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Based on document review and staff interview, it was determined that the Governing Body failed to ensure written Medical Staff bylaws and Medical Staff Rules and Regulations for effectively carrying out its responsibilities for the conduct of the hospital. The facility failed to ensure which categories of practitioners are eligible candidates for appointment to the medical staff for the hospital (see A 045); failed to appoint members to the medical staff (see A 046); failed to ensure the Medical Staff have bylaws (see A 047); failed to approve written Medical Staff bylaws that describe the privileging process to be used by the hospital (see A 050); and failed to have written criteria for appointment to the medical staff and granting of medical staff privileges that are not dependent solely upon certification, fellowship, or membership in a specialty body or society (see A 051).

The cumulative effect of these systematic problems resulted in the hospital's inability to ensure an effective Governing Body that is legally responsible for the conduct of the hospital.

Based on documentation review and staff interview, the Governing Body failed to ensure which categories of practitioners are eligible candidates for appointment to the medical staff for the hospital.

Findings included:

1. At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) indicated the Governing Board failed to ensure the Medical Staff have bylaws to define categories of practitioners that are eligible candidates for appointment to the medical staff. The Medical Staff does not have medical staff bylaws.

2. The facility lacked documentation that the Governing Body had required the Medical Staff to have medical staff bylaws that addressed the categories of practitioners that are eligible for appointment to the medical staff.

Based on documentation review and staff interview, the Governing Body failed to appoint members to the medical staff.

Findings included:

1. The Governing Board (Board of Directors) meeting minutes were reviewed for the previous 12 months and lacked documentation of the recommendations of appointment from the existing medical staff The hospital has 7 medical staff members that are employees of the hospital.

2. At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) indicated the Medical Staff are not appointed by the Governing Board. The Medical Staff does not have medical staff bylaws.

Based on staff interview, the Governing Body failed to ensure the Medical Staff has bylaws.

Findings included:

1. At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) indicated the Medical Staff does not have bylaws.

Based on document review and staff interview, the Governing Body failed to approve written Medical Staff bylaws that ensure that criteria for appointment to the Medical Staff address individual character, competence, training, experience and judgement for one (1) Medical Staff.

Findings included:

1. The 2014 Governing Board bylaws and 2014 Governing Board minutes indicated lack of written Medical Staff bylaws or Medical Staff Rules and Regulations that describe the criteria for selection to the medical staff to include individual character, competence, training, experience, and judgement.

2. At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) the Medical Staff are not appointed by the Governing Board and the Medical Staff does not have medical staff bylaws.

Based on document review and staff interview, the Governing Board failed to ensure the Medical Staff have medical staff bylaws that ensure medical staff membership was not dependent solely upon certification, fellowship or membership in a specialty body or society.

Findings included:

1. The 2014 Governing Board bylaws and 2014 Governing Board minutes indicated lack of written Medical Staff bylaws or Medical Staff Rules and Regulations that described staff privileges which are not dependent solely upon certification, fellowship, or membership in a specialty body or society.

2. At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) indicated the Medical Staff are not appointed by the Governing Board and the Medical Staff does not have medical staff bylaws.

Based on document review and staff interview, it was determined that the hospital failed to ensure an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program which is effective in carrying out its responsibilities for the conduct of the hospital. The facility failed to analyze, and track quality indicators and other aspects of performance that assess processes of care, hospital service and operations (see A273); failed to identify opportunities for improvement and changes that will lead to improvement (see A283). The governing body failed to ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services (see A308); failed to ensure an ongoing program for quality improvement and patient safety that is defined, implemented, and maintained and that the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and all improvement actions are evaluated (see A309).

The cumulative effect of these systematic problems resulted in an inability to ensure an effective quality and improvement program that is legally responsible for the conduct of the hospital.

Based on document review, the facility failed to ensure 7 of 7 services provided by contractors and 7 of 7 non-contracted services as part of its comprehensive quality assessment and improvement (QA&I) program.

Findings included:

1. Quality Assessment and Performance Improvement Plan (last reviewed 1/2013) indicated all services with direct or indirect impact on patient care quality shall be reviewed under the quality improvement program.

2. Review of the facility's Performance Improvement Plan indicated it did not include contracted services: Pharmacy, Biohazard Waste, Laundry, Maintenance, Radiology-Diagnostic, Psychology-Telepsychology, and Dietetic Services and did not include monitoring the following internal services: Medical Records. Laundry (Behavioral Health), Security, Alcohol/Drug, Response to Patient Emergency, Social Services, and Psychiatric Emergency.

3. At 10:15 AM on 10/7/2014, staff member #4 (Executive Director of Quality Improvement) confirmed contracted services: Pharmacy, Biohazard Waste, Laundry, Maintenance, Radiology-Diagnostic, Psychology-Telepsychology, and Dietetic Service Services and non-contracted services: Medical Records, Laundry (Behavioral Health), Security, Alcohol/Drug, Response to Patient Emergency, Social Services, and Psychiatric Emergency were not part of the hospital's comprehensive quality assessment and improvement (QA&I) program.

Based on documentation review and staff interview, the hospital failed to identify opportunities for improvement and changes that will lead to improvement for 14 of 14 services.

Findings included:

1. Review of the facility's Performance Improvement Plan and 2013/2014 Quality minutes for the hospital indicated it did not include contracted services for improvement and changes: Pharmacy, Biohazard Waste, Laundry, Maintenance, Radiology-Diagnostic, Psychology-Telepsychology, and Dietetic Services and did not include internal services for improvement and changes: Medical Records. Laundry (Behavioral Health), Security, Alcohol/Drug, Response to Patient Emergency, Social Services, and Psychiatric Emergency.

2. At 10:30 AM on 10/8/2014, staff member #2 (Chief Medical Officer) confirmed that the hospital was not specific on monitoring all services that affect the hospital.

Based on document review and staff interview, the facility failed to involve all hospital departments and services in the Quality and Improvement program: Pharmacy, Biohazard Waste, contracted Laundry, Maintenance, Radiology-Diagnostic, Psychology-Telepsychology, Dietetic Services, Medical Records, Laundry (Behavioral Health), Security, Alcohol/Drug, Response to Patient Emergency, Social Services, and Psychiatric Emergency.

Findings included:

1. The Bylaws of Hamilton Center, Inc did not address how the Governing Body will oversee the quality improvement program for the hospital.

2. The 2014 Hamilton Center, Inc Organizational Plan indicated it addresses the entire organization and not specifically the hospital. The inpatient services of the plan do not have a hospital-wide quality assessment and performance improvement efforts that addresses priorities for improved quality of care and patient safety and that all improvement actions are evaluated. The ongoing program for quality improvement and patient safety was not defined, implemented, and maintained.

3. Review of the facility's Performance Improvement Plan and 2013/2014 minutes indicated it did not include contracted services: Pharmacy, Biohazard Waste, Laundry, Maintenance, Radiology-Diagnostic, Psychology-Telepsychology, and Dietetic Services and did not include monitoring the following internal services: Medical Records. Laundry (Behavioral Health), Security, Alcohol/Drug, Response to Patient Emergency, Social Services, and Psychiatric Emergency.

4. At 10:15 AM on 10/7/2014, staff member #4 (Executive Director of Quality Improvement) confirmed contracted services: Pharmacy, Biohazard Waste, Laundry, Maintenance, Radiology-Diagnostic, Psychology-Telepsychology, and Dietetic Service Services and non-contracted services: Medical Records, Laundry (Behavioral Health), Security, Alcohol/Drug, Response to Patient Emergency, Social Services, and Psychiatric Emergency were not part of the hospital's comprehensive quality assessment and improvement (QA&I) program.

5. At 10:30 AM on 10/8/2014, staff member #2 (Chief Medical Officer) confirmed that the hospital was not specific on monitoring all services that affect the hospital.

Based on documentation review and staff interview, the Governing Body, Medical Staff and administrative staff failed to assure there was an effective quality improvement and patient safety program for the hospital that addressed quality improvement and patient safety, including the reduction of medical errors, hospital-wide quality assessment and performance improvement which addresses improved quality of care and patient safety.

Findings included.

1. The Bylaws of Hamilton Center, Inc did not address how the Governing Body will oversee the quality improvement and patient safety program for the hospital.

2. The 2014 Hamilton Center, Inc Organizational Plan indicated it addresses the the entire organization and not specifically the hospital. The inpatient services of the plan does not have a hospital-wide quality assessment and performance improvement efforts that address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. The ongoing program for quality improvement and patient safety was not defined, implemented, and maintained. This was evidenced by 14 of 14 services not being monitored: Pharmacy, Biohazard Waste, contracted Laundry services, Maintenance, Radiology-Diagnostic, Psychology-Telepsychology, Dietetic Service, Medical Records, internal Laundry Services (Behavioral Health), Security, Alcohol/Drug, Response to Patient Emergency, Social Services and Psychiatric Emergency.

3. At 10:30 AM on 10/8/2014, staff member #2 (Chief Medical Officer) confirmed that the hospital was not specific on monitoring all services that affect the hospital.

Based on document review and staff interview, it was determined that the Medical Staff failed to ensure written Medical Staff bylaws and Medical Staff Rules and Regulations for effectively carrying out its responsibilities for the conduct of the hospital. The facility failed to provide Medical Staff Periodic Appraisals by its members (see A 340), failed to ensure Medical Staff Credentialing Process (see A 341), failed to ensure Medical Staff bylaws (see A 353) failed to ensure the Governing Board has approved the Medical Staff bylaws (see A 354), failed to approve written Medical Staff bylaws that describe the privileging process to be used by the hospital (see A 355), failed to have an Organization of the Medical Staff (see A 356), failed to define the Medical Staff Qualifications (see A 357) and failed to have written criteria for Medical Staff privileging (see A 363).

The cumulative effect of these systematic problems resulted in the hospital's inability to ensure an effective Medical Staff that is legally responsible for the conduct of the hospital.

Based on documentation review and staff interview, the Medical Staff failed to conduct periodical review of its members for 7 of 7 physicians (M1, M2, M3, M4, M5, M6, and M7).

Findings included:

1. The seven Medical Staff employees performance evaluations were signed and approved by Human Resource Division. The evaluations lacked documentation the Medical Staff conducted periodic appraisals of staff M1, M2, M3, M4, M5, M6 and M7. The performance evaluations were not periodical reviews by the members of the Medical Staff.

2. At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) indicated the Medical Staff are not appointed by the Governing Board. Medical staff members are hired by human resources and the CEO has the hiring authority for all Medical Staff.

Based on document review and staff interview, the Medial Staff failed to examine credentials of medical staff for medical staff membership and make recommendations to the governing body on appointment of candidates for 7 of 7 medical staff members (M1, M2, M3, M4, M5, M6, and M7).


Findings included:

1. Review of medical staff M1, M2, M3, M4, M5, M6, and M7's files lacked documentation of the medical staff examining and making recommendation on appointment.

2. At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) indicated individuals are hired by Human Resources. The Medical Staff does not have Medical Staff bylaws.

Based on staff interview, the Medical Staff failed to adopt medical staff bylaws for one (1) medical staff.

Findings included:

At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) indicated there are no Medical Staff bylaws.

Based on staff interview, the Governing Body failed to approve medical staff bylaws for one (1) medical staff.

Findings included:

At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) indicated Medical Staff do not have bylaws for the Governing Body to approve.

Based on staff interview, the Medical Staff bylaws failed to include a statement of the duties and privileges of each category of medical staff.

Findings included:

At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) indicated there are no Medical Staff bylaws.

Based on staff interview, the Medical Staff failed to ensure bylaws that describe the organization of the Medical Staff.

Findings included:

1. At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) indicated the Medical Staff does not have bylaws.

Based on staff interview, the Medical Staff failed to have Medical Staff bylaws that describe the qualifications to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body.

Findings included:

1. At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) indicated the Medical Staff does not have bylaws.

Based on staff interview, the Medical Staff failed to have Medical Staff bylaws that include the criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges.

Findings included:

1. At 1:45 PM on 10/7/2014, staff member #2 (Chief Medical Officer) indicated the Medical Staff does not have bylaws.

Based on policy and procedure review, medical record review and interview, the facility failed to follow their policy regarding authentication of history and physicals for 16 of 18 closed records reviewed of patients hospitalized for over 48 hours (N2- N7, N11, N12, N14, and N16- N22).

Findings included:

1. The facility policy "Physical Exams", last reviewed 07/14, indicated, "1. A physical assessment will be completed, within twenty-four (24) hours of admission, by the attending psychiatrist, Nurse Practitioner, or family practice physician. ...4. A copy of the dictated physical examination will be placed on the chart within 48 hours of admission for review and signature by the physician. 5. The signature of the attending psychiatrist, family nurse practitioner, or the family practice physician must be obtained within 48 hours of admission."

2. The medical record for patient N2 indicated an admission on 08/20/14 with a history and physical (H & P) completed by the nurse practitioner on 08/21/14, but not authenticated until 08/27/14.

3. The medical record for patient N3 indicated an admission on 08/19/14 with an H & P completed by the nurse practitioner on 08/20/14, but not authenticated until 08/26/14.

4. The medical record for patient N4 indicated an admission on 07/26/14 with an H & P completed by the nurse practitioner on 07/27/14, but not authenticated until 08/09/14.

5. The medical record for patient N5 indicated an admission on 08/20/14 with an H & P completed by the nurse practitioner on 08/21/14, but not authenticated until 08/27/14.

6. The medical record for patient N6 indicated an admission on 08/21/14 with an H & P completed by the nurse practitioner on 08/22/14, but not authenticated until 08/26/14.

7. The medical record for patient N7 indicated an admission on 08/14/14 with an H & P completed by the nurse practitioner on 08/15/14, but not authenticated until 08/26/14.

8. The medical record for patient N11 indicated an admission on 09/04/14 with an H & P completed by the nurse practitioner on 09/05/14, but not authenticated until 09/09/14.

9. The medical record for patient N12 indicated an admission on 09/08/14 with an H & P completed by the nurse practitioner on 09/09/14, but not authenticated.

10. The medical record for patient N14 indicated an admission on 08/20/14 with an H & P completed by the nurse practitioner on 08/21/14, but not authenticated until 08/27/14.

11. The medical record for patient N16 indicated an admission on 08/26/14 with an H & P completed by the nurse practitioner on 08/27/14, but not authenticated until 09/02/14.

12. The medical record for patient N17 indicated an admission on 08/15/14 with an H & P completed by the nurse practitioner on 08/16/14, but not authenticated until 09/05/14.

13. The medical record for patient N18 indicated an admission on 08/12/14 with an H & P completed by the nurse practitioner on 08/13/14, but not authenticated until 08/27/14.

14. The medical record for patient N19 indicated an admission on 08/28/14 with an H & P completed by the nurse practitioner on 08/29/14, but not authenticated until 09/02/14.

15. The medical record for patient N20 indicated an admission on 08/27/14 with an H & P completed by the nurse practitioner on 08/28/14, but not authenticated until 09/02/14.

16. The medical record for patient N21 indicated an admission on 08/15/14 with an H & P completed by the nurse practitioner on 08/16/14, but not authenticated until 09/05/14.

17. The medical record for patient N22 indicated an admission on 09/01/14 with an H & P completed by the nurse practitioner on 09/02/14, but not authenticated until 09/11/14.

18. At 4:20 PM on 10/07/14, staff member A3, the Vigo County Services Director, who navigated the EMR (Electronic Medical Records) confirmed the H & Ps were not authenticated within 48 hours according to facility policy.

Based on medical record review and interview, the facility failed to ensure all medical records were completed within 30 days of discharge for 9 of 18 closed records reviewed of patients hospitalized for over 48 hours (N1, N2, N3, N5, N7, N12, N14, N18, and N19).

Findings included:

1. The medical record for patient N1 indicated an admission on 08/30/14 and a discharge on 09/02/14 with the dictated History & Physical (H & P) not countersigned by the physician until 10/05/14.

2. The medical record for patient N2 indicated an admission on 08/20/14 and a discharge on 08/25/14 with the dictated H & P not countersigned by the physician until 10/05/14.

3. The medical record for patient N3 indicated an admission on 08/19/14 and a discharge on 08/28/14 with the dictated H & P not countersigned by the physician until 10/05/14.

4. The medical record for patient N5 indicated an admission on 08/20/14 and a discharge on 08/26/14 with the dictated H & P not countersigned by the physician until 10/05/14.

5. The medical record for patient N7 indicated an admission on 08/14/14 and a discharge on 08/20/14 with the dictated H & P not countersigned by the physician until 10/05/14.

6. The medical record for patient N12 indicated an admission on 09/08/14 and a discharge on 09/15/14 with the dictated H & P not signed by the nurse practitioner or countersigned by the physician.

7. The medical record for patient N14 indicated an admission on 08/20/14 and a discharge on 08/22/14 with the dictated H & P not countersigned by the physician until 09/24/14.

8. The medical record for patient N18 indicated an admission on 08/12/14 and a discharge on 08/21/14 with the dictated H & P not countersigned by the physician until 10/05/14.

9. The medical record for patient N19 indicated an admission on 08/28/14 and a discharge on 08/31/14 with the dictated H & P not countersigned by the physician until 10/05/14.

10. At 4:20 PM on 10/07/14, staff member A3, the Vigo County Services Director, who navigated the EMR (Electronic Medical Records) confirmed the H & Ps were not countersigned by the physician within 30 days after discharge as required. He/she could not provide written documentation of this requirement by the facility, but indicated it was the expectation.

Based on document review, personnel file review, policy and procedure, observation and interview, the infection control officer failed to monitor staff immunization status for designated infectious diseases, as recommended by the CDC for 31 of 31 employees (A1, A2, A4, A5, A6, A7, A8, A9, A10, A11, A12, A13, A14, A16, A19, A20, N1, N2, N3, N4, N5, N6, N8, N9, N10, N11, N12, N13, N14, N15, and N16) and failed to ensure a safe environment for patients, staff and visitors by ensuring proper chenical use and proper cleaning of laundry equipment between patients.

Findings:

1. Hamilton Center, Inc Environment of Care Manual Consumer Health policy (last reviewed Sept 2014) stated, "To protect consumers, staff and the Hamilton Center, Inc (HCI) environment through the prevention and control of infections and infestations and the prevention and/or reduced transmission of health care-acquired infections. HCI adheres to rules, regulations and guidelines established by the U.S. Centers for Disease Control and Prevention (CDC) and the Indiana State Department of Health."

2. Center for Disease Control (CDC) recommended that all Healthcare personnel (HCP) be immune to Varicella. Evidence of Immunity in HCP includes documentation of varicella vaccine given, history of varicella based on physician diagnosis, laboratory evidence of immunity, or laboratory confirmation of disease. HCP who work in medical facilities should be immune to measles, mumps, and rubella. The HCP can be considered immune to measles, mumps, and rubella only if they have documentation of a physician diagnosed measles or mumps disease; or laboratory evidence of measles, mumps, or rubella immunity or appropriate vaccination against measles, mumps, and rubella.

3. Review of the hospital's staff health records indicated that 31 of 31 personnel records did not show documented evidence of immunization of Rubella, Rubeola, and Varicella (A1, A2, A4, A5, A6, A7, A8, A9, A10, A11, A12, A13, A14, A16, A19, A20, N1, N2, N3, N4, N5, N6, N8, N9, N10, N11, N12, N13, N14, N15, and N16). However, staff member A14 had documented evidence of immunization of Rubella and Rubeola only.

4. At 10:00 AM on 10/8/2014, staff member #15 (Administrative Assistant) confirmed that there was no documented evidence in the 31 employee files that were reviewed confirming immunization of Rubella, Rubeola, and Varicella.


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5. Beginning at 9:00 AM on 10/08/14, the inpatient unit was toured with staff members A3, the Vigo County Services Director, A10, the Director of 24-hr. Services, and A14, the Director of Nursing, and two stackable washer/dryer units were observed in a small, open room. The environmental services room was observed with cleaning supplies, equipment, and the disinfectant NABC, but no measuring devices were observed.

6. The facility policy "Laundry Care", last reviewed 09/14, indicated, "A. Hamilton Center, Inc. shall implement laundry procedures that prevent cross contamination and reduce occupational exposure based on Occupational Safety and Health Administration (OSHA) and Joint Commission of Accreditation of Healthcare Organizations (JCAHO) standards that emphasize hygienic handling, processing, and storage of laundry and staff's use of Universal Precautions. ...C. Hamilton Center, Inc. provides laundry equipment for consumer use in Inpatient Services, Child & Adolescent Services, Rehabilitation Services, and all residential services. Each service area is responsible for implementing procedures that comply with the following policy components for use in their respective program/service area. ...Special Precautions: 10. Consumer and facility laundry shall not be washed together. 11. Consumers clothes shall not be washed together."

7. The facility policy "Exposure Control Plan Methods of Ensuring Compliance", last reviewed 04/14, indicated, "III. A. Hamilton Center, Inc. Housekeeping Controls: The Facilities Manager and Housekeeping Supervisor are responsible for developing, implementing, and supervising a written schedule for cleaning and decontamination of the various areas of the Center. The schedule specifies the day and time of work and also the following information: 1. The area to be cleaned/decontaminated. 2. Cleansers and disinfectants to be used."

8. Manufacturer's label directions on the NABC disinfectant indicated the proper dilution for cleaning and disinfection was 1:10 or 12 ounces of chemical to each gallon of water.

9. At 10:00 AM on 10/08/14, staff member A10 indicated the patients/consumers washed their own clothes in the washer/dryer, but he/she was unsure of the cleaning process.

10. At 10:15 AM on 10/08/14, staff member A23, the Environmental Services Supervisor, indicated the NABC disinfectant was the product used for cleaning and mopping on the unit. He/she indicated he/she thought the disinfectant was run through the wash cycle daily.

11. At 10:30 AM on 10/08/14, staff members A24 and A25, two environmental services staff members who cleaned the unit, arrived to put supplies away, and were interviewed. They indicated they mixed about two ounces of chemical to each gallon of water, but confirmed they did not use any measuring device. When questioned regarding the amount of chemical they used for the each task, they indicated they put one capful of disinfectant into the small three liter bucket and filled with water to hold their rags to clean surfaces and put one and one-half capfuls into the five gallon bucket for mopping. (The capful referred to was the lid on the disinfectant which was approximately one-half an ounce.) Staff members A24 and A25 indicated they wiped the washer/dryer units with disinfectant daily and ran a wash cycle with disinfectant once a week. They indicated they did not use bleach on the unit because the smell bothered some of the patients.

12. At 12:20 PM on 10/08/14, staff member A13, the Infection Control Nurse, indicated Environment of Care rounds were performed quarterly with staff from Infection Control, Environmental Services, and Facilities Management, but confirmed there was no actual observation or monitoring of the cleaning staff or procedures. He/she confirmed there was no specific laundry policy to ensure proper disinfection between patients.

13. At 12:50 PM on 10/08/14, staff member A23 indicated all of the cleaning staff received a 3-day orientation and annual inservicing and were good about communicating and asking staff if they had any questions or concerns. He/she confirmed he/she did not actually observe the staff mixing chemicals and also confirmed the laundry policy was unclear. Staff member A23 provided documentation of cleaning checklists, dilution ratios, and a wet mopping procedure which indicated two ounces (1/4 cup) of Quat [disinfectant] should be put in the mop bucket. The procedure did not indicate how much water should be in the bucket and staff member A23 indicated Quat was not the chemical in use anymore.

Based on document review and staff interview, it was determined that the hospital failed to ensure a written agreement with an Organ Procurement Organization and Tissue and Eye Bank Agreements which are effective in carrying out its responsibilities for the conduct of the hospital. The facility failed to provide written policies and procedures (see A885), failed to have a written agreement with an Organ Procurement Organization (see A886), failed to have written Tissue and Eye Bank Agreements (see A887), failed to have a designated Requestor (see A889) and failed to educate staff in Organ Procurement (see A891).

The cumulative effect of these systematic problems resulted in an inability to ensure an effective organ procurement program that is legally responsible for the conduct of the hospital.

Based on staff interview, the hospital failed to ensure written policies and procedures to address its organ procurement responsibilities.

Findings included:

At 2:00 PM on 10/6/2014, staff member #2 (Chief Medical Officer) indicated the hospital does not have written procedures to address its organ procurement responsibilities.

Based on staff interview, the hospital failed to have a written agreement with an Organ Procurement Organization.

Findings included

At 12:45 PM on 10/6/2014, staff member #3 (Vigo County Director) indicated the hospital does not have any written agreement with an Organ Procurement Organization.

Based on staff interview, the hospital failed to ensure an agreement with a tissue bank and eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes.

Findings included:

At 3:15 PM on 10/6/2014, staff member #2 (Chief Medical Officer) indicated the hospital does not have any agreements with tissue and eye banks.

Based on documentation review and staff interview, the hospital failed to ensure at least one staff member was trained in the methodology for approaching potential donor families.

Findings included:

1. All staff personnel (M1 through M7, physicians; AH1 through AH10, nurse practitioners; A1, A2, A4 through A14, A16, A19, A20, non-nursing personnel; N1 trough N6, N8 through N12, N14 through N16, nursing personnel) training files were reviewed and none of the staff training documentation addressed methodology for approaching potential donor families.

2. At 12:45 PM on 10/6/2014, staff member #3 (Vigo County Director) indicated no staff were trained in the methodology for approaching potential donor families.

Based on staff interview, the hospital failed to work cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues.

Findings included:

1. At 12:45 PM on 10/6/2014, staff member #3 (Vigo County Director) indicated the hospital does not have any written agreement with an Organ Procurement Organization.

2. At 2:00 PM on 10/6/2014, staff member #2 (Chief Medical Officer) indicated the hospital does not have written procedures to address its organ procurement responsibilities and staff are not trained on organ procurement issues.