HospitalInspections.org

Based on record review and interview the hospital failed to ensure nursing personnel job descriptions were within standards set by the Oklahoma State Board of Nursing.

This failed practice had the potential for a licensed practical nurse (LPN) to practice outside their scope of practice and thereby increase the risk to patient safety.

Findings:

A review of Staff E, LPN, personnel file showed a document titled "Position Description: Licensed Practical Nurse" which included the following responsibilities:
~ the licensed practice nurse (LPN) assesses, plans, implements and documents and evaluates the nursing care for a group of assigned patients in the health care system
~LPN is accountable for implementation of the nursing process for an assigned number patients and directs subordinates in the implementation
~needs of patient will be assessed by LPN in collaboration with physicians, staff, patient and patient's family
~LPN is accountable for planning of procedures or tests and notifying the physician.

The "Oklahoma Nursing Practice Act" defines the scope of practice for an LPN includes but is not limited to:
~Contributing to assessment of health status of individuals and groups
~Participating in development/modification of plan of care
~Participating in the evaluation of responses to interventions

On 04/12/17 at 1:30 pm, Staff B stated this was the correct job description for the LPN.

Based on observation, interview, and record review, the hospital's Governing Body failed to:

a. ensure the reappointment process included evaluating the privileges requested by the applicant, and granting privileges within the hospital's scope of services and the applicants qualifications. (See tag A-0046)

b. ensure the hospital identified and evaluated all contracted services for quality and safety (See tag A-0084),

c. ensure the psychiatric unit was a safe and appropriate environment for all inpatient bedrooms on the psychiatric unit. (A-0144)

d. ensure the hospital developed and implemented an effective and active Quality Assessment and Performance Improvement program. (See tag A-0263);

e. ensure the hospital developed and implemented an effective infection control program to prevent, control and investigate infections and communicable diseases in patients and staff. (See tag A-0747, A-0748, A-0749, and A-0756.), and

f. ensure surgical services where provided according to national standards of practice. (See tags A-0747 and A-0940);

These failed practices had the potential to affect the quality of care for all patients receiving services at the hospital.



































GB

Based on interview and record review, the Governing Body failed to:
a. ensure the reappointment process included the granting of privileges requested by the medical staff applicants was approved in 8 of 8 practicioner files, and
b. acknowledge the supervision requirements for advanced practice registered nurses.

This failed practice had the potential for medical staff to perform unauthorized patient care services that were not within the hospital's scope of services and/or the applicant's qualifications and competencies.

Findings:

a. Reappointments

The hospital's "Medical Staff By-laws/ Rules and Regulations 06/16" showed reappointments and privileges would be recommended by the Credentials Committee to the medical staff and directed the medical staff's recommendations were to be "transmitted " to the Governing Body.

The credentialing files for 8 of 8 practioners (Staff W, X, Y , Z, AA, BB, CC,and DD) showed no documentation of the Governing Body's authorization for the privileges requested during the current reappointment period.

The credentialing file for Staff DD showed the Governing Body had granted Staff DD reappointment in 10/2012, 10/2014, and 10/2016 with no specific authorized privilege list associated with each reappointment.

On 04/19/17 at 2:15 pm, Staff R,the pharmacist, stated Propofol was administered in the OR. Staff DD provided anesthesia services and administered Monitored Anesthesia Care (MAC) for procedures such as endoscopy. MAC was not listed on staff DD's privileges. Staff CC also administered Profofol and MAC was not granted on the staff CC's privileges list.

On 04/18/17 at 9:30 am, Staff B and Staff EE stated it was an inconvenience for the Governing Body to sign the privilege list for applicants for each credentialing period. Staff EE stated the process would have to be changed as such that requests for reappointments and privileges would be associated with each credentialing period.

b. Supervision

The credentialing file for Staff AA, an advanced practice registered nurse, was reviewed. Staff AA's Oklahoma State Board of Nursing (OBN) license listed Staff Y and Staff DD as the "Supervising Physician for Certification".

The OBN's, "Agreement for Physician Supervising Advanced Practice Prescriptive Authority" documented the supervision of Advanced Practice Registered Nurses with prescriptive authority would oversee and accept responsibility for the ordering and transmission of written, telephonic, electronic or oral prescriptions for drugs and other medical supplies. Also, the agreement documented the supervising physician would be available for consultation, collaboration, assistance with medical emergencies, and patient referral through direct contact, telecommunications or other appropriate electronic means.

A review of the credentialing files for Staff Y and Staff DD showed no evidence the Governing Body had acknowledged both as supervising physicians for Staff AA. On Staff AA's privilege list was the handwritten phrase, "All privileges with Physician Supervision."

On 04/18/17 at 9:30 am, the Staff B and Staff EE stated they did not understand the credentialing supervision requirements of Staff AA.

Based on interview and document review, the hospital failed to ensure that contracted services were evaluated for safety and effectiveness.

This failed practice had the potential to increase the risk of substandard care and/or services to patients assigned to contracted staff.

Findings:

A review of an untitled document dated 02/01/17 showed all service contracts and equipment were evaluated by 7 criteria which was listed on the document. The document was reviewed and approved by the CEO, but not by the governing body.

A review of hospital policies showed no policy existed regarding the evaluation of contracted services.

No documentation was provided that showed contracted services had been evaluated by the governing body, who is responsible for oversight.

On 04/12/17 at 12:30 pm, Staff D stated the untitled document was the hospital's method of evaluating contracted services.

Based on record review, interview, and observation, the hospital failed to:

a. ensure all patients and/or patient representatives were provided patient rights information. ( see Tag A-0117)

b. ensure the Governing Body approved the grievance process, and were responsible for, or properly delegated, the operation of the grievance process, including grievance review and resolution. (see Tag A-0119)

c. establish a process for prompt resolution of patient grievances. (see Tag A-0122)

d. ensure the psychiatric unit was a safe and appropriate environment for all inpatient bedrooms on the psychiatric unit. (see Tag A-0144)

These failed practices had the potential to affect the rights of all patients admitted to the hospital, and the safety of those patients admitted to the inpatient psychiatric unit.

Based on record review and interview the hospital failed to ensure all patients and/or patient representatives were provided patient rights information.

This failed practice had the potential for patients and/or their representatives to be unaware of their rights as patients.

An untitled hospital document showed patient and/or patient representative were required to individually acknowledge receipt of the Inpatient Handbook, Swing Bed Handbook, Home Health Handout, Verbal Release Signed, and Advance Directive Handout among other items.

A document titled "Patient Handbook: A Guide to Your Stay" pages 4-6 contained Patients' Rights and Responsibilities.

Fifteen (Patients #1, 2, 3, 4, 7, 9, 10, 11, 12, 13, 14, 15, 17, 18, 21) of 22 medical records did not contain an acknowledgment by the patient and/or patient's representative of patient rights information by receipt of the "Inpatient Handbook".

Three (Patient #1, #3 and #16) of 13 medical records did not contain the notice of "An Important Message from Medicare" (IM) as required by Centers for Medicare and Medicaid.

On 4/20/17 at 12:30 pm, Staff B stated Patient Handbook given only to observation patients and in-patients at the time of admission. Outpatient surgery and Emergency Department patients do not receive the Patient Handbook at the time of admission. A check mark system is used to acknowledge receipt of admission paperwork including the Patient Handbook which includes patients rights and advance directives).

Based on record review and interview it was determined the hospital failed to:

a. provide written documentation to show the hospital's Governing Body approval for the grievance process, grievance policy, or responsibility delegation to a grievance committee.

b. ensure all data is reviewed, trended, and analyzed for grievances and/or complaints by the Governing Body or a Committee appointed by the Governing body.

c. ensure grievance data is incorporated in the hospital's Quality Assessment and Performance Improvement (QAPI) Program with analysis of the data and implementation of the grievance process to improve patient care.

d. ensure all complaints/grievances have an accurate tracking mechanism, and report accurate information to each delegated committee and/or the Governing Body.

This failed practice had the potential risk of repeated complaints/grievances on patient safety, patient care, and/or staff without rectifying the issues for improvement; and has the potential to neglect or omit submitted complaints/grievances pertaining to patient care and services provided; as well as report inaccurate information to the hospital's Governing Body or appointed committee.

Findings:

The hospital's policy titled, "Memorial Hospital Complaint/Grievance Policy" was presented to surveyors by hospital administrators. The policy did not contain a date or members' authentication of the Governing Body signifying approval of the document.

"Memorial Hospital Complaint/Grievance Policy" stated a grievance will be investigated and a final response will be formulated by the Compliance Officer; and may involve department manager and/or compliance committee which includes Administration, Director of Nursing (DON), and Compliance Officer. The grievances will be reported to the Quality Assurance (QA) committee monthly and the Hospital Board, as known as the Governing Body semi-annually.

Documents titled, "Memorial Hospital Medical Staff Quality Assurance Minutes", "Memorial Hospital Ancillary Quality Assurance Committee Minutes", "Medical Staff", and "Memorial Hospital Governing Board Minutes" were reviewed from dates ranging from June 2016 to April 2017. These documents did not contain any information pertaining to the grievance process being reviewed, trended, or analyzed by the Governing Body, appointed Committee, or QAPI.

According to the Complaint/Grievance policy, the hospital has a Compliance Committee. No Compliance Committee minutes were provided to show documentation of the committee reviewing, investigating, and/ or analyzing the hospital's submitted grievances.

The hospital's policy titled, "Memorial Hospital Complaint/Grievance Policy" stated:

~the Grievance/Compliance Officer is responsible for responding to complaints and/or grievances that are not resolved by the Charge Nurse and/or Director of Nursing.

~the Grievance/Compliance Officer will maintain grievances indefinitely as well as a grievance log.

~grievances will be reported to the Quality Assurance (QA) committee monthly and the Hospital Board, as known as the Governing Body semi-annually.

Documents titled, "Grievance Log 2017", "Patient Privacy Grievance Form", "Memorial Hospital Medical Staff Quality Assurance Minutes", "Memorial Hospital Ancillary Quality Assurance Committee Minutes", "Medical Staff", and "Memorial Hospital Governing Board Minutes" were reviewed.

Grievances for 2016

~"Grievance Log 2016" and "Patient Privacy Grievance Form" showed no grievances were submitted in 2016.

~"Memorial Hospital Medical Staff Quality Assurance Minutes" showed a total of 9 grievances submitted; 1 in May 2016, 4 in August 2016, and 4 in September 2016.

~"Memorial Hospital Ancillary Quality Assurance Committee Minutes" showed a total of 12 grievances submitted; 2 in June 2016, 2 in August 2016, 4 in September 2016, and 4 in October 2016.

~"Medical Staff" showed a total of 8 grievances submitted; 4 in August 2016 and 4 in September 2016.

Grievances for 2017

~"Grievance Log 2017" and "Patient Privacy Grievance Form" showed a total of 5 grievances; 3 in January 2017, 1 in February 2017, and 1 in March 2017.

~"Memorial Hospital Medical Staff Quality Assurance Minutes" showed a total of 4 grievances submitted; 3 in January 2017, none in February 2017, and 1 in March 2017.

~"Memorial Hospital Ancillary Quality Assurance Committee Minutes" showed a total of 4 grievances submitted; none in January 2017, 3 in February 2017 and 1 in April 2017.

~"Medical Staff" showed a total of 3 grievances submitted; 3 in January 2017 and none in February 2017.

~"Memorial Hospital Governing Board Minutes" showed a total of 3 grievances submitted; 3 in February 2017 and none in March 2017.

Surveyors requested (third request) grievances submitted in 2016 from the Grievance/Compliance Officer, Staff E, none were provided. Surveyors received grievances for 2014 instead.

On 4/17/17 at 1:37 PM, an interview was conducted with Staff E who stated she is not aware of issues, complaints, or grievances that go directly to Director of Nursing (DON) or the charge nurse. Surveyor inquired about a complaint which turns into a grievance as stated in the hospital's complaint/grievance policy. Staff E stated she is unsure because complaints are not documented.

Based on record review and interview, the hospital failed to establish a process for prompt resolution of patient grievances.

This failed practice had the potential to affect patient safety for grievances not being addressed or investigated.

Findings:

"Memorial Hospital Complaint/Grievance Policy" stated a written grievance should be in a sealed envelope labeled Compliance Officer, and filed with the hospital operator. The policy documented the hospital operator had within 30 days to submit the grievance to the Compliance Officer for investigation and resolution.

The hospital's policy titled, "Memorial Hospital Complaint/Grievance Policy" allowed 30 days, after a grievance is submitted, for a written response to be sent to the complainant.

The policy failed to ensure the nature of a grievance determined the time frame for investigating and resolving a situation(s). For urgent grievances, involving neglect and abuse, or situations that would endanger a patient, an immediate time frame would be required. For simple grievances, a shorter time frame than 30 days may be possible. For more complicated grievances, requiring extensive investigations, a 30 day time framed may be reasonable. CMS has determined 7 days as an appropriate average time frame for response, with most grievances also being resolved within that same time frame.

On 04/17/2017 at 1:37 PM, the hospital's grievance coordinator, Staff E, was not aware a 30 days period to respond to grievances would be unreasonable in situations involving serious allegations or potential patient harm..

Based on observation and interview, the hospital failed to ensure the psychiatric unit was a safe and appropriate environment for all inpatient bedrooms on the psychiatric unit.

This failed practice had the risk to injure patients by strangling themselves with the beds electrical cord or use the movable bed to barricade themselves in a bedroom.

Findings:

On 04/10/17 at 12:10 pm, during a tour of the inpatient psychiatric unit, the surveyor observed 10 of 10 hospital beds on wheels were not secured to the floor, and could be moved freely throughout the room. All the doors of the bedrooms opened inward to the patients' rooms.
The surveyor observed 4 of 10 bed's electrical cords were not secured in such a manner as to protect patients and prevent the cords from being used to strangulate.

On 04/20/17, Staff O stated the electrical cords on all psychiatric beds usually are protected by a rigid conduit, and the beds without them had been due to patients being transferred from the medical /surgical unit [in the medical/surgical unit beds] to the pysch unit.

Based on record review and interview, the hospital 's Quality Assessment and Performance Improvement program failed to:

a. develop a hospital-wide quality program that measured, analyzed, and tracked patient quality indicator data to improve health outcomes (see Tag A-0273)

b. ensure the hospital data collection was used to identify improvement opportunities, and to assist leadership in setting priorities for performance improvement activities based on patient safety, national standard of practice, quality of care and health outcomes and measurement of these activities to ensure sustainability (see Tag A-0283)

c. establish an on-going quality improvement program that tracked and analyzed medical errors and adverse patient events, and implemented preventative action plans (see Tag A-0286)

d. conduct annual quality improvement projects designed to improve the safety and quality of care (see Tag A-0297)

e. assign the Governing Body with full responsibility for establishing an on-going quality improvement program that included prioritizing and evaluating performance improvement efforts and conducting improvement projects annually (see Tag A-0309), and

f. provide adequate resources for establishing an on-going quality program that measured, analyzed and implemented improvements which were sustained (see Tag A-0315).


This failed practice had the potential to affect the safety and health of all patients receiving care due to the hospital's failure to identify risks and quality improvement opportunities and implement action plans to improve patient outcomes.

Based on record review and interview, the hospital failed to develop a hospital-wide quality program (through committee efforts and processes) that measured, analyzed, and tracked patient quality indicator data to improve health outcomes.

This failed practice had the potential to affect the safety and health of all patients receiving care due to the hospital's failure to identify risks and quality improvement opportunities, and implement action plans to improve patient outcomes.

Findings:

The surveyors requested the hospital's current Quality Improvement Plan and received a document titled, Quality Assurance Plan" dated 1988. The plan documented it would be reviewed annually.

The plan defined the program's responsibilities as pursuing opportunities to improve patient care, monitor and evaluate, and resolve identified problems. The plan failed to include the elements of measuring, and analyzing information. The plan documented the Ancillary Quality Assurance Committee was responsible for semi-annually monitoring and evaluating surgical services and providing annual monitoring of hospital-wide infection control.

On 04/18 17 at 9:30 am, the CNO stated there had been no updates to the plan.


The hospital's "Medical Staff Bylaws/Rules and Regulations" showed a multi-committee structure consisting of 9 committees that had operational and quality responsibilities.

On 04/18/17, Staff B,the CNO, who was also the Quality Manager, stated the hospital had and 2 additional committees, the Ancillary Quality Assurance Committee and Medical Quality Assurance Committee, which were not listed in the Medical Staff Bylaws. The CNO stated all committees were responsible for reporting information to the Governing Body.

The surveyors reviewed the following committees' meeting minutes from 01/17 to 03/17:
~Governing Body (which included credentialing, joint conference, medical record, pharmacy and therapeutic, environmental or infection, utilization review, transfusion, tissue and other special committees)
~Medical Executive Committee
~Medical Quality Assurance Committee
~Ancillary Quality Assurance Committee

The Governing Body minutes had a monthly attachment, which was an untitled one page document containing numerical data and bullet points information from the Ancillary Quality Assurance Committee, Medical Staff Quality Assurance Committee, and Medical Staff Committee. No topics were discussed in depth. The minutes recorded information with minimal data and no analysis to assist the Governing Body with the decision-making necessary to provide quality hospital services. There were no quality measurements, no evaluations or identifications of trends and root causes of topics listed.

The Medical Executive Committee minutes discussed general issues and identified problems such as missing orders, lab issues, infection control topics, and medical record completion back-log. There was no discussion as to the causes of issues or directives for a comprehesive action plan. There was no identification of the significant sterilization issues occurring in surgery and radiology. (see Tags A-0749 and A-0940).

The Medical Quality Assurance Committee minutes documented numerical statistics for set agenda topics. Grievance scenarios were listed, but not discussed. No identification of departmental and service line (including contract services) indicators and/or projects, no establishment of goals and action plans, no directive in the method of gathering data. Data was not analyzed or action plans developed to move issues towards sustained improvement. Although the Pharmacy and Therapeutic Committee gave a report within this committee, medication errors were not discussed, as provided on their report. The hospital's "Incident/ Accident Log March 2017" documented multiple wrong medication doses and missed medications. These medication errors were not discussed, trended, or analyzed within this committee or other committees.

The Ancillary Quality Assurance Committee minutes consisted of departmental reports which included general information broadcasts, numerical statistic information, nursing discussed various log deficiencies such as glucose monitoring and refrigerator temperature, and issues such as failure to complete admission screening needs had no discussion or action plan. The lab reported 2 possible transfusion reactions with one associated death, but had no discussion for a broader analysis of occurrences or trends identified. The minutes reflected only the data reporting and vague discussions of the Infection Control Committee. No evidence was found the surveillance activities were chosen and prioritized by the MEC. No evidence was found the MEC/GB provided direction for surveillance of infection control including detection, data collection and analysis, monitoring, and evaluation of preventive interventions. No benchmarks established or comprehensive quality improvement plan for noncompliance of activity.

The Ancillary Quality Assurance Committee and the infection Control Committee failed to ensure the disinfection / sterilization practices were according to manufacturer's guidelines and national standards for endoscopes, endoscope accessories, immediate use steam sterilization (IUSS), and steam sterilization through proper montioring, gathering data, trending and analyzing information and implementing action plans for quality patient outcomes.

The Governing Body allowed an unqualifiied staff to direct the Infection Control Program for the hospital. On 04/18/17, during an interview, Staff B, the CNO, and Staff E, the ICP, said a former staff had developed a number of infection control processes, which had not been reviewed or modified or approved by the Governing Body in recent years.

For Infection Control Findings, see Tags A-0747, A-0748, A-0479, and A-0756)


A document titled "Incident/Accident Log" showed type of incident/accident, date/time, person(s) involved, and information regarding the occurrence. No evidence of analysis for causes to implement preventative actions for medical errors and falls. January 2017 - March 2017 showed 10 wrong dose medications given, 13 missed medications, 2 near misses, 5 "variances", 1 injury, and 17 falls (16 patients, 1 visitor).

On 04/08/17 Staff B, the Quality Coordinator, stated these elements were not analyzed and trended and no action plans were developed.

Based on record review and interview, the hospital failed to ensure hospital used data collected to identify improvement opportunities to set priorities for performance improvement activities based on patient safety, quality of care and health outcomes and measurement of these activities to ensure sustainability.

This failed practice had the potential to affect the safety and health of all patients receiving care due to the hospital's failure to identify risks and quality improvement opportunities and implement action plans to improve patient outcomes.

Findings:

The hospital's "Medical Staff Bylaws/Rules and Regulations" were reviewed. This document outlined a multi-committee structure consisting of 9 committees that had operational and quality responsibilities.

The surveyors reviewed the following committees's meeting minutes from 01/17 to 03/17:
~Governing Body (which included credentialing, joint conference, medical record, pharmacy and therapeutic, environmental or infection, utilization review, transfusion, tissue and other special committees)
~Medical Executive Committee
~Medical Quality Assurance Committee
~Ancillary Quality Assurance Committee

The Governing Body minutes had a monthly attachment, which was an untitled one page document containing numerical data and bullet points information from the Ancillary Quality Assurance Committee, Medical Staff Quality Assurance Committee, and Medical Staff Committee. No topics were discussed in depth. The minutes recorded information with minimal data and no analysis to assist the Governing Body with the decision-making necessary to provide quality hospital services. There were no quality measurements, no evaluations or identifications of trends and root causes of topics listed.

The Medical Executive Committee minutes discussed general issues and identified problems such missing orders, lab issues, infection control topics, and medical record completion back-log. There was no discussion as to the causes of issues or directive for a comprehesive action plan. There was no identification of the significant sterilization issues occurring in surgery and radiology. (see Tags A-0749 and A-0940).

The Medical Quality Assurance Committee minutes documented numerical statistics for set agenda topics. Grievance scenarios were listed, but not discussed. No identification of departmental and service line (including contract services) indicators and/or projects, establishment of goals and action plans, no directive in the method of gathering data. Data was not analyzed or action plans developed to move issues towards sustained improvement. Although the Pharmacy and Therapeutic Committee gave a report within this committee, medication errors were not discussed. The hospital's "Incident/ Accident Log March 2017" documented multiple wrong medication doses and missed medications. These medication errors were not discussed, trended, or analyzed within this or other committees.

The Ancillary Quality Assurance Committee minutes consisted of departmental reports which included general information broadcasts, numerical statistic information, nursing discussed various log deficiencies such as glucose monitoring and refrigerator temperature, issues such as failure to complete admission screening needs had no discussion or action plan. The lab reported 2 possible transfusion reactions with one associated death, but had no discussion for a broader analysis of occurrences or trends identified. The minutes showed only data reporting and vague discussions of the Infection Control Committee. No evidence was found the surveillance activities were chosen and prioritized by the MEC. No evidence was found the MEC/GB provided direction for surveillance of infection control including detection, data collection and analysis, monitoring, and evaluation of preventive interventions. No benchmarks were established or comprehensive quality improvement plan for noncompliance of activity was documented.

A review of the hospital's `"Quality Assurance Plan 1988" showed the Ancillary Quality Assurance Committee was responsible for semi-annually monitoring and evaluating surgical services and providing annual monitoring of hospital-wide infection control. The CNO stated the plan had not been updated. The plan defined the program's responsibilities as pursuing opportunities to improve patient care, monitor and evaluate, and resolve identified problems. The plan failed to include the elements of measuring, and analyzing information. No evidence the plan had been revised to include current QAPI indicators or Performance Improvement projects for all departments and service lines (including contract services) to improve patient care. No documentation of key indicators for high risk, high volume or problem areas were identified in the plan for the current year.
The Ancillary Quality Assurance Committee and the infection Control Committee failed to ensure the disinfection / sterilization practices were according to manufacturer's guidelines and national standards for endoscopes, endoscope accessories, immediate use steam sterilization (IUSS), and steam sterilization through proper montioring, gathering data, trending and analyzing information and implementing action plans for quality patient outcomes.

On 04/10/17, the CNO, who was also the Quality Manager, stated the hospital had 2 additional committees, the Ancillary Quality Assurance Committee and Medical Quality Assurance Committee, which were not listed in the Medical Staff Bylaws. The CNO stated all committees were responsible for reporting information to the Govening Body.

For Infection Control Findings, see Tags A-0747, A-0748, A-0479, and A-0756.

Based on record review and interview, the hospital failed to establish an on-going quality improvement program that tracked and analyzed medical errors and adverse patient events, and the implementation of preventative action plans.

This failed practice had the potential to affect the safety and health of all patients receiving care due to the hospital's failure to identify risks and quality improvement opportunities and implement action plans to improve patient outcomes.

Findings:
The hospital's "Medical Staff Bylaws/Rules and Regulations" showed a multi-committee structure consisting of 9 committees that had operational and quality responsibilities.

On 04/18/17, Staff B, the CNO, who was also the Quality Manager, stated the hospital had and 2 additional committees, the Ancillary Quality Assurance Committee and Medical Quality Assurance Committee, which were not listed in the Medical Staff Bylaws. The CNO stated all committees were responsible for reporting information to the Govening Body.

The surveyors reviewed the following committees' meeting minutes from 01/17 to 03/17:
~Governing Body (which included credentialing, joint conference, medical record, pharmacy and therapeutic, environmental or infection, utilization review, transfusion, tissue and other special committees)
~Medical Executive Committee
~Medical Quality Assurance Committee
~Ancillary Quality Assurance Committee

The Governing Body minutes had a monthly attachment, which was an untitled one page document containing numerical data and bullet point information from the Ancillary Quality Assurance Committee, Medical Staff Quality Assurance Committee, and Medical Staff Committee. No topics were discussed in depth. The minutes recorded information with minimal data and no analysis to assist the Governing Body with the decision-making necessary to provide quality hospital services. There were no quality measurements, no evaluations or identifications of trends and root causes of topics listed.

The Medical Executive Committee minutes discussed general issues and identified problems such as missing orders, lab issues, infection control topics, and medical record completion back-log. There was no discussion as to the causes of issues or directives for a comprehesive action plan. There was no identification of the significant sterilization issues occurring in surgery and radiology. (see Tags A-0749 and A-0940).

The Medical Quality Assurance Committee minutes documented numerical statistics for set agenda topics. Grievance scenarios were listed, but not discussed. No identification of departmental and service line (including contract services) indicators and/or projects, no establishment of goals and action plans, no directive in the method of gathering data. Data was not analyzed or action plans developed to move issues towards sustained improvement. Although the Pharmacy and Therapeutic Committee gave a report within this committee, medication errors were not discussed, as provided on their report. The hospital's "Incident/ Accident Log March 2017" documented multiple wrong medication doses and missed medications. These medication errors were not discussed, trended, or analyzed within this committee or other committees.

A document titled "Incident/Accident Log" showed type of incident/accident, date/time, person(s) involved, and information regarding the occurrence. No evidence of analysis for causes to implement preventative actions for medical errors and falls. January 2017 - March 2017 showed 10 wrong dose medications given, 13 missed medications, 2 near misses, 5 "variances", 1 injury, and 17 falls (16 patients, 1 visitor). 01/17 to 03/17, no surgical cases or medical case were reviewed. No criteria was found as to what cases would be discussed.

On 04/18/17, Staff B, the CNO, and Staff E, the ICP, stated surgical site infection (SSI) surveillance was conducted on outpatients only. The CNO stated staff attempted to identify SSI by calling patients post surgery/ endoscopy. A review of the December 2016 call back log showed 10 of 17 patients were contacted. The ICP stated SSI surveillance also relied on physicians' office reporting infections to her.

The CNO stated there was no process established for evaluating readmissions in an attempt to identify failures in discharge planning or care decisions that if implemented, could have prevented readmissions. The CNO stated there was no process for reviewing transfered patients to evaluate quality of care.

Based on record review and interview, the hospital failed to conduct annual quality improvement projects designed to improve the safety and quality of care.

This failed practice had the potential to affect the safety and health of all patients receiving care due to the hospital's failure to identify risks and quality improvement opportunities and implement actions plans to improve patient outcomes.

Findings:

On 04/10/17, the surevyors requested the quality improvement projects for the hospital for 2016 and 2017, and Staff B, the CNO, stated the hospital had not completed Quality Improvement Projects for 2016.

Based on record review and interview, the hospital's Governing Body failed to assume full responsibility for establishing an on-going quality improvement program that included prioritizing and evaluating performance improvement efforts and conducting improvement projects annually.

The failure was most evident in the lack of development of a quality plan, including, but not limited to: infection control surveillance, adherence to high level disinfection and sterilization guidelines, evaluation of clinical practice such as clinical national standard protocols for high volume care for ED patients with chest pain, obstetric, and stroke, transfer patients and evaluation of patients readmitted within 30 days of discharge.

This failed practice had the potential to affect the safety and health of all patients receiving care due to the hospital's failure to identify risks and quality improvement opportunities and implement action plans to improve patient outcomes.

Findings:

General QAPI

The Governing Body Bylaws failed to designate the Governing Body as fully responsible for all of the hospital operation and conduct including, but not limited to quality improvement. The hospital's Quality Assurance was created in 1988 and had not been updated since.

Despite the 11 committee structure, the Governing Body failed to develop a hospital quality plan and quality improvement projects annually. 0n 04/18/17, during an interview, Staff B. the CNO, stated the hospital's quality indicators were not annually approved and prioritized by the Governing Body. The quality data was collected each month. The data was not analyzed, and used to develop comprehensive action plans to improve patient care, and show sustainment of the improvements.

On 04/10/17, The CNO stated the hospital had no completed performance improvement projects.

The Governing Body allowed a LPN, who by licensure was unqualifiied, to direct the Infection Control Program for the hospital. On 04/18/17, during an interview, CNO and ICP said a former staff had developed a number of infection control processes, which had not been reviewed and approved in recent years by the Governing Body.

Infection Control ( see Tags A-0747, A-0748, A-0479, and A-0756)

The hospital document titled, "Infection Prevention Annual Plan and Program 2016". The plan documented that policies would be enforced, the program would be evaluated for effectiveness, teaching would occur for evidence-based practice, and strategies would be identified for improvement through systematic ongoing collection, analysis and review. of data.

The Governing Body allowed a LPN, who by licensure was unqualifiied to direct the Infection Control Program for the hospital. On 04/18/17, during an interview, CNO and ICP said a former staff had developed a number of infection control processes, which had not been reviewed or modified or approved by the Governing Body in recent years.

The Governing Body failed to ensure disinfection / sterilization practices were developed, implemented, and maintained according to manufacturer's guidelines and national standards for endoscopes, endoscope accessories, transvaginal ultrasound probe, immediate use steam sterilization (IUSS), steam sterilization, glucometer, and linens. (see Tags A-0749 and A-0940).

On 04/18/17, The Staff B, the CNO and Staff E, the ICP, stated the primary infection control program had been developed years prior by the former CNO. Upon review of the processes, the CNO and ICP stated those processes had not been evaluated or updated. The CNO and ICP reviewed multiple data tools that were being completed monthly; yet, after discussion, they stated much of the information was not utilized for any quality purposes.

Clinical Protocols

In 2016, the hospital's delivered 41 newborns. On 04/10/17, the CEO stated the hospital had a large number of high risk deliveries from women with poor prenatal care and drug addiction. As documented on the December 2016 Monthly Summary , the Emergency Department rendered care to 3563 patients in 2016. A review of the ED log showed a high percent on the ED patients seen had a diagnosis of chest pain and possible stroke.

The hospital's "Surgeon's Meeting Agenda for 10/18/16" was reviewed. The CEO and CNO were in attendance. A physician had placed on the agenda to discuss the need to cross train OB nurse for emergency delivery. The surveyors found no incident associated with this topic or subsequent discussions of the development of a quality improvement initiative.

On 04/18/17, the CNO said she had plans for increasing staff''s OB competency, but no formal action plan had been presented to the Governing Body.

Evaluation of Quality of Care

Hospital document titled, "30 day readmission" from 04/01/16 through 03/01/17 was found in the infection control activities book. No summary, analysis or evaluation associated with this information was found. The documents contained 2- 10 patient names per month.

On 04/18/17, the CNO and ICP stated the hospital did not reassess and evaluate readmissions, track the rate and identify potentially preventable readmissions. The CNO stated transfers to other facilities for a higher level of care were not evaluated for quality and appropriateness of patient care.

Based on record review and interview, the Governing Body failed to provide adequate resources for establishing an on-going quality program that measured, analyzed and implemented improvements which were sustained.

This failed practice had the potential to affect the safety and health of all patients receiving care due to the hospital's failure to identify risks and quality improvement opportunities and implement action plans to improve patient outcomes.

Findings:

The hospital document titled, "Quality Assurance Plan 1988" assigned the following duties to the Quality Assurance Coordinator:

~implementing activities that monitor the quality and appropriateness of patient care,
~coordinating quality improvement activities in cooperation with the QA Committee,
~assist services and functions in the development of monitors and appropriateness of patient care,


On 04/18/17, the CNO stated she had the responsibility of Quality Manager and Chief Executive Officer. She stated she had been in those roles for about a year. She discussed multiple plans for quality improvement projects, but stated implementation was difficult due to the day to day operational demands of being the CNO.

The ICP , an LPN, stated since 2014, she was independently performing the duties of the ICP after the RN who she assisted resigned. The ICP stated she had continued many of the pre-established processes without evaluating them.

The director of surgery stated she was the 6th director since 2013, and had no expertise in endoscopy, which comprised a large part of the hospital's procedural services. Multiple times during the survey, the director of surgery, the CNO, and ICP referred the surveyor to the lead surgical technician for answers to questions regarding endoscopy, high level disinfection and sterilization.

Based on record review and staff interview the hospital failed to ensure healthcare providers completed a history and physical examination (H&P) in the patient's electronic health record within twenty-four (24) hours of admission per Medical Staff Bylaws/Rules & Regulations.

This failed practice had the potential for delayed recognition of medical conditions and interventions initiated of active problems that could influence recovery, functional status and quality of life for 8 of 24 patients whose H&P records were reviewed.

A document titled "Medical Staff Bylaws/Rules and Regulations" showed an addendum to the bylaws/rules and regulations requiring a history and physical to be completed within twenty-four (24) of admission approved by Medical Staff 04/01/07 and Governing Body on 07/10/07.

Patient #1 was admitted to observation on 03/17/17 following an outpatient ventral incision hernia procedure. Review showed H&P date of note was 03/17/17 at 1:00 pm, entry date was 03/28/17 at 10:42 am, 11 days after admission.

Patient #10 admitted on 03/19/17. Review showed H&P date of note was 03/19/17 at 5:45 pm, entry date 03/21/17 at 11:14 am and electronically signed at 11:33 am, two days after admission.

Patient #11 admitted on 03/25/19. Review showed H&P date of note was 03/25/17 at 4:00 pm, entry date 03/28/17 at 1:33 pm and electronically signed at 2:14 pm, three days after admission.

Patient #13 was admitted on 01/11/17 and discharged 01/13/17. Review showed H&P date of note was 01/11/17 at 3:35 pm, entry date 02/09/17 at 10:12 am, 33 days after admission.

Patient #15 was admitted on 03/24/17. Review showed H&P date of note was 03/24/17 at 4:00 pm, entry date 03/28/17 at 2:01 pm and electronically signed at 4:58 pm, four days after admission.

Patient #17 was admitted on 03/14/17. Review showed H&P date of note 03/14/17 at 5:00 pm, entry date 03/16/17 at 4:14 pm and electronically signed on 3/18/17 at 7:21 am, four days after admission.

Patient #19 open medical record indicated patient was admitted on 04/17/17. During record review on 04/19/17 at 9:15 am, there was no H&P in the electronic health record. Record review on 04/20/17 showed H&P date of note 04/17/17 at 11:35 am, "entry date" 04/19/17 at 2:30 pm and electronically signed at 7:10 pm, two days after admission.

Patient #20 was admitted on 01/03/17. Review showed H&P date of note 01/03/17 at 8:45 am, entry date 01/06/17 at 2:30 pm and electronically signed on 01/11/17 at 8:06 am, eight days after admission.

On 4/18/17 at 10:30 am, Staff G stated the date of the H&P note is entered by the healthcare provider and the system will log the entry date.

On 04/12/17 at 10:50 am, Staff B stated healthcare providers are aware they are responsible for documenting a history and physical (H&P) in the patient's chart within 24 hours of admission.

Based on record review and interview the hospital failed to ensure nursing staff assessed and monitored patients for pain according to hospital policy, current evidence based practice and individual condition.

This failed practice had the potential for 19 of 20 patients having poorly controlled pain affecting their psychological and functional status.

A document titled "Pain Management" showed all patients are assessed for presence, quality and intensity of pain at time of admission, asked about onset and chronic pain method normally used to best control pain ...pain monitored continuously ...pain well managed through either medication administration or alternative care ...pain scales used are Numeric and Wong-Baker Faces Scale (pictures used at bottom of policy to item these two pain scales).

Seven (Patient # 16, 19, 20, 21, 22, 23, and 24) of 24 medical records showed no documentation by nursing staff in the BCMA program of pain assessment when administering pain medications.

Seven (Patient #16, 19, 20, 21, 22, 23 and 24) of 24 medical records showed inconsistency in documentation by nursing staff for assessment and/or reassessment of pain after medication administration per hospital policy and procedures.

Nineteen (Patient #1, 2, 3, 7, 8, 9, 10, 11, 12, 13, 14, 16, 17, 18, 19, 20, 21, 22 and 23) of 20 medical records showed no documentation of an assessment for the presence, quality and/or intensity of pain, including onset and method normally used to best control pain at the time of admission per hospital policy.

On 4/18/17 at 9:50 am, Staff G stated there is a Numeric Pain Rating Scale built into the electronic Medication Administration Record/Bar Code Medication Administration (BCMA) program. The nurse assesses the patient's pain level using the numeric pain scale and documents the score verbalized by the patient into the MAR at the time medication(s) are administered. Staff G stated the Numeric Pain Rating Scale is not built into the nursing assessment flowsheet in the patient's electronic health record. Staff G stated nursing staff can document effectiveness of pain control measures in the BCMA program or in the Nurse Rounding notes.

On 4/20/17 at 12:00 pm, Staff B stated assessment of effectiveness for pain control measures are expected within 30 minutes to 1 hour after the administration of medication or as soon as the patient begins to wake from a surgical procedure. Nursing staff conducts patient round every two hours, pain assessment/reassessment would be included in those rounds. The document titled "Pain Management" is the current policy.

Based on record review and interview the hospital failed to ensure nursing staff maintained a nursing care plan by assessing patient's needs per hospital policy.

This failed practice had the potential to result in delayed recognition and/or treatment of active problems that could influence patient recovery, functional status and quality of life.

A document titled "Nursing Care Plan" showed care plans are initiated on admission, reviewed and updated minimum daily ...Plans include expected outcomes, goals, interventions and approaches to obtain goals ...based on assessment of patient's care needs (not diagnosis) and development of interventions in response to those needs.

A review of Patient #12 medical record showed: admitted on 1/03/17, complaints of constipation, abdominal pain and urinary tract infection (UTI). Suprapubic catheter and multiple sclerosis. Admitted with mild respiratory failure, confused and slightly obtunded. History of recurrent UTI, diabetes insulin dependent with recurrent hypoglycemia secondary sepsis, incontinence, and chronic pain. The patient's care plan problems included anxiety related to hospitalization and alteration in comfort related to nausea/vomiting. The patient's care plan did not address the patient's pain, risk of infection secondary to suprapubic catheter and urinary tract infection, diabetes as it relates to knowledge deficit, skin integrity secondary to incontinence, and risk of injury secondary to impaired mobility

A review of Patient #15 medical record showed: admitted 03/24/17, complaints of intractable back pain and inability to walk. History migraines and chronic obstructive pulmonary disease (COPD). The patient's care plan problems included alteration in respiratory status related to the loss of lung function and COPD, anxiety related to hospitalization, alteration in comfort related to pain, and Pain related to intractable back pain. The patient's care plan did not address the patient's impaired mobility secondary to severe pain and lumbar function and risk of injury related to weakness secondary to pain.

A review of Patient #17 medical record showed: admitted 03/14/17, from ED with complaints of severe back pain CT scan showed compression fracture T12 and T9. In wheelchair secondary to complaints of pain in back and inability to move. The patient's care plan problems included alteration in comfort related to pain, infection related to invasive lines, risk of injury related to weakness, unsteady gait. The patient's care plan did not address the patient's impaired mobility secondary to fracture, weakness, gait and pain. Care Plan was not kept current based on assessment and evaluation of interventions. Documentation showed "reviewed and continued" until patient was discharged on 03/20/17 and Care Plan "Resolved Response: Care Completed."

A review of Patient #19 medical record showed: admitted 04/17/17, from ED after several days of severe coughing, right upper abdominal pain and progressively worse shortness of breath. Diagnosis right lower lobe pneumonia. Past history included stroke, diabetes type 2 uncontrolled, and chronic obstructive pulmonary disease (COPD). Current nicotine dependent using smokeless tobacco and sometimes smokes. The patient's care plan problems included alteration in respiratory status related to infection and loss of lung function, and chest pain. The patient's care plan did not address uncontrolled diabetes as it relates to knowledge deficit and the care plan for alteration in respiratory status did not include interventions for smoking cessation counseling to address the patient's smoking on respiratory function.

A review of Patient #21 medical record showed: admitted 02/27/17, from ED with diagnosis of stroke, left side sensory loss and history of old lacunar infarct. Neuro exam showed left facial droop, diminished sensation to left side. Reports headache. Blood pressure on arrival 247/119. Past history hypertension, stroke, diabetes. The patient's care plan problems included alteration in comfort related to pain, risk of injury related to weakness. The patient's care plan did not include neurological impairment including sensory perception, alteration in blood pressure and diabetes as it relates to knowledge deficit.

Ten (Patient #1,2, 14, 15, 17, 18, 20, 21, 22, and 23) of 10 medical records showed when the Nursing Care Plan Problem: Comfort Alteration in Relation To: Pain was identified there was no evidence of interventions for performance of initial pain assessment and determination of comfort goal with client on admission and assess patient's pain every shift and as needed (PRN).

Three (Patient #1, 14 and 22) of 10 medical records showed Nursing Care Plans were "reviewed and continued" throughout the patient's hospital stay with no evidence of updates or revisions based on patient assessments and the Care Plan was not resolved at the time of patient discharge.

Five (Patient #15, 18, 20, 21, and 23) of 10 medical records showed Nursing Care Plans were "reviewed and continued" throughout the patient's hospital stay with no evidence of updates or revisions based on patient assessment until time of patient discharge when Care Plan was resolved.

On 04/19/17 at 12:10 pm, Staff B stated the nursing care plans are initiated by the registered nurse (RN) on admission, based on initial assessment and reviewed every shift. Care plans are individualized.

On 4/20/17 at 11:00 am, Staff B and Staff E stated once care plans are initiated goals cannot be resolved individually when they have been met. Nurse would need to remove entire care plan and initiate a new plan to identify new goals. Or nurse could make a comment goal had been met in notes.

Based on record review and interview the hospital failed to ensure healthcare providers provided an accurate time for written medical records.

This failed practice had the potential for patients to have inaccurate communication between healthcare providers as the medical record provides a sequential record of patient care, promoting patient safety through timely assessments, interventions and ensuring quality patient care.

A document titled "Anesthesia Intraoperative Record" showed no evidence of the actual time the post-anesthesia evaluation was performed by the anesthesia provider. Post-Anesthesia Care Unit (PACU) box in lower right corner of record contains assessment, time in and out of PACU and anesthesia provider's signature.

Seven (Patient #1, 2, 3, 5, 7, 8, and 9) of 7 medical records showed no evidence for the actual time the post-anesthesia evaluation was performed by the anesthesia provider.

On 4/12/17 at 1050 am, Staff B stated the Anesthesia Intraoperative Record is the only document for the post-anesthesia evaluation to be documented.

Based on record review and interview the hospital failed to demonstrate the development, implementation and approval process for standing orders that included the use of current nationally recognized evidence based guidelines.

This failed practice had the potential for inconsistencies in patient care and greater risk of medical errors for all patients for which these orders are used. Practices are not reflective of current evidence based practice, no process to address approval and revisions of standing orders that included pharmacy, nursing and medical staff, lack of education of staff to provide for successful implementation.

A document titled "Medical Staff Bylaws/Rules and Regulations" showed standing orders are formulated by conference between medical staff and administrator ...changed by mutual consent of medical staff and administrator ...administrator will notify personnel concerned.

A document titled "Chest Pain" showed purpose to provide prompt treatment for patient presenting to emergency department with chest pain ...if ischemic is suspected by the assessing RN, intravenous (IV) access and Chest Pain Protocol is to be initiated ...patient should be re-evaluated at minimum every hour or more often as indicated.

A document titled "Chest Pain Protocol" showed no evidence of current nationally recognized evidence based guidelines used for development. Document was attached to policy titled "Chest Pain," review date October 2016 and approved by Staff B. Emergency department policy and procedure manual last reviewed and signed by Chief of Staff and Administrator and Chief Nursing Officer (CNO) January of 2014.

A document titled "Chest Pain Order Set", "COPD/RAD/ASTHMA Order Set ED" and CHF Order Set ED" showed no evidence of nationally recognized evidence based guidelines used.

A document titled "Code Stroke Initial Orders" showed no evidence order set had been reviewed and revised utilizing current nationally accepted evidenced based stroke guidelines for the acute management of stroke.

A document titled "Medical Executive Committee Minutes" showed no evidence of presentation of the 'COPD/RAD/ASTHMA Order Set ED", "CHF Order Set ED", "Chest Pain Order Set", Chest Pain" policy, "Chest Pain Protocol" or "Code Stroke Initial Orders" for review or approval by medical staff for the year 2016.

On 4/18/17 at 9:30 am, Staff G stated she is not aware who developed the order sets, if it was approved by Pharmacy, Medical Executive Committee, Nursing Leadership and Governing Body prior to implementation.

On 4/18/17 at 3:02 pm, Staff B stated policy and procedures (P&P) review process starts with her. She reviews and signs policy and procedures per Governing Body. Policy and Procedures provided to Administrator and Chief of Staff for their review. Chief of Staff is responsible for informing medical staff of revisions to order sets, policies and procedures. Staff B was not able to provide evidence for use of nationally recognized evidenced based guidelines to develop the order sets, policy and procedure and protocol for chest pain.

Based on record review and interview the hospital failed to ensure physicians documented a reason for PRN medications based on current standards of practice.

This failed practice had the potential for increased risk of medical errors and adverse events for ten out of twenty-four patients.

A document titled "Physician/Provider Order Entry" showed physician/provider orders for medications must include at least ...specific instructions for use, when applicable. No evidence that "when applicable" is defined in the policy and procedure for physician/provider order entry.

Ten (Patient #12, 13, 16, 17, 19, 20, 21, 22, 23, and 24) of 24 medical records showed no indications provided for PRN medications ordered by the prescribing physician.

On 4/19/17 at 12:30 pm, Staff R stated hospital does not have a specific policy addressing PRN medications. Hospital does not require physicians to provide an indication for PRN medications, it is by physician preference.

Based on interview and record review, the hospital failed to have a process to quarantine infectious blood and blood components.

This failed practice increased the risk of patients requiring blood products to recieve infectious blood.

Findings:

A hospital policy titled, "HCV, HIV, and Other Blood Borne Pathogen Lookback Procedure (no date)" showed no process to quarantine infectious blood and blood components.

On 04/20/17 at 11:50 am, Staff R stated the hospital did not have a process or policy to quarantine infectious blood.

Based on interview and record review, the hospital failed to:

a. inspect and evaluate the temperature of refrigerator and blanket and fluid warming cabinet in the Labor and Delivery Department which affected the safety of approximately 21 infants delivered annually in the hospital, and

b. have a handwashing sink in the surgical decontamination room which potentially increased the infection control risk to the approximately 49 inpatient and 107 outpatient surgical/ endoscopic cases per year, and

c. ensure the psychiatric unit was a safe and appropriate environment for all inpatient bedrooms on the psychiatric unit., which increased the risk to injure psychatric patients by strangling themselves with the beds electrical cord or use the movable bed to barricade themselves in a bedroom.

Findings:

a. The hospital's labor and delivery refrigerator temperature log for Oct 2016-Dec 2016 was reviewed. There were 46 of 92 days of omissions on the log. In December 2016, it was documented the temperature had to be turned down.

The hospital policy titled, "Warmers, Blankets and Solution Care of the Patient using Supplies Stored in 06/16" documented a daily temperature log would be maintained and fluid should not be kept in warmer for longer than 14 days.

The hospital's labor and delivery blanket and solution warming cabinet log for Oct 2016-Dec 2016 was reviewed. There were 48 of 92 days omitted on the logs.

On 04/08/17, during an interview, Staff B, the Quality Coordinator, said the refrigerator and warming cabinet was to be checked daily and temperature recorded. She stated she had issues with the staff in the department complying with daily inspection and recording.

b. On 04/11/17 at 11:20 am, the Surgical Department's decontamination room was observed the room to have only one sink, and Staff L stated the sink was used for both instrument cleaning and handwashing.

c. On 04/10/17 at 12:10 pm, during a tour of the inpatient psychiatric unit. The unit consisited of 6 patient room and had an average census of 2-3 patients. The surveyor observed 10 of 10 hospital beds on wheels were not secured to the floor, and could be moved freely throughout the room. All the doors of the bedroom opened inward to the patients' rooms.

Additionally, on this tour, the surveyor observed 4 of 10 bed's electrical cords (bedrooms 206 and 201) were not secured in such a manner as to protect patients and prevent the cords from being used to strangulate.

On 04/20/17, Staff O stated the electrical cords on all psychiatric beds usually are protected by a rigid conduit, and the beds without them had been due to patients being transferred from the medical /surgical unit.

Based on observation, interview, and record review, the hospital failed to:

a. appoint a qualified infection control preventionist, (See tag: A-0748)

b. develop, implement, and maintain disinfection / sterilization practices according to manufacturer's guidelines and national standards for endoscopes, endoscope accessories, transvaginal ultrasound probe, immediate use steam sterilization (IUSS), steam sterilization, glucometer, and linens, (See tag: A-0749)

c. develop, implement, and maintain surveillance program to identify infection control risks, (See tag A-0749)

d. utilize EPA approved disinfectants as authorized by the Governing Body (See tag A-0749) , and

e. under leadership's direction, ensure infection control was incorporated into quality assurance and improvement and improvement. (See Tag A-0756)

These failed practices had the potential to negatively impact the effectiveness of the hospital's infection control program for the 711 inpatients and 107 outpatients that received care annually.

Based on interview and document review, the hospital failed to appoint a qualified infection control preventionist (ICP).

This failed practice resulted in the suboptimal development and implementation of infection control policies, and increased the infection control risk of the 711 inpatients and 107 outpatients serviced annually by the hospital.

Findings:

The hospital position description documented the ICP's principle accountabilities as displaying awareness of legal implications in nursing practice by maintaining accurate documentation, promptly reporting all situations with litigation potential, and maintaining a clean, safe and orderly environment.

This position description failed to assign essential responsibilities such as identify, investigate, report, prevent and control infections and communicable diseases with activities. There was no description of activities to be performed by the ICP that would maintain a sanitary environment, development and implementation of control measures, mitigation of risks, active surveillance, monitoring compliance with policy and procedures/ protocol, and program evaluation etc.

Although Staff E had evidence of participating in multiple APIC webinars, and other infection control training, she was not qualified, as a LPN, to fulfill the leadership duties necessary for an ICP. The Oklahoma Board of Nursing (OBN) differentiates between the responsibilities of a RN and LPN in OBN Nursing Practice Act. The Nurse Practice Act outlined the RN Scope of Practice, regarding nursing care, using verbs such as assessing, analyzing, establishing goals, planning strategies, establishing priorities, and implement strategies. The Scope of Practice for the LPN, regarding nursing care, included verbs such as contributing to assessment, participating in the development, implementing appropriate aspects, participating in evaluation.

During an interview, the Director of Nursing (DON) stated Staff E, a LPN, was the hospital's ICP. The DON stated Staff had not been formally appointed in the role of ICP by the Govening Body. The DON stated from 2013-2014, ICP was a dual role with a RN and Staff E performing the ICP responsibilities, however, upon the resignation of the RN, Staff E alone continued in the role.

The surveyors observed suboptimal development, implementation, and maintenance of an infection control surveillance program to identify infection control risks, including the lack of disinfection / sterilization practices according to manufacturer's guidelines and national standards. (See tag: A-0749)

Based on observation, interview, and document review, the hospital failed to ensure:

a. the disinfection / sterilization practices were according to manufacturer's guidelines and national standards for endoscopes, endoscope accessories, transvaginal ultrasound probe, immediate use steam sterilization (IUSS), steam sterilization, glucometer, and linens,

b. the surveillance program was developed, implemented, and maintained to identify infection control risks, and

These failed practices increased the risk of cross contamination to the patients receiving procedural and general patient care services.

Findings:

The hospital document titled, "Infection Prevention Annual Plan and Program 2016" showed policies would be enforced, the program would be evaluated for effectiveness, teaching would occur for evidence-based practice, and strategies would be identified for improvement through systematic ongoing collection, analysis and review. The plan failed as evidenced by:

a. Disinfection / Sterilization Practices
Endoscopes

In January 2017, the hospital performed 24 endoscopies, and in 2016, 113 endoscopies were performed. The surgical department disinfected endoscopes utilizing an automatic endoscope reprocessor, Steris System 1.

The Steris System 1 instruction for use manual was reviewed. On page i, the manual documented, "After completion of a cycle ...the processed load should be used immediately". The final cycle of this type of reprocessor does not flush air, alcohol, and air to reduce the risk of water borne bacteria contamination. Endoscopes reprocessed by this equipment, if stored, would not considered ready for use.

On 4/11/17 at 11:19 am, during a tour of the surgical department, the surveyors observed 4 endoscopes hanging in a ventilated cabinet with electrical caps on (per manufacturer, electrical caps should be removed when hanging to facilitate aeration of the scope).

The Staff B, the CNO, stated Staff L, the lead scrub technician, was the primary staff responsible for endoscope disinfection and management. Staff L said all staff would retrieve the endoscope from the cabinet for use in a procedure.

Staff L said endoscopes were reprocessed at one month when hung unused. The Director of OR and Staff L obtained the Steris System I manual from a file cabinet, and after review of the manual's instructions for immediate use, both stated they were unaware of the requirement to use immediately or reprocess before use.

Staff L stated if the Steris System 1 failed in operation, the scope would be disinfected manually in high level disinfection. Staff L stated manual disinfection of endoscopes had occurred within the year, but the documentation of such scopes could not be differentiated with those disinfected in the Steris System 1. Staff L stated the name of the patient or the high level disinfection quality control records could not be provided for any endoscopes manually reprocessed.

Staff L personnel file was reviewed for endoscopic disinfection competency. Staff L last evaluation for endoscopy competency was dated 2011. The competency was validated by Staff E, who by self report did not have specific knowledge about endoscopes and accessories.

Endoscope Accessories

Two types of water bottles are used during the performance of endoscopy. A water bottle that is pressurized is attached to the endoscope, and provides the water and air necessary to perform all procedures. Another water bottle also connected to the scope provides irrigation.

The hospital had no policy or competency for these bottles and tubing.

The manufacturer guidelines for use for both types of bottles were reviewed. The guidelines required the reusable bottle to be reprocessed daily by steam sterilization or high level disinfection.

Staff E stated she did not know how often the water bottles were cleaned, but the bottles were cleaned in enzyme, rinsed with water and air dried.

The endoscope manufacturer released a safety alert titled, "Olympus IMPORTANT SAFETY NOTICE 2009". The alert emphasized the specialized tubing ( MAJ- 855) must be reprocessed each time it is used in an endoscopy procedure. (This tubing is attached to the auxillary channel that is connected to the biopsy channel, and although there is a one way valve, can get contamination through back wash.)

There was no policy or competency for the specialized tubing ( MAJ- 855).

Staff E stated the specialized tubing ( MAJ- 855) was not reprocessed each time after use with the endoscope. Staff E and the Staff I, Director of OR, stated they did not know this reprocessing requirement for the tubing.

On 4/11/17 at 11:19 am, during tour of the operating room department, on the endoscopy cart, which Staff E and the OR Director identified as ready for use, both types of water bottles were filled with water from a procedure performed 13 days prior. MAJ -855 tubing was attached to the irrigation water bottle tubing. The tubing was filled with liquid, which can harbor water borne bacteria. Staff E stated the MAJ-855 tubing had also been hanging 13 days.


Transvaginal Ultrasound Probe

The Director of Radiology stated the hospital provided transvaginal ultrasound services within the radiology department, and performed 6 procedures in 2016. The surveyors requested the patient names who received transvaginal ultrasound services in 2017, and none were provided.

The hospital had no policy for the disinfection of the transvaginal ultrasound probe. The manufacturer's guidelines for the transvaginal probe was reviewed. The guidelines documented the probe should be reprocessed with high level disinfection (HLD) after each use.

In response to the surveyor's request to see the manufacturer's guidelines for the specific HLD that was being used to disinfect probe, Staff M and the DON provided instructions for use for an enzyme, not HLD. Both identified the chemical as the disinfectant used to reprocess probe.

The radiology supervisor stated Revital-Ox HLD was used to disinfect the vag probe, and the product did not require testing minimal effectiveness before each use. Review of the manufacturer's instruction for use for Revital-Ox said that the solution must be tested with a specified chemical indicator before each use.

During an interview, Staff M and the Radiology Supervisor stated there was no log book maintained documenting the probe disinfection. They stated there was no documentation of the patient's name, type of disinfectant used, lot numbers of chemical, testing for minimum effective concentration, and change of chemical per manufacturer's guidelines for any vag probes performed in 2016 and 2017.

Staff K identified herself as the primary staff for disinfecting the probe. No competency for the probe disinfection was found in Staff M's personnel file.


Immediate Use Steam Sterilization (IUSS)

The 01/31/17 Governing Body Meeting Minutes documented 107 outpatient and 49 inpatient surgeries were performed in 2016.

The hospital policy "Autoclave Sterilization Times" outlined "Flash" [IUSS] guidelines. The policy documented that immediate use steam sterilization (IUSS) should be avoided and used in emergency situations when no replacement instruments were available. The policy documented each "flash" autoclave had a log book to be completed.

The hospital document titled, "Steam Sterilization Load Log", in conjunction with the sterilizer run print outs were reviewed from 12/06/16 through 02/07/17. This review showed 64% (36 /56 loads) of the steam sterilization load run during that time frame had drying times of 4-5 minutes. Amongst other instruments in these loads were "rings" (see below Steam Sterilization for other instruments with short drying cycles) . None of these loads were documented on an IUSS log.

The Staff B, the CNO, stated Staff L, the lead scrub technician, had primary responsibility for instrument sterilization. Staff L functioned as a trainer for instrument reprocessing, and had been in this role for 6 years.

During an interview, Staff L: stated the surgical staff did not keep a IUSS log, and did not have a method of associating IUSS loads with the patients on which the instruments were used. Staff E stated drying times of 4 minutes were considered IUSS, and were performed for designated instruments such as batteries, LMA (laryngeal mask airways), and "rings". Staff L stated rings were processed by IUSS because the hospital only had one set, and a quick turnaround was required due to the patient caseloads.

Steam Sterilization

The 01/31/17 Governing Body Meeting Minutes documented 107 outpatient and 49 inpatient surgeries were performed in 2016.

The hospital policy "Autoclave Sterilization Times" documented the guidelines for the EXPRESS and Prevac settings for the steam sterilizer.

This policy documented EXPRESS cycle could be used on the following instruments: Stryker drill, TPS, Scopes, bipolar cord, cysto instruments, hysteroscopy instruments, fish, light source, camera, batteries, and laryngeal mask airway (LMA). Staff E stated EXPRESS steam sterilization drying times were 5 minutes. The sterilizer run print out verified EXPRESS cycle's drying time was 5 minutes. (EXPRESS cycles's drying time of 5 minutes qualifies as IUSS).

A hospital document titled, "Steam Sterilization Load Log" 12/6/16 through 02/07/17 were reviewed for EXPRESS cycles. The log showed EXPRESS loads included batteries and rings. The rings (also called T & A sets), were run three times on EXPRESS cycle. Staff E and the OR Supervisor stated the instruments' manufacturer's guidelines had not been consulted to determine if the EXPRESS cycle was the appropriate cycle setting for both the instruments listed in the policy and the instruments processed by the EXPRESS cycle.

The surveyor requested to see the manufacturer's instruction for use for the laryngeal mask airway (LMA). The DON provided the surveyor with a disposable LMA, and soon thereafter, the OR Supervisor provided the survyor with the insert from a reusable LMA. The OR Supervisor stated that until she had seen the insert, she did not know the manufacturer limited the number of reusable uses to 40. She stated the anesthesia staff had not been counting uses, and effective immediately, the department was switching to the disposable LMA.

The surveyor and Staff L reviewed the hospital policy, titled "Autoclave Sterilization Times". The policy documented that all instruments, not processed by IUSS or EXPRESS, would be "run with a 4 minutes sterilization cycle and a 1 minute dry cycle". Upon reading the 1 minute dry time, Staff E stated "one minute! That is not enough time to dry anything."

CDC "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" documented wrapped instruments should have a drying time of 20-30 minutes, textile packs 5-20 minutes, and wrapped utensils 20 minutes.

The hospital document titled, "Steam Sterilization Load Log" inconjunction with the sterilizer run print outs were reviewed from 12/06/16 through 02/07/17. This review showed PreVac cycles with drying times of 4 minutes occurred in 32% (18 /56 loads) of the steam sterilization loads. The loads included instruments such as rat tooth forceps, lap sets, needle drivers, cervical dilators, bipolar forceps, etc. An instrument load strip from 01/07/17 with a 4 minute drying time included a rat tooth forcep. Staff E stated the rat tooth forcep usually had a drying time of 20 minutes, but was dried at 4 minutes because there was just one load run for that day.

Staff L and the OR Supervisor stated the instruments' manufacturer's guidelines had not been consulted to determine if the PreVac with short drying times was the appropriate cycle setting for both the instruments processed in this way.

Glucometer

The manufacturer's guidelines document the exterior of glucometer should be cleaned with mild detergent or a bleach solution.

The hospital policy titled, "Cleaning of Contour Glucose 06/16" documented to clean testing meter with an approved disinfectant or specified bleach solution.

The DON stated the medical/surgical unit performed 949 finger stick blood sugar per month of test using a glucometer.

On 04/ 17/17 at 12:06 pm, Staff B and Staff C stated the blood sugar testing meters were cleaned with alcohol.

Laundry

The hospital provided in-house laundry service for all inpatient and outpatient services. On 04/10/17 at 11:30 am, the hospital's laundry department was toured. The department contained 2 large commercial washers and 2 dryers. The washers were computer programmed for prescribed additives including a bleach based solution.

The hospital document titled, "Laundry Job Description" was provided as the policy for laundry management. The guidelines failed to define the temperature and bleach additive requirements of the wash/rinse water.

CDC "Guidelines for Environmental Infection Control in Health-Care Facilities 2003" documented the parameters for health care facility laundry processing. The Process defined the washing water temperatures when using bleach additives.

The "03/07/17 Ancillary QA Minutes" were reviewed. The maintenance report documented "added hot water mixing valve to laundry...to maintain correct temperature..."

Staff P stated the temperature of the wash/rinse water was regulated at 70° F, and chemicals/detergents were added automatically by the commercial washer's computer program. Staff P stated no temperature logs were maintained for the wash/rinse.

b. Surveillance Program

The hospital's `"Quality Assurance Plan 1988" documented the Ancillary Quality Assurance Committee was responsible for semi-annually monitoring and evaluating surgical services and providing annual monitoring of hospital-wide infection control. The Ancillary Quality Assurance Committee minutes reviewed, reflected only data reporting and vague discussions of the Infection Control Committee. No evidence was found the surveillance activities were chosen and prioritized by the MEC. No evidence was found the MEC/GB provided direction for surveillance of infection control including detection, data collection and analysis, monitoring, and evaluation of preventive interventions. No benchmarks established or comprehensive quality improvement plan for noncompliance of activity.

The Infection Control Meeting minutes had a standing agenda item titled, "Surveillance Monitors". The meeting template documented surveillance monitors would be done in nursing units-areas, and observations would used to identifiy areas of improvement. The template documented in-services would be provided as needed. The following were listed as surveillance categories/areas: medical waste, check biohazard labeling, blood borne pathogen including housekeeping/laundry, engineering controls, PPE completed on Pharmacy, Dietary, Bridges, Respiratory Therapy, and Human Resources.

The hospital document titled, "Infection Control Report- Patient Surveillance Program" was reviewed. Staff B, the CNO, and Staff E, the ICP, stated the form was developed in years past by a former employee. Staff E, the ICP, stated she used this form to gather information regarding infections for inpatients only. The ICP stated she reviewed every inpatient chart evaluating lab, cultures, and temperatures daily. The ICP would complete the form for any patient she felt had significant symptoms,and then present the form to the infection control medical director to review to determine if the patient had gotten a nosocomial infection. The ICP stated she was given no criteria or parameters for lab values for determining if a patient had an infection.

On 04/08/17, during an interview, Staff E, the ICP, stated she was responsible for the hospital's infection control surveillance program.

Hand Hygiene
The Infection Control Meeting minutes for Nov-Dec 2016 and Feb 2017 was reviewed. The Infection Control minutes documented Hand Hygiene (HH) surveillance. The minutes documented ICP was doing random HH surveillance with 1:1 education if HH not done properly. The ICP stated the staff reeducation was not documented.

The "Hand Hygiene Observation Tool 10/16" documented:
~ED the Resp TX did not wear gloves with EKG (gloves are not generally necessary for performing EKG),
~Lab did wear gloves when drawing blood and did not wash hands,
~Nurse passing meds on 1W did not wash hands after leaving or before entering patient room,
~Nurse on 1 W drawing blood without gloves and no HH afterwards.

No corrective actions were listed regarding these examples of non-compliance except to continue to educate staff. No trending of staff or location source of noncompliance was documented. The follow-up actions was to continue with secret shopper and known surveillance. The ICP failed to measure and analyze hand hygiene surveillance information and plan strategies to minimize the occurrences of and risks from non-compliance.

During an interview, the ICP said most everyone performed [hand hygiene] well when she was present.

Foley
Throughout all levels of committee meetings, the ICP reported mandatory statistics for National Healthcare Safety Network (NHSN) for foley catheters. No discussions were documented associating Foley catheters with infections. Information was gathered for state reporting, but internal program was not developed to minimize urinary track infections (UTI). A review of the document titled, "Foley Tracking Sheet 12/2016" showed 8 of 17 patients as "yes" under the column of UTI. "Foley Track Sheet 11/2016" showed 11 of 21 with "yes" under the UTI column.

Sepsis
The hospital document titled, "Stilwell Memorial Hospital Sepsis Screening" was developed by a former staff in years past in order to gather data for a sepsis research project. Participation in the study had not been approved by the current Governing Body. The CNO and ICP stated data gathered was not provided to the medical director of infection control.

IV
The ICP maintained a daily untitled log that documented the date IVs were started and when the site was changed. The information gathered was provided to quality in terms of how many IV sites were changed according to policy. This ICP failed to correlate IV site changes with the actual condition of the site. The ICP monitored IV sites for adherence to the IV policy of changing the site every 72 hours. No discussion or trends documented regarding actual infected IV sites, or the condition of the IV site durations that extended beyond the 72 hours.

Immunizations
Within the Infection Control Committee minutes, the Influenza Vaccination was reported. The meetings minutes for 02/17 the status of the program, " We started giving flu vaccine in OCT 1, we have given 188 vaccines with 55 declines. 24 were given outside this facility." The ICP failed to report the goals of the program.

Sterilization and High Level Disinfection (Also see Tag A-0940)
The Infection Control Meeting minutes for Nov-Dec 2016 and Feb 2017 was reviewed. The minutes contained minimal evaluations and actions plans. These minutes were reviewed for ICP surveillance of the "Operating Room". The minutes contained only statistics for patient call back calls, and one entry of humidity issues. These minutes did not contain discussions of IUSS, steam sterilization practices, or endoscopic reprocessing. Staff E stated neither the ICP nor OR Supervisor did surveillance for IUSS, steam sterilization practices, or endoscopic reprocessing.

The The hospital performed high infection control risk practices, such as endoscope and accessory disinfection, surgical instrument sterilization, and transvaginal ultrasound probe disinfection.

Governing Body failed to ensure disinfection / sterilization practices were developed, implemented, and maintained according to manufacturer's guidelines and national standards for endoscopes, endoscope accessories, transvaginal ultrasound probe, immediate use steam sterilization (IUSS), steam sterilization, glucometer, and linens.
(see Tags A-0749 and A-0940).

On 04/18/17 at 09:11am, during an interview, the ICP stated she did not have competency for endoscopic reprocessing, did not review surgical sterilization logs, and did not review patient remissions to assess for surgical site/ nosocomial infections.

The Infection Control Meeting minutes for Nov-Dec 2016 and Feb 2017 contained the surveillance of the radiology department, which had no observations were made regarding the disinfection of the transvaginal ultrasound equipment.

Surgical Site Infectioon (SSI)
The SSI program had not been developed. On 04/18/17, during an interview, Staff B, the CNO and Staff E, the ICP, stated SSI surveillance was conducted for outpatients only. The CNO stated staff attempted to identify SSI by calling patients days post surgery/ endoscopy. A review of the December 2016 call back log showed only 10 of 17 patients were contacted. The ICP stated SSI surveillance also relied on physicians' office reporting infection to her. The Infection Control Meeting minutes for Nov-Dec 2016 and Feb 2017 was reviewed. The Infection Control Meeting minutes documented the OR staff was able to reach patients on average monthly :68% , 47%, 59%, and 65%

On the NHSN report, the ICP documented, "We did have a surgery pt that later developed an infection near her surgery site, but had sore on her abdomen prior to surgery." No evidence was found the infection control medical director evaluated this case.

Based on interview and document review, the Chief Executive Officer, Medical Staff, and the DON failed to ensure the infection control program addressed corrective actions plans and staff for issues identified by the ICP.

This failed practice created an ineffective infection control program and increased the infection control risk to the hospital's inpatients and outpatients.

Findings:

The hospital document titled, "Infection Prevention Annual Plan and Program 2016". The plan documented that policies would be enforced, the program would be evaluated for effectiveness, teaching would occur for evidence-based practice, and strategies would be identified for improvement through systematic ongoing collection, analysis and review. of data.

The Governing Body allowed a LPN, who by licensure was unqualifiied to direct the Infection Control Program for the hospital. On 04/18/17, during an interview, CNO and ICP said a former staff had developed a number of infection control processes, which had not been reviewed or modified or approved by the Governing Body in recent years.

The Governing Body failed to ensure disinfection / sterilization practices were developed, implemented, and maintained according to manufacturer's guidelines and national standards for endoscopes, endoscope accessories, transvaginal ultrasound probe, immediate use steam sterilization (IUSS), steam sterilization, glucometer, and linens. (see Tags A-0749 and A-0940).

On 04/18/17, The Staff B, the CNO and Staff E, the ICP, stated the primary infection control program had been developed years prior by the former CNO. Upon review of the processes, the CNO and ICP stated those processes had not been evaluated or updated. The CNO and ICP reviewed multiple data tools that were being completed monthly; yet, after discussion, they stated much of the information was not utilized for any quality purpose

Infection Control Findings ( see Tags A-0747, A-0748, and A-0479)

Based on record review and interview, the hospital failed to have an on-going quality program which included the reassessment of discharge planning to evaluate and identify any preventative readmissions.

This failed practice had to potential to result in the readmission of an average of 711 discharged patients per year, due to inadequate discharge planning or premature discharges.

Findings:

Hospital document titled, "30 day readmission" was found from 04/01/16 through 03/01/17 in the infection control activities book. No summary, analysis or evaluated associated with this information was found. The documents contain 2- 10 patient names per month.

On 04/18/17, during an interview, the CNO and ICP stated the hospital did not reassess and evaluate readmissions, track the rate and identify potentially preventable readmissions.

Based on observation, interview, and record review, the hospital failed to ensure the disinfection / sterilization practices were according to manufacturer's guidelines and national standards for endoscopes, endoscope accessories, immediate use steam sterilization (IUSS), and steam sterilization.

These failed practices increased the risk cross contamination to the patients receiving surgery and invasive procedures.

Findings:

On 04/18/17, the director of surgery stated she was the 6th director since 2013. The director stated she had no expertise in endoscopy, which comprised a large part of the hospital's procedural services. Multiple times during the survey, the director of surgery, the CNO, and ICP referred the surveyor to the lead surgical technician for answers to questions regarding endoscopy, high level diasinfection and sterilization.


Dsinfection / Sterilization Practices
Endoscopes

In January 2017, the hospital performed 24 endoscopies, and in 2016, 113 endoscopies were performed. The surgical department disinfected endoscopes utilizing an automatic endoscope reprocessor, Steris System 1.

The Steris System 1 instruction for use manual was reviewed. On page i, the manual documented, "After completion of a cycle ...the processed load should be used immediately". The final cycle of this type of reprocessor does not flush air, alcohol, and air to reduce the risk of water borne bacteria contamination. Endoscopes reprocessed by this equipment, if stored, would not considered ready for use.

On 4/11/17 at 11:19 am, during a tour of the surgical department, the surveyors observed 4 endoscopes hanging in a ventilated cabinet with electrical caps on (per manufacturer, electrical caps should be removed when hanging to facilitate aeration of the scope).

The Staff B, the CNO, stated Staff L, the lead scrub technician, was the primary staff responsible for endoscope disinfection and management. Staff L said all staff would retrieve the endoscope from the cabinet for use in a procedure.

Staff L said endoscopes were reprocessed at one month when hung unused. The Director of OR and Staff L obtained the Steris System I manual from a file cabinet, and after review of the manual's instructions for immediate use, both stated they were unaware of the requirement to use immediately or reprocess before use.

Staff L stated if the Steris System 1 failed in operation, the scope would be disinfected manually in high level disinfection. Staff L stated manual disinfection of endoscopes had occurred within the year, but the documentation of such scopes could not be differentiated with those disinfected in the Steris System 1. Staff L stated the name of the patient or the high level disinfection quality control records could not be provided for any endoscopes manually reprocessed.

Staff L personnel file was reviewed for endoscopic disinfection competency. Staff L last evaluation for endoscopy competency was dated 2011. The competency was validated by Staff E, who by self report did not have specific knowledge about endoscopes and accessories.

Endoscope Accessories

Two types of water bottles are used during the performance of endoscopy. A water bottle that is pressurized is attached to the endoscope, and provides the water and air necessary to perform all procedures. Another water bottle also connected to the scope provides irrigation.

The hospital had no policy or competency for these bottles and tubing.

The manufacturer guidelines for use for both types of bottles were reviewed. The guidelines required the reusable bottle to be reprocessed daily by steam sterilization or high level disinfection.

Staff E stated she did not know how often the water bottles were cleaned, but the bottles were cleaned in enzyme, rinsed with water and air dried.

The endoscope manufacturer released a safety alert titled, "Olympus IMPORTANT SAFETY NOTICE 2009". The alert emphasized the specialized tubing ( MAJ- 855) must be reprocessed each time it is used in an endoscopy procedure. (This tubing is attached to the auxillary channel that is connected to the biopsy channel, and although there is a one way valve, can get contamination through back wash.)

There was no policy or competency for the specialized tubing ( MAJ- 855).

Staff E stated the specialized tubing ( MAJ- 855) was not reprocessed each time after use with the endoscope. Staff E and the Staff I, Director of OR, stated they did not know this reprocessing requirement for the tubing.

On 4/11/17 at 11:19 am, during tour of the operating room department, on the endoscopy cart, which Staff E and the OR Director identified as ready for use, both types of water bottles were filled with water from a procedure performed 13 days prior. MAJ -855 tubing was attached to the irrigation water bottle tubing. The tubing was filled with liquid, which can harbor water borne bacteria. Staff E stated the MAJ-855 tubing had also been hanging 13 days.

Immediate Use Steam Sterilization (IUSS)

The 01/31/17 Governing Body Meeting Minutes documented 107 outpatient and 49 inpatient surgeries were performed in 2016.

The hospital policy "Autoclave Sterilization Times" outlined "Flash" [IUSS] guidelines. The policy documented that immediate use steam sterilization (IUSS) should be avoided and used in emergency situations when no replacement instruments were available. The policy documented each "flash" autoclave had a log book to be completed.

The hospital document titled, "Steam Sterilization Load Log", in conjunction with the sterilizer run print outs were reviewed from 12/06/16 through 02/07/17. This review showed 64% (36 /56 loads) of the steam sterilization load run during that time frame had drying times of 4-5 minutes. Amongst other instruments in these loads were "rings" (see below Steam Sterilization for other instruments with short drying cycles) . None of these loads were documented on an IUSS log.

The Staff B, the CNO, stated Staff L, the lead scrub technician, had primary responsibility for instrument sterilization. Staff L functioned as a trainer for instrument reprocessing, and had been in this role for 6 years.

During an interview, Staff L: stated the surgical staff did not keep a IUSS log, and did not have a method of associating IUSS loads with the patients on which the instruments were used. Staff E stated drying times of 4 minutes were considered IUSS, and were performed for designated instruments such as batteries, LMA (laryngeal mask airways), and "rings". Staff L stated rings were processed by IUSS because the hospital only had one set, and a quick turnaround was required due to the patient caseloads.

Steam Sterilization

The 01/31/17 Governing Body Meeting Minutes documented 107 outpatient and 49 inpatient surgeries were performed in 2016.

The hospital policy "Autoclave Sterilization Times" documented the guidelines for the EXPRESS and Prevac settings for the steam sterilizer.

This policy documented EXPRESS cycle could be used on the following instruments: Stryker drill, TPS, Scopes, bipolar cord, cysto instruments, hysteroscopy instruments, fish, light source, camera, batteries, and laryngeal mask airway (LMA). Staff E stated EXPRESS steam sterilization drying times were 5 minutes. The sterilizer run print out verified EXPRESS cycle's drying time was 5 minutes. (EXPRESS cycles's drying time of 5 minutes qualifies as IUSS).

A hospital document titled, "Steam Sterilization Load Log" 12/6/16 through 02/07/17 were reviewed for EXPRESS cycles. The log showed EXPRESS loads included batteries and rings. The rings (also called T & A sets), were run three times on EXPRESS cycle. Staff E and the OR Supervisor stated the instruments' manufacturer's guidelines had not been consulted to determine if the EXPRESS cycle was the appropriate cycle setting for both the instruments listed in the policy and the instruments processed by the EXPRESS cycle.

The surveyor requested to see the manufacturer's instruction for use for the laryngeal mask airway (LMA). The DON provided the surveyor with a disposable LMA, and soon thereafter, the OR Supervisor provided the survyor with the insert from a reusable LMA. The OR Supervisor stated that until she had seen the insert, she did not know the manufacturer limited the number of reusable uses to 40. She stated the anesthesia staff had not been counting uses, and effective immediately, the department was switching to the disposable LMA.

The surveyor and Staff L reviewed the hospital policy, titled "Autoclave Sterilization Times". The policy documented that all instruments, not processed by IUSS or EXPRESS, would be "run with a 4 minutes sterilization cycle and a 1 minute dry cycle". Upon reading the 1 minute dry time, Staff E stated "one minute! That is not enough time to dry anything."

CDC "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" documented wrapped instruments should have a drying time of 20-30 minutes, textile packs 5-20 minutes, and wrapped utensils 20 minutes.

The hospital document titled, "Steam Sterilization Load Log" inconjunction with the sterilizer run print outs were reviewed from 12/06/16 through 02/07/17. This review showed PreVac cycles with drying times of 4 minutes occurred in 32% (18 /56 loads) of the steam sterilization loads. The loads included instruments such as rat tooth forceps, lap sets, needle drivers, cervical dilators, bipolar forceps, etc. An instrument load strip from 01/07/17 with a 4 minute drying time included a rat tooth forcep. Staff E stated the rat tooth forcep usually had a drying time of 20 minutes, but was dried at 4 minutes because there was just one load run for that day.

Staff L and the OR Supervisor stated the instruments' manufacturer's guidelines had not been consulted to determine if the PreVac with short drying times was the appropriate cycle setting for both the instruments processed in this way.

Based on interview and document review, the hospital failed to:

a. conduct a surgical fire risk assessments for 7 of 7 patients ( Patient #1, 2, 3, 7, 8, 9, and 10) , and

b. conduct time out procedures for 7 of 7 patients ( Patient #1, 2, 3, 7, 8, 9, and 10) .

These failed practices potentially increased risk for patients in terms of surgical fire, wrong patient identification, wrong site surgeries, wrong surgery performed, and unavailability of specialty equipment needed for case.

Findings:

On 04/10/17 at 11:30 am, the DON stated the hospital provided surgical and endoscopic services.

a. Surgical fire risk
Food and Drug Administration article titled, "Preventing Surgical Fires: FDA Safety Communication" dated 10/13/11 recommended to reduce the risk of surgical fires by conducting a fire risk assessment at the beginning of each procedure amongst other interventions.

The hospital had no policy for conducting fire risk assessment prior to each surgery or invasive procedure.

On 04/11/17 at 11:20 am, during a tour of the surgical department, the surveyor observed oxygen, alcohol [fuel], and cautery [ignition] within the surgical suites.

The medical records of 7 patients who had surgical/endoscope procedures were reviewed. 7 of 7 patients failed to have documentation of a fire risk assessment being conducted prior to surgery/procedure.

b. Time out procedure

The hospital policy titled, "Correct patient, Correct Procedure, and Correct Site 6/16" showed the time out should be conducted prior to receiving any medication that could alter the patient's cognitive function. The policy documented when a patient arrived in the operating room, all members of the surgical team...should participate in a final "team time out". The team time out should consist of identifying the correct patient, correct type of procedure to be performed, correct procedural site was marked, and the availability of any specialized equipment.

The medical records of 7 patients who had surgical/endoscope procedures were reviewed. 7 of 7 patients failed to have documentation of a team time out in the operating room .

On 04/20/17 at 11:30 am, during an interview, Staff B, the DON, stated the surgical staff conducted a time out prior to all surgeries and invasive procedures, and stated the staff did not document the intra-operative time out in the electronic medical record per policy.

Based on record review and interview the hospital failed to ensure out-patient post-surgical patients were discharged utilizing standardized discharge criteria.

This failed practice increased the risk of post-operative complications and readmission to the hospital.

A document titled "Guidelines for Patient Care in Anesthesiology" showed anesthesia providers are responsible for ensuring the patient is discharged from the post-anesthesia care unit (based on policies established by the Department of Anesthesiology).

Document titled "Recovery Room Record" showed no evidence of discharge criteria for discharging a patient after surgery to home.

Review of policy and procedures for both Anesthesiology and Surgical Services showed no evidence of standardized criteria for discharging a patient or assessment parameters prior to discharge following a surgical procedure.

Four (Patient #2, 3, 8, and 9) of 4 medical records showed no established discharge criteria or assessment parameters of a patient prior to discharge following a surgical procedure.

Three (Patient #2, 3 and 8) of 4 medical records showed discharge order to "DC once criteria met". No evidence in charts of the criteria to be met for the patient to be discharged.

On 04/12/17 at 10:45 am, Staff I provided surveyor with a document entitled "Recovery Room Record" for post-surgical nurse monitoring (vital signs, administration of medication for pain, nausea and intravenous fluids, urine output, and post anesthesia score). Staff I stated assessment of patient's pain is performed on admission to recovery room by asking or looking at patient. Staff I stated anesthesia provider follows team with patient to recovery room.

On 04/19/17 at 12:00 pm, Staff B stated the hospital did not have standardized criteria or assessment requirements for discharging patients following surgery. No policy or procedure had been developed to assist nursing staff when a physician may enter an order to discharge patient once criteria is met. Unable to identify what the criteria is for the physician order "DC once criteria met".

Based on record review and interview the hospital failed to ensure emergency department (ED) policies and procedures were current, revised as necessary based on nationally acceptable standards of practice and approved by medical staff.

Document titled "Primary Stroke Center Classification" policy effective July 2011 and reviewed October 2016, approved by Staff B, states compliance with Oklahoma State Department of Health Emergency Stroke Services Classification ...facility meets following criteria for Primary Stroke Center certification ...stroke team members (nursing personnel) annual training on care of stroke patient ...All registered nurses (RNs) and licensed practical nurses (LPNs) required to renew National Institutes of Health Stroke Scale (NIHSS) annually ...response time standard for facility 15 minutes of arrival into ED. No evidence the policy had been revised or updated since its effective date of July 2011. It was last approved by Medical Staff and Governing Body on 01/14/14. Policy was not compliant with their current designation as a Level IV Stroke Referral Center as identified on the hospital's 2017 license signed by Staff A on 2/01/17.

Document titled "Stroke Protocol" policy effective February 2013 and reviewed October 2016, approved by Staff B, no evidence protocol or policy is based off current nationally acceptable evidence based guidelines for the care of the acute stroke patient. Protocol gives no guidance on how to effectively triage an acute stroke patient based on current evidence based standards.

A document titled "Code Stroke Initial Orders" showed no evidence order set had been reviewed and revised utilizing current nationally accepted evidenced based stroke guidelines for the acute management of stroke.

Document titled "Medical Staff" meeting minutes from September 2016 through March 2017 showed no documentation the medical staff reviewed and approved the "Stroke Protocol" and "Code Stroke Initial Orders" for the ED.

No evidence of policy or procedure and a written plan for transfer of acute stroke patients to Level I, II or III Stroke Centers including patients requiring stabilizing treatment prior to transfer and those who may be retained at hospital for palliative or end-of-life care under the Level IV Stroke Center designation.

On 04/10/17 at 12:44 pm, Staff A stated hospital was no longer a Primary Stroke Center and was now a Level IV Stroke Center.

On 04/19/17 at 2:55 pm, Staff B stated protocol for acute stroke patients was to take patient straight to CT and then to transfer patient. When CT was not working emergency medical service (EMS) would divert the patient. The hospital does not have any transfer protocols for stroke or other high risk conditions. Staff B stated that she did review and approve the "Primary Stroke Center Classification", "Stroke Protocol" and "Code Stroke initial Orders" in October 2016.

Based on record review and interview the hospital failed to
a. Ensure staff working in the emergency department (ED) had demonstrated specialized skills and competencies for working in the emergency department.

b. Ensure staff working in the emergency department had demonstrated education and competencies for stroke policy and protocols

These failed practices had the potential for all patients who received emergency services to be placed at risk secondary to lack of a comprehensive emergency nurse training program to ensure staff are able to make safe, effective and critical decisions in the emergency care environment.

American College of Emergency Physicians (ACEP) planning and resource guidelines for the ED state qualified ED staff should have knowledge and skills necessary to evaluate and manage those who present to the ED ...appropriate educated and qualified emergency care professionals in ED at all times ...Each nurse in ED should have demonstrated knowledge and skill necessary to delivery nursing care in accordance with the Emergency Nursing Practice Standards.

A document titled "Orientation" showed no evidence of specialized skills and competencies for working in the ED based on nationally evidence based guidelines and/or standards such as:

~Triage Assessment using the Emergency Severity Index (ESI) based on the Emergency Nurses Association and Agency for Healthcare Research and Quality (AHRQ) Guidelines

~Access/De-accessing Implanted Central Venous Devices using Association for Vascular Access (AVA) Guidelines

~Respiratory treatments, assessing, performing and documentation based on American Association for Respiratory Care (AARC) Guidelines

~Accessing, assembling and delivering oxygen cylinders with regulators based on American Association for Respiratory Care (AARC) Guidelines

~Electrocardiogram (ECG) 12 lead cardiac monitoring and rhythm recognition based on American Heart Association Guidelines

~Neurological Assessment using the Glasgow Coma Scale (GCS) based on the ENA

~Intravenous (IV) Conscious Sedation

~Rapid sequence intubation (RSI) and airway management

~Calculating and managing critical IV drips based on the American Society of Anesthesiologist Guidelines

A document titled "RN/LPN Employee Orientation Checklist" showed no evidence of ED competencies for triage assessment, managing conditions or basic emergency procedures.

A document titled "Primary Stroke Center Classification" showed Stroke Team Members (nursing personnel) will have annual training on the care of the stroke patient. All registered nurses and licensed practical nurses are required to renew their National Institutes of Health (NIH) Stroke Certification annually to ensure compliance with training.

Three (Staff S, T and U) of 3 personnel files reviewed showed:
~No evidence of demonstrated competencies in basic ED nursing care from review of the document titled "RN/LPN Employee Orientation Checklist" or any continuing educational activities.
~No evidence of annual stroke care education.

Staff S personnel file showed BLS expired as of 7/2016, ACLS 9/18/16 and NIH Stroke Scale certification obtained 07/25/13 and expired according to hospital policy on 7/25/14.

Staff T personnel file showed NIH Stroke Scale certification obtained 03/24/14 and expired according to hospital policy on 03/24/15.

Staff U personnel file showed NIH Stroke Scale certification obtained 04/18/15 and expired according to hospital policy on 04/18/16.

On 4/19/17 at 12:00 p.m. Staff B stated there were no specific competencies required for staff to work in the ED. The Staff were required to maintain Basic Life Support (BLS), Advanced Cardiovascular Life Support (ACLS), Pediatric Advanced Life Support (PALS) and the NIH Stroke Scale certification. Stated not sure about the status of the annual stroke training requirement in the stroke policy. Staff B stated she reviewed and approved the "Primary Stroke Center Classification" policy in October 2016.