THE ONGOING RESPONSIBILITIES OF EACH MEMBER OF THE MEDICAL STAFF INCLUDE: a.) providing patients with the quality of care meeting the professional standards of the medical staff of this hospital; b.) abiding by the medical staff Bylaws, Rules and Regulations."

The policy Number AS.16 latest revision 12/13/10 was reviewed on 5/17/11 at 3:30 p m. The Rapid Response Team-hospital main Campus policy reflected, "Policy: The Rapid Response Team (RRT) will be assigned each shift and consist of a Respiratory Therapist, Pharmacist, phlebotomist, and ICU (Intensive Care Unit) competent/Advanced Cardiac Life Support (ACLS) certified Registered Nurse (RN). The RRT will be using a standard assessment process with ACLS Standardized Procedure. SP.100 guidelines and Treatment of Opoid and/or Benzodiazepine (medications used for pain and relaxation) Standardized Procedure, SP 112 for treatment. The RRT functions under the authority of the ICU Medical director in collaboration with the Primary Care Physician or alternate physician specified in Section IV. Procedure: Licensed Nurse, physician or family member may request the RRT for evaluation of the questionable clinical condition of a patient such as (but not limited to): A. Acute Care areas: 1. Temperature less than or equal to 36 degrees centigrade or greater than or equal to 38 degrees centigrade 2. Pulse less than 50 or greater than 100 bpm (beats per minute) 3. Pain: new or significantly increased 4. Respiratory rate less than 6 or greater than 20 breaths per minute 5. SAO 2 (oxygen saturation) less than 90% and /or increasing O2 requirements 6. Systolic blood pressure less than 90 mm Hg (millimeters of mercury) or mean arterial pressure less than 65 mm Hg 7. Change in level of consciousness. 8. Urine output less than 0.5 ml/kg/hour (millimeters/kilogram) for 2 hours. 9. Delayed capillary refill/mottled skin (small blood vessels) 10. Any patient you are seriously concerned about but does not meet criteria... IV. Physician Responsibilities A. On acute care units, critical care physician will be notified if the severity of illness is perceived to warrant urgent critical care evaluation with a simultaneous call to the managing physician. If there is a delayed response from the physician greater than 15 minutes from the initial request, the RRT RN will consult with an alternate physician in the following order: 1. Critical Care Physician 2. Hospitalist 3. Emergency Department physician 4. Head of Department involved 5. Chief of Staff B. The ED physician shall maintain responsibility for the patient while in the Emergency Department (ED) or until hand-off to Intensivist is complete. C. The Intensivist shall respond either in person or by phone on notification by RRT RN. D. The RRT/Intensivist/managing physician/RN shall collaborate on course of treatment with the ultimate goal to be expedited access to care and transport the proper level of care."

The "Medscape" website Protocol for managing hypoglycemia reviewed on 5/17/11 indicated "treatment and disposition of hypoglycemia are guided by the history and the clinical picture. Serum glucose should be measured immediately, and frequently. Clinical appearance alone is unreliable and may not reflect the seriousness of the situation." Staff failed to recognize the patient was hypoglycemic (low blood sugar).

MD 4 was interviewed on 5/18/11 at 10:30 a.m. MD 4 stated she was the attending physician for Patient 12 when she was called on 4/18 /11 at or around 2:30 a.m. She stated she was informed that Patient 12 had a change in her level of consciousness. MD 4 stated she responded in a timely fashion and evaluated the patient's clinical status. She stated she did not consider hypoglycemia as the cause for Patient 12's change in her level of consciousness. She stated she did not order a blood glucose test. She stated she did not request assistance from the Rapid Response Team. She stated in retrospect she had made a judgement error. MD 4 stated the judgement error had negatively impacted the care received by Patient 12 which resulted in her death. She agreed this situation represented a serious and substantive quality of care issue.

CEO (Chief Executive Officer) was interviewed on 5/19/11 at 1:30 p.m. He stated he was familiar with the details of the cases corresponding to Patients 17 and 12 respectively. He stated as the CEO he had frequent interactions with both the Board of Directors and the Medical Staff leadership. He stated the hospital failed to provide quality care in both cases because the physicians involved did not seek appropriate consultations as called for in the medical staff rules and regulations.

MD 1 was interviewed on 5/19/11 at 1:45 p.m. he stated he was familiar with the cases of Patients 17 and 12. He stated he was aware the peer review process had been engaged to assess the practitioners performances in both cases. He stated judgement errors had been made in managing both patients. He stated the quality of care the patients received in both cases had been negatively impacted by the judgement errors which resulted in inappropriate care which resulted in patient deaths.

Based on staff interview, clinical record and administrative document review, the hospital failed to assume full responsibility for the medical staff when three physicians (MD's 4, 5 and 6) were in violation of the medical staff rules, regulation and bylaws and two patients (Patients 12 and 17) received substandard care placing both patients at risk. This occurred when:

The hospital's governing body, medical staff and administration failed to be responsible and accountable for ensuring clear expectations for safety were established when a total of three physicians (MD's 4, 5, and 6) failed to make appropriate medical judgements with failures to seek consultations on two separate occasions resulting in two patients (Patient 12 and 17) receiving substandard care which resulted in the deaths of both patients. (A353)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation: Medical Staff.

Based on staff interview, clinical record and administrative document, review the hospital failed to assume full responsibility for the medical staff when three physicians (MD's 4, 5, and 6) were in violation of the medical staff rules, regulations and bylaws and two patients (Patients 12 and 17) received substandard care which resulted in the deaths of both patients.

Findings:

1. THE RULES AND REGULATIONS OF THE MEDICAL STAFF of the hospital dated March 2011 were reviewed on 5/16/11 at 3:30 p.m. It indicated on Page 8 "GENERAL CONDUCT OF CARE - In the case of emergency, regardless of a practitioner's department or staff status, the practitioner attending the patient shall be expected to do all in his power to save the life of the patient, including calling appropriate consultation in accordance with known advanced directives. For the purpose of this section, an emergency is defined as A CONDITION IN WHICH THE LIFE OF THE PATIENT IS IN IMMEDIATE DANGER...and in which delay in administering treatment would increase the danger...14. Consultation with a member of the Consulting or Active medical staff is required in the following situations: a.) Where the diagnosis is obscure after ordinary diagnostic procedures have been completed; b.) When guidance in the choice of multiple therapeutic measures is desired or advisable; c.) In unusually complicated situations where specific skills of other practitioners may be needed; d.) In instances in which the patient exhibits severe psychiatric symptoms or suicidal tendencies and the patient is not under a psychiatrist's care; e.) When the patient (or family) requests a consultation; f.) Complex cases for which the attending needs advice."

The BYLAWS GOVERNING THE MEDICAL STAFF of the hospital dated January 2011 were reviewed on 5/17/11 at 3:30 p.m. It indicated on page 6 "2.5 BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP EXCEPT FOR HONORARY AND RETIRED STAFF, THE ONGOING RESPONSIBILITIES OF EACH MEMBER OF THE MEDICAL STAFF INCLUDE: a.) providing patients with the quality of care meeting the professional standards of the medical staff of this hospital; b.) abiding by the medical staff Bylaws, Rules and Regulations."

The policy Number AS.16 latest revision 12/13/10 was reviewed on 5/17/11 at 3:30 p m. The Rapid Response Team-hospital main Campus policy reflected, "Policy: The Rapid Response Team (RRT) will be assigned each shift and consist of a Respiratory Therapist, Pharmacist, phlebotomist, and ICU (Intensive Care Unit) competent/Advanced Cardiac Life Support (ACLS) certified Registered Nurse (RN). The RRT will be using a standard assessment process with ACLS Standardized Procedure. SP.100 guidelines and Treatment of Opoid and/or Benzodiazepine (medications used for pain and relaxation) Standardized Procedure, SP 112 for treatment. The RRT functions under the authority of the ICU Medical director in collaboration with the Primary Care Physician or alternate physician specified in Section IV. Procedure: Licensed Nurse, physician or family member may request the RRT for evaluation of the questionable clinical condition of a patient such as (but not limited to): A. Acute Care areas: 1. Temperature less than or equal to 36 degrees centigrade or greater than or equal to 38 degrees centigrade 2. Pulse less than 50 or greater than 100 bpm (beats per minute) 3. Pain: new or significantly increased 4. Respiratory rate less than 6 or greater than 20 breaths per minute 5. SAO 2 (oxygen saturation) less than 90% and /or increasing O2 requirements 6. Systolic blood pressure less than 90 mm Hg (millimeters of mercury) or mean arterial pressure less than 65 mm Hg 7. Change in level of consciousness. 8. Urine output less than 0.5 ml/kg/hour (millimeters/kilogram) for 2 hours. 9. Delayed capillary refill/mottled skin (small blood vessels) 10. Any patient you are seriously concerned about but does not meet criteria... IV. Physician Responsibilities A. On acute care units, critical care physician will be notified if the severity of illness is perceived to warrant urgent critical care evaluation with a simultaneous call to the managing physician. If there is a delayed response from the physician greater than 15 minutes from the initial request, the RRT RN will consult with an alternate physician in the following order: 1. Critical Care Physician 2. Hospitalist 3. Emergency Department physician 4. Head of Department involved 5. Chief of Staff B. The ED physician shall maintain responsibility for the patient while in the Emergency Department (ED) or until hand-off to Intensivist is complete. C. The Intensivist shall respond either in person or by phone on notification by RRT RN. D. The RRT/Intensivist/managing physician/RN shall collaborate on course of treatment with the ultimate goal to be expedited access to care and transport the proper level of care."

The "Medscape" website Protocol for managing obstetric hemorrhage (heavy bleeding) stated "Organization a. Call experienced staff in. b. Alert blood bank and hematologist. c. Designate a nurse to record VS (vital signs), urine output, and fluids/drugs administered d. Place operating room on standby"

MD 2 and 3 were interviewed together on 5/18/11 at 3:00 p.m. Both stated they were familiar with the care issues surrounding the case involving Patient 17 and MD 5. Patient 17 had vaginal bleeding after delivery of a baby early in the afternoon of 12/17/10. She was being managed in the operating room by MD5 and MD6. Both stated MD 5 failed to seek a consult from a more experienced colleague on 12/17/10 while treating Patient 17. Both stated MD 5 and MD 6 failed to request assistance in managing Patient 17. Both stated Patient 17 did not receive quality care directly related to judgement errors made by MD's 5 and 6 while managing Patient 17 which resulted in the death of Patient 17.

MD 5 was interviewed on 5/19/11 at 12:30 p.m. He stated he was the physician attending Patient 17 on 12/17/10. He stated he did not request a consult with a senior physician to assist him immediately while treating Patient 17 whom he was attending to. He stated he did not request the rapid response team to enter the operating room to assist in treating Patient 17 immediately. He stated a second physician was allowed into the operating room to assist only after he was prompted by a nurse to ask for assistance. He stated he should have sought a consult with a more experienced physician sooner to assist in the care of Patient 17. He stated he made judgement errors which directly impacted the quality of care of Patient 17 in a negative fashion which resulted in her death.

CEO (Chief Executive Officer) was interviewed on 5/19/11 at 1:30 p. m. He stated he was familiar with the details of the cases corresponding to Patients 17 and 12 respectively. He stated as the CEO he had frequent interactions with both the Board of Directors and the Medical Staff leadership. He stated the hospital failed to provide quality care in both cases because the physicians involved did not seek appropriate consultations as called for in the medical staff rules and regulations.

MD 1 was interviewed on 5/19/11 at 1:45 p. m. He stated he was familiar with the cases of Patients 17 and 12. He stated he was aware the peer review process had been engaged to assess the practitioners performances in both cases. He stated judgement errors had been made in managing both patients. He stated the quality of care the patients received in both cases had been negatively impacted by the judgement errors which resulted in inappropriate care and the deaths of both patients.

2. THE RULES AND REGULATIONS OF THE MEDICAL STAFF of the hospital dated March 2011 were reviewed on 5/16/11 at 3:30 p.m. It indicated on Page 8 "GENERAL CONDUCT OF CARE - In the case of emergency, regardless of a practitioner's department or staff status, the practitioner attending the patient shall be expected to do all in his power to save the life of the patient, including calling appropriate consultation in accordance with known advanced directives. For the purpose of this section, an emergency is defined as A CONDITION IN WHICH THE LIFE OF THE PATIENT IS IN IMMEDIATE DANGER...and in which delay in administering treatment would increase the danger...14. Consultation with a member of the Consulting or Active medical staff is required in the following situations: a.) Where the diagnosis is obscure after ordinary diagnostic procedures have been completed; b.) When guidance in the choice of multiple therapeutic measures is desired or advisable; c.) In unusually complicated situations where specific skills of other practitioners may be needed; d.) In instances in which the patient exhibits severe psychiatric symptoms or suicidal tendencies and the patient is not under a psychiatrist's care; e.) When the patient (or family) requests a consultation; f.) Complex cases for which the attending needs advice."

The BYLAWS GOVERNING THE MEDICAL STAFF of the hospital dated January 2011 were reviewed on 5/17/11 at 3:30 p.m. It indicated on page 6 "2.5 BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP EXCEPT FOR HONORARY AND RETIRED STAFF, THE ONGOING RESPONSIBILITIES OF EACH MEMBER OF THE MEDICAL STAFF INCLUDE: a.) providing patients with the quality of care meeting the professional standards of the medical staff of this hospital; b.) abiding by the medical staff Bylaws, Rules and Regulations."

The policy Number AS.16 latest revision 12/13/10 was reviewed on 5/17/11 at 3:30 p m. The Rapid Response Team-hospital main Campus policy reflected, "Policy: The Rapid Response Team (RRT) will be assigned each shift and consist of a Respiratory Therapist, Pharmacist, phlebotomist, and ICU (Intensive Care Unit) competent/Advanced Cardiac Life Support (ACLS) certified Registered Nurse (RN). The RRT will be using a standard assessment process with ACLS Standardized Procedure. SP.100 guidelines and Treatment of Opoid and/or Benzodiazepine (medications used for pain and relaxation) Standardized Procedure, SP 112 for treatment. The RRT functions under the authority of the ICU Medical director in collaboration with the Primary Care Physician or alternate physician specified in Section IV. Procedure: Licensed Nurse, physician or family member may request the RRT for evaluation of the questionable clinical condition of a patient such as (but not limited to): A. Acute Care areas: 1. Temperature less than or equal to 36 degrees centigrade or greater than or equal to 38 degrees centigrade 2. Pulse less than 50 or greater than 100 bpm (beats per minute) 3. Pain: new or significantly increased 4. Respiratory rate less than 6 or greater than 20 breaths per minute 5. SAO 2 (oxygen saturation) less than 90% and /or increasing O2 requirements 6. Systolic blood pressure less than 90 mm Hg (millimeters of mercury) or mean arterial pressure less than 65 mm Hg 7. Change in level of consciousness. 8. Urine output less than 0.5 ml/kg/hour (millimeters/kilogram) for 2 hours. 9. Delayed capillary refill/mottled skin (small blood vessels) 10. Any patient you are seriously concerned about but does not meet criteria... IV. Physician Responsibilities A. On acute care units, critical care physician will be notified if the severity of illness is perceived to warrant urgent critical care evaluation with a simultaneous call to the managing physician. If there is a delayed response from the physician greater than 15 minutes from the initial request, the RRT RN will consult with an alternate physician in the following order: 1. Critical Care Physician 2. Hospitalist 3. Emergency Department physician 4. Head of Department involved 5. Chief of Staff B. The ED physician shall maintain responsibility for the patient while in the Emergency Department (ED) or until hand-off to Intensivist is complete. C. The Intensivist shall respond either in person or by phone on notification by RRT RN. D. The RRT/Intensivist/managing physician/RN shall collaborate on course of treatment with the ultimate goal to be expedited access to care and transport the proper level of care."

The "Medscape" website Protocol for managing hypoglycemia reviewed on 5/17/11 indicated "treatment and disposition of hypoglycemia are guided by the history and the clinical picture. Serum glucose should be measured immediately, and frequently. Clinical appearance alone is unreliable and may not reflect the seriousness of the situation." Staff failed to recognize the patient was hypoglycemic (low blood sugar).

MD 4 was interviewed on 5/18/11 at 10:30 a.m. She stated she was the attending physician for Patient 12 when she was called on 4/18 /11 at or around 2:30 a.m. She stated she was informed that Patient 12 had a change in her level of consciousness. She stated she responded in a timely fashion and evaluated the patient's clinical status. She stated she did not consider hypoglycemia as the cause for Patient 12's change in her level of consciousness. She stated she did not order a blood glucose test. She stated she did not request assistance from the Rapid Response Team. She stated in retrospect she had made a judgement error. She stated the judgement error had negatively impacted the care received by Patient 12 which resulted in her death. She agreed this situation represented a serious and substantive quality of care issue.

CEO (Chief Executive Officer) was interviewed on 5/19/11 at 1:30 p.m. He stated he was familiar with the details of the cases corresponding to Patients 17 and 12 respectively. He stated as the CEO he had frequent interactions with both the Board of Directors and the Medical Staff leadership. He stated the hospital failed to provide quality care in both cases because the physicians involved did not seek appropriate consultations as called for in the medical staff rules and regulations.

MD 1 was interviewed on 5/19/11 at 1:45 p.m. he stated he was familiar with the cases of Patients 17 and 12. He stated he was aware the peer review process had been engaged to assess the practitioners performances in both cases. He stated judgement errors had been made in managing both patients. He stated the quality of care the patients received in both cases had been negatively impacted by the judgement errors which resulted in inappropriate care which resulted in patient deaths.

Based on staff interview and clinical record and administrative document review, the hospital failed to ensure RN 7 administered to Patient 12, Dextrose 50 percent in Water (a concentrated sugar solution which was also referred to as D50W). D50W was used to raise the blood sugar of a patient in accordance with the orders of the physician. The hospital failed to administer insulin to Patient 8 in accordance with the approved protocol (instructions) for insulin dose calculation. The hospital's failure to ensure the nurses administered medications in accordance with physician orders and with the approved protocol (instructions) for insulin dose calculation placed 2 of 51 patients (Patient's 12 and 8) at risk for abnormally low or high blood sugar, which could result in, blindness, kidney failure, coma, and death.
Findings:
1. On 5/19/11 at 12:00 p.m. in the Cardiovascular Intensive Care Unit conference room, a review of Patient 12's electronic clinical record with Registered Nurse (RN) 6, Cardiovascular Intensive Care), RPH 2 (Pharmacist, Clinical Coordinator) and ED/CCD (Registered Nurse and Director of Cardiovascular Intensive Care) revealed the following:
According to admissions records reviewed on 5/19/11, Patient 12 was a 77-year-old woman admitted on 4/27/11 to the hospital and MD 7 (Physician, a cardiovascular surgeon) was listed as her admitting physician. Patient 12's laboratory record dated 5/10/11 at 1:42 p.m. showed that she had a blood glucose of 59 (normal range for most patients would result in levels greater than 70). A review of a Medication Administration Record (MAR) dated 5/10/11 showed that RN 7 administered a dose of D50W 12.5 grams per 25 milliliters intravenously (injected through the vein) to Patient 12 on 5/10/11 at 1:42 p.m.
Review of the record revealed no physician order for the D50W. On 5/19/11 at 12:00 p.m., in an interview, RN 6 said, " I don't see an order for it." RPH 2 and ED/CCD indicated they were also unable to locate an order to administer D50W 12.5 grams per 25 milliliters intravenously to Patient 12. On 5/19/11 at 12:15 p.m. in an interview, Staff 3 (Certified Pharmacy Technician) discussed the missing dextrose order for Patient 12. Staff 3 said, " I didn't find an order either. "
On 5/19/11 at 12:20 p.m. in a telephone interview, RN 7 acknowledged administering a dose of D50W 12.5 grams on 5/10/11 to Patient 12 for which there was no documented physicians order. RN 7 said, " I remember talking to the doctor about it but I may not have written it down." RN 7 could not recall with certainty if she had spoken to MD 8 (Physician) or another doctor.
The Institute for Safe Medication Practices (ISMP) includes D50W, a concentrated solution, among its list of drugs, which have a heightened risk of causing significant patient harm when used in error.
2. On 5/18/11 at 9:45 a.m., a review of Patient 8's clinical record at the Intensive Care Unit (ICU) on the 2nd Floor indicated that insulin was ordered to be administered according to the medical staff's protocol (approved policy). Registered Nurse (RN 9) verified that according to the medication administration record the approved insulin protocol was not followed and insulin was administered in the wrong dose on 5/16/11 as follows:
? 2 p.m., According to protocol 3 units should be given, only 2 units were given.
? 4 p.m., 4 units should be given, only 3 units were given.
? 5 p.m., 4 units should be given, only 3 units were given.
? 6 p.m., 3 units should be given, no units given are recorded.
? 8 p.m., 4 units should be given, 3 units were given.
? 10 p.m., 4 units should be given, 5 units were given.
On 5/17/11 the following miscalculations were noted:
? Noon, 1 unit bolus should be given, 0 noted.
? 4 p.m., 3 unit bolus should be given, 1 unit given.
? 9 p.m., 3 unit bolus should be given, 0 noted.
? 10 p.m. insulin dose increased without a physician ' s order.

Based on interview and record review the hospital failed to ensure insulin administration in accordance with the insulin protocol ordered by MD 7 (Physician) for 2 of 51 patients reviewed (Patient 12 and Patient 8). RN 7 failed to implement the insulin protocol as she failed to: 1) Monitor Patient 1's blood glucose during the insulin infusion; 2) administer the ordered dose of D50W, (a medication used to treat low blood sugar; 3) and adjust the administration rate (titrate) of the insulin infusion (dose) based on patient specific glucose levels.
The hospital's failure to implement the orders above placed Patient 12 and Patient 8 at risk for adverse events associated with high and low blood sugar, which could include coma, and death. Insulin was a medication used in patients with diabetes to control blood sugar, and D50W was a dextrose (sugar) solution that is given in cases of low blood sugar to bring the patient's blood sugar back to normal (normal blood sugar range is 70 -110 milligrams per deciliter - a method of measurement).
Findings:
On 5/19/11 at 12:00 p.m., a review of the admissions records showed Patient 12 was a 77-year-old woman that had physician's orders dated 4/27/11 and signed at 6:30 p.m. The orders included an insulin protocol that gave nurses instructions on how often the patient's blood glucose (sugar) should be checked and how much insulin should be given in response to the changes in blood glucose levels during the administration of a continuous insulin infusion. The insulin protocol orders commenced with Patient 12's date of surgery.
a. On 5/19/11 at 12:00 p.m. in an interview and record review, RN 6 and RPH 2 confirmed that Patient 12 had active orders for an insulin protocol between 4/27/11 and 5/16/11. A review of the nursing flow sheet (dated 5/10/11) showed serial bedside blood glucose readings at 6:00 a.m. (133); at 7:00 a.m. (102); at 8:00 a.m. (109); at 9:00 a.m. (108); at 11:00 a.m.(103); at 1:00 p.m. (59); at 2:00 p.m. there were two readings (160 and 101). There was no blood glucose documented at 10:00 a.m. or 12:00 p.m. in accordance with the protocol. There was no clinical justification or documentation in the nursing notes for not following the insulin protocol and obtaining blood sugar readings every hour. In addition, there was no explanation from facility staff as to why two readings (10:00 a.m. and 12:00 p.m.) were not obtained and documented on time.
b. On 5/19/11 at 12:45 p.m. during a concurrent record review and interview, RN 6 acknowledged that the insulin protocol ordered by MD 7 for Patient 12 was not implemented on 5/10/11 and 5/11/11 as follow:.
On 5/10/11,
At 6:00 a.m., the blood glucose was 133; the protocol instructed the nurse to give 1 unit, but the patient received none.
At 7:00 p.m., the blood glucose was 121; the protocol instructed the nurse to give 1 unit, but the patient received 2 units.
At 8:00 p.m., the blood glucose was 131; the protocol instructed the nurse to give 1 unit, but the patient received 2 units.
And on 5/11/11,
At 1:00 a.m., the blood, glucose was 139; the protocol instructed the nurse to give 1 unit, but the patient received 2 units.
At 3:00 a.m., the blood glucose was 139; the protocol instructed the nurse to give 1 unit, but the patient received 2 units.
At 5:00 a.m., the blood glucose was 128; the protocol instructed the nurse to give 1 unit, but the patient received 2 units."
On 5/19/11 at 12:47 p.m. in an interview, RPH 2 said referring to Patient 12's insulin therapy, "It doesn't appear that it was fulfilled ...the protocol."
c. The insulin protocol instructed staff how to manage low blood sugar levels (hypoglycemia) for the range between 50 and 59 milligrams per deciliter. It instructed staff to "Decrease insulin infusion rate by half. Recheck POC (Point of Care, indicating to check blood sugar) in 15 minutes. Repeat steps as necessary." However, this was not followed. A record review of Patient 12 showed that on 5/10/11 between 1:00p.m. - 2:00 p.m. RN 7 discontinued the insulin infusion and no physician order was documented. On 5/19/11 at 12:20 p.m. in a telephone interview, RN 7 acknowledged discontinuing the insulin infusion for Patient 12 on 5/10/11 between 1 p.m. and 2 p.m., which was not consistent with the protocol and without a documented physicians order. RN 7 said, " I remember talking to the doctor about it but I may not have written it down." RN 7 could not recall with certainty if she had spoken to MD 8 or another doctor.
When the policy was requested, the Emergency Department/Critical Care Director (ED/CCD) provided the hospital's temporary policy, titled: "Hypoglycemia, Adult " (revised 10/22/07) which was effective through 7/30/11. The policy directed staff to "Stop insulin drip (if infusing), keep maintenance IV open and call physician" when blood sugar levels were between 41 and 60 milligrams per deciliter. However, the ED/CCD indicated the patient-specific insulin protocol orders in Patient 12's chart would take precedence over the hospital's "Hypoglycemia, Adult " policy.
d- On 5/19/11 at 12 p.m.,during the review of the insulin protocol for Patient 12, RN 6 stated, "The protocol states that if you have blood glucose of 50 to 59 you should administer D50W 10 grams per 20 milliliters intravenous (injected in the vein) push." RN 6 said that RN 7 "gave 12.5 grams (25 milliliters) of D50W. There is a discrepancy of 2.5 grams per 5 milliliters." RN 6 further explained that it was theoretically possible that a verbal order was taken which superseded the insulin protocol; however, RN 6 and RPH 2 were unable to find an order to administer 12.5 grams of D50W or to discontinue the insulin infusion. A review of the nursing flow sheet for Patient 12 showed that RN 7 had discontinued the insulin infusion between 1:00 p.m. and 2:00 p.m. on 5/16/11.
The Institute for Safe Medication Practices (ISMP) includes insulin and concentrated solutions (D50W) among its list of drugs, which have a heightened risk of causing significant patient harm when used in error. A review of the hospital ' s policy, "High Alert Medication Use" revealed that " Appendix A " lists insulin as a high alert medication and that was approved by the Pharmacy and Therapeutics Committee on 11/6/09.

Based on interview and record review the hospital failed to implement a system to ensure that verbal orders were used infrequently. During the week of 5/9/11 through 5/17/11, physicians had 880 unsigned verbal or telephone orders. Verbal and telephone orders have a higher potential for medication errors. Frequent use of telephone and verbal orders placed patients at heightened risk for receiving medications in error, as evidence by Patient 1 receiving 12.5 grams of D50W (a concentrated sugar solution used to raise blood sugar) without a physician ' s to do so.
Findings:
On 5/19/11 at 10:05 a.m. during a concurrent interview and record review of Patient 1 records, revealed 38 series of orders for Patient 1 between 4/28/11 and 5/11/11 which were designated as either " VORB " (Verbal Order Read Back) or " VOV " (Verbal Order Verified). The Director of Health Information (ADM 6) confirmed the acronyms had been conventionally used by nursing staff to document they received a verbal order from a physician. When asked about the frequency or changes in trends of verbal orders, she explained her department did not track the number of verbal orders; however, they tracked reports of unsigned verbal and or telephone orders.
A review of the hospital's report, entitled: "Verbal Order Telephone Order by MD (Past 7 days) " (dated 5/17/11) showed a section, "Top 10 MD's not signed orders (by highest volume of unsigned orders.)" Although, ADM 6 was unable to quantify the number of verbal orders during the inclusive reporting period between 5/9/11 through 5/17/11, ADM 6 confirmed that the top ten physicians with unsigned orders (orders awaiting signature) had used verbal orders 880 times that week. Of these, hospitalists (MD 9, MD 10, and MD 7) verbal orders accounted for 361 or 10 percent of all 880 unsigned verbal or telephone orders.
Verbal and telephone orders are associated with increased risk of errors.
On 5/19/11 at 1:00 p.m. in an interview, DPH (Director of Pharmacy) did not recall identifying verbal orders for medications as a concern. He did not know if the hospital had a system to ensure verbal orders were used infrequently. However, he acknowledged verbal orders were associated with medication errors identified with Patient 1.

Based on clinical record and administrative document review, the hospital failed to ensure all verbal orders were authenticated when 2 of 51 sampled patients (Patients 19 and 22) verbal orders were not authenticated within 48 hours according to Federal Law. This placed Patient's 19 and 22 at risk of receiving care and treatment in an unsafe environment.

Findings:

1. On 5/23/11 at 2:15 p.m., during a concurrent interview and record review for Patient 19, Medical Record Staff 1 stated the verbal order, dated 5/13/11 at 2:10 p.m., stamped "VERBAL ORDERS (VO's), M.D." could not be located in the facilities electronic system. She further stated orders stamped "VERBAL ORDER "were being researched to determine who the ordering physician was so that they can be authenticated.

Patient 19's verbal orders dated 5/13/11 at 2:10 p.m., indicated an order for "...Bilateral lower extremity venous doppler to rule r/o (rule out) DVT (deep vein thrombosis)" and "Vitamin K 5 mg (milligrams) sub-Q (under the skin) x 1 dose today." The order was signed as a telephone verbal order with the name of the physician and the nurse. It was stamped "Authenticated by" VERBAL ORDERS, M.D. On 5/18/11 5:40:32 AM. "

Patient 19's Ultrasound report dated 5/13/11 at 5:23 p.m., indicated a Venous Doppler - Bilateral (having two sides) Extremity (hands and feet) had been performed. As of 5/23/11, the order had not been signed by the physician.

On 5/23/11 the hospital policy titled "Assigning Deficiency for VOTO's (verbal orders telephone orders)" dated last reviewed on 11/223/09 was reviewed. Under "Purpose" the policy indicated "To identify and assure a deficiency is assigned ASAP after the MD writes verbal orders."

On 5/23/11 the current hospital "Medical Staff Rules and Regulations" indicated under "Medical Records: 1... All entries in the medical record must be legible, times, dated and authenticated."

2. On 5/23/11 at 3:00 p.m., during a concurrent interview and record review RN 16 stated Patient 22's "Newborn Admission Order" dated 5/17/11 at 7:10 a.m., did not appear authenticated. When asked to explain the form, he stated the "Newborn Admission Orders" was a template that was individualized to each patient depending on their needs. When asked to determine if the orders had been authenticated he went to the electronic record system. After review in the electronic system he stated he could not locate an authenticated copy of the orders. That time was 3 days past the 48 hours authentication requirement.

On 5/23/11 the hospital policy titled "Assigning Deficiency for VOTO's (verbal orders telephone orders)" dated last reviewed on 11/223/09 was reviewed. Under "Purpose" the policy indicated "To identify and assure a deficiency is assigned ASAP after the MD writes verbal orders."

On 5/23/11 the current hospital "Medical Staff Rules and Regulations" indicated under "Medical Records: 1... All entries in the medical record must be legible, times, dated and authenticated."


29441

Based on observation, staff interview and clinical record and administrative document review the hospital failed to ensure that only authorized personnel had access to locked areas in the Nuclear Medicine department's Hot Lab where radiopharmaceuticals (radioactive substances that may be used to treat cancer) and cold kits (drugs used for diagnosing) were stored. The hospital's failure to develop policies and procedures, which prevent unauthorized access by vendors, placed patients at risk for adverse events from loss of control of the drugs and diagnostic agent supplies.

Findings:

On 5/18/11 at 10:00 a.m., during a tour of the Nuclear Medicine department, the door to the unoccupied Hot Lab was observed propped open to the fullest extent. The door had a numeric keypad. NMT (Certified Nuclear Medicine Technician) was observed with his back to the lab attending to a patient at an imaging machine 10 feet away. He was not within line of sight of the surveyor standing in the doorway of the hot lab.
On 5/18/11 at 10:03 a.m. in an interview, the NMT acknowledged the lab contained drugs and radioactive pharmaceutical diagnostic agents. An inventory showed Normal Saline 10 milliliter vials, choletech (a kit used as a diagnostic agent), and radiopharmaceuticals. When asked who had access to these drugs and supplies, he said, "only people with the code." He elaborated that this included himself, nuclear medicine staff, the vendor, and the physicist. " When asked if pharmacy had access to the hot lab he said, No." When asked if vendors had access to the room he said, "Security escorts them into the department in the morning to drop off the radiopharmaceuticals." Staff NMT said, "The vendors have the code. When asked to verify, if the vendors were authorized to have access to the drug supply in the hot lab and the pharmacists were not," he said, "that's right."
A review on 5/19/11 of the hospital's policy titled, "Medication: Security in Patient Care Areas" (revised 11/18/10) showed: "All medications must be stored in a secure manner" ... "Access to medications is controlled by means of an automated dispensing cabinet security code, keys, keyless lock system or direct observation" ... "Only personnel legally authorized to administer medications or authorized by the District to handle medications may have access to the keys/codes" and, "Appropriate security of medications is validated by monthly inspections of all medication storage areas by Pharmacy."

A review of the hospital's policy, titled, "Medication Room Access" (revised 2/22/08) showed: "To ensure medication room access is limited to authorized personnel, medication room doors will remain closed and locked at all times the medication room is unoccupied. "The policy listed the following authorized personnel: nursing, pharmacy, respiratory therapists, central logistics, licensed psychiatric technicians, Emergency Department technicians, Intensive Care Unit aide, dialysis technicians, and other licensed patient care personnel. Security personnel or the contractor for radiopharmaceuticals were not listed in the policy.

The hospital's policies showed that prior to 5/19/11 the hospital had not designated security personnel and contracted vendors as authorized to access the Nuclear Medicine Department's hot lab (a designated drug storage area) during hours when the department was closed and unsupervised.

On 5/18/11 at 12 p.m. in an interview, the DPH (Director of Pharmacy) indicated that a pharmacist consistently performed monthly inspections in Nuclear Medicine and no issues had been brought to his attention regarding unauthorized access. He confirmed vendors were not designated as authorized to access the hot lab.

Based on observation, staff interview and clinical record and administrative document review, the facility was unable to provide comprehensive and accurate information in the areas of reporting, identifying, investigating, and controlling infections through out the facility. The inability to provide accurate information regarding these areas placed the patients at risk for communicable diseases and infections.

Findings:

1. On 5/23/11 at 11:10 a.m., during an observation, patient care rooms 4, 5, 6, and 9 in the critical care area of the main building were empty. The entry doors to the rooms was entirely covered with a clear plastic sheeting.

On 5/23/11 at 11:15 a.m., the FM (Facility Manager) indicated, "the rain blew in water through the windows, the rooms were tested and just came back with mold spores...so we moved the patients and closed the rooms."

On 5/24/11 at 3:30 p.m., the report submitted by the contracted Hazardous Waste company was reviewed . The report indicated the evaluation was "done 4/27/11 and was limited to the specific areas of request". The report indicated that apparent ongoing fungal mold was found on the walls of rooms 5, 6 and 9. The document further indicated ,"...Severe decayed and stained wall board was noted in rooms 1, 2, 3, 4, 5, 6 and 9...additionally stained ceiling tiles were seen in other rooms through out the unit... Initial wall and ceiling samples showed extremely high mold growth...of (atra) mold in both samples.. Penicillium/Aspergillus mold...was also found and is a cause for much concern...is compelling evidence of hidden reservoirs of mold growth...all decayed wallboard in rooms 1 and 3 should also be removed..."

2. On 5/23/11 at 2:20 p.m., the ICN (Infection Control Nurse) indicated that some of the patient care areas did not submit their infection rates and that is why some of the areas (on the Infection Risk Assessment form) are blank...they just did not submit them."

On 5/23/11 at 4:45 p.m., during a review of the Infection Prevention Risk Assessment Form, dated 2/11, the areas titled "Potential Event" listed 8 categories of infection monitoring: 1. Central Line Associated Bloodstream Infection, 2. Increased post operative infection risk due to failure to use preop interventions. 3. Hospital Acquired Infections due to improper hand hygiene. 4. Construction activity in the surgical suite. 5. Pathogen outbreak due to community or nosocomial event. 6. (duplication entry of 1.) Central Line Associated Bloodstream Infection. 7. TB (tuberculosis) Risk assessment in past year. 8. Patient with HAI due to inadequate equipment cleaning. The subcategories: Probability, Risk and Preparedness
identified low, medium, and high subsets. In the area of Preparedness, 6 of the 8 entries were in the poor and fair ratings.
The review of the total scores revealed errors in the interpretation of the "Risk Rating" as the key shows a rating of 8-10 as "A" High but was entered as "B."

3. On 5/20/11 at 11 a.m., during an observation tour of the patient care areas of the main building, floors 3 and 4 had a musty odor of mold near the patient and nutrition rooms.

On 5/20/11 at 11:05 p.m., the EVS (Environmental Supervisor) stated," it is from under the sinks...and it's a water problem."

4. On 5/2011 at 9:45 a.m., during an observation in the clean storage supply room #W228, on the 2W ICU (Intensive Care Unit), 2 Hemodialysis machines had white splash marks on their screens and throughout various parts of each machine. A whitish yellow liquid and a plastic sticky catheter was present in the tray near the main screen of Hemodialysis Machine 1.

On 5/20/11 at 10:20 a.m., the DRS (Director of Renal Services) indicated that the plastic catheter was a dialysis wand that was dirty and should have been thrown away. The DRS further stated, " I acknowledge that the dialysis machines are dirty."

On 5/23/11 at 11:30 a.m., the current facility policy and procedure dated 9/22/08 titled, "Disinfectant/Sanitizing Chemical, I. ...staff will clean/disinfect all surfaces in patient areas including...equipment with a District approved germicide solution. III. Surfaces cleaned should be wiped down thoroughly with the disinfectant." On 5/23/11 at 11:35 a.m., the current facility policy dated 1/1/10 titled Cleaning of Patient Care Equipment I. Purpose: To remove pathogens (bacteria) from patient care equipment, maintain patient safety, and prevent the transmission of infection by cross-contamination. II. Policy Statement...Patient care equipment that is identified as reusable will be routinely cleaned and disinfected before and after each use."