HospitalInspections.org

.
Based on observation, interview, and review of hospital policies and procedures, the Critical Access Hospital failed to ensure staff maintained supplies and equipment to meet patient needs during an emergency.

Failure to maintain emergency supplies and equipment risks patient injury or delays in emergency treatment.

Findings included:

1. Document review of the hospital's policy and procedure titled, " Malignant Hyperthermia," policy # 4176668, last approved 06/20, (Maliganat Hyperthermia:mA life-threatening reaction that occurs on administration of general anesthesia, characterized by hyper metabolism. This results in dangerously high body temperature, rigid muscles or spasms, and a rapid heart rate,) showed that the cooling nurse is responsible for obtaining the cold saline from the recovery room refrigerator.

2. On 11/03/21 at 9:00 AM, Surveyor #10 observed that the refrigerator in the recovery room did not contain cold saline for a malignant hyperthermia emergency.

3. During the observation, Surveyor #10 interviewed a recovery room Registered Nurse (Staff #1016) regarding the missing saline for a malignant hyperthermia emergency that is to be kept in the recovery room refrigerator. Staff #1016 confirmed there was no saline in the refrigerator.
.

.
Item #1 Operating room relative humidity & temperature

Based on observation, interview, and document review, the Critical Access Hospital failed to maintain the industry standard for relative humidity (RH) range and temperature range in the operating rooms during patient care as evidenced by hospital documentation of 185 of 321 cases between 05/25/21 and 11/04/21.

Failure to maintain proper RH and temperature ranges risks compromises to sterile supplies and adverse patient outcomes.

Reference: Centers for Disease Control and Prevention (CDC) Guidelines for Environmental Infection Control in Health-Care Facilities (2003), updated 07/19: Appendix B. Air 4. Ventilation Specifications for Health-Care Facilities, Table B.2. Ventilation requirements for areas affecting patient care in hospitals and outpatient facilities. Relative humidity (%): 30 - 60. Design temperature (degrees F [C]) - Operating/surgical cystoscopic rooms: 68 - 73 (20 - 23)

Facilities Guidelines Institute (FGI) Guidelines for Design and Construction of Health Care Facilities, Part 2 - Hospitals; Table 2.1.2 Ventilation Requirements for Areas Affecting Patient Care in Hospitals and Outpatient Facilities. Relative humidity (%): 30 - 60. Design temperature (degrees F/C) - Operating/surgical cystoscopic rooms: 68 - 73/20 - 23.

Findings included:

1. Document review of the hospital's policy titled, "Surgery Infection Control Measures," PolicyStat ID: 6791405, approved 11/21, showed that intraoperative infection prevention measures include keeping the relative humidity at 20 to 60 percent as recommended by the American National Standards Institute (ANSI), the American Society of Healthcare Engineers (ASHE), and the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), and temperature of the operating rooms will be maintained at 68 to 73 degrees F (American Institute of Architects, 1996, 2001).

Review of Surgery Checklist log sheets for Operating Room (OR) #1 for 160 patient care procedures between 07/01/21 and 11/04/21 showed 3 cases out of range for relative humidity and 88 cases out of range for temperature.

Review of Surgery Checklist log sheets for OR #2 for 161 patient care procedures between 05/25/21 and 11/04/21 showed 4 cases out of range for relative humidity and 97 cases out of range for temperature.

2. On 11/04/21 at 9:35 AM, Surveyor #10 interviewed a Surgical Technician (Staff #1023), about the temperature ranges in the OR during patient care procedures. Staff #1023 stated that some of the providers prefer a colder temperature.

Item #2 Pharmaceuticals stored appropriately

Based on observation, document review, and interview, the Critical Access Hospital failed to ensure that pharmaceuticals were stored at appropriate temperatures.

Failure to ensure that pharmaceuticals are stored at appropriate temperatures risks lack of efficacy of the medications.

Findings included:

1. Document review of the manufactures instructions for use for ISOVUE-370, lopamidol injection 76% (intravascular injection of radiopaque diagnostic agent) showed that it is desirable that the solutions of radiopaque diagnostic agents for intravascular use be at body temperature and stored at 20-25 degrees Celsius (66-77 degrees Fahrenheit).

2. On 11/02/21 at 11:30 AM, during a tour of the hospital's Imaging Services, Surveyor #6 and the Director of Ancillary Services (Staff #601) inspected the CT (Computed Tomography) Room. The observation showed a Ready-Box® media warmer unit with 4 100-mL vials of ISOVUE-370, each with a manufacturer expiration date of May 2024 and a handwritten expiration date of 12/21.

3. At the time of the observation, Surveyor #6 interviewed Staff #601 about the storage of the contrast media in a warmer unit and the handwritten expiration date on each vial. Staff #601 stated he would check with the CRNA (Certified Nurse Anesthetist) or Pharmacist.

4. During a tour of the Cat Scan room on 11/04/21, Surveyor #10 reviewed the Radiology Contrast Warmer temperature log sheets. The observation showed that the log sheets documented temperatures between 36-37 degrees Celsius for all shifts in September, October, and November of 2021.

5. On 11/04/21 at 9:10 AM, Surveyor #10 interviewed an X-ray Technician (Staff #1021) about the Isovue-370 in the warming unit. Staff #1021 stated that is was his understanding that when contrast is warm it is less viscous and increases the pressure of the scan for better images. Staff #1021 was unable to provide a policy regarding using the warmer for ISOVUE-370. Staff #1021 stated that the contrast is pulled, put on the counter, and sits at room temperature before injected. Staff #1021 could not confirm how they measured the temperature of the contrast prior to use.
.


.

.

Based on observation, interview, and document review, the Critical Access Hospital failed to meet the requirements of the Life Safety Code of the National Fire Protection Association (NFPA), 2000 edition.

Failure to ensure a fire-safe environment of hospital hazards risks patient, visitor, and staff safety.

Findings included:

Refer to deficiencies written on the CRITICAL ACCESS HOSPITAL MEDICARE LIFE SAFETY CODE inspection report found at Shell Q6LM21.
.

.
Based on interview and review of the hospital's quality improvement program plan, performance data, and Board of Commissioners documents, the Critical Access Hospital's Board of Commissioners failed to ensure that the hospital developed, implemented, and maintained an effective, ongoing hospital wide quality program as directed by hospital policy.

Failure to ensure the hospital implemented an ongoing, data driven, hospital wide quality improvement program limited the hospital's ability to identify quality and safety concerns and implement effective improvements to improve outcomes and prevent harm.

Findings included:

1. Document review of the hospitals Board of Commissioners By-Laws, dated 02/27/18, showed that the board shall maintain oversight and that the policies of the district are in proper relationship to community needs including requirements provided by WAC-243-320-131 as follows:

a. Establishing and approving a performance improvement plan

b. Providing organizational management and planning

2. Review of the hospital's document titled, "Quality Improvement Program Plan," policy # 10631267, last approved 11/21, showed the following:

a. The Board of Commissioners of the Okanagan Hospital's District #1 dba Three Rivers Hospital is responsible to oversee the Quality Improvement Program.

b. The Board of Commissioners reviews and approves the Hospital's Annual Quality Improvement Plan.

c. The board Receives monthly reports on a variety of hospital quality indicators or as requested.

d. The Board ensures that the Quality Department has the resource needed to carry out its responsibilities.

3. On 11/04/21 Surveyor #10 reviewed the hospital's quality spreadsheets for 2020 and 2021 year to date. Surveyor #10 observed that the hospital failed to collect data on its identified quality indicators for up to 21 months.

4. On 11/04/21 at 1:30 PM during an interview with Surveyor #10 about the hospital's Quality Improvement Program Plan, the Quality Director (Staff #1018) verified that the quality indicator spreadsheets for 2020 and 2021 were not comprehensive and were missing significant documentation of data for the hospital's identified quality improvement indicators. Staff #1018 stated that the hospital has experienced turnover and that she was contracted in 07/21 as the Interim Quality Director.
.

.
Based on interview and document review, the Critical Access Hospital failed to have a physician and a mid-level provider involved in the hospital's policy and procedure review process.

Failure to ensure a physician and mid-level provider are involved in the facility's policy and procedure review process may lead to sub-optimal patient care.


Findings included:

1. Document review of the hospital's Bylaws of the Medical Staff, Amended by the medical Staff 06/17/20
Approved by the Board of Commissioners 06/24/2020, showed that the Medical Staff duties and responsibilities shall include, but not limited to participating in the development of all Medical Staff and hospital policy, practice and planning.

Document Review of the Medical Staff Business Meeting Minutes for 03/21, 04/21, 05/21, 06/21, 07/21,09/21 showed no evidence that the committee participated in the development of all hospitals policies, practice and planning.

Document review of the Policy and Procedures Committee Meeting dated 06/16/21, showed the no evidence that a physician or mid-level provider was part of the policy and procedure committee.

1. On 11/02/21 at 9:25 AM, Surveyor #10 Interviewed the Chief Nursing Officer (Staff #1010) about a Physician and Physician Assistant being involved in the policy and procedure committee and review process. Staff #1010 stated that the policies used to go to the Medical Director for approval; however, they would sit in the providers que for months. The process was changed, and they are no longer sent to the Medical Director for review or approval. Staff #1010 confirmed that a mid-level provider is not involved in reviewing or approving the hospitals policies and procedures.

2. On 11/04/21 at 11:15 AM, Surveyor # 10 interviewed the Chief Executive Officer, (Staff #1014) regarding the involvement of a physician and mid-level provider in the development of all hospitals policies, practice and planning. Staff # 1014 stated that the Medical Staff Committee should be involved in the development of all hospitals policies, practice, planning and reviewing. Staff #1014 stated that he was unaware that this process was being missed.

3. On 11/04/21 at 11:25 AM, Surveyor # 10 interviewed the Chief Medical Officer (Staff #1017) regarding the participation of a physician and mid-level provider in the development of all hospitals policies, practice and planning. Staff #1017 stated that the patient care policies are discussed and read at Medical Staff Meetings. Surveyor #10 stated that after review of the minutes for the Medical Staff meetings for the last 6 months, that there was no evidence that policies were reviewed, approved or discussed. Staff #1017 stated that they do go over them in the meeting and that it just has not been documented.
.

.
Item #1 Surgical Site markings

Based on observation, interview, and review of hospital policies and procedures, the hospital failed to implement its policy and procedure for verification of the surgical site prior to initiating surgery for 1 of 1 patient (Patient #1010).

Failure to systematically verify a patient's surgical site risks medical errors and patient harm.

Findings included:

1. The hospital's policy and procedure titled, "Perioperative Patient Safety Verification Procedure," policy # 88188714, last approved 11/21, showed the following:

a. Surgical sites must be marked on all cases/procedures involving laterality (left, right) or multiple structures (toes, fingers).

b. Staff document the surgical site by placing a piece of tape at or near the incision/invasive site and write the surgical procedure on the piece of tape. A sterile marker is used.

c. DO NOT mark any non-operative/non-invasive site unless necessary for some other aspect of care. The physician/surgeon will use their initials or write, "Yes" to mark the correct site so the correct site mark is unambiguous.

2. On 11/03/21 at 2:00 PM, Surveyor #10 and the Chief Nurse Officer (Staff #1010) reviewed the medical record for Patient #1010 who underwent general anesthesia for a right shin wound debridement on 10/14/21. The intraoperative record review shows that the site was not marked.

3. At the time of the medical record review, Staff #1010 confirmed the finding and stated that the surgical site should be marked and documented prior to starting the case.

Item #2 Preoperative Assessment

Based on interview, record review and review of the hospital's policies and procedures, the hospital failed to implement its policy and procedure for consultation of higher risk patients receiving anesthesia for 2 of 2 charts reviewed ( Patient #1010 and #1014).

Failure to follow policies and procedures puts the patient at risk for harm related to unrecognized complications of anesthesia and delays in necessary treatment.

Findings included:

1. Document review of the hospital's policy and procedure titles, "ASA Classification System" policy # 5783064, last approved 08/19 showed that patients categorized as ASA P3 ( a patient with systemic disease that may limit activity and may be incapacitating. Defined as a patient with existing disease controlled or not) may be approved by the surgeon and anesthetist after careful consideration and consult.

2. On 11/03/21 at 2:00 PM, Surveyor #10 and the Chief Nurse Officer (Staff #1010) reviewed the medical record for the following:

a. Patient #1010 who underwent general anesthesia for a right shin wound debridement on 10/11/21. The review of the preanesthetic evaluation showed the patient was classified an ASA 3 for hypertension, acid reflux, alcohol abuse and peripheral artery diseases. Further review of the medical record revealed no documentation of careful consideration or consultation with the surgeon regarding the patients ASA classification of 3.

b. Patient #1014 who underwent general anesthesia for a Cervical Cone Biopsy on 10/13/21. The review of the preanesthetic evaluation showed the patient was classified an ASA 3 for non-Hodgkin's lymphoma in remission and a smoker of 40 years with room air saturation at 94%. Further review of the medical record revealed no documentation of careful consideration or consultation with the surgeon regarding the patients ASA classification of 3.

3. At the time of the medical record review, Staff #1010 confirmed the missing consults.

Item #3 Expired supplies

Based on observation, interview, and review of hospital policies and procedures, the Critical Access Hospital failed to ensure that supplies that exceeded their manufacturer's expiration date were not available for administration to patients.

Failure to ensure medication storage areas do not contain outdated or otherwise unusable supplies puts patients at risk for receiving supplies with compromised care.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Blood Glucose Monitor, Quality Control Checks " policy #4176779, last approved 08/19, showed that when opening a new bottle of glucose control solution, write the date on the label. Opened bottles of glucose control solution are good for 3 months, or until the expiration date, whichever comes first.

2. On 11/03/21 at 10:00 AM, Surveyor #10 inspected the Post Anesthesia Unit. The inspection showed Accuc-Chek (Blood sugar monitor) control solution I and II had no date recorded on the label for when it was opened, further inspection showed that the solution I and II expired on 10/31/21.

On 11/04/21 at 8:30 AM, Surveyor #10 inspected the Acute Care Unit. The inspection showed Accu-Chek control solution I and II had no date recorded on the label for when it was opened.

On 11/04/21 at 8:55 AM , Surveyor #10 inspected the Emergency Department. The inspection showed Accuc-Chek control solution I and II had no date recorded on the label for when it was opened.

3. On 11/03/21 at 10:00 AM, Surveyor #10 interviewed a Recovery Room registered nurse (Staff #1016) about the quality control solutions for the Accuc-Chek. Staff #1016 stated that they follow the expiration date on the bottle and when it expires, they replace them with new solutions. Staff #1016 confirmed there was no open date written on the solution label and that she was unaware that the date of opened was to be written on the label.

4. On 11/04/21 at 8:30 AM, Surveyor #10 interviewed an Acute Care registered nurse (Staff #1012) about checking for outdated supplies. Staff #1012 stated that the night nurse performs the quality checks and expirations on the Accu-Chek solutions. Staff #1012 confirmed there was no open date written on the solution and that the solution was expired.

5. On 11/04/21 at 8:55 AM , Surveyor 10 inspected the Emergency Department Registered Nurse (Staff #1014) about the quality control solutions for the Accuc-Chek. Staff #1014 stated that they follow the expiration date on the bottle and when it expires, they replace them with new solutions. Staff #1014 confirmed there was no open date written on the solution label.
.

.
Based on document review and interview the Critical Access Hospital failed to ensure that policies and procedures were reviewed biennial to reflect current standards of practice.

Failure to review policies and procedures biennial places patients and staff at risk for unsafe care and injury.

Findings included:

1. Document review of the hospital's Rules and Regulations of the Medical Staff, revised 06/04/20, showed that the Medical Staff shall initiate and adopt such clinical and ancillary service policies and procedures as it may deem necessary for the proper conduct of its work and shall periodically, at least every two years, review and revise its policies and procedures to comply with current staff practice. Recommended changes to the policies and procedures will be submitted to the medical staff. Following adoption, such policies and procedures shall become effective following approval of the hospital administrator.

2. From 11/02/21-11/04/21, Surveyor #10 reviewed numerous hospital policies that were not in compliance with the hospital's rules and regulations including but not limited to:

a. Anesthesia Safety, policy #4518317, last approved 01/13

b. Ambulatory Surgery Preoperative Assessment Criteria, policy #4512503, last approved 01/13

c. Postoperative Anesthesia Care, policy #4514700, last approved 01/13

d. Pre and Post Anesthesia Evaluation, policy #4514476, last approved 01/13

e. Anesthesia Responsibilities, policy #5783078, last approved 08/19

f. Ethics Policy (Facility Wide), policy #10048395, no date for last approval, last revised 10/21

g. Independent Contractor Review, policy #2893147, last approved 09/08

h. Invasive Procedures Site Identification (outside the OR), policy #4513948, last approved 01/13

i. Adverse Drug Reactions Reporting, policy #4518367, last approved 01/13

j. Zero Lift Policy, policy #2884086, last approved 01/06

k. Patient Safety in the Operating Room, policy #4514582, last approved 01/13

l. Guidelines for Administration of Anesthesia, policy #4513906, last approved 01/13

j. Ambulatory Surgery Preoperative Assessment Criteria, policy #4512503, last approved 01/13

k. ASA Classification System, policy #5783064, last approved 08/19

2. On 11/02/21 at 9:25 AM, Surveyor #10 Interviewed the Chief Nursing Officer (Staff #1010) regarding biennially policy review. Staff #1010 stated that the hospital uses policy stat and that not all policies are up to date.

3. On 11/04/21 at 1:30 PM, Surveyor #10 interviewed the Director of Quality (Staff #1018) about the process for policy review. Staff #1018 stated that the process has not been clear and that currently a new policy is pending regarding the development, review and revisions of the hospital's policy that will help direct the hospital's process regarding policies. Staff #1018 confirmed that the policy and procedure committee has met in 2021 and that she is unable to verify if the committee met in 2020.
.

.
Item #1 Informed Consents

Based on documentation review, medical record review and interview the Critical Access Hospital failed to ensure that medical healthcare providers properly executed Informed Consents for anesthesia by not signing, dating and timing anesthesia consent forms for 4 of 4 patients (Patient #1010, #1011, #1012 and Patient #1014).

Failure to ensure that informed consents are properly executed creates a risk for lack of understanding to what and when a patient consented to for a procedure involving anesthesia.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Informed Consents," last approved 02/20, showed the following:

a. The Anesthesia Provider and/or Provider obtaining the consent signs in the appropriate location.

b. The nurse witnessing the signature of the patient signs as a witness

c. The date and time of witnessing the signature is completed

Document review of the Rules and Regulations of the Medical Staff, dated 06/24/20, showed that a written, signed informed consent will be obtained prior to treatment.

2. On 11/03/21 at 11:30 AM, Surveyor #10 reviewed medical records with the Assistant Chief Nursing Officer (Staff #1019). The review showed 4 of 4 patients (Patient #1010, #1011, #1012 and Patient #1014) signed a "Consent for Anesthesia Services". There was no evidence documented of a signature, date or time by the Anesthesia Provider or a witness signature on the consent for anesthesia.

3. During the review Surveyor #10 interviewed the Assistant Chief Nursing Officer (Staff #1019) regarding the missing signature, dates and times. Staff #1019 confirmed there was no documented signature date or time by the Anesthesia Provider or a witness signature on the consent for anesthesia.

Item #2 History and Physicals

Based on medical record review and interview the Critical Access Hospital failed to ensure updated history and physicals, (H&P) were completed before surgery, for 2 of 4 patients reviewed (Patient #1010, and #1012).

Failure to ensure updated history and physicals prior to medical records risks medical errors and adverse patient outcomes.

Findings included:

1.Document review of the hospital's, " Rules and Regulations of the Medical Staff," revised 06/24/20, showed the following:

a. The H&P is recorded within 30 days before admission. An updated H&P shall be before a surgical procedure.

b. If the H&P is recorded within 30 days before admission, an updated medical record entry documenting and exam for any changes in the patient's condition must be completed and included in the medical record within 24 hours after admission and before surgery. The update can be brief and, if applicable, the practitioner may make an entry in the record that the H&P was reviewed, the patient was examined, and that no change has occurred in the patient's condition since the H&P was completed.

2. On 11/03/21 at 12:30 PM, Surveyor #10 reviewed medical records with the Chief Nursing Officer (Staff #1010). The review showed the following:

a. Patient #1010 underwent general anesthesia for a right shin wound debridement on 10/11/21. The medical chart review showed evidence of a "clinical note" by the surgeon (Staff #1020) dated 10/05/21 and electronically signed the note on 10/14/21 at 2:36 PM. The clinic note contained elements of a history and physical with no evidence of an update before surgery.

b. Patient #1012 underwent general anesthesia for a fracture to the left ankle on 10/14/21. The medical chart review showed an Emergency Department Provider Documentation Report dated 10/11/21 at 4:45 PM. There was no evidence the surgeon provided an history and physical prior to surgery.

3. At the time of the medical record review, Staff #1010 confirmed the finding and stated that a history and physical needs to be on the chart prior to surgery.
.

.
Based on interview, record review and document review, the Critical Access Hospital failed to meet the regulation and reflect professional standards for post-anesthesia evaluation for 4 of 4 patients reviewed (Patient #1010, #1011, #1012 and Patient #1014).

Failure to perform a comprehensive post-anesthesia evaluation of patients recovering from anesthesia places patients at risk of harm related to unrecognized complications of anesthesia and delays in necessary treatment.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Postoperative Anesthesia Care," policy #4514700, last approved 01/13, showed the following:

a. An anesthetist is responsible for post anesthesia care for all patients.

b. At least one post anesthetic visit will be recorded, describing the presence or absence of anesthesia related complications.

c. The post anesthesia visit will include, respiratory function, including rate, airway patency, oxygen saturation, cardiovascular function, including pulse rate and blood pressure, and mental status.

2. On 11/03/21 at 2:00 PM, Surveyor #10 and the Chief Nursing Officer (Staff #1010) reviewed the medical records for the following:

a. Patient #1010 underwent general anesthesia for a right shin wound debridement on 10/11/21. The post anesthesia note showed "airway/vital signs stable".

b. Patient #1011 underwent general anesthesia for a colonoscopy on 10/11/21. The post anesthesia note showed "airway/vital signs stable".

c. Patient #1012 underwent general anesthesia for a left ankle fracture on 10/14/21. The post anesthesia note showed "airway/vital signs stable".

d. Patient #1014 underwent general anesthesia for a Cervical Cone Biopsy on 10/13/21. The post anesthesia note showed "airway/vital signs stable".

3. At the time of the medical record review, Staff #1010 confirmed the finding and stated that the post evaluation should have all required elements. Staff #1010 presented a form that the facility had used in the past containing all the requirements for a post anesthesia evaluation. Staff #1010 stated that the anesthesia providers requested to use their own form.
.

.
Item #1 - On-site laundry quality control

Based on observation and interview the Critical Access Hospital failed to monitor laundry temperature parameters when laundering hospital linens in the on-site laundry facility.

Failure to ensure linen and laundry meets industry standards for cleanliness and sanitary condition puts patients and staff at increased risk to harmful pathogens.

Reference: Centers for Disease Control and Prevention (CDC) and the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guidelines for Environmental Infection Control in Health-Care Facilities 2003 Updated: July 2019; Recommendations - Laundry and Bedding IV. Laundry Process A. If hot-water laundry cycles are used, wash with detergent in water >160 degrees Fahrenheit (>71 degrees Celsius) for >25 minutes. D. Choose chemicals for low-temperature washing at proper use concentration if low-temperature (<160 degrees Fahrenheit [<70 degrees Celsius]) laundry cycles are used.

Findings included:

1. On 11/02/21 at 10:40 AM, Surveyor #6 inspected the on-site laundry with the Director of Ancillary Services (Staff #601) and the Facilities Manager (Staff #608). The observation showed 2 large commercial front loading washing machines, a smaller commercial top loading washing machine, and 3 large commercial dryer units.

2. At the time of the inspection Surveyor #6 requested policies relating to laundry quality control such as hot water wash cycle temperature and duration, and pH ranges. Staff #608 stated that he did not know of any policies but would look for them. The surveyor did not receive any laundry policies.

3. At the time of the inspection, Surveyor #6 interviewed Staff #608 about quality control standards of the laundry process. Staff #608 stated that the hot water wash was 160 degrees Fahrenheit, but he did not know how long the cycle was or whether there was a pH shift during the cycle. He stated that the laundry chemical contractor maintained the machines to meet regulatory requirements but did not provide documentation.

Item #2 - Disinfectant contact time

Based on observation, document review, and interview, the Critical Access Hospital failed to ensure 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 2 of 3 staff interviews (Staff #610 and Staff #611).

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

Reference: Centers for Disease Control and Prevention (CDC) Guidelines for Environmental Infection Control in Health-Care Facilities (2003), updated 07/19: Part II. E. Recommendations - Environmental Surfaces I. Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas A. Select EPA registered disinfectants and use them in accordance with manufacturer's instructions.

Findings included:

1. Document review of the manufacturer ' s instructions for use for Virex® II 256, a one-step disinfectant cleaner, showed that to disinfect, all surfaces must remain wet for 10 minutes.

2. On 11/03/21 at 10:20 AM, Surveyor #6 interviewed an Environmental Services (EVS) Housekeeper, (Staff #610) about the disinfectant used for daily cleaning and discharge cleaning of patient rooms. Staff #610 stated that she thinks the disinfectant is Virex 256, that it ' s the longest contact time, 5 to 10 minutes - 10 minutes at most. "

3. On 11/03/21 at 11:05 AM, Surveyor #6 interviewed and EVS Housekeeper (Staff #611) about the disinfectant used for Operating Room terminal cleaning. Staff #611 stated that the disinfected surfaces must stay wet for 2 hours.
.

.
Item #1 - Kitchen sanitation

Based on observation, document review, and interview, the Critical Access Hospital failed to provide a clean and sanitary kitchen environment by not maintaining an effective sanitizer solution for use on food contact and kitchen surfaces.

Failure to ensure appropriate concentration of sanitizer solution in food service settings puts patients and staff at increased risk of exposure to harmful microorganisms.

Findings included:

1. Document review of the product information for Oasis 146 Multi-Quat Sanitizer shows that it is an effective sanitizer at 200 ppm - 400 ppm active quat for used on food contact surfaces in 500 ppm hard water against listed bacteria.

2. On 11/02/21 between 8:40 AM and 9:40 AM, the Director of Ancillary Services (Staff #601), a Food Services staff member (Staff #602), and Surveyor #6 toured the hospital ' s food service kitchen. During the tour, Surveyor #6 used a Hydrion Qt-40 test paper to measure the concentration of quaternary sanitizer in a sanitizer bucket containing a wiping cloth. The test strip did not change color, indicating no effective sanitizing agent in the solution.

3. At the time of the observation, Surveyor #6 interviewed Staff #602 about the sanitizer concentration. Staff #602 stated that the sanitizer solution (Ecolab quaternary ammonia), was prepared at 6:00 AM daily and replaced with a new solution at 10:00 AM. Staff #602 replaced the sanitizer with a fresh solution.

Sanitizer solutions must meet specific concentrations for use according to federal regulations and manufacturer instructions.

Reference: 2009 FDA Food Code 3-304.14

Item #2 - Maintaining clean and sanitary environment

Based on observation and interview, the Critical Access Hospital failed to maintain a clean and sanitary environment by not ensuring patient care areas are adequately cleaned between patients.

Failure to properly clean patient care areas puts patients and staff at an increased risk of exposure to harmful microorganisms.

Reference: Centers for Disease Control and Prevention (CDC) Guidelines for Environmental Infection Control in Health-Care Facilities; Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPC) 2003, updated July 2019. Part II. Recommendations for Environmental Infection Control in Health-Care Facilities, E. Recommendations - Environmental Services, I. Cleaning and Disinfection Strategies for Environmental Surfaces in Patient-Care Areas, E. Keep housekeeping surfaces (e.g., floors, walls, and tabletops) visibly clean on a regular basis and clean up spills promptly. II. Cleaning Spills of Blood and Body Substances, A. Promptly clean and decontaminate spills of blood or other potentially infectious materials.

Findings included:

1. On 11/02/21 at 10:30 AM, during a tour of the hospital's Laboratory Services, Surveyor #6 and the Director of Ancillary Services (Staff #601) inspected the Blood Draw Room. The observation showed blood drops on the leg of the patient chair and on the floor.

2. At the time of the observation, Surveyor #6 interviewed Staff #601 about the hospital's expectations for sanitation in patient care areas. Staff #601 stated that the room, including the blood drops, should have been cleaned and sanitized after the last patient.

Item #3 - Endoscope Storage

Based on observation, document review, and interview, the Critical Access Hospital failed to prevent cross contamination of reprocessed endoscopes during storage.

Failure to store reprocessed endoscopes in a manner that prevents recontamination puts patients at increased risk of exposure to harmful microorganisms.

Reference: SGNA (Society of Gastroenterology Nurses and Associates, Inc.) Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes, 2018. Endoscope Reprocessing Protocol includes Storage. Endoscopes should hang freely so that they are not damaged or contaminated by physical impact ... hang vertically without coiling ...

Findings included:

1. Document review of the Olympus EVIS EXERA III COLONOVIDEOSCOPE Reprocessing Manual showed that before storing disinfected endoscope and accessories, all accessories should be detached.

2. On 11/03/21 between 8:30 AM and 9:00 AM, Surveyor #6 interviewed a Sterile Processing Technician (SPT) (Staff #603) about the reprocessing of an Olympus colonoscope following a patient procedure (no procedures were scheduled during the survey). Staff #603 described the reprocessing steps, including pre-cleaning immediately following patient procedure, leak testing, manual cleaning, visual inspection, high-level disinfection (HLD) with adherence to chemical instructions for use (IFU), and storage.

3. At the time of the interview, Surveyor #6 inspected the endoscope storage cabinet. The observation showed a colonoscope hanging with an auxiliary water line connected to colonoscope #97 and coiled around the insertion section. The surveyor asked Staff #603 about the auxiliary water line on the reprocessed colonoscope. Staff #603 stated that the Olympus Representative trained the SPTs and told them it was okay.

Item #4 - Hand Hygiene

Based on observation, document review, and interview, the Critical Access Hospital failed to ensure that hand hygiene (HH) supplies were available according to hospital procedure and accepted standards of practice.

Failure to provide hand hygiene supplies risks transmission of communicable diseases between staff and patients.

THIS IS A REPEAT CITATION - PREVIOUSLY CITED APRIL 2019

Reference: Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR), October 25, 2002 / Vol. 51 / No. RR-16, Guideline for Hand Hygiene in Health-Care Settings, Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Perceived barriers to adherence with HH practice recommendations include inaccessible HH supplies. Easy access to HH supplies is essential for optimal adherence to HH recommendations.

Findings included:

1. Document review of the hospital's policy titled, "Hand Hygiene - CDC Guidelines," PolicyStat ID: 9830240, revised 05/21, showed that staff are to perform hand hygiene (soap & water handwash that includes drying hands with a clean paper towel) or alcohol-based hand rub (ABHR) at specific times and situations that include, before each patient encounter, and after coming in contact with patient's intact skin.

Document review of the hospital's policy titled, "Central Supply (CS): Hand Hygiene," PolicyStat ID: 7799795, approved 06/20, showed that hand hygiene is the most important procedure for preventing the spread of infection; hand hygiene is required before leaving the decontamination room for staff and visitors; hand hygiene is required after cleaning patient care equipment; the use of gloves is not an exception to hand hygiene

2. On 11/02/21 at 12:00 PM, during a tour of the hospital's Imaging Services, Surveyor #6 and the Director of Ancillary Services (Staff #601) inspected the X-Ray room. The observation showed the room was not supplied with alcohol-based hand rub and the handwashing sink was not supplied with a paper towel dispenser.

3. At the time of the observation, Surveyor #6 interviewed a Radiology Technologist (RT) (Staff #604) about hand hygiene in the X-Ray room. Staff #604 stated that he uses the ABHR dispenser in the hall when he changes gloves and washes his hands in a patient bathroom across the hall for a soap & water handwash.

4. On 11/03/21 at 7:30 AM, Surveyor #6 & Surveyor #10 arrived together at the hospital. A Registered Nurse (RN) (Staff #605) screened the surveyors for symptoms of COVID-19, including verbal questions and a temperature assessment with a digital ear thermometer. At the time of the screening, Staff #605 did not perform hand hygiene before or after encounter with either surveyor, or after contact with either surveyor's intact skin.

5. On 11/03/21 between 8:30 AM and 9:00 AM, Surveyor #6 inspected the Sterile Processing Department's decontamination room. The observation showed the room was not supplied with alcohol-based hand rub.

6. At the time of the observation Surveyor #6 interviewed a Sterile Processing Technician (SPT) (Staff #603) about hand-hygiene during decontamination procedures. Staff #603 stated that soap & water handwashing was done at the surgical scrub sink prior to donning gloves and when hands are visibly soiled. The surveyor asked Staff #603 about hand-hygiene when gloves are changed during decontamination procedures. Staff #603 stated that ABHR was available outside the decontamination room.

Item #5 - Reprocessing instruments

Based on observation, document review, and interview, the Critical Access Hospital failed to effectively clean instruments prior to disinfection and sterilization procedures.

Failure to adequately clean reusable patient care instrumentation compromises subsequent decontamination or sterilization of instruments and risks increased patient exposure to harmful microorganisms.

Reference: Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Update: May 2019. William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Cleaning and decontamination should be done as soon as possible after items have been used.

Findings included:

1. Document review of the hospital's policy titled, "Preparation, Handling and Transportation of Contaminated Devices," PolicyStat ID: 7799530, approved 06/21, showed that used instruments should be transported to the Sterile Processing decontamination area as soon after use as possible.

Document review of the hospital's policy titled, "Decontamination of Surgical Instrumentation," PolicyStat ID: 7799115, approved 06/20, showed that all instruments should be decontaminated as soon as possible following the procedure.

2. On 11/02/21 at 2:20 PM, during a tour of the Emergency Department with the Director of Ancillary Services (Staff #601) and the Assistant Chief Nursing Officer (CNO) (Staff #607), Surveyor #6 observed instruments (a suture kit) soaking in a basin and a 1-gallon bottle of Steris® Multi-Enzymatic cleaner with a pump dispenser beside the utility sink.

3. At the time of the observation, Surveyor #6 interviewed an Emergency Room (ER) Technician (Staff #606) about the soaking instruments. Staff #606 described the cleaning steps for instruments: used instruments are brought to the Soiled Utility Room when the patient room is cleaned; the used instruments are soaked in the basin of diluted enzymatic cleaner for a few hours; the instruments are rinsed in tap water and placed on an absorbent sheet and allowed to air dry, finally, the instruments are carried to the Sterile Processing Department. Staff #606 stated that only 1 suture kit had been used since 10/31/21 so the basin of instruments was probably soaking since that date.

Item #6 - Chemical solutions

Based on observation, document review, and interview, the Critical Access Hospital failed to avoid possible sources of infection by not following chemical manufacturer instructions for use.

Failure to ensure appropriate use and mixture of chemical solutions puts patients and staff at increased risk of exposure to harmful microorganisms.

Findings included:

1. Document review of the product label for Steris® Multi-Enzymatic Cleaner showed that the directions included instruction to dilute the product 1/4 - ½ fl. oz. per gallon (1-4 mL per liter) of warm water, depending on soil load.

Document review of the hospital's policy titled, "Decontamination of Surgical Instrumentation," PolicyStat ID: 7799115, approved 06/20, showed that manufacturer ' s instructions for use for cleaning and cleaning agents must be followed.

2. On 11/02/21 at 2:20 PM, during a tour of the Emergency Department with the Director of Ancillary Services (Staff #601) and the Assistant Chief Nursing Officer (CNO) (Staff #607), Surveyor #6 observed a basin containing soaking instruments and a 1-gallon bottle of Steris® Multi-Enzymatic cleaner with a pump dispenser beside the utility sink.

3. At the time of the observation, Surveyor #6 interviewed an Emergency Room (ER) Technician Staff #606) about preparation of the enzymatic cleaner. Staff #606 stated that a basin is filled with enough water to cover the instruments and 2 pumps from the bottle of enzymatic cleaner is added to the water. Staff #606 stated she did not know how much cleaner was dispensed with each pump, and did not know how much water was in the basin.

Item #7 - Cleanable surfaces

Based on observation and interview, the Critical Access Hospital failed to maintain surfaces that are cleanable and non-absorbent

Failure to maintain cleanable, non-absorbent surfaces puts patients and staff at increased risk of exposure to harmful microorganisms.

Findings included:

1. On 11/02/21 at 10:40 AM, Surveyor #6 inspected the on-site laundry with the Director of Ancillary Services (Staff #601). The observation showed the vinyl laminate cover on the laundry folding table was peeling in several places such that it exposed the plywood surface, chipped in several places, and held together with adhesive tape in several places.

2. At the time of the observation Surveyor #6 asked Staff #601 about the areas of peeling, broken, and taped laminate. Staff #6 confirmed the areas of absorbent surface (exposed plywood) and uncleanable adhesive tape.
.

.

Based on interview, document review, and review of the hospital's quality program, the hospital failed to develop, implement, and maintain an annual hospital-wide, data-driven quality assessment and performance improvement program that included systematic data collection, analysis, and implementation of process improvement with oversight of the hospital's Board of Commissioners.

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:

Cross Reference C-1306

1. Failure to oversee the performance of all patient care services and departments limits the hospital's ability to identify problems, formulate action plans, and implement sustained improvements in clinical care and patient outcomes.

Cross Reference C-1313

2. Failure of the Board of Commissioners to include and oversee the quality and performance of all patient care services, departments, and locations risks provision of improper or inadequate care, adverse patient outcomes, and limits the hospital's ability to provide high quality clinical care and improve patient outcomes.

Cross Reference C-1321

3. Failure to 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.

Cross Reference C-1325

4. Failure to systematically collect, analyze, assess, and monitor quality care indicator data limits the hospital's ability to formulate action plans for improvement and reduces the likelihood of sustained improvements in clinical care and patient outcomes.

Due to the cumulative effect of deficiencies cited under 42 CFR 485.641, the Condition of Participation for Quality Assessment and Performance Improvement Programs was NOT MET.
.

.
Based on interview, document review, review of the hospital's Quality Improvement Program Plan, and the Board of Commissioners documents, the hospital failed to develop and implement an ongoing and comprehensive quality program that involved all departments of the hospital and failed to ensure that performance measures for all patient care services including contracted services.

Failure to oversee the performance of all patient care services and departments limits the hospital's ability to identify problems, formulate action plans, and implement sustained improvements in clinical care and patient outcomes.

Findings included:

1. Document review of the hospital's document titled, " Quality Improvement Program Plan," policy # 10631267, last approved 11/21, showed the following:

a. The Quality Improvement Program Plan promotes objective and systematic measurement, monitoring and evaluation of services and supports the implementation of quality improvement activities based on incident reporting and quality indicator measurements data collection.

b. The primary purpose of the Quality Improvement Program and Department is to analyze, interpret and integrate data from multiple sources within the hospital system and to formulate recommendations for quality improvement activities.

c. The Quality Improvement Department supports quality improvement plans, initiatives, data collection and analysis across the organization.

d. The department works with other departments to formulate department specific quality improvement and risk reduction plans and activities.

e. The Quality Improvement Department supports the Medical Staff Office (MSO) in its quality initiatives and activities by assisting in the creation of appropriate quality measures tools, by providing the MSO with quality measurement data from other departments or services.

f. The Quality Improvement Department works with other hospital departments and staff to collect and collate quality indicator data from across the organization.

g. The Quality Improvement Department is responsible for assimilating quality data and assisting in creating quality improvement initiatives for other hospital departments as requested.

h. The department creates meaningful quality measure data reports for the Board of Commissioners and other department directors and managers.

i. The Board of Commissioners of the Okanagan Hospital's District dba Three Rivers Hospital is responsible to oversee the Quality Improvement Program.

j. The Board of Commissioners reviews and approves the Hospitals Annual Quality Improvement Plan.

k. The board Receives monthly reports on variety of hospital quality indicators or as requested.

l. The Board ensures that the Quality Department has the resource needed to carry out its responsibilities.

2. Document review of the hospital's Board of Commissioners By-Laws, dated 02/27/21, showed that the board shall maintain oversight and that the policies of the district are in proper relationship to community needs including requirements provided by WAC-243-320-131 as follows:

a. establishing and approving a performance improvement plan

b. providing organizational management and planning

3. On 11/04/21 Surveyor #10 reviewed the hospital's quality indicator spreadsheets for 2021 which were adopted from 2020. Surveyor #10 found no evidence that the hospital departments were collecting, measuring, or analyzing data and reporting to the quality committee.

Surveyor #10 found no evidence that contracted services were listed as part of the Quality Improvement Plan or in the hospital's 2020 or 2021 spreadsheets.

Surveyor #10 reviewed the hospital's Quality Committee minutes for 02/25/21, 03/25/21, 05/27/21, 07/22/21, and 09/23/21. Surveyor #10 found no evidence that quality improvement indicators were reviewed or discussed.

Surveyor #10 reviewed the hospital's Board of Commissioners minutes dated 12/30/20, 01/27/21, 02/24/21, 03/31/21, 04/28/21, 05/26/21, 06/30/21, 08/25/21, and 09/20/21. Surveyor #10 found no evidence that the Quality Improvement Department reported quality performance improvement data to the Board of Commissioners.

Surveyor #10 reviewed the Medical Staff Meetings minutes for 03/17/21,04/21/21, 05/19/21, 06/16/21, 07/21/21, and 09/15/21. Surveyor #10 found no evidence that the Quality Improvement Department provided the Medical Staff committee with quality measurement data from other departments or services.

3. On 11/04/21 at 1:00 PM, during an interview with Surveyor #10 about the hospital's Quality Improvement Program Plan, the Quality Director (Staff #1018) verified the following:

a. That the hospital's quality improvement indicators were not in the hospital's quality plan. Staff #1018 stated that the indicators in the spreadsheets were the hospital's approved quality indicator for 2020 and were adopted for 2021.

b. That there was no evidence that the hospital included contracted services in the hospital quality program or that any type of quality review had been completed by the Quality Committee or Board of Commissioners.

c. That the quality indicator spreadsheets for 2020 and 2021 were missing significant documentation of data for the hospital's identified quality improvement indicators.

Surveyor #10 found no evidence that the Board of Commissioners approved the adoption of the 2020 indicators for the hospital's 2021 annual quality program.
.

.
Based on interview, document review, and review of the hospital's Quality Improvement Program Plan, the hospital's leadership and Board of Commissioners failed to provide oversight to ensure full implementation of the quality improvement plan.

Failure of the Board of Commissioners to include and oversee the quality and performance of all patient care services and departments, risks provision of improper or inadequate care, adverse patient outcomes, and limits the hospital's ability to provide high quality clinical care and improve patient outcomes.

Findings included:

1. Document review of the hospital's document titled, " Quality Improvement Program Plan," policy # 10631267, last approved 11/21 showed the following:

a. The Board of Commissioners of the Okanagan Douglas Hospital District #1 dba Three Rivers Hospital is responsible to oversee the Quality Improvement Program.

b. The Board of Commissioners reviews and approves the hospitals Annual Quality Improvement Plan.

2. Document review of the hospital's Board of Commissioners By-Laws, dated 02/27/2021 showed that the board shall maintain oversight and that the policies of the district are in proper relationship to community needs including requirements provided by WAC-243-320-131 as follows:

a. establishing and approving a performance improvement plan

b. providing organizational management and planning

3.Document review of the Quality Improvement Program Plan and quality indicator spreadsheets for 2020 and 2021 year to date. Surveyor #10 observed that the hospital failed to collect data on its identified quality indicators for up to 22 month and failed to implement quality improvement.

4. On 11/04/21 at 1:10 PM, during an interview with Surveyor #10 about the hospitals Quality Improvement Plan, the Quality Director (Staff #1018) verified that the quality indicator spreadsheets for 2020 and 2021 were missing significant documentation and data for the hospitals identified quality improvement indicators. Staff #1018 stated that the hospital contracted her services in 07/21 to assist with their quality program up to standards.
.

.
Based on interview and review of the hospital's Quality Improvement Program Plan, 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 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 document titled, " Quality Improvement Program Plan," policy # 10631267, last approved 11/21, showed the following:

a. The Quality Improvement Program Plan promotes objective and systematic measurement, monitoring and evaluation of services and supports the implementation of quality improvement activities based on incident reporting and quality indicator measurements data collection.

b. The primary purpose of the Quality Improvement Program Plan and Department is to analyze, interpret and integrate data from multiple sources within the hospital system and to formulate recommendations for quality improvement activities.

2. Document review of the hospital's Board of Commissioners By-Laws, dated 02/27/201 showed that the Board shall maintain oversight and that the policies of the district are in proper relationship to community needs including requirements provided by WAC-243-320-131 as follows:

a. establishing and approving a performance improvement plan

b. providing organizational management and planning

3. Surveyor #10 reviewed the hospital's Pharmacy and Therapeutic minutes for 06/03/21 the review showed the following:

a. The group reviewed 12 medication errors from 08/20 to 06/21.

b. Antibiotic Days of therapy report, no data available and the hospital is about 8 months behind in their metrics.

4. On 11/04/21 at 1:30 AM, Surveyor #10 interviewed the Director of Quality (Staff #1018) about the medication errors. Staff #1018 stated that medication errors and antibiotic therapy reports are not reported through quality. Staff #1018 stated that she was hired as an interim in 07/21 and that they are working on creating processes for monitoring, evaluating performance and reporting through quality.
.

.
Based on interview, document review, and review of the hospital's Quality Improvement Program Plan, the hospital failed to ensure that the quality improvement committee received reports and tracked process improvement for quality indicator data as directed by its quality improvement program plan.

Failure to systematically collect, analyze, assess, and monitor quality care indicator data limits the hospital's ability to formulate action plans for improvement and reduces the likelihood of sustained improvements in clinical care and patient outcomes.

Findings included:

1. Document review of the hospital's document titled, "Quality Improvement Program Plan," policy # 10631267, last approved 11/21, showed the following:

a. The Quality Improvement Department supports quality improvement plans, initiatives, data collection and analysis across the organization.

b. The Quality Improvement Department works with other hospital departments and staff to collect and collate quality indicator data from across the organization.

c. The Quality Improvement Department is responsible for assimilating quality data and assisting in creating quality improvement initiatives for other hospital departments as requested.

d. The department creates meaningful quality measure data repots for the Board of Commissioners and other department directors and managers.

2. Document review of indicators that had been completed and not reported through quality included the following:

a. Perioperative Chart reviews

b. Patient Medication Verifications

c. Discharge Dispositions

d. Trauma Chart reviews

e. Stroke

f. Chest Pain

g. Sepsis

h. Meaningful use

i. Monthly Expirations checks

j. Patient Falls

k. Medication Events

3. On 11/04/21 at 1:30 PM, the Director of Quality (Staff #1018) confirmed that the above data collected was separate from the hospital quality indicator spreadsheets and has not been reported through quality. Staff #1018 also confirmed the that quality data and performance evaluation of all patient care services had not been completed for 2020 or 2021.

4. Surveyor #10 found no evidence that quality indicators were gathered for 2020-2021.
.