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Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the Network Hospital staff reviewed the CAH's quality assurance plan, quality activities and provided input into areas which could be improved upon in accordance with 1 of 1 Network Agreements for Quality Assurance. The CAH administrative staff identified a census of 6 patients at the beginning of the survey. Failure to ensure the Network Hospital staff reviewed the CAH's quality assurance plan as well as quality activities and provided input into areas which could be improved upon in accordance with the Network Agreement for Quality Assurance could potentially result in the quality staff of the CAH failing to identify and act on patient care related issues, potentially cause adverse patient outcomes.

Findings include:

1. Review of the Network Agreement, dated April 11, 2008, revealed in part "...The HOSPITAL [Network Hospital] will have at least two (2) quality professionals visit the CAH to perform a quality of care audit, review the Quality Committee minutes, Peer review summary forms, Medical Staff minutes and then provide summary report and recommendations for the Medical Staff and Executive team...."

2. Review of CAH documentation revealed the lack of evidence showing the Network Hospital had at least two (2) quality professionals visit the CAH to perform a quality of care audit, review the Quality Committee minutes, Peer review summary forms, Medical Staff minutes and then provide summary report and recommendations for the Medical Staff and Executive team.

3. During an interview on 6/24/2021 at 8:15 AM, the Director of Quality confirmed the Network Hospital failed to have at least two (2) quality professionals visit the CAH to perform a quality of care audit, review the Quality Committee minutes, Peer review summary forms, Medical Staff minutes and then provide summary report and recommendations for the Medical Staff and Executive team.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the CAH's Medical Staff approved the updated blood bank agreement. Failure to ensure a current, approved blood bank agreement was in place could potentially interrupt the availability of blood products needed for emergencies resulting in patient harm and/or death. The Laboratory administrative staff reported the laboratory had 12 units of blood products available to CAH patients at the beginning of the survey.

Findings include:

1. Review of the "Blood Supply and Servies Agreement" Agreement, dated commencing 3/4/20, revealed the CAH's administrator signed the agreement on 3/4/20. The agreement lacked documentation the CAH's Medical Staff approved the agreement.

2. Review of the CAH's Medical Staff Meeting minutes for 1/20/20, 2/17/20, 3/16/20, and 4/20/20 , revealed the meeting minutes lacked documentation the CAH's Medical Staff approved the Blood Product Supply Agreement.

3. During an interview on 6/23/20 at 9:35 AM, the Chief Executive Officer confirmed the Blood Product Supply Agreement, dated commencing 3/4/20, lacked approval by the CAH's Medical Staff.

Based on observation and staff interviews, the Critical Access Hospital (CAH) failed to remove outdated supplies from the Family Medical Clinic. Failure to remove outdated patient supplies from the CAH's Family Medical Clinic resulted in expired supplies remaining available for use in patient care, potentially resulted in staff using the expired items for patient care after the manufacturers' expiration date (the date after which the manufacturer will no longer guarantee the safety and quality of the supply). The CAH identified 8,815 patients visits per year in the Family Medical Center from July 2020 - April 2021.

Findings include:

1. Observations during a tour of the Family Medical Center on 6/23/21 at 10:05 AM, revealed the following expired supplies:

Suite 1 Room C
a. 13 of 13 Puritan Sterile Nasophayngeal Foam Tipped Applicators (Q-tips), 13 expired 1/1/21

Suite 2 Room A
a. 1 of 10 ProAdvanatage Cotton Tipped Applicators (Q-tips), expired 10/2018
b. 5 of 10 MediChoice Cotton Tipped Applicators (Q-tips), 2 expired 5/30/21 and 3 expired 11/30/19

Suite 2 Room B
a. 4 of 15 Puritan Sterile Nasophayngeal Foam Tipped Applicators (Q-tips), 4 expired 11/2019
b. 1 box of 1 Halyard Sterile Nitrile Gloves -XL, expired 05/2021

Suite 2 Room C
a. 17 of 17 ProAdvanatage Cotton Tipped Applicators (Q-tips), 17 expired 10/2017

Suite 3 Room A
a. 1 box of 1 Kimberly-Clark Sterling Nitrile Gloves-Large, expired 1/2019

Suite 3 Room B
a. 4 of 9 Puritan Sterile Nasophayngeal Foam Tipped Applicators (Q-tips), 4 expired 6/1/21

Suite 7 Room A
a. 4 of 9 MediChoice Cotton Tipped Applicators (Q-tips), 4 expired 9/30/19

Suite 7 Room C
a. 2 of 4 bottles of Sodium Chloride 20 ml, 2 expired 2/2020

Suite 10 Room C
a. 3 of 15 Puritan Sterile Nasophayngeal Foam Tipped Applicators (Q-tips), 3 expired 5/1/20

Suite 11 Room C
a. 2 of 2 BBL Culture Swab Plus, expired 11/30/20

Storage Hallway Closet
a. 4 of 4 Pipet Curet-Endometrial Suction Curette - 3mm OD (used for obtaining a biopsy of the uterine lining for microscopic examination or culturing.), expired 2/15/21

2. During an interview at the time of the tour, the Clinic Nurse Manager revealed they expected the Family Medical Clinic staff to check the supplies every month and remove any outdated supplies. The Clinic Nurse Manager acknowledged the Family Medical Clinic staff failed to remove the expired supplies from the Family Medical Clinic. The Clinic Nurse Manager then acknowledged, that since the Family Medical Clinic staff failed to remove the expired supplies from the unit, the Family Medical Clinic staff could potentially use the expired supplies for patient care.

Based on document review, policy review, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 1 Pediatric Dentists (Pediatric Dentist J) selected for review received outside entity peer review by their Network Hospital to evaluate the appropriateness of diagnosis and treatment furnished to patients at the Critical Access Hospital, prior to reappointment to the medical staff. Failure to ensure all medical staff members received outside entity peer review, prior to reappointment, affects the CAH's ability to assure physicians provide quality care to the CAH patients. The CAH administrative staff identified the identified Pediatric Dentist J performed 172 surgical procedures from 7/1/2020 through 6/23/2021.

Findings include:

1. Review of the CAH's network agreement, effective 4/11/08, revealed in part " ... A [Network Hospital] designated quality professionals will review annually charts from the CAH. The purpose of these reviews is to identify opportunities for improvement in medical care and/or in the process of the delivery of care at CAH ...".

2. Review of a CAH policy titled "Medical Staff Peer Review," revised 1/2020, revealed in part "... The quality and appropriateness of diagnosis and treatment furnished by physicians are evaluated by the network hospital on an annual basis ..."

3. Review of the credential file and external peer review for Pediatric Dentist J revealed the medical staff approved her reappointment to the Medical Staff on 11/18/19. The Governing Board approved Pediatric Dentist J for reappointment to the Medical staff on 11/20/19. Pediatric Dentist J did not have any external peer results available for review prior to her reappointment.

4. During an interview on 6/24/21 at 8:05 AM, the Director of Quality reported the she did not find any external peer review results for Pediatric Dentist J. She acknowledged Pediatric Dentist J started performing surgical procedures in 2018 and the Director of Quality did not know why they failed to perform external peer review for Pediatric Dentist J. The Director of Quality confirmed she did not have any external peer review results for Pediatric Dentist J completed prior to her last reappointment to the Medical Staff.

Based on review of policies/procedures, meeting minutes, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the required group of professionals, including a physician and a mid-level provider, reviewed all patient care policies annually, in accordance with facility policy, for 9 of 28 patient care departments (Pulmonary Rehabilitation, Wound Care, Infusion/Chemotherapy, Sleep Study, Speech Therapy, Environmental Services, Nuclear Medicine, PET CT, and Echocardiogram). The CAH administrative staff identified a census of 6 patients at the beginning of the survey. Failure to ensure the required group of professionals reviewed all patient care policies annually 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 "Policy and Procedure Review," dated 6/5/18, revealed in part "... All patient care policies are reviewed on an annual basis by a group of professional personnel that includes one or more physicians and representatives of Orange City Area Health System (OCAHS) ...."

2. Review of a document titled "Critical Access Hospital Policy & Procedure Review," dated 6/22/21 through 8/28/21, revealed it lacked documentation that the required group of professionals, including a physician and mid-level provider, reviewed all policies for Pulmonary Rehabilitation, Wound Care, Infusion/Chemotherapy, Sleep Study, Speech Therapy, Environmental Services, Nuclear Medicine, PET CT, and Echocardiogram.

3. During an interview on 6/23/2021 at 3:45 PM, the Director of Quality verified the CAH lacked documentation that the required group of professionals, including a physician and mid-level provider, reviewed the policies for Pulmonary Rehabilitation, Wound Care, Infusion/Chemotherapy, Sleep Study, Speech Therapy, Environmental Services, Nuclear Medicine, PET CT, and Echocardiogram.

I. Based on observation, document review, and 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 hospital's administrative staff identified surgical services staff performed an average of 73 endoscope procedures per month during the fiscal year from July 2020 to June 2021.

Findings include:

1. Observations during a tour of the surgery department on 6/22/21 at approximately 8:20 AM in Operating Room (OR) #2 revealed 1 of 1 bottle ICUmedical 1000 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. Review of the manufacturer's instructions for the ICUmedical 1000 mL bottle of sterile water indicated in part, "Intended for use only as a single-dose or short procedure irrigation." "Unused portions should be discarded and a fresh container of appropriate size used for the startup of each cycle or repeat procedure." The hospital staff must discard any unused portions of the sterile water for irrigation after use on a single patient." The sterile water for irrigation did not contain any chemicals to prevent bacteria from growing in the sterile water once the hospital staff opened the bottles of sterile water for irrigation.

3. During an interview at the time of the tour, the Surgical Service Nurse Manager revealed that 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.

4. During an interview on 06/22/2021 at approximately 12:00 PM, the Surgical Service Nurse Manager verified they reviewed and confirmed the manufacturer's directions for the ICUmedical 1000 mL bottles of sterile water for irrigation. The Surgical Service Nurse Manager acknowledged the manufacturer did not support using the bottles of sterile water for irrigation for more than one patient.




II. Based on observation, document review and staff interview, the Critical Access Hospital (CAH) staff failed to store succinycholine (medication used to relax muscles during surgery) according to manufacturer's recommendations. Failure to ensure succinycholine is stored according to manufacturer's recommendations could potentially result in patients receiving a medication that does not work in the body as expected resulting in unintended consequences or side effects. The hospital's administrative staff identified surgical services staff performed an average of 73 endoscopic procedures per month during the fiscal year from July 2020 to June 2021.

Findings include:

1. Observations on 06/22/2021 at 8:20 AM, during a tour of the Operating Room (OR), with Surgical Services Nurse Manager indicated the succinycholine was monitored by pharmacy in both the OR Pyxis Medstations (an automated medication dispensing system supporting decentralized medication management) and anesthesiology cart.

2. During an interview on 06/21/2021 at 1:53 PM, the Pharmacy Director revealed succinylcholine is secured in a refrigerator in pharmacy. Once removed from the refrigerator, a date is placed on the bottle reflecting 30 days from the date that the pharmacy staff removed the bottle of succinylcholine from the refrigerator and placed the bottle in the OR Pyxis Medstations and in the anesthesiology cart until the cart is reviewed for outdates by a Pharmacy Tech every 30 days. The Pharmacy Director verified the CAH had no specific policy in regards to succinylcholine storage at room temperature. The Pharmacy Techs are in charge of outdates within the Pyxis Medstations and the anesthesiologist's cart and the pharmacy technicians discarded the succinylcholine (if unopened) every 30 days.

3. Review of the manufacturer's recommendations for the storage of succinycholine revealed in part: "Store in refrigerator 2 degrees - 8 degrees C [Celsius] (36-46 degrees F) ... the multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency."

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 1 open newborn medical record reviewed (Patient #3) and 2 of 4 closed newborn medical records reviewed (Patient #4 and Patient #5). Failure to administer erythromycin antimicrobial eye ointment within one 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 one 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 218 babies delivered July 1, 2019 - June 30, 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 "Guidelines For Administration Of Medications," revised 2/2021, revealed in part, "... to ensure the safe knowledgeable administration of medications prescribed by the physician.... Medications will be given ... [at] Specific times, as ordered by the physician ... Medication times may be changed or delayed at the discretion of the RN ... unless specifically ordered by the physician."

3. Review of newborn medical records revealed each record contained the standing physician orders for "erythromycin ophthalmic ointment to both eyes, within 1 hour of birth" and "Vitamin K , (Aquamephyton) 1 mg/0.5 ml injection, give within 1 hour of birth"

a. Review of Patient #3's open medical record revealed Patient #3 was born 6/21/21 at 1:11 AM. Patient #3's Medication Administration Record (MAR) documented erythromycin ophthalmic ointment was administered at 2:57 AM by RN S, 46 minutes beyond the "within 1 hour of birth" physician ordered time and Vitamin K (Aquamephyton) 1 mg was administered at 2:58 AM by RN S, 47 minutes beyond the "within 1 hour of birth" physician ordered time.

b. Review of Patient #4's closed medical record revealed Patient #4 was born 11/3/20 at 6:47 PM. Patient #4's Medication Administration Record (MAR) documented erythromycin ophthalmic ointment was administered at 9:09 PM by RN T, 1 hour and 21 minutes beyond the "within 1 hour of birth" physician ordered time and Vitamin K (Aquamephyton) 1 mg was administered at 9:09 PM by RN T, 1 hour and 21 minutes beyond the "within 1 hour of birth" physician ordered time.

c. Review of Patient #5's closed medical record revealed Patient #5 was born 10/15/20 at 5:02 PM. Patient #5's Medication Administration Record (MAR) documented erythromycin ophthalmic ointment was administered at 6:30 PM by RN U, 28 minutes beyond the "within 1 hour of birth" physician ordered time and Vitamin K (Aquamephyton) 1 mg was administered at 6:30 PM by RN U, 28 minutes beyond the "within 1 hour of birth" physician ordered time.

4. Review of CAH policy, "Skin to Skin Contact following Cesarean Section Births," effective 6/1/17, revealed in part, "Vit[amin] K and Eye ointment need to be given just prior to two hour time frame ..." The CAH Birth Center policy directed nursing staff to delay the administration of vitamin K and erythromycin ointment beyond the physicians written order to be administered within 1 hour of birth, and as directed in the statute and rules/regulations of the Iowa Administrative Code for the safety of the newborn.

5. During an interview on 6/22/21 at 11:00 AM, the Birth Center Manager revealed the Birth Center changed their policy to delay the administration of prophylactic eye ointment and vitamin K approximately 3 to 4 years ago when the Birth Center implemented the skin-to-skin policy. The nursing staff may delay the administration of these medications for 2 hours or more. The Birth Center Manager acknowledged she did not realize the physicians' order was specifically written to be administered within 1 hour of birth and that she was not aware of the Code of Iowa Statute and the Iowa Administrative Code guidance specific to the treatment of infant eyes.

6. During an interview on 6/24/21 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 document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to inform each patient of their visitation rights, including any clinical restriction or limitation on such rights, and the reasons for the clinical restriction or limitation for 1 of 5 registration areas (Physical Therapy/Occupational Therapy/Speech Therapy). Failure to inform each patient of their visitation rights could potentially result in limiting/restricting access of visitors to patients that infringed on their right to have a support person when they are provided any type of care, services, or treatment. The CAH's administrative staff identified 45,032 therapy procedures for Fiscal Year 2020 (July 1, 2019 - June 30, 2020).

Findings include:

1. Review of the CAH policy "Patient Bill of Rights & Visitation Policy", dated last 9/2020, revealed in part, "Patients shall have the right, subject to their consent, to receive the visitors they designate, including but not limited to: a spouse, support person, domestic partner (including a same-sex domestic partner), another family member, or a friend, and the right to withdraw or deny such consent at any time ..."

2. Observations during a tour of the patient registration areas on 6/22/21 at 12:10 PM revealed the CAH staff failed to post or otherwise make the patients' visitation rights information available to patients of the Physical Therapy/Occupational Therapy/Speech Therapy patient registration area.

3. During an interview on 6/22/2021, at the time of the Physical Therapy/Occupational Therapy/Speech Therapy patient registration area tour, the Director of Clinic Services confirmed the registration staff failed to have the Patient Rights and Responsibilities brochure, which contained the patient's visitation rights information, available to the patients and thus the visitation rights information was not available to any patients.

Based on observation, review of policies/procedures, and staff interviews, the Critical Access Hospital (CAH) Family Medical Clinic, Patient Appointment Center for Laboratory/Radiology, Physical/Occupational/ Speech Therapy(PT/OT/ST), Respiratory Therapy (RT) Department, and Infusion Clinic staff failed to protect all confidential patient information from unauthorized access 3 of 3 Outpatient Clinics. Failure to secure medical records against unauthorized access could result in identity theft and/or unauthorized disclosure of personal medical information. The CAH clinic administrative staff identified a combined average of 11,018 out-patient clinic visits from July 2020 to June 2021, sleep studies - 75, RT OP procedures - 65, Pulmonary Rehab procedures - 7 for the fiscal year July 1, 2019 - June 30, 2020.

Findings include:

1. Observation on 06/22/2021 at 1:10 PM, during a tour of the Physical/Occupational/Speech (PT/OT/ST) Department with the Therapy Department Manager, revealed 1 of 1 FAX machines located in an unlocked area of the patient registration area.

2. During an interview at the time of the tour of the Physical/Occupational/Speech (PT/OT/ST) Department, the Therapy Department Manager revealed the (PT/OT/ST) Department was staffed 7:00 AM - 5:00 PM Monday through Friday and locked when the department was closed. Housekeeping staff had access to the locked department and cleaned the areas before staff arrived. Fax machines are not secured and private patient information could be received before and after therapy hours. The Therapy Department Manager acknowledged this private and confidential patient information was not secured as hospital policy required.

3. Observation on 06/22/2012 at 11:00 AM, during a tour of the Radiology Department, 1 log book was left unsecured in an unlocked drawer in Ultrasound room 1 and 1 log book was unsecured left sitting on the counter of Ultrasound room 2 of the Radiology Department.

4. During an interview at the time of the tour of the Radiology Department, Ultrasound Technician R revealed the CAH radiology department staffed the Ultrasound area of the Radiology Department from 7:30 AM - 4:30 PM. Ultrasound Technician R acknowledged the ultrasound log books with private and confidential patient information was not secured after their shift as hospital policy required. Housekeeping staff cleaned the Ultrasound room after 6:00 PM without staff present.

5. Observation on 06/22/2021 at 12:10 PM, during a tour of the Patient Appointment Center (PAC) for Radiology, Laboratory, Pulmonary Rehab, Respiratory Therapy, and Infusion Clinic with the Director of Clinic Services revealed 1 of 1 FAX machine in the PAC area.

6. During an interview at the time of the PAC tour, PAC staff P and PAC staff Q revealed the PAC was staffed 7:00 AM - 5:00 PM Monday thru Friday. Fax machines are not secured and private patient information could be received before and after PAC hours. PAC staff P and PAC staff Q acknowledged the FAX machine with private and confidential patient information was not secured. Housekeeping staff had access to the locked department and cleaned the PAC area in the evening and on weekends when no staff was present.

7. Observation on 06/22/2021 at 1:14 PM, during a tour of the Infusion Clinic with the Infusion Supervisor, revealed 1 of 1 FAX machine located in the Infusion clinic.

8. During an interview at the time of the tour of the Infusion Clinic, the Infusion Supervisor revealed the Infusion Clinic was staffed from 8:00 AM - 4:00 PM Monday through Friday and was locked when the clinic is closed. Fax machines are not secured and private patient information could be received before and after clinic hours. The Infusion Supervisor acknowledged the FAX machine with private and confidential patient information was not secured. Housekeeping staff had access to the locked department and cleaned the clinic in the evening when no staff was present.

9. Observation on 06/22/21 at 2:00 PM, during a tour of the Respiratory Therapy department with Registered Respiratory Therapist (RRT) H, RRT I, and the Outpatient Nurse Manager, revealed a 2 drawer file cabinet containing approximately 100 orders for outpatient Respiratory Therapy, Sleep Study, and Pulmonary Rehab services which contained patient's medical information. The two drawer file cabinet did not contain a locking mechanism, potentially allowing unauthorized personnel access to confidential patient information.

10. During an interview on 06/22/2021, at the time of the tour, RRT H, RRT I, and Outpatient Nurse Manager revealed the Respiratory Office door was locked when the department was closed after 10:00 PM weeknights. RRT H and RRT I reported housekeeping had a key to the department and usually cleaned after the RRT left at 10:00 PM and the department was empty of staff. RRT H, RRT I, and the Outpatient Nurse Manager acknowledged unauthorized staff had access to unsecured confidential patient information contained in the two drawer unlocked file cabinet.

11. Observation on 06/23/2021 at 10:05 AM, during a tour of the Family Medicine Clinic (Acute care, Family Practice, and Surgery Clinics) with the Clinic Nurse Manager revealed 3 of 3 FAX machines in the Family Medicine Clinic.

12. During an interview on 06/23/2021 at approximately 3:00 PM, the Clinic Nurse Manager revealed the clinic hours are 7:30 AM - 5:00 PM Monday thru Friday and 8:00 AM - 12:00 PM on Saturday for Acute Care. Fax machines are not secured and private patient information could be received before and after clinic hours. Clinic Nurse Manager acknowledged the FAX machines with private and confidential patient information was not secured as hospital policy required. Housekeeping staff had access to the clinic and cleaned the clinic in the evening and on weekends when no staff was present.

13. During an interview on 06/23/2021 at approximately 4:00 PM Director of Clinic Services revealed the following:

a. PT/OT/ST received approximately 1 Fax per week after the therapy hours and had 1 unsecured FAX machine

b. PAC received approximately 105 Faxes from 3/22/21 - 6/22/21 after the clinic had closed and on weekends and had 1 unsecured FAX machine

c. Infusion Clinic received approximately 12 Faxes per month after the clinic had closed and had 1 unsecured FAX machine

d. Family Medicine Clinic, including Acute Care received approximately 317 Faxes per month after clinic hours and had 3 unsecured FAX machines.


14. Review of the policy "#HI.1.2, Scope of Service"revised 2/24/16, revealed in part, "Plan, maintain, and provide for the safeguard of the medical record and its contents against loss, damage, tampering, and unauthorized use. Protect the confidentiality of primary and secondary health records."

15. Review of the policy "# C-840, Subject: Confidentiality", revised 1/3/10, revealed in part, "Access to the medical record will be limited to staff involved [in the patient's care] ..."

Based on document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 3 Allied Health Professional selected for review (Allied Health Professional B), possessed the qualifications and had delineated surgical privileges approved by the Medical Staff and Board of Trustees to perform the role of first surgical assistant to assist in surgical procedures, according to the Medical Staff bylaws and CAH policies. The administrative staff identified Allied Health Professional B assisted in 81 surgical procedures, from 1/1/2021 to 6/22/2021.

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:

1. During an interview on 6/22/21, at 11:29 AM, the Surgical Services Nurse Manager reported Orthopedist A and Orthopedist O utilized Allied Health Professional B as a first assist for surgical procedures. Surgical Services Nurse Manager confirmed Allied Health Professional B assisted with all of Orthopedist A's surgeries on 6/22/21.

2. Review of the CAH Medical Staff Bylaws, approved by the Board of Trustees on 9/18/13, revealed in part "A practitioner may exercise only those clinical privileges specifically granted in accordance with these Bylaws and only privileges capable of being practiced in the Hospital may be requested ...".

3. Review of a CAH policy titled "Medical Staff Credentialing", revised 4/6/05, revealed in part "... Upon receipt of the copy of the completed application and verifications, the [CAH] Administration office personnel review the application and delineation of privileges requested for completeness ...".

4. Review of Allied Health Professional B's credential file revealed the privilege list, approved by Orthopedist A on 10/2/20, failed to identify any surgical privileges for Allied Health Professional B. The credential file revealed the Allied Health Professional Committee approved her reappointment to the Medical Staff on 12/20/20 and the Board of Trustees approved Allied Health Professional B for reappointment to the Medical staff on 1/20/21.

5. During an interview on 6/23/21 at 1:05 PM, the Director of Clinic Services acknowledged the medical staff appointment for Allied Health Professionals follows a different process than physicians, which includes approval by a Allied Health Professional committee and the Board of Trustees Body and confirmed the Medical Staff are made aware of the appointments but do not vote on approval.

6. During an interview on 6/23/21 at 1:23 PM, the Surgical Services Manager confirmed Allied Health Professional B's privilege list failed to identify privileges as a first surgical assist. She reported the surgery staff do not regularly check surgical privileges for scheduled procedures and the surgical department does not have a policy regarding the requirements for Allied Health professionals accompanying a physician to assist during a surgical procedure.

7. During an interview on 6/23/21 at 4:40 PM, the Quality Director acknowledged the concern for a provider assisting with surgical procedures without identified privileges and did not believe the CAH had a policy and procedure to define the requirements for Allied Health Professionals, assisting surgeons with surgical procedures for CAH patients.

8. During an interview on 6/24/21 at 8:45 AM, the Quality Director confirmed the CAH lacked a policy to address qualifications for a first surgical assist position and confirmed Allied Health Professional B's credential file failed to identify she held surgical privileges approved by the Medical Staff and Board of Trustees.

I. Based on document review, observation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 1 observed surgical staff (CST F) followed the manufacturer's instructions for use when cleaning endoscopes (flexible cameras physicians used to view inside a patient's body) after a colonoscopy for 1 of 1 patients observed (Patient #2). Failure to follow the manufacturer's instructions for use while cleaning endoscopes could potentially result in the cleaning process failing to remove all of the bacteria and debris in the endoscope, which could then potentially infect a different patient, since the staff members believed the scope was safe to use on another patient. The hospital's administrative staff identified surgical services staff performed an average of 73 endoscope procedures per month during the fiscal year from July 2020 to June 2021.

Findings include:

1. Review of the "OLYMPUS REPROCESSING MANUAL, Chapter 1, General Policy," provided by the Surgical Service Nurse Manager on 06/23/21 at approximately 1:00 PM revealed the following in part:

"The medical literature reports incidents of cross-contamination resulting from improper cleaning, disinfection, or sterilization ... An insufficiently cleaned, disinfected, or sterilized endoscope ... may pose an infection control risk to the patients ... All disinfection methods ... require thorough prior cleaning of the instrument being reprocessed. If the equipment is not adequately cleaned prior to disinfection/sterilization, these processes will be ineffective. Immediately after each patient procedure and before disinfection/sterilization, thoroughly clean the endoscope ..."

2. Review of the "OLYMPUS REPROCESSING MANUAL, Olympus TJF-Q90V, Chapter 5, Reprocessing the Endoscope (and related reprocessing accessories)," provided by the Surgical Service Nurse Manager on 06/23/21 at approximately 1:00 PM revealed the following requirements for staff when cleaning endoscopes:

a. "If the endoscope and accessories used in the patient procedure are not immediately cleaned after each patient procedure, residual organic debris will begin to dry and solidify, hindering effective removal and reprocessing efficacy."

b. "Follow the instructions provided by the detergent manufacturer regarding concentration, temperature, contact time and expiration date." "Immerse in freshly prepared detergent solution. Clean all external surfaces. Brush endoscope distal tip and, if applicable, brush and flush forceps-elevator."

c. "While immersed: Brush the insertion tube portion of the suction channel. Repeat until all debris is removed."

d. "While immersed: Brush the universal cord portion of the suction channel. Repeat until all debris is removed."

e. "While immersed: Brush the suction cylinder and instrument channel port. Repeat until all debris is removed."

f. "While immersed: Flush clean water through all channels (including auxiliary-water/elevator-wire, if applicable). Remove from water then flush air through all channels.


3. Review of the policy "Endoscope Cleaning and Reprocessing," effective 6/2005 and revised 6/7/11, revealed the CAH staff failed to include all of the steps required by the endoscope manufacturer, including immersion of endoscope in prepared detergent solution and during rinsing to immerse in clean water for agitation and flushing.

4. Observations on 06/22/21 at approximately 9:54 AM, in the GI room after Patient #2's colonoscopy, revealed CST F failed to keep the endoscope immersed while brushing ports, as required per the manufacturer's instructions.

5. During an interview at the time of the observations, CST F revealed they did not follow the required steps to safely clean the endoscope as recommended per the manufacturers.

6. During an interview with Surgical Service Nurse Manager, they acknowledged the steps outlined by the Endoscope Cleaning Guide should be followed to ensure effective disinfection/sterilization of the endoscopes.



II. Based on observation, document review, and staff interviews, the hospital's administrative staff failed to ensure 5 of 9 observed surgical staff (Anesthesiologist A, Physician B, CRNA D, PA B, and Physician G) wore head coverings which fully covered all of their 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 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 an average of 77 surgical procedures per month during the fiscal year from July 2020 to June 2021.

Findings include:

1. Observations on 06/22/21 at approximately 9:18 AM, during a Left Carpal Tunnel Release surgery (a surgical intervention that treats a tendon that has been pinched off causing numbness, muscle weakness, or atrophy of the hand) revealed Patient # 1 was undergoing a surgical procedure in operating room #2. Observations from inside the operating room revealed Anesthesiologist C and Physician A both wore a skull cap. The skull cap consisted of a cap covering forehead and central part of the surgical staff's hair. The skull cap did not cover the lower approximately 1 inch to 2 inches of surgical staff's hair on the sides of their heads and the hair on the back of their heads.

2. Observations on 06/22/2021 at approximately 9:33 AM, during a colonoscopy (an exam used to detect changes or abnormalities in the large intestine (colon) and rectum) revealed Patient #2 was undergoing a procedure in the GI Room (which is located within the surgical suite). Observations from inside the GI Room revealed CRNA D (Certified Registered Nurse Anesthetist) (a registered nurse with specialized training in administering medication to render a patient unconscious for surgery) wore a skull cap. CRNA D's skull cap consisted of a cap covering forehead and central part of the surgical staff's hair. The skull cap did not cover the lower approximately 1 inch to 2 inches of surgical staff's hair on the sides of their head and the hair on the back of their head. Physician G wore no hair covering during the procedure.

3. Observations on 06/22/2021 at approximately 11:29 AM, during an interview with the Surgical Services Nurse Manager, PA B (Physician Assistant) walked past the surveyor to operating room #2 wearing a skull cap. The skull cap consisted of a cap covering forehead and central part of the surgical staff's hair. The skull cap did not cover the lower approximately 1 inch to 2 inches of surgical staff's hair on the sides of their head and two to three inches of the hair on the back of their head.

4. During an interview on 06/22/2021 at approximately 12:00 PM, the Surgical Service Nurse Manager revealed the several of the surgical staff wear skull caps. The Surgical Service Nurse Manager reported the hospital followed the AORN (Association of Peri-Operative Registered Nurses, a nationally recognized guideline agency) guidelines statement for surgical attire.

5. Review of the AORN Guideline for Surgical Attire, copyright 2020, revealed in part, "The revision stated that the scalp and hair should be covered when entering the semi-restricted and restricted areas ..."

6. Review of the hospital's OR Surgical Attire, effective on 04/10/09 and revised on 7/1/19, revealed in part, "Surgical attire is worn to provide a barrier to contamination ... hair coverings." "All persons who enter the semi-restricted and restricted areas of the surgical suite should wear surgical attire ..." "Skullcaps that fail to cover side hair above the ears and hair at the nape of the neck should not be worn in the surgical suite."

7. During an interview on 06/24/2021 at approximately 9:57 AM, the Director of Patient Care acknowledged surgical staff was not covering their scalp and hair properly in semi-restricted and restricted areas within the surgical suites.

Based on review of documentation and staff interview, the Critical Access Hospital (CAH) administrative staff failed to evaluate all patient care services, including contracted services, offered at the CAH for 9 of 34 services (Environmental Services, Health Information Management, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, PET CT, Dexa Bone Scan, Ultrasound, and Computed Tomography [CT]. The administrative staff identified a current census of 6 inpatients at the beginning of the survey. 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's "Quality Assessment and Performance Improvement Plan," dated 4/21/21, revealed in part, "The QAPI plan applies to all departments, services, practitioners, and staff. Priorities will be directed by OCAHS strategic plan, as well as opportunities found for improvement related to care delivery and processes. All direct patient care departments will report quarterly to the OCAHS Quality Department. All other departments will report at least annually."

2. Review of the CAH's documents revealed the lack of documentation the CAH staff evaluated all patient care services, including contracted services, offered at the CAH (Environmental Services, Health Information Management, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, PET CT, Dexa Bone Scan, Ultrasound, and Computed Tomography [CT]).

3. During an interview on 6/23/21 at 3:45 PM, the Director of Quality verified the lack of documented evidence of evaluation of services for Environmental Services, Health Information Management, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, PET CT, Dexa Bone Scan, Ultrasound, and Computed Tomography [CT].