HospitalInspections.org

I. Due to a system error, the regulatory language failed to include the regulation found at C-0229

485.623(c)(3) Providing for an emergency fuel and water supply: and

This STANDARD is not met as evidenced by:

Based on policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to secure emergency fuel and water agreements with an outside entity, to ensure the availability of adequate water and fuel in the event of an interruption in the water supply. The administrative staff identified a census of 4 inpatients at the time of the survey, and reported an average daily census of 1 inpatient. The CAH identified 74 employees and 5 contracted staff, who regularly provide services to patients at the time of the survey. Failure to ensure emergency fuel and water is available to meet the facility's critical functions during an emergency/crisis situation inhibits the facility's ability to ensure patient safety and quality of care while responding to and recovering from a situation that resulted in disruption of water and/or power.

Findings include:

1. Review of the CAH policy "Emergency Drinking Water Supply," approved May 2019, revealed the policy contained the contact information for Water Company A for the CAH staff to request bottles of water in the event of a water supply disruption. The policy did not include any information indicating a contractual relationship between the CAH and Water Company A to provide emergency water supplies to the CAH or speak to the ability of Water Company A to meet the CAH's emergency water needs for 96 hours.

2. Review of the CAH policy "Hazard Vulnerability Analysis," approved June 2019, revealed in part "... A documented inventory of assets and resources on-site that are needed during the emergency/disaster will be maintained and evaluated as needed. At a minimum, this inventory should include: ... water, fuel ... The hospital keeps a documented inventory of assets it has on-site that would be needed in the event of an emergency or disaster, The inventory should include a minimum 96 hour supply sustainability for patients, visitors, and staff for the following: ... water (Food and Nutrition Services), Fuel (Facility Services - Maintenance) ... The hospital will provide for alternative sources of essential utilities, including : ... An alternate source of safe water ... Sufficient fuel to last for at least 96 hours of expanded operation ..."

3. During an interview on 7/23/19 at 9:30 AM, the Chief Executive Officer (CEO) reported the CAH lacked any written agreements for emergency fuel or water. The CAH's emergency water policy identified an outside entity but confirmed the CAH lacked a written agreement with the company to provide water to the CAH in an emergency situation. The CEO confirmed the CAH lacked a written agreement for the provision of the emergency fuel to the CAH.

4. During an interview on 7/23/19, at 2:00 PM, the Facilities Services Manager reported the CAH had verbal agreements for emergency fuel and water, but the agreements did not specify the amount of fuel or water the companies could supply to the CAH in an emergency situation. The Facilities Services Manager confirmed the CAH lacked written agreements for emergency fuel and water.

5. During an interview on 7/24/19, at 3:00 PM, the Facilities Services Manager confirmed the CAH lacked a documented inventory of assets on hand, as identified in their hazard vulnerability analysis policy.



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II. Based on document review, observation, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to post a notice conspicuously, in a place likely to be noticed by all individuals entering the dedicated emergency department (DED) that the CAH did not have either a medical doctor (MD) or doctor of osteopathy (DO) present at the hospital 7 days a week, 24 hours a day, and how the the CAH will meet the medical needs of any patient with an emergency medical condition at a time when there is no doctor of medicine or doctor of osteopathy present in the CAH. Failure to post the notice the CAH did not have a physician on-site 24 hours a day, 7 days a week resulted in the patients lacking sufficient information to determine if they wanted to receive emergency care at the CAH, without a physician present at all times. The CAH staff identified approximately 110 patients present to the DED for emergency care each month.

Findings include:

1. Review of the Emergency Department (ED) schedule for June 2019 revealed the CAH staff utilized a mixture of physicians, physician assistants (PAs) and Advanced Registered Nurse Practitioners (ARNPs, nurses with advanced training which allows them to diagnose, treat, and prescribe medications to patients). The CAH staff relied on ARNPs and PAs as the sole medical provider in the Emergency Department for 600 hours in June 2019 (out of 720 hours in the month).

2. Observations during a tour of the Emergency Department on 722/19 at 1:15 PM revealed the Emergency Department staff failed to provide notice to patients the CAH did not have a physician present at the CAH 24 hours per day, 7 days per week.

3. During an interview, at the time of the ED tour, the ED Manager revealed the CAH had PA's and ARNP's who served as the sole medical provider in the ED.

4. During an interview on 7/22/19 at 2:30 PM, Director of Patient Care services confirmed a MD or DO was not at the CAH 24 hours per day, 7 days per week.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the CAH's Medical Staff approved the updated blood bank agreement. The Laboratory administrative staff reported the laboratory had 12 units of blood products available to CAH patients at the beginning of the survey. Failure to ensure a current, approved blood bank agreement was in place could potentially interrupt the availability of blood products needed for emergencies resulting in patient harm and/or death.

Findings include:

1. Review of the "Blood Product Supply" Agreement, dated commencing May 1, 2019, revealed the CAH's administrator signed the agreement on 4/23/19. The agreement lacked documentation the CAH's Medical Staff approved the agreement.

2. Review of the CAH's Medical Staff Meeting minutes for March 21, 2019, April 22, 2019, and the Medical Staff Executive Meeting Minutes for June 13, 2019 and July 16, 2019, revealed the meeting minutes lacked documentation the CAH's Medical Staff approved the Blood Product Supply Agreement.

3. During an interview on 7/23/19 at 9:35 AM, the Chief Executive Officer confirmed the Blood Product Supply Agreement, dated commencing May 1, 2019, lacked approval by the CAH's Medical Staff.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to provide information to ensure the CAH provided acute inpatient care for a period that did not exceed, on an annual average basis, 96 hours per patient. The CAH administrative staff identified a census of 4 patients at the beginning of the survey. Failure to ensure the CAH's average annual patient length of stay did not exceed 96 hours could potentially result in the CAH staff admitting patients who required higher levels of care than the CAH staff could provide in 96 hours.

Findings include:

1. Review of the CAH's documentation revealed the CAH lacked a system to monitor the CAH's patients' length of stay and ensure the CAH patients do not exceed 96 hours in acute inpatient status, as measured on an annual average basis.

2. During an interview on 7/24/19 at 1:40 PM, the Chief Executive Officer verified the CAH failed collect and maintain information which ensured the CAH staff provided acute inpatient care for a period that did not exceed, on an annual average basis, 96 hours per patient.

Based on observation, document review, and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure staff inventoried and performed preventative maintenance on 11 of 11 Stryker electric hospital beds located in 8 of 8 inpatient rooms (Room #1, Room #2, Room #3, Room #4, Room #5, Room #6A and #6B, Room #7A and #7B, and Room #8A and #8B), 3 of 3 treatment tables in Therapy department, and 1 of 1 treatment table in 1 of 1 off site location. Failure to inventory equipment and perform preventative maintenance could potentially result in the equipment failing to function when needed for the care and treatment of a patient, and may result in delayed care, treatment, and patient harm. The CAH's administrative staff identified an average of 2 inpatients per day, 10 patients treated per day in the Therapy department, and average of 64 patients treated per month in the off-site location.

Findings include:

1. Observations during a tour of the Inpatient Unit on 7/22/19 at 12:50 PM with the Director of Patient Care Services revealed the following items lacked a biomedical or maintenance sticker to identify when the equipment was checked for electrical safety:

Room 1 electric Stryker hospital bed
Room 2 electric Stryker hospital bed
Room 3 electric Stryker hospital bed
Room 4 electric Stryker hospital bed
Room 5 electric Stryker hospital bed
Room 6A and 6B -- 2 electric Stryker hospital beds
Room 7A and 7B -- 2 electric Stryker hospital beds
Room 8A and 8B -- 2 electric Stryker hospital beds

2. Observations during a tour of the Therapy department on 7/23/19 at 8:45 AM with the Manager of Therapy Services revealed the following lacked a biomedical or maintenance sticker to identify when the equipment was checked for electrical safety:

Treatment room 1 electric treatment table
Treatment room 2 electric treatment table

3. Observations during a tour of the off-site Therapy department on 7/23/19 at 2:20 PM, with the Manager of Therapy Services, revealed the following lacked a biomedical or maintenance sticker to identify when the equipment was checked for electrical safety:

Big treatment room 1 electric treatment table.

4. Review of the Biomedical Service report revealed the CAH staff failed to include the above mentioned patient beds and the therapy treatment tablesin the biomedical safety checks. The report lacked documentation the Biomedical Services staff checked the equipment for electrical safety.

5. During an interview on 725/19 at 9:00 AM, the Director of Patient Care Services confirmed the CAH staff failed to inventory the equipment and document preventive maintenance on the equipment.

6. During an interview on 7/23/19 at 2:00 PM, the Facilities Services Manager reported he began identifying the pieces of equipment the Facilities Services department must check for patient safety and discovered today that neither his department nor the contracted bio-medical equipment service performed safety checks on the patient beds.

7. During an interview on 7/23/19 at 8:45 AM and 2:20 PM, the Manager of Therapy Services verified neither the Facilities Services department staff nor Biomedical Services staff had checked the treatment tables in the therapy department for electrical safety.

Based on review of Board of Trustees meeting minutes and staff interviews, the Board of Trustees (governing body) failed to ensure the Board of Trustees administered policies to determine and maintain quality health care at the Critical Access Hospital.

1. The Board of Trustees failed to ensure the Medical Staff followed their bylaws in the credentialing of the providers. Refer to C-241.

2. The Board of Trustees failed to ensure the CAH had an effective quality program with governing body oversight that evaluated all patient care services including contracted services and failed to ensure quality improvement information was reviewed. Refer to C-241.

3. The Board of Trustees failed to ensure the required group of professionals, including a physician and a midlevel provider, were involved in the development of the Critical Access Hospital policies. Refer to C-258 and C-263.

4. The Board of Trustees failed to ensure all policies and procedures were developed and reviewed annually by the required group of professionals that included a physician and a midlevel provider. Refer to C-272.

5. The Board of Trustees failed to ensure the CAH maintained a clinical records system in accordance with written policies and procedures. Refer to C-301, C-309, and C-311.

The cumulative effect of these systemic failures and deficient practices resulted in the facility's inability to ensure the quality health care provided to patients.

I. Based on document review and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure 4 of 7 providers (CRNA A, PA C, Family Practice Physician D, and Pathologist E) providing medical care to patients on-site at the CAH selected for review, submitted a list of specific privileges they wished to perform at the CAH prior to the CAH's Medical Staff and Board of Trustees (governing body) approving the practitioner's request to practice at the CAH. Failure of the Board of Trustees and Medical Staff to review all of the privileges requested by the practitioners could potentially result in the practitioners receiving privileges beyond the providers' or CAH staff's capabilities to safely provide care to the patients at the CAH. The CAH's administrative staff identified 18 members of the Medical Staff that provided medical care to patients on-site at the CAH.

The CAH administrative staff identified the Medical Staff members provided care to the following number of patients from 5/1/19 through 7/23/19 as follows:

- Certified Registered Nurse Anesthetist (CRNA) A: 14 patients
- Physician Assistant (PA) C: 83 patients
- Family Practice Physician D: 140 patients
- Pathologist E: 0 patients

Findings include:

1. Review of the medical staff bylaws, approved on 2/25/19, revealed in part "... procedures for appointment and reappointment are outlined in the Avera Merrill Pioneer Hospital Credentialing Policy ...".

2. Review of the CAH policy "Credentialing Policy," approved on 2/25/19, revealed in part "...The complete application shall consist of ... department privileges being requested and completion of retrospective privilege form ... every initial application for staff appointment must contain a request for the specific clinical privileges desired by the applicant ... The completed application shall be presented to the Professional Activities Committee (PAC) ... The PAC shall then present a recommendation to the governing board ... Any recommendation [for] reappointment [must] also include the clinical privileges to be granted ... the governing body shall at its next regular meeting after the receipt of the application and supporting material and the recommendation of the PAC ... Accept and take final action on the application ..."

3. Review of credential files for the identified providers revealed the following:

a. CRNA A's credential file revealed the CAH's Medical Staff approved CRNA A's application to the Medical Staff, including CRNA A's ability to provide care to patients at the CAH on 6/13/19. CRNA A signed the form listing the procedures CRNA A intended to perform at the CAH on 6/15/19 (2 days after the Medical Staff approved CRNA A's application to provide care to the patients at the CAH).

b. PA C's credential file revealed PA C requested privileges to practice at the CAH on 3/20/19. The Medical Staff approved PA C's request to practice at the CAH on 4/22/19. The Board of Trustees approved PA C's request to practice at the CAH on 4/29/19. PA C's credential file revealed the physician who agreed to allow PA C practice under their medical licence (a necessary step prior to approval by the Medical Staff and Board of Trustees) signed the application for PA C to practice at the CAH on 6/13/19 (almost 2 months after the Medical Staff and Board of Trustees approved PA C's application).

c. Family Practice Physician D's credential file revealed the Medical Staff approved Family Practice Physician D's application to practice at the CAH on 3/21/19. The Board of Trustees approved Family Practice Physician D's application to practice at the CAH on 3/26/19. Family Practice Physician D signed the form listing the procedures Family Practice Physician D intended to perform at the CAH on 4/1/19 (6 days after the Board of Trustees approved Family Practice Physician D's application and 11 days after the Medical Staff approved Family Practice Physician D's application).

d. Pathologist E's credential file revealed the Medical Staff approved Pathologist E's application to practice at the CAH on 3/21/19. The Board of Trustees approved Pathologist E's application to practice at the CAH on 3/26/19. Pathologist E signed the form listing the procedures Pathologist E intended to perform at the CAH on 4/23/19 (29 days after the Board of Trustees approved Pathologist E's application and 34 days after the Medical Staff approved Pathologist E's application).


4. During an interview on 7/23/19 at 1:40 PM, the Chief Executive Officer (CEO) confirmed that CRNA A, Family Practice Physician D, and Pathologist E requested privileges to practice at the CAH after the Medical Staff and Board of Trustees approved their application. The CEO also confirmed that PA C's supervising physician signed the supervision agreement form after the Medical Staff and Board of Trustees approved PA C's application to practice at the CAH.




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II. Based on review of documentation, governing board meeting minutes, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to present or document information regarding the Quality Improvement activities at the Board of Trustees meetings so board members could exercise oversight of the quality for all patient care services, including contracted services, offered at the CAH for 18 of 21 departments (Dietary, Maintenance, Housekeeping, Pharmacy, Physical Therapy, Occupational Therapy, Speech Therapy, Surgery, Anesthesia, Infection Control, Skilled Nursing, Health Information Management, Emergency Room, Diabetic Education, Chemotherapy/Infusion, Cardiac Rehabilitation, Nuclear Medicine and Magnetic Resonance Imaging [MRI]). The administrative staff identified a current census of 4 patients at the time of the survey. Failure of the CAH Board of Trustees to review and evaluate Quality Improvement information could potentially result in the Board of Trustees inability to provide effective oversight to the Quality Improvement committee and result in the CAH staff delaying actions to correct any identified deficiencies in the quality of care provided to patients at the CAH.


Findings include:

1. Review of the CAH "Avera Merrill Pioneer Hospital Quality Plan Reporting and Improvement Focus May 2019 - June 2019" revealed in part, "...The governing body and/or administration develop a culture that involves leadership seeking input of quality issues as well as opportunities for improvement. The governing body assures adequate resources exist to conduct Quality Assessment and Performance Improvement (QAPI) efforts ... Quality Assurance Performance Improvement (QAPI) is a data driven, proactive approach used to identify, analyze and improve existing care processes in order to meet goals and thresholds identified within the strategic plan...."

2. Review of the Board of Trustees Meeting minutes from March 25, 2019 to June 24, 2019 revealed the meeting minutes lacked documentation the Board of Trustee members reviewed and evaluated the CAH's Quality Improvement activities.

3. Review the CAH's Quality Improvement documentation revealed the CAH staff failed to perform problem prevention and identification, corrective action taken, and outcome of effective actions from the following departments: Dietary, Maintenance, Housekeeping, Pharmacy, Physical Therapy, Occupational Therapy, Speech Therapy, Surgery, Anesthesia, Infection Control, Skilled Nursing, Health Information Management, Emergency Room, Diabetic Education, Chemotherapy/Infusion, Cardiac Rehabilitation, Nuclear Medicine and Magnetic Resonance Imaging.

4. Review of the CAH's Quality Improvement documentation revealed the CAH lacked evidence of any quality improvement activities prior to 5/1/19.

5. During an interview on 7/24/19 at 1:40 PM, the Director of Patient Care Services acknowledged the CAH lacked evidence of any quality improvement activities performed at the CAH for any CAH department prior to 5/1/19.

6. During an interview on 7/25/19 at 11:55 AM, Board of Trustees member A acknowledged the lack of information on the quality improvement activities conducted at the CAH prior to 5/1/19 interfered with the Board of Trustees's ability to make decisions related to the quality of patient care provided at the CAH.

Based on document review and staff interview, the Critical Access Hospital (CAH) staff failed to ensure 2 of 2 sampled mid-level providers (Advanced Registered Nurse Practitioner (ARNP) F and Physician Assistant (PA) G), notified a physician when they admitted a patient to the CAH for inpatient care, for 3 of 6 closed medical records reviewed (Patient #9, Patient #10, and Patient #11). Failure of ARNP F and PA G to notify a physician of the admission could potentially result in ARNP F and PA G's patients receiving inadequate or substandard care because ARNP F and PA G did not discuss the patient's plan of care and medical needs with a physician. The CAH's administrative staff identified a current inpatient census of 4 patients at the beginning of the survey.

Findings include:

1. Review of Patient #9's medical record revealed that PA G admitted Patient #9 to the CAH on 6/12/19 for evaluation of abdominal pain. The medical record lacked documentation that PA G notified a physician that PA G admitted Patient #9 to the CAH for inpatient medical care.

2. Review of Patient #10's medical record revealed that PA G admitted Patient #10 to the CAH on 5/23/19 for treatment of Patient #10's shortness of breath. The medical record lacked documentation that PA G notified a physician that PA G admitted Patient #10 to the CAH for inpatient medical care.

3. Review of Patient #11's medical record revealed that ARNP F admitted Patient #11 to the CAH on 5/7/19 for treatment of a hip fracture. The medical record lacked documentation that ARNP F notified a physician that ARNP F admitted Patient #11 to the CAH for inpatient medical care.

4. Review of the CAH's policies revealed the CAH lacked a policy requiring an ARNP or PA to notify a physician when the ARNP or PA admitted a patient to the CAH for inpatient medical care.

5. Review of the CAH's "Bylaws of the Medical Staff," dated 2019, revealed the bylaws lacked a requirement for the ARNP or PA to notify a physician when the ARNP or PA admitted a patient to the CAH for inpatient medical care.

6. During an interview on 7/24/19 at approximately 3:30 PM, the Director of Patient Care Services verified the medical records lacked documentation that PA G or ARNP F notified a physician when they admitted the patients to the CAH for inpatient medical care. The Director of Patient Care Services also verified the CAH lacked a requirement for an ARNP or PA to notify a physician when an ARNP or PA admitted a patient to the CAH for inpatient medical care.

Based on review of policies/procedures, meeting minutes, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the required group of professionals, including a physician and a mid-level provider, reviewed all patient care policies annually for 21 of 22 patient care departments (Nursing, Laboratory, Radiology, Dietary, Maintenance, Housekeeping, Physical Therapy, Occupational Therapy, Speech Therapy, Surgery, Anesthesia, Infection Control, Quality, Skilled Nursing, Health Information Management, Emergency Room, Diabetic Education, Chemotherapy/Infusion, Cardiac Rehabilitation, Nuclear Medicine, and MRI). The CAH administrative staff identified a census of 4 patients at the beginning of the survey. Failure to ensure the required group of professionals reviewed all patient care policies annually could potentially result in the CAH staff failing to identify patient care needs not addressed in the CAH policies/procedures.

Findings include:

1. Review of the CAH policies revealed that the required group of professionals, including a physician and mid-level provider, only reviewed the Pharmacy policies, during a medical staff meeting on June 13, 2019.

2. Review of the CAH policies revealed the policies lacked documentation that the required group of professionals, including a physician and mid-level provider, reviewed the Nursing, Laboratory, Radiology, Dietary, Maintenance, Housekeeping, Physical Therapy, Occupational Therapy, Speech Therapy, Surgery, Anesthesia, Infection Control, Quality, Skilled Nursing, Health Information Management, Emergency Room, Diabetic Education, Chemotherapy/Infusion, Cardiac Rehabilitation, Nuclear Medicine, and MRI policies within the prior year.

3. During an interview on 7/24/19 at 2:25 PM, the Chief Executive Officer (CEO) confirmed the CAH lacked a policy addressing the annual review of patient care policies, and the CAH lacked a requirement that a physician and mid-level provider participate in the annual policy review. The CEO verified the required group of professionals, including a physician and mid-level provider, only reviewed the Pharmacy policies, and failed to review the Nursing, Laboratory, Radiology, Dietary, Maintenance, Housekeeping, Physical Therapy, Occupational Therapy, Speech Therapy, Surgery, Anesthesia, Infection Control, Quality, Skilled Nursing, Health Information Management, Emergency Room, Diabetic Education, Chemotherapy/Infusion, Cardiac Rehabilitation, Nuclear Medicine, and MRI policies.

I. Based on document review and staff interview, the Critical Access Hospital (CAH) staff failed to implement an effective infection control program that took into account historical data, tracked patient infections, and identified hospital specific infection control issues into an ongoing infection control program. Failure to access and utilize historical infection control data significantly limited the CAH's ability to implement appropriate infection control interventions to address identified infection control issues potentially resulted in the CAH staff potentially failing to identify historical infection control problems, the CAH staff potentially failing to implement measures to address historical infection control problems, and the CAH staff potentially failing to prevent a recurrence of historical infection control problems. The CAH Administrative staff reported a census of 4 patients on entrance.

Findings include:

1. Review of the CAH policies revealed the policies lacked information on the Infection Control program prior to May 1, 2019.

2. Review of the CAH's Infection Control Committee meeting minutes revealed the Infection Control Committee meeting minutes lacked any information from the Infection Control Committee meetings prior to May 1, 2019.

3. Review of the CAH's Infection Control monitoring data revealed the CAH lacked any information on Infection Control monitoring which occurred prior to May 1, 2019.

4. During an interview on 7/24/19 at 1:00 PM, the Director of Patient Care Services revealed the hospital underwent a change of ownership on May 1, 2019. The Director of Patient Care Services indicated the CAH's prior owners, Hospital System A, transferred control of the CAH to the current owners on May 1, 2019. Hospital System A claimed ownership of all the Infection Control program materials created during Hospital System A's control of the CAH and did not provide any information on the Infection Control program to the CAH after the transfer of control occurred. Thus, the CAH lacked any historical documentation for the Infection Control program prior to May 1, 2019 which the CAH staff could utilize to develop the current infection control program.




II. Based on document review and staff interviews, the Critical Access Hospital (CAH) failed to implement an effective surveillance program for patients and hospital personal which included a clearly defined process for surveillance and follow up of all lab cultures and tracking of hospital personnel's illnesses. Failure to follow up on all lab cultures and track hospital personnel's illness may result in missed opportunities to identify, investigate, and control infections, potentially allowing the spread of communicable diseases to the hospital's patients, staff, and the community. The CAH administrative staff identified 74 staff members worked at the CAH, the CAH had a census of 4 inpatients at the start of the survey, and approximately 110 patients per month presented to the emergency room for emergency care.

Findings include:

1. Review of the "Infection Prevention Program and Surveillance Policy," dated 4/2019, revealed in part, "... Documents infections or epidemiological significance among employees ... Employee Health Nurse will coordinate the Employee Health Program and assure adequate surveillance of infections in personnel, ... Avera Merrill Pioneer Hospital will do total surveillance of all infections for the patient population served , ... The Iowa Department of [Public] Health will be notified of all reportable infections involving ... Avera Merrill Pioneer Staff, ... purpose: to collect data about infections, detect any changes in data trends, identify problems and reduce adverse patient outcomes."

2 During an interview on 7/24/2019 at approximately 1:00 PM, the Director of Patient Care Services revealed the Infection Preventionist checked the lab culture results on a monthly basis, due to the low volume of laboratory cultures. The Director of Patient Care Services acknowledged that only checking the lab culture results once a month would prevent the Infection Preventionist from identifying positive culture results and addressing the possible spread of infections between patients, staff members, and the community in a timely manner.

The Director of Patient Care Services revealed the CAH lacked a mechanism to track the illnesses of staff members and thus lacked the ability to identify if an illness was spreading between staff members, and potentially placing patients at risk to develop the illness spreading between staff members.



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III. Based on policy review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to develop and implement a water management plan which included a facility risk assessment and implementation of policies and procedures developed to mitigate the risk of Legionella infections. The CAH administrative staff identified at census of 4 inpatients at the time of the survey. Failure to develop and implement a water management plan could potentially result in the CAH staff failing to identify and implement a program which reduces the risk of Legionella infections, which could potentially result in patients developing a life threatening infection.

Findings include:

1. Review of the CAH's policies/procedures revealed the CAH lacked a policy/procedure which included a facility risk assessment and included implementation of procedures to mitigate the risk of Legionella infections.

2. During an interview on 7/23/19, at 2:30 PM, the Facilities Services Manager acknowledged the CAH lacked a water management plan to address the potential risks associated with Legionella infections (a bacteria that grows in water and can cause life-threatening pneumonia infections). The Facilities Services Manager reported the CAH staff had performed some initial assessments of the risk posed by Legionella bacteria. However, the CAH lacked evidence of a documented program, including risks identified by the CAH staff, testing protocols developed and implemented by the CAH staff, and policies/procedures related to the water management plan.

3. During a follow-up interview on 7/24/19 at 3:40 PM, the Facilities Services Manager provided a policy titled "Water Management Program." The Facilities Services Manager confirmed he created the policy after the surveyor requested the policy. He again confirmed the CAH staff had not completed a full risk assessment for Legionella bacteria nor had the CAH staff documented completing any of the procedures identified in the policy presented to the surveyor.

Based on review of documentation and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to create and maintain 1 of 1 list of contracted services which described the nature and scope of the services provided. The administrative staff identified a current census of 4 inpatients at the time of the survey. Failure to maintain a list of contracted services, including the delineation of the nature and scope of contracted services, could potentially result in the CAH's administrative staff failing to ensure the contracted services provided quality services to the CAH's patients and the contracted services met their responsibilities under the contracts.

Findings include:

1. Review of documents provided by the CAH staff revealed the CAH lacked a list of contracted services, which included a description of the nature and scope of the services provided by each contracted entity.

2. During an interview on 7/24/19 at 10:10 AM, the Chief Executive Officer (CEO) confirmed the CAH lacked a list of contracted services provided at the CAH, including a description of the nature and scope of the services provide by each contracted entity.

The CEO acknowledged the CAH staff were in the process of compiling a list of contracted services by contacting each department and requesting information on any contracted services the department utilized. However, the CAH staff had not created a list of contracted services provided at the CAH due to other priorities following the change in management of the CAH on May 1, 2019.

Based on review of documentation and staff interviews the Critical Access Hospital (CAH) Administrative Staff failed to ensure the Health Information Management (HIM) Department developed, implemented, and maintained policies and procedures governing patient medical records.

1. The Critical Access Hospital (CAH) Administrative Staff failed to ensure the CAH staff maintained: patient medical records for patients that received care prior to 5/1/19; a sample list of patient medical records for patients that received care at the CAH prior to 5/1/19; and the ability to compile and retrieve data for quality assurance purposes. Please refer to C-301.

2. The Critical Access Hospital (CAH) Administrative staff failed to ensure the CAH staff maintained written policies and procedures for the use and removal of records from the CAH and the conditions for release of information. Please refer to C-309.

3. The Critical Access Hospital (CAH) Administrative Staff failed to ensure the CAH's HIM staff maintained patient medical records for at least 6 years from the date of the last entry and longer if required per state law. Please refer to C-311.

The cumulative effect of these systemic failures and deficient practices resulted in the facility's inability to ensure the quality health care provided to patients by the maintenance of patient medical records.

Based on document review and staff interviews, the Critical Access Hospital (CAH) Administrative Staff failed to ensure the CAH's Health Information Management (HIM) staff maintained: patient medical records for patients that received care at the CAH prior to 5/1/19; the ability to create a sample list of patient medical records for patients that received care at the CAH prior to 5/1/19; and the ability to compile and retrieve data for quality assurance purposes. The CAH Administrative Staff identified 4 inpatients at the beginning of the survey. Failure to maintain a complete medical record for patients that receive medical care at the CAH prior to 5/1/19 could potentially result staff lacking information on the patients' prior medical care, potentially resulting in the CAH staff delaying care or potentially providing inappropriate care, which could potentially result in patients failing to improve from the CAH staff's medical care or life-threatening delays in providing appropriate care to the CAH's patients.

Findings include:

1. Review of the CAH policy "Right to Request Confidential Communication for [Protected Health Information]," approved 4/2019, revealed in part "Avera requires individuals to make a request for confidential communication in writing, using the 'Request for Confidential Communication' form available in the HIM Department or from the Privacy Officer ..."

2. Review of the undated document, "Request of Records," required patients to contact the CAH's previous network hospital (Health System A) if the patient required access to any part of their medical record for care received at the CAH prior to 5/1/19 (the date the CAH changed ownership).

3. Review of the current network hospital's policy "Confidential Information," effective 1/2017, revealed in part " ... Patient related information is the property of the covered entity; however, the information in the medical records belong to the patient ... Original source patient information is the property of the covered entity and may be removed from the facility only upon receipt of a court order, subpoena duces tecum, or administrative approval/departmental policy ... Any questions regarding release of medical information should be referred to the HIM Department ... "

4. Review of the current network hospital's policy "Record Retention," approved on 9/6/17, revealed in part " ... Documents shall be retained as required by federal and state law or regulations as described on the attached Record Retention Schedule ... Records will be managed responsibly and retention schedules followed as identified in the policy."

5. During an interview on 7/23/19 at 9:30AM, the Health Information Management (HIM) Site Coordinator reported since the change in ownership, beginning on 5/1/19, the CAH's HIM staff had view only access to a patient medical record prior to 5/1/19 for continuity of care and could not release any portion of a record, upon request, for care provided at the CAH prior to 5/1/19.

The HIM Site Coordinator acknowledged that the CAH HIM staff could not process any requests for patient medical records for care which occurred at the CAH prior to 5/1/19. If the patient required medical records for care they received at the CAH prior to 5/1/19, the patient had to contact the CAH's prior network hospital to receive the medical record of care the patient received at the CAH.

6. During an interview on 7/24/19 at 8:00 AM , the Chief Executive Officer and the Director of Patient Care Services verified the CAH HIM staff lacked the ability to generate a list of patients who received care at the CAH prior to 5/1/19. The inability to generate a list of patients who received care at the CAH prior to 5/1/19 resulted in the CAH staff's inability to generate data for the CAH's quality improvement program.

7. During an interview on 7/24/19 at 9:30 AM, the HIM Site Coordinator reported the CAH lacked policies for the management of patient records but would follow the current network hospital's HIM policies, pending the development of CAH specific policies.

Based on document review and staff interviews the Critical Access Hospital (CAH) Administrative staff failed to ensure the CAH maintained written policies and procedures for the use and removal of records from the CAH and the conditions for release of information. The CAH administrative identified 4 patients at the beginning of the survey.

Failure to ensure the CAH HIM staff maintained patient records in accordance with policy and procedure could potentially result in the patient's inability to obtain a copy of a previous encounter which could result in delay of treatment and continuity of care, could potentially result in the release of the patient's medical records to an unauthorized person, or could potentially result in the CAH HIM staff failing to maintain the patient's complete medical record.

Findings include:

1. Review of the network hospital policy "Confidential Information," effective January 2017, revealed the policy lacked information specific to the CAH.

2. Review of the network hospital policy, "Record Retention," effective September 6, 2017, revealed the policy lacked information specific to the CAH.

3. During an interview on 7/24/19 at 9:30 AM, the HIM Site Coordinator reported the CAH lacked policies specific to the CAH for the management of patient records. The HIM Site Coordinator confirmed the CAH would follow the network hospital's HIM policies, pending the development of CAH specific policies.

Based on document review and staff interviews the Critical Access Hospital (CAH) Administrative Staff failed to ensure the CAH Health Information Management (HIM) staff maintained patient medical records for at least 6 years from the date of the last entry and longer if required per state law. The CAH Administrative Staff identified 4 patients at the beginning of the survey. Failure to maintain a complete medical record for patients that receive medical care at the CAH prior to 5/1/19 could potentially result staff lacking information on the patients' prior medical care, potentially resulting in the CAH staff delaying care or potentially providing inappropriate care, which could potentially result in patients failing to improve from the CAH's medical care or life-threatening delays in providing appropriate care to the CAH's patients.

Findings include:

1. During an interview on 7/23/19 at 9:30 AM, the Health Information Management (HIM) Site Coordinator reported since the change in ownership, beginning on 5/1/19, the CAH's HIM staff had view only access to a patient's medical record for care received at the CAH prior to 5/1/19, for continuity of care, and the CAH's HIM staff could not release any portion of a record upon request, for care provided at the CAH prior to 5/1/19.

2. During an interview on 7/24/19 at 8:00 AM , the Chief Executive Officer and the Director of Patient Care Services verified the CAH HIM staff lacked the ability to generate a list of patients who received care at the CAH prior to 5/1/19. The inability to generate a list of patients who received care at the CAH prior to 5/1/19 prevented the CAH staff from knowing if the patient had previously received care at the CAH, which would require the HIM staff to check the CAH's prior owner's medical record system every time a patient was admitted to the CAH, to determine if the patient previously received care at the CAH and access the patient's prior medical records.

The CAH failed to develop and implement an effective quality assurance program.

- The CAH's Quality Assurance/Improvement program lacked problem prevention, identification, identification of corrective actions, implementation of corrective actions, evaluation of corrective actions, and measures to improve quality on a continuous basis. Please refer to C-336.

- The CAH failed to evaluate all patient services including contracted services. Please refer to C-337.

The cumulative effect of these systemic failures and deficient practices resulted in the facility's inability to ensure the CAH staff provided quality health care provided to patients.

Based on review of documentation and staff interview, the Critical Access Hospital (CAH) administrative staff failed to develop, evaluate, and implement an effective Quality Improvement Program to evaluate and improve the quality and appropriateness of patient care and to improve quality on a continuous basis including all services, including contracted services, offered at the CAH for 18 of 21 departments (Dietary, Maintenance, Housekeeping, Pharmacy, Physical Therapy, Occupational Therapy, Speech Therapy, Surgery, Anesthesia, Infection Control, Skilled Nursing, Health Information Management, Emergency Room, Diabetic Education, Chemotherapy/Infusion, Cardiac Rehabilitation, Nuclear Medicine and Magnetic Resonance Imaging [MRI]). The administrative staff identified a current census of 4 inpatients at the time of the survey. Failure to create and implement an effective quality improvement program that included involvement of all of the CAH's departments to improve quality on a continuous basis could potentially result in the CAH staff's failure to identify, monitor, address, and improve patient care problems in each patient care area through the efforts of all involved departments.

Findings include:

1. Review of the CAH "Avera Merrill Pioneer Hospital Quality Plan Reporting and Improvement Focus May 2019 - June 2019" revealed in part, "...The governing body and/or administration develop a culture that involves leadership seeking input of quality issues as well as opportunities for improvement. The governing body assures adequate resources exist to conduct Quality Assessment and Performance Improvement (QAPI) efforts ... Quality Assurance Performance Improvement (QAPI) is a data driven, proactive approach used to identify, analyze and improve existing care processes in order to meet goals and thresholds identified within the strategic plan...."

2. Review of the CAH's documents revealed the CAH staff lacked evidence concerning problem prevention, identification, corrective action taken, and the outcomes of effective action from the following departments: Dietary, Maintenance, Housekeeping, Pharmacy, Physical Therapy, Occupational Therapy, Speech Therapy, Surgery, Anesthesia, Infection Control, Skilled Nursing, Health Information Management, Emergency Room, Diabetic Education, Chemotherapy/Infusion, Cardiac Rehabilitation, Nuclear Medicine and Magnetic Resonance Imaging.

3. Review of the CAH's quality improvement documentation revealed the CAH lacked any evidence of quality improvement activities at the CAH prior to 5/1/19.

4. During an interview on 7/24/19 at 1:40 PM, the Director of Patient Care Services acknowledged the CAH lacked documented evidence the CAH staff performed any quality improvement activities for any CAH department prior to 5/1/19.

Based on review of documentation and staff interview, the Critical Access Hospital (CAH) quality improvement staff failed to evaluate all patient care services provided for 18 of 21 departments (Dietary, Maintenance, Housekeeping, Pharmacy, Physical Therapy, Occupational Therapy, Speech Therapy, Surgery, Anesthesia, Infection Control, Skilled Nursing, Health Information Management, Emergency Room, Diabetic Education, Chemotherapy/Infusion, Cardiac Rehabilitation, Nuclear Medicine and Magnetic Resonance Imaging [MRI]). The administrative staff identified a current census of 4 patients at the time of the survey. Failure to monitor and evaluate all patient care services for quality of care could potentially expose patients to inappropriate and/or substantial care.

Findings include:

1. Review of the CAH "Avera Merrill Pioneer Hospital Quality Plan Reporting and Improvement Focus May 2019 - June 2019" revealed in part, "...The governing body and/or administration develop a culture that involves leadership seeking input of quality issues as well as opportunities for improvement. The governing body assures adequate resources exist to conduct Quality Assessment and Performance Improvement (QAPI) efforts ... Quality Assurance Performance Improvement (QAPI) is a data driven, proactive approach used to identify, analyze and improve existing care processes in order to meet goals and thresholds identified within the strategic plan...."

2. Review of the CAH's documents revealed the CAH staff lacked evidence concerning problem prevention, identification, corrective action taken, and the outcomes of effective action from the following departments: Dietary, Maintenance, Housekeeping, Pharmacy, Physical Therapy, Occupational Therapy, Speech Therapy, Surgery, Anesthesia, Infection Control, Skilled Nursing, Health Information Management, Emergency Room, Diabetic Education, Chemotherapy/Infusion, Cardiac Rehabilitation, Nuclear Medicine and Magnetic Resonance Imaging.

3. Review of the CAH's quality improvement documentation revealed the CAH lacked any evidence of quality improvement activities at the CAH prior to 5/1/19.

4. During an interview on 7/24/19 at 1:40 PM, the Director of Patient Care Services acknowledged the CAH staff lacked documented evidence of any quality improvement activities which occurred at the CAH prior to 5/1/19. The Director of Patient Care confirmed that not all departments reported information which related to patient care to the CAH's quality improvement program.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure all swing bed patients received the required Swing Bed Patient Rights. Failure to present all of the required rights to the swing bed patients and/or their legal representative could result in the patients and/or their legal representatives being unaware of all their rights as swing bed patients and thus being unable to exercise their rights. The CAH administrative staff identified a census of 2 swing bed patients on entrance.

Findings include:

1. Review of the brochure "Patient Rights and Responsibilites," revealed the CAH staff failed to include the following information related to skilled bed patient rights:

a. In the case of a resident adjudged incompetent under the laws of a State by a court of competent jurisdiction, the rights of the resident devolve to and are exercised by the resident representative appointed under State law to act on the resident's behalf. The court-appointed resident representative exercises the resident's rights to the extent judged necessary by a court of competent jurisdiction, in accordance with State law.

b.The resident has the right to be informed of, and participate in, his or her treatment, including:

(i) The right to be fully informed in language that he or she can understand of his or her total health status, including but not limited to, his or her medical condition.

c. The right to be informed, in advance, of changes to the plan of care.

d. The right to request, refuse, and/or discontinue treatment, to participate in or refuse to participate in experimental research, and to formulate an advance directive.

e. Choice of attending physician. The resident has the right to choose his or her attending physician.

f. The right to retain and use personal possessions, including furnishings, and clothing, as space permits, unless to do so would infringe upon the rights or health and safety of other residents.

g. The right to share a room with his or her spouse when married residents live in the same facility and both spouses consent to the arrangement.

h. The facility must provide immediate access to a resident by immediate family and other relatives of the resident, subject to the resident's right to deny or withdraw consent at any time;

i. The facility must provide immediate access to a resident by others who are visiting with the consent of the resident, subject to reasonable clinical and safety restrictions and the resident's right to deny or withdraw consent at any time;

j. The resident has a right to choose to or refuse to perform services for the facility and the facility must not require a resident to perform services for the facility. The resident may perform services for the facility, if he or she chooses, when-

k. The resident has the right to send and receive mail, and to receive letters, packages and other materials delivered to the facility for the resident through a means other than a postal service, including the right to:

l. The facility must-

(i) Inform each Medicaid-eligible resident, in writing, at the time of admission to the nursing
facility and when the resident becomes eligible for Medicaid of-

(A) The items and services that are included in nursing facility services under the State plan and for which the resident may not be charged;
(B) Those other items and services that the facility offers and for which the resident may be
charged, and the amount of charges for those services; and

(ii) Inform each Medicaid-eligible resident when changes are made to the items and services
specified in §483.10(g)(17)(i)(A) and (B) of this section.

m. The facility must inform each resident before, or at the time of admission, and periodically during the resident's stay, of services available in the facility and of charges for those services, including any charges for services not covered under Medicare/Medicaid or by the facility's per diem rate.

(i) The resident has a right to personal privacy and confidentiality of his or her personal and medical records.

2. During an interview on 7/22/19 at 3:50 PM, the Director of Patient Care Services confirmed the CAH staff provided the Patient Rights Brochure to all patients, including skilled patients, and acknowledged the brochure lacked the required language for swing bed patients.

3. During an interview on 7/24/19 at 2:35 PM, the Chief Executive Officer confirmed the CAH lacked a policy ensuring the CAH staff informed swing bed patients of all their rights.

Based on document review and staff interviews, the Critical Access Hospital (CAH) staff failed to develop a comprehensive activities care plan for 2 or 2 open swing bed patient medical records (Patient #6, and Patient #7) and 1 of 1 reviewed closed swing bed patient medical record (Patient #8). Failure to develop a comprehensive activities care plan that meets the physical and psychosocial needs of the individual patients could potentially impede the patient's progression toward attaining goals and achieving the highest level of well-being and independence possible. The CAH administrative staff identified a census of 2 swing patients at the beginning of the survey.

Findings include:

1. Review of the policy "Comprehensive Care Plan," effective 4/2019, revealed in part, "...A comprehensive care plan will be developed for each swing bed patient within 7 days after the completion of the comprehensive assessment...include objectives and timetables to meet a swing bed patient's medical, nursing, mental and psychosocial needs...."

2. Review of the policy "Activities," effective 4/2019, revealed in part, "...Based on the comprehensive assessment and care plan, along with the preferences of each swing bed resident, an ongoing program to support a resident's choice of activities will be provided. Activities will be offered as appropriate to each resident to meet interests and support the physical, mental, and psychosocial well-being, while encouraging both independence and interaction with others...."

3. Review of medical records revealed the following:

a. The CAH staff admitted Patient #6 to swing bed status on 7/16/19. The Activity Coordinator completed an initial assessment for Patient #6 on 7/17/19. Patient #6's medical record lacked evidence the CAH staff created an activity care plan that directed staff to provide individual or group activities chosen by the patient.

b. The CAH staff admitted Patient #7 to swing bed status on 7/10/19. The Activity Coordinator completed an initial assessment for Patient #7 on 7/11/19. Patient #7's medical record lacked evidence the CAH staff created an activity care plan that directed staff to provide individual or group activities chosen by the patient.

c. The CAH staff admitted Patient #8 to swing bed status on 6/25/19. The CAH staff discharged Patient #8 from swing bed status on 7/1/19. The Activity Coordinator completed an initial activities assessment for Patient #8 on 6/25/19. Patient #8's medical record lacked evidence the CAH staff created an activity care plan that directed staff to provide individual or group activities chosen by the patient.

4. During an interview on 7/22/2019 at 12:45 PM, the Director of Patient Care Services acknowledged Patient #6's, Patient #7's, and Patient #8's medical record lacked an activities care plan.

Based on document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure physicians ordered specialized rehabilitation services for 1 of 2 open swing bed patients (Patient #6) and 1 of 1 reviewed closed swing bed patient (Patients #8). Failure to ensure a physician ordered specialized rehabilitation services could result in swing bed patients not receiving specialized rehab services appropriate to their medical condition. The CAH administrative staff identified a census of 2 swing bed patients at the beginning of the survey.

Findings included:

1. Review of the CAH's policies/procedures revealed the CAH lacked a policy/procedure which addressed the requirement for a physician to order specialized rehabilitation services for swing bed patients.

2. Review of Patient #6's open medical record revealed the CAH staff admitted Patient #6 for swing bed level care on 7/16/19. Advanced Registered Nurse Practitioner (ARNP, a nurse with advanced training who may prescribe therapies) H wrote an order on 7/19/19 at 4:16 PM for the Physical Therapist to evaluate and treat Patient #6 and for the Occupational Therapist to evaluate and treat Patient #6.

Review of Patient #8's open medical record revealed the CAH staff admitted Patient #8 for swing bed level care on 6/25/19. The CAH staff discharged Patient #8 on 7/1/19. ARNP I wrote an order on 6/25/19 at 2:22 PM for the Physical Therapist to evaluate and treat Patient #6 and for the Occupational Therapist to evaluate and treat Patient #6.

3. During an interview on 7/23/2019 at 3:07 PM, the Director of Patient Care Services acknowledged that ARNP H wrote the therapy orders for Patient #6 and ARNP I wrote the therapy orders for Patient #8 when the patients received swing bed services. The Director of Patient Care Services acknowledged a physician did not write the therapy orders for Patient #6 and Patient #8.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the availability of dental services to patients receiving swing bed level care at the CAH. Failure to ensure the availability of dental services to swing bed level patients at the CAH could potentially result in the patients developing dental concerns requiring a dentist's specialized knowledge and the CAH staff lacking access to a dentist willing or available to meet the patient's dental needs. The administrative staff identified a census of 2 swing bed patients at the time of the survey.

Findings include:

1. Review of the policy "Dental Services," effective 4/2019, revealed in part, the CAH "...will provide dental care to patients in the Swing Bed Program upon request of the patient and/or the attending physician..." "Patients demonstrating a need of routine or emergency dental care shall have arrangements made for the provision of these dental services."

2. During an interview on 7/22/2019 at 12:45 PM, the Director of Patient Care Services revealed the CAH lacked a formal agreement with a dentist or other mechanism to ensure the availablity of dental services to the CAH's swing bed patients.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to inform each patient of their visitation rights, including any clinical restriction or limitation on such rights, and the reasons for the clinical restriction or limitation for the inpatient units, ER, and 1 of 1 off-site clinic (PT clinic). Failure to inform each patient of their visitation rights could potentially result in limiting/restricting access of visitors to patients that infringed on their right to have a support person when they are provided any type of care, services, or treatment. The CAH's administrative staff identified a census of 4 on entrance, 175 ER patients per month, and 64 patient visits per month at the off-site PT clinic.

Findings include:

1. Observation during a tour of the inpatient unit on 7/22/19 at 12:50 PM revealed the CAH staff displayed the "Patient Rights and Responsibilities" brochure at the nurses' station.

2. Observations during a tour of the ER on 7/22/19 at 1:15 PM revealed the CAH staff displayed the "Patient Rights and Responsibilities" brochure at the nurses' station.

3. Review of the brochure "Patient Rights and Responsibilities," revised 4/2019, revealed the brochure lacked information to inform patients and/or their support person of the reasons the CAH staff could place clinical restrictions or limitations on the patient's right to receive visitors.

4. Observations during a tour of the off-site PT clinic on 7/23/19 at 2:20 PM revealed the CAH clinic staff failed to post or otherwise make the patients' rights information available to patients of the CAH clinic.

5. During an interview at the time of the tour, the Manager of Therapy Services verified the CAH clinic staff did not post or otherwise make the patients' rights information available to patients of the CAH clinic.

6. During an interview on 7/23/19 at 1:40 PM, the Director of Patient Care Services confirmed the CAH staff provide the brochure "Patient Rights and Responsibilities" to all patients at registration or admission. The Director of Patient Care Services acknowledged the CAH staff failed to include the reasons the CAH staff could place clinical restrictions or limitations on the patient's right to receive visitors in the brochure.