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Based on observation, review of high level disinfectant (HLD) documentation and policy review, and interview, it was determined the facility failed to prevent and control the likely spread of infection in that laryngoscope blades (three straight and two curved) in one of one emergency cart located in the radiology department were not packaged to prevent contamination; and failed to ensure high level disinfection was performed according to manufacturer's instructions and facility policy in two of two (Respiratory Therapy and Radiology) departments that perform HLD. Failure to follow manufacturer's instructions and policy did not assure patients would be protected from likely sources of infection. The failed practice was likely to affect all patients who required intubation. Findings follow:

A. Review of facility policy, "High Level Disinfection and Packaging of Laryngoscope Blades and Handles," dated 11/30/17 showed Laryngoscope blades are classified as semi-critical devices and per the CDC (Centers for Disease Control and Prevention) guidelines for device reprocessing, laryngoscopes are to undergo meticulous cleaning followed by high-level disinfection between each patient use, packaged in the appropriate sterile packaging, and sealed.

B. Record review of Manufacturer's instructions observed on the Cidex OPA bottle 02/12/19 at 3:02 PM showed that Cidex OPA was used for High Level Disinfection of laryngoscope blades that were completely immersed for a minimum of 12 minutes at 20 degrees Celsius (68 degrees Fahrenheit) to destroy all pathogenic microorganisms. After 12 minutes, the laryngoscope blades were to be removed from the solution and rinsed thoroughly with sterile water or potable tap water.
1) Review of the Cidex OPA Solution Test Strip Manufacturer's Instruction for use on 02/15/19 at 1:38 PM showed that bottle was to be stored at controlled room temperature (15-30 degrees Centigrade or 59 - 86 degrees Fahrenheit). The Cidex OPA solution should be tested before each use with the test strips in order to prevent dilution of the minimum effective concentration (MEC) of 0.3% of the product. When a test strip bottle was opened for the first time, the date opened was to be recorded in the space provided on the label and do not use any remaining strips 90 days after opening the bottle. Do not leave the test strip bottle open for more than 30 minutes. Improper storage or use of test strips may result in false readings.
2) The Quality Control (QC) procedure per the manufacturer's instructions showed to prepare positive and negative control solutions for testing, and following the Directions for Use, submerge three test strips in each of the freshly prepared solutions for one second then remove. The three strips dipped in the full strength positive control solution should exhibit a complete purple color on the pad at 90 seconds. The three strips dipped in the diluted negative control should remain completely blue or have an incomplete color change to purple when read at 90 seconds. The manufacturer's recommendation was for testing of positive and negative controls to be performed on each newly opened test strip bottle of Cidex OPA Solution Test Strips. After the initial testing, controls for QC should be performed at regularly established times. The purpose of the QC testing was to minimize errors between different users, prevent the use of outdated materials or product that had been improperly stored or handled.

C. Review of the Semi-critical Device Disinfection Log located in the Respiratory Therapy Department on 02/12/19 at 3:22 PM showed from 12/17/17 - 11/05/18, 16 of 16 times the facility failed to document the temperature of the Cidex OPA solution; minimum effective concentration, and the original Cidex OPA container was not dated when opened. There was no documentation of QC results. The Respiratory Therapy Manager confirmed the findings by interview at the time of observation.

D. Observation on 02/12/19 at 2:50 PM of the Emergency Cart located in the radiology department showed three straight and two curved laryngoscope blades and one handle. The blades and handle were in a bin on a blue towel in the top drawer of the emergency cart. The blades and handle were not packaged to prevent contamination. This was confirmed by the Respiratory Therapy Manager and Radiology Technician #1 at 2:56 PM on 02/12/19.

E. Observation of the Ultrasound Room with the Director of Radiology and Radiology Technician #1 on 02/15/19 at 1:08 PM showed the temperature of the Cidex OPA used for high level disinfection of transvaginal and transrectal ultrasound probes were not being maintained above the minimum temperature of 68 degrees F as required by the manufacturer for manual reprocessing. The room did not have heat or a way to regulate the temperature of the Cidex OPA solution. The Cidex OPA test strip bottle currently in use was observed on the counter and the lid was not closed, which left the strips exposed. The test strips bottle was not dated when opened. The findings were verified by Radiology Technician #1 and the Director of Radiology at the time of observation.

F. Review of the Cidex OPA In-Use Solution Log Sheet for HLD of transvaginal and transrectal ultrasound probes in the Radiology Department on 02/15/19 at 1:40 PM showed from 09/28/19 - 01/31/19 the following:
1) The temperature of the Cidex OPA solution was documented below the minimum temperature of 68 degrees F a total of 16 of 29 times from 09/28/18 - 01/31/19.
2) QC results were not documented when each test strip bottle was opened. The last date that was documented that a test strip bottle was first opened was 07/20/18 and a "do not use after" date of 10/20/18 was documented at the top of the form. There was no evidence a new test strip bottle was opened after 07/20/18 or after the do not use after date of 10/20/18 from 10/26/18 - 01/31/19. There was no evidence a QC was performed from 07/21/18 - 01/31/19. This was confirmed at the time of observation by Radiology Technician #1.

Based on observation and interview, it was determined the facility failed to ensure a sanitary environment was maintained in the dietary department in that: crawling bugs were observed, there was an accumulation of grease and old fried potatoes under the deep fryer, and raw potatoes were soft and sprouting. The facility could not ensure food would be stored and prepared in a sanitary manner or that foodborne illness would be prevented. The failed practice was likely to affect any patient or staff who was provided food. Findings follow:

A. Observation of the Dietary Department on 02/12/19 showed:
1) 3:23 PM: Signage on the outside of the dietary department that the dining room was closed. The Dietary Manager stated in an interview they were not admitting patients at this time and that the last food order was 12/2018 and they have admitted no patients since last week.
2) 3:44 PM: Two crawling bugs observed on the inside of the oven and one crawling on the outside knob of the stove. The Dietary Manager confirmed at the time of observation that the bugs appeared to be cockroaches.
3) 3:46 PM: An accumulation of dark colored grease and several pieces of fried potatoes were under the deep fryer base. The Dietary Manager confirmed the finding at the time of observation.
4) 4:00 PM: There were 13 raw potatoes in a rolling wire basket that were in various stages of sprouting and soft in several places. The Dietary Manager confirmed the finding at the time of observation.
B. In an interview with the Dietary Manager, it was confirmed on 02/12/19 that the Dietary Department did not have a contract for a company to spray for insects and they would contact the Maintenance Department if something needed to be sprayed.


28438

Based on observation and interview, it was determined the facility failed to mitigate the risk of infection in that:
1. Clean patient supplies (Intravenous (IV) fluid room, sterile items, shower chairs, bedside commodes, IV poles, tube feeding and gloves) were stored in an area where a dirty lawnmower was stored;
2. The lawnmower was stored under the intake to the ventilation system of the clean patient supply room.
3. The IV fluid room contained three ceiling tiles that were stained, crumbling and falling from the ceiling.
The failed practices placed the patients at risk of infection from cross contamination and had the potential to affect all patients on which the items were used. Findings follow:

A. Observation on 02/12/19 at 1:50 PM showed the following:
1) Clean patient supplies (IV fluid room, sterile items, shower chairs, bedside commodes, IV poles, tube feeding and gloves) were stored in an area where a dirty lawnmower was stored.
2) The lawnmower was stored under the intake to the ventilation system of the clean patient supply room.
3) The IV fluid room contained three ceiling tiles that were stained, crumbling and falling from the ceiling.

B. The findings were confirmed in an interview with the Human Resources Manager on 02/12/19 at 1:50 PM.


Based on observation and interview, it was determined the facility failed to mitigate the risk of infection in that:
1. Ten (Trauma Room #1, Outpatient Rooms #1, #2 and #3, Ambulatory Care #1, #2 and #3, Isolation Room #12 and Rooms #14 and #24) of 13 (Trauma Room #1, Outpatient Rooms #1, #2 and #3, Ambulatory Care #1, #2 and #3, Isolation Rooms #12 and #13, Rooms #14 and #24 and two beds in Room #19) bedframes and bed side rails observed had a buildup of rust.
2. Tears were present in the vinyl of 3 (two mattresses in Room #19 and Room #24) of 13 (Trauma Room #1, Outpatient Rooms #1, #2 and #3, Ambulatory Care #1, #2 and #3, Isolation Rooms #12 and #13, Rooms #14 and #24 and two beds in Room #19) patient bed mattresses observed.
3. Rust was present on one of one Chest Bucky (x-ray equipment) observed in the Radiology Department.
4. Missing laminate around the patient vanity, exposing wood in Room #16 and Room #17. Wood has a porous nature and cannot be disinfected.
The failed practice did not allow for disinfection of the bedframes, mattresses, and vanity due to the porous nature of rust and wood, and the abosorbent nature of mattresses. The failed practice had the potential to affect all patients seen at the facility. Findings follow:

A. Observation on 02/12/19 showed the bedframes and bed side rails in the following rooms had a buildup of rust:
1) Trauma Room #1: Confirmed in an interview with Advanced Practice Nurse (APN) #1 at 12:40 PM.
2) Outpatient Room #1, #2 and #3: Confirmed in an interview with APN #1 at 1:05 PM.
3) Ambulatory Care #1 and #2: Confirmed in an interview with APN #1 at 1:20 PM.
4) Ambulatory Care #3: Confirmed in an interview with APN #1 at 1:30 PM.
5) Isolation Room #12: Confirmed in an interview with the Facility Manager at 3:50 PM
6) Rooms #14 and #24: Confirmed in an interview with Registered Nurse (RN) #1 at 4:00 PM.

B. Observation on 02/12/19 showed tears in the vinyl of the bed mattresses in the following rooms:
1) Two mattresses in Room #19: Confirmed in an interview with RN #1 at 4:00 PM.
2) Room #24: Confirmed in an interview with RN #1 at 4:00 PM.

C. Observation on 02/12/19 showed the Chest Bucky in the Radiology Department had a buildup of rust. The findings were confirmed in an interview with the Facility Manager on 2:40 PM.


30580

Based on Bylaws of the Medical Staff review, Policy and Procedure review, Emergency Department Provider Calendar review, Physician e-mail review and interview, it was determined the facility failed to have a physician available for care in the Emergency Department for one (#1) of 20 (#1-#20) patient and on 02/14/19 and thereafter. The failed practice affected Patient #1 and had the potential to affect all patients presenting to the Emergency Department on 02/14/19 and thereafter. The cumulative effect of the systematic deficient practice resulted in noncompliance with the Condition of Participation for Emergency Services. See C-0207 for details.

Based on Bylaws of the Medical Staff review, Policy and Procedure review, Emergency Department Provider Calendar review, Physician e-mail review and interview, it was determined the facility failed to have a physician available for care in the Emergency Department for one (#1) of 20 (#1-#20) patient and on 02/14/19 and thereafter. The failed practice did not ensure safe patient care in that a physician was not available to provide a medical screening exam or stabilizing treatment to Patient #1. The failed practice affected Patient #1 and had the potential to affect all patients presenting to the Emergency Department on 02/14/19 and thereafter. Findings follow:

A. Review of the Bylaws of the Medical Staff with an approved date of 05/09/12 showed the following for Emergency Services:
1. Emergency Room coverage would be assigned to Active Staff physicians on a rotating basis, as coordinated by the Chief of Staff, and the Medical Staff would be responsible for establishing policies and procedures for this area.
2. An appropriate medical record, signed by the attending physician, shall be kept for every patient receiving emergency services, and be incorporated in the patient's Hospital record, if one already exists. The record shall at least include the following:
a) Pertinent history of the injury or illness, including details of first aid or emergency care given prior to the patient's arrival at the Hospital.
b) Description of significant clinical, laboratory and x-ray findings.
c) Diagnosis.
d) Treatment given.
e) Condition of patient on discharge or transfer.
f) Final diagnosis, including instructions given to the patient and/or the family relative to necessary follow-up care.

B. The findings of A were confirmed in an interview with the Director of Nursing on 02/15/19 at 9:20 AM. The Director of Nursing confirmed the Bylaws of the Medical Staff with an approved date of 05/09/12 were the most current bylaws.

C. Review of the facility's "Policy and Procedure Manual for Critical Access Hospitals Emergency Department" with a signature date of 03/28/18 with a policy titled, "Emergency Department Category of Service," with a revision date of 2010 showed the Emergency Department was categorized as providing Level IV service offering emergency treatment 24 hours a day. At least one physician was to be on duty in the emergency room 24 hours a day.

D. The findings of C were confirmed in an interview with the Director of Nursing on 02/15/19 at 9:20 AM.

E. Review of the February 2019 Emergency Department provider calendar on 02/14/19 showed an Advanced Practice Nurse (APN) or a Physician was scheduled for each day. Review of the February 2019 NP/MD (Nurse Practitioner/Physician) Back-Up calendar showed Physician #4 was listed as the back-up physician for APN #1 (Corporate Nursing Officer) and APN #2.

F. Review of an email from Physician #2 sent to the Owner on 02/11/19 showed, "Dear (Owner). It has been a trend at your side delaying payments for Doctors, Nurses and other staff at DQMC (De Queen Medical Center). This email is referring to most of your physicians who were kind enough to schedule shifts at your hospital without being certain of the timely reimbursement as a gesture to keep the hospital running, some were even kinder to continue working without being paid hoping that you will honor your word and promises for them to be compensated for all the time they spent working and maintaining the operation of the hospital, yet you continue to delay and even deny their payments in an very unprofessional manner. At this time, we as the main group of physicians working at DQMC regret to inform you that starting today 02/11/2019 (we) will not cooperate with you in running the ED (Emergency Department) at your hospital, unless we get fully reimbursed for all the delayed unpaid hours. It's your full responsibility to find alternate coverage for all the scheduled shifts at ED. We all stand as one body and we all hope that you return to your senses and look at this entire case with appreciation rather than denial." The email was addressed to the Owner and was from Physician #1, #2, and #3.

G. In an interview with the Director of Nursing and the ER Supervisor on 02/14/19 at 8:40 AM, the ER Supervisor stated the Emergency Department no longer had provider (APN or Physician) coverage. The Director of Nursing stated no physician was willing to cover the Emergency Department due to financial concerns. The ER Supervisor stated the facility went on "diversion" as of 02/14/19 at 8:15 AM when APN #1 left the facility. The Director of Nursing stated Physician #1 and #5 refused to staff the ER. The Director of Nursing stated the Chief of Staff (Physician #4) resigned as of 02/13/19.

H. In an interview with the Director of Nursing and ER Supervisor on 02/15/19 at 8:55 AM, the ER Supervisor stated the Emergency Department did not have provider coverage at that time. The Director of Nursing stated that if a patient presented to the Emergency Room, the staff would inform the patient a provider was not available for treatment. The ER Supervisor stated if the patient felt their condition was an emergency, the staff would ask the patient if they wanted the staff to call 911.

I. In a telephone interview with the Director of Nursing on 02/19/19 at 8:30 AM, she stated the facility did not have provider coverage. The Director of Nursing confirmed the facility had not had provider coverage since 02/14/19 at 8:15 AM.

J. Review of Patient #1's clinical record on 02/15/19 showed the patient presented to the Emergency Department on 02/14/19 at 10:55 AM. Nursing Note (no time provided) showed, "Explained to parents no provider in ER." There was no evidence a medical screening exam was conducted by a physician to determine if an emergent condition existed. There was no evidence stabilizing treatment was provided. The findings were confirmed in an interview with the Emergency Room Supervisor on 02/15/19 at 12:55 PM.

Based on observation and interview, it was determined the facility failed to ensure mechanical, electrical and patient-care equipment was maintained in a safe operating condition in that the Safety Inspections were not performed on an annual basis by a Biomedical Officer. The failed practice did not ensure the equipment was maintained for patient safety. The failed practice had the potential to affect all patients seen at the facility. Findings follow:

A. Observation on 02/12/19 showed the "Safety Inspection" sticker on the equipment showed the inspections were performed as follows:
1) Ambulatory Care #1 and #2: Intellivue monitor safety inspection done on 10/2017 and due on 10/2018. The findings were confirmed in an interview with Advanced Practice Nurse (APN) #1 at 1:20 PM.
2) Emergency Department Hallway:
a. EKG (electrocardiogram) machine safety inspection done on 10/2017 and due on 10/2018.
b. Emergency Gas Shutoff safety inspection done on 10/2017 and due on 10/2018.
c. The findings were confirmed in an interview with APN #1 at 1:25 PM.
3) Ambulatory Care #3: Baby scales safety inspection done on 10/2017 and due on 10/2018. The findings were confirmed in an interview with APN #1 at 1:30 PM.
4) Emergency Department: Portable X-Ray machine safety inspection done on 10/2017 and due on 10/2018. The findings were confirmed in an interview with APN #1 at 2:05 PM.
5) CT (Computerized Tomography) Room: Code Master Defibrillator safety inspection done on 10/2017 and due on 10/2018. The findings were confirmed in an interview with the Facility Manager at 2:55 PM.
6) Respiratory Therapy Department:
a. Uni-Vent portable ventilator safety inspection done on 10/2017 and due on 10/2018.
b. Chest physiotherapy percussor safety inspection done on 10/2017 and due on 10/2018.
c. The findings were confirmed in an interview with the Respiratory Therapy Manager at 3:20 PM.
7) Laboratory: CBC (Complete Blood Count) machine safety inspection done on 10/2017 and due on 10/2018. The findings were confirmed in an interview with the Laboratory Director at 3:35 PM.
8) Storage Room: Infant Warmer System safety inspection done on 02/2016 and due on 02/2017. The findings were confirmed in an interview with the Emergency Room Supervisor on 02/13/19 at 11:15 AM.

B. In an interview with the Facility Manager on 02/12/19 at 1:40 PM, he stated a Biomedical Officer used to perform the safety inspection on the equipment. The Facility Manager stated the facility no longer had a contract with the Biomedical Officer.


Based on observation and interview, it was determined the facility failed to ensure electrical wires were not exposed for five of five (Ambulatory Care #3, hallway outside Ambulatory Care #1, hallway outside Ambulatory Care #3 and two in the hallway near the Respiratory Therapy Department) wall boxes observed. The failed practice placed the patients and staff at risk of exposure to electricity and had the potential to affect all patients seen at the facility and all staff in the facility. Findings follow:

A. Observation on 02/12/19 showed there was an open wall box in Ambulatory Care #3 in the Emergency Department. The open wall box contained exposed wires. The findings were confirmed in an interview Advanced Practice Nurse (APN) #1 on 02/12/19 at 1:30 PM.

B. Observation on 02/12/19 showed there was an open wall box in the hallway outside Ambulatory Care #1 and in the hallway outside Ambulatory Care #3. The open wall boxes contained exposed wires. The findings were confirmed in an interview with the Facility Manager on 02/12/19 at 1:40 PM.

C. Observation on 02/12/19 showed there were two open wall boxes in the hallway near the Respiratory Therapy Department. The open wall boxes contained exposed wires. The findings were confirmed in an interview with the Facility Manager on 02/12/19 at 3:05 PM.

D. In an interview with the Facility Manager on 02/19/19 at 1:30 PM, he stated the facility had no funds to purchase the covers for the wall boxes.

Based on review of Governing Body Bylaws, Bylaws of the Medical Staff, notices from American Esoteric Laboratories, Hospital Memo, State of Arkansas Department of Finance and Administration Accounts Receivable Unit, State of Arkansas Department of Workforce Services, Robert S. McGinnis, Jr. Attorney at Law, State Systems, Incorporated, Physician email and interview, it was determined the Governing Body failed to ensure the facility was capable of providing safe patient care by approving and appointing an administrator to oversee day-to-day operations; failed to ensure supplies and services were available by paying incurred invoices; failed to ensure physician coverage for Emergency Department by payment of their fees; and failed to ensure the physical environment was maintained in good repair. The cumulative effect of the systematic deficient practices resulted in noncompliance with the Condition of Participation for Organizational Structure which affected all persons in the facility. (Related Citations: C-0200, C-0207, C-0222, C-0241, C-0276, C-0278, C-0283, and C-0301)

A. Review of Governing Body Bylaws with approval date of 12/07/05 showed Objectives of the Board of Directors. To establish and maintain an institution with permanent facilities that include patient beds and medical services to provide diagnosis and treatment for patients in need of medical and rehabilitation care. The Director of Nursing confirmed the Governing Body Bylaws approved 12/07/05 was the current edition on 02/14/19 at 11:40 AM.

1) Review of Bylaws of the Medical Staff with approval date of 05/09/12 revealed the Chief Executive Officer means the individual appointed by the Board of Directors to act in its behalf in the overall management of the Hospital. Their title is Administrator. On interview with the Director of Nursing on 02/12/19 at 1:10 PM, she confirmed there was no Administrator and had not been since November, 2018.

2) Review of American Esoteric Laboratories (AEL) notice dated 02/11/19 provided by the Human Resources Manager 02/15/19 at 10:00 AM showed, "numerous attempts have been made to resolve the outstanding balance accumulated by DeQueen Medical Center ... To date, those efforts have been unsuccessful. Therefore, due to non-payment for laboratory services provided by AEL and the inability to reach a payment resolution, AEL will discontinue services on your account 02/16/19 ... in the amount of $116,967.77." The amount listed represents invoices July 2018 thru January 2019. The Human Resources manager confirmed non-payment on 02/15/19 at 10:30 AM.

3) Review of Hospital Memo provided by the Laboratory Director 02/12/19 at 12:40 PM showed, "due to a shortage of lab supplies, DeQueen Medical Center will now be on ambulance diversion. We will also not be admitting any patients for acute care that require the testing listed below: Sodium, Potassium, Chloride, Magnesium, CKMP (creatine kinase muscle brain) used to diagnose acute myocardial infarction, BNP (brain natriuretic peptide) used to diagnose heart failure, PT/PTT (prothrombin time/partial prothrombin time) used to analyze blood clotting ability, ALT (alanine aminotransferase) used to analyze liver function, Lipid Panel, Hemoglobin A1C."

4) During interview with the Human Resources Manager on 02/12/19 at 1:00 PM she stated staff had not been paid since 01/25/19 and docs (doctors) were leaving due to not being paid. On interview with the Laboratory Director on 02/12/19 at 3:35 PM he stated he and his laboratory staff had not been paid as of 01/25/19. On interview with RN #1 and RN #3 on 02/12/19 at 4:20 PM they stated they had not been paid as of 01/25/19. On interview with the Director of Nursing 0n 02/13/19 at 1:00 PM, she stated no one had been paid since 01/25/19.

5) Review of State of Arkansas Department of Finance and Administration Accounts Receivable Unit notice dated 02/04/19 provided by the Human Resources Manager on 02/15/19 at 10:00 AM showed "your business has failed for two (2) months or more to file its Excise or Withholding Wage Tax returns or failed to pay the Excise or Withholding Tax due. Tax Year Ending December 31, 2018: August 2018 - non-filed, September 2018 - non-filed, October 2018 - non-filed, November 2018 - non-filed. The Human Resources Manager confirmed non-payment on 02/15/19 at 10:30 AM.

6) Review of State of Arkansas Department of Workforce Services notice dated 02/11/19 provided by the Human Resources Manager on 02/15/19 at 10:00 AM showed Third and Final Notice of Delinquent contributions totals $7,977.07. The Human Resources Manager confirmed non-payment on 02/15/19 at 10:30 AM.

7) Review of Robert S. McGinnis, Jr. attorney at law notice dated 01/24/19 provided by the Human Resources Manager on 02/15/19 at 10:00 AM revealed goods, wares, merchandise and/or services were provided to DeQueen Medical Center by Abernathy Company. DeQueen Medical Center accepted the goods, wares, merchandise and/or services and agreed to pay for the goods, wares, merchandise and/or services provided. DeQueen City Medical Center failed to pay for the goods, wares, merchandise and/or services provided and owes Abernathy company $11,647.14. The Human Resources Manager confirmed non-payment on 02/15/19 at 10:30 AM.

8) Review of State Systems, Inc. (incorporated) dated 02/04/19 provided by the Human Resources Manager on 02/15/19 at 10:00 AM showed a balance due on 12/31/18 of $69,493.00. The Human Resources Manager confirmed non-payment on 02/15/19 at 10:30 AM.

9) Review of Physician email notice dated 02/11/19 provided by the Human Resources Manager on 02/14/19 showed, "It has been a trend ...delaying payments for Doctors, Nurses and other staff at DQMC (DeQueen Medical Center). This email is referring to most of your physicians who were kind enough to schedule shifts at your hospital without being certain of the timely reimbursement as a gesture to keep the hospital running, some were even kinder to continue working without being paid hoping that you will honor your word and promises for them to compensate them for all the time they spent working and maintaining the operation of the hospital yet you continue to delay and even to deny their payments in a very unprofessional manner. At this time, we as the main group of physicians working at DQMC regret to inform you that starting today 2/11/19 will not cooperate with you in running the ED (Emergency Department) your hospital, unless we all get fully reimbursed for all the delayed unpaid hours. It is your full responsibility to find alternative coverage for all the scheduled shifts at ED. We all stand as one body and we all hope that you return to your senses and look at this entire case with appreciation rather than denial." The email was addressed to the Owner and was from Physician #1, Physician #2 and Physician #3.

B. During interview with the Director of Nursing 02/15/19 at 08:45 AM she confirmed the hospital continued to be on full Emergency Department diversion related to inability to ensure supplies and staff were available to safely care for patients. She stated anyone arriving at the Emergency Room was told to see their primary care physician or to call 911.

Based on Bylaws of the Medical Staff review, Physician and Advanced Practice Nurse (APN) credential file review and interview, it was determined the facility failed to ensure two (#4 and #5) of five (#1-#5) Physicians and one (#2) of two (#1 and #2) APNs providing care in the Emergency Department were privileged by the Governing Body to provide care in the Emergency Department. The failed practice did not ensure the Physicians and the APNs were determined eligible of providing emergency care. The failed practice had the potential to affect all patients seen by Physician #4 and #5 and APN #2 in the Emergency Department. Findings follow:

A. Review of the Bylaws of the Medical Staff on 02/14/19 with an approval date of 05/09/12 showed the following:
1) Purpose: To strive to ensure a high level of professional performance of all individuals authorized to practice in the Hospital, through appropriate delineation of the clinical privileges that each may exercise in the Hospital and through an ongoing review and evaluation of each individual performance in the Hospital.
2) Definitions: The term "Allied Healthcare Professional" means an individual, other than a licensed physician, who exercises independent judgment within the areas of his professional competence and who was qualified to render direct or indirect care under the supervision of a practitioner who has been accorded privileges to provide such care in the Hospital. Such ALPs (Allied Healthcare Professionals) shall include chiropractors, dentist, podiatrist, and surgeon assistants, medical students, intern residents, nurse clinicians, clinical psychologists, physician assistants, or other individuals granted clinical privileges at the Hospital (under) supervision of a medical doctor.
3) Medical Staff Membership: The process for the granting of privileges to Allied Healthcare Professionals was to be the same as for the Medical Staff, as defined by the Medical Staff Bylaws, who shall not be considered a voting member of the Medical Staff, with the exception of the Department of Chiropractic Chairman, who shall be a voting member.
4) Medical Staff Membership: Appointments to the Medical Staff shall confer on the appointee only such clinical privileges as have been granted by the Board of Directors, in accordance with the Bylaws.
5) Clinical Privileges: Every individual practicing in this Hospital by virtue of Medical Staff membership or otherwise, shall, in connection with such practice, be entitled to exercise only those clinical privileges specifically granted to them by the Board, except as provided in Section 2 and 3 of this Article VI.

B. In an interview with the Director of Nursing on 02/14/19 at 2:45 PM, she confirmed the Bylaws of the Medical Staff with an approval date of 05/09/12 was the current version of the Bylaws.

C. Review of Physician #4's credential file on 02/15/19 showed there was no evidence the Physician was privileged for the Emergency Department by the Governing Body or Medical Staff.

D. Review of Physician #5's credential file on 02/15/19 showed there was no evidence the Physician was privileged for the Emergency Department by the Governing Body or the Medical Staff.

E. Review of APN #2's credential file on 02/15/19 showed there was no evidence the APN was privileged for the Emergency Department by the Governing Body or the Medical Staff.

F. The findings of C, D and E were confirmed in an interview with the Human Resources Manager on 02/15/19 at 11:50 AM.


Based on Bylaws of the Medical Staff review, Physician credential file review and interview, it was determined the facility failed to have a process in place to ensure two (#4 and #5) of five (#1-#5) Emergency Department Physicians practiced at the facility with a current Arkansas license. The failed practice did not ensure the patients seen in the Emergency Department were seen by a physician with a current Arkansas license. The failed practice had the potential to affect all patients seen by the physicians. Findings follow:

A. Review of the Bylaws of the Medical Staff on 02/14/19 with an approval date of 05/09/12 showed the term "Medical Staff" meant all medical doctors holding current, unlimited license to practice in the State of Arkansas who are privileged to attend patients in the Hospital.

B. In an interview with the Director of Nursing on 02/14/19 at 2:45 PM, she confirmed the Bylaws of the Medical Staff with an approval date of 05/09/12 was the current version of the Bylaws.

C. Review of Physician #4's credential file on 02/15/19 showed the Physician's license expired on 07/31/18.

D. Review of Physician #5's credential file on 02/15/19 showed the Physician's license expired on 09/30/18.

E. The findings of C and D were confirmed in an interview with the Human Resources Manager on 02/15/19 at 11:50 AM.

Based on review of policy and procedures, manufacturer's instructions, observation and interview, it was determined the facility failed to ensure drugs and biologicals were stored to ensure temperature and humidity requirements were maintained. The Pharmacy did not have heat or air conditioning available to set a temperature range to ensure the safety and the integrity of drugs and biologicals stored in the pharmacy. The failed practice was likely to affect any patient who was administered medication from the facility. Findings follow:

A. Review of policy and procedure titled, "Drug Inventory Control", reference #6151 on 02/15/19 showed Medications were to be stored under proper conditions as stated by the medication manufacturer to assure stability of that medication. The room temperature of drug storage areas will also be monitored and temperature logs maintained.

B. Review of policy and procedure titled, "Storage of Pharmaceuticals," policy # 020-4570 on 02/15/19 showed all pharmaceuticals must be stored under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation and security. All products must be stored following manufacturer's guidelines specific for temperature (USP/NF drug monographs may be consulted).

C. Record review on 02/15/19 at 11:16 AM of a product insert for Pantoprazole Sodium for injection, stored on the shelf in the pharmacy, showed the vials were to be stored at 20 - 25 degrees Celsius (C) or 68 - 77 degrees Fahrenheit (F).

D. The Director of Pharmacy was interviewed on 02/15/19 from 10:24 AM - 10:40 AM. and stated that the pharmacy is located in an area that does not have heat or air-conditioning. The Director of Pharmacy stated the room temperature range should be between 68 - 77 degrees F and this is based on the most common range for the medications stored. She stated the last time she had heat/air was last winter. She has had no heat this winter. There was an electric wall heater and air conditioner unit but it has not worked since the summer of 2017.

E. The Director of Pharmacy had a wall mounted thermometer so the room temperature could be monitored. There was no staff routinely in the Pharmacy after she left in the afternoon and so when the Director of Pharmacy was not present, the room temperature and humidity was not routinely monitored.


Based on observation, review of documents and interview, it was determined the facility failed to ensure the Laminar hood (used to exclude contaminants from sensitive processes such as intravenous preparations) was inspected per recommended standards. Failure to ensure inspections were performed routinely did not ensure the safety or integrity of any drug that is prepared utilizing the Laminar Hood. The failed practice was likely to affect any patient who required drugs prepared in the Laminar hood. Findings follow:

A. The Director of Pharmacy was interviewed on 02/15/19 from 11:00 AM - 11:06 AM and observation of the Laminar hood equipment maintenance sticker showed it should have been serviced prior to the expiration date of January 2019. The Director of Pharmacy stated the last time the hood was used was approximately four months ago.

B. Review of email messages provided 02/15/19 at 11:15 AM by the Director of Pharmacy showed an email had been sent by the company who checks the Laminar Hood to schedule a service for the IV hood to get the IV hood "back on schedule this month." Requested payment of $310 for the previous two invoices and the visit for 01/2019.

C. All findings were verified by the Director of Pharmacy at the time of interview and observation.

Based on review of manufacturer's instructions, observation and interview, it was determined the facility failed to ensure patient care supplies and equipment in the Radiology Department were maintained according to manufacturer's instructions, expiration date and facility policy. The failed practice did not ensure Radiology equipment would be readily available; operational, safe for use and in date. The failed practice was likely to affect any patient who required services provided by Radiology. Findings follow:

A. Review of manufacturer's instructions provided by the Director of Radiology on 02/15/19 showed Cidex OPA was used for High Level Disinfection (HLD) of ultrasound probes and that the device was to be completely immersed for a minimum of 12 minutes at 20 degrees Celsius (C) or 68 degrees Fahrenheit (F) to destroy all pathogenic microorganisms. After 12 minutes, the device was to be removed from the solution and rinsed thoroughly with sterile water or potable tap water.
1) Review of the Cidex OPA Solution Test Strip Manufactures Instruction for use on 02/15/19 at 1:38 PM showed for storage of the test strips, to keep the cap tightly closed. Store bottle at controlled room temperature (15-30 degrees C or 59 - 86 degrees F). The Cidex OPA solution should be tested before each use with the test strips in order to prevent dilution of the minimum effective concentration (MEC) of 0.3% of the product. When a test strip bottle was opened for the first time, the date opened was to be recorded in the space provided on the label and do not use any remaining strips 90 days after opening the bottle. Do not leave the test strip bottle open for more than 30 minutes. Improper storage or use of test strips may result in false readings.
2) Review of the Quality Control (QC) procedure per the manufacturer's instructions showed to prepare positive and negative control solutions for testing, and following the Directions for Use, submerge three test strips in each of the freshly prepared solutions for one second then remove. The three strips dipped in the full strength positive control solution should exhibit a complete purple color on the pad at 90 seconds. The three strips dipped in the diluted negative control should remain completely blue or have an incomplete color change to purple when read at 90 seconds. The manufacturer's recommendation is for testing of positive and negative controls to be performed on each newly opened test strip bottle of Cidex OPA Solution Test Strips. After the initial testing, controls for QC should be performed at regularly established times. The purpose of the QC testing was to minimize errors between different users, prevent the use of outdated materials or product that had been improperly stored or handled.
3) Review of the manufacturer's instructions for the Soak Station GUS Wall-mounted disinfection equipment for transvaginal and transrectal ultrasound probes, model G10VPL on 02/15/19 at 1:38 PM showed the filters were to be changed every 6 months and could be changed by staff. This was verified with the Director of Radiology and Radiology Technician #1 at the time of manufacturer instruction review.
4) A current list of Radiology Equipment was provided by the Director of Radiology on 02/13/19 at 3:01 PM. The last preventive maintenance for the following equimpent listed as "in service" was 04/11/17:
a) Quantum Rad Room INDi XL Series, model # VZW 2930RB3-01
b) GE Portable X-ray AMX-4 IV, model #46-315161G1
c) X-rite Densitometer, model #331
d) Toshiba CT Scanner, model #TSX-101A/RD
e) Kodak CR Direct View, CR 825, model #K 4190-1096
f) Kodak CR Cassettes
g) Toshiba Aplio 500 Ultrasound Unit, model #USUG-A506A
h) Medrad Stellant CT injector, model #IPX1 201422

B. Review of radiology policy and procedure dated 05/17/18, titled "Radiation Protection Program Guidelines" provided by the Director of Radiology on 02/13/19 showed preventive maintenance for all diagnostic and therapeutic radiologic equipment was to ensure a safe working condition. Safety and calibration checks were to be conducted according to manufacturer's directions, but not to exceed one year intervals. Inspection of all leaded gloves, aprons and similar protective devices were to be conducted at least once a year with documentation to include: the name of the examiner, identification of the protective device examined and the results plus corrective action taken.

C. Review on 02/12/19 of the policy and procedure, dated 07/2011, and titled "Protective Lead Aprons" showed all lead shields, aprons, gonad and thyroid shields were to be inspected for cracks and breaks annually. The results of the inspection were to be documented on an apron inspection form located in the Quality Assurance Manual. By interview on 02/12/19 at 3:00 PM, Radiology Technician #1 stated that radiology staff performed the last CT scan of the barrier lead aprons on 03/15/17.

D. Observation of the Ultrasound Room with the Director of Radiology and Radiology Technician #1 on 02/15/19 at 1:08 PM showed the temperature of the Cidex OPA used for high level disinfection of transvaginal and transrectal ultrasound probes were not being maintained above the minimum temperature of 68 degrees F as required by the manufacturer for manual reprocessing. The room did not have heat or a way to regulate the temperature of the Cidex OPA solution.
1) The Cidex OPA test strip bottle currently in use was observed on the counter and the lid was not closed, which left the strips exposed. The test strips bottle was not dated when opened. The findings were verified by Radiology Technician #1 and the Director of Radiology at the time of observation.
2) Observation of the Ultrasound Room with the Director of Radiology and Radiology Technician #1 showed a GUS Wall-mounted soak station for disinfection of Transvaginal and Transrectal Ultrasound Probes, model G10VPL that was located in an adjacent room. The sticker on the GUS system showed the last service was 10/2017. There was no evidence the system had received routine maintenance since 10/2017. A copy of the manufacturer's instructions was received on 02/15/19 at 1:38 PM. Radiology Technician #1 verified all the findings. Documentation of the last filter change (performed by staff) was 12/2017 and this was confirmed by the Director of Radiology and Radiology Technician #1 on 02/15/19 at 1:50 PM.

E. Review of the Cidex OPA In-Use Solution Log Sheet on 02/15/19 at 1:40 PM showed from 09/28/19 - 01/31/19 the following:
1) The temperature of the Cidex OPA solution was documented below the minimum temperature of 68 degrees F a total of 16 of 29 times from 09/28/18 - 01/31/19.
2) Quality Control (QC) results were not documented when each test strip bottle was opened. The last date that was documented that a test strip bottle was first opened was 07/20/18 and a "do not use after" date of 10/20/18 was documented at the top of the form. There was no evidence a new test strip bottle was opened after 07/20/18 or after the do not use after date of 10/20/18 from 10/26/18 - 01/31/19. There was no evidence a QC was performed from 07/21/18 - 01/31/19.

F. Review of Invoice #2823 provided by the Director of Radiology showed the most recent physicist report was on 05/12/16. In a letter dated 05/16/16 and signed by Medical Physicist #1 it stated that the annual Radiology, Mammography and CT surveys were each tested to ensure compliance with state and federal regulations. On 02/12/19 at 2:37 PM while on tour, Radiology Technician #1 verified that the last physicist report was 05/12/16. The Director of Radiology verified on 02/13/19 at 3:00 PM that the 05/12/16 physicist report was the last physicist visit.

Based on observation, interview, review of Emergency Department Log and patient census, it was determined the facility failed to follow their policy to ensure an Emergency Room medical record was completed for 3 (#21 - #23) of 20 (#1 - #20) patients who were listed on the facility census for 02/03/19. Failure to have a medical record did not ensure patients would be identified and a record of emergency department treatment would be created. The failed practice affected Patients #21 - #23 and was likely to affect any patient who presented to the Emergency Department for treatment. Findings follow:

A. Review of the facility policy on 02/15/19 titled, "Emergency Department: Initiating Treatment," dated 04/10/08, showed all patients who present for treatment will have a chart initiated to document events in the emergency room and will be triaged by the nursing staff. The patient's response to treatment and all pertinent observations were to be documented.

B. On 02/15/19 a copy of the total census was received from the facility Information Technology Department. Patients #21, #22, and #23 were selected from the list for review of their medical records. The Emergency Log was reviewed and showed the names of Patients #21, #22 and #23 had been marked through. Another name had been written above the lined through the entry. On 02/15/19 at 11:30 AM the Emergency Room Supervisor provided printed copies of the following electronic documents:
1) Patient #21: The electronic print out for Patient #21 was dated 02/03/19. The document showed the patient type was Emergency Room. The date of service was 02/03/19. The description statement as entered by the facility showed "No cards. Patient left without being seen. Pts (patients) ARK Medicaid is inactive at this time."
2) Patient #22: The electronic print out for Patient #22 was dated 02/03/19. The document showed the patient type was Emergency Room. The date of service was 02/03/19. The description statement as entered by the facility showed "No cards. Patient left without being seen."
3) Patient #23: The electronic print out for Patient #23 was dated 02/03/19. The document showed the patient type was Emergency Room. The date of service was 02/03/19. The description statement as entered by the facility showed "No cards. Patient left without being seen."

C. In an interview with the Emergency Room Supervisor and the Director of Nursing on 02/15/19, at 12:40 PM they stated the nurse made an error on the log. The Emergency Room Supervisor stated the nurse on duty in the Emergency Department should not have marked through the patients' names and that the patients left while the nurse on duty was taking care of an emergency in the parking lot. She was not aware Patient #21, #22 and #23 had left until she went to call them back to a room. The Emergency Room Supervisor confirmed at the time of interview that there is no medical record associated with these patients for the visit listed on the electronic medical record or the Emergency Department Log.