The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MERCY MEDICAL CENTER 333 MERCY AVENUE MERCED, CA 95340 Feb. 25, 2016
VIOLATION: GOVERNING BODY Tag No: A0043
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 2 (MD 2) failed to comply with the facility's Universal Protocol (time out - a suspension of all activity in the Operating Room to verify patient name, surgeon name, procedure being done, and site of the procedure) policy while treating Patient 1 resulting in Patient 1 having a surgery on the wrong knee. (see A-49)

2.) 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 and failed to provide an adequate mechanism for sufficient oversight of the medical staff when the Medical Staff was not notified and educated regarding policy changes which were put in place after MD 2 had performed a wrong site surgery on Patient 1. (see A-309)

3.) The governing body failed to enforce the Medical Staff bylaws, rules and regulations and ensure the medical staff was accountable to the governing body for the quality of care provided to all patients when MD 2 failed to comply with the facility (time-out) policy while treating Patient 1 resulting in Patient 1 having surgery performed on the wrong knee. (see A-353)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
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 2 failed to comply with the facility Universal Protocol (time-out - a suspension of all activity in the Operating Room to verify patient name, surgeon name, procedure being done, and site of the procedure) policy while treating Patient 1 resulting in Patient 1 having surgery performed on the wrong knee.

This failure resulted in Patient 1 undergoing a wrong site surgery and the prolonged risk associated with surgery and anesthesia.

Findings:

A review of Patient 1's operative report and administrative documents (Root Cause Analysis) indicated Medical Doctor 2 (MD 2) performed a wrong-site surgery on Patient 1 on January 13, 2016. Prior to this event the MD 2 failed to follow the Universal Protocol policy (PC 214) and did not visualize the mark he had previously made on the left knee during the time out process prior to the surgical procedure.

On 2/23/16 at 3:00 p.m., during an interview, MD 2 stated he performed a wrong-site surgery on Patient 1 on January 13, 2016. He stated the time out was not performed according to the Universal Protocol (PC 214) prior to beginning the procedure. MD 2 stated he never looked to identify his own marking of the correct site prior to starting the surgery on the incorrect site because he failed to perform the time-out correctly as he was obliged to do. He stated his violation of the Universal Protocol (PC 214) prior to beginning the procedure led directly to his performing surgery on the wrong knee. He stated he understood his failure to follow the Universal Protocol (PC 214) was a violation of the Medical Staff bylaws, rules and regulations. He stated as a member of the facility's Medical Staff he was obligated to comply with all of the facility's policies including the Universal Protocol (PC 214).

On 2/23/16 at 4:00 p.m., during an interview, MD 1 stated he was the Vice President of Medical Affairs and the Chief Medical Officer of the facility and he represented the governing body. MD 1 stated MD 2 had performed a wrong-site surgery on Patient 1 on January 13, 2016. MD 1 stated during this event the time out was not performed according to policy. MD 1 stated MD 2's violation of the Universal Policy (PC 214) was in turn a violation of the Medical Staff bylaws, rules and regulation which require members of the Medical Staff to obey all facility policies. MD 1 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. MD 1 stated, as the representative of the governing body, he knew the governing body 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 2/23/16 at 4:30 p.m., during an interview, the Surgical Services Director (RN 3) stated MD 2 had performed a wrong-site surgery on Patient 1 on January 13, 2016. RN 3 stated during this event the time out was not performed according to policy.

Page 4 of the facility's Medical Staff Rules and Regulations indicated "MEDICAL STAFF RULES & REGULATION S ARTICLE I GENERAL PROVISIONS Department Rules and Regulations Each Department of the Medical Staff shall enact rules and regulations to specifically govern those activities of medical practices for which they have been charged (collectively, "Departmental Rules and Regulations"). All such Departmental Rules and Regulations must be consistent with the Medical Staff Bylaws and these Rules and Regulations and be approved by the respective Department, the Executive Committee and the Governing Board. The Departmental Rules and Regulations of each Department shall be reviewed annually by the Department and the Executive Committee. Departmental Rules and Regulations shall be available in the Department of Medical Staff Services. Medical Staff Bylaws and Policies and Rules and Regulations In addition the Medical Staff Bylaws, there shall be policies, procedures and rules and regulations that shall be applicable to all members of the Medical Staff and other individuals who have been granted clinical privileges or a scope of practice. All Medical Staff policies, procedures and rules and regulations shall be considered an integral part of the Medical Staff Bylaws, subject to the amendment and adoption provisions contained in the Medical Staff Bylaws."

Page 10 of the facility's Hospital Community Board bylaws indicated "8.2 Quality Assessment, Performance Improvement. Patient Safety and Utilization Management. This Hospital Community Board is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital; (ii) assuring that quality and patient safety issues are addressed and resolved appropriately; (iii) assuring quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital are consistent with the standards, policies and procedures established by the [Corporate] Board and the [Corporate] Quality Committee; and (iv) communicating quality and patient safety issues of concern and potential performance improvement measures to the [Corporate] Quality Committee. The Hospital Community Board shall assure that the Medical Staff (a) participates in the measurement, assessment and improvement of clinical and non-clinical processes affecting patient care and (b) takes a leadership role where the clinical processes are the primary responsibility of physicians. The activities of the Local Hospital (including outcomes, recommendations and actions) undertaken pursuant to this Section 8.2 shall be reported to this Hospital Community Board, and also to the [Corporate] Quality Committee in accordance with policies and procedures adopted from time to time by the [Corporate] Quality Committee."
VIOLATION: QAPI Tag No: A0263
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 and failed to provide an adequate mechanism for sufficient oversight of the medical staff when the Medical Staff was not notified and educated regarding policy changes which were put in place after MD 2 had performed a wrong site surgery on Patient 1. (see A-309)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on staff interview and administrative document review, the facility failed to ensure clear expectations for safety were established when Physician (MD) 2 was not aware of policy and procedure changes made that impacted surgeons, staff members and patients in the operating room.

This failure had the potential to put patients in the operating room at risk of wrong site surgery.

Findings:

On 2/22/16 at 1:45 p.m., during a group interview, MD 2 stated on 1/13/16 he spoke to Patient 1 in the pre-op area (an area in the hospital where patients are prepared for surgery, consents are signed, and physicians and nurses discuss the planned procedure with the patient). MD 2 and Patient 1 both agreed the surgical site was Patient 1's left knee. MD 2 stated he wrote a big "YES" on Patient 1's left thigh above her knee with a surgical marking pen. He stated when in the operating room he did not visualize the mark he made prior to making the first incision on Patient 1's right knee. MD 2 stated the drape (a cloth used to cover non-sterile areas of the body near the surgical site) covered the mark he made. MD 2 stated as of the date of the interview, he was aware the policy regarding surgical site verification was being reviewed but was not aware the policy had been changed. MD 1 stated he had not reviewed the revised policy. He stated because the revised policy did not affect the surgeons they were not informed. MD 1 stated the surgeon is the leader in the operating room and needed to be aware of changes in policy related to the operating room. MD 1 stated, "We should have informed the physicians of the changes in that they are the leaders of the surgical team." Registered Nurse (RN) 3 stated all (non-physician) staff were made aware of the policy change. She stated after the policy change the surgeons were not challenged about their knowledge of the policy change prior to entering the operating room. RN 3 agreed with MD 1 that the surgeon was the leader in the operating room.

The facility policy and procedure titled, "Universal Protocol" [the time out policy, a suspension of all activity in the Operating Room to verify patient name, surgeon name, procedure being done, and site of the procedure] dated 10/14, indicated on pages 3 and 4 ".... The OR Circulator/Procedural (RN) [Registered Nurse; a member of the surgical team in the operating room but outside of the sterile field who is responsible for managing nursing care of the patient in the room]... Confirm that the LIP's [Licensed Independent Practioner, such as the surgeon] "YES" mark is on the correct side and site.... Surgical/Pre-Procedure "Time-Out"... The "Time-Out will be initiated by the circulating/procedural RN. It involves each member of the surgical team (includes the individual performing the procedure, the anesthesia provider, the circulating nurse, the operating room technician, and other active participants) ... During the "Time-Out", the team members agree on the following: ... The correct site .... This mark will be made with a surgical skin-marking pen on the correct side and the site adjacent or on the planned incision site. The mark should be sufficiently permanent to remain after the prep and visible after the patient is draped...."
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
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 wrong site surgery for Patient 1. After the wrong site surgery the medical staff leadership and the governing body failed to ensure the medical staff was informed of the changes in policy and procedure (Universal Protocol, PC 214) policies and procedures implemented to prevent and reduce a wrong site surgery.

Findings:

A review of Patient 1's clinical records and administrative documents (Root Cause Analysis) indicated Medical Doctor 2 (MD 2) performed a wrong-site surgery on Patient 1 on January 13, 2016. Prior to this event the MD 2 failed to follow the Universal Protocol policy (time out, a suspension of all activity in the Operating Room to verify patient name, surgeon name, procedure being done, and site of the procedure, PC 214) and did not visualize the mark he had previously made on the left knee during the time out process prior to the surgical procedure.

On 2/23/16 at 3:00 p.m., during an interview, MD 2 stated he performed a wrong-site surgery on Patient 1 on January 13, 2016. MD 2 stated during this event the time out was not performed according to the Universal Protocol (PC 214) prior to beginning the procedure. MD 2 stated he never looked to identify his own marking of the correct site prior to starting the surgery on the incorrect site because he failed to perform the time-out as he was obliged to do. He stated he was not familiar with the changes that had been made to the Universal Protocol (PC 214) after the wrong site surgery on 1/13/16 and he stated he had made no effort to learn of any policy changes which had been implemented as a means of preventing a wrong site surgery from occurring again. He stated the surgical services director had made no effort to educate or inform the medical staff about the policy violation which had led to the wrong site surgery. He stated the surgical services director had made no effort to educate or inform the medical staff about the policy changes implemented to prevent another wrong site surgery from occurring. He stated he was not at all familiar with the policy changes implemented to prevent another wrong site surgery.

On 2/23/16 at 4:00 p.m., during an interview, MD 1 stated he was the Vice President of Medical Affairs and the Chief Medical Officer of the facility and he represented the governing body. He stated MD 2 had performed a wrong-site surgery on Patient 1 on January 13, 2016. MD 1 stated during this event the time out was not performed according to policy. MD 1 stated following this incident changes were made in Universal Protocol (PC 214), however, the medical staff leadership and the governing body failed to do enough to educate the physicians and inform them of the changes. MD 1 stated the governing body failed to provide adequate oversight to implement and maintain a quality assessment performance improvement (QAPI) program which satisfactorily addressed physician awareness of the wrong site surgery problem. He stated the QAPI program failed to provide an adequate mechanism for sufficient oversight of the medical staff when there was no effort made to inform physicians of changes implemented to specifically prevent wrong site surgeries. When asked why physicians were not educated regarding the policy changes, MD 1 stated, "We should have informed the physicians of the changes in that they are the leaders of the surgical team." MD 1 stated he knew he 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 2/23/16 at 4:30 p.m., during an interview, the Surgical Services Director (RN 3) stated MD 2 had performed a wrong-site surgery on Patient 1 on January 13, 2016. RN 3 stated during this event the time out was not performed according to policy. RN 3 stated following this incident changes were made in Universal Protocol (PC 214), however, the medical staff leadership and the governing body failed to ensure that the Medical Staff were made aware of those changes. She stated the medical staff leadership and the governing body failed to hold the medical staff accountable for the quality of care in the facility when they failed to educate the physicians about the Universal Protocol (PC 214) changes. She stated the governing body failed to provide adequate oversight to implement and maintain any QAPI projects which satisfactorily addressed wrong site surgeries. RN 3 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 within the operating room theatre. RN 3 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 especially those being treated in the operating rooms.

A review of the facility's performance improvement projects through the QAPI program during 2016 indicated that no projects were initiated in regard to improving compliance with the Universal protocol (PC 214)policy by the MD 2 or other members of the Medical Staff medical staff.

Page 10 of the facility's Hospital Community Board bylaws indicated "8.2 Quality Assessment, Performance Improvement. Patient Safety and Utilization Management. This Hospital Community Board is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital; (ii) assuring that quality and patient safety issues are addressed and resolved appropriately; (iii) assuring quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital are consistent with the standards, policies and procedures established by the [Corporate] Board and the [Corporate] Quality Committee; and (iv) communicating quality and patient safety issues of concern and potential performance improvement measures to the [Corporate] Quality Committee. The Hospital Community Board shall assure that the Medical Staff (a) participates in the measurement, assessment and improvement of clinical and non-clinical processes affecting patient care and (b) takes a leadership role where the clinical processes are the primary responsibility of physicians. The activities of the Local Hospital (including outcomes, recommendations and actions) undertaken pursuant to this Section 8.2 shall be reported to this Hospital Community Board, and also to the [Corporate] Quality Committee in accordance with policies and procedures adopted from time to time by the [Corporate] Quality Committee."

Page 2 of the facility's 2016 Performance Improvement Plan indicated "PERFORMANCE IMPROVEMENT PLAN FY 2016 INTRODUCTION [Hospital], based on the Mission and Vision of the Medical Center and [Corporate Name], is committed to fostering an environment that encourages performance assessment and improvement related to important governance, management, clinical and support functions. The Administrative and Medical Staff leaders agree to work mutually toward those goals. PURPOSE The purpose of the organizational Performance Improvement Plan (PI Plan) at [Hospital] is to ensure that the Governing Body, medical staff, and professional service staff demonstrate a consistent endeavor to deliver safe, effective, and optimal patient care and services in an environment of minimal risk. In keeping with [Hospital's] mission to foster, nurture and perpetuate the concept of a family centered, quality conscious, and cost effective medical center of excellence, the organizational PI Plan allows for a systematic, coordinated, continuous, and data-driven approach to improving performance focusing upon processes and mechanisms that address these values. GOALS The primary goals of the [Hospital] PI Plan are based on annual performance and are to: Continually and systematically plan, design, measure, assess, and improve performance of priority focus areas, To improve healthcare outcomes, and To reduce and prevent medical/health care errors. ACTIONS To achieve these goals the plan strives to: Incorporate performance improvement throughout the facility. Provide a systematic mechanism for [hospital] staff, departments, and professions to function collaboratively in their efforts toward performance improvement. Provide feedback and learning throughout the organization. Identify "customer'' expectations, needs, and requirements and evaluate [Hospital's] performance in meeting these needs. Determine ongoing opportunities for improvement by analyzing [Hospital's] performance. Plan and incorporate processes for conducting thorough and credible root cause analyses, focusing on process and system factors in response to sentinel events and other critical incidents as defined by the hospital. Develop methods for continuously improving measures of patient outcomes and satisfaction. Continuously improve clinical and operational processes relative to the dimensions of performance that include-safety: the avoidance of injuries to patients from the care that is intended to help them - Effectiveness: providing services based on scientific knowledge to all who could benefit and refraining from providing services to those not likely to benefit."
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on staff interview, clinical record and administrative document review, the governing body failed to enforce the bylaws and ensure the medical staff was accountable to the governing body for the quality of care provided to all patients when MD 2 failed to comply with the facility (time-out, a suspension of all activity in the Operating Room to verify patient name, surgeon name, procedure being done, and site of the procedure) policy while treating Patient 1 resulting in Patient 1 having surgery performed on the wrong knee. (see A-353)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: MEDICAL STAFF BYLAWS Tag No: A0353
Based on staff interview, clinical record and administrative document review, the governing body failed to enforce the bylaws and ensure the medical staff was accountable for the quality of care provided to all patients when MD 2 failed to comply with the facility (time-out, a suspension of all activity in the Operating Room to verify patient name, surgeon name, procedure being done, and site of the procedure) policy while treating Patient 1.

This failure resulted in Patient 1 having surgery performed on the wrong knee.

Findings:

On 2/23/16 at 3:00 p.m., during an interview, MD 2 stated he performed a wrong-site surgery on Patient 1 on January 13, 2016. MD 2 stated during this event the time out was not performed according to the Universal Protocol (PC 214) prior to beginning the procedure. MD 2 stated he never looked to identify his own marking of the correct site prior to starting the surgery on the incorrect site because he failed to perform the time-out as he was obliged to do. He stated his violation of the Universal Protocol (PC 214) prior to beginning the procedure led directly to his performing surgery on the wrong knee. He stated he understood his failure to follow the Universal Protocol (PC 214) was a violation of the Medical Staff bylaws, rules and regulations. He stated as a member of the facility's Medical Staff he was obligated to comply with all of the facility's policies including the Universal Protocol (PC 214).

On 2/23/16 at 4:00 p.m., during an interview, MD 1 stated he was the Vice President of Medical Affairs and the Chief Medical Officer of the facility and he represented the governing body. MD 1 stated MD 2 had performed a wrong-site surgery on Patient 1 on January 13, 2016. MD 1 stated during this event the time out was not performed according to policy. MD 1 stated MD 2's violation of the Universal Policy (PC 214) was in turn a violation of the Medical Staff bylaws, rules and regulation which require members of the Medical Staff to obey all facility policies. MD 1 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. MD 1 stated, as the representative of the governing body, he knew the governing body 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 2/23/16 at 4:30 p.m., during an interview, the Surgical Services Director (RN 3) stated MD 2 had performed a wrong-site surgery on Patient 1 on January 13, 2016. RN 3 stated during this event the time out was not performed according to policy.

A review of Patient 1's clinical records and administrative documents (Root Cause Analysis) indicated Medical Doctor 2 (MD 2) performed a wrong-site surgery on Patient 1 on January 13, 2016. Prior this event the MD 2 failed to follow the Universal Protocol policy (PC 214) and did not visualize the mark he had previously made on the left knee during the time out process prior to the surgical procedure.

Page 4 of the facility's Medical Staff Rules and Regulations indicated "MEDICAL STAFF RULES & REGULATION S ARTICLE I GENERAL PROVISIONS Department Rules and Regulations Each Department of the Medical Staff shall enact rules and regulations to specifically govern those activities of medical practices for which they have been charged (collectively, "Departmental Rules and Regulations"). All such Departmental Rules and Regulations must be consistent with the Medical Staff Bylaws and these Rules and Regulations and be approved by the respective Department, the Executive Committee and the Governing Board. The Departmental Rules and Regulations of each Department shall be reviewed annually by the Department and the Executive Committee. Departmental Rules and Regulations shall be available in the Department of Medical Staff Services. Medical Staff Bylaws and Policies and Rules and Regulations In addition the Medical Staff Bylaws, there shall be policies, procedures and rules and regulations that shall be applicable to all members of the Medical Staff and other individuals who have been granted clinical privileges or a scope of practice. All Medical Staff policies, procedures and rules and regulations shall be considered an integral part of the Medical Staff Bylaws, subject to the amendment and adoption provisions contained in the Medical Staff Bylaws."

Page 10 of the facility's Hospital Community Board bylaws indicated "8.2 Quality Assessment, Performance Improvement. Patient Safety and Utilization Management. This Hospital Community Board is responsible for assuring that health care services provided at the Local Hospital are of high quality, safe, effective, efficient and consistent with community standards. This Hospital Community Board shall be responsible for: (i) ongoing quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital; (ii) assuring that quality and patient safety issues are addressed and resolved appropriately; (iii) assuring quality assessment, performance improvement, patient safety and utilization management activities of the Local Hospital are consistent with the standards, policies and procedures established by the [Corporate] Board and the [Corporate] Quality Committee; and (iv) communicating quality and patient safety issues of concern and potential performance improvement measures to the [Corporate] Quality Committee. The Hospital Community Board shall assure that the Medical Staff (a) participates in the measurement, assessment and improvement of clinical and non-clinical processes affecting patient care and (b) takes a leadership role where the clinical processes are the primary responsibility of physicians. The activities of the Local Hospital (including outcomes, recommendations and actions) undertaken pursuant to this Section 8.2 shall be reported to this Hospital Community Board, and also to the [Corporate] Quality Committee in accordance with policies and procedures adopted from time to time by the [Corporate] Quality Committee."
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on staff interview, clinical record, and administrative document review, the hospital failed to have a system in place to ensure surgical services were conducted in accordance with acceptable standards and to ensure the safety of patients. The hospital failed to ensure the "time out" process was adhered to for Patient 1 who suffered an avoidable wrong site surgery on the right knee. (refer to A-951)

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.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observation, staff interview, clinical record, and administrative document review, and nationally recognized standards for handwashing in the peri-operative setting, the hospital failed to ensure policies and procedures were implemented for 2 of 33 sampled patients (Patients 1 and 10) when:

1. The circulating nurse (RN 5) placed the leg holder on Patient 1's right leg rather than the left (correct) leg; During the "time-out" (a suspension of all activity in the Operating Room to verify patient name, surgeon name, procedure being done, and site of the procedure) in the Operating Room (OR) the surgical staff did not visualize the mark the surgeon (MD 2) placed on Patient 1's left knee and then performed a wrong site surgery on Patient 1's right knee; and

2. Registered Nurse 1 (RN 1) did not perform hand hygiene according to nationally accepted standards when preparing Patient 10 for surgery.

These failures resulted in Patient 1 undergoing a prolonged surgery with anesthesia and the risks associated with surgery and anesthesia; and resulted in the pain from surgery on the incorrect body part; and had the potential to cause Patients 1 and 10 to develop infections and have prolonged stays in the hospital.

Findings:

1. On 1/13/16 at 12:40 p.m., the pre-operative (pre-op) section of Patient 1's chart indicated Patient 1 was admitted to the Hospital prior to a scheduled left knee arthroscopy (an examination of the interior of a joint using a scope that is inserted into the joint through a small incision in the patient's skin) surgery.

On 1/13/16 at 12:40 p.m. a hospital form titled, "Consent for Surgery" was signed by Patient 1. The consent indicated the procedure as "Left knee arthroscopy, medial [situated in or toward the middle of the body] and/or lateral [situated in or toward the side of the body] meniscectomy [surgical removal of disk of cartilage between two bones], chondroplasty [repair of cartilage]."
Patient 1's nurses notes on the day of surgery, 1/13/2016 at 3:25 p.m., indicated "...knee holder on right side of OR table... Foot of bed dropped and RN prepped right knee/leg to tourniquet. Pt [patient] right knee draped. Surgical pause performed. Procedure began."

On 1/20/16 at 2:00 p.m., during an interview, RN 5 stated while she was prepping the operating room for surgery, she placed the knee holder on the right side of the operating table. She said she then went to interview Patient 1. The surgery was discussed including the the surgery site, the left knee. RN 5 stated this information was also put on the "white" board in the operating room (the white board is a board in the operating room, visible to all surgical staff, where the information for the surgery is written. That information includes items such as the patients name, and surgical site).

On 1/13/16 at 1:28 p.m., RN 5 documented Patient 1 was in the OR. A surgical pause (time-out) was documented at 1:46 p.m. The pre-operative diagnosis indicated "Left Knee MMT, LMT"(medial and lateral meniscus tear). The pre-operative information indicated the surgical site was confirmed as the "LT" (left).

On 1/13/16 at 3:10 p.m., the "Operative/Procedure Report", dictated by MD 2, indicated, "The left knee was marked with [yes] but the right knee was prepped for surgery. Tourniquet was applied and the leg placed in a right knee holder... The initial incisions were made both anteromedial and anterolateral. The scope was placed and a diagnostic arthroscopy revealing degenerative joint disease of the right knee ...Right knee irrigation was completed wrong side, identification completed, and the scope was withdrawn... The room was prepared and the left knee clearly identified and then carefully prepped and draped...."

On 1/13/16 at 3:25 p.m., the operative report nurse's note indicated, "...Knee holder on right side of OR table, SCD [sequential compression device, used to keep blood circulating through veins] tubing on left. Pt [Patient] anesthetized. Surgical tech and surgeon entered the room. Right thigh tourniquet applied by surgeon. Left leg placed on pillow by RN. Foot of bed dropped and RN prepped right knee/leg to tourniquet. Pt right knee draped. Surgical pause performed. Procedure began. RN identified wrong site surgery being performed and asked procedure to stop. Verification of correct site confirmed as left knee. Charge nurse notified. Surgeon decided to close right knee and proceed with correct knee surgery... Pt right knee w/dressing placed on knee pillow, [MD 2] applied left thigh tourniquet and placed left leg in knee holder. Left knee draped after RN prepped left leg to tourniquet. Surgical pause performed prior to procedure start...."

On 1/13/16 at 3:55 p.m., a post-operative pain assessment indicated Patient 1 had pain bilateral (both) knees at a level of 4/10 with support given as comfort measure. On 1/13/16 at 4:05 p.m. she reported a pain level of 5/10, bilateral knees, and was medicated. On 1/13/16 at 4:20 p.m. she reported a pain level of 3/10, bilateral knees, with support given as comfort measure.

On 2/22/16 at 2:07 p.m., MD 1 stated, "I don't believe the surgeon visualized the mark."

On 2/22/16 at 3:37 p.m., the Director of Risk Management (DRM) stated the operating room (OR) registered nurse (RN) 5 did not visualize the surgeon's mark on Patient 1's leg.

On 2/23/16 at 1:45 p.m., during an interview, MD 2 stated the circulating nurse (RN 5) put the knee holder on the right side of the bed in the OR. He stated he saw RN 5 struggling to put a tourniquet on Patient 1's right leg. MD 2 entered the OR and placed the tourniquet in the appropriate position on Patient 1's leg. He stated the OR had a white board on the wall where the circulating RN wrote the patient's name, the surgeon's name, the surgery to be performed, and the surgical site. MD 2 stated he did not visualize the mark he made in pre-op on Patient 1's leg during the surgical "time out". He stated the mark was covered by either the surgical drape or the patient's pannus (panniculus; a medical term describing a dense layer of fatty tissue in the lower abdominal area).

The hospital policy and procedure titled, "Universal Protocol" dated 10/14, indicated ".... D. 4. ...Sites are marked when there is more than one possible location for the procedure... c. 3) ...The mark should be sufficiently permanent to remain after the prep [a procedure to prepare the skin for surgery] and visible after the patient is draped.... E. The OR Circulator/Procedural (RN) ...3. Verify the procedure and site with the patient matching it with information from the LIP's [Licensed Independent Practioner's, such as surgeons] order, H&P [history and physical], Pre-Anesthesia Assessment, Surgical Consent... 4. Perform visual confirmation with the pre-op RN or LVN that the LIP's 'YES' mark is on the correct side and site... 6. Confirm required patient positioning... 7. Document the following on the OR White Board before the procedure begins. ...Site and Side. G. Surgical/Pre-Procedure "Time-Out" (final assessment)... 2. The "Time-Out" will be initiated by the circulating/procedural RN. It involves each member of the surgical team (includes the individual performing the procedure, the anesthesia provider, the circulating nurse, the operating room technician, and other active participants who will be participating in the procedure from the beginning). ...4. During the "Time-Out", the team members agree on the following: ...b. The correct site (with visual "stop and look" confirmation)..."

2. On 2/23/16 at 8:30 a.m., during an observation in outpatient endoscopy, (endoscopy is a procedure used to examine a person's digestive tract using an endoscope, a flexible tube with a light and camera attached to it.) Registered Nurse 1 (RN 1) came in to start an IV on Patient 10. RN 1 touched Patient 10's arm with bare hands and then put on gloves without cleansing hands. After starting the IV, RN 1 removed gloves and without cleansing hands began to do other care on Patient 10.

On 2/23/16 at 10:15 a.m., during an interview, RN 1 stated, "Yes, I did forget to do correct hand cleansing prior to starting the IV and after starting it."

The Association of periOperative Registered Nurses (AORN; a nationally accepted resource for recommendations for practice relating to perioperative nursing) "Guideline for Hand Hygiene", 2016 Edition, indicated "Recommendation II A standardized procedure for handwashing should be followed. ...IIa. A hand wash should be performed ...before and after every patient contact, before putting gloves on and after removing gloves or other personal protective equipment, any time there is a possibility that there has been contact with blood or other potentially infectious materials or surfaces,..."

The hospital policy and procedure titled, "Hand Hygiene" dated 8/15, indicated on pages 1 and 2 "Hand antisepsis [cleansing to remove germs] with antimicrobial soap or alcohol based hand rub is indicated ...before invasive procedures such as IV insertion.... All personnel must perform hand hygiene at the following times: ... Before and after direct contact with patients... After removing gloves...."