HospitalInspections.org

Based on document review and staff interview, the hospital administrative staff failed to ensure the hospital's governing body approved 1 of 1 grievance process policy. The hospital's administrative staff identified a current census of 13 inpatients at the beginning of the survey. Failure of the governing body to approve the grievance process could potentially create a barrier for hospital staff to resolve patient grievances.

Findings include:

1. Review of the hospital policy "Patient Concerns and Grievance Process," last approved 07/2020, revealed in part, "... Lakes Regional Healthcare's Board of Trustees has delegated the responsibility for the oversight review and resolution of patient grievances to the as hoc Patient Grievance and Sanctions Committee...."

Review of Board of Trustees Meeting minutes from August 18, 2019 through September 2, 2020 lacked approval of the grievance process policy.

2. During an interview on 09/24/2020 at 8:50 AM, the Chief Nursing Officer confirmed the lack of approval of the grievance process policy by the Board of Trustees.

Based on document review and staff interview, the hospital failed to ensure the patients rights document provided to patients contained information of their right to be free from all forms of abuse or harassment. The hospital's administrative staff identified a current inpatient census of 12 at the beginning of the survey. Failure to inform the patient of their rights could result in the patient not aware of there right to be free from abuse or harassment, thus the potential harm to the patient.

Finding include:

1. Review of the hospital's document titled "Patient or Representative Rights and Responsibilities," dated September 2020, contained information available to inpatients and outpatients regarding their patient rights. Further review of the document revealed it lacked information to patients of their right to be free from all form of abuse or harassment.

Review of hospital policy "Patient or Representative Rights and Responsibilities," effective 04/2020, lacked evidence of informing patients of their right to be free from all form of abuse or harassment.

2. During interview on 09/23/2020 at 9:10 AM, the Quality Specialist acknowledged the patient rights policy and information available to patients regarding their rights failed to inform the patient of their rights to be free from all forms of abuse or harassment.

Based on document review and staff interview, the hospital failed to ensure the patients rights document provided to patients contained information of their right to be free from physical or mental abuse and corporal punishment and restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. The hospital's administrative staff identified a current inpatient census of 12 at the beginning of the survey. Failure to inform the patient of their rights could result in the patient not aware of there right to be free from physical or mental abuse and corporal punishment and restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff, thus the potential harm to the patient.

Finding include:

1. Review of the hospital's document titled "Patient or Representative Rights and Responsibilities," dated 09/2020, contained information available to inpatients and outpatients regarding their patient rights, lacked evidence of information to patients of their right to be free from physical or mental abuse and corporal punishment and restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff.

Review of the hospital policy "Patient or Representative Rights and Responsibilities," effective 04/2020, lacked evidence of information to patients of their right to be free from physical or mental abuse and corporal punishment and restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff.

2. During interview on 09/23/2020 at 9:10 AM, the Quality Specialist acknowledged the patient rights policy and information available to patients regarding their rights failed to inform the patient of their rights to be free from physical or mental abuse and corporal punishment and restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff.

Based on observation, document review, and staff interview, the hospital's administrative staff failed to ensure the staff removed outdated medications from 1 of 1 medication supply room in 1 of 2 outpatient clinics (NW Iowa Bone, Joint, & Sports Surgeon Clinic). The hospital's administrative staff identified an average of 581 patient visits per month in the NW Iowa Bone, Joint & Sports Surgeon Clinic. Failure to remove outdated medications from the hospital's supplies, available for patient use, could potentially result in the staff using expired medications for patient use after the manufacturer's expiration date, potentially resulting in the staff using medication on a patient after the date which the manufacturer guaranteed the sterility and efficacy of the medication.

Findings included:

1. Observations on 09/22/2020 at 10:45 AM during a tour of the NW Iowa Bone, Joint & Sports Surgeon Clinic
Emergency Department, with the Chief Nursing Officer (CNO), revealed the following outdated medications for injection (used to administer medications into a patient' joint), readily available for patient use, in 1 of 1 locked medication/supply cabinets:
- 1 of 1 10 ml vial Xylocaine with Epinephrine 1:100,000 Inj. expired 4/2018 and labeled as opened 9/1/2020
- 2 of 2 30 ml vials Xylocaine with Epinephrine 1:100,000 Inj. expired 8/1/2020.

2. Review of the hospital policy "Outdated or Unusable Medications," effective 09/2018, revealed in part, "... Outdated meds shall be checked monthly and reordered as needed. Outdates shall be pulled and stored from general stock until they can be processed...."

3. During an interview on 09/22/2020, at the time of the observation, the CNO acknowledged the clinic staff failed to remove the expired medication from the locked supply cabinet.

Based on observation, policy review, and staff interview, the Hospital x-ray staff failed to ensure staff secured 2 of 2 radiation exposure cord to not allow staff access into the x-ray rooms during completion of radiologic tests of patients (Emergency Room and NW Iowa Bone, Joint, & Sports Surgeons Clinic). The hospital x-ray staff reported completing an average of 250 x-rays per month in the emergency room and an average of 38 x-rays per week in the NW Iowa Bone, Joint, & Sports Surgeons Clinic. Failure to secure radiation exposure cords could allow staff access to the x-ray room while performing an x-ray procedure and exposing staff to unnecessary radiation.

Findings include:

1. Observations during tour of the emergency department on 09/23/2020 at 8:30 AM, with the Imaging Service Manager, revealed 1 of 1 unsecured exposure cord in 1 of 1 x-ray room the staff failed to secure, which allowed a staff member to enter approximately 4 feet into the x-ray room and still activate the x-ray machine.

Observations during tour of the NW Iowa Bone, Joint, & Sports Surgeons Clinic on 09/21/2020 at 3:40 PM, with the Imaging Service Manager, revealed 1 of 1 unsecured exposure cord in 1 of 1 x-ray room the staff failed to secure, which allowed a staff member to enter approximately 6 feet into the x-ray room and still activate the x-ray machine.

2. Review of the hospital policy "Radiation Guidelines - LRH [Lakes Regional Hospital] Personnel," dated revised 03/2020, revealed in part, "... Operator will stand in x-ray control cubicle during every exposure ... while in the Imaging Department." The policy lacked guidance related to radiation safety for staff while performing x-ray procedures.

3. During an interview on 09/21/2020 at 3:40 PM and 09/23/2020 at 8:30 AM, the Imaging Service Manager confirmed the 2 radiation exposure cords were not secured and would allow staff to access into the x-ray room during x-ray procedures.

I. Based on observation and staff interviews, the Hospital failed to remove outdated supplies from the Emergency Department (ED), acute care unit (Med/Surg), and the Surgery Services Department (OR). Failure to remove outdated patient supplies from the Hospital's ED, Med/Surg unit, and OR supplies, resulted in expired supplies remaining available for use in patient care, potentially resulted in staff using the expired items for patient care after the manufacturers' expiration date (the date after which the manufacturer will no longer guarantee the safety and quality of the supply) causing serious complications. The Hospital identified an average of approximately 677 patient visits per month in the ED, 11.6 average daily census on Med/Surg unit, and approximately 41 surgical procedures per month .

Findings include:

1. Observations during a tour of the Med/Surg on 09/21/2020 at 1:15 PM with the Chief Nursing Officer (CNO), revealed the following expired supplies:

Dirty Utility Room 2E Hallway
Cupboard
2 of 2 bottles, Bleach Germicidal Cleaner, expired 4/6/2020

Medication/Pyxis room
Treatment cart
a. 1 of 1 box, large Lavendar Nitrile gloves, expired 04/2020
b. 1 of 1 package, Vaseline gauze strip 3x9, expired 01/2020
c. 8 of 8 small packages, Povidone Iodine, expired 01/2020

Observations during a tour of the Surgical Services Unit on 09/22/2020 at 8:50 AM with the Director of Surgical and Anesthesia Services, revealed the following expired supplies:

Post Anesthesia Care Unit (PACU)
Supply room
a. 12 of 12 sterile packages, Spinocan Spinal Needle 22Ga. 4 3/4 inch Reference # 333315, expired 07/2020
b. 4 of 5 500ml bags, Lactated Ringers (LR), 3 expired 05/2020 and 1 expired 08/2020

Endo Room 1
4 of 4 opened and undated 1000ml, Baxter Sterile Water, label specifies to discard unused portion.

Observations during a tour of the ED on 09/22/2020 at 3:05 PM with the Director of ER and Outpatient Services revealed the following expired supplies:

Trauma Room
Crash cart/drawer 3
1 of 1 packages, Secondary IV Set tubing, expired 08/2020

Broselow Cart/bottom drawer
1 of 1 kit, Avera Umbilical Vessel Insertion Tray, expired 11/30/2019

2. During an interview at the time of the Med/ Surg Unit tour, the CNO revealed they expected the Med/Surg staff to check the supplies every month and remove any outdated supplies. The CNO acknowledged the Med/Surg staff failed to remove the expired supplies from the Med/Surg Unit. The CNO then acknowledged, that since the Med/Surg staff failed to remove the expired supplies from the department, the Med/Surg staff could potentially use the expired supplies for patient care.

During an interview at the time of the Surgical Services Unit tour, the Director of Surgical and Anesthesia Services revealed they expected the surgery staff to check the supplies every month and remove any outdated supplies. The Director of Surgical and Anesthesia Services acknowledged the sugery staff failed to remove the expired supplies from the Surgical Services Unit. The Director of Surgical and Anesthesia Services then acknowledged, that since the surgery staff failed to remove the expired supplies from the surgery department, the surgery staff could potentially use the expired supplies for patient care.

During an interview at the time of the ED, Director of ER and Outpatient Services revealed they expected the ED staff to check the supplies every month and remove any outdated supplies. The Director of ER and Outpatient Services acknowledged the ED staff failed to remove the expired supplies from the ED. The Director of ER and Outpatient Services then acknowledged, that since the ED staff failed to remove the expired supplies from the ED, the ED staff could potentially use the expired supplies for patient care.




II. Based on observation, document review and staff interviews, the Hospital surgical services staff failed to monitor and document temperature and humidity in the surgical suite (3 OR rooms, 1 Endoscopy Procedure Room, 1 Post Anesthesia Recovery Room, 1 decontamination room, 1 central sterilizer room, and adjacent sterile storage area). Failure to monitor temperature and humidity in the surgical suite (3 OR rooms, 1 Endoscopy Procedure Room, 1 Post Anesthesia Recovery Room, 1 decontamination room, 1 central sterilizer room, and adjacent sterile storage area) can potentially result in the buildup of humidity that contains bacteria that can fall onto sterilized surfaces, operating tools or possibly into an open wound potentially causing serious infections in patients. The Hospital administrative staff reported the surgical services staff performed an average of 42 surgery procedures per months.

Findings include:

1. Observations during a tour of the surgical suite on 09/22/2020 at approximately 8:15 AM, with the Director of Surgical and Anesthesia Services, revealed the surgical services staff lacked documentation that the surgical services staff checked the temperature and humidity in all areas of the surgical suite.

2. During an interview at the time of the tour, the Director of Surgical and Anesthesia Services confirmed that surgery staff did not do any type of temperature or humidity monitoring for 3 OR rooms, Endoscopy 1, the adjacent surgical instrument and endoscope cleaning room, and central sterilizer room. The Director of Surgical and Anesthesia Services also indicated the hospital based their surgical policies on the AORN (Association of peri-Operative Registered Nurses, a nationally recognized guideline agency) guidelines.

3. Review of the AORN Guidelines for Environment of Care, part 2, copyright 2018, revealed in part: "Relative humidity should be maintained within the HVAC [Heating, Ventilation, Air Conditioning] design parameters ... The temperature should be maintained within the limits recommended for each area (ie, unrestricted, semi-restricted, restricted) ... The HVAC system is intended to reduce the amount of environmental contaminates (eg, microbial laden skin squames, dust, lint) in the surgical suite."

4. During an interview on 09/22/2020 at approximately 9:15 AM, the Director of Surgical and Anesthesia Services acknowledged AORN standards require temperature and humidity monitoring in the surgical suite.

5. During an interview on 9/22/2020at approximately 9:40 AM, Director of Surgical and Anesthesia Services and the Director of Facilities acknowledged the lack of a formal process to monitor temperature and humidity in all areas of the surgical suite.




III. Based on observation, document review and staff interviews, the Hospital failed to ensure proper water temperature for 1 of 1 products used to disinfect surgical endoscopes. Failure to ensure proper water temperature could potentially result in the enzymatic detergents not functioning adequately and failing to remove all bacteria or other infectious agents from the endoscopes, potentially allowing the bacteria or other infectious agents to pass to the next patient, potentially resulting in the next patient developing a life-threatening infection. The hospital's administrative staff identified the surgical services staff performed an average of 16 endoscopies per month.

Findings include:

1. Observation on 09/22/2020, at approximately 9:00 AM, during the tour of the Surgical Services unit revealed the Sterile Processing Department (SPD) staff failed to clean the autoclave chambers according to the Manufacturer Recommendations (MFRs).

2. Review of documentation from the manufacturer's recommendations for Medivator Intercept Detergent revealed the SPD staff should use water with a temperature between 68 - 95 degrees Fahrenheit (F).

3. During an interview at the time of the tour, the Director of Surgical and Anesthesia Services revealed the surgical services staff do not test the water temperatures during the endoscope reprocessing while using Medivator Intercept Detergent. The surgical services staff let the water run until it is warm, fill the sink with appropriate amount of water, and measured Intercept and then the surgical services staff begin cleaning and processing the endoscope.

Based on observation, policy review, and staff interview, the Acute Care Hospital (ACH) failed to ensure that 1 of 1 infection preventionist/infection control professional responsible for the infection prevention and control program individual had been appointed by the Governing Body, and that the appointment was based on the recommendations of medical staff leadership and nursing leadership. Failure to comply with regulations could potentially hinder the infection prevention and control program including surveillance, prevention, and control of hospital-acquired infections, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and address any infection control issues, potentially causing harm to patients and their safety.

Findings include:

1. Review of Policies and Procedures revealed that no policy existed regarding an appointment for the Infection Preventionist by the Governing Board.

2. Review of the Medical Staff Meeting Minutes from August 2019 to September 2020 revealed that an appointment had not been made by the Governing Board for the position of Infection Preventionist.

3. Review of the Governing Board Meeting Minutes from August 2019 to September 2020 revealed that an appointment had not been made by the Governing Board for the position of Infection Preventionist.

4. Interview with Infection Preventionist on 09/23/2020 at 10:30 AM confirmed that the Infection Preventionist had not been appointed by the Governing Board.

5. Interview with Chief Nursing Officer (CNO) on 09/23/2020 at 02:10 PM confirmed that new regulations had been received from CMS and the appointment of the Infection Control Preventionist by the Governing Board had been discussed, however, the Infection Preventionist had not been appointed by the Governing Board.

6. Interview with Chief Medical Officer (CMO) on 09/24/2020 at 07:40 AM confirmed that the Infection Preventionist had not been appointed by the Governing Board.

Based on observation, document review, and staff interviews, the Hospital surgical staff failed to ensure Surgeon A, Surgeon B, Surgeon C, and Surgeon D completed the medical record with a pre-operative review and update to the History & Physical (H&P) for 4 of 5 reviewed patient charts (Patient #1, Patient #2, Patient #3, and Patient #4). Failure to assess the patient pre-operatively for any changes in their condition since the patient's H&P was completed might result in Surgeon A, Surgeon B, Surgeon C, and Surgeon D failing to detect a change in the patient's condition between the H&P examination and the surgical procedure, potentially resulting in the patient experiencing a life-treating complication during surgery. The Hospital's administrative staff identified the surgical staff performed an average of 42 surgical procedures per month.

Findings include:

1. Review of the "Medical Staff Bylaws and Rules and Regulations Policy," reviewed 07/01/2020, revealed in part, " ...refer to the policy: History and Physical Requirements for Surgical Patients".

Review of the "History and Physical Requirements for Surgical Patients" approved 10/2018, revealed in part "... an updated exam must be completed ... and placed in th record prior to the surgery or procedure ... If during the update, no changes in the patient's medical conditon have occured the practitioner may indicate ... the H&P was reviewed, the patient was examined and no change had occurred since the H&P was completed".

2. Review of medical records revealed the following:

a. Patient #1 underwent a surgical procedure on 07/13/2020. Surgeon A failed to document, prior to the surgical procedure, that they evaluated Patient #1 and Patient #1 could still safely undergo the surgical procedure.

b. Patient #2 underwent a surgical procedure on 08/06/2020. Surgeon B failed to document, prior to the surgical procedure, that they evaluated Patient #2 and Patient #2 could still safely undergo the surgical procedure.

c. Patient #3 underwent a surgical procedure on 09/02/2020. Surgeon C failed to document, prior to the surgical procedure, that they evaluated Patient #3 and Patient #3 could still safely undergo the surgical procedure.

d. Patient #4 underwent a surgical procedure on 09/22/2020. Surgeon D failed to document, prior to the surgical procedure, that they evaluated Patient #4 and Patient #4 could still safely undergo the surgical procedure.

3. During an interview on 09/22/2022 at 1:15 PM, the Director of Surgical and Anesthesia Services, verified that Surgeon A, Surgeon B, Surgeon C, and Surgeon D failed to document in the medical records, prior to the surgical procedure, for Patient #1, Patient #2, Patient #3, and Patient #4, that Surgeon A, Surgeon B, Surgeon C, and Surgeon D assessed the patient for changes between the completion of the H&P examination and the surgical procedures.