HospitalInspections.org

I. Based on document review, observation, and staff interviews, the critical access hospital's administrative staff failed to ensure the operating room staff followed the manufacturer's recommendations for cleaning endoscopes (long, flexible devices used by physicians to look inside a patient's body). Please refer to C-0278.

The cumulative effect of these failures and deficient practices resulted in the hospital's inability to provide a sanitary environment to avoid sources of transmission of infections and communicable diseases. The hospital's surgical staff performed approximately 500 surgical procedures using endoscopes per year.



II. During the recertification survey that ended on 10/24/2019, the on-site survey team identified an Immediate Jeopardy (IJ) situation (a crisis situation that placed the health and safety of patients at risk) related to the Condition of Participation for Infection Control (42 CFR 482.42). The hospital staff failed to ensure the operating room staff followed the manufacturer's recommendations for cleaning endoscopes.

While on-site, the survey team identified an Immediate Jeopardy (IJ) situation and notified the administrative staff on 10/22/2019. The administrative staff promptly took action to remove the immediacy of the situation. The CAH staff removed the immediacy prior to the survey team exiting the survey when the administrative staff took the following actions:

a. contacted the endoscope manufacturer to obtain any remedial actions necessary to remediate the prior deficient endoscope cleaning practices and to provide on-site training for proper cleaning practices.

b. arranged for the CAH staff to complete competency training from the endoscope manufacturer's representative for proper cleaning of the endoscopes and created a process for formally communicating the changes to the operating room nursing leadership and staff.

c. created a process to address any changes in practice suggested by the endoscope manufacturer's representative, and compare the suggested changes to the existing formal cleaning practices.

d. updated the policy on endoscope cleaning to reflect the manufacturer's recommendations.

e. created a skill competency using the manufacturer's recommendations for cleaning the endoscopes.

f. re-trained all staff who clean endoscopes using the new competencies and validated the staff member's ability to cleanse the endoscope according to the manufacturer's recommendations.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the nursing staff notified the patient's physician timely when the nursing staff made a medication error for 2 of 14 medication errors reviewed (Patient #9 and Patient #10). Failure to notify the physician of medication errors could potentially result in the provider not knowing about the medication error and either failing to take steps to address the consequences of the medication error, or the provider making a medical decision without the knowledge of the medication error, either way potentially resulting in inappropriate treatment or even a fatal reaction. The CAH administrative staff reported a census of 5 patients on entrance, and an average daily census of 9.7 patients per day.

Findings include:

1. Review of the policy "Medication Administration Errors," last approved 05/2019, revealed in part, "When a medication error occurs, the person who discovers the error will submit the incidence.... Following completion of the report form and notification of the physician, the report shall be forwarded to the pharmacy."

2. Review of medication errors from November 2018 to October 2019 revealed:

a. The nursing staff made a medication error on 07/01/2019 at 11:57 AM which involved Patient #9. Patient #9's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #9's medical care of the medication error.

b. The nursing staff made a medication error on 02/10/19 at 18:46 PM which involved Patient #10. Patient #10's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #10's medical care of the medication error.

3. During an interview on 10/22/19 at 11:15 AM, the Utilization Review Manager acknowledged the medication error paperwork for Patient #9 and Patient #10 lacked documentation the nursing staff notified the patient's provider of the medication error.

I. Based on document review, observation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 2 of 2 observed surgical staff (OR Nurse Manager and RN B) followed the manufacturer's instructions for use when cleaning endoscopes (flexible cameras physicians used to view inside a patient's body) after a colonoscopy for 1 of 1 patients observed (Patient #1). Failure to follow the manufacturer's instructions for use while cleaning endoscopes could potentially result in the cleaning process failing to remove all of the bacteria and debris in the endoscope, which could then potentially infect a different patient, since the staff members believed the scope was safe to use on another patient. The CAH performed an average of 500 endoscopies per year.

Findings include:

1. Review of "OLYMPUS REPROCESSING MANUAL, Chapter 1, General Policy," provided by the CNO (Chief Nursing Officer) on 10/22/19 at approximately 11:00 AM revealed the following in part:

"The medical literature reports incidents of cross-contamination resulting from improper cleaning, disinfection, or sterilization ... An insufficiently cleaned, disinfected, or sterilized endoscope ... may pose an infection control risk to the patients ... All disinfection methods ... require thorough prior cleaning of the instrument being reprocessed. If the equipment is not adequately cleaned prior to disinfection/sterilization, these processes will be ineffective. Immediately after each patient procedure and before disinfection/sterilization, thoroughly clean the endoscope ..."

2. Review of "OLYMPUS REPROCESSING MANUAL, Chapter 5, Reprocessing the Endoscope (and related reprocessing accessories)," provided by the CNO on 10/22/19 at approximately 11:00 AM revealed the following requirements for staff when cleaning endoscopes:

a. "If the endoscope and accessories used in the patient procedure are not immediately cleaned after each patient procedure, residual organic debris will begin to dry and solidify, hindering effective removal and reprocessing efficacy. Preclean the endoscope and the accessories at the bedside in the patient procedure room immediately after each patient procedure. Immediately following the patient procedures ... Wipe the insertion section ... Dip a clean, lint free cloth or sponge in the water and wipe the entire insertion section of the endoscope."

b. "Follow the instructions provided by the detergent manufacturer regarding concentration, temperature, contact time and expiration date. Leave the endoscope ... immersed in the detergent solution, according to the instructions of the detergent manufacturer."

c. "Immerse the endoscope in the detergent solution. Thoroughly brush or wipe all external surfaces of the endoscope, using clean lint-free cloths, brushes, or sponges."

d. "[Suction] detergent solution through the instrument channel and the suction channel. Flush the air/water channel with detergent solution."

e. "Immerse the endoscope ... in detergent solution. Leave the endoscope ... immersed in the detergent solution, according to the instructions of the detergent manufacturer."

f. "Remove detergent solution from all channels. Fill a clean, large basin with ... water ... immerse the endoscope ... in the water and gently agitate ... to thoroughly rinse ... flush the suction channel with 90 ml [milliliters] of water ... flush the air/water channel with 90 ml of water.

g. "Remove the endoscope with attached accessories from the water ... flush the suction channel with 90 ml of air ... flush the air/water channel with 90 ml of air."

h. "Dry the external surfaces of the endoscope ... by wiping with a clean, lint free cloth. Inspect all items for residual debris. Should any debris remain, repeat the entire cleaning procedures until all debris is removed."


3. Review of the manufacturer's instructions for "Carefusion Enzymatic Presoak and Detergent," revealed in part, "Recommended soak time for instruments is 5 minutes or longer ... Solution should be aspirated through lumens and channels of instruments. Scrub instruments and rinse thoroughly with warm water, aspirating water through lumens and channels to completely remove all traces of solution."

4. Review of the policy "Cleaning and Sterilization of Endoscopes," approved 10/2019, revealed the CAH staff failed to include all of the steps required by the endoscope manufacturer, including aspiration of detergent through the suction and air/water channels, and aspiration of water through the suction and air/water channels.

5. Observations on 10/22/2019 at approximately 8:40 AM, in the endoscopy room after Patient #1's colonoscopy, revealed the OR Nurse Manager failed to wipe down the entire endoscope per the manufacturer's instructions before taking the endoscope out of the room for further cleaning.


6. Observations on 10/22/19, beginning approximately 8:45 AM, in the endoscopy cleaning room after Patient #1's colonoscopy, revealed the following:

a. RN B placed the colonoscope in a small sink filled with water and CareFusion Enzymatic Presoak and Detergent. RN B failed to submerge the entire colonoscope in the solution as required per the manufacturer's instructions.

b. RN B failed to thoroughly clean or brush all external surfaces of the endoscope, as required per the manufacturer's instructions.

c. RN B failed to aspirate detergent solution through the instrument and the suction channels, as required per the manufacturer's instructions.

d. RN B failed to soak the endoscope for 5 minutes in the enzymatic presoak as required per the manufacturer's instructions.

e. RN B failed to completely rinse the endoscope to remove detergent solution from the endoscope.

f.. RN B failed to remove the detergent solution from all channels of the endoscope by flushing them with water, as required per the manufacturer's instructions.

g. RN B failed to remove the water from all channels of the endoscope by flushing the endoscope channels with a syringe, as required by the manufacturer's instructions.

h. RN B failed to dry the external surfaces of the endoscope, as required per the manufacturer's instructions.


7. During an interview at the time of the observations, RN B revealed they did not know all of the required steps to safely reprocess the colonoscope per the manufacturer's recommendations or the enzymatic detergent manufacturer's requirements to safely and appropriately clean the endoscope. RN B verified observed process was the same process used by the other surgical staff to clean the endoscopes.




II. Based on observation, staff interview, and document review, the Critical access Hospital (CAH) administrative staff failed to ensure 1 of 1 observed Certified Registered Nurse Anesthetist (CRNA) A cleansed the stopper on medication vials prior to removing the medication from the vial for 2 of 2 observed patients (Patient #1 and Patient #2. Failure to cleanse the stopper could potentially result in the staff introducing bacteria, viruses, or fungi into the medication and then administering the contaminated medication to the patient. Administering contaminated medication could potentially result in the patient developing a life threatening infection. The CAH staff performed an average of 500 endoscopies per year.

Findings include:

1. Observations on 10/22/2019 in the endoscopy room during a colonoscopy for Patient #1 revealed the following:

a. At approximately 8:15 AM, CRNA A (a nurse with specialized training to administer medication to ensure patients do not feel pain during surgery) removed the plastic cover on the top of the medication vial and removed Propofol (drug used to help patients relax during a procedure) with a needle attached to a syringe. CRNA A failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

b. At approximately 8:16 AM, CRNA A removed the plastic cover on the top of the medication vial and removed Lidocaine (drug used to prevent the pain of Propofol injection) with a needle attached to a syringe. CRNA A failed to cleanse the vial stopper with 70% alcohol prior to removing the medication from the vial.


2. Observations on 10/22/2019 in the endoscopy room during a colonoscopy for Patient #2 revealed the following:

a. At approximately 8:55 AM, CRNA A removed the plastic cover on the top of the medication vial and removed Propofol with a needle attached to a syringe. CRNA A failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

b. At approximately 8:55 AM, CRNA A removed the plastic cover on the top of the medication vial and removed Lidocaine with a needle attached to a syringe. CRNA A failed to cleanse the vial stopper with 70% alcohol prior to removing the medication from the vial.


3. During an interview at approximately 8:56 AM, CRNA A acknowledged they failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medications from the vials.

4. Review of the CAH policy, "Clinical Nursing Skills, Procedures and Techniques," approved 10/2019, revealed in part, "...most updated edition of 'Clinical Nursing Skills and Techniques' by Perry and Potter is the primary resource and authority for Clinical Nursing skills used [at the CAH] ..."

5. Review of "Clinical Nursing Skills & Techniques," by Perry and Potter, copyright 2018, revealed in part, "... Not all drug manufacturers guarantee that rubber seals of unused vials are sterile. Swabbing with alcohol reduces transmission of microorganisms."

6. An interview on 10/22/19 at approximately 11:30 AM, revealed the CNO expected all nursing staff at the CAH, including the CRNA, must follow the clinical guidelines, as outlined in "Clinical Nursing Skills" by Potter & Perry. Thus, the CNO expected the CRNA to cleanse the rubber stopper on medication vials prior to accessing the medication.





III. Based on observation, staff interview, and document review, the Critical access Hospital (CAH) administrative staff failed to ensure 1 of 1 observed Certified Registered Nurse Anesthetist (CRNA A) cleansed the intravenous (IV) connector prior to injecting medication into the IV for 1 of 1 observed patients (Patient #1). Failure to cleanse the IV connector could potentially result in the CRNA introducing bacteria, viruses, or fungi into the IV which could potentially result in the patient developing a life threatening infection. The CAH performed an average of 500 endoscopies per year.

Findings include:

1. Observation on 10/22/2019 in the endoscopy suite during a colonoscopy for Patient #1 revealed the following:

a. At approximately 8:18 AM, CRNA A (a nurse with specialized training to administer medication during surgery to ensure patients do not feel pain) used a syringe to inject Propofol and Lidocaine into Patient #1's IV. CRNA A failed to cleanse the IV connector with 70% isopropyl alcohol prior to injecting the medication.

b. At approximately 8:20 AM, CRNA A used a syringe to inject Propofol and Lidocaine into Patient #1's IV. CRNA A failed to cleanse the IV connector with 70% isopropyl alcohol prior to injecting the medication.


2. During an interview at approximately 8:56 AM, CRNA A confirmed CRNA failed to cleanse the IV connector prior to injecting medication, and acknowledged should probably do so.

3. Review of the CAH policy "Clinical Nursing Skills, Procedures and Techniques," approved 10/2019, revealed in part, "... most updated edition of 'Clinical Nursing Skills and Techniques' by Perry and Potter is the primary resource and authority for Clinical Nursing skills used [at the CAH] ..."

4. Review of "Clinical Nursing Skills & Techniques," by Perry and Potter, copyright 2018, revealed in part, "Use vigorous mechanical scrubbing methods when disinfecting needleless connectors before each access using 70% isopropyl alcohol, [iodine solutions], or [a greater than] 0.5 [percent] chlorhexidine ... solution. Disinfect [the access port] before each access when multiple accesses are required."

5. An interview on 10/22/19 at approximately 11:30 AM, revealed the CNO expected all nursing staff at the CAH, including the CRNA, must follow the clinical guidelines, as outlined in "Clinical Nursing Skills" by Potter & Perry. Thus, the CNO expected the CRNA to cleanse the intravenous needless access port prior to administering medication to patients.

I. Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) radiology staff failed to ensure staff secured 1 of 1 radiation exposure cord to not allow staff access into x-ray room 2 during completion of radiological tests on patients. The CAH radiology staff reported completing an average of 15 x-rays per month in room 2. Failure to secure radiation exposure cords could allow staff access to the x-ray room while performing an x-ray procedure and expose staff to unnecessary radiation.

Findings include:

1. Observations during tour of the radiology department on 10/21/19 at 2:25 PM, with the Radiology Manager, revealed 1 of 1 unsecured exposure cord in x-ray room 2, which allowed a staff member to enter approximately 8 feet into the x-ray room and still activate the x-ray machine.

2. Review of the CAH policy "Hospital Personnel Radiation Monitoring Practice," dated 9/1999, revealed in part,
"...When technologists are performing x-ray examinations, the technologist will stay behind the lead walls. The trigger is to remain behind the lead barrier. If a technologist has to hold a patient, they will be shielded and another technologist will be exposing the image ..."

3. During an interview on 10/22/19 at 2:55 PM, the Radiology Manager confirmed the staff failed to secure the radiation exposure cord and would allow staff to access into the x-ray room during x-ray procedures.



II. Based on policy review, document review, and staff interview, the Critical Access Hospital (CAH) radiology staff failed to a provide dosimeter badge (small devices used to measure staff member's exposure to radiation) for operating room staff while performing procedures in the operating room that involved a C-Arm fluoroscope (a portable device creating real-time radiological images). Radiology staff identified approximately 2 procedures performed per month using the C-Arm with fluoroscopy. Failure to provide operating room staff with dosimeter badges could potentially allow a staff member to receive unrecognized large quantities of radiation, and result in health hazards for the exposed staff member.

Findings include:

1. Review of the CAH policy "X-ray Precautions in the Operating Room," dated 10/2019, revealed in part "... Scatter radiation is monitored in the Operating Room by use of a monitoring badge. The first of every month, the monitoring badge is replaced by a Radiologic Technologist. The monitoring badge is kept on the anesthesia unit in OR 1, where all of the surgical procedures take place ..."

2. Review of dosimeter badge reports for July, August, and September 2019 documented 1 surgery badge and the reports lacked evidence the radiology staff monitored the radiation exposure for all of the operating room staff potentially exposed to radiation during use of the C-Arm Fluoroscope.

3. During an interview on 10/21/2019 at 2:40 PM, the Radiology Manager acknowledge the CAH does not provide individual operating room staff dosimeter badges to monitor their radiation exposure while using the C-Arm fluoroscope during procedures in the operating room.

Based on document review and staff interviews, the Critical Access Hospital (CAH) surgical staff failed to ensure Surgeon Q, Surgeon R, and Surgeon S completed the medical record with a pre-operative review and update to the History & Physical (H&P) for 1 of 1 open (Patient #1) and 3 of 5 closed patient charts reviewed (Patient #11, Patient #12, and Patient #13). Failure to assess the patient pre-operatively for any changes in their condition since the patient underwent an examination for the H&P could potentially result in Surgeon Q, Surgeon R, and Surgeon S failing to detect a change in the patient's condition between the H&P examination and the surgical procedure, potentially resulting in the patient experiencing an unexpected, life-treating complication during surgery. The Operating Room (OR) Manager identified the CAH staff performed approximately 101 surgical procedures per month.


Findings include:

1. Review of medical records revealed the following:

a. Patient #1 underwent a surgical procedure on 10/22/2019. Surgeon S failed to document, prior to the surgical procedure, that they evaluated Patient #1, and Patient #1 could still safely undergo the surgical procedure.

b. Patient #11 underwent a surgical procedure on 10/04/2019. Surgeon Q failed to document, prior to the surgical procedure, that they evaluated Patient #11, and Patient #11 could still safely undergo the surgical procedure.

c. Patient #12 underwent a surgical procedure on 10/04/2019. Surgeon Q failed to document, prior to the surgical procedure, that they evaluated Patient #12, and Patient #12 could still safely undergo the surgical procedure.

d. Patient #13 underwent a surgical procedure on 10/07/2019. Surgeon R failed to document, prior to the surgical procedure, that they evaluated Patient #13, and Patient #13 could still safely undergo the surgical procedure.


2. During an interview on 10/24/2019 at 09:30 AM, the OR manager verified that Patient #1, Patient #11, Patient #12, and Patient #13's medical records lacked documented evidence that Surgeon Q, Surgeon R, or Surgeon S assessed the patients prior to the surgical procedure for changes in their health status between the completion of the H&P exam and the surgical procedure.

3. During an interview on 10/24/2019 at 09:45 AM, Surgeon Q confirmed he failed to document his pre-operative assessment in Patient #11 and Patient #12's medical records.

Based on review of closed surgical patient medical records and staff interviews, the Critical Access Hospital (CAH) anesthesia staff failed to ensure Certified Registered Nurse Anesthetist (CRNA, a nurse with advanced training in administering anesthesia medications) T accurately documented the time of the post-anesthesia evaluation for 2 of 2 patients who required general anesthesia for a surgical procedure (Patient #11 and Patient #12). Failure to accurately document the time anesthesia staff completed the post-anesthesia evaluation could potentially result in the patients developing complications and the other medical providers failing to adequately address the complications, as the other medical providers lacked a clear timeline for the patient's care. The CAH staff identified CRNA T administers anesthesia to an average of 36 surgical patients monthly.

Findings include:

1. Review of closed surgical patient medical records revealed:

a. Patient #11 underwent surgical repair of an inguinal hernia on 10/04/2019. The CAH staff took Patient #11 to the Operating Room (OR) at 10:35 AM. Following the surgical procedure, CRNA T took Patient #11 to the Post-Anesthesia Care Unit (PACU) at 12:50 PM. CRNA T documented they completed the post-anesthesia evaluation at 12:50 PM (the same time the Patient #11 left the OR).

b. Patient #12 underwent dilation and curettage (scraping the walls of the uterus) and hysterscopic (examination of the uterus) on 10/04/2019. The CAH staff took Patient #12 to the Operating Room (OR) at 02:50 PM. Following the surgical procedure, CRNA T took Patient #12 to the Post-Anesthesia Care Unit (PACU) at 03:45 PM. CRNA T documented they completed the post-anesthesia evaluation at 03:45 PM (the same time Patient #12 left the OR).

2. During an interview on 10/24/2019 at 10:15 AM, CRNA T acknowledged they documented the post-anesthesia evaluation for Patient #11 and Patient #12 at the same time CRNA T documented the patients left the OR. CRNA T revealed the post-anesthesia evaluation occurred after the patients left the OR, but CRNA T failed to document the correct time that CRNA T performed the post-anesthesia evaluation.

3. During an interview on 10/24/2019 at 09:45 AM the Operating Room Manager acknowledged CRNA T failed to accurately document the time CRNA T conducted the post-anesthesia evaluation for Patient #11 and Patient #12.

Based on document review and staff interviews, the Critical Access Hospital (CAH) staff failed to develop a comprehensive activities care plan for 1 of 1 open swing bed patient (Patient #8) and 5 of 5 reviewed closed swing bed patients' medical records (Patient #3, Patient #4, Patient #5, Patient #6, and Patient #7). Failure to develop a comprehensive activities care plan that meets the physical and psychosocial needs of the individual patients could potentially impede the patient's progression toward attaining goals and achieving the highest level of well-being and independence possible. The CAH administrative staff identified an average of swing-bed patient length of stay of 4.6 days in 2019 and a census of 1 swing bed patient on entrance.

Findings include:

1. Review of the policy, "Activity Program," effective 05/2019, revealed in part, "... An activities plan will be developed for each patient consistent with his/her interests and wishes ..."

2. Review of medical records revealed the following:

a. The CAH staff admitted Patient #3 to swing bed status on 01/06/2019. The CAH staff discharged Patient #3 from swing bed status on 01/09/2019. The Social Worker completed an initial activities assessment for Patient #3 on 01/08/2019. Patient #3's medical record lacked evidence the CAH staff created an activity care plan that directed staff to provide individual or group activities chosen by the patient.

b. The CAH staff admitted Patient #4 to swing bed status on 05/28/2019. The CAH staff discharged Patient #4 from swing bed status on 05/31/2019. The Social Worker completed an initial activities assessment for Patient #4 on 05/28/19. Patient #4's medical record lacked evidence the CAH staff created an activity care plan that directed staff to provide individual or group activities chosen by the patient.

c. The CAH staff admitted Patient #5 to swing bed status on 06/17/2019. The CAH staff discharged Patient #5 from swing bed status on 06/20/2019. The Social Worker completed an initial activities assessment for Patient #5 on 06/18/2019. Patient #5's medical record lacked evidence the CAH staff created an activity care plan that directed staff to provide individual or group activities chosen by the patient.

d. The CAH staff admitted Patient #6 to swing bed status on 04/18/2019. The CAH staff discharged Patient #6 from swing bed status on 04/22/2019. The Social Worker completed an initial activities assessment for Patient #6 on 04/19/2019. Patient #6's medical record lacked evidence the CAH staff created an activity care plan that directed staff to provide individual or group activities chosen by the patient.

e. The CAH staff admitted Patient #7 to swing bed status on 08/05/2019. The CAH staff discharged Patient #7 from swing bed status on 08/08/2019. The Social Worker completed an initial activities assessment for Patient #7 on 08/08/2019. Patient #7's medical record lacked evidence the CAH staff created an activity care plan that directed staff to provide individual or group activities chosen by the patient.

f. The CAH staff admitted Patient #8 to swing bed status on 10/21/2019. The Social Worker completed an initial activities assessment for Patient #8 on 10/22/2019. Patient #8's medical record lacked evidence the CAH staff created an activity care plan that directed staff to provide individual or group activities chosen by the patient.


3. During an interview on 10/22/2019 at 01:05 PM, the Social Worker and Utilization Review Nurse acknowledged Patient #3, Patient #4, Patient #5, Patient #6, Patient #7, and Patient #8's medical records lacked an activities care plan.