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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 who received services in the CAH.

Findings include:

Please refer to Life Safety Code inspection tags: K0131, K0225, K0311, K0321, K0324, K341, K0343, K0353, K0372, K0761, K0901, K0918, K0919, and K0132.

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 implementing and monitoring policies and bylaws governing the CAH's total operation related to following medical staff by-laws, ensuring peer review had been completed, and ensuring ongoing quality assurance projects.

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 following medical staff by-laws.

See C330: The CAH failed to ensure periodic evaluation and quality review of their services. The cumulative effect of these systemic problems resulted in the CAH's inability to maintain effective quality assurance processes in order to ensure provision of quality health care.

Based on interview and document review, the governing body failed to ensure the medical staff by-laws were followed to ensure a chief of staff and vice chief of staff had been appointed, medical staff meetings were being held according to the by-laws, and active medical staff met the qualifications to be considered active medical staff. Additionally, the governing board failed to revise the medical staff by-laws to reflect current critical access hospital (CAH) practices. This deficient practice had the potential to affect all current and all future patients of the CAH.

Findings include:

A current roster of the medical staff (undated) was provided and indicated only one physician (MD-C) who was identified as the entire medical staff, and was also identified as the chief of staff.

The medical staff meeting minutes from January 2017 through May 2018 were reviewed and the following was identified:
For the 2017 calendar year, medical staff meetings were held on January 25, 2017; May 24, 2017; and September 13, 2017. A total of three (3) medical staff meetings were held. The medical staff by-laws indicated the following related to medical staff meetings: Article VII (7) titled Medical Staff Meetings Section 1. indicated regular medical staff meetings would be conducted monthly or no less than eight (8) times a year, and in order to better assure good patient care, meetings of the active medical staff with physician consultants and non-physician consultants (or department managers/administrative staff) may be considered a staff meeting. A review of the medical staff business by the medical staff (whether one or more) may, with proper documentation constitute a medical staff meeting. The medical staff by-laws article VII (7) titled Medical Staff Meetings Section 2. Quorum indicated a presence of fifty percent of the total membership of the active medical staff shall constitute a quorum.
Medical staff meeting minutes dated 1/25/17, revealed MD-C had been elected the chief of staff for 2017. There was no vice chief of staff elected for 2017, even though they had more than one active medical staff on the roster during 2017. The medical staff meeting minutes dated 1/30/18, was the first medical staff meeting held after the start of the calendar year, and revealed no discussion or election of the chief of staff or vice chief of staff for 2018.

The medical staff by-laws indicated the following related to appointment of the chief of staff and vice chief of staff: Article IV (4) Section 3. Election of Officers A. Officers will be elected at the first meeting of the calendar year of the medical staff. Only members of the active medical staff shall be eligible to vote. Article IV (4) Section 4. of the medical staff by-laws indicated Term of Office included the following: Officer, when elected, shall serve a one year term or until a successor is elected and qualified. Officers shall take office on the first day following the first meeting of the year. No person shall hold the same office for more than two consecutive terms.

Review of the governing board meeting minutes from 1/1/18-5/1/18, revealed no discussion related to the lack of an elected chief of staff and vice chief of staff. There was no evidence the governing board had been notified the medical staff were not following the by-laws related to holding medical staff meetings and what the medical staff meetings discussed. Additionally, the board meeting minutes had not reflected the medical staff were not able to follow their by-laws due to a lack of medical staff membership, nor was there discussion on revising the medical staff by-laws.

The chief of staff (MD-C) was not on-site or available for interview during all days of the survey May 29-31, 2018. A review of MD-C's employment agreement dated 1/1/17, indicated that MD-C would be traveling from out of state to continue his medical practice at Kittson Memorial Healthcare Center. MD-C was considered not only as an active member of the medical staff, but was the chief of staff even though the by-laws indicated in Article III (3) Section 2. Categories of the Medical Staff: The active medical staff shall consist of physicians who regularly admit patients to the hospital, who are located close enough, in terms of time, to the hospital to provide continuous care to their patients, and assume all functions and responsibilities of membership on the active medical staff...

The chief executive officer (CEO) was interviewed on 5/31/18, at 1:45 p.m. during which he established that MD-C was the chief of staff, MD-C's main residence was in the state of Florida, and MD-C traveled into Hallock, MN working approximately 11 days per month. The CEO confirmed the medical staff meeting minutes and the governing board meeting minutes lacked election of a chief of staff and vice chief of staff for the 2018 calendar year. The CEO confirmed that the governing body meeting minutes had not reflected any business discussed during medical staff meetings, or noted medical staff meetings had not been conducted according to the medical staff by-laws. The CEO confirmed that the board meeting minutes had not discussed revising the medical staff by-laws to reflect current CAH practices.

Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure policies and procedures were developed and implemented related to non-pharmacy staff compounding sterile preparations (CSPs) for immediate use. Additionally, the CAH failed to have documented training and competency testing of non-pharmacy staff who compounded medications, according to Untied States Pharmacopoeia Convention chapter (USP) <797>. In addition, based on observation, interview, and document review, the CAH failed to ensure expired intravenous solutions (IV) were intentionally not available for patient use, and/or failed to develop and implement policies and procedures for medication/solution procurement during nationwide medication/solution shortages that would include use of expired medications/solutions.

Findings include:

A United States Pharmacopoeia (USP) 797 Table of Risk Level Characteristics dated 2009, identified three categories of risk level associated with compounding sterile medication(s). A "Low-Risk Level" was identified with the following characteristics:
- Mode with no more than three sterile ingredients,
- No more than two entries into any one sterile container or sterile administration device,
- Compounded using closed or sealed systems and,
- Compounded using only simple manipulations.

On 5/29/18, at 12:30 p.m. the pharmacist in charge stated pharmacy hours were Monday through Friday, 8:00 a.m. to 5:00 p.m.; after 5:00 p.m. an after-hours pharmacy was utilized. Pharmacist indicated hospital registered nurses (RNs) mixed low-level sterile compounds such as intravenous (IV) antibiotics. Pharmacist indicated to her knowledge the hospital had not conducted formal training and testing to determine RNs were competent for CSPs for immediate use or otherwise.

On 5/30/18, at 3:35 p.m. RN-A and RN-B stated they had both mixed IV antibiotics such as Rocephin when the pharmacy was not open. RN-A stated they would receive a label that contained the recipe for mixing the medication from the off-site after hours pharmacy. RN-A indicated the after-hour pharmacy would verify through a video monitor the right medications were used, however did not oversee the mixing process, and did not verify the final product. RNs indicated upon hire during the orientation process, the pharmacist reviewed the procedure/and or demonstrated the process of mixing medication, however no return demonstration was required. Both RN-A and RN-B confirmed they had not received any on-going education since orientation, nor had either been formally trained and/or tested for competency in preparing CSPs. Both RN's indicated if a new medication was added to the pharmacy formulary that required mixing, the pharmacist would provide and explain the new medication to them.


Hospital policy Compounding Sterile Medications dated 8/2017, included: All compounding policies and procedures will follow USP General Chapter <797> Pharmaceutical Compounding-Sterile Preparations. These situations do not apply in situations where medications are compounded for immediate use, such as when nurses prepare IV solutions for immediate administration to be administered within one hour of compounding.

On 5/30/18, at 9:40 a.m. a tour of the operating room (OR) was conducted with chief nursing officer (CNO) and licensed practical nurse (LPN)-A. The OR crash cart contained two 100 milliliter (ml) bags of 5% Dextrose Injection USP (United States Pharmacopoeia) that had an expiration date of Jan 2018. A label that was affixed to the bag dated 2/1/18, included "Due to nationwide IV fluid shortages, KMH's [Kittson Memorial Hospital] medical director has approved the continued use of Dextrose 5% 100 ml bags (expired 1/31/18) until further supply can be obtained from pharmacy."

-At 9:45 a.m. the CNO stated the pharmacist was responsible for procurement and supply of solutions. The CNO also indicated the pharmacist was responsible for ensuring medication supplies in the crash cart were not outdated.

-At 11:15 a.m. the pharmacist in charge stated the hospital had experienced difficulty obtaining 100 ml bags of D5 and normal saline (NS) through their supplier, and the solutions had been on back order since November of 2017. Pharmacist further stated she had not attempted to use another supplier related to a contractual agreement, however, later used a secondary market. The pharmacist indicated the issue was presented to the pharmacy and therapeutics committee, and the medical director had approved the use of the expired solutions. Pharmacist indicated that decision was made to use expired products because the benefits seemed to outweigh of the risks. Pharmacist stated the hospital had not contacted the manufacturer of the solutions, the Minnesota Department of Health, the Federal Drug Administration, or the Centers of Disease Control, in order to ascertain safety and/or stability of the solutions past the expiration date. However, the pharmacist stated she had attempted to try to find research on safety and stability of the solutions but was not able to come up with anything. The pharmacist indicated the hospital did not have difficulty obtaining 50 ml and 1000 ml of D5 or normal saline solutions, and the use of the expired bags was not necessary and was avoided.

On 5/30/18, at 3:35 p. m. registered nurse (RN)-A and RN-B confirmed there had been expired solutions in the medication room, crash carts, and pharmacy. RN-A and RN-B stated when they received an order that required the use of the expired solutions they would ask pharmacist for an alternative mixing recipe that did not require the use of the expired bags of solutions. RN-A and RN-B stated to their knowledge no expired solutions were used.

Pharmacy Therapeutics Meeting minutes dated 1/30/18, included an update on IV fluid shortages that reported the inventory of 31 bags of NS 100 ml that had expired, and 14 bags of D5 100 ml that had expired. The minutes indicated the solutions were approved to be used even though they were past the manufacturer's expiration date.

Pharmacy Therapeutics Meeting minutes dated 5/14/18, included an update on IV fluid shortages. The minutes indicated the medical director's signature was on file for the use of the expired products during the nationwide shortage. The minutes indicated the hospital used a secondary market to obtain more solutions and the only expired product remaining in the hospital was NS 100 ml and D5 100 ml bags. The minutes also included: the medical director asked if there was any research on the safety and stability of using expired IV fluids; to which the pharmacist stated that she had not come across any literature, and was doing her best to secure product.

An FDA statement pertaining to IV solutions fluid shortage dated 1/16/18, indicated "We encourage health care organizations and hospitals to contact FDA directly if they aren't receiving the products they need."

Hospital policy Drug Storage Area Reviews dated 8/2017, directed all drug storage areas shall be reviewed by the pharmacist on a monthly basis.

Hospital policy Expired Medications dated 8/2017, directed pharmacy staff shall be responsible for checking and removing outdated medications in the pharmacy, nursing floor stock, crash carts, and anywhere else in the hospital medications are stored. Outdated or otherwise unusable drugs are to be removed from stock and sequestered from other medication so they are not dispensed. Unless otherwise stated on the manufacturer's packaging, the expiration date on the package will be deemed to be the last day of the stated month.

Based on interview and document review, the critical access hospital (CAH) failed to ensure completion of Medication Inadvertent Incident Reports (MIIR) according to the hospital's policies and procedures for 12 of 12 MIIRs reviewed. In addition, the facility failed to identify and develop quality improvement actions plans for potential patterns of intravenous (IV) medications/solutions infused not in accordance with physician orders. This had the potential to effect all hospital patients.

Findings include:

The CAH policy Medication Errors dated 8/9/17, reflected a scoring system for level of severity resulting from actual or potential medication errors:

Level 0: No error occurred, potential error (near miss)
Level 1: Error occurred without harm to patient
Level 2: Error occurred, increase monitoring but no change in vital signs or any patient harm
Level 3: Error resulted in need for increased monitoring, there was change in vital signs but no ultimate patient harm; any error needing increased laboratory monitoring
Level 4: Error resulted in need for treatment with another drug, increased length of stay, patient transfer to a higher level of care (i.e., ICU) or required intervention to prevent permanent impairment of damage
Level 5: Error resulted in permanent patient harm
Level 6: Error resulted in patient death

The policy also directed the following:

When a medication error occurs the following should occur in this order:
-Notify the physician and evaluate the patient
-Perform any necessary clinical interventions, within the patient care provider's scope of practice to reduce the negative effects of the identified error
-Record the medications as given in the medical record
-Record the observed and assessed outcome of the patient in the medical record
-Record notification of physician in the medical record with any resultant orders
-Record any actions and clinical interventions taken and the patient's response to same
-Report the error in detail on a medication inadvertent incident report

All medication error reports will be reviewed by the DON and Pharmacist and categorized according to severity, type, cause and drug class involved.
All medication errors will be referred to the Medical Staff.

MIIRs reviewed since 6/2/17, lacked evidence medication errors were referred to the medical staff and revealed the following:

MIIR dated 6/2/17, indicated normal saline intravenous (IV) fluid was administered at 255 milliliters (ml) per hour instead of 125 ml per hour and marked as an actual medication error. The MIIR indicated staff person involved was "None." In addition, the MIIR did not accurately reflect the scoring system per policy for severity of incident; severity indicated "Minor."

MIIR dated 6/14/17, indicated Levofloxacin 250 milligrams (mg) IV was infused over one half hour instead of one hour, and marked as an actual medication error. The MIIR lacked identification of medication error type, and did not accurately reflect the scoring system per policy for severity of incident; severity indicated "Minor."

MIIR dated 8/8/17, indicated Ativan 0.5 mg was administered instead of Xanax 0.5 mg and was identified as an actual medication error. The MIIR did not accurately reflect the scoring system per policy for severity of incident; severity of incident indicated "Minor."

MIIR dated 8/8/17, indicated a potential for medication error after discovery of conflicting doses of Xanax between patient's hospital and home medication lists. The MIIR lacked assessment of the severity of the incident.

MIIR dated 10/12/17, indicated a potential medication error where Enalapril 5 mg was removed from after hours hospital pharmacy instead of two 2.5 mg tabs of Eliquis. The MIIR did not accurately reflect the scoring system per policy for severity of incident; severity of incident indicated "None."

MIIR dated 11/3/17, indicated Epinephrine 1.0 mg was administered instead of 0.5 mg dose and was recorded as an actual medication error. The MIIR did not accurately reflect the scoring system per policy for severity of incident; severity of incident indicated zero.

MIIR dated 2/11/18, indicated Zofran 8 mg was given intramuscular instead of by mouth and was recorded as an actual medication error. The MIIR lacked identification of type of medication error, date and time the physician was notified, whom the physician was notified by, any adverse reactions, severity of the incident, and the supervisor's signature.

MIIR dated 2/25/18, indicated Vancomycin 1250 mg intravenous (IV) was administered over 60 minutes instead of 90 minutes; the error was not identified as actual or potential and did not include the name of the staff involved in the incident. The MIIR also lacked assessment of the severity of incident.

MIIR dated 2/27/18, indicated Diomox was given to a patient that had an allergy to Bactrim, was recorded as an actual medication error. The MIIR lacked the dose of Diomox administered, identification of the type of error that occurred, and assessment of the severity of the incident.

MIIR dated 3/2/18, indicated Percocet 5/325 mg two tabs by mouth was given instead of ordered hydrocodone and was recorded as an actual medication error. The MIIR lacked assessment of the severity of the incident.

MIIR dated 4/5/18, indicated Humalog insulin 40 units was administered to a patient without double check verification by another nurse and was recorded as an actual incident. The MIIR lacked supervisor signature and assessment of severity of incident.

MIIR dated 4/19/18, indicated omitted dose of Lisinopril 20.0 mg and hydrochlorothiazide 12.5 mg. The MIIR did not accurately reflect the scoring system per policy for severity of incident; severity indicated "None."

On 5/30/18, at 10:30 a.m. pharmacist in charge was interviewed and verfied the pharmacy department did not have any current quality improvement project, nor had a quality assurance project been developed based on medication errors patterns and/or trends. Pharmacist stated the medication errors and adverse drug events were closely monitored and the director of nursing would track and trend the errors. Pharmacist indicated the MIIRs should have been completed per policy.

On 5/31/18, at 1:15 p.m. chief nursing officer (CNO) was interviewed and indicated all the areas on the medication error report forms should be completed per hospital policy.


MIIR dated 6/2/17, indicated normal saline intravenous (IV) fluid was administered at 255 milliliters (ml) per hour instead of 125 ml per hour and marked as an actual medication error. The MIIR indicated staff corrective action was performed with staff member involved.

MIIR dated 6/14/17, indicated Levofloxacin 250 milligrams (mg) IV was infused over one half hour instead of one hour and marked as an actual medication error. The MIIR indicated staff corrective action was performed with staff member involved.

MIIR dated 2/25/18, indicated Vancomycin 1250 mg intravenous (IV) was administered over 60 minutes instead of 90 minutes. The MIIR indicated corrective action was performed with staff member involved.

Pharmacy quality assurance reports were reviewed since June 2017. The reports revealed the hospital pharmacy did not have a quality assurance project from July through September of 2017 (3rd quarter), and did not identify the potential pattern of infusing IV medications and/or solutions not in accordance with physician orders.

On 5/30/18, at 10:30 a.m. pharmacist in charge was interviewed, and verfied the pharmacy department did not have any current quality improvement project, nor had a quality assurance project been developed based on medication errors patterns and/or trends. Pharmacist stated the medication errors and adverse drug events were closely monitored and the director of nursing would track and trend the errors.

Based on observation, interview, and document review, the critical access hospital (CAH) failed to ensure staff properly disinfected the multi-use glucometer equipment after patient testing for 1 of 1 patient (P6) observed for blood glucose monitoring.

Findings include:

On 5/29/18, at 1:53 p.m. registered nurse (RN)-R was observed to obtain a multi-use glucometer from the medication room drawer. RN-R entered P6's room, and obtained a blood sample to check P6's blood glucose. RN-R placed the multi-use glucometer in a vinyl zip case and left P6's room. RN-R went to the medication room, obtained a disinfectant wipe (disinfectant cleaner RTC 40), quickly wiped over the surface of the multi-use glucometer (less than 30 seconds) and the vinyl zip case, then put the multi-use glucometer and case in the medication room drawer. RN-R stated her usual practice was to use an alcohol wipe for about ten seconds on the multi-use glucometer. RN-A stated would usually let the machine air dry for three minutes as the by the disinfectant wipes directed. RN-R stated she did not know how long to keep wiping with the disinfectant wipe.

On 5/30/18, at 2:10 p.m. licensed practical nurse (LPN)-L was observed to obtain a multi-use glucometer from the medication room in a vinyl zip case. LPN-L went to P6's room, obtained a blood sample to check P6's blood glucose, put the multi-use glucometer in the vinyl zip case, and left P6's room. LPN-L wiped the multi-use glucometer with a Sani Cloth approximately 30 seconds, and let the multi-use glucometer air dry. LPN-L stated she always used the purple top Sani Cloth to clean the multi-use glucometer and let dry for two minutes. LPN-L read the label of the Sani Cloth directions, then stated she had not been cleaning the multi-use glucometer correctly. LPN-L stated she should have been keeping the multi-use glucometer wet for two minutes as directed on the Sani Cloth label.

Review of the manufacture's instructions for the multi-use glucometer undated, indicated to always use Super Sani Cloth to clean and disinfect the meter. Do not us any other cleaning or disinfecting solution. Using solutions other than Super Sani Cloth could result in damage to the system components.

Review of the Sani Cloth manufacture's written instructions undated, located on the container label of the Sani-Cloth container, indicated the treated surface was to remain wet for two minutes, and then let air dry.

Based on interview and document review, the critical access hospital (CAH) lacked evidence informed consents for anesthesia were obtained for 3 of 3 eye surgical records (P1, P2, P3) reviewed. In addition, the CAH failed to ensure informed consent for anesthesia were timed and dated for 2 of 2 endoscopy surgical records (P4, P5) reviewed.

Findings include:

P1's surgical and anesthesia record dated 2/27/18, lacked evidence of an anesthesia informed consent.

P2's surgical and anesthesia record dated 12/19/17, lacked evidence of an anesthesia informed consent.

P3's surgical and anesthesia record dated 3/27/18, lacked evidence of an anesthesia informed consent.

P4's paper anesthesia record dated 12/14/17, included a section for pre-operative anesthesia plan. The plan identified "Sedation" and risk and benefits explained. The section was signed by P4 and the certified registered nurse anesthetist (CRNA), however, the form lacked the date and time the form was signed by P4 and the CNRA.

P5's paper anesthesia record included a section for pre-operative anesthesia plan. The plan identified "Sedation" and risks and benefits explained. The section was signed by P5 and the CRNA, however, the form lacked the date and time the form was signed by P5 and the CRNA.

On 5/31/18, at 1:15 p.m. chief nursing officer (CNO) verified that P1, P2, and P3's records lacked an anesthesia informed consent. CNO further verified P4 and P5's informed consents lacked the date and time the consents were signed by the patients and CRNA. CNO stated anesthesia informed consents should include the time and dates of the CRNA and patient's signatures.

Undated facility policy and procedure Pre-operative Care directed to have a surgical permit and anesthesia permit signed and witnessed; this must be done before the patient is given pre-operative hypnotic or narcotic.

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 5 of 5 surgical patients (P1, P2, P3, P4, and P5) reviewed. This deficient practice had the potential to affect all CAH surgical patients.

Findings include:

On 5/31/18, at 11:00 a.m. surgical record review was completed with the administrator of clinics and admissions.

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

P1 had cataract removal and intra-ocular lens implant of right eye on 2/27/18. P1's pre-operative evaluation form was incomplete; the blood oxygen saturation area was left blank/was not documented as having been assessed. In addition, the Laboratory Results section was also blank with the exception of the hand written word "Reviewed." Furthermore, the pre-operative evaluation did not include the time the assessment was completed. Review of the post-anesthesia follow-up report was incomplete, whereas it did not identify the time of disposition back to the pre-operative room, and lacked P1's vital signs at the time of disposition.

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

P2 had cataract removal and intra-ocular lens implant of left eye on 12/19/17. P2's pre-operative evaluation form was incomplete and the following areas were blank/were not documented as having been assessed: height, blood pressure, oxygen saturations, identification if smoker, pre-anesthesia medications, and laboratory results. In addition, the pre-operative evaluation did not include the time the assessment was completed. Review of the post-anesthesia follow up report was incomplete, whereas it did not identify the following: level of consciousness/alertness, the time of disposition back to the pre-operative room, and lacked P2's vital signs at the time of disposition.

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

P3 had cataract removal and intra-ocular lens implant of the left eye on 3/27/18. P3's pre-operative evaluation form was incomplete and the following areas were blank/were not documented as having been assessed: oxygen saturations, gastrointestinal history, and potential airway problems. In addition, the Laboratory Results area was blank except for the notation of "Reviewed in chart," and the Past Surgical History was blank with the notation of "See chart." Furthermore, the preoperative evaluation did not include the time in which the assessment was completed. Review of the post-anesthesia follow-up report was incomplete whereas it did not identify the time of disposition back to the pre-operative room, and lacked P3's vital signs at the time of disposition.

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

P4 had a colonoscopy and esophagogastroduodenoscopy with possible biopsy and/or polyp removal on 12/14/17. P4's pre-operative evaluation form was incomplete and the following areas were blank/were not documented as having been assessed: weight, height, oxygen saturations, past surgical history, airway assessment, potential airway problems, the physician performing the procedure, and the time evaluation was completed. Review of the post-anesthesia follow-up lacked the following information: assessment of P4's temperature, level of consciousness/alertness, if R4 had been stable at the time of disposition, and where P4 had been dispositioned to.

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

P5 had a colonoscopy with possible biopsy and/or polyp removal on 2/8/18. P5's pre-operative evaluation form was incomplete and the following areas were blank/were not documented as having been assessed: weight, height, blood pressure, respirations, temperature, oxygen saturations pre-anesthesia medications, history of smoking, and past surgical history. The pre-operative report also lacked the time the evaluation was completed. Review of the post-anesthesia evaluation assessment failed to include any observations and/or complications during post anesthesia recovery, even though vital sign documentation reflected R5 was potentially hypotensive with a blood pressure of 84/56 mm/hg at the time of disposition back to the pre-operative room.

During the record review, the administrator of clinics and admissions confirmed anesthesia pre and post-operative forms were incomplete for 5 of 5 surgical patients reviewed.

On 5/31/18, at 1:15 p.m. chief nursing officer (CNO) verified the anesthesia records for P1, P2, P3, P4, and P5 were incomplete with blank areas, which indicated the blank areas had not been fully assessed. CNO stated the forms should not be left with blank areas, that it is the certified registered nurse anesthetists responsibility (CRNA) to ensure all required areas are assessed and recorded on the anesthesia record forms.

A pre-operative anesthesia assessment policy and procedure pertaining to required assessments for CRNA's was requested and not received.

A post-operative anesthesia assessment policy and procedure pertaining to monitoring, assessments, and disposition requirements for CRNA's was requested and not received.

Based on interview and document review, the critical access hospital (CAH) lacked evidence 3 of 5 surgical patients (P2, P4, P5) reviewed were discharged in the company of a responsible adult without evidence of exemption by the practitioner who performed the surgical procedures. Additionally, the surgical discharge policy and procedure lacked the requirement for discharging patients in the company of a responsible adult except when exempted by the physician. This had the potential to effect all patients who elected to have surgical procedures at the CAH.

Findings include:

On 5/31/18, at 11:00 a.m. surgical records were reviewed with administrator of clinics and admissions.

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

P2 had cataract removal and intra-ocular lens implant of left eye on 12/19/17, with sedation. Nurse's notes dated 12/19/17, at 2:05 p.m. indicated P2 discharged ambulatory, and was accompanied by the licensed practical nurse (LPN). P2's nursing notes lacked indication P2 was discharged with a responsible adult, and P2's surgical record lacked evidence of an annotation of exemption by the physician.

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

P4 had a colonoscopy and esophagogastroduodenoscopy with possible biopsy and/or polyp removal on 12/14/17. P4's surgical record lacked documentation P4 was discharged with a responsible adult, and lacked evidence of an annotation of exemption by the physician.

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

P5 had a colonoscopy with possible biopsy and/or polyp removal on 2/8/18. P5's surgical record lacked documentation P5 was discharged with a responsible adult, and lacked evidence of an annotation of exemption by the physician.

During the record review on 5/31/18, administrator of clinics and admissions confirmed the lack of documentation that P2, P4, and P5 were discharged home with a responsible adult, and the records lacked evidence of a physician annotation of exemption.

On 5/31/18, at 1:15 p.m. chief nursing officer (CNO) confirmed P2's nurse's notes indicated R2 was not discharged in the care of a responsible adult. CNO indicated she could not find evidence in P4 or P5's electronic record they had been discharged with a responsible adult. CNO indicated the hospital always ensured patients discharged in the care of a responsible adult, and stated the record should always reflect documentation of that.

Review of hospital policy Post Anesthetic Care Unit Discharge Policy dated 7/2012, lacked the requirement of patient discharge with responsible adult with the exemption of physician exemption.

Based on interview and review of facility policies and quality assurance documentation, the critical access hospital (CAH) failed to ensure periodic evaluation and quality review of their services. The cumulative effect of these systemic problems resulted in the CAH's inability to maintain effective quality assurance processes in order to ensure provision of quality health care. Therefore, the CAH was unable to meet this condition of participation. These deficient practices have the potential to impact all patients receiving services from the CAH.

Findings include:

C331-The CAH failed to ensure a policy or procedure had been developed that identified what information and how the information should be included in the periodic evaluation, how the Critical Access Hospital (CAH) was going to conduct the periodic evaluation, and who was responsible for conducting the periodic evaluation.

C332- The CAH failed to ensure a review of the utilization of Critical Access Hospital (CAH) services including the number of patients served and the volume of services had been completed.

C333- The CAH failed to ensure a representative sample of active and closed inpatient and outpatient records were reviewed. This had the potential to affect all current and future inpatients and swing bed patients of the CAH.

C335- The CAH failed to review and evaluate the CAH's utilization of services in order to determine if changes needed to be made during their annual CAH evaluation.

C336- The CAH failed to ensure the overall ongoing quality assurance activities were consistently reported the the governing board and medical staff.

C337- The CAH failed to ensure the governing board had been apprised of quality improvement (QI) initiatives on an ongoing basis. This deficient practice had the potential to affect all current and future patients of the CAH.

C339- The CAH failed to ensure peer review was conducted for 2 of 2 certified registered nurse anesthetist's (CRNA-B, CRNA-B) randomly reviewed.

C340- The CAH failed to ensure peer review was conducted for 2 of 3 medical doctors (MD-A, MD-B) randomly reviewed.

C342- The CAH failed to ensure quality assurance/performance improvement projects were developed and integrated into the CAH's quality improvement program for pharmacy services. In addition, the CAH failed to ensure dietary services performance improvement project had measurable goals with timelines, measurable action plans with timelines, and ongoing evaluation and reevaluation of goals and action plans.

Based on interview and document review, the critical access hospital (CAH) failed to ensure a policy or procedure had been developed that identified what information and how the information should be included in the periodic evaluation, how the CAH was going to conduct the periodic evaluation, and who was responsible for conducting the periodic evaluation.

Findings include:

The director of health information management services (HIMS) was interviewed on 5/29/18, at 3:00 p.m. and stated she did not know how to complete a periodic CAH evaluation. HIMS director further stated she had never been trained how to complete the CAH periodic evaluation, and was not aware what needed to be included in the periodic evaluation.

Review of the items provided by the HIMS director revealed the following was included: A list of services provided by the CAH, a spread sheet of numbers with a monthly accounting of volumes of patient admissions, discharges, deaths, patient days, swing bed admissions, respite stays, observation patients, emergency room visits, surgeries, lab tests, and radiology tests from July of 2015, through July 2017. Additionally, analysis of the aforementioned data had not been completed or provided.

The director of HIM was interviewed on 5/31/18, at 4:30 p.m. during which she confirmed that the CAH did not have a policy or procedure that directed how to complete a periodic evaluation.

Based on interview and document review, the critical access hospital (CAH) failed to ensure a review of the utilization CAH services included the number of patients served, and the volume of services had been completed. This deficient practice had the potential to affect all current and future patients of the CAH.

Findings include:

Review of the items provided by the health information management services (HIMS) director revealed the following was included: A list of services provided by the CAH, a spread sheet of numbers with a monthly accounting of volumes of patient admissions, discharges, deaths, patient days, swing bed admissions, respite stays, observation patients, emergency room visits, surgeries, lab tests (total not what type), and radiology tests inpatient and outpatient totals along with the following test volumes (MRI's, CT, EKG, ultrasound , and mammograms), from July 2015, through July 2017. Additionally, analysis of the aforementioned data had not been completed or provided. The review of patient volumes had not included any outpatient services that included, but were not limited to the following: infusion services, physical therapy, occupational therapy, and speech therapy. Additionally, the CAH had not reviewed volumes of contracted services provided.

The director of HIMS was interviewed on 5/31/18, at 4:30 p.m. during which she confirmed that the CAH did not have a policy or procedure that directed how to complete a periodic evaluation, and stated she did not know how to complete a review of the CAH's utilization of services.

Based on interview and document review, the critical access hospital (CAH) failed to ensure a representative sample of active and closed inpatient and outpatient records were reviewed. This had the potential to affect all current and future inpatients and swing bed patients of the CAH.

The findings include:

A review of the CAH's periodic evaluation completed 7/16/17, lacked indication a representative sample of inpatient and outpatient records had been reviewed. The CAH lacked documentation of the review of the 10% minimum required active and closed records for all services provided by the CAH.

On 5/31/18, at 1:45 p.m. the chief executive officer (CEO) stated the health information manager was responsible for completing the periodic review of the CAH and was responsible for ensuring a sample of active and closed inpatient and outpatient records were reviewed. The CEO confirmed the minutes from the annual periodic review completed on 7/16/17, did not include the analysis of the sample of active and closed inpatient and outpatient records.

The health information management director (HIM) was interviewed on 5/31/18, at 4:30 p.m. during which she confirmed that the minimum of 10% active and closed records for all services provided by the facility were not reviewed, and criteria for the record reviews had not been established. The HIM director confirmed the CAH did not have a policy or procedure that directed the CAH how to complete a periodic evaluation or the active and closed record review for all services provided.

Based on interview and document review, the critical access hospital (CAH) failed to review and evaluate the CAH's utilization of services in order to determine if changes needed to be made during their annual CAH evaluation. This had the potential to affect all CAH patients.

Findings include:

Review of the minutes of the 7/16/17, CAH periodic evaluation provided by the health information management services (HIMS) director revealed the following was included: A list of services provided by the CAH, a spread sheet of numbers with a monthly accounting of volumes of patient admissions, discharges, deaths, patient days, swing bed admissions, respite stays, observation patients, emergency room visits, surgeries, lab tests (total not what type), and radiology tests inpatient and outpatient totals along with the following test volumes (MRI's, CT, EKG, ultrasound and mammograms), from July 2015, through July 2017. Additionally, analysis of the aforementioned data had not been completed or provided. The review of patient volumes had not included any outpatient services that included, but were not limited to the following: infusion services, physical therapy, occupational therapy, and speech therapy. Additionally, the CAH had not reviewed volumes of contracted services provided.

The meeting minutes lacked discussion regarding an evaluation of the services provided by the CAH and whether the utilization of services remained appropriate or if changes needed to be made.

On 5/31/18, at 4:30 p.m. the HIMS director confirmed the utilization of services report lacked information of other service lines which had been provided by the CAH in 2016 and 2017, such as physical therapy, occupational therapy, speech therapy, categories of surgical procedures, diagnostic radiology and out-patient infusion center along with the financial impact they had made on the CAH. The director of HIMS verified the CAH annual review was not an inclusive list of services provided by the CAH. Additionally, there was no evidence a discussion related to the assessed needs of the community in relation to services provided by the CAH had occurred during the annual periodic evaluation.

Based on interview and document review, the critical assess hospital (CAH) failed to ensure the overall ongoing quality assurance activities were consistently reported to the governing board and medical staff. This deficient practice had the potential to affect all current and all future patients.

Findings include:

The governing body meeting minutes from March 2017, through May 2018, were reviewed. The minutes lacked evidence the governing body had been apprised of ongoing quality assurance (QA) activities, nor was there any evidence the board commented on any ongoing quality assurance activities. The meeting minutes were reviewed for the following related to QA: problem prevention, identification and data analysis for measures to improve quality on a continuous basis.

The CEO was interviewed on 5/31/18, at 1:45 p.m. during which he confirmed that there was no documented evidence in the governing body meeting minutes the governing body had been apprised on ongoing QA activities.

Based on interview, and document review, the critical access hospital (CAH) failed to ensure the governing board had been apprised of quality improvement (QI) initiatives on an ongoing basis. This deficient practice had the potential to affect all current and future patients of the CAH.

Findings include:

Review of the Quality Improvement Program policy dated as revised on 1/16, indicated the quality improvement plan for Kittson Memorial Healthcare Center was adopted by the Medical Staff on 5/14/18, and approved by the governing board on 1/13/18 (there is no indication identified as to the reason the governing board approved the quality improvement plan prior to the medical staff approval) for year 2018. Review of the plan revealed that under Category II. Authority and Responsibility 1. Board of Directors: revealed the board of directors had delegated the authority and responsibility for the evaluation of patient care and appropriate use of facility services to the medical staff, administration, QI coordinator, and other professional personnel. Additionally, the QI policy indicated the board would only receive annual and quarterly reports on the findings of the QI activities.

The governing board meeting minutes were reviewed from May 2017, through May 2018, which revealed there was no evidence the governing body actively participated in ongoing quality assurance projects. The only governing body meeting minutes that mentioned ongoing quality assurance was dated 1/16/18, and indicated the board of directors gave approval of the Quality Assurance and Improvement Program. There was no additional information included in the minutes that indicated the governing board had reviewed and gave input on the identified projects chosen for each department, or the CAH as a whole.

The quality improvement coordinator was interviewed on 5/31/18, at 4:30 p.m. and stated she was unaware how the governing board was apprised of ongoing quality improvement information, or how the governing body provided feedback related to quality improvement projects for the CAH. The QI coordinator stated that she had not been in charge of the quality improvement committee for longer than a month.

The chief executive officer (CEO) was interviewed on 5/31/18, at 1:35 p.m. during which he confirmed the governing body meeting minutes from 1/16/18-5/1/18, lacked evidence the governing board had been actively involved in the CAH ongoing quality improvement efforts.

Based on interview and document review, the critical access hospital (CAH) failed to ensure peer review was conducted for 2 of 2 certified registered nurse anesthetists (CRNA-B, CRNA-B) randomly reviewed. This deficient practice had the potential to affect all future surgical patients of the CAH.

Findings include:

The director of health information management services (HIMS) was interviewed on 5/31/18, at 4:30 p.m. and stated all the CAH mid-level providers had random peer review provided by an outside agency to assess the quality and appropriateness of diagnosis and treatment provided by the CAH physician and mid-level providers (physician's assistants and nurse practitioners). The HIMS director was asked to provide peer review for certified registered nurse anesthetist (CRNA)-A and CRNA-B who provided CAH surgical patients with anesthesia services. The HIMS director confirmed that the aforementioned CRNAs provided services to the CAH patients, however, peer review had not been completed. The HIMS director further stated that the CAH did not have a policy or procedure that directed peer review activities, or identified how CRNA peer review would be conducted, how often, or criteria for the selection of patient cases that might require peer review. The HIMS director confirmed the outcome of peer review was provided to the chief of the medical staff, however, was not reported to the governing board.

Based on interview and document review, the critical access hospital (CAH) failed to ensure peer review was conducted for 2 of 3 medical doctors (MD-A, MD-B) randomly reviewed. This deficient practice had the potential to affect all future surgical patients of the CAH.

Findings include:

The director of health information management services (HIMS) was interviewed on 5/31/18, at 4:30 p.m. and stated all of the CAH physicians have random peer review provided by an outside agency to assess the quality and appropriateness of diagnosis and treatment provided by the CAH physician. The HIMS director was asked to provide peer review for MD-A who was an ophthalmic (eye) surgeon who provided the CAH patients eye surgeries, and MD-B who performed colonoscopies for the CAH patients. The HIMS director confirmed that the aforementioned physicians provided services to the CAH patients, but didn't have any peer review completed. The HIMS director further stated the CAH did not have a policy or procedure that directed peer review activities, and identified how physician peer review would be conducted, how often, or criteria for the selection of patient cases that would require peer review.

Based on interview and document review, the critical access hospital (CAH) failed to ensure quality assurance/performance improvement projects were developed and integrated into the CAH's quality improvement program for pharmacy services. In addition, the CAH failed to ensure dietary services performance improvement project had measurable goals with timelines, measurable action plans with timelines, and ongoing evaluation and reevaluation of goals and action plans. This had the potential to effect all current and future CAH patients.

Findings include:

On 5/30/18, at 10:30 a.m. pharmacist in charge was interviewed, and verfied the pharmacy department did not have any current quality improvement project, nor had a quality assurance project be developed based on medication errors patterns and/or trends.

Dietary services quality assurance (QA) projects were reviewed since April 2017, and revealed the following:

The second quarter April-June of 2017, lacked a QA project for dietary services.

The third quarter July-September of 2017, lacked a QA project for dietary services.

The fourth quarter October-December of 2017, included the dietary QA project as ice machines to be completely cleaned and sanitized twice monthly. Review of the QA plan revealed lacked reasons on why the project was selected. The project lacked identification of measurable goals, and a timeline for goal completion. The project also lacked corresponding action plans with timelines in order to meet the goal. The project results revealed July, September, and November were completed 50%, and August, October, and December were completed 100%. The results included shortage of staff, staffing had improved, would continue to monitor for three more months, then change criteria.

The first quarter January-March 2018, identified the same QA project as previous quarter. The results revealed January, February, and March completion was 50%. The action plan and results were also repeated from previous quarter. The QA project continued to lack identification of measurable goals, and timeline for goal completion as well as corresponding action plans with timelines.

On 5/31/18, at 2:00 p.m. certified dietary manager (CDM) was interviewed and verified dietary services QA project was cleaning of the ice machines. CDM stated the project was determined based on findings as a result of a survey inspection that alerted the dietary department the ice machines had not been sanitized per recommendations. CDM further stated the goal was the cleaning of the machines was 100%. CDM stated she would only analyze the cleaning checklist at the end of the quarter, and indicated periodic audits were not completed within the quarter in order to determine progression toward goal. CDM indicated the goal of 100% wasn't obtained related to staffing, and did not assess or create an action plan on how the goal would be met with a staff shortage. CDM conceded the QA plan did not outline measurable goals, timelines, or action plans.

Hospital Quality Improvement Program adapted by medical staff on 5/14/18, and approved by the governing board on 1/13/18, included:
- To promote and maintain high quality health care to the patients in this facility within the resources available to this facility. This goal will be accomplished in the promotion and maintenance of high quality care through analysis, review, evaluation, and other QI activities of hospital wide practice.
- The following departments will participate in evaluations included: dietary and pharmaceutical services.
Under the section Ongoing Facility Department Monitoring Functions included:
- All departments will identify major aspects of care in their particular areas of concern and prioritize these aspects of care according to high risk, high usage, and degree of patient care, cost of resources and other areas of concern.
- Departments shall continually monitor and collect data from identified problem indicators.
- The problems identified from the collection of data shall be evaluated and analyzed to determine probable causes of the problem and if problem can be prevented. Criteria are then developed to improve or prevent the identified problem.
- Recommendations for action and correction of the problem are developed by the department managers and shared with staff.
- Follow-up study of the problem is set up and completed according to the necessary monitoring system steps required to solve the problem usually on a monthly/quarterly basis.

Based on observation and interview, the facility did not provide an essential electrical system in accordance with NFPA 99 (2012) Health Care Facilities Code and NFPA 110 (2010) Standard for Emergency and Standby Power Systems. This had the potential to affect all hospital patients.

Findings include:

On 05/30/18, from 7:30 a.m. to 11:00 a.m. a tour of the facility was completed. Observations revealed the emergency shut off button on the generator was not located outside of the enclosure. The maintenance supervisor confirmed the deficient practice at that time.