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Tag No.: C0914

I. Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) Surgery Department and the Diagnostic Imaging Department staff failed to monitor or log the temperature of 3 of 4 blanket warmers specified for the use of warming blankets. Failure to ensure the CAH Surgery and Diagnostic Imaging staff used an approved and monitored blanket warmer could potentially result in patients receiving blankets that were too hot, resulting in unintended consequences or side effects including severe bodily burns. The CAH Surgery Department staff identified the surgical staff performed 1806 surgical procedures for the year, 2020. The CAH administrative staff identified the diagnostic imaging staff used warm blankets on approximately 10 patients per day.

Findings include:

1. Observations on 4/6/21 at approximately 2:30 PM, during a tour of Diagnostic Imaging with the Director of Diagnostic Imaging, revealed 2 Pedigo 2010 S blanket warmers being used for warming blankets. 1 warmer was located in an x-ray alcove with the regulator set at 150 degrees Fahrenheit with the outside thermometer showing 170 degrees Fahrenheit. 1 warmer was located in the Cat Scan (CT) room with the regulator set at 150 degrees Fahrenheit with the outside thermometer showing 220 degrees Fahrenheit. The Director of Diagnostic Imaging reported the blanket warmers were not monitored or logged daily for temperature control.

2. Review of the Manufacturer's Operating Instructions for the Pedigo warming cabinet revealed in part "A thermostat should be placed or recalibrated by placing a quality, thermal indicator ..."

3. Observations on 4/8/2021 at approximately 9:50 AM, during a tour of the Post Anesthesia Care Unit (PACU) with the Operating Room Manager, revealed a blanket warmer being used for warming blankets. The Operating Room Manager reported the blanket warmer in the PACU was not monitored or logged daily for temperature control. The Operating Room Manager revealed the blanket warmer located inbetween the 2 major Operating Rooms (OR) had a SIMS card to assist in monitoring the temperature.

4. Review of Guidelines for Perioperative Practice 2020 Edition-AORN revealed in part "Monitoring the temperature of warming cabinets is necessary to verify that temperature settings are maintained within specified limits. A malfunctioning cabinet can cause temperature variation ..."

5. During an interview on 4/8/2021 at 8:55 AM, the Director of Diagnostic Imaging acknowledged the blanket warmers were not monitored or logged for temperature accuracy and the CAH lacked a policy for monitoring the blanket warmers.

6. During an interview on 4/8/2021 at 9:58 AM, the Operating Room Manager acknowledged the blanket warmers were not monitored or logged for temperature accuracy and lacked a policy for monitoring the blanket warmers.




II. Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the 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 potentially result in the staff using the supplies for patient care that the item's manufacturer no longer warranted as safe and effective for patient care. The CAH staff reported providing an average of daily census of 9 patient encounters.

Findings include:

1. Observation while in the Critical Access Hospital (CAH) on 4/5/21 through 4/8/21 revealed the following:

On 4/5/21 at 1:20 PM in 2nd Floor Store Room revealed:

a. 9 of 9 boxes of 24 - 8 ounce cartons of nutrition supplement, expired on 4/1/21.


On 4/5/21 at 1:27 PM in Medical Surgical (Med-Surg) Storage Room revealed:

a. 1 of 2 packages IV extension tubing, expired 3/2021


On 4/5/21 at 3:25 PM in Med-Surg Medication Room revealed 1 of 3 IV start phlebotomy trays contained:

a. 4 of 4 yellow top BD vacutainer blood tubes, 3 expired on 12/31/20 and 1 on 2/28/21

b. 2 of 2 blue top BD vacutainer blood tubes, expired on 2/28/21

c. 1 of 1 27 G (gauge) 1/2" BD needle, expired on 1/2021


On 4/5/21 at 3:30 PM on Med-Surg medication cart revealed:

a. 2 of 2 Portex blood sampling kits, 1 expired on 3/2019; 1 expired on 7/2017

b. 1 of 1 non-breather mask, expired 11/2012

c. 1 of 1 adult nasal cannula non-flared nasal cannula, expired 10/2013

d. 2 of 2 oxygen supply tubing (7 foot) with mask, 1 expired 3/13/15; 1 expired 5/15/15


On 4/6/21 at 9:37 AM in Operating Room #2's Anesthesia Cupboard/Cart revealed:

a. 8 of 8 Ambu King airway masks, size 4 single use, expired 3/2021

b. 2 of 2 ICU Medinc IV connector, expired 2/2021

c. 1 of 1 Treva Albuteral Sulfate HFA inhalation, 200 meter inhalation 8.5 gram, expired 1/2021

d. 1 of 3 Teleflex laryngeal mask size 3, expired 6/28/20


On 4/6/21 at 3:35 PM in Laboratory revealed:

a. 398 of 400 BD Vacutainer blood tubes 8.5mL (milliliter) 16 x100 mm (millimeter) expired 1/31/20.


2. During an interview at the time of each tour, CNO, Operating Room Manager and Laboratory Director revealed they expected their staff to check the supplies every month and remove any outdated supplies. The CNO, Operating Room Manager and Laboratory Director acknowledged their staff failed to remove the expired supplies from their department. The CNO, Operating Room Manager and Laboratory Director acknowledged since their staff failed to remove the expired supplies from the department, their staff could potentially use the expired supplies for patient care.

RECORDS SYSTEM

Tag No.: C1110

Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) surgical staff failed to ensure Surgeon K and Surgeon L completed the medical record with a pre-operative review and update to the History & Physical (H&P) for 3 of 5 reviewed patient charts (Patient #3, Patient #4, Patient #5). 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 K and Surgeon L 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 CAH's administrative staff identified the surgical staff performed 1,806 surgical procedures for the year 2020.

Findings include:

1. Review of the "Medical Staff: Rules and Regulations," revised 8/2017, revealed in part, "A history and physical must be completed before surgery or another procedure that will require anesthesia ..."

2. Review of the "Medical Staff Bylaws," revised 8/2017, revealed in part "An updated examination of the patient, including any changes in the patient's condition, shall be completed and documented ... prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination is completed within 30 days ..."


3. Review of medical records revealed the following:

a. Patient #3 underwent a surgical procedure on 1/4/21. Surgeon L failed to document, prior to the surgical procedure, that they evaluated Patient #3, and Patient #3 could still safely undergo the surgical procedure.

b. Patient #4 underwent a surgical procedure on 2/1/21. Surgeon L failed to document, prior to the surgical procedure, that they evaluated Patient #4, and Patient #4 could still safely undergo the surgical procedure.

c. Patient #5 underwent a surgical procedure on 2/2/21. Surgeon K failed to document, prior to the surgical procedure, that they evaluated Patient #5, and Patient #5 could still safely undergo the surgical procedure.


3. During an interview on 4/7/21 at 2:15 PM, the Operating Room Manager, verified that Surgeons K and L failed to document in the medical records, prior to the surgical procedure, for Patient #3, Patient #4, and Patient #5, that Surgeons K and L assessed the patient for changes between the completion of the H&P examination and the surgical procedures.

PROTECTION OF RECORD INFORMATION

Tag No.: C1120

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the Obstetric (OB) Nursing staff kept patient medical information secure from unauthorized access in 1 of 1 OB Department FAX Machines and in 1 of 1 OB unlocked file cabinets. Failure to keep patient medical information confidential could potentially result in unauthorized access of a patient's personal/medical information and potentially result in unauthorized release of personal information. The CAH staff identified the FAX machine received Protected Health Information (PHI) on 21 OB patients of Provider A, from October 2020 to present. The CAH staff also identified 19 OB patient's PHI documents stored in 1 of 1 unlocked file cabinets

Findings include:

1. Review of the policy "Secure Storage and Transport of Health Information," dated 11/2016, revealed in part, "All protected health information (PHI) in paper or electronic form must be transported and stored in a secure manner to safeguard it against improper disclosure or loss"..."Protected health information means information that relates to any of the following: Past, present, or future physical or mental health condition of an individual ... The provision of healthcare to an individual".

2. Observations on 4/5/21 at 2:25 PM, during a tour of the OB department, revealed 1 of 1 FAX machines was located in an unlocked area of the OB nurses's station space, potentially allowing unauthorized personnel access to confidential patient information.

3. Observation on 4/5/21 at 2:30 PM, during tour of the OB department, revealed 19 sheets of purple paper in a folder located in an unlocked file cabinet identified by RN B as a "patient kardex" (a patient record keeping system preprinted or handwritten that is centrally located and contains patient PHI) with information that included but not limited to, patient name, age, provider name, estimated date of confinement (baby due date), gravida (number of times a woman has been pregnant), para (number of pregnancies reaching viable term including live births and stillbirths), and abortion (miscarriage or elective termination of a pregnancy); 5 of 5 papers contained information for April 2021 OB patients and 14 of 14 papers contained information for May 2021 patients.

4. During an interview on 4/5/2021 at approximately 2:30 PM, at the time of the tour, the Inpatient Services Manager and RN B revealed the FAX machine was not secured and private patient information, predominately OB-Prenatal office notes dictated by Provider A at remote clinic locations, throughout the prenatal course, are received, printed out, and remained on the FAX machine until OB staff retrieved the information. The OB staff retrieved the information received via this FAX machine "every couple of days." The Inpatient Services Manager and RN B acknowledged that the private patient information on the FAX machine was available for unauthorized personnel access as patient care staff, environmental services staff, and/or maintenance staff could enter the OB unit on a daily basis. Both the Inpatient Services manager and RN B acknowledged the private and confidential patient information was not secured as the hospital policy required.

5. During an interview on 4/5/2021 at approximately 2:30 PM, at the time of the tour, the Inpatient Services Manager and RN B revealed the file cabinet below the desk at the nurse's station was not secured and contained 19 sheets of paper with private PHI on upcoming OB patients, for the current and subsequent month; 5 of 5 for April 2021 and 14 of 14 for May 2021. The Inpatient Services Manager and RN B acknowledged that the private patient information in the file cabinet was available for unauthorized personnel access as patient care staff, environmental services staff, and/or maintenance staff could enter the OB unit on a daily basis. Both the Inpatient Services Manager and RN B acknowledged the private and confidential patient information was not secured as hospital policy requires.

INFECTION PREVENT & CONTROL POLICIES

Tag No.: C1206

Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the surgical staff performed hand hygiene before and after donning/doffing gloves for aseptic tasks, contacted inanimate objects, and patient contact during 2 of 2 observed patient surgical procedures, (Patient #1 & Patient #2). Failure to ensure surgical staff followed the approved Hand Hygiene Policy could potentially result in the surgical staff failing to remove bacteria which contaminated their hands during a procedure and could potentially transmitting bacteria to another patient, potentially causing a life-threatening infection. The CAH reported an average of 151 patient encounters per month in 2020.

Findings include:

1. Review of the "Hand Hygiene policy", reviewed on 4/2020, revealed in part, "... if hands/nails are not visibly soiled, a waterless hand sanitizer may be used. Hand hygiene should be consistently practiced: Before and after patient contract ...before and after glove use ... after handling potentially contaminated items or supplies (sic)."

2. Observation on 4/6/21 in Operating Room #2, beginning at 8:07 AM, during Patient #1's LEEP procedure (Loop electrosurgical excision procedure, a wire loop heated by electric current to remove cells and tissue in a woman's lower genital tract) revealed the following:

a. at 8:07 AM, prior to exiting Operating Room (OR) #2, removed their gloves and failed to perform hand hygiene.

b. at 8:11 AM, RN D removed their non-sterile gloves and failed to perform hand hygiene prior to opening the supply cupboard door, typing on the computer keyboard, and exiting OR #2 room.

c. at 8:13 AM, RN D failed to perform hand hygiene before donning sterile gloves to perform the perineal and vaginal skin prep of Patient #1.

d. at 8:43 AM, RN F removed their non-sterile gloves and donned new non-sterile gloves, without performing hand hygiene, then removed the non-sterile gloves without performing hand hygiene before exiting OR #2.


3. Observation on 4/6/21 at 9:04 AM, following Patient #1's LEEP procedure, revealed the OR staff took the surgical instruments to the decontamination room, where Sterile Processing Technician E removed their non-sterile gloves and failed to perform hand hygiene prior to starting the washer sterilizer.


4. Observation on 4/7/21 in Operating Room (OR) #1, beginning at 8:00 AM, during Patient #2's colonoscopy procedure revealed the following:

a. at 8:14 AM, RN G removed their non-sterile gloves and failed to perform hand hygiene prior to using a pen and charting on paper.

b. at 8:15 AM, RN G removed their non-sterile gloves and failed to perform hand hygiene.

c. at 8:16 AM, RN G removed their non-sterile gloves and failed to perform hand hygiene.

d. at 8:22 AM, RN G removed their non-sterile gloves and failed to perform hand hygiene.

e. at 8:25 AM, Surgeon I removed their gown and non-sterile gloves. Surgeon I failed to perform hand hygiene prior to opening the door to the endoscopy cleaning room and placing their gown in the laundry hamper. Surgeon I then proceeded to the computer using the keyboard and mouse to document.


5. During an interview on 4/08/21 at 9:57 AM, the CNO and Operating Room Manager acknowledged the OR staff failed to follow the CAH's hand hygiene policy.