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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,

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. Failure to ensure that staff wore proper Personal Protective Equipment (PPE) when entering isolation rooms.

Cross Reference: Tag A 0749

2. Failure to include surveillance, prevention, and control of healthcare associated infections (HAI) issues identified by public health authorities in the hospitals Risk Evaluation and Infection Control Plan.

3. Failure to develop and maintain effective infection control and sanitization practices for reprocessing shared patient medical equipment (respirator exhalation valves).

4. Failure to prevent cross contamination during use of portable medical equipment from patients in contact isolation.

5. Failure to provide a handwashing station in the soiled utility room used for high-level disinfection (HLD) of shared patient care equipment (ventilator exhalation valves).

6. Failure to ensure Environmental Services (EVS) staff had knowledge of the contact time (time required to effectively reduce the amount of pathogens) for disinfectant chemicals used in patient care areas.

7. Failure to ensure that staff members properly utilized cleaning chemicals when performed housekeeping functions.

8. Failure to ensure that proper backflow prevention was established for dialysis equipment.

9. Failure to develop and implement an effective infection prevention and control program that ensured compliance with nationally recognized infection and control precautions regarding tuberculosis (TB) screening and Hepatitis B (Hep B) (part of Blood Borne Pathogens required training).

Cross Reference: Tag A 0750

10. Failure to ensure that an effect process was in place to notify Providers and Staff of critical value results for patients with Multi-Drug Resistant Organisms (MDRO's).

11. Failure to ensure staff followed its policies and procedures for tracheostomy dressing changes.

Cross Reference: Tag A 0776

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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Based on interview, document review, review of the hospital's quality and performance improvement program, and review of Governing Body documents, the Governing Body failed to ensure that the hospital had an effective system in place to evaluate, and ensure that contracted patient care services were provided to patients in a safe and effective manner for 2 of 4 contracts reviewed.

Failure to develop a coordinated process to oversee the performance of all patient care services and departments risks provision of improper or inadequate care and adverse patient outcomes.

Findings included:

1. Document review of the hospital's policy titled, "Contracts," policy number 15.0, no date, showed that contracts will be properly executed and maintained for all Clinical, Non-Clinical, and Physicians Service Providers. The Chief Executive Officer shall ensure that all contracts are reviewed annually by the hospital Board of Directors. The review will include the following:

a. Review of the contract terms and appropriate supporting documentation.

b. Review of the liability insurance requirements, including proof of insurance.

c. Ensure necessary clauses are included in contracts.

d. Fees are appropriate based on market conditions.

e. Determination on quality of services received.

f. Determination of continuation of services.

2. On 05/06/21, Investigator #5 reviewed the hospital's document titled, "2020 Contract Services Tracking and Reporting Tool." Instructions on the document stated that the Responsible Party is the individual responsible for obtaining the data from the vendor and placing it into the tool. They are also responsible for making sure any recommendations from the facility are communicated to the vendor. The Responsible Party is to put the vendor correct name in and enter the agreed upon indicators/monitors. These expectations should be agreed upon as part of the contract and they will be utilized in the annual evaluation of the contracted vendors.

The document showed quality data and analysis from January 2020 through December 2020 and listed 36 contracted services with quality data and indicators being collected, input, and reviewed on a monthly basis.

Investigator #5 observed that 25 of the 36 contracts were missing data for 5 months or more, 3 contracts had no quality indicators identified, and 11 of the 25 contracts missing data contained what appeared to be canned text in the columns identified as "Findings/Analysis" and "Recommendations, Actions, and Follow Up" despite the missing data entry, and 2 of the 4 contracts reviewed were not on the list.

3. On 05/06/21 at 3:00 PM, Investigator #5 asked the Director of Quality (Staff #501) how contract review could be accomplished per documentation in the Quality and Governing Body Minutes, when so much quality indicator data, analysis and Follow up was missing. Staff #501 verified the finding and stated that the hospital had identified gaps in the contract review process.

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Based on interview and document review, the hospital failed to identify and maintain a list of all contracted patient care services.

Failure to identify and track all contracted patient care services limited the hospitals ability to ensure that those services were evaluated for safe, effective quality care.

Findings included:

1. Document review of the hospital's policy titled, "Contracts," policy number 15.0, no date, showed that contracts will be properly executed and maintained for all Clinical, Non-Clinical, and Physicians Service Providers. All clinical contract agreements will be documented on the contract listing form (link provided within the contract).

Document review of the hospitals plan titled, "Organizational Plan for the Delivery of Patient Care, Treatment, and Services: 2021 Seattle Market Plan for the Provision of Patient Care," dated 2020, showed that all services essential in providing quality patient care, treatment, and services are provided to patients either directly by the hospital or through referral, consultation or through contract with providers that can supply quality services. Essential services provided on a regular basis, which are performed outside the organization or performed by another source, are approved by the Medical Staff and the organization (Kindred Hospital) has written agreements to ensure the source(s) meet applicable accreditation standards.

2. On 05/04/21 at 11:30 AM, during inspection of the hospital's Respiratory Therapy clean and dirty rooms, Staff #508 stated that the hospital contracted with Virginia Mason Hospital to provide sterilization of the reusable ventilator equipment. Investigator #5 requested the contract and contract review for Virginia Mason Hospital related to sterilization of reusable patient care equipment.

3. On 05/05/21 at 10:15 AM, the Director of Quality (Staff #501) verified that the hospital did not have a contract with Virginia Mason to provide sterilization for the reusable respiratory equipment and the hospital did not have a process in place to ensure quality of the services provided. He stated that effective immediately, the hospital was changing to single use ventilator exhalation valves and that the hospital had secured enough supply to last 2 months while the hospital evaluated its processes.

4. On 05/06/21 at 3:15 PM, during review of the employee record for a Registered Nurse (Staff #510), the Chief Clinical Officer (Staff #512) stated that Staff #510 was a contracted travel nurse who owned his own Staffing Agency that also provided additional Registered Nurse to work for the hospital under a contracted service arrangement. She stated that Staff #510 had worked at the facility for 10 years. Investigator #5 requested the agencies contract and contract review.

On 05/06/21, Investigator #5 reviewed the hospital's document titled, "2020 Contract Services Tracking and Reporting Tool." Instructions printed on the document showed that the Responsible Party was to complete the template including information for every clinical and non-clinical service. The document did not include any identification of contracts for Virginia Mason Hospital (equipment sterilization services), or for Westfield Nursing Agency (Travel Nurse Agency), or a contract for Registered Nurse Traveler (Staff #510).

5. On 05/07/21 at 12:00 PM, the Quality Director (Staff #501) provided Investigator with a copy of a contract titled, "Westfield Nursing Agency, LLC: Staffing Agreement: Traveler Position: (and listed the Name of a Registered Nurse)." Staff #501 stated that this contract was the staff agency owned by the Registered Nurse (Staff #510) whose employee file was reviewed the previous day but was for a different traveler supplied by the agency. The hospital failed to provide the Investigator with a contract for the Staffing Agency or for Staff #510. Staff #501 verified that a contract was for Westfield Nursing Agency was not listed in the list of hospital contracted services and had not been reviewed.
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Based on observation, interview, and document review, the hospital failed to ensure that staff wore proper Personal Protective Equipment (PPE) when entering isolation rooms.

Failure to wear proper PPE places patients and staff at risk of exposure to or infection from pathogens.

Findings included:

1. Document review of the hospital's document titled "Face Shield to be Worn with a Mask", no number, last updated 11/12/20, showed that each staff will be provided a face shield and that the face shield should be worn while working.

Document review of the hospital's Washington State Hospital Association Contact Precaution Signage titled, "Contact Precautions," dated 05/19, showed that staff must gown and glove at the door.

2. On 05/04/21 at 9:28 AM, Investigator #7 and the Director of Clinical Nursing Services (Staff #703) inspected the hospital's 4th floor. Investigator #7 observed an Environmental Specialist (EVS) (Staff #706) cleaning room #414 with no face shield or eye protection.

3. At the time of the observation, Staff #703 verified that it was the hospital's policy for all staff to wear eye protection when working.

4. On 05/04/21 at 9:30 AM, Investigator #5 observed a Certified Nursing Assistant (CNA) (Staff #507) providing patient care to a patient, (Patient #505), in contact isolation, staff was not wearing eye protection.

5. At the time of the observation, the Director of Infection Control (Staff #502) stated that it was hospital policy for all staff to wear protective eyewear while in patient rooms related to COVID.

6. On 05/05/21, at 8:30 AM, Investigator #5 observed a Respiratory Technician (Staff #504) and a Respiratory Technician Student (Staff #505) providing direct care to a ventilated patient in contact isolation in the hospital's Intensive Care Unit (ICU) (Patient #503). Investigator #5 observed that the staff were not wearing protective eyewear.

7. At the time of the observation, during interview with Investigator #5, Staff #504 and Staff #505 stated that they did not know they should be wearing eyewear.

8. At the time of the observation, the Director of Infection Control (Staff #502) stated that it was hospital policy for all staff to wear protective eyewear while in patient rooms and that the hospital had provided education to all staff related to the use of protective eyewear during COVID.

9. On 05/05/21 at 8:52 AM, Investigator #5 and the Director of Infection Control (Staff #502) observed a Radiology Technician (Staff #503) enter a room of a patient in contact isolation (Patient #501). Staff #503 failed to don appropriate Personal Protective Equipment (PPE) including a gown and eyewear prior to entering the patient room.

10. At the time of the observation, during interview with Investigator #5, Staff #503 told the Investigator he was just entering the room to retrieve the XRAY machine.

11. On 05/05/21 at 8:55 AM, Staff #502 verified the finding and stated that Staff must perform hand hygiene and don PPE prior to entering the rooms of patient's in contact isolation.

12. On 05/05/21 at 9:20 AM, Investigator #5 observed a Respiratory Therapist (Staff #506) was providing care to a patient in Contact Isolation in room #309. Staff #506 failed to tie the isolation gown in the back which resulted in the gown shifting to the side while the staff was providing care. The Investigator noted that the staff members clothing was touching the patient's blankets.

13. At the time of the observation, the Director of Infection Control (Staff #502) confirmed the finding and stated that the hospital had identified the issue prior and had been educating staff on proper donning of isolation gowns.
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Item #1 Infection Control Program and Healthcare Associated Infections (HAI's)

Based on document review and interview, the hospital failed to include surveillance, prevention, and control of healthcare associated infections (HAI) issues identified by public health authorities in the hospitals 2020 Infection Control Risk Assessment Evaluation and 2021 Infection Control Plan.

Failure to include HAI issues in the infection prevention and control program risks disease outbreaks among patients and staff.

Findings included:

1. Document review of a letter dated 12/29/20 from Washington State Department of Health's (DOH), Healthcare Associated Infections and Antimicrobial Resistance Program, showed that the hospital had 10 cases of Enterobacter cloacae (E. cloacae) with New Delhi metallo-ß-lactamase (NDM) resistance mechanism between 12/2019 and 12/29/20.

Document review of the hospitals document titled, "Kindred Seattle-Positive CRPA (carbapenem-resistant pseudomonas aeruginosa) Cases June 2020-April 2021," showed that 22 of the 35 patients diagnosed with CRPA between 05/02/20 and 02/03/21 were hospital acquired infections.

Document review of a letter dated 04/20/21 from Public Health Seattle & King County (PHSKC) and Washington State Department of Health (DOH), showed that the hospital has had 8 cases of carbapenem-resistant Pseudomonas aeruginosa (CRPA) in between 01/2021 and 04/10/21.

Document review of the hospital's Annual Infection Prevention and Control Program Evaluation Year: - 2020 / Risk Assessment Year Evaluated: 2020 / IP Plan Year - 2021 showed that the plan did not include surveillance, prevention, or control interventions of hospital acquired NDM or CRPA.

2. On 05/06/21 at 1:30 PM, during review of the hospital's Infection Control Program, Investigator #5 noted that the Hospital's Infection Control Risk Assessment Evaluation for year 2020 and the Infection Control Plan for 2021 failed to mention the CRPA outbreak identified by the King County Department of Health or include any prevention or control plans, interventions, or activities for the CRPA.

3. At this time, during interview with Investigator #5, the Director of Quality (Staff #501) stated that the Infection Control Plan priorities were provided by the hospital's parent company, but that the hospital had developed and implemented individual action plans per the findings of King County Department of Health.

Item #2 Reprocessing Shared Patient Medical Equipment

Based on observation, document review, and interview, the hospital failed to develop and maintain effective infection control and sanitization practices for reprocessing shared patient medical equipment (respirator exhalation valves).

Failure to implement an effective infection control and sanitization practice for infection prevention and control risks patient and staff exposure to communicable disease.

References: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2009, updated 05/19. Recommendations: C. 2. Cleaning of Patient-Care Devices b. Meticulously clean patient-care items with water and detergent, or with water and enzymatic cleaners before high-level disinfection or sterilization procedures.

Guidelines for Preventing Health-Care-Associated Pneumonia, 2003. Recommendations of the Centers for Disease Control and Prevention (CDC) and the Healthcare Infection Control Practices Advisory Committee (HICPAC) Part II. Recommendations of HICPAC III. Prevention of Transmission of Microorganisms. A. Sterilization or Disinfection and Maintenance of Equipment and Devices 1. General measures a. Thoroughly clean all equipment and devices to be sterilized or disinfected.

Findings included:

1. Document review of the hospital's policy titled, "CORE: Respiratory Care Routine Responsibilities," policy number H-PC 06-005, reviewed 06/27/18, showed that staff on all shifts clean and sterilize dirty equipment and that all equipment should be changed as needed when visibly dirty or per manufacturer's guidelines.

Document review of the hospital's policy titled, "CORE: Cleaning of Shared Patient Medical Equipment," policy number H-IC 02-015, reviewed 06/28/19, showed that ventilators should be disinfected daily with an Environmental Protection Agency (EPA) registered disinfectant.

Document review of the hospital's policy titled, "4543 Seattle First Hill Facility Specific Policy, Equipment, Removal from Patient Rooms," policy number H-RC 05-016, reviewed 08/07/19, showed that respiratory staff will clean and disinfect all reusable equipment with approved disinfectant.

Document review of the hospital's document titled, "CMS TOC (Centers for Medicare & Medicaid Transitions of Care) for IC PSI (Infection Control Patient Safety Initiative) Worksheet March 2020/Tab 11," no document number, no date, showed reprocessing of semi-critical equipment: ventilator exhalation valves are sterilized off campus; non-disposable, reusable ventilator parts are manually cleaned with an approved enzymatic detergent following manufacture guidelines; manufacturer's instructions should be posted in HLD (high-level disinfection) work area (posted in dirty utility room).

Document review of the operator's manual for VELA (Trademark) Ventilator Diamond Series, 33379-001 Version A showed that cleaning recommendations for an exhalation valve body included a multi-step process with enzymatic detergent followed by rinsing in a bath of sterile USP (United States Pharmacopeia) water.

Document review of the operator's manual for VELA 33373-001 Version A showed that the method for cleaning an exhalation valve body includes soaking in Revital-Ox (an enzymatic detergent) and rinsing in distilled water.

Review of manufacturer instruction for use (IFU) for Endozime® AW Triple Plus® with A.P.A. (an enzymatic detergent) showed : 1.Dilute Endozime® AW Triple Plus® at only 1/2 ounce per one (1) gallon (4 mL/liter) of water; 2. Submerge instruments and scopes to be cleaned; 3. Soak for two (2) minutes to remove all organic soils; 4. Rinse thoroughly with tap, distilled, or sterile water.

2. On 05/04/21 at 11:30 AM, Investigator #5 and the Director of Respiratory Therapy (Staff #508) inspected Respiratory Therapy located in the hospital's basement and observed the hospital process for the cleaning and disinfection of the Vella Ventilator exhalation valves. Investigator #5 observed the following:

a. A large clear plastic storage container containing 3 exhalation valves sitting on a counter near a sink. The container was labelled, 'Dirty Exhalation Valves Only."

b. 3 full gallons and one partial gallon of Endozime Triple Action cleaner expired in 12/2020.

c. A single sink with writing, "4-6 G" and a line drawn with a permanent marker noting the water level.

d. A bottle of test strips expired on 01/01/21.

e. A drawer containing packages of sterilized exhalation valves labelled as processed by Virginia Mason Hospital.

3. At the time of the observation, during discussion with Investigator #5, Staff #508 stated that the hospital had identified that there was a gap in the process for Staff transporting the contaminated exhalation valves to the dirty utility room and she did not know if there was any pre-cleaning process for the exhalation valves. She stated that she did not know how long the dirty valves had been sitting inside the bin on the sink. Staff #508 verified the expired cleaning solution and test strips. Staff #508 verified that the range in water of 4-6 gallons did not match the concentration requirements on the label. Staff #508 stated that after the valves were cleaned with the enzymatic detergent, the valves were placed in a peel pack with an indicator and sent to Virginia Mason Hospital to be sterilized. Investigator #5 asked how quality was tracked and if the hospital had identified any correlation with ventilator cleaning and Carbapenem-Resistant Pseudomonas Aeruginosa (CRPA) outbreak. Staff #508 stated she did not know.

3. On 05/05/21 at 10:10 AM, Investigator #6 and the Interim Director of Clinical Nursing (Staff #601) inspected the basement soiled utility room where used patient care equipment (exhalation valves for ventilators) are processed prior to sterilization. The observation showed:

a. A 1-gallon bottle of Endozime® AW Triple Plus® with A.P.A. (an enzymatic detergent) approximately 2/3 full; the bottle had a manufacturer's stamped expiration date of 12/20; the bottle had a hand-written label, "3 Pumps = 1 oz" and the utility sink showed a hand-drawn marker line, labeled "4-6 G fill line." Investigator #6 found no instructions for manually disinfecting ventilator exhalation valves posted; no manufacturer instructions for any enzymatic detergent posted.

b. An instrument transport container containing 2 exhalation valves was observed. Investigator #6 found no indication whether they had been cleaned and soaked according to manufacturer instructions

4. At the time of the observation, Investigator #6 interviewed Staff #601 about the hospital's procedure for reprocessing respirator exhalation valves. Staff #601 stated there was not a written procedure and described the steps: after use, staff break down the respirator while it's in the patient room, staff use a disinfectant wipe to disinfect the machine, the exhalation valves are taken downstairs (to the soiled utility room) and placed in a "soiled" bin by the sink, when there are enough collected a designated person soaks and air dries the exhalation valves, then places them in sterilization bags with an indicator, and transports them to another hospital for sterilization. Staff #601 stated that as of 05/05/21 all ventilator valves will be single use.

On 05/05/21 at 10:15 AM, the Director of Quality (Staff #501) verified that the hospital did not have a contract with Virginia Mason to provide sterilization for the reusable respiratory equipment and the hospital did not have a process in place to ensure quality of service provided by the contractor. He stated that effective immediately, the hospital was changing to single use ventilator exhalation valves and that the hospital had secured enough supply to last 2 months while an appropriate process for cleaning and sterilization was developed and implemented.

Item #3 Cross Contamination

Based on observation, interview, and document review, the hospital failed to prevent cross contamination during use of portable medical equipment from patients in contact isolation.

Findings included:

Failure to ensure that effective procedures are in place to prevent cross contamination could result in the transfer of infection from patient to equipment to patient and result in patient harm and death.

1. Document review of the hospital's policy titled, "CORE: Transmission-Based Precautions," policy number H-IC 02-002, release date 06/19, showed the following:

a. Contact precautions are to be implemented when there is increased potential for extensive environmental contamination and risk for transmission.

b. Indirect contact transmission involves contact of a susceptible host with a contaminated intermediate object, usually inanimate, in the patient's environment.

c. Staff are to don gowns whenever anticipating that clothing will have direct contact with the patient or potentially contaminated environmental surfaces or equipment in close proximity to the patient.

d. Patient care equipment should be cleaned in the patient's room and then brought out to dry.

2. On 05/05/21 at 8:52 AM, Investigator #5 and the Director of Infection Control (Staff #502) observed a Radiology Technician (Staff #503) enter the room of a patient in contact isolation (Patient #501). Staff #503 removed a portable XRAY machine from the patient room and then cleaned the high touch areas of the machine in the hallway.

3. On 05/05/21 at 9:10 AM, Investigator #5 and the Director of Infection Control (Staff #502) observed a Radiology Technician (Staff #503) perform a portable Chest XRAY for a patient in Contact Isolation (Patient #502). Investigator #5 observed Staff #503 remove the protective plastic sleeve from the radiography phosphor XRAY Plate (imaging plate is housed in a special cassette and placed under the body part or object to be examined and the x-ray exposure is made. The imaging plate is then run through a special laser scanner, or CR reader, that reads and converts the image to a digital radiograph) and placed the plate on the patient's bedside table, contaminating the XRAY Plate. Staff #502 removed his PPE including his gown and gloves, and then picked up the contaminated XRAY Plate. Staff #502 walked out of the patient room and tucked the plate under his arm contaminating his shirt, arm sleeve and pants.

4. At the time of the observation, Staff #502 confirmed the cross contamination and stated that the hospital had some opportunities to improve related to contact precautions.

Item #4 - Soiled Utility Room Handwashing Station

Based on observation and interview, the facility failed to provide a handwashing station in the soiled utility room used for high-level disinfection (HLD) of shared patient care equipment (ventilator exhalation valves).

Failure to provide hand-washing stations places staff at increased risk of exposure to infectious microorganisms during reprocessing of contaminated patient care equipment.

Reference: Facilities Guidelines Institute (FGI) Guidelines for Design and Construction of Health Care Facilities, Part 2 - Hospitals; 2.1-2.3.8.1 Soiled workrooms shall contain (1) A clinical sink (or equivalent flushing-rim fixture) and a hand-washing station. Both fixtures shall have a hot and cold mixing faucet.

Findings included:

1. On 05/05/21 at 10:10 AM, Investigator #6 and the Interim Director of Clinical Nursing (Staff #601) inspected the basement soiled utility room where used patient care equipment (exhalation valves for ventilators) are processed prior to sterilization. The observation showed the room was equipped with a single basin utility sink and was not equipped with a handwashing sink.

2. At the time of the observation, Investigator #6 interviewed Staff #601 about whether the room was intended to be used as a soiled utility room. Staff #601 verified there was no hand washing sink in the dirty utility room and stated that as far as she knew it had always been used to reprocess patient care equipment.

Item #5 Disinfectant Chemicals Instructions for Use (IFU)

Based on observation, document review, and interview, the hospital failed to ensure Environmental Services (EVS) staff had knowledge of the contact time (time required to effectively reduce the amount of pathogens) for disinfectant chemicals used in patient care areas as evidenced by 5 of 6 EVS staff interviews (Staff #605, Staff #606, Staff #607, Staff #807, and Staff #809).

Failure to allow adequate time for disinfection of surfaces puts patients, staff, and visitors at increased risk of exposure to harmful microorganisms.

Reference: Centers for Disease Control and Prevention (CDC) Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007), updated 07/19: Recommendations VI. Standard Precautions F. Care of the Environment 3. Use EPA-registered disinfectants in accordance with manufacturer ' s instructions.

Findings included:

1. Document review of the product label for Signet Neutral Disinfectant DS1 showed that for use as a one-step, general, hospital, medical disinfectant, fungicide, virucide, cleaner, treated surfaces must remain wet for 10 minutes.

Document review of the product label for Signet Heavy Duty Non-Acid Washroom Cleaner/Disinfectant RR1 showed that for use as a one-step cleaner/disinfectant and fungicide, surfaces must remain wet for 10 minutes.

Document review of the product label for Clorox Healthcare Bleach Germicidal Disinfectant showed that a contact time of 3 minutes is required for all pathogens listed on the product label, including Clostridium difficile and the COVID-19 virus (SARS-CoV-2) on hard, nonporous surfaces.

2. On 05/04/21 at 10:30 AM, Investigator #8 and the Environmental Services (EVS) Manager (Staff #806) observed an EVS staff member (Staff #807) perform a daily cleaning of a patient room on the 2nd floor Intensive Care Unit (ICU). The investigator interviewed Staff #807 about the chemicals in use. Staff #807 stated that the disinfectants were Clorox bleach and DS1 (Signet Neutral Disinfectant). Investigator #8 asked Staff #807 about the contact time for each of the disinfectants. Staff #807 stated that both Clorox bleach and DS1 have a contact time of 3 minutes.

3. On 05/05/21 at 10:30 AM, the Interim Director of Clinical Nursing (Staff #601) & Investigator #6 observed the daily cleaning of patient room #206. The Environmental Services staff member (Staff #605) used a spray bottle containing Clorox Healthcare Bleach Germicidal Disinfectant to wet a wiping cloth that she used to disinfect surfaces. The investigator asked Staff #605 about the contact time required for the product. Staff #605 stated the contact time was 3 to 5 minutes.

4. On 05/05/21 between 11:24 AM and 12:55 PM, Investigator #8 and the EVS Manager (Staff #806) observed 3 EVS staff members (Staff #809, Staff #810, and Staff #811) as they performed a discharge clean of patient room #301. The observation showed:

a. The discharged patient had been treated under contact precautions for a Carbapenem-resistant Enterobacteriaceae (CRE) infection (strains of bacteria that are resistant to carbapenem and other antibiotics).

b. The EVS staff members used Clorox Healthcare Bleach Germicidal Disinfectant to spray directly onto high-touch surfaces, waited several minutes, and wiped the surface with a wiping cloth.

c. EVS staff sprayed Clorox directly onto the patient mattress and allowed it to dry. Investigator #8 observed the drying time was approximately 12 minutes.

5. At the time of the observation, Investigator #8 interviewed Staff #809 about how long the mattress should remain wet. Staff #809 stated that the mattress needed to stay wet for 10 minutes. Investigator #8 asked Staff #811 about the contact time for the Clorox. Staff #811 stated the contact time for Clorox is 3 minutes.

6. On 05/05/21 at 1:45 PM, the Interim Director of Clinical Nursing (Staff #601) and Investigator #6 observed the discharge cleaning of patient room #402 by 2 Environmental Services staff members (Staff #606 & Staff #607). The investigator interviewed Staff #606 & Staff #607 about the chemical products they were using. Staff #607 stated she was using a spray bottle containing Clorox Healthcare Bleach Germicidal Disinfectant and that the contact time was 3 to 5 minutes. Staff #606 stated she was using DS1 and that it should remain wet for 5 to 10 minutes.

7. On 05/06/21 at 11:55 AM, Investigator #8, interviewed EVS Manager (Staff #806) regarding the contact times. The EVS Manager (Staff #806) acknowledged the contact time for Signet Neutral Disinfectant DS1 was 10 minutes as noted on the dispenser label.

Item #6 Aerosol Spray Disinfectant

Based on observation and interview, the hospital failed to ensure that staff members properly utilized cleaning chemicals when performing housekeeping functions.

Failure to properly perform housekeeping functions places staff, patients, and visitors at increased risk of exposure to harmful microorganisms.

Reference: Guidelines for Environmental Infection Control in Health-Care Facilities. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). 2003, Updated 07/19. Part II Recommendations for Environmental Infection Control in Health-Care Facilities; E. Recommendations - Environmental Services; E.I. Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas; G. Avoid large-surface cleaning methods that produce mists or aerosols or disperse dust in patient-care areas.

Findings included:

1. On 05/05/21 between 11:24 AM and 12:55 PM, Investigator #8 and the Environmental Services Manager (Staff #806) observed 3 EVS staff members (Staff #809, Staff #810, and Staff #811) as they performed a discharge clean of patient room #301. The observation showed:

a. The discharged patient had been treated under contact precautions for a Carbapenem-resistant Enterobacteriaceae (CRE) infection (strains of bacteria that are resistant to carbapenem and other antibiotics).

b. The EVS staff members used Clorox Healthcare Bleach Germicidal Disinfectant to spray directly onto high-touch surfaces, waited several minutes, and wiped the surface with a wiping cloth.

2. On 05/05/21 at 1:45 PM, the Interim Director of Clinical Nursing (Staff #601) & Investigator #6 observed the discharge cleaning of patient room #402 by 2 Environmental Services (EVS) staff members (Staff #606 & Staff #607). The observation showed that Staff #607 sprayed Clorox Healthcare Bleach Germicidal Disinfectant from a spray bottle onto the counter surfaces around the handwashing sink in the patient room and the counter surfaces around the handwashing sink in the patient bathroom.

3. At the time of the observation, Investigator #6 interviewed Staff #607 about use of spray bottles to apply disinfectant. Staff #607 stated that she sprayed the surfaces directly and did not know that aerosol application of disinfectants could disperse microbes or dust.

4. On 05/05/21 at 2:00 PM, Investigator #6 interviewed the Manager of Environmental Services (EVS) (Staff #608) about EVS staff member education related to surface cleaning methods that produce aerosols or disperse microbes or dust. Staff #608 stated that he was not aware of such methods but would direct EVS staff members to spray disinfectant into a wiping cloth before disinfecting surfaces.

Item #7 Dialysis Equipment Backflow Prevention

Based on interview, observation, and document review, the hospital failed to ensure that proper backflow prevention was established for dialysis equipment.

Failure to establish backflow prevention risks contamination of the potable water supply and dialysis equipment and places patient, staff, and visitors at risk for waterborne illness.

Findings included:

1. Document review of the Fresenius 2008K Hemodialysis Machine Operator's Manual © Copyright 2000 - 2015 Fresenius USA, Inc. showed that operators must comply with all local regulations in respect of separation of devices in the water supply in case of back siphonage; an air gap must be created between the machine's drain line and its drain; Chapter 2 Daily Preparation for Treatment checklist includes, the machine's drain line is inserted into a drain with an air gap.

2. On 05/05/21 at 7:45 AM, Investigator #6 interviewed the dialysis contractor, ARC Dialysis Manager (Staff #601) about the dialysis services provided at the hospital. During the interview, Staff #601 stated that the inpatient dialysis equipment was drained to the patient bathroom handwashing sink.

3. On 05/05/21 at 8:05 AM, the ARC Dialysis Manager (Staff #603), the Interim Director of Clinical Nursing (Staff #601) & Investigator #6 observed the dialysis equipment set-up in patient rooms #414 and #415. The observation showed:

a. In patient room #414 the drain hoses from the dialysis equipment rested in the basin, below the flood level rim of the handwashing sink and did not have the required air gap to prevent backflow.

b. In patient room #415 the drain hoses from the dialysis equipment were fastened to the faucet with the ends resting in the basin, below the flood level rim of the handwashing sink and did not have the required air gap to prevent backflow.

Item #8 - Employee Screening

Based on 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 and control precautions regarding tuberculosis (TB) screening and Hepatitis B (Hep B) for a Registered Nurse (RN) assigned to patient wound care and treatment (Staff #814).

Failure to implement infection control procedures consistent with national guidelines places patients, staff, and visitors at risk of illness from exposure to communicable disease.

References: Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Healthcare Facilities, 2005. Morbidity Mortality Weekly Report (MMWR) Volume 54, December 30, 2005.

Washington Administrative Code (WAC) 246-320-156 Management of Human Resources

Washington Administrative Code (WAC) 296-823 Occupational Exposure to Bloodborne Pathogens

Findings included:

1. On 05/05/21 between 2:00 PM and 3:50 PM, Investigator #8 and the Chief Clinical Officer (Staff #802), reviewed personnel records for 10 hospital staff members. The review showed:

a. The hospital did not have documentation of tuberculosis screening upon hire for a Registered Nurse (RN) (Staff #814).

b. The hospital did not have documentation that Hepatitis B vaccine information was provided to Staff #814 during her Blood Borne Pathogens training.

2. At the time of the review, Staff #802 stated that Staff #814 would be removed from the schedule immediately and remain off the schedule until Tb screening could be completed & Hepatitis B vaccine information could be documented.


Cross Reference: Tag A 0084 and Tag A 0085
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Item #1 Reporting Critical Culture Results

Based on medical record review and interview, the hospital failed to ensure that an effective process was in place to notify Providers and Staff of critical value results for patients with Multi-Drug Resistant Organisms (MDRO's).

Failure to ensure prompt notification of MDRO infections risks delay in treatment and delay of appropriate safeguard interventions that could result in patient harm, harm to other patients in the facility, and patient death.

Findings included:

1. Document review of the hospital's policy titled, "Critical Laboratory Values," policy number LAB 01.002, revised 12/19, showed the following:

a. Critical results are test values that indicate a potential critical disease state in a patient and of which the attending or covering physician team should be made aware of as quickly as possible.

b. Critical Values include any positive test except urine and stool cultures.

c. The House Supervisor should communicate critical values to the patient care team immediately or within 30 minutes of notification from the laboratory.

d. Calls from the Laboratory service with critical results information will be given to the House Supervisor or the patient's licensed nurse. The House Supervisor or patient's licensed nurse must document and read back the results.

e. The House Supervisor or patient nurse must document the critical result, the name of the lab employee calling in the result and sign the critical result call back form according to the laboratory documentation policy and procedure.

2. On 05/05/21 at 1:45 PM, Investigator #5 and the Director of Nursing and Clinical Services (Staff #509) reviewed the medical records for 3 discharged patients diagnosed with nosocomial Carbapenem-Resistant Pseudomonas Aeruginosa (CRPA) and 3 current patients diagnosed with nosocomial CRPA. Investigator #5 found no evidence for 4 of 6 medical records (Patients #506, #507, #508, and #509) that the provider was notified of the critical laboratory results for CRPA infection.

3. At the time of the observation, Staff #509 verified that there was no evidence that the patient's Providers were notified of the positive laboratory cultures.

4. On 05/06/21 at 11:55 AM, the Director of Quality (Staff #501) verified the finding and stated that the hospital's contracted laboratory vendor (Lab Corp) did not notify the hospital of positive respiratory cultures. Staff #501 stated that Lab Corp's policy was only to call the hospital for positive cultures results taken from sterile body fluids and that because sputum is not sterile, the facility was not notified at all per the hospitals Critical Value Policy of the MDRO CRPA infections for 3 of the 4 infections identified by Investigator #5. Staff #501 stated that the hospital was not aware that the positive sputum culture results were not being reported to the hospital.

Item #2 Tracheostomy Dressing Changes

Based on observation, interview and document review, the hospital failed to ensure staff followed its policies and procedures for tracheostomy dressing changes for 1 of 1 observations of care.

Failure to ensure that staff members follow hospital policy for tracheostomy dressing changes places patients at risk for developing infections and death.

Findings included:

1. Document review of the hospitals plan titled, "Organizational Plan for the Delivery of Patient Care, Treatment, and Services: 2021 Seattle Market Plan for the Provision of Patient Care," dated 2020, showed that Kindred Healthcare will utilize Wolters Kluwer and Lippincott Solutions integrated application suite of online standards of care and procedures as reference and resource for nurses and clinicians.

Document Review of the hospital's procedure titled, "Lippincott Procedures-Tracheostomy tube cannula and stoma care," revised 11/20/20, showed that after removing the dirty Tracheostomy dressing staff are to remove their gloves and perform hand hygiene. Prior to placing a clean dressing staff are to don clean gloves.

2. On 05/05/21 at 9:22 AM, Investigator #5 and the Director of Infection Control (Staff #502) observed a Respiratory Technician (Staff #504) perform Tracheostomy Care for a patient in contact isolation (Patient #504). During the dressing change, Investigator #5 observed that Staff #504 failed to change his gloves and perform hand hygiene after removing the dirty tracheostomy dressing prior to applying the clean dressing. Investigator #5 observed Staff #504 retrieve additional dressing and supplies from a container holding clean supplies using contaminated gloves 3 times during the tracheostomy care observation.

3. At the time of the observation, Staff #502 stated that Staff #504 should have changed his dirty gloves and performed hand hygiene before he opened and applied the clean dressing.


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