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Based on personnel record review, review of the Medical Staff Bylaws, and staff interview, the CAH (Critical Access Hospital) failed to maintain current credentialing files with current licensure, certifications or registrations on 1 of 11 medical staff (E10) records reviewed. Findings include.

The facility failed to obtain a current state license on E11, who provided patient care services on a consulting basis.

On 8/11/10, at 11:00 a.m. the Physician Services Coordinator stated E11 works on a consulting basis by reading sleep study results after they are read by the internal medicine doctor. She stated E11 does not have a current Minnesota license, but does have a North Dakota license. However, she verified the credentialing file lacked the current North Dakota license. She stated E11 did not really need a Minnesota license because he was not actually seeing patients.

On 8/12/10, at 10:20 a.m. the Chief Nursing Officer (CNO) verified consulting physicians should have a current Minnesota license.

The Medical Staff Bylaws dated 7/30/09, indicated, "only Physicians licensed to practice in the State of Minnesota......shall be qualified for membership on the Medical Staff."

Based on observation and staff interview, the CAH failed to ensure patient bathroom water temperatures were maintained to ensure the safety of patients at 1 of 4 offsite clinics (Grand Forks). Findings include:

On 08/11/10 at approximately 2:15 p.m. the environment was toured with the clinic office coordinator (COC). The patient bathroom by the procedure room (for cystoscopy) and the lab draw room was observed to have hot water that immediately felt very hot/scalding on the surveyor's hand. The hot water's temperature was taken, in the presence of the COC, and read 138.7 degrees F, with steam observed to be coming off the water stream. At this time, the COC verified the findings.

Upon interview after this, the COC stated she didn't realize the water was that hot. She stated maintenance is through the hospital. She said they come and do routine maintenance checks, but she was unsure as to how often. She said the clinic calls the hospital when they have a maintenance question or concern/problem and someone comes as soon as they can. The COC pointed out the mechanical room, which was across the hall from the bathroom. She stated the clinic had one water heater and attempted to find a dial on the water heater to see what the temperature was set on. However, she was unable to determine the water temperature setting. She stated no patients had complained about the hot water or had been hurt by it. She locked the patient bathroom and was observed telling two other staff members to not let patients use the bathroom. The COC stated she would call the hospital to have maintenance come check the water and that no patients would be allowed to use the bathroom until maintenance came and fixed the problem.

Based on observation and staff interview, the CAH failed to ensure the appropriate storage of biohazardous waste at 1 of 4 offsite clinics (Grand Forks). Findings include:

On 08/11/10, at 2:15 p.m. a tour of the clinic's environment with the clinic office coordinator (COC) was completed. Lab room #1 was used to draw blood specimens from patients and to spin down the blood specimens. Blood collection tubes and various other supplies were stocked in this room. There was a large Sharps bin/container on the floor that was overflowing with sharps. The container was not closed or sealed, and was still in use. There was a full Sharps box in a locked container secured to the wall. The Sharps box was not closed or sealed, and it was still in use. However, an empty Sharps box was observed to be sitting on top of it. In addition a full Sharps box that was closed or sealed off was observed to be sitting in the right hand corner of the counter top.

Upon interview at this time, the COC stated she did not know why the Sharps receptacles were not taken out of use and taken out of the room to be disposed of properly. She added she was not sure whose task it was to do that.

Based on review of the Medical Staff Bylaws and credentialing procedures and staff interview, the governing body failed to assume full responsibility for the implementation of policies governing the total operations of the facility. The medical staff failed to submit all the appropriate documents before appointment and approval by the medical director for 8 of 12 medical and ancillary staff (E1, E2, E3, E4, E5, E7, E11 and E12) files reviewed. Findings include:


The facility failed to complete the National Practitioner Data Bank (NPDB) inquiries for all medical and ancillary staff filing for reappointment of clinical privileges as directed in the Medical Staff Bylaws.


The Medical Staff Bylaws dated 7/30/09, stated "the Physician Services Coordinator shall make an inquiry to the National Practitioner Data Bank ("NPDB") at least every two (2) years for every Medical Staff member."


E1 was approved for reappointment on 12/5/08. The most current NPDB results were from 2006.

E2 was approved for reappointment on 9/25/09. The most current NPDB results were from 8/23/07.

E3 was approved for reappointment on 9/25/09. The most current NPDB results were from 8/16/07.

E4 was approved for reappointment on 9/25/09. The most current NPDB results were from 9/12/07.

E5 was approved for reappointment on 9/25/09. The most current NPDB results were from 9/14/07.

E7 was approved for reappointment on 10/1/08. The most current NPDB results were from 6/26/06.

E11 was approved for reappointment on 12/5/08. The most current NPDB results were from 8/4/06.

E12 was approved for reappointment on 9/25/09. The most current NPDB results were from 9/4/2007.


On 8/11/10, at 12:00 p.m. the Physician Service Coordinator verified the credentialing records lacked a current NPDB inquiry with reappointment. She thought she had completed them at the time of the reappointment. However, upon request, the facility unable to provide documentation that an inquiry was completed at the time of the reappointment.

Based on staff interview and review of facility policies the CAH (Critical Access Hospital) failed to develop or revise policies with the advice of a group of professional personnel that included at least one mid-level practitioner such as a physician assistant (PA), nurse practitioner (NP), or clinical nurse specialist. Findings include:



A review of the Critical Access Policy Committee revealed no PA, NP or CRNA (mid-level practitioners) were present on the committee during the last CAH utilization review.

On 8/13/10, at 9:45 a.m. the education coordinator and chief nursing officer (CNO) verified no mid-level staff were present on the committee. They further verified the facility does employee mid-level staff. The education coordinator stated they were not required to have a mid-level staff on the committee because they had a full time physician. They both added a mid-level staff had been part of the Critical Access Policy Committee in the past.

Based on observation and staff interview, the Critical Access Hospital (CAH) failed to ensure that all drugs and biologicals were safetly stored in 2 departments (obstetrics, medical unit) utilizing medications. Findings include:

During the tour of the obstetrics (OB) hall on 08/11/10, at 11:15 a.m. unsecured medication was observed in an unlocked drawer at the end of the OB hall. The key was in the unlocked drawer. The cupboard and the drawer were at the end of the OB hallway and there was a bathroom just beyond this area. This area was routinely used by hospital staff and the public including children who would have access to the medication. As RN-D and the surveyor stood there, a secretary walked by and went into the bath room. The unlocked drawer with medications was unable to be visually monitored from the nursing station.

Medication stored in the unlocked and unsecured medication drawer was Pitocin (an exogenous hormone) 10 units per ml injections (18) vials.

At approximately 11:15 a.m. on 8/11/10, RN-D who was the Inpatient Unit Supervisor verified these findings. She indicated children were allowed to visits their mothers and would use this hall to do so. She further indicated the drawer should have been locked.


At approximately 11:00 a.m. on 8/11/10, during a tour of the medical unit, a patient's hallway medication box was observed to have a syringe with an empty bottle of Ondansetron 4 mg per 2 ml taped to it. This medication is used to prevent nausea and vomiting from the use of chemotherapy. The syringe had a clear liquid in it and was not labeled or dated.

Interview with the Inpatient Unit Supervisor at approximately 11:00 a.m. on 8/11/10, indicated staff should not have left a syringe without a label on it. She then interviewed the nurse caring for the patient and that nurse indicated she did not know who had left the unlabeled and undated syringe in her patient's medication box.

Based on observation, staff interview, manufacturer instructions for the use of a germicidal, and policy review, the Critcal Access Hospital (CAH) failed to maintain an adequate system to identify and implement appropriate interventions to prevent the spread of infection for 1 of 1 patient (P2) who received blood glucose testing by the use of a glucometer. Findings include:

The CAH failed to ensure adequate disinfection of a glucometer used for multiple patients.

On 8/11/10, at 10:50 a.m. RN-E was observed to take the multiple patient use glucometer to P2's room and precede to do a blood sugar check. She did not wash the glucometer before she began. RN-E donned gloves, and stuck the patient's finger with the lancet. After sticking the patient with the lancet she touched the glucometer with her gloves on. She completed a blood glucose test using the glucometer. Following this, RN-E was observed to wipe off the glucometer with a pre moistened "Steris Coverage Plus Germicidal" wipe once. This was completed in less than 15 seconds. The glucometer was dry by 30 seconds. She returned it to the storage box in less than 30 seconds.

Interview at this time with RN-E indicated that she had been told to wipe down the glucometer after each use. She indicated she had never been told she needed to keep the glucometer wet with the solution for any prescribed length of time. She stated she wipes it down and puts it away.

Review of the "Steris Coverage Plus Germicidal" instructions on effective cleaning of equipment indicated objects were to kept wet five minutes.

The policy for blood glucose testing dated 5/25/10, indicated: "Wipe down monitor after each patient use using a manufacturer approved disinfectant (eg. Coverage Plus R wipes)." There was no other information on how to use the product the CAH had suggested the staff use for glucometer cleaning.

On 8/12/10, at 10:05 a.m. the Infection Control Coordinator indicated the policy on cleaning the glucometer only addressed wiping the glucometer down after use. She indicated the staff had been educated to use the wipes; however, did not address how the wipes were to be used. She confirmed the glucometer should have been kept wet for 5 minutes as their approved disinfectant indicated was needed to be effective.

Based on interview and policy review, the Critical Access Hospital (CAH) failed to designate an individual who is responsible for the operation of the outpatient services department and to establish policies to ensure the integration of outpatient services with inpatient services. Findings include:

The organizational chart of the facility identified at least two managerial personnel that supervised departments providing outpatient services. The same day surgery department reported directly to the Chief Nursing Officer. Rehabilitation services that included physical, occupational, speech, respiratory/pulmonary therapies, cardiac rehab and sleep studies, all reported to the interim administrator/care center administrator.

The Chief Nursing Officer (CNO) verified during interview on 8/12/10, at 8:00 a.m. the CAH had not designated accountability of the outpatient services to a single individual. The CNO indicated the CAH's outpatient services operated under the administrative responsibility of at least two individuals as per the organizational design chart. The CNO was unable to provide written policies that outlined the integration of outpatient services, including an established method of communication between outpatient service departments to corresponding inpatient services.

Rehab manager-A also verified during interview on 8/10/10, at 1:30 p.m., the interim administrator was the individual rehab services was responsible to operationally.


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On 8/11/10, at 2:00 p.m. the clinic manager stated she thought the CNO would be the individual responsible for outpatient services.

Based on Medical Staff Bylaws review, record review, and interview, the Critical Access Hospital (CAH) failed to ensure all entries made in the medical record were timed, dated, and authenticated for 10 of 20 inpatients (P1, P2, P3, P4, P5, P14, P15, P16, P18, P19) reviewed receiving services at the CAH. Findings include:

The medical staff bylaws dated 7/30/09, stated "all clinical entries in the patient's medical record shall be accurately dated, timed and the author identified."


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The following inpatient records had incomplete entries.

P1 was admitted to the CAH on 8/11/10. P1's admission orders dated 8/11/10, lacked the time of the physician's order. Two physician telephone orders dated 8/11/10, did not include the date or time the physician had signed the orders. In addition, the two telephone orders did not include the time the orders were taken. The physician order dated 8/11/10, lacked the time of the order.

P2 was admitted to the CAH on 8/06/10. The admission orders dated 8/06/10, lacked timing of the physician signature.

P3's emergency room orders by the physician dated 7/30/10, lacked a time and date of the physician's signature. Ten orders from 7/31/10, through 8/04/10, which had been signed by the physician were not timed or dated when signed.

P4 was admitted to the CAH on 8/10/10. P4's telephone orders dated 8/10/10, were not timed as to when they were taken. The 8/11/10, order by the physician lacked the time of the order. The 8/11/10, telephone orders by the physician did not include the time they were received.

P5 was admitted to the CAH on 8/11/10. The 8/11/10, written order lacked the time the physician had signed the order.



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P14's telephone order dated 10/18/09, lacked a time and date of the physician signature. The physician orders dated 10/19/09, and 10/20/09, lacked the time of the entries.

P15's telephone physician order dated 10/2/09, lacked the time and date of the physician's signature. The 10/3/09, physician order lacked the time of the entry.

P16's telephone physician order dated 5/19/10, lacked a time and date of the physician signature. The 5/21/10, and 5/22/10, physician orders lacked the time of the entry.

P18's physician orders dated 1/11/10, and 1/14/10, lacked the time of the entry.

P19's two physician telephone orders dated 6/21/10, and 6/22/10, lacked the date and time of the physician signature. The physician order dated 6/22/10, lacked the time of the entry.


Medical records staff-B verified on 8/13/10, at 10:30 a.m., that for each patient's record there were some orders that were not both dated and timed for all entries noted. A review of the records identified one or more orders sections were lacking that included admission orders, interim orders (medications, studies, treatments), and discharge orders in the handwritten sections of the medical records.

Based on interview, manufacturer directions, and policy review, the CAH was found not to be in compliance with the Condition of Participation of Surgical Services. The CAH failed to ensure proper sterilization of surgical instruments for 7 of 7 surgical outpatients (SOP 1-7) who underwent cataract extraction with intraocular lens implant on 7/19/10. This practice could potentially effect most patients provided eye surgery at the CAH. Findings include:

During the tour of the surgical department on 8/11/10, at 2:45 p.m. the Surgical Services RN Manager (RNM-A) was interviewed regarding the use of flash sterilization. She stated the microsurgical eye instruments were washed between cases and then placed in the flash sterilizer in a tray (not wrapped) and the high speed autoclave cycle was used for 3 minutes for metal instruments and 10 minutes for the Phaco hand piece instrument used. The ophthalmologist did not bring any instruments with them and the two sets of eye instruments used were owned by the hospital. RNM-A reported the two sets of the microsurgical instruments used for cataract extractions were generally prepackaged sterilized for use with the first two cases; however, subsequent cases utilized instruments sterilized using the flash sterilization method.

At this time, RNM-A reported eye cases were routinely scheduled one day per month and about "50% of the time," there were additional cases that required use of flash sterilization. The Same Day Surgery RN-B verified the number of cases generally ranged from "two to nine." The schedule from the previous 3 months was requested and identified there were 7 eye cases (SOP 1-7) completed on 7/19/10.

The manufacturer recommendations and facility policies for use of flash sterilization on surgical instruments were requested.

On 8/12/10 at 1:30 p.m. the RNM-A provided a copy of the recommendations from the manufacturer (Amsco) pertaining to sterilization of microsurgical instruments and the facility policy. The manufacturer recommendations identify the Gravity Flash cycle for unwrapped goods were 3 minutes (270 deg.F) for utensils and 10 minutes for other instruments or porous materials. No dry time was indicated for unwrapped goods other than one to two minutes to help reduce excess steam vapor at the end of the cycle. The sterilizer also identified a Pre-vac cycle setting for double wrapped instrument sets and tray weighing under 17 pounds with a 4 minute sterilize time (270 deg.F) and a dry time of 20 minutes (15-30 minutes.)

RNM-A verified at 1:30 p.m. the instruments used were not wrapped prior to placing in the flash sterilizer.

The facility policy (undated) for flash steam sterilization identified the method, "is to be used only for emergency situations or if there is insufficient time to sterilize an item by the preferred prepackaged method--if an item is dropped on the floor and if there is no other alternative. Packaging and wrapping material are not to be used in the flash sterilization cycles."

Based on interview, and review of the Quality Assurance (QA) Plan, the critical access hospital (CAH) failed to provide an effective quality assurance program to evaluate the quality and appropriateness of the treatment and services furnished in the CAH related to 2 16 services or departments reviewed. Findings include:

The following service or department did not have an effective QA plan:

Rehab Services

On 8/10/10, at 1:30 p.m. Rehab manager-A reported the Quality Assurance program for Physical, Occupational, and Speech therapies consisted mainly of the patient satisfaction data gathering process. Rehab manager-A also stated the response numbers by patients had been low and the number of surveys distributed had been increased to get significant numbers returned. Although some discussion of the results had been performed in departmental meetings, manager-A was unable to provide information that elaborated on data analysis, identification/implementation of corrective actions and a method for evaluation of the corrective actions.

Manager-A also reported there were no specific treatment outcome projects in process and the QA council meetings were not a forum to discuss specific questions/answers related to each departments' QA projects. Additionally, manager-A verified there were no specific protocols or forms used by various departments to gather, record and analyze the data; each department had different methods. Manager-A also reported there was an interdepartmental project of stroke care. However, the development process had been ongoing since 2008, and approval for the process was still awaiting full medical staff approval.

During interview on 8/13/10, at 9:10 a.m. the QA lead person responsible to direct the QA at the CAH hospital verified neither she nor the committee closely reviewed each department's QA projects. However, the expectation was that their projects be customer focused and follow a previous Minnesota Hospital Association initiative. The QA lead added she was not aware of what problems rehab was working on. She added maybe they need to get into that format and broaden the scope of the Quality Council with more clinical focus.


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Dietary Department

Review of dietary department work notes and discussion with the Dietary Manager on 8/11/2010, at approximately 3:00 p.m., revealed the dietary department is not a part of the overall hospital Quality Assurance program.

At this time, the Dietary Manager stated that an internal auditing and department performance system is in place and provided records of monitoring and data collection. She stated that the contract dietary services provided by New Horizon Foods, Inc. do not report to or work in cooperation with the overall hospital Quality Assurance program.