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Based on staff interview, clinical record and administrative document review, the governing body failed to have an organizational structure which took full legal responsibility for determining, implementing and monitoring policies to ensure the provision of health care in a safe environment when:

1) The governing body failed to ensure the medical staff was accountable for the quality of care provided to all patients when Medical Doctor 1 (MD 1) failed to comply with the facility time-out policy while treating Patient 1 resulting in Patient 1 having a nerve block placed on the wrong ankle. (see A-49)

2) The governing body failed to provide adequate oversight to implement and maintain a quality assessment performance improvement (QAPI) program which satisfactorily reduced medical errors. The QAPI program failed to provide an adequate mechanism for sufficient oversight of the medical staff when MD 1 failed to comply with the facility time-out policy while treating Patient 1 resulting in Patient 1 having a nerve block placed on the wrong ankle. (see A-309)

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

Based on staff interview, clinical record and administrative document review, the governing body failed to ensure the medical staff was accountable for the quality of care provided to all patients when MD 1 failed to comply with the facility (time-out) policy while treating Patient 1 resulting in Patient 1 having a nerve block placed for the wrong ankle. (Block was placed on opposite side instead of the side being operated on.)

Findings:

A review of Patient 1 and 2's clinical records and administrative documents (Root Cause Analysis) indicated Medical Doctor 2 (MD 2) performed a wrong-site surgery on Patient 2 on May 20, 2015. During this event the time out process did not take place prior to the surgical procedure according to policy (Universal protocol for preventing wrong site, wrong procedure, wrong person surgery- TX 04.011). Following this incident changes were made in practice and policy (including changes to TX 04.011) in the facility as a means of preventing an incident of this sort from recurring and to hold the medical staff accountable for the quality of care rendered to patients. The medical staff leadership and the governing body failed to ensure the medical staff complied with policies and procedures implemented to prevent and reduce medical errors and a second incident occurred December 16, 2015 when Medical Doctor 1 (MD 1) performed a wrong-site block on Patient 1. During this event the time out was not performed prior to the block according to the amended Universal protocol for preventing wrong site, wrong procedure, wrong person surgery (TX 04.011).

On 1/25/16 at 10:30 a.m., during an interview, the Chief Executive Officer (CEO) stated she was the CEO of the facility and she represented the governing body. The CEO stated MD 2 had performed a wrong-site surgery on Patient 2 on May 20, 2015. The CEO stated during this event the time out was not performed according to policy. The CEO stated following this incident several changes were made in practice in the facility, however, the medical staff leadership and the governing body failed to do enough to prevent an incident of this sort from recurring. The CEO stated there was a second incident that occurred December 16, 2015 when MD 1 performed a wrong-site block on Patient 1. The CEO stated during this event the time out was not performed according to policy. The CEO stated the medical staff leadership and the governing body realized they had to failed to hold the medical staff accountable for the quality of care in the facility. The CEO stated there were changes implemented following the second incident which should have been implemented after the first incident. The CEO stated, she knew she had the responsibility for ensuring that medical staff leadership and the governing body held the medical staff accountable for the quality of care provided to all patients.

On 1/25/16 at 2 p.m., during an interview, the Chief Quality Officer (CQO) stated MD 2 had performed a wrong-site surgery on Patient 2 on May 20, 2015. The CQO stated during this event the time out was not performed according to policy. The CQO stated following this incident several changes were made in practice in the facility, however, the medical staff leadership and the governing body failed to do enough to prevent an incident of this sort from recurring. The CQO stated there was a second incident on December 16, 2015 when MD 1 performed a wrong-site block on Patient 1. She stated during this event the time out was not performed according to policy. She stated the medical staff leadership and the governing body realized they had failed to hold the medical staff accountable for the quality of care in the facility. The CQO stated there were changes implemented following the second incident which should have been implemented after the first incident. The CQO stated, she shared the responsibility for ensuring that medical staff leadership and the governing body held the medical staff accountable for the quality of care provided to all patients.

On 1/25/16 at 3:10 p.m., during an interview, MD 2 stated he performed a wrong-site surgery on Patient 2 on May 20, 2015. He stated during this event the time out was not performed prior to beginning surgery according to policy. MD 2 stated he never looked to identify his own marking of the correct site prior to starting surgery on the incorrect site because he failed to perform the time-out as he was obliged to do.

On 1/26/16 at 9:10 a.m., during an interview, MD 1 stated he performed a wrong-site nerve block on Patient 2 on December 16, 2015. MD 1 stated during this event the time out was not performed prior to beginning the procedure according to policy. MD 1 stated he never looked to identify the surgeon's marking of the correct site prior to starting the nerve block on the incorrect site because he failed to perform the time-out as he was obliged to do.

Page 4 of the facility's policy and procedure entitled, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery" (TX04.011) dated 9/25/13 indicated, "Time-Out The purpose of the time-out is to conduct a standardized final assessment that the correct patient, site, and procedure are identified. During the time-out, all activities are suspended to the extent possible so that the team members can focus on active confirmation of the patient, site, and procedure. Upon arrival to the location that the procedure will be performed and prior to prepping and draping of the patient, the circulating nurse, operating room technician, and anesthesiologist, if present, will identify the patient, the planned procedure, and procedural site, if applicable. The time-out is conducted after the patient is prepped and draped, but prior to the first instrument being passed, and includes the following characteristics. UP.01.03.01 EP 1, EP 2 If not the surgeon, the circulating nurse will initiate the time-out. During the time-out, all activities are suspended to the extent safely possible. The time-out is an active verbal confirmation of the correct patient, correct site, and correct procedure for the correct patient. Verbal confirmation requires the present individuals to verbally express: Correct patient Correct site Correct procedure for the correct patient UP.01.03.01 EP 4 In the operating room, the entire surgical team will participate in the time-out, but at a minimum must have the anesthesiologist, circulating nurse, operating room technician, and physician present. Outside of the operating room, the time-out is performed by the physician and registered nurse who will be present for the procedure. The time-out is documented in the medical record. UP.01.03.01 EP 5"

The facility's governing body bylaws, Medical Staff bylaws, rules and regulations, and the Performance Improvement Plan were among the documents requested on 1/25/16 at 10 a.m. as a part of the usual survey process.
A signed, undated copy of the Amended and Restated Bylaws of the Board of Managers indicated in Article II, Section 4 "The Board shall have overall governance, administrative and professional responsibility for the Hospital... QUALITY PERFORMANCE RESPONSIBILITIES - The Board has the final moral, legal, and regulatory responsibility for the safety and quality of care, treatment and services in the Hospital's facilities. To exercise this quality oversight responsibility, the Board shall: ... Adopt a Performance Improvement Plan and Risk Management Plan for the Hospital and provide for resources and support systems to ensure that the plans can be carried out... Ensure that management reviews and assesses the attitudes and opinions of those who work in the organization to identify strengths, weaknesses, and opportunities for improvement. Monitor programs and services to ensure that they comply with policies and standards relating to quality. Take corrective action when appropriate and necessary to improve quality performance. MANAGEMENT PERFORMANCE RESPONSIBILITIES - The Board is the final authority regarding oversight of management performance by the Hospital's Chief Executive Officer ("CEO") and support staff. To exercise this authority, the Board shall: Recruit, employ, and regularly evaluate the performance of the CEO. Evaluate the performance of the CEO annually. Communicate regularly with the CEO regarding goals, expectations, and concerns. Periodically review management succession plans to ensure leadership continuity. Establish specific performance policies which provide the CEO with a clear understanding of what the Board expects, and update these policies based on changing conditions. Medical Executive Committee... shall review and evaluate the qualifications, credentials, performance and professional competence, and character of applicants and staff members, and make recommendations to the Board of Managers regarding staff membership and renewals of membership, clinical privileges, and correction action; take reasonable steps to promote ethical conduct and competent clinical performance on the part of all members including the initiation of and participation in medical staff corrective or review measures when warranted... Medical Staff Quality Improvement Committee... This committee shall review and recommend for approval of the Medical Executive Committee plans for maintaining quality patient care within the hospital. The primary functions of the committee include surgical case review, death review, root cause analysis (RCA), sentinel events, CDPH [California Department of Public Health] notifications, patient transfers, medical peer review... continuous quality improvement, evaluation of patient care and organization functions,"

Based on staff interview, clinical record and administrative document review, the governing body failed to ensure the hospital ' s Quality Assurance and Performance Improvement (QAPI) program fully implemented and evaluated safety measures to prevent wrong site surgery.

This failure to ensure effective safety measures resulted in an avoidable hospitalization for Patient 1 after a wrong site procedure in December 2015 and prolonged surgery and recovery time for Patient 2 in May 2015. (see A-49 and A-309)

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

Based on staff interview, clinical record and administrative document review, the governing body failed to ensure the hospital ' s Quality Assurance and Performance Improvement (QAPI) program fully implemented and evaluated safety measures to prevent wrong site surgery.

This failure to ensure effective safety measures resulted in an avoidable hospitalization for Patient 1 after a wrong site procedure in December 2015 and prolonged surgery and recovery time for Patient 2 in May 2015.

Findings:

A review of Patient 1 and 2's clinical records and administrative documents (Root Cause Analysis) indicated Medical Doctor 2 (MD 2) had performed a wrong-site surgery on Patient 2 on May 20, 2015. During this event the time out process did not take place prior to the surgical procedure according to policy (Universal protocol for preventing wrong site, wrong procedure, wrong person surgery- TX 04.011). Following this incident changes were made in practice and policy (including changes to TX 04.011) in the facility as a means of preventing an incident of this sort from recurring and to hold the medical staff accountable for the quality of care rendered to patients. The medical staff leadership and the governing body failed to ensure the medical staff complied with policies and procedures implemented to prevent and reduce medical errors and there was a second incident on December 16, 2016 when Medical Doctor 1 (MD 1) performed a wrong-site block on Patient 1. During this event the time out was not performed prior to the block according to the amended Universal protocol for preventing wrong site, wrong procedure, wrong person surgery (TX 04.011).

A review of the facility's performance improvement projects through the QAPI program during 2015 indicated that no projects were initiated in regard to improving compliance with the "Time Out" policy by the medical or surgical staff.


On 1/25/16 at 10:30 a.m., during an interview, the Chief Executive Officer (CEO) stated she was the CEO of the facility and she represented the governing body. The CEO stated MD 2 had performed a wrong-site surgery on Patient 2 on May 20, 2015. The CEO stated during this event the time out was not performed according to policy. The CEO stated following this incident several changes were made in practice in the facility, however, the medical staff leadership and the governing body failed to do enough to prevent an incident of this sort from recurring. The CEO stated there was a second incident that occurred December 16, 2015 when MD 1 performed a wrong-site block on Patient 1. The CEO stated during this event the time out was not performed according to policy. The CEO stated the medical staff leadership and the governing body realized they had to failed to hold the medical staff accountable for the quality of care in the facility. The CEO stated the governing body failed to provide adequate oversight to implement and maintain a quality assessment performance improvement (QAPI) program which satisfactorily reduced medical errors. The QAPI program failed to provide an adequate mechanism for sufficient oversight of the medical staff when MD 1 failed to comply with the facility time-out policy while treating Patient 1 resulting in Patient 1 having a nerve block placed on the wrong ankle. When asked why a performance improvement project related to "Time Outs" had not been initiated in QAPI, The CEO stated, "We were stretched too thin during that time and we didn't get to it." The CEO stated, she knew she had the responsibility for ensuring that medical staff leadership and the governing body held the medical staff accountable for the quality of care provided to all patients.

On 1/25/16 at 2 p.m., during an interview, the Chief Quality Officer (CQO) stated MD 2 had performed a wrong-site surgery on Patient 2 on May 20, 2015. The CQO stated during this event the time out was not performed according to policy. The CQO stated following this incident several changes were made in practice in the facility, however, the medical staff leadership and the governing body failed to do enough to prevent an incident of this sort from recurring. The CQO stated there was a second incident on December 16, 2015 when MD 1 performed a wrong-site block on Patient 1. She stated during this event the time out was not performed according to policy. She stated the medical staff leadership and the governing body realized they had failed to hold the medical staff accountable for the quality of care in the facility. The CQO stated there were changes implemented following the second incident which should have been implemented after the first incident. The CQO stated, she shared the responsibility for ensuring that medical staff leadership and the governing body held the medical staff accountable for the quality of care provided to all patients. The governing body failed to provide adequate oversight to implement and maintain a QAPI which satisfactorily reduced medical errors. The QAPI program failed to provide an adequate mechanism for sufficient oversight of the medical staff when MD 1 failed to comply with the facility time-out policy while treating Patient 1 resulting in Patient 1 having a nerve block placed on the wrong ankle. The CQO stated she knew she had the responsibility for ensuring that medical staff leadership and the governing body held the medical staff accountable for the quality of care provided to all patients.

On 1/25/16 at 3:10 p.m., during an interview, MD 2 stated he performed a wrong-site surgery on Patient 2 on May 20, 2015. He stated during this event the time out was not performed prior to beginning surgery according to policy. MD 2 stated he never looked to identify his own marking of the correct site prior to starting surgery on the incorrect site because he failed to perform the time-out as he was obliged to do.

On 1/26/16 at 9:10 a.m., during an interview, MD 1 stated he performed a wrong-site nerve block on Patient 2 on December 16, 2015. MD 1 stated during this event the time out was not performed prior to beginning the procedure according to policy. MD 1 stated he never looked to identify the surgeon's marking of the correct site prior to starting the nerve block on the incorrect site because he failed to perform the time-out as he was obliged to do.

The facility's Organizational Performance Improvement Plan dated 12/16/2014, indicated on page 2 "INTRODUCTION At [the Hospital], Quality is defined as delivering excellence in care, service and performance. Quality is achieved by maintaining an excellence focus and continuously improving services. [The hospital] has adopted a Performance Improvement Plan to guide the organization in its continuous pursuit of excellence. The goal of the plan is to build successful performance improvement systems that imbed quality into the organization's structure, processes and culture, and demonstrate that [the hospital] is the preferred provider and choice for surgery PURPOSE To consistently achieve this goal, the Organizational Performance Improvement Plan shall be a coordinated, comprehensive and continuous effort to measure, assess and improve the performance of all care and services provided. Its purpose shall be to provide, within available resources, for optimal outcomes that consistently exceed a high standard of practice in the industry, minimize the risks, and are cost-effective. This document provides a clear understanding of the needs and issues at hand by creating a concrete plan of action. SCOPE The intent of the organization-wide Performance Improvement Plan is to guide all components of the organization toward obtaining high quality patient outcomes and providing services that meet or exceed the expectations of our customers. GOALS AND OBJECTIVES 1. To utilize an organization-wide approach to improve functions carried out by [the hospital], using team efforts whenever possible to increase the probability of desired outcomes, including patient, family, physician and staff satisfaction, by assessing and improving the processes that most affect those outcomes. To provide a mechanism for establishing and resetting organization-wide performance improvement goals."

The Hospital's governing body bylaws, Medical Staff bylaws, rules and regulations, and the Performance Improvement Plan were among the documents requested on 1/25/16 at 10 a.m. as a part of the usual survey process.
A signed, undated copy of the Amended and Restated Bylaws of the Board of Managers indicated in Article II, Section 4 "The Board shall have overall governance, administrative and professional responsibility for the Hospital... QUALITY PERFORMANCE RESPONSIBILITIES - The Board has the final moral, legal, and regulatory responsibility for the safety and quality of care, treatment and services in the Hospital's facilities. To exercise this quality oversight responsibility, the Board shall: ... Adopt a Performance Improvement Plan and Risk Management Plan for the Hospital and provide for resources and support systems to ensure that the plans can be carried out... Ensure that management reviews and assesses the attitudes and opinions of those who work in the organization to identify strengths, weaknesses, and opportunities for improvement. Monitor programs and services to ensure that they comply with policies and standards relating to quality. Take corrective action when appropriate and necessary to improve quality performance. MANAGEMENT PERFORMANCE RESPONSIBILITIES - The Board is the final authority regarding oversight of management performance by the Hospital's Chief Executive Officer ("CEO") and support staff. To exercise this authority, the Board shall: Recruit, employ, and regularly evaluate the performance of the CEO. Evaluate the performance of the CEO annually. Communicate regularly with the CEO regarding goals, expectations, and concerns. Periodically review management succession plans to ensure leadership continuity. Establish specific performance policies which provide the CEO with a clear understanding of what the Board expects, and update these policies based on changing conditions. Medical Executive Committee... shall review and evaluate the qualifications, credentials, performance and professional competence, and character of applicants and staff members, and make recommendations to the Board of Managers regarding staff membership and renewals of membership, clinical privileges, and correction action; take reasonable steps to promote ethical conduct and competent clinical performance on the part of all members including the initiation of and participation in medical staff corrective or review measures when warranted... Medical Staff Quality Improvement Committee... This committee shall review and recommend for approval of the Medical Executive Committee plans for maintaining quality patient care within the hospital. The primary functions of the committee include surgical case review, death review, root cause analysis (RCA), sentinel events, CDPH [California Department of Public Health] notifications, patient transfers, medical peer review... continuous quality improvement, evaluation of patient care and organization functions,"

Page 4 of the facility's policy and procedure entitled, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery (TX 04.011) dated 9/25/13, indicated on page 4 "Time-Out The purpose of the time-out is to conduct a standardized final assessment that the correct patient, site, and procedure are identified. During the time-out, all activities are suspended to the extent possible so that the team members can focus on active confirmation of the patient, site, and procedure. Upon arrival to the location that the procedure will be performed and prior to prepping and draping of the patient, the circulating nurse, operating room technician, and anesthesiologist, if present, will identify the patient, the planned procedure, and procedural site, if applicable. The time-out is conducted after the patient is prepped and draped, but prior to the first instrument being passed, and includes the following characteristics. UP.01.03.01 EP 1, EP 2 If not the surgeon, the circulating nurse will initiate the time-out. During the time-out, all activities are suspended to the extent safely possible. The time-out is an active verbal confirmation of the correct patient, correct site, and correct procedure for the correct patient. Verbal confirmation requires the present individuals to verbally express: Correct patient Correct site Correct procedure for the correct patient UP.01.03.01 EP 4 In the operating room, the entire surgical team will participate in the time-out, but at a minimum must have the anesthesiologist, circulating nurse, operating room technician, and physician present. Outside of the operating room, the time-out is performed by the physician and registered nurse who will be present for the procedure. The time-out is documented in the medical record. UP.01.03.01 EP 5"

Based on observation, staff interview, clinical and administrative document review, the hospital failed to provide surgical services in accordance with nationally recognized standards when:

1. The hospital failed to implement effective policies and procedures to prevent wrong site surgeries for 2 of 29 sampled patients. (See A 951)

2. An anesthesiologist - medical doctor that puts patients to sleep during surgery, (MD 5) and a circulating Licensed Nurse (LN) 1 were observed with their hair exposed during a surgical procedure for 1 of 7 tracer patients (Patient 7) in the Operating Room (OR). (See A 951)

3. LN 1 was observed wearing an exposed necklace with a dangling pendant during a surgical procedure for 1 of 7 tracer patients (Patient 7) in the OR. (See A 951)

4. A pre-operative (pre-op) Licensed Nurse, LN 2, did not perform hand hygiene (wash hands or use an alcohol-based hand rub) prior to putting on gloves to start an intravenous (IV) infusion (catheter inserted into a vein to administer fluids and medications) for 1 of 7 tracer patients (Patient 7). (See A 951)


The cumulative effects of these systemic problems resulted in the hospital's inability to provide patient care in a safe manner.

Based on observation, staff interview, clinical record and administrative document review, the hospital failed to ensure surgical services were performed in accordance with acceptable standards of care and practice when:

1. The hospital failed to ensure policies and procedures were followed and a high standard of patient care maintained resulting in Patients 1 and 2 having surgical procedures done on the incorrect side. ( Left instead of right and right instead of left.)

2. An anesthesiologist - medical doctor that puts patients to sleep during surgery, (MD 5) and a circulating Licensed Nurse (LN) 1 were observed with their hair exposed during a surgical procedure for 1 of 7 tracer patients (Patient 7) in the Operating Room (OR).

3. LN 1 was observed wearing an exposed necklace with a dangling pendant during a surgical procedure for 1 of 7 tracer patients (Patient 7) in the OR.

4. A pre-operative (pre-op) Licensed Nurse, LN 2, did not perform hand hygiene (wash hands or use an alcohol-based hand rub) prior to putting on gloves to start an intravenous (IV) infusion (catheter inserted into a vein to administer fluids and medications) for 1 of 7 tracer patients (Patient 7).

These failures resulted in the hospital's inability to provide patient care in a safe manner.


FINDINGS:

1. An examination of Patient 2's clinical record indicated Patient 2 came into the hospital on 5/20/15 for a left knee arthroscopy due to chronic pain. In the OR, Medical Doctor (MD) 2 operated on the patient's right knee due to the lack of a Time-out (a check with each member of the surgical team to make sure the correct patient is about to undergo the correct procedure, on the correct site, TO) being performed.

On 1/25/16 at 3:10 p.m., during an interview, MD 2 stated he performed a wrong-site surgery on Patient 2 on 5/20/15. He stated a TO was not performed according to hospital policy prior to beginning surgery.

An examination of Patient 1's clinical record indicated Patient 1 came in to the hospital on 12/16/15 for surgery on her right ankle because of instability. In the OR, MD 1 performed a nerve block (process of injecting an anesthetic drug next to a nerve in order to block pain) for the left ankle due to the lack of a TO being performed. This resulted in Patient 1's admission to the hospital while the wrong side block wore off and for pain control.

On 1/26/16 at 9:10 a.m., during an interview, MD 1 stated he performed a wrong-site regional block on Patient 2 on 12/16/15. He stated a TO was not performed according to hospital policy prior to beginning the procedure.

On 1/25/16, during an interview at 9:35 a.m., the Chief Executive Officer (CEO) stated the primary reason for the a wrong-site surgery on 5/20/15 [Patient 2] and wrong site regional block [Patient 1] on 12/16/15 was failure to follow the facility's policy and procedure related to TOs.

On 1/25/16 at 1:21 p.m., during an interview, the Chief Nursing Officer (CNO) stated there were numerous areas of the facility's TO policy and procedure that were not being followed that led to a wrong-site surgery on 5/20/15 and a wrong site regional block on 12/16/15. The CNO stated the facility did not take the first wrong-site surgery seriously and that led to the second wrong-site regional block on 12/16/15.

During a concurrent interview on 1/25/16 at 1:59 p.m., the Chief Executive Officer (CEO) stated, and the CNO confirmed, following the 5/20/15 wrong-site surgery, a total of 30 monthly TO audits were to begin in June 2015 and that did not happen.

On 1/28/16 at 7:50 a.m., during an interview, the CEO stated they can not determine yet if the revised TO policy and procedure, dated 1/25/15, will be effective in correcting wrong-site surgeries.

On 1/28/16 at 10:45 a.m., during a concurrent interview, MD 3 (Chief of Staff) and MD 4 (Chairman of Board of Managers) stated they cannot determine yet if the revised TO policy and procedure, dated 1/25/16, will be effective in correcting wrong-site surgeries.

A review of TO audits, from November 2015 through January 2016, indicated TOs were non-compliant: five out of 10 times (50%) in November 2015; 18 out of 33 times (55%) in December 2015; and 18 out of 30 times (60%) in January 2016.

The hospital policy and procedure titled, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery," dated 9/25/13, indicated, "PROCEDURE... Time-Out: 1. Upon arrival to the location that the procedure will be performed and prior to prepping and draping of the patient, the circulating nurse, operating room technician, and anesthesiologist, if present, will identify the patient, the planned procedure, and procedural site, if applicable. 2. The time-out is conducted after the patient is prepped and draped, but prior to the first instrument being passed, and includes the following characteristics. a. If not the surgeon, the circulating nurse will initiate the time-out. b. During the time-out, all activities are suspended to the extent safely possible. c. The time-out is an active verbal confirmation of the correct patient, correct site, and correct procedure for the correct patient. Verbal confirmation requires the present individuals to verbally express: correct patient, correct site, correct procedure for correct patient. d. In the operating room, the entire surgical team will participate in the time-out, but at a minimum must have the anesthesiologist, circulating nurse, operating room technician, and physician present..."

2. On 1/26/16 at 10:57 a.m., during an observation of a surgical procedure on Patient 7 in the OR , LN 1 was observed with hair hanging out of the head cover by approximately one to two inches. The anesthesiologist (MD 5) was observed with her side burns and hair exposed below the head cover by approximately two to three inches.

On 1/26/16 at 11:17 a.m. during an interview, the CNO stated all hair is to be covered during surgical procedures in the OR.

On 1/27/16 at 1:23 p.m., during an interview, LN 1 stated, "Hair is supposed to be completely covered; my hair has always been out a little bit and it was accepted."

On 1/28/16 at 2:10 p.m. during an interview, the Chief of Staff (MD 3) stated it is an expectation for all physicians to follow the facility policy regarding completely covering their hair.

The hospital policy and procedure titled, "Operating Room Attire" dated 1/15/13, indicated "POLICY... 4. All head and facial hair is to be covered with disposable surgical cap or hood while in the restricted areas of the
surgical suite."

The Association of periOperative Registered Nurses (AORN) publication, "Guidelines for Perioperative Practice," dated 3/9/12, indicated, "Guideline for Surgical Attire, Recommendation III - Personnel entering the semi-restricted or restricted areas should cover the head, ears, and facial hair. Hair and skin can harbor bacteria that can be dispersed into the environment... The benefit of covering the head, ears, and hair is the reduction of the patient's exposure to potentially pathogenic microorganisms from the perioperative team member's head, hair, ears, and facial hair..."

3. On 1/26/16 at 10:57 a.m., during an observation of a surgical procedure on Patient 7 in the OR, LN 1 was observed wearing an exposed necklace with a dangling pendant, 3/4 inch by 3/4 inch, during a surgical procedure.

On 1/26/16 at 11:17 a.m., during an interview, the CNO stated it is hospital policy for all jewelry to be covered and not visible in the OR. She further stated, "This is Infection Control 101."

On 1/27/16 at 1:23 p.m., during an interview, LN 1 confirmed that her necklace should have been under her scrubs."

The "Association of periOperative Registered Nurses (AORN)" publication, "Guidelines for Perioperative Practice," dated 3/9/12, indicated, "Guideline for Surgical Attire, Recommendation I... 1. j. Jewelry (e.g., earrings, necklaces, bracelets, rings) that cannot be contained or confined within the scrub attire should not be worn in the semi-restricted or restricted areas."

4. On 1/26/16 at 9:50 a.m., during an observation in the pre-op area, LN 2 was observed putting on gloves to start an IV on Patient 7 without performing hand hygiene.

On 1/26/16 at 10:15 a.m., during an interview, the CNO stated hospital policy is "to wash hands before and after patient contact and after gloving or if your hands are soiled or you break technique..."

On 1/26/16 at 10:18 a.m., during an interview, LN 2 stated it is hospital policy to perform hand hygiene before and after putting on gloves.

The hospital policy and procedure titled, "Peripheral IV Placement, Maintenance, Discontinuation, and Infiltration Management" dated 10/21/13, indicated "PROCEDURE: INITIATING IV ACCESS - 4. Procedure for IV placement: a. Perform hand hygiene... h. Prepping the site: i. perform hand hygiene ii. Use Universal Precautions..."

The Center for Disease Control (CDC) publication titled, "Hand Hygiene is the #1 Way to Prevent the Spread of Infections: A Patient's Guide" undated, indicated, "... Healthcare providers should practice hand hygiene: ... before putting on gloves. Wearing gloves alone is not enough to prevent the spread of infection..."