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2000 S MAIN

FAIRFIELD, IA 52556

PATIENT CARE POLICIES

Tag No.: C1006

Based on document review and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure the Laboratory Department follow the CAH's policy and procedure on the compliance of standard precautions usage during lab draws. Failure to observe the standard precautions could potentially result in the introduction of blood borne pathogens which can cause disease and other harmful effects. The CAH Administrative staff identified a current census of 16 patients on entrance.

Findings include:

1. Review of the CAH's policy, "Exposure Control Plan For Bloodborne Pathogens", effective 6/2022, revealed in part, " ...All employees must observe standard precautions to prevent contact with blood or other potentially infectious materials (OPIM) ... treat all blood and other potentially infectious materials with appropriate precautions such as: use gloves, masks...if blood or OPIM exposure is anticipated."

2. Review of the CAH's policy, "Laboratory", effective 12/2021, revealed in part, " ...Standard Precautions must be adhered to when obtaining, handling or processing ALL blood/body fluid specimens or potentially infectious materials."

3. Observation during a tour of the medical surgical floor on 7/25/2022 at 10:25 AM with Medical Surgical Registered Nurse (RN) Manager revealed Phlebotomist E was in ICU 125 room performing a lab draw on Patient #2. Phlebotomist E removed the middle finger from the glove on the left hand before performing the draw. Phlebotomist E used the uncovered middle finger to palpate vein in order to locate the vein before inserting the needle to obtain the blood.

4. During an interview on 7/25/2022 at approximately 11:30 AM with Medical Surgical RN Manager acknowledged Phlebotomist E should have followed standard precautions.

5. During an interview on 7/25/2022 at 2:45 PM with Infection Preventionist acknowledged all staff should follow the policy and procedures for standard precautions.

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 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 bacterial growing in the sterile water and potentially causing an infection in the next patient. The hospital's administrative staff identified a current census of 16 patients on entrance.

Findings include:

1. Observations during a tour of the surgery department on 7/26/2022 at approximately 8:45 AM during a demonstration of an endoscopic cleaning revealed 1 of 1 bottle ICUmedical 1000 milliliter (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) was not changed prior to the next endoscopic procedure.

2. Review of the manufacturer's instructions indicated in part... "Sterile Water for Irrigation, USP contains no bacteriostat antimicrobial agent or added buffer and is intended for use only as a single-dose or short procedure irrigation."

3. Review of the CAH's policy, "Infection Control: Single-Use Sterile Drugs and Devices" effective 2/2022 revealed in part, " ...Unused portions of single-use sterile drugs shall not be saved for later use."

4. During an interview on 7/26/2022 at approximately 8:45 AM with the Manager of Peri-Op Services, acknowledged 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.

PROTECTION OF RECORD INFORMATION

Tag No.: C1120

Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure the hospital staff kept patient medical information secure from unauthorized access. Failure to keep patient medical information confidential could potentially result in theft of a patient's information and potentially result in identity theft. The CAH's administrative staff identified a current census of 16 patients on entrance.

Findings include:

1. During a tour of the Central Sterile Core in the Surgical Services Department on 7/26/2022 at 8:45 AM with the Manager of Peri-Op Services and the Assistant Manager of Peri-Op Services revealed 45 patient labels attached to endoscopy decontamination record that were placed in an open bin. Each of these patients had under gone an endoscopic procedure (the insertion of a long, thin tube directly into the body to observe an internal organ or tissue in detail).

2. Review of the CAH's policy titled "HIPAA-Minimum Necessary," effective 12/2021, revealed in part "...the following categories of employees have no permitted access to confidential health care information ... Environmental Services."

3. During an interview on 7/26/2022 at 8:45 AM with the Manager of Peri-Op Services and Certified Surgical Technician (CST) A, revealed Environmental Services cleans the Central Sterile Core every night unsupervised. The Manager of Peri-Op Services acknowledged any patient information should be secured.

4. During a tour of the CAHs Professional Clinic on 7/26/22 at 4:00 PM with the Clinical Manager, revealed an unlocked cupboard behind registration desk 1, containing approximately 390 patient medical records.

5. During an interview at the time of the observation, the Clinic Manager acknowledged the cupboards containing the patient medical records remained unlocked after the clinic was closed and no longer staffed. Environmental Services cleans the Clinical area unsupervised after hours.

DESIGNATION OF QUALIFIED PRACTITIONERS

Tag No.: C1142

Based on observation, document review, and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure 1 of 1 Orthopedic Physician Assistant (Orthopedic PA D), who performed the role of first surgical assistant with Orthopedist F, possessed the qualifications and had delineated surgical privileges to perform the role of first surgical assistant, according to the Medical Staff bylaws. The administrative staff identified Orthopedic PA D assisted with 40 orthopedic procedures from 7/1/2021 to 6/30/2022. Failure to ensure the qualifications of all individuals providing assistance to surgical procedures of CAH patients could potentially result in the performance of care beyond their capabilities and placing the patient at risk for surgical complications and potential harm.

Findings include:

During a tour of the Surgical Department on 7/26/2022, at approximately 8:45 AM, with the Peri-Op Services Manager and Peri-Op Services Assistant Manager, observation revealed the department stored lists of the approved privileges for approved medical staff to perform or assist during surgical procedures. During an interview at the time, the Peri-Op Manager reported she receives a copy of approved privileges, which are available to surgical staff to ensure only authorized individuals perform the approved privileges. The Manager of Peri-Op Services identified Orthopedic PA D performs the role of first surgical assistant for Orthopedist F and confirmed the surgical staff do not have a list of privileges for Orthopedic PA D.

Review of the Bylaws of the Medical Staff, approved by the CAH Board of Directors on 12/6/2021, revealed in part "... All Medical and Surgical Assistants who request privileges to provide services in the Hospital under the direction and supervision of a Medical Staff member shall do so on an appropriate form approved by the Board of Trustees. Applicants shall submit information pertaining to their education background and their experience in the specialty in which the privileges are requested, providing dates, places and descriptions of duties performed and by whom supervised ... Every physician or AHP [Allied Health Professional] providing clinical services at this Hospital by virtue of Medical Staff membership or otherwise, shall be entitled to exercise only those clinical privileges specifically granted to him by the Board of Trustees ...".

During an interview on 7/27/22, at 1:40 PM, the Board/Medical Staff Services Manager reported when a credentialed physician wants to bring someone with to assist with patient care, she verifies a valid license and malpractice insurance, but the process does not include a request for privileges, education background and experience in their specialty. The Board/Medical Staff Services Manager confirmed they do not utilize a specific form or policy, approved by the Board of Trustees for staff brought in by a credentialed provider or require the applicant to submit information pertaining to their education background and experience, as identified in the Medical Staff Bylaws.

INFECTION PREVENT & CONTROL POLICIES

Tag No.: C1206

Based on observation, document review, and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure 2 out of 5 observed surgical staff wore head coverings which fully covered all of the staff's hair. Failure to wear head coverings that fully cover all hair could potentially result in bacteria, fungi, or viruses on the surgical staff members' hair contaminating the environment and potentially resulting in the patient developing a life-threatening surgical site infection. The CAH's's administrative staff identified the surgical services staff performed an average of 796 surgical procedures per month during the fiscal year from July 2021 to June 2022.

Findings include:

1. During an observation on 7/26/2022 at approximately 8:45 AM, during a colonoscopy (an exam used to detect changes or abnormalities in the large intestine (colon) and rectum) revealed Patient #1 was undergoing a procedure in the Endoscopy procedure room (which is located within the surgical suite). Physician B wore a skull cap which did not cover 3 inches of hair and Registered Nurse (RN) C wore a skull cap which did not cover 1 inch of hair during the procedure.

2. Review of the CAH's policy, "Surgical Attire," effective on 5/2020, revealed in part ... "All personnel must cover head and facial hair, including sideburns and nape of the neck, when in the semi-restricted and restricted areas."

3. During an interview on 7/26/2022 at approximately 8:45 AM, the Manager of Peri-Op Services acknowledged Physician B and RN C did not full cover their hair during the procedure. The Manager of Peri-Op Services further acknowledged the hospital followed the AORN (Association of Peri-Operative Registered Nurses, a nationally recognized guideline agency) guidelines statement for surgical attire.

4. Review of the AORN Guideline for Surgical Attire, copyright 2021, revealed in part, "Cover the scalp and hair when entering the semi-restricted and restricted area. [Recommendation]." " ... hair and skin can harbor bacteria that may dispersed into the perioperative environment."