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Based on record review and interview, the hospital failed to address deficiencies found in the documentation of medical records and timely notification of deaths for the organ procurement center for 4 patients in a review of death records during 2018 and 2019.

Findings include:

Record review on 2/5/2020 of the hospital's policy with a subject title of "1. Organ and Tissue Donation" with an effective date of 6/92 under the Title of "ASYSTOLIC DEATH" revealed, "All deaths must be reported by the nurse and/or designee to NED's (New England Donor Service) 24 hour number...in a timely manner, as defined by (Centers for Medicare & Medicaid Services) CMS as within one hour of pronouncement of death. 2. The physician of record or his designee is responsible for declaring death and of informing the family of the patient's death. Record of death (date and time) shall be documented in the patient's medical record".

Record review on 2/5/2020 of the Asystolic Referral program for organ donors with Staff D, (Vice President Risk and Management & Medical Records), revealed that there were three patients where the facility failed to contact the organ bank in a timely manner. The dates of the events were 3/12/18, 4/23/19, and 7/21/19. In all three of the events the referral times where over 2 hours before the organ bank was contacted. Additionally, on 4/11/19 another case occurred where the organ bank was contacted in a timely manner but there is no documentation in the record by the nursing staff or physician on what occurred. (Cross Refer to C1511)

Interview on 2/5/2020 at approximately 1:30 p.m. with Staff D revealed that the organ bank was notified timely on the 4/11/19 case and the body had been placed on ice, but was never harvested. Staff D also indicated that no documentation indicated as to what happened prior to the body being released to the funeral home. Staff D also indicated that no quality assurance was completed on this case to determine what occurred.

Interview on 2/6/20 at 10:30 a.m. with Staff A (Vice President Quality Improvement and Patient Safety) and Staff B (Director of Risk) revealed the 4 above cases had been brought to the QAPI but no actions for improvement were taken.

Based on observation and interview, it was determined that the facility failed to ensure adequate space by maintaining a physical separation between the decontamination and sterilization areas in central sterile.

Findings include:

Review on 2/10/2020 of the Association of periOperative Registered Nurses (AORN). (2016). p 666-667
Sterilization III: ...A controlled environment is intended to facilitate effective decontamination, assembly, sterilization, and storage and to minimize environmental contamination and maintain sterility of sterilized items.

IIIb. Functional workflow patterns should be established to create and maintain physical separation between the decontamination and sterilization areas. Physical separation aids in achieving environmental and microbial control. During manual cleaning of instruments, particulates, aerosolized matter, dust, and microbial counts are elevated. Physical separation and vented airflow to the outside minimizes potential contamination of processed items.

Observation on 2/6/20 at approximately 1:00 p.m. in the central sterile work room revealed a staff member from central processing carrying an endoscope through a door that is between the decontamination room and clean sterilization area and place the scope into the sterilizer. Interview with Staff I (Central Sterile Reprocessing Supervisor) at that time revealed staff walk through the central processing area, open the door and usually reach into the decontamination area grabbing the scope off the shelf to the right of the door and come back into the sterilization area and place the scope in the steris machine.

Based on observation, interview, and record review, the hospital failed to ensure that glucometers are maintained in safe operating condition by monitoring the expirations dates of control solution and test strips at 1 of 2 glucometer testing stations.

Findings include:

Observation and record review on 2/4/20 at 10:00 a.m. of one set of two glucometer stations on the inpatient unit revealed that the glucometer testing strips and the glucometer high and low testing solutions had no "opened on" dates labeled on each bottle/container.

Interview on 2/4/20 at 10:05 with Staff C (Registered Nurse) confirmed the above observation.

Review on 2/6/20 at 12:00 p.m. of manufacturer's instructions (StatStrip Glucose Hospital Meter Test Strips, Nova Biomedical) for the glucose test strips reveal, under section 11. Expiration "...Once opened, the StatStrip Glucose Hospital Meter Test Strips are stable when stored as indicated for up to 180 days or until the expiration date, whichever comes first."

Review on 2/6/20 at 12:00 p.m. of manufacturer's instructions (StatStrip Glucose Hospital Meter Test Strips, Nova Biomedical) for the high and low glucose testing solutions revealed, under section Expiration, "The expiration date is printed on the control vials. Once opened, the solutions stored as indicated will be stable for up to 3 months or until the expiration date, whichever comes first".

Based on interviews and observation, it was determined that the facility failed to secure sharps waste containers located in an outpatient medical office building on the Critical Access Hospital campus.

Findings include:

Interview on 2/4/2020 at 1:50 p.m. with Staff F (Clinical Nurse) revealed when sharps waste containers are full in pediatric practice, the sharps containers are removed and stored in the basement of the medical office building located on the CAH campus.

Observation on 2/4/2020 at 2:45 p.m. of the medical office building basement revealed 1 large blue bin full of sharps waste containers. The blue bin was not locked or secured within a locked room and was available to the general public.

Interview on 2/4/2020 at 2:45 p.m. with Staff D (VP Risk Management) confirmed the full sharps containers were not secured and were available to the general public. Staff D revealed the blue bin was 64 gallons.

Based on observation, record review, and interview it was determined that the hospital failed to maintain proper pressure and documentation showing that all isolation rooms and surgical procedure rooms are maintained at the proper air changes per hour and proper differential pressure across the envelope or space.

Findings include:

Review of the guidelines on 2/7/2020 Guidelines for Design and Construction of Hospitals The Facility Guidelines Institute (FGI) 2018 edition. Published by The Facility Guidelines Institute 9750 Fall Ridge Trail St. Louis, MO 63127 revealed the following:

ASHE Standard 170-Ventilation of Health Care Facilities 7. Space Ventilation
7.2.1 Airborne Infection Isolation (AII) Rooms.
a. Each AII room shall comply with requirements of Tables 6-1, 6-2, and 7-1. AII room shall have a permanently installed device and/or mechanism to constantly monitor the differential air pressure between the room and adjacent spaces of the room when occupied by patent's with an airborne infectious disease...

b. All air from the AII rooms shall be exhausted directly to the outdoors.

c. All exhaust air from the AII rooms, associated anterooms, and associated toilets rooms shall be discharged directly to the outdoors without mixing with exhaust air from any other non-AII room or exhaust system.

d. Exhaust air grilles or registers in the patient room shall be located directly above the patent bed or the ceiling or on the wall near the head of the bed unless it can be demonstrated that such a location is not practical.

e. The room envelop shall be sealed to limit leakage air flow at 0.01in. wc (water column) (2.5Pa) (Pascal Pressure Unit) differential pressure across the envelope.

f. Differential pressure between AII rooms and adjacent spaces that have a different function shall be a minimum of -00.01wc (-2.5 Pa).

Table 7-1 Design Parameters AII rooms, Negative, minimum outdoor ach (air changes per hour) 2, Minimum total ach 12, AII room air exhausted directly to outdoors, air recalculated by means of room units (No), RH (Relative Humidity) max 60. Temperature 70-75.

Observation on 2/5/20 and 2/6/20 during tour of the hospital reveals that there are four isolation rooms. The rooms were named as follows:

1) ER (Emergency room) 5
2) MS (Medial Surgical) 110
3) MS (Medical Surgical) 133
4) SCU (Special Care Unit) 4.

Review on 2/5/20 and 2/6/20 of the monthly records for differential pressure revealed that for the past year ER 5 and SCU 4 running at 0.001-0.005.

Interview on 2/5/20 at 1:30 p.m. with Staff G (Director of the Emergency Department) revealed that the ER 5 has been used several times over the past year for isolation. Staff G stated every time maintenance checks the wall gauge maintenance told Staff G the room was working fine with no issues.

Review on 2/5/2020 of the gauge readings provided by Staff J (Director of Facilities) revealed the units were not running with the correct pressure causing the differential pressure at the doorway to be less then required. Also it was found that there are no testing logs confirming that the units were running at or above negative 12 air changes per hour in each room.

Review on 2/5/2020 of the logs for the negative pressure rooms also has an entry on 1/29/20 that stated "I was told today 1/29/20 that SCU Room #104 is no longer a negative pressure room. The removal process will be started as soon as room is cleared out."

Interview on 2/5/2020 at approximately 11:00 a.m. with Staff J revealed that they were responsible for the negative pressure rooms and maintaining the logs.

Based on observations, record review and staff interviews, it was determined the facility failed to ensure outdated drugs are not available for use in outpatient settings.

Findings include:

Observation in Enterology exam room 242 on 2/5/2020 at 1:55 p.m. revealed two 20 milliliter bottles of "Lidocaine HCL 1% and Epinephrine 1:100,000" (Lidocaine) which had expired 12/1/2019.

Review on 2/5/2020 of "Exam Room QA 2020" log sheet for room 242 revealed weekly checks for expired supplies had been performed 5 times this year.

Interview with Staff E (Licensed Practical Nurse) on 2/5/2020 at 1:55 p.m. confirmed the presence of 2 expired bottles of Lidocaine that were stored in Enterology exam room 242.

Observation of the crash cart container located in the "Clean" Laboratory of primary care services on 2/5/2020 at 2:40 p.m. revealed a sticker on the outside of the container that included the last check (6/7/2019) and the next medication to expire (8/2019). In the crash cart container were the following expired medications: 1 mL bottle of "DiphenhydrAmine HCL injection" (50 mg/mL) expired 8/2019, 1 unopened bottle (25 tablets, 0.4 mg each) of Nitroglycerin sublingual tablets expired 10/2019, and 4 Aspirin chewable tablets (81 mg each) expired 11/2019.

Interview with Staff E (Licensed Practical Nurse) on 2/5/2020 at 2:40 p.m. confirmed the presence of expired medications listed above stored in the crash cart located in the "Clean" Laboratory of primary care services.

Based on observation of exam rooms and staff interviews, the CAH (Critical Access Hospital) failed to ensure exam room furniture was maintained to avoid sources of transmission of infection.

Findings include:

Observation on 2/4/2020 at 1:55 p.m. of the exam table in pediatric room 3 revealed a small tear (less than 1 inch) and an area where stitching had come undone approximately the size of a nickel. Each of these areas exposed a porous padding material that cannot be disinfected.

Interview on 2/4/2020 at 1:55 p.m. with Staff F (Clinical Nurse) confirmed the presence of the tear and area where stitching had come undone on exam table in room 3. Staff F revealed a request to repair or remove the exam table out of service had not yet been made at the time of the observation.

Observation on 2/4/2020 at 2:15 p.m. of an exam chair in ophthalmology exam room 1 revealed two tears in the seat of the exam chair approximately 1 inch in length each. Additional observations in exam rooms 1, 2 and 3 between 2:15 and 2:30 p.m. revealed a clear plastic sheathing over the end of the arms of the 3 of 3 exam chairs. An unknown material/residue was observed under the plastic sheathing. The clear plastic sheathing fit loose enough over the arms of the chairs so that someone could put their fingers underneath and touch the unknown material/residue.

Interview on 2/4/2020 at 2:30 p.m. with Staff F (Clinical Nurse) confirmed the presence of the tears in chair of exam room 1 and the unknown material/residue on the exam chairs in exam rooms 1, 2, and 3.

Based on record review and interview, it was determined that the hospital failed to ensure staff were educated on donation issues; and failed to document maintenance of one potential donor, in a survey sample of 4 deceased patients, while awaiting final disposition by the designated requestor. (Patient identifier is #14.)

Findings include:

Review of the Memorandum of Understanding between the facility and the Organ Bank, entered into on 2/1/2010 revealed that "[Organ Bank] staff shall act as the Designated Requestors for Donor Hospital...." and "... As the Designated Requestor, [Organ Bank] staff shall initiate discussions with the appropriate Potential Donor family members in cases where there is a clinical potential for donation of organs, tissues or eyes for transplantation...." The Duties of the Donor Hospital include "Collaborate with [Organ Bank] staff (who are the Designated Requestors) in approaching families to discuss donation...." Duties of the Attending Physician include "... Following the determination of death of the donor by the appropriate physician(s), collaborate with [Organ Bank] in the maintenance of Potential Donors and in its approach to the family to ensure that the initiation of donation requests and the obtaining of informed consent to donation in accordance with applicable laws and regulations...."

Review of the facility's policy "Subject: Death of a Patient" with an "Effective Date: 6/2011" revealed that the Organ Bank "... will determine if the patient is a potential organ or tissue donor and will take responsibility for all contact with the family .... All documentation related to a patient death will be completed in the space provided in the medical record...."

Patient #14's record was reviewed with Staff H, (Nurse Informaticist), who navigated the computer record. Review of Patient #14's emergency room record revealed that this patient arrived to the emergency room on 4/11/19 in active CPR [cardiopulmonary resuscitation], and was pronounced dead at on 4/11/19 at 7:41 a.m. The death record revealed that the Organ Bank was called on 4/11/19 at 8:13 a.m. and the patient was identified as a potential donor. Additional review of the hospital record revealed no evidence that the donor option was discussed with the family, and no documentation that a designated requestor spoke with the family. Review of the Mortician's Receipt revealed that the remains of Patient #14 were received by the Mortician on 4/11/19 at 3:57 or 3:59 p.m. [the time entry is not clearly legible on the document upon record review].

Interview on 2/5/20 at about 2:15 p.m. with Staff G, (Director of Emergency Services), revealed that Staff G heard the family tell the physician that they didn't want the patient to be a donor, but Staff G does not know if the Organ Bank ever contacted the family, and this was not documented in the record.

Review of the Memorandum of Understanding between the facility and the Organ Bank, entered into on 2/1/2010 revealed that the Duties of the Organ Bank include "... Conduct periodic in-service education programs on organ, tissue and eye donation...." Duties of the Donor Hospital include "... Train the members of its medical staff with the current medical standards with respect to brain death criteria and with all relevant Donor Hospital policies and procedures...."

Records of education on donation issues were requested for review, and the facility was unable to provide documentation of any trainings related to such issues, which addressed topics covered, and a log of presenter(s) and attendee(s) with accompanying dates of actual trainings.