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Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure the staff removed outdated medication and supplies from the Surgery area. Failure to remove outdated medications and supplies from the CAH's supplies, available for patient use, could potentially result in the staff using expired medications and/or supplies for patient use after the manufacturer's expiration date, potentially resulting in the staff using medication on a patient after the date which the manufacturer guaranteed the sterility and efficacy of the medication and supplies. The CAH administrative staff identified a total average of 97 surgical procedures per month for fiscal year 2020.

Findings include:

1. Observation during a tour of the Surgery Department on 10/19/21 at 8:45 AM revealed the following outdated supplies:

a. In OR Utility Room:
- 1 of 1 Covidien truclear dense tissue shaver plus, expired on 9/27/2021
- 2 of 2 Stryker rev cement mixing system, expired 9/1/2021
- 2 of 2 boxes of 100 non-sterile gloves size 6 1/2, expired 12/2019
- 2 of 2 box of 100 non-sterile gloves size 7, expired 11/2019
- 2 of 2 box of 100 non-sterile gloves size 7 ½, expired 11/2019
- 2 of 2 box of 100 non-sterile gloves size 8, expired 12/2019.

b. In OR Crash Cart:
- 2 of 2 Needle-Pro edge 21 guage (G) 1/12", expired 11/2018
- 3 of 3 BD Insyte autoguard 22 G 1", expired 11/201
- 3 of 3 BD Insyte autoguard 20 G 1", expired 01/2019
- 3 of 3 BD Insyte autoguard 24 G 3/4", expired 08/2018
- 3 of 3 Alaris IV injector, expired 11/2020
- 2 of 2 Centurion IV start kit, expired 07/31/2019
- 2 of 2 Comfort sampler blood gas system, expired 06/2018
- 2 of 2 Needle-Pro fixed needle insulin syringe, expired 7/2015
- 1 of 3 Mallinckrodt oral nasal tracheal tube 8mm, expired 06/2019
- 1 of 3 Mallinckrodt oral nasal tracheal tube 8mm, expired 06/2016
- 1 of 3 Mallindkrodt oral nasal tracheal tube 8mm, expired 10/2021
- 1 of 1 Mallinckrodt oral nasal tracheal tube 6mm, expired 4/2020
- 1 of 1 Mallinckrodt oral nasal tracheal tube 6.5mm, expired 3/2020
- 1 of 2 Mallinckrodt oral nasal tracheal tube 7mm, expired 08/2019
- 1 of 1 Raytec gauze sponge, expired 11/2019
- 1 of 1 Medi-Vak yankauer suction handle, expired 02/2017
- 2 of 3 Lubricating jelly 4.25 oz., expired 02/2018
- 1 of 3 Lubricating jelly 4.25 oz., expired 08/2017.

2. Review of CAH policies revealed the lack of a policy to address the management of the outdated supplies of the crash cart and utility room.

3. During an interview on 10/19/21 at approximately 9:45 AM, the Director of Surgical Services acknowledged several outdates in the surgical utility room and crash cart. The Director of Surgical Services also acknowledged the CAH did not have a policy for the management of outdated supplies of the crash cart, but did have a process for the management of outdated supplies in the utility room.

Based on document review and staff interview, the Critical Access Hospital (CAH) staff failed to ensure 2 of 2 Advanced Registered Nurse Practitioners (ARNP J and ARNP K), notified a physician when they admitted a patient to the CAH for inpatient care, for 2 of 4 open acute records reviewed (Patient #9 and Patient #10) and 1 of 1 closed acute patient records (Patient #8) and 5 of 5 skilled closed records reviewed (Patient #5, Patient #6, Patient #7, Patient #11, and Patient #12). Failure of ARNP J and ARNP K to notify a physician of the admission could potentially result in ARNP J's and ARNP K's patients receiving inadequate or substandard care because ARNP J and ARNP K did not discuss the patient's plan of care and medical needs with a physician. The CAH's administrative staff identified a current inpatient census of 5 inpatients at the beginning of the survey.

Findings include:

1. Review of the CAH's policy "Physician and Mid-Level Responsibilities," effective 6/1/18, revealed in part, "... Hospitalist Mid-Level will document discussion of admission from Physician On-Call or Primary Physician ...."

2. Review of the CAH's Medical Staff Rules and Regulations, approved 3/29/21, revealed in part, "Whenever a patient is admitted by a non-physician practitioner a physician is notified of the admission in a timely manner and no later than 8:00 AM the following morning ...."

3. Review of Patient #13's open acute medical record revealed that ARNP J admitted Patient #13 to the CAH on 10/15/21 for osteomyelitis (an infection of a bone). The medical record lacked documentation that ARNP J notified a physician that ARNP J admitted Patient #13 to the CAH for inpatient medical care.

4. Review of Patient #10's open acute medical record revealed that ARNP J admitted Patient #10 to the CAH on 10/18/21 for transurethral resection of the prostate (a surgical treatment for an enlarged prostate). The medical record lacked documentation that ARNP J notified a physician that ARNP J admitted Patient #10 to the CAH for inpatient medical care.

5. Review of Patient #8's closed acute medical record revealed that ARNP K admitted Patient #8 to the CAH on 9/13/21 for pulmonary emboli (blood clots in the lungs) and anemia. The medical record lacked documentation that ARNP K notified a physician that ARNP K admitted Patient #8 to the CAH for inpatient medical care.

6. Review of Patient #11's closed skilled medical record revealed that ARNP J admitted Patient #11 to the CAH on 8/18/21 for weakness. The medical record lacked documentation that ARNP J notified a physician that ARNP J admitted Patient #11 to the CAH for inpatient medical care.

7. Review of Patient #5's closed skilled medical record revealed that ARNP J admitted Patient #5 to the CAH on 7/3/21 for a quadricep tear (a torn muscle in the leg). The medical record lacked documentation that ARNP J notified a physician that ARNP J admitted Patient #5 to the CAH for inpatient medical care.

8. Review of Patient #6's closed skilled medical record revealed that ARNP J admitted Patient #6 to the CAH on 8/2/21 for a wound infection. The medical record lacked documentation that ARNP J notified a physician that ARNP J admitted Patient #6 to the CAH for inpatient medical care.

9. Review of Patient #7's medical record revealed that ARNP J admitted Patient #7 to the CAH on 9/16/21 for strengthening. The medical record lacked documentation that ARNP J notified a physician that ARNP J admitted Patient #7 to the CAH for inpatient medical care.

10. During an interview on 10/20/21 at 2:45 PM, ARNP K acknowledged that ARNP K does not notify a physician when they admitted the patients to the CAH for inpatient medical care.

11. During an interview on 10/20/21 at 2:50 PM, the Med-Surg/OB Manager reported they did not know the ARNPs had to notify a physician when an ARNP admitted a patient to the CAH for inpatient care.

Based on review of policies/procedures, meeting minutes, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure all patient care policies were reviewed annually by the required group of professionals, including a physician and a mid-level provider, in accordance with facility policy, for 8 of 24 patient care departments (Radiology including Nuclear Medicine, Positron Emission Tomography/Computed Tomography (PET/CT), Computed Tomography (CT), Dexa Scan, and Ultrasound; Obstetrics, Pulmonary Rehabilitation, Wound, Maintenance, Health Information Management, Specialty Clinic, and Radiation Oncology). The CAH administrative staff identified a census of 5 patients at the beginning of the survey. Failure to ensure all patient care policies were reviewed annually by the required group of professionals could potentially result in the CAH staff failing to identify patient care needs not addressed in the CAH policies/procedures.

Findings include:

1. Review of the CAH policy, "CAH Policy Procedure Development & Review," dated 5/12/21, revealed in part, "All policies and procedures of Shenandoah Medical Center and affiliated clinics related to patient care shall be developed, executed, and reviewed annually by the Critical Access Hospital Committee. The CAH Professional/Advisory Committee is comprised of: Medical Staff Member, One Mid-Level Practitioner ..."

2. Review of the "Critical Access Hospital Professional Advisory Committee Meeting Minutes," dated 8/20/20; 3/31/21; 6/30/21; and 9/29/21, revealed the Professional Advisory Committee failed to annually review and approve policies for Radiology including Nuclear Medicine, Positron Emission Tomography/Computed Tomography (PET/CT), Computed Tomography (CT), Dexa Scan, and Ultrasound; Obstetrics, Pulmonary Rehabilitation, Wound, Maintenance, Health Information Management, Specialty Clinic, and Radiation Oncology.

3. During an interview on 10/21/21 at 12:20 PM, the Executive Assistant confirmed the Professional Advisory Committee failed to annually review and approve policies for Radiology including Nuclear Medicine, Positron Emission Tomography/Computed Tomography (PET/CT), Computed Tomography (CT), Dexa Scan, and Ultrasound; Obstetrics, Pulmonary Rehabilitation, Wound, Maintenance, Health Information Management, Specialty Clinic, and Radiation Oncology.

Based on observation, document review, and staff interviews, the Critical Access Hospital (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 Administrative staff identified that the surgery staff performed an average of 23 endoscope procedures per month for fiscal year 2020.

Findings include:

1. Observations during a tour of the surgery department on 10/20/21 at approximately 8:00 AM in Encoscopy Suite #1 revealed 1 of 1 Baxter 500 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. During an interview on 10/20/21 at 8:00 AM, at the time of the tour, the Director of Surgical Services 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.

3. During an interview on 10/20/2021 at approximately 11:10 AM, the Director of Surgical Services reported that the Materials Management Supervisor contacted McKesson via phone and McKesson verified the Baxter 500 mL bottle of sterile water was for single patient use only. The Director of Surgical Services acknowledged the product manufacturer did not support using the bottles of sterile water for irrigation for more than one patient.

Based on observation, document review and staff interviews, Critical Access Hospital (CAH) administration failed to ensure 1 of 1 reviewed laboratory staff members (Laboratory Lead Technologist) had color vision proficiency prior to interpreting the results of fecal occult blood (blood in stool) tests for all laboratory and emergency nursing staff who read the results of the test. Failure to test all laboratory and nursing staff for color blindness before performing this test may result in staff misreading the results of the fecal occult blood test which could potentially adversely affect the diagnosis and treatment plan for patients. The CAH laboratory staff performed 58 fecal occult blood tests from 1/1/21 to present.

Findings include:

1. Observation on 10/20/2021 at 11:45 AM, during a tour of the Laboratory with the Laboratory Lead Technologist, revealed the laboratory staff utilized Beckman Coulter Hemoccult slides to check stool for occult blood.

2. During an interview at the time of the tour of the laboratory, the Laboratory Lead Technologist reported the laboratory and nursing staff identified a positive occult blood test result by identifying the slide turned the color blue. The Laboratory Lead Technologist acknowledged the laboratory and nursing staff interpreting the test would require the ability to identify the color blue.

3. Review of manufacturer's recommendations for Beckman Coulter Hemoccult slides, dated March 2015, revealed in part: "Because this test is visually read and requires color differentiation, it should not be interpreted by individuals with blue color deficiency (blindness)...."

4. Review of CAH policy "Lab - Hemoccult," dated 6/12/13, revealed in part, "Because this test is visually read and requires color differentiation, it should not be interpreted by individuals with blue color deficiency...."

5. Review of personnel files revealed the Laboratory Lead Technologist started working at the CAH on 6/20/18. The Laboratory Lead Technologisr's personnel file lacked documentation the CAH staff tested the Laboratory Lead Technologist for blue color vision proficiency upon hire or at any time after hire.

6. During an interview on 10/20/2021 at 11:45 AM, the Laboratory Lead Technologist confirmed the CAH administrative staff did not currently require color blind testing of laboratory or nursing staff and had not performed testing for color blindness on any of the CAH laboratory staff.

7. During an interview on 10/20/21 at 3:10 PM, the Executive Assistant Human Resources confirmed the CAH administrative staff did not currently require color blind testing of laboratory or nursing staff and had not performed testing for color blindness on any of the CAH laboratory and nursing staff.

8. During an interview on 10/21/2021 at 10:00 AM, the Emergency Room Manager reported the emergency room nursing staff identified a positive occult blood test result by identifying the slide turned the color blue. The Emergency Room Manager acknowledged the emergency room nursing staff interpreted positive occult blood test results. The Emergency Room Manager confirmed CAH administrative staff did not currently require color blind testing of emergency room nursing staff and had not performed testing for color blindness on any of the CAH emergency room nursing staff.

Based on document review and staff interviews, the Critical Access Hospital (CAH) Administrative staff failed to ensure obstetrical nursing staff administered newborn erythromycin ophthalmic (eye) ointment and aquamephyton (vitamin K) intramuscularly (IM) injection within 1 hour of birth as ordered by the physician for 1 of 4 closed newborn medical records reviewed (Patient # 2). Failure to administer erythromycin antimicrobial eye ointment within 1 hour of birth, as ordered by the physician, may increase the risk of the newborn for the development of sight-threatening gonococccal eye infection and/or potential blindness. Failure to administer Vitamin K intramuscularly within 1 hour of birth, as ordered by the physician, could potentially lead to the development of Vitamin K deficiency bleeding (VKDB), a condition in which newborn babies bleed uncontrollably because they do not have enough vitamin K in their blood, which could result in excessive blood loss and potential death of the newborn baby. The CAH administrative staff identified 89 babies delivered from January 1, 2020 through December 31, 2020.

Findings include:

1. Review of the "2013 Appendices to the Guidelines for Perinatal Services", Iowa Department of Public Health, revealed in part, "Appendix 8 ... Statute and Rules for Ophthalmia Prophylactics ... Code of Iowa 139 A.38: Medical treatment of newly born ... Each physician attending the birth of a child, shall cause to be instilled into the eyes of the newly born infant a prophylactic solution approved by the Iowa department of public health ... Iowa Administrative Code 641-1.7(139 A): Treatment of infant eyes ... Prophylaxis should be given after birth, but in no instance delayed for more than one hour after delivery ..."

2. Review of the CAH policy "Eye Treatment of the Newborn", effective 6/19/13, revealed in part, "...Ophthalmic ointment must be administered within the first hour of life...".

3. Review of 4 newborn medical records revealed each record contained the standing physician orders for "erythromycin 0.5% ophthalmic ointment ... both eyes ONCE ... To be given within 1 hour of birth" and "phytonadione (vitamin K) injectable 1 milliGRAM IntraMuscular ONCE, To be given within 1 hour ..."

4. Review of Patient #2's closed medical record revealed Patient #2 was born 9/19/2021 at 5:51 AM. Patient #2's Medication Administration Record (MAR) documented erythromycin ophthalmic ointment was administered at 8:00 AM by RN I, 1 hour and 9 minutes beyond the "within 1 hour of birth" physician ordered time and Vitamin K, (Aquamephyton) 1 mg was administered at 8:00 AM by RN I, 1 hour and 9 minutes beyond the "within 1 hour of birth" physician ordered time.

5. During an interview on 7/1/21 at 9:20 AM, the CNO acknowledged the nursing staff often delayed the administration of newborn vitamin K and erythromycin eye ointment beyond the physician ordered administration time and as outlined in the Iowa Administrative Code.

Based on review of records, policy, and staff interviews the Critical Access Hospital's (CAH) Administrative staff failed to ensure 2 of 2 patients (Patient #3 and Patient #4) cesarean section obstetrical medical records reviewed had a properly executed surgical informed consent. Failure to properly execute an informed consent may result in a patient not provided with information, explanations,options and consequences in a timely manner needed in order to make an informed consent for a caesarean section and could potentially result in misunderstanding and/or the patient having received an unwanted procedure. The CAH administrative staff identified 20 C-sections from 10/1/20 - 10/22/21.

Findings include:

1. Review of medical records revealed:

a. Patient #3's "Disclosure and Consent for Operation and Medical Procedures: Labor and Delivery" lacked the name of the doctor who explained the procedure, name of the doctor authorized to do the procedure, and failed to check the box that identified "Admission to labor and delivery with planned Cesarean Section".

b. Patient #4's "Disclosure and Consent for Operation and Medical Procedures: Labor and Delivery" lacked the time the consent was signed by Patient #4 and witnessed by RN G. The pre printed Providers Statement, "I have explained: The patient's condition, need for treatment, the procedure and the risks, relevant treatment options and their risks, likely consequences if those risks occur, and the significant risks and problems specific to this patient. I have given the patient/guardian an opportunity to ask questions about any of the above matter and to raise any other concerns, which I have answered as fully as possible. I am of the opinion that the patient/guardian understood the above information." lacked OB/GYN Surgeon H's signature, date and time.


2. Review of policy "Informed Consent" revised on 04/01/2018, revealed in part, "... to ensure that patients receive adequate information to knowledgeably evaluate treatment options, risks and benefits to give informed consent prior to ... performance of ... operative procedures ... All parts of the consent are completed and/or marked out ... the witness and the Witness shall sign, date and time the Informed consent ... shall sign, date and time the informed consent ... The Provider, the Patient and the Witness shall sign, date and time the informed consent."

3. During an interview on 10/19/2021 at 14:10 PM, the OB Supervisor verified the OB staff and surgeons are responsible to assure the surgical consents are completed prior to the patient signing and staff witnessing the signature. The OB Supervisor confirmed Patient #3 and Patient #4's surgical consent forms lacked required elements of documentation for a properly executed informed consent.

Based on observation, document review, and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure the CAH staff kept patient medical information secure from unauthorized access in 1 of 1 radiology reading office. The Radiology Manager identified approximately an average of 12 patient entries for each year for 2017, 2018, 2019 and 2020, and 9 patient entries for 2021 in 1 log book stored unsecured on an open shelf in the radiology reading room. Failure to keep patient medical information confidential could potentially result in theft of a patient's information and potentially result in identity theft or unauthorized release of a patient's private medical information.

Findings include:

1. Observations on 10/19/21 at approximately 2:15 PM, during a tour of the radiology reading room with the Radiology Manager, revealed 1 log book stored unsecured on an open shelf in the radiology reading room with approximately an average of 12 patient entries for each of 2017, 2018, 2019 and 2020, and 9 patient entries for 2021. The Radiology Manager identified Housekeeping staff have access to the unlocked radiology reading room when radiology staff were not present.

2. Review of the CAH policies revealed the lack of a policy to ensure that all locations where medical records are stored or maintained will ensure the integrity, security and protection of the records.

3. During an interview on 10/19/21 at approximately 2:15 PM, the Radiology Manager acknowledged the patient entries in the 1 unsecured log book contained patient information and Housekeeping staff have access to the radiology reading room. The Radiology Manager verified the Housekeeping staff do not have the need to know the patient information contained in the log book.

I. Based on observation, document review, and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure 1 of 2 OB/GYN (Obstetrics and Gynecology, OB/GYN A) physicians selected for review, held approved privileges prior to performing surgical procedures, following their initial appointment to the Medical Staff. Failure to ensure OB/GYN A had ongoing surgical privileges to perform surgical procedures could potentially result in the CAH staff allowing OB/GYN A to perform a procedure he lacked competence and skill to safely perform and could potentially result in a practitioner providing care beyond their capabilities and compromise safety of CAH patients. The CAH administrative staff identified OB/GYN A, appointed to the CAH Medical Staff on 7/22/2015, performed 49 InterStim surgical procedures from 10/1/20 to 10/22/21.

Findings include:

1. Review of the CAH Medical Staff by-laws, approved 3/29/19, revealed in part "... assure appropriate delineating of the clinical privileges that each practitioner may exercise in the Hospital ... Initial appointment and reappointments shall be made by the Board ... appointment to the Medical Staff shall confer ... only the such clinical privileges as have been granted by the Board ... Every practitioner practicing at this Hospital ... shall ... be entitled to exercise only those clinical privileges specifically granted to the practitioner by the Board."

2. Review of the CAH "Medical Staff Credentialing Policy", effective 6/3/20, revealed in part "It is the policy of the [Hospital] to collect, verify and assess per Bylaw requirements, information required for ... on-going reappointment for all applicants wishing to obtain privileges ... reappointment for periods not to exceed two-years contingent upon on-going approval ... Completed packets ... include the ... Delineation of privileges request form ...".

3. Review of the CAH Policy "Medical Staff Credentialing Procedure", effective 6/3/20, revealed in part, "When someone requests privileges at [hospital] send the following forms ... Privilege form to go with their particular specialty ... Reappointment applications: ... Check privilege list to see if they have requested new privileges ... Once the Board has signed off they now have privileges ... Mark privileges approved as determined by Medical Staff and Board... ".

4. Review of the CAH surgery schedule for 10/19/21 revealed OB/GYN A scheduled to perform 4 InterStim Placements (implantation of a programmable stimulator below the skin, which delivers low amplitude electrical stimulation via lead to the sacral nerve which is a treatment for urinary incontinence, high urinary frequency and urinary retention) surgeries at 7:30 A.M., 9:00 AM, 10:30 AM, and 11:30 AM.

5. Observation on 10/19/21 at 10:30 AM, revealed OB/GYN A performed an InterStim Placement surgery on Patient #1.

6. Review of OB/GYN A's credential file revealed a privilege list, effective 5/24/21 to 5/24/23, approved by the Governing Body on 5/24/21, failed to identify privileges to perform the InterStim procedure, which OB/GYN A performed per the CAH's surgery schedule at 7:30 AM, 9:00 AM, 10:30 AM, and 11:30 AM and observed being performed on Patient #1 at 10:30 AM.

7. During an interview on 10/20/2021 at 11:00 AM, the Executive Assistant acknowledged OB/GYN A's reappointment delineation of privileges failed to identify privileges to perform InterStim placement.

8. During an interview on 10/21/2021 at 11:45 AM, the CEO confirmed that OB/GYN A's reappointment credential file and list of privileges lacked documentation that the Medical Staff or CAH Governing Body approved OB/GYN A to perform the InterStim placement at the CAH, despite observations of OB/GYN A performing the procedure at the CAH on 10/19/21.





II. Based on observation, document review, and staff interviews, the Critical Access Hospital's administrative staff failed to ensure a current roster listing each practitioner's surgical privileges was available in the surgical suite and area/location where the scheduling of surgical procedures is done. Failure to maintain a current list of procedures in the surgical suite available for surgical staff to access and verify a provider's privileges prior to scheduling and performance of a procedure may result in a provider performing a procedure for which they are not privileged to perform due to lack of training, skills, quality, and or sufficient knowledge and may result in a poor patient outcome. The CAH administrative staff identified 1,532 surgical procedures performed from 10/1/21 through 10/22/21.

Findings include:

1. Review of CAH documents, including the Medical Staff Bylaws, Rules and Regulations, Board Bylaws, administrative policies, and surgical policies revealed lack of a policy or guidance to ensure a current roster listing each surgical practitioner's privileges was maintained and accessible in the surgery department to all surgical staff.

2. During an interview on 10/19/21 at 8:53 AM, at the time of the tour of the Surgical Department, the Director of Surgical Services reported she maintained a list of current surgical practioner's privileges in a file on her computer in her office. The Director of Surgical Services verified the list of surgical practitioner's privileges was not available at the scheduling desk or to any other surgical staff for their review prior to scheduling or performance of a procedure.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program individual (or individuals), had been appointed by the Governing Body, and that the appointment was based on the recommendations of medical staff leadership and nursing leadership. Failure to comply with regulations could potentially hinder the infection prevention and control program including surveillance, prevention, and control of hospital-acquired infections (HAI)s, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and address any infection control issues, potentially causing harm or death to patients and their safety. The CAH administrative staff identified an inpatient census of 5 patients upon entrance.

Findings include:

1. Review of the CAH's Policies and Procedures revealed that no policy existed regarding an appointment for the Infection Preventionist by the Governing Board.

2. Review of the Governing Board Meeting Minutes from 4/27/20 revealed in part, "... CNO presented ...[Staff B's name] started as Infection/Quality RN...." The meeting minutes lacked documentation that the Governing Board had approved Staff B's appointment to the Infection Preventionist position prior to Staff B starting work as the CAH's Infection Preventionist.

3. Review of the Medical Staff Meeting minutes from 5/20/20 revealed in part, "... CNO reported ... Quality: [Staff B's name] hired as new Infection/Quality RN...". The meeting minutes lacked documentation that the Medical Staff had approved Staff B's appointment to the Infection Preventionist position prior to Staff B starting work as the CAH's Infection Preventionist or prior to the CAH's Governing Board approving Staff B's appointment as the CAH's Infection Preventionist.

4. During an interview on 10//20/21 at 1:00 PM, the Executive Assistant provided the meeting minutes the CNO had informed her which contained the information regarding the new infection preventionist. The executive assistant acknowledged the minutes simply informed the Governing Board in April 2020 the name of the new Infection Preventionist and then a month later in May 2020 informed the Medical Staff the name of the new infection preventionist.

I. Based on observation, document review, and staff interviews, the hospital's administrative staff failed to ensure 1 out of 10 observed surgical staff wore head coverings which fully covered all of their hair. Failure to wear head and facial hair coverings that fully cover all hair could potentially result in bacteria, fungi, or viruses on the surgical staff members' hair entering the environment and potentially resulting in the patient developing a life-threatening surgical site infection. The hospital's administrative staff identified the surgical services staff performed approximately 1532 surgical procedures from 10/1/20 to 10/22/21.

Findings include:

1. Observations on 10/19/2021 at approximately 10:30 AM, during an InterStim placement (implantation of a programmable stimulator subcutaneously, which delivers low amplitude electrical stimulation via lead to the sacral nerve. A treatment for urinary incontinence, high urinary frequency and urinary retention) revealed Patient #1 was undergoing the procedure in the operating room. Observations from inside the operating room revealed CRNA Student C did not wear a hair covering during the procedure that completely covered the hair on the nape of the neck nor fully covered the beard or sideburns. Approximately 3 inches of hair was exposed at the back of CRNA's Student C's head and both sides of their face in front of the ears, extending below the bottom edge of the head covering. The surgical face mask did not fully contain the beard hair that extended bilaterally up toward the ears.

2. Review of the CAH's policy, "Surgical Attire Policy," not dated, revealed in part, "Hair is to be covered ... If beard is present, it will be covered with hair cover ...".

3. During an interview on 10/19/21 at approximately 8:31 AM, the Director of Surgical Services acknowledged CRNA Student C did not wear hair coverings that fully covered all hair. The Director of Surgical Services reported 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", published 5/30/17, revealed in part, "A clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn."





II. Based on document review and staff interview the Critical Access Hospital (CAH) administrative staff failed to ensure their system to identify and prevent transmission of infections and communicable diseases to patients included health exams every 4 years for hospital employees. The problem was identified for 3 of 3 employees selected for review (RN D, Surgical Tech E, and Laundry Staff F). Failure to identify infections and communicable diseases among hospital staff could potentially result in the transmission of a communicable disease to patients. The administrative staff identified 97 hospital staff employed over 4 years, provided service to CAH patients.

Findings include:

1. Review of personnel files revealed the following:

a. RN D's employee file revealed the CAH staff last performed a heath exam on RN D, prior to hire on 6/2016 (greater than the 4 years allowed).

b. Surgical Technician E's employee file revealed the CAH staff last performed a health exam on Surgical Tech E on 12/6/2007. (greater that 4 years allowed)

c. Laundry Staff F's employee file revealed the CAH staff last performed a health exam on Laundry Staff F on 9/19/2008. (greater than 4 years allowed)


2. During an interview on 10/21/21, at 8:40 AM, the Executive Assistant to Human Resources (HR) confirmed the CAH currently did not require a health exam every 4 years and was not aware of this requirement. The Executive Assistant to HR confirmed the CAH lacked a policy to define the health requirements for hospital employees, including the requirement to perform a health exam every 4 years.

Based on review of documentation and staff interview, the Critical Access Hospital (CAH) administrative staff failed to evaluate all patient care services for 4 of 24 patient care services (Speech Therapy, Sleep Study, Specialty Clinic, and Infusion). The CAH administrative staff identified a current census of 5 inpatients at the beginning of the survey, Speech Therapy had approximately 10 outpatients per day, and Specialty Clinic patient 7,467 patient visits for 2020. Failure to evaluate all patient care services could potentially result in the CAH staff's failure to identify, monitor, address, and improve patient care problems in each patient care area through the efforts of all involved patient care services.

Findings include:

1. Review of the CAH "Quality, Risk Management and Patient Safety" document, dated 5/12/20, revealed in part, "The goal of the quality program is to evaluate all patient care services and other services affecting patient health and safety."

2. Review of the Quality Assurance Committee Meeting minutes for 6/10/20; 12/17/20; 2/23/21; 5/18/21; and 9/24/21 revealed the meeting minutes lacked documentation that the CAH staff evaluated all patient care services offered at the CAH (Speech Therapy, Sleep Study, Specialty Clinic, and Infusion).

3. During an interview on 10/21/21 at 11:00 AM, the Education Coordinator and Executive Assistant verified the lack of documented the CAH's Quality Assurance Committee evaluated the Speech Therapy, Sleep Study, Specialty Clinic, and Infusion services offered to patients.

Based on review of policy/procedure and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure 1 of 1 abuse policy contained the required language in the regulations that all alleged violations involving abuse, neglect, exploitation or mistreatment, including injuries of unknown source and misappropriation of resident property, are reported immediately, but not later than 2 hours after the allegation is made, if the events that cause the allegation involve abuse or result in serious bodily injury, or not later than 24 hours if the events that cause the allegation do not involve abuse and do not result in serious bodily injury, to the administrator of the facility and to other officials (including to the State Survey Agency) for swing bed patients. The CAH administrative staff identified a monthly average of 7 skilled patients per month from 1/1/21 through 10/18/21. Failure to include the required language in the abuse policy could potentially prevent CAH staff from reporting alleged violations involving abuse to the CAH administrator and to other officials (including to the State Survey Agency) in a timely manner.

Findings include:

1. Review of the CAH's policy "Adult & Neglect, Identifying and Reporting," approved 10/14/20, failed to include the required language in the regulations that all alleged violations involving abuse, neglect, exploitation or mistreatment, including injuries of unknown source and misappropriation of resident property, are reported immediately, but not later than 2 hours after the allegation is made, if the events that cause the allegation involve abuse or result in serious bodily injury, or not later than 24 hours if the events that cause the allegation do not involve abuse and do not result in serious bodily injury, to the administrator of the facility and to other officials (including to the State Survey Agency).

2. During an interview on 10/19/21 at 1:30 PM, the Chief Nursing Officer (CNO) acknowledged the abuse policy failed to include the required language in the regulations that all alleged violations involving abuse, neglect, exploitation or mistreatment, including injuries of unknown source and misappropriation of resident property, are reported immediately, but not later than 2 hours after the allegation is made, if the events that cause the allegation involve abuse or result in serious bodily injury, or not later than 24 hours if the events that cause the allegation do not involve abuse and do not result in serious bodily injury, to the administrator of the facility and to other officials (including to the State Survey Agency).

Based on document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure physicians ordered specialized rehabilitation services for 3 of 5 reviewed closed swing bed patients (Patient #5, Patient #6, and Patient #7). Failure to ensure a physician ordered specialized rehabilitation services could result in swing bed patients not receiving specialized rehabilitation services appropriate to their medical condition. The CAH administrative staff identified an average of 7 swing bed admissions in Fiscal Year 2021.

Findings include:
1. Review of the CAH's policies/procedures revealed the CAH lacked a policy/procedure which addressed the requirement for a physician to order specialized rehabilitation services for swing bed patients.

2. Review of Patient# 5's closed medical record revealed the CAH staff admitted Patient# 5 for swing bed level care on 7/6/21. Advanced Registered Nurse Practicioner (ARNP) (a staff member with advanced training to diagnose and treat patients) ARNP J wrote an order on 7/6/21 at 1:08 PM for the Physical Therapist to evaluate and treat Patient # 5 and for the Occupational Therapist to evaluate and treat Patient # 5.

3. Review of Patient# 6's closed medical record revealed the CAH staff admitted Patient# 6 for swing bed level care on 8/5/21. ARNP J wrote an order on 8/5/21 at 1:36 PM for the Physical Therapist to evaluate and treat Patient# 6 and for the Occupational Therapist to evaluate and treat Patient #6.

4. Review of Patient # 7's closed medical record revealed the CAH staff admitted Patient# 7 for swing bed level care on 9/20/21. ARNP J wrote an order on 9/20/21 at 12:19 PM for the Physical Therapist to evaluate and treat Patient# 7 and for the Occupational Therapist to evaluate and treat Patient # 7.

5. During an interview on 10/192021 at 2:15 PM, the Assistant Chief Nursing Officer (CNO) acknowledged a physician did not write the therapy orders for Patient #5, Patient #6, and Patient #7. The CNO also acknowledged the CAH lacked a mechanism to ensure a physician wrote the therapy order for a Swing Bed patient.