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Based on observation, interview and record review, the governing body failed to ensure that:

1. The contracted services (services provided by an outside company) for Central Processing (sterilization of surgical instruments) and Environmental Services (EVS-hospital cleaning including Central Processing area) were provided in compliance with the Infection Control Condition of Participation. (Refer to A-0083).

2. The contracted services for Central Processing (sterilization of surgical instruments) and Environmental Services (EVS-hospital cleaning including Central Processing area) were provided in a safe and effective manner. This practice increased the risk of infection for all surgical patients. (Refer to A-0084)

3. That all services performed under a contract were provided in a safe and effective manner for 6 of 6 contracted services for the health information management/medical records department. This failure had the potential for unauthorized persons gaining access to medical records. (Refer to A-0084)

4. All hospital departments and contracted services were monitored for quality of services provided (Refer to A-0263).

5. The contracted services for Central Processing and Environmental Services were evaluated by the quality team for quality of services provided. This practice increased the risk of infection for all surgical patients. (Refer to A-0308)

6. A medication review and documentation system was in place that accurately reflected physician/practitioner medication orders in the event the staff were unable to access electronic medical records, physician orders, and Medication Administration Records (MAR-record of all drugs given to a patient) (Refer to A-0431).

7. The hospital provided a sanitary environment to avoid sources of transmission of infections and communicable diseases and failed to have an active program for the prevention, control and investigation of infections and communicable diseases. (Refer to A-0747)

The cumulative effect of these systemic practices increased the risk of poor health outcomes for a universe of 184 patients by failing to comply with the Condition of Participation for Governing Body.

Based on observation, interview and record review, the governing body failed to ensure that the contracted services (services provided by an outside company) for Central Processing (sterilization of surgical instruments) and Environmental Services (EVS-hospital cleaning including Central Processing area) were provided in compliance with the Infection Control Condition of Participation.

This practice increased the risk of infection for a universe of 184 surgical patients.

Findings:

Review of the hospital's 2015 Infection Prevention and Control Plan, approved by the governing body 8/26/15, indicated the plan was a hospital-wide program for the purposes of preventing and controlling infections and transmission of infection that included surveillance as a function of the Infection Control program. This Plan listed facility goals that included minimizing the risk of transmitting infections with the use of procedures, medical equipment and medical devices, and to maintain a sanitary environment to avoid sources and transmission of infections and communicable disease. Another goal listed was that problems identified through active surveillance could be addressed by the hospital's quality assurance program.

Further, the 2015 Infection Prevention and Control Plan indicated a Strategy of the Plan was to reduce the risk associated with procedures, medical equipment and medical devices by implementing the appropriate storage, cleaning, disinfection, sterilization, and/or disposal of supplies and equipment.

Review of the hospital's Organization-Wide Risk Assessment of 2014, approved by the governing body 8/26/15, indicated a risk identified as "EOC (Environment of Care) Potential for transmission of infection related to procedures, medical equipment, and medical devices related to appropriate storage, cleaning, disinfection, sterilization, reuse and/or disposal of supplies and equipment." The list of Strategies listed to reduce risk included "regular rounding and inspecting the environment cleanliness by IC (Infection Control) and EVS (Environmental Services)" and "weekly EOC rounds."

During an interview with the ICM (Infection Control Manager) on 2/22/16 at 12:05 PM, she stated she was a member of the EOC team and participated in observation rounds of the OR (Operating Room) quarterly, and twice a year for all other areas. She further stated there was no "surveillance tool" used during the observation rounds. The ICM was unable to provide documentation of surveillance rounds done in the CSP (Central Sterile Processing), OR, or sterile supply rooms.

During tours of the hospital on 2/22/16 and 2/23/16, the following observations were made as related to the Infection Control Program:

1. During an observation of the CSP (Central Sterile Processing) area, on 2/22/16 at 1:00 PM, accompanied by the ICM (Infection Control Manager) and CSS (Central Services Supervisor), eight of eight peel packages contained instruments in the closed hinge position.

During an interview with the CSS immediately following the observation, he stated he could not tell if the tips of the instruments were sterilized because they were not open and exposed to the sterilant.

During an interview with the ICM immediately following the observation, she stated if the tips of the instruments were closed or touching, sterilization could not be guaranteed. She stated that the hospital has adopted the AORN (Association of periOperative Registered Nurses) Guidelines as one of the hospital's nationally recognized infection control standards.

Review of the hospital P&P (Policy and Procedure) titled, "Sterilization", dated 3/16/14, indicated sterilization practices would follow AORN recommended practices. The policy indicated items should be prepared and packaged so sterility can be achieved and maintained to the point of use.

According to AORN, Guidelines for PeriOperative Practice 2013, Guidelines for Selection and Use of Packaging Systems for Sterilization, V.h. "Items to be sterilized should be placed in the package or tray in an open or unlocked position. The open or unlocked position facilitates sterilant contact of all surfaces of the item."

During an interview with ORT 1 (Operating Room Technician), on 2/23/16 at 10:30 AM, she stated she had not received competency training for decontamination and sterilization of surgical instruments, but was currently taking a course to get certified. During this interview, she stated she had too many duties, and the duties are "too much for me," stating she was frequently called away from one duty to the next prior to completion. She stated she was unable to monitor the sterile packages and peel packs for integrity and sterility.

Review of the hospital's Infection Prevention P&P (Policy and Procedure) titled "High Level Disinfection", dated 12/4/13, indicated quality-control programs would be documented and would include "competency assurance, and continuing education."

Review of the hospital's job description for "Central Services Technician" indicated general duties included collecting used equipment, decontaminating and cleaning reusable items; maintaining processing supply inventory; cleaning shelves, carts, tables, sinks, and counter tops; performs daily and weekly cleaning of work surfaces, sterilizers and aerators.

Review of ORT 1's competencies provided by the facility did not include documented evidence of competencies validated for duties required of a Central Services Technician according to the hospital's job description.

Review of the hospital P&P titled, "Packaging Systems for Sterilization", dated 3/16/14, indicated personnel would demonstrate competence in the use of sterilization packaging systems and accessories, and further, administrative personnel would periodically assess and document the competency of personnel. The policy indicated ongoing education of personnel would occur to assist in the development of knowledge, skills, and behaviors that affect patient outcomes.

The AORN "Guidelines for PeriOperative Practice, 2016 edition, Guidelines for Cleaning and Care of Surgical Instruments and Powered Equipment" was reviewed. Recommendation XV indicated, "Perioperative team members with responsibilities for cleaning and caring of instruments used in surgery should receive initial and ongoing education and complete competency verification activities related to cleaning and care of surgical instruments.

2. During an observation of the L&D soiled utility room/decontamination room, on 2/23/16 at 11:15 AM, accompanied by the ICM, a "hopper/bedpan hopper" (a utility sink with a flushing mechanism designed to rinse soiled bedpans) was noted to be half-filled with soapy water.

During an interview with L&D Technician 1, on 2/23/16 at 11:15 AM, she stated she rinsed the maternal/fetal monitoring transducers in the "hopper".

Review of L&D Technician 1's competencies provided by the facility did not include documented evidence of ongoing validation of training or competencies for the years of 2013, 2014, 2015 or 2016, related to instrument cleaning, or sterilization and storage of L&D instruments

During an interview with the ICM immediately following the observation, she stated the "hopper" was not to be used for the cleaning of any instrument or equipment as it could potentially be a source of infectious agents.

Because of the serious potential harm to all patients who have surgery at the hospital related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was identified and called on 2/23/16, at 3:10 PM with the Chief Executive Officer, Director of Quality Management, and the Peer Review Manager.

During an interview with the DQM (Director of Quality Management), on 2/29/16 at 1:45 PM, she stated all infection control issues were discussed during the infection control meetings. During this interview, she further stated she had not seen any documented evidence of active surveillance rounds that were done in the CSP area, operating rooms, or sterile supply rooms, and was "unsure if any had been done in the past."

On 3/2/16, at 2:09 PM, the Director of Quality Management was informed the Immediate Jeopardy to patient safety was removed after the plan of correction was submitted, accepted, implemented, and verified.

The AORN "Standards and Recommended Practices, 2013 edition, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment" was reviewed.

Under Recommendation XII, it read: "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces. Proper organization will facilitate sterilant contact on all surfaces and adequate drying.

XII.a. Instruments should be placed in a container tray or basket that is large enough to evenly distribute the metal mass in a single layer. Instruments should be contained within the tray or basket in a manner that protects the instruments from damage and prevents puncturing of the sterilization wraps. Overloading trays can cause wet packs because an increase in metal mass in the tray results in more condensate, which requires additional drying at the end of the cycle.

XII.b. Broad-surfaced instruments and those with concave surfaces (e.g., malleable retractors, hip skids) should be placed on edge. Instruments placed on edge facilitate drying because in this position, steam condensate will drain off the instrument rather than pool on it.

XII.c. Instruments with hinges should be opened and those with removable parts should be disassembled when placed in trays designed for sterilization, unless the manufacturer has provided validated instructions to the contrary. Sterilization occurs only on surfaces that have direct contact with the sterilant. Disassembly of multiple-part instruments and those with sliding parts (e.g., retractors) enables the sterilant to contact all surfaces.

XII.c.1. Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments."

3. During an observation of the CSP area, on 2/22/16 at 1:45 PM, accompanied by the ICM, CSM (Central Services Manager), and CSS, the following was observed:

a. The Getinge Group washer/disinfector had palpable, thick white "water spots" on the conveyor area, and palpable dust buildup on the edges of the conveyor area.

During an interview with the CSM on 2/22/16 at 1:45 PM, he stated the central services staff were responsible for cleaning of CSP area equipment and dust should not be on the equipment. He further stated that the facility has "hard water" which contributed to the water spots.

During an interview with the DQM (Director of Quality Management) on 2/25/16 at 2:15 PM, the DQM stated she was unable to locate documentation to indicate the Getinge Washer/Disinfector had been cleaned, was unable to locate manufacturer's instructions for cleaning, and did not have a P&P regarding cleaning and maintenance of the washer/disinfector.

During an interview with the CSM on 3/2/16 at 11:40 AM, he stated the facility did not have a log to indicate cleaning or maintenance of the washer, and further stated that a log for cleaning was being developed.

4. The #2 STERIS sterilizer had brownish "drip" staining located on the front of the equipment and down the adjacent walls to the side and under the sterilizer.

During an interview with the CSS immediately following the observation, he stated he thought EVS was responsible for cleaning the equipment and walls.

During an interview with the CSM on 2/22/16 at 1:45 PM, he stated the central services staff were responsible for cleaning of CSP area equipment.

During an interview with the DQM on 2/25/16 at 2:15 PM, she stated she was unable to locate documentation to indicate the STERIS sterilizers had been cleaned, was unable to locate manufacturer's instructions for cleaning, and did not have a P&P regarding cleaning and maintenance of the STERIS sterilizers.

During an interview with the CSM on 3/2/16 at 11:40 AM, he stated the facility did not have a log to indicate cleaning or maintenance of the sterilizer, and further stated that a log for cleaning was being developed.

Review of the hospital P&P titled, "Sterilization", dated 3/16/14, indicated inspection and cleaning of the sterilizers would be performed according to the manufacturer's written instructions.

The AORN "Guidelines for PeriOperative Practice, 2016 edition, Guidelines for Cleaning and Care of Surgical Instruments" was reviewed. Recommendation X read, "Surgical instruments should be inspected and evaluated for cleanliness and correct working order after decontamination and if soiled or defective, should be removed from service until they are cleaned or repaired." Section X.a.3 indicated, "Lighted magnification should be used to inspect hard-to-clean areas of devices for cleanliness."

5. A window between the decontamination area and the GI lab anteroom was open.

During an interview with GI lab staff 1, on 2/23/16 at 10:00 AM, she stated she was responsible for decontaminating and sterilizing the endoscopes. During this interview, she stated she was not aware of nationally accepted standards that the facility adopted.

Review of GI Lab Staff 1's competencies provided by the facility did not include documented evidence of ongoing validation of training or competencies related to the cleaning or sterilization of endoscopes, or infection control of the GI lab decontamination room environment.

Review of the hospital P&P titled, "Packaging Systems for Sterilization", dated 3/16/14, indicated personnel would demonstrate competence in the use of sterilization packaging systems and accessories, and further, administrative personnel would periodically assess and document the competency of personnel. The policy indicated ongoing education of personnel would occur to assist in the development of knowledge, skills, and behaviors that affect patient outcomes.

During an interview with the ICM immediately following the observation, she stated the window should not be open because of the potential splashing of contaminated water during cleaning of endoscopes into the anteroom could occur. She further stated she had observed the window being open in the past and had instructed the GI staff to keep it closed.

6. During an observation of the L&D surgical area, accompanied by the ICM, on 2/23/16 at 11:00 AM, the door to the sterile supply room was propped open with a wheeled cart containing shelves holding sterile surgical instruments.

During an interview with the ICM immediately following the observation, she stated the door should be closed at all times.

During an interview with L&D Technician 1, on 2/23/16 at 11:00 AM, she stated she often leaves the door open when she is in a hurry.

Review of L&D Technician 1's competencies provided by the facility did not include documented evidence of ongoing validation of training or competencies for the years of 2013, 2014, 2015 or 2016, related to sterilization and storage of L&D instruments

Review of the hospital P&P titled, "Sterilization", dated 3/16/14, indicated sterilization practices would follow AORN recommended practices. The policy indicated items should be prepared and packaged so sterility can be achieved and maintained to the point of use. Further, the policy indicated sterile package compromise could be due to multiple handling that leads to loss of package integrity and exposure to airborne contaminants.'

The facility document titled, "Bylaws of the Governing Board of (...facility name here.....)", dated 8/27/2015 indicated " ...Article 1. General Functions and Responsibilities of the Governing Board. Section 1. Duties and Functions Generally ...1. Hospital Matters ...ii. Oversee and have ultimate accountability for the safety and quality of patient care, treatment, and services at the Hospital ...vi. Enforce policy relating to the general conduct of the Hospital to ensure compliance with the requirements of all applicable federal and state laws and accrediting bodies ...Article V. Governing Board Operation and Duties. Section 1. General Functions ...the Governing Board is responsible for compliance with The Joint Commission ("TJC") standards, Title 22 licensure regulations, Medicare conditions of participation and Department of Public Health directives ... "

Based on document review and interviews, the governing body failed to ensure

1. That all services performed under a contract were provided in a safe and effective manner in 6 of 6 contracted services for the health information management/medical records department. This failure had the potential for unauthorized persons gaining access to medical records.

2. The contracted services (services provided by an outside company) for Central Processing (sterilization of surgical instruments) and Environmental Services (EVS-hospital cleaning including Central Processing area) were provided in a safe and effective manner. This practice increased the risk of infection for all surgical patients.

Findings:

1. The agreement with the company providing off-site storage of medical records, effective 9/10/14, was reviewed on 2/24/16. The list of hospital staff who were authorized to request records was received on 2/25/16 and reviewed concurrently with HIM 1, who stated that of the 6 staff listed, one person was no longer employed by the hospital as of March 2014.

The administrative policy, "Contracted Vendor Services: Processing, Management & Quality Assurance," was reviewed on 2/25/16. Section E.2. Quality Monitoring. Evaluations: stated: "At least annually, an evaluation of the contracted service or product is required to assess whether they are providing quality products/services or are operating in a safe and effective manner and are in compliance with regulatory and hospital standards and policies."

An interview with Admin 3 on 2/25/16 at 11:30 AM revealed that there had not been any annual evaluations of the company that provided off-site storage of medical records, because she thought the company did not bring staff to work at the hospital and acknowledged that the policy did not allow for that as an exception to being reviewed annually.

Additionally, the annual evaluations of 5 other contracted services of the medical records department were reviewed on 2/24/16. These evaluations were for the review period of 2013-2014. During separate interviews on 2/25/16 with HIM 1 and Admin 3, they each confirmed that there had not been evaluations completed in 2015.



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2. Review of the hospital's 2015 Infection Prevention and Control Plan, approved by the governing body 8/26/15, indicated the plan was a hospital-wide program for the purposes of preventing and controlling infections and transmission of infection that included surveillance as a function of the Infection Control program. This Plan listed facility goals that included minimizing the risk of transmitting infections with the use of procedures, medical equipment and medical devices, and to maintain a sanitary environment to avoid sources and transmission of infections and communicable disease. Another goal listed was that problems identified through active surveillance could be addressed by the hospital's quality assurance program.

Further, the 2015 Infection Prevention and Control Plan indicated a Strategy of the Plan was to reduce the risk associated with procedures, medical equipment and medical devices by implementing the appropriate storage, cleaning, disinfection, sterilization, and/or disposal of supplies and equipment.

Review of the hospital's Organization-Wide Risk Assessment of 2014, approved by the governing body 8/26/15, indicated a risk identified as "EOC (Environment of Care) Potential for transmission of infection related to procedures, medical equipment, and medical devices related to appropriate storage, cleaning, disinfection, sterilization, reuse and/or disposal of supplies and equipment." The list of Strategies listed to reduce risk included "regular rounding and inspecting the environment cleanliness by IC (Infection Control) and EVS (Environmental Services)" and "weekly EOC rounds."

During an interview with the ICM (Infection Control Manager) on 2/22/16 at 12:05 PM, she stated she was a member of the EOC team and participated in observation rounds of the OR (Operating Room) quarterly, and twice a year for all other areas. She further stated there was no "surveillance tool" used during the observation rounds. The ICM was unable to provide documentation of surveillance rounds done in the CSP (Central Sterile Processing), OR, or sterile supply rooms.

During an interview with QM 14, on 2/25/2016, at 10:50 AM, she reviewed the "Reporting Schedule to PIPS (Performance Improvement Patient Safety) Committee" and was unable to find documentation of quality reporting by Central Processing (where surgical instruments are sterilized) or Environmental Services (EVS-hospital cleaning including Central Processing area). She stated the quality evaluation of the contracted service "EVS is not being reported to me." She stated there was no current EVS Performance Improvement Project (PIP-such as cleanliness of the Central Processing area).

During an interview with QM 14, on 2/25/2016, at 1:50 PM, she reviewed the list of Performance Improvement Projects for 2015 and was unable to find documentation of the annual summary of contracts. QM 14 confirmed that contracted services were not evaluated annually. She stated that the evaluation of contracted services "doesn't go through quality."

During an interview with QM 17, on 2/25/2016, at 2:45 PM, she stated that the Quality team hasn't monitored the EVS Operating Room (O.R.) cleaning and was not involved in the oversight of the EVS contracted service.

During an interview with Admin 3, on 2/26/2016, at 10:40 AM, she stated she was the contract administrator and reviewed all contracts with outside vendors. When Admin 3 was asked if the quality of services provided by the contracted service for the Central Processing contract was evaluated? She stated, " No." When Admin 3 was asked if the Central Processing contract was reviewed through quality? She stated, "No. This one will now, it's scheduled."

During an interview with Governing Board Member 1 (GB 1), on 2/29/2016, at 12:25 PM, he stated he was aware the hospital had an ongoing contract with the EVS contracted service, but he was uncertain if any renewal of the contract had come up during his three years on the Governing Board. He stated he was unaware of any changes. When asked if it was true that the Governing Board does not review the quality of contracted services, GB 1 stated, "That is a fair statement. We should if needed." When asked if the quality team reported to the Governing Board, regarding the quality of the EVS and Central Processing contracted services, GB 1 stated "I don't get that feedback."

During an interview with QM 17, on 2/29/2016, at 1:45 PM, she stated the Environment of Care (EOC) committee toured the facility and reported abnormal findings to the Quality team. QM 17 stated, "I have never seen findings from Central Processing ...I don't think they were being done. There is no policy regarding who evaluates the quality of contracted services."

The facility document titled, "Bylaws of the Governing Board of (...hospital name here...), dated 8/27/2015, indicated " ...Article 1. General Functions and Responsibilities of the Governing Board. Section 1. Duties and Functions Gnerally ...1. Hospital Matters ...ii. Oversee and have ultimate accountability for the safety and quality of patient care, treatment and services at the Hospital ... "

Based on observation, interview and record review, the hospital failed to ensure a sign was posted in the Emergency Department (E.D.) that indicated a patient's EMTALA (Emergency Medical Treatment And Labor Act) rights.

This failure increased the risk of a loss of patient's rights for a universe of 184 patients.

Findings:

During an observation on 2/19/2016, at 10:25 AM, in the Emergency Department lobby, there was no evidence of a sign that indicated a patient's EMTALA rights (a patient's right to an emergency screening exam and stabilization of an emergency medical condition regardless of their ability to pay for services received).

During a concurrent interview with ED Manager 12 she confirmed there was no evidence of a sign that indicated the patient's EMTALA rights. ED Manager 12 stated, "the sign was taken down while the walls were recently painted." She stated she would instruct the staff to replace the sign right away.

The facility policy and procedure titled, "(...facility name here...) Compliance Manual", dated 5/28/2014, indicated "Emergency Medical Treatment and Labor Act (EMTALA). (facility initials here) facilities and their personnel are expected to comply with all applicable requirements of the Emergency Medical Treatment and Active Labor Act ("EMTALA") (Section 1867 (a) of the Social Security Act).

EMTALA is a federal law requiring, among other things, that a Medicare-participating hospital with an emergency department provide a medical screening examination ("MSE") to any individual who comes to the emergency department ("ED") and requests such an examination regardless of his/her ability to pay or insurance coverage status."

The facility document titled, "Bylaws of the Governing Board of (...facility name here...), dated 8/27/2015, indicated "...Article 1. General Functions and Responsibilities of the Governing Board. Section 1. Duties and Functions Generally ...1. Hospital Matters ...vi. Enforce policy relating to the general conduct of the Hospital to ensure compliance with the requirements of all applicable federal and state laws and accrediting bodies ..."

Based on observation, interview and record review, the hospital failed to ensure that the Quality program:

1. Had documented evidence of quality monitoring for the sterilization of surgical instruments (See A-0273).

2. Provided documented evidence of identification of adverse patient events for analysis (See A-0286).

3. Evaluated the quality of services provided by all departments and contracted services (See A-0308).

4. Ensured there was a medication review and documentation system in place that accurately reflected physician/practitioner medication orders in the event the staff were unable to access electronic medical records, physician orders, and Medication Administration Records (MAR-record of all drugs given to a patient) (See A-0431).

The cumulative effect of these practices increased the risk of surgical infection and an overall poor health outcome for a universe of 184 patients and the inability of the hospital to comply with the statutorily mandated Condition of Participation Quality Assurance Performance Improvement Services.

Based on observation, interview and record review, the facility failed to ensure there was documented evidence the Central Processing Services (sterilization of surgical instruments) contracted service (service provided by an outside company) was monitored for quality by the Quality team.

This practice increased the risk of infection for all surgical patients and for a universe of 184 patients admitted to the facility.

Findings:

During an interview with Admin 1, on 2/22/2016, at 11:55 AM, the survey team requested a list of hospital-wide quality indicators (items monitored for quality of patient care). Admin 1 stated, " \I am trying to get the list of quality indicators." The facility was unable to comply with the request.

During an interview with QM 14, on 2/25/2016, at 10:50 AM, she reviewed the, "Reporting Schedule to PIPS (Performance Improvement Patient Safety) Committee" and was unable to find documentation of quality reporting by Central Processing (area surgical instruments were sterilized).

During an interview with QM 17, on 2/29/2016, at 1:45 PM, she stated the Environment of Care (EOC) committee toured the facility and reported their abnormal findings to the Quality team. QM 17 stated, "I have never seen findings from Central Processing."

The facility document titled, "Quality Assurance Performance Improvement Plan 2015" indicated "...Attachment D. Performance Improvement Initiatives (plans) 2015 ..." indicated "2015 Goal and Objectives ...7. Sustain a PI (Performance Improvement) program that reflects the complexity of the hospital's organization and services, and involves all departments and services."

Based on interview and record review, the facility failed to provide documented evidence of the identification of adverse patient events for analysis.

This lack of documented evidence of reported adverse patient events increased the risk that similar adverse events could occur in the future to a universe of 184 patients.

Findings:

During an interview with Admin 1, on 2/19/2016, at 3:20 PM, the survey team requested information regarding all serious preventable events identified by the hospital in the last 12 months. The facility was unable to comply with the request.

During an interview with Admin 1, on 2/22/2016, at 11:45 AM, the survey team requested a list of reported adverse events and incidents for the last 12 months. Admin 1 stated, "I have been trying to get the information since Friday ...I can't access the information."

During an interview with Admin 1, on 2/23/2016, at 11:45 AM, Admin 1 stated she had paper records available of the risk management occurrence reports. The survey team requested the reports for the last 12 months. The facility was unable to comply with the request.

The facility policy and procedure titled, "Occurrence Notification Process" dated 9/23/2015, indicated, "Purpose: To provide guidelines to improve patient care, ensure safe healthcare facility practices through concurrent identification of serious injuries, and conducting timely peer review, evaluation of patient care, and intervention to reduce occurrences ...Procedure: A. Patient Occurrence Method of Reporting. 1. Any healthcare facility employee or staff member who discovers, is directly involved in or responds to an occurrence is to complete or direct completion of an occurrence report. Submission of the report should occur within 72 hours of the event. 2. Drug administration errors, adverse drug reactions, or incompatibilities and for any error the physician will be verbally notified immediately and, if appropriate, to the hospital-wide quality assurance program."

The facility document titled, "Quality Assurance Performance Improvement Plan 2015" indicated "...The program supports ...Acknowledging, investigating and taking action related to unanticipated adverse events ...Confidentiality ...Some information may be disseminated on a "need to know basis" as required by agencies such as: Federal review agencies; Regulatory bodies ..."

Based on observation, interview and record review, the governing body did not ensure the contracted services (services provided by an outside company) for Central Processing (sterilization of surgical instruments) and Environmental Services (EVS-hospital cleaning including Central Processing area) were evaluated by the quality team for quality of services provided. This practice increased the risk of infection for a universe of 184 patients.

Findings:

Review of the hospital's 2015 Infection Prevention and Control Plan, approved by the governing body 8/26/15, indicated the plan was a hospital-wide program for the purposes of preventing and controlling infections and transmission of infection that included surveillance as a function of the Infection Control program.

This Plan listed facility goals that included minimizing the risk of transmitting infections with the use of procedures, medical equipment and medical devices, and to maintain a sanitary environment to avoid sources and transmission of infections and communicable disease. Another goal listed was that problems identified through active surveillance could be addressed by the hospital's quality assurance program.

Further, the 2015 Infection Prevention and Control Plan indicated a Strategy of the Plan was to reduce the risk associated with procedures, medical equipment and medical devices by implementing the appropriate storage, cleaning, disinfection, sterilization, and/or disposal of supplies and equipment.

Review of the hospital's Organization-Wide Risk Assessment of 2014, approved by the governing body 8/26/15, indicated a risk identified as "EOC (Environment of Care) Potential for transmission of infection related to procedures, medical equipment, and medical devices related to appropriate storage, cleaning, disinfection, sterilization, reuse and/or disposal of supplies and equipment." The list of Strategies listed to reduce risk included "regular rounding and inspecting the environment cleanliness by IC (Infection Control) and EVS (Environmental Services)" and "weekly EOC rounds."

During an interview with the ICM (Infection Control Manager) on 2/22/16 at 12:05 PM, she stated she was a member of the EOC team and participated in observation rounds of the OR (Operating Room) quarterly, and twice a year for all other areas. She further stated there was no "surveillance tool" used during the observation rounds. The ICM was unable to provide documentation of surveillance rounds done in the CSP (Central Sterile Processing), OR, or sterile supply rooms.

During an interview with QM 14, on 2/25/2016, at 10:50 AM, she reviewed the "Reporting Schedule to PIPS (Performance Improvement Patient Safety) Committee" and was unable to find documentation of quality reporting by Central Processing (where surgical instruments were sterilized) or Environmental Services (EVS- hospital cleaning including Central Processing area). She stated the quality evaluation of the contracted service "EVS is not being reported to me." She stated there was no current EVS Performance Improvement Project (PIP- such as cleanliness of the Central Processing area).

During an interview with QM 14, at 2/25/2016, at 1:50 PM, she reviewed the list of Performance Improvement Projects for 2015 and was unable to find documentation of the annual summary of contracts. QM 14 confirmed that contracted services were not evaluated annually. She stated that the evaluation of contracted services "doesn't go through quality."

During an interview with QM 17, on 2/25/2016, at 2:45 PM, she stated the Quality team hasn't monitored the EVS Operating Room (O.R.) cleaning and are not involved in the oversight of the EVS contracted service.

During an interview with Admin 3, on 2/26/2016, at 10:40 AM, she stated she was the contract administrator and reviewed all contracts the facility made with outside vendors. When Admin 3 was asked if the quality of services provided by the Central Processing contract was evaluated? She stated, "No." When Admin 3 was asked if the Central Processing contract was reviewed through Quality? She stated, "No. This one will now, it's scheduled."

During an interview with Governing Board Member 1 (GB 1), on 2/29/2016, at 12:25 PM, he stated he was aware the hospital had an ongoing contract with the EVS contracted service, but he was uncertain if any renewal of the contract had come up during his three years on the Governing Board. He stated he was unaware of any changes. When asked if it was true that the Governing Board does not review the quality of contracted services, GB 1 stated, "That is a fair statement. We should if needed." When asked if the quality team reported to the Governing Board, regarding the quality of the EVS and Central Processing contracted services, GB 1 stated, "I don't get that feedback."

During an interview with QM 17, on 2/29/2016, at 1:45 PM, she stated the Environment of Care (EOC) committee toured the facility and reported abnormal findings to the Quality team. QM 17 stated, "I have never seen findings from Central Processing ...I don't think they were being done. There is no policy regarding who evaluates the quality of contracted services."

The facility document titled, "Quality Assurance Performance Improvement Plan 2015" indicated "...Quality Management Committee ...Every department with clinical responsibilities or that provides support to clinical activities provides a summary report of their department's quality activities at least annually to the QM (Quality Management) Committee. Additionally, clinical contract service Quality report is presented annually ..."

Based on interview and record review, the facility failed to ensure the registered nurse (RN) supervised and evaluated the care of patients, as per facility policy, when one of 37 sampled patient's (Patient 36), repeated refusal of medication was not reported to the physician.

This failure had the potential to interfere with the patient receiving the appropriate care and treatment for elevated blood sugar.

Findings:

On 2/25/16, the medical record for sampled Patient 36 was reviewed. Patient 36 was admitted to the facility on 2/5/16, with diagnoses that included right foot, 5th toe wound infection, osteomyelitis (infection of the bone), necrosis (dead tissue), and diabetes (elevated blood sugar).

Review of the Medication Administration Record (MAR) dated 2/9/16 (0700) thru 2/10/16 (0659), indicated that the patient refused the following prescribed insulin (medication to reduce elevated blood sugar):

-Novolog Mix 70/30 7 units (measurement) SQ (given into the fatty layer of skin) BID (twice a day), refused on 2/9/16 at 9 AM and 9 PM.

-Novolog 1-6 units SQ AC/HS (before meals/at bedtime), refused on 2/9/16, 7:30 AM.

On 2/25/16, at 2:05 PM, RN 34 was interviewed. RN 34 stated the physician should have been notified and documented on the nursing assessment notes. RN 34 was unable to locate documentation in the patient's record that the physician was notified.

On 2/29/16, facility Policy#: CPM. PC. 095, approved on: 1/24/2014, titled, " Refusal to Permit Medical Treatment (formerly Refusal to Consent/Treatment)," was reviewed and indicated, "...Procedure: 1. The physician will be immediately notified whenever a patient refuses treatment ordered by that physician..."

Based on document review and staff interview, the hospital failed to ensure the nursing staff implemented the hospital's Policy and Procedures (P&P) for safe medication administration for 1 of 37 sampled patients (Patient 37).

This failure resulted in the nursing staff failing to clarify incomplete medication orders received by telephone and failing to administer ipratropium/albuterol (0.5 mg/3 mg) resulting in a medication error for Patient 37

These failures had the potential to result in harm to a universe of 184 patients from medication errors.

Findings:

Review of the hospital's P&P titled, "Medication Administration Guidelines" dated 9/13, read in part "... Medication orders shall include specific drug, dosage, route, and frequency of administration. All PRN (as needed) orders shall include an indication for their use. The indication shall be written by the prescriber on the original order and be transcribed onto pharmacy profile and the electronic MAR (medication administration record)... Other medications must be clarified with the physician. The person administering PRN medications must assess if the indication for the PRN order is fulfilled ..."

Review of the hospital's P&P titled, "Medication System Pharmacy Responsibilities" dated 1/13; read in part "...Medication orders should contain the medication, dose, route, frequency and strength ..."

On 2/25/16 at 11:20 AM, Patient 37's medical record review was initiated. The review showed orders written on 2/8/16, during the time the facility had no access to electronic health records as a result of a cyber attack occurring on 2/5/16, ipratropium 0.5 mg/albuterol 3 mg every 6 hours (for wheezing), normal saline at 50 ml/hr (hydration) and guaifenesin dextromethorphan (DM) 10 ml every 4 hours as needed for cough did not have the route of administration. There had been no clarification of the above orders contrary to the above hospital's P&P.

Review of the medication administration record (MAR) for 2/7/16 through 2/10/16, showed there was no specific indication for use documented on the MAR for the following PRN medications:

- acetaminophen 650 mg orally (for fever),
-dextrose 50% intravenous (IV) injection (for low blood sugar),
-glucagon 1 mg intramuscularly (for low blood sugar),
-lorazepam 2 mg IV (for agitation),
-morphine 2 mg IV(for pain),
-guaifenesin DM 10 ml and
-ipratropium 0.5 mg/albuterol 3 mg.

Review of medication orders showed ipratropium/albuterol (0.5 mg/3 mg) every 6 hours (scheduled) was ordered on 2/8/16 at 9 PM.

The MAR review showed ipratropium/albuterol (0.5 mg/3 mg) was transcribed as PRN instead of scheduled as ordered on the 2/8/16 and the 2/10/16 MAR.

Review of the MAR also showed administration of ipratropium 0.5 mg/albuterol 3 mg had not been documented for Patient 37 between 2/8/16 at 9 PM, and 2/10/16 at 6:15 PM, when the patient was discharged resulting in medication errors.

During the staff interview on 2/25/16 at 2:30 PM, the Clinical Coordinator of Pharmacy Services acknowledged Patient 37's medication orders had been written on 2/8/16 without the route of administration and the PRN medications on the MAR did not have specific indications for use.

During a staff interview on 2/26/16 at 10:45 AM, the Manager of Inpatient Pharmacy Services reviewed Patient 37's medical record and acknowledged administration had not been documented for ipratropium 0.5 mg/albuterol 3 mg from 2/8/16 through 2/10/16.

Based on interviews, document reviews, and medical record reviews, the facility failed to ensure:

1. Medical Record services were under the supervision of a credentialed person as required by State regulation. (Refer to A-0432)

2. Medical record policies and procedures were comprehensive, descriptive of current practices, and reviewed within the time frame required by hospital policy. (Refer to A-0432)

3. Approval was obtained from the local Department of Health for medical record storage off the hospital premises resulting in the unauthorized storage of patient medical records with the potential for unauthorized persons gaining access to protected health information. (Refer to A-0432 and A-438)

4. A medication review and documentation system was in place that accurately reflected physician/practitioner medication orders in the event staff were unable to access electronic medical records, physician orders, and Medication Administration Records (MAR) (Refer to A-0450, Complaint Number: CA00476056).

A MAR is a form on which physician/practitioner medication orders are transcribed to provide nurses a standardized format on which to review prescribed medications, how, when, and under what circumstances the medications are to be administered, document all medications administered, and patient response.

5. Entries in patient paper medical records used while the facility computer systems were down, were accurate, complete, and reflective of patient care (Refer to A-0450)

a. One of thirty seven sampled patients had missing Medication Administration Records (MAR). (Refer to A-0450)

b. Two of thirty seven sampled patient's MAR did not include accurate dates, times, indications for as needed medications and/or medication route (how the medication was to be administered). (Refer to A-0450)

c. Three of thirty seven sampled patient's MAR did not indicate medication administration frequency (number of hours between doses). (Refer to A-0450)

d. One of thirty seven sampled patients had a medication listed on the MAR that did not have a physician's order, and was non-formulary (a medication not available in the facility). (Refer to A-0450)

e. One of thirty seven sampled patients had an illegible physician order for a medication with no documentation of order clarification, and errors in the transcription of the medication onto the MAR. (Refer to A-0450)

6. Verbal and telephone orders were dated, timed, and authenticated by the physician/practitioner within the time frame required by hospital policy. (Refer to A-0454)

The cumulative effect of these deficient practices resulted in the facility's inability to ensure the provision of services for the Medical Records Condition of Participation for a universe of 184 patients.

Based on interviews and document review, the facility failed to ensure:

1. The medical record services were under the supervision of a credentialed person who possessed adequate qualifications to ensure compliance with this regulation as required by federal and state laws and regulations.

2. The policies and procedures of the medical record services were comprehensive, descriptive of current practices, and reviewed as frequently as hospital policy required (every 3 years).

These failures resulted in the facility's inability to comply with requirements of this regulation for a universe of 184 patients.

Findings:

1. During an interview with HIM 1 (Health Information Manager) on 2/19/16 at 11:45 AM, he stated that he did not currently possess one of the credentials required by State regulation. This fact was confirmed by the CFO (Chief Financial Officer) during an interview on 2/19/16 at 3:30 PM.

In addition, the personnel file of HIM 1 was reviewed on 2/25/16 concurrently with HR 1 (Vice President of Human Resource). There was no documented evidence which showed HIM 1 had one of the required credentials, which was confirmed by HR 1.

California Code of Regulations, Title 22, section 70747(b) states in part: "The medical records service shall be under the supervision of a registered health information administrator or registered health information technician."

2. The administrative policy, "Policies and Procedures, Plans and Standardized Procedures Approval Process," approved 2/25/15, stated on page 3: "Unless otherwise specified in regulation, all policies must be reviewed and approved at least every three years ...."

During an interview with the Executive Assistant (Admin 4) on 2/25/16 at 11:45 AM, she confirmed that the Health Information Management (HIM) policies were last approved in 2012 and provided a list of the HIM Policy Manual table of contents supporting this.

The policy, "Record Retention Requirement", last approved 9/22/09, was not descriptive of the facility's exact period of time medical records were retained. Also, there was no policy provided that defined what portions of the various components of a medical record were considered by the facility to be their "legal record."

The legal health record serves to identify what information constitutes the official business record of an organization for evidentiary purposes.

Based on document review and interview, the facility failed to ensure that medical records were properly stored by failing to obtain prior approval from the local department of health for the storage of patient medical records off the hospital premises, in accordance with State regulation.

This failure resulted in the unauthorized storage of patient medical records with the potential for unauthorized persons to gain access to protected health information for patients treated at the facility.

Findings:

California Code of Regulations, Title 22, Section 70751(f) states: "Medical records shall be filed in an easily accessible manner in the hospital or in an approved medical record storage facility off the hospital premises."

During an interview with HIM 1 (Health Information Management) on 2/19/16 at 11:45 AM, he stated that medical records have been stored in an off-site location with a contracted vendor.

The contract, effective 9/10/14 was reviewed on 2/19/16. After an extensive search, on 2/25/16 HIM 1 stated that the facility apparently had not requested or received a letter from the local department of health granting approval for this off-site medical record storage arrangement. He also stated that there were no written, current policies and procedures addressing the transporting, retrieval, retention, maintenance of confidentiality and security of the medical records being stored.

Based on interview and record review, the facility failed to ensure a medication review and documentation system that accurately reflected physician/practitioner medication orders was in place in the event staff were unable to access electronic Medication Administration Records (MAR) and physician orders.

The Medication Administration Record (Mar) is a form on which physician medication orders are transcribed. Hospital nursing staff review the MAR prior to administering any medication and document all medications administered to patients on the form. The MAR, in accordance with hospital policy and accepted standards of nursing practice, must accurately reflect the physicians orders, including:

-The name of the patient
-The name of the medication
-The prescribed dose (amount)
-The time the medication is to be administered
-The route (how and where the medication goes into the body)
-The frequency (how often and/or the time period between doses)
-The indications (patient symptoms) for as needed (PRN) medications

This failure resulted in the MAR for three of thirty seven sampled patients (Patient's 15, 16 and 36) having inaccurate and/or missing required components for safe medication administration. This deficient practice had the potential to result in medication errors, over or under medicating patients, adverse medication reactions or other adverse patient events for a universe of 184 patients.

Findings:

1. On 2/23/16, a review of Patient 16's medical record indicated she was admitted to the facility as an inpatient with a diagnoses that included cerebral vascular accident (stroke).

Review of Patient 16's paper physician orders revealed on 2/9/16, the physician wrote an order that appeared to read:

-Tylenol 10 Q (every) 3 hours prn for temp (temperature) 99.5 or pain.

Review of a computer generated print out of Patient 16's physician orders indicated on 1/31/16 the physician wrote the following order:

-Acetaminophen (generic name for Tylenol) 650 mg (milligrams) oral every 4 hours PRN Pain or Fever greater than 101 F (fahrenheit-a temperature scale). Maximum 4 gm (grams) acetaminophen per day.

On 2/25/16, at 1:55 PM, during a record review with RN 27 (Registered Nurse), the RN stated, "I have never heard of a 10 mg Tylenol dose, I don't know what that doctor was writing. The nurse should have gotten clarification of the order."

A concurrent review of Patient 16's paper MAR's revealed:

-"Tylenol 650 mg. PO (by mouth) Q 4 hours PRN" was transcribed onto two undated, and untimed MAR's.
-"Tylenol 650 mg. oral for pain, temp greater than 99.5" was transcribed onto the paper MAR on 2/13/16 and 2/15/16.

RN 27 confirmed she had no way of knowing what days the two undated and untimed MAR's were for, the medication transcriptions did not indicate what the indications (symptoms) for the medication were, and the 2/13/16 and 2/15/16 transcriptions did not indicate how frequently the medication could be administered to Patient 16, although the physician's order stating the patient was to only receive a maximum dosage of 4 gm. per day.

During the same interview and record review with RN 27, she acknowledged paper MAR's were missing for 2/7/16, 2/8/16, and there were two incomplete MAR's dated 2/9/16 to 2/10/16.

Further review of a total of three undated and untimed MAR's revealed the following medications did not have indications for which the medications were to be administered:

-MOM (Milk of Magnesia: a laxative used to treat constipation) 30 ml (milliliters-a unit of measurement) PO (by mouth) Q 12 hours prn. No indication was listed.

-Ultram (a pain medication) 50 mg. PO Q 4 hours prn, the undated and untimed MAR's indicated this medication had been administered three times. No indication was listed.

On 2/26/16 at 11:20 AM, during an interview with RN 28, in the presence of Unit Manager (UM 26), and RN 29, RN 28 acknowledged she had transcribed the medications onto the two undated, and untimed paper MAR's. RN 28 stated with the computers being down as a result of the "cyber-attack occurring at the facility, they had to transcribe the medications onto the MAR based on the medications listed on the Omnicell (automated medication dispensing system). RN 28 was unable to determine what dates and times two of the three undated and untimed MAR's represented. The third undated and untimed MAR had been transcribed by an RN whose signature was illegible. UM 26 and RN 27 were unable to determine who's signature it was.

During the same record review with UM 26 and RN 29, they were asked to find a physician's order for the following medication transcribed onto Patient 16's MAR's dated 2/9/16 to 2/10/16, and 2/10/16 to 2/11/16:

-Omeprazole (a drug that reduces stomach acid) 5 mg PO BID (two times a day)

The medication was documented as having been administered one time on 2/10/16 at 9 AM, and crossed off as though administered on 2/10/16 at 9 PM, however, there was heavily blacked out writing by the crossed out time, making it hard to determine if the medication was administered or not. The medication was not documented as discontinued on either document.

UM 26 was unable to find a physician's order for the medication in the hand written MD orders or the computer generated orders for the time period before and after the cyber attack. Both staff members expressed confusion regarding how or where the nurse that transcribed the medication onto the MAR got that information.

On 2/26/16 at 9:30 AM, Pharmacist 6 stated, "We don't carry Omeprazole so this was a transcription error."

2. Review of Patient 15's clinical record indicated he was admitted to the facility with diagnoses that included bilateral pleural effusions (build up of fluid between the lungs and chest cavity on both sides).

Review of Patient 15's paper MAR dated 2/7/16 to 2/8/16, revealed the following medications did not have indications documented on the MAR:

-Acetaminophen 650 mg. GT (gastrostomy tube: a tube surgically placed in the abdomen through which nourishment and medications are administered) Q 6 hours PRN. No indication was listed.

-Hydralazine (a blood pressure medication) 5 mg. IV (via small tube in vein) Q 6 hours PRN. No indication was listed.

-Lactulose (used in the treatment of constipation) 20 ml. GT BID PRN. No indication was listed.

Review of all of Patient 15's paper MAR's dated 2/5/16 to 2/15/16 revealed the medication Hydralazine was transcribed onto every MAR without indications for when the medication was to be administered. Further review indicated the medication was administered to Patient 15 on three occasions for elevated blood pressure. Parameters outlining when the medication was to be administered were not documented on the MAR.

Review of Davis' on-line medication guide via Nursing Central, a nurse resource site, (unboundmedicine.com) indicated Hydralazine is a medication classified as a vasodilator, it relaxes the blood vessels so that blood can flow more easily. "The medication is used to treat high blood pressure...blood pressure should be closely monitored..."

A copy of Patient 15's physician orders, one month prior to the cyber attack were requested on 2/22/16, but were not received.

On 3/10/16, at 2:45 PM, RN 36 verbally read the physician's order dated 1/19/16:

-Hydralazine 5 mg. IV every 6 hours prn systolic blood pressure greater than 160 (top number in blood pressure reading, indicates the amount of pressure in arteries when the heart beats and pushes blood through the arteries).

On 2/26/16 at 9:30 AM, Pharmacist 6 stated prior to this incident they (Pharmacy) did not have a contingency plan in place if staff were unable to access computers. "We printed out the Omnicell profiles so the nurses could create a MAR. The first night the nurses sent it to us, then the nurses would reconcile the MAR's every twenty four hours, after the first two days we asked the nurses to send the MD orders with the MAR."

Review of the facility's "Information Systems Contingency Plan" indicated all users would use down time forms. The forms, manually completed would, become the operational patient record...All patients....that requires documentation will be completed and the forms filed either on the chart or within a department to provide a record of it's activity during the outage.

During an interview with Health Information Management (HIM 2) on 2/26/16 at 10 AM. When asked if paper files were stored anywhere else, he replied all files should be in the medical record.

Review of an undated on-line article titled, "The Five Rights of Medication Administration", published by the Institute for Healthcare Improvement, www.ihi.org, indicated, "One of the recommendations to reduce medication errors and harm is to use the [five rights] the right patient, the right drug, the right dose, the right route, and the right time. The five rights are...desired outcomes of safe medication practices. The healthcare practitioner's duty...to achieve the five rules but to follow the procedural rules designed by the organization...if the procedural rules cannot be followed because of system issues, healthcare practitioner's also have a duty to report the problem so it can be remedied.



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3. On 2/25/16, the medical record for sampled Patient 36 was reviewed. Patient 36 was admitted to the facility on 2/5/16, with diagnoses that included right foot, 5th toe wound infection, osteomyelitis (infection of the bone), necrosis (dead tissue), and diabetes (elevated blood sugar). Review of the patient's medication administration record (MAR) indicated the Medication Administration Record was undated.

The following PRN (as needed) orders did not have documented indications for use:

-Tylenol 650 mg PO (by mouth) q (every) 6 hours. No indication was listed.

-Dex 4 (glucose tablets to raise low blood sugar) 15 gm (grams-unit of measurement) PRN. No indication was listed.

-Dextrose (sugar) 50% 0.5 gm/ml (gram/milliliter [units of measurement]) 50 ml IV (give through the vein) PRN. No indication was listed.

-Norco (pain medication) 5/325 mg 1 tab (tablet) PO q 6 hours PRN. No indication was listed.

The following medication did not have documented indications for use or route of administration:

-Dextrose 5% (5) (dextrose 5% in water). No indication or route of administration was listed.

The following medication was documented as given at 10:05 PM. There was no documented blood pressure, date, or effectiveness of medication:

-Clonidine 0.1 mg PO q 6 hour PRN SBP > 170

On 2/29/16, at 3:05 PM, RN 34 was interviewed, and agreed the MAR was incomplete. RN 34 stated that the MAR should have been dated, the indications for PRN's, the patient's blood pressure, the effectiveness of the medication, and administration routes should all have been documented.

On 2/29/16, the facility policy titled, "Medication Administration Guidelines," approved on 1/28/15, was reviewed and indicated, "...Policy:...PRN (as needed) medication orders must have a documented indication...5. Medication Orders:...b. All PRN orders shall include an indication for their use. The indication(s) shall be written by the prescriber on the original order and be transcribed onto the Pharmacy profile and the electronic MAR...c. ...The person administering PRN medications must assess if the indication for the PRN order is fulfilled and if the prescribed time interval has elapsed. If any questions arise, the physician shall be called for clarification...10. Charting: a. All medications will be charted immediately after they are given..."

Based on document and record review and interview, the facility failed to ensure:

1. Verbal orders were dated, timed and authenticated in accordance with medical staff rules and regulations for 1 of 37 medical records (Patient 31) reviewed.

2. Telephone orders for medications were authenticated by the ordering physician within 48 hours of being ordered for 1 of 37 medical records (Patient 37) reviewed.

These failures had the potential to result in medication errors or other adverse patient events for a universe of 184 patients.

Findings:

1. The Medical Staff Rules and Regulations, last approved 8/27/14, were reviewed. Article IV. A. 6. f. Medical Records General Guidelines, Physician Orders indicated: "Telephone orders for Medications shall be signed, dated, and timed by the ordering physician or another physician involved in the patient's care, within 48 hours of being given."

The Medical Record for Patient 31 was reviewed concurrently with HIM 1 on 2/25/16. There was a telephone order on 2/11/16 at 6:35 PM which had not been signed. This finding was confirmed by HIM 1.



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2. Review of the hospital's Policy and Procedures (P&P) titled, "Physician's Orders: Verbal/Telephonic" dated 11/12, read in part "...Verbal/telephonic orders for medications must be signed, dated and timed by ordering/attending physician within 48 hours of being given ..."

On 2/25/16 at 11:20 AM, Patient 37's medical record review was initiated. The review showed telephone orders for normal saline infusion (for hydration) on 2/6/16 at 4:30 PM, and several other medications on 2/8/16 at 6:20 PM and at 9 PM, had not been authenticated contrary to the hospital's P&P.

On 2/26/16 at 10:18 AM, the Interim Director, Health Information Management reviewed Patient 37's medical record and acknowledged the above medication orders had not been authenticated.

Based on interview and record review, the facility failed to ensure that a History and Physical was completed for 1 of 37 sampled patients (Patient 34).

This failure had the potential to result in a lack of knowledge of the patients overall condition that would affect the planned course of treatment.

Findings:

1. During a review of the clinical record for Patient 34, the OB (Obstetric) History and Physical Note dated 1/23/2016, at 10:33 AM, indicated ... "Vital Signs" followed by four areas to provide information titled, "Temperature", "Pulse", "Respirations", and "Blood Pressure." All four areas were left blank. "Exam" (Physical Exam) was followed by several areas to provide information titled, "Neck", "Heart", "Lungs", "Breasts", "Back", "Neurologic (nerves)", "Reflexes", "Extremities" (arms & legs). All eight areas were left blank.

During an interview with HIM 2, on 2/23/2016, at 4:50 PM, he reviewed the clinical record and was unable to find documentation of a completed History and Physical for Patient 34.

The facility document titled, "...(Facility Name Here)...Medical Staff Bylaws" dated 10/22/2014, indicated ... "3.4 Responsibilities of the Medical Staff Members. Each member of the Medical Staff shall ...15. Complete a brief written admitting note and a dictated history and physical (H&P) ... A. History and Physical Basic Requirements ...3. A short form H&P may be used for outpatient cases and for obstetric patients admitted for vaginal deliveries. It should address the following ...(e) A relevant physical examination of those body systems pertinent to the operative or invasive procedure performed, but including at a minimum an appropriate assessment of the patient's cardiorespiratory (heart & lung exam) status."

Based on interview and record review, the facility failed to ensure a discharge summary was completed for 1 of 37 sampled patients (Patient 35).

This failure had the potential to result in the unawareness of the outcome of the patient's hospitalization, disposition and any follow up care needed.

Findings:

During a review of the clinical record for Patient 35, the Discharge Summary was noted to be absent from the chart.

During an interview with Admin 12, on 2/23/2016, at 9:10 AM, she reviewed the clinical record and was unable to find documentation of a Discharge Summary for Patient 35.

The facility policy and procedure titled, "Chart Completion, Hospital" dated 11/27/2012, indicated "...General Discussion ...G. ...If a dictation service is utilized to dictate discharge summaries for physicians, the attending physician must, at the time of discharge, document the final diagnosis and all secondary diagnoses in the final progress note. The dictation service must use these diagnoses in their dictation. The attending physician remains responsible for the timely completion of the discharge summary."

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

1. Safe delivery of emergency medications for a universe of 184 patients. This failure resulted in the emergency medications stored inside the carts not matching the emergency medication lists posted outside the emergency crash carts and the hospital malignant hyperthermia's Policy and Procedures (P&P).

2. The nursing staff implemented the P&P regarding accountability for controlled medication wastage. This failure had a potential to result in medications not readily available during medical emergencies and for the diversion of controlled medications.

Findings:

1. Review of the hospital's P&P titled, "Crash Cart and Defibrillator Check procedures" dated 1/16, read in part "Purpose: To ensure standardized emergency supplies and equipment are readily available for immediate use ..."

The emergency crash cart is used for storing emergency medications and medical supplies needed during a medical emergency.

On 2/22/16 at 3:30 PM, during an observation and concurrent staff interview on the Surgical Intensive care Unit (SICU) in the presence of the Manager of Inpatient Pharmacy Services (MIPS) and the Clinical Coordinator of Pharmacy Services, procainamide 100 mg/ml 10 ml vial (antiarrhythmic agent) was listed outside of the crash cart, however three vials of procainamide 500 mg/ml 2 ml were inside the crash cart.

On 2/23/16 at 10:30 AM, during an observation and concurrent staff interview in the Medical Intensive care Unit (MICU) in the presence of the MIPS and the MICU Clinical Coordinator, procainamide 100 mg/ml 10 ml was listed outside of the crash cart, however three vials of procainamide 500 mg/ml 2 ml were inside the crash cart.

The MIPS stated the procainamide 100 mg/ml 10 ml vials listed outside the crash cart were not available, procainamide 500 mg/ml 2 ml vials were stocked instead.

Review of the hospital's P&P titled, "Malignant Hyperthermia" dated 8/13, read in part "...Pharmacy will check the outdates and stock level of drugs on the malignant hyperthermia cart on a routine basis ... References: ...Malignant Hyperthermia Association of the United States (MHAUS); www.mhaus.org ; retrieved on 5/17/2013 ..."
Malignant Hyperthermia Association of the United States (MHAUS) online web site checked on 3/2/16, showed "Malignant Hyperthermia (MH) is a potentially fatal, inherited disorder usually associated with the administration of certain general anesthetics and /or the drug succinylcholine ...Without proper or prompt treatment ... mortality is extremely high ..."

On 2/24/16 at 3:35 PM, during an observation in the OR suites, the medications inside the MH cart did not match the medications listed on the MH P&P. In addition the medications listed on the hospital's MH P&P did not match the MHAUS list of medications, in spite of the MHAUS referenced in the MH P&P.

Lidocaine 2% syringe (for ventricular tachycardia), epinephrine 1:10,000 syringe (used in pulseless arrest and bradycardia algorithms), atropine 0.1 mg/ml syringe(to reduce excessive saliva production), calcium chloride 10 % syringe (used for low calcium level), sodium nitroprusside 50 mg/1 ml vial (to produce controlled low blood pressure), procainamide 500 mg/ml 2 ml, heparin 1000 units/ml 10 ml (injectable blood thinner) and dopamine 400 mg/5 ml 10 ml (to treat symptoms of shock) were not listed on the MH P&P medication list but were available in the MH cart.
The MIPS and RN 11 acknowledged the medications listed in the MH P&P did not match the medications in the MH cart.

2. Review of the hospital's P&P titled "Omnicell, Automated Medication Dispensing System" dated 10/14, read in part "... Controlled Substances that are wasted must be documented at the automated medication dispensing unit (AMDU) by two licensed users using the waste function- the individual who wastes the medication and a witness. The witness must physically witness all wastage ..."

On 2/23/16 at 9:45 AM, RN 8 was observed during the process of administering hydromorphone injection (for pain) to Patient 18. RN 8 pulled the hydromorphone 1 mg/1 ml injection from the Omnicell (an automated medication dispensing unit) and LVN 7 cosigned the wastage. RN 8 proceeded to Patient 18's room and administered hydromorphone 0.5 mg injection, the unit's Clinical Coordinator witnessed the remaining hydromorphone 0.5 mg injection's wastage. LVN 7 cosigned hydromorphone injection wastage with RN 8; however she did not physically witness the wastage which was contrary to the hospital's P&P.

During the staff interview on 2/23/16 at 10 AM, LVN 7 stated she was supposed to physically witness the hydromorphone injection wastage when she cosigned the wastage on the Omnicell. LVN 7 acknowledged she had not physically witnessed the hydromorphone injection wastage.

The MIPS and the unit Clinical Coordinator acknowledged the potential for controlled drug diversion when the nurse who cosigned wastage did not physically witness the wasting, as in the above situation.

Based on observation, staff interview, and record review, the hospital failed to ensure the compounded Sterile Products (CSPs) prepared by the hospital's inpatient pharmacy were assigned beyond use dates (BUDs) consistent with the current professional standard of practice. In addition, the pharmacy failed to label their CSPs with BUDs.

These failures had the potential to result in a universe of 184 patients being exposed to preventable infections and medications which may no longer provide the intended benefit.

The beyond use date is the date after which the medication must not be used, stored or transported.

Findings:

Review of the hospital's Policy and Procedures (P&P) titled, "Pharmacy Compounded Sterile Products" dated 10/14, read in part "...Products compounded by the Pharmacy Department are limited to low risk level products as defined by USP <797> .... Environmental, process and preparation quality controls will meet the requirements of USP <797> ... All Pharmacy prepared sterile products should bear an appropriate beyond use date. Prepared IV's with additives - 7 days in refrigeration and 24 hours at room temperature, unless manufacturer recommends otherwise ... Labeling, Sterile products should be labeled with the following information: ... Beyond use date ..."

USP (United States Pharmacopoeia) is a scientific, non- profit organization that sets the quality, purity, identity and strength standards for medications ... manufactured and consumed worldwide. USP is federally recognized as an authoritative source regarding minimum standards of safe practice applicable to both sterile and non-sterile compounding. USP <797> (USP chapter 797) establishes the minimum standard of practice applicable when preparing, storing, and transporting CSPs to be followed by all health care personnel in any setting.

Review of the USP <797> Risk Level Assessment read in part:

Low Risk Level requirements: Prepared in ISO Class 5 laminar flow hood, located in ISO Class 7 buffer areas with ISO Class 8 ante area.

Low Risk with < 12 Hour beyond use date requirements: Prepared in ISO Class 5 hood, compounding area is segregated from non-compounding areas and administration must start no later than 12 hours after preparation.

On 2/22/16 at 12:20 PM, during an observation and concurrent staff interview in the inpatient pharmacy in the presence of the Manager of Inpatient Pharmacy Services (MIPS) 0.45 % sodium chloride with potassium chloride 40 meq/L (milliequivalents per liter: a unit of measurement) (hydration with potassium supplement) one liter bag compounded by pharmacy, labeled for Patient 17 was observed with other compounded intravenous (IV) products awaiting delivery. Patient 17's compounded IV bag was observed to have no beyond use date (BUD) noted on the label, contrary to the hospital's P&P.

On 2/23/16 at 9:15 AM, during an observation in the medical surgical unit in the presence of the MIPS, a pharmacy prepared intravenous piggy bag (IVPB) of vancomycin (antibiotic) 1 gm (gram)/250 ml (milliliters) was noted. This vancomycin IVPB did not have any BUD on the label.

During the concurrent staff interview, the MIPS acknowledged Patient 17's compounded IV bag and the vancomycin bag were not labeled with the BUDs. She acknowledged pharmacy had not been labeling CSP with the BUD; the practice had been CSPs were good for 24 hours.

During the staff interview on 2/23/16 at 4:15 PM, the MIPS and the Clinical Coordinator of Pharmacy Services acknowledged the USP <797> Risk Level Assessment showed the hospital sterile products compounding room met the requirement for Low Risk Level with < 12 hour beyond use date. The PM stated she would change the BUD for CSPs to comply with the correct risk level and label the CSPs with BUDs.

Based on observation, staff interview, and document review, the hospital failed to ensure expired and unusable drugs were not available for patients use in the patient care areas and the operating rooms (OR).

These failures had the potential to result in patients' exposure to drugs which may not provide the intended benefit for a universe of 184 patients.

Findings:

Review of the hospital's Policy and Procedures (P&P) titled, "Disposal of Medications" dated 9/13, read in part "...All unused contaminated, deteriorated or outdated drugs and solutions will be returned to the pharmacy department for proper disposal and/or destruction ..."

Review of the hospital's P&P titled, "Labeling and Storage of Pharmaceuticals" dated 9/13, read in part "...All multi-dose vials are to be marked with the date of expiration and discarded after 28 days or per manufacturer's recommendation (whichever is sooner) ..."

Review of the hospital's P&P titled, "Area Inspections" dated 1/13; read in part "...A pharmacist, pharmacy technician and/or pharmacy intern will make routine monthly inspections of all drug storage areas of the hospital ... A record of these inspections will be kept to verify ...there are no outdated medications ..."

On 2/23/16 at 11:05 AM, during an observation and concurrent staff interview on the telemetry unit, Patient 19's Humalog and Levemir insulin vials (used to reduce blood sugar) were observed with no date of expiration marked on the vials. RN 9 stated the insulin vials were good for 90 days at room temperature. The Manager of Inpatient Pharmacy Services (MIPS) stated the vials should be labeled with 28 days expiration date when opened.

On 2/24/16 at 3:15 PM, during an observation and staff interview in OR 1, with RN 11 and the MIPS, an opened glycopyrrolate 1 mg/5 ml (to reduce secretions in the mouth, throat and stomach) multi-dose vial (MDV) and an opened Bloxiverz 10 mg/10 ml MDV (for reversal of the effects of non-depolarizing neuromuscular blocking agents) were noted. These opened MDVs had not been dated with the expiration dates. The MIPS stated pharmacy technician changed out all opened vials daily; however she was unable to determine or confirm when these vials were opened.

Two ampules of Naropin 0.5 % 20 ml injection (for production of regional or local anesthesia and for pain management) with expiration date of 12/15 were also observed in OR 1. The MIPS and RN 11 acknowledged the expired medications.

Based on observation, interview, and record review, the hospital failed to provide a sanitary environment to avoid sources of transmission of infections and communicable diseases and failed to have an active program for the prevention, control and investigation of infections and communicable diseases for a universe of 184 patients when:

1. The contracted services of central processing was not integrated into the QAPI program. (Refer to A-0308).

2. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards: (Refer to A-0749, finding 1) as evidenced by the following:

a. Hinged instruments were processed in closed positions,
b. Rigid trays were not loaded in a manner that allowed instruments to have maximum exposure to the sterilizing agent, and
c. Staff were not competent and trained on job specific current national recognized standards and policies regarding sterile processing of surgical instruments.

Because of the serious potential harm to all patients who have surgery at the hospital related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was identified and called on 2/23/16, at 3:10 PM, with the Chief Executive Officer, Director of Quality Management, and the Peer Review Manager.

On 3/2/16, at 2:09 PM, the Director of Quality Management was informed the Immediate Jeopardy to patient safety was removed after the plan of correction was submitted, accepted, implemented, and verified.

3. The Central Sterile Processing area was noted to have dust and debris covering the stainless steel surfaces of the instrument preparation and packaging areas and inside blue plastic bins holding sterilized peel packs, and the stainless steel surfaces had several areas of black-colored residue. (Refer to A-0749, finding 2)

4. The Getinge Group (manufacturer) washer/disinfector, and STERIS (manufacturer) sterilizers (specialized equipment used to clean or sterilize surgical instruments) located in the Central Sterile Processing area were found to be visibly dirty and not cleaned regularly in accordance with manufacturer's instructions. (Refer to A-0749, finding 3)

5. Visual inspection of surgical equipment and devices for residual soil prior to sterilization did not occur. (Refer to A-0749, finding 4)

6. Sanitary conditions of patient care areas of GI (gastro-intestinal) lab, and surgical room environments did not follow nationally accepted standards: (Refer to A-0749, finding 5) as evidenced by the following:

a. Two of two GI labs, identified by staff as prepared for immediate patient use, contained trash from previous procedures in the trash receptacles, and dust and debris on equipment inside the labs,
b. A window between the GI lab anteroom and decontamination was open,
c. Operating Room (OR) 1, identified by staff as cleaned and ready for use, contained trash from a previous procedure in the trash receptacle, the OR table pad had a dry, brownish stain located in the middle, midway down the pad, and the base of an IV (intravenous) pole had a thick buildup of a brownish-red crusty substance.
d. The door to the sterile supply room in Labor and Delivery containing sterile instruments was propped open.

7. Multi-patient use external fetal/maternal monitors/transducers rinsed in "hopper", also known as a "bedpan hopper" (a fixture used for the rinsing of bedpans and soiled linens) did not follow nationally accepted standards. (Refer to A-0749, finding 6)

8. The facility did not perform active surveillance of the Central Sterile Processing area, Operating Rooms, or sterile supply rooms, to ensure hospital plans, policies, and procedures were implemented. (Refer to A-0748, and A-0749, finding 7)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

Based on observation, interview, and record review, the hospital failed to implement an effective Infection Control program. The facility failed to perform active surveillance of the CSP area (Central Sterile Processing), operating rooms, or sterile supply rooms, to ensure hospital plans and policies were implemented for a universe of 184 patients.

Findings:

During tours of the hospital on 2/22/16 and 2/23/16, the following 17 observations were made as related to the Infection Control Program:

1. During an observation of the CSP area, on 2/22/16 at 1:00 PM, accompanied by the ICM (Infection Control Manager) and CSS (Central Services Supervisor), eight of eight peel packages contained instruments in the closed hinge position.

2. During an observation of the CSP area, on 2/22/16 at 1:09 PM, accompanied by the ICM and CSS, a vaginal speculum (An instrument used to widen the opening of the vagina so that the cervix is more easily visible) inside a peel pack had white spots on the metal.

3. During an observation of the CSP area, on 2/22/16 at 1:15 PM, accompanied by the ICM and CSS, two of two stainless steel tables with a lower shelf, were noted to have a thick layer of dust accumulation on the lower shelves. Nine of nine blue plastic bins located on the lower shelves containing peel packs with instruments inside, had thick layers of dust accumulated formed into small, white, fuzzy balls. The lower shelves and the top of the stainless steel tables were observed to have several areas of black-colored substances.

4 and 5. During an observation of the CSP area, on 2/22/16 at 1:45 PM, accompanied by the ICM, CSM (Central Services Manager), and CSS, the following was observed:

a. The Getinge Group (manufacturer) washer/disinfector had palpable, thick white "water spots" on the conveyor area, and palpable dust buildup on the edges of the conveyor area.

b. The #2 STERIS (manufacturer) sterilizer had a brownish "drip" staining located on the front of the equipment and down the adjacent walls to the side and under the sterilizer.

6 and 7. During an observation of the GI (gastro-intestinal) lab on 2/23/16 at 9:40 AM, accompanied by the ICM, the following was observed:

a. Two of two GI labs had trash receptacles containing items from previous procedures, and supply carts and computer carts inside the GI lab had dust, black particles, and debris located on the lower areas of the equipment.

b. A window between the decontamination area and the GI lab anteroom (protects patients/staff by isolating individual rooms, reducing exposure to dust and associated pathogens) was open.

8. During an observation of the sterile supply room located in the OR (Operating Room) area, on 2/23/16 at 10:30 AM, accompanied by the ICM, a rigid tray of surgical instruments was opened and observed. Inside the tray, surgical instruments were packed tightly with three layers of instruments. The hinged instruments were in the locked position with the tips closed and touching.

9. During an observation of the sterile supply room located in the OR, on 2/23/16 at 10:30 AM, accompanied by the ICM, peel packs containing surgical instruments were stored vertically in plastic bins. Some of the plastic bins were overcrowded and peel packs were bent and crinkled.

10. During an observation of OR 1, on 2/23/16 at 10:45 AM, accompanied by the ICM, a dry, brownish stain was observed on the OR table pad, located midway down in the middle of the pad.

11. During an observation of OR 1, on 2/23/16 at 10:45 AM, accompanied by the ICM, the base of an IV pole (intravenous, pole designed to hold equipment) was observed to have a thick, crusty, buildup of a reddish-brown substance.

12. During an observation of OR 1, on 2/23/16 at 10:45 AM, the trash receptacle was observed to have items from a previous procedure.

13. During an observation of the sterile supply room located in the surgical area of L&D, on 2/23/16 at 11:00 AM, accompanied by the ICM, peel packs containing surgical instruments were stored vertically in plastic bins. Some of the plastic bins were overcrowded and peel packs were bent and crinkled. Bins located on a shelf near to the floor contained peel packs that were observed to be soiled and bent.

14. During an observation of the sterile supply room located in the surgical area of L&D (Labor and Delivery), on 2/23/16 at 11:00 AM, accompanied by the ICM, a rigid tray of surgical instruments was opened and observed. Inside the tray, surgical instruments were packed tightly. Twenty-one hinged instruments were in a closed position with tips touching.

15. During an observation of the sterile supply room located in the L&D surgical area, on 2/23/16 at 11:00 AM, accompanied by the ICM (Infection Control Manager), a vaginal speculum inside a peel pack had white spots observed on the metal.

16. During an observation of the L&D surgical area, accompanied by the ICM (Infection Control Manager), on 2/23/16 at 11:00 AM, the door to the sterile supply room was propped open with a wheeled cart containing shelves holding sterile surgical instruments.

17. During an observation of the L&D soiled utility room/decontamination room, on 2/23/16 at 11:15 AM, accompanied by the ICM, a "hopper/bedpan hopper" (a utility sink with a flushing mechanism designed to be used for rinsing of bedpans) was noted to be half-filled with soapy water.

During an interview with L&D Technician 1, on 2/23/16 at 11:15 AM, she stated she rinsed the maternal/fetal monitoring transducers in the "hopper".

During an interview with the ICM on 2/22/16 at 12:05 PM, she stated she was a member of the EOC (Environment of Care) team and participated in observation rounds of the OR quarterly, and twice a year for all other areas. She further stated there was no "surveillance tool" used during the observation rounds. The ICM was unable to provide documentation of surveillance rounds done in the CSP, OR, or sterile supply rooms.

During an interview with the DQM (Director of Quality Management), on 2/29/16 at 1:45 PM, she stated all infection control issues were discussed during the infection control meetings. During this interview, she further stated she had not seen any documented evidence of active surveillance rounds that were done in the CSP area, operating rooms, or sterile supply rooms, and was "unsure if any had been done in the past."

Review of the hospital's 2015 Infection Prevention and Control Plan, approved by the governing body 8/26/15, indicated the plan was a hospital-wide program for the purposes of preventing and controlling infections and transmission of infection that included surveillance as a function of the Infection Control program. This Plan listed facility goals that included minimizing the risk of transmitting infections with the use of procedures, medical equipment and medical devices, and to maintain a sanitary environment to avoid sources and transmission of infections and communicable disease. Another goal listed was that problems identified through active surveillance could be addressed by the hospital's quality assurance program.

Further, the 2015 Infection Prevention and Control Plan indicated a Strategy of the Plan was to reduce the risk associated with procedures, medical equipment and medical devices by implementing the appropriate storage, cleaning, disinfection, sterilization, and/or disposal of supplies and equipment.

Review of the hospital's Organization-Wide Risk Assessment of 2014, approved by the governing body 8/26/15, indicated a risk identified as "EOC Potential for transmission of infection related to procedures, medical equipment, and medical devices related to appropriate storage, cleaning, disinfection, sterilization, reuse and/or disposal of supplies and equipment." The list of Strategies listed to reduce risk included "regular rounding and inspecting the environment cleanliness by IC (Infection Control) and EVS (Environmental Services)" and "weekly EOC rounds."

Based on observation, interview, and record review, the hospital failed to ensure it's ICPs (Infection Control Practitioners) had a system to identify, report, investigate, and control infections and communicable diseases, as evidenced by:

1. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards;

a. Hinged instruments were processed in closed positions,

b. Rigid trays were not loaded in a manner that allowed instruments to have maximum exposure to the sterilizing agent,

c. Staff were not competent and trained on job specific current national recognized standards and policies regarding sterile processing of surgical instruments.

Because of the serious potential harm to all patients who have surgery at the hospital related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was identified and called on 2/23/16, at 3:10 PM with the Chief Executive Officer, Director of Quality Management, and the Peer Review Manager.

On 3/2/16, at 2:09 PM, the Director of Quality Management was informed the Immediate Jeopardy to patient safety was removed after the plan of correction was submitted, accepted, implemented, and verified.

2. The CSP (Central Sterile Processing) area was noted to have dust and debris covering the stainless steel surfaces of the instrument preparation and packaging areas and inside blue plastic bins holding peel packs stored on the bottom shelf, and the stainless steel surfaces of the instrument preparation areas had several areas of black-colored residue.

3. The Getinge Group (manufacturer) washer/disinfector, and STERIS (manufacturer) sterilizers (specialized equipment used to clean or sterilize surgical instruments) located in the CSP area were found to be visibly dirty and not maintained in accordance with manufacturer's instructions.

4. Visual inspection of surgical equipment and devices for residual soil prior to sterilization did not occur.

5. Sanitary conditions of patient care areas of GI (gastro-intestinal) lab, and surgical room environments did not follow nationally accepted standards:

a. Two of two GI labs, identified by staff as ready for immediate patient use, contained trash from previous procedures in the trash receptacles, and dust and debris on equipment inside the labs,

b. A window between the GI lab anteroom and decontamination room was open,

c. OR 1 (Operating Room), identified by staff as cleaned and ready for use, contained trash from a previous procedure in the trash receptacle, the OR table pad had a dry, brownish stain located in the middle, midway down the pad, and the base of an IV pole had a thick buildup of a brownish-red crusty substance.

d. The door to the sterile supply room in L&D (Labor and Delivery) containing sterile instruments was propped open.

6. Multi-patient use external fetal/maternal monitors/transducers rinsed in a "hopper", also known as a "bedpan hopper" (a fixture used for the rinsing of bedpans and soiled linens) did not follow nationally accepted standards.

7. The facility did not perform active surveillance of the CSP area, ORs, or sterile supply rooms, to ensure hospital plans and policies were implemented.

8. The facility did not maintain a system to ensure sterile packages were inspected for integrity during storage, and ensure compromised packages were removed.

9. Five intravenous pumps that had been removed from patient rooms after use were stored in the hallway of the Asian Pavilion Medical/Surgical Unit.

10. In the Asian Pavilion Medical/Surgical Unit, an ice machine's exit chute was observed to be coated with a yellow and white substance build up.

Findings:

1a. During an observation of the CSP area, on 2/22/15 at 1:00 PM, accompanied by the ICM (Infection Control Manager) and CSS (Central Services Supervisor), eight of eight peel packages contained instruments with closed hinges.

During an interview with the CSS immediately following the observation, he stated he could not tell if the tips of the instruments were sterilized because they were not open and exposed to the sterilant.

During an interview with the ICM immediately following the observation, she stated if the tips of the instruments were closed or touching, sterilization could not be guaranteed. She stated that the hospital has adopted the AORN (Association of periOperative Registered Nurses) Guidelines as one of the hospital's nationally recognized infection control standards.

Review of the hospital P&P (Policy and Procedure) titled, "Sterilization", dated 3/16/14, indicated sterilization practices would follow AORN recommended practices. The policy indicated items should be prepared and packaged so sterility can be achieved and maintained to the point of use.

According to AORN, Guidelines for PeriOperative Practice 2013, Guidelines for Selection and Use of Packaging Systems for Sterilization, V.h. "Items to be sterilized should be placed in the package or tray in an open or unlocked position. The open or unlocked position facilitates sterilant contact of all surfaces of the item."

1b. During an observation of the sterile supply room located in the OR, on 2/23/16 at 10:30 AM, accompanied by the ICM, a rigid tray of surgical instruments was opened and observed. Inside the tray, surgical instruments were packed tightly with three layers of instruments. The hinged instruments were in the locked position with the tips closed and touching.

During an interview with the ICM immediately following the observation, she stated if the tips of the instruments were closed or touching, sterilization could not be guaranteed.

During an observation of the sterile supply room located in the surgical area of L&D, on 2/23/16 at 11:00 AM, accompanied by the ICM a rigid tray of surgical instruments was opened and observed. Inside the tray, surgical instruments were packed tightly. 21 hinged instruments were in a closed position with tips touching.

During an interview with the ICM immediately following the observation, she stated the sterility of the instruments could not be guaranteed.

Review of the hospital P&P (Policy and Procedure) titled, "Sterilization", dated 3/16/14, indicated sterilization practices would follow AORN recommended practices. The policy indicated items should be prepared and packaged so sterility can be achieved and maintained to the point of use.

According to AORN, Guidelines for PeriOperative Practice 2013, Guidelines for Selection and Use of Packaging Systems for Sterilization, V.h. "Items to be sterilized should be placed in the package or tray in an open or unlocked position. The open or unlocked position facilitates sterilant contact of all surfaces of the item."

The AORN "Standards and Recommended Practices, 2013 edition, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment" was reviewed.

Under Recommendation XII, it read: "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces. Proper organization will facilitate sterilant contact on all surfaces and adequate drying.

XII.a. Instruments should be placed in a container tray or basket that is large enough to evenly distribute the metal mass in a single layer. Instruments should be contained within the tray or basket in a manner that protects the instruments from damage and prevents puncturing of the sterilization wraps. Overloading trays can cause wet packs because an increase in metal mass in the tray results in more condensate, which requires additional drying at the end of the cycle.

XII.b. Broad-surfaced instruments and those with concave surfaces (e.g., malleable retractors-an adjustable surgical instrument with which a surgeon can either actively separate the edges of a surgical incision or wound, or can hold back underlying organs, hip skids-device used in hip surgeries) should be placed on edge. Instruments placed on edge facilitate drying because in this position, steam condensate will drain off the instrument rather than pool on it.

XII.c. Instruments with hinges should be opened and those with removable parts should be disassembled when placed in trays designed for sterilization, unless the manufacturer has provided validated instructions to the contrary. Sterilization occurs only on surfaces that have direct contact with the sterilant. Disassembly of multiple-part instruments and those with sliding parts (e.g., retractors) enables the sterilant to contact all surfaces.

XII.c.1. Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments."

c. During an interview with ORT 1 (Operating Room Technician), on 2/23/16 at 10:30 AM, she stated she had not received competency training for decontamination and sterilization of surgical instruments, but was currently taking a course to get certified. During this interview, she stated she had too many duties, and the duties are "too much for me," stating she was frequently called away from one duty to the next prior to completion. She stated she was unable to monitor the sterile packages and peel packs for integrity and sterility.

Review of the hospital's Infection Prevention P&P (Policy and Procedure) titled "High Level Disinfection", dated 12/4/13, indicated quality-control programs would be documented and would include "competency assurance, and continuing education."

Review of the hospital's job description for "Central Services Technician" indicated general duties included collecting used equipment, decontaminating and cleaning reusable items; maintaining processing supply inventory; cleaning shelves, carts, tables, sinks, and counter tops; performs daily and weekly cleaning of work surfaces, sterilizers and aerators.

Review of ORT 1's competencies provided by the facility did not include documented evidence of competencies validated for duties required of a Central Services Technician according to the hospital's job description.

Review of L&D (Labor and Delivery) Technician 1's competencies provided by the facility did not include documented evidence of ongoing validation of training or competencies for the years of 2013, 2014, 2015 or 2016, related to sterilization and storage of L&D instruments.

Review of GI Lab Staff 1's competencies provided by the facility did not include documented evidence of ongoing validation of training or competencies related to the cleaning or sterilization of endoscopes, or infection control of the GI lab decontamination room environment.

Review of the hospital P&P titled, "Packaging Systems for Sterilization", dated 3/16/14, indicated personnel would demonstrate competence in the use of sterilization packaging systems and accessories, and further, administrative personnel would periodically assess and document the competency of personnel. The policy indicated ongoing education of personnel would occur to assist in the development of knowledge, skills, and behaviors that affect patient outcomes.

The AORN "Guidelines for PeriOperative Practice, 2016 edition, Guidelines for Cleaning and Care of Surgical Instruments and Powered Equipment" was reviewed. Recommendation XV indicated, "Perioperative team members with responsibilities for cleaning and caring of instruments used in surgery should receive initial and ongoing education and complete competency verification activities related to cleaning and care of surgical instruments.

2. During an observation of the CSP area, on 2/22/16 at 1:15 PM, accompanied by the ICM and CSS, two of two stainless steel tables with a lower shelf, were noted to have a thick layer of dust accumulation on the lower shelves.

Nine of Nine blue plastic bins located on the lower shelves containing peel packs with instruments inside, had thick layers of dust accumulated formed into small, white, fuzzy balls.

The lower shelves and the top of the stainless steel tables were observed to have several areas of black-colored substances.

During an interview with the ICM immediately following the observation, she stated the black-colored substance was residue from tape and adhesive, and was not considered a clean surface.

During an interview with the CSS immediately following the observation, he stated that EVS (Environmental Services) were responsible for cleaning the tables and surfaces "a couple times per week."

During an interview with the CSM on 2/22/16 at 1:45 PM, he observed the dust and areas of black-colored residue on the stainless steel tables,. He stated the central services staff were responsible for cleaning the stainless steel tables and equipment inside the CSP area. He stated, "All flat surfaces should be cleaned every eight hours."

3. During an observation of the CSP area, on 2/22/16 at 1:45 PM, accompanied by the ICM, CSM (Central Services Manager), and CSS, the following was observed:

a. The Getinge Group washer/disinfector had palpable, thick white "water spots" on the conveyor area , and palpable dust buildup on the edges of the conveyor area.

During an interview with the CSM on 2/22/16 at 1:45 PM, he stated the central services staff are responsible for cleaning of CSP area equipment and dust should not be on the equipment. He further stated that the facility has "hard water" which contributed to the water spots.

During an interview with the DQM (Director of Quality Management) on 2/25/16 at 2:15 PM, she stated she was unable to locate documentation to indicate the Getinge Washer/Disinfector had been cleaned, was unable to locate manufacturer's instructions for cleaning, and did not have a P&P regarding cleaning and maintenance of the washer/disinfector.

During an interview with the CSM on 3/2/16 at 11:40 AM, he stated the facility did not have a log to indicate cleaning or maintenance of the washer, and further stated that a log for cleaning was being developed.

b. The #2 STERIS sterilizer had brownish "drip" staining located on the front of the equipment and down the adjacent walls to the side and under the sterilizer.

During an interview with the CSS immediately following the observation, he stated he thought EVS was responsible for cleaning the equipment and walls.

During an interview with the CSM on 2/22/16 at 1:45 PM, he stated the central services staff were responsible for cleaning of CSP area equipment.

During an interview with the DQM on 2/25/16 at 2:15 PM, she stated she was unable to locate documentation to indicate the STERIS sterilizers had been cleaned, was unable to locate manufacturer's instructions for cleaning, and did not have a P&P regarding cleaning and maintenance of the STERIS sterilizers.

During an interview with the CSM on 3/2/16 at 11:40 AM, he stated the facility did not have a log to indicate cleaning or maintenance of the sterilizer, and further stated that a log for cleaning was being developed.

Review of the hospital P&P titled, "Sterilization", dated 3/16/14, indicated inspection and cleaning of the sterilizers would be performed according to the manufacturer's written instructions.

4. During an observation of the CSP area, on 2/22/16 at 1:09 PM, accompanied by the ICM and CSS, a vaginal speculum inside a peel pack had white spots on the metal.

During an interview with the ICM immediately following the observation, she stated, "it looks like water spots."

During an interview with the CSS immediately following the observation, he stated he did not visually examine all instruments prior to placing them into the peel packs.

During an observation of the L&D surgical area in the sterile supply room, on 2/23/16 at 11:00 AM, accompanied by the ICM, a vaginal speculum inside a peel pack had white spots on the metal.

During an interview with the ICM immediately following the observation, she stated there should not be any white spots or visible staining on the instrument after sterilization.

Review of the hospital P&P titled, "Sterilization", dated 3/16/14, indicated sterilization practices would follow AORN recommended practices. The policy indicated the reliability of sterilization is affected negatively by the number, type, and inherent resistance of microorganisms, including biofilms, on items to be sterilized. Soils, oils, and other materials may shield items from contact with the sterilant or combine with and inactivate the sterilant and must therefore be removed completely.

Review of the hospital P&P titled, "Instrument Care and Cleaning", dated 3/16/14, indicated instruments would be inspected for defects prior to being put into use.

The AORN "Guidelines for PeriOperative Practice, 2016 edition, Guidelines for Cleaning and Care of Surgical Instruments" was reviewed. Recommendation X read, "Surgical instruments should be inspected and evaluated for cleanliness and correct working order after decontamination and if soiled or defective, should be removed from service until they are cleaned or repaired." Section X.a.3 indicated, "Lighted magnification should be used to inspect hard-to-clean areas of devices for cleanliness."

5. During an observation of the GI lab on 2/23/16 at 9:40 AM, accompanied by the ICM, the following was observed:

a. Two of two GI labs had trash receptacles containing items from previous procedures, and supply carts and computer carts inside the GI lab had dust, black particles, and debris located on the lower areas of the equipment.

During an interview with GI lab staff 1, present during the observation, she stated the rooms had previously been cleaned and were ready for the next procedure. She observed the trash and stated the rooms would need additional cleaning before a patient procedure could be performed, including cleaning of supply and computer carts.

During an interview with the ICM immediately following the observation, she stated there should not be trash from previous procedures, and equipment inside the lab should be clean.

b. A window between the decontamination area and the GI lab anteroom was open.

During an interview with GI lab staff 1, on 2/23/16 at 10:00 AM, she stated she was responsible for decontaminating and sterilizing the endoscopes. During this interview, she stated she was not aware of nationally accepted standards that the facility adopted.

Review of GI Lab Staff 1's competencies provided by the facility did not include documented evidence of ongoing validation of training or competencies related to the cleaning or sterilization of endoscopes, or infection control of the GI lab decontamination room environment.

Review of the hospital P&P titled, "Packaging Systems for Sterilization", dated 3/16/14, indicated personnel would demonstrate competence in the use of sterilization packaging systems and accessories, and further, administrative personnel would periodically assess and document the competency of personnel. The policy indicated ongoing education of personnel would occur to assist in the development of knowledge, skills, and behaviors that affect patient outcomes.

During an interview with the ICM immediately following the observation, she stated the window should not be open because of the potential splashing of contaminated water during cleaning of endoscopes into the anteroom could occur. She further stated she had observed the window being open in the past and had instructed the GI staff to keep it closed.

c. During an observation of OR 1, on 2/23/16 at 10:45 AM, accompanied by the ICM, the trash receptacle was observed to have items from a previous procedure.

During an interview with the EVS Manager, on 2/23/16 at 10:45 AM, she stated the trash should be removed by EVS when cleaned after every surgical procedure.

During this observation of OR 1, also observed was a dry, brownish stain on the OR table pad, located midway down in the middle of the pad.

During an interview with the ICM immediately following the observation, she stated the pad should be clean, intact, and without staining of any type. She stated she could not determine the cleanliness of the OR table pad.

During this observation of OR 1, the base of an IV pole (a pole designed to hold equipment such as an intravenous pump) was observed to have a thick, crusty, buildup of a reddish-brown substance.

During an interview with the ICM immediately following the observation, she stated "anytime there is dirt in a sterile area, I am concerned." She stated the reddish-brown substance "could be rust" and that the surface was compromised and not clean as would be expected in the OR.

During an interview with the EVS Manager, on 2/23/16 at 10:45 AM, she stated EVS staff should have cleaned the reddish-brown substance from the IV pole or removed it from use.

d. During an observation of the L&D surgical area, accompanied by the ICM, on 2/23/16 at 11:00 AM, the door to the sterile supply room was propped open with a wheeled cart containing shelves holding sterile surgical instruments.

During an interview with the ICM immediately following the observation, she stated the door should be closed at all times.

During an interview with L&D Technician 1, on 2/23/16 at 11:00 AM, she stated she often leaves the door open when she is in a hurry.

Review of L&D Technician 1's competencies provided by the facility did not include documented evidence of ongoing validation of training or competencies for the years of 2013, 2014, 2015 or 2016, related to sterilization and storage of L&D instruments

Review of the hospital P&P titled, "Sterilization", dated 3/16/14, indicated sterilization practices would follow AORN recommended practices. The policy indicated items should be prepared and packaged so sterility can be achieved and maintained to the point of use. Further, the policy indicated sterile package compromise could be due to multiple handling that leads to loss of package integrity and exposure to airborne contaminants.'

6. During an observation of the L&D soiled utility room/decontamination room, on 2/23/16 at 11:15 AM, accompanied by the ICM, a "hopper/bedpan hopper" (a utility sink with a flushing mechanism designed to rinse soiled bedpans) was noted to be half-filled with soapy water.

During an interview with L&D Technician 1, on 2/23/16 at 11:15 AM, she stated she rinsed the maternal/fetal monitoring transducers in the "hopper".

Review of L&D Technician 1's competencies provided by the facility did not include documented evidence of ongoing validation of training or competencies for the years of 2013, 2014, 2015 or 2016, related to instrument cleaning, or sterilization and storage of L&D instruments

During an interview with the ICM immediately following the observation, she stated the "hopper" was not to be used for the cleaning of any instrument or equipment as it could potentially be a source of infectious agents.

7. During an interview with the ICM on 2/22/16 at 12:05 PM, she stated she is a member of the EOC (Environment of Care) team and does observations rounds of the OR quarterly, and twice a year for all other areas. She further stated there is no "surveillance tool" used during the observation rounds.

Surveillance of healthcare-associated infections (HAI) is the cornerstone of an effective infection prevention program. By definition, surveillance is a comprehensive method of measuring outcomes and related processes of care, analyzing the data, and providing information to members of the healthcare team to assist in improving those outcomes and processes. APIC supports the use of automated surveillance technologies as an essential part of infection prevention and control activities. APIC (Association for Professionals in Infection Control and Epidemiology).

During an interview with the DQM (Director of Quality Management), on 2/29/16 at 1:45 PM, she stated all infection control issues are discussed during the infection control meetings. During this interview, she further stated she had not seen any documented evidence of active surveillance rounds that were done in the CSP area, operating rooms, or sterile supply rooms, and was "unsure if any had been done in the past."

8. During an observation of the sterile supply room located in the OR area, on 2/23/16 at 10:30 AM, accompanied by the ICM, peel packs containing surgical instruments were stored vertically in plastic bins. Some of the plastic bins were overcrowded and peel packs were bent and crinkled.

During in interview with the ICM immediately following the observation, she stated the sterility of instruments enclosed in peel packs with crinkled and worn packaging material could not be guaranteed.

During an interview with ORT 1, on 2/23/16 at 10:30 AM, she stated she had not been able to inspect peel packs for package integrity and remove compromised peel packs because she has too many duties.

During an observation of the sterile supply room located in L&D, on 2/23/16 at 11:00 AM, accompanied by the ICM, peel packs containing surgical instruments were stored vertically in plastic bins. Some of the plastic bins were overcrowded and peel packs were bent and crinkled. Bins located on a shelf near to the floor contained peel packs that were soiled and bent.

During an interview with L&D Technician 1 immediately following the observation, she stated the instruments in peel packs located on a shelf near the floor have been there a very long time because they were not used by physicians any longer, and were bent and soiled because of being brushed up against over a long period of time.

Review of the hospital P&P titled, "Sterilization", dated 3/16/14, indicated sterilization practices would follow AORN recommended practices. The policy indicated items should be prepared and packaged so sterility can be achieved and maintained to the point of use. Further, the policy indicated sterile package compromise could be due to multiple handling that leads to loss of package integrity and exposure to airborne contaminants.

Review of the hospital P&P titled, "Event Related Shelf Life and Sterile Packaging", dated 3/16/14, indicated items would be considered sterile unless the package/pack/tray/container was damaged. Damage included exposure to a contaminated or unsafe environment. The policy further indicated it was the Central Service and end-user staff's responsibility for checking the integrity of packaging and storage methodology.

Review of the hospital P&P titled, "Shelf Life, Rotation of Supplies", dated 3/16/14, indicated the integrity of sterile supplies and packages would be achieved by storage on shelves, bins, or drawers aimed a protecting the items from damage. Stored items should be checked on a routine basis, and sterile packages that look worn or mishandled would be removed and reprocessed. The policy further instructed that sterile supplies should be handled gently so as not to bend, crush, or compress items and result in puncture or rupture of the package.

The AORN "Standards and Recommended Practices, 2013 edition, Recommended Practices for Selection and Use of Packaging Systems for Sterilization was reviewed and indicated:

"Sterilized packages should be considered sterile until an event occurs to compromise the package barrier integrity. Events that may affect the sterility of a package include, but are not limited to:

a. multiple handling that leads to seal breakage or loss of package integrity;
b. compression during storage,
c. storage conditions (e.g., type of shelving, cleanliness, traffic control).



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9. On the afternoon of 2/18/16 at 3:40 PM, during an initial tour of the Asian Pavilion Medical/Surgical Unit, five intravenous pumps were observed on top of an isolation cart in the hallway near the dirty utility room. At that same time, when questioned about the pumps, Nurse Manager 37 stated that they had been used in patient rooms and were to be sent downstairs to be cleaned. She offered no reason as to why they were stored in the hallway as she then pushed the cart and the pumps into the dirty utility storage room.

10. On the afternoon of 2/18/16 at 3:45 PM, during an initial tour of the Asian Pavilion Medical/Surgical Unit, the ice machine's exit chute was observed to be coated with a yellow and white substance build up.

At the time of discovery, Nursing Associate Administrator 1 stated that the Plant Maintenance Department was responsible for cleaning the ice machines and agreed this machine was in need of cleaning.

On the morning of 2/19/16 at 9:45 AM, an interview was conducted with Facilities Manager 23. He stated that they clean the ice machine's interior workings twice a year, but the plastic part of the exit chute is not included in that cleaning. He said that the Environmental Services Department was Responsible for that.

On the morning of 2/19/16 at 10:05 AM, an interview with EVS Manager 21 was conducted. She said that they only clean the outside of the machine. She said they would never use their cleaners on the inside of the plastic chute because of the possibility of contaminating the ice.



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11. During an observation on 2/18/2016, at 4:45 PM, in the Surgical Services area, the Operating Room (O.R.) temperature and humidity log for February 2016 indicated an absence of documented temperature and humidity readings for 2/6/2016, 2/7/2016, 2/13/2016, 2/14/2016 and 2/15/2016.

During a concurrent interview with Surgical RN 11, he reviewed the O.R. temperature and humidity log and was unable to find documentation of temperature or humidity readings for 2/6/2016, 2/7/2016, 2/13/2016, 2/14/2016 and 2/15/2016.

During a review of the Operating Room (O.R.) Management log for 2/6/2016, 2/7/2016, 2/13/2016, 2/14/2016 and 2/15/2016, indicated that three surgeries were performed during the time period when no temperature or humidity readings were documented (2/7/2016, 2/13/2016 and 2/15/2016).

A review of the O.R. Management log for 2/5/2016-2/7/2016, indicated an "ORIF (open reduction internal fixation) Hip Nailing (Right)" (a hip surgical procedure) was performed in O.R. Room 1 at 8:00 AM on 2/7/2016.

The O.R. Management log for 2/13/2016- 2/13/2016, indicated a "Laparoscopic Cholecystectomy" (removal of the gall bladder using a scope through a small skin incision) was performed in O.R. Room 1 at 9:00 AM on 2/13/2016.

The O.R. Management log for 2/15/2016-2/15/2016, indicated a "Laparoscopic Ovarian Cystectomy, possible Laparotomy (Left)" (surgery for an ovarian cyst using a scope through a small skin incision, possibly through a larger skin incision) was performed in O.R. Room 1 at 4:30 PM on 2/15/2016.

During an interview with Admin 12, 0n 2/24/2016, at 4:20 PM, she reviewed the O.R. Management logs for 2/7/2016, 2/13/2016 and 2/15/2016 and confirmed three surgeries were performed in the O.R. on days there was no documented evidence of temperature or humidity readings.

Review of the CMS (Centers for Medicare and Medicaid Services) Survey and Certification, 13-25, dated 4/19/13 regarding relative humidity (RH) stipulates the following:

"Temperature, humidity and airflow in anesthetizing locations must be maintained within acceptable standards to inhibit microbial growth, reduce risk of infection, control odor,
and promote patient comfort. Hospitals must maintain relative humidity (RH) levels at 35 percent or greater in each anesthetizing location..............Hospitals must maintain records that demonstrate they have achieved the required levels...............Each operating room should have separate temperature control. Acceptable standards such as from the Association of Operating Room Nurses (AORN) or the Facilities Guidelines Institute (FGI) should be incorporated into hospital policy."

12. During an observation on 2/18/2016, at 4:35 PM, in Operating Room (O.R.) two, the O.R. table arm board (where patient rests his/her arm) pad was noted to be missing some material (a one centimeter circle of material) from the top surface. This made it impossible to disinfect the arm board pad in an effective manner between patients. During a concurrent interview with Surgical TN 11, he confirmed the observation and removed the arm board pad from O.R. two.

The facility policy and procedure titled, "Cleaning in Perioperative and Procedure Service, Environmental" dated March 24, 2015, indicated "...Procedure ...B. Safe, clean environment should be reestablished after each surgical and invasive procedure... 2. Mattresses and padded positioning device surfaces (e.g., OR beds, arm boards, patient transport carts) should be moisture-resistant and intact ...c. Damaged or worn coverings will be replaced ..."

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

1. Documented evidence that the Operating Room (O.R.) temperature and humidity was monitored during all surgeries.

2. All surfaces of the O.R. table were intact for effective cleaning and disinfection.

3. Surgical instruments were sterilized in a manner consistent with nationally recognized standards.

These practices increased the risk of an infection for a universe of 184 patients.

Findings:

1. During an observation on 2/18/2016, at 4:45 PM, in the Surgical Services area, the Operating Room (O.R.) temperature and humidity log for February 2016 indicated an absence of documented temperature and humidity readings for 2/6/2016, 2/7/2016, 2/13/2016, 2/14/2016 and 2/15/2016.

During a concurrent interview with Surgical RN 11, he reviewed the O.R. temperature and humidity log and was unable to find documentation of temperature or humidity readings for 2/6/2016, 2/7/2016, 2/13/2016, 2/14/2016 and 2/15/2016.

During a review of the Operating Room (O.R.) Management log for 2/6/2016, 2/7/2016, 2/13/2016, 2/14/2016 and 2/15/2016, indicated that three surgeries were performed during the time period when no temperature or humidity readings were documented (2/7/2016, 2/13/2016 and 2/15/2016).

A review of the O.R. Management log for 2/5/2016-2/7/2016, indicated an "ORIF [open reduction internal fixation] Hip Nailing (Right)" (a hip surgical procedure) was performed in O.R. Room 1 at 8:00 AM on 2/7/2016.

The O.R. Management log for 2/13/2016- 2/13/2016, indicated a "Laparoscopic Cholecystectomy" (removal of the gall bladder using a scope through a small skin incision) was performed in O.R. Room 1 at 9:00 AM on 2/13/2016.

The O.R. Management log for 2/15/2016-2/15/2016, indicated a "Laparoscopic Ovarian Cystectomy, possible Laparotomy (Left)" (surgery for an ovarian cyst using a scope through a small skin incision, possibly through a larger skin incision) was performed in O.R. Room 1 at 4:30 PM on 2/15/2016.

During an interview with Admin 12, 0n 2/24/2016, at 4:20 PM, she reviewed the O.R. Management logs for 2/7/2016, 2/13/2016 and 2/15/2016 and confirmed three surgeries were performed in the O.R. on days there was no documented evidence of temperature or humidity readings.

Review of the CMS (Centers for Medicare and Medicaid Services) Survey and Certification, 13-25, dated 4/19/13 regarding relative humidity (RH) stipulates the following:

"Temperature, humidity and airflow in anesthetizing locations must be maintained within acceptable standards to inhibit microbial growth, reduce risk of infection, control odor,
and promote patient comfort. Hospitals must maintain relative humidity (RH) levels at 35 percent or greater in each anesthetizing location..............Hospitals must maintain records that demonstrate they have achieved the required levels...............Each operating room should have separate temperature control. Acceptable standards such as from the Association of Operating Room Nurses (AORN) or the Facilities Guidelines Institute (FGI) should be incorporated into hospital policy."

2. During an observation on 2/18/2016, at 4:35 PM, in Operating Room (O.R.) two, the O.R. table arm board (where patient rests his/her arm) pad was noted to be missing some material (a one centimeter circle of material) from the top surface. This made it impossible to disinfect the arm board pad in an effective manner between patients. During a concurrent interview with Surgical TN 11, he confirmed the observation and removed the arm board pad from O.R. two.

The facility policy and procedure titled, "Cleaning in Perioperative and Procedure Service, Environmental" dated March 24, 2015, indicated "...Procedure ...B. Safe, clean environment should be reestablished after each surgical and invasive procedure ...2. Mattresses and padded positioning device surfaces (e.g., OR beds, arm boards, patient transport carts) should be moisture-resistant and intact ...c. Damaged or worn coverings will be replaced ..."

3. During an observation of the CSP (Central Sterile Processing) area, on 2/22/16 at 1:00 PM, accompanied by the ICM (Infection Control Manager) and CSS (Central Services Supervisor), eight of eight peel packages contained instruments in the closed hinge position.

During an interview with the CSS immediately following the observation, he stated he could not tell if the tips of the instruments were sterilized because they were not open and exposed to the sterilant.

During an interview with the ICM immediately following the observation, she stated if the tips of the instruments were closed or touching, sterilization could not be guaranteed. She stated that the hospital has adopted the AORN (Association of periOperative Registered Nurses) Guidelines as one of the hospital's nationally recognized infection control standards.

Review of the hospital P&P (Policy and Procedure) titled, "Sterilization", dated 3/16/14, indicated sterilization practices would follow AORN recommended practices. The policy indicated items should be prepared and packaged so sterility can be achieved and maintained to the point of use.

According to AORN, Guidelines for PeriOperative Practice 2013, Guidelines for Selection and Use of Packaging Systems for Sterilization, V.h. "Items to be sterilized should be placed in the package or tray in an open or unlocked position. The open or unlocked position facilitates sterilant contact of all surfaces of the item."