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Based on observation and interview, the facility failed to ensure stocked supplies for multiple patient use had not been stored in a negative pressure room used repeatedly by patients. This had the potential to affect all patients who utilize the emergency department.

Findings include:

A tour of the emergency department (ED) was completed on 8/8/17, at 11:20 a.m. It was noted in emergency room Bay 2, there were patient supplies stocked in the open shelves on the east wall. The stocked supplies included multiple IV bags with different solutions, dressing supplies, oral thermometers, and tape.

During interview with registered nurse (RN)-C on 8/8/17, at 11:20 a.m. she stated the supplies that are kept in Bay 2 of the ED were for patient use, and were routinely restocked. RN-C stated Bay 2 of the ED was used by multiple patients and their family members, and they could potentially have an infectious disease process. RN-C also stated patients and/or their family members could readily access the supplies, potentially contaminating them.

The chief nursing officer (CNO) was interviewed on 8/10/17, at 8:33 a.m. during which she confirmed Bay 2 of the ED had stocked supplies for multiple patient use that were not secured from potential patient cross contamination.

A policy regarding stock patient supplies in the emergency department was requested but not available.

Based on interview and document review, the critical access hospital (CAH) failed to monitor and track humidity levels in 2 of 2 operating rooms.

Findings include:

On 8/8/17, at 9:00 a.m. surgical service manager (SSM) reported there was no digital monitoring display for humidity levels located in the two operating rooms (OR). SSM stated the humidity levels in the OR suites were kept at zero, however, the surgical staff did not check the humidity levels. SSM stated the maintenance department monitored and tracked the levels by means of a computerized system which allowed for continuous monitoring. SSM stated if the humidity levels were too high, an alarm would sound to alert staff.

On 8/8/17, at 10:00 a.m. the surgical technician (ST)-A was interviewed and stated there was no panel or display which indicated the humidity levels in either OR.

On 8/9/17, at 1:55 p.m. the assistance plant engineer (PE)-A verified the surgical area was not equipped with digital humidity level displays, and stated the levels were electronically displayed in the maintenance room. PE-A stated the levels were checked daily however, the daily checks were for functionally of the system and no monitoring for appropriate humidity levels/parameters were being done. PE-A provided a humidity level printout for 8/9/17, which revealed a humidity level of 59.22% and indicated "Normal." PE-A stated the minimum level was to be 35% humidity and he did not know what the maximum level parameter was. PE-A stated the CAH did not document /track the humidity levels, and he was only able to provide today's reading. In addition, PE-A stated the electronic system was not set up to alarm when the humidity levels were outside of the safe parameters however, the system could be set up to alert staff of unsafe humidity levels. PE-A stated there was no policy or procedure related to monitoring humidity levels.

Based on observation, interview, and document 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 Life Safety Code inspection tags: K-0211, K-0321, K-0331, K-0353, K-0355, K-0363, K-0711, K-0712.

Based on interview and document review, the critical access hospital (CAH) was found not to be in compliance with 485.627 Condition of Participation for Organizational Structure due to the failure of the governing body to assure full legal responsibility for the implementing and monitoring policies and bylaws governing the CAH's total operation related to the credentialing/recredentialing of providers.

Findings include:

See C241: The governing body failed to assume full legal responsibility for the implementation of medical staff and governing body by-laws related to the appointment/reappointment of medical staff to ensure patients received quality care.

Based on interview and document review, the critical access hospital (CAH) failed to ensure 8 of 12 providers (MD-A, MD-B, MD-C, MD-D, MD-E, MD-F, MD-G, and certified registered nurse anesthetist [CRNA]-A) had been appropriately re-credentialed. This had the potential to affect all patients served by the CAH.

Findings include:

On 8/9/17, at 2:16 p.m. the credentialing files were reviewed with the director of Quality Health Management (QHM). The QHM director stated the current credentialing/re-credentialing process for the CAH was coordinated through herself. In addition, the QHM stated once a request for privileges was received, they were sent for medical staff review and recommendation; and then sent on to the governing board for final approval. The QHM verified the following findings:

1. MD (medical doctor)-A's credentialing file indicated MD-A had submitted an application for the reappointment of privileges at the CAH on 5/19/17. The CAH's medical staff recommendation for reappointment was dated 7/20/17. The governing board approved MD-A's reappointment on 5/18/17 (63 days prior to having received the medical staff recommendation for reappointment). At that time, the QHM indicated she thought the date of the governing board approval was incorrect and should have been 6/18/17 (still 33 days prior to having received the medical staff recommendation for reappointment). The QHM verified MD-A's request for privileges did not follow the CAH's medical staff bylaws, as MD-A's request for reappointment should have gone to the medical staff first for review and recommendation prior to be forwarded to the governing board for approval.

2. MD-B's credentialing file indicated MD-B had last been credentialed on 6/4/14. On 8/10/17, at 8:56 a.m. QHM confirmed MD-B's privileges had expired on 6/4/16; as the CAH's medical staff bylaws indicated providers would be re-credentialed every two years. QHM stated that MD-B was longer scheduled at the CAH, however verified MD-B had worked at the CAH after the privileges had expired. QHM confirmed MD-B had last worked in the CAH's emergency room in March 2017, and that MD-B should have been re-credentialed prior to 6/4/16.

3. MD-C's credentialing file indicated MD-C had submitted an application for privileges on 8/1/16. However, MD-C's credentialing file lacked documentation that MD-C's request for privileges had been forwarded on to the medical staff for review and recommendation, or to the governing board for approval. On 8/10/17, at 8:56 a.m. QHM verified MD-C's 8/1/16, request for privileges should have been forwarded o the medical staff for recommendation and to the governing board for approval.

4. MD-D's credentialing file indicated MD-D had last been credentialed on 6/3/15. On 8/11/17, at 8:56 a.m. QHM confirmed MD-D's privileges had expired on 6/3/17. QHM confirmed MD-D was still an active member of the medical staff at the CAH and should have gone through the reappointment process before 6/3/17.

5. MD-E's credentialing file indicated MD-E had submitted an application for the reappointment of privileges at the CAH on 5/23/17. The CAH's medical staff recommendation for reappointment was dated 7/20/17. The governing board approved MD-E's reappointment on 7/8/17 (12 days prior to the medical staff's recommendation for reappointment).

6. MD-F's credentialing file indicated MD-F had submitted an application for the reappointment of privileges at the CAH on 6/19/17. The CAH's medical staff recommendation for reappointment was dated 7/20/17. The governing board approved MD-E's reappointment on 7/8/17 (12 days prior to the medical staff's recommendation for reappointment).

7. MD-G's credentialing file indicated MD-G had submitted an application for reappointment of privileges at the CAH on 2/1/17. The CAH's medical staff recommendation for reappointment was dated 4/20/17. The governing board approved MD-G's reappointment n 4/18/17 (2 days prior the medical staff recommendation for reappointment).

8. CRNA-A's credentialing file indicated CRNA-A had last been credentialed on 10/1/14. On 8/11/17, at 8:56 a.m. QHM confirmed CRNA-A's privileges had expired on 10/1/16. QHM confirmed CRNA was still an active member of the affiliated staff at the CAH and should have gone through the reappointment process before 10/1/16.

On 8/9/17, at 3:03 p.m. QHM confirmed it was the CAH's expectation that the credentialing/re-credentialing process be followed as outlined in the medical staff and governing body bylaws.

On 8/10/17, at 8:30 a.m. the chief nursing officer (CNO) confirmed the credential/re-credential process should be followed as indicated by the medical staff and governing body bylaws.

Medical Staff Bylaws of Ely-Bloomenson Community Hospital dated 10/1/14, indicated the medical staff were advisory to the governing body, and the CAH and the medical staff's recommendations and actions are subject to the ultimate authority and approval of the governing body. "The medical staff shall review the application for appointment/reappointment and the governing body may concur or not concur with the recommendations of the medical staff. In either case, the decision of the governing body shall be final. Initial appointments to the medical staff should be for a period of two years and reappointments should be for a period of up to two years."

Restated Bylaws of Ely-Bloomenson Community Hospital undated, indicated the board of directors would organize the physicians and appropriate other persons granted practice privileges in the hospital into a medical staff under medical staff bylaws.

Based on interview and document review, the critical access hospital (CAH) failed to ensure 2 of 4 patient grievances (P21, P22) had been responded to in a timely manner.

Findings include:

Review of P21's grievance communication form indicated the following:
Over the weekend of 6/2/17, the chief executive officer (CEO) received a message from P21's family member regarding concerns regarding P21's care. On 6/5/17, the CEO, the Director of Quality and Health Management (DQHM) and a medical records staff person called P21's family member to hear specific concerns. The family member's concerns included how P21 was cared for in the facility, and the facility had an incorrect date of birth for P21, which made his transfer to a larger facility difficult. An internal plan of investigation was implemented due to information gathered during the 6/5/17, telephone call.

On 8/9/17, at 9:11 a.m. DQHM stated the Public Relations/Community Benefits Coordinator (PR/CBC) tried calling the family member several times, leaving a message, but was unsure if a written letter was sent. DQHM stated frequently they will follow-up grievances by phone, and it depended on how much follow-through they get from the patient. DQHM confirmed they did not send a letter to P21 or the family member concluding this grievance.

On 8/9/17, at 9:40 a.m. PR/CBC stated she and the facility CEO tried to call P21's family member several times. The PR/CBC stated they typically tell people the facility action by phone, not in writing.

Review of P22's grievance communication form indicated the following:
On 1/18/17, at approximately 10:00 p.m. P22 was brought to the facility emergency room by a family member. The family member later complained to the facility about the lack of professionalism and lack of care she felt P22 received. The Patient Relations Communication Form (PRCF) dated 1/19/17, indicated DQHM and PRCBC had reviewed the complaint and initiated appropriate internal investigation. The PRCF indicated a telephone call was left for P22's family member, but did not indicate if a written response was sent.

On 8/9/17, at 9:11 a.m. DQHM stated she verbally told P22's family member that they were addressing issues, but did not send a written response to the complaint.

On 8/10/17, at approximately 9:00 a.m. DQHM confirmed they did not send letters to P21 or P22 regarding their complaints.

The facility policy Complaints, Grievances and Appeals Process, dated 10/12/15, indicated any verbal contact will be followed up by a written response which included: name of the hospital contact person, steps taken on behalf of the patient to investigate the grievance, results of the grievance process, and date of completion.

Based on interview and document review, the critical access hospital (CAH) failed ensure an ongoing, comprehensive infection control surveillance program related to the tracking and trending of infections. In addition, the CAH failed to ensure the operating room suites were cleaned with a disinfectant effective against killing Clostridium difficile.

Findings include

On 8/8/17, at 1:30 p.m. the Infection Preventionist (IP) was interviewed and verified she was the person responsible for the CAH's infection control program. IP stated the infections that were tracked and trended on a daily basis were health care acquired infections (HAIs), infections in patients with an indwelling urinary catheters, and staff infections. IP reported no HAIs were identified within the last three months. IP stated the infection log for July 2017, had not yet been completed, and the August 2017, infection control log had not been started. The IP stated infection logs were completed at the end of the month, and consisted of the culture and sensitivity reports from lab, and identification of antibiotic changes. The IP reported patients that had other infections and symptoms of illnesses were not tracked, and it was expected nursing staff would identify and report to her with any indication of possible spread of those infections, and the nurses would initiate practices that would prevent the spread of infection.

The lab's Specimen Report log for June 2017 identified by the IP as the June 2017, infection control log consisted of all the lab results from hospital patients, clinic patients, and emergency room(ER) patients. The report did not clearly identify the patient status at the time of the lab draw, and included only date, time, test type, results of the test, and hand written identification of antibiotics that were prescribed next to the antibiotic sensitivity results. The infection control log lacked where the patient was located (hospital, clinic, or ER), any signs and symptoms of the infection, the onset and duration of symptoms and illness, and methods used to prevent and/or contain to stop the spread of the infections.

The facility policy Infection Control-Program Overview and Performance Improvement undated, directed the CAH to use continuous collection and/or screening of data to identify isolated incidents, or potential infectious outbreaks.

The facility policy Infection Control Surveillance Guidelines and Healthcare Associated Infection Definitions dated 5/14, directed through data collection and surveillance, Infection Control monitors for community acquired, healthcare acquired, and reportable infections. The policy directed recommended practices to include data should be collected consistently, appropriate information sources should be available, an appropriate approach to surveillance should be determined.

On 8/8/17, at 9:00 a.m. surgical service manager (SM) was interviewed and stated the operating room (OR) suites were cleaned between patients, and terminally cleaned at the end of the surgical day. SM reported staff used Virex II 256 disinfectant on large surfaces, and Oxivir Tb Wipes on smaller surfaces such as cords and computer screens. At 9:30 a.m. surgical technician (ST)-A reported the same process.

On 8/8/17, at 9:35 a.m. SM referenced the product labels for both cleaners, and verified neither label indicated effectiveness against Clostridium difficile (C-diff, a bacterium that causes inflammation of the colon). SM stated the facility should be using a cleaning product that would be effective against C-diff, especially since colonoscopy procedures were performed in the OR suites.

On 8/8/17, at 1:30 p.m. the Infection Preventionist (IP) indicated she was not aware of which cleaning products were used by the surgical department, because they had their own infection control polices. IP reported the ORs needed to be cleaned with a product that killed C-diff spores.

The Infection Control Committee meeting minutes dated 1/28/15, indicated the committee determined the Devise brand Oxivir Tb wipes and liquid would be the disinfectant for normal cleaning. Clorox Bleach wipes would be used for C-diff spores, and would be labeled for C-diff cleaning only.

Oxivir Tb Wipes product label indicated when used as directed, the product was highly effective against a broad-spectrum of pathogenic microorganisms and included a complete list of those microorganisms; C-diff was not included.

Virex II 256 product labeled included a complete list of microorganisms the product was effective against killing; C-diff was not included on the list.

The facility policy Housekeeping Procedures reviewed 2/17, directed operating rooms would be cleaned after every surgical procedure and terminally cleaned at the end of the day using an approved germicidal disinfectant. The policy did not identify the name(s) of the approved disinfectant(s).

Based on interview and document review, the critical access hospital (CAH) failed to ensure the list of services furnished under arrangement or agreement included the key components of these services provided to the CAH. This had the potential to affect all patients who received services at the CAH.

Findings include:

On 8/9/17, at 10:37 a.m. the director of Quality Health Management (QHM) provided the CAH's current list of services provided through arrangement or agreement. This Contracts/Agreements Index dated 4/12/17, identified the company which the CAH had the contract/agreement with and the services which were being contracted. However, QHM confirmed this list of services provided by contract/agreement lacked identification of whether the services were being offered, on or off-site; whether there was a limit on the volume or frequency of the services provided; and when the services were available.

Based on interview and document review, the critical access hospital (CAH) failed to ensure each medical record entry was properly authenticated with a timed and dated signature for 12 of 26 patients (P1, P2, P3, P11, P12, P23, P24, P25, P26, P6, P10, P14) who received services at the CAH.

Findings include:

P1 was admitted to the CAH on 8/5/17. On 8/5/17, and 8/7/17, the Physician Orders lacked a time for which the orders had been written. The hand written brief history and physical (H&P) on 8/5/17, and the physician progress notes on 8/6/17, and 8/7/17, lacked a time they had been written.

P2 was admitted to the CAH on 2/6/17. On 2/6/17, the Physician Orders lacked a time which the orders had been written. In addition, a verbal order taken by a registered nurse (RN) dated 2/6/17, was signed but not dated or timed when verified by the physician.

P3 was admitted to the CAH on 3/26/17. On 3/28/17, the Physician Orders lacked a time which the order had been written. In addition, verbal and telephone orders taken by an RN dated 3/28/17, lacked a dated, timed, physician verification signature.

On 8/8/17, at 11:48 a.m. RN-A verified the above noted findings for P1, P2, P3, and stated all orders should be signed, dated, and timed.

P11 was admitted to the CAH on 6/18/17. On 6/20/17, 6/21/17, and 6/22/17, the Physician Orders lacked a time when the orders had been written. In addition, a telephone order taken by an RN dated 6/19/17, lacked a dated, timed, physician verification signature.

P12 was admitted to the CAH on 3/31/17. On 3/31/17, and 4/1/17, the Physician Orders lacked a time when the orders had been written. In addition, verbal orders taken by an RN dated 3/31/17, lacked a dated, timed, physician verification signature.

On 8/8/17, at 2:45 p.m. RN-A verified the above noted findings for P11 and P12.

On 8/9/17, at 3:10 p.m. the director of Quality Health Management (QHM) confirmed all physician orders and progress notes should be dated, timed and signed. All verbal or telephone orders should be verified by the physician as soon as possible and include the physician's signature, date and time the physician is verifying the orders.

The facility policy Verbal and/or Telephone Orders dated 12/2016, directed verbal and telephone orders should be signed and dated by the prescribing practitioner within seven days. When the ordering physician was unavailable, it was acceptable for another team member or the attending staff to authenticate the verbal orders.

Medical Staff Bylaws of Ely Bloomenson Community Hospital, dated 10/1/14, section 3.5 Basic Responsibilities of Membership directed an expectation of the medical staff was to prepare and complete medical records in a timely fashion.


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P23 was admitted to the CAH on 6/20/17, for a surgical procedure. The Anesthesia Record form dated 6/20/17, included a Post Anesthesia Note section that lacked a time of the physician's signature. In addition, the Post Anesthesia Care Standing Orders form included a nurse signature that was dated and timed for 6/20/17, at 9:17 a.m. however, the orders lacked a physician signature, time, and date.

On 8/9/18, at 9:15 a.m. surgical services manager (SM) confirmed all orders and physician entries into the medical record should be signed, timed, and dated. SM verified P23's record lacked timing of the note entry and the standing orders lacked the physician signature, date, and time.

The facility policy Post Endoscopic Procedure Recovery reviewed 2016, directed documentation entries must all be timed and dated.

P24 was admitted to the CAH for observation on 5/18/17. The Physician Order form dated 5/18/17, included an order to admit to observation status. The form lacked physician signature and timing of the orders. Physician Order form dated 5/19/17, that indicated to discharge P24, lacked physician timing of the order.

P25 was admitted to the CAH for observation on 5/3/17, and was discharged from the CAH on 5/4/17. The record lacked a physician discharge order that was signed, timed, and dated.

P26 was admitted to the CAH for observation on 6/30/17. The record indicated on 7/5/17, P26 moved to a lower level of care. The record lacked a physician discharge order from observation status that was signed, timed, and dated. P26 was then discharged from the CAH on 7/11/17, for which the record included a discharge order, however lacked physician timing of the order.

On 8/9/17, at 1:30 p.m. registered nurse (RN)-B confirmed all orders into the medical record should be signed, timed, and dated. RN-B verified P24's orders dated 5/18 and 5/19/17 lacked physician signatures and timing of the orders, P25's record lacked a physician's order to discharge, and P26's record lacked a physician order to discharge from observation status, and the physician timing on the discharge order dated 7/11/17.

The facility policy Observation Status dated of 12/21/09, directed patient observation ends when the physician has ordered the patient released or admitted as an inpatient.

P6 was admitted to the CAH on 6/16/17. On 6/16/17, the Physician Orders lacked a time which the orders had been written. In addition, a physician order written on 6/17/17, lacked a time which the orders had been written.

P10 was admitted to the CAH on 3/24/17. On 3/26/17, and 3/27/17, the physician progress notes lacked a time which they were written. In addition, Physician Orders written on 3/24/17, 3/25/17, and 3/27/17, lacked a time that the orders were written. Verbal orders dated 3/25/17, and 3/26/17, were not dated, timed, or signed when verified by the physician.

P14 was admitted to the facility on 7/2/17. Physician Orders on 7/1/17, 7/2/17, 7/3/17, and 7/4/17, lacked a time which the orders had been written. In addition, P14's medical record lacked a discharge summary during a record review on 8/8/17, greater than 30 days after P14's discharge.

On 8/8/17, at approximately 3:00 p.m. RN-D confirmed the above findings for P6, P10, and P14.