HospitalInspections.org

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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, record review, and review of the hospital's quality documents showed the following:

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

Cross Reference: A-0283

2. Failure to systematically collect, aggregate, and analyze data regarding medication errors and adverse patient events.

Cross Reference: A-0286

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 including infection control and pharmacy.

Cross Reference: A-0308

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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Based on interview and review of quality documents, the hospital failed to develop action plans when performance goals were not being met.

Failure to take actions aimed at performance improvement and failure to develop action plans when goals are not met puts patients at risk of harm from inadequate and inappropriate treatment.

Findings included:

1. Document review of the hospital's policy titled, "Trios Health Quality Improvement and Patient Safety Plan 2019," approved 03/27/19 showed that the hospital's approach to performance improvement is continuously assessed and revised to meet the goal of ensuring that patient outcomes are continually improved and safe care is provided. When opportunities for improving performance are identified, a proactive approach is used to redesign the involved process, or to design a new process. Quality measures that fall below the established threshold for 3 consecutive months (or 90 days) will require a Plan-Do-Study-Act (PDSA) with follow up until again reaching threshold.

2. On 05/21/20 at 1:15 PM, Investigator #5, Investigator #2, a Quality Consultant (Staff #505), a Quality Programs Specialist (Staff #517), and a Risk Manager (Staff #518) reviewed the hospitals Quality Program and Quality documents from 03/2019 through 03/2020. Investigator #5 found no evidence the hospital developed or implemented quality improvement action plans for 2 of 3 indicators reviewed when the hospital consistently failed to meet its goals.

3. At the time of the review, Staff #505 and Staff #518 verified the finding and stated that the minutes did not reflect actions taken by the hospital.
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Based on interview and review of the hospital's quality improvement program and performance data, the hospital failed to ensure that data related to medication errors and adverse events were aggregated and analyzed for patterns, trends, and common factors through the hospital's quality program.

Failure to systematically collect, aggregate, and analyze data regarding medication errors and adverse patient events limits the hospital's ability to develop action plans to prevent medical errors and patient injuries.

Findings included:

1. Document review of the hospital's policy titled, "Trios Health Quality Improvement and Patient Safety Plan 2019," approved 03/27/19 showed that the hospital's approach to performance improvement is continuously assessed and revised to meet the goal of ensuring that patient outcomes are continually improved and safe care is provided. The hospital recognizes that there must be an integrated and coordinated approach to reducing errors and hazardous conditions. Examples of information utilized to achieve this goal included: variance related data such as medication errors and falls, infections control surveillance, sentinel event alerts, quality measure data, and patient satisfaction reports. Quarterly Quality Department reports included occurrence reports, patient satisfaction, sentinel event/serious safety event, precursor and near miss, infection control surveillance data, medication errors, corporate quality indicators and departmental performance improvement reports.

Document review of the hospital's policy titled, "Unusual Occurrence Incident Report Policy," policy number KGH002776, revised 06/19, showed that trend reports related to unusual occurrences will be provided routinely to the Quality Committee. Performance improvement will be identified through review of the trends and response to identified trends will be assigned to appropriate teams to address.

Document review of the hospital's policy titled, "Sentinel Events, Reports of Adverse Events, and Mandatory Reporting to CMS," policy number KGH002606, revised 03/16, showed that a summary of sentinel events the root cause identified, and the improvement plans will be reported to the Quality Council, Quality Management Committee, and other committees as appropriate.

2. On 05/21/20 at 1:15 PM, Investigator #5, Investigator #3, a Quality Consultant (Staff #505), a Quality Programs Specialist (Staff #517), and a Risk Manager (Staff #518) reviewed the hospitals Quality Program and Quality documents from 03/2019 through 03/2020. Investigator #5 found no evidence that medication errors, incident reports, or adverse events data were aggregated and analyzed for patterns, trends, and common factors through the hospital's quality program.

3. On 05/21/20 at 12:10 PM, the hospital's Risk Manager (Staff #517) stated that the incident reports and adverse event data were not aggregated, analyzed for trends, or reviewed as part of the hospital's quality program.

4. On 05/21/20 at 2:00 PM, Staff #518 stated that Pharmacy did not report up through the Quality Program.
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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, and included all hospital departments and services including infection control and pharmacy.

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 policy titled, "Trios Health Quality Improvement and Patient Safety Plan 2019," approved 03/27/19, showed that the hospital's approach to performance improvement is continuously assessed and revised to meet the goal of ensuring that patient outcomes are continually improved and safe care is provided. The hospital recognizes that there must be an integrated and coordinated approach to reducing errors and hazardous conditions. Examples of information utilized to achieve this goal included: variance related data such as medication errors and falls, infections control surveillance, sentinel event alerts, quality measure data, and patient satisfaction reports. Safety goals included monitoring of hospital-wide indicators in comparison to their thresholds and achievement of a patient safety conscious environment integrated throughout the facility.

2. On 05/21/20 at 1:15 PM, Investigator #5, Investigator #2, a Quality Consultant (Staff #505), a Quality Programs Specialist (Staff #517), and a Risk Manager (Staff #518) reviewed the hospitals Quality Program and Quality documents from 03/2019 through 03/2020. Investigator #5 found no evidence that the hospital's Infection Control Committee was integrated into the hospital's Quality Program.

3. At the time of the observation, a Quality Consultant (Staff #505) verified the finding and stated that the hospital had recently hired an Infection Preventionist and the plan for 2020 was to revitalize the hospital's Infection Control Program.

4. On 05/21/20 at 2:00 PM, Staff #518 stated that Pharmacy did not report up through the Quality Program.
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Based on observation, interview, and document review, the hospital failed to develop and implement an effective infection prevention and control program.

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

Findings included:

1. The hospital failed to ensure the infection control program documented infection prevention, surveillance, and control activities.

Cross Reference: Tag A0773

2. The hospital failed to ensure that the infection control program collaborated with the Quality Assurance and Performance Improvement program on infection control issues and activities.

Cross Reference: Tag A0774

3. The hospital failed to ensure that staff followed COVID-19 symptom screening processes when reporting to their assigned shifts.

Cross Reference: Tag A0749

4. The hospital failed to ensure that staff were fit tested and utilized appropriate airborne isolation precautions for staff working with COVID-19 positive or suspect patients.

Cross Reference: Tag A0749

5. The hospital failed to ensure that staff leaving COVID-19 positive or suspect patient rooms removed personal protective equipment properly.

Cross Reference: Tag A0749

6. The hospital failed to ensure staff properly reprocessed flexible endoscopes

Cross Reference: Tag A0749

7. The hospital failed to prevent cross contamination by ensuring clean and dirty items are properly stored.

Cross Reference: Tag A0749

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

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Based on observation, interview, and document review, the hospital failed to ensure staff followed procedures for screening at the beginning of their shift for fever and signs/symptoms of illness as directed by hospital policy for 4 of 11 staff reviewed (Staff #501, #502, #503, and #504) (Item #1), failed to ensure that staff were fit tested and utilized appropriate airborne isolation equipment for 2 of 5 staff reviewed (Staff #509 and Staff #511) (Item #2), failed to ensure that staff were performing air seal checks prior to using airborne isolation equipment for 1 of 3 staff interviewed (Staff #512) (Item #3), failed to ensure staff properly performed the leak test when reprocessing a flexible endoscope (Item #4), failed to ensure staff properly stored items to prevent cross contamination between clean and dirty equipment (Item #5), and failed to ensure staff doffed personal protective equipment according to hospital policy for 2 of 4 observations (Staff #513 and #515).

Failure to comply with policies and procedures to prevent transmission of infections puts patients, staff, and visitors at risk from communicable illnesses.

Findings included:

Item #1 Screening

1. Document review of the hospital's policy titled, "COVID-19 Staff & Provider Screening," no policy number, dated 04/20, showed that staff and providers are to take their temperature and answer the screening questions and record the information on the login sheet prior to the start of their shift. If staff has a temperature greater than 100 degrees or staff check the box for either of the other symptoms they are to immediately put on an ear-loop mask, wipe down the thermometer, and notify their supervisor for further directions.

2. On 05/20/20 at 9:20 AM, Investigator #5, a Quality Consultant (Staff #505) and the Operating Room Manager (Staff #506) reviewed the staff Covid-19 Screening Login Sheets. Investigator #5 observed that a Registered Nurse (Staff #501) on duty at the time of the observation had not documented the required screening.

3. At the time of the observation, Staff #505 and #506 confirmed the finding and stated that the RN should have documented the screening.

4. On 05/20/20 at 10:10 AM, Investigator #5, a Quality Consultant (Staff #505) and the Operating Room Manager (Staff #506) reviewed the staff Covid-19 Screening Login Sheets. Investigator #5 observed that 3 of 3 Physicians on duty in the Operating room (Staff #502, #503, and #504) had not documented the required screening.

At the time of the observation, Staff #505 stated that the Physicians could have completed their screening at the Emergency Room Entrance or at the 4th Floor Clinic Entrance.

5. On 05/20/20 at 10:23 AM until 10:40 AM, Investigator #5, a Quality Consultant (Staff #505) and the Infection Preventionist (Staff #507) reviewed the documents and hospital procedures for Covid-19 screening at the Emergency Room entrance, Medical Office Care Center entrance, and in the 4th Floor Clinic. At the time of the review, Staff #505 verified that Staff #502, #503, and #504 did not document Covid-19 screening at the Emergency Room entrance, Medical Office Care Center entrance, or in the provider's Clinic. Staff #505 stated the hospital had no other entrances for staff or Physicians. Staff #507 stated that the Clinic was closed on Wednesday's and the Provider should have completed the daily screening in the Operating Room.

Item #2 Fit Testing

1. Document review of the hospital's policy and procedure titled, "Respiratory Protection Plan," policy number KGH003622, reviewed 04/15, showed that:

a. Respirators are selected for use in specific applications based upon design and performance criteria and the nature of the operation in question. They should not be used for applications that have not been evaluated or for operations not intended when initially selected.

b. The process for obtaining a respirator consists of determination of proper respirator, medical evaluation of each user, training of each user, fit testing of each user on the specific models of respirator to be used, issuance of the respirators, instructions on the proper size to be used which occurs after fit testing and medical evaluation, and further evaluation and training annually in accordance with Washington State Hospital Association (WSHA) standards.

c. Fit testing will be performed annually or in accordance with WSHA and Occupational Safety and Health Administration (OSHA) guidelines. The employee will be assigned respirators for which he/she have been successfully fit tested.

d. Employees using respirators will be provided with the necessary training and education regarding proper use, storage, inspection, and cleaning of the respirator.

e. Records of fit testing will be kept in the Employee health file and contain identification of the employee tested, the type of test performed, the make, model and size of the respirator, the date of the fit test, pass/fail results of the qualitative test performed or other record of quantitative fit testing performed.

f. The Program Administrator is responsible to arrange for the necessary medical surveillance, clearance, and fit testing for pertinent employees and to ensure periodic program evaluation is completed to ensure the respiratory protection program is being implemented for all employees. Program effectiveness is determined in part by determination of proper use, maintenance, and storage of respirators, and that disposable N95 filtered masks are not reused.

g. Supervisors are responsible to ensure that employees have received appropriate testing, medical evaluations, and fit testing for the proper respirator worn.

2. On 05/02/20 at 2:25 PM, Investigator #5, the Interim Director of Women's and Children's Hospital (Staff #508), a Quality Consultant (Staff #505), and a Registered Nurse (Staff #509) inspected a bin containing Respiratory Protection equipment located at the Women's and Children's Hospital. Investigator #5 observed one box of size large "Duck Bill" respirators (a type/style of N95 Particulate Respirator Masks) and one box of size medium "Duck Bill" respirators.

3. Investigator #5 asked Staff #509 if Staff were Fit Tested for the "Duck Bill" Respirators. Staff #509 stated that the "Duck Bill" respirators were to be used if the other N95 masks were not available. When asked if Staff #509 or Staff #511 had been fit tested she stated that the staff were not Fit Tested, but that if any employee had questions around the fit of the mask they would call Infection Control (IC) and IC would come to the hospital and fit test.

4. At this same time, Staff #505 stated that she was unaware of Fit Testing for the "Duck Bill" respirators at the Women's and Children's Hospital.

5. On 05/21/20 at 10:00 AM, Investigator # 2 reviewed personnel files with a human resources coordinator (Staff #204). Record review of fit testing records showed the following:

a. A Registered Nurse (RN) (Staff #511)was fitted for a 3M 1860 respirator (a standard mask model different from the duck bill masks) on 02/27/18. No other fit testing documentation was available at the time of review.

b. A RN (Staff #509) was fitted for a 3M 1860 respirator on 02/26/19. No other fit testing documentation was available at the time of review.

Item #3 Safety Seal Checks

1. Document review of the hospital's policy and procedure titled, "Respiratory Protection Plan," policy number KGH003622, reviewed 04/15, showed that Respiratory Protection Guidelines will cover procedures for inspecting, donning, and removing checking the fit/seal and actual wearing of the type of respirator to be chosen according to airborne hazards and proper cleaning, storage, and maintenance of the respirator.

2. On 05/20/20 at 2:00PM, during inspection of the Women's and Children's Hospital, Investigator #5 asked a Registered Nurse (Staff #512) to explain and demonstrate how to perform a "Seal Check" after donning an N95 mask. Staff #512 was unable to explain or demonstrate how to perform a "Seal Check."

3. At the time of the observation, Staff #509 confirmed the finding and stated that fit testing was performed annually.
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Item #4 Endoscope Reprocessing

1. Record review of the policy and procedure titled, "Endoscope Processing and Storage," policy number KGH003794, dated 03/14, showed that staff should follow Olympus reprocessing guidelines for reprocessing endoscopes.

Record review of the manufacturer's instructions for use from Olympus titled, "Endoscope Cleaning Guide," showed that staff should angulate the tip of the endoscope while performing the leak test.

2. On 05/20/20 at 9:30 AM, Investigator #2 observed an Endoscopy Technician (Staff #201) performing a reprocessing procedure of an endoscope. During the procedure, Staff #201 performed the leak test but did not angulate the tip of the endoscope.

3. Following the procedure, Investigator #2 interviewed the Endoscopy Supervisor (Staff #202) about the leak test process. Staff #202 stated that staff are required to perform the tip angulation when conducting a leak test.

Item #5 Storage of Items in Soiled Utility

1. Record review of the policy titled, "Medical Gas Storage," policy number KGH003893, revised 08/19, did not show where unopened gas canisters were required to be stored.

Record review of the policy titled, Policy for Hazardous Materials & Waste Inventory," policy number EC.02.02.01EP1, reviewed 08/19, did not show how hazardous waste and clean items should be separated during storage.

2. On 05/20/20 at 1:45 PM, Investigator #2 inspected a soiled utility room in the Special Care Unit of the Labor and Delivery Department. The observation showed the following items stored in the soiled utility room:

a. Holiday decorations in a storage tote resting on the counter of the utility room.

b. a space heater stored on the ground in the room.

c. full oxygen cylinders

3. At the time of the observation, the Quality Analyst (Staff #203) escorting the investigator confirmed the observations of clean items stored in the soiled utility room.

4. On 05/21/20 at 4:30 PM, Investigator #2 requested policies on equipment storage from a quality consultant (Staff #210). Staff #210 brought the aforementioned policies regarding equipment storage.

Item #6 - Doffing of Personal Protective Equipment

1. Record review of the hospital document titled, "Sequence for Removing PPE for reusable Face Shield/Goggles," no policy number, no date, showed that staff are to wash their hands after removing their gown, prior to removing their reusable face mask or goggles.

Record review of the document titled, "Special Droplet/Contact Precautions," revised 03/03/20, showed that staff are to wash or sanitize hands after removing gowns and prior to removing face coverings.

2. On 05/21/20 at 9:00 AM, Investigator #5, a Quality Specialist (Staff #514), and the Director of 2N and 3N Departments (Staff #516) observed a Nursing Assistant (Staff #513) doff personal protective equipment (PPE). Investigator #5 observed that Staff #513 failed to wash her hands after removing her gown prior to removing her mask and eye cover.

3. At the time of the observation, Stff #513 verified the observation and stated that the staff member should have washed her hands.

4. On 05/21/20 at 9:25 AM, Investigator #5 and the Director of 2N and 3N Departments (Staff #516) observed a Registered Nurse (Staff #515) leaving a COVID 19 isolation room. The room had no window to observe doffing. Investigator #5 asked Staff #515 to explain how to doff PPE. Staff #515 was unable to explain or demonstrate the appropriate sequence for doffing PPE.

5. At the time of the finding, Investigator #5 observed that the hospital's signage posted contained conflicting instructions for removing PPE. The signage developed by the hospital failed to instruct staff to wash hands after doffing the gown prior to removing mask/eye covers. Staff #516 verified the discrepancy and stated that the hospital document should have instructed staff to wash their hands after doffing their gloves and gown.
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Based on record review and interview, the hospital failed to ensure that the infection control committee maintained documentation of infection surveillance, prevention, and control activities.

Failure to maintain records of infection surveillance, prevention, and control activities risks delays in implementation of infection control activities designed to prevent infections and risks infection of patients and staff.

Findings included:

1. Record review of the document titled, "Infection Prevention & Control Plan 2020," policy number KGH003752, revised 02/20, showed that the Infection Control Committee monitors and analyzes incidents, causes, and trends of infection. The infection Control Committee reports findings and recommendations via the Quality Assurance and Performance Improvement (QAPI) Committee. The plan did not indicate the frequency of Infection Control Committee meetings nor requirements for documentation of the committee's meetings or activities.

Record review of the infection control meeting minutes from 03/04/19 showed five goals and action plans that the infection control program would undertake. No minutes for infection control meetings were available until meetings held on 03/20/20 and 05/15/20, a period of over 1 year. The meeting minutes for 03/20/20 and 05/15/20 did not include any updates on control activities except for routine surveillance and the hospital's response to the COVID-19 pandemic.

2. On 05/21/20 at 2:15 PM, Investigator #2 and #5 conducted a QAPI meeting to discuss the hospital's quality program and how the infection control program interacted with the committee. During the interview, a Quality Consultant (Staff #207) stated that there was no onsite Infection preventionist from 08/19 to 02/20. Staff #207 stated that the committee did not have minutes for meetings held from 03/19 to 03/20. Staff #207 stated that another hospital within the system provided consultation while the hospital was searching for a new infection preventionist. No documentation of any meetings with the consultant were provided.

3. On 05/22/20 at 10:35 AM, a Quality Registered Nurse (RN) (Staff #208) provided power point presentations for infection control meetings held on 05/21/19 and 08/20/19. The presentations listed the discussion topics for the meetings, including infection rates and other data, but did not contain any documentation of members present, approval of consent agenda items listed, or any actions the committee took for items that required process improvement activities.
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Based on record review and interview, the hospital failed to ensure that the infection control committee collaborated with the hospital's Quality Program (QAPI) on infection control issues and activities.

Failure to collaborate with the QAPI program on infection control issues and activities risks delays in implementation of infection control activities designed to prevent infections and risks infection of patients and staff.

Findings included:

1. Record review of the document titled, "Infection Prevention & Control Plan 2020," policy number KGH003752, revised 02/20, showed that the Infection Control Committee monitors and analyzes incidents, causes, and trends of infection. The infection Control Committee reports findings and recommendations via the Quality Assurance and Performance Improvement (QAPI) Committee. The plan did not indicate the frequency of reporting to the QAPI Committee.

2. On 05/21/20 at 2:15 PM, Investigator #2 and #5 conducted a QAPI meeting to discuss the hospital's quality program and how the infection control program interacted with the committee. During the interview, a Quality Consultant (Staff #207) stated that there was no onsite Infection preventionist from 08/19 to 02/20. Staff #207 stated that the committee did not have minutes for meetings held from 03/19 to 03/20.

During the meeting, a Quality RN (Staff #208) stated that the previous infection preventionist had issues with documentation of infection control activities.

3. On 05/22/20 at 10:35 AM, a Quality Registered Nurse (RN) (Staff #208) provided power point presentations for infection control meetings held on 05/21/19 and 08/20/19. Record review of the presentation from 08/20/19 showed that the infection control committee had identified gaps in the Bloodborne Pathogen Program, including no processes for tracking, comparing, and reporting exposure rates, no demonstration in reduction of incidences, missing elements to the bloodborne pathogen policy, and six to seven exposures that year. The presentation also listed numerous future work groups and improvement projects to address bloodborne pathogen exposures.

No other documentation regarding performance improvement projects related to bloodborne pathogen exposure was provided.

4. On 05/22/20 at 11:00 AM, Investigator #2 interviewed the Quality RN (Staff #208) and the interim occupational health nurse (Staff #209) regarding occupational health and staff exposures at the hospital and any performance improvement projects that were being handled through the QAPI program. Staff #209 stated that the department head and employee health evaluate issues relating to staff exposures. Staff #208 stated that the QAPI committee was not tracking any performance improvement plans with regard to occupational health and staff exposure and that infection control or employee health had not brought the aforementioned projects to the QAPI Committee.
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