The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

CRAWFORD COUNTY MEMORIAL HOSPITAL 100 MEDICAL PARKWAY DENISON, IA 51442 Sept. 17, 2020
VIOLATION: BLOOD STORAGE Tag No: C0892
Based on review of the blood bank agreement, Medical Staff Meeting minutes, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the CAH's Medical Staff approved 1 of 1 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 14 units of blood products available to CAH patients at the beginning of the survey.

Findings include:

1. Review of the "Blood Supply and Services Agreement", dated 7/1/2012, signed by the Chief Executive Officer on 07/11/2012. The agreement lacked approval by the CAH's Medical Staff.

Review of the "Contract Extention Document," dated 7/1/2020, between the CAH and the Blood Supply Center, signed by the Chief Executive Officer on 06/17/2020 and the agreement lacked approval by the CAH's Medical Staff.

2. Review of the CAH's Medical Staff Meeting minutes 7/14/2020 and 8/11/2020 lacked evidence the Blood Bank Agreement Amendment was approved by the CAH's Medical Staff.

3. During an interview on 09/15/2020 at 1:20 PM, the Executive Assistant acknowledged the Blood Bank Agreement dated 7/1/2012 and the Contract Extention Document dated 7/1/2020 lacked approval by the CAH's Medical Staff.
VIOLATION: QUALITY ASSURANCE Tag No: C0340
Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 3 of 8 active physicians (Physician A, Physician B and Physician D) and 1 of 3 consulting physicians (Physician C) selected for review received outside entity peer review to evaluate the appropriateness of diagnosis and treatment furnished to patients at the Critical Access Hospital. Failure to ensure all medical staff members received outside entity peer review, affects the CAH's ability to assure physicians provide quality care to the CAH patients.

The CAH administrative staff identified the physicians provided care to an approximate number of patients from July 1, 2019 to June 30,2020 as follows:

- Physician A: 64 patients
- Physician B: 190 patients
- Physician C: 112 patients
- Physician D: 15 patients

Findings include:

1. Review of the CAH's network agreement, effective 11/1/10, revealed in part, "... The parties agree [Network Hospital], through participating members of its medical staff ... shall ... provide objective oversight and assistance to the CAH in reviewing the quality and appropriateness of the diagnosis and treatment furnished by CAH's doctors of medicine or osteopathy ..."

2. Review of a document titled "Agreement for Medical Review Services", dated 1/1/18, revealed in part " ... [Quality Improvement Organization] possess the professional capabilities to review health care procedures and services, including the review of the quality, necessity and appropriateness of medical services, and whereas, the [CAH] has the present need or contemplates the future need for the services which are or may be provided by [Quality Improvement Organization] ... The parties hereby enter into this Agreement for purposes of establishing a contractual relationship for the providing of medical review services ... [Quality Improvement Organization] hereby agrees to provide review services, as may be requested or required by participant, including peer review ..."

3. Review of external peer review completed for the applicable physicians selected for review revealed the following:

a. The Medical Staff approved Physician A for reappointment to the Medical Staff on 6/11/2019. The Board of Trustees approved Physician B for reappointment to the Medical Staff on 6/24/2019. Physician A's file lacked the results of any external peer review conducted prior to Physician A's reappointment to the Medical Staff.

b. The Medical Staff approved Physician B for reappointment to the Medical Staff on 3/13/2018. The Board of Trustees approved Physician B for reappointment to the Medical Staff on 3/19/2018. Physician B's file lacked the results of any external peer review conducted prior to Physician B's reappointment to the Medical Staff.

c. The Medical Staff approved Physician C for reappointment to the Medical Staff on 1/14/2020. The Board of Trustees approved Physician C for reappointment to the Medical Staff on 1/20/2020. Physician C's file lacked the results of any external peer review conducted prior to Physician C's reappointment to the Medical Staff.

d. The Medical Staff approved Physician D for reappointment to the Medical Staff on 8/14/18. The Board of Trustees approved Physician D for reappointment to the Medical Staff on 8/27/18. Physician D's file lacked the results of any external peer review conducted prior to Physicians D's reappointment to the Medical Staff.

4. During an interview on 9/16/20, at 9:40 AM, the Director of Care Integration identified one of her responsibilities included the coordination of external peer review for the CAH physicians. She acknowledged the CAH lacked a policy to define the external peer review process but reported she sends a minimum of one patient medical record to the Quality Improvement Organization for each physician in a 2 year credential cycle, and a summary of the evaluation is included in the re-appointment packet, provided to the Medical Staff and Board of Trustees for approval.

5. During an interview on 9/16/20, at 3:10 PM, the Director of Care Integration confirmed the CAH lacked documentation of external peer review, completed prior to their last reappointment, for Physicians A, B, C and D.
VIOLATION: AGREEMENTS FOR CREDENTIALING AND QLTY ASSURAN Tag No: C0870
I. Based on document review and staff interview, the Critical Access Hospital (CAH) failed to ensure the Network Hospital staff evaluated the CAH's credentialing process, in accordance with 1 of 11 Network Agreements for credentialing. The CAH staff reported 8 active, 35 courtesy/consulting, 62 telemedicine, and 24 allied health professional medical staff members. Failure to ensure the Network Hospital staff evaluated the CAH's credentialing process, in accordance with the Network Agreement for credentialing, could potentially result in the facility's Medical Staff and Board of Directors failure to credential all medical staff members per the facility's policy. The CAH administrative staff identified a census of 13 patients at the beginning of the survey.

Findings include:

1. Review of the Network Agreement, dated 11/1/10, revealed in part, "... The CAH and [Network Hospital] hereby enter in a Credentialing Agreement for purposes of providing credentials verification oversight. This will involve an analysis by the appropriate personnel at [Network Hospital] of CAH's credentialing process. This process results in the verification of credentials by the CAH for determination of privileges, which can be afforded at the facility. Credentialing process overview documentation shall be provided by [Network Hospital] to the CAH for purposes of evaluating its credentialing process ...."

Further document review revealed the lack of documentation the Network Hospital reviewed the CAH's credentialing process in accordance with the Network Agreement.

2. During an interview on 9/16/2020, at 11:45 PM, the Director of Care Integration confirmed their network hospital does not participate in any oversight or review of credentialing activities and have not for several years.




II. Based on document review and staff interview, the Critical Access Hospital (CAH) failed to ensure the Network Hospital staff annually reviewed the CAH's quality assurance plan and provided input into areas which could be improved upon in accordance with 1 of 1 Network Agreements for Quality Assurance. Failure to ensure the Network Hospital staff annually reviewed the CAH's quality assurance plan 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. The CAH administrative staff identified a census of 13 patients at the beginning of the survey.

Findings include:

1. Review of the Network Agreement, dated 11/1/2010, revealed in part ". . . The parties agree that [Network Hospital], through participating members of its medical staff or other personnel designate by [Network Hospital], shall meet with the CAH's QA (Quality Assurance) representatives no less than on an annual basis to provide objective oversight and assistance to the CAH in reviewing the quality and appropriateness of the diagnosis and treatment furnished by CAH's doctors of medicine or osteopathy and to assist the CAH to implement its QA Plan, to review findings under the CAH's QA Plan and to propose improvement plans and/or recommend corrective action ..."

2. Review of CAH documentation revealed the lack of evidence showing the Network Hospital staff annually reviewed the CAH's quality assurance plan and provided input into areas which could be improved upon per the Network Agreement.

3. During an interview on 9/16/2020, at 11:45 AM, the Director of Care Integration confirmed the Network Hospital does not review the CAH's quality assurance plan or provide input into into areas which could be improved upon per the Network Agreement.
VIOLATION: MAINTENANCE Tag No: C0914
Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) staff failed to remove outdated supplies from 1 of 1 inpatient birthing units (New Beginnings Birth Center). Failure to remove outdated patient supplies from the CAH's supplies, available for use in patient care, could potentially result in staff using the expired items for patient care after the manufacturers' expiration date, indicating the staff should not use the supplies for patient care. The CAH administrative staff identified approximately 122 deliveries in fiscal year 2019.

Findings include:

1. Observations on 9/14/20 at 2:40 PM, during a tour of the New Beginnings Birth Center, revealed the following expired supplies:

OB Store Room:
a. 1 of 1 Koala 1 PC 5000 Intrauterine Pressure System catheter, expired 2016-08
b. 1 of 1 "Pediatric Chest Tube Set" with following supplies bagged together in large clear plastic bag:
1 of 3 Argyle Trocar Catheter - Use by 2020-03
2 of 3 Argyle Trocar Catheter - Use by 2017-12
4 of 4 Povidone -Iodine Swabsticks - Exp 9/2017
1 of 1 4-0 Ethicon silk suture - Exp 7-2018
1 of 1 Bard-Parker #10 Protected disposable Scalpel - Exp 2016-12
1 of 1 8.5 Fr Fuhrman Pleural/Pneumopericardial Drainage Set - Exp 2018-11-12
1 of 1 Curity-Non Adherent Strips - Exp 2020-04
1 of 1 BD Heimlich Chest Drain Valves - Exp 2020-08
c. 7 of 7 SonoSite Eclipse probe covers - Exp 2020-01-16

Annex Room:
a. Bin 1 10 of 10 Red Top blood tubes - Exp 12-12-19
Bin 2 5 of 11 Red Top blood tubes - Exp 2017-07
5 of 11 Red Top blood tubes - Exp 2018-8-01
1 of 11 Red Top blood tubes - Exp 2020-7-11

b. Modified Crash Cart - Baby - IV drawer
1 of 1 BD Spinal needle 22G 3.50 in - Exp 2020-05
1 of 1 Scalpel disposable #11 - Exp 2020-08

2. During an interview on 9/14/2020 at the time of the tour, the Director of Medical Unit and OB and the CNO verified the outdated supplies in the New Beginnings Birth Center. The Director of Medical Unit and OB reported OB staff nurses checked monthly for outdated supplies on their downtime and acknowledged she had not monitored to verify outdate checks had been completed.

During an interview on 9/15/20 at 1:30 PM, the CNO verbalized the hospital lacked a policy on monitoring for outdated supplies.
VIOLATION: ORGANIZATIONAL STRUCTURE Tag No: C0960
Based on document review and staff interviews, the Critical Access Hospital's (CAH's) administrative staff:

1. Failed to ensure the CAH had a policy that directed staff how to handle an allegation of patient abuse by a staff member.

2. Failed to ensure the CAH staff reported a potential patient abuse by a staff member in a timely manner.

3. Allowed a staff member to work and care for patients for an additional 15 days after being acused of patient abuse.

4. Failed to report the incident of potential patient abuse for 14 days to the required entities.

Please refer to C-0962 for additional information. The cummulative effect of these failures and deficient practices resulted in the CAH staff's inability to ensure safe patient care while in the hospital.


II. During the course of the investigation of complaint # -I, the on-site survey team identified an Immediate Jeopardy (IJ) situation (a crisis situation that placed the health and safety of patients at risk) related to the Condition of Participation for Organizational Structure (42 CFR 485.627). The hospital staff failed to identify an incident as potential patient abuse and report the incident for 2 days after the incident.

1. The Critical Access Hospital's administrative staff's failed to develop and implement an abuse policy that included identifying and preventing abuse of patients in the hospital.

2. While on-site, the survey team identified an Immediate Jeopardy (IJ) situation and notified the administrative staff on 09/15/2020 at 2:32 PM. The administrative staff promptly took action to abate the immediacy of the situation. The hospital staff removed the Immediate Jeopardy prior to the exit date of the complaint investigation. A condition level deficiency remained for the Condition of Participation for Organizational Structure (42 CFR 485.627).

The corrective action plan included:

a. The staff member involved in the potential patient abuse incident was suspended pending the hospital's investigation.

b. The CAH adopted an internal abuse prevention and reporting policy that included:
- Definition of dependent adult abuse
- Prevention of dependent adult abuse
- Identification of dependent adult abuse
- Requirements for reporting and steps on how to report suspected dependent adult abuse
- Separating the alleged abuser from patients pending the hospital's investigation
- Hospital investigation process, and penalties for failure to report, hospital steps hospital takes to address reports of suspected abuse, including suspension of alleged perpetrator.

c. Immediate education of staff that they understood and would comply with the Identifying and Preventing Abuse in the Hospital: Screening, Training, Prevention and Reporting Policy.

The following Condition level deficiency remained for the Condition for Organizational Structure (42 CFR 485.627).
VIOLATION: GOVERNING BODY OR RESPONSIBLE INDIVIDUAL Tag No: C0962
Based on document review and staff interviews, the Critical Access Hospital's (CAH's) administrative staff failed to ensure the CAH staff reported a potential patient abuse by 1 of 1 staff member (CRNA A) in a timely manner, failed to ensure the CAH had a policy that directed staff how to handle an allegation of patient abuse by staff member, allowed CRNA A to work for an additional 15 days after being accused of patient abuse, and failed to report the incident of potential patient abuse for 14 days to the required entities for 1 of 1 patient reviewed (Patient #1). The administrative staff identified CRNA A provided patient care to approximately 54 patients per month. Failure of staff to identify and report an allegation of patient abuse could potentially result in the alleged perpetrator abusing other patients. The failure to identify a potential allegation of dependent adult abuse and separate the alleged perpetrator from other patients could potentially place all other patients at risk for abuse from the alleged perpetrator. The failure also potentially could result in other staff failing to identify instances of potential abuse, resulting in the staff failing to intervene in other situations of potential dependent adult abuse.

Findings include:

1. Review of Patient #1's medical record revealed that Patient #1 arrived to the CAH's Emergency Department (ED) via ambulance on 8/24/2020 at 4:48 PM. Patient #1 had multiple fractures, including a right leg fracture, following a head-on motorcycle accident. Patient #1 was thrown from their motorcycle after hitting the other motorcycle. ED Physician E documented that Patient #1 was hysterical upon arrival at the ED, due to the pain in their right leg. The EMS staff had administered 8 mg of morphine IV (a large dose of morphine) to Patient #1 prior to their arrival at the ED. In the ED, Certified Registered Nurse Anesthetist A (CRNA, a nurse with advanced training in administering anesthesia and pain control) administered IV Ketamine (a short-acting anesthesia medication) 30 mg at 5:02 PM and IV Ketamine 20 mg at 5:13 PM. Patient #1 received IV Dilaudid 1 mg (a very strong pain control medication) at 5:24 PM. The CAH staff transferred Patient #1 to another hospital via helicopter at 5:40 PM. The CAH staff documented Patient #1 rated their pain as 10 on a scale of 1 - 10, with 10 as the most severe pain, at the time of the transfer.

2. During an interview on 9/14/2020 at 12:25 PM, Paramedic C revealed he provided care to Patient #1 at the scene of the accident, during transport to the hospital, and in the ED on 8/24/2020. When Paramedic C arrived at the scene of the accident, Patient #1 had signs consistent with a fractured wrist, and the EMS staff splinted Patient #1's wrist at the scene of the accident. Patient #1 also had signs consistent with a fractured right leg where Patient #1 broke the bone in multiple places, including the bone possibly pushing out through Patient #1's skin (an open compound fracture, an extremely painful fracture where slight movements of the broken limb can cause excruciating pain).

Upon arrival at the hospital, Patient #1 was screaming from tremendous pain. CRNA A came into Patient #1's ED room and administered IV Ketamine 30 mg to Patient #1. Patient #1 stopped screaming for about 3 to 4 minutes after receiving the Ketamine, and then resumed screaming.

While preparing to transfer Patient #1 to another hospital via helicopter, Paramedic C explained to the staff present in the room with Patient #1 (CRNA A, Operating Room (OR) Registered Nurse (RN) B, and Scrub Tech D) that CRNA A would lift the patient's right leg while Paramedic C slid a splint under the patient's right leg and OR RN B would secure the splint in place. Patient #1 was screaming in pain while Paramedic C prepared to splint Patient #1's leg. OR RN B asked if the CAH staff needed to give Patient #1 anything for pain before the splint was applied, CRNA A said "it doesn't [explicative] matter - [they are] going to scream no matter what".

CRNA A lifted Patient #1's leg up and was not gentile with Patient #1's leg. Paramedic C quickly slid the splint under Patient #1's leg and OR RN B quickly secured the splint to Patient #1's leg. The CAH staff then transferred Patient #1 to another hospital via helicopter.


3. During an interview on 9/14/2020 at 2:10 PM, OR RN B revealed they provided care to Patient #1 in the ED on 8/24/2020. Patient #1 was loud and screaming in pain. Patient #1 had bleeding from the outside of their right foot and OR RN B gently applied gauze over the bleeding, to control the bleeding. OR RN B did not apply pressure to the gauze, as Patient #1 screamed in severe pain every time OR RN B touched Patient #1's foot. The CAH staff had administered morphine to Patient #1 for the pain, but Patient #1 still was screaming in pain. When OR RN B had to pick up Patient #1's leg to allow ED Physician E to examine Patient #1's ankle, Patient #1's ankle was very swollen and unstable. Holding Patient #1's leg, OR RN B could feel Patient #1's bones moving where the bones shouldn't be moving.

While preparing to splint Patient #1's leg, OR RN B had their back to Patient #1. When OR RN B turned around, CRNA A was holding Patient #1's leg and it appeared CRNA A was not being gentle while holding Patient #1's leg. Paramedic C and OR RN B quickly secured the splint to Patient #1's leg, as Patient #1 was screaming again, due to the pain.


4. During an interview on 9/14/2020 at 3:45 PM, Scrub Tech D revealed they assisted in Patient #1's care on 8/24/2020, mostly by talking to Patient #1 and documenting the care provided to Patient #1. While Paramedic C and OR RN B stabilized Patient #1's ankle, CRNA A appeared to be in a bad mood, as CRNA A was frequently using foul language and curse words. CRNA A told Patient #1 they needed to quit screaming.

When Paramedic C was ready to splint Patient #1's ankle, CRNA A was standing at Patient #1's right lower side. CRNA A reached out with their right hand and picked up Patient #1's right ankle with one hand from the top side of Patient #1's ankle. Patient #1 screamed in severe pain when CRNA A grabbed Patient #1's ankle (instead of lifting Patient #1's ankle from the underside, stabilizing the ankle from moving, and minimizing the pain caused to Patient #1). While CRNA A grabbed Patient #1's ankle, CRNA A stated "what does it matter [their] going to [explicative bomb] scream anyway."


5. Review of an undated CAH document "Investigation Notes," revealed the CAH staff reported their concerns about CRNA A's behavior to the CEO on 8/26/20 (2 days after Patient #1's motorcycle accident). The document further reveals the CAH staff did not separate CRNA A from other dependent adults until 9/10/20 (17 days after CRNA A allegedly abused Patient #1 and 15 days after the staff reported the allegation of abuse to the CEO).

6. Review of the CAH's policies revealed the CAH lacked a policy which provided guidance to the staff on how to handle a situation where a staff member was accused of abusing a patient.

7. During an interview on 9/15/2020 at 12:35 PM, the CEO acknowledged the CAH lacked a policy that provided guidance to the CAH staff on how to handle a situation where a staff member was accused of abusing a patient. The CEO verified the CAH lacked a policy requiring the staff to notify the Iowa Department of Inspections & Appeals if the CAH staff suspected a staff member had abused a patient. Additionally, the CEO acknowledged CRNA A worked for 2 days before the CAH staff notified the CEO about CRNA A possibly abusing Patient #1. The CEO further acknowledged CRNA A that CRNA worked for 17 days until the CAH staff separated CRNA A from all dependent adults.

8. Review of facility documentation revealed that CRNA A provided care to 26 patients from 8/24/2020 through 9/10/2020, including patients under general anesthesia in the operating rooms.
VIOLATION: PATIENT CARE POLICIES Tag No: C1008
Based on review of policies/procedures, meeting minutes, documents, and staff interviews, 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 for 14 of 25 patient care departments (Ambulance, Anesthesia, Cardiopulmonary, Diabetic Education, Dietary, Discharge Planning, Education, emergency room , Environmental Services, Infection Control, Medical Unit, Pharmacy, Speech Therapy, and Surgery). The CAH administrative staff identified a census of 13 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 failure to identify patient care needs not addressed in the CAH policies/procedures.

Findings include:

1. Review of the CAH policy "Critical Access Hospital Committee," last reviewed 10/2018, revealed in part, "... The CAH Committee shall: Approval annual policy and procedure revisions for all patient services departments...."

2. Review of the "CAH Annual Program Evaluation," dated 12/17/2019, lacked annual approval for all policies for Ambulance, Anesthesia, Cardiopulmonary, Diabetic Education, Dietary, Discharge Planning, Education, emergency room , Environmental Services, Infection Control, Medical Unit, Pharmacy, Speech Therapy, and Surgery.

3. During an interview on 09/16/2020 at 1:35 PM, the Executive Director Care and Integration indicated the review of annual policies were included in the Annual Program Evaluation dated 12/17/2019. The Executive Director Care and Integration confirmed not all patient care department policies were reviewed annually by the required group of professionals.
VIOLATION: PATIENT CARE POLICIES Tag No: C1016
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


I. Based on observation, document review, and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure pharmacy oversite of wasting and documentation of all narcotics/controlled substances including 1 of 1 observed Epidural Fentanyl infusion (Patient #1). Failure of pharmacy oversight in the wasting and documentation of epidural Fentanyl infusions could result in the potential for theft and/or unauthorized use of narcotic/controlled medications. The CAH staff identified approximately 85 epidural (provides anesthesia that creates a band of numbness from the bellybutton to upper legs) procedures were performed in fiscal year 2019 for control of pain during labor.

Findings include:

1. Observations during a tour of the New Beginnings Birth Center, on 9/14/2020 at approximately 3:10 PM, revealed a locked Epidural Infusion pump containing an IV infusion bag labeled Fentanyl 500 mg/250 ml injection for Epidural use, with approximately 100 ml of fluid remaining, IV tubing attached and hanging over the pump in LDRP 2 (Labor, Delivery, Recovery, Postpartum room #2). The door frame of LDRP 2 held two magnetic stickers stating "CLEAN" and "STOCKED". LDRP 2 was unoccupied and the patient bed was made up with clean linen.

During an interview at the time of the tour, Director of Medical Unit and OB confirmed the Epidural Fentanyl infusion should have been wasted at the time the infusion was discontinued. The Director did not know the name of the patient (Patient #1) that received the Epidural infusion or how long the epidural Fentanyl infusion had been left unattended in a room identified as clean and ready for the next labor patient admission.

2. Review of the "Epidural/CSE/Intrathecal" policy dated reviewed 9/2019, revealed in part, "... document when epidural pump is turned off ... drug ... and amount of epidural solution infused ... wasting of remaining epidural solution ... [that] contains a narcotic ... must be accounted for and wasted like any other narcotic ..."

Review of the "Controlled Substances" pharmacy policy, reviewed 9/2019, revealed in part, "Wasting of Substance in Patient Care Areas" failed to address wasting of epidural narcotic infusions.


3. Review of Patient #1's medical record revealed that RN G documented on 9/11/2020 at 9:30 AM an Epidural Fentanyl infusion was initiated for pain control while Patient #1 was in labor. RN G documented that same day, 9/11/2020 at 4:34 PM, "epidural is off" following delivery of the baby. The documentation lacked the name of the drug infused and the amount of epidural Fentanyl solution that was infused as required per CAH policy.

Review of the Epidural infusion pump "Delivery Log" for 9/11/2020, retrieved from the pump's internal memory, by the Director of the Pharmacy on 9/16/2020 at 2:33 PM revealed in part, "ANES LABOR EPIDURAL ... CONTINUOUS & DEMAND ... FENT 2 MCG-BUP O.125 ml ... 9/11/2020 9:29:50 AM ... delivery started ... 9/11/2020 4:42:01 delivery stopped ... 9/11/2020 4:42:08 PM Power down." The pump event log documented 106.35 ml had been infused and 160 ml of the Fentanyl infusion fluid remained in the bag when the infusion was stopped.

4. During an interview on 9/15/2020 at 12:55 PM, Director of Pharmacy verbalized he expected narcotic medication waste to be completed within approximately 1 hour of discontinuation. The Director of Pharmacy acknowledged the "Controlled Substances Policy" failed to address wasting of an epidural narcotic infusion. The Director of Pharmacy noted an Epidural infusion is not documented on the Medication Administration Record (MAR) and therefore there is no alert to nursing or pharmacy staff that the required documentation had not been completed. The Director confirmed that 3 days had passed before the Fentanyl Infusion, a Narcotic and Controlled drug, was found and properly wasted.



II. Based on observation, document review, and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure the staff removed outdated medication from 1 of 1 [DIAGNOSES REDACTED] Cart. Failure to remove outdated medications from the CAH's supplies, available for patient use, could potentially result in the staff using expired medications 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. The CAH's administrative staff identified an average of approximately 1,062 surgical cases in fiscal year 2019.

Findings include:

1. Observations on 9/16/2020, during a tour of the Post Anesthesia Care Unit, revealed 10 of 10 Calcium Gluconate 1000mg/10 ml vials expired 7/2020 in the [DIAGNOSES REDACTED] (a type of severe reaction to particular medications used during general anesthesia, among those who are susceptible) Emergency Cart.


2. Review of "Outdated Medication Policy" effective 3/2018, revealed in part, "Outdated medications will be removed from stock and disposed of ..."

3. During an interview on 9/16/20, at the time of the observation, the Surgery RN F acknowledged all 10 calcium gluconate vials were outdated and reported the pharmacy staff is responsible for monitoring the medications for outdates.

4. During an interview on 9/16/20 at approximately 12:45 PM, the Director of Pharmacy acknowledged that the 10 vials of calcium gluconate in the [DIAGNOSES REDACTED] Emergency Cart had outdated and it was the pharmacy department's responsibility to check the cart monthly. The Director of the Pharmacy reported he discovered the [DIAGNOSES REDACTED] emergency cart had been omitted from the "Monthly Crash Cart Drawer Expiration Date Monthly Check" list the the pharmacy technician utilized to document the required checks for each medication cart the pharmacy is responsible for.

5. Review of document "Monthly Crash Cart Drawer Expiration Date Monthly Check, Form #: Pharm174", dated Formulated 6/2017, lacked [DIAGNOSES REDACTED] Emergency Cart on its list.
VIOLATION: AGREEMENTS AND ARRANGEMENTS Tag No: C1042
Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to maintain 1 of 1 complete list of contracted services that described the nature and scope of services provided. The CAH administrative staff identified a census of 13 patients at the beginning of the survey. Lack of a complete list of contracted services, including the delineation of the nature and scope of the contracted services, could potentially result in failure of compliance of the contracted services' responsibilities.

Findings include:

1. Review of documents revealed some of the contracted services provided by the CAH included stereotactic biopsy, blood bank agreement, positron emission tomography (PET) scans and computerized tomography scan (CT).

2. Review of an undated document titled "Contracted Services [CAH] revealed the list failed to identify all of the CAH's contracted services, and failed to include the description of the nature and scope of each service.

3. During an interview on 9/15/20, at 12:41 PM, the Chief Nursing Officer (CNO) and the Chief Executive Officer (CEO) reported the list of contracted services provided had been quickly compiled upon request. The CEO confirmed the CAH lacked a complete list of contracted services and failed to include a description of the nature and scope of the services each contracted entity would provide.
VIOLATION: PROTECTION OF RECORD INFORMATION Tag No: C1120
I. Based on observation, document review, and staff interview, the Critical Access Hospital's administrative staff failed to ensure the radiology staff kept patient medical information secure from unauthorized access in 1 of 1 x-ray film storage room. The Radiology Manager identified approximately 575 x-ray films stored in 1 of 1 x-ray film storage room. Failure to keep patient medical information confidential could potentially result in theft of a patient's information and potentially result in identify theft.

Findings include:

1. Observation on 09/15/2020 at approximately 11:40 AM during a tour of the radiology department with the Radiology Director revealed 1 of 1 x-ray film storage room. The Radiology Director identified approximately 575 x-ray film stored on 2 open shelves in the x-ray film storage room.

2. Review of the policies revealed the lack of a policy that addressed security of x-ray films from unauthorized staff.

3. During an interview at the time of the tour, the Radiology Manager acknowledged the housekeeping staff have keys to access to the x-ray film storage room when Radiology staff are not present.

4. During an interview on 09/16/2020 at 9:05 AM, the Radiology Manager confirmed the lack of a policy that addressed security of x-ray films from unauthorized staff.







II. Based on observation, document review, and staff interview, the Critical Access Hospital's administrative staff failed to ensure the Health Information Management (HIM) staff kept patient medical information secure from unauthorized access in 1 of 1 Health Information Management office. Failure to keep patient medical information confidential could potentially result in theft of a patient's information and potentially result in identity theft. The HIM Manager identified the department stored approximately 25 paper patient records.

Findings include:

1. Review of a CAH policy titled "Security & Protection of The Medical Record In Paper Form", approved 9/2019, revealed in part "... To prevent unauthorized access to patient medical records ... The department is locked during all hours ... After hours retrieval of paper medical records will be limited to Nursing staff for the purpose of patient care ..."

2. Review of a CAH employee identification badge access report, generated to identify CAH employees able to access the HIM department, revealed 267 employees from all CAH departments, including, but not limited to, Storeroom, Environmental Services, Interpreter, Greeter, Dietary, Information Systems and Thrift Shop.

3. Review of CAH employee identification badge access report, generated to identify the employees who accessed the HIM department in the month of August 2020, revealed 4 employees accessed the area after staffed hours, whose job functions do not include the need to access patient medical records (Environmental Services, Greeter and Maintenance.

4. Observation upon entry into the HIM department, on 9/14/20, at 2:45 PM, revealed both department doors required an employee identification badge to unlock the door. Observation in the department revealed an open shelving unit with file crates, which held patient medical records filed for provider signatures or other required documentation. During an interview at the time, the Director of HIM reported the staff assigned to work in the office and nurses had badge access to enter, in addition to housekeeping staff and janitors, however they only entered during staffed hours. The Director of HIM reported additional staff may have the ability to enter with their identification badge but would check with Information Technology (IT) department.

5. During an interview on 9/14/20, at 3:30 PM, the Director of HIM reported she confirmed with IT all CAH employees had 24 hour employee identification badge access to the HIM department. She reported access to confidential patient information would be limited to only the few papers record waiting for provider follow-up, but acknowledged the unsecured records would be accessible to anyone entering the area. The Director of HIM confirmed the unsecured patient information included information such as patient names, date of birth, medical record numbers, diagnoses, addresses, test results, etc. and all CAH employees do not need access to patient information.

6. During an interview on 9/14/20, at 3:40 PM, the Chief Financial Officer reported the CAH had the ability to review employee identification badge access history to the HIM department, but confirmed the CAH did not regularly monitor the access history.

7. During an interview on 9/14/20, at 4:40 PM, the Director of Care Integration, reported she is the CAH's privacy officer, acknowledged all CAH employees do not need access to patient medical records, and thought access to the HIM department had restrictions to staffed hours for those employees whose job did not require access to patient medical records.

8. During an interview on 9/14/20, at 4:55 PM, the Director of Care Integration confirmed the employee identification badge readers on both HIM department doors allowed access to all employees 24 hours a day.

9. During an interview on 9/16/20, at 9:00 AM, the Manager of Information Technology confirmed all staff employee identification badges allow access to the HIM office 24 hours daily.

10. During an interview on 9/16/20 at 1:45 PM, the Director of HIM confirmed anyone entering the HIM area would have access to the unsecured records in the office and all employees do not need access to patient medical records.