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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. The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to meet this condition. This had the potential to affect any patient receiving services from the CAH.

Findings include:

See C241: Based on staff interview and document review, the critical access hospital (CAH) failed to ensure there was an effective governing body, that assumed full legal responsibility to ensure policies were implemented to provide quality health care in a safe environment for 3 of 6 surgical joint patients (P1, P2, & P3) reviewed, this resulted in an immediate jeopardy for P1 who was readmitted with pulmonary emboli after having been discharged without a surgeon prescribed anticoagulant. The CAH's failure to ensure the governing body monitored hospital practices and procedures to provide quality health care in a safe environment had the potential to affect all current and future joint patients.

See C270: Based on observation, interview and document review, it was determined the Critical Access Hospital (CAH) failed to adequately ensure provision of services for nursing care related to medication administration. The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to meet this condition. This had the potential to affect any surgical patient receiving services from the CAH.

See C297: Based on document review and interview, the critical access hospital (CAH) failed to provide anticoagulation therapy upon hospital discharge from in-patient stays for 3 of 6 surgical patients (P1, P2, P3) after total joint surgeries. This resulted in an immediate jeopardy situation when P1 was re-hospitalized six days after discharge related to multiple right lung pulmonary embolisms. In addition, P2, P3 and any future patients that required joint surgery, were at risk when they did not recieve the prescribed anticoagulant therapy prescribed by the surgeon post surgery.

See C330-Based on review of facility policies, quality assurance documentation and interview, the critical access hospital (CAH) failed to ensure quality assurance activities had been reported to the governing board for review and discussion. The cumulative effect of this systemic problem resulted in the critical access hospital'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.

Based on staff interview and document review, the critical access hospital (CAH) failed to ensure there was an effective governing body, that assumed full legal responsibility to ensure policies were implemented to provide quality health care in a safe environment for 3 of 6 surgical joint patients (P1, P2, & P3) reviewed, this resulted in an immediate jeopardy for P1 who was readmitted with pulmonary emboli after having been discharged without a surgeon prescribed anticoagulant. The CAH's failure to ensure the governing body monitored hospital practices and procedures to provide quality health care in a safe environment had the potential to affect all current and future joint patients.

Findings include:

The administrator of the CAH was interviewed on 3/12/18, from 10:45 a.m. to 11:30 a.m. during which he confirmed the West Board of Quality Committee was the governing body responsible for the day-to-day operation of Essentia Health Fosston CAH. The administrator stated he made a report to the board every month the CAH's quality activities, policy reviews, and fiduciary concerns.


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The governing board failed to ensure procedures related to the transition or hand-off of pertinent care and medication orders from the surgical department were implemented. The orders and/or recommendations did not carry through to the patient's hospital After Visit Summary (AVS).

P1 had a total knee arthroplasty on 2/9/18, with hospitalization for follow-up care. P1 was discharged to home on 2/10/18, without post-operative anticoagulant therapy prescribed by the surgeon. P1 was re-admitted to the hospital on 2/16/18, with multiple pulmonary embolisms (PE-blood clots).

P1's postoperative surgical records included the following orders from the surgeon included a prescription for:
Lovenox 30 milligrams (mg)/.03 milliliters (ml) subcutaneous injection every 24 hours for 10 days with a start date of 2/10/18, and a stop date of 2/20/18.

P1's After Visit Summary (patient discharge summary) dated 2/9/18-2/10/18, did not include the surgeon prescribed order for Lovenox or any anticoagulation therapy. In addition, the discharge summary did not include education or information pertaining to anticoagulation therapy or prevention of deep vein thrombosis or pulmonary embolisms after major joint surgery.

P1's hospital visit note dated 2/20/18, indicated P1 had presented to the emergency room after one day of worsening calf pain with redness, shortness of breath and fatigue. The note indicated P1 was re-admitted to the hospital for diagnoses including deep vein thrombosis (DVT) and pulmonary embolisms (blood clots).

A computerized tomography (CT) scan dated 2/16/18, indicated P1 had multiple segmental and supplemental right pulmonary emboli. P1's chart did not reflect an ultrasound to confirm or rule out DVT until 2/21/18, at which time the results were negative for DVT.

P1's physician discharge summary dated 2/20/18, indicated P1 was found to have pulmonary embolus with respiratory status diminishing, and indicated Coumadin anticoagulation therapy was initiated with routine PT/INRs necessary (laboratory test to monitor blood clotting time). The discharge summary further indicated discharge medications included Coumadin 7.5 mg every day.

On 3/7/18, at 12:20 p.m. a surgical nurse, registered nurse (RN)-A, stated the surgeon had ordered Lovenox for 10 days with a start date of 2/10/18 and end date of 2/20/18. RN-A confirmed the Lovenox was discontinued upon discharge by the discharging provider. RN-A confirmed P1 was re-admitted to the hospital with multiple pulmonary embolisms. RN-A further explained the hospital surgeons have order sets that were supposed to carry over when patients were admitted to the hospital from surgery.

On 3/7/18, at 4:15 p.m. the director of nursing services (DNS) and RN-B stated P1's medical record had been reviewed by an administrative team, related to P1's hospital readmission, and verified they'd become aware P1 was sent home without anticoagulation therapy. The DNS stated the case had been sent for peer review because P1 had not been prescribed Aspirin upon discharge per protocol. At the time of this conversation, neither the DNS nor RN-B were aware the surgeon had ordered Lovenox for P1. The omission of Lovenox had also not been identified during the peer review administrative record review. When brought to their attention, the DNS and RN-B reviewed P1's medication record and verified the order for Lovenox for 10 days. Neither was aware how/why the order had been automatically discontinued upon discharge. The DNS further stated the hospital protocol indicated prior to a patient discharge, a registered nurse was suppose to review the discharge summary with the patient. The DNS stated had this happened appropriately, the RN should have identified the lack of anticoagulation therapy and consulted with the physician.

P2 had a total knee replacement on 1/26/18, was hospitalized for post-operative care, and discharged home without anticoagulation therapy.

P2's inpatient medication orders included Aspirin 325 mg twice a day as ordered by the PA-C. The record further indicated a stop date for the Aspirin of 1/29/18, when the discharging physician automatically stopped the Aspirin order upon P2's discharge from the hospital.

P2's Discharge to Home Instructions dated 1/26/18, did not include any medication orders. In addition, the discharge summary did not include education or information pertaining to anticoagulation therapy, prevention of deep vein thrombosis or pulmonary embolisms after major joint surgery.

P3 had a total knee replacement on 1/12/18, was admitted to the hospital for post-operative care, and then discharged home without anticoagulation therapy.

P3's surgical records indicated the right total knee replacement surgery was performed on 1/12/18. The surgical record further indicated the surgeon's physician assistant-certified (PA-C) had given orders including Aspirin 325 mg twice per day with a start date of 1/12/18. No stop date and or duration was indicated on the order.

P3's Discharge Summary dated 1/16/18, did not include medication orders for Aspirin or other medications for anticoagulation therapy. In addition, the discharge summary also did not include education or information pertaining to anticoagulation therapy, prevention of deep vein thrombosis or pulmonary embolisms after major joint surgery.

On 3/9/18, at 7:15 a.m. registered nurse (RN)-C verified P2 and P3's post-operative medications included Aspirin 325 mg twice per day and verified the orders had been stopped on the day of discharge. RN-C further verified P2 and P3's discharge summaries lacked orders for Aspirin. RN-C was not aware of why the orders were automatically stopped on discharge. RN-C stated after joint surgery, the surgeon would typically prescribe Aspirin or some other form of anticoagulation for 4-6 weeks to prevent blood clots.

On 3/9/18, at 12:20 p.m. medical doctor (MD)-A an orthopedic surgeon, stated he was not aware 3 of 6 surgical patients were discharged without a form of anticoagulation therapy. MD-A stated the issue was very concerning as it could lead to very negative outcomes for patients. MD-A stated he was specific about anticoagulation after surgery and followed trends per standards of practice. MD-A also stated the patient's medical history dictated which type of anticoagulation was used. MD-A stated patients that were higher risk for blood clots were prescribed Lovenox and patients that were at lower risk were prescribed Aspirin 325 mg once or twice a day depending on medical history. MD-A stated orthopedic patients, especially total hip or knee replacements, should definitely be on some form of anticoagulation therapy after discharge, verifying it was an expectation. MD-A further clarified his expectation that the discharge summary should clearly specify the type of anticoagulation prescribed after surgery, and should include education on prevention of DVT's and PE's. MD-A reiterated that regardless of who discharged the patient, discharge orders for joint surgeries should automatically include either Lovenox or Aspirin.

On 3/9/18, at 1:00 p.m. the DNS verified being unaware P2 and P3 had been discharged without Aspirin orders for anticoagulation therapy following joint surgery. The DNS also confirmed P2 and P3 had not received instruction or orders to continue the Aspirin therapy after discharge. The DNS stated the lack of anticoagulation upon discharge seemed to be a system failure that was very concerning as it could have caused systemic harm, and confirmed it was a standard of practice to have some form of anticoagulation after a joint procedure. The DNS further stated the expectation was for physicians and nurses to use their critical thinking skills during review of discharge medications to identify and clarify concerns, and stated patients should be given education on anticoagulation and blood clots which should be indicated on their discharge summary. The DNS also explained that patient education should be reinforced during their hospital stay, and on their discharge summaries.

On 3/9/18, at 4:40 p.m. the DNS indicated after root cause analysis of the cases were reviewed, system gaps were identified which included the surgeon's orders did not flow through to patient discharge summaries from the inpatient hospitalization.

On 3/12/18, at 8:30 a.m. the DNS provided order sets used by the orthopedic surgeons for outpatient and inpatient surgeries. The DNS stated the order sets that had been used did not include post-operative anticoagulation therapy.

Based on observation, interview and document review, it was determined the Critical Access Hospital (CAH) failed to adequately ensure provision of services for nursing care related to medication administration. The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to meet this condition. This had the potential to affect any surgical patient receiving services from the CAH.

The findings include:

See C297: The CAH failed to meet the Condition of Provision of Services: The CAH failed to ensure anticoagulant medications were provided upon discharge in accordance with surgeon orders for 3 of 6 total joint surgical patients whose records were reviewed.

Based on observation, interview and policy review, the critical access hospital (CAH) failed to ensure medications were stored in a secure manner to prevent access by unauthorized individuals in 1 of 1 trauma bay in the emergency room. This had the potential to affect all patients who received care in the CAH's emergency room.

Findings include:

During a tour of the emergency room with registered nurse (RN)-B on 3/7/18, at 10:30 a.m. multiple medication vials were found in two plastic Sharps containers (one blue and one black colored), used to discard needles. These containers were observed on the counter, unsecured, in the trauma bay of the emergency room. It was noted that several vials of Fentanyl (a narcotic liquid medication schedule II controlled substance) that had been used but still had a few drops left in the bottom, and a vial of ketamine (a liquid I.V. anesthetic medication schedule III controlled substance) that still had approximately 1/3 of the medication still in the vial had been discarded in these Sharps containers. At that time, RN-B who identified herself as the director of the emergency room, demonstrated how easy it would be to remove the vials that contained unused portions of Fentanyl and ketamine from the plastic container because it had a large opening in the top, approximately as large as a medium size apple. RN-B turned the container upside down and all of the vials easily came out. RN-B confirmed patients and family members were left in the trauma bay unattended and would have access to the medications. RN-B confirmed medications and vials should not be discarded in these containers.

The quality assurance director was interviewed on 3/12/18, at 2:39 p.m. during which she confirmed that the staff who work in the emergency room had not disposed of the medications in accordance with the facility's policy for medical waste disposal.

The facility's policy for Hazardous Materials and Waste Management dated 3/12, included the following: "Essentia Health Fosston maintains appropriate handling and storage areas for hazardous wastes that are separated and maintained to minimize the possibility of contamination of food, clean and sterile goods, or contact with staff, visitors, or patients. Hazardous wastes are moved in covered or closed containers..."

The facility's policy for Hazardous Waste dated 3/08, indicated department managers were responsible for ensuring proper disposal containers were available and used correctly. The policy indicated the black boxes were used for P list waste (acute hazardous waste (P-list) list in 40 CFR 261.33 (e) ) and needed to be separated from all other hazardous waste. The blue boxes were supposed to be used for hazardous waste that was also contaminated with infectious waste. The policy indicated the Hospital Pharmacy was responsible for the method of identifying, segregating and properly managing pharmaceutical waste.

Based on observation, interview and document review, staff at the critical access hospital (CAH) failed to implement protocols for appropriate cleaning/disinfection of the surgical environment and patient beds used during endoscope surgical procedures, colonoscopies, to minimize risk of infection. This had the potential to affect any surgical patients.

Findings include:

On 3/6/18, at 10:00 a.m. registered nurse (RN)-D surgical manager stated the hospital had two operating rooms suites and the hospital performed surgeries and colonoscopies every week. RN-D stated the one operating room was generally reserved for colonoscopies procedures.

On 3/7/18, at 10:35 a.m. following an esophagogastroduodenoscopy, registered radiology technician (RTR)-A was observed to wipe down screens and surfaces using PDI Sani-Cloth AF3 wipes. Surgical nurse RN-E stated high touch surfaces, equipment in rooms, and patient beds were wiped down with those wipes between each patient. RN-E stated no other cleaners were used for cleaning/disinfecting between patients. At 11:00 a.m. RTR-A reported she had just finished cleaning the other operating room following a colonoscopy procedure. RTR-A stated equipment such as screens, monitors, and other surfaces were wiped down with the same Sani-Cloth wipes and no other cleaning agent was used for those surfaces. RTR-A further indicated the patient beds used during the procedures were also cleaned with the same wipes.

On 3/9/18, at 9:00 a.m. the director of nursing services (DNS) stated she also served as the CAH's infection control coordinator. The DNS verified the PDI Sani-Cloth AF3 wipes package label did not indicate they were effective against clostridium difficile (C-Diff) spores. The DNS further stated patients who had colonoscopy procedures were not routinely tested for C-Diff, so staff would not know whether a patient might be infected. The DNS verified a bleach or comparable cleaning/disinfecting agent was not used for cleaning/disinfecting the operating rooms or the beds between each patients and did not think housekeeping was using a cleaner/disinfectant that would be effective against C-Diff when they the rooms were terminally cleaned either. The DNS stated when they were aware a patient was infected with C-Diff, they did clean the rooms and equipment with a bleach solution.

On 3/12/18, at 4:15 p.m. RN-D reported the PDI Sani-Cloth AF3 wipes were used on surfaces and beds after and/or between patients. RN-D stated housekeepers did the terminal clean which included the use of Oxivir Five 16 Concentrate to clean walls and counter tops, and the cleaner was peroxide based. RN-D stated Virex II 256 was used to clean/disinfect the floors.

The manufacturers' labels for the PDI Sani-Cloths AF3, Virex II 256, and Oxivir Five 16, included a list of organisms the products would kill however, Clostridium difficile was not included.

The CAH's policy Cleaning and Disinfecting Shared Equipment last reviewed 6/16/17, included: To reduce and/or prevent infections through cleaning, sanitizing and disinfection shared medical equipment. *if C-Diff is present or suspected, the hard surfaces will be washed with an approved cleaner and then wiped down with the approved bleach solution.

The CAH's policy Control of Cross Contamination last reviewed 8/8/16, included:
B. After procedure all items that have come in contact with the patient and/or sterile filed should be considered contaminated. 5. All equipment and furniture used during procedure should be cleaned with a disinfectant solution. Mechanical friction should be used. 7. Floors should be cleaned with disinfectant solution and mop head changed after each case.

The CAH's policy Cleaning Between Patients last reviewed 8/18/16, included: To provide a safe, clean environment for patient by ensuring appropriate cleaning between surgical cases to prevent cross contamination. 4. The operating rooms cleaning process: (f). mattresses and other equipment and surface areas will be cleaned and disinfected with an EPA-registered hospital disinfectant between patients. 5. Recovery room and outpatient bay cleaning process: (a). Transport carts including attachments, work surface, table and equipment will be cleaned between each patient with disinfectant that is EPA-registered hospital disinfectant.

The CAH's undated Equipment Cleaning Guideline included guidelines for use of disinfectant wipes or disinfectant solutions, but did not specifically identify which wipes or which solutions were to be used.

Based on document review and interview, the critical access hospital (CAH) failed to provide anticoagulation therapy upon hospital discharge from in-patient stays for 3 of 6 orthopedic surgical patients (P1, P2, P3) after total joint surgeries. This resulted in an immediate jeopardy situation when P1 was re-hospitalized six days after discharge related to multiple right lung pulmonary embolisms. In addition, P2, P3 and any future patients that required joint surgery, were at risk when they did not recieve the prescribed anticoagulant therapy prescribed by the surgeon post surgery.

The immediate jeopardy began on 3/9/18, at 2:46 p.m. after record review and interview identified lack of anticoagulation orders prescribed by the orthopedic surgeon to continue anticoagulation upon discharge, and administrative nursing staffs' unawareness of the lack of anticoagulation orders upon discharge. The director of nursing services (DNS) and quality assurance director were notified of the immediate jeopardy on 3/9/18, at 2:46 p.m. The immediate jeopardy was removed on 3/12/18, at 2:45 p.m.

Findings included:

P1 had a total knee arthroplasty on 2/9/18, with hospitalization for follow-up care. P1 was discharged to home on 2/10/18, without post-operative anticoagulant therapy prescribed by the surgeon. P1 was re-admitted to the hospital on 2/16/18, with multiple pulmonary embolisms (PE-blood clots).

P1's history and physical (H&P) dated 2/1/18, indicated the visit was related to a pre-operative evaluation for total knee replacement on 2/9/18. The H&P indicated P1 was obese, currently smoked cigarettes, had no previous bleeding history, and was cleared for anesthesia and surgery.

P1's postoperative surgical records included the following orders from the surgeon included a prescription for:
Lovenox 30 milligrams (mg)/.03 milliliters (ml) subcutaneous injection every 24 hours for 10 days with a start date of 2/10/18, and a stop date of 2/20/18.

P1's inpatient hospital medication administration record (MAR) indicated P1 had received Lovenox 30mg/0.3 ml injection every 24 hours subcutaneously with a start date of 2/10/18, and a stop date of 2/10/18 (day P1 discharged). The MAR indicated the first dose of Lovenox was administered on 2/10/18, at 6:03 a.m.

P1's inpatient hospital medication orders included the Lovenox for 10 doses as ordered by the surgeon. The record further indicated a stop date of 2/10/18, for the Lovenox, and the Lovenox prescribed by the surgeon for 10 days, had been automatically stopped upon discharge by a physician who completed P1's discharge orders.

P1's After Visit Summary (patient discharge summary) dated 2/9/18-2/10/18, did not include the surgeon's order for Lovenox or any anticoagulation therapy. In addition, the discharge summary did not include education or information pertaining to anticoagulation therapy or prevention of deep vein thrombosis or pulmonary embolisms after major joint surgery.

P1's hospital visit note dated 2/20/18, indicated P1 had presented to the emergency room after one day of worsening calf pain with redness, shortness of breath and fatigue. The note indicated P1 was re-admitted to the hospital for diagnoses including deep vein thrombosis (DVT) and pulmonary embolisms (blood clots).

A computerized tomography (CT) scan dated 2/16/18, indicated P1 had multiple segmental and subsegmental right pulmonary emboli. P1's chart did not reflect an ultrasound to confirm or rule out DVT until 2/21/18, at which time the results were negative for DVT.

P1's physician discharge summary dated 2/20/18, indicated P1 was found to have pulmonary embolus with respiratory status diminishing, and indicated Coumadin anticoagulation therapy was intiated with routine PT/INRs necessary (laboratory test to monitor blood clotting time). The discharge summary further indicated discharge medications included Coumadin 7.5 mg every day.

On 3/7/18, at 12:20 p.m. a surgical nurse, registered nurse (RN)-A, stated the surgeon had ordered Lovenox for 10 days with a start date of 2/10/18 and end date of 2/20/18. RN-A confirmed the Lovenox was discontinued upon discharge by the discharging provider. RN-A confirmed P1 was re-admitted to the hospital with multiple pulmonary embolisms. RN-A further explained the hospital surgeons have order sets that were supposed to carry over when patients were admitted to the hospital from surgery.

On 3/7/18, at 4:15 p.m. the director of nursing services (DNS) and RN-B stated P1's medical record had been reviewed by an administrative team, related to P1's hospital readmission, and verified they'd become aware P1 was sent home without anticoagulation therapy. The DNS stated the case had been sent for peer review because P1 had not been prescribed Aspirin upon discharge per protocol. At the time of this conversation, neither the DNS nor RN-B were aware the surgeon had ordered Lovenox for P1. The omission of Lovenox had also not been identified during the peer review administrative record review. When brought to their attention, the DNS and RN-B reviewed P1's medication record and verified the order for Lovenox for 10 days. Neither was aware how/why the order had been automatically discontinued upon discharge. The DNS further stated the hospital protocol indicated prior to a patient discharge, a registered nurse was suppose to review the discharge summary with the patient. The DNS stated had this happened appropriately, the RN should have identified the lack of anticoagulation therapy and consulted with the physician.

On 3/8/18, at approximately 8:00 a.m. the DNS stated when the physician completed the After Visit Summary, the physician checked boxes that indicated which medication would be continued after discharge in order for the medication to be listed on the AVS. The DNS stated the physician completing the AVS had not checked the box to continue Lovenox upon discharge as prescribed by the surgeon.

P2 had a total knee replacement on 1/26/18, was hospitalized for post-operative care, and discharged home without anticoagulation therapy.

P2's preoperative evaluation history and physical (H&P) dated 1/10/18, for left total knee replacement scheduled for 1/26/18, cleared P2 for anesthesia and surgery as planned.

P2's surgical record indicated the left total knee replacement surgery was performed on 1/26/18. The surgical record further indicated the surgeon's physician assistant (PA) had given orders including Aspirin 325 mg twice per day with a start date of 1/26/18. No stop date and/or duration was indicated on the order.

P2's inpatient medication administration record (MAR) included Aspirin 325 mg twice a day, with a start date of 1/26/18 and an end date of 1/29/18 (date P2 discharged). The MAR indicated P2 was administered one dose on 1/26/18, two doses on 1/27/18 and 1/28/18, and one dose prior to discharge on 1/29/18.

P2's inpatient medication orders included Aspirin 325 mg twice a day as ordered by the PA-C. The record further indicated a stop date for the Aspirin of 1/29/18, when the discharging physician automatically stopped the Aspirin order upon P2's discharge from the hospital.

P2's Discharge to Home Instructions dated 1/26/18, did not include any medication orders. In addition, the discharge summary did not include education or information pertaining to anticoagulation therapy, prevention of deep vein thrombosis or pulmonary embolisms after major joint surgery.

P3 had a total knee replacement on 1/12/18, was admitted to the hospital for post-operative care, and then discharged home without anticoagulation therapy.

P3's pre-operative history and physical (H&P) dated 12/28/17, for right total knee replacement on 1/12/18, included medical history of complications related to the right knee and indicated P3 smoked cigarettes. The H&P indicated P3 was cleared for anesthesia and surgery as planned.

P3's surgical records indicated the right total knee replacement surgery was performed on 1/12/18. The surgical record further indicated the surgeon's physician assistant-certified (PA-C) had given orders including Aspirin 325 mg twice per day with a start date of 1/12/18. No stop date and or duration was indicated on the order.

P3's medication administration record (MAR) included the order for Aspirin 325 mg twice a day; the start date of 1/12/18 and the end date of 1/16/18 (date P3 discharged). The MAR indicated P3 was administered one dose on 1/12/18, two doses on 1/13/18, 1/14/18, 1/15/18, and one dose prior to discharge on 1/16/18.

P3's inpatient medication orders included Aspirin 325 mg twice a day as ordered by the PA. The record further indicated a stop date of 1/16/18, when the discharging physician automatically stopped the Aspirin order upon P3's discharge from the hospital.

P3's Discharge Summary dated 1/16/18, did not include medication orders for Aspirin or other medications for anticoagulation therapy. In addition, the discharge summary also did not include education or information pertaining to anticoagulation therapy, prevention of deep vein thrombosis or pulmonary embolisms after major joint surgery.

On 3/9/18, at 7:15 a.m. registered nurse (RN)-C verified P2 and P3's post-operative medications included Aspirin 325 mg twice per day and verified the orders had been stopped on the day of discharge. RN-C further verified P2 and P3's discharge summaries lacked orders for Aspirin. RN-C was not aware of why the orders were automatically stopped on discharge. RN-C stated after joint surgery, the surgeon would typically prescribe Aspirin or some other form of anticoagulation for 4-6 weeks to prevent blood clots.

On 3/9/18, at 12:20 p.m. medical doctor (MD)-A an orthopedic surgeon, stated he was not aware 3 of 6 surgical patients were discharged without a form of anticoagulation therapy. MD-A stated the issue was very concerning as it could lead to very negative outcomes for patients. MD-A stated he was specific about anticoagulation after surgery and followed trends per standards of practice. MD-A also stated the patient's medical history dictated which type of anticoagulation was used. MD-A stated patients that were higher risk for blood clots were prescribed Lovenox and patients that were at lower risk were prescribed Aspirin 325 mg once or twice a day depending on medical history. MD-A stated orthopedic patients, especially total hip or knee replacements, should definitely be on some form of anticoagulation therapy after discharge, verifying it was an expectation. MD-A stated if there were any questions, or concerns he'd expect the discharging provider to contact him. He also stated he expected providers to contact him if they were going to change and/or discharge a patient with no anticoagulation therapy including Aspirin. MD-A explained templates and order sets used for prescribing anticoagulation. He confirmed the orders were supposed to carry over to the inpatient. MD-A further clarified his expectation that the discharge summary should clearly specify the type of anticoagulation prescribed after surgery, and should include education on prevention of DVT's and PE's. MD-A explained his physician assistant (PA-C) typically put in the order sets for him, followed the patient's progress through the inpatient stay, and the PA or family practice doctors completed the discharge orders. MD-A reiterated that regardless of who discharged the patient, discharge orders for joint surgeries should automatically include either Lovenox or Aspirin.

On 3/9/18, at 1:00 p.m. the DNS verified being unaware P2 and P3 had been discharged without Aspirin orders for anticoagulation therapy following joint surgery. The DNS also confirmed P2 and P3 had not received instruction or orders to continue the Aspirin therapy after discharge. The DNS stated the lack of anticoagulation upon discharge seemed to be a system failure that was very concerning as it could have caused systemic harm, and confirmed it was a standard of practice to have some form of anticoagulation after a joint procedure. The DNS further stated the expectation was for physicians and nurses to use their critical thinking skills during review of discharge medications to identify and clarify concerns, and stated patients should be given education on anticoagulation and blood clots which should be indicated on their discharge summary. The DNS also explained that patient education should be reinforced during their hospital stay, and on their discharge summaries.

On 3/9/18, at 4:40 p.m. the DNS indicated after root cause analysis of the cases were reviewed, system gaps were identified which included the surgeon's orders did not flow through to patient discharge summaries from the inpatient hospitalization.

On 3/12/18, at 8:30 a.m. the DNS provided order sets used by the orthopedic surgeons for outpatient and inpatient surgeries. The DNS stated the order sets that had been used did not include post-operative anticoagulation therapy.

The hospital's policy West Region Surgical Unit Standard of Care reviewed 1/5/17, included:
2. The standards of care are based upon relevant professional organization standards. These standards are applied as appropriate for specific unit setting and population served.
-Medication, IVs, Treatments; The patient will receive therapies according to established practices. Standard of Care: provide treatments, medications, and IV's per orders as guided by facility policies and procedures.
-Handover of Care; the patient may expect pertinent information to be shared to ensure safe continuity of care when staff transitions occur. Standard of Care: Follow SBAR (Situation, Background, Assessment, Recommendation) format for handovers at break, change of shift, other coverage transfer to another unit, transfer to surgery or procedural area. Bedside report is expected.
-Transfers within the Hospital. Standard of Care: call report to receiving nurse in the SBAR format.
-Readiness for Discharge; the patient may expect to receive education to enable him/her to resume care at home in a manner and pace that he/she comprehends. Standard of Care: Planning for discharge begins at admission. Progress toward readiness for discharge is evaluated for discharge throughout the stay. Assure the patient receives an After Visit Summary with written discharge instructions with diagnoses, instructions for self home care and prescription, and instructions for follow-up care. Review the AVS with patient and family.

The IJ that began on 3/9/18, at 2:46 p.m. was removed on 3/12/18, at 2:45 p.m. when it could be verified by interview and document review, that the the hospital had implemented a removal plan including implementation of protocols for each surgical specialty to have customized discharge instructions; initiation of a standardized post total joint education program; initiation of mandatory discharge requirements for total joint patients to ensure they received appropriate anticoagulation medications; nursing leadership initiation of education for all staff to policies and procedures related to anticoagulation therapy needs upon discharge for orthopedic patients who required them; and development and implementation of post surgical procedures for verbal report and order communication between the surgeon and the hospital's primary care physicians.

Based on record review and interview, the hospital failed to ensure informed consents for surgery were timed and dated for 4 of 15 surgical records (P3, P7, P8 and P12) reviewed.

The findings include:

P3's Affirmation of informed Consent for Surgical Medical or Diagnostic Procedures was signed and dated by P3, the licensed practical nurse (LPN), and the surgeon. However, lacked the time when the consent was signed.

P7's Affirmation of Informed Consent for Surgical Medical or Diagnostic Procedures was signed and dated by P7, the registered nurse (RN), and the surgeon. However, lacked the time when the consent was signed.

P8's Affirmation of Informed Consent for Surgical Medical or Diagnostic Procedures was signed by P8. However, lacked the date and time of when the consent was signed. In addition, the surgeon signed the consent and the consent lacked the date and time it was signed.

P12's Affirmation of Informed Consent for Surgical Medical or Diagnostic Procedures lacked the time in which the surgeon signed the form

On 3/12/18, at approximately 8:30 a.m. registered nurse (RN)-D surgical manager, stated the expectation of informed consents to be fully completed with signatures, dates and times. RN-D stated the surgeon was supposed to sign and date, and indicate the time this was done. RN-D stated the nurse witness and patient then sign/date/time the form only after the procedure was verified and the risk and benefits were explained to the patient.

On 3/12/18, at 3:00 p.m. director of nursing services (DNS) stated surgical procedure consent forms must be completed prior to the procedure and must include signature of patient with date and time, signature of the nurse witness with date and time, and signature of the surgeon with date and time.

The hospital's Informed Consent Policy was requested and not provided.

Based on interview and record review, preoperative history and physical documentation was not reviewed by the surgeon prior to surgical procedures for 4 of 15 surgical patient records reviewed (P1, P4, P5 and P6).

The findings include:

P1's preoperative history and physical (H&P) dated 2/1/18, indicated P1 was scheduled for left total knee arthroplasty on 2/9/18, and was cleared for anesthesia and surgery.
P1's surgical record lacked evidence the surgeon had reviewed and/or signed the preoperative H&P prior to performing the surgical procedure.

P4's preoperative evaluation H&P dated 2/20/18, indicated P4 was scheduled for ankle fracture repair on 2/26/18, and was cleared for anesthesia and surgery.
P4's surgical record lacked evidence the surgeon had reviewed and/or signed the preoperative H&P prior to performing the surgical procedure.

P5's preoperative evaluation H&P dated 12/29/17, indicated P5 was scheduled for right foot osteotomy and was cleared for surgery.
P5's surgical record lacked evidence the surgeon had reviewed and/or signed the preoperative H&P prior to performing the surgical procedure.

P6's preoperative evaluation H&P dated 2/12/18, indicated P6 was scheduled for removal of hardware on 2/19/18, and was cleared for anesthesia and surgery.
P6's surgical record lacked evidence the surgeon had reviewed and/or signed the preoperative H&P prior to performing the surgical procedure.

On 3/7/18, at 12:20 p.m. registered nurse (RN)-A stated the surgeon was supposed to review the preoperative H&P prior to the procedure and write a note indicating the H&P had been reviewed. RN-A explained the note was sometimes referred to as an "interval note." RN-A verified surgical records for P1, P5, and P6 lacked evidence of the surgeon's "interval note" or evidence the surgeon had reviewed the preoperative H&P.

On 3/8/18, at 8:15 a.m. registered nurse (RN)-D surgery manger stated surgeons were to review the pre-operative H&P's prior to surgery to ensure there has not been any conditions changes since the time of the H&P was performed and they were to document they had reviewed it. RN-D stated this was a standard of practice for patient safety.

On 3/8/18, at 8:45 a.m. director of nursing services (DNS) stated the expectation was surgeons reviewed the preoperative H&P and document they had reviewed it. DNS also stated the surgeons review and documentation of the H& P review was a standard of practice.

On 3/12/18, at approximately 8:30 a.m. RN-D verified surgical records for R4, R5, and R6 lacked a surgeon's note indicating review of the preoperative H&P and at approximately 3:30 p.m., verified R1's record did not have a surgeon's note that indicated the preoperative H&P was reviewed.

Based on review of facility policies, quality assurance documentation and interview, the critical access hospital (CAH) failed to ensure quality assurance activities had been reported to the governing board for review and discussion. The cumulative effect of this systemic problem resulted in the critical access hospital'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:

See C337-Based on document review and staff interview, the CAH failed to ensure quality assurance activities were reported to the governing board for review and discussion on a continuous basis, to ensure quality of all patient care services.

Based on interview and document review, the facility failed to implement quality assurance and performance improvement measures when a patient was rehospitalized after having been discharged following a joint surgery without the surgeon prescribed anticoagulant. The patient was readmitted with multiple pulmonary embolisms. This had the potential to affect all current and future patients that required joint surgery whom were prescribed anticoagulation therapy by the surgeon that required postoperative hospitalization.

Findings include:

An interview regarding the QA processes of the CAH was conducted on 3/12/18, at 2:00 p.m. with the registered nurse (RN) quality assurance (QA) director who verified she was in charge of the charge of the Fosston CAH QA program. The QA director stated the Fosston CAH QA committee met quarterly and reviewed ongoing QA projects. It was learned that although a peer review was conducted related to the omission of a physician ordered Aspirin upon discharge for a patient following joint surgery, the review failed to identify the system problem related to the omission of the anticoagulation medication (Lovenox) ordered by the surgeon. The root cause analysis conducted during the QA review failed to include a comprehensive evaluation of the quality of services provided by the medical staff so changes could be implemented to prevent the potential adverse effects of omitting anticoagulant medications post-op. The following review was noted:


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P1's medical record was reviewed on 3/7/18, and revealed P1 had left total knee arthroplasty on 2/9/18, the orthopedic surgeon had prescribed Lovenox 30 milligrams (mg)/.03 milliliters (ml) subcutaneous injection every 24 hours for 10 days; start date of 2/10/18 and a stop date of 2/20/18. P1 was discharged from the hospital on 2/10/18, however the record indicated the Lovenox was discontinued upon hospital discharge. P1 presented to the emergency room on 2/16/18, with multiple pulmonary embolisms (PE-blood clots), was admitted to hospital and discharged on 2/20/18.

Further medical record review revealed, P2 had a total knee replacement on 1/26/18, was admitted to the hospital for post-operative care, was prescribed Aspirin 325 mg twice a day for anticoagulation therapy and discharged home without an order to continue the Aspirin on 1/29/18. P3 had a total knee replacement on 1/12/18, was prescribed Aspirin 325 mg twice a day for anticoagulation therapy, and discharged home without an order to continue the Aspirin on 1/16/18.

On 3/7/18, at 4:15 p.m. director of nursing services (DNS) and RN-B stated they were aware P1 was sent home without anticoagulation therapy. P1's medical record was reviewed by an administrative team, related to P1's readmission to the hospital. However, the administrative team review did not identify there had been an order for the Lovenox, only that P1 had been discharged without Aspirin per hospital protocol. The DNS stated the case was sent to peer review because of the readmission and no Aspirin had been prescribed upon discharge. DNS explained prior to a patient's discharge a registered nurse was to go through the discharge summary with the patient and should have identified the lack of anticoagulation therapy and consulted with the physician. DNS indicated sometimes there seemed to be a disconnect with order sets from the surgery to an inpatient hospital stay and there were times when surgeons needed to be contacted to give directions for post-surgical care. The DNS indicated the transition from surgery to inpatient would make a good performance improvement project.

On 3/9/18, at 12:20 p.m. orthopedic surgeon, MD-A was not aware 3 of 6 surgical patients were discharged without a form of anticoagulation therapy. MD-A stated the issue was very concerning as it could lead to very negative outcomes for patients. MD-A stated that orthopedic patients especially total hip or knee replacements should definitely be on some form of anticoagulation therapy after discharge and it was an expectation. DR-A explained templates and order sets were used for prescribing anticoagulation; the orders were supposed to carry over to the inpatient. MD-A expected the discharge summary to clearly specify the type of anticoagulation prescribed after surgery and education on prevention of deep vein thrombosis and pulmonary embolisms.

On 3/9/18, at 1:00 p.m. the DNS was not aware P2 and P3 had been discharged without Aspirin anticoagulation therapy following joint surgery. DNS verified P2 and P3 were not given instruction or orders to continue Aspirin after discharge. DNS stated the lack of anticoagulation upon discharge seemed to be a system failure that was very concerning as it could have caused systemic harm. DNS indicated no other patient records had been reviewed after the P1's hospital readmission to determine if there was a systemic problem.

On 3/9/18, at 4:40 p.m. DNS indicated after root cause analysis of the cases were reviewed, system gaps were identified which included the surgeon's orders did not flow through to patient discharge summaries from the inpatient hospitalization.

On 3/12/18, at 10:00 a.m. current nursing performance improvement (PI) projects were reviewed with the DNS, the projects did not include activities that identified improvement with transition orders and/or communication from the surgery to inpatient care to the discharge of the patient from the hospital.

Review of the facility's unsigned policy titled "Essentia Health FY [fiscal year] 18 Quality Management (QM) Plan", provided the following information: Section V. AUTHORITY, ACCOUNTABILITY, AND STRUCTURE OVERVIEW indicated the following: "The Essentia Health Board of Directors is ultimately responsible for assuring that high quality care is provided to our patients...The Essentia Health Board of Directors oversee's the effective functioning of activities related to the provision of quality patient care patient/staff safety, quality management, infection prevention and control, risk management, patient experience, regulatory/accreditation standards and strategic direction for quality expenditures. The Essentia Health Board of Directors has delegated responsibility to the Markets and to the Hospitals/Clinics and Professional Staff leadership in the Markets and Hospitals/Clinics to provide for, and implement, the planned systematic, organization-wide approach to process design and quality management, analysis and improvement. The Essentia Health Board of Directors is responsible for oversight, feedback and approvals of all issues related to Quality Management."