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Based on observation, document review, and staff interview it was determined that the Critical Access Hospital (CAH) failed to ensure that an adequate supply of an emergency medication for the treatment of malignant hyperthermia was available for use in the recovery room. This has the potential to affect all patients receiving surgical services.

Findings include:

1. On 07/16/19 at 12:00 PM, a tour of the Recovery area was conducted. The Malignant Hyperthermia Cart contained 2 vials of Ryanodex 250 mg (50 milligram/milliliter).

2. On 07/17/19 at approximately 10:00 AM, the Hospital policy "Malignant Hyperthermia ( reviewed by the Hospital: 03/21/17)" was reviewed. The policy references "Malignant Hyperthermia Association of the United States Guidelines".

3. On 07/17/19 at approximately 10:30 AM, the "Malignant Hyperthermia Association of the United States 2018 Guidelines" was reviewed. The current standard of practice for 2018 "recommends that centers stock a minimum of... three 250-mg vials of Ryanodex."

4. On 07/18/19 at approximately 10:00 AM, an interview with the Surgery Department Manager (E #9) was conducted. E #9 stated "We use the Malignant Hyperthermia Association Guidelines" and verbally agreed there should have been 3 vials of Ryanodex. E #9 stated "We initially stocked only 2 because the pharmacy only had that amount. We should have ordered more to be able to stock the recommended amount."

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Critical Access Hospital Sample Validation Survey conducted on 7/15-16/19, the surveyors find that the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see C231.

Based on observation, document review, and staff interview it was determined the Critical Access Hospital (CAH) failed to ensure patient care equipment was maintained and safe for usage. This has the potential to affect all patients receiving services through the Infusion Center, with an average monthly census of 200 patients.

Findings include:

1. On 07/16/19 at approximately 3:15 PM, a tour of the Infusion Center was conducted with the Corporate Compliance Officer (E #2). The area contained a "Bair Paws" (warming device for patients), which was available for patient use, with the last preventative maintenance completed on 01/07.

2. On 07/18/19 at approximately 9:00 AM, the Hospital policy titled "Medical Equipment Management" (reviewed by the Hospital: 4/26/2018) was reviewed. The policy states "All medical equipment used in the hospital must be evaluated by the Maintenance Department before use for possible inclusion into the Medical Equipment Management Program." The document titled "Clintech Corporation Electrical Safety and Preventative Maintenance Schedule for Paris Community Hospital" was also reviewed. The policy indicated, "Semi-Annual performance verifications on the following items:.... Patient Warmers."

3. On 07/16/19 during the tour of the Infusion Center, E #2 verified the above item's preventative maintenance date and stated, "Biomed should check the device and they have not."

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Critical Access Hospital Sample Validation Survey conducted on 7/15-16/19, the surveyors find that the facility does not comply with the applicable provisions of the 2012 Edition of the NFPA 101 Life Safety Code.

See the Life Safety Code deficiencies identified with K-Tags on the CMS Form 2567, dated 7/16/19.

A. Based on observation, document review, and staff interview it was determined the Critical Access Hospital (CAH) failed to ensure expired biologicals and medications were removed from the patient care area, potentially affecting all patients receiving care, current census of 2 patients.

Findings include:


1. On 07/16/19 at 12:00 PM, a tour of the Surgical Department was conducted with the Chief Nursing Officer (E #8) and the Surgery Department Manager (E #9). The malignant hyperthermia cart in the recovery area contained 10% calcium chloride 1 gram with an expiration date of 7/1/19.


2. On 07/19/19 at 4:40 PM, The CAH policy "Recalled/Discontinued/Returned/Unused/Expired Medications" (Original Issue Date" 6/9/05) was reviewed. The policy indicated "The hospital is responsible to manage, control and dispose of unused, expired or returned medications to keep patients safe and to prevent diversion...The unused, expired, and returned medications are stored separately on the nursing units until pharmacy is able to pick up for disposal and return."

3. On 07/15/19, at approximately 4:30 PM, an interview with E# 1 was conducted. E #1 verified the medication was expired and should have been removed from patient area.



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B. Based on observation, document review, and interview, it was determined the Critical Access Hospital (CAH) failed to ensure medications were managed in a manner that is safe and appropriate. This has the potential to affect all patients receiving services through the Surgery Department.

Findings include:

1. On 07/16/19 between 10:30 AM and 12:00 PM, a tour of the Surgical Department was conducted with the Chief Nursing Officer (E #8) and the Surgery Department Manager (E #9). In OR (operating room) #2 in the anesthesia cart the following was noted:
- two (2) open single use vials of Fentanyl Citrate 250 micrograms/milliliter.
- one (1)-3 milliliter syringe labeled Decadron milligram/milliliter (no patient label, no expiration date, no signature of who prepared the syringe)
- one (1)- 10 ml syringe labeled Propofol 10 milliliter with expiration of 07/15/19 at 7:00 PM (no patient label, no signature of who prepared the syringe)
- one (1)-3 milliliter syringe labeled Rocoronium Bromide 10 milligrams/milliliter (filled past the milliliter mark, no patient label, no expiration date, no signature of who prepared the syringe)

2. On 07/16/19 at approximately 2:00 PM, the Hospital policy "Preparation/Labeling and Dispensing of Medications" (reviewed by the Hospital: 4/2019) was reviewed. The policy stated ".... At a minimum all medications are labeled with the following especially whenever medications are prepared and not immediately administered: Drug name, strength, and amount (if not apparent from the container), Expiration date,... Expiration time, when expiration occurs in less than 24 hours..."

3. On 07/16/19 at approximately 2:30 PM, the Hospital policy "Medications Storage and Access" (last revised by the Hospital: 05/20/19) was reviewed. The policy stated "... Controlled medications are stored, distributed and accounted for according to all federal and state laws and standards of professional practice.... The destruction of partial doses of controlled medications must be done and recorded by two nurses or a nurse and a pharmacist."

4. On 07/16/19 during the tour, an interview with the Surgery Manager (E #9) and Certified Registered Nurse Anesthetist (E #11) was conducted. E #9 and E #11 confirmed the above findings and stated "the Fentanyl is single use and should have been wasted. The syringes of medications should not be have been left in the drawer and should have been disposed of properly."

A. Based on observation, document review and staff interview it was determined the Critical Access Hospital (CAH) failed to ensure policies regarding proper storage and disposal of sharps were followed to prevent possible injury and transmission of infection. This has the potential to affect all inpatients, outpatients and staff-current census 2.

Findings include:

1. On 7/15/19 at 1:15 PM, a tour of the Special Care Unit (SCU) was conducted. One (1) biohazard sharps container on the medication cart was over the required fill line.

2. On 7/15/19, an interview with the Corporate Compliance Officer (E#2) was conducted. E#2 visualized the sharps container and confirmed it was full and should be replaced.

3. On 7/15/19 at 2:00 PM, a tour of the Radiology department was conducted. One (1) biohazard sharps container in the Fluoroscopy room was completely full.

4. On 7/15/19 at 2:15 PM, an interview was conducted with the Quality Manager (E #1). E #1 visualized the sharps container and confirmed it was full and would be replaced.

5. The CAH policy dated 11/1/2016, titled, "Handling, Storage and Disposal of Biohazardous Waste" (last revised by the Hospital: 05/2019) was reviewed. Under "Policy:" bullet 3 "Sharps containers are replaced when container/receptacle is full."


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B. Based on observation, document review, and staff interview, it was determined the CAH failed to ensure all staff in the surgery department followed policies to prevent the possibility of transmission of infection, potentially affecting all patients receiving surgical services.

Findings include:

1. On 07/17/19 at between 9:40 AM and 10:39 AM, an observation of an endoscopic procedure was conducted with the Chief Nursing Officer (E #8). Pt #17 was admitted on 07/17/19 for an esophagogastroduodenoscopy and a colonoscopy. At the end of the procedures at approximately 10:40 AM, the general surgeon (E #12) removed the gown and gloves. E #12 then went to computer and started typing, without the benefit of performing hand hygiene.

2. On 07/17/19 at approximately 2:00 PM, the Hospital policy "Hand Hygiene" (last revised by the Hospital: 05/20/19) was reviewed. The policy stated "2) If hands are not visibly soiled, alcohol-based hand rubs are acceptable for routinely decontaminating hands in the following instances: ... after removing gloves."

3. On 7/17/19 during the observation, an interview was conducted with E#8. E #8 verbally agreed E #12 did not perform hand hygiene after removal of the gloves and it should have been completed.



C . Based on observation, document review, and staff interview it was determined the Critical Access Hospital (CAH) failed to ensure expired cleaning and patient care supplies were removed from the patient care area, potentially affecting all patients receiving care, current census of 2 patients.

Findings include:

1. On 07/15/19 at approximately 2:00 PM, a tour of the Radiology Department with the Quality Manager (E #1) was conducted. During the tour, three (3) ProVent Arterial Blood Samplings kits were found with an expiration date of 5/18/19 and one (1) 1000 ml (milliliter) glass" Evacuated Container" was found with an expiration date of 6/1/19.

2. On 07/15/19 at approximately 4:00 PM, a tour of the Physical Therapy Department with the Quality Manager (E #1) and the Physical Therapy Manager (E #5) was conducted. During the tour, two (2) 16 fluid ounces 70% isopropyl rubbing alcohol were found with an expiration date of 3/2019.

3. On 07/16/19 at 12:00 PM, a tour of the Surgical Department was conducted with the Chief Nursing Officer (E #8) and the Surgery Department Manager (E #9). In the pre-operative supply room there were bleach wipes with an expiration date of 6/19.

4. On 07/16/19 at 4:00 PM, the CAH policy "Receiving and Discarding Supplies" (original issue date: 1998) was reviewed. The policy required, "Materials held either in a using department or in the hospital stores will be reviewed periodically to determine any excess, obsolete, or expired quantities. Items determined to be in excess, obsolete, or expired shall be deleted from inventory by either returning to the vendor for credit, destroyed or donated to charity."

5. On 07/15/19, at approximately 4:30 PM, an interview with E# 1 was conducted. E #1 verified the patient care supplies and cleaning supplies were expired and should have been removed from patient area.

Based on observation, document review, and staff interview it was determined the CAH (Critical Access Hospital) failed to ensure the dietary staff followed established policies and procedures to maintain a sanitary food service environment. This has the potential to affect all patients, staff, and visitors receiving dietary food services in the hospital-current census-2.

Findings include:

1. On 7/16/19 at 9:30 AM, a tour of the Dietary Department was conducted with Quality Manager (E#1) and Dietary Manager (E#6). The following were noted: the "Freezer Temperature Log Form" was reviewed. The log lacked documentation of the freezer temperatures being recorded on 7/14/19 at 1:30 PM and 7/15/19 at 5 AM, 1:30 PM and 7:00 PM. The following expired food items were identified: three (3) 64 ounces of Alsace Carmel expired 3/2019; three (3)- 64 ounces of Alsace Chocolate expired 11/15/18; two (2)- 15 ounce containers ground ginger expired 1/16/18.

2. On 7/16/19 at 2:00 PM, the Hospital policy " First In First Out (FIFO) Policy" (last revised by the Hospital: 05/2019)was reviewed. The policy required, "Products are to be dated with an expiration date when received."

3 On 7/16/2019 at 2:50 PM, the Hospital Policy "Refrigerator/Freezer Temperature Log Policy" (last revised by the Hospital: 05/2019) was reviewed. The policy required, "temperatures are to be checked and documented three times daily at the following time: 5:00 AM; 1:30 PM and 7:00 PM.

4 On 7/16/19 at 9:30 AM,during the tour of the Dietary Department, E #6 explained all food items brought into the dietary department are labeled with the date the item was received not the expiration date. On 7/16/19 at 10:45 AM, an interview with the Dietary Manager (E #6) was conducted. E#6 reviewed the log and confirmed the temperature policy was not followed.

Based on document review and staff interview, it was determined for 3 of 6 (Pt #7, Pt #9, Pt #11) patients, the CAH failed to ensure blood administration records were accurate and complete. This has the potential to effect all patients receiving blood served by the CAH current census 2.

Findings include:

1. On 6/17/19 at 1:00 PM, the medical record of Pt #7, Pt #9 and Pt #11 were reviewed for compliance with blood administration documentation. The patient records lacked the required documentation:

a. Pt #7 was admitted to the infusion clinic on 4/29/19 with a diagnosis of Anemia. Pt #7 received one (1) unit of blood on 5/15/19. The "Blood Administration Record" lacked two (2) Registered Nurse (RN) initials verifying the Patient Group Type, Blood Bank/ Arm ID (identification), Donor Group/Type and Donor ID.
b. Pt #9 was admitted to infusion clinic on 4/29/19 with a diagnosis of Anemia. Pt #9 received one (1) unit of blood on 4/29/19. The "Blood Administration Record" lacked two (2) RN initials verifying the Patient Group Type, Blood Bank Arm ID, Donor Group/Type and Donor ID.
c. Pt #11 was admitted to inpatient 6/28/19 with a diagnosis of Anemia. Pt #11 received one (1) unit of blood on 6/28/19. The "Blood Administration Record" lacked two (2) RN initials verifying the Patient Group Type, Blood Bank Arm ID , Donor Group/Type and Donor ID.

2. On 7/17/19 at 4:00 PM, the CAH policy "Blood Administration " (reviewed by the Hospital: 4/26/2018) was reviewed. The policy required on page 3, "Both licensed individuals with documented competencies, will document information on the blood transfusion record."

3. On 7/17/19 at 4:40 PM, an interview with the Chief Nursing Officer (E #8) was conducted. E#8 reviewed the "Blood Administration Record" and confirmed lack of documentation and the inconsistency of documentation on the "Blood Administration Record." E #8 stated "The intention of the Blood Transfusion policy was 2 (two) registered nurses verify the required information and put their initials to indicate the safety check was completed."