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Based on interview and record review, the facility failed to comply with Rural Health Clinic (RHC) standards when the facility failed to conduct an evaluation of its total clinical program, at least annually, including a review of the number of patients served, volume of services provided, and a representative sample of RHC patient records. This failure had the potential for quality of care issues to go unnoticed and for the facility to not meet the needs of the patient population served by the RHC.

Findings:

On 6/6/18 at 3:46 pm, during an interview and concurrent record review with the Director Outpatient Clinics (DOC) and Certified Medical Assistant (CMA), the DOC was unable to provide documentation of the facility's required annual Clinic Program Evaluation and confirmed it was not available for review.

Based on interview and record review, the facility failed to ensure that required education, training, and competencies were completed for five out of seven employee files reviewed. This failure had the potential for staff to be performing work tasks and patient care without the necessary education, training, and competency validation.

Findings:

1. On 6/6/18 at 9:50 am, in an interview and concurrent record review, Human Resources Director (HRD) was unable to confirm primary source verification of licensure upon hire for Nurse Manager (NM) on 5/30/12. HRD confirmed that evidence of verification with the California Board of Registered Nursing was not in the employee file.

2. During an interview and record review on 6/6/18 at approximately 9:55 am, HRD indicated that a required Advanced Cardiac Life Support (ACLS - clinical interventions for the urgent treatment of heart attack, stroke and other life-threatening emergencies in adults and knowledge to carry them out) certification in the employee file for Registered Nurse (RN) E had expired on 3/18. It was confirmed with HRD that a copy of RN E's current ACLS certification card was not available.

A review of the medical records for Patients 13, 14, 16, 17, 18, 19, and 20, indicated that RN E had provided the post-procedure care for these patients and did not have a current ACLS certification card, required by her job description, at the time she provided the care.

HRD also indicated that a required Pediatric Advanced Life Support (PALS - clinical interventions for the urgent treatment of heart issues, breathing issues and other life-threatening emergencies in infants/children and knowledge to carry them out) certification was absent from NM's employee file. It was confirmed with HRD that a copy of NM's current PALS certification card was not available.

A review of the medical records for Patients 13, 14, 15, 16, 17, 18, 19, and 20, indicated that NM was present and participated in their procedures, when procedural/conscious sedation (a technique of administration of medications to induce a state that allows the patient to tolerate unpleasant procedures while maintaining heart and breathing function) was administered and did not meet the facility qualifications as outlined in the policy titled, "Conscious Sedation," revised 5/22/18.

A review of the facility policy/procedure titled, "Conscious Sedation," revised 5/22/18, indicated that to be qualified to perform conscious sedation, the Registered Nurse must be currently certified in ACLS and PALS.

3. On 6/7/18 at 8:05 am, during an interview and concurrent record review with Infection Control Nurse (ICN), it was confirmed that detailed flexible endoscope (an instrument used to examine the interior of a hollow organ or cavity of the body) cleaning and disinfection competencies were inadequate and had not been validated for Manager Purchasing (MP) responsible for cleaning and disinfecting flexible endoscopes. A review of the facility document titled, "Audit Tool: Sterilization & HLD (High Level Disinfection - the process of cleaning something with a chemical to destroy bacteria)," completed by ICN with MP, on 2/7/18, indicated "Endoscopes cleaned each endoscopy day, hung in cabinet, not touching each other" as the only validating competency statement.

4. On 6/7/18 at approximately 8:10 am, during an interview and concurrent record review with ICN, it was confirmed that written tests utilized to validate employee competency had not been graded. A review of the competency records for Environmental Services Staff (EVS), competency document EVS Infection Prevention Quiz, completed on 1/29/18, was not graded to validate competence. A review of the competency records for NM and RN E, competency documents Conscious Sedation Post Completion Test, completed on 9/13/18 and 9/12/13, were not graded to validate competence.

5. On 6/7/18 at 10:55 am, during an interview and concurrent record review with Director Plant Services (DPS), it was confirmed that EVS began orientation to the department before receiving adequate education and orientation to the facility. It was confirmed that EVS was hired on 1/12/17. A review of the facility Start of Work Orientation Checklist for EVS confirmed that she had started work on 1/24/17 and completed general facility orientation on 4/7/17. It could not be validated that she had completed initial education on the topics of emergency codes, utility/gas shut-off valves, evacuation plans, location of department fire extinguishers, disaster phone tree, and Safety Data Sheets, prior to beginning work on 1/24/17.


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6. During an interview on 6/6/18 at 2:30 pm, HRD accessed a computerized employee file for review. The file was for an Emergency Department RN (RN W) currently working in the Emergency Department (ED).

A review of the employee file indicated the ACLS certification card for RN W had expired. There was no current ACLS card in the employee file as required by the ER Nurse Job Description. HRD confirmed there was no current ACLS card and stated the employee would be contacted immediately for a copy of a new/current card.

Based on observation, interview, and document review, the hospital failed to have an emergency medication Crotalidae Polyvalent Immune Fab (anti-venom), an antidote to treat poisonous snake bites, available for patients. The hospital failed to store any anti-venom. This failure increased the potential for a negative outcome for patients bitten by a poisonous snake.

Findings:

A review on 6/5/18 of the manufacturer information for the Crostalidae Polyvalent Immune Fab (anti-venom) indicated, "A safe, effective way to treat...snakebites in the emergency setting...recommended initial dose...4 to 6 vials infused IV (directly into a vein) over 60 minutes. Repeat, if necessary, until initial control is achieved. Initial control is defined as complete arrest of local manifestations and normalization of coagulation test results and systemic signs..."

During an observation on 6/5/18 at 3:45 am in the medication room, it was observed that there were no vials of anti-venom. During an interview with the Pharmacy Nurse, she stated that there were rattles snakes in the area and that when patients got bitten, they would be transferred to another hospital that was about 30-45 minutes away.

During an interview on 6/5/18 at 10:43 pm, Licensed Nurse E (LN E) and Registered Nurse A (RN A) stated that that were rattlesnakes in the area. LN E stated she recently saw a rattlesnake on her property which was near the hospital. LN E and RN A both agreed that it could take several hours before getting to their rural hospital if a patient was bitten and then if they were transferred to another hospital, it would take at least another 45 minutes before getting treated. They acknowledged that prognosis would be better the sooner you administered the anti-venom and it would be a good idea to have some in the hospital.

Based on observation, interview, and record review, the facility failed to ensure that all equipment and supplies in the Emergency Department (ED) had not expired, and that medications and supplies commonly used in life-saving procedures were secured and available. This had the potential to put patients at risk for poor clinical outcomes including infection and inaccurate test results.

Findings:

1. On 6/4/18 at 2 pm, an inspection of the Pediatric (infants and children) Broselow cart (supplies and equipment needed for pediatric emergencies in a color coded system based on size) in the ED was conducted with Registered Nurse (RN) B. In the pink section of the Broselow cart, there were two intravenous needles and a bone marrow needle that expired in 6/2017.

During a concurrent interview, RN B confirmed the above items had expired.

2. During a concurrent interview and inspection of the cabinets and drawers in the ED annex room, on 6/5/18 at 8:15 am, RN B confirmed three vacutainers (containers to send specimens to the lab) expired in 10/2017.


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3. A review of the facility policy/procedure titled, "Management of Patients with Malignant Hyperthermia (a severe reaction to particular drugs that are often used during surgery and invasive procedures)," revised 3/2017, did not address checking the integrity of the malignant hyperthermia cart.

A review of the facility policy/procedure titled, "Crash Carts, Medications, Restocking, Sealing," revised 2/2014, indicated that crash carts (a wheeled cart used to carry and transport medications and equipment for use in an emergency) are to be checked daily by assigned personnel.

On 6/4/18 at 2:45 pm, during an observation and concurrent interview with Nurse Manager (NM), the malignant hyperthermia cart in the Post Anesthesia Care Unit (PACU) was observed. NM confirmed the cart was checked monthly to ensure it's integrity, rather than daily.

On 6/6/18 at 2:05 pm, during an observation and concurrent interview with Certified Medical Assistant (CMA), an emergency medication tote box for anaphylaxis (a severe, potentially life-threatening allergic reaction) was observed in a cabinet in the Rural Health Clinic medication storage room. The tote box was observed not to have tamper seals securing the box.

Based on observation and interview, the hospital failed to ensure the prompt disposal of biohazard waste. This failure had the potential to result in work-related injuries.

Findings:

During an observation on 6/4/18 at approximately 1 pm, a hazardous waste container in the CT Scan (special x-ray test) room was filled above the "full" line and was too full to be closed per regulatory requirements. During a concurrent interview, the Radiology Department Supervisor confirmed the container had been overfilled by weekend staff.

A review of the facility document titled, "Exposure Control Plan," indicated the containers must be replaced when two-thirds full.

Based on observation, interview, and document review, the hospital failed to appropriately store medications in accordance with manufacturers' specifications and professional standards of practice as evidenced by:

1. The hospital staff failed to store "protect from light" medications appropriately when Lidocaine with Epinephrine (medication used for local anesthesia) was stored under direct light. This failure increased the potential for administering compromised medications.

2. The hospital failed to have a beyond-use-date for opened medication suspensions in accordance with professional standards of practice for beyond-use dating. This failure increased the potential for administering compromised and/or expired medications.

Findings:

1. A review on 6/5/18 of the hospital policy titled, "Crash Cart Medication Inventory," dated 2/2015, indicated that the following medications and the quantity were to be found in the emergency crash cart:

*Adenocard (used to treat irregular heartbeats) 6 milligrams (mg)/2 milliliters (ml), #3
*Epinephrine (used to treat severe asthma and life-threatening allergic reactions) 1:10,000, #8
*Narcan (used to treat narcotic overdose in emergency situations) 0.4 mg/ml vial, #1
*Procainamide (used to treat heart rhythm problems) 100 mg/ml, #3
*Vasopressin (used in critical care environment to treat septic shock) 20 units/ml amps, #2

During an observation on 6/5/18 at 1:15 pm, in the Acute Care Nursing Station, the crash cart inventory had the following missing medications:

*Adenocard 6 mg/2 ml, #1
*Epinephrine 1:10,000, #7
*Narcan 2 mg/2 ml syringe, #1
*Procainamide 100 mg/ml, none found
*Vasopressin 20 units/ml amps, #3

During an interview on 6/5/18 at 1:16 pm, the Pharmacy Nurse stated there was a discrepancy between the hospital policy and what was actually stocked in the crash cart. She said that the hospital would review the contents of the cart to ensure that it was appropriately stocked.

A review on 6/5/18 of the hospital policy titled, "Crash Cart Medication Inventory," dated 2/2015, indicated that the following medications and the quantity were to be found in the emergency malignant hyperthermia (severe reaction that occurs to particular medications used during surgery) cart:

*Chilled normal saline (hydration solution) 3 liters in Emergency Room (ER) refrigerator
*Regular Insulin (used to treat hugh blood sugar levels) 100 units/ml x 1 in the refrigerator at nurse's station

During an observation on 6/5/18 at 1:15 pm in the Acute Care Nursing Station, the malignant hyperthermia cart inventory was observed and had the following missing medications:

*No chilled normal saline was found in the ER refrigerator
*No refrigerator at the nursing station

During an interview on 6/5/18 at 1:45 pm, the Pharmacy Nurse stated there was a discrepancy between the hospital policy and what was actually stocked in the malignant hyperthermia cart. She said that the hospital policy needed to be updated. She acknowledged the importance of having an adequately stocked emergency medication supply in case of an actual emergency.

2. A review on 6/5/18 of the document titled, "Revised USP Standards for Product Dating, Packaging, and Temperature Monitoring" indicated, "the beyond-use for multiple-unit containers as not later than (a) the expiration date on the manufacturer's container or (b) one year from the date the drug is dispensed, whichever is earlier."

During an observation on 6/5/18 at 3:59 pm, there were multiple opened suspensions that did not have a beyond-use-date. The multiple opened suspensions that did not have a beyond-use-date included:

*Megestrol Acetate Suspension (used to treat weight loss) 40 mg/ml 240 ml
*Lactulose Solution (for constipation) 10 grams/15 946 ml
*Guaifenesin Syrup (cough medicine) 473 ml
*Acetaminophen Liquid (pain reliever) 160 mg/5 ml

During an interview on 6/5/18 at 4:08 pm, the Pharmacy Coordinator stated that she did not know that liquids and suspensions should be dated with a beyond-use-date of 1 year or the manufactures' expiration date whichever is earlier once opened. She also stated that she would start dating as required within United States Pharmacopeia (USP) standards.

Based on observation and interview, during an initial walkthrough, the facility failed to maintain an environment free of disrepair and clutter. This failure had the potential to put patients at risk for infection when:

1. Paper signs were taped above a hopper sink and instrument-cleaning sink in the soiled utility room on the Acute Care Unit that prohibited surface disinfection (the process of cleaning something with a chemical to destroy bacteria).

2. Floor tiles were missing with exposed subfloor in Central Service that prohibited adequate sanitation and cleaning.

3. Holes were in the wall by the steam sterilizer in Central Service.

4. Unsuitable trim made from wood was above the steam sterilizer that prohibited surface disinfection.

5. Sheet of paper was taped over a wall-mounted observation camera in the Post Anesthesia Care Unit (PACU) that prohibited surface disinfection.

6. Wall covering was missing at the upper right corner of the warming cabinet in the Operating/Procedure Room that prohibited surface disinfection.

7. Anti-skid surface on the step of an exam table in the Rural Health Clinic Exam Room 3 was in disrepair, which prohibited adequate sanitation and cleaning.

8. Red tape in the Rural Health Dental Clinic instrument processing area marking the decontamination zone was cracked and in disrepair that prohibited surface disinfection.

9. Corrugated cardboard boxes were stored on the floor in the Rural Health Dental Clinic, resulting in potential for spreading microorganisms by insects potentially harbored in the corrugations of the boxes.

Findings:

1. On 6/4/18 at 1:09 pm, during an interview and concurrent observation with Environmental Services Staff (EVS), she observed and confirmed the paper signs above the hopper sink and instrument-cleaning sink could not be wiped down or disinfected.

2. On 6/4/18 at 1:40 pm, during an interview and concurrent observation with Manager Purchasing (MP), she observed and confirmed the floor tiles missing in Central Service prohibited adequate sanitation and cleaning.

3. On 6/4/18 at 1:40 pm, during an interview and concurrent observation with MP, she observed and confirmed holes in the wall by the steam sterilizer in Central Service.

4. On 6/4/18 at 1:40 pm, during an interview and concurrent observation with MP, she observed and confirmed the wood trim above the steam sterilizer in Central Service was unsuitable and prohibited surface disinfection.

5. On 6/4/18 at 2:45 pm, during an interview and concurrent observation with Nurse Manager (NM), she observed and confirmed the sheet of paper taped over the wall mounted observation camera in the PACU prohibited proper cleaning and surface disinfection.

6. On 6/4/18 at 2:45 pm, during an interview and concurrent observation with NM, she observed and confirmed wall covering was missing at the upper right corner of the warming cabinet in the Operating/Procedure Room that prohibited surface disinfection.

7. On 6/6/18 at 2:05 pm, during an interview and concurrent observation with Certified Medical Assistant (CMA) in the Rural Health Clinic, it was observed and confirmed that the anti-skid surface on the step of an exam table in Exam Room 3 was in disrepair, which prohibited adequate sanitation and cleaning.

8. On 6/6/18 at 3 pm, during an interview and concurrent observation with Registered Dental Assistant (RDA) in the Rural Health Dental Clinic, it was observed and confirmed that the red taped used for marking the decontamination zone of the instrument processing area was cracked and in disrepair prohibiting surface disinfection.

9. On 6/6/18 at 3 pm, during an interview and concurrent observation with RDA in the Rural Health Dental Clinic, it was observed and confirmed that corrugated cardboard boxes were being stored on the floor, resulting in the potential for spreading of microorganisms by insects potentially harbored in the corrugations of the boxes.

Based on observation, interview, and record review, the facility failed to monitor temperature and humidity in sterile supply storage areas and temperature laboratory refrigerator/freezers according to nationally recognized standards. This failure had the potential to adversely affect the integrity of the sterile supplies and laboratory test results.

Findings:

A review of the facility policy titled, "Storage of Sterile Supplies," revised 3/2017, indicated that all sterile supplies should be stored in a secure location, which maintains the integrity of the sterile item. Storage of sterile supplies should be done under conditions, which tend to preserve, not threaten the integrity of the packaging.

A review of the facility policy titled, "Equipment Logs and Guidelines," dated 2/2015, indicated that temperature and humidity are monitored and recorded daily. Days when closed, the log will read "CLOSED."

On 6/4/18 at 2:45 pm, during an interview, concurrent observation and record review with Nurse Manager (NM) in the Operating/Procedure Room, she confirmed that temperature and humidity were not monitored or recorded on days the room was not in use. A review of the Surgery Temperature and Humidity Log for the months of April - June 2018 revealed numerous days when the temperature and humidity were not monitored or recorded, and simply indicated "closed" on the log.

On 6/4/18 at 2:45 pm, during an interview and concurrent observation with NM, it was observed and confirmed that temperature and humidity were not monitored or documented in the Ante Room outside of the Operating/Procedure Room. NM observed and confirmed the covered cart stored in the room contained sterile supplies.

On 6/4/18 at 8:20 am, during a walkthrough of the Laboratory it was noted that the facility Laboratory Temperature Log was missing documentation of refrigerator/freezer temperatures on 4/1/18, 4/20/18, and 5/10/19. In a concurrent interview, Lab Phlebotomist (LP) confirmed the temperatures were missing from the log.

On 6/4/18 at 8:25 am, during an interview and concurrent observation with Lab Manager (LM), it was confirmed the refrigerator/freezer temperatures should have been recorded on the facility Laboratory Temperature Log on 4/1/18, 4/20/18, and 5/10/18.

A review of the facility Laboratory policy titled, "Lab Assistant Daily Tasks," dated 3/2016, indicated refrigerator/freezer temperatures were to be monitored and recorded daily in the "AM."

On 6/4/18 at 3:25 pm, during a confirming interview and concurrent observation with Manager Purchasing (MP), it was confirmed that temperature and humidity were not being monitored in Central Service and in the facility Sterile Supply Area (cage) where sterile supplies are stored.

On 6/6/18 at 2:05 pm, during a walkthrough of the Rural Health Clinic with Certified Medical Assistant (CMA), it was observed and confirmed that temperature and humidity were not being monitored or recorded in the clinic sterile supply storage room.

Based on interview and record review, the facility failed to have a governing body that assumed full legal responsibility for determining, implementing, and monitoring policies governing the hospital's total operation and for ensuring that those policies were administered so as to provide quality health care in a safe environment as evidenced by:

1. Failure to have a credible review by the governing body of the hospital's quality plan. (Refer to C 241)

2. Failure to develop, implement, and annually review patient care policies. (Refer to C 270)

3. Failure to ensure surgical procedures were conducted in a safe manner in accordance with accepted professional standards. (Refer to C 320)

4. Failure to provide periodic evaluation and quality assurance review of all services provided directly and by contracted services. (Refer to C 330)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Organizational Structure.

Based on document review and staff interview, the governing body (Board of Directors: BOD) failed to ensure that the medical staff Bylaws, Rules and Regulations and Administrative Policies were carefully developed, revised, implemented, administered, and monitored; the Quality Assurance program included facility high risk areas; and allied health professionals were proctored per the facility policy, so as to ensure that quality health care was provided in a safe manner and safe environment. These failures permitted the hospital to operate without functional safeguards designed to ensure quality health care in a safe environment and could contribute to patient or staff harm.

Findings:

During an interview on 6/4/18 at 12:45 pm, the Chief Executive Officer (CEO) stated he was leaving on vacation in two hours and would be unavailable during the survey, but the Chief Financial Officer (CFO) would be available.

During an interview on 6/7/18 at 8:20 am, the Administrative Assistant (Admin) A said the CFO was unavailable, although she would be in to listen to the survey team's exit conference. Admin A was asked if the CEO could answer questions by phone and she said the CEO was not available by phone. Admin A said she would answer any questions to the best of her capability.

1. The facility policy, titled, "Policy and Procedures, Management of," dated 6/2015, indicated, policies and procedures including department specific procedures will be reviewed at least annually.

A review of the facility's policies indicated the following policies and their last revision or review dates: Triage Guidelines, 3/2006; EMTALA Patient Transfer,10/2015; Monitoring Effects of Drugs - Medication Error Reporting, 4/2014; Administration of Medications, 4/2014; Prescribing/Ordering General Practices, 4/2014; Crashcarts, 4/2014; Refrigerated Drug Storage, 2/2006; Drug Procurement Inventory Control, 2/2014; Fentanyl Patch Order, 8/2015; Medication Error Reduction, 1/2015; Antimicrobial Stewardship, 7/2015; Maintenance of Dental Equipment, 11/16/05; Statin Autoclave, 7/25/02; Clinic Triage Guidelines, 6/2002; Lab Assistant Daily Tasks, 3/2016; Management of Patients with Malignant Hyperthermia, 3/2017; Storage of Sterile Supplies, 3/2017; Access to Central Supply, 9/2016; Equipment Logs and Guidelines, 2/2015; Event-Related Shelf Life and Sterile Packaging, 3/2017; Outpatient Procedures, 3/2017; Surgical Site Identification and Time Out Process, 2/2015; High Level Disinfection of Endoscopes, 2/2015. The High Level Disinfection of Endoscopes policy used as a reference, the 2006 AORN (Association of periOperative Registered Nurses).

During a concurrent interview and review of the above policies and dates on 6/7/18 at 9 am, Admin A confirmed, according to the facility's policy, all patient care policies were reviewed annually through the Medical Executive Committee (MEC) ending with the Board of Directors (BOD). Admin A confirmed many were past due. Admin A was unable to explain why the MEC and BOD reviewed and approved the High Level Disinfection of Endoscopes policy, on 1/2015, when the policy referenced and used 2006 AORN guidelines.

2. During a concurrent interview and document review, on 6/7/18 at 9 am, Admin A provided a current copy of Medical Staff Bylaws Rules and Regulations, revised 8/14/2004. Admin A said a revised copy would go to the Board of Directors for final approval on 6/28/18. Appendix III Rules and Regulations for The "Medical Staff Bylaws, Revised 8/12/04" were reviewed and indicated the following: Section 9.3-2 Medical Executive Duties (c) receiving and acting upon reports and recommendations from medical staff committees, and assigned activity groups; (d) recommending actions to the board of directors on matters of a medical -administrative nature; (f) evaluating the medical care rendered to patients in the hospital. 9.3-3 Meetings The medical executive committee shall meet as often as necessary, but at least once a month and shall maintain a record of its proceedings and actions. 9.12 Quality Assessment Committee 9.12-1 Composition The quality assessment coordinator shall consist of the medical executive committee, quality assessment coordinator, medical staff coordinator, director of nursing services, and the chief executive officer. 9.12-2 Duties (a) recommend for approval of the medical executive committee and board of directors plans for maintaining quality patient care within the hospital. (iv) monitor the results of quality assessment activities throughout the hospital. Appendix III Rules and Regulations for Allied Health Professionals E. Evaluation Review and Discharge Policies A. Allied health professional shall be subject to a continuing audit by the attending physician. A probationary review after 90 days will be formalized by and through the credential committee. Protocols and operating procedures will be reviewed annually.

Admin A stated the MEC and BOD reviewed the Quality Assurance Committee minutes. When asked what the CEO and BOD understood about the Quality Improvement process, Admin A was unable to explain and deferred the question to the CEO and CFO.

Admin A stated the facility felt since they were so small, QA only needed to be reported quarterly, not monthly. She confirmed during the last year from 4/2017 through 4/2018, three QA reports were reviewed by the MEC, 7/2017, 1/2018, and 4/2018. Admin A also confirmed there was no monthly MEC meeting during 11/2017 and 12/2017.

Issues found on survey relating to pharmacy, nursing, clinic, dietary, infection control, policies, quality improvement and not part of the current QA program were discussed with Admin A. Admin A could not provide an explanation as to why these issues had not been identified or why they were not part of the facility's current QA program and deferred these questions to the CEO and CFO who were not available.

3. Admin A provided Appendix D from the policy and procedure manual that dealt with supervision and scope of practice for NPs and PAs. "Appendix D: Nurse Practitioner and Physician Assistant Supervision and Scope of Practice," dated 8/2016, was reviewed. It read under "Initial Evaluation for Both Nurse Practitioners and Physician Assistants: For the first 3 months, 20% of charts written by the Nurse Practitioner or Physician Assistant will be randomly selected and reviewed and co-signed by the collaborating or supervising supervisor each month. For the following 3 months, 20 randomly selected charts written by the Nurse Practitioner or Physician Assistant will be reviewed and co-signed by the collaborating or supervising physician." "Continuing Evaluation: Monthly review and co-signature by the collaborating or supervising physician, or alternate collaborating or supervising physician, of 5% randomly selected charts written by the Nurse Practitioner or Physician Assistant."

During an interview on 6/7/18 at 11:30 am, the Director of Outpatient Clinics stated she did not have access to proctoring reports on NPs and PAs, and deferred to the Clinical Informatics Nurse (CI) who was unavailable.

During a concurrent interview and document interview with CI, on 6/12/18 at 8:30 am, records for three mid-level practitioners (PA 1, PA 2, and FNP 3) were reviewed. The policy requirements were met for one of the three mid-level practitioners.

CI stated PA 1 started work on 7/1/17. There were no co-signatures of physicians for either the first three months (7/1/17 - 9/20/17) or the second three months (10/1/17 - 12/31/17) of her employment. From 1/1/18 - 5/31/18, the required number of records, per the policy, had been reviewed and co-signed by her supervising physician.

CI stated FNP 3 was a long term provider. From 6/1/17 - 5/31/18, she had seen 1509 patients and 51 or 3% had been reviewed and co-signed by the supervising physician.

4. During an interview on 6/7/18 at 12:10 pm, the above issues relating to policy review, pharmacy, emergency and nursing services, and clinic and QA issues were discussed with BOD 1, as well as the unavailability of key staff during the survey including the CEO and CFO. He said the BOD depends upon reports from staff and he was not aware of multiple major issues. BOD 1 said it sounded like the facility needed another staff member.

Based on record review and interview, the facility failed to ensure its medical staff members reviewed and co-signed records of patients cared for by two of three mid-level health providers (Nurse Practitioners (FNP) and Physician Assistants (PA), in accordance with their policy and procedure. This lack of oversight has the potential to lead to substandard patient care and put patients at risk for poor outcomes.

Findings:

During an interview on 6/7/18 at 9 am, the Administrative Assistant (Admin) A said the clinic could provide reports showing physician supervision and co-signatures of patients seen by FNP's and PA's. Admin A provided Appendix D from the policy and procedure manual that dealt with supervision and scope of practice for NP's and PA's.

"Appendix D: Nurse Practitioner and Physician Assistant Supervision and Scope of Practice," dated 8/2016, was reviewed. It read under "Initial Evaluation for Both Nurse Practitioners and Physician Assistants: For the first 3 months, 20% of charts written by the Nurse Practitioner or Physician Assistant will be randomly selected and reviewed and co-signed by the collaborating or supervising supervisor each month. For the following 3 months, 20 randomly selected charts written by the Nurse Practitioner or Physician Assistant will be reviewed and co-signed by the collaborating or supervising physician." "Continuing Evaluation: Monthly review and co-signature by the collaborating or supervising physician, or alternate collaborating or supervising physician, of 5% randomly selected charts written by the Nurse Practitioner of Physician Assistant."

During an interview on 6/7/18 at 11:30 am, the Director of Outpatient Clinics stated she did not have access to proctoring reports on NP's and PA's and referred me to the Clinical Informatics Nurse (CI) who was unavailable.

During a concurrent interview and document interview with CI, on 6/12/18 at 8:30 am, records for three mid-level practitioners (PA 1, PA 2, and FNP 3) were reviewed. The policy requirements were met for one of the three mid-level practitioners.

CI stated PA 1 started work on 7/1/17. There were no co-signatures of physicians, as required by policy, for either the first three months (7/1/17 - 9/20/17) or second three months (10/1/17 - 12/31/17) of her employment. From 1/1/18 - 5/31/18, the required number of records, per the policy, had been reviewed and co-signed by her supervising physician.

CI stated FNP 3 was a long term provider. From 6/1/17 - 5/31/18 she had seen 1509 patients and 51 or 3% had been reviewed, and co-signed by the supervising physician instead of 5% as required by policy.

Based on observation, interview, and record review, the hospital failed to ensure that the provision of services was done in a safe manner, as evidenced by:

1. Failure to have numerous patient care policies reviewed by medical professionals. (Refer to C 272)

2. Failure to implement hospital policy for emergency medications when some of the medications of the emergency medication supply were not found in the crash cart as per hospital policy. (Refer to C 276)

3. Failure to ensure that infection control policies and practices were followed. (Refer to C 278)

4. Failure to ensure safe food handling practices and failure to ensure the nutritional needs of the patients were met. (Refer to C 273, C 279)

5. Failure to ensure nutritional care policies were reviewed annually by medical professionals. (Refer to C 280)

6. Failure to implement its triage (process of sorting people based on their need for immediate medical treatment) guidelines policy and procedure and its patient assessment/reassessment policy. (Refer to C 294)

7. Failure to implement physician orders. (C 297)

8. Failure to inspect radiation shielding devices according to manufacturer recommendations. (C 283)

9. Failure to maintain a current list of all contracted services, to ensure all contracted services are evaluated, and failure of the Chief Executive Officer (CEO) to provide oversight of contracted services. (C 291 and C 292)

10. Failure to develop and maintain current care plans for inpatients. (C298)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Provision of Services.

Based on interview and record review, the facility failed to ensure all patient care policies including those for the emergency department, pharmacy, central supply, perioperative, clinic, and lab departments were reviewed at least annually. This failure had the potential for unsafe care to occur including infections and medication errors.

Findings:

The facility policy, titled, "Policy and Procedures, Management of," dated 6/2015, was reviewed and indicated, policies and procedures including department specific procedures will be reviewed at least annually.

A review of the facility's policies indicated the following policies and their last revision or review dates: Triage Guidelines, 3/2006; EMTALA Patient Transfer,10/2015; Monitoring Effects of Drugs - Medication Error Reporting, 4/2014; Administration of Medications, 4/2014; Prescribing/Ordering General Practices, 4/2014; Crashcarts, 4/2014; Refrigerated Drug Storage, 2/2006; Drug Procurement Inventory Control, 2/2014; Fentanyl Patch Order, 8/2015; Medication Error Reduction, 1/2015; Antimicrobial Stewardship, 7/2015; Maintenance of Dental Equipment, 11/16/05; Statin Autoclave, 7/25/02; Clinic Triage Guidelines, 6/2002; Lab Assistant Daily Tasks, 3/2016; Management of Patients with Malignant Hyperthermia, 3/2017; Storage of Sterile Supplies, 3/2017; Access to Central Supply, 9/2016; Equipment Logs and Guidelines, 2/2015; Event-Related Shelf Life and Sterile Packaging, 3/2017; Outpatient Procedures, 3/2017; Surgical Site Identification and Time Out Process, 2/2015; High Level Disinfection of Endoscopes, 2/2015. The High Level Disinfection of Endoscopes policy used as a reference, the 2006 AORN (Association of periOperative Registered Nurses).

During a concurrent interview and review of the above policies and dates, on 6/7/18 at 9 am, Administrative Assistant (Admin) A confirmed, according to the facility's policy, all patient care policies were reviewed annually through the Medical Executive Committee (MEC) ending with the Board of Directors (BOD). Admin A confirmed many were past due but that they were in the process of implementing a new program that would include the date the policy was due to be reviewed and to notify the department manager. Admin A said she expected the program to be implemented by the end of June 2018.

Admin A was unable to explain why the MEC and BOD reviewed the policy relating to High Level Disinfection of Endoscopes in 2015 when the policy referenced 2006 AORN guidelines. She stated the CEO would be the one to answer that question, but he was unavailable.


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During a concurrent interview and record review, on 6/7/18 at 10 am, the Radiology Department Supervisor provided three departmental policies that had not been reviewed on an annual basis.

The policy titled, "Radiation Safety Policy" was three years out of date.

The policy titled, "Radiation Badge Monitoring Policy" was three years out of date.

The policy titled, "Patient Shielding Policy" was two years out of date.

These policies were not reviewed at least annually by a group of professional personnel at the facility as required.

Based on review of food and nutrition services policies and procedures and consultant Registered Dietitian interview, the hospital failed to ensure comprehensive development and implementation of policies and procedures associated with nutrition care delivery. Failure to ensure operational policies may result in lack of comprehensive nutrition assessment and medical nutrition therapy for patients who are nutritionally compromised.

Findings:

On 6/4/18 beginning at 3 pm, it was noted that the hospital was utilizing a policy and procedure manual intended for use in the Long Term Care Setting. While foodservice operations would be consistent in both the acute and long term care setting, there was lack of development of nutrition care policies and procedures specific to the hospital setting with respect to the provision of medical nutrition therapy.

In an interview on 6/7/18 beginning at 9:15 am, with the consultant Registered Dietitian (RD), he stated he was unaware of any hospital policies and procedures that reflected the scope and operations for clinical nutrition care.

Review of hospital policy titled, "Nutrition Screening and Assessment," dated 6/06, intended to provide guidance for nursing staff, listed a screening process intended to determine nutritional risk of inpatients. The document did not include operational procedures for the provision of nutrition care that would be implemented by the RD.

Based on observation, interview, and document review, the hospital failed to implement its policy for emergency medications when some of the medications of the emergency medication supply were not found in two emergency crash carts, and when medications were not safely secured in an emergency medication tote box. These failures had the potential for necessary medications not being available in case of an emergency and for unlicensed individuals to access medications.

Findings:

1. A review of the hospital's policy titled, "Crash Cart Medication Inventory," dated 2/15, indicated that the following medications and the quantity were to be found in the emergency crash cart:

*Adenocard (used to treat irregular heartbeats) 6 milligrams (mg)/2 milliliters (ml), #3
*Epinephrine (used to treat severe asthma and life-threatening allergic reactions) 1:10,000, #8
*Narcan (used to treat narcotic overdose in emergency situations) 0.4 mg/ml vial, #1
*Procainamide (used to treat heart rhythm problems) 100 mg/ml, #3
*Vasopressin (used in critical care environment to treat septic shock) 20 units/ml amps, #2

During an observation of the crash cart inventory in the Acute Care Nursing Station, on 6/5/18 at 1:15 pm, the following medications were observed to be missing:

*Adenocard 6 mg/2 ml, #1
*Epinephrine 1:10,000, #7
*Narcan 2 mg/2 ml syringe, #1
*Procainamide 100 mg/ml, none found
*Vasopressin 20 units/ml amps, #3

During an interview on 6/5/18 at 1:16 pm, the Pharmacy Nurse stated there was a discrepancy between the hospital policy and what was actually stocked in the crash cart. She said that the hospital would review the contents of the cart to ensure that it was appropriately stocked.

A review of the hospital's policy titled, "Crash Cart Medication Inventory," dated 2/15, also indicated that the following medications and the quantity were to be found in the emergency malignant hyperthermia (severe reaction that occurs to particular medications used during surgery) cart:

*Chilled normal saline (hydration solution) 3 liters in ER (Emergency Room) refrigerator
*Regular Insulin (used to treat high blood sugar levels) 100 units/ml x 1 in the refrigerator at nurse's station

During an observation of the crash cart inventory in the Acute Care Nursing Station, on 6/5/18 at 1:15 pm, the following medications were observed to be missing:

*No chilled normal saline was found in the ER refrigerator
*No refrigerator at the nursing station

During an interview on 6/5/18 at 1:45 pm, the Pharmacy Nurse stated there was a discrepancy between the hospital policy and what was actually stocked in the malignant hyperthermia cart. She said that the hospital policy needed to be updated. She acknowledged the importance of having an adequately stocked emergency medication supply in case of an actual emergency.


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2. On 6/4/18 at 1:32 pm, during an interview and concurrent observation with Licensed Nurse (LN) D and Registered Nurse (RN) A, they observed and confirmed there were unsecured saline flush syringes, syringes, and needles on a cart in the Acute Care Nurses Station, which were accessible to unlicensed individuals when the nurses' station was unattended.

On 6/4/18 at 2 pm, during an interview with Manager Purchasing (MP), she confirmed that saline flushes, syringes, and needles should be stored in a secure location inaccessible to unauthorized and unlicensed individuals.

On 6/6/18 at 2:05 pm, during an interview and concurrent observation with Certified Medical Assistant (CMA), an emergency medication tote box for anaphylaxis (severe, potentially life-threatening allergic reaction) was observed in a cabinet in the Rural Health Clinic medication storage room. The tote box was observed not to have tamper seals securing the box.

Based on observation, interview, and document review, the facility failed to maintain a system for controlling sources of infections in accordance with internal policies and procedures, nationally recognized infection control practices, guidelines, and regulations when items were not stored in a manner to prevent potential contamination, the environment was not maintained in a manner to allow for adequate cleaning and disinfection, and staff competencies were not evaluated for one employee, as evidenced by:

1. Paper signs were taped above a hopper sink (used for rinsing) and instrument-cleaning sink in the soiled utility room on the medical unit that prohibited surface disinfection (the process of cleaning something with a chemical to destroy bacteria).

2. Oral suction tips and tubing were hanging from the suction container, unprotected by a wrapper, in patient care areas resulting in potential contamination.

3. Floor tiles were missing with exposed subfloor in Central Service that prohibited adequate sanitation and cleaning.

4. Pegboard was on the wall in Central Service that prohibited adequate sanitation and cleaning.

5. Unsuitable trim made from wood was above the steam sterilizer that prohibited surface disinfection.

6. Colonoscopes (used to examine the bowel) were stored in an improper manner resulting in potential contamination.

7. A sheet of paper was taped over a wall-mounted observation camera in the Post Anesthesia Care Unit (PACU) that prohibited surface disinfection.

8. Temperature and humidity were not monitored on weekends, in areas where sterile supplies were stored.

9. Anti-skid surface on the step of an exam table in the Rural Health Clinic Exam Room 3 was in disrepair, which prohibited adequate sanitation and cleaning.

10. Red tape in the Rural Health Dental Clinic instrument processing area, marking the decontamination zone, was cracked and in disrepair that prohibited surface disinfection.

11. Table top instrument sterilizers in the Rural Health Dental Clinic were located in the designated decontamination zone of the instrument processing area, violating separation of clean and dirty areas.

12. Open boxes of peel packages, used for instrument sterilization, were stored on an open shelf above the instrument-cleaning sink in the Rural Health Dental Clinic, resulting in contamination of the packaging.

13. Sterile supplies were stored in the cupboard under the clean sink in the instrument processing area in the Rural Health Dental Clinic resulting in potential contamination.

14. Corrugated cardboard boxes were stored on the floor in the Rural Health Dental Clinic, resulting in potential for spreading microorganisms by insects potentially harbored in the corrugations of the boxes.

15. Competencies were not evaluated or documented for staff responsible for the cleaning and disinfecting of flexible endoscopes (an instrument used to examine the interior of a hollow organ or cavity of the body).

These failures had the potential to put patients at risk for infection.

Findings:

1. On 6/4/18 at 1:09 pm, during an interview and concurrent observation with Environmental Services Staff (EVS), she observed and confirmed the paper signs above the hopper sink and instrument-cleaning sink could not be wiped down or disinfected.

2. On 6/4/18 at 1:25 pm, during an interview and concurrent observation with Director Plant Services (DPS), he observed and confirmed the oral suction tips and tubing hanging from the suction containers, unprotected by a wrapper, in patient care areas resulted in the potential for contamination.

3. On 6/4/18 at 1:40 pm, during an interview and concurrent observation with Manager Purchasing (MP), she observed and confirmed the missing floor tiles in Central Service prohibited adequate sanitation and cleaning.

4. On 6/4/18 at 1:40 pm, during an interview and concurrent observation with MP, she observed and confirmed the pegboard on the wall in Central Service prohibited adequate sanitation and cleaning.

5. On 6/4/18 at 1:40 pm, during an interview and concurrent observation with MP, she observed and confirmed the wood trim above the steam sterilizer in Central Service was unsuitable and prohibited surface disinfection.

6. On 6/4/18 at 2 pm, during an interview and concurrent observation with MP, she observed and confirmed that two flexible colonoscopes were improperly stored in the flexible endoscope storage cabinet with the tips touching the surface of the bottom of the cabinet, resulting in contamination and potential damage to the tips of the scopes.

A review of the facility policy/procedure titled, "High Level Disinfection of Endoscopes," dated 2/2015, indicated that endoscopes were to be stored in a manner that protected the endoscopes.

7. On 6/4/18 at 2:45 pm, during an interview and concurrent observation with Nurse Manager (NM), she observed and confirmed the sheet of paper taped over the wall mounted observation camera in the PACU prohibited proper cleaning and surface disinfection.

8. On 6/4/18 at 2:45 pm, during an interview, and concurrent observation and record review, with NM in the Operating/Procedure Room, she confirmed that temperature and humidity were not monitored or recorded on days the room was not in use. A review of the Surgery Temperature and Humidity Log for the months of April through June 2018 revealed numerous days where the temperature and humidity were not monitored or recorded and indicated "closed" on the log.

On 6/4/18 at 2:45 pm, during an interview and concurrent observation with NM, it was observed and confirmed that temperature and humidity were not monitored or documented in the Ante Room outside of the Operating/Procedure Room. NM observed and confirmed the covered cart stored in the room contained sterile supplies.

A review of the facility policy titled, "Storage of Sterile Supplies," revised 3/2017, indicated supplies were to be stored in an area protected from moisture and under conditions which do not threaten the integrity of the packaging.

A review of the facility policy titled, "Equipment Logs and Guidelines," dated 2/2015, indicated that temperature and humidity are monitored and recorded daily. Days when closed, the log will read "CLOSED."

According to Association of periOperative Registered Nurses (AORN) Guidelines for Practice (2017), Guideline for Sterilization: Room temperature, humidity, and ventilation must be controlled in accordance with local, state, and federal policy and regulation. The shelf life is dependent on packaging material, storage conditions, transport and handling. An event must occur to compromise package content sterility. Events that may compromise the sterility of a package include moisture penetration.

9. On 6/6/18 at 2:05 pm, during an interview and concurrent observation with Certified Medical Assistant (CMA) in the Rural Health Clinic, it was observed and confirmed that the anti-skid surface on the step of an exam table in Exam Room 3 was in disrepair, which prohibited adequate sanitation and cleaning.

10. On 6/6/18 at 3 pm, during an interview and concurrent observation with Registered Dental Assistant (RDA) in the Rural Health Dental Clinic, it was observed and confirmed that the red taped used for marking the decontamination zone of the instrument processing area was cracked and in disrepair prohibiting surface disinfection.

11. On 6/6/18 at 3 pm, during an interview and concurrent observation with RDA in the Rural Health Dental Clinic, it was observed and confirmed that the tabletop instrument sterilizers were located within the designated decontamination zone of the instrument processing area, in violation of separation of clean and dirty areas.

12. On 6/6/18 at 3 pm, during an interview and concurrent observation with RDA in the Rural Health Dental Clinic, it was observed and confirmed that open boxes of peel packages used for instrument sterilization were stored on an open shelf above the instrument-cleaning sink in the decontamination zone, resulting in contamination of the packaging.

13. On 6/6/18 at 3 pm, during an interview and concurrent observation with RDA in the Rural Health Dental Clinic, it was observed and confirmed that sterile supplies were stored in the cupboard under the clean sink in the instrument processing area, resulting in potential contamination from moisture.

A review of the facility policy titled, "Storage of Sterile Supplies," revised 3/2017, indicated supplies were to be stored in an area protected from moisture and under conditions which do not threaten the integrity of the packaging. No sterile packages of any type shall be placed next to or below any sink.

14. On 6/6/18 at 3 pm, during an interview and concurrent observation with RDA in the Rural Health Dental Clinic, it was observed and confirmed that corrugated cardboard boxes were being stored on the floor, resulting in the potential for spreading of microorganisms by insects potentially harbored in the corrugations of the boxes.

15. On 6/7/18 at 8:05 am, during an interview and concurrent record review with Infection Control Nurse (ICN), it was confirmed that detailed flexible endoscope cleaning and disinfection competencies were inadequate and had not been validated for MP responsible for cleaning and disinfecting flexible endoscopes. A review of the facility document titled, "Audit Tool: Sterilization & HLD (High Level Disinfection)," completed by ICN with MP on 2/7/18, indicated "Endoscopes cleaned each endoscopy day, hung in cabinet, not touching each other" as the only validating competency statement.

Based on observation, dietary and administrative staff interview, and departmental document review, the hospital failed to ensure safe and effective delivery of food and nutrition services for 36 of 36 sampled patients when 1a) raw meat was not accurately labeled during the thawing process; b) food capable of supporting growth associated with foodborne illness were thawed without time/temperature monitoring; c) corrugated boxes were retained in food storage areas; d) food ingredient labels were discarded; e) there was a lack of cool down monitoring of leftover foods; 2) the ice machine on the nursing unit was not clean and not maintained in accordance with manufacturers' guidance; 3) two staff members exhibited facial piercings during food production activities; 4) chemical sanitizer was stored in the food production sink; 5) there was lack of an effective air gap in food service equipment and the nursing unit ice machine; 6) there was a torn and soiled refrigerator gasket in the nursing unit nourishment refrigerator and 7) Patient 31 was at nutritional risk and did not receive a comprehensive nutritional assessment.

Failure to ensure safe and effective implementation of food and nutrition services had the potential to result in promoting practices associated with foodborne illness, cross contamination (transfer of bacteria from one substance or item to another), and compromised nutritional status.

Findings:

Dietetic Services
1. During the initial tour on 6/4/18 beginning at 1 pm the following was observed:

a. The United States Department of Agriculture, Food Safety Inspection Service (USDA-FSIS) recommends that thawed ground beef is utilized within 1-2 days.

In the walk-in refrigerator there were multiple five pound packages of thawing ground meat. A five pound package of ground turkey was labeled as being pulled from the freezer on 6/3/18 with a use by date of 6/8/18. The package was mostly frozen. Similarly, there was a second package identified by Dietary Staff (DS) 1 as ground beef with a pull date of 5/31/18 with a use by date of 6/3/18. The package had a second label indicating a pull date of 6/3/18 with a use by date of 6/8/18.

In a concurrent interview, DS 1 stated a package usually took a minimum of two days to fully thaw. Based on labeling of the ground meat, DS 1 was unable to determine the pull date and acknowledged since it was thawed, it was likely that it was pulled prior to 6/3/18.

A review of a departmental policy titled, "Food Preparation," dated 2018, estimated thawing time as 24 hours for every five pounds of frozen meat in the refrigerator. The policy also guided staff to use thawed meat within 2 days.

b. Listeria monocytogenes, a bacteria associated with foodborne illness, can be found in ready -to -eat (RTE) meat and poultry products. Time/temperature control for food safety during the thawing process can minimize the risk of bacterial growth during food production and storage (USDA-FSIS)

In the two-compartment sink there was a one gallon water pitcher filled with running water containing a sealed one pound package of deli meat. In a concurrent interview, DS 1 stated the meat would be used to prepare sandwiches later in the day.

In a follow up observation, on 6/4/18 at 3:30 pm (two hours later), staff had added a second package to the water pitcher. Both packages were fully thawed, soft to touch. It was also noted the water temperature was 60°F (degrees Fahrenheit). In a concurrent interview, DS 2 stated there was no temperature monitoring of food items when thawing meat under running water.

A review of a departmental policy titled, "Thawing of Meats," dated 2018, guided "...the food product cannot remain in the danger zone (41°F to 140°F) for more than four hours..." including the time required to thaw, prepare, store and distribute the item.

c. During an observation on 6/4/18 at 1:15 pm, dietary staff was labeling sealed nutritional supplements obtained from a corrugated cardboard box. As staff was removing the supplements from the box, it contained a deceased black household fly. In a concurrent interview with DS 1, she stated when boxes of supplements were delivered from the food vendor, they were stored in the walk-in refrigerator. DS 1 also stated that depending on the item the corrugated box may be retained during storage.

In an interview on 6/4/18 at 10:30 am with the Infection Control Nurse (ICN), she stated staff should not be retaining corrugated boxes and she was unaware that dietary continued to retain boxes. She also acknowledged the hospital currently did not have a policy for staff guidance. In a follow up interview, on 6/4/18 at 4:30 pm, the ICN presented printed information that advised the removal of all cardboard boxes as they were susceptible to moisture, water, vermin and bacteria during warehouse or storeroom storage. In an additional interview, on 6/5/18 at 3:30 p.m., the ICN stated the hospital did not complete environment of care rounds which may have identified the observed practice.

d. The Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108282) requires that all affected packages of food labeled on or after January 1, 2006 identify on the label the names of the food sources of any major food allergens used as ingredients in the food. Providing the name of the food source on the label of packaged foods alerts consumers to the presence of a major food allergen and may prevent an inadvertent exposure (USDA Food Code 2017, Annex 3).

During an observation on 6/4/18 beginning at 1 pm in the two-door freezers adjacent to the food production area, there were multiple convenience food items such as ravioli, pizza, and chicken nuggets. The items were removed from their original packaging, including ingredients, potential allergens, and were unlabeled. In a concurrent interview, DS 1 stated that due to the lack of freezer space, the items were removed from boxes. In a follow up interview on 6/4/18 at 3:30 pm, the Dietary Services Supervisor (DSS) stated they used to maintain a binder with ingredients of the convenience items but was unsure of what happened to it. She also stated ingredients could be found from the food vendor's website, however acknowledged that only she and DS 1 had access to the computer. There would be no after hours or weekend access by staff to identify potential food allergens that could affect patient safety.

e. Potentially Hazardous Foods are those capable of supporting bacterial growth associated with foodborne illness. Protein and cooked starch based foods such as meat and potatoes are considered PHF's and require time/temperature control for food safety. Cooked PHF's require monitoring during the cool down process to ensure controls are within specified parameters (USDA Food Code, 2017).

During an observation on 6/4/18 beginning at 1 pm, there were two plates of food in the glass door refrigerator. In a concurrent interview, DS 1 stated the meals were leftovers from lunch and were intended for emergency room patients. DS 1 stated the meals were placed in the refrigerator at approximately 12 pm. In a follow up observation, on 6/4/18 at 2:10 pm, the temperatures of the chicken and potatoes were 60°F and 58°F respectively. In a concurrent observation with DS 1, the surveyor asked her to describe how the hospital ensured the food remained safe. DS 1 stated the item would be discarded if not consumed within 24 hours. DS 1 acknowledged there was no temperature monitoring after the item was placed in the refrigerator.

The facility policy titled, "Cooling and Reheating Potentially Hazardous Foods (PHF)...," dated 2018, guided staff to document cool down temperatures on the cool down log.

A review of the departmental document, with DS 1, titled, "Cool Down Log," dated 3/1-5/30/18, noted while there were entries on the log, they did not reflect individual leftover meals. It was also noted that meat sauce prepared on 5/30/18 was not monitored in accordance with facility guidelines. The guidance noted that once food dropped to 140°F, staff should begin the cooling process. The cooling process for the meat sauce was initiated at 5 pm when the recorded temperature was 102°F.

In an interview on 6/5/18 at 1:10 pm with DS 2, she indicated she was new to food production activities and at the time believed she filled out the form correctly. DS 2 also acknowledged she was not fully comfortable with the cool down concept and likely required additional training.

A review of position description titled, "FNS [Food and Nutrition Services] Director," dated 2018, noted it was the responsibility of this position for supervision of preparation and service of all food.

2. On 6/5/18 at 3:55 pm, preventative maintenance for the hospital's ice machine was reviewed with the Director of Plant Services (DPS). The DPS stated the ice machine was cleaned and sanitized on a quarterly basis using a cleaning/bleach solution. Observation of the internal components of the ice machine revealed widespread, significant build-up of white chalky material resembling coarse pepper on the components of the machine. There was also a black unidentifiable material on an interior drain hose of the machine. Additionally, there was a black substance on the sides and underneath the chute that dispersed the ice. The DPS acknowledged the machine was not maintained in a clean and sanitary manner.

In a follow up interview on 6/6/18 at 9:30 am, the DPS revealed that the chemical used to remove the build-up was "CLR," a calcium, lime rust remover, however, he indicated this was not the chemical recommended by the manufacturer. In a follow up observation on 6/6/18 at 3:50 pm, the DPS presented the solution used to sanitize the interior component of the ice machine along with manufacturers' guidance. The manufactures' label listed the product as a germicidal/bleach solution intended for use on non-porous surfaces such as walls and toilets. The product was not intended for food contact surfaces.

Manufacturers' guidance recommended a semi-annual cleaning of the ice machine with a caveat that "...More frequent cleaning and sanitization may be required in some conditions..." The manufacturer also recommended a specific scale away product as the cleaning solution as well as a 5.25% sodium hypochlorite (chlorine bleach) sanitizing solution. It would also be the expectation that the bleach used would be safe for use on food contact surfaces. Additionally, the manufacturer recommended inspections and cleaning of water hoses, inlet, dispensing and drain water valves and condenser.

It was also noted that the ice machine did not have an air gap to ensure protection from potential wastewater contamination.

The hospital document titled, "Maintenance Procedure for Cleaning and Sanitizing Ice Machines," revised 10/12, was not fully consistent with the manufacturers' guidance. The policy did not utilize the recommended ice machine cleaner and did not include the necessity to use food safe chemicals in the recommended concentrations. It is also the expectation that all food service equipment be clean to sight and touch (USDA Food Code, 2017).

3. During an observation of general food production activities on 6/5/18 and 6/6/18, between the hours of 8 am and 5 pm, it was noted that two dietary staff members retained facial piercings during food production activities. In an interview on 6/6/18 at 3:30 pm with the ICN and Administrative Staff (AS), they were unsure of the hospital's policy and whether facial piercings were allowed if covered or were not allowed. During a concurrent review, the dietary policy titled, "Dress Code," dated 2018, listed a recommendation as "7. ...no facial jewelry ..." Hospital employee handbook effective 11/1/16 guided staff "The wearing of rings or studs in nose, lip, tongue or eyebrow..." is prohibited.

A review of six hospital documents titled, "Sanitation Survey Form," from 12/22/17 through 5/25/18, failed to identify the presence of dietary staff with facial piercings. The section listing "no nail polish or excessive jewelry" was listed as in compliance in the six reviewed reports.

4. During food production observation on 6/5/18 beginning at 10:35 am, the chemical sanitation bucket was stored in the sink next to the stove. In a follow up observation on 6/5/18 at 11 am, dietary staff was observed draining vegetables in the sink with the chemical bucket present.

In an interview on 6/6/18 at 11:30 am, the DSS acknowledged that staff needed to find another place for the chemical bucket.

The facility policy titled, "Food Preparation," dated 2018, listed "10. Do not use...sanitizer in the food preparation or food storage areas in any way that could result in contamination..."

5. The USDA Food Code 2017 requires that equipment and fixtures utilized for the storage, preparation and handling of food shall discharge through a waste pipe that does not connect directly with the drainage system, rather discharges into the drainage system through an air break or air gap.

A general kitchen observation, on 6/4/18 beginning at 3:45 pm, revealed that the food production sink next to the stove and the two-compartment sink did not have air gaps.

In an interview on 6/5/18 beginning at 2:30 pm with the DPS, he confirmed there was no air gap. The DPS demonstrated that the two-compartment sink as well as the single food production sink drained directly into the facility grease trap which was directly connected to the waste water drainage system.

In an observation on 6/4/18 at 3:55 pm, it was also noted that while the ice machine in the hospital's nourishment room had a drain pipe for discharged water, the pipe was inserted below the rim level of the floor sink. It would be the standard of practice to ensure the installation of an effective air gap that was twice the diameter of the discharge pipe (USDA Food Code, 2017).

A review of six departmental documents, from 12/22/17 through 5/25/18, did not identify the lack of air gaps as an issue.

In an interview on 6/7/18 beginning at 9:15 am with the consultant Registered Dietitian (RD), he acknowledged the necessity for air gaps; however he had not identified this issue.

6. During a review of the nursing unit nourishment room on 6/5/18 beginning at 3:55 pm, in the presence of the POE, it was noted that the gasket on the under counter refrigerator was torn and was not clean. In a concurrent interview he acknowledged this was not identified.

In an interview on 6/6/18 at 3:30 pm, the ICN acknowledged that she did not routinely complete environment of care rounds.

Nutrition Care
7. Patient 31's medical record was reviewed and indicated she was admitted to the hospital on 12/20/17 with a diagnosis of a post-operative left hip wound infection. It was also noted that a wound culture, dated 12/19/17, indicated a Methicillin Resistant Staphylococcus Aureus (MRSA-an antibiotic resistant bacterial infection) of the wound.

In an interview on 6/4/18 beginning at 4:10 pm, Registered Nurse (RN) A stated that a nutrition risk screening was completed at the time of admission. RN A stated that if a patient was determined to be at nutritional risk, identified as a Priority 1 or 2, nursing staff would contact the RD and discuss the case. RN A also stated as an example, patients with enteral feedings would be a Priority 1 nutritional risk.

In a follow up interview with RN A on 6/5/18 at 9:30 am, she stated that since Patient 31 was eating well, she was not at nutritional risk and therefore was not referred to the RD.

The hospital policy titled, "Skin and Wound Assessment, Care and Treatment-Appendix VI," guided nursing staff to obtain an order for nutrition consult. There was no documented consultation.

In an interview on 6/7/18 at 9:15 am, the RD stated that he covered all clinical and nutrition needs of patients; however he left it to nursing staff to determine nutritional risk. He also stated he came to the facility weekly and checked patients at that time unless nursing initiated a referral. The RD acknowledged that he had remote access to inpatient records, however unless nursing staff completed a referral, he did not review inpatients for nutritional status outside of the weekly visits. He also stated it was rare that he received a physician consult.

Based on observation, interview, and record review, the facility failed to inspect radiation shielding devices according to manufacturer's recommendations. This failure had the potential to expose patients and personnel to radiation hazards.

Findings:

On 6/4/18 at 2 pm, observations made during a tour of the radiology department, and a concurrent interview with the Radiology Department Supervisor, revealed:

1. The facility had no policy and procedure in place for the routine inspection of shielding aprons and gloves, used for the protection of staff and patients.

2. The manufacturer recommended annual leak inspections for these shielding devices.

3. The facility had no inspection log or system to identify each shielding device as per manufacturer's recommendations.

4. There were three shielding devices, two vests, and one thyroid collar (used to protect the thyroid gland from radiation) that were folded over filing cabinets rather than being hung as per manufacturer's recommendations.

Based on interview and record review, the facility failed to maintain an accurate list of all services furnished under contracts or agreements, and to ensure that the list included the nature and scope of the services provided.

Findings:

During a concurrent interview and record review, on 6/6/18 at 9 am, Administrative Assistant (Admin) A provided a list of all contracts. Admin A confirmed some were current, while others had expired. On review, 56 of 253 (22%) contracts that appeared on the list had expired.

Admin A confirmed a formal contract review process did not exist, and that there was no formal contract review tool, setting forth contract performance standards/requirements, available for contract performance review by the facility.

Admin A confirmed the Chief Executive Officer (CEO) delegated contract review to the Department Directors. Absent CEO oversight, the Department Directors would have had to be asked if the contracts were current. The CEO was not available for interview.

A concurrent review of the contract list revealed that 25 of 253 (9.8%) listed contracts did not have the required nature and scope of the services provided.

Based on interview and record review, the facility failed to ensure the Chief Executive Officer (CEO), responsible for facility operations, provided direct oversight to ensure contractors of services furnished services that enabled the facility to comply with all applicable conditions of participation and standards.

Findings:

During a concurrent interview and record review, on 6/6/18 at 9 am, Administrative Assistant (Admin) A provided a list of all contracts. Admin A confirmed some were current, while others had expired. On review, 56 of 253 (22%) contracts that appeared on the list had expired, and 25 of 253 (9.8%) listed contracts did not have the required nature and scope of the services provided.

Admin A confirmed the CEO had been delegated contracting authority by the Board of Directors (Board), and in turn, the CEO had delegated contract review to the Department Directors. The CEO did not provide direct oversight to ensure a contractor of services furnished services that enabled the Critical Access Hospital (CAH) to comply with all applicable conditions of participation and standards for the contracted services.

Based on interview and record review, the facility failed to implement its triage guidelines policy and procedure for two of eight Emergency Department (ED) records (Patients 25 and 27) reviewed, and its patient assessment/reassessment policy for four of eight ED records (Patients 23, 25, 26, and 27) when when triage acuities were inaccurate and vital signs were not repeated in a timely manner (in accordance with the policy). This had the potential to result in a serious, rapid, and unrecognized decline in the conditions of Patients 23, 25, 26, and 27.

Findings:

The facility's policy titled, "Triage Guidelines," dated 5/2006, was reviewed and read, "Purpose: Triage is a system of classification for prioritizing patient care, medical screening, care and treatment. Each patient presenting to the hospital requesting or in need of medical care will be triaged into Level 1-5, based upon assessment by the Registered Nurse. . . . Triage Level I: Requires Immediate Resuscitation. . .Triage Level II: High Risk, Emergent. . . Examples of ESI Level 2: Consider Level II for any patient with Danger Zone Vital Signs:Any age with SPO2 (oxygen saturation) less than 90% on Room Air, chest pain, children with seizures. . .Triage Level III: Urgent. . . Level IV and V: non-urgent."

The facility's policy titled, "Patient Assessment/Reassessment and Care planning," dated 3/2017, was reviewed. Under a section titled, Emergency Services Reassessment it read: ESI Level 1 and 2: every 15 minutes unless directed by a physician. ESI Level 3: every 2 hours, after medication or treatment and a minimum of one hour prior to discharge. ESI 4 and 5: every 4 hours, and at least one hour prior to discharge."

1. A review of Patient 25's record indicated she presented to the ED on 3/8/18 at 11:49 am with a complaint of chest pain. The triage, done at 11:59 am, assessed Patient 25 as a Level 4 - non-urgent. Patient 25 had a pain level of 10 out of 10, oxygen saturation on room air was 88% and blood pressure (BP) was critically low at 72/49 (normal 110-120/70-80). Patient 25's BP was repeated at 1:15 pm and remained low at 86/52. No additional BP's or pain assessments were documented. Patient 25 was discharged from the ED and admitted to the hospital at 2:17 pm.

During a concurrent interview and record review on 6/6/18 at 9:25 am, the Chief Nursing Officer (CNO) confirmed the above findings and stated the Triage should have been a Level 2, not 4. She confirmed the BP should have been repeated within at least 30 minutes and confirmed no repeat pain assessment was done while Patient 25 remained in the ED.

2. A review of Patient 27's record indicated he was a nine month old who presented to the ED on 1/26/18 at 8:58 am with a complaint of new onset seizures. Pulse, respiratory rate and temperature were taken at 9:11 am. Patient 27 was assigned a Triage level of 5 - non-urgent. Vital signs were not repeated while Patient 27 remained in the ED. The ED physician noted Patient 27's last seizure had occurred while in the waiting room of the hospital. Patient 27 was transferred via lifeflight to another facility at 1:51 pm.

During a concurrent interview and record review on 6/6/18 at 4:15 pm, the CNO confirmed Patient 27 should have been at least a Triage Level 2 given his age and seizure activity. She confirmed there were no additional vital signs charted after 9:11 am although vital signs should have been repeated per their policy.

3. A review of Patient 23's record indicated he presented to the ED on 2/8/18 at 12:14 pm with testicular pain. He was assessed as Triage Level 3. The last vital signs were done at 2:39 pm. Patient 23 was transferred from the ED at 4:25 pm.

During a concurrent interview and record review on 6/6/18 at 9:50 am, the CNO confirmed Patient 23's vital signs were not rechecked one hour prior to transfer according to their policy.

4. A review of Patient 26's record indicated she presented to the ED on 3/3/18 at 1:59 pm with a complaint of her legs not working right. The last vital signs were done at 2:50 pm. Patient 23 was discharged from the ED at 4:45 pm.

During a concurrent interview and record review on 6/6/18 at 9:40 am, the CNO confirmed Patient 26's vital signs were not rechecked one hour prior to discharge according to their policy.

Based on observation, nursing staff interview, and medical record and nursing document review, the hospital failed to ensure effective delivery of nursing service in accordance with standards of practice and hospital policies for four of 36 sampled patients (Patients 31, 33, 34, and 32) when nursing staff failed to 1a) comprehensively assess and document an infected surgical wound for Patient 31; 1b) assess and reassess the pain levels for Patient 31; 1c) refer Patient 31 to the Registered Dietitian in accordance with nursing policy; 2) comprehensively assess and document a hospital acquired pressure wound for Patient 33. Staff also failed to ensure physician orders for wound treatment and complete an admission nutrition risk screening for Patient 33; 3) refer Patient 34 who was at moderate nutritional risk to the Registered Dietitian and 4) refer Patient 32 to the Registered Dietitian in accordance with physicians orders.

Findings:

1. Patient 31's medical record was reviewed on 6/5/18 beginning at 2 pm. Patient 31 was admitted on 12/20/17 with an admission diagnosis of a post-operative left hip wound infection. A review of a wound culture, dated 12/19/17, indicated a Methicillin Resistant Staphylococcus Aureus (MRSA-an antibiotic resistant bacterial infection) of the wound.

a. A review of a hospital document titled, "Patient Photos," dated 12/20/17 at 5 pm, indicated a photo of the surgical wound was taken. While the facility took a total of four pictures during the hospital admission, none of the photos were labeled as to the date and/or time they were taken, and two of the four photos were of poor quality and had no patient identifier. Additionally, there were no documented wound measurements.

In a concurrent interview, Registered Nurse (RN) A stated that when photos were taken, the "patient photo" form would be filled out. The information on the form included a patient label, date and time of photo, photo number, description of the wound, measurements, the name of the nurse completing the form and the hospital's department. RN A confirmed that the camera used to take pictures had the ability to designate a photo number and acknowledged the lack of wound measurements.

A review of an hourly rounding note, dated 12/21/17 at 2:52 pm, noted drainage from the wound. Similar documentation was entered on 12/25/17 at 6:40 am and 10 pm.

A review of physicians orders, from 12/21/17-12/27/17, revealed no documentation of any surgical wound treatment orders.

A hospital policy titled, "Skin and Wound Assessment, Care and Treatment," dated 10/30/09, provided specific instructions for camera operations. The policy noted that a single use wound measuring guide should be included in the photo depicting both the length and width of the wound. The policy provided specific clinical outcomes and interventions for non-pressure related injuries such as surgical wounds.

b. A review of admission physicians orders for Patient 31 included Norco 5-325 (a pain medication) every 4 hours as needed for moderate to severe pain. A review of the medication administration record (MAR) for Patient 31 revealed that Norco was given nine times from 12/21-27/17; however the effectiveness of pain control was not consistently evaluated.

A review of the hospital policy titled, "Pain Management," dated 3/18, noted that pain will be reassessed within 60 minutes following administration of pain medication with the reassessed score documented in the EMR (electronic medical record).

A review of the MAR for Norco 5-325 revealed a dose was given on 12/21/17 at 9:36 am. There was no pain reassessment. A second dose of Norco was given on 12/21/17 at 1:40 pm. There was no documented pain reassessment in accordance with hospital policy. On 12/24/17 at 7:20 am, nursing staff documented a pain level of 3-4; however Patient 31 did not want pain medication. On 12/24/17 at 9:24 am, nursing staff documented the administration of one dose of Norco. There was no documented nursing reassessment until 12/25/17 at 7:45 am. It was noted that nursing completed a second nursing shift assessment on 12/25/17 at 19:52 am. These shift assessments noted a pain scale of 3-4 and 0 retrospectively, "no pain medication needed." The MAR documented dosages of Norco on 12/25/17 at 8:05 am, 12:40 pm and 5:47 pm. The pain scale summary, information which was derived from the "Vitals Report," documented pain levels ranging from 2-4 after medication administration. There was no additional documentation or pain assessment to support administration and/or pain reassessment of the pain medication for the administered doses. Similar inconsistencies were noted on 12/26 at 8:18 am, 1:43 pm, when two additional doses of Norco were given.

c. In an interview on 6/4/18 beginning at 4:10 pm, RN A stated that a nutrition risk screening was completed at the time of admission. RN A stated that if a patient was determined to be at nutritional risk, identified as a Priority 1 or 2, nursing staff would contact the Registered Dietitian (RD) and discuss the case. RN A also stated nutrition risk rescreening was completed every 3 days.

Patient 31 was not assessed for nutrition risk at the time of admission. A nutrition risk reassessment screening was completed on 12/26/17, six days after readmission. It was also noted that on 12/23/17, Patient 31 had an albumin level (a measure or protein stores) of 2.3 grams/deciliter (a metric unit of measure, normal 3.4-4.8 gm/dl). Additional lab on 12/26/17 revealed an albumin of 2.4 gm/dl. Review of a hospital document titled, "Nutrition Screening, Acute Nursing," dated 6/5/18, indicated that an albumin of 2.4 gm/dl or less would be a Priority I-High nutrition risk patient.

It was also noted that throughout the course of hospitalization, Patient 31's hemoglobin (blood protein responsible for transporting oxygen) and hematocrit (a ratio of the total volume of red blood cells) were below normal. The values for hemoglobin were an average of 9.9 mg/dl (normal 11.5-16.2) from 12/20-12/26/17 and hematocrit values were an average of 30.7 percent (normal 37-48%). There was no nutrition assessment in relation to these values.

On 12/20/17 the physician ordered daily weights. With the exception of 12/21 and 12/26/17, there were no additional weights taken. It was also noted that there was no admission diet order. In an interview on 6/6/18 at 2 pm with ICN, she stated that Patient 31 was transferred between an acute and swing bed status and it appeared that when Patient 31 was admitted to the acute on 12/20/17, not all orders were rewritten, rather nursing staff processed the diet order from the patient's swing bed admission.

In an interview on 6/6/18 at 1:30 pm, the ICN confirmed the lack of documentation in accordance with facility policy for wound care, lack of treatment orders for the surgical wound, and lack of nursing referral to the RD for a patient at nutritional risk.

Hospital policy titled, "Patient Assessment/Reassessment and Care Planning," dated 3/18, noted that Priority 1 and 2 patients are referred for RD assessment.

2. Patient 33's medical record was reviewed on 6/6/18 beginning at 8:20 am. Patient 33 was admitted through the emergency room on 6/2/18 with symptoms including generalized weakness. A review of a nursing admission assessment, dated 6/2/18, described the patient as being at high risk for falls and at no risk for developing skin breakdown. There was no documented nutrition risk screening.

A review of a hospital document titled, "Assessment Report," dated 6/3/18 and signed on 7:37 pm, noted that "patient has pressure ulcer to coccyx." Additional documentation titled, "Hourly Rounding," dated 6/4/18 at 3:35 pm, was reviewed and noted a small decubitus on the left upper coccyx that was covered with a dressing. There was no additional description of the wound. A follow up hourly rounding note, dated 6/5/18 at 8 pm, noted the wound on the sacrum "appears to be an open blister with minimal serous drainage. Cleaned wound with skintegrity wound cleanser, applied sure prep, and dressed wound with hydrocolloid dressing ..." There was no additional wound description.

A review of physicians orders beginning on 6/3/18 failed to note physician ordered treatments for the pressure ulcer. It was also noted that nursing staff continued to assess Patient 33 as being at "no risk" of developing a pressure ulcer from 6/2/18 through 6/5/18 despite the development of a pressure wound on 6/3/18.

During an observation in the presence of the surveyor on 6/6/18 at 2:10 pm, the wound was confirmed. In a concurrent interview, RN A she stated while the hospital had a camera, it was old and the quality of the photos was poor.

Hospital policy titled, "Skin and Wound Assessment, Care and Treatment," dated 10/20/09, defined the assessment procedure to identify the presence of wounds. Once identified nursing staff would determine etiology and classification as well as a assigning a number to the wound followed by photographs. Would documentation would also include a comprehensive description of the wound including measurements and staging of wounds.

3. Patient 34's medical record was reviewed. Patient 34 was admitted on 3/5/18 with diagnosis including pneumonia (a lung infection). A comprehensive admission assessment, dated 3/5/18, noted Patient 34 lost 30 pounds within the previous six months that was attributed to medication changes. An admission diet order, dated 3/5/18, was a diabetic diet. A follow up nutrition rescreening, dated 3/8/18, designated the patient at moderate nutritional risk, a Priority 2. There was no documented referral, follow up or nursing consultation with the RD for evaluation of nutritional risk.

In an interview on 6/7/18 at 9:15 am, the Registered Dietitian (RD) stated that he covered all clinical and nutrition needs of patients; however he left it to nursing staff to determine nutritional risk. He also stated he came to the facility weekly and only checked patients at that time unless nursing did a RD referral. The RD acknowledged that he had remote access to inpatient records, however unless nursing staff completed a referral he did not review inpatients for nutritional status. He also stated it was rare that he received a physician consult.

A hospital policy titled, "Patient Assessment/Reassessment and Care Planning," dated 3/18, noted that Priority 1 and 2 patients are referred for RD assessment.

4. Patient 32's medical record was reviewed. Patient 32 was admitted on 1/2/18 with a diagnosis of heart failure. Admission physician's orders, dated 1/2/17, included a referral to the RD. There was no indication that nursing staff forwarded the request to the RD.

In an interview on 6/5/18 at 9:30 am with RN A, she stated if the patient was eating well, nursing staff probably did not see the necessity to complete the referral.

Based on medical record review, nursing staff interview, and document review, the hospital failed to ensure the development of care plans for three of 36 sampled patients (Patients 1, 31, and 33). Failure to ensure the development of care plans in accordance with patient status may result in unmet needs and lack of continuity of care. Additionally failure to develop measurable goals and objectives and routine reassessment of progress may result in extended hospital stays.

Findings:

1. Patient 31 was admitted on 12/20/17 with admission diagnosis of a post-operative left hip wound infection. It was also noted that a culture dated 12/19/17 indicated a Methicillin Resistant Staphylococcus Aureus (MRSA-an antibiotic resistant bacterial infection) of the wound. Medical record review was conducted on 6/5/18 beginning at 2 pm.

Review of hospital document titled, "Care Plan Report," from 12/20-12/27/17, noted the development of two care plans listed as pain management and exercise promotion. There was no care plan development to mitigate the risk of spreading the MRSA bacterial infection to patients, care staff and visitors.

A review of hourly rounding notes, dated 12/24/18 from 7 am-7:21 pm, noted the patient had visitors as well as ambulating in the hallways.

A review of nursing rounding notes, dated 12/25/17 from 6:40 am-7:04 pm, documented the wound was draining, the patient was ambulating in the building and had had visitors. Similar activities were noted on 12/26 and 12/27/17.

Centers for Disease Control recommends contact precautions when the hospital deems MRSA to be of special clinical and epidemiologic significance. Care plan development for contact precautions would ensure care is provided in accordance with standards of practice on patient placement, gloving, gowning, patient transport, patient care equipment and environmental measures.

A review of a hospital policy titled, "Patient Assessment/Reassessment and Care Planning," dated 3/18, guided staff to gather data from various clinical disciplines and integrate into the nursing care plan to effectively identify patient needs and promote coordinated care and services. The policy also described the elements of a care plan including patient needs, care goals, and interventions. The policy also guided nursing staff to chart progress toward care plan goals in the medical record and based on patient response the care plan may be modified.

In an interview on 6/6/18 beginning at 2:10 pm, the ICN acknowledged that there was no care plan developed for wound care or infection control measures for Patient 31.

2. Patient 33 was admitted through the emergency room on 6/2/18 with symptoms including generalized weakness. Medical record review was conducted on 6/6/18 beginning at 8:20 am. A nursing admission assessment, dated 6/2/18, described the patient as being at high risk for falls and at no risk for developing skin breakdown. There was no documented nutrition risk screening.

A review of a hospital document titled, "Assessment Report," dated 6/3/18 and signed on 7:37 pm, noted "patient has pressure ulcer to coccyx ..." The coccyx is a small triangular area at the base of the spinal column. Additional documentation titled, "Hourly Rounding," dated 6/4/18 at 3:35 pm, noted a small decubitus on the left upper coccyx that was covered with a dressing. There was no additional description of the wound. A follow up hourly rounding note, dated 6/5/18 at 8 pm, noted the wound on the sacrum "appears to be an open blister with minimal serous drainage. Nursing staff failed to develop a care plan in relationship to the development and treatment of a pressure ulcer after admission.


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3. Patient 1's record was reviewed and indicated she was admitted to the facility on 11/18/17. Further review of the record revealed no documented evidence that a care plan had been developed.

During a concurrent interview and record review, on 6/7/18 at 10 am, Registered Nurses (RN U and RN V) confirmed that there was no care plan in Patient 1's record.

Based on interview, and review of 10 outpatient procedure patient records and eight Emergency Department (ED) patient records, the facility failed to ensure:

1. A pertinent updated history and physical was completed for three of ten outpatients (Patients 11, 12, and 15). This failure had the potential for patient complications related to the procedures performed, when a re-examination of the patients' conditions prior to the procedures was not performed by Medical Doctor (MD) 2.

2. The proper transportation including the appropriate personnel and equipment was arranged, or refusal for transportation was documented for one of eight ED patients (Patient 22), when Patient 22 was transferred to another facility. This had the potential to result in a serious decline in the health of the patient.

3. The physician certification forms included a summary of the risks for two of eight ED patients (Patients 22 and 27). This failure had the potential to transfer individuals without their knowledge of the risks of the transfer.

Findings:

1. A review of the medical records for outpatient procedure Patients 11 and 12 indicated the required history and physical was completed more than 24 hours prior to the procedures and had not been updated before the procedures were performed. Both Patients 11 and 12 had outpatient urology procedures performed on 5/24/18. The history and physical performed by MD 2 for Patient 11 was dated 5/22/18 and the history and physical performed by MD 2 for Patient 12 was dated 5/8/18. An update to each history and physical should have included a re-examination of the patient by MD 2 and documentation of any changes in the patient's condition, since last seen.

A review of the medical record for outpatient procedure Patient 15 confirmed the required history and physical, prior to MD 2 performing the procedure, was not in the record.

On 6/5/18 at 8:30 am, during an interview and concurrent medical record review with Nurse Manager (NM), she confirmed the required history and physical updates for Patient 11 and Patient 12 were not documented. She also confirmed the required history and physical for Patient 15 was not in the record.

On 6/6/18 at 1:30 pm, during a concurrent interview with Health Information Management (HIM) Tech 1 and HIM Tech 2, they confirmed that a history and physical was required for outpatient non-sedation procedures, such as urology procedures. They also confirmed that the history and physical must be updated if more than 24 hours passed since the provider last performed the history and physical.

2. A review of Patient 22's record indicated he was a two year old who presented to the ED on 1/21/18 at 8:20 pm with a complaint of abdominal pain. He was transferred to another facility at 10:41 pm. The Transfer Consent and Physician Certification form included documentation that the mode of transfer was by private car. The necessary personnel and equipment sections were not completed. There was a section where the patient or patient's representative could indicate refusal of transportation, but this was left blank and not signed.

During a concurrent interview and record review on 6/6/18 at 10 am, the Chief Nursing Officer (CNO) confirmed sections of the form as stated above were not completed. The CNO stated she thought transportation would have been arranged if necessary and this was a documentation issue. She confirmed the refusal of transportation by Patient 22's family was not charted by either the nurse or physician.

The hospital's policy and procedure titled, "EMTALA Patient Transfer Policy," dated 10/2015, was reviewed. It indicated, "The Transfer Consent/Physician Certification and Orders shall be completed prior to transfer. The patient shall also consent/refuse the transfer in accordance with the sections identified for the patient."

3a. A review of Patient 22's record indicated he was a two year old who presented to the ED on 1/21/18 at 8:20 pm with a complaint of abdominal pain. He was transferred to another facility at 10:41 pm. The Transfer Consent and Physician Certification form had a section for risks to be documented and this was left blank.

During a concurrent interview and record review on 6/6/18 at 10 am, the CNO confirmed the risks of the transfer had not been documented.

b. A review of Patient 27's record indicated he was a nine month old who presented to the ED on 1/26/18 at 8:58 am with a complaint of new onset seizures. The Transfer Consent and Physician Certification form had a section for risks to be documented and this was left blank.

During a concurrent interview and record review on 6/6/18 at 4:15 pm, the CNO confirmed the risks of the transfer had not been documented.

Based on observation, interview, and record review, the facility failed to perform procedures in a safe manner for five of 36 sampled patients (Patients 11, 12, 13, 15, and 52) when:

1. Colonoscopes (used to examine the bowel) were stored with the tips touching the surface of the bottom of the storage cabinet resulting in potential contamination.

2. Facility sterilized supplies and instruments did not indicate an expiration date.

3. Temperature and humidity were not consistently monitored where sterile supplies were stored.

4. A malignant hyperthermia (a severe reaction to particular drugs that are often used during surgery and invasive procedures) cart was not checked daily for integrity.

5. Intravenous procedural sedation (a technique of administration of medications to induce a state that allows the patient to tolerate unpleasant procedures while maintaining heart and breathing function) privilege was not evident for a credentialed physician, Medical Doctor (MD) 3.

6. A log or register of surgical procedures performed was not kept as required.

7. Flexible endoscope (an instrument used to examine the interior of a hollow organ or cavity of the body) cleaning and disinfection procedures were outdated.

8. Patient history and physical was not performed and/or updated prior to urology (branch of medicine that deals with diseases of the urinary tract) procedures for three of 36 sampled patients (Patients 11, 12, and 15).

9. Time out or universal protocol (a national recognized safety measure which helps assure that the correct procedure is performed on the correct patient) was not being performed consistently for invasive procedures, for four of 36 sampled patients (Patients 11, 12, 13, and 52).

10. Advanced Cardiac Life Support (ACLS - clinical interventions for the urgent treatment of heart attack, stroke and other life-threatening emergencies in adults and knowledge to carry them out) and Pediatric Advanced Life Support (PALS - clinical interventions for the urgent treatment of heart issues, breathing issues and other life-threatening emergencies in infants/children and knowledge to carry them out) certifications were not current for registered nurses participating in intravenous procedural sedation procedures.

11. Competencies were not evaluated or documented for staff responsible for cleaning and disinfecting of flexible endoscopes.

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Surgical Services and had the potential for adverse patient outcomes.

Findings:

1. On 6/4/18 at 2 pm, during an interview and concurrent observation with Manager Purchasing (MP), she observed and confirmed that two flexible colonoscopes were improperly stored in the flexible endoscope storage cabinet with the tips touching the surface of the bottom of the cabinet, resulting in contamination and potential damage to the tips of the scopes.

A review of the facility policy/procedure titled, "High Level Disinfection (the process of cleaning something with a chemical to destroy bacteria) of Endoscopes," dated 2/2015, indicated that endoscopes were to be stored in a manner that protected the endoscopes.

2. On 6/4/18 at 2:45 pm, during a walkthrough of the Operating/Procedure Room with Nurse Manager (NM), facility sterilized instrument trays were observed in the stainless steel/glass storage cabinets and the trays did not have expiration dates. A confirming interview with NM indicated expiration dating was not being utilized for facility sterilized supplies and instruments. NM was unsure as to whether or not the facility had a program flex for use of event-related shelf life (length of time an item may be stored without becoming unfit for use).

A review of the facility policy titled, "Storage of Sterile Supplies," revised 3/2017, indicated that any item sterilized by the facility was to be identified on the outside of the wrapper with the month, day and year sterilized, but did not indicate a program flex for use of event-related shelf life.

A review of the facility policy titled, "Event-Related Shelf Life and Sterile Packaging," revised 3/2017, indicated that sterility of facility sterilized items will be event-related rather than date-related and the integrity of the package will be the determining factor in establishing sterility of the sterilized items. The package wrapper will be identified by an event-related label, indicating "STERILE UNLESS OPENED." The policy did not reference a required program flex for use of event-related shelf life.

On 6/6/18 at 8:47 am, during an interview with MP, she confirmed the facility did not have the required program flex for use of event-related shelf life for facility-sterilized items.

3. On 6/4/18 at 2:45 pm, during an observation, interview and record review with NM in the Operating/Procedure Room, she confirmed that the temperature and humidity were not monitored or recorded on days when the room was not in use. A review of the Surgery Temperature and Humidity Log for the months of April through June 2018 revealed numerous days where the temperature and humidity were not monitored or recorded and indicated "closed" on the log.

During a concurrent observation and interview with NM, on 6/4/18 at approximately 2:45 pm, it was observed and confirmed that the temperature and humidity were also not monitored or documented in the Ante Room outside of the Operating/Procedure Room. NM observed and confirmed the covered cart stored in the room contained sterile supplies.

A review of the facility policy titled, "Storage of Sterile Supplies," revised 3/2017, indicated supplies were to be stored in an area protected from moisture and under conditions which did not threaten the integrity of the packaging.

A review of the facility policy titled, "Equipment Logs and Guidelines," dated 2/2015, indicated that temperature and humidity are monitored and recorded daily. Days when closed, the log will read "CLOSED."

According to AORN (Association of peri-Operative Nurses) Guidelines for Practice (2017), Guideline for Sterilization: Room temperature, humidity, and ventilation must be controlled in accordance with local, state, and federal policy and regulation. The shelf life is dependent on packaging material, storage conditions, transport and handling. An event must occur to compromise package content sterility. Events that may compromise the sterility of a package include moisture penetration.

4. On 6/4/18 at approximately 2:45 pm, during an interview and concurrent observation with NM, the malignant hyperthermia cart in the Post Anesthesia Care Unit (PACU) was observed and confirmed to be checked monthly, rather than daily to ensure integrity of the cart.

A review of the facility policy/procedure titled, "Management of Patients with Malignant Hyperthermia," revised 3/2017, did not address checking the integrity of the cart.

A review of the facility policy/procedure titled, "Crash Carts (a cart that carries medicine and equipment for use in an emergency), Medications, Restocking, Sealing," revised 2/2014, indicated that crash carts are to be checked daily by assigned personnel.

5. On 6/5/18 at 10 am, during an interview and concurrent record review with Administrative Assistant (Admin) A, a review of the credentialing file for MD 3 was found to be missing the intravenous procedural sedation privilege credentialing criteria and evidence of successful completion of the test. Admin A confirmed the documents were not in the file.

A review of the facility policy/procedure titled, "Conscious Sedation," revised 5/22/18, indicated that conscious (procedural) sedation is provided by those providers who have completed all required competencies. Individuals administering conscious sedation must be qualified and have the appropriate credentials.

6. On 6/5/18 at 1:20 pm, during an interview with NM, it was confirmed that a required log of procedures performed, including patient name, patient's identification number, date of procedure, name of provider performing the procedure, name of nursing personnel, type of anesthesia, procedure performed, pre and post-procedure diagnosis, and age of the patient was not being kept.

7. A review of the facility policy/procedure titled, "High Level Disinfection of Endoscopes," dated 2/2015, did not address current standards for cleaning and disinfection of flexible endoscopes. The policy/procedure referenced the AORN Standards, Recommended Practices and Guidelines, 2006 Edition rather than current standards (revised 2018).

On 6/5/18 at 3:15 pm, an interview with NM confirmed the facility policy/procedure titled, "High Level Disinfection of Endoscopes," dated 2/2015, to be the current policy/procedure.

8. A review of the medical record for outpatient procedure Patients 11 and 12, indicated the required history and physical was completed more than 24 hours prior to the procedure and had not been updated before the procedure was performed. Both Patient 11 and Patient 12 had outpatient urology procedures performed on 5/24/18. The history and physical performed by MD 2 for Patient 11 was dated 5/22/18 and the history and physical performed by MD 2 for Patient 12 was dated 5/8/18. There was no update to the history and physical, including re-examination of the patient by MD 2 and/or documentation of any changes in the patient's condition since last seen.

A review of the medical record for outpatient procedure Patient 15 confirmed the required history and physical prior to MD 2 performing the procedure was not in the record.

On 6/5/18 at 8:30 am, during an interview and concurrent medical record review, NM confirmed the required history and physical updates for Patients 11 and 12 were not documented. NM also confirmed the required history and physical for Patient 15 was not in the record.

On 6/6/18 at 1:30 pm, a concurrent interview with Health Informations Management Technician (HIM Tech) 1 and HIM Tech 2, confirmed that a history and physical was required for outpatient non-sedation procedure patients such as urology procedures. It was also confirmed the history and physical must be updated if more than 24 hours have passed since the provider performed the history and physical.

9. A review of the medical records for outpatient procedure Patients 11, 12, and 13, indicated that a time out was not performed immediately prior to their urological procedure and documented in their medical record.

A review of the facility policy titled, "Surgical Site Identification and Time Out Process," dated 2/2015, indicated that immediately prior to the start of the procedure, the entire team will by a "time out" and verify and confirm consent, patient name, correct side/site and procedure being performed, and document in the procedure record.

During an interview on 6/6/18 at 8:30 am, NM confirmed that a time out was not performed for outpatient procedures when sedation was not used, such as urology procedures. NM also confirmed that the facility did not have a policy in effect requiring a time out immediately prior to performing invasive procedures.

On 6/6/18 at 3:20 pm, during an interview and concurrent record review in the Rural Health Clinic with HIM Tech 3 and Certified Medical Assistant (CMA), they confirmed that Patient 52 had a suture removal office procedure by MD 3. HIM Tech 3 and CMA confirmed that a time out was not performed immediately prior to the procedure or documented in the patient record.

10. A review of the facility policy/procedure titled, "Conscious Sedation," revised 5/22/18, indicated that to be qualified to perform conscious sedation, the Registered Nurse (RN) must be currently certified in Advanced Cardiac Life Support (ACLS) and Pediatric Advanced Life Support (PALS).

On 6/6/18 at 9:50 am, an interview and concurrent record review with Human Resources Director (HRD) indicated that a required ACLS certification in the employee file for RN E had expired on 3/18. It was confirmed with HRD that a copy of RN E's current ACLS certification card was not available.

A review of the medical records for Patients 13, 14, 16, 17, 18, 19, and 20, indicated that RN E had provided the post-procedure care for these patients and did not have a current ACLS certification card, required by her job description, at the time she provided the care.

On 6/6/18 at 9:50 am, an interview and concurrent record review with HRD, indicated that a required PALS certification for NM was absent from the employee file. It was confirmed with HRD that a copy of NM's current PALS certification card was not available.

A review of the medical records for Patients 13, 14, 15, 16, 17, 18, 19, and 20, indicated that NM was present and participated in their procedures, when procedural/conscious sedation was administered, and did not meet the facility qualifications as outlined in the policy titled, "Conscious Sedation," revised 5/22/18.

A review of the facility policy/procedure titled, "Conscious Sedation," revised 5/22/18, indicated that to be qualified to perform conscious sedation, the RN must be currently certified in ACLS and PALS.

11. On 6/7/18 at 8:05 am, during an interview and concurrent record review with Infection Control Nurse (ICN), it was confirmed that detailed flexible endoscope cleaning and disinfection competencies were inadequate and had not been validated for MP responsible for cleaning and disinfecting flexible endoscopes.

A review of the facility document titled, "Audit Tool: Sterilization & HLD (High Level Disinfection)," completed by ICN with MP on 2/7/18, indicated "Endoscopes cleaned each endoscopy day, hung in cabinet, not touching each other" as the only validating competency statement.

Based on interview and record review, the facility failed to ensure that qualified providers were privileged to administer intravenous procedural sedation (conscious sedation, a technique of administration of medications to induce a state that allows the patient to tolerate unpleasant procedures while maintaining heart and breathing function). This failure had the potential for adverse outcomes for patients receiving intravenous procedural sedation by Medical Doctor (MD) 3.

Findings:

On 6/5/18 at 10 am, during an interview and concurrent record review with Administrative Assistant (Admin) A, a review of the credentialing file for MD 3 was found to be missing the intravenous procedural sedation privilege credentialing criteria and evidence of successful completion of the test. Admin A confirmed the documents were not in the file.

A review of the facility policy/procedure titled, "Conscious Sedation," revised 5/22/18, indicated that conscious sedation is provided by those providers who have completed all required competencies. Individuals administering conscious sedation must be qualified and have the appropriate credentials.

Based on observation, interview, and record review, the hospital failed to ensure the provision of services were performed in a safe manner, as evidenced by:

1. Failure to perform periodic evaluations of the quality improvement program. (Refer to C 331)

2. Failure to implement a food and nutrition services quality improvement program. (Refer to C 336)

3. Failure to perform routine evaluations of contracted services for food and nutrition services, medical records, and pharmacy. (Refer to C 337)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Periodic Evaluation and Quality Review.

Based on interview and record review, the facility failed to ensure it conducted a periodic (annual) evaluation of its Quality and Performance Improvement Program (QAPI) when it did not meet in 2017. This had the potential for a negative impact on quality care and patient safety.

Findings:

A facility policy titled "Quality and Performance Improvement Plan" last revised 4/2015, was reviewed and indicated that the purpose of QAPI to develop and implement and maintain an effective, ongoing hospital wide data driven quality, safety and performance improvement program in order to assess and to continuously improve the care and service they deliver to their patient. The QAPI program and the plan are measured and assessed annually through policy review and the appropriate committees and board directors.

During a concurrent interview and record review with the Quality Assurance Coordinator on 6/6/18, at 10 am, there was no evidence found in their records that the QAPI leaders carried out or arranged for a periodic (annual) evaluation of its quality improvement program and did not follow their policy.

Based on interview and hospital document review, the facility failed to ensure the development of a performance improvement program that reflected the depth and scope of food and nutrition services. Failure to evaluate and develop improvement plans for the service may result in practices that affect patient safety and medical status.

Findings:

Performance improvement is measuring the output of a particular process or procedure, then modifying the process or procedure to increase the output, increase efficiency, or increase the effectiveness of the process or procedure (Centers for Disease Control).

On 6/6/18 beginning at 1:30 pm, the hospital's performance improvement plan for food and nutrition services was evaluated. Performance indicators were submitted to the committee on 7/18/17 and 12/5/17, and 1/23/18. Performance indicators listed included resident preference tray cards updated, disaster storage inventory updated, and disaster binder up to date. The goal for each of these three indicators was listed as 95 percent (%) compliance. It was noted that the department maintained 100% compliance for greater than 12 months. There was no evidence that continuing to collect or present the specified elements demonstrated an opportunity for improvement. It was also noted there was no evaluation of operational processes within food services or nutrition care.

In an interview on 6/7/18 at 9:15 am, with the consultant Registered Dietitian (RD), his responsibilities were described as covering all clinical nutritional needs as well as providing some oversight to foodservice operations. He also stated, to his knowledge, there were no performance improvement indicators for either foodservice or clinical nutrition care. He also stated, to his knowledge, the Chief Nursing Officer assumed the responsibility of the performance improvement program. The facility did not identify opportunities for improvement in relationship to safe food handling practices, sources of cross contamination in food production and/or storage, or lack of effective nutrition referral and assessment for hospitalized patients.

Review of position description titled, "QA/UR/EHS (Quality Assurance/Utilization Review) Coordinator," dated 2/14, revealed it was the responsibility of this position to demonstrate effectiveness in planning and implementing the quality improvement program to meet the needs of the facility.

Based on interview and document review, the hospital failed to ensure its contracted service for pharmacy, clinical records, and dietitian services was adequate when they were unable to provide evidence the services had been evaluated. This had the potential to result in an increase in medication errors, decline in patient health and nutritional status, and inaccurate and incomplete medical records.

Findings:

1. A list of the contracted services included a pharmacy consultant. During an interview on 6/7/18 at 12:05 pm, the Pharmacy Nurse confirmed the pharmacy consultant reviews and revises all pharmacy related policies and procedures.

A review of the Medication Error Reduction Plan policy indicated it was last reviewed on 1/2015.

A review of other pharmacy related policies indicated the following revision or review dates: Monitoring Effects of Drugs - Medication Error Reporting, 4/2014; Administration of Medications, 4/2014; Prescribing/Ordering General Practices, 4/2014; Crashcarts, 4/2014; Refrigerated Drug Storage, 2/2006; Drug Procurement Inventory Control, 2/2014; Fentanyl Patch Order, 8/2015; and Antimicrobial Stewardship, 7/2015.

During an interview on 6/6/17 at 4:15 pm, the Chief Nursing Officer confirmed the pharmacy consultant could not provide evidence of an annual review of the medication error reduction plan for 2016 and 2017.

2. During an interview on 6/6/18 at 8:15 am, the Health Information Management Director said the facility has a contract with a RHIT (Registered Health Information Technician) who provides supervision and oversight to her and to the facility's HIM department. A copy of the RHIT consultant's contract was provided and was current.

During an interview on 6/7/18 at 9 am, the Administrative Assistant (Admin) A stated the Chief Financial Officer (CFO) would evaluate the RHIT contract, but was not present in the facility and was unavailable to answer questions. She said she was unsure who would evaluate the pharmacy consultant's contract. Admin A was unable to produce an evaluation for the RHIT consultant and said she was unaware of any evaluation form that was used for any of the facility's contracted services.


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3. During the initial tour on 6/4/18 beginning at 1 pm, it was noted that the dietetic services was staffed by a dietary supervisor.

In an interview on 6/6/18 at 3 pm, the Dietary Services Supervisor (DSS) stated that Registered Dietitian services were established through a contract.

During the survey on 6/4-6/7/18, issues were identified related to safe food handling practices including but not limited to operations that put patients at risk for foodborne illness, environmental, physical and chemical cross contamination of food (Cross Reference W-279); lack of effective identification and referral of patients at nutritional risk (Cross Reference W-297); lack of effective policies and procedures for the implementation of nutrition care (Cross Reference W-273) and lack of development of an effective performance improvement program (Cross Reference W-337).

In an interview on 6/7/18 beginning at 9:15 am, the consultant Registered Dietitian stated he was unfamiliar with any evaluation of his contract. He also stated that he fulfilled the role of a preceptor for the DSS as she was completing an on-line training program.

In an interview on 6/7/18 at 4 pm, the Director of Plant Services (DPS) stated he was the administrative position responsible for food and nutrition services oversight. He also stated he did not evaluate the effectiveness of the services provided under this contract and it would be the responsibility of the department manager to evaluate the contract. The DPS stated he did not possess any professional certification or training in relationship to dietetic services. Neither the DPS nor DSS would have the specialized training or skill set to evaluate the effectiveness of services provided by the contracted Registered Dietitian.

Based on interview and document review, the hospital failed to implement hospital policy when nurses did not document their pain assessments after administering morphine (opioid pain medication) for one of 36 sampled patients (Patient 35). This failure increased the risk for adverse side effects and under treating pain due to the lack of monitoring of pain medication therapy.

Findings:

A review on 6/6/18 of the hospital policy and procedure titled, "Pain Management," dated 3/2017, indicated "The goal of pain management is to minimize the amount, duration and intensity of pain to a level that is acceptable to the patient...Patients will be assessed for the presence or absence of pain during the initial assessment and periodically thereafter...document assessment and patient responses in the EMR [electronic medical record]..."

A review on 6/6/18 of the clinical record indicated Patient 35 was in pain and was administered intravenous (IV, directly into the vein) morphine. Patient 35's physician's orders were for morphine 3 mg every two hour as needed for pain.

A review on 6/6/18 of the Medication Administration Record (MAR) indicated IV morphine was administered and there were missing assessments documented:

*8/15/17 at 6:30 am 3 mg administered but no pain scale assessment documented prior to administration and no reassessment
*8/15/17 at 9:50 am 3 mg administered but no pain scale assessment documented prior to administration and no reassessment
*8/15/17 at 5:47 pm 3 mg administered but no pain scale assessment documented prior to administration and no reassessment
*8/16/17 at 5:04 am 3 mg administered but no pain scale assessment documented prior to administration and no reassessment

A review on 6/6/18 of Patient 35's medication admission record (MAR) indicated Registered Nurse (RN) A was the nurse who administered the IV morphine to Patient 35. During an interview on 6/6/18 at 2 pm, RN A stated that the computer system did not support documentation of pain assessments before and after administering morphine. She said there really wasn't a place to document the pain assessment in the computer.

During an interview on 6/6/18 at 2:05 pm, Pharmacy Nurse stated, after the review of the above nurse assessments, there was no documented reason why missing assessments were not completed. She also stated the nurses also looked at behaviors to see if patients needed more or less pain medications; however, this information was also not documented in the clinical record. The Pharmacy Nurse acknowledged assessments were used to monitor for the appropriateness of the pain medication therapy. This was especially important for patients on opioids such as IV morphine.

Based on review of the disaster preparedness operational plan for dietetic services, hospital document review, and administrative interview, the hospital failed to ensure adequate food and water supplies when the planned patient and staff census was limited to 60 people. The hospital did not fully evaluate necessary staffing to care for patient needs during a widespread disaster. Failure to ensure food and water provisions in the event of a disaster may put both patients and staff at risk for undernutrition resulting in compromised nutritional status for patients and associated patient care activities.

Findings:

On 6/5/18 beginning at 9 am, the hospital's emergency preparedness plan for food services was reviewed with the Dietary Services Supervisor (DSS). In a concurrent interview, the DSS stated the feeding plan incorporated 60 people. This plan was intended to include hospital patients as well as the hospital's distinct part skilled nursing facility and staff. The surveyor asked the DSS how the hospital determined the number for feeding plan. The DSS stated this was the number determined by her predecessor.

In an interview and concurrent document review on 6/6/18 at 2 pm, with Administrative Staff (AS) B, of the hospital's Emergency Operations Plan, she acknowledged there was no assessment of the number of staff that may be required to care for the patients.

The scope of the plan included all hospital departments incorporating an all hazards approach addressing a full range of major disasters and other emergencies. The policy also indicated that the hospital "...will assist staff with support for food, water.." Additionally "...The dietary department will maintain a three day supply of emergency water and food per department policies and procedures.."

Review of the facility's bed capacity revealed there were nine general acute beds and 27 distinct part skilled nursing beds, all of which would rely on food and water from dietary services. Additionally, a staffing roster, dated 5/1/18, revealed there were greater than 40 employees including positions such as physicians, nursing, dietary, housekeeping, information technology, respiratory therapy, maintenance and ambulance staff all of which would be necessary to facilitate patient care in a disaster.