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Based on observation, interview and document review, the critical access hospital (CAH) failed to ensure the equipment in X-Ray room 1, was maintained in a manner that would minimize risk for infection. This would have the potential to affect all patients who would receive X-Rays.

Findings include:

A tour of the radiology department was conducted on 5/7/18, at 2:30 p.m. In X-Ray room 1, a vinyl mat, approximately five feet in length, three feet wide and two inches thick was positioned upon the X-Ray table. The mat had large tears in the vinyl which extend along both sides with exposed foam padding protruding out from the mat. This foam padding was not be able to be cleaned. A loose sheet draped over the mat extended only a few inches on each side.

On 5/7/18, at 3:00 p.m. the radiology manager confirmed the foam padding was protruding and was uncleanable. The radiology manager stated the mat needed to be replaced.

The Department Cleanliness policy #3804133, last reviewed 7/2016 included, "All equipment used in direct patient contact was to be cleaned after each use with an approved germicide."

Based on observation, interview, and record review, the Critical Access Hospital (CAH) was found to be out of compliance with Life Safety Code requirements. These findings have the potential to affect all patients in the hospital.

Findings include:

Please refer to the Life Safety Code inspection tag: K0363

Based on interview and document review, the critical access hospital (CAH) failed to ensure an ongoing, comprehensive infection control surveillance program related to the tracking and trending of infections was in place. This had the potential to effect all hospital patients. In addition, the critical access hospital (CAH) failed to implement protocols for appropriate disinfection of the surgical environment used during endoscopy procedures which included, but were not limited to colonoscopies, to minimize risk of infection. This had the potential to affect all surgical patients.

Findings Include:

Review of the CAH infection control logs from January 2017, through May 2018, revealed the CAH had not completed an ongoing infection control surveillance program that tracked and trended infections in real time.

On 5/10/18, at 9:10 a.m. the chief nursing officer (CNO) indicated she was responsible for the infection control program and acted as the infection preventionist. The CNO stated infection control surveillance logs were compiled at the end of every month from information gathered from pharmacy and lab reports. The CNO indicated infections and/or signs and symptoms of infection were not tracked or logged on a daily basis, however, were discussed in a morning report every day. The CNO confirmed the last log that was completed was for March 2018, and tracking logs had not been initiated for April or May 2018.

The Reporting/Investigating of Infections policy dated 8/2017, included:
2. The administrative assistant and assistant director of nursing or designee will document both culture proven and infection in the infection control software (ICOA).
3. The infection control nurse (ICN) will review this data along with culture reports, other lab data and other information pertinent to the case via the electronic record for surveillance and investigational purposes.
4. The ICN, in conjunction with members of the Infection Control Committee, will investigate outbreaks or clusters.

An infection control surveillance program policy and procedure was requested and but not provided.

CLEANING OF PROCEDURE ROOM

A tour of the endoscopy procedure room was conducted on 5/8/18, at 7:45 a.m. with registered nurse (RN)-A surgical manager, who indicated the hospital had two operating rooms suites and an endoscopy suite. RN-A indicated endoscopy procedures including colonoscopies were usually performed on a weekly basis.

On 5/8/18, at 10:45 a.m. housekeeper (HSK)-A stated the endoscopy suite was cleaned between cases and terminally cleaned at the end of the day. HSK-A indicated Oxivir TB (disinfectant/sanitizer) was used on high touch surfaces and Oxivir Five 16 Concentrate was used to clean floors and walls.

On 5/8/18, at 2:45 p.m. RN-A reviewed and verified the disinfectant/sanitizer package labels did not indicate they were effective against clostridium difficile (C-Diff) spores. RN-A further stated patients who had colonoscopy procedures were not routinely tested for C-Diff, so staff would not know whether a patient might be infected or not. RN-A verified a bleach or comparable cleaning/disinfecting agent was not used for cleaning disinfecting the endoscopy suite between each patient or when the suite was terminally cleaned. RN-A indicated the endoscopes were cleaned with a high-level disinfectant that were effective against killing C-Diff spores.

On 5/10/18, at 9:10 a.m. the CNO indicated she was responsible for the infection control program and acting as the infection preventionist. CNO stated when there was known or suspected cases of C-Diff, bleach or comparable disinfectant/cleaner was used to clean patient rooms. The CNO further indicated patients undergoing a colonoscopy were not tested for C-Diff prior to procedures and staff would not know if the patient was infected with the C-Diff organism.

The manufacturer's labels for the Oxivir TB and Oxivir Five 16, included a list of organisms the products would kill however, Clostridium difficile was not included.

The Surgery Environment of Care policy dated 2/2018, instructed staff that during routine turnover cleaning and terminal cleaning to use a hospital approved disinfectant/sanitizer. The policy did not direct staff on the appropriate disinfectant to use to minimize the spread of infection in endoscopy procedure rooms.

Review of the CAH's guideline titled Infection Control Reminders dated 3/8/16, included the following: 1. Cleaning/Environment C-Diff utilize bleach.

Based on interview and document review, the critical access hospital (CAH) failed to ensure contracted services for anesthesia and rehabilitation services had quality assurance program improvement (QAPI) projects in place. This had the potential to effect all patients that receive anesthesia and rehabilitation services.

Findings include:

On 5/8/18, at 8:00 a.m. registered nurse (RN)-A surgical director indicated anesthesia completed their own quality assurance projects. RN-A further indicated she used to do projects for anesthesia as a back up to ensure there was a project in place. RN-A stated she was not aware of what anesthesia was currently working on or if they had a current project in place. RN-A indicated the last project anesthesia had sent to her via email was on 5/7/18. The document Bigfork Valley Anesthesia Quality Improvement Audit indicated the audit pertained to the discharge of patients from phase I post-anesthesia recovery. The document was not dated and did not indicate the period of time the project had started and/or ended. RN-A was not aware when the project had started, when and/or what time period the data had been collected, when or if the project had been completed. RN-A indicated previous quality projects were completed on 2/14/17, and 5/2017.

On 5/10/18, at 3:50 p.m. the chief nursing officer (CNO) confirmed anesthesia services did not have a current QAPI in place.


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REHABILITATION SERVICES

The CAH contracted services for rehabilitation services, which included occupational therapy, physical therapy and speech therapy did not have an ongoing QAPI in place.

On 5/10/18, at 11:00 a.m. the physical therapist confirmed rehabilitations services did not have a QAPI program at this time, however, stated there were plans to develop one, but nothing had been implemented as of yet.

Based on interview and document review, the critical access hospital (CAH) failed to ensure a comprehensive list of all services furnished under arrangement or agreements had been maintained. This had the potential to affect all patients receiving services at the CAH.

Findings include:

During the entrance conference on 5/7/18, at 10:45 a.m. the chief executive officer (CEO) was asked for the CAH's comprehensive list of agreements/contracted services. The CEO was interviewed again on 5/7/18, at 1:45 p.m. during which he asked for clarification what the list of agreements/contracts being requested included. The CEO confirmed the CAH did not have a comprehensive list of all agreements/contracts offered by the CAH which included the name of the agreement/contract, the service being offered, whether the service was offered on-or or off-site, whether there was any limit on the volume or frequency of the service provided, and when the service was available.

A policy that described how the CAH was going to maintain a list of contracts/agreements that included the name of the agreement/contract, the service being offered, whether the service is offered on-or or off-site, whether there is any limit on the volume or frequency of the service provided, and when the service is available was requested but not provided

Based on interview and document review, the critical access hospital (CAH) failed to ensure informed consents for surgery and anesthesia were timed and dated for 6 of 6 surgical records (P1, P2, P3, P4, P5, and P6) reviewed.

Findings include:

P1's Consent for Anesthesia Services form was signed and dated by P1 and the certified registered nurse anesthetist (CRNA) however, the form lacked the time when the consent was signed by P1 and the CRNA.

P1's Authorization and Informed Consent To Operation or Procedure form was signed and dated by P1 however, lacked the time when the consent was signed. The surgeon signed the consent however, the consent lacked the date and time it was signed.

P2's Consent for Anesthesia Services form was signed, dated, and timed by P2. The CRNA signed the consent however, the consent lacked the date and time it was signed.

P2's Authorization and Informed Consent To Operation or Procedure was signed and dated however, lacked the time it was signed. The surgeon signed the consent however, the consent lacked the date and time it was signed.

P3's Consent for Anesthesia Services was signed, dated, and timed by P3. The CRNA signed the consent however, the consent lacked the date and time it was signed.

P3's Authorization and Informed Consent To Operation or Procedure was signed, dated, and timed. The surgeon signed the consent however, the consent lacked the date and time it was signed.

P4's Consent for Anesthesia Services was signed, dated, and timed by P4. The CRNA signed the consent however, the consent lacked the date and time it was signed.

P4's Authorization and Informed Consent To Operation or Procedure was signed and dated, however, lacked the time it was signed. The surgeon signed the consent however, the consent lacked the date and time it was signed.

P5's Consent for Anesthesia Services was signed, dated, and timed by P5. The CRNA signed the consent however, the consent lacked the date and time it was signed.

P5's Authorization and Informed Consent To Operation or Procedure was signed, dated, and timed. The surgeon signed the consent however, the consent lacked the date and time it was signed.

P6's Consent for Anesthesia Services was signed, dated, and timed by P6. The CRNA signed the consent however, the consent lacked the date and time it was signed.

P6's Authorization and Informed Consent To Operation or Procedure was signed, dated, and timed. The surgeon signed the consent however, the consent lacked the date and time it was signed.

On 5/9/18, at 9:30 a.m. registered nurse (RN)-A surgical director verified the lack of dates and times on the aforementioned forms and stated the procedural consents should have included the time and date the physician and patient signed the form. RN-A further confirmed the anesthesia consents should included the time and date the CRNA and patient signed the form.

On 5/10/18, at 1:45 p.m. chief nursing officer (CNO) stated the procedural consents should have been signed, dated, and timed by the physician and patient. The CNO further stated the anesthesia consents should have also been signed, timed, and dated by the patient and the CRNA.

The Informed Consent policy dated 1/2018, indicated informed consent was required each time a procedure involving a risk was performed on a patient so the patient could make an intelligent and informed decision. The policy indicated the consent form would be signed by the patient and informing physician when the patient understood the information. The policy did not identify and/or address the dating or timing of the consents.

Based on interview and document review the critical access hospital (CAH) failed to ensure surgeons' completed the operative report immediately following surgery as directed by the medical staff bylaws for 3 of 6 records reviewed (P1, P2, P3). This had the potential to effect all surgical patients.

Findings include:

Northern Itasca Hospital District Big Fork Valley Medical Staff Bylaws Rules and Regulations dated 1/10/18, included under Section 2 Surgery (B); A full description of any operation shall be dictated by the surgeon immediately following the surgery.

On 5/9/18, at 9:00 a.m. surgical cases were reviewed with registered nurse (RN)-A, the surgical director which revealed three surgical patients (P1, P2, P3) surgeon's operative report was not immediately completed after the surgical procedure.

P1's operative report indicated P1 had an open reduction internal fixation of a left tibial plateau fracture with allograft augmentation on 12/21/17, and was admitted to the hospital for observation following the procedure. The surgeons operative report was completed the next day on 12/22/17.

P2's operative report indicated P2 had a right total knee arthroplasty on 1/16/18, and was admitted to the hospital for observation following the procedure. The report indicated the surgeon had not dictated and/or completed the operative report until 1/18/18, two days later.

P3's operative reported indicated P3 had a right total knee arthroplasty on 1/23/18, and was admitted to the hospital for observation following the procedure. The report indicated the surgeon had not dictated and/or completed the operative report until 1/24/18, the next day.

On 5/8/18, at 9:30 a.m. RN-A confirmed the operative report should be completed immediately following surgery.

On 5/10/18, at 1:15 p.m. RN-A provided the Delinquent Medical Records policy along with the medical staff by-laws. RN-A indicated the policy and the bylaws were conflicting in that the policy indicated the operative report would be dictated within 24 hours; whereas the bylaws indicated the operative report would be dictated immediately following surgery.

On 5/10/18, at 1:45 p.m. chief nursing officer (CNO) verified the policy and the medical staff bylaws conflicted and stated the medical staff bylaws should be followed.

The Delinquent Medical Records policy dated 7/2017, included: An operative report will be dictated within 24 hours post-surgery.

Based on interview and document review, the critical access hospital (CAH) failed to ensure anesthesia evaluations had been completed prior to and following surgery for 6 of 6 surgical patients (P1, P2, P3, P4, P5, P6) reviewed. This deficient practice had the potential to affect all CAH surgical patients.

Findings include:

On 5/9/18, at 9:00 a.m. surgical record review was completed with the surgical director/registered nurse (RN)-A. RN-A stated the CAH's anesthesia services were provided under agreement which utilized certified registered nurse anesthetists (CRNA's) for the delivery of anesthesia.

P1's surgical record was reviewed and the following was identified:

-P1 had an open-reduction internal fixation of a left tibial plateau fracture with allograft augmentation on 12/21/17. P1's Preoperative Evaluation form was incomplete and the following areas were blank/were not documented as having been assessed: Previous anesthesia/operations/complications indicated "multiple", height, weight, and family history of anesthesia complications areas were all blank. In addition, the pre-anesthesia assessment did not include the time the assessment was completed. Review of the post-anesthesia follow-up report revealed it failed to include oxygen use if any, temperature, and any observations and/or complications occurring during post-anesthesia recovery even though the documentation indicated P1's respirations were two per minute post-anesthesia.

P2's surgical record was reviewed and the following was identified:

-P2 had a right total knee arthroplasty on 1/16/18. Review of the Preoperative Anesthesia Evaluation revealed it was incomplete. The following areas were left blank/were not documented as having been assessed: age, respirations, temperature, family history of anesthesia complications, airway class mall score (used to predict the ease of endotracheal intubation), and problem list/diagnoses.

P3's surgical record was reviewed and the following was identified:

-P3 had right total knee arthroplasty on 1/23/18. Review of the Preoperative Anesthesia Evaluation revealed it was incomplete. The following areas were left blank/were not documented as having been assessed: age, height, respirations, temperature, airway class mall, family history of complications, and problem list/diagnoses.

P4's surgical record was reviewed and the following was identified:

-P4 had a right shoulder arthroscopy and debridement on 1/9/18. Review of the Preoperative Anesthesia Evaluation revealed it was incomplete. The following areas were left blank/were not documented as having been assessed: age, height, weight, family history of anesthesia complications, and problem list/diagnoses. Review of the post anesthesia follow-up report lacked any observations and/or complications occurring during post-anesthesia recovery.

P5's surgical record was reviewed and the following was identified:

-P5 had a colonoscopy on 5/4/18. Review of the Preoperative Anesthesia Evaluation revealed it was incomplete. The following areas were left blank/were not documented as having been assessed: age, height, temperature, family history of anesthesia complications, and problem list/diagnoses. The post-anesthesia follow-up report was reviewed and did not include assessment of all required areas included; level of consciousness, pulmonary status, oxygen utilization, and any observations and/or complications during post-anesthesia recovery.

P6's surgical record was reviewed and the following was identified:

-P6 had a diagnostic colonoscopy related to persistent bloating and abdominal pain on 11/29/18. Review of the Preoperative Anesthesia Evaluation revealed it was incomplete. The following areas were left blank/were not documented as having been assessed: temperature, family history of anesthesia complications, problem list/diagnoses. The post anesthesia follow-up report was reviewed and did not include assessment of all required areas including: temperature and any observations and/or complications occurring during the post-anesthesia recovery.

On 5/10/18, at 10:30 a.m. RN-A confirmed the aforementioned patient forms were incomplete.

On 5/10/18, at 1:45 p.m. the chief nursing officer (CNO) confirmed the anesthesia evaluations were incomplete and the areas should have been completed.

The following CAH's anesthesia policies were reviewed: Outpatient Anesthesia dated, 1/2017, PACU Assessment Phase 1 dated 12/2016, Post Anesthesia Care Unit Discharge Phase 1 dated 12/2016, and Discharge Criteria from Outpatient Day surgery dated 1/2017. None of the policies provided included the required documentation consistent with the federal regulation for the preoperative anesthesia evaluation or the post-anesthesia evaluations.