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200 MAIN STREET

GUTTENBERG, IA 52052

PERIODIC EVALUATION

Tag No.: C0332

Based on review of policies/procedures, documentation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to provide a periodic evaluation of the total CAH program which included the number of patients served and the volume of services provided at the CAH for 22 of 22 services provided. Failure to include the number of patients served and the volume of services for each service provided at the CAH could potentially result in the CAH failing to meet the needs of their patients. The CAH staff identified a current census of 4 inpatients at the beginning of the survey.

Findings include:

1. Review of CAH Board Meeting Minutes from Fiscal Year 2019 revealed the meeting minutes lacked evidence the CAH staff included the total number of patient served and volume of services for each of the 22 CAH services provided.

2. During an interview on 2/12/2020 at 11:20 AM, the Director of Performance Excellence, verified the total program evaluation failed to include the number of patient served and the volume of services for each of the 22 services provided by CAH staff. The Director of Performance Excellence, acknowledged the CAH lacked a policy to address the periodic evaluation of its total CAH program.

COMPLIANCE FED, ST, AND LOCAL LAWS AND REGS

Tag No.: C0812

Based on observation and staff interview, the Critical Access Hospital (CAH) Administrative staff failed to post a notice in a place likely to be noticed by all individuals entering the dedicated Emergency Department that the CAH does not have a physician present in the hospital 24 hours a day, 7 days a week, and indicate how the CAH will meet the medical needs of any patient with an emergency medical condition. Failure to post a notice in a noticeable place in the Emergency Department that the CAH lacks 24/7 physician coverage interferes with a patient's ability to make an informed decision if the patient wants to receive care at the CAH. The Administrative Staff revealed approximately 1738 patients present to the emergency department per year seeking emergency medical treatment.


Findings Include:

1. Observations on 2/10/2020 at 10:00 AM, during a tour of the Emergency Department, revealed the CAH lacked a posted notice that the CAH did not have a physician present in the hospital 24 hours a day, 7 days a week.

2. During an interview on 2/10/2020 at the time of the tour, the Director of Ambulatory Services verified the CAH did not have a physician present in the hospital 24 hours a day, 7 days a week. The Director of Ambulatory Services confirmed the CAH lacked the required prominently displayed notice.

3. During an interview on 2/11/2020, the ER Manager confirmed the CAH did not have a physician in house 24 hours a day, 7 days a week and that the CAH staff failed to display a notice in a clearly visible area to ED patients that the CAH did not have a physician present in the hospital 24 hours a day, 7 days a week.

AGREEMENT FOR CRED. AND PRIV FOR TELEMEDICINE

Tag No.: C0872

I. Based on document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 2 of 2 applicable teleradiologists selected for review (Physician A and Physician B), received outside entity peer review prior to reappointment, to evaluate the appropriateness of diagnosis and treatment furnished to patients at the Critical Access Hospital. Failure to ensure all medical staff members received outside entity peer review, in the appropriate time frame, affects the CAH's ability to assure physicians provide quality care to the CAH patients. The CAH administrative staff identified Physician A provided care to 96 patients during fiscal year 2019 and Physician B provided care to 105 patients during fiscal year 2019.


Findings include:

1. Review of Physician A's credential file and external peer review revealed the medical staff approved Physician A's re-appointment to the medical staff on 3/20/18 and the governing body approved Physician A's re-appointment to the medical staff on 3/27/18. Physician A's credential file and external peer review information lacked evidence the CAH staff arranged for an external peer review of Physician A prior to the medical staff and governing body re-appointing Physician A to the medical staff.

2. Review of Physician B's credential file and external peer review revealed the medical staff approved Physician B's re-appointment to the medical staff on 7/19/18 and the governing body approved Physician B's re-appointment to the medical staff on 7/24/18. Physician B's credential file and external peer review information lacked evidence the CAH staff arranged for an external peer review of Physician B prior to the medical staff and governing body re-appointing Physician B to the medical staff.

3. During an interview on 2/13/20, at 8:10 AM, the Lab/Imagining Manager confirmed the CAH staff failed to have external entity peer review completed for Physician A prior to Physician A's re-appointment to the medical staff.

4. During an interview on 2/12/20, at 2:30 PM, the Revenue Cycle Manager confirmed the CAH staff failed to have external entity peer review completed for Physician B prior to Physician A's re-appointment to the medical staff.











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MAINTENANCE

Tag No.: C0914

Based on observation and staff interviews, the Critical Access Hospital (CAH) staff failed to remove outdated supplies from 1 of 1 inpatient units (Medical/Surgical Unit), the Surgery Department, and Emergency Department (ED). The CAH staff identified a census of 4 inpatients on entrance, 432 surgical cases per year in the Surgery Department, and 1738 patient visits in the ED per year. Failure to remove outdated patient supplies from the CAH's supplies, available for use in patient care, could potentially result 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), indicating the staff should not use the supplies for patient care.

Findings include:

1. Observations during a tour of the Med/Surg Unit on 02/10/2020 at 10:30 AM, revealed the following expired supplies:

Clean Supply Room
a. 1 of 1, Conveen Optima (male external condom catheter), 1 expired 02/2019

Crash Cart
a. 2 of 2, Lifeshield Primary Plum Y-Type Blood Sets (IV tubing to administer blood products), 2 expired 12/1/2019
b. 1 of 1, Sunmed Adult Introducer Bougie (airway management device--intubation aid), 1 expired 12/2019
c. 3 of 3, Mallinckrodt Intubating Stylets (a device for use in facilitating intubation of endotracheal tubes), 3 expired 01/2020

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

3. Review of the "Crash Cart Check and Documentation Policy," reviewed 2/2017, revealed in part. "Each crash cart is to be checked for intactness, a lock number, and outdates on weekly basis. At a minimum, once a month, each cart is opened and all supply contents are verified."

4. Observations during a tour of the Surgery Department on 02/11/2020 at 9:30 AM revealed the following expired supplies:

a. 6 of 6, Glidescope-- Small Glide Rite Single Use Stylet (assists in endotracheal tube control for fast intubation), 6 expired 01/09/2018
b. 7 of 7, Glidescope LoPro S1 Blade (a device used for better visualization for difficult airway management), 7 expired 10/14/2019
c. 7 of 7, Glidescope LoPro S2 Blade, 7 expired 09/29/2019
d. 9 of 9, Glidescope LoPro S4 Blade, 9 expired 11/24/2019

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

6. Observations on 2/10/2020 at 10:00 AM, during a tour of the Emergency Department revealed the following expired supplies:

Supplies at the ER Nurse's Station
Stemi-Kit (emergency kit with supplies utilized when a patient has a heart attack)
a. 1 of 1, Blue-top vacuette blood tube expired 9-8-2019
b. 1 of 1, Red-top BD vacutainer blood tube expired 11-30-2019
c. 1 of 1, Green-top BD vacutainer blood tube expired 12-31-2019

TNKase #2 Kit (emergency kit utilized when a patient has a stroke)
a. 3 of 3, clave connectors expired 08-2015
b. 2 of 2, 20G Introcan Safety IV Catheters expired 12-2013
c. 2 of 2, 18 G Introcan Safety IV Catheters expired 01-2014
d. 3 of 3, 22G 1 ½ 3 ml syringes with safety needle, 2 expired 07-2014, 1 expired 1-0-2014

Red cart
1 liter bottle Sterile Water for Irrigation expired 1-February 2020

ER Exam Room 5
1 of 2, Xpert Vaginal/Endocervical Speciman Collection Kit expired 01/2020

OB Precip Tray (used for emergency delivery of a baby)
a. 2 of 2, Size 8 Protexis sterile gloves expired 01-2020
b. 2 of 2, Size 7 ½ Protexis sterile gloves expired 01-2020
c. 2 of 2, Red-top BD vacutainer blood tubes expired 11-30-2019

Trauma 1 Room
Glass Cupboard
a. 1 of 2, 5% Dextrose and 0.45% Sodium Chloride for Injection 1000 ml expired 1 Jan 2020
b. 1 of 1, Adult Lumbar Puncture Tray 20G 3 ½ in Spinal needle expired 10-31-2019

7. During an interview on 02/10/2020, at the time of the tour, the Director of Ambulatory Services verified the outdated supplies in the emergency department and expected the ER staff to check the supplies every month and remove any outdated supplies. The Director of Ambulatory Services acknowledged the ED staff failed to remove the expired supplies from the ED, the ED staff could potentially use the expired supplies for patient care.

PATIENT CARE POLICIES

Tag No.: C1016

Based on observation, document review, and interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure the surgery staff changed the sterile water flush bottles after an endoscopy procedure for each patient, in accordance with the manufacturer's directions. Failure to change the flush bottle of sterile water after each patient could potentially result in bacteria growing in the sterile water and potentially causing an infection in the next patient. The Surgery Manager identified that the surgery staff performed an average of 268 endoscopy procedures per year.

Findings include:

1. Observations during a tour of the surgery department on 02/11/2020 at approximately 9:50 AM in Operating Room #2 (OR) revealed 1 of 1 bottle Hospira 1000 mL bottle of sterile water for irrigation connected to the endoscopy equipment (a nonsurgical procedure where a physician inserts a flexible camera into a patient's body to examine the digestive tract). Review of the manufacturer's instructions indicated in part, "intended for use only as a single-dose or short procedure. When smaller volumes are required the unused portion should be discarded." (The hospital staff must discard any unused portions of the sterile water for irrigation after use on a single patient. The sterile water for irrigation did not contain any chemicals to prevent bacteria from growing in the sterile water once the hospital staff opened the bottles of sterile water for irrigation.)

2. During an interview on 02/11/2020 at the time of the tour, the Surgery Manager revealed the surgery staff opened a bottle of sterile water for irrigation each day the surgical staff perform endoscopic procedures and connect the bottle of sterile water for irrigation to the endoscopy equipment. The equipment contained a one-way valve to prevent backflow between patients to prevent contamination of the source bottle. The surgery staff changed the flush tubing between the patient and the one-way valve after each endoscopy procedure, but did not change the tubing between the one-way valve and the bottle of sterile water for irrigation or replace the bottle of sterile water for irrigation between endoscopy procedures. The surgery staff would only discard the bottles of sterile water for irrigation once they completed all of the endoscopy procedures for the day or if the bottle ran empty.

3. During an interview on 02/11/2020 at approximately 1:40 PM, the Surgery Manager stated she reviewed the manufacturer's directions for the Hospira 1000 mL bottles of sterile water for irrigation. The Surgery Manager acknowledged the manufacturer did not support using the bottles of sterile water for irrigation for more than one patient.