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Based on record review and interview, the Hospital failed to have a Governing Body that was effective in its responsibility of managing outpatient services for seven (7) community health centers (CHC) ( #1, #2, #3, #4, #5, #6 and #7 [which included the satellite emergency facility at #7]).

Findings include:

1. The Hospital failed for seven (7) of 17 Outpatient Clinics (Community Health Centers (CHC) ( #1, #2, #3, #4, #5 #6 and #7 [which included the satellite emergency facility]), to ensure outpatient services were organized and integrated with Hospital Inpatient Services.

a. CHC #1, #2,#3, #4, #5, #6 and #7 (which included the satellite emergency facility), were operating independently of the Hospital with their own bylaws, own non-medical staff, were financially independent, had their own policies and procedures, did not report adverse events and declared their independence to survey staff that they were Federally Qualified Health Centers and did not have to abide by the Hospital Conditions for Participation.

b. The nursing staff and all support staff at the seven of the Community Health Centers ( #1, #2, #3,#4, #5, #6, #7 [which included the satellite emergency facility]) were not staff of the Hospital but employed directly by the CHCs and did not report to the Hospital.

c. Review of Hospital-wide Quality Assurance Meeting Minutes and Board of Trustee Meeting Minutes, indicated that Community Health Centers (CHC) #1, #2, #3, #4, #5, #6 and #7 (which included the satellite emergency facility), did not consistently report quality and infection control issues to the Hospital wide Quality Assurance Committee and did not have its governance responsible to the Hospital Board of Trustees.

Based on record review and interview, the Hospital failed to obtain informed consents to treat two patients (Patient #15 and Patient #6), in a total sample of 32, in accordance with its policy and procedure. Findings include:

1. The Hospital failed to follow its' policy and procedure for activating a patient's health care proxy for one (Patient #15), requiring their health care proxy to be activated.

According to the Policy titled "Health Care Proxy", dated 12/18, before relying on the Proxy, the attending physician must document, in writing, in the patient's medical record that the patient lacks capacity to make health care decisions and the cause, nature, extent and duration of the patient's incapacity.

The Surveyor reviewed the informed consent for Patient #15 at 1:30 P.M., on 3/25/19. The informed consent for gastro-intestinal procedure had been completed by telephone earlier that day. The Surveyor reviewed Patient #15's medical record and did not find that the Health Care Proxy had been invoked according to policy and there was no statement that Patient #15 lacked capacity to make an informed consent.



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2. For Patient #6, a newborn, admitted through the emergency room on 3/20/2019, review of the informed consent for treatment on 3/25/2019, indicated that it was not signed by any parent or legal guardian and no telephone consent to treat was obtained. There was only a notation that read "mother unable to sign."

During an interview on 3/26/2019 at approximately 11:00 A.M., Registered Nurse (RN) #6, who was the infant's primary nurse, said the mother had been at the bedside every day and all day since the infant was admitted.

During an interview, on 3/26/2019, at 11:30 A.M., the Pediatric Nurse Manager said that the admissions staff in the Emergency Department (ED) were supposed to get consent but when they cannot they are supposed to come up to the unit to get the consent the following day. The Pediatric Nurse Manager said there must have been a break in the system for no consent to be obtained for five days.

The Hospital failed to limit the information placed on the telemetry (electrical recording of the heart's rhythm) displays posted in the corridors for one of three patient care units observed. Findings include:

The Surveyor observed the telemetry displays mounted in the corridors of Medical Intensive Care Unit A, Medical Intensive Care Unit B and the Surgical Intensive Care Unit on 3/25/19 at 2:30 P.M.

Unlike the Medical Intensive Care Units, where the patient's first initial and last names were posted, the Surveyor observed on the Surgical Intensive Care Unit displays, that the patient's full first and last name were posted. The Charge Nurse said that depending on the length of the patient's name both first and last names were posted.

This violated patient privacy as anyone could see who was a patient on the unit by looking at the displays.

Based on record review and interview, the initial nursing care plans for three of seven pediatric patients reviewed (#4, #6 and #7), in a total sample of 32, lacked interventions for identified problems and lacked measurable goals. Findings include:

1. For Patient #4, a toddler admitted with status asthmaticus (asthma attack), urinary tract infection (UTI) and airway infections, the nursing care plan identified fluid and electrolyte imbalance as a problem on the nursing care plan with no goals.

There were no interventions on the initial nursing care plan to address the problem of fluid and electrolyte imbalance.

2. For Patient #6, an uncircumcised newborn baby, admitted with an upper respiratory infection and a UTI caused by E.coli (fecal organism causing e.coli infections secondary to poor cleaning of the penis foreskin in uncircumcised males that can be life threatening in infants).

Review of the initial nursing care plan indicated a plan for knowledge deficit which did not have any interventions to address the new parents knowledge deficit about causes and prevention of E.coli UTI in their infant and proper cleaning of the penis foreskin to prevent further infections.

Review of nursing notes five days after admission did not show any documentation of any education to address this knowledge deficit.

3. For Patient #7, a newborn admitted with an upper airway infection, dehydration and the flu, the nursing care plan identified ineffective breathing as a problem with a goal of ability to function at an adequate level.

There were no interventions on the initial care plan and the goal was not measurable.

During an interview on 3/26/2019 at approximately 12:00 P.M., staff was unable to describe what an adequate level of function for this infant, who had underlying lung disease, to measure progress in his/her respiratory function.

Based on observations and interviews the Hospital failed to maintain the minimum requirements for sterile compounding as outlined in the United States Pharmacopeia (USP) 797 authoritative guideline, at the sterile compounding site located at the Cancer Center of the Hospital. Findings include:

The USP <797> includes standards for various processes, precautions and
quality assurance practices required and recommended for the safe preparation of all
risk levels of Compounded sterile products (CSPs). Evaluation and monitoring/testing of the environment in which compounding takes place and, if applicable, the adjacent "ante-" and "buffer" areas, including facility layout, design, environmental controls, restricted access, air quality standards and testing, surface characteristics, furnishings, cleaning and disinfection procedures.


1) The Surveyor observed that the anteroom ceiling light fixtures are not smooth, mounted flush or sealed to prevent growth of microbial agents in crevices and dark spaces where they can thrive.

2) The Surveyor interviewed Pharmacist #2 on 03/26/2019 at 1:30 P.M. Pharmacist #2 said that personnel do not clean the walls nor the ceilings of the anteroom and the hazardous buffer room as required on a regularly basis to prevent microbial growth.

Based on observations, record reviews and interviews the Hospital failed to adhere to their policy and meet infection control standards related to disposal of a dropped medication syringe, contamination of point of care testing strips and disinfection of equipment between patients. Findings include:


1) The Surveyor observed, on 3/26/19 at approximately 10:45 A.M., Anesthesiologist #1 picked up a capped syringe that had been inadvertently dropped onto the floor in the operating room. Anesthesiologist #1 proceeded to administer the medication in the syringe intravenously to Patient #27.

The Surveyor interviewed Anesthesiologist #1 on 3/26/19. Anesthesiologist #1 said the syringe was capped and the sterility of the medication was not compromised. Anesthesiologist #1 said she should have disposed of the syringe that dropped on the floor and not administered it to Patient #27.

2.) The Surveyor observed Registered Nurse (RN) #5 perform point of care testing on Patient # 14 at 11:35 A.M. on 3/25/19. RN #5 performed hand hygiene and donned her gloves. RN #5 then proceeded to identify Patient #14 using his/her identification bracelet and handling Patient #14's arm. RN #5 then opened the test strip bottle and removed a test strip. RN #5 had touched Patient #14, thus her gloves were no longer clean and RN #5 contaminated the remaining test strips in the container.

According to the Policy "Equipment Disinfection", dated 2/19, any equipment removed from a patient's environment will be disinfected prior to use on another patient.

3.) The Surveyor toured the Clean Supply Storage Area of the Medical Intensive Care Unit at 10:40 A.M. on 3/25/19. Three Bair Hugger Units (reusable patient warming unit) were available for use. All the three units were stickered with "clean" stickers designating the unit as clean. There were some stickers that had been partially removed and others that had been removed leaving a discolored and sticky residue. One of the hoses on a Bair Hugger Unit had been repaired using tape wrapped around the hose. These conditions prevented these units from being adequately sanitized between patient uses. Both the Nurse Manager and the Assistant Nurse Manager also made the observation.

The Hospital failed for seven of 17 Outpatient Clinics (Community Health Centers (CHC) ( #1, #2, #3, #4, #5, #6 and #7 [which included the satellite emergency facility at #7]) to ensure outpatient services were organized and integrated with Hospital Inpatient Services. Findings include:

Review of the organization chart for ambulatory services, provided by the hospital on 3/25/2019, indicated there were seven CHC 's, one with three sites and one with two sites, one CHC that was a Federal Qualified Health Center (FQHC) with it's own Medicare provider number, for a total of eight CHC's; four radiology health centers and six centers identified as hospital clinics. CHC #7 consisted of radiology, pharmacy, laboratory services and one satellite emergency facility (SEF) which were all located on the first floor of CHC #7.

The Surveyor received a copy of the Hospital's Bylaws, CHC's #2's Bylaws, CHC's #1's Bylaws and CHC's #5, #6 and #7's Bylaws which indicated the Community Health Centers had their own separate Bylaws that were not integrated with the Hospital Inpatient Services.

Review of the Hospital's Policies and Procedures (P&P's), including: "Reporting of Adverse Events to External Regulatory Agencies", dated 9/2003 and reviewed and revised 4/2018; "STARS Online Incident Reporting", dated 4/1997 and reviewed and revised 4/2018; "AED (Phillips Heartstart FR2) Procedure", dated 12/2009 and reviewed and revised 11/2018; and "Code Blue/Cardiopulmonary Resuscitation", dated 3/2001 and reviewed and revised 11/2018, indicated the header of all the P&P's contained the name and logo of the Hospital.

Community Health Centers #5, #6, #7:

Review of CHCs #5, #6 and #7's Bylaws, dated as amended and restated 9/19/18, indicated the header of the Bylaws contained the name of CHC #5, #6 and #7 and not the name or logo of the Hospital. There was no documentation in the Bylaws to indicate that the Clinic operated under, or was an integrated part of, the Hospital. There was no documentation to indicate CHC #5, #6 and #7's Bylaws were approved by the Hospital's Governing Body.

CHCs #5, #6 and #7's review of the "Medical Staff Governance and Oversight Role Document", dated as adopted by the CHC's Medical Staff on 11/19/2010, indicated membership of the CHC's Medical Staff is open to all clinical providers who regularly provide clinical services at the health center, this includes providers who are privileged at the Hospital. The Document referred to the Medical Staff as CHC #5, #6 and #7's Medical Staff, not the Hospital's Medical Staff. Although the Document indicated Medical Staff membership and employment at CHC #5, #6 and #7 are contingent on maintaining active clinical privileges at the Hospital, the Document provided no indication that the CHC #5, #6 and #7's CHCs Medical Staff was integrated with the Hospital's Medical Staff. The header on the Document contained the name of CHC #5, #6 and #7 and did not contain the name or logo of the Hospital.

Review of CHC #5, #6 and #7's Policies and Procedures (P&P's) indicated the P&P's header contained the name and logo of CHC #5, #6 and #7 and not the name or logo of the Hospital.

Review of a procedure consent form at CHC # 6, dated 3/13/19 and signed by Outpatient #7, provided no documentation to indicate the form was representative of the Hospital's Form. The header of the Consent Form had the name and logo of CHC #5, #6 and #7 and not the Hospital's name or logo.

During a group interview, at 12:15 P.M. and throughout the day on 3/26/19, conducted at CHC #6 and #7, the Surveyor interviewed the Clinic's Vice President (VP) and Chief Behavioral Health Officer, The VP of Campus Operations (VP#2), The VP of Health Center Operations (VP#3), The Chief Medical Officer (CMO #1), The Facilities Manager, the Employee Health and Infection Control Nurse and Director #1:

VP #1 said Clinic #5, #6 and #7 operated independently from the Hospital. VP #1 said Clinic #7 was composed of Community Health Centers (CHC) #5, #6 and #7. VP #1 and CMO #1 said CHC #5, #6 and #7's had it's own set of Policies and Procedures, Medical Staff, Governing Body and By Laws that were not integrated with the Hospital. The VP said Clinic #1 was financially independent from the Hospital. VP #1 said Clinic #5, #6 and #7 had it's own Human Resources Department which was not integrated with the Hospital and he said Clinic #5, #6 and #7's staff were not employees of the Hospital.

CMO #1 said, at 1:10 P.M. on 3/26/19, that the Clinic was licensed under the Hospital to allow for billing of outpatient hospital services.

Community Health Center #2:

Review of CHC #2's Bylaws, dated as amended and restated 9/19/18, indicated the header of the Bylaws contained the name of CHC #2 and not the name or logo of the Hospital. There was no documentation in the Bylaws to indicate that CHC #2 operated under, or was an integrated part of, the Hospital. There was no documentation to indicate CHC #2's Bylaws were approved by the Hospital's Governing Body. The Bylaws indicated the purpose of the Corporation is to improve the health of the medically underserved population in the service area by operating a federally qualified health center (FQHC).

Review of CHC #2's Policies and Procedures (P&P's) including "Incident Reporting and Management Utilizing Quantros", dated 1/98 reviewed and revised 4/19 and "Blood or Body Fluid Exposure", dated 1/98 reviewed and revised 10/18, indicated the header contained the name and logo of CHC #2 and did not contain the name or logo of the Hospital.

During a group interview, at 11:45 A.M. on 3/28/19, conducted at CHC #2, the Surveyors interviewed CHC #2's Chief Medical Officer (CMO #2), the Director of Finance, Compliance Officer, Lab Manager, Director of Nursing, Chief Human Resource Officer and Executive Assistant to the President and CEO. The CMO #2 said CHC #2 had it's own Governing Body that functioned independently from the Hospital, as it was a Federally Qualified Health Center (FQHC). CMO #2 said CHC #2's Governing Body was responsible for approving CHC #2's Policies. CMO #2 said there was no member of CHC #2's Governing Body who was also a member of the Hospital's Governing Body. CMO #2 and the Compliance Officer said CHC #2 utilized an incident and event reporting application, that was different from and not integrated with the Hospital's incident and event reporting application, to report adverse events at CHC #2. CMO #2 said CHC #2 had it's own Human Resources Department which was not integrated with the Hospital and he said CHC #2's employees were not employees of the Hospital.

Community Health Center #1:

Review of CHC #1's Bylaws, dated as effective 6/24/14, indicated the Header of the Bylaws contained the name and logo of CHC #1 and not the name or logo of the Hospital. Documentation indicated CHC #1's Bylaws were signed by a CHC #1 clerk and reviewed and approved by CHC #1's Board on 6/23/14. There was no documentation to indicate the Hospital reviewed or approved CHC #1's Bylaws. There was no documentation in the Bylaws to indicate that CHC #1 operated under, or was an integrated part of, the Hospital. The Bylaws indicated CHC #1 evaluated itself periodically for efficiency, effectiveness and compliance with all requirements imposed under FQHC section 330 of PHS act 42 USC parag 254 (b)..."

Review of CHC #1's Policies and Procedures (P&P's) including "Incident Reporting and Management Utilizing Quantros", dated 3/98 reviewed 3/18, indicated the Headers contained the name and logo of CHC #1 and did not contain the name or logo of the Hospital.

A report builder document, provided by the Compliance Director on 3/28/19, indicated CHC #1 had an adverse patient event at a severity level H, which indicated a severe event, reported at CHC #1 on 7/3/18. The report builder document indicated this adverse patient event was not reported to the Hospital.

CHC #1's "Incident Reporting and Management Utilizing Quantros Policy", dated 3/98 reviewed 3/18, indicated an actual event at severity level H was a severe event that required intervention to sustain life. The policy indicated the next severity level, I, was death due to an event or cause unknown. The Policy indicated CHC #1 utilized on-line data management system for patients, visitors and employees to report concerns and compliments and the data is reviewed by CHC #1's leadership and compliance. There was no indication of the Hospital being notified or integrated into CHC #1's incident reporting.

During a group interview, at 9 A.M. on 3/28/19, conducted at CHC #1, the Surveyors interviewed CHC #1's Chief Medical Officer (CMO #3), The Nurse Manager of Primary Care, Compliance Manager and Privacy Officer, Chief Operating Officer, Compliance Director and Patient Safety Officer. CMO #3 and COO said the following:

- CHC #1 had it's own Board of Directors who functioned independently from the Hospital.
- CHC #1's Governing Body functioned independently from the Hospital.
- CHC #1 had it's own Performance Committee that functioned independently from and did not report to the Hospital.
- CHC #1 had it's own set of Bylaws which were independent from the Hospital.
- Medical Staff credentialing was outsourced to the Hospital.
- CHC #1 had it's own internal Human Resources department which was not integrated with the Hospital and that employees of CHC #1 were not employees of the Hospital.
- CHC #1 utilized an Incident and Event Reporting Application, that was different from and not integrated with the Hospital's Incident and Event Reporting Application, to report adverse events at CHC #1.
- CHC #1 was a FQHC.

The Surveyor interviewed Director #1 at 10 A.M. on 3/25/19 and throughout the survey. Director #1 said he was responsible for outpatient radiology services for the Hospital's radiology services located off campus at satellite locations. Director #1 said he was not responsible for radiology services at CHC #1, CHC #2 and CHC #5, #6 and #7 because they were not run by the Hospital.

The Surveyor interviewed the Senior Vice President (VP) of Ambulatory Services (VP #4) at 8:25 A.M. on 3/27/19. VP #4 said he was responsible for the Hospital's Outpatient Services. VP #4 said all Outpatient Services reported up to him. VP #4 said CHC #5, #6 and #7 operated independently of the Hospital and did not report up to him or anyone at the Hospital. VP #4 said CHC #5, #6 and #7 had it's own staff and it's own Governing Body, independent from and not integrated with the Hospital's Governing Body.

During an interview, on 3/27/2019 at approximately 8:30 A.M., the Senior VP of Ambulatory Services for the hospital said 6 of the 7 CHC's were FQHC's per HRSA (Health Resources and Services Administration) that were put under the hospital's license when two hospitals merged back in 1996 to become the existing hospital it is today. He said that the hospital only provides technical assistance to the sites for compliance.

Review of licensure and interview with the Vice President of Quality and Risk Management on 3/28/2019 at 12:00 P.M., indicated that an 8th CHC was licensed as a FQHC with it's own Medicare provider number and the 7 other CHC's all operated under the Hospital's Medicare provider number.

Based on interview with outpatient services administrative personnel and the Hospital's Chief Nursing Officer, the nursing staff and all support staff at the seven community health centers ( #1, #2, #3, #4, #5, #6, #7 [which included the satellite emergency facility at #7]) were not staff of the Hospital but employed directly by the CHCs and did not report to the Hospital. Findings include:

1. During a group interview, at 12:15 P.M. and throughout the day on 3/26/19, conducted at CHC #7, the Surveyor interviewed the Clinic's Vice President (VP) and Chief Behavioral Health Officer, The VP of Campus Operations, The VP of Health Center Operations, The Chief Medical Officer (CMO), The Facilities Manager, the Employee Health and Infection Control Nurse and Director #1. This group was also responsible for CHC #5 and #6.

VP #1 said CHC ##5, #6, and #7 operated independently from the Hospital. VP #1 and CMO #1 said CHC #5, #6 and #7 had it's own Human Resources Department which was not integrated with the Hospital and VP #1 said Clinic #5, #6 and #7's staff were not employees of the Hospital.

2. During a group interview, at 11:45 A.M. on 3/28/19, conducted at CHC #2, the Surveyors interviewed Clinic #2's Chief Medical Officer (CMO #2). CMO #2 said Clinic #2 had it's own Human Resources Department which was not integrated with the Hospital and he said CHC #2's employees were not employees of the Hospital.

3. During a group interview, at 9 A.M. on 3/28/19, conducted at CHC #1, the Surveyors interviewed CHC #1's Chief Medical Officer (CMO #3) and Chief Operating Officer (COO) who said CHC #1 had it's own internal Human Resources department which was not integrated with the Hospital and that employees of CHC #1 were not employees of the Hospital.

Based on record review, review of Hospital wide Quality Assurance Meeting Minutes, Board of Trustee Meeting Minutes and Infection Control (IC) Committee Meeting Minutes, Community Health Centers (CHC) #1, #2, #3, #4, #5 and #6 and #7, which included an SEF ( satellite emergency facility) did not consistently report quality and infection control issues to the Hospital wide Quality Assurance Committee and did not have its governance responsible to the Hospital Board of Trustees. Findings include:

1. Review of Infection Control Committee Meeting Minutes, dated 1/17/2017, indicated that CHC #5 of which there are three (3) sites, reported infection control data to the committee but had not reported previously. Another IC committee report was reviewed from 11/16/2017 and no data from this center was reported. The action plan indicated annual data would be reported. It was unable to be determined which site the data was reported for.

Review of the 11/16/2017 meeting minutes indicated CHC #2 reported infection control data but did not reported any data in 1/17/2019.

No other CHC's reported any infection control data in 1/17/2017 or 11/16/2019.

The Hospital did not provide any IC meeting minutes for 2018.

2. Review of the Board of Trustee Quality and Patient Safety Committee Minutes, dated 4/11/2017, indicated a review of a sentinel event that occurred at CHC # 5 or #6 ( not identified in report).

Review of the Board of Trustees Meeting Minutes from 5/9/2017, 8/8/2017, 6/5/2017, 11/14/2017, 2/13/2018, 5/8/2018, 8/14/2018, 10/11/2018 and 11/13/2018 indicated no discussion of any activities at any of the CHCs or the SEF.

3. At CHC #1, the Surveyor was provided a Report Builder Document, by the Compliance Officer on 3/28/19, indicated CHC #1 had an adverse patient event at a severity level H, which indicated a severe event, reported at CHC #1 on 7/3/18. The Report Builder Document indicated this adverse patient event was not reported to the Hospital.

CHC #1's Incident Reporting and Management Utilizing Quantros Policy, dated 3/98 reviewed 3/18, indicated an actual event at severity level H was a severe event that required intervention to sustain life. The policy indicated the next severity level, I, was death due to an event or cause unknown. The Policy indicated CHC #1 utilized on-line data management system for patients, visitors and employees to report concerns and compliments and the data is reviewed by CHC #1's leadership and compliance. There was no indication of the Hospital being notified or integrated into CHC #1's incident reporting.

On the incident report was a written notation that said "not reported to.." to the main hospital.