HospitalInspections.org

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Based on observation, interview, and record review the facility failed to ensure 2 sterile Obstetric (OB) trays and 1 sterile pack of two curved metal instruments (instruments used for the labor and delivery of newborns) was appropriately labeled after sterilization. These failed practices had the potential to compromise the sterility/cleanliness of medical devices that could affect direct patient care and outcomes during life-saving treatment. Findings:

An observation of the OB triage room of the Emergency Department on 3/21/22 at 4:43 PM, revealed:
- one sterile, wrapped tray labeled "OB Tray" with a sterilization sticker which read "Sterilized 444;"
- one sterile, wrapped tray labeled "OB Tray" that had no sterilization sticker; and
- one sterile, individual package of two curved metal instruments, which was not label, that had no sterilization sticker.

During an interview on 3/21/22 at 5:30 PM, Certified Nursing Assistant (CNA) #2 (who was the lead sterilizer for the facility) stated all sterile packages should be labeled and have the load number (the number to indicate which set of instruments were sterilized in the autoclave together, this allows instruments to be traced and tracked if a concern of sterility occurs in the future) and date of sterilization on the outer packaging.

During an interview on 3/21/22 at 5:45 PM, CNA #2 stated the one OB tray with the identification sticker which read "Sterilized 444" indicated the lot number for when that tray had been sterilized and agreed there was no date of sterilization on the sticker. He/she stated the other sterile OB tray and the unlabeled sterile pack of two curved metal instruments in the OB room did not have sterilization stickers. CNA #2 further stated that the facility should take the identified equipment out of service and re-sterilized.

Review of the "Daily Sterilization Records Forms," that documented the lot number and date of all sterilizations for all sterilized medical instruments for the facility, revealed that lot #444 was sterilized on 10/24/15. Further review revealed that lot #444 included two OB trays and two OB tools in this sterilization load.

Review of the facility's policy "Packaging, Storage, and Shelf Life," revised 3/28/18, revealed: " ...Packaging Procedure ... Label the package. Labeling must include description of package contents and load number. Use a permanent marker to write on sterilization tape or the plastic side of a peel pouch. When writing on peel pouches, make sure the ink is on the outer margin of the pouch. Initials of the package assembler/sterilizer operator and date of sterilization must be written in log book ..."

Further review of the facility's policy revealed no indication the sterilization date should have been included on the sterile packages.

Review of the "AORN [Association of Perioperative Registered Nurses - who represent registered nurses who facilitate the management, teaching, and practice of perioperative nursing] 2018 Guidelines for Perioperative Practice," revealed: "Packages to be sterilized should be labeled. Accurate labeling provides identification of the package contents as well as information that enables tracking of the sterilizer, sterilization cycle, personnel involved in the sterilization process, and the patient for whom the items were used ... Package labels should include:
- the sterilizer number or unique identifier if more than one sterilizer is in use;
- the cycle or load number;
- the date of sterilization;
- a description of the package contents ...; and
- identification of the assembler."
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Based on observation, interview, and record review the facility failed to ensure one infusion pump and one HEPA (high efficiency particulate air) filter had properly scheduled preventative maintenance. This failed practice had the potential for equipment failure when needed to meet patient needs. Findings:

An observation on 3/21/22 at 4:45 PM of the Emergency Department (ED) Room #1 revealed a HEPA filter, a "Sanuvair, Sanuvox S300 Air Filtration unit with UVC Bio-disinfection," Asset property tag #3575, had no preventative maintenance sticker.

An observation on 3/21/22 at 5:06 PM of the outpatient infusion room revealed an infusion pump, an "ICU Medical Plum 360," Asset property tag # 3569, had no preventative maintenance sticker.

During an interview on 3/23/22 at 1:18 PM, the Facility Manager stated the patient care equipment had preventative maintenance scheduled annually by a contracted service through Southcentral Biomed. The Facility Manager further stated the HEPA filter in ED Room #1 and the infusion pump in the outpatient infusion room had not been serviced on the last annual inspection of biomedical equipment, which occurred in August 2021.

Review of the facility's policy "Biomedical Equipment Management," last revised 1/17/22, revealed: " ...Biomedical equipment, both clinical and nonclinical, will be maintained at optimum performance through inspection, testing, and scheduled preventative and emergency maintenance. Biomedical equipment inspection will occur at least annually ... Definitions ... Clinical Equipment: This includes therapeutic, diagnostic, and monitoring devices that are directly involved in resident/patient care ... Non-Clinical Equipment: This refers to analytical and other miscellaneous equipment that is not used in direct patient treatment, such as laboratory analytical equipment. Preventative Maintenance: This is the systematic care, servicing, and inspection for the purpose of maintaining equipment in a serviceable condition and detecting and corrective defects before they result in equipment failure ..."
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Based on record review and interview the facility failed to ensure: 1) one Doctor of Medicine (MD) maintained credentialing/appointment to the medical staff and 2) the medical bylaws were current. This failed practice had the potential to affect the quality of care provided to patients. Findings:

Credentialing/Appointment

Record review on 3/24/22 revealed the Chief Executive Officer (CEO) was a Doctor of Medicine (MD) with the specialty of Family Practice and Emergency Department (ED). Further review revealed the CEO's Credentialing began 10/31/19 and expired on 10/31/21. Further review revealed the CEO's last appointment to the facility's medical staff was November 2019.

During an interview on 3/24/22 at 8:00 am, Human Resources (HR) stated the term of appointment for medical staff was revised from a two-year term to a three-year term on 10/14/20. She further stated that any credentialing or appointments made prior to 10/14/20 would have still been subjected to the two-year term of appointment parameters.

HR further stated that the CEO should have initiated a reappointment application prior to October 2021.

During an interview on 3/24/22 at 11:31 am, the CEO stated she had not completed a reappointment application since 2019.

Review of the on-call medical staff schedule, dated 10/31/21 to 3/24/22, revealed during the time the CEO's credentialing and appointment to the medical staff was expired, the CEO covered Emergency Department/Critical Access Hospital (CAH) shifts for patient care 6 times (2/4/22; 2/10/22; 2/24/22; 2/25/22; 3/3/22; and 3/4/22).

Review of the facility's policy "Credentialing/Re-Credentialing," revised 1/6/22, revealed: " ... CMS [Centers for Medicaid and Medicare Services] expects that all physician practitioners granted privileges are also appointed as members of the medical staff ... All Physicians and Allied Health Professionals requesting privileges at [Facility Name] are subject to approval by the Chief Executive Officer and will be credentialed upon that approval ..."

Review of the facility's policy "Credentialing Process," revised 11/19/20, revealed: " ... Credentialing/Privileging is completed under the guidelines found in the Med [medica] staff bylaws; ultimately, the [Facility Name] Board of Authority, the governing entity of [Facility Name], appoints physicians and grants privileges ..."

Review of the facility's "[Facility's Name] Medical Staff Bylaws," last revised 10/14/20, revealed: "Article II Membership Section 1. Membership Qualifications: Membership on the staff of [Facility Name] is a privilege which shall be extended only to those practitioners legally licensed to practice in the State of Alaska who strictly meet and continue to meet the standards and requirements set forth in these bylaws and can document that they are qualified to provide high quality patient care, treatment and services within the scope of the Privileges requested ... Section 4. Procedure for Reappointments: 1. At least sixty (60) days prior to the termination of the Medical Staff three-year period [or two-year period prior to 10/14/20], the active staff shall undertake a review of all information available on the then members of the Medical Staff, for the purpose of determining justification for their reappointment to the Medical Staff for the ensuing three-year period ... 2. As least thirty (30) days prior to the termination of the medical staff three-year period [or two-year period prior to 10/14/20], the Medical Director shall make its recommendation to the Governing Body recommending the reappointment or non-reappointment of privileges (including increases or restrictions) of each member of the Medical Staff for the ensuing three-year period ..."

Medical Bylaws

Record review on 3/21/22 revealed the Medical Staff Bylaws were adopted 10/7/2015 and last revised 10/14/20. Further review revealed the 2020 Bylaws were adopted, with signature approval, on 11/2/20 by the Administrator and Chief of Staff and on 11/18/20 by the Board Chairman.

During an interview on 3/23/22 at 9:00 am, the CEO stated the Medical Bylaws need to be reviewed annually and were reviewed in September 2021. She further stated the Bylaws were not revised, therefore the date on the Bylaws was not changed. When asked to see the approval signatures for the September 2021 review, the CEO stated there was no signature approval.

Review of the facility's "[Facility's Name] Medical Staff Bylaws, last revised 10/14/20, revealed: " ... For the purpose of these bylaws, the Medical staff year commences on the first (1st) day of January and ends on the thirty-first (31st) day of December of each year."

"Article IX Amendments to Bylaws: These bylaws may be amended after notice is given at any regular meeting. Such notice shall be laid on the table until the next regular meeting and shall require a two-thirds majority of those present for adoption. Amendments so made, shall be effective when approved by the governing board. Article X Adoption: These bylaws, together with the appended rules and regulations, shall be adopted at any regular meeting of the Medical staff; shall replace any previous bylaws, rules and regulations; and shall become effective when approved by the governing board of the Medical Canter. They shall, when adopted and approved, be equally binding on the governing board and the Medical staff."

Further review of the Medical Bylaws revealed no indication that the Bylaws needed to be reviewed and approved annually, regardless of whether amendments to the Bylaws were made or not.
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Based on record review, observation, and interview the facility provided dressing changes to one patient's wound (#1) without a medical order. This failed practice created a risk for inconsistent treatment resulting in poor wound healing. Findings:

Record review on 3/21-25/22 revealed Patient #1 had diagnoses that included a chronic deformation to the bones and tissues of the foot that can cause deformity, numbness and skin breakdown and atrial fibrillation (a rapid heart rate that can cause poor blood flow).

During an observation on 3/21/22 at 4:11 PM, Patient #1 was observed seated in a recliner in his/her room. The Patient did not have a sock on the left foot. The foot was elevated on a pillow and a wound was observed on the bottom of the foot.

During and interview on 3/21/22 at 4:11 PM, Patient #1 stated he/she was waiting for the Physician to examine his/her foot. The Patient stated he/she was at the hospital for physical therapy and wound care.

Review of the Treatment Administration Record (TAR) and physician orders in the medical record revealed no information about the treatment to Patient #1's foot.

During an interview on 3/25/22 at 10:30 AM, when asked why type of treatment Patient #1 received to his/her left foot, Licensed Nurse (LN) #1 stated it was an "biologic [type if drug class]" and covered with an Adaptic (non-adhering) dressing. The LN was unable to locate orders for the dressing changes. When asked how staff monitored how often the dressing needed to be done and where it was documented, LN #1 replied they tracked the dressing changes on the desk calendar at the nursing station and documented the information in the nurses' notes.

During an interview on 3/25/22 at 10:55 AM, when asked what treatment Patient #1 was to receive on his/her foot, Physician #2 located a progress not from his visit with Patient on 3/10/22. During the interview, the Physician stated he had been unbale to enter Adaptic dressing order into the facilities electronic medical record system.

Review Physician #2's Progress Note, dated 3/10/22, revealed "Left Foot Ulcer" "Q [every] 48 hr [hour] Adaptic/Bactroban [antibiotic ointment] dressing changes" and "Start biological graft once available." Rep for company will help demonstrate application processes."

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Based on record review and interview the facility failed to maintain records that included evidence of properly executed informed consents for 1 non-English speaking patient (#7), out of 1 non-English speaking patients sampled. Specifically, the hospital did not provide a Spanish interpreter for patient #7 while completing Emergency Department (ED) admission paperwork that included consent for treatment, patient rights and responsibilities, and consent for the use and disclosure of protected health information (PHI). This failed practice violated the patient's right to be receive all information about the rights of a patient and any proposed treatment in terms he/she could understand. Findings:

Record review from 3/21-25/22 revealed Patient #7 was seen in the facility's ED on 8/1/21 for shortness of breath with chest pain.

Review of the "Nursing Triage" Admission Data, dated 8/1/21, revealed Patient #7 was accompanied to the ED by a "Friend."

Review of the ED admission paperwork for Patient #7, dated 8/1/21, revealed:

1. The Patient's "Patient Information Sheet" indicated Patient #7's language was "Spanish."

2. The Patient's "Consent for Treatment and Financial Agreement," which was in English, was signed by the Patient and witnessed by Certified Nursing Assistant (CNA) #1.

3. The Patient's "Consent for the Use and Disclosure of Protected Health Information (PHI)," which was in English, was signed by the friend that accompanied Patient #7 to the ER, "For: [Patient's name] By: [accompanying friend]." Further review revealed the statement "I fully understand and ACCEPT the terms of this consent." This consent form also documented that consent was received by CNA #1.

4. The Patient's "[Facility] Hospital Patient Rights and Responsibilities," which was in English, was signed by the friend that accompanied Patient #7 to the ER, "For: [Patient's name] By: [accompanying friend]." Further review revealed this form was also signed by CNA #1.

Review of Patient #7's "ED Note" written by Physician #1, dated 8/1/21, revealed: "[He/she] is from Mexico and is Spanish-Speaking only. [He/she] denies any fever, but is having difficulty conversing due to [his/her] breathing situation ..."

Further review of Patient #7's medical record revealed no documentation as to who interpreted for Patient #7, and if the friend did interpret, if the interpreter service was utilized to confirm the translation from the friend was accurate.

During an interview on 3/26/22 at 7:30 AM, the Chief Nursing Officer (CNO) stated Physician #1 who treated Patient #7 on 8/1/21 was fluent in Spanish, however Physician #1 confirmed with her that he did not interpret for this Patient during his/her care.

During an interview on 3/25/22 at 10:33 AM, CNA #2 stated when a non-English speaking patient arrived in the ED, he/she would call the facility's interpreter service "Language Link" immediately to help complete paperwork, processing, and assessments. CNA #2 further stated family or friends accompanying patients would not be used for interpreting for the patient.

During an interview on 3/25/22 at 10:33 AM, Licensed Nurse (LN) #1 stated it was best to call "Language Link" to help complete assessments and paperwork with a non-English speaking patient. LN #1 further stated family or friends should not interpret for patients.

An observation of the ED on 3/25/22 at 10:40 AM, revealed the number for the "Language Link" interpreter service was located by the ED Nurse's desk phone and by each phone in ED rooms #1 and #2. Below the numbers there were detailed instructions on how to call the interpreter service.

Review of the facility's policy "Interpreter Services," effective 7/29/20, revealed: " ... [Facility] shall use a qualified translator when translating written content in paper or electronic form. All vital documents shall be translated in frequently encountered languages. Vital documents that are not available in a written translation shall be verbally translated to the patient. The provision of oral translation of all vital documents shall be documented in the patient's medical record."

"The following types of encounters, when performed by providers who do not speak the same language spoken by the patient, shall require the use of healthcare interpreter services, including, but not limited to: ... explaining patient rights and responsibilities, obtaining informed consent ... obtaining financial and insurance information ..."

"[facility] shall not: require a patient with limited English proficiency to provide his/her own interpreter. Rely on an adult accompanying a patient with limited English proficiency to interpret or facilitate communication, except: in an emergency involving an imminent threat to the safety or welfare of an individual where there is not qualified interpreter for the individual with limited English proficiency immediately available."

"Where the individual with limited English proficiency specifically requests that the accompanying adult interpret for facilitate communication, the accompanying adult agrees to provide such assistance, and reliance on that adult or such assistance is appropriate under the circumstances ..."

" ... Should a patient insist upon the use of a friend or family member to provide him/her with interpreting service, staff shall ensure that a healthcare interpreter is also present in person or via telephone to participate in the exchange to confirm that the translation represents an accurate portrayal of the information to staff and to patient ..."
"Telephone Interpreting Services: [Facility] provides a qualified interpreter for an individual with limited English proficiency through telephone interpreting services ..."

" ... Procedure: Upon presentation to [Facility], language needs shall be determined for all patients: ... When a patient self-identified as not being fluent in English, the patient's primary language shall be documented in the patient's medical record. The name of the individual who interprets for the patient shall be documented in the medical record."
"Acceptable methods for the provision of interpreter services shall include, but not limited to, the following: In-person interpreting, Telephone-based interpreting Company Name: Language Link ..."
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Based on interview and record review the facility's infection prevention and control program failed to:

1) ensure the facility followed instructions provided by the manufacturer for the chemical cleaners and disinfectants in the decontamination process of medical instruments;

2) ensure the facility supplied the needed chemical cleaner, Cidex OPA Concentrate (a high level disinfecting solution), for the proper disinfection of transvaginal ultrasound probes, as per the facility's policy and procedures; and

3) ensure the facility followed manufacturer's recommendations for the sterilization of laryngoscope blades (a smooth metal blade used through the mouth and throat to open the airway for the insertion of endotracheal tubes to assist in breathing).

These failed practices had the potential to compromise the decontamination and sterility of medical instruments, to include instrument failure during patient care, which could increase the risk of infection transmission and poor outcome. Findings:

Chemical Cleaners and Disinfectants in the Decontamination Process:

During an interview on 3/21/22 at 5:20 PM, Certified Nursing Assistant (CNA) #2 (who was the lead sterilizer for the facility and facility identified trainer for all staff who assist with the decontamination/sterilization of medical instruments) stated there were specific steps to decontaminate medical instruments:

1) Used medical instruments were rinsed at the point of care and placed in grey rigid, covered tubs.

2) These tubs were transported to the soiled room; the instruments were placed in different grey tubs on a table within the soiled room and sprayed with "Pre-Klenz Instrument Transport Gel" (which helps maintain moisture of instruments and protect instrument surfaces from corrosion).

3) Personal Protective Equipment (PPE) of a disposable gown, shoe coverings, eye protection, and gloves are worn during the decontamination of medical instruments.

4) Two sinks were used for the first step of cleaning the instruments, a dirty side and a clean side. The dirty side would be filled with tap water to the indicated pre-measured "fill" line (a piece of blue tape on the side of the sink) and "Prolystica Enzymatic Presoak and Cleaner" (a low foaming cleaner for surgical instruments designed for both manual and automatic cleaning) would be added to the water by pressing a pre-dosed button on an adjusted dispenser twice.

5) The instruments were scrubbed clean and rinsed with tap water in the clean side sink.

6) The instruments were then placed in a "Cavitator Ultrasonic Cleaner" (generates ultrasonic waves that create millions of tiny bubbles through the process of cavitation, cleaning and polishing every surface and hard to reach space to dislodge trapped debris) with "Enzol Enzymatic Detergent"(a mild pH enzyme-based presoak plus cleaner for removing tough, dried on or hard to reach organic matter from instruments), 2 pumps of the detergent for every 6 cups of water, and they were cleansed in the ultrasonic cleaner for 6 minutes.

7) The instruments were then taken from the Cavitator and placed in a separate, dry sink and sprayed with "Weiman Germicidal Solution" (a general-purpose cleaner, deodorizer and disinfectant) and left to sit for 6 minutes.

8) The instruments were then rinsed with distilled water and placed on blue medical towels, to dry for 24 hours.

9) The next day, the instruments were ready to pack.

10) If the instrument was individually packaged, it would be placed in a sterile package 1 inch away from the opening. Any sharps (instruments that have a blade or sharp edge) would be placed on a sharps card first to prevent puncturing of the package. A sterilization indicator strip would also be included into the packaging. Then this package would be sealed using a machine to seal the package closed.

11) If the instruments were a set that needed to be packaged together, they would be placed in metal trays and wrapped with blue medical paper-like wrappings and taped closed with special sterilization indicator tape (tape that will react to sterilization, by showing brown lines, to indicate the package is sterile).

12) The individual packages and instrument tray wraps would then be sterilized in the autoclave, a "STERIS Amsco Century V-120 Prevacuum Sterilizer" (prevacuum - the process of the evacuation of air from the autoclave chamber prior to the sterilization process, as air in the chamber can result in sterilization failure) and once cooled would be labeled with an identification sticker that had the lot number and date they were sterilized.

13) The sterilized trays and packages would be stored in the sterilized, temperature-controlled room until used.

Review of the "Enzol Enzymatic Detergent" directions for use, dated 2021, revealed: ...May be used for precleaning instruments in automated equipment such as ... ultrasonic cleaners ... Thoroughly rinse the equipment aspirating water through all channels, to remove traces of Enzol Detergent ...." Based on these instructions, the facility did not rinse the medical instruments after the Cavitator ultrasonic cleansing, to remove the Enzol Enzymatic Detergent, prior to the application of Weiman Germicidal Solution.

Review of the "Weiman Germicidal Solution" directions for use, dated 8/9/13, revealed "Surgical Instrument Presoak: Fill appropriate sized container with sufficient amount of Weiman Germicidal Solution [this product] in which to completely immerse instruments. Place precleaned instruments in undiluted solution to presoak surgical instruments for a minimum of 10 minutes then proceed with normal sterilization procedure." Based on these instructions, the facility did not immerse the medical instruments as recommended and did not keep the instruments in the Germicidal Solution for the recommended minimum timeframe of 10 minutes.

Review of the facility's policy "Products for Cleaning and Disinfection," revised 3/28/18, revealed: " ...The terms chemical cleaner and disinfectant refer to any product used in the cleaning, decontamination, and disinfection process of surgical instruments, including enzymatic products, detergents, descalers, pre-soaks, and instrument lubricants ... The instructions provided by the manufacturer of the chemical cleaners and disinfectants are strictly adhered to. This includes the minimum and maximum effective concertation, immersion time, and water temperature ..."

Transvaginal Ultrasound Probes:

During an interview on 3/24/22 at 5:00 PM, CNA #2 stated that transvaginal ultrasound probes were supposed to be cleaned using "Cidex OPA Concentrate" by soaking them for 15 minutes, thoroughly rinsing them off, and allowing them to air dry prior to them being placed back into service, however the facility had been without Cidex OPA Concentrate for about 2 or 3 years.

CNA #2 further stated that transvaginal ultrasound probes had not been used for years at the facility and could not identify how the facility would clean the probes if they were to be used.

An observation of the OB triage room on 3/21/22 at 4:45 PM, revealed a "Siemen Healthineers" Ultrasound machine with a transvaginal ultrasound probe present and ready for patient use.

During an interview on 3/25/22, the Material Manager stated the facility had not ordered Cidex OPA Concentrate since they moved to an electronic ordering system, which was about three years ago. She could not remember the last time Cidex OPA Concentrate was ordered.

Review of the facility's policy "Disinfection of Semi-Critical Items," revised 3/28/18, revealed: " ...High level decontamination. The removal of pathogens by soaking in an antimicrobial solution. The only high level decontamination liquid approved for use at [Facility Name] is CIDEX OPA ... Semi-Critical Items. These are items that may be used inside the body in areas not considered to be sterile ... At [Facility Name] the transvaginal probe ... are considered semi-critical. The following policy provides for the decontamination of semi-critical items to include, but not limited to transvaginal ultrasound probes. Procedure ...

- After use, the probe cover will be removed from the transvaginal probe and the excess transducer gel wiped off with a sporicidin disinfectant towel.

- The probe ... will be inspected for any debris. Any material will be washed off with soap and water or enzymatic cleaner.

- In a well ventilated area the decontamination container will be filled to a ... adequate level with Cidex OPA to cover the instrument. The Cidex OPA Solution test strip will be used to test for strength. If adequate, the test result and date will be logged. The solution must be discarded at 14 days even if the test strip indicates the solution is still good ... The transducer must be disconnected and only the transducer is submerged. A timer is set for 12 minutes. Due to possible damage with prolonged exposure the probe should be removed as soon as practical after the timer has gone off.

- Soak the probe ... in potable water for one minute and rinse... Repeat the process for a total of 3 rinses.

- Return the item back to service ..."

Laryngoscope Blades:

During an interview on 3/24/22 at 5:00 PM, CNA #2 stated the laryngoscope blades were sterilized through the same decontamination and sterilization process as all other medical instruments, to include the autoclave.

An observation of Emergency Department (ED) Room #2 on 3/24/22 at 5:26 PM, revealed a variety of "WelchAllyn" laryngoscope blades, both straight and curved, in a soft blue case ready for use if needed.

An observation of the sterile instrument room on 3/24/22 at 5:26 PM, revealed 2 "American Diagnostic Corporation (ADC)" laryngoscope blades in individual sterile packaging.

Review of the "WelchAllyn Standard Laryngoscope Blade Care and Maintenance," undated, revealed: " ... Warning: Ultrasonic cleaning is not recommended ... Steam Autoclave is appropriate ... Note: Do not exceed temperature of 280° F [Fahrenheit] and pressure of 28 psi [pounds per square inch]."

Review of the "ADC Satin Standard, Fiber Optic and Disposable Laryngoscope Blades and Handles Directions for Use," undated, revealed: " ... Cleaning, Disinfecting, and Sterilization Procedures ... Cleaning Procedure for All Reusable Models ... Warning: Ultrasonic cleaning is not recommended ... Steam Sterilization for Standard and Fiberoptic Blades: Sterilizer Type: Prevacuum ... Full Cycle Time: 4 minutes; Minimum Dry Time: 20 minutes ..."

Review of the facility's autoclave, a "STERIS Amsco Century V-120 Prevacuum Sterilizer," operating instructions, dated 8/7/08, revealed a typical 275° F Prevac (prevacuum) Cycle (which was the cycle setting the facility used for sterilization of medical instruments) had a sterile time of 3 minutes and a dry time of 16 minutes.

Review of two randomly selected autoclave sterilization printed cycle reports from the facility's autoclave records, which were 275° F Prevac (prevacuum) Cycles, revealed:

- on 3/15/22, a 275° F Prevac Cycle, revealed the maximum psi reached was 36.0 psi. The sterilization time was 3 minutes, dry time was 16 minutes.

- on 3/22/22, a 275° F Prevac Cycle, revealed the maximum psi reached was 36.6 psi. The sterilization time was 3 minutes, dry time was 16 minutes.

Based on manufacturer's guidelines, these cycles would have exceeded the 28 psi recommended limit for the WelchAllyn laryngoscope blades and would not have been long enough for the recommended 4 minute full sterilization time or a minimum dry time of 20 minutes for the ADC laryngoscope blades.

Review of the "Daily Sterilization Records Forms," dated 10/12/16 to 4/12/21, the facility had sterilized 7 laryngoscope blades in the autoclave using this 275° F Prevac Cycle.

Review of the facility's policy "Disinfection of Semi-Critical Items," revised 3/28/18, revealed: " ...When possible heat tolerant laryngoscope blades will be sterile using applicable procedures ..."
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Based on interview and record review the facility' Infection Preventionist failed to ensure the competency-based training and education provided to personnel on the facility's current decontamination/sterilization process was consistent with the facility's actual decontamination/sterilization process being used. This failed practice had the potential for inconsistent decontamination/sterilization of medical instruments resulting in sterilization failure, which could increase the risk of the infection transmission and affect patient outcome. Findings:

During an interview on 3/21/22 at 5:20 PM, Certified Nursing Assistant (CNA) #2 (who was the lead sterilizer for the facility and facility identified trainer for all staff who assist with the decontamination/sterilization of medical instruments) stated there were specific steps to decontaminate and sterilize medical instruments:

1) Used medical instruments were rinsed at the point of care and placed in grey rigid, covered tubs.

2) These tubs were transported to the soiled room; the instruments were placed in different grey tubs on a table within the soiled room and sprayed with "Pre-Klenz Instrument Transport Gel" (which helps maintain moisture of instruments and protect instrument surfaces from corrosion).

3) Personal Protective Equipment (PPE) of a disposable gown, shoe coverings, eye protection, and gloves are worn during the decontamination of medical instruments.

4) Two sinks were used for the first step of cleaning the instruments, a dirty side and a clean side. The dirty side would be filled with tap water to the indicated pre-measured "fill" line (a piece of blue tape on the side of the sink) and "Prolystica Enzymatic Presoak and Cleaner" (a low foaming cleaner for surgical instruments designed for both manual and automatic cleaning) would be added to the water by pressing a pre-dosed button on an adjusted dispenser twice.

5) The instruments were scrubbed clean and rinsed with tap water in the clean side sink.

6) The instruments were then placed in a "Cavitator Ultrasonic Cleaner" (generates ultrasonic waves that create millions of tiny bubbles through the process of cavitation, cleaning and polishing every surface and hard to reach space to dislodge trapped debris) with "Enzol Enzymatic Detergent"(a mild pH enzyme-based presoak plus cleaner for removing tough, dried on or hard to reach organic matter from instruments), 2 pumps of the detergent for every 6 cups of water, and they were cleansed in the ultrasonic cleaner for 6 minutes.

7) The instruments were then taken from the Cavitator and placed in a separate, dry sink and sprayed with "Weiman Germicidal Solution" (a general-purpose cleaner, deodorizer and disinfectant) and left to sit for 6 minutes.

8) The instruments were then rinsed with distilled water and placed on blue medical towels, to dry for 24 hours.

9) The next day, the instruments were ready to pack.

10) If the instrument was individually packaged, it would be placed in a sterile package 1 inch away from the opening. Any sharps (instruments that have a blade or sharp edge) would be placed on a sharps card first to prevent puncturing of the package. A sterilization indicator strip would also be included into the packaging. Then this package would be sealed using a machine to seal the package closed.

11) If the instruments were a set that needed to be packaged together, they would be placed in metal trays and wrapped with blue medical paper-like wrappings and taped closed with special sterilization indicator tape (tape that will react to sterilization, by showing brown lines, to indicate the package is sterile).

12) The individual packages and instrument tray wraps would then be sterilized in the autoclave, a "STERIS Amsco Century V-120 Prevacuum Sterilizer" (prevacuum - the process of the evacuation of air from the autoclave chamber prior to the sterilization process, as air in the chamber can result in sterilization failure) and once cooled would be labeled with an identification sticker that had the lot number and date they were sterilized.

13) The sterilized trays and packages would be stored in the sterilized, temperature-controlled room until used.

During an interview on 3/23/22 at 3:00 PM, CNA #2 stated he/she was taught the decontamination/sterilization process by attending a training at Providence Hospital with another employee, CNA #4 (who no longer works at the facility). CNA #2 stated he/she had trained three other staff (CNA #1 and #3, Lab Tech #1) to assist with decontaminating and sterilizing medical instruments.

During an interview on 3/24/22 at 4:20 PM, the Chief Nursing Officer (CNO), who was the facility's Infection Preventionist, stated CNA #2 completed training and a competency checklist for the decontamination/sterilization of medical instruments prior to staff assisting in the process.

Review of the facility's "Sterile Process Competency Inventory" used for training and competency check off for decontamination/sterilization of medical instruments, undated, revealed: "Staff will be able to demonstrate the flow of items through Sterile Processing Department progressively from being contaminated to clean, to sterile ... Presoaking with Pre-Klenz - should be done as soon as possible after instrument is used. Spay Pre-Klenz on until evenly coated. Manually Cleaning Instruments: Fill sink with warm water to appropriate level to fully immerse surgical instruments. Use STERIS Acu-sinQ Enzymatic Dosing system to dispense precise amounts (1/8 to 1/2 fl. oz per gallon water) of Enzymatic presoak and cleaner (Prolystica). Clean instruments for a minimum of 1 to 5 minutes .... After cleaning all surfaces must be thoroughly rinsed with warm water. Lay instruments out on drying cloth to dry making sure they are opened and placed in single layer ..."

Further review of the competency inventory revealed no review or check off for: 1) Step 2: the use of the Cavitator ultrasonic cleaner with Enzol Enzymatic Detergent; 2) Step 3: the use of the Weiman Germicidal Solution; or 3) rinsing the instruments in distilled water prior to drying.

During an interview on 3/24/22 at 4:55 PM, Licensed Nurse (LN) #3 stated he/she created the "Sterile Process Competency Inventory" for training and competency check off by observing a complete sterilization procedure.

During an interview on 3/24/22 at 5:00 PM, CNA #2 stated the 3 steps to disinfect medical instruments prior to sterilization was used every time decontamination of instruments occurred.

During an interview on 3/24/22 at 5:15 PM, the CNO was unable to provide proof of Providence Hospital training for CNA #2 or competency check offs for CNA #1, CNA #3, or Lab Tech #1 who decontaminate and sterilize instruments during the course of the survey.

During a post survey email, dated 3/25/22, the CNO stated that CNA #2 was trained by the past employee CNA #4, and only provided proof of Providence Hospital training for CNA #4. The facility was unable to provide proof of training for CNA #2.

The CNO further stated CNA #2 only completed training on how to decontaminate the instruments for CNA #1 and Lab Tech #1, and the sterilization of instruments had not been completed yet. The CNO further stated CNA #2 trained CNA #3 on both the decontamination and sterilization of medical instruments, however the facility could not locate that CNA #3's proof of training.
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Based on interview, observation, and record review the facility failed to ensure the Infection Preventionist (IP) audited the facility's infection prevention and control policies, and standard operating procedure for the decontamination/sterilization of medical instruments, matched the facility's actual decontamination/sterilization process being used. This failed practice created an inconsistency in the facility's policy and procedures, as well as the standard operating procedure, to decontaminate medical instruments prior to sterilization, which if followed, could jeopardize the decontamination of medical instruments prior to sterilization resulting in sterilization failure. Findings:

During an interview on 3/21/22 at 5:20 PM, Certified Nursing Assistant (CNA) #2 (who was the lead sterilizer for the facility and facility identified trainer for all staff who assist with the decontamination/sterilization of medical instruments) stated there were specific steps to decontaminate and sterilize medical instruments:

1) Used medical instruments were rinsed at the point of care and placed in grey rigid, covered tubs.

2) These tubs were transported to the soiled room; the instruments were placed in different grey tubs on a table within the soiled room and sprayed with "Pre-Klenz Instrument Transport Gel" (which helps maintain moisture of instruments and protect instrument surfaces from corrosion).

3) Personal Protective Equipment (PPE) of a disposable gown, shoe coverings, eye protection, and gloves are worn during the decontamination of medical instruments.

4) Two sinks were used for the first step of cleaning the instruments, a dirty side and a clean side. The dirty side would be filled with tap water to the indicated pre-measured "fill" line (a piece of blue tape on the side of the sink) and "Prolystica Enzymatic Presoak and Cleaner" (a low foaming cleaner for surgical instruments designed for both manual and automatic cleaning) would be added to the water by pressing a pre-dosed button on an adjusted dispenser twice.

5) The instruments were scrubbed clean and rinsed with tap water in the clean side sink.

6) The instruments were then placed in a "Cavitator Ultrasonic Cleaner" (generates ultrasonic waves that create millions of tiny bubbles through the process of cavitation, cleaning and polishing every surface and hard to reach spaces to dislodge trapped debris) with "Enzol Enzymatic Detergent"(a mild pH enzyme-based presoak plus cleaner for removing tough, dried on or hard to reach organic matter from instruments), 2 pumps of the detergent for every 6 cups of water, and they were cleansed in the ultrasonic cleaner for 6 minutes.

7) The instruments were then taken from the Cavitator and placed in a separate, dry sink and sprayed with "Weiman Germicidal Solution" (a general purpose cleaner, deodorizer, and disinfectant) and left to sit for 6 minutes.

8) The instruments were then rinsed with distilled water and placed on blue medical towels, to dry for 24 hours.

9) The next day, the instruments were ready to pack.

10) If the instrument was individually packaged, it would be placed in a sterile package 1 inch away from the opening. Any sharps (instruments that have a blade or sharp edge) would be placed on a sharps card first to prevent puncturing of the package. A sterilization indicator strip would also be included into the packaging. Then this package would be sealed using a machine to seal the package closed.

11) If the instruments were a set that needed to be packaged together, they would be placed in metal trays and wrapped with blue medical paper-like wrappings and taped closed with special sterilization indicator tape (tape that will react to sterilization, by showing brown lines, to indicate the package is sterile).

12) The individual packages and instrument tray wraps would then be sterilized in the autoclave and once cooled would be labeled with an identification sticker that had the lot number and date they were sterilized.

13) The sterilized trays and packages would be stored in the sterilized, temperature-controlled room until used.

An observation of the soiled room on 3/25/22, revealed a "Standard Operating Procedure: Decontamination, Packaging, and Sterilization of Stainless Steel Instruments" guideline, dated 10/8/15, on the wall. Further review revealed:

- "Purpose: To establish guidelines for manual decontamination, packaging and sterilization of stainless steel surgical instruments:

- Guidelines: General Considerations:
" Manufacturer's guidelines for cleaning and sterilization of medical devices are followed for all instruments. A copy of the manufacturers guidelines for cleaning and sterilization is retained in the facility in a location easily accessible to staff ...
" Staff who are involved in processing instruments are trained as part of their initial orientation ...

- Decontamination Process:
" Step 1: Items begin the decontamination process at the point of use by personnel who are wearing the appropriate Personal Protective Equipment (PPE). All disposable items, including sharps are removed and disposed of at the point of use.
" Step 2: Instruments are transported from the point of use to the decontamination room in a rigid puncture-proof container. Enzymatic spray is applied to the instruments. Small items that do not pose a sharps injury risk may be transported to the decontamination room in a plastic biohazard bag.
" Step 3: Put on PPE, including disposable impervious gown, hair covering, face shield, shoe covers, and general purpose utility gloves.
" Step 4: Place instruments in a basin of tap water and instrument detergent. Make sure to follow detergent manufacturer's guidelines for concentration and temperature.
" Step 5: Use a soft brush to clean instruments, paying close attention to difficult to clean areas such as box locks and hinges. Instruments are brushed under water to prevent aerosol contamination.
" Step 6: Rinse thoroughly with tap water.
" Step 7: Visually inspect all instruments to make certain that all bio burden has been removed and that the instruments are in good working order.
" Step 8: Apply germicide to all surfaces of the instruments. Allow germicide to remain in wet contact with the instruments for the length of time specified on the disinfectant container label. Remove gloves and wash hands.
" Step 9: Put on a new pair of gloves. Perform a thorough final rinse using distilled, deionized or reverse osmosis water. Inspect instruments while rinsing to make certain that they are clean.
" Step 10: Place instruments on a clean dry surface. Remove all PPE and wash hands.
" Step 11: Transport instruments to the designated clean instrument processing area. Dry instruments with compressed air or a lint free towel. Apply a small amount of water soluble, steam tolerant lubricant to areas where metal slides against metal (i.e.: box lock, hinge, etc.) if indicated.
" Step 12: Return to the decontamination area. Put on PPE and clean the work area. All cleaning equipment, including brushes are either disinfected (wash, rinse, apply germicidal, rinse again, and allow to dry) or discard at the end of the day ..."

Further review of the "Standard Operating Procedure: Decontamination, Packaging, and Sterilization of Stainless Steel Instruments" revealed no guideline for the use of the "Cavitator Ultrasonic Cleaner" used in the facility's current decontamination process.

Review of the facility's policy "Cleaning & Care of Instruments & Other Medical Equipment," revised 3/28/18, revealed the same guidelines as the "Standard Operating Procedure: Decontamination, Packaging, and Sterilization of Stainless Steel Instruments" and contained no guideline for the use of the "Cavitator Ultrasonic Cleaner" used in the facility's decontamination process.

During an interview on 3/24/22 at 10:00 AM, when asked how the facility monitored the decontamination/sterilization process for consistent policy and procedures and adherence the process, the Infection Preventionist (IP) stated she completed a "EOC [Environment of Care] Rounds Checklist" regularly. The IP further stated she did have a "Sterile Processing Checklist" audit sheet for monitoring the facility's decontaminating and sterilizing procedure, however, did not use it.

Review of the IP's "EOC Rounds Checklist" revealed only one question for the monitoring of decontaminating procedure: "Staff able to explain how semi-critical and critical equipment is handled for use including: how to transport, store, whether high-level disinfected or sterilized." Further review revealed no monitoring of the facility's policies and procedures, or the standard operating procedure, the facility had in place for the decontamination/sterilization of medical instruments and no monitoring for the procedures currently used.
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Based on record review and interview the hospital failed to ensure organ, tissue, and eye procurement policies and procedures were properly written and implemented to address its organ procurement responsibilities according to the Condition of Participation: CFR 485.643 Organ, Tissue, and Eye Procurement. Findings:

The hospital failed to:

Ensure notification to the Organ Procurement Organization (OPO - not-for-profit organizations responsible for recovering organs from deceased donors for transplantation in the United States) occurred for patients whose death was imminent or who had died at the facility. Reference at C tag 1503.

Ensure the family of each potential donor was informed of its option to either donate or not donate organs, tissues, or eyes for patients whose death was imminent or who had died in the facility. Reference at C tag 1507.

Ensure all Licensed Nurses were trained regarding organ procurement responsibilities and how to work with the OPO for patients whose death was imminent or who had died at the facility. Reference at C tag 1511.

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Based on record review and interview the facility failed to ensure notification to the Organ Procurement Organization (OPO - not-for-profit organizations responsible for recovering organs from deceased donors for transplantation in the United States) occurred for 5 patients (Patient #'s 5, 9, 13, 20, and 21), out of 6 sampled patients, whose death was imminent or who had died in the facility. This failed practice violated the facility's responsibility, under contract with the OPO, to address possible organ procurement. Findings:

OPO Contract

Review of the facility's "Memorandum of Agreement between [Facility Name] and Life Alaska Donor Service," dated 2015, revealed: " ...Responsibilities of Hospital: 1) Call the donor referral line [number listed] in a timely manner to report all deaths or imminent deaths. 2) Work cooperatively with Life Alaska in offering the option of donation and the facilitation of donation process on medically suitable cases ..."

Patient #5

Record review on 3/21-25/22 revealed Patient #5 expired at the facility on 6/30/21 after he/she arrived at the Emergency Department (ED) for altered mental status and hyperglycemia. Further review revealed no documentation, from the Licensed Nurse (LN) or the Attending Physician, that OPO was contacted to be notified of this death.

During an interview on 3/25/22 at 1:33 PM, the Chief Nursing Officer (CNO) stated the OPO documentation was missing from Patient #5's medical record.

Patient #9

Record review on 3/21-25/22 revealed Patient #9 expired at the facility on 9/4/21 after he/she arrived at the ED for cardiac arrest. Further review revealed no documentation, from the Licensed Nurses or the Attending Physician, that OPO was contacted to be notified of this death.

During an interview on 3/25/22 at 1:12 PM, the CNO stated the OPO documentation was missing from Patient #9's medical record.

The CNO further stated that it was the facility's expectation that the LN would contact the OPO in the event of imminent death or a death and document this contact in the patient's medical record.

Patient #13

Record review on 3/21-25/22 revealed Patient #13 expired at the facility on 3/5/22 after he/she arrived at the ED for cardiac arrest. Further review revealed no documentation, from the LN or the Attending Physician, that OPO was contacted to be notified of this death.

During an interview on 3/25/22 at 1:27 PM, the CNO stated the OPO documentation was missing from Patient #13's medical record.

Patient #20

Record review on 3/21-25/22 revealed Patient #20 expired at the facility on 6/25/21 after he/she arrived at the ED on 6/24/21 for shortness of breath and pain and admitted to the facility for observation.

Review of Patient #20's "Death Summary" from the attending physician, dated 6/25/21, revealed: "the Patient is a [age and sex] with longstanding history of coronary artery disease, congestive heart failure, and end stage renal disease who is a comfort 1 [Comfort One Program - do not resuscitate protocol where terminally ill patients do not want life-saving measures when they stop breathing and/or their heart stops beating] with 3 days of progressive dyspnea ... Patient was admitted comfort care over night ... [He/she] woke up this morning ... had some sort of syncopal event [fainting or passing out] ... the [spouse] advised [the patient] was a DNR [do not resuscitate] ... the patient was pronounced dead ..."

Further review revealed no documentation, from the LN or the Attending Physician, that OPO was contacted to be notified of this death.

Patient #21

Record review on 3/21-25/22 revealed Patient #21 expired at the facility on 9/2/21 after he/she arrived at the ED on 9/1/21 for shortness of breath and pain and admitted to the facility for observation.

Review of Patient #21's "Death Summary" note from the attending physician, dated 9/2/21, revealed: "[Patient #21] was an [age and sex] with a history of COPD, and recent CVA and MI, who presented with respiratory distress. At the time of presentation, the patient was only wanting comfort measures and did not want any invasive procedures or diagnostics performed ... Patient was then admitted and placed on comfort measures only ... [he/she] continued to decline until the time of [his/her] death."

Further review of Patient #21's medical record revealed no documentation, from the LN or the Attending Physician, that OPO was contacted to be notified of this death.

Review of the facility's policy "Death of a Patient or DOA [Dead on Arrival]," revised 10/11/18, revealed: " ...The Organ Procurement Organization (OPO) Life Alaska donor services shall be notified of all deaths occurring within the facility or DOA brought into the facility ..."
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Based on record review and interview the facility failed to ensure the family of each potential donor was informed of their option to either donate or not donate organs, tissues, or eyes for 5 patients (#'s 5, 9, 13, 20, and 21), out of 6 patients sampled, whose death was imminent or who had died in the facility. This failed practice violated the facility's responsibility, under contract with the Organ Procurement Organization (OPO - not-for-profit organizations responsible for recovering organs from deceased donors for transplantation in the United States), to address possible organ procurement. Findings:

OPO Contract

Review of the facility's "Memorandum of Agreement between [Facility Name] and Life Alaska Donor Service," dated 2015, revealed: " ...Responsibilities of Hospital: 1) Call the donor referral line [number listed] in a timely manner to report all deaths or imminent deaths. 2) Work cooperatively with Life Alaska in offering the option of donation and the facilitation of donation process on medically suitable cases ... Responsibilities of Life Alaska: 1) Provide a high standard of compassion and emotional support for all potential donors and their families. 2) Offer donor families a long-term bereavement care support program. 3) Provide a 24-hour Alaska telephone number [number listed] and qualified staff to evaluate all referrals and assist however needed in seeking permission from potential donor families ..."

Patient #5

Record review on 3/21-25/22 revealed Patient #5 expired at the facility on 6/30/21 after he/she arrived at the Emergency Department (ED) for altered mental status and hyperglycemia. Further review revealed no documentation, from the Licensed Nurse (LN) or the Attending Physician, that OPO was contacted to be notified of this death.

During an interview on 3/25/22 at 1:33 PM, the Chief Nursing Officer (CNO) stated the OPO documentation was missing from Patient #5's medical record.

Patient #9

Record review on 3/21-25/22 revealed Patient #9 expired at the facility on 9/4/21 after he/she arrived at the ED for cardiac arrest. Further review revealed no documentation, from the Licensed Nurses or the Attending Physician, that OPO was contacted to be notified of this death.

During an interview on 3/25/22 at 1:12 PM, the CNO stated the OPO documentation was missing from Patient #9's medical record.

The CNO further stated that it was the facility's expectation that the LN would contact the OPO in the event of imminent death or a death and document this contact in the patient's medical record.

Patient #13

Record review on 3/21-25/22 revealed Patient #13 expired at the facility on 3/5/22 after he/she arrived at the Emergency Department (ED) for cardiac arrest. Further review revealed no documentation, from the LN or the Attending Physician, that OPO was contacted to be notified of this death.

During an interview on 3/25/22 at 1:27 PM, the CNO stated the OPO documentation was missing from Patient #13's medical record.

Patient #20

Record review on 3/21-25/22 revealed Patient #20 expired at the facility on 6/25/21 after he/she arrived at the ED on 6/24/21 for shortness of breath and pain and admitted to the facility for observation.

Review of Patient #20's "Death Summary" from the attending physician, dated 6/25/21, revealed: "the Patient is a [age and sex] with longstanding history of coronary artery disease, congestive heart failure, and end stage renal disease who is a comfort 1 [Comfort One Program - do not resuscitate protocol where terminally ill patients do not want life-saving measures when they stop breathing and/or their heart stops beating] with 3 days of progressive dyspnea ... Patient was admitted comfort care over night ... [He/she] woke up this morning ... had some sort of syncopal event [fainting or passing out] ... the [spouse] advised [the patient] was a DNR [do not resuscitate] ... the patient was pronounced dead ..."

Further review revealed no documentation, from the LN or the Attending Physician, that OPO was contacted to be notified of this death.

Patient #21

Record review on 3/21-25/22 revealed Patient #21 expired at the facility on 9/2/21 after he/she arrived at the ED on 9/1/21 for shortness of breath and pain and admitted to the facility for observation.

Review of Patient #21's "Death Summary" note from the attending physician, dated 9/2/21, revealed: "[Patient #21] was an [age and sex] with a history of COPD [chronic obstructive pulmonary disease], and recent CVA [cerebrovascular accident] and MI [myocardial infarction], who presented with respiratory distress. At the time of presentation, the patient was only wanting comfort measures and did not want any invasive procedures or diagnostics performed ... Patient was then admitted and placed on comfort measures only ... [he/she] continued to decline until the time of [his/her] death."

Further review of Patient #21's medical record revealed no documentation, from the Licensed Nurse (LN) or the Attending Physician, that OPO was contacted to be notified of this death.

During an interview on 3/24/22 at 2:43 PM, the Chief Executive Officer (CEO) stated, in regard to informing family of organ donation for potential donors, it was the responsibility of the Licensed Nurses to contact Life Alaska upon an imminent death or death at the facility and it was Life Alaska who contacted the family for the possibility of organ donation. The CEO further stated the facility did not have "Designated Requestors" (specially trained staff who would approach and inform family members about the possibility of organ donation) as Life Alaska takes on this responsibility once notified by the facility.

During an interview on 3/24/22 at 4:50 PM, the CNO stated it was the Licensed Nurse's responsibility to contact Life Alaska in the event of an imminent death, or death at the facility. The CNO stated there was a form, "Consent for Organ and Tissue Donation," undated, in the facility, but only the contact information on the back, for Life Alaska, was used by the Nurses, as Life Alaska themselves contacted the families of potential donors once contacted by the facility's Licensed Nurses. The CNO further stated that staff at the facility did not approach families of potential donors to inform them of the possibility of organ donation.

Review of the facility's policy "Death of a Patient or DOA [Dead on Arrival]," revised 10/11/18, revealed: " ...The Organ Procurement Organization (OPO) Life Alaska donor services shall be notified of all deaths occurring within the facility or DOA brought into the facility ..."
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Based on record review and interview the facility failed to ensure all Licensed Nurses (LNs) were trained regarding organ procurement responsibilities and how to work with the Organ Procurement Organization (OPO- not-for-profit organizations responsible for recovering organs from deceased donors for transplantation in the United States). This failed practice violated the facility's responsibility, under contract with the OPO, to address possible organ procurement. Findings:

OPO Contract

Review of the facility's "Memorandum of Agreement between [Facility Name] and Life Alaska Donor Service," dated 2015, revealed: " ...Responsibilities of Hospital: 1) Call the donor referral line [number listed] in a timely manner to report all deaths or imminent deaths. 2) Work cooperatively with Life Alaska in offering the option of donation and the facilitation of donation process on medically suitable cases. 3) Work cooperatively with Life Alaska to educate Hospital Staff on donation and transplant issues ...."

OPO training

During an interview on 3/23/22 at 1:52 PM, LN #2 stated when a death occurs, and confirmed by the attending physician, the family was notified, and the Medical Examiner was contacted. A death certificate would be completed. The LN would the prepare the body for the morgue by removing everything from the body, cleaning the body, and placing the body in a body bag. LN #2 stated all belongings would be gathered and taken with the body to the morgue.

When asked about organ donation and/or organ procurement procedures, LN #2 stated it was the physician who discussed with the family. LN #2 further stated he/she thought OPO training was part of orientation.

During an interview on 3/24/22 at 10:00 AM, Human Resources stated that in addition to face-to-face staff orientation/education, the facility had a central training program called "Relias." She further stated there was no OPO training assigned to patient care staff in this program.

During an interview on 3/24/22 at 2:43 PM, the Chief Executive Officer (CEO) stated, in regard to informing family of organ donation for potential donors, it was the responsibility of the Licensed Nurses to contact Life Alaska upon an imminent death or death at the facility and it was Life Alaska who contacted the family for the possibility of organ donation. The CEO further stated the facility did not have "Designated Requestors" (specially trained staff who would approach and inform family members about the possibility of organ donation) as Life Alaska takes on this responsibility once notified by the facility.

Review of the facility's policy "Death of a Patient or DOA [Dead on Arrival]," revised 10/11/18, revealed: " ...Policy ... The Organ Procurement Organization (OPO) Life Alaska donor services shall be notified of all deaths occurring within the facility or DOA brought into the facility ...Procedure ... Life Alaska is to be notified of all deaths at [number listed] ..."

Further review of the policy revealed no procedure on how the Life Alaska contact would be documented in patient medical records.

During an interview on 3/24/22 at 4:20 PM, the Chief Nursing Officer (CNO) stated that upon hire the Licensed Nurses were asked to read through all policies and procedures of the facility as part of their orientation/education, to include the policy "Death of a Patient or DOA." The CNO further stated there was no focused face-to-face training for the steps to take, or the Licensed Nurse's responsibilities, in the event of an imminent death or death in the facility.

The CNO further stated the facility's policy "Death of a Patient or DOA" did not include a process for how to document Life Alaska notification in patient medical records.
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Based on record review and interview the facility failed to ensure comprehensive care plans for 2 swing bed patients (#s 1 and 2) contained elements for identified health conditions, and safety. This failed practice placed the patients at risk for injury and/or harm from inconsistent interventions and potential poor outcomes in healing. Findings:

Patient #1

Record review on 3/21-25/22 revealed Patient #1 had diagnoses that included Atrial fibrillation (a rapid heart rate that commonly causes poor blood flow), heart failure, and hypertension (high blood pressure).

An observation during an initial tour on 3/21/22 at 4:00 PM revealed Patient #1 in his/her room, a pacemaker monitor, used by the cardiologist to monitor pacemaker functionality was located on a nearby end table.

Review of patient #1's comprehensive care plan, undated with a target date of 3/06/22, revealed no information about his/her cardiac disease process and potential interventions that would monitor cardiac function and identify interventions for patient teaching.

Review of Patient #1's comprehensive care plan, undated with a target date of 4/23/22, provided by fax post exit on 3/25/22 at 12:00 PM, revealed no information about his/her cardiac disease and potential nursing interventions that would monitor cardiac function and patient teaching.

Patient #2

Record review on 3/21-25/22 revealed Patient #2 had diagnoses that included dementia and failure to thrive.

Review of an "Elopement Assessment Tool", unsigned and undated, revealed Patient #2 "Has history of wandering (past hospitalization or history from resident/family)", "Medical diagnosis of dementia/cognitive impairment; diagnosis impacting gate/mobility or strength", "Has wandered aimlessly within the home or off the grounds", and "has wandered in the past month."

During an interview on 3/24/22 at 1:00 PM, Licensed Nurse (LN) #1 was asked about Patient #2's wandering. The LN stated the Patient wore a WanderGuard bracelet. When asked how the bracelet was tested to ensure it was functional, LN #1 said the Patient often set off the alarms when going out the door. When asked if he/she knew about a WanderGuard detector, used to check the battery, and where it was located, LN #1 and the LN working in Long Term Care were unable to locate the device. The LN stated nursing staff documented the checks of the WanderGuard on the nursing desk calendar.
Review of the desk calendar revealed no information about monitoring the WanderGaurd.

Review of Patient #2's undated comprehensive care plan, with a target date of 3/06/22, located in the medical record, did not address the wandering or safety interventions, including the WanderGuard.

Review of a "Care Plan Conference Summary", dated 1/27/22, revealed "Safety" "WanderGuard Bed Lowered."

Review of Patient #2's comprehensive care plan, undated with a target date of 4/30/22, provided by fax post exit on 3/25/22 at 12:00 PM, revealed

"Problem" "[Patient's name] has impaired cognitive function, impaired thought process, confusion and impaired communication r/t [related to] DX [diagnosis of] dementia and memory loss."

"Goal" "[Patient name] will maintain [his/her] current function and decision making ability and ability to make [his/her] needs known. [He/she] will maintain [his/her] ability to make [him/herself] understood when communicating with others. [He/she] will continue to follow simple direction which will help maintain [his/her] dignity through the next review date."

"Interventions" listed included "WanderGuard in place."

Review of the nursing orders, physician orders, and treatment administration record did not address the use of the WanderGuard or how often the device should be checked for placement or functionality.

Review on 3/24/22 of the Instructions for the "WanderGaurd BLUE Tag", dated 2019, revealed "Weekly testing and maintenance of this Product, as described in the Product documentation, is essential to verify the system is operating correctly and to ensure the probability of detecting an alarm/and or locating the transmitter are maximized.

"The failure to undertake regular testing and maintenance will increase the risk of system failure and failure to detect resident wandering."

Review of the "WanderGaurd Blue Wander Management System User and Deployment Guide", dated 7/16/17, revealed
"It is recommended to use the WanderGuard BLUE Detector to check the Tag battery at least once a week ... The ninety-day Tag begins sending a low battery message to the Detector two weeks prior to the 90-day expiration date ... The three-year Tag indicates the low battery two months prior to the three-year term. Battery lifetime is guaranteed only if the Tag was activated prior to the 'Activated By' date listed on the back label

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