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Based on staff interview, clinical record and administrative document review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital when:

1.) No system was in place to ensure physicians (MD 1 and MD 2) followed Medical Staff bylaws, rules and regulations and hospital policies and procedures as it relates to the safety and quality of surgical procedures and protecting against wrong site surgeries. MD 1 performed a wrong site surgery on Patient 1 and MD 2 performed a wrong side surgery on Patient 2. (see A-49, A-347, A-951)


2.) No system was in place to ensure the medical staff credentialing process appropriately assessed the competence of provisional physicians. Six (6) of eight (8) credential files revealed provisional physicians were not being assessed for competence in accordance with the bylaws, rules and regulations. (see A-50, A-357)

3.) The Quality Improvement (QI) Program of the hospital did not develop and implement a QI project after two wrong site surgeries were identified. (see A 283)

4.) The governing body failed to recruit and hire a qualified professional to fill the role of Infection Control Preventionist and failed to implement an effective hospital-wide Infection Control Program. (See A-748)

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.

Based on staff interview, clinical record and administrative document review, the governing body failed to ensure the medical staff was accountable to the governing body for the quality of care provided to all patients when:

1) Medical Doctor 1 (MD 1) performed a wrong-side surgery on Patient (Pt) 1. MD 1 failed to comply with the hospital time-out (suspension of all activity in the Operating Room to verify patient name, surgeon name, procedure being done, and site of the procedure) policy while performing surgery on Pt 1. MD 1 performed an unnecessary radiofrequency ablation (heat applied focally to relieve nerve pain) applied to the wrong side of the lower back on Pt 1.

2) Medical Doctor 2 (MD 2) performed surgery on the wrong site of Patient 2. MD 2 performed an arthrodesis (surgical fusion of joint usually done to reduce pain) on the left thumb rather than the correct site of the left index finger.

These failures resulted in unnecessary surgeries to parts of the body that were not consented to have surgery.

Findings:

On 4/26/16 at 1 p.m., during an interview, the Chief Executive Officer (CEO) acknowledged his position of leadership and stated he knew he had the responsibility for ensuring the Medical Staff was held accountable for the quality of care dispensed to patients. He acknowledged MD 1 had failed to follow the facility's policy and procedure. He acknowledged MD 1's failures resulted in pt. 1 receiving unnecessary treatment. He stated that a root cause analysis had been done and the case was currently under peer review.

MD 1 was unavailable for interview.

Governing body minutes, medical staff rules, regulations and bylaws and the medical staff roster were requested on 4/25/16 at 11 a.m. as a part of the usual survey process. The facility's policies for credentialing and peer review, selected credential files and the minutes from both the medical executive committee and the peer review committee were among those documents requested and reviewed on 4/25/16 at 1 p.m. as a part of the usual survey process.

A review of Patient 1's clinical records and administrative documents (Root Cause Analysis) indicated MD 1 performed a wrong-side radiofrequency ablation to the right lumbosacral (lower back) region of Pt 1's back at 8:21 a.m. on 12/3/15. For this surgery MD 1 failed to follow the facility's policy and procedure for Marking and Verification of Pain Management Procedure site. MD 1 a.) failed to mark the procedure site, b.) failed to perform a time-out (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) according to policy, and c.) failed to verify the correct surgical site. After Pt 1 was discharged, his wife realized the wrong side had been treated. She contacted the facility at 11 a.m. and Pt 1 was transported back to the facility where the correct side was treated.

On 4/26/16 at 1 p.m., during an interview, the Chief Executive Officer (CEO) acknowledged his position of leadership and stated he knew he had the responsibility for ensuring the Medical Staff was held accountable for the quality of care dispensed to patients. He acknowledged MD 2 had failed to deliver quality care to Pt 2. He acknowledged MD 2's failure resulted in Pt 2 receiving unnecessary surgery. He stated that a root cause analysis had been done and the case was currently under peer review.

On 4/26/16 at 1:26 p.m., during an interview MD 2 stated he was the orthopedic surgeon who performed the wrong-site surgery on Pt 2. He stated he had marked the correct digit (left index finger) in the preoperative area. He stated a time-out was performed correctly according to the facility's policy and procedure for Marking and Verification of Pain Management Procedure site. He stated in spite of the identifying mark and the time-out, he simply began to operate on the wrong digit. He acknowledged he was responsible for performing the wrong site surgery.

A review of Patient 2's clinical records and administrative documents (Root Cause Analysis) indicated Medical Doctor 2 (MD 2) performed a wrong-site surgery on Pt. 2 on 2/19/16. For this surgery the correct surgical site (left index finger) had been marked by MD 2 and a time-out was performed in accordance with the facility's policy and procedure for Marking and Verification of Pain Management Procedure site. Having marked the correct operative site in addition to performing the time-out MD 2 made an incision on the wrong operative site (left thumb) and began operating at 11:38 a.m. At 11:53 a.m. MD 2 was notified by the circulating nurse that he was operating on the wrong digit. Upon being notified of the error, MD 2 finished surgery on the wrong digit. He then performed the arthrodesis (surgical procedure to relieve pain in a joint) on the correct digit (left index finger).

Based on staff interview and review of administrative documents and policies for credentialing, the governing body failed to ensure the criteria for selecting provisional medical staff were followed. Review of six of eight credential files (MD 3, MD 4, MD 5, MD 6, MD 7, MD 8) indicated provisional physicians were not assessed for competence in accordance with the bylaws, rules and regulations.

This failure resulted in the potential harm of selecting medical practitioners who were not fully qualified to provide services to patients.
Findings:

Governing body minutes, medical staff rules, regulations and bylaws and the medical staff roster were requested on 4/25/16 at 11 a.m. as a part of the usual survey process. The facility's policies for credentialing and peer review, selected credential files and the minutes from both the medical executive committee and the peer review committee were among those documents requested and reviewed on 4/25/16 at 1 p.m. as a part of the usual survey process.

After discussing credentialing of medical staff including policies and procedures, eight physician credential files (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, and MD 8) were reviewed on 4/25/16 at 1:30 PM with Medical Staff credentialing coordinator (MSC).

The credential files were chosen for review because they had all been appointed to the medical staff and granted clinical privileges. Review of the eight credential files indicated six provisional physicians (MD 3, MD 4, MD 5, MD 6, MD 7, and MD 8) had been appointed to the Medical Staff and granted privileges. They were not assessed for competence in accordance with the bylaws, rules and regulations. All six provisional physicians had engaged in sufficient number of patient encounters to allow for the assessments. There was no evidence in the credential files they had been proctored in accordance to directions written in the Bylaws, Rules and Regulations.

On 4/25/16 at 2 p.m., during a joint interview, the MSC and the Director of Clinical Services (DCS) stated overseeing and managing the credential files was the responsibility of the MSC. They stated the credential files had been out of order for some time. They stated they were aware of the credentialing issues regarding lack of proctoring. They stated this was a chronic problem that had been brought to the attention of the medical staff leadership and the representatives of the governing body. They stated in spite of their efforts to make leadership aware of the credentialing and medical staff issues, the problems persisted. They stated the physicians were uncooperative in addressing medical staff credentialing issues. They stated that they simply did not have enough time or assistance from the medical staff leadership to correct all the problems with the credential files. They stated the governing body was not actively involved in the credentialing process on a regular basis.

On 4/26/16 at 1 p.m., during an interview, the Chief Executive Officer (CEO) acknowledged he was responsible for ensuring Medical Staff credentialing was performed properly and in accordance with the Bylaws, Rules and Regulations. He acknowledged the fact that the MSC and the DCS had made efforts to inform the Medical Staff leadership of those problems. He stated they knew these practices were in violation of the bylaws, rules and regulations as well as the Medical Staff credentialing policy. He stated he was not actively involved in the credentialing process on a regular basis.

Review Governing Body bylaws dated 4/1/16, indicated "ARTICLE 5: MANAGEMENT AND CONTROL OF THE COMPANY: 5.1. Management of the Company by the Board. 5.1.1. Exclusive Management by the Board. The Company is 'Manager-managed,' and the business, property and affairs of the Company shall be managed by a Board of Managers [the 'Board']. The Board shall have full, complete and exclusive authority, power and discretion to manage and control the business, property and affairs of the Company, to make all decisions regarding those matters and to perform any and all other acts or activities customary or incident to the management of the Company's business, property and affairs. The Managers shall only act as a Board and shall not have any power in their individual capacities to bind the Company. Where not in conflict with the terms of this Agreement, the Board has the authority to adopt rules and procedures for the orderly conduct of meetings and the operation of the Company. The Board is the 'Governing Body' of the Company. The Board is authorized to promulgate Governing Body Bylaws for the Company and such Governing Body Bylaws may address issues such as quality of care, additional procedures for Board meetings, the appointment and composition of committees and overall operation of the Company. 5.4.2 Officer Duties. Administrator. The Board shall appoint an administrator who shall be responsible for the day-to-day operations of the Company as set forth in the Medical Staff Agreement (MSA)."

The hospital policy and procedure titled "Medical Staff Bylaws" dated 9/15/11, indicated "3.5 PROVISIONAL STAFF: 3.5-1 QUALIFICATIONS: The provisional staff shall consist of members who: (a) Meet the general Medical Staff membership qualifications set forth in Sections 3.2-1(a) and (b) or 3.4-1(a)-(d); and (b) Immediately prior to their application and appointment were not members (or were no longer members) in good standing of this Medical Staff. 3.5-2 PREROGATIVES: The provisional staff member shall be entitled to: (a) Admit patients and exercise such clinical privileges as are granted pursuant to Article V; and (b) Attend meetings of the medical staff, including open committee meetings and educational programs, but shall have no right to vote at such meetings, except within committees when the right to vote is specified at the time of appointment. Provisional staff members shall not be eligible to hold office in the Medical Staff organization, but may serve upon committees. 3.5-3 OBSERVATION OF PROVISIONAL STAFF MEMBER: Each provisional staff member shall undergo a period of observation by designated monitors as described in Section 5.3. The purpose of observation shall be to evaluate the member's (1) proficiency in the exercise of clinical privileges initially granted and (2) overall eligibility for continued staff membership and advancement within staff categories. Observation of provisional staff members shall follow whatever frequency and format the Medical Executive Committee deems appropriate in order to adequately evaluate the provisional staff member including, but not limited to, concurrent or retrospective chart review, mandatory consultation, and/or direct observation. Appropriate records shall be maintained. The results of the observation shall be communicated by the Chief of the Service to the Medical Staff Professional Practices Committee. 3.5-4 TERM OF PROVISIONAL STAFF STATUS: A member shall remain in the provisional staff for a period of 12 months, unless that status is extended by the Medical Executive Committee for an additional period of up to 12 months, upon a determination of good cause, which determination shall not be subject to review pursuant to Articles VI or VII. 3.5-5 ACTION AT CONCLUSION OF PROVISIONAL STAFF STATUS: (a) If the provisional staff member has satisfactorily demonstrated the ability to exercise the clinical privileges initially granted and otherwise appears qualified for continued Medical Staff membership, the member shall be eligible for placement in the active, courtesy or consulting staff as appropriate, upon recommendation of the Medical Executive Committee; and (b) In all other cases, the appropriate Chief of Service shall advise the Medical Staff Professional Practice Committee which shall make its report to the Medical Executive Committee which, in turn, shall make its recommendation to the Board of Directors regarding a modification or termination of clinical privileges or termination of Medical Staff membership."

Based on staff interview and administrative document review, the hospital failed to develop, maintain, and implement an effective Quality Assessment and Performance Improvement (QAPI) when:

1. Two wrong site surgeries were identified and no Quality Improvement project was developed and implemented. (see A283)

2. No Infection Control QI project was developed and implemented to address the need for a hospital wide Infection Control Program that is led by a qualified Infection Control Preventionist. (see A 283, A748)


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.

Based on interview and administrative document review, the hospital failed to identify opportunities to improve in high-risk, high volume areas when:

1. There was no Quality improvement (QI) project initiated after two incidences of wrong site procedures.

2. No QI project was developed and implemented to recruit and hire and qualified Infection Control Preventionist to direct an effective, hospital-wide Infection Control Program.

This failure had the potential to put all patients in danger of receiving wrong site surgery.

Findings:

1. On 4/28/16 at 10:30 a.m., during an interview, the Director of Quality (DQ) stated the hospital had not initiated improvement projects aimed at preventing wrong site surgeries. The DQ was unable to state why no projects had been initiated and stated a project should have been developed and initiated.

A review of Patient 1's clinical records and administrative documents (Root Cause Analysis) indicated MD 1 performed a wrong-side radiofrequency ablation to the right lumbosacral (lower back) region of Patient (Pt) 1's back at 8:21 a.m. on 12/3/15. Prior to this event MD 1 failed to follow the the facility's policy and procedure for Marking and Verification of Pain Management Procedure site. MD 1 a.) failed to mark the procedure site, b.) failed to perform a time-out (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) according to policy and c.) failed to verify the correct surgical site. After Pt. 1 had been discharged his wife realized the wrong side had been treated. She contacted the facility at 11 a.m. and Pt.1 was transported back to the facility where the correct side was treated.


A review of Patient 2's clinical records and administrative documents (Root Cause Analysis) indicated Medical Doctor 2 (MD 2) performed a wrong-site surgery on Pt 2's left index finger at 11:38 a.m. on 2/19/16. Prior to this event the correct surgical site had been marked by MD 2 and a time-out was performed in accordance with the facility's policy and procedure for Marking and Verification of Pain Management Procedure site. Having marked the correct operative site in addition to performing the time-out MD 2 made an incision on the wrong operative site (left thumb) and began operating at 11:38 a.m. At 11:53 a.m. MD 2 was notified by the circulating nurse that he was operating on the wrong digit. Upon being notified of the error, MD 2 finished surgery on the wrong digit. He then performed the arthrodesis (surgical procedure to relieve pain in a joint) on the correct digit (left index finger).
2. On 4/25/16 at 9 a.m., during the entrance conference interview, the IC stated that she did not have experience or certification in infection control.

On 4/25/16 at 9 a.m., during the entrance conference interview, the Director of Clinical Services stated that she thought the hospital could hire an unqualified person for infection control and then send them for training.

Review of the administrative document entitled, "Job Description Infection Preventionist" dated 11/13, indicated, "Minimum Qualifications... Two years of experience in Infection control or progressive experience in nursing, epidemiology, or public health... Required Certification/Registration... Current Certification in Infection Control (CIC) by the Certification Board of Infection Control"

Based on staff interview, clinical record and administrative document review, the governing body failed to ensure the medical staff was accountable to the governing body for the quality of care provided to all patients and failed enforce the bylaws and when:


1) Medical Doctor 1 (MD 1) failed to comply with the facility time-out policy while treating Patient 1 resulting in Patient 1 having a radiofrequency ablation (heat applied focally to relieve nerve pain) applied to the wrong side of the lower back. (see A-347)

2) Medical Doctor 2 (MD 2) complied with the facility time-out policy, however, failed to provide quality care to patient 2 when he performed surgery on the wrong site resulting in Patient 2 having unnecessary surgery (see A-347)

3.) Six (6) out of a total of eight (8) credential files revealed provisional physicians were not being assessed for competence in accordance with the bylaws, rules and regulations. (A- 357)


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.

Based on staff interview, clinical record and administrative document review, the medical staff failed to be accountable to the governing body for the quality of care provided to all patients when:


1) Medical Doctor 1 (MD 1) failed to comply with the facility time-out policy while treating Patient 1 (Pt)resulting in Pt1 having a radiofrequency ablation (heat applied focally to relieve nerve pain) applied to the wrong side of the lower back.

2) Medical Doctor 2 (MD 2) complied with the facility time-out policy, however, failed to provide quality care to Patient 2 (Pt) when he performed surgery on the wrong site resulting in Pt 2 having unnecessary surgery.

Findings:

Governing body minutes, medical staff rules, regulations and bylaws and the medical staff roster were requested at 11:00 a.m. on 4/25/16 as a part of the usual survey process. The facility's policies for credentialing and peer review, selected credential files, selected administrative documents and the minutes from both the medical executive committee and the peer review committee were among the documents requested and reviewed at 1:00 p.m. on 4/25/16 as a part of the usual survey process.

1) A review of Pt 1's clinical records and administrative documents (Root Cause Analysis) indicated Medical Doctor 1 (MD 1) performed a wrong-side radiofrequency ablation (heat applied focally to relieve nerve pain) to the right lumbosacral (lower back) region of Pt. 1's back at 8:21 a.m. on 12/3/15. For this procedure MD 1 did not follow e the facility's policy and procedure for Marking and Verification of Pain Management Procedure site. The clinical record did not indicate: MD 1 a.) marked the procedure site, b.) performed a time-out (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) according to policy and c.) verified the correct surgical site. The clinical record indicated later on the morning of 12/3/15, after examining her husband's back, Pt. 1's wife realized the wrong side had been treated. She contacted the facility at 11:00 a.m. and Pt. 1 was transported back to the facility where the correct side was treated.

On 4/26/16 at 1 p.m., during an interview, the Chief Executive Officer (CEO) acknowledged his position of leadership and stated he knew he had the responsibility for ensuring the Medical Staff was held accountable for the quality of care dispensed to patients. He acknowledged MD 1 had failed to follow the facility's policy and procedure. He acknowledged MD 1's failures resulted in pt. 1 receiving an unnecessary procedure. He stated that a root cause analysis had been done and the case was currently being peer reviewed.

MD 1 was unavailable for interview.

2.) A review of Patient 2's clinical records and administrative documents (Root Cause Analysis) indicated Medical Doctor 2 (MD 2) performed a wrong-site surgery on pt. 2's left index finger at 11:38 a.m. on 2/19/16. Prior to this event the correct surgical site had been marked by MD 2 and a time-out was performed in accordance with the facility's policy and procedure for Marking and Verification of Pain Management Procedure site . Having marked the correct operative site in addition to performing the time-out, MD 2 made an incision on the wrong operative site (left thumb) and began operating at 11:38 a.m. At 11:53 a.m. MD 2 was notified that he was operating on the wrong digit. Upon being notified of the error MD 2 finished surgery on the wrong digit. He then performed the arthrodesis (surgical fusion of a joint in order to relieve pain on the correct digit (left index finger).

On 4/26/16 at 1 p.m., during an interview, the Chief Executive Officer (CEO) acknowledged his position of leadership and stated he knew he had the responsibility for ensuring the Medical Staff was held accountable for the quality of care dispensed to patients. He acknowledged MD 2 had failed to deliver quality care to Pt. 2. He acknowledged MD 2's failure resulted in Pt. 2 receiving unnecessary surgery. He stated that a root cause analysis had been done and the case was currently being peer reviewed.

On 4/26/16 at 1:26 p.m., during an interview, MD 2 stated he was the orthopedic surgeon who had performed the wrong-site surgery on Pt.2. He stated he had marked the correct digit (left index finger) in the preoperative area. He stated a time-out was performed correctly according to the facility's policy and procedure for Marking and Verification of Pain Management Procedure site. He stated in spite of the identifying mark and the time-out he simply began to operate on the wrong digit. He acknowledged he was responsible for performing the wrong site surgery.

Based on staff interview, clinical record and administrative document review, the governing body failed to ensure the medical staff was accountable to the governing body for the quality of care provided to all patients and failed to enforce the bylaws when:

Six (6) out of a total of eight (8) credential files revealed provisional physicians were not being assessed for competence in accordance with the bylaws, rules and regulations.

This failure resulted in the potential harm of medical practitioners performing services to patients who may not be qualified to do so.

Findings:

Governing body minutes, medical staff rules, regulations and bylaws and the medical staff roster were requested on 4/25/16 at 11:00 a.m. as a part of the usual survey process. The facility's policies for credentialing and peer review, selected credential files and the minutes from both the medical executive committee and the peer review committee were among those documents requested and reviewed on 4/25/16 at 1:00 p.m. as a part of the usual survey process.

After discussing credentialing of medical staff including policies and procedures, eight (8) physician credential files (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8) were reviewed on 4/25/16 at 1:30 p.m. with Medical Staff credentialing coordinator (MSC).

The credential files for were chosen as a part of the credential file review sample because they had all been appointed to the medical staff and granted clinical privileges. Examination of the eight (8) credential files revealed six (6) provisional physicians (MD 3, MD 4, MD 5, MD 6, MD 7, MD 8) who had been recently been appointed to the Medical Staff and granted privileges were not assessed for competence in accordance with the bylaws, rules and regulations. All six provisional physicians had engaged in sufficient numbers of patient encounters to allow for the assessments of their, however, there was no evidence in the credential files they had been proctored according to the Bylaws, Rules and Regulations.

On 4/25/16 at 2 p.m., during a joint interview, the MSC and the Director of Clinical Services (DCS) stated overseeing and managing the credential files was the responsibility the MSC. They stated the credential files had been out of order for some time. They stated they were aware of the credentialing issues, specifically the lack of proctoring. They stated this was a chronic problem that had been brought to the attention of the medical staff leadership and the representatives of the governing body. They stated in spite of their efforts to make leadership aware of the credentialing and medical staff issues, the problems persisted. They stated the physicians were uncooperative in addressing medical staff credentialing issues. They stated they simply did not have enough time or assistance from the medical staff leadership to correct all the problems with the credential files. They stated the governing body was not actively involved in the credentialing process on a regular basis.

On 4/26/16 at 1 p.m., during an interview, the Chief Executive Officer (CEO) acknowledged his position of leadership and stated he knew he had the responsibility for ensuring Medical Staff credentialing was performed properly and in accordance with the Bylaws, Rules and Regulations. He acknowledged the fact that the MSC and the DCS may have made efforts to inform the Medical Staff leadership of those problems, however, he stated he had not been made aware of the fact that there were problems with regard to the medical staff credential files. He stated they knew these practices were in violation of the bylaws, rules and regulations as well as the Medical Staff credentialing policy. He stated he was not actively involved in the credentialing process on a regular basis.


A copy of the Governing Body bylaws dated 4/1/16 states on page 18 "ARTICLE 5: MANAGEMENT AND CONTROL OF THE COMPANY. Management of the Company by the Board. Exclusive Management by the Board. The Company is "Manager-managed," and the business, property and affairs of the Company shall be managed by a Board of Managers (the "Board"). The Board shall have full, complete and exclusive authority, power and discretion to manage and control the business, property and affairs of the Company, to make all decisions regarding those matters and to perform any and all other acts or activities customary or incident to the management of the Company's business, property and affairs. The Managers shall only act as a Board and shall not have any power in their individual capacities to bind the Company. Where not in conflict with the terms of this Agreement, the Board has the authority to adopt rules and procedures for the orderly conduct of meetings and the operation of the Company. The Board is the "Governing Body" of the Company. The Board is authorized to promulgate Governing Body Bylaws for the Company and such Governing Body Bylaws may address issues such as quality of care, additional procedures for Board meetings, the appointment and composition of committees and overall operation of the Company. If there is a conflict between the Governing Body Bylaws and this Agreement, this Agreement shall control."

Page 22 states "5.4.2 Officer Duties Administrator. The Board shall appoint an administrator who shall be responsible fro the day-to-day operations of the Company as set forth in the Medical Staff Agreement (MSA)."

Page 7 of a signed copy of the facility Medical Staff Bylaws states"PROVISIONAL STAFF
3.5-1 QUALIFICATIONS The provisional staff shall consist of members who:
Meet the general Medical Staff membership qualifications set forth in Sections 3.2-1(a) and (b) or 3.4-1(a)-(d); and Immediately prior to their application and appointment were not members (or were no longer members) in good standing of this Medical Staff. 3.5-2 PREROGATIVES The provisional staff member shall be entitled to: (a) Admit patients and exercise such clinical privileges as are granted pursuant to Article V; and (b) Attend meetings of the medical staff, including open committee meetings and educational programs, but shall have no right to vote at such meetings, except within committees when the right to vote is specified at the time of appointment. Provisional staff members shall not be eligible to hold office in the Medical Staff organization, but may serve upon committees. 3.5-3 OBSERVATION OF PROVISIONAL STAFF MEMBER Each provisional staff member shall undergo a period of observation by designated monitors as described in Section 5.3. The purpose of observation shall be to evaluate the member's (1) proficiency in the exercise of clinical privileges initially granted and (2) overall eligibility for continued staff membership and advancement within staff categories. Observation of provisional staff members shall follow whatever frequency and format the Medical Executive Committee deems appropriate in order to adequately evaluate the provisional staff member including, but not limited to, concurrent or retrospective chart review, mandatory consultation, and/or direct observation. Appropriate records shall be maintained. The results of the observation shall be communicated by the Chief of the Service to the Medical Staff Professional Practices Committee. 3.5-4 TERM OF PROVISIONAL STAFF STATUS A member shall remain in the provisional staff for a period of 12 months, unless that status is extended by the Medical Executive Committee for an additional period of up to 12 months, upon a determination of good cause, which determination shall not be subject to review pursuant to Articles VI or VII. 3.5-5 ACTION AT CONCLUSION OF PROVISIONAL STAFF STATUS If the provisional staff member has satisfactorily demonstrated the ability to exercise the clinical privileges initially granted and otherwise appears qualified for continued Medical Staff membership, the member shall be eligible for placement in the active, courtesy or consulting staff as appropriate, upon recommendation of the Medical Executive Committee; and In all other cases, the appropriate Chief of Service shall advise the Medical Staff Professional Practice Committee which shall make its report to the Medical Executive Committee which, in turn, shall make its recommendation to the Board of Directors regarding a modification or termination of clinical privileges or termination of Medical Staff membership.

Based on observation, staff interview, and document review, the hospital failed to provide a sanitary environment to avoid sources of transmission of infections and communicable diseases and did not have an active program for the prevention, control and investigation of infections and communicable diseases when:

1. The hospital's Infection Control Preventionist was not qualified by education, experience, training or certification. (See A-748)

2. The hospital did not ensure a Post Anesthesia Care Unit (PACU) ice machine used for patients was cleaned in accordance with manufacturer's guidelines; a blood pressure cord, heart monitor cords and a gurney were not disinfected in accordance with manufacturer's guidelines; An anesthesiologist (medical doctor, MD 10) did not use safe injection practices in accordance with the Centers for Disease Control infection prevention guidelines. (See A-749)

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

Based on interview and administrative document review the hospital failed to ensure that their Infection Control Officer (IC) was qualified through education, training, experience, or certification to coordinate the hospital's infection control program.

This failure had the potential for inadequate infection control oversight and exposure of patients and staff to cross contamination and infection.

Findings:

On 4/25/16 at 9 a.m., during the entrance conference interview, the IC stated that she did not have experience or certification in infection control.

On 4/25/16 at 9 a.m., during the entrance conference interview, the Director of Clinical Services stated that she thought the hospital could hire an unqualified person for infection control and then send them for training.

Review of the administrative document entitled, "Job Description Infection Preventionist" dated 11/13, indicated, "Minimum Qualifications... Two years of experience in Infection control or progressive experience in nursing, epidemiology, or public health... Required Certification/Registration... Current Certification in Infection Control (CIC) by the Certification Board of Infection Control"

Based on observation, interview and administrative document review, the hospital failed to ensure risks contributing to health care associated infections were monitored and mitigated when:

1) One out of three ice machines was found to be visibly dirty.

2) Certified Nursing Asssistant (CNA) was not disinfecting the cords for the blood pressure and heart monitor, or the guerney, properly between patients.

3) Three of four anesthesiologists were not observing safe injection practices.

These failures had the potential for cross contamination and infection for patients in the Operating Room (OR) and Post Anesthesia Care Unit (PACU).

Findings:

1) On 4/25/16 at 10:10 a.m., during a concurrent observation and staff interviews, a counter top ice machine in the PACU was found to have calcium build-up on the dispensing spout. After removing the filter from the side of the machine, allowing a view of the inside, calcium build-up completely coated all of the parts inside.

On 4/25/16 at 10:15 a.m., during an interview, the Infection Control nurse (IC), stated after viewing the calcium build-up inside the machine and on the dispensing spout, "Yes I see it.", and "It shouldn't be that way".

On 4/25/16 at 10:30 a.m., during an interview, the Engineering Manager (EM) was asked how often the machine gets cleaned. The EM stated every six months. When asked if he ever saw this machine this bad he stated, he has never looked at this machine because the night shift person is the one who cleans it. He continued to say that they use the Manufacturer's Guidelines for cleaning the machine.

The individual responsible for cleaning the ice machines was not available for interview.

The facility's cleaning log indicated the ice machine was last cleaned in November, 2015.

On 4/27/16 at 2:00 p.m., during a concurrent observation and staff interviews, the same counter top ice machine in the PACU was viewed by the Interim Director of Operations (IDO) and the Director of Clinical Services (DCS) to have calcium build-up on the dispensing spout and coating all of the inside parts.

On 4/27/16 at 2:22 p.m., the DCS stated that the build-up of calcium was very bad.

On 4/27/16 at 2:23 p.m., the IDO stated it was so bad that they wouldn't even try to clean it. It would be immediately taken out of service and the hospital will purchase a new one to replace it.

2) On 4/27/16 at 7:35 a.m., a CNA was observed cleaning station four in the PACU. When asked how cleaning was done the CNA stated she wipes down the blood pressure and heart monitor cords and hangs them up then wipes down the guerney. The CNA stated she uses disinfectant wipes for cleaning. When asked what the dwell time (amount of time a disinfectant has to stay wet on an object's surface to achieve disinfection) was for the wipes she was using, she had no idea what dwell time meant. When told that it is the amount of time the disinfectant needs to stay wet, the CNA stated she just wiped the objects and let them dry. The dwell time for the product the CNA was using is two minutes and the objects were almost completely dry before the two minutes were up.

3) On 4/26/16 at 8:15 a.m., MD 10 was observed injecting medication into a port of the intravenous line (IV-directly into a vein) without cleansing the port with alcohol first.

On 4/26/16 at 8:45 a.m., MD 3 was observed opening a new medication vial and piercing it with a needle without wiping the cap off with alcohol first.

On 4/26/16 at 10:10 a.m., MD 11 was observed opening a new medication vial and piercing it with a needle without wiping the cap off with alcohol first. MD 11 then injected medication into a port of the IV without cleansing the port with alcohol first.

On 4/26/16 at 1:30 p.m., during an interview, MD 11 stated he had not been cleansing the caps of newly opened medication vials before piercing them with a needle. "Sometimes the surgeons are pushing you to get things done."

On 4/26/16 at 2:05 p.m., during an interview, MD 3 stated he was not cleansing the caps of newly opened medication vials before piercing them with a needle. MD 3 stated he did not wipe the ports of the IV line before giving medication. "I wasn't aware that I was supposed to do that."

On 4/26/16 at 2:45 p.m., during an interview, MD 10 stated he knew he was supposed to cleanse the IV port prior to injecting medications. "I must have just gotten busy."

On 4/26/16 at 12:30 p.m., during an interview, MD 13, the Director of Anesthesia Services, stated he thought the anesthesiologists were all aware of safe injection practices but "they think they're not important."

The Centers for Disease Control and Prevention (CDC) guidelines entitled, "Medication Preparation - Safe Practices for Medical Injections" dated 3/2/11, indicated, "Parenteral (intravenous or intramuscular) medications should be accessed in an aseptic (germ free) manner. This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. Proper hand hygiene should be performed before handling medications and the rubber septum (stopper) should be disinfected with alcohol prior to piercing it."

The American Journal of Infection Control dated April 2010, indicated," Disinfect IV ports and vial stoppers by wiping and using friction with a sterile 70% isopropyl alcohol... Allow the port to dry before accessing."

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. Medical Doctor 1 (MD 1) failed to comply with the facility time-out (a process done before procedures start to verify the team have the right patient, right procedure and right equipment) policy while treating patient 1, resulting in pt 1 having a radiofrequency ablation (heat applied focally to relieve nerve pain) applied to the wrong side of his lower back. (See A-951)

2. Medical Doctor 2 (MD 2) failed to provide quality care to patient 2 when he performed surgery on the wrong site resulting in Patient 2 having unnecessary surgery. (See A-951)


3. A medical doctor (MD 9) did not perform hand hygiene (wash hands or use an alcohol-based hand rub) prior to putting on gloves and performing a procedure for one of two tracer patients (patients observed from admission through discharge) (Patient 3) in Procedure Room 2. (See A-951)

4. Nine departures from required surgical attire in the perioperative area (restricted and nonrestricted areas requiring special attire) were observed: a) MD 12 had an exposed necklace during a procedure; b) The Endoscopy Manager (EM) and the Surgical Technician (ST) had exposed hair; c) MD 3, MD 9, and Registered Nurse 1 (RN 1) had their arms exposed; d) MD 13 had his ears exposed; RN 3 and RN 4 had their noses exposed.
(See A-951)

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.

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

1. Medical Doctor 1 (MD 1) failed to comply with the facility time-out (a process done before procedures start to verify the team have the right patient, right procedure and right equipment) policy while treating Patient (Pt) 1 resulting in Pt 1 having an unnecessary radiofrequency ablation (heat applied focally to relieve nerve pain) applied to the wrong side of the lower back.

2. Medical Doctor 2 (MD 2) failed to provide quality care to Patient 2 when he performed surgery on the wrong site resulting in Patient 2 having unnecessary surgery.

3. A medical doctor (MD 9) did not perform hand hygiene (wash hands or use an alcohol-based hand rub) prior to putting on gloves and performing a procedure for one of two tracer patients (patients observed from admission through discharge) (Patient 3) in Procedure Room 2.

4. Nine departures from required surgical attire in the perioperative area (restricted and nonrestricted areas requiring special attire) were observed: a) MD 12 had an exposed necklace during a procedure; b) The Endoscopy Manager (EM) and the Surgical Technician (ST) had exposed hair; c) MD 3, MD 9, and Registered Nurse 1 (RN 1) had their arms exposed; d) MD 13 had his ears exposed; RN 3 and RN 4 had their noses exposed.

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

FINDINGS:

1. A review of Patient 1's clinical records and administrative documents (Root Cause Analysis) indicated MD 1 performed a wrong-side radiofrequency ablation to the right lumbosacral (lower back) region of pt.1's back at 8:21 a.m. on 12/3/15. Prior to this event, MD 1 failed to follow the the facility's policy and procedure for Marking and Verification of Pain Management Procedure site. MD 1 a.) failed to mark the procedure site, b.) failed to perform a time-out (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) according to policy, and c.) failed to verify the correct surgical site. After pt 1 had been discharged his wife realized the wrong side had been treated. She contacted the facility at 11 a.m. and pt.1 was transported back to the facility where the correct side was treated.

On 4/26/16 at 1 p.m., during an interview, the Chief Executive Officer (CEO) acknowledged his position of leadership and stated he knew he had the responsibility for ensuring the Medical Staff was held accountable for the quality of care dispensed to patients. He acknowledged MD 1 had failed to follow the facility's policy and procedure. He acknowledged MD 1's failures resulted in pt. 1 receiving unnecessary treatment.

Despite repeated requests, MD 1 refused to make himself available for an interview with the medical consultant of the survey team.

2. A review of Patient 2's clinical records and administrative documents (Root Cause Analysis) indicated Medical Doctor 2 (MD 2) performed a wrong-site surgery on pt. 2's left index finger at 11:38 a.m. on 2/19/16. Prior to this event the correct surgical site had been marked by MD 2 and a time-out was performed in accordance with the facility's policy and procedure for Marking and Verification of Pain Management Procedure site. Having marked the correct operative site in addition to performing the time-out, MD 2 made an incision on the wrong operative site (left thumb) and at 11:38 a.m. began operating. At 11:53 a.m., MD 2 was notified by the circulating nurse that he was operating on the wrong digit. Upon being notified of the error, MD 2 finished surgery on the wrong digit. He then performed the arthrodesis (surgical procedure to relieve pain in a joint) on the correct digit (left index finger).

On 4/26/16 at 1:26 p.m., during an interview, MD 2 stated he was the orthopedic surgeon who had performed the wrong-site surgery on Pt.2. He stated he had marked the correct digit (left index finger) in the preoperative area. He stated a time-out was performed correctly according to the facility's policy and procedure for Marking and Verification of Pain Management Procedure site. He stated in spite of the identifying mark and the time-out, he simply began to operate on the wrong digit. He acknowledged he was responsible for performing the wrong site surgery.

3. On 4/25/16 at 3:36 p.m., during an observation, MD 9 did not perform hand hygiene prior to putting on gloves and performing an esophagogastroduodenoscopy (EGD) procedure (test to examine the lining of the throat, stomach, and first part of the small intestines) on Patient 3.

On 4/27/16 at 8:25 a.m. during a telephone interview, MD 9 stated he was not aware of the policy to perform hand hygiene prior to putting on gloves.

On 4/27/16 at 8:32 a.m., during an interview, the Interim Director of Operations (IDO) stated the facility follows the Association of periOperative Registered Nurses (AORN) standards and the facility policy indicated hand hygiene is to be performed prior to putting on gloves.

The hospital policy and procedure titled, "Hand Hygiene" dated 2/12/15, indicated "PURPOSE... to provide guidelines for effective hand hygiene, in order to prevent the transmission of bacteria, germs, and infections... POLICY: 1.d. Before and after invasive procedures [entry of a body cavity], even if gloves are worn..."

The Association of periOperative Registered Nurses (AORN) publication titled, "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 putting gloves on and after removing gloves..."

4. a) On 4/25/16 at 3:38 p.m., MD 12 was observed wearing an exposed necklace with a dangling pendant during an EGD procedure on Patient 3 in Procedure Room 2.

On 4/26/16 at 12:49 p.m., during an interview, the Director of Clinical Services (DCS) stated the policy indicated all jewelry was to be covered during procedures in the Procedure Rooms.

On 4/28/16 at 11:27 a.m., during an interview, MD 12 stated she was aware of the facility policy that exposed necklaces should not be worn in the Procedure Rooms. She stated the necklace was of extreme importance and "I will try to keep it covered but I will never take it off."

The hospital policy and procedure titled, "Operating Room and Sterile Processing Dress Code" dated 10/30/14, indicated "PROCEDURE: A.9 Jewelry including earrings, necklaces, watches, and bracelets that cannot be contained or confined within the surgical attire should not be worn..."

The 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."

b) On 4/25/16 at 10 a.m., the Endoscopy Manager (EM) was observed to have her hair outside of her hat while in the semi-restricted area. In a concurrent interview, the EM was asked if she would do anything different if going into a procedure room. The EM stated she would do nothing different.

On 4/25/16 at 10:30 a.m., during a concurrent observation and interview, the surgical Technician (ST) was observed in the operating room with her hair outside her hat. The Interim Director of Operations (IDO) concurred that her hair was outside her hat.

The hospital's policy entitled "Operating Room Dress Code" dated 4/2014, indicated, "... Clean closed scrub jacket with cuffs down to the wrist... Head covering should cover facial hair, including sideburns and the nape of the neck."

c) On 4/25/16 at 10:30 a.m., during a concurrent observation and interview, two physicians and a circulating nurse (MD 3, MD 9, and RN 1) were observed with their bare arms exposed in the operating room. The IDO concurred that their arms were exposed and sent jackets in for them to put on.

The AORN "Guidelines for Perioperative Practice" indicated, "When in the restricted areas, all nonscrubbed personnel should completely cover their arms with a long-sleeved scrub top or jacket."

d) On 4/26/16 at 9:55 a.m., MD 13 wore a skull cap with his ears exposed while performing an EGD and colonoscopy (an examination used to find abnormalities in the large intestine and rectum) on Patient 4 in Procedure Room 2.

On 4/26/16 at 9:58 a.m., two registered nurses (RN 3 and RN 4) were observed wearing masks that did not cover their noses completely, leaving their noses exposed during two procedures on one of two tracer patients, Patient 4, in Procedure Room 2;

On 4/26/16 at 11:01 a.m., during an interview, MD 13 stated he did not know the facility policy regarding the covering of ears during procedures in the Procedure Rooms.

On 4/26/16 at 1:01 p.m., during a concurrent interview, the IDO stated and the DCS confirmed the facility policy indicated the ears and noses are to be covered during procedures in the Procedure Room.

On 4/27/16 ay 8:03 a.m., during a concurrent interview, RN 3 and RN 4 stated they were aware of the facility policy to cover the nose during procedures. Both stated the mask must have slipped down from their noses.

The hospital policy and procedure titled, "Operating Room and Sterile Processing Dress Code" dated 10/30/14, indicated "PROCEDURE: A.6. Masks should cover the mouth and nose ..."

On 4/27/16 at 8:21 a.m., during an interview, the IDO stated the facility follows the Association of periOperative Registered Nurses (AORN) standards.

The AORN publication, "Guidelines for Perioperative Practice," dated 3/9/12, indicated, "Guideline for Surgical Attire, Recommendation III - Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair... 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..."


The AORN publication, "Guidelines for Perioperative Practice," dated 3/9/12, indicated, "Guideline for Surgical Attire, Recommendation I, h.2. The surgical mask should cover the mouth and nose and be secured in a manner that prevents venting at the sides of the mask..."