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Based on staff interview, and document review, the Critical Access Hospital (CAH) administrativie staff failed to ensure that the "Simplified Diet Manual", Twelfth Edition, used as the basis for diet orders and for planning therapeutic diets was approved for use by the medical staff. Failure to have the diet manual approved by the medical staff could potentially result in the medical staff being uninformed in the interpretation of the therapeutic diets provided to patients and potential failure to meet a patient's nutritional needs. The CAH administrative staff identified approximately 536 patient meals are provided each month.

Iowa Administrative Code 481-51.20 (2) d. A current diet manual approved by the dietitian and the medical staff shall be used as the basis for diet orders and for planning therapeutic diets. The diet manual shall be reviewed, revised and updated at least every five years. Copies of the diet manual shall be readily available to all medical, nursing, and food service personnel.
Findings include:

1. Review of "Simplified Diet Manual", Twelfth Edition, published 2016 revealed in part, "Manual Review and Approval...diet manual is intended as a guide for the prescription and interpretation of diets or nutrtion plans...The manual has been reviewed and approved by the following:.....", lacked approval of medical staff in a list of approval signatures.

2. During an interview on 6/13/2019 at 9:50 AM, the Regulatory Specialist acknowledged the Simplified Diet Manual lacked Medical Staff approval and the Administrative staff had not been aware of this requirement.

I. Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) staff failed to remove outdated supplies from 1 of 1 Medical/Surgical Unit, 1 of 1 Emergency Department and 1 of 1 Urgent Care Clinic. Failure to remove outdated patient supplies from the CAH's supplies, available for use in patient care, could potentially result in staff using the expired items for patient care after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, indicating the staff should not use the supplies for patient care. The CAH staff reported upon entrance on 6/10/2019 at 9:45 AM the CAH's census was 6 patients, and reported approximately 263 patients presented to the emergency department for emergency care per month and approximately 170 patients presented to the urgent care department for urgent health care per month.

Findings include:

1. Observations on 6/10/19 at 10:25 AM, during a tour of the Medical/Surgical Unit, revealed 2 of 4 AliMed Bed & Chair Sensor Pads ( pad that senses patient movement off a chair/bed triggering a
monitor) expired 4/5/18 and 5/24/18.

During an interview on 6/10/19 at the time of the tour, Patient Care Coordinator confirmed the outdated supplies in the Medical Surgical supply closet and reported nursing staff should be checking the supplies monthly.

Review of manufacturer's recommendation revealed in part: ..."We recommend that the use of this product does not exceed twelve months ...."

2. Observations on 6/10/19 at 2:50 PM, during a tour of the Emergency Department, revealed the following expired supplies:

a. 1 of 1 Arrow Multi-Lumen CVC Kit, (used for intravenous access of large blood vessels), located in the Medication Room, expired 4/30/19
b. 1 of 1 PleurGuide Disposable Chest Tube Kit (a sterile small tube placed into pleural space of the lung to allow air or fluid to be drained), located on the Trauma Cart, expired 1-31-2019
c. 1 of 1 Aptima Urine Specimen Collection Kit, located on the Women's Health Cart, expired 5-31-2019

During an interview on 6/10/2019 at the time of the tour, the Director of Patient Care Services verified the outdated supplies in the emergency department. The Director of Patient Care Services reported it was the responsibility of the emergency nursing staff to monthly monitor and remove from use outdated patient care supplies.

3. Observations during a tour of the Urgent Care patient exam rooms on 6/9102019 at approximately 3:40 PM revealed 1 of 5 containers of KIMTECH WETTASK System of 40 wet task wipes (used for disinfection environmental surfaces and patient care equipment), container in exam room 3, expired 3/9/2019.

During an interview on 6/10/2019, at the time of the tour, the Clinic Nurse Manager verified the KIMTECH WETTASK disinfectant wipes in Urgent Care Room 3 were outdated.

4. During an interview on 10/10/2018 at 10:25 AM, the Regulatory Specialist revealed the critical access hospital failed to have a policy on checking for outdated supplies and removing outdated supplies from patient care.



II. Based on observation, policy review, and staff interview, facility staff failed to secure 15 of 15 large compressed air gas storage cylinders and 2 of 2 large compressed nitrogen gas storage cylinders in the Biohazard Waste Storage Room. All compressed gases are hazardous because of the high pressures inside the cylinders. Gas can be released deliberately by opening the cylinder valve, or accidentally from a broken or leaking valve or from a safety device. Escaping gas will propel the cylinder with enough force to penetrate cinder block walls. To prevent ballistic missile type injury all cylinders, even empty ones, should be handled as if they are pressurized. Failure to secure compressed medical gas cylinders increases the risk of knocking over the cylinder causing the valve to break and the cylinder becoming an uncontrolled rocket or pinwheel inflicting severe damage and/or injury. The CAH administrative staff identified a census of 6 patients upon entrance.

Findings include:

1. Observations on 6/13/19 at 8:57 AM, during the environmental tour, revealed 15 of 15 large unsecured compressed air gas cylinders and 2 of 2 large unsecured Nitrogen Gas cylinders in the Biohazard Waste Storage Room.

During an interview on 6/13/19, at the time of the observation, the Facility Services Manager acknowledged the 15 large compressed air cylinders and the 2 nitrogen gas cylinders should be secured. The Facility Services Manager stated they ran out of storage space in Medical Gas Storage and had to store the the additional medical gas cylinders in the adjacent Biohazard Waste Store Room.

2. Review of facility policy "Oxygen Supply," revision date 11/15, revealed the following in part "... Free standing cylinders must be chained or supported by a cylinder stand or cart ..."

3. During an interview on 6/13/10:04 AM, the Regulatory Specialist revealed the Oxygen Supply Policy covered the storage of all medical gas cylinders and verified the 15 compressed air cylinders and 2 nitrogen cylinders lacked the chains required to support the cylinders.

Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure that outdated medications were not available for patient use. Failure to remove outdated medications from the CAH's supplies, available for patient use, could potentially result in the staff using expired medications for patient use after the manufacturer's expiration date indicating staff should not use the medication for patient care. The hospital's administrative staff identified approximately 263 patients presented to the emergency department per month for emergency care.

Findings included:

1. Observations on 6/10/2019, during a tour of the emergency department medication room, revealed 3 of 3 outdated 30 ml vials of Bacteriostatic 0.9 % Sodium Chloride (utilized to reconstitute medication), expired 5/1/2019, readily available to be provided to patients, in a medication/supply drawer.

2. During an interview on 6/10/19, at the time of the observation the Director of Patient Care Services revealed it is the responsibility of the ER nurse to monitor for outdated medications/supplies outside of the medication dispensing cabinet.

The Director of Patient Care Services verified 3 of 3 Sodium Chloride vials were expired and should not be used.

3. During an interview on 6/13/2019, the Regulatory Specialist revealed there was not a hospital policy regarding the monitoring and removal of outdated supplies from patient care areas.

Based on observation, staff interview, and document review, the Critical access Hospital (CAH) administrative staff failed to ensure 1 of 1 observed Certified Registered Nurse Anesthetist (CRNA) cleansed the stopper on medication vials prior to removing the medication from the vial for 1 of 1 patient observed patients (Patient #1). Failure to cleanse the stopper could potentially result in the staff introducing bacteria, viruses, or fungi into the medication and then administering the contaminated medication to the patient. Administering contaminated medication could potentially result in the patient developing a life threatening infection. The CAH's administrative staff Regulatory Specialist identified the Critical Access Hospital staff performed an average of 1220 procedures requiring anesthesia from 7/1/2018 to 4/30/2019.

Findings include:

1. Observation on 6/11/2019 in the operating room (OR) during a surgical procedure for Patient #1 revealed the following:

a. At approximately 11:48 AM the CRNA (a nurse with specialized training to administer the medication used during surgery to ensure patients do not feel pain during surgery) removed the plastic cover on the top of the medication vial and removed 10 mg (milligrams) of Decadron (drug used for the prevention of postoperative nausea and vomiting) with a needle attached to a syringe. CRNA failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.
b. At approximately 11:48 AM the CRNA removed the plastic cover on the top of the medication vial and removed 4 mg (milligrams) of Zofran (drug used for the prevention of postoperative nausea and vomiting) with a needle attached to a syringe. The CRNA failed to cleanse the vial stopper with 70% alcohol prior to removing the medication from the vial.
c. At approximately 11:48 AM the CRNA removed the plastic cover on the top of the medication vial and removed 30 mg (milligrams) of Toradol (drug used to decrease swelling, pain, or fever postoperative) with a needle attached to a syringe. The CRNA failed to cleanse the vial stopper with 70% alcohol prior to removing the medication from the vial.

2. During an interview on 6/12/2019 at 2:15 PM, the CRNA acknowledged they failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medications from the vials
.
3. Review of the CAH policy Medication Administration approved 10/2018 revealed in part: ..."The vial rubber septum is to be disinfected with alcohol each time prior to piercing it ...."

Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure that the dietary staff prepared and served a therapeutic diet (a diet ordered as part of the patient's treatment for a disease or clinical condition, to eliminate, decrease, or increase certain substances in the diet, or to provide mechanically altered food when indicated) in accordance with the physician's written order. Failure to provide a therapeutic diet ordered by a physician may result in a patient receiving food that may be contraindicated with their medical needs.. The CAH reported the dietary department provides an average of 18 patient meals per day.

Findings include:

1. Observations on 6/11/19 at approximately 11:20 AM, a lunch tray identified by dietary staff as prepared for Room 211, Patient #2 contained a banana, chocolate pudding, skim milk, a small covered bowl, and a covered plate.

2. Review of document "CURRENT DIET LISTING", Date: 06/11/19 @ 1001 AM, revealed in part, 6/11/19 MEAL : LUNCH...211 ... [Patient #2's name]...Full Liquid Diet..." Hand written below computer generated printed diet orders.." 211-..ckn soup, baked pot, butter, banana, choc. pud., skim..."

3. Review of an untitled document which identified food and beverages availablefor patients to choose on a Full Liquid diet, failed to include chicken noodle soup, baked potato, and banana.

4. Review of document "Food & Nutrition: Therapeutic Diets", Revision Date: 6/06, revealed in part, "Therapeutic diets are prepared and served as prescribed by the attending physician."

5. Review of document, "Hospital Meal Service: Room Service Tray Delivery", Revision Dates 3/19, revealed in part, "Meal requests are made by phone...All requests are corrected based on patient's dietary restrictions at the time of the order...All patient meals are checked for accuracy..."

6. During an interview at the time of the observation, Dietary Aide Staff A reported she received a phone call from a nurse that patient #2, room 211, requested chicken soup, a baked potato with butter, a banana, chocolate pudding and skim milk for lunch.

7. During an interview at the time of the observation, the Assistant Supervisor of Nutrition and Food Services verifieed at the time Dietary Aide Staff A received the nurse generated phone call with Patient #2's food items request, while the patient remained on a Full Liquid Diet. The Assistant Supervisor of Nutrition and Food Services confirmed the dietary staff failed to checkfor accuracy of food items requested by the patient's dietary restrictions at the time of the order and prior to delivery of the tray.

8. During an interview at the time of the observation, the Regulatory Specialist acknowledged Patient #2 did not receive a Full Liquid Diet as ordered by Patient #2's physician.

Based on observation, document review, and staff interviews, Critical Access Hospital (CAH) administrative staff failed to ensure CAH staff tested the laboratory staff, nursing staff, and medical providers for color blindness so staff could correctly interpret the test results for occult blood (blood in the stool) for 1 out of 1 Laboratory Manager , 1 out of 1 clinic LPN (LPN B), and 1 out of 1 medical doctor (Physician F) reviewed. Failure to test laboratory staff, nursing staff, and medical providers for color blindness before performing this test may result in staff misreading the results of the hemoccult slide which could potentially adversely affect the diagnosis and treatment plan for patients. The CAH identified a census of 6 patients on entrance, and performed approximately 49 occult blood tests from 7/1/18 to 5/31/19.

Findings include:

1. Observation on 6/12/2019 at 11:00 AM during a tour of the Medical Clinic with the Clinic Nurse Manager, revealed Medical Clinic staff utilized Beckman Coulter Hemoccult Slides for testing of occult blood (blood in the stool).

2. During an interview at the time of the tour, the Clinic Nurse Manager confirmed the CAH staff did not test the nursing staff members for color blindness.

Interview on 6/10/2019 at 3:55 PM with Laboratory Manager revealed laboratory staff read occult blood results during laboratory hours. Laboratory Manager revealed the laboratory staff trained the nursing staff on how to read the occult blood test results if the nursing staff obtained the sample after the laboratory staff went home for the day. Laboratory Manager confirmed they did not test the laboratory staff for color blindness.

3. Review of personnel files revealed the following:
a. Review of LPN B's personnel file revealed the CAH staff did not test LPN B for color blindness.
b. Review of Physician F's personnel file revealed the CAH staff did not test Physician F for color blindness.
c. Review of Laboratory Manager's personell file revealed the CAH staff did not test Labortory Manager for color blindness. .

4. During an interview on 6/13/19, the Education and Quality Coordinator revealed the CAH staff did not perform color blindness testing on individuals who could interpret the hemoccult test results..

5. Review of the manufacturer's directions for the Beckman Coulter Hemoccult Slides, copyright 2015, revealed in part, "...The Hemoccult test is a rapid and qualitative method for detecting fecal occult blood (blood in the stool). Read results within 60 seconds, a blue color will appear on the slide after two drops of developer applied directly over the fecal (stool) smear if positive for blood...Because this test is visually read and requires color differentiation, it should not be interpreted by individuals with blue color deficiency (blindness)..."

6. Review of the policy "Hemoccult" effective date 4/23/14 revealed in part,"This test is read visually and requires color differentiation. It should not be interpreted by staff with blue color blindness...."