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

SONOMA SPECIALTY HOSPITAL 501 PETALUMA AVENUE SEBASTOPOL, CA 95472 June 13, 2017
VIOLATION: CONTRACTED SERVICES Tag No: A0085
Based on interview and document review the hospital failed to follow their policy and procedure to ensure a current list of all contracted services that included a process which included tracking the name of the service (vendor, contractor) the purpose of the contract, the contract's expiration/renewal date and the personnel/department responsible for oversight of the contract. This failure had the potential to result in contractual disputes, inefficient use of services, loss of services, resulting in the needs of the patients not being met.

Findings:

During an interview on 6/7/17 at 2:30 p.m. and 6/9/17 at 11:15 a.m., the Chief Executive Officer (CEO) stated when queried, "The contracts were not currently being tracked and reviewed as of 10/2016" and concurred he was responsible for the oversight.

During review of the policy and procedure 861-08, "Contract Services, Review and Approval of"[Sic] with a revision date of 3/21/16 indicated the CEO will maintain a master list [data base of contracts], name of the contracting agency, expiration/renewal date, and general purpose of the contract.
VIOLATION: MEDICAL STAFF - BYLAWS AND RULES Tag No: A0048
Based on interview and document review the hospital failed to ensure their Medical Staff's Bylaws were current. This failure has the potential for the hospital to not be compliant with current laws and may not reflect the organization's current practices.

Findings:

During a document review on 6/9/17 of the hospital's Medical Staff's Bylaws indicated, "These Bylaws shall be reviewed by the Medical Staff at least every two years." The same document indicated, "Reviewed, approved and adopted. The Medical Staff on March 31, 2015." [Sic]

During an interview on 6/9/17 at 10:40 a.m., the CEO concurred the Medical Staff Bylaws needed to be updated.
VIOLATION: INSTITUTIONAL PLAN AND BUDGET Tag No: A0073
Based on interview, document review and review of the hospital's policy and procedure the hospital failed to have an annual operating budget projected beyond 6/2017. This failure had the potential for the Governing Body, the Administrative Staff, and the Medical Staff to be unaware of critical changes with the Hospital's finances.

Findings:

During a document review with concurrent interview on 6/9/17 at 9 a.m., of the hospital's Organization Chart dated 5/1/17 with the Chief Executive Officer (CEO), he concurred the Chief Financial Officer (CFO), the Controller, and the Financial Analyst/AP/Payroll Director positions were vacant. In addition, the CEO indicated the "Business Office and Payroll" were staffed with companies contracted by the hospital.

During a document review with concurrent interview on 6/9/17 at 9 a.m. and 6/12/17 at 10:50 a.m., of the "FY 2016/17 Operating Forecast/Budget" indicated the "Year 1 Pro Forma Income Statement and Balance Sheet" encompassed projections for 7/2016 to 6/2017. The CEO stated the "FY 2016/17 Operating Forecast/Budget" has not been projected beyond 6/2017. "I am looking for a CFO." The CEO stated he had taken his current position in March 2017. His goal would be to seek input and to see if priorities have changed related to the budget currently in place. The CEO went on to say, the Hospital District (Palm Drive Health Care District) was trying to secure a CFO; however there was nothing in writing at this time indicating any confirmation. When queried on who was doing the financials he stated a Board Member with the assistance from a member of the community who had qualifications. He responded when queried on how the Hospital District /Board responded to those circumstances, the CEO stated the members of the Board of Directors are aware of the situation.

During a document review with concurrent interview on 6/13/17 at 10:40 a.m., a draft copy of the Governing Body Minutes dated 5/22/17 indicated the same Financial Report from 3/31/17 was presented to the Governing Body. The CEO stated, if he had money I would have a CFO.

During the review of the Palm Drive Healthcare District Governing Body Bylaws revised 2/22/16 indicated in 4.1f Governing Body, "To develop, oversee and implement capital and operating budgets for the Hospital, and to adopt and amend the Hospital's institutional strategic plan."
VIOLATION: INSTITUTIONAL PLAN AND BUDGET Tag No: A0077
Based on interview, document review and review of the hospital's policy and procedure the hospital failed to have Administrative Staff for planning the Institutional Plan and Budget when three of the seven key positions in the organization's Finance Department were vacant. And, one of the seven positions were under contract. The collection, analysis, dispersion of financial information to assist the Governing Body, the Administrative staff, and the Medical Staff for being aware of problem areas, respond to excessive costs effectively and determine the best ways to maximize profits was not being accomplished by all entities. This failure had the potential for the Governing Body, the Administrative Staff, and the Medical Staff to be unaware of critical changes with the Hospital's finances.

Findings:

The Health Care District was described as follows:

The Health Care District consists of five (5) elected members. The Health Care District Board of Directors' "Amended and Restated Bylaws adopted 3/6/17 under Article III Board of Directors, Section 3 Powers and Duties "...(a) To control and be responsible for the management of all operations and affairs of the District."

The Health Care District Governing Body Bylaws adopted 3/17/15 and revised 2/22/16, under "Formation" indicated, "The Governing Body is a duly authorized subcommittee of the Board of Directors (Board) ... / The powers of the Governing Body are delegated and specified by the Board pursuant to the District Bylaws and the terms of the Management Services Agreement between the District and the Sonoma West Medical Center dated, 3/18/15 (the Management Agreement"). Under Article 2 Scope of Governing Body Authority, 2.1 Authority of the Governing Body. .... "The Governing Body shall have overall administrative and professional responsibility for the Hospital. Pursuant to a delegation of authority by the District Board, the Governing Body is organized to serve as the governing body of the hospital facility owned by the District." ..."The Governing Body shall consist of eleven (11) voting members appointed in accordance with the Bylaws of the District....

During a document review with concurrent interview on 6/9/17 at 9 a.m., of the hospital's Organization Chart dated 5/1/17 with the Chief Executive Officer (CEO), he concurred the Chief Financial Officer (CFO), the Controller, and the Financial Analyst/AP/Payroll Director positions were vacant. In addition, the CEO indicated the "Business Office and Payroll" were staffed with companies contracted by the hospital.

During a document review with concurrent interview on 6/9/17 at 9 a.m. and 6/12/17 at 10:50 a.m., of the "FY 2016/17 Operating Forecast/Budget" indicated the "Year 1 Pro Forma Income Statement and Balance Sheet" encompassed projections for 7/2016 to 6/2017. The CEO stated the "FY 2016/17 Operating Forecast/Budget" has not been projected beyond 6/2017. "I am looking for a CFO." The CEO also stated he had taken his current position in March 2017. His goal would be to seek input and to see if priorities have changed related to the budget currently in place. The CEO went on to say, the Hospital District (Health Care District) was trying to secure a CFO; however there was nothing in writing at this time indicating any confirmation. When queried on who was doing the financials he stated a Board Member with the assistance from a member of the community who had qualifications. He responded when queried on how the Hospital District /Board responded to those circumstances, the CEO stated the members of the Board of Directors are aware of the situation.

During a document review with concurrent interview on 6/13/17 at 10:40 a.m., a draft copy of the Governing Body Minutes dated 5/22/17 indicated the same Financial Report from 3/31/17 was presented again to the Governing Body. The CEO stated, if he had money I would have a CFO.

During the review of the Healthcare District's Governing Body Bylaws revised 2/22/16 indicated in 4.1f Governing Body, "To develop, oversee and implement capital and operating budgets for the Hospital, and to adopt and amend the Hospital's institutional strategic plan."
VIOLATION: GOVERNING BODY Tag No: A0043
Based on staff interviews; review of administrative records; policies and procedures; infection control, physical environment, quality assurance, performance improvement and governing body documentation; it was determined that the hospital's Governing Body failed to:

1. Ensure the Medical Staff's Bylaws were current (Refer to A-0048);
2. Have Administrative Staff for planning the Institutional Plan and Budget when 3 of the 7 key positions in the organization's Finance Department were vacant. And, 1 of the 7 positions was under contract. (Refer to A-0077);
3. Ensure a contractor providing services complied with standards for the particular contract service (Refer to A-0083);
4. Ensure contractors [current and past] provided services in a safe and effective manner (Refer to A-0084);
5. Ensure a current list of all contracted services that included a process which included tracking the name of the service (vendor, contractor) the purpose of the contract, the contract's expiration/renewal date and the personnel/department responsible for oversight of the contract. (Refer to A-0085);
6. Ensure a comprehensive hospital-wide Quality Assurance and Performance Improvement Program was continually being defined, implemented with current data-driven quality indicators, tracked, monitored, evaluated and sustained with the allocation for adequate resources to be made available to those departments in need of assistance (Refer to A-0263);
7. Maintain the physical environment when routine and preventive maintenance and testing activities were not performed Refer to (A-0700);
8. Ensure the routine and scheduled preventive maintenance of vital services and equipment in the facility were completed (Refer to A-0701) [Immediate Jeopardy # 1 was called];
9. Ensure the availability, the amount and safety of the hospital's emergency water supply for patients, visitors and staff (Refer to A-0703) [Immediate Jeopardy # 2 was called];
10. Ensure the Infection Control Program included:
a. Screening of vendors in the Operating Room,
b. Monitoring personnel's respirator fit tests
c. Monitoring personnel's Tuberculosis tests,
d. Processing of sterile instruments in area confirmed to have black mold. (Refer to A-0747);
11. Ensure the Infection Control Program included:
a. Screening of vendors in the Operating Room,
b. Monitoring personnel's respirator fit tests,
c. Monitoring personnel's Tuberculosis tests,
d. Processing of sterile instruments in area confirmed to have black mold (Refer to A-0748);
12. Ensure the Infection Control Program implemented:
a. Screening of vendors in the Operating Room,
b. Monitoring personnel respirator fit tests
c. Monitoring personnel Tuberculosis tests (Refer to A-0749); and
13. Ensure the Infection Control Nurse implemented a corrective action plan to remediate the black mold in the SPD area. (Refer to A-0756).

The cumulative effects of these systemic problems resulted in the hospital's governing body, administrative officials and the medical staff's inability to ensure the provision of quality health care and services in a safe environment.
VIOLATION: CONTRACTED SERVICES Tag No: A0083
Based on interview and document review the Governing Body failed to ensure a contractor providing services complied with standards for the particular contract service for a certified environmental hygienist (a person whose job it is to protect the health of workers and the general public) when mold and possible asbestos was discovered in the Sterile Processing Department. This failure has the potential of a noncertified hygienist to not recognize health hazards, test the environment for those hazards, determine if there is a risk to human health in a particular situation, and recommend controls or means of protection from the recognized health hazard.

During an interview with the Infection Control Nurse on 6/1/17 at 12:25 p.m., when asked why Company I was chosen to do air and surface sampling in the Perioperative area, she stated the company had been used before by the hospital for a similar problem in another area of the hospital. When asked if Company I had a certified industrial environmental hygienist, she stated she did not know. A document provided by the facility from Company I, dated 9/25/16, indicated the Environment Vendor was a Certified Microbial Consultant, and not a Certified Industrial Environmental Hygienist.

During an interview on 6/1/17 at 3:45 p.m., the Chief Executive Officer and the Chief NO were queried if the hygienist who performed the initial examination and testing for mold in the Perioperative Area and the Sterile Processing Department were certified. The CEO stated he would find the answer. The CNO stated staff used the same contractor that was utilized when there was a similar incident in the past.

During an interview on 6/6/17 at 9:20 a.m., the Certified Industrial Environmental Hygienist from Company J was onsite for her initial evaluation of the sites (fourteen days after the initial discovery).
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Based on interview and document review the Governing Body failed to ensure contractors [current and past] provided services in a safe and effective manner when-

1. A noncertified industrial environmental hygienist performed tests that required a certified hygienist when mold and possible asbestos was discovered the Sterile Processing Department. This failure had the potential of a noncertified hygienist to not recognize health hazards, test the environment for those hazards, determine if there is a risk to human health in a particular situation, recommend controls or means of protection from the recognized health hazard and create a delay in response to a health hazard.

2. The hospital's website held-out to the public that Imaging Services were available at the hospital when in-fact the service had been terminated. This failure had the potential of patients seeking medical attention as a result of the hospital's website to present at the hospital for imaging services and then having to be sent to another hospital to have the studies completed.

Findings:

1. During an interview with the Infection Control Nurse on 6/1/17 at 12:25 p.m., when asked why Company I was chosen to do air and surface sampling in the Perioperative area, she stated the company had been used before by the hospital for a similar problem in another area of the hospital. When asked if Company I had a certified industrial environmental hygienist, she stated she did not know. A document provided by the facility from Company I, dated 9/25/16, indicated the Environment Vendor was a Certified Microbial Consultant, and not a Certified Industrial Environmental Hygienist.

During an interview on 6/1/17 at 3:45 p.m., the Chief Executive Officer (CEO) and the Chief Nursing Officer (CNO) were queried if the hygienist who performed the initial examination and testing for mold in the Perioperative Area and the Sterile Processing Department were certified. The CEO stated he would find the answer. The CNO stated staff used the same contractor that was utilized when there was a similar incident in the past.

During an interview on 6/6/17 at 9:20 a.m., the Certified Industrial Environmental Hygienist from Company J was onsite for her initial evaluation of the sites.

2. During an interview on 6/9/17 at 11:30 a.m., the CEO corroborated that the hospital no longer had a contract with Contract Provider G who provided the magnetic resonance imaging (MRI-a test that uses a magnetic field and pulses of radio wave energy to make pictures of organs and structures inside the body) mobile unit that was on the hospital's State License as a service they provided to the community. The hospital's website held-out to the public under services provided, Medical Imaging- "MRI Friday and Saturday Appointments ONLY. Saturday exams will not offer contrast." The CEO stated in response to the MRI mobile unit no longer being available to patients, "No funds, no contract."

The Palm Drive Health Care District Board of Directors' "Amended and Restated Bylaws adopted 3/6/17 under Article III Board of Directors, Section 3 Powers and Duties "...(a) To control and be responsible for the management of all operations and affairs of the District."
VIOLATION: QAPI Tag No: A0263
Based on observation, interview and document review, the hospital failed to provide for an ongoing, comprehensive, hospital-wide Quality Assurance and Performance Improvement (QAPI) Program that included all the elements of the Program when-

1. Qualified staff resigned suddenly with no one ensuring the program was being implemented with data not being collected, measured, analyzed and tracked related to patient care, services, safety and general operations (Refer to A-0273);
2. Systems were not in place to monitor care and services, drawing data from multiple sources and looking at any program activities, their affect on all systems of care and whether improvements were sustained (Refer to A-0283);
3. The hospital did not have an active program scope and program activities with a concern for safety (Refer to A-0286);
4. The hospital did not conduct performance improvement projects related to the scope and complexity of its services and operations (Refer to A-0297);
5. The Quality Assessment and Performance Improvement (QAPI) Program did not show the complexity of the full range of services offered by the hospital and evidence of an active QAPI Program (Refer to A-0308);
6. The hospital's Governing Body had not be accountable for ensuring an ongoing program for quality improvement in patient care and services and patient safety were being implemented and maintained when every aspect of the QAPI Program had not been fully active (Refer to A-0309); and
7. The hospital's Governing Body did not ensure that adequate resources for the Quality Assurance and Performance Improvement Program existed when every aspect of the QAPI Program had not been fully active (Refer to A-0315).

These cumulative effects of these systemic problems resulted in the the hospital's governing body, administrative officials and the medical staff's inability to ensure the provision of quality health care and services in a safe environment.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on document review and interviews the hospital failed to ensure the Quality Assurance and Performance Improvement (QAPI) Program was being implemented when data was not being collected, measured, analyzed and tracked related to patient care, services, safety and general operations for the last two quarters starting in 1/2017. These failures led to the potential of the patient's quality of life, their quality of care and services being adversely affected.

Findings:

During an interview on 6/7/17 at 9:50 a.m., with the Chief Executive Officer (CEO) and the Chief Nursing Officer (CNO), both concurred the QAPI Program had not been ongoing for the last two quarters. They stated the following:

1. The Interim Quality/Risk Manager left on 4/7/17 with a "two day" notice;
2. There had been no collection of data for the QAPI Program since 1/2017.;
3. By the end of the first quarter of 2017, all except one Department Manager left the Hospital Leadership Team;
4. The following are Department Managers' start dates for the new Leadership Team:
2/15/17 Human Resource
3/2017 CEO
3/12/17 Rehabilitation
3/13/17 Director of Nursing
4/14/17 Peri-Operative Services
4/23/17 Engineering
5/1/17 CNO
5/1/17 Health Information

During document reviews 6/1/17 to 6/13/17 the following information was compiled:

1. Policy Pro # 861-05[Sic] titled, "Quality Assessment and Performance Improvement (QAPI) Plan 2015 with an effective date of 4/1/15 and review date of 9/1/17;
2. The "QAPI Plan 2017" had an origination date of 4/1/15. It was last revised as a DRAFT on 12/15/16 and reviewed on 12/16/16;
3. There are still open positions for Department Managers;
4. The Quality Council "a multidisciplinary Committee responsible for the development and oversight of the QAPI Program" had its last meeting 1/12/17 at which time the Medical Executive Committee approved the Plan.
5. Documentation that the Governing Board received a last report on the QAPI Plan was in 10/17;
6. The Policy 861-05 indicated The Quality Council Meeting should be meeting quarterly;
7. The Patient Safety Program "Integrated with QAPI in order to provide a systematic, coordinated approach to the maintenance and improvement of patient safety, and ongoing proactive reduction in medical/health care errors". Pharmacy on 5/18/17 had a "Quality Meeting" in which the CNO, DON and the Pharmacist in Charge were present. "They reviewed event reports with action plans on every event." This was the only Quality Meeting of record since 1/17. The Prime Grant tracks hospital re-admissions. These are the only two QAPI projects that had any activity.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on document review and interviews the hospital failed to ensure systems were in place to monitor care and services, drawing data from multiple sources and looking at any program activities, their affect on all systems of care and whether improvements were sustained when QAPI Program had not been active for the last two quarters beginning 1/2017. These failures led to the potential of the patient's quality of life, their quality of care and services being adversely affected.

Findings:

During an interview on 6/7/17 at 9:50 a.m., with the Chief Executive Officer (CEO) and the Chief Nursing Officer (CNO), both concurred the QAPI Program had not been ongoing for the last two quarters. They stated the following:

1. The Interim Quality/Risk Manager left on 4/7/17 with a "two day" notice;
2. There had been no collection of data for the QAPI Program since 1/2017.;
3. By the end of the first quarter of 2017, all except one Department Manager left the Hospital Leadership Team;
4. The following are Department Managers' start dates for the new Leadership Team:
2/15/17 Human Resource
3/2017 CEO
3/12/17 Rehabilitation
3/13/17 Director of Nursing
4/14/17 Peri-Operative Services
4/23/17 Engineering
5/1/17 CNO
5/1/17 Health Information

During document reviews 6/1/17 to 6/13/17 the following information was compiled:

1. Policy Pro # 861-05[Sic] titled, "Quality Assessment and Performance Improvement (QAPI) Plan 2015 with an effective date of 4/1/15 and review date of 9/1/17;
2. The "QAPI Plan 2017" had an origination date of 4/1/15. It was last revised as a DRAFT on 12/15/16 and reviewed on 12/16/16;
3. There are still open positions for Department Managers;
4. The Quality Council "a multidisciplinary Committee responsible for the development and oversight of the QAPI Program" had its last meeting 1/12/17 at which time the Medical Executive Committee approved the Plan.
5. Documentation that the Governing Board received a last report on the QAPI Plan was in 10/17;
6. The Policy 861-05 indicated The Quality Council Meeting should be meeting quarterly;
7. The Patient Safety Program "Integrated with QAPI in order to provide a systematic, coordinated approach to the maintenance and improvement of patient safety, and ongoing proactive reduction in medical/health care errors". Pharmacy on 5/18/17 had a "Quality Meeting" in which the CNO, DON and the Pharmacist in Charge were present. "They reviewed event reports with action plans on every event." This was the only Quality Meeting of record since 1/17. The Prime Grant tracks hospital re-admissions. These are the only two QAPI projects that had any activity.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interview with document review the hospital's Quality Assurance and Performance Improvment Program (QAPI) failed to have an active program scope and program activities with a concern for safety when the QAPI Program had not been active for the last two quarters beginning 1/2017 and the last report to the Governing Body was 10/2016. These failures led to the patient's quality of life, their quality of care and services being adversely affected when mold and possible asbestos was discovered in the Sterile Processing Department.

Findings:

During an interview on 6/7/17 at 9:50 a.m., with the Chief Executive Officer (CEO) and the Chief Nursing Officer (CNO), both concurred the QAPI Program had not been ongoing for the last two quarters. They stated the following:

1. The Interim Quality/Risk Manager left on 4/7/17 with a "two day" notice;
2. There had been no collection of data for the QAPI Program since 1/2017.;
3. By the end of the first quarter of 2017, all except one Department Manager left the Hospital Leadership Team;
4. The following are Department Managers' start dates for the new Leadership Team:
2/15/17 Human Resource
3/2017 CEO
3/12/17 Rehabilitation
3/13/17 Director of Nursing
4/14/17 Peri-Operative Services
4/23/17 Engineering
5/1/17 CNO
5/1/17 Health Information

During document reviews 6/1/17 to 6/13/17 the following information was compiled:

1. Policy Pro # 861-05[Sic] titled, "Quality Assessment and Performance Improvement (QAPI) Plan 2015 with an effective date of 4/1/15 and review date of 9/1/17;
2. The "QAPI Plan 2017" had an origination date of 4/1/15. It was last revised as a DRAFT on 12/15/16 and reviewed on 12/16/16;
3. There are still open positions for Department Managers;
4. The Quality Council "a multidisciplinary Committee responsible for the development and oversight of the QAPI Program" had its last meeting 1/12/17 at which time the Medical Executive Committee approved the Plan.
5. Documentation that the Governing Board received a last report on the QAPI Plan was in 10/17;
6. The Policy 861-05 indicated The Quality Council Meeting should be meeting quarterly;
7. The Patient Safety Program "Integrated with QAPI in order to provide a systematic, coordinated approach to the maintenance and improvement of patient safety, and ongoing proactive reduction in medical/health care errors". Pharmacy on 5/18/17 had a "Quality Meeting" in which the CNO, DON and the Pharmacist in Charge were present. "They reviewed event reports with action plans on every event." This was the only Quality Meeting of record since 1/17. The Prime Grant tracks hospital re-admissions. These are the only two QAPI projects that had any activity.
VIOLATION: QAPI PERFORMANCE IMPROVEMENT PROJECTS Tag No: A0297
Based on document review and interview the hospital failed to ensure the hospital conducted performance improvement projects related to the scope and complexity of its services and operations when the QAPI Program had not been active for the last two quarters beginning 1/2017. This failure led to the patient's quality of life, their quality of care and services being adversely affected.

Findings:

During an interview on 6/7/17 at 9:50 a.m., with the Chief Executive Officer (CEO) and the Chief Nursing Officer (CNO), both concurred the QAPI Program had not been ongoing for the last two quarters. They stated the following:

1. The Interim Quality/Risk Manager left on 4/7/17 with a "two day" notice;
2. There had been no collection of data for the QAPI Program since 1/2017.;
3. By the end of the first quarter of 2017, all except one Department Manager left the Hospital Leadership Team;
4. The following are Department Managers' start dates for the new Leadership Team:
2/15/17 Human Resource
3/2017 CEO
3/12/17 Rehabilitation
3/13/17 Director of Nursing
4/14/17 Peri-Operative Services
4/23/17 Engineering
5/1/17 CNO
5/1/17 Health Information

During document reviews 6/1/17 to 6/13/17 the following information was compiled:

1. Policy Pro # 861-05[Sic] titled, "Quality Assessment and Performance Improvement (QAPI) Plan 2015 with an effective date of 4/1/15 and review date of 9/1/17;
2. The "QAPI Plan 2017" had an origination date of 4/1/15. It was last revised as a DRAFT on 12/15/16 and reviewed on 12/16/16;
3. There are still open positions for Department Managers;
4. The Quality Council "a multidisciplinary Committee responsible for the development and oversight of the QAPI Program" had its last meeting 1/12/17 at which time the Medical Executive Committee approved the Plan.
5. Documentation that the Governing Board received a last report on the QAPI Plan was in 10/17;
6. The Policy 861-05 indicated The Quality Council Meeting should be meeting quarterly;
7. The Patient Safety Program "Integrated with QAPI in order to provide a systematic, coordinated approach to the maintenance and improvement of patient safety, and ongoing proactive reduction in medical/health care errors". Pharmacy on 5/18/17 had a "Quality Meeting" in which the CNO, DON and the Pharmacist in Charge were present. "They reviewed event reports with action plans on every event." This was the only Quality Meeting of record since 1/17. The Prime Grant tracks hospital re-admissions. These are the only two QAPI projects that had any activity.
VIOLATION: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT Tag No: A0308
Based on document review and interviews the hospital failed to ensure the Quality Assessment and Performance Improvement (QAPI) Program showed the complexity of the full range of services offered by the hospital and evidence of an active QAPI Program when the Program had not been active for the last two quarters beginning 1/2017. This failure led to the potential of the patient's quality of life, their quality of care and services being adversely affected.

Findings:

During an interview on 6/7/17 at 9:50 a.m., with the Chief Executive Officer (CEO) and the Chief Nursing Officer (CNO), both concurred the QAPI Program had not been ongoing for the last two quarters. They stated the following:

1. The Interim Quality/Risk Manager left on 4/7/17 with a "two day" notice;
2. There had been no collection of data for the QAPI Program since 1/2017.;
3. By the end of the first quarter of 2017, all except one Department Manager left the Hospital Leadership Team;
4. The following are Department Managers' start dates for the new Leadership Team:
2/15/17 Human Resource
3/2017 CEO
3/12/17 Rehabilitation
3/13/17 Director of Nursing
4/14/17 Peri-Operative Services
4/23/17 Engineering
5/1/17 CNO
5/1/17 Health Information

During document reviews 6/1/17 to 6/13/17 the following information was compiled:

1. Policy Pro # 861-05[Sic] titled, "Quality Assessment and Performance Improvement (QAPI) Plan 2015 with an effective date of 4/1/15 and review date of 9/1/17;
2. The "QAPI Plan 2017" had an origination date of 4/1/15. It was last revised as a DRAFT on 12/15/16 and reviewed on 12/16/16;
3. There are still open positions for Department Managers;
4. The Quality Council "a multidisciplinary Committee responsible for the development and oversight of the QAPI Program" had its last meeting 1/12/17 at which time the Medical Executive Committee approved the Plan.
5. Documentation that the Governing Board received a last report on the QAPI Plan was in 10/17;
6. The Policy 861-05 indicated The Quality Council Meeting should be meeting quarterly;
7. The Patient Safety Program "Integrated with QAPI in order to provide a systematic, coordinated approach to the maintenance and improvement of patient safety, and ongoing proactive reduction in medical/health care errors". Pharmacy on 5/18/17 had a "Quality Meeting" in which the CNO, DON and the Pharmacist in Charge were present. "They reviewed event reports with action plans on every event." This was the only Quality Meeting of record since 1/17. The Prime Grant tracks hospital re-admissions. These are the only two QAPI projects that had any activity.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on interview and document review the hospital's Governing Body had not been accountable for ensuring an ongoing program for quality improvement in patient care and services and patient safety were being implemented and maintained when every aspect of the QAPI Program had not been fully active for the last two quarters beginning 1/2017 and the last report to the Governing Body was 10/2016. These failures led to the potential of the patient's quality of life, their quality of care and services being adversely affected.

Findings:

During an interview on 6/7/17 at 9:50 a.m., with the Chief Executive Officer (CEO) and the Chief Nursing Officer (CNO), both concurred the QAPI Program had not been ongoing for the last two quarters. They stated the following:

1. The Interim Quality/Risk Manager left on 4/7/17 with a "two day" notice;
2. There had been no collection of data for the QAPI Program since 1/2017.;
3. By the end of the first quarter of 2017, all except one Department Manager left the Hospital Leadership Team;
4. The following are Department Managers' start dates for the new Leadership Team:
2/15/17 Human Resource
3/2017 CEO
3/12/17 Rehabilitation
3/13/17 Director of Nursing
4/14/17 Peri-Operative Services
4/23/17 Engineering
5/1/17 CNO
5/1/17 Health Information

During document reviews 6/1/17 to 6/13/17 the following information was compiled:

1. Policy Pro # 861-05[Sic] titled, "Quality Assessment and Performance Improvement (QAPI) Plan 2015 with an effective date of 4/1/15 and review date of 9/1/17;
2. The "QAPI Plan 2017" had an origination date of 4/1/15. It was last revised as a DRAFT on 12/15/16 and reviewed on 12/16/16;
3. There are still open positions for Department Managers;
4. The Quality Council "a multidisciplinary Committee responsible for the development and oversight of the QAPI Program" had its last meeting 1/12/17 at which time the Medical Executive Committee approved the Plan.
5. Documentation that the Governing Board received a last report on the QAPI Plan was in 10/17;
6. The Policy 861-05 indicated The Quality Council Meeting should be meeting quarterly;
7. The Patient Safety Program "Integrated with QAPI in order to provide a systematic, coordinated approach to the maintenance and improvement of patient safety, and ongoing proactive reduction in medical/health care errors". Pharmacy on 5/18/17 had a "Quality Meeting" in which the CNO, DON and the Pharmacist in Charge were present. "They reviewed event reports with action plans on every event." This was the only Quality Meeting of record since 1/17. The Prime Grant tracks hospital re-admissions. These are the only two QAPI projects that had any activity.
VIOLATION: PROVIDING ADEQUATE RESOURCES Tag No: A0315
Based on interview and document review the hospital's Governing Body failed to ensure that adequate resources for the Quality Assurance and Performance Improvement Program existed when every aspect of the QAPI Program had not been fully active for the last two quarters beginning 1/2017. This failure led to the potential of the patient's quality of life, their quality of care, safety and services being adversely affected.

Findings:

During an interview on 6/7/17 at 9:50 a.m., with the Chief Executive Officer (CEO) and the Chief Nursing Officer (CNO), both concurred the QAPI Program had not been ongoing for the last two quarters. They stated the following:

1. The Interim Quality/Risk Manager left on 4/7/17 with a "two day" notice;
2. There had been no collection of data for the QAPI Program since 1/2017.;
3. By the end of the first quarter of 2017, all except one Department Manager left the Hospital Leadership Team;
4. The following are Department Managers' start dates for the new Leadership Team:
2/15/17 Human Resource
3/2017 CEO
3/12/17 Rehabilitation
3/13/17 Director of Nursing
4/14/17 Peri-Operative Services
4/23/17 Engineering
5/1/17 CNO
5/1/17 Health Information

During document reviews 6/1/17 to 6/13/17 the following information was compiled:

1. Policy Pro # 861-05[Sic] titled, "Quality Assessment and Performance Improvement (QAPI) Plan 2015 with an effective date of 4/1/15 and review date of 9/1/17;
2. The "QAPI Plan 2017" had an origination date of 4/1/15. It was last revised as a DRAFT on 12/15/16 and reviewed on 12/16/16;
3. There are still open positions for Department Managers;
4. The Quality Council "a multidisciplinary Committee responsible for the development and oversight of the QAPI Program" had its last meeting 1/12/17 at which time the Medical Executive Committee approved the Plan.
5. Documentation that the Governing Board received a last report on the QAPI Plan was in 10/17;
6. The Policy 861-05 indicated The Quality Council Meeting should be meeting quarterly;
7. The Patient Safety Program "Integrated with QAPI in order to provide a systematic, coordinated approach to the maintenance and improvement of patient safety, and ongoing proactive reduction in medical/health care errors". Pharmacy on 5/18/17 had a "Quality Meeting" in which the CNO, DON and the Pharmacist in Charge were present. "They reviewed event reports with action plans on every event." This was the only Quality Meeting of record since 1/17. The Prime Grant tracks hospital re-admissions. These are the only two QAPI projects that had any activity.
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community.

Based on observation, interview and record review, the hospital failed to maintain the physical environment when routine and preventive maintenance and testing activities were not performed. This had the potential for physical plant services to be interrupted and to jeopardize the safety of patients, staff and visitors when:
1. mold and possible asbestos was discovered in the sterile processing department,
2. the containment area in the sterile processing department had lost its integrity,
3. the emergency water supply was not monitored, tested or safely accessible,
4. the ice machine was not cleaned according to manufacturers recommendation,
5. the blanket warmer in the Emergency Department did not have a current monitoring log and,
6. the hospital maintenance schedule was not adhered to.

Findings:

An email dated 5/30/17, at 5:49 p.m., was received by the Department from the county health department indicating the hospital had called to report the presence of Stachybotrys (black mold) in their surgical instrument processing room. The email indicated that sterile trays processed at the time the odor of mold was detected had been sequestered.

1. An interview with the Infection Control Nurse on 5/31/17, at 10:25 a.m., revealed she and the Engineer had done safety rounds on 5/23/17 in Zone 5, an area in the facility that included the Sterile Processing Department. The Infection Control Nurse stated she smelled a strong odor of mildew upon entering the SPD.

A document provided by the hospital on [DATE], titled "Environment of Care Impact Permit", dated 5/23/17, "Inspection only of area behind base board on under sink cabinet. Immediate area to be cube contained. ...Facilities/Engineer to wear N95 respirator at all times in area until it is closed again... This is an assessment of an odor coming from under sterile processing sink in packing area. No work is to be done, on an assessment." The document indicated a note dated 5/25/17 indicated "SPD remains shut, hospital has adequate packs for general emerging needs per SPD/OR receptionist. 9:30 a.m., Hygienist on site...SPD to remain closed." An entry in this document dated 5/26/17 at 4:30 p.m., indicated a call by the hygienists, areas of SPD room both inside and outside of containment area test positive for only one organism, Stachybotrys." An entry in this document dated 5/31/17 indicated,"Discussion yesterday with Admin did not dissuade scheduled surgeries."

An observation on 5/31/17, at 10:45 a.m., of the surgical area of the hospital, revealed surgery staff transporting a post operative patient from Operating Room 1 (OR 1). Licensed Staff E was observed transporting a covered metal table with dirty surgical instruments into the Decontamination Room from OR 1. During an interview with Licensed Staff E, she stated they had told us there was mold in the processing area, but it was business as usual for retrieving instrument from the sterile supply room. The Decontamination Room door had a sign posted that read, "Do not enter without N95 mask (a tightly fitting respiratory mask used as personal protection to filter 95% of airborne particles)." Licensed Staff E was observed on 5/31/17, at 10:45 a.m., wearing a regular surgical mask and entering the Decontamination Room to drop off the table with dirty surgical instruments.

During an interview with Infection Control Nurse on 6/1/17, at 12:50 p.m., she stated the decision was made by the DON, Physician B and herself to use Operating Room 2 (OR 2) to assemble the instruments after they had been cleaned in the Decontamination Room, then go to the SPD to drop off the instruments in the autoclave. The Infection Control Nurse stated when the autoclave was finished, staff would go back into the SPD to retrieve instruments from the autoclave.

During an interview with the Infection Control Nurse on 6/1/17 at 12:25 p.m., when asked why the company, Contract Provider I, was chosen to do air and surface sampling Perioperative area, she stated the company had been used before by the facility for a similar problem in another area of the facility. When asked if Contract Provider I had a certified industrial environmental hygienist, she stated she did not know. A document provided by the hospital from Contract Provider I, dated 9/25/16, indicated the Contract Provider I was a Certified Microbial Consultant, and not a certified industrial environmental hygienist.

Documents provided by the hospital titled "Non-Viable Air Fungal Analysis" dated 5/26/17, from Contract Provider I indicated Stachybotrys level of 13 in the containment area and a level of 120 outside of the containment area.

During an interview with Contract Provider I on 6/1/17 at 2:10 p.m., he stated any amount of spores is significant in this environment. The Contract Provider I had returned to the facility to do a second set of sampling in the Perioperative area.

An interview with Physician A on 6/12/17, at 1:30 p.m., indicated he was notified of the mold in the SPD area on 5/29/17.

During an interview with Physician B on 6/12/17, at 2:05 p.m., she stated she was involved in how to keep operating safely for patients and staff.

During an interview with Physician C on 6/13/17, at 9:45 a.m., he stated the Administrator had called him and then put out an email about the mold, but he did not recall the date. A copy of the 'blast' email sent by the Administrator was dated 6/2/17 at 6:27 p.m. (Refer to A0701, Item #1)

2. During an observation on 5/31/17, at 10:45 a.m., in the Sterile Processing Department (SPD) was a double entry containment area made with plastic sheets hanging from the ceiling to the floor. The containment area was approximately 3 feet by 8 feet that the Engineer and the Infection Control Nurse had identified as the source of the mold. There were 2 inch wide strips of tape that had been used to secure the plastic to the ceiling, but the tape was coming away from the ceiling on both sides, leaving an open gap of approximately 12 inches on each side. The double entry containment plastic also had a zipper that went from the floor and continued up to enclose an entry to the containment area. This zipper had been pulled down leaving an opening of approximately 12 inches. When this zipper was opened, a second zippered plastic enclosure was seen. This second zippered area also was not contained as the zipper had been left unzipped approximately 12 inches. The SPD room also contained 2 autoclaves (used to sterilize instruments) and a sterrad (device used for low temperature sterilization). (Refer to A0701, Item #2)

3. An interview with the Dietary Supervisor on 6/7/17 at 9:20 a.m., when asked where the emergency water is located, he stated it is in the water tank out back and you turn on a valve for it. When asked how many gallons were in the tank he stated, I do not know.

During a concurrent observation and interview with the Engineer, on 6/7/17 at 9:35 a.m. the Engineer stated he considered the 1500 gallons of water in the green tank was for toilet flushing. The green tank was a large round, green tank on the facility property outside of the Riser Room. The Engineer did not provide documentation of when the water in the green tank had been changed or monitored. When the Engineer was asked how the emergency water could be accessed, he stated there was a hose and a valve in the Riser Room. A concurrent observation and interview with the Engineer, on 6/7/17 at 9:50 a.m., regarding the hose to access the emergency water, he pointed to a clear plastic bag that contained a hose. When asked if it was a potable (safe for drinking) water hose, he stated he did not know and did not provide documentation about the water hose. The Engineer was asked when the water was last checked for bacteria or total number of gallons, he stated he did not know.

During an interview with the Engineer or 6/8/17 at 9:20 a.m., he stated he had not been able to find documentation on when the water was brought in and that nothing has been done. He stated he deemed it usable for flushing toilets.

During an interview with the Administrator and the CNO on 6/8/17 at 9:20 a.m., they were asked if they considered the water in the green tank drinkable, they stated no. The Administrator and the CNO stated the water had not been tested or verified that the tank still contains 1500 gallons.

The hospital policy titled "Loss of Water Services (Code Dry)", dated 4/15, indicated "Code Dry Plan - List of Supplies Available: 30 cases of bottled water."

The hospital book titled "Facility Maintenance Schedule 2015," contained a document indicating, "Potable Water Backup; Take Sample of backup potable water supply; Test for bacterial content and record results; Test water for Chlorine content and record results; Inspect bag for potable water connection; Drain and refill tank on annual basis; Chlorinate water as needed; Work to be done by certified contractor." The completion date indicated 7/12/15. (Refer to A0703)

4. During a concurrent observation and interview with the Director of Nursing (DON) on 6/8/17 at 11 a.m., an ice machine used for patients was located in a separate room on the medical surgical unit. The DON was asked about the last cleaning, she stated she did not know.

A concurrent observation and interview on 6/8/17 at 11:08 with the Engineering, a second ice machine was located in the Cafe. The Engineering stated he had cleaned the ice machine at the same time he changed the filter. The filter was dated 12/2016. The Engineer was asked how he cleaned the ice machines, he stated he followed manufacturer's recommendation. He stated he had the product for cleaning, but not the descaling product. He did not provide a log for cleaning or descaling either ice machine.

A document provided by the hospital titled "Scotsman HID Ice Maker-Dispenser PM", undated, indicated "Typically twice per year for scale removal and sanitizing....6. Mix a solution of 12 ounces of Scotsman Clear 1 ice machine scale remover and 12 ounces of clean, potable water."

The hospital policy titled "Ice Machine Cleaning", dated 8/15, indicated "The engineering Department shall clean the ice machines once per quarter per manufacturer's recommendation (Scotsman). This includes: ...Cleaning any scale buildup." (Refer to A0701, Item #3)

5. During a concurrent interview and observation on 6/5/17, at 11:05 a.m., in the Emergency Department, Licensed Staff D stated he did not know where to see the temperature for the blanket warmer. Licensed Staff D stated we just gauge the temperature it by its warmth. There was no log provided to indicate routine temperature monitoring of the blanket warmer. There was no external or internal thermometer to check the temperature in the blanket warmer.

The policy provided by the hospital titled "Warmers", dated 5/15, indicated, "This policy describes the process required to maintain and monitor a warming cabinet to minimize the risk of patient and staff injury....Temperatures will be logged by the department in which they reside daily when the department is occupied....Blanket warmers will be equipped with either an integrated thermometer or a digital remote reading thermometer that can be read externally."
(Refer to A0701, Item #4)

6. During an interview with the Engineer, on 6/7/17, at 10:20 a.m., after reviewing the book titled, "Facility Maintenance Schedule 2015," he stated the work was not being done. The Engineer stated that he went by the work order created by the previous department director who was no longer employed at the facility. When the Engineer was asked if the tasks in the above book were completed, he stated he did not have documentation of the work being completed and had not entered it into the log.

A document provided on 6/7/17 by the Engineer, titled, "Service work performed by James", dated 6/7/17, documented events performed by engineering. The document list indicated tasks completed, 5 tasks in 2016 and 3 tasks completed in 2017 by engineering.

The hospital provided a book titled "Facility Maintenance Schedule 2015," that listed systems and the frequency for checking. A review of the book indicated there were no recent entries for the checking of the different systems. (Refer to 0701, Item #5)
VIOLATION: MAINTENANCE OF PHYSICAL PLANT Tag No: A0701
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured.

Based on observation, interview and record review, the hospital failed to ensure that routine and scheduled preventive maintenance of vital services and equipment in the facility were completed. This had the potential for equipment necessary for patient care to be unmonitored and unsafe for use.
1. mold and possible asbestos was discovered in the sterile processing department,
2. the containment area in the sterile processing department had lost its integrity,
3. the ice machine was not cleaned according to manufacturers recommendation,
4. the blanket warmer in the Emergency Department did not have a current monitoring log and,
5. the hospital maintenance schedule was not adhered to.

Findings:

1. An interview with the Infection Control Nurse on 5/31/17, at 10:25 a.m., revealed she and the Engineer had done safety rounds on 5/23/17 in Zone 5, an area in the facility that included the Sterile Processing Department. The Infection Control Nurse stated she smelled a strong odor of mildew upon entering the SPD.

A document provided by the hospital on [DATE], titled "Environment of Care Impact Permit", dated 5/23/17, "Inspection only of area behind base board on under sink cabinet. Immediate area to be cube contained. ...Facilities/Engineer to wear N95 respirator at all times in area until it is closed again... This is an assessment of an odor coming from under sterile processing sink in packing area. No work is to be done, on an assessment." The document indicated a note dated 5/25/17 indicated "SPD remains shut, hospital has adequate packs for general emerging needs per SPD/OR receptionist. 9:30 a.m., Hygienist on site...SPD to remain closed." An entry in this document dated 5/26/17 at 4:30 p.m., indicated a call by the hygienists, areas of SPD room both inside and outside of containment area test positive for only one organism, Stachybotrys." An entry in this document dated 5/31/17 indicated,"Discussion yesterday with Admin did not dissuade scheduled surgeries."

An observation on 5/31/17, at 10:45 a.m., of the surgical area of the hospital, revealed surgery staff transporting a post operative patient from Operating Room 1 (OR 1). Licensed Staff E was observed transporting a covered metal table with dirty surgical instruments into the Decontamination Room from OR 1. During an interview with Licensed Staff E, she stated they had told us there was mold in the processing area, but it was business as usual for retrieving instrument from the sterile supply room. The Decontamination Room door had a sign posted that read, "Do not enter without N95 mask (a tightly fitting respiratory mask used as personal protection to filter 95% of airborne particles)." Licensed Staff E was observed on 5/31/17, at 10:45 a.m., wearing a regular surgical mask and entering the Decontamination Room to drop off the table with dirty surgical instruments.

During an interview with Infection Control Nurse on 6/1/17, at 12:50 p.m., she stated the decision was made by the DON, Physician B and herself to use Operating Room 2 (OR 2) to assemble the instruments after they had been cleaned in the Decontamination Room, then go to the SPD to drop off the instruments in the autoclave. The Infection Control Nurse stated when the autoclave was finished, staff would go back into the SPD to retrieve instruments from the autoclave.

During an interview with the Infection Control Nurse on 6/1/17 at 12:25 p.m., when asked why the company, Contract Provider I, was chosen to do air and surface sampling Perioperative area, she stated the company had been used before by the facility for a similar problem in another area of the facility. When asked if Contract Provider I had a certified industrial environmental hygienist, she stated she did not know. A document provided by the hospital from Contract Provider I, dated 9/25/16, indicated the Contract Provider I was a Certified Microbial Consultant, and not a certified industrial environmental hygienist.

Documents provided by the hospital titled "Non-Viable Air Fungal Analysis" dated 5/26/17, from Contract Provider I indicated Stachybotrys level of 13 in the containment area and a level of 120 outside of the containment area.

During an interview with Contract Provider I on 6/1/17 at 2:10 p.m., he stated any amount of spores is significant in this environment. The Contract Provider I had returned to the facility to do a second set of sampling in the Perioperative area.

An interview with Physician A on 6/12/17, at 1:30 p.m., indicated he was notified of the mold in the SPD area on 5/29/17.

During an interview with Physician B on 6/12/17, at 2:05 p.m., she stated she was involved in how to keep operating safely for patients and staff.

During an interview with Physician C on 6/13/17, at 9:45 a.m., he stated the Administrator had called him and then put out an email about the mold, but he did not recall the date. A copy of the 'blast' email sent by the Administrator was dated 6/2/17 at 6:27 p.m.

2. During an observation on 5/31/17, at 10:45 a.m., in the Sterile Processing Department (SPD) was a double entry containment area made with plastic sheets hanging from the ceiling to the floor. The containment area was approximately 3 feet by 8 feet that the Engineer and the Infection Control Nurse had identified as the source of the mold. There were 2 inch wide strips of tape that had been used to secure the plastic to the ceiling, but the tape was coming away from the ceiling on both sides, leaving an open gap of approximately 12 inches on each side. The double entry containment plastic also had a zipper that went from the floor and continued up to enclose an entry to the containment area. This zipper had been pulled down leaving an opening of approximately 12 inches. When this zipper was opened, a second zippered plastic enclosure was seen. This second zippered area also was not contained as the zipper had been left unzipped approximately 12 inches. The SPD room also contained 2 autoclaves (used to sterilize instruments) and a sterrad (device used for low temperature sterilization).

3. During a concurrent observation and interview with the Director of Nursing (DON) on 6/8/17 at 11 a.m., an ice machine used for patients was located in a separate room on the medical surgical unit. The DON was asked about the last cleaning, she stated she did not know.

A concurrent observation and interview on 6/8/17 at 11:08 with the Engineering, a second ice machine was located in the Cafe. The Engineering stated he had cleaned the ice machine at the same time he changed the filter. The filter was dated 12/2016. The Engineer was asked how he cleaned the ice machines, he stated he followed manufacturer's recommendation. He stated he had the product for cleaning, but not the descaling product. He did not provide a log for cleaning or descaling either ice machine.

A document provided by the hospital titled "Scotsman HID Ice Maker-Dispenser PM", undated, indicated "Typically twice per year for scale removal and sanitizing....6. Mix a solution of 12 ounces of Scotsman Clear 1 ice machine scale remover and 12 ounces of clean, potable water."

The hospital policy titled "Ice Machine Cleaning", dated 8/15, indicated "The engineering Department shall clean the ice machines once per quarter per manufacturer's recommendation (Scotsman). This includes: ...Cleaning any scale buildup."

4. During a concurrent interview and observation on 6/5/17, at 11:05 a.m., in the Emergency Department, Licensed Staff D stated he did not know where to see the temperature for the blanket warmer. Licensed Staff D stated we just gauge the temperature it by its warmth. There was no log provided to indicate routine temperature monitoring of the blanket warmer. There was no external or internal thermometer to check the temperature in the blanket warmer.

The policy provided by the hospital titled "Warmers", dated 5/15, indicated, "This policy describes the process required to maintain and monitor a warming cabinet to minimize the risk of patient and staff injury....Temperatures will be logged by the department in which they reside daily when the department is occupied....Blanket warmers will be equipped with either an integrated thermometer or a digital remote reading thermometer that can be read externally."


6. During an interview with the Engineer on 6/7/17, at 10:15 a.m., when queried about the hospital book titled "Facility Maintenance Schedule 2015," he stated that he agreed that the list of items to be checked was not being done. The list of "Systems" also indicated the frequency to be checked. A sample of the entries in the hospital book indicated the last time checked as follows:
# Transfer Switch Test - monthly. Completed 7/22/15,
# AHU 1-5 Mainenance - Quarterly. Completed 7/14/15
# Medical Gas Pad - A - Annual. Completed 7/6/15. Daily - "Inspect gas pad for any changes in status. Check liquid oxygen levels in dewar tanks and call supplier for replacements as needed. Inspect locks and fencing. Check gas pressure for nitrous and nitrogen. Complete Daily Gas Log."
# Ice Machine Cafeteria - monthly. Last completed 7/31/15.
# Potable Water Backup - monthly. Completed 7/12/15. "Take Sample of backup potable water supply. Test for bacterial content and record results. Test water for Chlorine content and record results. Inspect bag for potable water connection. Drain and refill tank on annual basis. Chlorinate water as needed."

The Engineer did not provide logs to document that preventive maintenance and monitoring had been done.
VIOLATION: EMERGENCY GAS AND WATER Tag No: A0703
There must be facilities for emergency gas and water supply.

Based on observation, interview and record review, the hospital did not ensure a safe and adequate emergency water supply for the hospital. In the event of an emergency, this had the potential for patients, staff and visitors to be without a safe water supply.

Findings:

During an interview with the Dietary Supervisor on 6/7/17 at 9:20 a.m., when asked where the emergency water is located, he stated it is in the water tank out back and you turn on a valve for it. When asked how many gallons were in the tank he stated, I do not know.

During a concurrent observation and interview with the Engineer, on 6/7/17 at 9:35 a.m. the Engineer stated he considered the 1500 gallons of water in the green tank was for toilet flushing. The green tank was a large round, green tank on the hospital property outside of the Riser Room. The Engineer did not provide documentation of when the water in the green tank had been changed or monitored. When the Engineer was asked how the emergency water could be accessed, he stated there was a hose and a valve in the Riser Room. A concurrent observation and interview on 6/7/17 at 9:50 a.m., with the Engineer regarding the hose to access the emergency water, he pointed to a clear plastic bag that contained a hose. When asked if it was a potable (safe for drinking) water hose, he stated he did not know and did not provide documentation about the safety of the water hose. The Engineer was asked when the water was last checked for bacteria or total number of gallons, he stated he did not know.

During an interview with the Engineer or 6/8/17 at 9:20 a.m., he stated he had not been able to find documentation on when the water was put in the tank and that no testing had been done. He stated he deemed it usable for flushing toilets.

During an interview with the Administrator and the CNO on 6/8/17 at 9:20 a.m., they were asked if they considered the water in the green tank drinkable, they stated no. The Administrator and the CNO stated the water had not been tested or verified that the tank still contains 1500 gallons.

The facility policy titled "Loss of Water Services (Code Dry)", dated 4/15, indicated "Code Dry Plan - List of Supplies Available: 30 cases of bottled water."

The hospital book titled "Hospital, Facility Maintenance Schedule 2015," contained a document indicating "Potable Water Backup; Take Sample of backup potable water supply; Test for bacterial content and record results; Test water for Chlorine content and record results; Inspect bag for potable water connection; Drain and refill tank on annual basis; Clorinate water as needed; Work to be done by certified contractor." The last completion date indicated 7/12/15.

A document provided by the hospital from Contract Provider K indicated the last bacterial test of the water in the tank was done on 4/16.
VIOLATION: INFECTION CONTROL Tag No: A0747
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases.

Based on interview and record review, the hospital failed to ensure the infection control program included:
1. screening of vendors in the Operating Room,
2. monitoring personnel's respirator fit tests
3. monitoring personnel's [DIAGNOSES REDACTED] tests,
4. processing of sterile instruments in area confirmed to have black mold.
These failures had the potential to affect the health of patient's, staff and visitors.

Findings:

1. During an interview with the Infection Control Nurse on 6/9/17, at 10 a.m., when asked about vendors in the hospital, she stated there was nothing for the monitoring of vendors and did not think they had that many vendors coming to the hospital. When asked the process for vendors she stated they would approach the Operating Room (OR) Manager, the equipment would then go through cleaning and maintenance and then she would make her recommendation. When asked about the vendors in the OR, she stated she was not aware of vendors being in the OR. The Infection Control Nurse also stated she was glad that had been brought to her attention and she would like to see what they were doing in the OR. When asked abut monitoring and health clearance of the vendors, she stated she does not do that.

A list of vendors in the OR provided by the OR Manager on 6/12/17, listing 13 individuals from different companies that come to the OR during surgeries. The OR Manager stated there were no files containing health or background clearance information for the vendors on the list that was provided.

The hospital policy titled "Management of Clinical Vendor Services", undated, indicated "Procedure:
1. HR (Human Resources) will provide the vendor a packet that contains the following:
a. Vendor staff profile, confidentiality agreement, vendor and agency staff attestation.
b. Vendor representative will provide current files on staff assigned to work at the hospital. Files should include the following documents:
i. Current CPR (cardiopulmonary resuscitation) for clinical and pharmacy staff,
ii. Current primary source verification,
iii Background check...,
iv. Documentation of Federal and State OIG (Office of Inspector General) search,
v. Evidence of current TB ([DIAGNOSES REDACTED]) screening (within one year);
vi. Drug Screen,
vii. Physical for all vendor staff.
2. Clinical Vendor Staff will return to HR:
a. To receive their Vendor ID badge. Vendor staff member will wear badge while working at the hospital.
b. Signed vendor staff profile, confidentiality agreement, vendor and agency staff attestation for each member working on site." (Refer to A0748, Item #1)

2. During record review on 6/8/17 of personnel files, there was either no documentation or expired documentation of current N95 respirator fit tests for the following personnel:
Unlicensed Staff F - 8/13
Licensed Staff E - no documentation
OR Manager - 7/15
Administrator - no documentation
Engineer - no documentation
DON - no documentation
Dietary Supervisor - no documentation
Housekeeper - 7/15

A document titled "Proper Use, Filtration, and Fit", dated 2016, published by the CDC (Centers for Disease Control and Prevention) indicated "Respirator fit can be a complex subject, OSHA's(Occupational Safety and Health Administration) 1910.134, respiratory protection standard requires respirator fit testing initially and annually thereafter."

The hospital policy titled "Personal Respiratory Protection Program in Infection Prevention", dated 9/21/16, indicated, "B. 1. v. Provide or arrange for annual respirator fit testing." (Refer to A0748, Item #2)

3. During hospital personnel record review on 6/8/17, the hospital failed to monitor and document the required TB (tuberculosis) test for the following personnel:
Sterile Processing Technician - given 11/16, but not read
Dietary Supervisor - 6/3/16
Housekeeping - "needs chest X-ray"

The hospital policy titled "Prevention and Control Plan For Transmission of [DIAGNOSES REDACTED] (TB)", dated 9/15, indicated "C. 1. Screening shall be performed annually for all employees." (Refer to A0748, Item #3)

4. A document provided by the hospital, titled "Addendum log for Environment of Care Impact for Project: Sterile processing and sink area", dated 5/26/17, indicated that at 4:30 p.m., the Infection Control Nurse had been notified by Contract Provider I, that "areas of SPD (Sterile Processing Department) room both inside and outside of containment area test positive for only one organism, ... Stachybotrys (black mold)." An additional entry by the Infection Control Nurse in the document at 5:30 p.m., indicated "Unlicensed Staff H advises we need to process an additional ortho pack and 2 abdominal packs... Unlicensed Staff H was asked if it would work to convert OR 2 to a sterile processing area, that the only time any entrance into the actual SPD area would be needed would be to place a pack in sterilizer and then immediately leave and that he would have to wear an N95 mask while briefly in there even with the Hepa scrubber (portable air filtration unit) present. Unlicensed Staff H Stated this would work for him...."

During an observation on 5/31/17, at 12:25 p.m., a surgical patient was being pushed on a gurney to the Post operative area from OR 1.

The hospital document titled "Operating Room Schedule", dated 5/31/17, indicated there were 4 surgeries scheduled by Physician F.

During an interview with Physician F, on 6/13/17, at 1:30 p.m., when asked when he was advised of the mold in the SPD, he stated Monday, 5/29/17 or Tuesday, 5/30/17 after the holiday.

During an interview with Unlicensed Staff H, on 6/1/17, at 3 p.m., he stated he had come in on the night of 5/26/17 to process ortho and trauma trays. Unlicensed Staff H stated the trauma trays were done in the event of an emergency. When asked what resources he had used, he stated the Infection Control Nurse.

During an interview with Contract Provider J, on 6/6/17 at 9:15 a.m., she stated that the results of the environmental sampling indicated the decontamination area of SPD had a very high level of Stachybotrys, in the thousands and no one should have gone into that room. The baseline level is zero. (Refer to A0756)
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
A person or persons must be designated as infection control officer or officers to develop and implement policies governing control of infections and communicable diseases.

The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases.

Based on interview and record review, the hospital failed to implement the infection control program included:
1. screening of vendors in the Operating Room,
2. monitoring personnel's respirator fit tests
3. monitoring personnel's Tuberculosis tests,
4. processing of sterile instruments in area confirmed to have black mold.
These failures had the potential to affect the health of patient's, staff and visitors.

Findings:

1. During an interview with the Infection Control Nurse on 6/9/17, at 10 a.m., when asked about vendors in the hospital, she stated there was nothing for the monitoring of vendors and did not think they had that many vendors coming to the hospital. When asked the process for vendors she stated they would approach the Operating Room (OR) Manager, the equipment would then go through cleaning and maintenance and then she would make her recommendation. When asked about the vendors in the OR, she stated she was not aware of vendors being in the OR. The Infection Control Nurse also stated she was glad that had been brought to her attention and she would like to see what they were doing in the OR. When asked abut monitoring and health clearance of the vendors, she stated she does not do that.

A list of vendors in the OR provided by the OR Manager on 6/12/17, listing 13 individuals from different companies that come to the OR during surgeries. The OR Manager stated there were no files containing health or background clearance information for the vendors on the list that was provided.

The hospital policy titled "Management of Clinical Vendor Services", undated, indicated "Procedure:
1. HR (Human Resources) will provide the vendor a packet that contains the following:
a. Vendor staff profile, confidentiality agreement, vendor and agency staff attestation.
b. Vendor representative will provide current files on staff assigned to work at the hospital. Files should include the following documents:
i. Current CPR (cardiopulmonary resuscitation) for clinical and pharmacy staff,
ii. Current primary source verification,
iii Background check...,
iv. Documentation of Federal and State OIG (Office of Inspector General) search,
v. Evidence of current TB (tuberculosis) screening (within one year);
vi. Drug Screen,
vii. Physical for all vendor staff.
2. Clinical Vendor Staff will return to HR:
a. To receive their Vendor ID badge. Vendor staff member will wear badge while working at the hospital.
b. Signed vendor staff profile, confidentiality agreement, vendor and agency staff attestation for each member working on site."

2. During record review on 6/8/17 of personnel files, there was either no documentation or expired documentation of current N95 respirator fit tests for the following personnel:
Unlicensed Staff F - 8/13
Licensed Staff E - no documentation
OR Manager - 7/15
Administrator - no documentation
Engineer - no documentation
DON - no documentation
Dietary Supervisor - no documentation
Housekeeper - 7/15

A document titled "Proper Use, Filtration, and Fit", dated 2016, published by the CDC (Centers for Disease Control and Prevention) indicated "Respirator fit can be a complex subject, OSHA's(Occupational Safety and Health Administration) 1910.134, respiratory protection standard requires respirator fit testing initially and annually thereafter."

The hospital policy titled "Personal Respiratory Protection Program in Infection Prevention", dated 9/21/16, indicated, "B. 1. v. Provide or arrange for annual respirator fit testing."

3. During hospital personnel record review on 6/8/17, the hospital failed to monitor and implement the required TB (tuberculosis) test for the following personnel:
Sterile Processing Technician - given 11/16, but not read
Dietary Supervisor - 6/3/16
Housekeeping - "needs chest X-ray"

The hospital policy titled "Prevention and Control Plan For Transmission of Mycobacterium tuberculosis (TB)", dated 9/15, indicated "C. 1. Screening shall be performed annually for all employees."

4. A document provided by the hospital, titled "Addendum log for Environment of Care Impact for Project: Sterile processing and sink area", dated 5/26/17, indicated that at 4:30 p.m., the Infection Control Nurse had been notified by Contract Provider I, that "areas of SPD (Sterile Processing Department) room both inside and outside of containment area test positive for only one organism, ... Stachybotrys (black mold)." An additional entry by the Infection Control Nurse in the document at 5:30 p.m., indicated "Unlicensed Staff H advises we need to process an additional ortho pack and 2 abdominal packs... Unlicensed Staff H was asked if it would work to convert OR 2 to a sterile processing area, that the only time any entrance into the actual SPD area would be needed would be to place a pack in sterilizer and then immediately leave and that he would have to wear an N95 mask while briefly in there even with the Hepa scrubber present. Unlicensed Staff H Stated this would work for him...."

During an observation on 5/31/17, at 12:25 p.m., a surgical patient was being pushed on a gurney to the Post operative area from OR 1.

The hospital document titled "Operating Room Schedule", dated 5/31/17, indicated there were 4 surgeries scheduled by Physician F.

During an interview with Physician F, on 6/13/17, at 1:30 p.m., when asked when he was advised of the mold in the SPD, he stated Monday, 5/29/17 or Tuesday, 5/30/17 after the holiday.

During an interview with Unlicensed Staff H, on 6/1/17, at 3 p.m., he stated he had come in on the night of 5/26/17 to process ortho and trauma trays. Unlicensed Staff H stated the trauma trays were done in the event of an emergency. When asked what resources he had used, he stated the Infection Control Nurse.

During an interview with Contract Provider J, on 6/6/17 at 9:15 a.m., she stated that the results of the environmental sampling indicated the decontamination area of SPD had a very high level of Stachybotrys, in the thousands and no one should have gone into that room. The baseline level is zero.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on interview and record review, the hospital failed to ensure the infection control program implemented:
1. screening of vendors in the Operating Room,
2. monitoring personnel respirator fit tests
3. monitoring personnel Tuberculosis tests,

These failures had the potential to affect the health of patient's, staff and visitors.

Findings:

1. During an interview with the Infection Control Nurse on 6/9/17, at 10 a.m., when asked about vendors in the hospital, she stated there was nothing for the monitoring of vendors and did not think they had that many vendors coming to the hospital. When asked the process for vendors she stated they would approach the Operating Room (OR) Manager, the equipment would then go through cleaning and maintenance and then she would make her recommendation. When asked about the vendors in the OR, she stated she was not aware of vendors being in the OR. The Infection Control Nurse also stated she was glad that had been brought to her attention and she would like to see what they were doing in the OR. When asked abut monitoring and health clearance of the vendors, she stated she does not do that.

A list of vendors in the OR provided by the OR Manager on 6/12/17, listing 13 individuals from different companies that come to the OR during surgeries. The OR Manager stated there were no files containing health or background clearance information for the vendors on the list that was provided.

The hospital policy titled "Management of Clinical Vendor Services", undated, indicated "Procedure:
1. HR (Human Resources) will provide the vendor a packet that contains the following:
a. Vendor staff profile, confidentiality agreement, vendor and agency staff attestation.
b. Vendor representative will provide current files on staff assigned to work at the hospital. Files should include the following documents:
i. Current CPR (cardiopulmonary resuscitation) for clinical and pharmacy staff,
ii. Current primary source verification,
iii Background check...,
iv. Documentation of Federal and State OIG (Office of Inspector General) search,
v. Evidence of current TB (tuberculosis) screening (within one year);
vi. Drug Screen,
vii. Physical for all vendor staff.
2. Clinical Vendor Staff will return to HR:
a. To receive their Vendor ID badge. Vendor staff member will wear badge while working at the hospital.
b. Signed vendor staff profile, confidentiality agreement, vendor and agency staff attestation for each member working on site."

2. During record review on 6/8/17 of personnel files, there was either no documentation or expired documentation of current N95 respirator fit tests for the following personnel:
Unlicensed Staff F - 8/13
Licensed Staff E - no documentation
OR Manager - 7/15
Administrator - no documentation
Engineer - no documentation
DON - no documentation
Dietary Supervisor - no documentation
Housekeeper - 7/15

A document titled "Proper Use, Filtration, and Fit", dated 2016, published by the CDC (Centers for Disease Control and Prevention) indicated "Respirator fit can be a complex subject, OSHA's(Occupational Safety and Health Administration) 1910.134, respiratory protection standard requires respirator fit testing initially and annually thereafter."

The hospital policy titled "Personal Respiratory Protection Program in Infection Prevention", dated 9/21/16, indicated, "B. 1. v. Provide or arrange for annual respirator fit testing."

3. During hospital personnel record review on 6/8/17, the hospital failed to monitor and document the required TB (tuberculosis) test for the following personnel:
Sterile Processing Technician - given 11/16, but not read
Dietary Supervisor - 6/3/16
Housekeeping - "needs chest xray"

The hospital policy titled "Prevention and Control Plan For Transmission of Mycobacterium tuberculosis (TB)", dated 9/15, indicated "C. 1. Screening shall be performed annually for all employees."