HospitalInspections.org

Based on document review and interview, the hospital failed to incorporate and use quality indicator data to monitor the effectiveness and safety of services and quality for 5 of 5 monitors reviewed for data details (contracted biohazard waste hauler, contracted blood bank, housekeeping, laundry and maintenance) (See tag A273), based on document review and interview, the hospital failed to maintain an effective, data-driven quality assessment and performance improvement (QAPI) program that focused on indicators related to improved health outcomes and the prevention and reductions of medical errors (See tag A283), and based on document review and interview, the hospital failed to analyze causes and implement preventive actions for reports of medical errors related to 1 (one) medical staff (MS) member (MD1) and failed to ensure staff followed their policies/procedures for reporting and/or completing documentation of incidents in 5 of 5 events (See tag A286).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure that an effective quality program was in place.

Kentuckiana Medical Center LLC was found not in compliance with Requirements for Participation in Medicare/Medicaid, 42 CFR Subpart 482.41(b), Life Safety from Fire and the 2012 edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC), Chapter 19, Existing Health Care Occupancies.

This one story facility with an atrium was determined to be of Type II (000) construction and was fully sprinklered. The facility has a fire alarm system with smoke detection in the corridors, spaces open to the corridors and patients rooms. The facility has a capacity of 42 and had a census of 18 at the time of this survey.

Based on record review, observation and interview, the facility failed to maintain 3 of 16 corridors from obstructions (see tag K211), the facility failed to ensure the means of egress through 1 of 3 ER exits were readily accessible (see tag K222), the facility failed to replace sprinkler heads in 1 of 1 sprinkler system in accordance with LSC 9.7.5 (see tag K353), the facility failed to ensure 1 of 3 E wing corridor was separated from the corridors by a partition capable of resisting the passage of smoke (see tag K361), the facility failed to ensure the penetrations caused by the passage of wire and/or conduit through 4 of 8 smoke barrier walls were protected to maintain the smoke resistance of each smoke barrier (see tag K372), the facility failed to conduct quarterly fire drills for 1 of 4 quarters (see tag K712), the facility failed to ensure 8 of 8 fire drills shall be held at expected and unexpected times for under varying conditions to simulate the unusual conditions that can occur in an actual emergency for the last 4 quarters (see tag K712), the facility failed to ensure 8 of 8 fire drills included the verification of transmission of the fire alarm signal and simulation of emergency fire conditions for the last 4 quarters (see tag K712), the facility failed to ensure 2 of 2 space heater was in accordance with 19.7.8 (see tag K781).

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure that all locations from which it provides services are constructed, arranged and maintained to ensure the provision of quality health care in a safe environment.

Based on document review, observation and interview, the facility failed to ensure staff follow their policies/procedures for Surgical Instrument Counts, Aseptic Technique in the Operating Room (OR), Sterility of Items, Infection Control for Anesthesiology, Care of Surgical Specimens, Staff Responsibilities in the Operating Room, Methods of Infection Control Surveillance and Infection Control Plan in 1 (Surgery Department) of 5 areas toured (see tag A749).

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 by following policies and procedures for infection control.

Based on document review and interview, the governing body (GB) failed to ensure medical staff (MS) selection was based on competence, training, experience and judgement for 1 of 4 Active Staff MS members (MD1), failed to ensure application/reapplication processes were in agreement with the MS Bylaws for references and failed to ensure continued MS membership was based on competence and judgement following reported concerns related to MD1.

Findings include:

1. Review of MS Bylaws, Approved 4/4/18, indicated the following:
A. ARTICLE III. MEMBERSHIP MEDICAL STAFF APPOINTMENT
i. 1. c) No physician shall be entitled to membership on the Medical Staff or to the exercise of particular Clinical Privileges in the Hospital merely based solely: iii) Has Current or previously had MS membership or Privileges in this Hospital, or is a current or former MS member or holds or has held privileges in any other hospital or other health care facility. Appointments to the MS are based upon, but not limited to current licensure, education and relevant training, experience, ability and current clinical competence.
ii. 2. Qualifications for Membership. To assure the MS and Board of Managers (BOM) provide patients with quality care, treatment and services, the criteria and qualifications for membership have been established. Appointment to the Hospital MS is a privilege, which shall be extended only to professionally competent individual practitioners who continuously meet the qualifications, standards, and requirements set forth in these Medical Staff Bylaws, the MS Rules and Regulations, Hospital Bylaws, policies and procedures, Hospital Corporate Compliance Plan, and other requirements of policies established from time to time by the BOM. All individual practitioners must demonstrate to the satisfaction of the MS and the BOM that he/she meets all of the following qualifications for membership: g) Must be able to document their background, experience, training, judgment, individual character as well as demonstrate competence, physical and mental capabilities, and adherence to any and all the ethics of their profession. h) Must demonstrate their ability to work with and related to people, including other interpersonal skills in working with and relating to MS Members, Hospital employees and administration, the BOM, patients and visitors, and the community in general, in a cooperative, professional manner that maintains and promotes an environment of high quality medical care. j) Demonstrates freedom from, or adequate control over, any physical or mental impairment that would significantly affect his or her ability to practice including, but not limited to, abuse of any type of substance or chemical abuse that affects cognitive, motor or communication ability in any manner that interferes with, or has a reasonable probability of interfering with the qualifications for membership such that patient care is,, or is likely to be, adversely affected.
iii. 5. Procedures for Appointment and Reappointment. The mechanics for evaluating applications for initial appointment and for conducting periodic reappraisals for reappointment to the staff are outlined in Article VI of these Bylaws and will be conducted in agreement with the designated credentialing agency.
B. ARTICLE IV. MEDICAL STAFF CATEGORIES
i. 2. Active Staff. Shall consist of the Practitioners who have demonstrated an interest and commitment to the Hospital through patient care activities, as well as Hospital and MS services. a) Qualifications: An Active Staff Member must: i.) Be active in MS affairs and active in the clinical affairs of the Hospital; ii) Routinely admit, treat and care for patients at the Hospital;
ii. 11. Ongoing Professional Practice Evaluation (OPPE). All Active and Courtesy MS members will be evaluated every six (6) months or three (3) times within a two (2) year appointment cycle in accordance with the OPPE policy and procedure. i. OPPE provides a structure for monitoring, evaluating, documenting and reporting performance of MS practitioners and allied health professionals who are granted clinical privileges to provide care, treatment and service in accordance with the credentialing and privileging processes and requirements of the MS.
iii. 12. Focused Professional Practice Evaluation (FPPE). FPPE is an assessment of data or events, which related to the performance or behavior of a specific practitioner holding clinical privileges. The focused review is to determine whether the practitioner's performance or behavior meets the minimum standard of behavior or clinical care that is established by the medical staff. Triggers for FPPE may be single incident or evidence of a clinical practice trend. i) The FPPE process may be triggered when a practitioner has the credentials to suggest competence, but additional information or a period of evaluation is needed to confirm competence. ii) FPPE may be triggered when a currently privileged practitioner's ability to provide safe, high-quality patient care is questioned as documented by reports from others (e.g. OPPE Report). iii) FPPE is the evaluation process utilized upon the granting of initial privileges and/or when additional/new privileges are granted.
C. ARTICLE VI. APPLICATION, APPOINTMENT AND REAPPOINTMENT PROCEDURES
i. 4. Application Contents. Every Application must include at least the following: a) The names and complete addresses of at least three (3) physicians or other practitioners, as appropriate who have had recent experience in observing and working with the Applicant, and who can provide adequate information pertaining to the Applicant's present professional clinical competence and character. Except for graduate medical education, these references may not be from individuals associated or about to be associated the the applicant in professional practice or personally related to the applicant. At least one (1) reference shall be from a practitioner who has had experience in observing and working with the applicant.

2. Review of MS credential files indicated MD1 was reappointed to the Active MS and granted privileges on 6/27/18 and was granted additional privileges 7/20/18.
A. The file indicated MD1 made application and requested privileges on 3/1/18 for the following: Amputations, Hemodialysis access procedures, Laparotomy and Vein ligation and stripping.
B. OPPE Summaries for the 2 year appointment cycle prior to the 6/27/18 reappointment indicated the following:
i. OPPE Period from 7/1/16 to 12/31/16. The practitioner has not provided an adequate volume of patient care and treatment in order to form an opinion. (Competency documentation may be required from primary facility at time of reappointment). Included was an attachment with facility documentation for hospital activity for MD1 dated 7/1/16 to 12/31/16 as follows: Admits - 0, Consults - 0, Discharges - 0.
ii. OPPE Period from 1/1/17 to 6/30/17. This OPPE summary report for the above-named practitioner is being made based on a combination of the following: Chart review. Direct Observation. Monitoring diagnostic and treatment techniques and clinical practice patterns. Discussion with other individuals involved in care of each patient. Other: Competency Evaluation Form. In accordance with MS Policy #MS 1.19, I have reviewed the attached documentation and agree with the findings. The physician named above is considered to be competent for the privileges requested. "(In accordance with attached evaluation)" was written in the document. Included was an attachment with facility documentation for hospital activity for MD1 dated 1/7/17 to 6/30/17 as follows: Admits - 0, Consults - 0, Discharges - 0. Also included as an attachment was a document titled CLINICAL COMPETENCY EVALUATION FORM, indicated to be from MD1's primary facility, signed by MD1 on 7/24/17 and a person titled as Chairman/Director on 7/21/17. The document lacked documentation of the number of admissions, consultations, procedures and discharges and lacked documentation of the name of the facility.
iii. OPPE Period from 7/1/17 to 12/31/17. This OPPE summary report for the above-named practitioner is being made based on a combination of the following: Chart review. Direct Observation. Monitoring diagnostic and treatment techniques and clinical practice patterns. Discussion with other individuals involved in care of each patient. In accordance with MS Policy #MS 1.19, I have reviewed the attached documentation and agree with the findings. The physician named above is considered to be competent for the privileges requested. Included was an attachment with facility documentation for hospital activity for MD1 dated 7/1/17 to "12/31/2018" as follows: Admits - 0, Discharges - 0, Consults - 0, Procedures - 0. Also included as an attachment was a document titled CLINICAL COMPETENCY EVALUATION FORM, indicated to be from MD1's primary facility, signed by MD1 on 1/24/18 and a person titled as CPCS (Certified Provider Credentialing Specialist) on 1/24/18. The document lacked indication of what type of clinical competence was denoted as "satisfactory" and lacked documentation of types of procedures and consultations performed by MD1. An attached document titled Surgeon Procedure List, indicated to be 2017 Total, lacked documentation of competency or outcomes of procedures performed by MD1.
iv. The file indicated a PEER REFERENCE was completed on 7/5/18 by MD5, Medical Director/Family Medicine practitioner with the following information: EVALUATIONS: Clinical Competence: Above Average. Above information is based on the following (the following were indicated by check marks): Close Personal Observation. A Composite of Evaluations. The file lacked documentation of number of observations, dates or outcomes for close personal observations of clinical competence for MD1, surgeon, by MD5, family practice physician.
C. Review of MD1's application dated 3/1/18 indicated, in section XII. PEER REFERENCES that the applicant was to name two (2) peers who had personal knowledge of current clinical abilities and ethical character to provide specific written comments on those matters. Section XII further indicated that at least one of the references must have had organizational responsibility for the applicants' performance. Three references were not requested as per the Bylaws, nor were 3 listed. Documentation within the file indicated only 1 listed peer reference provided feedback. The file lacked documentation of a reference who had had organizational responsibility for the performance of MD1.
D. The credential file indicated that on 7/20/18, an addendum was submitted as a request for additional privileges for MD1 as follows: I request addition of the following privileges and the reason for the addition. - Management of hernias. - Intended to request this privilege at reappointment. Letter dated 7/20/18 indicated that effective 7/20/18, MD1 had been granted Temporary/Expedited Hernia Management privileges.

3. Review of facility documents indicated the following:
A. Review of a letter dated 7/3/18 indicated that an operating room staff member expressed concern and complaint related to patient care and treatment provided by MD1.
B. Review of incident reports (IR) indicated that on 6/24/18, MD1 was named in an incident involving incorrect suture count at the end of surgery and a missing needle.

4. A. On 8/14/18, between approximately 12:30 p.m. and 1:30 p.m., the following was indicated in interview:
i. A8, CST (Certified Surgery Technician), indicated that multiple operating room staff had reported up issues related to MD1 and his/her surgery practices. A8 indicated that he/she was unaware of any follow up pertaining to incidents and/or complaints. Example given by A8 was as follows: Patients return frequently following surgery by MD1. A8 indicated MD1 let go of a "fem" one time during surgery. A8 also indicated that during a recent surgery, an item (debakey) could not be located at the time the physician wanted to close the patient, the surgery staff asked for him/her to stop/hold to locate the item prior to closing the patient, but MD1 refused and closed the patient prior to finding the instrument.
ii. A9, CST, indicated, he/she did write up the notice of concerns, dated 7/3/18, related to patient care provided by MD1and hand delivered it to A1, Chief Nursing Officer (CNO) on that same date. A9 indicated that A1 told him/her that the matter would be reviewed. A9 stated he/she had not heard anything more, to date, verbally or in writing.
B. On 8/14/18, between approximately 3:30 p.m. and 4:00 p.m., MD5, Medical Directory, indicated the following:
i. MD5 indicated he/she was aware of a situation in which a patient of MD1 had a hematoma (draining) in ICU (Intensive Care Unit) and MD1 was a bit cavalier about the issue. When asked about concerns/complaints from staff related to MD1, MD5 indicated he/she was not in the surgery department. When asked about MD1 having a high number of SSI (Surgical Site Infections), MD5 indicated the facility was going to compare that to other facilities and if MD1 fell out of the normal range, then it would be addressed. MD5 indicate no FPPE had been done for any issue(s) related to MD1. When asked if he/she believed an FPPE should have been completed for review of MD1, MD5 indicated "I believe so."
ii. In credential file review, A6, MS Coordinator, verified that no FPPE had been done on MD1 within the past 2 years. A6 confirmed that MS Bylaws were not in agreement with the application/reapplication form for the number of references required. A6 also verified that the application for MD1 was processed with only 1 (one) reference check and that the reference documentation did not indicate the reference to have had organizational responsibility for the performance of MD1.

Based on document review and interview, the hospital failed to ensure prompt resolution of patient grievances and failed to provide written notice with stated number of days expected for follow-up, for 4 of 6 patient grievances and 1 employee grievance, related to patient care, within the past 12 months.

Findings include:

1. Review of the policy titled Patient Grievances, Last Updated: 3/10/2018, indicated the following:
A. Policy: The hospital provides for and welcomes concerns, complaints grievances, and suggestions from patients, family, visitors, vendors, and employees.
B. Procedure:
i. 1. Patient/Family and Visitors: A "patient grievance" is a written or verbal complaint (when the verbal complaint about patient care is not resolved at the time of the complaint by staff present) by a patient, or the patient's representative regarding the patient's care, abuse or neglect, or concerns regarding premature discharge. A written complaint is always considered a grievance, whether from an inpatient, outpatient, release/discharged patient or their representative regarding patient care provided, abuse or neglect.
ii. 3. If a patient, family, or visitor voices a concern, complaint or grievance, the employee or physician will initiate a Patient Complaint Form and then forward the form immediately to the Chief Operating Officer (COO) and Chief Nursing Officer (CNO). Whenever possible, the complainant will be included in all processes surrounding the complaint issue, from the investigation to its resolution.
iii. 4. The (Hospital) will make every attempt to complete or resolve a grievance within 7 days. If (the Hospital) is unable to complete or resolve the grievance within 7 days, The (Hospital) will inform the patient and/or their representative or visitor in writing that the hospital is still attempting to resolve the grievance and they will receive written notice of resolution within 30 days.
iv. 5. In the resolution of the grievance, (Hospital) will provide the patient, family or visitor with a written notice of its' decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process and the date of completion.
v. 7. Review and follow-up will be reported to the Performance Improvement Committee (QAPI), Medical Executive Committee (MEC) and Board of Managers (BOM) as indicated by nature of the complaint.
C. Employees:
i. Employees wishing to voice a concern, complaint or grievance will be given a blank Complaint Form and asked to complete the form.
ii. The completed form will be given to the Human Resource Coordinator for review and follow-up.
iii. Results of the review may be shared with the complainant.
iv. Review and follow-up will be reported to the QAPI Committee, MEC and Management Committee as indicated by the nature of the complaint.

2. Review of complaints and grievances for the past 12 months, indicated the following:
A. Date of Initial Complaint: 7/15/18. The form indicated Additional Follow-up required. Additional follow-up: BOD (Board of Directors) to review this case. May also need Peer review. The hospital lacked documentation of follow-up within 7 days and lacked documentation of written notice to the patient or their representative.
B. Date of Initial Complaint: 10/30/17. The form indicated Additional Follow-up required. The hospital lacked documentation of resolution within 7 days and lacked documentation of written notice sent to the patient or their representative, within 7 days, with a stated number of days for investigation to be completed. The file indicated that the patient representative returned contact to the hospital complaining that no follow-up had been received since a discussion/meeting with A1, CNO on 10/30/18, but lacked documentation of the date of that contact.
C. The files indicated a written complaint, dated 9/12/17, was received, unable to determine date received. The file lacked documentation of a Patient Complaint Form. The complaint/grievance file indicated 2 letters, dated 10/20/17 and 10/27/17, were written to the complainant. The letters lacked a stated number of days in which the complainant could expect a response with resolution from the hospital.
D. The files indicated a written complaint, dated 8/30/17, was received, certified mail stamp, indicated 31, Aug. '17. The file lacked documentation of a Patient Complaint Form. The complaint/grievance file indicated 3 letters, dated 9/6/17 and 10/20/17 and 10/27/17 were written to the complainant. The letters lacked a stated number of days in which the complainant could expect a response from the hospital.

3. Review of a letter dated 7/3/18 indicated that an operating room staff member expressed concern and complaint as a patient advocacy plea related to patient care and treatment provided by surgeon/physician, MD1. The facility lacked documentation of review and/or follow-up of the complaint/grievance.

4. On 8/14/18, between approximately 12:30 p.m. and 1:30 p.m., A9, CST, indicated, he/she did write up a notice of concerns related to patient care provided by MD1 and hand delivered it to A1, Chief Nursing Officer (CNO). A9 verified it was the document dated 7/3/18 and further indicated the complaint was presented to A1 on the same date. A9 indicated that A1 told him/her that the matter would be reviewed. A9 stated he/she had not heard anything more, to date, verbally or in writing.

5. On 8/20/18 between approximately 1:30 p.m. and 2:00 p.m., A1 verified the following:
A. No written response had been sent to the patient or representative related to the complaint documented as 7/15/18 and no resolution was documented.
B. RE: Complaint dated 10/30/17. The hospital lacked documentation of resolution within 7 days and lacked documentation of written notice sent to the patient or their representative, within 7 days, with a stated number of days for investigation to be completed.
C. RE: Written complaint dated 9/12/17. The file lacked documentation of a Patient Complaint Form. The letter dated 10/20/17 lacked a stated number of days in which the complainant could expect a response from the hospital and that both letters were beyond the 7 day response time indicated by their policy.
D. RE: Written complaint dated 8/30/17. The file lacked documentation of a Patient Complaint Form. The letters lacked a stated number of days in which the complainant could expect a response from the hospital.

Based on document review, observation and interview, the facility failed to ensure the privacy and security of each patient's Protected Health Information (PHI) in 1 (Medical Surgical Unit) of 5 areas toured.

Findings include:

1. Policy/procedure, Health Information Management Plan, revised/reapproved 3/30/2018 indicated on page 3: "Access to patient health information is restricted to individuals who have the need, reason and authority to access such information".

2. While on tour of the Medical Surgical Unit on 8/20/18 at approximately 1330 hours, accompanied by staff N2, patient medical record information was visible on a computer monitor screen in public hallway and patient charts were observed on a countertop accessible to unauthorized individuals.

3. Staff N2 was interviewed on 8/20/18 at approximately 1330 hours and confirmed patient medical record information was visible on a computer monitor screen in the public hallway of the Medical Surgical unit. Staff N2 confirmed clinical staff had not properly secured the patient medical record information prior to walking away from the computer monitor allowing for access of unauthorized persons.

Based on document review and interview, the hospital failed to incorporate and use quality indicator data to monitor the effectiveness and safety of services and quality for 5 of 5 monitors reviewed for data details (contracted biohazard waste hauler, contracted blood bank, housekeeping, laundry and maintenance).

Findings include:

1. Review of the hospital policy titled Performance Improvement Plan, Date Last Updated: 3/21/2018: indicated the following:
A. Policy: 6. The Organizational Program, established by the medical staff and interdisciplinary PI (Performance Improvement) Committee (PIC), with support and approval from the Board of Directors (BOD), has the responsibility for data collection in every aspect of patient care; from the time the patient enters the Hospital through diagnosis, treatment, recovery and discharge. 7. Analysis of data is completed in order to identify and resolve any breakdowns that may result in sub-optimal patient care and safety.
B. Goals of Performance Improvement:
i. 3. Focus upon the scope of services performed throughout the Hospital, and how well it is performed to provide healthcare. To facilitate this goal, emphasis is placed upon "dimensions of performance". These dimensions of performance include: Efficacy of the procedure or treatment in relation to the patient's condition; Appropriateness of a specific test, procedure or service to meet the patient's condition; Safety of the patient (and others) to whom the services are provided; Efficiency with which services are provided; Respect and caring with which services are provided.
ii. 4. Provide for a Hospital wide program that ensure the Hospital designs processes well and systematically measures, analyzes and improves its performance to achieve optimal patient health outcomes in a collaborative, cross-departmental, interdisciplinary approach.
C. Measurement: Measurement is the foundation of quality assurance/improvement activities. Measurement involves the collection of data and forms the basis for determining the level of performance of existing processes and the outcomes resulting from these processes. Measurement will be systematic, related to relevant dimensions of performance, and be appropriate in scope and focus. 3. Intensive assessment will occur in the following cases: *When there is an undesirable variation.

2. Review of Quality Assurance/Performance Improvement (QAPI) meeting minutes dated 2/2/18, 3/30/18, 5/24/18 and 7/6/18, lacked documentation of 2018 data measurements for contracted biohazard waste hauler, contracted blood bank, housekeeping, laundry and maintenance. Attached reports indicated performance percentages for biohazard waste hauler, contracted blood bank, housekeeping, laundry and maintenance; but lacked documentation of frequency and detail at which data would be collected. The attached report titled "Blood Bank" lacked documentation of monitors specific to the contracted blood bank service.

3. The following was indicated in interview:
A. On 8/17/18 between approximately 1:15 p.m. and 2:45 p.m., A1, Chief Nursing Officer (CNO), indicated that QAPI training of staff did not include how to measure quality data and verified that the hospital had not established the detail of data collection for reporting indicator outcomes. A1 verified that the data documentation titled "Blood Bank" was not that of the contracted blood bank services. A1 also indicated that he/she could not show actual data collection and analysis for housekeeping to verifying the percentage documented on the report.
B. On 8/17/18 between approximately 2:00 p.m. and 2:45 p.m., A14, Plant Operations, verified he/she was responsible for data collection of biohazard waste hauler, housekeeping, laundry and maintenance indicators. A14 indicated he/she had not had any formal training for QAPI and verified that he/she could not show that a systematic measurement was in place for data collection of those indicators.

Based on document review and interview, the hospital failed to take appropriate action to address opportunities for improvement by failing to complete analysis of 14 surgical site infections (SSI), by failing to implement preventive actions for reported patient safety issues pertaining to 1 physician's services (MD1) and by failing to review and follow-up on patient grievances according to policy for 2 of 2 complaints/grievances in 2018.

Findings include:

1. Review of hospital policies indicated the following:
A. The Performance Improvement Plan, Last Updated: 3/21/18, indicated the following:
i. POLICY: 6. The Organizational Program, established by the medical staff (MS) and interdisciplinary PI (Performance Improvement) Committee (PIC), with support and approval from the Board of Directors (BOD), has the responsibility for data collection in every aspect of patient care; from the time the patient enters the Hospital through diagnosis, treatment, recovery and discharge. 7. Analysis of data is completed in order to identify and resolve any breakdowns that may result in sub-optimal patient care and safety.
ii. GOALS OF PERFORMANCE IMPROVEMENT: 9. The status of identified problems is tracked to assure improvement or problem resolution. 10. Information from departments and the findings of improvement activities are used to detect trends, patterns of performance or potential problems that affect more than one department.
iii. SCOPE OF SERVICES: 8. At monthly/bimonthly/quarterly meetings of committees, findings of the Safety Committee, continuous performance improvement activities or the staff an appropriate departments and disciplines that impact patient care, safety, and medical staff services is reviewed, assessed and evaluated, including, but not limited to: Operative and Invasive Procedure Data collection; Surveillance, Prevention, and Control of Infection; Provision of Care; Complaints/Grievances; Medical Staff (MS) will review licensed independent practitioner and allied health staff issues through its process of peer review.
B. The Patient Grievances policy, Last Updated: 3/10/18, indicated the following:
i. Policy: The hospital provides for and welcomes concerns, complaints grievances, and suggestions from patients, family, visitors, vendors, and employees.
ii. Procedure: 7. Review and follow-up will be reported to the Performance Improvement (QAPI) Committee, Medical Executive Committee (MEC) and Board of Managers (BOM) as indicated by the nature of the complaint. Employees: -Employees wishing to voice a concern, complaint or grievance will be given a blank Complaint Form and asked to complete the form. -Results of the review may be shared with the complainant. -Review and follow-up will be reported to the QAPI Committee, MEC and Management Committee as indicated by the nature of the complaint.

2. Review of hospital documents indicated the following:
A. The log of SSIs, SSI date range from 1/17/18 through 7/27/18, indicated the hospital had logged 14 surgical site infections. Five (5) of the 14 were documented to have occurred between 7/15/18 and 7/27/18. B. Review of a letter dated 7/3/18 indicated that an operating room staff member expressed concern and complaint related to patient care and treatment provided by MD1.
C. Review of complaints and grievances for calendar year 2018, indicated the hospital documented 2 complaints as follows:
i. Date of Initial Complaint: 7/15/18. The Patient Complaint form indicated Additional Follow-up required. Additional follow-up: BOD (Board of Directors) to review this case. May also need Peer review.
ii. Unable to determine initial date of complaint, due to lack of documentation. Earliest date complaint file documentation indicated an incident report was completed about a patient stay on 1/12-1/13 (year not indicated), the date of the event was not documented. Handwritten notes indicated someone, name not indicated, spoke with a family member about a complaint/grievance on 1/24/18.

3. Review of meeting minutes indicated the following:
A. Quality Assurance/Performance Improvement (QAPI) meeting minutes dated 2/2/18, 3/30/18, 5/24/18 and 7/6/18, lacked documentation of review, analysis and/or implementation of preventive actions for SSIs and lacked documentation of follow-up for complaints and grievances from patients/representatives and lacked documentation or review and/or follow-up of complaints from staff.
B. Minutes from the document titled "Special Meeting to Discuss SSI with (MD1), dated 8/2/18, lacked documentation of what infections were being reviewed, and lacked documentation of review and analysis of data collected for the 14 SSIs. The minutes indicated that SSIs for 1 specific physician, MD1, were discussed; however, the minutes lacked documentation of preventive action to be implemented.
C. MEC meeting minutes dated 4/4/18, 6/20/18, 6/27/18, 7/23/18 and 8/1/18 lacked documentation of review, analysis and/or implementation of preventive actions for the 14 SSIs, complaints from staff and/or patient complaints and grievances.
D. The hospital lacked documentation of Peer Review meeting minutes following the 7/3/18 complaint on MD1.
E. BOD meeting minutes dated 4/4/18, 6/20/18 and 6/27/18 lacked documentation of the GB having received Quality Management reports of review, analysis and/or implementation of preventive actions taken for SSIs in 2018 and lacked documentation of review or follow-up of patient and/or staff complaints and grievances.

4. The following was indicated in interview:
A. On 8/14/18, between approximately 12:30 p.m. and 1:30 p.m., A9, CST, indicated, he/she did write up a notice on 7/3/18 of concerns related to patient care provided by MD1 and hand delivered it to A1, Chief Nursing Officer (CNO) on that date. A9 indicated that A1 told him/her that the matter would be reviewed. A9 stated he/she had not heard anything more, to date, verbally or in writing.
B. On 8/14/18, between approximately 3:30 p.m. and 4:00 p.m., MD5, Medical Directory, when asked about concerns/complaints from staff related to MD1, indicated he/she was not in the surgery department. When asked about MD1 having a high number of SSI (Surgical Site Infections), MD5 indicated the facility was going to compare that to other facilities and if MD1 fell out of the normal range, then it would be addressed. MD5 indicate no Peer review had been done for any issue(s) related to MD1. When asked if he/she believed a focused evaluation should have been completed for review of MD1, MD5 indicated "I believe so."
C. On 8/17/18 at approximately 1:15 p.m., A1, CNO, verified that 7/6/18 was the most recent QAPI meeting and that SSIs were not included. On 8/20/18 between approximately 1:30 p.m. and 2:00 p.m., A1 verified that QAPI, MEC and BOD meeting minutes lacked documentation of complaint and grievance follow-up.

Based on document review and interview, the hospital failed to analyze causes and implement preventive actions for reports of medical errors related to 1 (one) medical staff (MS) member (MD1) and failed to ensure staff followed their policies/procedures for reporting and/or completing documentation of incidents in 5 of 5 events.

Findings include:

1. Review of the hospital policy titled Performance Improvement Plan, Date Last Updated: 3/21/2018: indicated the following:
A. Policy: 6. The Organizational Program, established by the medical staff and interdisciplinary PI (Performance Improvement) Committee (PIC), with support and approval from the Board of Directors (BOD), has the responsibility for data collection in every aspect of patient care; from the time the patient enters the Hospital through diagnosis, treatment, recovery and discharge. 7. Analysis of data is completed in order to identify and resolve any breakdowns that may result in sub-optimal patient care and safety.
B. Goals of Performance Improvement:
i. 3. Focus upon the scope of services performed throughout the Hospital, and how well it is performed to provide healthcare. To facilitate this goal, emphasis is placed upon "dimensions of performance". These dimensions of performance include: Efficacy of the procedure or treatment in relation to the patient's condition; Appropriateness of a specific test, procedure or service to meet the patient's condition; Safety of the patient (and others) to whom the services are provided; Efficiency with which services are provided; Respect and caring with which services are provided.
ii. 4. Provide for a Hospital wide program that ensure the Hospital designs processes well and systematically measures, analyzes and improves its performance to achieve optimal patient health outcomes in a collaborative, cross-departmental, interdisciplinary approach. These processes include mechanisms to assess the needs and expectations of the patients and their families, staff and others. Process design contains the following focus elements: Consistency with the organization's mission, vision, values, goals, objectives, and plans; Meets the needs of individuals served, staff and others; Use of clinically sound and current data sources (for instance, use of practice guidelines, information from relevant literature and clinical standards); Incorporates available information from internal sources and other organizations about the occurrence of medical errors and sentinel events to reduce the risk of similar events in this institution.
iii. 9. The status of identified problems is tracked to assure improvement or problem resolution.
iv. 10. Information from departments and the findings of improvement activities are used to detect trends, patterns of performance or potential problems that affect more than one department.
C. Measurement: 3. Intensive assessment will occur in the following cases: *When there is an undesirable variation

2. Review of the Medical Staff (MS) Bylaws, approved 4/4/18, indicated the following in Article X. Committees.
A. 4. Performance Improvement/Quality Assessment Committee. b) Duties. ii) The Committee shall be responsible for assuring the implementation of a planned and systematic process for monitoring and evaluating the quality of the care and treatment of patients served and the clinical performance of all individuals with Clinical Privileges. The Committee shall review the performance improvement/quality assessment activities of each Department to see that areas for improvement are being identified; corrective action is being taken as appropriate and follow-up assessments are being completed. Review and evaluation shall include selected deaths, unimproved cases, tissues, infections, complications, and error in diagnosis and results of treatment. The Committee shall report in writing its conclusions, recommendations, action taken and the results of actions to the MEC (Medical Executive Committee).
B. 8. Professional Review Committee (PRC) or Appeals Committee. b) Duties: The PRC Committee shall perform the following functions: i) Provide a gathering point for the consideration of all concerns expressed by the MS, Hospital staff, Administration, and the public, dealing with the professional behavior of members of the MS, Independent Practitioners, and Allied Health Professionals. c) Meetings: The PRC shall meet as needed. A record of the proceedings and actions taken by the Committee shall be maintained. This Committee shall submit a written report to the MEC and Risk Manager.

3. Review of Governing Body (GB) Bylaws, Revision: 3/21/18, indicated the following: Article 3, MEMBERSHIP & MEETING OF THE BOARD OF DIRECTORS/TRUSTEES. 3.11 RESPONSIBILITIES. (a) Assuming responsibility for Medical Staff oversight and quality care evaluation as described in Section 7.2 and 8.1 of these bylaws. (d) Establishing, maintaining and supporting, through the CEO (Chief Executive Officer) and the MS and its designated committees a comprehensive hospital-wide program for ; receiving reports of information on a regular basis from the MS, and assuring that all aspects of the program are performed appropriately and that administrative assistance is available to the MS.

4. Review of incident reports (IR) indicated that on 6/24/18, MD1, Active Medical Staff Member, was named in an incident involving incorrect suture count at the end of surgery and a missing needle.

5. Review of a letter dated 7/3/18 indicated that an operating room staff member expressed concern and complaint related to processes of patient care and treatment provided by MD1.

6. Review of facility complaints and grievances indicated that on 7/15/18 a complaint/grievance was called in from a patient's family to voice concern related to the patient's condition and the patient having had "multiple surgeries", the patient having had a left AKA (above the knee amputation) and developed acute tubular necrosis. The document indicated the family also voiced concern that the patient may have to undergo additional surgeries for wound management and requested a second opinion. The document indicated MD1 was the surgeon of subject. Documentation on the form, titled "The Patient Complaint/Grievance Log", further indicated the following: Additional Follow-up required. Additional follow-up (hand written in was the following): BOD to review this case. May also need Peer Review.

7. Review of hospital meeting minutes indicated the following:
A. Quality Assurance/Performance Improvement (QAPI) meeting minutes dated 2/2/18, 3/30/18, 5/24/18 and 7/6/18, lacked documentation of review of problems and tracking of problems to assure improvement or problem resolution related to issues identified in IRs, staff submitted concerns and patient complaints pertaining to MD1.
B. MEC meeting minutes dated 4/4/18, 6/20/18, 6/27/18 and 8/1/18, lacked documentation of Performance Improvement/Quality Assessment Committee (QAPI) written conclusions, recommendations, actions taken and results of actions related to review and evaluation of unimproved cases, infections and/or complications. The 8/1/18 minutes indicated the MEC reviewed minutes of the SSI (surgical site infection) Committee from 6/31/18, however, notes under the section titled Recommendation/Action, lacked documentation of conclusions, recommendations or actions taken.
C. The hospital lacked documentation of any PRC meetings within the past year.
D. GB meeting minutes dated 4/4/18, 6/6/18, 6/27/18, 7/23/18 and 8/1/18, lacked documentation of GB review or provision of administrative assistance/problem resolution related to issues identified in IRs, staff submitted concerns and patient complaints pertaining to MD1. The minutes also lacked documentation of the BODs having reviewed the 7/15/18 documented complaint/grievance.
E. Document titled "Special Meeting to Discuss SSI with (MD1)", August 2, 2018 Meeting Minutes, indicated a meeting was held with MD5, Medical Director; A1, Chief Nursing Officer; MD1 and A6, Executive Assistant. The meeting minutes indicated the group discussed the following issues/concerns:
i. An IR where a patient of MD1 had a hematoma, MD1 removed surgical site staples from patient in ICU (intensive care unit), then used a Yankauer suction to aspirate drainage from the incision.
a) Minutes indicated the suction was observed to be in the neck, under the skin "to suck out the clot".
b) MD1 indicated that had he/she known the Yankauer suction was clean, but not sterile, he/she would not have used it. CNO informed the hospital did not have sterile suction on the floors/units.
c) The minutes indicated the patient later, in a few hours, returned to the OR (operating room) following the removal of staples in ICU.
d) CNO noted that the incident was just one instance that had been observed.
e) MD5 indicated that it is not good surgical technique to do in the ICU.
ii. Increased infection rates of MD1's surgery patients.
a) CNO indicated there had been six (6) infections since 4/20/18 and three of those were the same patient.
iii. General outcomes of MD1s patients: The minutes indicated that this year (2018), MD1 had 39 cases (25 patients). Of that 25, 9 patients were brought back and 1 of those patient was brought back 5 times.
iv. Recommendations/Actions:
a) MD5 asked that surgeries be scheduled properly with A13, OR Director, to ensure good amount of prep time.
b) MD5 indicated what would be considered as "enough" would be to spend the right amount of time prepping the patient, trying to think ahead and think about infections. The minutes indicated that MD1 stated he/she did not know how the surgical team prepped at the hospital.
v. CNO reported that he/she had complaints from OR nurses about MD1 calling them names.
vi. MD1 stated that his/her case "tomorrow" would be a fresh start.

8. The following was indicated in interview:
A. On 8/14/18, between approximately 12:30 p.m. and 1:30 p.m.:
i. A8, CST (Certified Surgery Technician), indicated that multiple operating room staff had reported up issues related to MD1 and his/her surgery practices. A8 indicated that he/she was unaware of any follow up pertaining to incidents and/or complaints. Example given by A8 was as follows: Patients return frequently following surgery by MD1. A8 indicated MD1 let go of a "fem" one time during surgery. A8 also indicated that during a recent surgery, an item (debakey) could not be located at the time the physician wanted to close the patient, the surgery staff asked for him/her to stop/hold to locate the item prior to closing the patient, but MD1 refused and closed the patient prior to finding the instrument.
ii. A9, CST, indicated, he/she did write up a notice of concerns related to patient care provided by MD1 and hand delivered it to A1, Chief Nursing Officer (CNO). A9 verified it was the document dated 7/3/18 and further indicated the complaint was presented to A1 on the same date. A9 indicated that A1 told him/her that the matter would be reviewed. A9 stated he/she had not heard anything more, to date, verbally or in writing.
B. On 8/14/18, between approximately 3:30 p.m. and 4:00 p.m., MD5, Medical Directory, indicated the following:
i MD5 indicated he/she was aware of a situation in which a patient of MD1 had a hematoma (draining) in ICU (Intensive Care Unit) and MD1 was a bit cavalier about the issue. When asked about concerns/complaints from staff related to MD1, MD5 indicated he/she was not in the surgery department. When asked about MD1 having a high number of SSI (Surgical Site Infections), MD5 indicated the facility was going to compare that to other facilities and if MD1 fell out of the normal range, then it would be addressed.
C. On 8/17/18 at approximately 1:15 p.m., A1, CNO, verified that 7/6/18 was the most recent QAPI meeting.

9. Review of facility documents and surgery logs between 8/1/18 and 8/16/18, indicated MD1 performed surgeries/procedures beyond 8/1/18 through 8/10/18, prior to this survey and remained a member of the MS with surgical privileges during that time.












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10. Policy/procedure LS 1.16, Incident Reports and Reportable Events, revised/reviewed 3/21/2018 indicated:
A. Page 1: "An Incident is broadly defined as any happening (occurrence) that is not consistent with the routine operation of the facility. Included in this definition are accidents (with or without injury) involving patients, visitors, and employees. Also, included are violations of established procedures, disturbances, or other unfavorable situations that may damage the facility's public reputation or image".
B. Page 5: "Major categories of Incidents: Patients: Medication errors, leaving the facility against medical advice, failure to treat, refusal of treatment or examination, slips, falls, burns, testing and treatment errors, hostility, allegations of wrong-doing by facility personne, sentinel or reportable events as required by ISDH to be reported publicly, etc.".
C. Page 6: "19. The Chief Nursing Officer and Chief Operating Officer will note any fact developed during investigation, any additional action taken, communication with individuals involved, and any recommendations for prevention. 20. The initial investigator, the Chief Nursing Officer or Chief Operating Officer, will sign and date the form. 21. Investigation to completed within 7 days of occurrence. 22. Once the investigation is complete, the occurrence will be presented at the Quality Improvement Committee, Medical Executive Committee, and Board of DIrectors".

11. Policy/procedure OR 3.14, Reporting Incidents, revised/reviewed 3/30/2018 indicated:
A. Page 1: "There will be a prompt reporting of incidents in order to facilitate the identification of trends or problem areas that could affect quality of patient care or could lead to claims against the hospital or its employees. 1. Incident/unusual occurrence reports should be filled out for the following operating room related occurrences, but not limited to: Incorrect sponge, needles, sharps or instrument count. Omission of a count required by policy. Break in sterile technique, exposing patient to potential contamination".
B. Page 2: "Guidelines for completing an incident/unusual occurrence report including the following: An incident report is completed for any unusual occurrence (the person who witnessed or was involved in the incident should complete the report). The incident report is completed as soon after the incident occurs as is possible. When a physician is involved, his or her signature is requested".

12. Review of Incident Report indicating an event that occured on 6/24/18 in the operating room (OR) related to medical record (MR) 1, lacked documentation of the following: recommendation for prevention; signature and date of initial investigator (Chief Nursing Officer or Chief Operating Officer); completed investigation details presented to Quality Improvement Committee, Medical Executive Committee and Board of Directors; documentation of involved physician signature.

13. Review of facility incident reports from 1/1/8 through 8/15/18 lacked documentation of a completed incident report for the following events:
A. Review of employee grievance dated 7/2/18 at 1243 hours from staff N1 written to staff N2 indicated: "Medical staff D1 would not let me properly drape the patient. Throughout the case he/she was pulling the bottom drape up breaking sterility. I told him/her several times the field was no longer sterile and was told it's fine...While suturing the incision site, medical staff D1 would not hand the used needles back or place them back in the needle holder. He/she was throwing them in the pool of blood on the drapes".
B. Review of employee grievance dated 7/3/18 per staff N3 written to staff N2 indicated: "1. After one of the surgeries, medical staff D1 would not allow me to clean up the patient prior to sending him/her back to Intensive Care Unit (ICU) and his/her family. He/she insisted that the protocol would cool him/her down...3. In another procedure medical staff D1 went ahead and closed the patient prior to Radiology's report and breakdown. Two needles were missing, two separate times".
C. Review of report communicated via email from staff N4 to staff N5 dated 8/2/18 at 0755 hours indicated: "I am providing you with a detailed list of all the infection control safety items I have addressed...One of them had to do with medical staff D2 wanting housekeeping to go into the dumpster to get out his/her surgical instrument that was thrown away that belonged to him/her. He/she used it for intubation and was not ever cleaned by our sterile processing staff. Then he/she found it and took it into use on a new procedure, dirty. This was immediately addressed and staff N2 was called this happened on 7/20/18".
D. Review of report communicated via email from staff N4 to staff N5, staff N2, staff N6, staff N7, staff N8, staff N9 and staff N10 on 8/2/18 at 1427 hours indicated: "I am letting you know we had a surgical site infection and here is the specific patient information:...This patient had a tricuspid valve placed that failed the internal sterilization indicator but was used on the patient anyway. Medical staff D3 is aware this was used because it was used at his/her direction".

14. On 8/14/18 at approximately 1215 hours, staff N1 (Surgical Technician) was interviewed and confirmed he/she communicated written concerns to staff N2 (Chief Nursing Officer) regarding medical staff D1 on 7/2/18. Staff N1 confirmed he/she did not receive a response regarding concerns that were communicated and/or was not instructed to complete incident report details.

15. On 8/14/18 at approximately 1245 hours, staff N3 (Surgical Technician) was interviewed and confirmed he/she communicated written concerns to staff N2 on 7/3/18 regarding medical staff D1.

16. On 8/14/18 at approximately 1300 hours, staff N11 (Surgical Technician) was interviewed and confirmed he/she verbally communicated concerns regarding medical staff D1 to his/her supervisors, staff N6 (Director of Surgical Services) and staff N7 (Operating Room Manager) on 7/27/18. Staff N11 confirmed on 7/27/18 he/she was working as the surgical technician in a carotid endarterectomy procedure with medical staff D1 and wittnessed mutiple breaks in sterility including medical staff D1's handling of the speciman with ungloved hands and rinsing blood soiled shoes in physician's lounge sink. Staff N11 confirmed he/she was not asked per his/her supervisors to document details of the events in an incident report.

17. On 8/14/18 at approximately 1315 hours, staff N7 was interviewed and confirmed he/she has received verbal and written concerns related to medical staff D1's failure to follow protocol in the operating room. Staff N7 confirmed he/she has not completed or requested staff members complete details of incident reports. Staff N7 confirmed he/she should follow policies/procedures related to documentation of incident reports.

18. On 8/14/18 at approximately 1330 hours, staff N6 was interviewed and confirmed multiple surgical staff members have communicated concerns to him/her regarding medical staff D1's failure to follow protocol in the operating room. Staff N6 confirmed there is a lack of incident report documentation related to the communicated concerns of staff members. Staff N6 confirmed he/she should follow policies/procedures related to documentation of incidents/events.

19. On 8/17/18 at approximately 1300 hours, staff N12 (Housekeeping) was interviewed and confirmed on 7/20/18 while cleaning OR 3, medical staff D2 asking him/her to check the trash for a missing surgical instrument. Staff N12 confirmed he/she did not search the trash for the missing surgical instrument because it was considered biohazard trash and it was against policy/procedure. Staff N12 confirmed the missing surgical instrument was located in the decontamination room. Staff N12 confirmed he/she did not know if the instrument had been cleaned and/or sterilized.

20. On 8/17/18 at approximately 1230 hours, staff N2 was interviewed and confirmed an instrument internal sterilization indicator had failed and was knowingly used in a procedure conducted by medical staff D3 as mentioned in an email dated 8/2/18 from staff N4. Staff N2 confirmed an incident report had not been completed.

Based on document review and interview, the hospital failed to ensure the medical staff (MS) enforced their bylaws for staff category membership of 1 of 4 MS members (MD1) appointed to the Active Staff (AS), for election of officers in the past 9 years, composition of committees for 2018 and by failing to review patient care issues/concerns related to 1 physician (MD1).

Findings include:

1. Review of MS Bylaws, Approved 4/4/18, indicated the following:
A. ARTICLE IV. MEDICAL STAFF CATEGORIES
i. 2. Active Staff. Shall consist of the Practitioners who have demonstrated an interest and commitment to the Hospital through patient care activities, as well as Hospital and MS services. a) Qualifications: An Active Staff Member must: i.) Be active in MS affairs and active in the clinical affairs of the Hospital; ii) Routinely admit, treat and care for patients at the Hospital;
ii. 11. Ongoing Professional Practice Evaluation (OPPE). All Active and Courtesy MS members will be evaluated every six (6) months or three (3) times within a two (2) year appointment cycle in accordance with the OPPE policy and procedure. i. OPPE provides a structure for monitoring, evaluating, documenting and reporting performance of MS practitioners and allied health professionals who are granted clinical privileges to provide care, treatment and service in accordance with the credentialing and privileging processes and requirements of the MS.
iii. 12. Focused Professional Practice Evaluation (FPPE). FPPE is an assessment of data or events, which related to the performance or behavior of a specific practitioner holding clinical privileges. The focused review is to determine whether the practitioner's performance or behavior meets the minimum standard of behavior or clinical care that is established by the medical staff. Triggers for FPPE may be single incident or evidence of a clinical practice trend. i) The FPPE process may be triggered when a practitioner has the credentials to suggest competence, but additional information or a period of evaluation is needed to confirm competence. ii) FPPE may be triggered when a currently privileged practitioner's ability to provide safe, high-quality patient care is questioned as documented by reports from others (e.g. OPPE Report). iii) FPPE is the evaluation process utilized upon the granting of initial privileges and/or when additional/new privileges are granted.
B. ARTICLE VII. THE DELINEATION OF CLINICAL PRIVILEGES
i. 10. Temporary Privileges. a) Temporary privileges may be granted as described in subparagraph (b) of this Section, and are available only to a licensed independent Practitioner when documentation submitted substantially supports that the requesting Practitioner has the requisite qualifications, ability and judgement to perform the privileges requested, and only after the Practitioner shows that the professional liability insurance requirements of these Bylaws has been met. Temporary privileges may be granted as described in subparagraph (b) of the Section only in the following events: i) To fulfill an important patient care need; or ii) When an Applicant with a complete, clean application from the verification agency is awaiting review and approval of the Medical Staff Executive Committee (MEC) and the Board of Managers (BOM) for final approval. b) After reviewing the favorable recommendation of the Department Chair, the Chief Executive Officer (CEO) may grant temporary privileges under the following circumstances: i) Applicants. Temporary privileges shall not routinely be granted to MS Applicants except under circumstances as the CEO determines are necessary for patient care or otherwise in the best interest of the Hospital. Upon recommendation by the CEO, temporary privileges may be granted to an Applicant for MS membership only after receipt of the following, including, but not limited to: Written verification of relevant training or experience. Written verification of current competence.
C. ARTICLE VIII. OFFICERS
i. 3. Election of Officers. a) The President-elect shall be elected by voting in person or duly executed proxy during the fourth quarter of the MS year. Only members of the Active MS shall be eligible to vote. Officers so elected shall take office on January 1st of the MS year. b) The MEC shall appoint a Nominating Committee composed of at least five members of the MS including the CEO. The Nominating Committee shall offer one or more nominees for the office of President-elect. Nominations and the date of election must be announced to all members of the Active MS (AMS) at least thirty (30) days prior to the election. c) Members of the AMS may also make nominations to the Nominating Committee by petition. Such petition must be submitted at least ten (10) days prior to the date of election. d) The President-elect shall, upon completion of his or her term of office in that position, immediately success to the office of the President.
ii. Term of Office. The officers shall serve a term of one (1) year, but may be re-elected for one (1) additional term resulting in no more than two (2) consecutive full-year terms. Each officer shall serve until the end of his or her term and until a successor is elected, unless he or she sooner resigns or is removed from office.
D. ARTICLE X. COMMITTEES
i. 2. Medical Staff Executive Committee (MEC). a) Composition: The MEC shall be a standing body and shall consist of the following members: President of the MS who shall be the Chairman of the Committee, immediate Past President of the MS, Chairman of the BOM, CEO, Chiefs of the Departments, Vice-Chairman of the Departments, and ex-officio staff as the committee deems appropriate.
ii. 8. Professional Review Committee (PRC) or Appeals Committee. a) Composition: The PRC shall be composed of at least six (6), but no more than nine (9) voting members; the President of the MS, President Elect of the MS, immediate Past president of the MS, CEO, Chief Medicine Officer, Chief Surgery Officer, and Chairman of the BOM. b) Duties: The PRC Committee shall perform the following functions, including, but not limited to: i) Provide a gathering point for the consideration of all concerns expressed by the MS, Hospital staff, Administration, and the public, dealing with the professional behavior of members of the MS, Independent Practitioners, and Allied Health Professionals. c) Meetings: The PRC shall meet as needed. A record of the proceedings and actions taken by the Committee shall be maintained. This Committee shall submit in a written report to the MEC and the Risk Manager.

2. Review of MS credential files and the hospital's Privileges Granted List indicated the following;
A. MD1 was reappointed to the AMS on 6/27/18. Facility documentation lacked documentation of MD1 having routinely admitted, treated and cared for patients at the Hospital as required for Active Staff membership in the MS Bylaws. OPPE Summaries for the 2 year appointment cycle prior to the 6/27/18 reappointment indicated the following:
i. OPPE Period from 7/1/16 to 12/31/16. The practitioner has not provided an adequate volume of patient care and treatment in order to form an opinion. (Competency documentation may be required from primary facility at time of reappointment). Included was an attachment with facility documentation for hospital activity for MD1 dated 7/1/16 to 12/31/16 as follows: Admits - 0, Consults - 0, Discharges - 0.
ii. OPPE Period from 1/1/17 to 6/30/17. This OPPE summary report for the above-named practitioner is being made based on a combination of the following: Chart review. Direct Observation. Monitoring diagnostic and treatment techniques and clinical practice patterns. Discussion with other individuals involved in care of each patient. Other: Competency Evaluation Form. In accordance with MS Policy #MS 1.19, I have reviewed the attached documentation and agree with the findings. The physician named above is considered to be competent for the privileges requested. "(In accordance with attached evaluation)" was written in the document. Included was an attachment with facility documentation for hospital activity for MD1 dated 1/7/17 to 6/30/17 as follows: Admits - 0, Consults - 0, Discharges - 0. Also included as an attachment was a document titled CLINICAL COMPETENCY EVALUATION FORM, indicated to be from MD1's primary facility, signed by MD1 on 7/24/17 and a person titled as Chairman/Director on 7/21/17. The document lacked documentation of the number of admissions, consultations, procedures and discharges and lacked documentation of the name of the facility.
iii. OPPE Period from 7/1/17 to 12/31/17. This OPPE summary report for the above-named practitioner is being made based on a combination of the following: Chart review. Direct Observation. Monitoring diagnostic and treatment techniques and clinical practice patterns. Discussion with other individuals involved in care of each patient. In accordance with MS Policy #MS 1.19, I have reviewed the attached documentation and agree with the findings. The physician named above is considered to be competent for the privileges requested. Included was an attachment with facility documentation for hospital activity for MD1 dated 7/1/17 to "12/31/2018" as follows: Admits - 0, Discharges - 0, Consults - 0, Procedures - 0. Also included as an attachment was a document titled CLINICAL COMPETENCY EVALUATION FORM, indicated to be from MD1's primary facility, signed by MD1 on 1/24/18 and a person titled as CPCS (Certified Provider Credentialing Specialist) on 1/24/18. The document lacked indication of what type of clinical competence was denoted as "satisfactory" and lacked documentation of types of procedures and consultations performed by MD1. An attached document titled Surgeon Procedure List, indicated to be 2017 Total, lacked documentation of competency or outcomes of procedures performed by MD1.
B. Following reappointment of MD1 on 6/27/18, he/she was granted Temporary/Expedited privileges for an additional procedure on 7/20/18 by the CEO.
i. The credential file indicated that on 7/20/18, an addendum was submitted as a request for additional privileges for MD1 as follows: I request addition of the following privileges and the reason for the addition. -Management of hernias. -Intended to request this privilege at reappointment.
ii. Letter dated 7/20/18 indicated that effective 7/20/18, MD1 had been granted Temporary/Expedited Hernia Management privileges by the CEO.
iii. The credential file indicated MD1 had performed 2 ventral hernia repairs out of 229 procedures in 2017 at another hospital, but lacked documentation of MD1's competency, ability and judgement to perform the privileges requested.
iv. The credential of MD1 lacked documentation of favorable recommendation of the Department Chair prior to approval from the CEO.

3. Review of hospital documents indicated the following:
i. Review of general committee and officer elected documents between 2016 to 2018, lacked documentation of a change in MS President/Medical Director. All documentation reviewed, including, but not limited to; BOM meeting minutes, MEC meeting minutes, QAPI (Quality Assurance Performance Improvement) meeting minutes, indicated MD5 to be the Medical Director/President of the MS. This was confirmed in interview.
ii. Review of a letter dated 7/3/18 indicated that an operating room staff member expressed concern and complaint related to patient care and treatment provided by MD1.
iii. Review of incident reports (IR) indicated that on 6/24/18, MD1 was named in an incident involving incorrect suture count at the end of surgery and a missing needle.
iv. Review of facility complaints and grievances indicated that on 7/15/18 a complaint/grievance was called in from a patient's family to voice concern related to the patient's condition and the patient having had "multiple surgeries", the patient having had a left AKA (above the knee amputation) and developed acute tubular necrosis following previous surgeries by MD1. The document indicated the family also voiced concern that the patient may have to undergo additional surgeries for wound management and requested a second opinion. Documentation on the form, titled "The Patient Complaint/Grievance Log", further indicated the following: Additional Follow-up required. Additional follow-up (hand written in was the following): BOD to review this case. May also need Peer Review.
v. Review of hospital surgery logs indicated that MD1 performed a hernia repair on 7/20/18.

4. Review of hospital meeting minutes indicated the following:
A. MEC meeting minutes dated 4/4/18, 6/20/18, 6/27/18 and 8/1/18, lacked documentation of MEC composition to include the following members as required by the Bylaws: Immediate Past President of the MS, Chiefs of the Departments and Vice-Chairman of the Departments.
B. The hospital lacked documentation of any PRC formation or meeting minutes.
C. The hospital lacked documentation of Peer review/Peer review meeting minutes related to the patient complaint.

5. The following was indicated in interview:
A. On 8/14/18, between approximately 12:30 p.m. and 1:30 p.m.:
i. A8, CST (Certified Surgery Technician), indicated that multiple operating room staff had reported up issues related to MD1 and his/her surgery practices. A8 indicated that he/she was unaware of any follow up pertaining to incidents and/or complaints. Example given by A8 was as follows: Patients return frequently following surgery by MD1. A8 indicated MD1 let go of a "fem" one time during surgery. A8 also indicated that during a recent surgery, an item (debakey) could not be located at the time the physician wanted to close the patient, the surgery staff asked for him/her to stop/hold to locate the item prior to closing the patient, but MD1 refused and closed the patient prior to finding the instrument.
ii. A9, CST, indicated, he/she did write up a notice of concerns related to patient care provided by MD1 and hand delivered it to A1, Chief Nursing Officer (CNO). A9 verified it was the document dated 7/3/18 and further indicated the complaint was presented to A1 on the same date. A9 indicated that A1 told him/her that the matter would be reviewed. A9 stated he/she had not heard anything more, to date, verbally or in writing.
B. On 8/14/18, between approximately 3:30 p.m. and 4:00 p.m., MD5, Medical Directory, indicated the following:
i MD5 indicated he/she was aware of a situation in which a patient of MD1 had a hematoma (draining) in ICU (Intensive Care Unit) and MD1 was a bit cavalier about the issue. When asked about concerns/complaints from staff related to MD1, MD5 indicated he/she was not in the surgery department. When asked about MD1 having a high number of SSI (Surgical Site Infections), MD5 indicated the facility was going to compare that to other facilities and if MD1 fell out of the normal range, then it would be addressed. MD5 indicate no Peer review had been done for any issue(s) related to MD1. When asked if he/she believed a focused evaluation should have been completed for review of MD1, MD5 indicated "I believe so."
C. i. On 8/15/18 between approximately 10:30 a.m.:30 p.m., A6, MS Coordinator, verified MD1 had not routinely admitted, treated and cared for patients at the Hospital in 2016 or 2017 prior to reappointment to the AMS and in fact had no (0) activity at the hospital during that time.
ii. On 8/15/18 between approximately 1:45 p.m. and 3:00 p.m., A6 verified that documentation obtained from an outside hospital was a log of procedures performed, but did not address the competency of MD1.
A6 indicated he/she was the one who checked to see that MD1 had performed that type of procedure (hernia repair), verified that 2 hernia repairs were documented out of 229 procedures in 2017, that only 1 year was reviewed and verified that the hospital did not have documentation of MD1's competency, ability and judgement to perform the privileges requested. A6 verified that the CEO granted the privileges.
iii. On 8/15/18 between approximately 4:15 p.m. and 5:00 p.m., A6 verified that MD5 had been President/Director of MS since the hospital opened and that the only change of directors occurs if someone leaves a position.
D. On 8/15/18 between approximately 3:30 p.m. and 4:00 p.m., A15, Chief Operating Officer (COO), indicated that MD5 had always been President of the MS since the facility opened in 2009. A15 also verified the MEC was not comprised of members in agreement with the MS Bylaws by that there was no Past President and that Chiefs of Departments had not been included on the committee nor in the MEC meetings.

Based on document review, observation and interview, the facility failed to ensure staff follow their policy/procedure for medication administration for 1 (Surgery Department) of 5 areas toured:

Findings include:

1. Policy/procedure, OR 6.03, Labeling and Dispensing of Medications on the Sterile Field, revised/reapproved 3/30/2018 indicated on page 2: "7. No medication will be administered if there is any doubt as to its identity, strength or sterility".

2. Policy/procedure, 13-01, Administration of Medications: General, revised/reapproved 12/21/2017 indicated on page 3: "Medications shall be administered by the individual who prepared the dose...".

3. While on tour of the Surgery Department in Operating Room 2 on 8/20/18 at approximately 1200 hours, accompanied by staff N2, medical staff D5 was observed holding an unlabeled syringe. Medical staff D5 was heard asking medical staff D4 the strength of Heparin that had been drawn up in the syringe. Prior to medical staff D5 administering the Heparin filled syringe to the patient, medical staff D4 verbalized the strength of Heparin he/she had drawn up in the syringe prior to the start of surgery. Medical staff D5 was then observed administering the heparin.

4. Staff N2 was interviewed on 8/20/18 at approximately 1330 hours and confirmed staff should follow policy/procedure for medication administration.

Based on observation and interview, the facility failed to replace sprinkler heads in 1 of 1 sprinkler system in accordance with LSC 9.7.5. NFPA 25, 2011 edition, at 5.2.1.1.1 sprinklers shall not show signs of leakage; shall be free of corrosion, foreign materials, paint, and physical damage; and shall be installed in the correct orientation (e.g., up-right, pendent, or sidewall). Furthermore, at 5.2.1.1.2 any sprinkler that shows signs of any of the following shall be replaced: (1) Leakage (2) Corrosion (3) Physical Damage (4) Loss of fluid in the glass bulb heat responsive element (5) Loading (6) Painting unless painted by the sprinkler manufacturer. This deficient practice could affect staff only, the facility failed to ensure 1 of 3 E wing corridor was separated from the corridors by a partition capable of resisting the passage of smoke as required in a sprinklered building, or met an Exception per 19.3.6.1(7). LSC 19.3.6.1(7) states that spaces other than patient sleeping rooms, treatment rooms, and hazardous areas shall be open to the corridor and unlimited in area, provided: (a) The space and corridors which the space opens onto in the same smoke compartment are protected by an electrically supervised automatic smoke detection system in accordance with 19.3.4, and (b) Each space is protected by an automatic sprinklers, and (c) The space does not to obstruct access to required exits. This deficient practice could affect staff and at least 7 patients, the facility failed to ensure the penetrations caused by the passage of wire and/or conduit through 4 of 8 smoke barrier walls were protected to maintain the smoke resistance of each smoke barrier. LSC Section 19.3.7.5 requires smoke barriers to be constructed in accordance with LSC Section 8.5 and shall have a minimum ½ hour fire resistive rating. This deficient practice could affect staff and at least 7 patients.


Findings include:

1. Based on observation with the COO and the Plant Operations #1 on 08/27/18 between 2:05 p.m. and 3:17 p.m., the following was discovered:
a) a sprinkler head was painted in the Electrical room #5
b) a sprinkler head was covered in a silver material in the Electrical room #3
c) a sprinkler head was painted in the Medical Gas room
Based on interview at the time of observation, the COO and the Plant Operations #1 acknowledged and confirmed each sprinkler head was painted or covered.

2. Based on observation with the COO and the Plant Operations #1 on 08/27/18 at 1:44 p.m., the Nourishment area was open to the corridor. Furthermore, LSC 19.3.6.1(7) was not met because the room was not protected by an electrically supervised automatic smoke detection system. Based on interview at the time of observation, the COO and the Plant Operations #1 confirmed the area is open to the corridor and no hardwired detector was installed.

3. Based on observations with the COO and the Plant Operations #1 on 08/27/18 between 3:51 p.m. and 4:15 p.m., the following unsealed penetrations were discovered:
a) a one inch gap around pipe above the drop ceiling in the ICU Entrance smoke barrier
b) a two inch by one and a half inch gap around HVAC above the drop ceiling in the smoke barrier near patient room W-103
c) a six inch gap above the drop ceiling in the ER Waiting room bathroom smoke barrier
d) a four inch gap inside conduit around wires above the drop ceiling in the OR to Cath Lab smoke barrier
Based on interview at the time of each observation, the COO and the Plant Operations #1 acknowledged each aforementioned condition and provided the measurements.

Based on record review, observation and interview, the facility failed to maintain 3 of 16 corridors from obstructions per 19.2.1 LSC 19.2.1 states that every aisle, passageway, corridor, exit discharge, exit location, and access shall be in accordance with Chapter 7, unless otherwise modified by 19.2.2 through 19.2.11. LSC 7.1.10. Means of egress shall be continuously maintained free of all obstructions or impediments to full instant use in the case of fire or other emergency. LSC 7.1.10.2.1 No furnishings, decorations, or other objects shall obstruct exits or their access thereto, egress therefrom, or visibility thereof. This deficient practice could affect staff and at least 11 patients, the facility failed to ensure the means of egress through 1 of 3 ER exits were readily accessible. This deficient practice could affect staff and up to 3 patients, the facility failed to ensure 2 of 2 space heater was in accordance with 19.7.8. This deficient practice could affect staff and up to 13 patients.


Findings include:

1. Based on observation with the COO and the Plant Operations #1 on 08/27/18 between 1:50 a.m. and 2:21 p.m., the following was discovered:
a) a soiled linen cart was in the corridor outside patient room E-209
b) a soiled linen cart was in the corridor outside patient room W-101
c) two separate soiled linen carts and two carts with supplies were in the corridor near Electrical room 3
Based on interview at the time of each observation, the COO and the Plant Operations #1 acknowledged that impediments such as the soiled linen carts and supply carts were potential impediments to full use of the means of egress access corridors.

2. Based on observation with the COO and the Plant Operations #1 on 08/27/18 at 2:46 p.m., the exterior sliding glass exit doors would not automatically open. Based on interview at the time of the observations, the ER staff indicated that they turned the automatic open feature off because it was letting hot air inside. The COO and the Plant Operations #1 confirmed they were unaware staff turned off the access-controlled egress doors automatic feature.

3. Based on observation with the COO and the Plant Operations #1 on 08/27/18 at 1:27 p.m. then again at 2:55 p.m., a space heater was discovered in the Nurse Educator office. Then again, a space heater was discovered in the CT Staff area. Based on interview at the time of each observation, the COO and the Plant Operations #1 was unaware each space heater was in the building and confirmed no documentation was available to prove the heating element does not exceed 212 degrees.

1. Based on record review and interview, the facility failed to conduct quarterly fire drills for 1 of 4 quarters. LSC 19.7.1.6 requires drills to be conducted quarterly on each shift under varied conditions. This deficient practice affects all staff and patients, the facility failed to ensure 8 of 8 fire drills shall be held at expected and unexpected times for under varying conditions to simulate the unusual conditions that can occur in an actual emergency for the last 4 quarters. This deficient practice affects all occupants, the facility failed to ensure 8 of 8 fire drills included the verification of transmission of the fire alarm signal and simulation of emergency fire conditions for the last 4 quarters. This deficient practice affects all patients in the facility as well as staff and visitors.

Findings include:

Based on record review of titled "Security/Observer's Form For Fire Drill/Fire Alarm" with the COO and the Plant Operations #1 on 07/16/18 at 10:47 a.m., there was no documentation for a second shift fire drill in the third quarter of 2017. Based on interview at the time of record review, the COO and the Plant Operations #1 were unable to provide further documentation.

2. Based on record review and interview, the facility failed to ensure 8 of 8 fire drills shall be held at expected and unexpected times for under varying conditions to simulate the unusual conditions that can occur in an actual emergency for the last 4 quarters. This deficient practice affects all occupants.

Findings include:

Based on record review of titled "Security/Observer's Form For Fire Drill/Fire Alarm" with the COO and the Plant Operations #1 on 07/16/18 at 10:47 a.m., the documentation for the drills for the past twelve months failed to document simulation of emergency fire conditions. Based on interview at the time of record review, the COO and the Plant Operations #1 confirmed no documentation was available showing the simulation of emergency fire conditions.

3. Based on record review and interview, the facility failed to ensure 8 of 8 fire drills included the verification of transmission of the fire alarm signal and simulation of emergency fire conditions for the last 4 quarters. This deficient practice affects all patients in the facility as well as staff and visitors.

Findings include:

Based on record review of titled "Security/Observer's Form For Fire Drill/Fire Alarm" with the COO and the Plant Operations #1 on 07/16/18 at 10:47 a.m., the documentation for the drills for the past twelve months lacked verification of the transmission of the signal for drills. Additionally, documentation failed to include simulation of emergency fire conditions. Based on interview at the time of record review, the COO and the Plant Operations #1 confirmed no documentation was available showing the times when the monitoring company received the fire alarm signal.

Based on document review and interview, the hospital failed to ensure equipment was maintained and was on a schedule of appropriate frequency with the manufacturer's recommended maintenance schedule for 11 of 17 pieces of equipment reviewed (front freezer, walk-in freezer, steam table, anesthesia machine, operating room (OR) bed, portable x-ray, centrifuge, medication pump, ventilator and 2 table top sterilizers).

Findings include:

1. Review of the policy titled Scope of Service - Environmental Services Department, Last Updated: 3/21/18, indicated the following: Plant Operations and Maintenance. The plant operations and maintenance department's objective is to reduce disruption, extend equipment life, control costs and/or reduce exposure to liability by doing the following: The policy lacked documentation of regular and preventive maintenance schedules for equipment.

2. On 8/17/18 between approximately 10:30 a.m. and 11:30 a.m., during tour of the kitchen, in the presence of A2, Operations Manager, the following was observed:
A. In the front serving area was a reach-in freezer, with heavy frost build-up on the inside top interior area.
B. In the walk-in freezer, ice was noted on the floor and around the interior door.
C. In the preparation area was a steam table.

3. Review of preventive maintenance (PM) documents indicated the hospital lacked documentation of PM for the following pieces of equipment and/or lacked documentation of PM in accordance with manufacturer recommended schedule.
A. Front kitchen reach-in freezer
B. Walk-in freezer
C. Steam table
D. Anesthesia machine, serial number (s/n) ASAE-0136
E. OR bed #2
F Portable x-ray machine
G. Hitachi centrifuge
H. Medication pump s/n 14044162
I. Ventilator s/n ASAE-0136
J. 2 Sterrad table top sterilizers

4. Review of manufacturer recommended PM schedules indicated the following:
A. The hospital lacked manuals for the following manuals, therefore unable to determine manufacturer recommended PM schedules for the following: Kitchen freezers (2), steam table, OR bed, portable x-ray, centrifuge and ventilator.
B. Drager Anesthesia Workstation: Maintenance Intervals. Every 6 months: Inspection and service by trained service personnel.
C. Sterrad sterilizers. Maintenance. Regularly scheduled, or PM must be performed at the interval specified on the system. The PM interval is 650 cycles or every 6 months, whichever comes first.

5. On 8/20/18 between approximately 11:00 a.m. and 1:00 p.m., A14, Plant Operations Manager, indicated most equipment had repairs and/or electrical current leakage checks, but no PM. A14 indicated the hospital did not have documentation of PM for the front kitchen reach-in freezer, the walk-in freezer, the steam table, anesthesia machine, OR bed, centrifuge, medication pump, venitlator or the 2 table top sterilizers within the past 12 months.

Based on document review, observation and interview, the facility failed to ensure staff follow their policies/procedures for Surgical Instrument Counts, Aseptic Technique in the Operating Room (OR), Sterility of Items, Infection Control for Anesthesiology, Care of Surgical Specimens, Staff Responsibilities in the Operating Room, Methods of Infection Control Surveillance and Infection Control Plan in 1 (Surgery Department) of 5 areas toured.

Findings include:

1. Policy/procedure OR 3.03, Surgical Counts - Instruments, revised /reviewed 3/30/2018 indicated:
A. Page 1: "Suture tags, bulldogs (both metal and plastic), and parsonette epicardial retractor instruments shall be counted on all surgical procedures requiring the opening of the abdominal, retroperitoneal or thoracic cavity. Closure count is taken following sharps and sponge count and as wound closure begins".
B. Page 2: "When a discrepancy cannot be reconciled: The surgeon will review the x-ray and will decide if the patient can be moved from the OR.

2. Policy/procedure OR 4.04, Aseptic Technique in the OR, revised/reviewed 3/30/2018 indicated:
A. Page 1: "All persons working in the Operating Room must be alert to contamination and aid in maintaining aseptic conditions. When there is doubt concerning the sterility of an item, it is to be considered unsterile and not used".
B. Page 2: "Tables draped with sterile drapes are sterile only at table level. Materials (i.e. sutures and laparotomy sponges, suctions, or cauteries) that hang over the edge of the sterile field are not considered sterile and are discarded. Items that fall below the level of the sterile field are not brought back onto the sterile field".

3. Policy/procedure IC 4.14, Sterility of Items, revised/reviewed 3/30/2018 indicated: "It is the responsibility of each health care worker to assess each package and its contents to assure that sterile conditions have been maintained".

4. Policy/procedure IC 4.24, Infection Control for Anesthesiology, revised/reviewed 3/30/2018 indicated:
A. Page 2: "5. Any reusable object in direct contact with mucous membranes shall receive at least high level disinfection prior to reuse (such as laryngoscope blades). 9. Separate clean and dirty work areas shall be defined and maintained. 10. Used laryngoscope blades and any other non-disposable equipment that comes in contact with patients' mucous membranes shall be separated from sterile supplies and disinfected between patients. 13. Gloves shall be worn when cleaning items contaminated with patients' blood, other body fluids or excretions. Handwashing shall always be performed after removal of gloves".
B. Page 4: "8. Stopcocks, multi-dose vials, infusion ports on intravascular lines, and other portals of access to sterile fluids shall be handled with aseptic technique by wiping the septum with alcohol before each puncture and always using a sterile needle to enter the system".

5. Policy/procedure OR 5.01, Care of Surgical Specimens, revised/reviewed 3/30/2018 indicated: "4. Specimens are handled with gloves".

6. Policy/procedure OR 8.04, Staff Responsibilities in the Operating Room, revised/reviewed 3/30/2018 indicated on page 2: "4. Infection Control: Principles of sterile technique shall be adhered to throughout the OR procedure. Universal precautions, protective care procedures shall be utilized".

7. Policy/procedure IC 1.09, Methods of Infection Control Surveillance, revised/reviewed 3/30/2018 indicated:
A. Page 1: "If an infection is reported, a Post-Operative Infection Report is initiated by the Infection Control Nurse (ICN) and is forwarded to the Chief Nursing Officer for review and presentation to the Infection Control Committee (ICC) and Medical Staff Executive Committee (MEC). A Performance Improvement (PI) Summary Report for reported infections will be completed.
B. Page 2: "Different Types of Surveillance: 1. Routine monitoring for compliance with infection control policies and procedures including, but not limited to, handwashing, sterilization testing and reported infections. 2. Focus surveillance or prevalence studies depend on the number of beds in the hospital and/or a specific problem. Data is gathered for a specific surgical procedure, surgeon or is organism-specific. An identified trend will result in a focused study".

8. Policy/procedure IC 1.02, Infection Control Plan, revised/reviewed 3/9/2018 indicated:
A. Page 4: "An overall infection rate is calculated with the Infection Report initiated by the ICN and is forwarded to the Infection Control Committee for review and presentation to the Medical Staff Executive Committee. In addition, a Performance Improvement Trending Report for reported infections will be completed. The Infection Prevention/Infection Control program shall identify, and evaluate trends of cluster of nosocomial infections and communicable diseases with implementation of successful corrective action plans in affected problem areas".

9. Review of employee grievance dated 7/2/18 from staff N1 written to staff N2 indicated: "Medical staff D1 would not let me properly drape the patient. Throughout the case he/she was pulling the bottom drape up breaking sterility. I told him/her several times the field was no longer sterile and was told it's fine...While suturing the incision site, medical staff D1 would not hand the used needles back or place them back in the needle holder. He/she was throwing them in the pool of blood on the drapes".

10. Review of employee grievance dated 7/3/18 per staff N3 written to staff N2 indicated: "...3. In another procedure medical staff D1 went ahead and closed the patient prior to Radiology's report and breakdown. Two needles were missing, two separate times".

11. Review of report communicated via email from staff N4 to staff N5 dated 8/2/18 at 0755 hours indicated: "I am providing you with a detailed list of all the infection control safety items I have addressed...One of them had to do with medical staff D2 wanting housekeeping to go into the dumpster to get out his/her surgical instrument that was thrown away that belonged to him/her. He/she used it for intubation and was not ever cleaned by our sterile processing staff. Then he/she found it and took it into use on a new procedure, dirty. This was immediately addressed and staff N2 was called this happened on 7/20/18".

12. Review of report communicated via email from staff N4 to staff N5, staff N2, staff N6, staff N7, staff N8, staff N9 and staff N10 on 8/2/18 at 1427 hours indicated: "I am letting you know we had a surgical site infection and here is the specific patient information:...This patient had a tricuspid valve placed that failed the internal sterilization indicator but was used on the patient anyway. Medical staff D3 is aware this was used because it was used at his/her direction".

13. Review of the Surgical Site Infection (SSI) Log from 1/1/18 through 8/3/18 indicated the facility identified 13 patients that developed SSI's. As documented, the SSI's resulted on the following dates: 1/17/18, 2/2/18, 3/27/18, 4/24/18, 5/11/18, 5/2/18, 6/26/18, 7/5/18, 7/6/18, 7/15/18, two identified on 7/20/18 and 7/24/18. The facility lacked documentation of identified SSI's from 8/3/18 through 8/20/18. The facility lacked documentation of Post-Operative Infection Reports as well as Performance Improvement Summary Reports for the SSI infections noted on the 2018 SSI Log.

14. Review of meeting minutes from Infection Control Committee (ICC) Meeting dated 8/15/18 lacked documentation of presentation of Post-Operative Infection Reports and Performance Improvement Summary Reports as indicated in policy/procedure Methods of Infection Control Surveillance.

15. Review of Infection Control Program lacked documentation of weekly surveillance/monitoring of activities by the ICN, OR Manager and CNO as mentioned in the facility's Centers for Medicare and Medicaid Services (CMS) Plan of Correction dated 7/30/18. The Infection Control Program also lacked documentation of routine monitoring for compliance with infection control policies/procedures, focused surveillance/prevalence studies and identified trends.

16. On 8/14/18 at approximately 1200 hours, staff N1 (Surgical Technician) was interviewed and confirmed he/she communicated written concerns to staff N2 (Chief Nursing Officer) regarding medical staff D1 on 7/2/18.

17. On 8/14/18 at approximately 1245 hours, staff N3 (Surgical Technician) was interviewed and confirmed he/she communicated written concerns to staff N2 on 7/3/18 regarding medical staff D1.

18. On 8/14/18 at approximately 1300 hours, staff N11 (Surgical Technician) was interviewed and confirmed he/she verbally communicated concerns regarding medical staff D1 to his/her supervisors, staff N6 (Director of Surgical Services) and staff N7 (Operating Room Manager) on 7/27/18. Staff N11 confirmed on 7/27/18 he/she was working as the surgical technician in a carotid endarterectomy procedure with medical staff D1 and witnessed multiple breaks in sterility including medical staff D1's handling of the specimen with ungloved hands and rinsing blood soiled shoes in physician's lounge sink.

19. On 8/14/18 at approximately 1315 hours, staff N7 was interviewed and confirmed he/she has received verbal and written concerns related to medical staff D1's failure to follow protocol in the operating room.

20. On 8/14/18 at approximately 1330 hours, staff N6 was interviewed and confirmed multiple surgical staff members have communicated concerns to him/her regarding medical staff D1's failure to follow protocol in the operating room.

21. On 8/15/18 at approximately 1330 hours, staff N2 (Chief Nursing Officer) was interviewed and confirmed the facility has identified 13 patients that developed SSI's in 2018. Staff N2 confirmed 6 of those identified SSI's resulted in July 2018. Staff N2 confirmed the facility lacked documentation of Post-Operative Infection Reports as well as Performance Improvement Summary Reports for the identified SSI's and lacked documentation of weekly and routine monitoring of infection control surveillance activities as outline in the POC and the Infection Control Plan. Staff N2 confirmed the facility lacked documentation of an overall calculated infection rate and a Performance Improvement Trending Report as indicated in the Infection Control Plan.

22. On 8/17/18 at approximately 1300 hours, staff N12 (Housekeeping) was interviewed and confirmed on 7/20/18 while cleaning OR 3, medical staff D2 asking him/her to check the trash for a missing surgical instrument. Staff N12 confirmed he/she did not search the trash for the missing surgical instrument because it was considered biohazard trash and it was against policy/procedure. Staff N12 confirmed the missing surgical instrument was located in the decontamination room. Staff N12 confirmed he/she did not know if the instrument had been cleaned and/or sterilized.

23. While on tour of facility on 8/20/18 at approximately 1045 hours accompanied by staff N2, medical staff D5 was observed in OR 2 during a procedure placing a contaminated/dirty surgical instrument on the top surface of the anesthesia supply cart which also contained clean supplies.

24. While on tour of facility on 8/20/18 at approximately 1100 hours accompanied by staff N2, medical staff D4 was observed in OR 2 picking up a contaminated/dirty surgical instrument without gloved hands.

25. While on tour of facility on 8/20/18 at approximately 1115 and 1130 hours accompanied by staff N2, medical staff D5 and staff N14 were observed drawing up medications from vials and administering medication per intravenous (IV) route without swabbing top of vial and IV ports with alcohol.

26. While on tour of facility on 8/20/18 at approximately 1215 hours accompanied by staff N2, staff N13 was observed in OR 2 during a procedure retrieving a 1000 ml normal saline bottle from the trash and carrying it to the sterile field.

27. While on tour of facility on 8/20/18 at approximately 1245 hours accompanied by staff N2, medical staff D3 was observed in OR 2 during a procedure placing his/her surgical magnifying glasses in a wooden box without cleaning/disinfecting. Medical staff D3 was observed leaving OR 2 with box containing glasses in hand.

28. While on tour of facility on 8/20/18 at approximately 1230 accompanied by staff N2, staff N13 was observed reaching his/her contaminated gloved hand into his/her pocket to silence a ringing cell phone while he/she was assisting in the surgical instrument count and handling bloody gauze pads.

29. On 8/20/18 at approximately 1330 hours, Staff N2 confirmed medical staff D5 should not have placed a contaminated dirty instrument on a surface with other clean supplies. Staff N2 confirmed medical staff D4 should not have picked up a contaminated/dirty surgical instrument with ungloved hands. Staff N2 confirmed staff N13 should not have retrieved a 1000 ml normal saline bottle from the trash. Staff N2 confirmed medical staff D3 should not have placed contaminated/dirty glasses in his/her storage box. Staff N2 confirmed staff should not be touching cell phones with contaminated gloved hands. Staff N2 confirmed staff should be using aseptic technique when administering medications. Staff N2 confirmed an instrument internal sterilization indicator had failed and was knowingly used in a procedure conducted by medical staff D3 as mentioned in an email dated 8/2/18 from staff N4. Staff N2 confirmed he/she had received written concerns regarding medical staff D1 from staff N1 on 7/2/18 and staff N3 on 7/5/18