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.

HARRISON MEDICAL CENTER 2520 CHERRY AVENUE BREMERTON, WA 98310 Sept. 3, 2020
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
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Based on observation and interview, the hospital failed to maintain the patient care environment and supplies with intact, non-absorbent, cleanable surfaces.

Failure to ensure patient care equipment and supplies have non-absorbent, cleanable surfaces places patients and staff at increased risk of exposure to harmful microorganisms.

References: Association of periOperative Registered Nurses (AORN) Guideline for Environmental Cleaning, (2020) - "Recommendation 2.13, Before cleaning, inspect mattresses and padded positioning device surfaces (e.g., OR beds, arm boards, patient transport carts) for any moisture. Non-intact surfaces may become reservoirs for microorganisms and may harbor pathogens. ... Regular inspection for visible signs of compromise or wear, such as tears, cracks, pinholes or stains, facilitates prompt replacement and prevention of cross contamination resulting from underlying surface exposure."

AORN Guideline for Design and Maintenance of the Surgical Suite, (2020) - "Recommendation 12.2, Maintain the integrity of structural surfaces (e.g., doors, floors, walls, ceilings, cabinets) and have surfaces repaired when damaged." "Recommendation 12.2.1 Report damage to floors, walls, ceilings, cabinets, and other structural surfaces according to the health care organization's policy. Damaged structural surfaces may create a reservoir for the collection of dirt and debris that cannot be removed during cleaning."

Findings included:

1. Document review of the hospital ' s " Infection Prevention and Control Standard, 153.00, " PolicyStat ID: 56, revised 06/18, showed that the Association of Operating Room Nurses (AORN) Standards are used to guide the hospital ' s strategies for preventing the spread of pathogens in the Inpatient Hospital Setting.
2. On 09/01/20, between 6:30 PM and 9:40 PM, Investigator #6, Investigator #7, and the Environmental Services (EVS) Director (Staff #604) observed the terminal cleaning of Operating Room (OR) #4 by an EVS Technician (Staff #605). The observation showed the following absorbent and/or un-cleanable surfaces:

a. Surgical positioner strap pulling away from base housing, exposing underlying fabric.

b. A hole (approximately " diameter) in the vinyl cover of a cushion for the procedure table. The hole exposed the foam cushion. Several other cushions showed wear at the corners exposing the fabric backing.

c. A piece of foam sticker on the underside of the procedure table.

d. Adhesive tape, used to secure laminated signs, pulling away from the wall, exposing adhesive surface. Adhesive tape strand (approximately 6" long) and sticker/label residue on the Pyxis (an automated medication dispenser).

e. Non-laminated sheet of paper and self-adhesive notes on the white board. Non-laminated paper is absorbent and not cleanable.

f. Several cracked and broken ceramic wall tiles. Cracked and broken areas of the floor covering at the wall coving.

3. At 9:30 PM Investigator #6 interviewed Staff #605 about the procedure for reporting damaged patient care supplies, equipment, or structures. Staff #605 stated that he should replace the damaged item or report it to the OR manager, and or complete an electronic work order. Investigator #6 asked Staff #605 whether he noticed any items in OR#4 that should be replaced or repaired. Staff #605 stated that he had not.
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VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
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Based on interview and review of the hospital's quality and safety program, the hospital failed to develop a systematic process for creating, implementing, monitoring, and evaluating performance improvement action plans for identified deficiencies as directed by its quality improvement plan.

Failure to develop and implement corrective action plans for identified problems and monitor for sustained improvement limits the hospital's ability to provide high quality clinical care and improve patient outcomes.

Findings included:

1. Document review of the hospital's quality improvement plan titled, "Coordinated Quality Improvement and Patient Safety Program," policy number 78, approved 09/19, showed the following:

-The purpose of the plan is to define the framework for the hospital's organization-wide coordinated quality improvement and patient safety program and to describe the hospital's approach to care error prevention.

-The plan strives to track the status of identified problems to assure improvement or problem resolution.

-The plan strives to evaluate and revise when necessary, the objectives, scope, organization and mechanics for overseeing improvement, patient safety, and service quality.

-To provide consistent and effective approach to improvement the hospital has adopted the "Plan, Do Study, Act" methodology (PDSA) which includes plan the improvement, do the planned interventions, study the effectiveness of the actions, and act to improve the action and hold the gains. If the process was not successful, repeat the PDSA cycle.

The Harrison Quality Improvement and Safety Committee (HQISC) is responsible for assuring that organizational activities and action plans are effective in achieving improvement goals developed in response to performance data or quality/patient safety/infection prevention issues that are identified including sentinel events. It is the responsibility of this committee to ensure that patient, employee, and environmental safety is intrinsic to Harrison Hospital's culture through policy and procedural development, review, and approval, as well as leadership support.

2. On 09/02/20, Investigator #5 reviewed the hospital' dashboard titled, "CHI Franciscan St. Michael Medical Center Quality and Safety Metrics," dated 08/28/20. The document showed that the hospital failed to meet its metrics (identified in red and defined as "below baseline") for the following:

a. Stage 3 or 4 pressure ulcers for 2 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

b. Postoperative Respiratory Failure for 2 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

c. Postoperative Pulmonary Embolism or Deep Vein Thrombosis for 3 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

d. Postoperative Wound Dehiscence for 2 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

e. Mortality for Acute Myocardial Infarction for 4 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

f. Mortality for Heart Failure for 6 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

g. Mortality for Pneumonia for 4 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

h. Mortality for Chronic Obstructive Pulmonary Disease for 2 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

i. Mortality for Coronary Artery Bypass Graft for 2 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

j. Unplanned Readmission Acute Myocardial Infarction for 6 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

k. Unplanned Readmission Heart Failure for 2 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

l. Unplanned Readmission Chronic Obstructive Pulmonary Disease for 3 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

m. Unplanned Readmission Coronary Artery Bypass Graft for 5 of 6 months (January-June 2020) reviewed and for the fiscal year to date.

3. On 09/02/20, Investigator #5 reviewed the HQISC meeting minutes for dates 10/24/19, 12/05/19, 01/23/20, 02/27/20, 04/23/20, 05/28/20, and 06/25/20. Investigator #5 found no evidence in the meeting minutes that the hospital's Quality Committee reviewed data, developed process improvement plans, or reassessed effectiveness of interventions for the metrics not meeting target identified in the hospital's Quality and Safety Metrics Dashboard

4. From 9:30 AM to 11:00 AM, Investigator #5, Investigator #6, and the hospital's Quality Improvement and Patient Safety committee (HQISC) reviewed the hospital's Quality and Process Improvement program. At this time, Investigator #5 discussed with the committee the lack of reporting of data, data analysis, tracking and trending, and process improvement activities related to the metrics identified in the hospital's Quality Plan and the HQISC minutes.

5. On 09/03/20 at 9:30 AM, the Senior Vice-President of Operations (Staff #520) stated that hospital's quality plan had not been updated to reflect the CommonSpirit Health System level Quality initiatives and that the hospital's quality initiatives were directed by CommonSpirit Health System Quality Program. Staff #520 stated that the metrics identified by the CommonSpirit Health System Quality program included Early Management of Sepsis and Reduction in Hospital Acquired Clostridium Difficile Infections, and Patient Experience and that this was reflected in the hospital's Quality Committee meeting minutes.

6. On 09/03/20 at 10:00 AM, the Interim Division Vice President for Quality (Staff #521) stated that the goals reflected on the dashboard were stretch goals and that these metrics were discussed at the Board Quality and the CHI Franciscan Quality and Value Committee.

7. On 09/03/20, hospital staff provided the Investigators with meeting minutes for hospital subcommittees. The review showed the following:

a. Harrison Medical Center Readmission Committee minutes dated 01/28/20 and 02/25/20. Investigator #5 found no evidence that process improvement plans were provided to the hospital's Quality Improvement and Patient Safety Committee.

b. St. Michael Medical Center Skin Integrity Committee with meeting minutes dated 12/10/19, 02/11/20, 07/14/20, and 08/11/20. Investigator #5 found no data related to hospital acquired pressure ulcers. Investigator #5 found no evidence that process improvement information or plans were provided to the hospital's Quality Improvement and Patient Safety Committee.

8. The hospital provided the Investigators with 1 month of CHI Franciscan Health Quality and Value Committee minutes dated 06/16/20. Investigator #5 found no evidence that metrics identified on the dashboard failing to meet goal were analyzed or reviewed by the CHI Franciscan Quality and Value Committee.

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VIOLATION: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT Tag No: A0308
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Based on interview and document review, the hospital's Governing Body failed to provide oversight of the hospital's quality program in order to ensure the quality program reflected the complexity of the organization and services as outlined in the hospital's Quality Plan (Item #1), and involved all hospital departments including those furnished under contract (Item #2)

Failure to ensure that the hospital's Quality Program reflected the complexities of services provided, limits the hospital's ability to identify areas of concern related to quality and safety, and limits the hospital's ability to implement process improvement actions to improve care outcomes and patient safety.

Findings included:

Item #1 Quality Plan

1. Document review of the hospital's quality improvement plan titled, "Coordinated Quality Improvement and Patient Safety Program," policy number 78, approved 09/19, showed the following:

-The purpose of the plan is to define the framework for the hospital's organization-wide coordinated quality improvement and patient safety program and to describe the hospital's approach to care error prevention.

-The purpose of the coordinated quality improvement and patient safety program is to systematically plan, design, measure, assess, and improve performance of key functions and processes relative to patient safety, clinical care, and services.

-The plan communicates necessary information among departments and services when opportunities to improve patient care, patient safety, and service quality involve more than one department.

-The plan strives to track the status of identified problems to assure improvement or problem resolution.

-The plan strives to evaluate and revise when necessary, the objectives, scope, organization and mechanics for overseeing improvement, patient safety, and service quality.

-The plan strives to communicate patient safety and service quality information throughout the organization.

-To provide consistent and effective approach to improvement the hospital has adopted the "Plan, Do Study, Act" methodology (PDSA) which includes plan the improvement, do the planned interventions, study the effectiveness of the actions, and act to improve the action and hold the gains. If the process was not successful, repeat the PDSA cycle.

The scope of the patient safety program includes identification of potential errors and instances of patient harm include review of data including, but not limited to the following:

-Adverse Drug Events

-Hospital-Acquired infections and other conditions

-Communicable disease exposure

-Patient Falls

-Procedural Mishaps

-Transfusion Reactions

-Restraint Use

-Hazardous Conditions

-Preventable Deaths and Complications

-Other Patient Incidents/Unexpected Clinical Events

-Sentinel Events and Near Misses

-Patient Complaints related to Accidents, Injuries, or Treatment

-Pain Assessment and Pain Management

-Safe use of Opioid medications

-Medical Alarm Safety

It is the responsibility of the CHI Franciscan Board to ensure there is an ongoing program of quality improvement and patient safety defined, implemented and maintained. Periodic updates will be provided to the CHI Franciscan Board relative to performance on key quality metrics and patient safety initiatives.

The Harrison's Board of Directors, the Governing Body, is responsible for the quality and safety of patient care in the organization. The Board reviews the organizational goals for improving quality and safety of patient care and receives regular reports on key quality and patient safety initiatives and results. The Board may delegate responsibility of overseeing the Coordinated Quality Improvement and Patient Safety Program to other committees within the organization.

Harrison's Executive team has the delegated authority and responsibility for implementing the objectives of the Coordinated Quality Improvement and Patient Safety Program.

The Vice President of Medical Affairs/Associate Chef Medical Officer is the chief administrative leader responsible for clinical quality within the organization.

The Harrison Quality Improvement and Safety Committee (HQISC) is responsible for assuring that organizational activities and action plans are effective in achieving improvement goals developed in response to performance data or quality/patient safety/infection prevention issues that are identified including sentinel events. It is the responsibility of this committee to ensure that patient, employee, and environmental safety is intrinsic to Harrison Hospital's culture through policy and procedural development, review, and approval, as well as leadership support. The HQISC may delegate any function within its responsibility for the implementation of the Coordinated Quality Improvement and Patient Safety Program to another regularly constituted committee as appropriate.

The HQISC reports monthly to the Board of Directors. This report shall review the quality improvement activities conducted by the committee or its designee's and actions taken as a result of those activities.

2. On 09/02/20, Investigator #5 reviewed the HQISC meeting minutes for dates 10/24/19, 12/05/19, 01/23/20, 02/27/20, 04/23/20, 05/28/20, and 06/25/20. The review showed:

a. Investigator #5 found no evidence in the meeting minutes that the hospital reviewed aggregated data, developed process improvement plans, or reassessed effectiveness of interventions for the metrics identified in the hospital's Quality Plan including:

-Adverse Drug Events

-Communicable disease exposure

-Procedural Mishaps

-Transfusion Reactions

-Restraint Use

-Hazardous Conditions

-Preventable Deaths and Complications

-Other Patient Incidents/Unexpected Clinical Events

-Sentinel Events and Near Misses

-Patient Complaints related to Accidents, Injuries, or Treatment

-Pain Assessment and Pain Management

-Safe use of Opioid medications

-Medical Alarm Safety

b. Document review of Harrison Quality and Safety Committee minutes dated 10/24/19 showed under the row titled, "Reports: Sepsis" that an annual update was provided regarding Sepsis. The document stated that Sepsis was now one of the 3-quality measures that CommonSpirit will be focusing on.

c. Document review of Harrison Quality and Safety Committee minutes dated 01/23/20 showed an attached document titled, "Harrison Medical Center Medical Staff Medical Executive Committee Minutes," dated 01/16/20, which showed that the Quality and Patient Safety Goals for Fiscal Year 2020 will focus on hypertension management, sepsis early management bundle compliance, and hospital acquired Clostridium Difficile infection reduction. The document shows that the information was informational only and no committee action was required.

3. From 9:30 AM to 11:00 AM, Investigator #5, Investigator #6, and the hospital's Quality Improvement and Patient Safety committee (HQISC) reviewed the hospital's Quality and Process Improvement program. At this time, Investigator #5 discussed lack of documentation of data collection and process improvement in the minutes compared to the hospital's Quality Plan.

4. On 09/03/20 at 9:30 AM, the Senior Vice-President of Operations (Staff #520) stated that the hospital's quality plan had not been updated to reflect the CommonSpirit Health System level quality initiatives and that the hospital's quality initiatives were directed by CommonSpirit Health System Quality Program. Staff #520 stated that the metrics identified by the CommonSpirit Health System Quality program included Early Management of Sepsis and Reduction in Hospital Acquired Clostridium Difficile Infections and that this was reflected in the hospital's Quality Committee meeting minutes.

5. On 09/03/20 at 11:00 AM, Investigator #5 and Investigator #6 and the hospital's Governing Board reviewed the Governing Body's role in Quality Improvement in the Hospital. The Senior Vice-President of Operations (Staff #520) stated that this board does not oversee Quality and that the Board has delegated the quality authority to CHI Franciscan Quality and Values Committee.

6. At this time, a Board Member (Staff #527) stated that 6 or 7 board members attend the hospital Quality meetings.

7. On 09/03/20 at 11:40 AM, the Chairman of the St Michael's Governing Board (Staff #528) stated that hospital's Quality information to the St. Michael's Governing Board is only informational and that the Franciscan Quality and Values Committee are responsible for the Quality Program oversite.

8. Investigator found no evidence that the hospital collected, analyzed, assessed, and implemented process improvement as needed for the metrics outlined in their Quality Plan, and found no evidence that in a move to a System Level Quality program that the initiatives reflected the complexity of the hospital's organization and services; involved all hospital departments and services, and included those services furnished under contract or arrangement.

Item #2 Contracted Services

1. Document review of the hospital's quality improvement plan titled, "Coordinated Quality Improvement and Patient Safety Program," policy number 78, approved 09/19, showed the
scope of the patient safety program failed to include performance review for contracted services.

2. On 09/03/20 at 11:40 AM, the Chairman of the St Michael's Governing Board (Staff #528) stated that hospital's Quality information to the St. Michael's Governing Board is only informational and that the Franciscan Quality and Values Committee are responsible for the Quality Program oversite.

3. On 09/03/20 at 2:30 PM, Investigator #5 and the Quality and Accreditation Director (Staff #524) reviewed 3 clinical contracts. The review showed that 1 clinical contract did not have review of documentation completed and 1 clinical contract was reviewed at the system level.

4. On 09/03/20 at 2:40 PM, Staff #524 stated that contracted service review was not reported through the local hospital's quality committee but through a system level committee.

5. Investigator #5 found no evidence that the hospital collected, analyzed, assessed, and implemented process improvement for services furnished under contract or arrangement through the hospital's quality committee. Investigator #5 found no evidence that the hospital's Governing Body provided oversight for quality improvement review or activities for services furnished under contract or arrangement.

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VIOLATION: UNIFIED AND INTEGRATED QAPI PROGRAM Tag No: A0320
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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Based on interview and document review, the hospital's System Level Governing Body failed to ensure that the hospital's quality program and quality plan, under a System Level Unified and Integrated Quality Program, incorporated Washington State Hospital Licensing Regulations (Item #1), failed to ensure that the plan reflected the hospital's unique circumstances, patient populations, and services (Item #2), and failed to establish and implement policies and procedures to ensure that the needs and concerns of the hospital were given due consideration, and that the program had mechanisms in place to ensure that hospital issues were considered and addressed (Item #3).

Failure to ensure that a System Level Unified and Integrated Quality Program and policies and procedures incorporated State regulatory requirements, reflected the hospital's unique circumstances, patient populations and services, and ensured that policies and procedures and included mechanisms to ensure that hospital issues were considered and addressed, limits the hospital's ability to implement process improvement actions to improve care outcomes and patient safety.

Reference:

Washington Administrative Code (WAC) 246-320-171 Hospitals must: (1) Have a hospital-wide approach to process design and performance measurement, assessment, and improving patient care services according to RCW 70.41.200 and include, but not be limited to:

(a) A written performance improvement plan that is periodically evaluated

(b) Performance improvement activities, which are interdisciplinary and include at least one member of the governing authority

(c) Prioritize performance improvement activities

(d) Implement and monitor actions taken to improve performance

(e) Education programs dealing with performance improvement, patient safety, medication errors, injury prevention

(f) Review serious or unanticipated patient outcomes in a timely manner

(2) Systematically collect, measure and assess data on processes and outcomes related to patient care and organization functions.

(3) Collect, measure and assess data including, but not limited to:

(a) Operative, other invasive, and noninvasive procedures that place patients at risk

(b) Infection rates, pathogen distributions, and antimicrobial susceptibility profiles

(c) Death

(d) Medication use

(e) Medication management or administration related to wrong medication, wrong dose, wrong time, near misses and any other medication errors and incidents

(f) Injuries, falls; restraint use; negative health outcomes and incidents injurious to patients in the hospital;
(g) Adverse events listed in chapter 246-302 WAC

(h) Discrepancies or patterns between preoperative and postoperative (including pathologic) diagnosis, including pathologic review of specimens removed during surgical or invasive procedures

(i) Adverse drug reactions (as defined by the hospital)

(j) Confirmed transfusion reactions

(k) Patient grievances, needs, expectations, and satisfaction

(l) Quality control and risk management activities.

Findings included:

Item #1 Meeting State Quality Program Licensing Regulations

1. Document review of the hospital's quality improvement plan titled, "Coordinated Quality Improvement and Patient Safety Program," policy number 78, approved 09/19, showed the following:

-The purpose of the plan is to define the framework for the hospital's organization-wide coordinated quality improvement and patient safety program and to describe the hospital's approach to care error prevention.

-The purpose of the coordinated quality improvement and patient safety program is to systematically plan, design, measure, assess, and improve performance of key functions and processes relative to patient safety, clinical care, and services.

-The plan communicates necessary information among departments and services when opportunities to improve patient care, patient safety, and service quality involve more than one department.

-The plan strives to track the status of identified problems to assure improvement or problem resolution.

-The plan strives to evaluate and revise when necessary, the objectives, scope, organization and mechanics for overseeing improvement, patient safety, and service quality.

-The plan strives to communicate patient safety and service quality information throughout the organization.

-To provide consistent and effective approach to improvement the hospital has adopted the "Plan, Do Study, Act" methodology (PDSA) which includes plan the improvement, do the planned interventions, study the effectiveness of the actions, and act to improve the action and hold the gains. If the process was not successful, repeat the PDSA cycle.

The scope of the patient safety program includes identification of potential errors and instances of patient harm include review of data including, but not limited to the following:

-Adverse Drug Events

-Hospital-Acquired infections and other conditions

-Communicable disease exposure

-Patient Falls

-Procedural Mishaps

-Transfusion Reactions

-Restraint Use

-Hazardous Conditions

-Preventable Deaths and Complications

-Other Patient Incidents/Unexpected Clinical Events

-Sentinel Events and Near Misses

-Patient Complaints related to Accidents, Injuries, or Treatment

-Pain Assessment and Pain Management

-Safe use of Opioid medications

-Medical Alarm Safety

It is the responsibility of the CHI Franciscan Board to ensure there is an ongoing program of quality improvement and patient safety defined, implemented and maintained. Periodic updates will be provided to the CHI Franciscan Board relative to performance on key quality metrics and patient safety initiatives.

The Harrison's Board of Directors, the Governing Body, is responsible for the quality and safety of patient care in the organization. The Board reviews the organizational goals for improving quality and safety of patient care and receives regular reports on key quality and patient safety initiatives and results. The Board may delegate responsibility of overseeing the Coordinated Quality Improvement and Patient Safety Program to other committees within the organization.

Harrison's Executive team has the delegated authority and responsibility for implementing the objectives of the Coordinated Quality Improvement and Patient Safety Program.

The Vice President of Medical Affairs/Associate Chief Medical Officer is the chief administrative leader responsible for clinical quality within the organization.

The Harrison Quality Improvement and Safety Committee (HQISC) is responsible for assuring that organizational activities and action plans are effective in achieving improvement goals developed in response to performance data or quality/patient safety/infection prevention issues that are identified including sentinel events. It is the responsibility of this committee to ensure that patient, employee, and environmental safety is intrinsic to Harrison Hospital's culture through policy and procedural development, review, and approval, as well as leadership support. The HQISC may delegate any function within its responsibility for the implementation of the Coordinated Quality Improvement and Patient Safety Program to another regularly constituted committee as appropriate.

The HQISC reports monthly to the Board of Directors. This report shall review the quality improvement activities conducted by the committee or its designee's and actions taken as a result of those activities.

Document review of the hospital's quality improvement plan titled, "Coordinated Quality Improvement and Patient Safety Program," policy number 78, approved 09/19, showed the scope of the patient safety program failed to include systematic collection, measurement, and assessment of data on processes and outcomes related to patient care and organization functions and services including:

a. Operative, other invasive, and noninvasive procedures that place patients at risk

b. Medication use

c. Medication management or administration related to wrong medication, wrong dose, wrong time, near misses and any other medication errors and incidents

d. Discrepancies or patterns between preoperative and postoperative (including pathologic) diagnosis, including pathologic review of specimens removed during surgical or invasive procedures

e. performance review for contracted services

Document review of a document titled, "Board of Stewardship Trustees Approved Quality and Patient Safety Goals Fiscal Year 2020,) dated 07/30/19, showed that the quality/patient safety measures approved by the CommonSpirit Health Board of Stewardship Trustees for the Fiscal Year 2020 for the systems acute care hospitals included Sepsis Early Management Bundle Compliance ns Hospital-Acquired Clostridium difficile ([DIAGNOSES REDACTED]) Infection Reduction.
2. On 09/02/20, Investigator #5 reviewed the HQISC meeting minutes for dates 10/24/19, 12/05/19, 01/23/20, 02/27/20, 04/23/20, 05/28/20, and 06/25/20. The review showed:

a. Investigator #5 found no evidence in the meeting minutes that the hospital reviewed aggregated data, developed process improvement plans, or reassessed effectiveness of interventions for the metrics identified in the hospital's Quality Plan including:

-Adverse Drug Events

-Communicable disease exposure

-Procedural Mishaps

-Transfusion Reactions

-Restraint Use

-Hazardous Conditions

-Preventable Deaths and Complications

-Other Patient Incidents/Unexpected Clinical Events

-Sentinel Events and Near Misses

-Patient Complaints related to Accidents, Injuries, or Treatment

-Pain Assessment and Pain Management

-Safe use of Opioid medications

-Medical Alarm Safety

b. Document review of Harrison Quality and Safety Committee minutes dated 10/24/19 showed under the row titled, "Reports: Sepsis" that an annual update was provided regarding Sepsis. The document stated that Sepsis is now one of the 3 quality measures that CommonSpirit will be focusing on.

c. Document review of "Harrison Quality and Safety Committee minutes," dated 01/23/20, showed an attached document titled, "Harrison Medical Center Medical Staff Medical Executive Committee Minutes," dated 01/16/20, which showed that the Quality and Patient Safety Goals for Fiscal Year 2020 will focus on hypertension management, sepsis early management bundle compliance, and hospital acquired Clostridium Difficile infection reduction. The document showed that the information was informational only and no committee action was required.

3. From 9:30 AM to 11:00 AM, Investigator #5, Investigator #6, and the hospital's Quality Improvement and Patient Safety committee (HQISC) reviewed the hospital's Quality and Process Improvement program. At this time, Investigator #5 discussed with the committee the lack of reporting of data, data analysis, tracking and trending, and process improvement activities related to the metrics identified in the hospital's Quality Plan and the HQISC minutes. The Senior Vice-President of Operations (Staff #520) stated that the hospital's quality plan had not been updated to reflect the CommonSpirit Health System level Quality initiatives and that the hospital's quality initiatives were directed by CommonSpirit Health System Quality Program. Staff #520 stated that the metrics identified by the CommonSpirit Health System Quality program included Early Management of Sepsis and Reduction in Hospital Acquired Clostridium Difficile Infections, and Patient Experience and that this was reflected in the hospital's Quality Committee meeting minutes.

4. Investigator #5 found no evidence that under a System Level Unified and Integrated Quality Program that the plan included collection, assessment, and implementation of process improvement for metrics required by Washington State Hospital Regulations outlined in WAC 246-320-171.

Item #2 Unique Hospital Circumstances, Populations, and Services

Cross Reference A-321

Item #3 Policy and Procedure to Address Needs, Concerns, and Issues

Cross Reference A-322

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VIOLATION: SYSTEM QAPI HOSPITAL CIRCUMSTANCES Tag No: A0321
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Based on interview and document review, the hospital's System Level Governing Body failed to ensure that the hospital's quality program, under a System Unified and Integrated Quality Program, reflected the complexity of the organization and services, included all hospital departments and services, and focused on indicators related to improved health outcomes and the prevention and reduction of medical errors.

Failure to ensure that the hospital's Quality Program reflected the complexities of services provided, limits the hospital's ability to identify areas of concern related to quality and safety, and limits the hospital's ability to implement process improvement actions to improve care outcomes and patient safety.

Findings included:

1. Document review of the hospital's quality improvement plan titled, "Coordinated Quality Improvement and Patient Safety Program," policy number 78, approved 09/19, showed the following:

-The purpose of the plan is to define the framework for the hospital's organization-wide coordinated quality improvement and patient safety program and to describe the hospital's approach to care error prevention.

-The purpose of the coordinated quality improvement and patient safety program is to systematically plan, design, measure, assess, and improve performance of key functions and processes relative to patient safety, clinical care, and services.

-The plan communicates necessary information among departments and services when opportunities to improve patient care, patient safety, and service quality involve more than one department.

-The plan strives to track the status of identified problems to assure improvement or problem resolution.

-The plan strives to evaluate and revise when necessary, the objectives, scope, organization and mechanics for overseeing improvement, patient safety, and service quality.

-The plan strives to communicate patient safety and service quality information throughout the organization.

-To provide consistent and effective approach to improvement the hospital has adopted the "Plan, Do Study, Act" methodology (PDSA) which includes plan the improvement, do the planned interventions, study the effectiveness of the actions, and act to improve the action and hold the gains. If the process was not successful, repeat the PDSA cycle.

The scope of the patient safety program includes identification of potential errors and instances of patient harm include review of data including, but not limited to the following:

-Adverse Drug Events

-Hospital-Acquired infections and other conditions

-Communicable disease exposure

-Patient Falls

-Procedural Mishaps

-Transfusion Reactions

-Restraint Use

-Hazardous Conditions

-Preventable Deaths and Complications

-Other Patient Incidents/Unexpected Clinical Events

-Sentinel Events and Near Misses

-Patient Complaints related to Accidents, Injuries, or Treatment

-Pain Assessment and Pain Management

-Safe use of Opioid medications

-Medical Alarm Safety

It is the responsibility of the CHI Franciscan Board to ensure there is an ongoing program of quality improvement and patient safety defined, implemented and maintained. Periodic updates will be provided to the CHI Franciscan Board relative to performance on key quality metrics and patient safety initiatives.

The Harrison's Board of Directors, the Governing Body, is responsible for the quality and safety of patient care in the organization. The Board reviews the organizational goals for improving quality and safety of patient care and receives regular reports on key quality and patient safety initiatives and results. The Board may delegate responsibility of overseeing the Coordinated Quality Improvement and Patient Safety Program to other committees within the organization.

Harrison's Executive team has the delegated authority and responsibility for implementing the objectives of the Coordinated Quality Improvement and Patient Safety Program.

The Vice President of Medical Affairs/Associate Chief Medical Officer is the chief administrative leader responsible for clinical quality within the organization.

The Harrison Quality Improvement and Safety Committee (HQISC) is responsible for assuring that organizational activities and action plans are effective in achieving improvement goals developed in response to performance data or quality/patient safety/infection prevention issues that are identified including sentinel events. It is the responsibility of this committee to ensure that patient, employee, and environmental safety is intrinsic to Harrison Hospital's culture through policy and procedural development, review, and approval, as well as leadership support. The HQISC may delegate any function within its responsibility for the implementation of the Coordinated Quality Improvement and Patient Safety Program to another regularly constituted committee as appropriate.

The HQISC reports monthly to the Board of Directors. This report shall review the quality improvement activities conducted by the committee or its designee's and actions taken as a result of those activities.

Document review of the hospital's quality improvement plan titled, "Coordinated Quality Improvement and Patient Safety Program," policy number 78, approved 09/19, showed the
scope of the patient safety program failed to include performance review for contracted services.

2. On 09/02/20, Investigator #5 reviewed the HQISC meeting minutes for dates 10/24/19, 12/05/19, 01/23/20, 02/27/20, 04/23/20, 05/28/20, and 06/25/20. The review showed:

a. Investigator #5 found no evidence in the meeting minutes that the hospital reviewed aggregated data, developed process improvement plans, or reassessed effectiveness of interventions for the metrics identified in the hospital's Quality Plan or as required by regulation including:

-Adverse Drug Events

-Communicable disease exposure

-Procedural Mishaps

-Transfusion Reactions

-Restraint Use

-Hazardous Conditions

-Preventable Deaths and Complications

-Other Patient Incidents/Unexpected Clinical Events

-Sentinel Events and Near Misses

-Patient Complaints related to Accidents, Injuries, or Treatment

-Pain Assessment and Pain Management

-Safe use of Opioid medications

-Medical Alarm Safety

b. Document review of Harrison Quality and Safety Committee minutes dated 10/24/19 showed under the row titled, "Reports: Sepsis" that an annual update was provided regarding Sepsis. The document stated that Sepsis is now one of the 3 quality measures that CommonSpirit will be focusing on.

c. Document review of Harrison Quality and Safety Committee minutes dated 01/23/20 showed an attached document titled, "Harrison Medical Center Medical Staff Medical Executive Committee Minutes," dated 01/16/20, which showed that the Quality and Patient Safety Goals for Fiscal Year 2020 will focus on hypertension management, sepsis early management bundle compliance, and hospital acquired Clostridium Difficile infection reduction. The document showed that the information was informational only and no committee action was required.

3. From 9:30 AM to 11:00 AM, Investigator #5, Investigator #6, and the hospital's Quality Improvement and Patient Safety committee (HQISC) reviewed the hospital's Quality and Process Improvement program. At this time, Investigator #5 discussed with the committee the lack of reporting of data, data analysis, tracking and trending, and process improvement activities related to the metrics identified in the hospital's Quality Plan and the HQISC minutes. The Senior Vice-President of Operations (Staff #520) stated that the hospital's quality plan had not been updated to reflect the CommonSpirit Health System level Quality initiatives and that the hospital's quality initiatives were directed by CommonSpirit Health System Quality Program. Staff #520 stated that the metrics identified by the CommonSpirit Health System Quality program included Early Management of Sepsis and Reduction in Hospital Acquired Clostridium Difficile Infections, and Patient Experience and that this was reflected in the hospital's Quality Committee meeting minutes.

4. Investigator #5 found no evidence that the hospital collected, analyzed, assessed, and implemented process improvement for the metrics outlined in their Quality Plan.

5. Investigator #5 found no evidence that under a stated System Level Quality program that the initiatives reflected the complexity of the hospital's organization and services; involved all hospital departments and services, included those services furnished under contract or arrangement, took into account the hospital's unique circumstances, or any significant differences in patient populations and services offered by hospital.

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VIOLATION: SYSTEM QAPI POLICIES AND PROCEDURES Tag No: A0322
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Based on interview and document review, the hospital's System Level Governing Body failed to establish and implement policies and procedures to ensure that the needs and concerns of the hospital were given due consideration, and that the unified and integrated QAPI program had mechanisms in place to ensure that issues localized to the hospital were duly considered and addressed.

Failure to ensure that the hospital's Quality Program Plan was updated and provided mechanisms to ensure that the needs and concerns of the hospital were given due consideration, and that the unified and integrated QAPI program had mechanisms in place to ensure that issues localized to the hospital were duly considered and addressed limited the hospital's ability to identify areas of concern related to quality and safety, and limited the hospital's ability to implement process improvement actions to improve care outcomes and patient safety.

Findings included:

1. Document review of the hospital's quality improvement plan titled, "Coordinated Quality Improvement and Patient Safety Program," policy number 78, approved 09/19, showed the following:

-The purpose of the plan is to define the framework for the hospital's organization-wide coordinated quality improvement and patient safety program and to describe the hospital's approach to care error prevention.

-The purpose of the coordinated quality improvement and patient safety program is to systematically plan, design, measure, assess, and improve performance of key functions and processes relative to patient safety, clinical care, and services.

-The plan communicates necessary information among departments and services when opportunities to improve patient care, patient safety, and service quality involve more than one department.

-The plan strives to track the status of identified problems to assure improvement or problem resolution.

-The plan strives to evaluate and revise when necessary, the objectives, scope, organization and mechanics for overseeing improvement, patient safety, and service quality.

-The plan strives to communicate patient safety and service quality information throughout the organization.

-To provide consistent and effective approach to improvement, the hospital has adopted the "Plan, Do Study, Act" methodology (PDSA) which includes plan the improvement, do the planned interventions, study the effectiveness of the actions, and act to improve the action and hold the gains. If the process was not successful, repeat the PDSA cycle.

The scope of the patient safety program includes identification of potential errors and instances of patient harm include review of data including, but not limited to the following:

-Adverse Drug Events

-Hospital-Acquired infections and other conditions

-Communicable disease exposure

-Patient Falls

-Procedural Mishaps

-Transfusion Reactions

-Restraint Use

-Hazardous Conditions

-Preventable Deaths and Complications

-Other Patient Incidents/Unexpected Clinical Events

-Sentinel Events and Near Misses

-Patient Complaints related to Accidents, Injuries, or Treatment

-Pain Assessment and Pain Management

-Safe use of Opioid medications

-Medical Alarm Safety

It is the responsibility of the CHI Franciscan Board to ensure there is an ongoing program of quality improvement and patient safety defined, implemented and maintained. Periodic updates will be provided to the CHI Franciscan Board relative to performance on key quality metrics and patient safety initiatives.

The Harrison's Board of Directors, the Governing Body, is responsible for the quality and safety of patient care in the organization. The Board reviews the organizational goals for improving quality and safety of patient care and receives regular reports on key quality and patient safety initiatives and results. The Board may delegate responsibility of overseeing the Coordinated Quality Improvement and Patient Safety Program to other committees within the organization.

Harrison's Executive team has the delegated authority and responsibility for implementing the objectives of the Coordinated Quality Improvement and Patient Safety Program.

The Vice President of Medical Affairs/Associate Chief Medical Officer is the chief administrative leader responsible for clinical quality within the organization.

The Harrison Quality Improvement and Safety Committee (HQISC) is responsible for assuring that organizational activities and action plans are effective in achieving improvement goals developed in response to performance data or quality/patient safety/infection prevention issues that are identified including sentinel events. It is the responsibility of this committee to ensure that patient, employee, and environmental safety is intrinsic to Harrison Hospital's culture through policy and procedural development, review, and approval, as well as leadership support. The HQISC may delegate any function within its responsibility for the implementation of the Coordinated Quality Improvement and Patient Safety Program to another regularly constituted committee as appropriate.

The HQISC reports monthly to the Board of Directors. This report shall review the quality improvement activities conducted by the committee or its designee's and actions taken as a result of those activities.

Document review of the hospital's quality improvement plan titled, "Coordinated Quality Improvement and Patient Safety Program," policy number 78, approved 09/19, showed the
scope of the patient safety program failed to include performance review for contracted services.

2. On 09/02/20, Investigator #5 reviewed the HQISC meeting minutes for dates 10/24/19, 12/05/19, 01/23/20, 02/27/20, 04/23/20, 05/28/20, and 06/25/20. A note attached to the meeting minutes noted that the July 2020 meeting had been cancelled. The review showed:

a. Investigator #5 found no evidence in the meeting minutes that the hospital reviewed aggregated data, developed process improvement plans, or reassessed effectiveness of interventions for the metrics identified in the hospital's Quality Plan or as required by regulation including:

-Adverse Drug Events

-Communicable disease exposure

-Procedural Mishaps

-Transfusion Reactions

-Restraint Use

-Hazardous Conditions

-Preventable Deaths and Complications

-Other Patient Incidents/Unexpected Clinical Events

-Sentinel Events and Near Misses

-Patient Complaints related to Accidents, Injuries, or Treatment

-Pain Assessment and Pain Management

-Safe use of Opioid medications

-Medical Alarm Safety

b. Document review of Harrison Quality and Safety Committee minutes dated 10/24/19 showed under the row titled, "Reports: Sepsis" that an annual update was provided regarding Sepsis. The document stated that Sepsis was now one of the 3 quality measures that CommonSpirit will be focusing on.

c. Document review of Harrison Quality and Safety Committee minutes dated 01/23/20 showed an attached document titled, "Harrison Medical Center Medical Staff Medical Executive Committee Minutes," dated 01/16/20, showed that the Quality and Patient Safety Goals for Fiscal Year 2020 will focus on hypertension management, sepsis early management bundle compliance, and hospital acquired Clostridium Difficile infection reduction. The document shows that the information was informational only and no committee action was required.

3.From 9:30 AM to 11:00 AM, Investigator #5, Investigator #6, and the hospital's Quality Improvement and Patient Safety committee (HQISC) reviewed the hospital's Quality and Process Improvement program. At this time, Investigator #5 discussed with the committee the lack of reporting of data, data analysis, tracking and trending, and process improvement activities related to the metrics identified in the hospital's Quality Plan and the HQISC minutes. The Senior Vice-President of Operations (Staff #520) stated that hospital's quality plan had not been updated to reflect the CommonSpirit Health System level Quality initiatives and that the hospital's quality initiatives were directed by CommonSpirit Health System Quality Program. Staff #520 stated that the metrics identified by the CommonSpirit Health System Quality program included Early Management of Sepsis and Reduction in Hospital Acquired Clostridium Difficile Infections, and Patient Experience and that this was reflected in the hospital's Quality Committee meeting minutes.

7. Investigator found no evidence that the hospital collected, analyzed, assessed, and implemented process improvement as needed for the metrics outlined in their Quality Plan.

8. Investigator #5 found no evidence that under a stated System Level Quality Program that policies and procedures were developed and implemented to ensure that the needs and concerns of the hospital were given due consideration, and that the unified and integrated QAPI program had mechanisms in place to ensure that issues localized to the hospital were duly considered and addressed.


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VIOLATION: LICENSURE OF PERSONNEL Tag No: A0023
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Based on observation, interview, and record review, the hospital failed to ensure that all staff are appropriately trained for tasks being performed, as required by State law, for 3 of 7 personnel files reviewed (Staff #601, Staff #602, and Staff #603).

Failure to ensure that staff have the proper training and competency to perform their assigned job duties places patients and staff at increased risk of exposure to harmful microorganisms.

References: Washington Administrative Code (WAC) 246-320-156 Management of human resources; (8) Give infection control information to staff upon hire and annually which includes: (a) Education on general infection control according to chapter 296-823 WAC bloodborne pathogens exposure control; (b) Education specific to infection control for multidrug-resistant organisms; and (c) General and specific infection control measures related to the patient care areas where staff work.

Findings included:

1. Record review of the personnel files for 7 staff members showed that two Biotechnicians (Staff #601 & Staff #602), who performed repair and maintenance on Controlled Air Purifying Respirators (CAPR), did not have annual infection control training, including use of disinfectant chemicals.

- Record review of the personnel files for 7 staff members showed that an Equipment Technician (Staff #603) had not received initial or in-service competency training or evaluation.

2. On 08/26/20 at 11:00 AM, Investigator #5 observed two Biotechnicians (Staff #601 and Staff #602) as they evaluated the working condition of CAPRs that had been sent to BioMed for repair. At the time of the observation, Investigator #5 interviewed Staff #601 and Staff #602 about their procedure and the disinfection process. Neither Staff #601 nor Staff #602 could state the contact time for the disinfectant in use.
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VIOLATION: QAPI Tag No: A0263
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Based on observation, interview, and review of quality documents, the hospital failed to develop a hospital-wide quality assessment and performance improvement (QAPI) plan to monitor, evaluate, and improve the quality of patient care services through systematic data collection, analysis, and implementation and monitoring of quality activities.

Failure to systematically collect and analyze hospital-wide performance data limited the hospital's ability to identify problems and formulate action plans. This reduced the likelihood of sustained improvements in clinical care and patient outcomes.

Findings included:

Interview and document review showed the following:

1. Failure to systematically collect, aggregate, and analyze quality indicator data as part of the hospital's overall quality program as defined in its policy and procedure.

Cross Reference A-0273

2. Failure to develop action plans when performance goals are not being met.

Cross Reference: A-0283

3. Failure to provide oversight of the hospital's quality program in order to ensure the quality program reflected the complexity of the organization and services, and included all hospital departments and services.

Cross Reference: A-0308

4. Failure to ensure that the hospital's quality program, under a System Unified and Integrated Quality Program, reflected the complexity of the organization and services, included all hospital departments and services, and focused on indicators related to improved health outcomes and the prevention and reduction of medical errors.

Cross-Reference A-0321

5. Failure to establish and implement policies and procedures under a unified and integrated QAPI program that ensured that the needs and concerns of the hospital were given due consideration, and that the unified and integrated QAPI program had mechanisms in place to ensure that issues localized to the hospital were duly considered and addressed.

Cross Reference A-0322

6. Failure to develop and implement an effective infection prevention and control program puts patients, staff, and visitors at risk of illness from communicable diseases.

Cross Reference: A-0747

Due to the scope of the deficiencies cited under 42 CFR 482.21; the Condition of Participation for Quality was NOT MET.

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VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
.

Based on interview, and review of the hospital's quality program and quality documentation, the hospital failed to systematically collect, aggregate, and analyze quality indicator data as part of the hospital's overall quality program as defined in its policy and procedure.

Failure to collect, aggregate and analyze data to improve patient outcomes puts patients at risk of substandard care.

Findings included:

1. Document review of the hospital's quality improvement plan titled, "Coordinated Quality Improvement and Patient Safety Program," policy number 78, approved 09/19, showed the following:

-The purpose of the plan is to define the framework for the hospital's organization-wide coordinated quality improvement and patient safety program and to describe the hospital's approach to care error prevention.

-The purpose of the coordinated quality improvement and patient safety program is to systematically plan, design, measure, assess, and improve performance of key functions and processes relative to patient safety, clinical care, and services.

-The plan communicates necessary information among departments and services when opportunities to improve patient care, patient safety, and service quality involve more than one department.

-The plan strives to track the status of identified problems to assure improvement or problem resolution.

-The plan strives to evaluate and revise when necessary, the objectives, scope, organization and mechanics for overseeing improvement, patient safety, and service quality.

-The plan strives to communicate patient safety and service quality information throughout the organization.

-To provide consistent and effective approach to improvement the hospital has adopted the "Plan, Do Study, Act" methodology (PDSA) which includes plan the improvement, do the planned interventions, study the effectiveness of the actions, and act to improve the action and hold the gains. If the process was not successful, repeat the PDSA cycle.

The scope of the patient safety program included identification of potential errors and instances of patient harm and included review of data including, but not limited to the following:

-Adverse Drug Events

-Hospital-Acquired infections and other conditions

-Communicable disease exposure

-Patient Falls

-Procedural Mishaps

-Transfusion Reactions

-Restraint Use

-Hazardous Conditions

-Preventable Deaths and Complications

-Other Patient Incidents/Unexpected Clinical Events

-Sentinel Events and Near Misses

-Patient Complaints related to Accidents, Injuries, or Treatment

-Pain Assessment and Pain Management

-Safe use of Opioid medications

-Medical Alarm Safety

It is the responsibility of the CHI Franciscan Board to ensure there is an ongoing program of quality improvement and patient safety defined, implemented and maintained. Periodic updates will be provided to the CHI Franciscan Board relative to performance on key quality metrics and patient safety initiatives.

The Harrison's Board of Directors, the Governing Body, is responsible for the quality and safety of patient care in the organization. The Board reviews the organizational goals for improving quality and safety of patient care and receives regular reports on key quality and patient safety initiatives and results. The Board may delegate responsibility of overseeing the Coordinated Quality Improvement and Patient Safety Program to other committees within the organization.

Harrison's Executive team has the delegated authority and responsibility for implementing the objectives of the Coordinated Quality Improvement and Patient Safety Program.

The Vice President Medical Affairs/Associate Chief Medical Officer is the chief administrative leader responsible for clinical quality within the organization.

The Harrison Quality Improvement and Safety Committee (HQISC) is responsible for assuring that organizational activities and action plans are effective in achieving improvement goals developed in response to performance data or quality/patient safety/infection prevention issues that are identified including sentinel events. It is the responsibility of this committee to ensure that patient, employee, and environmental safety is intrinsic to Harrison Hospital's culture through policy and procedural development, review, and approval, as well as leadership support. The HQISC may delegate any function within its responsibility for the implementation of the Coordinated Quality Improvement and Patient Safety Program to another regularly constituted committee as appropriate.

The HQISC reports monthly to the Board of Directors. This report shall review the quality improvement activities conducted by the committee or its designee's and actions taken as a result of those activities.

2. On 09/02/20, Investigator #5 reviewed the HQISC meeting minutes for dates 10/24/19, 12/05/19, 01/23/20, 02/27/20, 04/23/20, 05/28/20, and 06/25/20. The review showed:

a. Investigator #5 found no evidence in the meeting minutes that the hospital reviewed aggregated data, developed process improvement plans, or reassessed effectiveness of interventions for the metrics identified in the hospital's Quality Plan including:

-Adverse Drug Events

-Communicable disease exposure

-Procedural Mishaps

-Transfusion Reactions

-Restraint Use

-Hazardous Conditions

-Preventable Deaths and Complications

-Other Patient Incidents/Unexpected Clinical Events

-Sentinel Events and Near Misses

-Patient Complaints related to Accidents, Injuries, or Treatment

-Pain Assessment and Pain Management

-Safe use of Opioid medications

-Medical Alarm Safety

3. Document review of Harrison Quality and Safety Committee minutes dated 12/05/19 showed a report of falls using a data range from 07/18-08/19. The report showed interventions implemented by the hospitals Fall Committee. Investigator #5 found no further data presentation or evaluation of process improvement activities.

4. From 9:30 AM to 11:00 AM, Investigator #5, Investigator #6, and the hospital's Quality Improvement and Patient Safety committee (HQISC) reviewed the hospital's Quality and Process Improvement program. At this time, Investigator #5 discussed with the committee the lack of reporting of data, data analysis, tracking and trending, and process improvement activities related to the metrics identified in the hospital's Quality Plan and the HQISC minutes.

5. On 09/03/20 at 9:30 AM, the Senior Vice-President of Operations (Staff #520) stated that hospital's quality plan had not been updated to reflect the CommonSpirit Health System level Quality initiatives and that the hospital's quality initiatives were directed by CommonSpirit Health System Quality Program. Staff #520 stated that the metrics identified by the CommonSpirit Health System Quality program included Early Management of Sepsis and Reduction in Hospital Acquired Clostridium Difficile Infections, and Patient Experience and that this was reflected in the hospital's Quality Committee meeting minutes.

Investigator found no evidence that the hospital collected, analyzed, assessed, and implemented process improvement for the metrics outlined in the hospital's Quality Plan.
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VIOLATION: INFECTION CONTROL Tag No: A0747
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Based on observation, document review, and interview, the hospital failed to develop and implement an effective infection prevention and control program that ensured compliance with nationally recognized infection prevention and control precautions and failed to ensure that staff followed hospital policies and industry standards for maintaining, repairing, disinfecting, and appropriate use of Personal Protective Equipment (PPE).

Failure to develop and implement an effective infection prevention and control program puts patients, staff, and visitors at risk of illness or communicable diseases.

Findings included:

1. The hospital failed to develop and implement an effective infection prevention and control program that ensured compliance with nationally recognized infection prevention and control precautions.

2. Failed to ensure that staff followed National Centers for Disease Control and Prevention (CDC) guidelines standards for Personal Protective Equipment.

3. Failed to develop and implement an effective process to ensure staff were fit tested for N95 Mask use (Item #3).

4. Failed to develop and implement an effective process for maintenance and repair of Controlled Air Purifying Respirator/ Powered Air Purifying Respirators (CAPR/PAPR).

5. Failed to ensure staff utilized safe infection control practices when cleaning or changing filters in CAPR/PAPRs.

6. Failed to ensure that hospital staff performed hand hygiene (HH) according to hospital procedure and accepted standards of practice.

7. Failed to change gloves after they were contaminated during environmental cleaning procedures.

Cross Reference: Tag A 0749

Due to the scope and severity of deficiencies cited under 42 CFR 482.42, the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship Programs was NOT MET.


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VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
.
Based on observation, interview, and document review, the hospital failed to develop and implement an effective infection prevention and control program that ensured compliance with nationally recognized infection prevention and control precautions (Item #1), failed to ensure that staff followed National Centers for Disease Control and Prevention (CDC) Recommendations for Personal Protective Equipment (Item #2), failed to develop and implement an effective process to ensure staff were fit tested for N95 Mask use (Item #3), failed to develop and implement an effective process for maintenance and repair of Controlled Air Purifying Respirator/ Powered Air Purifying Respirators (CAPR/PAPR) (Item #4), failed to follow the manufacturer ' s instruction for use (IFU) for CAPR/PAPR filters (Item #5),failed to maintain CAPR/PAPR in good repair according to the manufacturer ' s IFU (Item #6) failed to ensure staff utilized safe infection control practices when cleaning or changing filters in CAPR/PAPRs (Item #7), failed to ensure that hospital staff performed hand hygiene (HH) according to hospital procedure and accepted standards of practice (Item #8), and failed to change gloves after they were contaminated during environmental cleaning procedures (Item #9).

Failure to develop and implement an effective infection prevention and control program and practices, based on current national guidelines and industry standards, puts patients, staff, and visitors at risk of illness from communicable diseases.

Findings included:

Item #1 Compliance with nationally recognized infection prevention and control precautions.

Reference: Centers for Disease Control and Prevention (CDC), "Summary for Healthcare Facilities: Strategies for Optimizing the Supply of PPE during Shortages," updated 07/15/2020, showed the following strategies for healthcare facilities in the Contingency Capacity:

Decisions to implement contingency status are based upon these assumptions:

-Facilities understand their current N95 respirator inventory and supply chain.

-Facilities understand their N95 respirator utilization rate.

-Facilities are in communication with local healthcare coalitions and federal, state, and local public health partners (e.g., public health emergency preparedness and response staff) to identify additional supplies.

-Facilities have already implemented conventional capacity measures.

-Facilities have provided health care professionals (HCP) with required education and training, including having them demonstrate competency donning and doffing, with any Personal Protective Equipment (PPE) ensemble that is used to perform job responsibilities, such as provision of patient care.

-Facilities electively cancel elective and non-urgent procedures and appointments for which PPE is typically used by HCP.

-Decrease length of hospital stay for medically stable patients with COVID-19.

-Temporarily suspend annual fit testing.

-Use N95 respirators beyond the manufacturer-designated shelf life for training and fit testing.

-Extend the use of N95 respirators by wearing the same N95 for repeated close contact encounters with several different patients.

Additional guidance on extended use:

-Extended use refers to the practice of wearing the same N95 respirator for repeated close contact encounters with several different patients, without removing the respirator between patient encounters.

-Extended use is well suited to situations wherein multiple patients with the same infectious disease diagnosis, whose care requires use of a respirator, are cohorted (e.g., housed on the same hospital unit).

-It can also be considered to be used for care of patients with tuberculosis, varicella, and measles, other infectious diseases where use of an N95 respirator or higher is recommended.

-When practicing extended use of N95 respirators, the maximum recommended extended use period is 8-12 hours.

-Respirators should not be worn for multiple work shifts and should not be reused after extended use.

-N95 respirators should be removed (doffed) and discarded before activities such as meals and restroom breaks.

Washington State Department of Health, "Conservation of Personal Protective Equipment," dated June 8, 2020 showed the following:

-Healthcare facilities and EMS should utilize the Centers for Disease Control and Prevention Strategies to Optimize PPE. DOH recommends that these organizations implement engineering and administrative measures to the greatest extent possible. DOH also recommends that each organization convene a multidisciplinary team to monitor current and future PPE supply-demands and develop its most appropriate PPE usage strategy using the CDC guidelines. Organizations should aim to practice CDC's conventional PPE usage if possible.

1. Document review of the hospital's policy and procedure titled, "Covid-19 Policy," policy number 25, effective 06/20, showed that fitted N95 masks with a face shield can be used up to 5 times among multiple patients and stored in a paper bag when not in use. Fitted N95 masks with goggles may be reused for the same patient and stored in a paper bag.

2. On 08/26/20 at 10:00 AM, the Chief Operating Officer (Staff #501) stated that the hospital was functioning under the "contingency phase" of the CDC guidelines.

3. On 08/28/20 at 1:05 PM, Staff #501 provided Investigators with a document titled "Washington State Department of Health, Conservation Strategies for Personal Protective Equipment," dated 04/23/20. Staff #501stated that the hospital was utilizing PPE conservation guidelines established in the DOH document.

4. On 08/28/20 at 1:05 PM, Staff #501 provided Investigators with a document titled, "COVID-19 Disaster Plan Update," dated 06/18/20. Document review showed that the hospital educated staff to reuse N95 masks until visibly soiled, wet, or damaged, if the mask was protected by a face shield. Staff #501 stated that hospital provided education to staff based on the DOH document dated 04/23/20.

5. At this time, Staff #501 verified that the hospital had not updated its processes for N95 mask conservation per the CDC guidelines as outlined in the DOH document titled "Conservation of Personal Protective Equipment," updated on 06/08/20.

Item #2 Centers for Disease Control and Prevention (CDC) guidelines standards for Personal Protective Equipment

Reference: Centers for Disease Control and Prevention (CDC), "Summary for Healthcare Facilities: Strategies for Optimizing the Supply of PPE during Shortages," updated 07/15/2020, showed the following strategies for healthcare facilities in the Contingency Capacity:

-Temporarily suspend annual fit testing.

-Use N95 respirators beyond the manufacturer-designated shelf life for training and fit testing.

-Extend the use of N95 respirators by wearing the same N95 for repeated close contact encounters with several different patients.

-Extended use refers to the practice of wearing the same N95 respirator for repeated close contact encounters with several different patients, without removing the respirator between patient encounters.

-Extended use is well suited to situations wherein multiple patients with the same infectious disease diagnosis, whose care requires use of a respirator, are cohorted (e.g., housed on the same hospital unit).

-It can also be considered to be used for care of patients with tuberculosis, varicella, measles, and other infectious diseases where use of an N95 respirator or higher is recommended.

-When practicing extended use of N95 respirators, the maximum recommended extended use period is 8-12 hours.

-Respirators should not be worn for multiple work shifts and should not be reused after extended use.

-N95 respirators should be removed (doffed) and discarded before activities such as meals and restroom breaks.

Washington State Department of Health, "Conservation of Personal Protective Equipment," dated June 8, 2020 showed the following:

-Healthcare facilities and EMS should utilize the Centers for Disease Control and Prevention Strategies to Optimize PPE. DOH recommends that these organizations implement engineering and administrative measures to the greatest extent possible. DOH also recommends that each organization convene a multidisciplinary team to monitor current and future PPE supply-demand and develop its most appropriate PPE usage strategy using the CDC guidelines. Organizations should aim to practice CDC's conventional PPE usage if possible.

1. Document review of the hospital's policy and procedure titled, "Covid-19 Policy," policy number 25, effective 06/20, showed the following:

-Fitted N95 masks with a face shield can be used up to 5 times among multiple patients and stored in a paper bag when not in use.

-Fitted N95 masks with goggles may be reused for the same patient and stored in a paper bag. If used for an aerosol generating procedure (AGP) on any patient, discard the N95 after use.

-During a code blue (medical emergency), all patients will be considered COVID-19 carriers. Cardiopulmonary resuscitation and intubation are AGPs.

Document review of the hospitals Covid-19 policy addressing N95 mask use, reuse, and disposal, showed that the policy did not meet current CDC contingency guidelines for PPE utilization.

Document review of the hospital's N95 mask inventory list provided to Investigators on 08/28/20 at 3:00 PM showed that the only N95 masks in stock and available for use included:

-Moldex size medium/large
-3M 1860
-Gersen 1730
-3M 1860 Small
-Alph Protech 695
-3M 8511
-AMMEX N95CMA

2. On 08/26/20 at 12:00 PM, during interview with Investigator #5, a Registered Nurse (RN) (Staff #502) stated that she had 2, previously used, N95 masks in her locker that she had used during a code blue for 2 different patients. She stated that the hospitals policy was to save and reuse the N95 masks and that the used masks were to be stored in a paper bag. Investigator #5 observed the 2 previously used masks and noted a third N95 in the bag. Staff #502 stated that the third mask had not been used and verified that it was co-mingled with the 2 previously used N95 masks.

3. On 08/26/20 at 2:20 PM, Investigator #5 observed a RN (Staff #503) carrying a previously used N95 mask in a biohazard bag in her pocket. During interview with Investigator #5, Staff #503 stated that she had utilized the mask during an APG procedure earlier in the day.

4. On 08/27/20 at 8:40 AM, during interview with Investigator #5, a RN (Staff #504) stated that the N95 mask she was wearing (3M 1870) was a model that the hospital no longer carried. Staff #504 stated that she had not been fit tested for any other type of mask so she had been wearing the same N95 mask for weeks.

5. On 08/27/20 at 9:30 AM, during interview with Investigator #5, a RN (Staff #505) stated that she thought the hospital policy was to save and reuse the N95 masks between patients but that she reuses the same N95 mask for a few shifts and then she disposes of it.

6. On 08/27/20 at 9:50 AM, during interview with Investigator #5, a RN (Staff #506) stated that the hospital's policy was that the staff could reuse the N95 masks for up to 7 days. She stated that she saves her mask for reuse and stores the N95 mask in her locker between uses.

7. On 08/27/20 at 11:00 AM, during interview with Investigator #5, a RN (Staff #509) stated that he was caring for 4 patients, had completed his patient assessments and his morning medication administrations, and was using his second N95 mask for the morning. Staff #509 stated that he changed his N95 mask after 5 uses and that a use was defined as "each time he entered a patient room." Investigator #5 observed that Staff #509 was wearing a 3M 1860 N95 mask.

8. On 08/27/20 at 11:30 AM, Investigator #5 and the Charge Nurse (Staff #510) reviewed the unit inventory sheets, performed a physical count, and observed staff on the unit wearing the same 3M 1860-style N95 masks. Document review of the inventory sheets, observation of the physical mask count, and observation of staff on the unit wearing the same style mask did not support the claim that Staff #509 discarded his N95 mask after 5 uses. Staff #510 verified the finding.

9. On 08/27/20 at 3:48 PM, during interview with Investigator #5, a RN (Staff #507) stated that he wore his N95 mask for a week at a time between multiple patients.

10. On 08/27/20 at 4:01 PM, during interview with Investigator #5, a RN (Staff #508) stated he wore his N95 mask for "about" a week at a time. Staff #508 stated that he had cared for 2 COVID-19 positive patients, but did not know they were COVID-19 positive until after the completion of the procedure. Staff #508 stated that the hospital policy was to reuse the masks and he continued to wear the same N95 mask for the remainder of the week during other patient procedures.

11. On 09/01/20 at 1:30 PM, during interview with Investigator #5, a RN (Staff #511) stated that she was caring for a patient who was suspected to have COVID-19, and that she was awaiting COVID-19 test results for the patient. Investigator #5 observed that Staff #511 was wearing a 3M 1860 mask that appeared large on the staff members face with visible gaps in the seal between the staff member's mask and face. Staff #511 stated that she had been fit tested for the "envelope" style N95 mask, but that the hospital was out of those masks. She stated that she was wearing the 3M 1860, but had not been fit tested for it.

12. Document review of the hospital's N95 fit-test tracking document titled, "N95 Fit Test," dated 08/27/20, showed that Staff #511 had only been fit tested for the 3M 1870 N95, and that she had failed fit testing for the 3M 1860 N95 mask.

13. On 09/01/20 at 2:00 PM, Investigator #5 observed a Physician (Staff #512) wearing an N95 mask model 3M 1870. Staff #512 stated that he changed his mask between patients and that he obtained his mask from a bin located under the nurse station desk. Investigator #5 and Staff #511 reviewed the contents of the bin and observed that there were no 3M 1870 N95 masks in the bin. Staff #512 then stated that he obtained his masks from the Nursing Supervisor between patients.

14. On 09/01/20 at 2:20 PM, during interview with Investigator #5, the Assistant Nurse Manager (Staff #513) stated that the hospital did not have any more 3M 1870 N95 masks in stock and that the masks were not available from the nursing supervisor.

15. On 09/01/20 at 2:30 PM, a Quality Manger (Staff #515) verified that the hospital did not have any 3M 1870 masks available.

Item #3 N95 Mask Fit testing

1. Document review of the hospital's N95 fit-test tracking document titled, "N95 Fit Test," dated 08/27/20, showed that 285 staff were fit tested for only the 3M 1870 N95 mask.

Document review of the hospital's N95 mask inventory list provided to DOH Investigators on 08/28/20 at 3:00 PM showed that the only N95 masks in stock and available for use at the hospital included:

-Moldex size medium/large
-3M 1860
-Gersen 1730
-3M 1860 Small
-Alph Protech 695
-3M 8511
-AMMEX N95CMA

2. On 08/27/20 at 8:40 AM, during interview with Investigator #5, a RN (Staff #504) stated that the N95 mask that she was wearing (3M 1870) was a model that the hospital no longer carried. Staff #504 stated that she had not been fit tested for any other type of mask so she had been wearing the same mask for weeks.

3. Document review of the hospital's N95 fit-test tracking document titled, "N95 Fit Test," dated 08/27/20, showed that Staff #504 had only been fit tested for the 3M 1870 N95.

4. On 08/27/20 at 11:07 AM, Investigator #5 asked a Charge Nurse (Staff #510) how she knew when making staff assignments for COVID-19 positive or COVID-19 rule out patients whether staff had been fit tested and that the corresponding masks were available. Staff #510 stated that staff are responsible to know their mask type and size.

5. On 08/28/20 at 9:30 AM, during interview with Investigator #5, the Chief Operating Officer (Staff #501) stated that the hospital was challenged in their ability to ensure fit testing for staff related to frequent changes in the available models of N95 masks.

6. On 09/01/20 at 1:30 PM, during interview with Investigator #5, a RN (Staff #511) stated that she was caring for a patient who was suspected to have COVID-19 and they were awaiting test results. Investigator #5 observed that Staff #511 was wearing a 3M 1860 mask that appeared large on the staff member's face. Staff #511 stated that she had been fit tested for the "envelope" style N95, but that the hospital was out of those masks. She stated that she was wearing the 3M 1860, but had not been fit tested for it.

7. Document review of the hospital's N95 fit-test tracking document titled, "N95 Fit Test," dated 08/27/20, showed that Staff #511 had only been fit tested for the 3M 1870 N95 and that she had failed fit testing for the 3M 1860 N95 mask.

8. On 09/01/20 at 2:20 PM, Investigator #5 asked the Assistant Nurse Manager (Staff #513) how the charge nurse knew, when making staff assignments for COVID-19 positive or COVID-19 rule out patients, whether staff had been fit tested and that the corresponding masks were available. Staff #513 stated that the staff N95 log for the types and sizes of N95 masks are kept on an Excel spreadsheet. Investigator #5 asked if this information was available to the charge nurses or staff on the units. Staff #513 stated that the spreadsheet was kept in the manager's office.

9. Investigator #5 found no evidence that the hospital had an effective process in place to ensure staff were fit tested for N95 masks and that the corresponding masks were available for use by staff.

Item #4 Maintenance and Repair of Controlled Air Purifying Respirator (CAPR)/ Powered Air Purifying Respirators (PAPR)

Filter Change Monitoring

Reference: MAXAIR Systems CAPR and PAPR manufacturer instruction for use, no date, showed that relative to filter loading in a typical healthcare environment the filter should be replaced every 6 to 12 months. Relative to contamination from blood, bodily fluids, or other harmful means, as well as regards to physical damage, the filter should be inspected before use and replaced appropriately.

Document review of the hospital's checklist titled, "PAPR and CAPR Daily Checklist," showed that the daily checklist must be completed at least once daily, if equipment is broken a work order is to be completed and the equipment is to be placed in a red biohazard bag and a copy of the work order is to be taped to the biohazard bag. The column titled, "Filter expiration date" states that the date is located on a pink sticker; if missing the sticker or date, replace filter and ensure pink sticker is dated 1 year from current date.

1. On 08/27/20 at 4:30 PM, Investigator #5 reviewed a sample of the hospital's CAPR/PAPR checklists. The review showed inconsistent documentation of filter checks including no documentation of filter check/changes including:

Unit 2 SE

a. 08/03/20: 5 of 7 CAPRS documentation had no filter date, 1 of 7 illegible filter date, and 1 of 7 filter dated

b. 08/04/20: 7 of 7 CAPRS had no documentation

c. 08/05/20: 1 of 7 CAPRS no filter date documentation, 6 of 7 check marked as filter date compliant

d. 08/05/20: 7 of 7 CAPRS had no documentation

e. 08/06/20: 1 of 7 had no documentation, 6 of 7 check marked filter date compliant

f. 08/07/20: 5 of 7 documented as no filter dates, 2 of 7 documented filter date compliant

g. 08/07/20: 3 of 8 documented as missing filter dates, 5 of 8 documented filter date compliant

h. 08/08/20: 5 of 7 documented as no filter dates, 2 of 7 documented filter date compliant

i. 08/09/20: 5 of 7 documented as no filter dates, 2 of 7 documented filter date compliant

j. 08/10/20: 5 of 7 documented as no filter dates, 2 of 7 documented filter date compliant

k. 08/10/20: 4 of 7 documented as no filter dates, 3 of 7 documented filter date compliant

l. 08/11/20: 4 of 8 documented as missing filter dates, 4 of 8 documented filter date compliant

m. 08/12/20: 5 of 8 documented as missing filter dates, 3 of 8 documented filter date compliant

o. 08/13/20: 5 of 8 documented as missing filter dates, 3 of 8 documented filter date compliant

p. 08/13/20: 8 of 8 documented filter date compliant

q. 08/14/20: 4 of 8 documented as missing filter dates, 4 of 8 documented filter date compliant

r. 08/15/20: 6 of 9 documented as missing filter dates, 3 of 9 documented filter date compliant

s. 08/16/20: 6 of 8 documented as missing filter dates, 2 of 8 documented filter date compliant

t. 08/17/20: 4 of 6 documented as missing filter dates, 2 of 6 documented filter date compliant

u. 08/17/20: 5 of 7 documented as missing filter dates, 2 of 7 documented filter date compliant

v. 08/17/20: 5 of 7 documented as missing filter dates, 2 of 7 documented filter date compliant

w. 08/18/20: 4 of 7 documented as missing filter dates, 3 of 7 documented filter date compliant

x. 08/18/20: 5 of 8 documented as missing filter dates, 3 of 8 documented filter date compliant

y. 08/18/20: 5 of 7 documented as missing filter dates, 2 of 7 documented filter date compliant

z. 08/19/20: 5 of 7 documented as missing filter dates, 2 of 7 documented filter date compliant

Unit Heart and Vascular Lab

a. 08/14/20: Documentation is blank

b.08/15/20: No checklist provided to investigators

c. 08/16/20: No checklist provided to investigators

d. 08/17/20: Documentation is blank

e. 08/18/20: Documentation is blank

f. 08/19/20: Documentation is blank

g. 08/20/20: Documentation is blank

h. 08/21/20: Documentation is blank

i. 08/22/20: No checklist provided to investigators

j. 8/23/20: No checklist provided to investigators

k. 08/24/20: Documentation is blank

l. 08/25/20: Documentation is blank

m. 08/26/20: Documentation is blank

2. At the time of the finding, the Safety and Accreditation Manager (Staff #515) verified the finding and stated that the hospital had identified a gap in their process.

Item #5 Expired/Undated CAPR/PAPR Filters in Use

Reference: MAXAIR Systems CAPR and PAPR manufacturer instruction for use, no date, showed that relative to filter loading in a typical healthcare environment the filter should be replaced every 6 to 12 months. Relative to contamination from blood, bodily fluids, or other harmful means, as well as regards to physical damage, the filter should be inspected before use and replaced appropriately.

1. On 08/26/20 at 11:15 AM Investigator #5 observed 1 of 2 CAPR/PAPRs checked with incomplete filter dating. Investigator #5 was unable to determine the date of the filter change.

2. At the time of the finding, a Biomed Technician (Staff #516) verified the finding.

3. On 08/26/20 at 2:40 PM, Investigator #5 observed 1 of 2 CAPR/PAPRs checked with expired filter dating. The filter was dated 04/19/18.

4. At the time of the finding, a Registered Nurse (Staff #503) verified the finding.

5. On 08/27/20 at 11:00 AM, Investigator #5 observed 1 of 1 CAPR/PAPRs checked with an incomplete date. Investigator #5 was unable to determine the date of the filter change.

6. At the time of the finding, a Unit Secretary (Staff #518) verified the finding.

7. On 08/27/20 at 3:15 PM, Investigator #5 observed 4 of 4 CAPR/PAPRs checked with undated filters.

8. At the time of the observation, the Safety and Accreditation Manager (Staff #515) verified the finding.

Item #6 Broken Equipment Repair

1. Document review of the MAXAIRCAPR HELMETS instructions for use, no date showed the following:

-DO NOT use if any component is damaged. If any components are damaged or contaminated and therefore unfit for safe and effective use, they should be replaced immediately

Document review of the hospital's checklist titled, "PAPR and CAPR Daily Checklist," showed that the daily checklist must be completed at least once daily, if equipment is broken a work order is to be completed and the equipment is to be placed in a red biohazard bag and a copy of the work order is to be taped to the biohazard bag.

2. On 08/26/20 at 11:20 AM, during an interview with Investigator #5, the Director of Biomed (Staff #517) stated that the Biomed department receives CAPR/PAPRs with clear tape applied by staff. Staff #517 stated that the CAPR/PAPRs are returned for use if it does not appear that the CAPR/PAPR is compromised.

3. On 08/26/20 at 11:45, a RN (Staff #519) stated that sometimes the CAPR/PAPRs are repaired with tape.

4. On 08/27/20 at 12:15 PM, during interview with Investigator #5, a Charge Nurse (Staff #510) stated that she has received CAPR/PAPRs that have been returned for use with clear tape applied over cracks in the CAPR/PAPR helmets.

Item #7 Infection Control Practices

Reference: MAXAIR Systems CAPR and PAPR manufacturer instructions for use, no date, showed the following:

-Always wear body protection appropriate to the exposure the MAXAIR Systems have been subjected to when cleaning and decontaminating the MAXAR System.

-Use Quaternary Ammonia, Bleach, or Alcohol based wipes for decontamination.

1. Document review of the hospital's checklists titled, "PAPR and CAPR Daily Checklist," showed that the daily checklist must be completed at least once daily, if equipment is broken a work order is to be completed and the equipment is to be placed in a red biohazard bag and a copy of the work order is to be taped to the biohazard bag.

2. On 08/26/20 at 11:00 AM, during interview with Investigator #5, a BioMed Technician (Staff #516) verified that staff send CAPR/PAPRs to the BioMed department for repair in red biohazard bags. Staff #516 stated that there was a station with a rolling cart just outside the department door where Biomed staff clean equipment. Investigator #5 found no evidence of a cleaning station located outside the Biomed department entrance.

3. Staff #516 obtained a container of "gray top" wipes from under his desk. Staff #506 was unable to identify the dwell time for the "gray top" wipes. Investigator #5 and Staff #516 reviewed the manufacturer instructions noting the dwell time for the quaternary ammonia product to be 3 minutes.

4. On 08/26/20 at 11:10 AM, during interview with Investigator #5, the Director of BioMed Services (Staff #517) stated that the BioMed staff did not receive formal education on infection control or equipment disinfection.

5. On 08/27/20 at 11:10 AM, Investigator #5 observed a Unit Secretary (Staff #518) changing a helmet filter in a CAPR/PAPR on a chair at the nurses station. Staff #518 was not wearing PPE.

6. At this time, during interview with Investigator #5, Staff #518 verified the CAPR/PAPR had been utilized for patient care with COVID-19 positive patients and stated that she did not know what the policy was for PPE usage when changing out the CAPR/PAPR filters.

7. On 08/27/20 at 11:15 AM, the Safety and Accreditation Manager (Staff #515) stated that the staff should be utilizing PPE to change the filters.

8. On 08/27/20 at 3:30 PM, during the employee file review for Staff #517 and Staff #516, Investigator #5 and Investigator #6 found no evidence the Biomed staff received current infection control education.

9. On 08/28/20 at 11:30 AM, Staff #515 told the investigators that Staff #516 and Staff #517 had not completed the 2020 Infection Control Training annual update, which is assigned to staff each January and required to be completed by March.

Item #8 Hand Hygiene

1. Document review of the hospital's employee training manual titled, "Annual Update Infection Prevention (2020)" showed that hospital staff are to rub hands thoroughly until dry when sanitizing hands using a waterless alcohol-based solution.

2. On 09/01/20, between 6:30 PM and 9:40 PM, Investigator #6, Investigator #7, and the Environmental Services (EVS) Director (Staff #604) observed the terminal cleaning of Operating Room (OR) #4 by an EVS Technician (Staff #605). The observation showed that in 4 of 4 hand hygiene observations, Staff #605 waved his hands after using an alcohol-based hand sanitizer without rubbing his hands thoroughly until dry.

3. At 9:30 PM, Investigator #6 interviewed Staff #605 about the hospital's expectations for hand-hygiene. Staff #605 stated that it was difficult to don gloves after using the hand sanitizer.

Item #9 Glove Change

1. Document review of the hospital ' s policy titled, " Standard Precautions Policy, 939.50 " PolicyStat ID: 87, reviewed 12/18, showed that staff are to change gloves when soiled.

2. On 09/01/20, between 6:30 PM and 9:40 PM, Investigator #6, Investigator #7, and the Environmental Services (EVS) Director (Staff #604) observed the terminal cleaning of Operating Room (OR) #4 by an EVS Technician (Staff #605). The observation showed that Staff #605 picked up debris from the floor with gloved hands and continued cleaning without performing hand-hygiene or donning clean gloves 3 times.

3. At 9:30 PM, Investigator #6 interviewed Staff #605 about the hospital's expectations for glove use. Staff #605 stated that he should have removed his gloves after contact with the floor, performed hand hygiene, and donned clean gloves.
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