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Based on review of personnel and credential interviews with hospital staff, the hospital does not ensure that services provided by contract comply with the same standards required of services provided by employees of the hospital. Employees providing patient care services through a contract service do not have competencies, orientation to the hospital or an immunization history as required of hospital employees.

Findings:

1. Contract employees who provide PICC ( peripherally inserted central catheter ) care to hospital patients do not have evidence of orientation, compentency and immunization history.

2. Dietary employees provided by contract do not have evidence of orientation, compentency and an immunization history.

3. This was verified by hospital staff on 09/20/12 in the afternoon.

Based on record review and interviews with hospital staff, the hospital does not ensure the hospital maintains a list of all contracted services. The list of contracted services provided for review did not have all the services which are provided by contract listed. Laundry services and sleep lab services provided by contract were not included on the list provided for review. This was verified on 09/20/12 in the afternoon.

Based on review of medical staff, governing body and quality assurance/performance improvement documentation and and interviews with hospital staff, the hospital does not ensure the QAPI (quality assurance/performance improvement) program includes all hospital departments and services provided by contract. Radiology, dietary and sleep lab services were not evaluated as part of the hospital's QAPI program. This was verified by hospital staff on 09/20/12 in the afternoon.

Based on review of medical records and documentation of care the facility failed to provide registered nursing assessments at least every 24 hours for each patient. None of the medical records reviewed included a consistent registered nurse assessment of patients. Some of the medical records of outpatients did not have an initial registered nurse assessment although a surgical procedure was performed on the patient. None of the contracted services patients reviewed included a registered nurse assessment.

Based on interviews with staff, review of medical records and review of policy and procedure the facility failed to implement a medical records system which allows timely access to accurate and complete patient information.

Findings:

1. On 9/20/12 surveyors requested records. During the reviews the surveyors encountered multiple difficulties finding treatments, responses to treatments, orders for care performed, vital sign monitoring, nursing assessments, nursing narrative, physical therapy, recreation therapy documentation. These findings were confirmed with staff on 9/20/2012.

2. On 9/19/2012 surveyors were told medical records are electronic and paper. Staff told surveyors there were no policies and procedures for electronic documentation. Policies and procedures for medical records services do not stipulate what documents are electronic and what documents are paper to be scanned. There are no processes reviewed, approved, and implemented integrating the hard copy documents into the electronic documentation. There are no policies and procedures reviewed, approved and implemented stipulating use of and documenting in the electronic medical record.

3. There are no policies and procedures stipulating when a chart is considered complete in the electronic medical record. Multiple charts reviewed were not complete. There was no documentation medical records were reviewed for completion and accuracy.

4. Surveyors found entries made in charts which included "float rn" "post op nurse". There was no information in the chart identifying these care providers.
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5. Surveyors were provided two medical records for patient's admitted to the sleep apnea program. The documentation did not match other outpatient medical records. The sleep apnea medical records did not have all the required elements of an outpatient record as stipulated in medical staff bylaws.

6. There policies in place regarding medical record security and authorizations to access electronic records.

Based on review of medical records and interviews with staff the hospital failed to ensure unauthorized individuals had access to electronic medical records.

Findings:

1. Some patient's had orders in their records where the care giver was identified as "float RN" and "post op nurse" was identified with an identification number (ID). The hospital could not provide documentation who these caregivers were. The facility could not identify personnel providing care. During the survey this was brought to the attention of Staff C. Staff C told surveyors they were not aware of clinicians entered as generic providers.


2. On 9/20/12 Staff C told surveyors the facility did not have policies and procedures stipulating documentation and use of the electronic medical record. There was no process or policy indicating what practitioners had permission to document in different areas of the medical record. There was no policy and procedure indicating what personnel could enter physician orders and how and when orders were verified by the ordering practitioner.

3. Review of Governing Body Meeting Minutes 2011-2012, Quality Meeting Minutes 2011- 2012 did not include documentation Medical Records policies and procedures had been revised, reviewed, and implemented to insure records were accessed only by practitioners caring for the patient.

Based on record review and interviews with hospital staff, the hospital does not ensure medical records services are provided in a organized and structured manner. The facility failed to maintain a medical record for every patient evaluated or treated in the hospital.

Findings:

1. On 9/20/2012 surveyors were told the facility had been converting to electronic medical record.

2. On 09/19/2012 surveyors asked if Medical Records policy and procedure included policy on electronic format. Staff C told surveyors no. There were no policies and procedures developed, reviewed, approved and implemented stipulating all required elements for inpatient and outpatient medical records. There were no policies and procedures developed, reviewed, approved and implemented indicating how to access a complete medical record for inpatients and outpatients. There were no policies indicating what documents comprised a complete outpatient record or a complete inpatient record. There were no policies on documentation standards including processes used to document in the electronic record. There were no policies indicating integration of paper medical records into the electronic medical record. The policy and procedures did not reflect the current medical records practice. There were no policies addressing use of the electronic documentation system and how the clinicians accessed particular documents.

3. On 9/19/2012 surveyors were told the facility had a contract with a sleep disorder facility. Staff B told surveyors these facilities created a medical record within the hospital's system. Surveyors reviewed sleep apena medical record documentation. Records from sleep apnea did not have the same elements as the hospital's other outpatient records.

4. The facility's medical records are a combination of electronic medical records and scanned documents. On 9/19/2012 surveyors requested multiple complete closed medical records. Some of the records requested did not have initial nursing assessments. All of the inpatient records did not have consistent documentation of a registered nurse assessment every 24 hours. Staff C told surveyors it was possible the nursing staff was documenting the assessment electronically. There was no evidence the medical records are reviewed for completion. The facility could not provide complete medical records timely.

5. None of the inpatient medical records reviewed had nutritional screen documentation. There was no documentation by nutrition staff nutritional assessments or recommendations for changes in diet.

6. None of the inpatient medical records reviewed had physical therapy documentation of treatments and evaluations when ordered.

7. Several records reviewed by surveyors did not have complete assessments by nursing personnel and/or did not have initial nursing assessments.

8. Several records did not include intravenous infusion totals during any of the perioperative period.

9. Several records did not have electronic signatures and were labeled "post op nurse" or "float rn". There was no documentation provided identifying all personnel providing care.

10. History and physicals on several charts were dictated a mininimum of twenty four hours after the patient was admitted. There was no handwritten admission note in the medical records for these patients which meet the time requirement.

11. Discharge summaries on several charts were dictated months after the patient discharged. There was no handwritten discharge summary in the medical record..

Based on review of medical records, interviews with staff, review of meeting minutes, and hospital documents the facility failed to provide a medical record containing all the required elements.

Findings:

1. All medical records reviewed for intravenous fluid infusion rates, amounts infused, amounts started did not have all of the documentation. Surveyors were unable to find the amounts of fluids initiated, the amounts infused in each area (preoperatively, intraoperatively, and post anesthesia discharge).

2. Read back verbal orders were used. There was no date or time of physician authentication.

3. Several orders lacked the amount of fluid to be hung, the rate of infusion, or the amount infused. Examples: LR (lactated ringers) at 150. There is no rate of infusion per hour or the volume of fluid to be initiated documented. MS (morphine sulfate) 1-4 mg for severe pain. There was no documentation quantifying "severe pain" or how often the medication could be administered. Ancef preop (preoperatively. There was no dose specified, admixture, or rate of infusion written in the order.

4. Several medical records reviewed included orders for intake and output. None of the records reviewed consistently included intravenous fluid administration totals from all patient care areas.
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5. The above findings were reviewed at the exit conference 9/20/2012. No further documentation was provided.

Based on review of medical records, interviews with staff, and review of meeting minutes, the hospital failed to ensure medical records included a timely discharge summary. The facility failed to ensure a complete medical record was available to patients in a timely manner. Five of five medical records reviewed for discharge summary stipulated the discharge summary was transcribed greater than thirty days after discharge.

Based on review of medical records, contracts, and interviews with staff the facility failed to have a radiologist supervising the radiology services.

Findings:

1. On 9/19/2012 Staff C told surveyors the Staff J was the radiologist in charge. There was no information provided to surveyors indicating Staff J had accepted the responsibilities of chief radiologist.

2. On 9/20/2012 Staff J's credentialing file was reviewed. Staff J had been granted privileges as a radiologist. There was no information in the credentialing file indicating Staff J had accepted the responsibilities of chief radiologist. There was no contract provided stipulating the additional responsibilities of the chief radiologist had been accepted by Staff J.

3. On 9/19/2012 surveyors reviewed policy and procedure. There was no policy and procedure for cleaning and sanitizing equipment and surfaces in the radiology policies. There was no handwashing/hand hygiene policy utilizing current infection control practices.

4. On 9/19/2012 surveyors reviewed quality assurance data. There was no documentation of all radiology services evaluated as part of the QAPI process.

5. On 9/19/2012 surveyors reviewed the current physicist report. The report was dated Feb 2011. The facility policy stipulates the report will be completed on an annual basis. The facility failed to follow their policy.

5. The above findings were reviewed with administration at the time of the exit conference. No further documentation was provide

Based on review of medical records, hospital contracts, and interviews with staff the facility failed to have only qualified personnel designated by the radiologist in charge and/or the medical staff use radiology equipment and administer procedures. There was no evidence in personnel files the radiologist/medical staff had reviewed equipment, technique, shielding, and radiation safety requirements and determined staff qualifeid to operate specific equipment.

Based on record review and interviews with hospital staff the hospital does not ensure there is a organized dietary service with oversight by a registered dietitian. The hospital did not have evidence that a dietitian was providing oversight or services with regularly scheduled visits and oversight of clinical nutritional services. The facility failed to meet the nutritional needs of the patient.

Findings:

1. On 9/19/2012 Staff C told surveyors the facility had a contract for food service and the kitchen was not part of the licensed facility. The dietary contract provided to surveyors indicates the contractor will provide a "nutrition services general manager and the hospital will provide clinical dietitians. There was no documentation provided a clinical dietitian provided services to the facility. Surveyors requested "consultant dietitian reports". None were provided.
There was no orientation, training, or competency file for the dietitian.

2. On 9/19/2012 surveyors requested files for dietary employees. The facility did not have a current list of contracted dietary employees providing services to patient care areas. There was no documentation provided the facility had a certified dietary manager which is required by State and Federal regulation when the dietitian is a consultant.

3. On 9/19/2012 surveyors requested dietary policies and procedures and a copy of the current Diet Manual reviewed and approved by Medical Staff. Surveyors reviewed three policies. According to Staff C the remainder of the dietary policies were under review. There were no policies and procedures developed, reviewed, approved, and implemented to guide processes between the contract nutritional services company and the facility. Later during the day, Staff C brought surveyors contractor policies. These policies did not address food and nutrition services specific to the facility. There were no policies and procedures provided to surveyors which included how the food preparation would be accomplished. There were no policies regarding specialized menus, approval of menus, supplements etc.


4. Several patients did not have a complete nutritional screen or the screen did not match documentation in the history and physical. There was no documentation the hospital identified patients at nutritional risk and provided nutritional care based on the patient's assessment.

5. The facility did not have any documentation regarding contracted food service employees. There was no information available to determine if contracted staff had been educated regarding safe food handling, infection control processes, diets, modification of diets, and portioning. The facility failed to train staff, implement policies, and oversee processes to ensure patients nutritional needs are met.

6. Meeting minutes reviewed for 2012 did not document that a dietitian was attending or providing reports in any of the hospital's meetings.

9. The Dietary manual provided to surveyors was dated 2006. The current manual was not in the facility. There was no documentation the dietitian reviewed and approved diets and special diets at the facility.

10. Dietary/kitchen inspection reports were found in the manuals. There was no documentation the inspection reports had been reviewed or acted on in any committee meetings or governance. There was no documentation the dietitian was aware of the inspection findings.

11. Policies and procedures provided to surveyors did not contain all the required elements. The policies did not include portioning, revision of special diets, substitutions, use of equipment, sanitization of equipment/department.

12. The facility utilizes a electronic medical record. There was no policy governing documentation of the dietitian consult. There were no dietitian consults found in any records. There was no documentation of a nutrition screen by nursing. These findings were confirmed with Staff C on 9/20/2012.

Based on review of medical records, policies and procedures, dietary consultation reports, and interviews with staff, the facility failed to ensure dietary services were provided in an organized manner and problems identified in dietary were included in quality assurance performance improvement activities (QAPI).

Findings:

1. No dietitian reports were provided during the survey to show the dietitian was actively supervising dietary services at the hospital. There was no list or documentation provided by the consulting dietitian regarding consultations. There was no evidence the dietitian provided oversight to dietary/clinical staff ensuring compliance with dietetic policies effecting patient treatment. There was no job description for the dietitian or dietary manager. There was no evidence of any orientation, training, or competencies for any food service personnel. There was no evaluation of the personnel of the food and nutrition services.

2. On 09/19/2012 surveyors were provided a food services contract. The contract stipulates the dietitian will be provided by the hospital. There is no contract language indicating the responsibilities of the dietitian. There were no monthly reports indicating the dietitian oversaw all required elements of the dietary program.

3. On 9/19/2012 surveyors asked if there was a list of patients the dietitian had consulted with. No documentation was provided. There was no evidence in the medical record the dietitian consulted on any patients. .

4. Dietary policies and procedures were provided 09/19/2012. There were three policies in the diet manual . The departmental policies did not have policies regarding portioning. The process for nutritional assessment and nutritional screen did not match the nursing policies regarding assessment and screening. There were no policies for cleaning and sanitizing the department and equipment. There was list of approved cleaners and sanitizers for use in the kitchen.
There was no evidence any Infection Control processes had been integrated into the dietary department. .

5. There was no documentation in the Quality Assurance Performance Improvement (2012) meeting minutes the clinical nutritional services participated in the program. There was no documentation the dietitian, the dietary department, or clinical nutritional services participated in any of the hospital committees.

6. The facility did not have a current Diet Manual reviewed and approved through Medical staff.

7. The facility did not have a list of contracted dietary staff. There was no documentation any of the food service personnel were trained, qualified, and competent to carry out the functions of the dietary department.

Based on review of personnel files, contracts, policies and procedures the facility failed to provide a full-time qualified, competent, dietary manager. The facility has a contract with a contract food service. There is no documentation the Dietary Manager is a certified dietary manager or a registered dietary technician as required by State/Federal regulation standards. This finding was verified with administration at the exit conference.

Based on review of hospital documents and interviews, the hospital failed to ensure a qualified dietitian supervises the nutritional aspects of patient care.

Findings:

1. The hospital did not have documentation that dietitian was licensed, trained, competent, and evaluated.

2. There is no evidence a licensed/registered dietitian supervises the serving of modified diets to hospital patients. There is no documentation a dietitian monitors food service preparation or delivery by the contracted food service.

3. There is no documentation in the medical records, a licensed dietitian completed a nutritional assessment or a screen on patient's requiring nutritional consult.

4. There are no consulting dietitian reports. The facility could not provide documentation the consulting dietitian had been working with the facility or the contracted service vendor.

Based on interviews and review of contracts the facility failed to provide qualified dietary staff.

Findings:

1. Surveyors requested a list of dietary personnel. This document was not received.

2. On 9/20/2012 Staff C told surveyors the facility did not have a list of contracted dietary employees.

3. The facility did not have evidence any of the food services personnel were qualified, trained, and competent.

Based on review of medical records, policy and procedure, and interviews with staff the facility failed to provide nutritional services that met the needs of the patient. On 09/20/2012 surveyors reviewed patient records. Review of the patient's medical records indicate patients had varying comorbidities. Several records reviewed indicated patients had disease processes which would increase their nutritional risk. There was no documentation current menus had been reviewed and revised by a clinical dietitian to meet the needs of the types of patients the facility cared for. There was no documentation the supplements and parenteral nutrition were reviewed and approved by the dietitian. There was no documentation modified diets were reviewed and revised by the dietitian.

Based on a review of policies and procedures, medical records, and staff interviews, the hospital failed to ensure the therapeutic diets were meeting the needs of the patients. According to hospital policy all patients will be assessed by the dietitian within 24 or 48 hours of being assigned a "C" or "B" level of nutrition status. There was no documentation in the medical records of any patients with nutritional status levels seen by a dietitian or certified dietary manager. There was no documentation the facility had a qualified dietitian review nutritional needs of patients and ensure the nutritional needs of patients are met.

Based on review of medical records, policies, interviews with staff and hospital documents the facility failed to meet the nutritional needs of the patients in accordance with recognized dietary practices.
There was no evidence a qualified competent dietitian oversaw the dietary department. There was no evidence patients were nutritionally screened and interventions based on recognized practice were implemented.

Based on review of hospital documents, meeting minutes, and interviews the facility did not have a current therapeutic diet manual reviewed and approved through governance, dietitian, and medical staff. The manual at the facility was dated 2006. There was no documentation it was utilized to assist with ordering and preparing patient diets.

Based on interviews with staff and a tour of the hospital the facility failed to provide services in procedure rooms with adequate ventilation, temperature, and humidity control.

1. On 9/19/2012 surveyors toured the surgical area. Review of humidity and temperature logs indicated procedures were performed during times when the humidity was not in the correct range. There was no documentation staff notified plant operations the readings were not within limits. There was no documentation the facility acted on the humidity not being within range by cancelling or postponing cases until the temperature and humidity were within range.

2. On 9/20/2012 Staff F verified procedures had been done in these rooms.

3. These findings were presented at the exit conference. No further documentation was provided.

Based on interviews with staff and review of hospital documentation, the hospital failed to maintain an active ongoing program to prevent, control, and investigate infections and communicable diseases to minimize infections and communicable diseases in patients and staff.

Findings:

1.

Based on review of infection control data, surveillance activities, and meeting minutes, and hospital documents, and interviews with hospital staff, the hospital failed to ensure the infection control practitioner (ICP) developed and maintained a comprehensive system for reporting, analyzing and controlling infections and communicable diseases among patients and staff and ensuring a sanitary environment.

Findings:

The surveyors requested and reviewed meeting minutes and surveillance activities provided for 2011 and 2012 containing Infection Control. The surveyors originally reviewed Quality Council meeting minutes, but on 09/20/2012, administrative staff told the surveyors that the Safety committee acted as the infection control committee. This committee does not have a physician on the committee. These findings reflect review of both committee meeting minutes.

1. The meeting minutes did not reflect that the infection control program contained a system for review and analysis with plans of action and follow-up monitoring to ensure plans of actions were effective.

a. Meeting minutes documented nosocomial/hospital acquired infections occurred to patients in the hospital. The meeting minutes and documents provided did not demonstrate an analysis had occurred to identify if corrective actions, or policies and procedures or protocols revision need to occur or follow-up to ensure any corrective actions/revisions taken were effective.

b. Meeting minutes reported surgical site infections (SSI), but there was no review of SSIs to ensure the infections were not due to flashed instruments and implants. Although review sheets had a section regarding use of "flash" sterilization, it was left blank on the review sheets. On 09/20/2012 at 1145, Staff D confirmed, at the time of surveyors' review, that the "flash" sterilization log and sterilizer tapes did not contain identifiers to ensure instruments could be traced to the individual patients when more than one load/cycle was processed.

c. Meeting minutes contained a section labeled Employee Health; however,
i. Immunization history was not discussed. Review of staff (contract and employee), and physicians did not have complete immunization histories as required by Oklahoma State Hospital Licensure Standards and recommended by Centers for Disease Control (CDC) and its advisory Committee on Immunization Practices (ACIP).
ii. The only topics in the minutes were related to employee injuries and exposures. There was no review of staff illnesses/infections to ensure transmissions between staff and patients and/or staff and staff had not occurred.

d. Meeting minutes did not reflect the infection control program had been reviewed and reviewed annually as required by Oklahoma State Licensure Hospital Standards. The policies and the infection control program/plan was last reviewed in 2010.

e. The only surveillance, other that patient infections, recorded in the meeting minutes was hand washing surveillance. Corrective actions/follow-up only documented "continue to monitor" and "increase education." The meeting minutes did not reflect measurable outcomes, teaching/inservice that was provided and follow-up to determine whether the corrective actions were effective.

2. Although the most current plan/program (2010) documented that established policies and procedures/practices would be monitored, but meeting minutes and surveillance documents provided did not reflect this was performed.

a. Surgical practices and central sterile use of "flash" sterilization on routine basis were not monitored and part of the infection control surveillance/monitoring program. Meeting minutes did not reflect analysis of this practice with plans of action to reduce the use. (Refer to Tag A-951 for details).

b. Surveillance/monitoring activities did not contain evidence isolation practices were monitored to ensure policies and procedures were followed and measures were taken to contain and prevent transmission of infections and communicable diseases throughout the hospital.

c. The current plan stipulated, "Outsourced laundry facilities shall be toured on an annual basis." Meeting minutes and surveillance activities did not contain evidence this had been performed.

d. Monitoring/surveillance activities did not demonstrate the infection control practitioner had monitored to ensure disinfectants had been applied according to manufacture guidelines, in all departments, to ensure a safe and sanitary environment and prevent the transmission of infections and communicable diseases.

Based on review of hospital policies and meeting minutes and infection control documents, the hospital failed to ensure the infection control program tracked staff incidents related to infections and communicable diseases to ensure transmission between staff and staff and patients did not occur.

Findings:

1. Infection control documents did not contain evidence staff illnesses were tracked. Only patient infections were listed.

2. Meeting minutes containing infection control and employee health did not contain reference to analysis of staff illnesses to analyze if transmission between staff and patients occurred.

Based on review of hospital documents and meeting minutes concerning infection control, and infection control policies and procedures, and interviews with hospital staff, the hospital's leadership failed to ensure infection control activities, issues, and problems, through Quality Assessment and Performance Improvement (QAPI):
1. Were monitored, reviewed and analyzed;
2. Corrective actions were taken to prevent, identify and manage infections and communicable diseases with measures that resulted in improvement on an ongoing basis; and
3. Corrective actions were followed to ensure improvement resulted and alternative solutions/actions were not needed.

Findings:

1. Meeting minutes that contain infection control data reported nosocomial infection. The QAPI meeting minutes did not contain analysis or plans of action taken to reduce infections. The only action recorded was to continue to monitor and trend.

2. The QAPI program has not provided oversite of the infection control program to ensure a safe environment.
Monitoring activity, in addition to the reported patient infections, only recorded handwashing observation/monitoring. The documents presented for review did not show any surveillance/monitoring to ensure infection control policies were followed. This included, but not limited to:
a. Surgical Services practices;
b. Isolation practices;
c. Disinfectant practices.

3. Review of infection control data showed patient's admitted with infectious diseases and patients who acquired nosocomial infections while in the hospital. Meeting minutes did not contain evidence the hospital leadership analyzed the data; developed a plan of action to reduce and/or prevent transmission of organisms; and provide follow-up to ensure corrective actions taken were effective.

4. Documents provided did not contain evidence the infection control/prevention program monitor/reviewed staff illness to ensure transmission between staff and patients did not occur. Meeting minutes did not reflect this had been identified or reviewed as a possible avenue to reduce transmissions of infections.

Based on policy and procedure review, document review and staff interview, it was determined the hospital failed to ensure surgical services were provided in accordance with acceptable standards of practice as evidenced by:

a. failure to ensure there was a clearly defined organizational structure within the surgery department to include all job descriptions, responsibilities and functions;

b. failure to review and update surgical department policies and procedures to reflect current standards of practice. The policies and procedures were not comprehensive in a manner and scope to address the surgical services provided;

c. failure to strictly limit flash sterilization to emergency situations and to prohibit routine flash sterilization for reasons of convenience; and

d. failure to document all items sterilized in each load for each sterilizer in order to quickly and efficiently identify any items that may need to be recalled in the event of suspected sterilizer failure.

The hospital failed to meet the Medicare Hospital Condition of Participation for 42 CFR 482.51- Surgical Services. See A Tags 0941 and 0951.

Based on record review, policy and procedure review and staff interview, it was determined the hospital failed to ensure a clearly defined organizational structure within the surgery department to include all job descriptions and their functions. Findings:

A review of all hospital job codes indicated the following positions were used within the surgery department:

patient care technician
patient care assistant
surgery technician
certified surgery technician
certified robotics technician
sterile supply technician
central supply technician
central supply technician lead
registered nurse
registered nurse charge
registered nurse lead charge
certified first assistant I
certified first assistant II
specialty leader surgical services
unit secretary
surgery scheduler
anesthesia technician

There was no organizational chart within the surgical department's policies and procedures that documented lines of authority and delegation of responsibility.

The surgery department had no documentation of job descriptions and qualifications for each job category. There was no documentation job-specific skills competencies.

On 09/20/12, staff D stated many job responsibilities within the OR overlapped. She was not certain of the lines of authority and responsibility.

Based on policy and procedure review, document review and staff interview, it was determined the hospital failed to ensure policies governing surgical services reflected current standards of practice and were comprehensive in manner and scope to address the surgical services provided. Findings:

1. A review of the surgical services policy and procedure manual provided by hospital leadership indicated some of the surgery department policies were last reviewed in June of 2010. Not all policies were reviewed at that time. Some surgery policies had not been reviewed since 2004.

There was no documentation the surgery department policies and procedures had ever been reviewed and approved by the chief of surgery and the director of perioperative services. There was no documentation the surgery department policies as a whole had been approved by the medical executive committee and the governing body.

2. The surgical services department policies and procedures did not have documentation specifically related to:

~ delineation of a line of authority within the surgery department;

~ responsibilities and duties for all job categories of those personnel working in the surgery department;

~ policies and procedures to govern all tasks performed by staff working in surgery;

~ policies and procedures for the presence of product representatives and other non-staff personnel within the operating rooms;

~ policies and procedures related to the use of department specific equipment including electrocautery, patient warming devices, patient safety and positioning devices, sequential compression devices, laparoscopic and robotic equipment, and sterilizers;

~ policies and procedures related to surgical skin prep, universal protocol (time out), surgical counts and other surgical tasks;

~ emergency preparedness procedures to include cardiopulmonary arrest, power failure and intranet connectivity failure;

~ policies and procedures addressing the surgery department's responsibilities during internal and external disasters;

~ infection control responsibilities including the handling of contaminated cases and departmental surveillance of aseptic and sterile technique and the reporting of other departmental infection control activities to the hospital infection control department;

~ policies and procedures regarding the care and handling of surgical specimens; and

~ protocols for all surgical procedures performed including laparoscopic and robotic surgeries.

On the afternoon of 09/19/12, staff C was asked if the surveyors had been provided all of the surgery department policies and procedures. She stated they had.

Staff D was asked if she was familiar with the surgery department policies and procedures. She stated she was not.

3. A hospital policy from the central sterile department titled, "Flash Sterilization", was last revised in August of 2010 and had no documentation of approval by any hospital leadership.

The policy documented, "... Flash sterilization shall be done only under the following circumstances... emergency situation during a procedure in which an instrument is contaminated and there is no replacement item... an implantable device, which the manufacturer recommends flashing only... flash sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method... Documentation of cycle information and monitoring results is maintained to provide for tracking of the flashed item(s) to the individual patient..."

This policy was not found within the surgery department policies and procedures. The central sterile processing department manual documented this policy was "in review" and was not available to staff within the current manual.

An infection control report to the Quality Council Meeting, dated 11/08/11, documented the surgery department's flash sterilization volume for the year 2011 as follows:

January 188 (flash loads)
February 171
March 162
April 176
May 181
June 198
July 182
August 179
September 201
October 226

A review of September 2012 records for sterilizers # 4, 7, 8, and #10 (sterilizers located in the sub-sterile areas between operating rooms) documented flash sterilization was performed several times a day. When the reason for flash sterilization was documented, it was documented as "turnover." The flash sterilization records did not include a patient name, the name of the person running the load and verification of appropriate parameters of sterilization. There was not always documentation of what was contained in the flash load.

There was no documentation biological testing had been done on each sterilizer at the the start of the day before flash sterilization was done.

Sterilizer records for autoclaves used between the OR suites documented various items were flash sterilized including cholecystectomy sets, Zimmer sets (which included 15 or more pieces), tonsillectomy sets and various implants.

Staff E was asked why flash sterilization was performed. She stated, "Whenever there is not enough time for regular turnover of instruments or if there are not enough instruments for the amount of surgeries going on." She was asked how many cholecystectomy and tonsillectomy sets were available for use. She stated, "Five or six of each set."

She was asked if the hospital performed emergency surgeries. She stated it did not. She was asked if flash sterilization was done every day on a routine basis. She stated it was.

According to the Centers for Disease Control (CDC -- Infection Control and Hospital Epidemiology, "Guidelines for Prevention of Surgical Site Infection" April 1999, page 261) and Prevention and the Association of Operating Room Nurses (AORN -- "Perioperative Standards and Recommended Practices", pages 578- 581, 2008 edition) the use of "flash" sterilization for the routine sterilization of instruments, for reasons of convenience, or used as an alternative to purchasing additional instrument sets and/or to save time is not recommended. Flash sterilization, according to current CDC guidelines, should be limited to the purpose of sterilizing a surgical instrument in an emergency, such as when a needed instrument has been dropped or otherwise becomes contaminated and there is no replacement immediately available.

4. A central sterile policy titled, "Lot Load Monitoring" documented, "... All materials sterilized, shall be Lot and Load monitored. A method of record keeping for the purpose of product recall, which would be indicated if an unsatisfactory test result is received, malfunction of a sterilizer is suspected, or any similar occurrence will be maintained on a daily basis in the CP Monitor Log..."

The policy documented that each item sterilized would be labeled with a load or lot control number. The policy did not state that the contents of each sterilizer load would be documented, i.e.. all items, instruments or sets in each load would be listed on the daily sterilizer packet.

A review of records for the sterilizers in the central processing area were reviewed for August and September 2012. None of the envelopes containing the sterilizer tapes documented what items were run in each load.

Staff D was asked how staff would retrieve items from a suspected sterilizer load failure. She stated they would have to look through all the department sterile items to find those items with the matching lot number.

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

a. there was a clearly defined organizational structure within the anesthesia department; and

b. failed to ensure anesthesia department policies and procedures were current and reviewed annually by the chief of anesthesiology, the medical executive committee and the governing body. Findings:

The anesthesia department policies and procedures were last reviewed in 2004 and had no documentation of an organizational structure. On 09/19/20, staff C stated the anesthesia department utilized anesthesiologists, certified registered nurse anesthetists and an anesthesia technician.

There was no documentation of job descriptions and scope of responsibilities and lines of authority. There was no documentation of anesthesia coverage for the operating room.

The most current anesthesia policy and procedure was reviewed in June of 2010. The policy titled, "Anesthesia Machine Care", documented, "... Appropriate care of the anesthesia machine in the peri-operative area... This policy is specifically designed for Nurse Techs/licensed personnel responsible for stocking, maintenance, cleaning and calibration of the machine, monitors and equipment. The procedures of this policy will be carried out by Nurse Techs and/or licensed personnel daily before use and post OR case..."

There were no staff identified as "nurse tech" on the hospital operating room staff roster. The staff roster did reference an anesthesia technician was employed for the operating room.

There was no reference in the anesthesia machine policy to an anesthesia technician and that person's responsibilities for the anesthesia machine and related equipment. There were no policies within the anesthesiology department that referenced an anesthesia technician.

The policy also documented, "... The Chief of Anesthesia and Anesthesia Department staff will do an annual review of all safety regulations..." There was no documentation the surgery department safety policies had be reviewed by the Chief of Anesthesiology, the medical staff or the governing body since 2004.

Based on interviews, job descriptions, policies and procedures the hospital failed to ensure the Director of Rehabilitation was qualified through licensure and experience. According to administration, Staff F is the Director of Rehabilitiation. Staff F is not a licensed therapist. There are no other personnel listed as overseeing the clnical component of the rehabilitation unit. This finding was verified with administration at the time of the exit.