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1600 DIAMOND STREET

ONAWA, IA 51040

EMERGENCY AND SUPPLIES

Tag No.: C0888

Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure the staff removed outdated supplies from the Emergency Department area. Failure to remove outdated supplies from the CAH's supplies, available for patient use, could potentially result in the staff using expired supplies for patient use after the manufacturer's expiration date, potentially resulting in the staff using the supplies on a patient after the date which the manufacturer guaranteed the sterility and efficacy of the supplies. The CAH administrative staff identified a total average of 308 patients that present to the emergency room in fiscal year from July 2021 to June 2022.

Findings include:

1. During a tour of the Emergency Department (ED) on 11/14/22 at 11:00 AM with the Director of Emergency Department Services revealed the following outdated supplies:

In the Pediatric Crash Cart:

a. 2 of 2 Covidien Shiley Intubating Stylet, 6 Fr/Ch (2.0 mm), expired on 5/17/2022.

b. 2 of 2 DuPont Tyvek Sheridan/HVT I.D. 6.0 mm O.D. 8.2 mm cuffed tracheal tube, expired on 8/14/22.

c. 2 of 2 DuPont Tyvek Sheridan/HVT I.D. 6.5 mm O.D. 8.9 mm cuffed tracheal tube, expired on 6/20/22.

d. 1 of 1 DuPont Tyvek Sheridan/HVT I.D. 7.0 mm O.D. 9.0 mm cuffed tracheal tube, expired on 4/5/22.

e. 2 of 2 DuPont Tyvek Sheridan/HVT I.D. 8.0 mm O.D. 10.9 mm cuffed tracheal tube, 1 expired on 6/26/22 and 1 expired 4/20.

f. 1 of 1 King LTS-D, 60-80 mL, expired on 11/1/22.

g. 1 of 1 ROM Plus Collection Kit, expired on 8/12/22.

h. 1 of 1 Encore Latex Textured Powder Free size 7 gloves, expired on 6/26/22.

i. 5 of 5 Nitrile Exam Sterile Gloves Medium, expired on 1/1/22.

j. 3 of 3 Nitrile Exam Sterile Gloves Large, expired on 12/1/21.

k. 2 of 2 Transystem Sterile Transport Swab, expired on 7/31/22.

l. 1 of 1 SuctionPro72 Singe Lumen Closed Ventilation Suction Catheter with T Connector, 570 mm length, 14 Fr 4.7 mm, expired on 4/1/22.

In the Adult Crash Cart:

a. 1 of 1 Yankauer Suction Instrument, expired on 9/4/22.

b. 2 of 2 Gammex Non-Latex size 7 ½ Surgical Gloves, expired on 7/15/22.

In the Intravenous (IV) Station cupboard:

a. 66 of 66 Novofine Autocover 30 gauge x 1/3" (8mm) needles, expired on 10/31/22.

b. 5 of 5 BD 1 mL Syringe Luer-Lok tip, 2 expired on 7/20, 1 expired on 3/31/22, 2 expired on 10/31/21.

2. Review of policy, "Outdates/Supplies" revealed in part, " ...Materials Management staff are responsible for checking outdates in the MM storeroom, Med/Surg, Surgery & ER storeroom, Med/Surg and ER crisis drawers and dressing carts." " ...the departments are responsible for checking outdates in all other areas."

3. During an interview on 11/14/22, at approximately 11:00 AM, the Director of Emergency Services verified each of the items were outdated. The Director of Emergency Services acknowledged the department did have a requirement to have staff check for outdated supplies and equipment, and that the quarterly cleaning and checking of supplies was not adequate to ensure no outdated supplies were available for patient use.

NUMBER OF BEDS

Tag No.: C0902

Based on observation and staff interviews, the Critical Access Hospital (CAH) staff failed to ensure their total number of beds available for inpatients did not exceed 25. Failure to ensure the CAH maintained a 25-bed count could potentially result in the CAH's ability to provide adequate care and services. The CAH administrative staff identified a census of 8 inpatients at the beginning of the survey.

Findings include:

1. Observation during tour of the inpatient care area with the Director of Medical/Surgical on 11/14/22 at 2:20 PM revealed 26 beds were available for inpatient use.

2. Review of policy, "Beds-Acute and Skilled Care," effective 11/24/20 revealed in part, " ...Acute and skilled (swingbed) level of care will be provided in the 25 hospital-type beds set up and staffed .... Pediatric cribs count in the 25 acute care beds."

3. During an interview on 1115/22 at 8:15 AM, the Director of Medical/Surgical acknowledged the hospital's total number of beds available for inpatients was 25 that included 1 crib stored in a former patient room being utilized as an office on the inpatient area of the medical surgical floor.

MAINTENANCE

Tag No.: C0914

Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure surgical staff routinely clean surgical equipment. Failure to clean surgical equipment based on manufacturer's recommendation could result in a potential risk to patient safety. The CAH administrative staff identified a daily average monthly census of 59 surgeries/procedures during the fiscal year from July 2021 to June 2022.

Findings include:

1. Review of policy, "Environmental Cleaning in the Surgical Practice Setting" effective 8/9/20, revealed in part, " ...All ...equipment in the surgical practice setting should be cleaned according to an established schedule ...sterilizers ..."

2. During a tour of the Surgical suite on 11/17/22 at approximately 8:30 AM with Director of Peri-Op Services revealed the Steris Amsco Century V116 and V120 sterilizers and the L&R Ultrasonic tabletop machine have not been on a routine cleaning schedule per CAH's policy and manufacturer's guidelines.

3. Review of Operator Manual, " Amsco Century Medium Steam Sterilizers" revealed in part, "the chamber drain strainer must be cleaned at least once a day ...the entire chamber should be wiped down and rinsed following any spills or other soilings."

4. Review of the Operator Manual, "Ultrasonic Cleaning System Tabletop & Recessed Models" revealed in part, " ...tank bottom is covered with soil particles ...empty, clean the tank with warm water and a non-abrasive cloth."

5. During an interview on 11/17/22 at approximately 12:00 PM with Director of Peri-Op Services acknowledged surgery staff have not cleaned the steam sterilizers or the ultrasonic tabletop cleaner per manufactures guidelines or CAH's policy.

PATIENT CARE POLICIES

Tag No.: C1016

I. Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure clinic staff removed and disposed of any outdated medical equipment and supplies. Failure to remove and discard of expired medical equipment and supplies based on manufacturer's recommendation could result in a potential risk to patient safety. The CAH administrative staff identified a daily average census of 5 inpatients that presented to the Medical Surgical floor during the fiscal year from July 2021 to June 2022.

Findings include:

1. During a tour while in the CAH's medical surgical unit on 11/14/2022 at approximately 2:20 PM with the Medical/Surgical Director revealed the following:

In the clean supply room revealed:

a. 11 of 11 Monoject ½ mL Insulin Safety Syringe 29G x 1/2", expired on 9/30/22.

2. During an interview at the time of each tour, Medical/Surgical Director acknowledged they expected their staff to check the supplies every month and remove any outdated supplies. This failure to remove the expired supplies from their department could result in potential use of the expired supplies for patient care.

II. 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 endoscope procedures 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 hospital's administrative staff identified surgical services staff performed an average of 36 endoscope procedures per month during the fiscal year from July 2021 to June 2022.

Findings include:

1. Observations during a tour of the surgery department on 11/16/2022 at approximately 8:20 AM in Procedure room revealed 1 of 1 bottle Baxter 1000 mL bottle of sterile water for irrigation connected to the endoscope equipment (a nonsurgical procedure where a physician inserts a flexible camera into a patient's body to examine the digestive tract).

2. Review of the manufacturer's instructions indicated in part... "The contents of opened container should be used immediately to minimize potential for bacterial growth and pyrogen formation, and the unused contents of opened containers must be discarded, since Sterile Water for Irrigation, USP does not contain an antimicrobial agent." 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.

3. During an interview at the time of the tour, Director of Peri-Op Services and Certified Surgical Technologist (CST) A stated the surgery staff opened the bottles of sterile water for irrigation each day for endoscope procedures that are scheduled and connected it to the 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 endoscope 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 endoscope procedures. The surgery staff would only discard the bottles of sterile water for irrigation once they completed all of the endoscope procedures for the day or if the bottle ran empty.

4. During an interview on 11/16/2022 at approximately 11:28 AM, with the Director of Peri-Op Services verified they reviewed and confirmed the manufacturer's directions for the Baxter 1000 mL bottles of sterile water for irrigation. The Director of Peri-Op Services acknowledged the manufacturer did not support using the bottles of sterile water for irrigation for more than one patient and was unaware of this practice.