HospitalInspections.org

Based on interview and document review, the facility did not have an effective governing body that carried out the functions required of a governing body by the following:

1. The Governing Body failed to ensure that the facility's bylaws governing the granting of medical staff privileges applied equally to all practitioners by failing to ensure ongoing peer review for one anesthesiologist. ( A tag 50)

2. The Governing Body failed to ensure that it's Sentinel Event policy and procedure was implemented when it did not perform a thorough and credible root cause analysis of a significant event that resulted in a patient's (1) death. (A tag 287)

3. The Governing Body failed to ensure that measurable quality indicators were established for Outpatient Services in an effort to assess and determine the effectiveness of those services and identify opportunities for performance improvement. (A tag 298)

4. The Governing Body failed to ensure that benchmarks (a standard by which something can be measured or judged) were established for the purpose of analyzing and comparing it's performance during Code Blue and RRT (Rapid Response Team) responses. (A tag 267 # 2)

5. The Governing Body failed to ensure that measurable and quantifiable quality indicators for an emergency response procedure and process were established. (A tag 267 #1)

6. The Governing Body failed to ensure that data collected for the purpose of measuring and determining the hospital's performance in Code Blue responses was accurate and consistent. (A tag 274)

7. The Governing Body failed to ensure that policies and procedures and job descriptions pertaining to minimum requirements necessary for Registered Nurses (RNs) in the Operating Room (OR) and Post Anesthesia Care Unit (PACU) were implemented. In addition, the Governing Body failed to ensure that the job descriptions and policies were consistent in the minimum requirements for RNs in those areas. (A tag 397)

8. The Governing Body failed to ensure that a formal training program for training RNs in specialized patient care areas, such as the OR and PACU, was established, in an effort to ensure that competent resource nurses were available at all times for novice staff. (A tag 397)

The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Governing Body and failure to provide care to their patients in a safe environment.

Based on interview, record and document review the hospital failed to ensure that an effective Quality Assessment and Performance Improvement program (QAPI) was implemented.

Findings:

1. The hospital failed to implement it's Sentinel Event policy and procedure when it did not perform a thorough and credible root cause analysis of a significant event that resulted in a patient's (1) death. (A tag 287)

2. The hospital failed to establish quality indicators to monitor the effectiveness of its Outpatient Services. (A tag 298)

3. The hospital failed to analyze signficant variations in its Code Blue and Rapid Response Team responses in order to identify performance improvement opportunities. (A tag 288)

4. The hospital failed to establish measurable and quantifiable quality indicators for an emergency response procedure and process. (A tag 267 # 1)

5. The hospital failed to establish benchmarks (a standard by which something can be measured or judged) for the purpose of analyzing and comparing it's performance during Code Blue and RRT responses. (A tag 267 # 2)

6. Data concerning Code Blue success rates was inconsistent and inaccurate. (A tag 274)


The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Quality Assessment and Performance Improvement.

Based on interview and record review, the facility failed to ensure that the Medical Staff operated under the Bylaws approved by the Governing Body and was responsible for the quality of care provided to patients as evidenced by the following:

The Medical Staff failed to ensure that peer review was instituted for one staff Anesthesiologist as specified in the Medical Staff Bylaws to evaluate this practitioner's qualifications and demonstrated competencies within the applicable scope of practice or privileges that have been granted. (A 340)

The failure by the Medical Staff to ensure that peer review for Anesthesia services resulted in a failure to protect the life or well-being of patient(s) and to reduce a substantial and imminent likelihood of significant impairment of the life, health or safety of any patient or prospective patient.

The cumulative effect of this systemic problem resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Medical Staff and failure to provide care to their patients in a safe environment.

Based on interview and record review, the facility failed to ensure that Anesthesia Services operated under a qualified Anesthesiologist, and enforced the Bylaws approved by the Governing Body, and was responsible for the quality of care provided to patients, as evidenced by the following:

The hospital failed to ensure that peer review was instituted for one staff Anesthesiologist as specified in the Medical Staff Bylaws, to evaluate this practitioner's qualifications and demonstrated competencies within the applicable scope of practice or privileges that have been granted. (A 353)

The hospital failed to ensure that one Anesthesiologist (MD2) implemented the hospital's Rules and Regulations requiring that, a pre-anesthesia assessment was completed and documented, for 1 patient (1) who required resuscitation immediately after an outpatient procedure requiring general anesthesia and subsequently expired. In addition, the facility failed to ensure that one Anesthesiologist (MD2) implemented the criteria for selecting patients for outpatient surgery, by allowing Patient 1, who did not meet outpatient selection criteria, to undergo an outpatient procedure under anesthesia . (A 1003)

The hospital failed to ensure that one Anesthesiologist (MD2), documented a complete recovery from general anesthesia evaluation note, for patients that had surgery with general anesthesia prior to discharge, for 32 of 32 medical records reviewed. (A 1005)

The failure by the Anesthesia Services to enforce the Bylaws, resulted in a failure to protect the life or well-being of patients and to reduce a substantial and imminent likelihood of significant impairment of the life, health or safety of any patient or prospective patient. The cumulative effect of these systemic problems resulted in the facility's failure, to deliver care in compliance with the Condition of Participation for Anesthesia Services and failure to provide care to their patients in a safe environment.

Based on interview and record review, the hospital failed to ensure that it's Outpatient Selection Criteria policy and procedure was implemented, for 1 patient (1) who underwent an outpatient bronchoscopic procedure. Immediately following the procedure, Patient 1 required emergency resuscitative procedures and ultimately expired.

Findings:

Patient 1 was admitted to the hospital on 10/19/11, with diagnoses that included chronic cough, trach (tracheotomy - a surgical procedure in which an opening is made in the windpipe for the passage of air) pain and difficult trach change, according to the History and Physical. A review of Patient 1's medical record was conducted on 10/25/11 at 3:15 P.M. Patient 1 was morbidly obese (5 feet 3 inches tall and weighed approximately 300 pounds). She also had a history of respiratory failure which resulted in the insertion of a tracheotomy tube (a tube that goes thorough a surgical opening made in the front of the neck into the windpipe) for breathing. On 10/19/11, Patient 1 underwent an outpatient bronchoscopy (a procedure using a bronchoscope to see inside of the lungs), with bronchial lavage (fluid is squirted into the lung and then recollected for examination), and bronchial brushing (a small brush is used to remove cells from the lung for examination). A tracheotomy change and laryngoscopy (a procedure to view the voice box) were also performed. These procedures were performed under general anesthesia. Immediately following the procedure, Patient 1's heart rate began to dropped to about 30 to 40 beats a minute. Cardio-pulmonary resuscitation (CPR) was initiated. Patient 1 was transferred to another local hospital because the intensive care unit of the treating hospital was full. Patient 1 expired on 10/20/11.

After a review of all of Patient 1's previous medical records, it was determined that Patient 1 had undergone eight (8) outpatient bronchoscopic procedures under general anesthesia, between December 2009 and October 2011, at this facility.

A review of the hospital's policy and procedure entitled "Criteria for Selecting Patients for Outpatient Surgery," was conducted on 10/25/11 at 3:35 P.M. This policy indicated that "the goal of patient selection for outpatient surgery is to select the patient who will benefit most from a minimal stay in the hospital. The entire peri-operative experience should be safe, efficient and minimally stressful to the patient...Factors to consider in the selection of outpatients should include, but not limited to: ...C. Not morbidly obese D. No history of airway obstruction or post-operative respiratory problem."

An interview was conducted with Patient 1's Anesthesiologist (MD 2) on 10/25/11 at 3:30 P.M. The Anesthesiologist stated that he would definitely classify Patient 1 as morbidly obese. He believed that Patient 1 actually weighed about 340 to 350 pounds.

On 10/25/11 at 4:55 P.M., an interview was conducted with the Pre-operative Registered Nurse (RN 1). After review of the policy and procedure, RN 1 noted that Patient 1 did not fit the criteria for selection as a candidate for outpatient surgery because she was morbidly obese.

An interview was conducted on 11/1/11 at 10:30 A.M. with the physician (MD 1) that performed the broncoscopic procedure on Patient 1 on 10/19/11. MD 1 reviewed the hospital's policy and procedure and then acknowledged that Patient 1 was morbidly obese, and also had a history of airway obstruction.

According to the hospital's Criteria for Selecting Patients for Outpatient Surgery, Patient 1 was not a candidate for outpatient surgery.

On 10/26/11 at 4:20 P.M., a meeting was held with the Chief Executive Officer, the Chief Operating Officer and the Director of Quality Improvement to inform them that a situation of Immediate Jeopardy was determined to be present. After reciept of an acceptable corrective action plan, the Immediate Jeopardy was abated on 10/26/11 at 7:45 P.M.

The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Outpatient Services, and failure to provide care to their patients in a safe environment.

Based on interview and document review, the Governing Body failed to ensure that the facility's bylaws governing the granting of medical staff privileges applied equally to all practitioners, by failing to ensure ongoing peer review for one anesthesiologist (MD 2).

Findings:

A review of the Anesthesiologist's (MD 2) credential file was conducted on 10/27/11 at 10:55 A.M. A document titled "Reappointment Profile" indicated under the quality assurance activities that nothing was documented pertaining to medical chart review, drug usage evaluation or surgical procedure case review. A document titled "Physician Report Card" indicated that nothing was documented regarding utilization of facilities, non-compliant medication orders or medical records review. The reappointment profile specified under the approval section that "in my review of these records I have found the practitioner to have the proper education, training experience and competence as well as the professional performance and judgment to perform all of the procedures requested." The reappointment profile was signed by the Chief of Staff Select and approved by the Medical Executive Committee (MEC) and Governing Board (GB) on 4/29/11.

A review of the Medical Staff Bylaws was conducted on 10/27/11 at 2 P.M. The bylaws specified under ongoing professional performance evaluations (OPPE) that the Medical Staff shall recommend, for MEC and GB approval, the criteria to be used in the conduct of OPPE to include but not limited to: 1) periodic chart review, 2) direct observation 3) monitoring of diagnostic and treatment techniques, 4) discussion with other individuals involved in the care of each patient including consulting physicians, assistants at surgery, nursing and administrative personnel, 5) as otherwise defined in these bylaws or applicable OPPE policies. Ongoing performance reviews shall be factored into the decision to maintain, revise or revoke a practitioner's existing privileges.

An interview with the Governing Board which included the Chief Executive Officer, Chief of Medical Staff, Director of Psychiatry and House Physician was conducted on 11/1/11 at 2:30 P.M.. The board acknowledged that they had no knowledge regarding the lack of ongoing peer review for MD 2 on staff at the facility. The GB acknowledged that the lack of ongoing peer review for a practitioner was in violation of the facilities bylaws regarding medical staff membership and granting of privileges.

Based on interview and document review, the Medical Staff failed to ensure that peer review was instituted for one staff Anesthesiologist (MD 2) as specified in the Medical Staff Bylaws, to evaluate this practitioner's qualifications and demonstrated competencies within the applicable scope of practice or privileges that have been granted.

Findings:

A review of the Anesthesiologist's (MD 2) credential file was conducted on 10/27/11 at 10:55 A.M. A document titled "Reappointment Profile" indicated under the quality assurance activities, that nothing was documented pertaining to medical chart review, drug usage evaluation or surgical procedure case review. A document titled "Physician Report Card" indicated that nothing was documented regarding utilization of facilities, non-compliant medication orders or medical records review. The reappointment profile specified under the approval section that "in my review of these records I have found the practitioner to have the proper education, training experience and competence as well as the professional performance and judgment to perform all of the procedures requested." The reappointment profile was signed by the Chief of Staff Select and approved by the Medical Executive Committee (MEC) and Governing Board (GB) on 4/29/11.

A review of the Medical Staff Bylaws was conducted on 10/27/11 at 2:00 P.M. The bylaws specified under ongoing professional performance evaluations (OPPE) that the Medical Staff shall recommend, for MEC and GB approval, the criteria to be used in the conduct of OPPE to include but not limited to: 1) periodic chart review, 2) direct observation 3) monitoring of diagnostic and treatment techniques, 4) discussion with other individuals involved in the care of each patient including consulting physicians, assistants at surgery, nursing and administrative personnel, 5) as otherwise defined in these bylaws or applicable OPPE policies. Ongoing performance reviews shall be factored into the decision to maintain, revise or revoke a practitioner's existing privileges.

An interview was conducted on 10/27/11 at 10:50 A.M. with the Chief of Medical Staff (CMS). The CMS stated that because there was only one Anesthesiologist (MD 2) on the active Medical Staff, that there was no medical record or case review for Anesthesia services. He stated that the physician report card that is used as a quality measure of physician performance was not applicable to the practice of MD 2, and explained that is why no data had been filled out on that form. He acknowledged that MD 2 should have had ongoing peer review by another physician qualified to administer anesthesia to comply with the facility's bylaws.

The hospital failed to implement policies and procedures and job descriptions, pertaining to minimum requirements necessary for Registered Nurses (RNs) in the Operating Room (OR) and Post Anesthesia Care Unit (PACU). Job descriptions and policies were inconsistent in the minimum requirements for RNs in those areas. In addition, the hospital trained RNs for specialized patient care areas, such as the OR and PACU, without the establishment of a formal training program or plan in an effort to ensure that competent resource nurses were available at all times for novice staff.

Findings:

1. A review of PACU RN 1's personnel file was conducted on 11/1/11 at 9:00 A.M. PACU RN 1 was hired by the hospital on 10/21/09, to work in the Medical-Surgical patient care unit. According to the file, PACU RN 1 now worked in the PACU. There was no signed PACU RN job description in PACU RN 1's personnel file.

An interview was conducted with the Chief Operating Officer (COO) and the Director Of Nurses (DON) on 11/1/11 at 9:15 A.M. Per the COO, in 2009 PACU RN 1 was hired as a "new grad" (newly graduated from nursing school with no prior experience) for the medical-surgical patient care unit. PACU RN 1 worked on the medical-surgical unit until 3 months ago when she was hired to train in the PACU and OR patient care areas.

A review of the Job Specifications section of the Criteria Based Performance Standards for a PACU RN, dated 5/7/08, indicated that the required Experience/Specialized skills for a PACU RN was "At least 1 year experience in Recovery Room."

Per the "Hospital Discharge of Post-Anesthesia Patients from the Post-Anesthesia Care Unit" hospital policy and procedure, dated 12/20/11, the Minimum Experience, Training and Education Required of Designated R.N. Staff: At least one (1) year experience in PACU and/or critical care nursing.

A review of the Job Specifications section of the Criteria Based Performance Standards for an OR RN, dated 9/09, indicated that the required Experience/Specialized Skills for an OR RN was "two recent years circulating experience."

There was no evidence in PACU RN 1's personnel file, that she had the minimum required experience to work in the OR or PACU areas.

On 11/1/11 at 11:10 A.M., an interview was conducted with the COO and the OR Lead RN (ORLRN). Per the COO and the ORLRN, PACU RN 1 was "independent" to work in the PACU area since she had completed a 3 month preceptorship. However, the COO stated that PACU RN 1 would always have an experienced PACU RN with her. Per the ORLRN, PACU RN 1 was currently being trained to work in the OR. The ORLRN stated that PACU RN 1 was also eligible to be "on call" for emergencies as a PACU nurse. Per the ORLRN, when PACU RNs were called in for emergencies, they were called in as the only PACU RN. The other nursing personnel called in were OR RNs, who did not have competencies in PACU nursing. Therefore, if PACU RN 1 were called in for an emergency, she would not have an experienced competent PACU RN as a resource.

The COO acknowledged that the experience and/or specialized skills requirement for a PACU RN, as outlined in the hospital's policy and procedure, was in conflict with the experience requirements noted in the PACU RN job description. The ORLRN further stated that, although the PACU had an orientation for new hire PACU and OR RNs, there was no formal in-hospital training program for training a new PACU or OR RN, who did not have the required minimum experience. The ORLRN acknowledged that PACU RN 1 did not have any PACU/critical care or OR experience, which was the current minimum required qualification to work as a PACU or OR RN.



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2. An interview was conducted with Post Anesthesia Care Unit (PACU) Registered Nurse (RN 2) on 10/25/11 at 5:05 P.M. RN 2 stated that he had worked at the hospital for 3 years as a Medical/Surgical RN. Recently, he had begun orientation and in-hospital training to work as a PACU RN.

A review of RN 2's personnel file was conducted on 11/1/11 at 10:10 A.M. RN 2 was hired as a Medical/Surgical RN on 1/14/08. According to RN 2's resume, he had no prior PACU experience. There was no evidence on RN 2's resume that he ever had any critical care nursing experience.

A review of the Job Specifications section of the Criteria Based Performance Standards for a PACU RN, dated 5/7/08, indicated that the required Experience/Specialized skills for a PACU RN was "At least 1 year experience in Recovery Room."

Per the "Hospital Discharge of Post-Anesthesia Patients from the Post-Anesthesia Care Unit" hospital policy and procedure, dated 12/20/11, the Minimum Experience, Training and Education Required of Designated R.N. Staff: At least one (1) year experience in PACU and/or critical care nursing.

An interview was conducted with the Chief Operating Officer (COO), the Director of Nursing (DON), the RN Educator (RNE) and the Operating Room Lead RN (ORLRN) on 11/1/11 at 11:10 A.M. The COO acknowledged that the experience and/or specialized skills requirement for a PACU RN outlined in the hospital's policy and procedure was in conflict with the experience requirements noted in the PACU RN job description. The ORLRN further stated that, although the PACU had an orientation for new hire PACU RNs, there was no formal in-hospital training program for training a new PACU RN who did not have the required experience. And, the ORLRN acknowledged that PACU RN 2 did not have any PACU experience which was the current required qualification to work as a PACU RN.

Based on interview and record review, the hospital failed to ensure that the medical record of 1 of 32 sampled patients (1) was accurate and complete.

Findings:

Patient 1 was admitted to the hospital on 10/19/11, with diagnoses that included chronic cough, trach (tracheotomy - a surgical procedure in which an opening is made in the windpipe for the passage of air) pain and difficult trach change, according to the History and Physical. A review of Patient 1's medical record was conducted on 10/25/11 at 3:15 P.M. On 10/19/11, Patient 1 underwent an outpatient bronchoscopy (a procedure using a bronchoscope to see inside of the lungs) with bronchial lavage (fluid is squirted into the lung and then recollected for examination) and bronchial brushing (a small brush is used to remove cells from the lung for examination). A tracheotomy change and laryngoscopy (a procedure to view the voice box) were also performed. These procedures were performed under general anesthesia. There was a form located on Patient 1's medical record entitled "Pre-Anesthesia Evaluation." This form provided space for the documentation of Patient 1's past medical history. At the bottom of the form, there was a section for the Anesthesiologist's pre-anesthesia evaluation and comments. This portion of the form was blank. There was no other documentation in Patient 1's medical record that a Pre-Anesthesia Evaluation had been completed. On another form in Patient 1's medical record, entitled "Universal Protocol - Time Out," the Operating Room Registered Nurse (RN 2) had documented that a Pre-Anesthesia Note was present.

A concurrent interview was conducted with RN 2 and the Chief Operating Officer (COO) on 10/27/11 at 2:30 P.M. RN 2 explained that the Pre-Anesthesia Note was the documentation in the medical record of the pre-operative assessment performed by the Pre-Operative Nurse. The COO explained to RN 2 that the Pre-Anesthesia Note is the documentation of the pre-anesthesia evaluation performed by the Anesthesiologist. The COO and RN 2 both acknowledged that there was no documentation in Patient 1's medical record that the Pre-Anesthesia evaluation by an anesthesiologist had been performed prior to Patient 1 undergoing a procedure in the Operating Room under general anesthesia.

Based on observation, interview and record review, the hospital failed to ensure that plant operations had knowledge of, and was performing, preventative maintenance for 13 refrigerators located throughout the hospital.

Findings:

A general observation tour of the Post Anesthesia Care Unit (PACU) was conducted on 10/27/11 at 8:20 A.M. A small refrigerator used for the storage of medications, was observed in the PACU. A preventative maintenance (PM) sticker on the refrigerator indicated that the next PM had been due on 10/15/11.

An interview was conducted with a Plant Operations Technician on 10/27/11 at 9:00 A.M. The Technician stated that he checked the refrigerator's temperature and that the refrigerator was either working or not. He further stated that he was not aware of manufacturer's recommendations for any preventative maintenance for the refrigerator.

A general observation tour of the Medical/Surgical Unit was conducted on 10/27/11 at 9:20 A.M. There were three medication rooms on the Medical/Surgical Unit. Each medication room contained a small medication refrigerator with a PM sticker indicating that the next PM had been due on 10/15/11.

An interview was conducted with the Lead Technician of Plant Operations on 10/27/11 at 9:30 A.M. The Lead Technician stated that he was not knowledgeable of what needed to be done for preventative maintenance of the refrigerators. He further stated that there were 13 small refrigerators located throughout the hospital. The last time that PM was done on the 13 refrigerators was 10/15/10. The PM on the refrigerators was to be done yearly. The Lead Technician stated that he was going to contact the manufacturer to obtain the manufacturer's recommendations for PM of the refrigerators.

On 10/27/11 at 10:00 A.M., the Lead Technician received electronic mail from the manufacturer which informed the Lead Technician that annual PM of the refrigerators should include the following:

Clean Condenser
Check and Properly Adjust Thermostat and Air Dampers
Check Automatic Defrost Cycle
Check Door Seals for Air Leaks
Clean Defrost Evaporation Pan
Check Defrost Drain for Blockage and Leaks
Level Cabinet
Inspect Electrical System

Based on observation, interview and document review, the facility failed to implement their policy and procedure (P&P) regarding temperature and humidity monitoring, by failing to ensure documentation of what action was taken when the humidity levels and temperature were out of range. As a result, there was no documentation of what action was taken to address high humidity levels, that can potentially lead to an increased risk of infections for patients undergoing surgery. In addition, the facility failed to implement their surgical scrub policy and procedure, by failing to ensure that there was a timing mechanism available in the scrub sink area.

Findings:

On 10/27/11 during a tour of the Operating Room (OR) at 9:00 A.M., a nonfunctioning clock was observed over the surgical scrub sinks. There was no other timing device observed in the scrub sink area.

A review of the facility's policy and procedure (P&P) titled "Surgical Scrub" was conducted on 10/27/11 at 9:00 A.M. The P&P specified that "the operating team will scrub for 5 minutes with appropriate antimicrobial soap preparation. Each scrub after that will be 3 minutes in length."

On 10/27/11 at 09:30 A.M., the OR temperature report and humidity logs were reviewed. At the bottom of the form the acceptable range for humidity specified 30-60%, and temperature specified 68 to 72 degrees F. The logs indicated that on 10/23/11, the humidity in OR 1 was 66%, temperature (Degrees F) in OR 1 was 64.1, OR 2 was 64.3 and OR 3 was 65. On 10/24/11, Humidity in OR 1 was 65% and OR 3 was 67%, Temperature in OR 1 was 65.9. On 10/25/11 humidity in OR 1 was 62% and in OR 3 was 64%. Temperature in OR 1 was 63 and in OR 3 was 63.9. On 10/26/11 temperature in OR 1 was 60.8, OR 2 was 65.9, OR 3 was 58.9 and OR 4 was 65.2. There was no documentation of what action was taken for the high humidity levels or low temperatures.

A review of the facility s P&P titled "relative humidity," was conducted on 10/27/11 at 10:00 A.M. The P&P specified that if the temperature or humidity was not conforming to the acceptable range that the director of plant operations will be contacted; or, to adjust the temperatures in the room before attempting to monitor humidity.

On 10/27/11 at 10:00 A.M., the Director of Quality Improvement was interviewed. She acknowledged that there was no timing mechanism near the scrub sinks to implement the facilities P&P on surgical scrub. She also acknowledged that the facility failed to ensure documentation of what action was taken for humidity and temperatures that were out of acceptable ranges.

Based on interview and chart review, the facility failed to ensure that one Anesthesiologist (MD2), implemented the hospital's Rules and Regulations requiring that a pre-anesthesia assessment was completed and documented, for 1 patient (1) who required resuscitation immediately after an outpatient procedure requiring general anesthesia, and subsequently expired. In addition, the facility failed to ensure that one Anesthesiologist (MD2), implemented the criteria for selecting patients for outpatient surgery, by allowing Patient 1 to undergo an outpatient procedure under anesthesia who did not meet the outpatient selection criteria.

Findings:


Patient 1 was admitted to the hospital on 10/19/11, with diagnoses that included chronic cough, trach (tracheotomy - a surgical procedure in which an opening is made in the windpipe for the passage of air) pain and difficult trach change according to the History and Physical. A review of Patient 1's medical record was conducted on 10/25/11 at 3:15 P.M. Patient 1 was morbidly obese (5 feet 3 inches tall and weighed approximately 300 pounds). She also had a history of respiratory failure which resulted in the insertion of a tracheotomy tube (a tube that goes through a surgical opening made in the front of the neck into the windpipe) for breathing. On 10/19/11, Patient 1 underwent an outpatient bronchoscopy (a procedure using a bronchoscope to see inside of the lungs) with bronchial lavage (fluid is squirted into the lung and then recollected for examination) and bronchial brushing (a small brush is used to remove cells from the lung for examination). A tracheotomy change and laryngoscopy (a procedure to view the voice box) were also performed. These procedures were performed under general anesthesia. Immediately following the procedure, Patient 1's heart rate began to drop to about 30 to 40 beats a minute. Cardio-pulmonary resuscitation (CPR) was initiated. Patient 1 was transferred to another local hospital because the intensive care unit of the treating hospital was full. Patient 1 expired on 10/20/11.

A form titled "Pre-Anesthesia Evaluation" was reviewed on 10/27/11 at 9 A.M. The form indicated that nothing was documented under the section titled "Anesthesiologist's Comments." There was no other documentation of a pre-anesthesia assessment for patient 1.

A review of the hospital's policy and procedure entitled "Criteria for Selecting Patients for Outpatient Surgery," was conducted on 10/25/11 at 3:35 P.M. This policy indicated that "the goal of patient selection for outpatient surgery is to select the patient who will benefit most from a minimal stay in the hospital. The entire peri-operative experience should be safe, efficient and minimally stressful to the patient...Factors to consider in the selection of outpatients should include, but not limited to: ...C. Not morbidly obese D. No history of airway obstruction or post-operative respiratory problem."

An interview was conducted with Patient 1's Anesthesiologist (MD 2) on 10/25/11 at 3:30 P.M. MD 2 stated that he would definitely classify Patient 1 as morbidly obese. He believed that Patient 1 actually weighed about 340 to 350 pounds.

MD 2 was interviewed again on 11/1/11 at 8:45 A.M. He stated that the patient was obese and had a history of Chronic Obstructive Pulmonary Disease with Tracheostomy. He acknowledged that Patient 1 did not meet the selection criteria for outpatient surgery based on her obesity and medical history. He stated that a pre-anesthesia assessment was not documented because Patient 1 was very "anxious" and he wanted to take her back to the O.R. where it was quiet and she could calm down.

A review of the hospital's Rules and Regulations regarding Anesthesia specified that, "the anesthesiologist shall maintain a complete anesthesia record, which includes evidence of preanesthetic evaluation."

An interview was conducted on 11/1/11 at 10:30 A.M., with the physician (MD 1) that performed the broncoscopic procedure on Patient 1 on 10/19/11. MD 1 reviewed the hospital's policy and procedure and then acknowledged that Patient 1 was morbidly obese, and also had a history of airway obstruction.

Based on interview, medical record and document review, the facility failed to ensure that the Anesthesiologist (MD 2), documented a complete recovery from general anesthesia evaluation note, for patients that had surgery with general anesthesia prior to discharge, for 32 of 32 medical records reviewed.

Findings:

On 10/27/11 at 11:00 A.M., 32 medical records of patients that underwent surgical procedures with general anesthesia were reviewed. A review of a document titled "Anesthesia Record," indicated at the bottom of this form under a section marked "condition at close," was documented "vitals stable." There was no documentation by MD 2 in the 32 post anesthesia notes of the patients' respiratory rate, airway patency, oxygen saturation, pulse and blood pressure, mental status, temperature, pain, or nausea and vomiting or post-operative hydration.

A review of the facility's Rules and Regulations regarding Anesthesiology was conducted on 10/27/11 at 3:00 P.M. The rules and regulations specify that "the anesthesiologist shall maintain a complete anesthesia record, which includes evidence of post-anesthetic follow up of the patient's condition."

MD 2 was interviewed on 11/1/11 at 8:45 A.M. He stated that he documented the patients' post anesthesia evaluation as "vitals stable" on the bottom of the anesthesia record. He acknowledged that he was not documenting in the post anesthesia note the patients' post general anesthesia evaluation data such as respiratory rate, airway patency, oxygen saturation, pulse and blood pressure, mental status, temperature, pain, or nausea and vomiting or post-operative hydration.

Based on interview and document review, the hospital failed to establish measurable and quantifiable quality indicators for an emergency response procedure and process. Quality indicators that were established for the Rapid Response Team process (RRT, a hospital team that provides early intervention and stabilization of a patient to prevent clinical deterioration) were not measurable; therefore, opportunities for improvement in that process could not be objectively and quantifiably determined. The hospital failed to establish benchmarks (a standard by which something can be measured or judged) for the purpose of analyzing and comparing it's performance during Code Blue and RRT responses.

Findings:

1. On 10/27/11 the hospital's "Organizationwide Performance Improvement Plan 2011" was reviewed. Per the plan, leadership determined those hospital processes to monitor, with specific focus on those that were "high-risk, high-volume, or problem prone." According to the plan, data must be measured. Those measures would have a "documented numerator and a denominator statement.... with defined data elements and allowable values."

On 10/27/11 at 10:30 A.M., an interview and review of the quality indicators selected by the hospital to measure its performance relative to the RRT process was conducted with the Chief Administrative Officer (CAO) and the Director of Quality Improvement (DQI).

Those quality indicators included:

1. Upon arrival, the primary nurse provided an informative patient report.
2. Equipment was readily available.
3. Equipment provided functioned appropriately.
4. Medications were accurately dispensed.
5. Medications were provided in a timely manner.
6. Communication to and from the primary nurse was effective in facilitating the delivery of care.
7. The persons/staff in the area where the event took place were courteous and helpful.
8. Patient outcome was improved because of RRT assistance.
9. The attending/primary physician worked collaboratively and responsively with the RRT on-site/on-call physician.
10. The RRT members felt they worked collaboratively when managing the crisis.
11. The RRT members felt comfortable and confident in managing the event.
12. The RRT nurse was knowledgeable and efficient in assessing and implementing care needs.
13. The RRT respiratory therapist was knowledgeable and efficient in assessing and implementing care needs.
14. Communication to and from the RRT nurse and/or respiratory care therapist was effective in facilitating the delivery of care.
15. The RRT was courteous and helpful.

None of the above indicators were quantifiably measurable. The indicators focused on subjective, rather than measurable objective determinants of process or patient outcome effectiveness.

On 10/27/11 at 11:00 A.M., the CAO and DQI acknowledged that the RRT quality indicators were not measurable with defined data elements and values. The indicators selected relied on subjective opinion rather than quantifiable measures for improvement.

2. On 10/27/11 the hospital's "Organizationwide Performance Improvement Plan 2011" was reviewed. Per the plan, "data are collected to monitor the stability of existing processes, identify opportunities for improvement, identify changes that will lead to improvement, and sustain improvement." Data measures were to allow for "comparison over time within the organization or between organizations and other entities. The performance measures are the benchmarks or statistical measures for comparison."

A review of the hospital's 2011 Performance Improvement Report Card Summary Data form was reviewed on 10/27/11 at 11:15 with the Director of Quality Improvement (DQI). Per the report, no benchmarks had been established as a point of reference in order to evaluate the functions and performance measures pertaining to the hospital's Code Blue and RRT response process.

An interview was conducted with the DQI on 10/27/11 at 11:30 A.M. Per the DQI, the hospital's corporate office had not established benchmarks for those processes for the past 2-3 years. The DQI acknowledged that the Code Blue and RRT performance measures should have established benchmarks in order to more effectively evaluate the hospital's performance.

Based on interview and document review, the hospital failed to implement its organizational 2011 Performance Improvement Plan. Relevant data pertaining to Code Blues (a hospital code used to indicate that a patient requires emergent resuscitation) was collected and reported inaccurately and inconsistently within the organization. In addition, the hospital's data reporting tool, which demonstrated whether or not the hospital had met its benchmark for successful Code Blue episodes, contained an inaccurate benchmark (a standard by which something can be measured or judged) which therefore would not render the data useful for the purpose of accurately analyzing and comparing it's performance.

Findings:

A review of the hospital's "2011 Organization Wide Performance Improvement Plan" was conducted on 10/27/11. Per the plan, "data are collected to monitor the stability of existing processes, identify opportunities for improvement, identify changes that will lead to improvement, and sustain improvement." According to the plan, data must be "reported in a way that is useful to the organization and other interested stakeholders."

On 10/27/11 at 8:50 A.M., the hospital's Patient Safety Performance Improvement Committee Meeting Minutes, dated 3/24/11, was reviewed with the Chief Administrative Officer (CAO) and the Director of Quality Improvement (DQI). The minutes indicated that in February of 2011 there were 5 reported Code Blue episodes and 100 % of the patients were stabilized. In the next sentence the minutes indicated that there were 7 Code Blue episodes in February of 2011 in which 4 of the patients expired and 3 survived. The CAO and the DQI were unable to verbalize the discrepancy in the reported data.

A review of the hospital's data reporting tool for January, February, and March 2011 documented that there were 7 reported Code Blues in February of which 3 were successful. Per the tool, the hospital had achieved a 42.86% success rate for Code Blue procedures in February. According to the tool, the hospital's benchmark pertaining to achieving successful Code Blue episodes was 20% (meaning the standard the hospital compared itself to was a 20% success rate for a Code Blue response, or 1 out of 5 patient survival rate). Per the tool, the hospital would have exceeded the standard it compared itself to. The DQI was unable to verbalize why the hospital had set such a low Code Blue survival rate as its standard or benchmark. The DQI stated that the hospital's corporate office determined the benchmarks.

On 10/27/11 at 11:30 A.M., the DQI stated that she contacted the hospital's corporate office regarding the Code Blue benchmark. Per the DQI the data reporting tool was not accurate and the 20% benchmark for Code Blue episodes was inaccurate. Per the DQI, the corporate office had not set any benchmark for Code Blue episodes, in order to analyze and compare it's performance.

On 11/1/11 at 2:45 P.M. a joint interview was conducted with members of the hospital's Governing Body which included the Chief of Medical Staff (CMS), the Chief of Surgery (CS), the Chief Executive Officer (CEO), the Director of Psychiatry (MD 4) and House Physician (MD 3). MD 3 stated that the hospital's Governing Body received routine updates and reported data concerning the hospital's Code Blue episodes. None of the members were aware of the discrepancy in Code Blue data. None of the members verbalized any response when informed of the inaccurate benchmarking standard that was set pertaining to the hospital's Code Blue episodes. The CEO acknowledged that the organization needed to make improvements in it's quality improvement process.

Based on interview and record review, the hospital failed to implement it's Sentinel Event policy and procedure when the hospital failed to perform a thorough and credible root cause analysis of a significant event that resulted in a patient's (1) death.

Findings:

Patient 1 was admitted to the hospital on 10/19/11, with diagnoses that included chronic cough, trach (tracheotomy - a surgical procedure in which a surgical opening is made in the windpipe for the passage of air), pain and difficult trach change, according to the History and Physical. A review of Patient 1's medical record was conducted on 10/25/11 at 3:15 P.M. Patient 1 was morbidly obese (5 feet 3 inches tall and weighed approximately 300 pounds). She also had a history of respiratory failure which resulted in the insertion of a tracheotomy tube (a tube that goes thorough a surgical opening made in the front of the neck into the windpipe) for breathing. On 10/19/11, Patient 1 underwent an outpatient bronchoscopy (a procedure using a bronchoscope to see inside of the lungs), with bronchial lavage (fluid is squirted into the lung and then recollected for examination), and bronchial brushing (a small brush is used to remove cells from the lung for examination). A tracheotomy change and laryngoscopy (a procedure to view the voice box), were also performed. These procedures were performed under general anesthesia. Immediately following the procedure, Patient 1's heart rate began to drop to about 30 to 40 beats a minute. Cardio-pulmonary resuscitation (CPR) was initiated. Patient 1 was transferred to another local hospital because the intensive care unit of the treating hospital was full. Patient 1 expired on 10/20/11.

An interview was conducted with the Director of Quality Improvement (DQI) on 10/26/11 at 2:20 P.M. The DQI stated that, according to the hospital's Quality Improvement process, Patient 1's death was classified as a "death occurring within 48 hours of surgery." A root cause analysis (RCA - a technique used to identify the conditions that initiate an occurrence of an undesired activity or state) was conducted. The first RCA session was held on 10/19/11, and a second session was held on 10/25/11. An issue was identified by the RCA team because a hospital wide code blue was not activated when Patient 1's heart rate dropped dangerously low and CPR was initiated in the Operating Room. However, the DQI acknowledged that the RCA team did not identify, and was not aware, that according to the hospital's Criteria for Selecting Patients for Outpatient Surgery policy and procedure, Patient 1 was not a candidate for outpatient surgery. Also, the American Society of Anesthesiology (ASA - a system for assessing the fitness of patients before surgery) classification of Patient 1 was not reviewed as part of the hospital's investigation. At the time of survey (seven days after the incident occurred) there had been no peer review of the two physicians who rendered care to Patient 1. And, the RCA team did not investigate the lack of documentation of a pre-anesthesia physician evaluation or the adequacy of the pre-operative medical screening.

The hospital's policy and procedure entitled "Sentinel Event (an unexpected occurrence involving death or serious physical or psychological injury) Response - Root Cause Analysis" was reviewed. The policy and procedure indicated that "The (root cause) analysis identifies changes, which would be made in systems and processes - either through the redesign or development of new systems and processes - that would reduce the risk of such events occurring in the future. The (root cause) analysis is thorough and credible. To be thorough the root cause analysis must include...A determination of human and other factors most directly associated with the sentinel event and the process(es) and systems related to the occurrence."

The hospital failed to conduct a thorough and credible root cause analysis.

Based on interview and document review, the facility failed to analyze significant variations in it's Code Blue (a hospital code used to indicate that a patient requires emergent resuscitation) and Rapid Response Team (RRT, a hospital team that provides early intervention and stabilization of a patient to prevent clinical deterioration) processes, in an effort to identify opportunities for improvement and implement preventive actions and learning. A delayed intubation procedure (placement of a breathing tube via the mouth into a patient's windpipe) during a Code Blue, the late delivery of a crash cart, and the malfunction of an oxygen level measuring device during two separate Rapid Response Team responses, were not analyzed to determine the causes for the variation in processes that occurred, for the benefit of performance improvement and patient safety.

Findings:

1. On 10/27/11 at 10:00 A.M., an interview and document review was conducted with the Chief Administrative Officer (CAO) and the Director of Education (DE). The CAO also performed risk management duties at the facility and reviewed evaluation forms pertaining to Code Blue and Rapid Response Team events.

A Risk Management Code Blue data collection form (which tracked whether or not certain quality indicators pertaining to the Code Blue process were met or not met), was reviewed on 10/27/11 at 10:15 A.M., with the CAO. Per the form, a Code Blue was called for Patient 2 on 1/27/11 at 8:43 A.M. One of the quality indicators on the form was whether the patient was intubated within 3 minutes of the code call. According to the form, Patient 2 was not intubated within 3 minutes. Per the form, the patient was intubated at 8:53 A.M., 10 minutes after the code was called. The CAO was unaware of why there was a delay in the intubation procedure. The CAO was unable to produce any analysis or further evaluation of that event in an effort to identify any opportunities for performance improvement.

A RRT Evaluation Form dated 5/27/11, indicated that on that same date, the RRT was called for Patient 3. Per the form, "the oxygen saturation probe is unreliable, it worked <50% of the rapid response." The CAO and DE were unable to verbalize any follow up or analysis that was done as a result of the malfunctioning probes.

Another RRT Evaluation Form dated 8/9/11, indicated that on that same date, the RRT was called for Patient 4. Per the Evaluation Form, emergency equipment was not readily available because there was a delay in the delivery of a crash cart. In addition, an oxygen saturation device (measures a patient's oxygen level) malfunctioned. The CAO was unable to produce any analysis of that process variation. Initially the DE stated he didn't know about the event. However, later during the interview, the DE stated that the Code Blue was called in the Behavioral Health Unit (BHU), and staff ran to the Medical-Surgical unit to obtain a crash cart, rather than retrieve the BHU's own crash cart. At the bottom of the Evaluation Form was a section entitled "Process Improvement," "briefly describe a change that would improve the RRT response." That section of the form was left blank. Another section was entitled "Education," " briefly describe what the team learned during this event." That section was left blank. There was no documented evidence to demonstrate that the facility analyzed the event to determine why staff brought the wrong crash cart or why the oxygen saturation monitor malfunctioned.

A review of all Patient Safety/Performance Improvement, Medical Executive, and Governing Body Meeting Minutes for 2011 to date, was conducted on 10/27/11 at 10:45 A.M. There was no documentation in the Minutes of those meetings pertaining to the above events and process variations in the facility's emergency response procedures.

A review of the facility's "Organizationwide Performance Improvement Plan 2011" was conducted on 10/27/11 at 11:00 A.M. The Plan documented that "intensive assessment is initiated when: an important single event, level of performance, and patterns or trends vary significantly and undesirably from those expected." " Information from data analysis is used to make changes that improve performance and patient safety and reduce the risk of sentinel events."

A review of the Code Blue Event/Cardiopulmonary Arrest policy and procedure dated 5/4/11 was reviewed on 10/27/11. Per the policy, the Chief Nursing Officer (CNO) "logs the code data, aggregates and analyzes the data, and reports trends to appropriate committees i.e. Quality Council, Medical Staff. etc...for the identification of opportunities for improvement."

On 10/27/11 at 11:30 A.M. an interview was conducted with the DAO, DE, and the Director of Quality Improvement (DQI). All acknowledged that the facility had not implemented its 2011 Performance Improvement Plan and Code Blue policies concerning the analysis of process variations that occurred during those emergency response procedures in an effort to identify opportunities for improvement and enhancement of patient safety.

Based on interview and document review, the facility failed to establish measurable quality indicators in an effort to assess and determine the effectiveness of Outpatient Services and identify opportunities for performance improvement.

Findings:

A review of the facility's "Organizationwide Performance Improvement Plan 2011" was conducted on 10/27/11 at 11:00 A.M. The Plan documented that hospital "leaders must decide which processes to monitor..Leaders determine the importance of the organization's processes in relation to its mission, available resources and functions, as well as concerns of the individuals served..." Specifically, those processes selected should include those that are high-risk, high-volume or problem prone.

On 11/1/11 at 12:30 P.M., a joint interview was conducted with the Chief Operating Officer (COO), the Director of Nursing (DON), the Director of Quality Improvement (DQI), the Chief of Surgery (COS), and the Chief Administrative Officer (CAO). A review of the hospital's data relative to Outpatient Services was requested and reviewed. According to the COO, the hospital had not established specific criteria or quality indicators by which to measure or determine the effectiveness of outpatient services. Per the COO, the hospital combined outpatient and inpatients services together. The COO stated that the amount of outpatient services provided was small in proportion to inpatient services.

However, according to a document entitled "Case Volume 2011," the hospital performed 1,070 procedures (surgical, endoscopic, and electroconvulsive therapy) on outpatients versus 557 procedures performed on inpatients.

On 11/1/11 at 2:45 P.M., an interview was conducted with members of the hospital's Governing Body which included the Chief of Medical Staff (CMS). The CMS acknowledged that the hospital should have established separate quality indicators to determine the effectiveness of its Outpatient Services given the volume of outpatient procedures performed.