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

1. Failure to ensure that the surgical environment, the sterile supply processing and storage environment, surgical equipment processing, use of patient care equipment, surgical attire, use of personal protective equipment, and record keeping was in accordance with nationally accepted standards of practice. Refer to C 320, findings 1-19.

These failures placed patients at risk for infection and other adverse events that could negatively impact patients' health status.

2. Failure to have a robust quality program designed to ensure the identification and remediation of deficient practices. Refer to C 337.

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

Based on interview and record review, the hospital failed to ensure the electronic health record system (EHR) had personnel and their qualifications accurately authenticated:

1. The system for authenticating codes assigned to registry staff was not maintained.

2. Nursing Staff codes did not include their qualifications.

3. Over 50 pages of Patient 20's clinical record were found in Patient 1's medical record binder in the medical surgical nursing unit.

These failures had the potential for record security and inaccuracies.

Findings:

1. During Patient 1's record review, the nursing staff entries were noted as authenticated by Nurse T.

On 12/5/16 at 2:50 pm, Administrative (Admin) Nurse A reviewed Patient 1's record and stated the code Nurse T had been assigned to a registry nurse.

Admin Nurse produced a log to demonstrate how the code assigning was recorded each day the registry personnel worked. The log was not completed for any of the days Patient 1 was admitted.

Admin Nurse A acknowledged the system for authenticating registry staff codes in the EHR had not been maintained.

The American Health Information Management Association (AHIMA) website advised on authorship authentication Integrity issues, as follows: "Authorship attributes the origin or creation of a particular unit of information to a specific individual or entity acting at a particular time. When there are multiple authors or contributors to a document, all signatures should be retained so that each individual's contribution is unambiguously identified. Some EHR systems allow more than one individual to add text to the same progress note entry or flow sheet. If the EHR does not have functionality to enable both providers to document and sign, it may be impossible to verify the actual service provider or the amount of work performed by each provider.

2. Patient 1's record contained a variety of nursing entries but the reader could not identify if the author was a Registered Nurse (RN, a Licensed Vocational Nurse (LVN, or a Certified Nurse Assistant (CNA).

On 12/5/16 at 2:50 pm, Admin Nurse A reviewed Patient 1's record and acknowledged the system for naming conventions in the EHR had not been maintained to include the appropriate qualifications.

A request was made for the polices related to the above EHR issues but none was provided by the end of the survey.

AHIMA website listed standards for signatures in the patient record as "Entries are typically authenticated by a signature. At a minimum the signature should include the first initial, last name and title/credential."



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3. During a review of Patient 2's paper medical record (chart) at the medical-surgical nursing station at approximately 8:45 am on 12/6/16, over 50 pages of Patient 1's clinical record were found misfiled in Patient 2's chart.

During an interview at approximately 8:50 am on 12/6/16, Nursing Staff AA stated that the misfiled record was Patient 1's clinical record from another hospital where the patient was transferred to for a surgical procedure. Nursing Staff AA stated that the misfiled record needed to be removed from Patient 2's chart and she did not know how Patient 1's record was misfiled in Patient 2's chart. Nursing Staff AA immediately took out the misfiled pages from Patient 2's chart.

Based on observation, interview, and record review, the facility failed to ensure that policies and procedures were developed and or implemented that reflected the Association of periOperative Registered Nurses (AORN) standards of practice when:

1. Temperature and humidity levels in the surgical department were not being monitored daily.

2. Temperature and humidity levels were not being monitored in the room where sterile instruments were being stored.

3. The room for decontaminating dirty surgical instruments was not stocked with all the necessary personal protective equipment for staff.

4. The gown that was worn by a surgical technologist to clean a dirty colonoscope was not impervious to fluids.

5. Flexible endoscopes were not being reprocessed according to AORN standards of practice.

6. The log book that was used for logging the reprocessing of endoscopes did not identity which flexible endoscope was reprocessed.

7. There was no process in place that identified which of the flexible endoscopes were being used on the patients.

8. There was no process in place that visually flagged when the flexible endoscope was last reprocessed.

9. The flexible endoscopes were not being stored according to AORN standards of practice.

10. An iris scissor and a minor tray was resterilized in a fashion that could not guarantee that all of the surfaces of the hinged instruments had been adequately exposed to the sterilization process.

11. An instrument was observed marked with a piece of tape that was brittle and had a brownish red substance where the Central Sterile Technician (CS Tech) had removed the brittle tape.

12. There was no evidence that the flexible scope reprocessor was tested before a flexible endoscope was reprocessed and used on Patient 24.

13. Anesthetist C was observed wearing a long sleeved top that was not covered by surgical attire, thus not meeting AORN standards of practice.

14. The facility did not maintain manufacturer's written instructions for the cleaning of surgical instruments.

15. Surgical Technologist did not remove and dispose of the gown and gloves that were worn during a colonoscopy before leaving the surgery room.

16. The decontamination room, sub-sterile room, the room used to store sterile instruments, and the Central Sterile processing room, were not being monitored for room air exchanges and for the presence of negative and positive pressures.

17. OR 1 and OR 2 did not meet the minimum requirements of 20 air exchanges per hour.

18. A glucometer (device used to check a person's blood sugar levels) manufactured for personal use only was being used for patients in the recovery room.

19. Surgical technologist did not perform hand hygiene after removing gloves that were used to clean a flexible endoscope.

These widespread systemic failures placed all patients undergoing surgical procedures at risk for possible exposure of disease causing organisms that could lead to infection which could compromise the patient's health and well-being.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Quality Review and Periodic Evaluation.

Findings:

1. On 12/5/16 at 9:38 am, during an interview with the Operating Room Supervisor (ORS), the ORS stated that the hospital based their practice on the Association of PeriOperative Registered Nurses (AORN) guidelines and standards of practice.

(AORN guidelines and standards of practice are designed to promote safe surgical practices to ensure optimal outcomes for patients undergoing surgery and other invasive procedures).

The 2016 Edition of Guidelines for Perioperative Practice indicated, under section IV. f, indicated that "The temperature should be maintained within the limits recommended for each area."

On 12/5/16 at 9:41 am, a concurrent interview and review of the surgery's temperature and humidity logs was conducted with the ORS.
The logs had no temperature or humidity readings documented as follows:

February 2015, 10 out of 28 days had no temperatures or humidity documented.

December 2015, 11 of 31 days had no temperatures or humidity documented.

January 2016, 14 of 31 days had no temperatures or humidity documented.

July 2016, 17 of 31 days had no temperatures or humidity documented.

November 2016, 13 of 30 days had no temperatures or humidity documented.

A document provided by the Facility Manager, titled, Operating Rooms, with an All Rights Reserved 2015 date, indicated, "Temperature and humidity for each operating room must be documented on at least a daily basis."

During an interview on 12/5/16 at 3:11 pm with the ORS, the ORS verified that the temperatures and humidity were not monitored on weekends, holidays, or when the OR was closed.

2. The 2016 Edition of Guidelines for Perioperative Practice indicated that the temperature range for the clean/sterile storage areas is 72 to 78° Fahrenheit, with a maximum relative humidity allowed of 60%.

On 12/5/16 at 11:25 am, during a tour of the surgery department, two cabinets that had glass doors was observed. Inside the cabinets was a collection of sterilized surgical instruments.

A concurrent interview was conducted with a Central Sterile staff member (CS) on 12/5/16 at 11:25 am. (Central Sterile is the department that prepares and resterilizes the surgical instruments). CS was asked if the room, where the sterile instruments are stored, was monitored for temperature and humidity. The CS verified that this information was not monitored.

3. A facility policy and procedure titled, "Employee Exposure Control Plan", with a review date of 8/11/16, was reviewed.

According to the policy, jobs with tasks that routinely involve exposure or potential exposure to blood, body fluids or tissues are considered a "Category 1". Some of the job roles in this category included the Central Processing Technician, nurses, Surgical Technologist, and Housekeepers.

The policy indicated it's the facility's responsibility to provide appropriate types and supplies of protective equipment (gloves, goggles, eye shields, masks, gowns), and to ensure that personnel use appropriate personal protective equipment.

The policy additionally indicated that masks and eye protection (such as goggles, face shields) are used whenever splashes or sprays may generate droplets of infectious materials.

Protective clothing (such as gowns and aprons) is worn whenever potential exposure to the body is anticipated.

On 12/5/16 at 9:38 am, a tour of the surgery department was conducted with the Operating Room Supervisor (OR S), the Surgical Technologist (ST), and the Central Sterile staff member (CS).

The room where the surgical instruments are initially decontaminated right after surgery was observed. Inside the room was a sink, a hopper (like a large toilet used to flush liquid waste down the drain), a container of germicidal wipes, and a couple of boxes of exam gloves.

In a concurrent observation and interview with the ORS, on 12/5/16 at 9:38 am, the ORS was asked if they stock any other type of personal protective equipment (PPE) in the decontamination room like gowns, masks, and or eye protection. The ORS verified there was not an adequate supply of PPE stocked in the room.

4. The 2016 Edition of the AORN Guidelines for Perioperative Practice, Guideline for Processing Flexible Endoscopes, Recommendation II, indicated that contaminated flexible endoscopes are a potential source of transmissible pathogens (disease causing germs). Personal protective equipment helps to protect processing and procedural personnel from exposure to blood, body fluids, and other potentially infectious materials.
II.e.2. Personnel working in the endoscopy processing room and handling contaminated flexible endoscopes should wear PPE that includes:
· surgical masks in combination with eye protection devices, such as goggles, glasses with solid side shields, or chin length face shields;
· fluid-resistant gowns;
· general purpose utility gloves with cuffs that extend beyond the cuff of the gown; and
· fluid-resistant shoe covers.

On 12/6/16 at 10:55 am, the Surgical Technician (ST), that had just finished a surgery where a flexible endoscope was used, exited the procedure room and entered the decontamination room with the contaminated scope. The ST was wearing a yellow long-sleeved gown that was tied at the waist and at the back of the neck. After the ST decontaminated the scope, she threw the yellow gown and gloves into the trash receptacle in the decontamination room.

On 12/7/16 at 3:30 pm, a box containing the yellow disposable gowns was observed. The name of the company along with the gown's order number indicated that the gown was a "Universal cover Gown" used for isolation. "For use in minimal fluid settings."

On 12/7/16 at 10:15 am, the OR S was interviewed. The OR S was asked if the yellow gowns were impervious. (Impervious gowns are those that do not allow fluids to pass through the gown). The OR S acknowledged the gowns were not impervious.

5. An article titled, Effectively Processing Flexible Endoscopes, published in the November 2016, vol. 104, NO. 5, AORN Journal read, "As the number of endoscopic procedures (procedure that uses a lighted camera or scope to look directly into the body for diagnosing medical conditions) performed in the United States has increased, so has wide-spread concern about the risks associated with the complexity of handling, reprocessing, and storing flexible endoscopes. Endoscopes have complex designs with multiple narrow channels, which make cleaning difficult and increase the potential for inadvertent damage. Improper cleaning and drying of endoscopes can lead to a buildup of bioburden." (Bioburden is the number of bacteria living on a surface that has not been sterilized).

During a concurrent observation and interview with the OR S in the sub-sterile room of the surgery department, on 12/5/16 at 10:17 am, the OR S was asked where the compressed air was for drying the inside of the scopes after reprocessing. The OR S stated that they did not have compressed air in the sub-sterile room.

A facility policy and procedure titled, Flexible Endoscopes, Cleaning and Processing, formulated 11/2016, was reviewed.

According to the policy, after the scope is disinfected, "Rinse the flexible endoscope and flush the internal channels with water, then rinse and flush using alcohol. Dry the flexible endoscope and the internal channels using low-pressure forced air.

On 12/6/16 at 11:45 am, an observation of the cleaning and reprocessing of a flexible endoscope (scope) occurred. In the sub-sterile room, where the machine used to mechanically disinfect the scope is located, the ST removed the scope from the machine and hung it on a hook on a pole allowing the scope to hang vertically. Next, the ST flushed the scope with 10 cc of 70% alcohol. Alcohol was observed coming from the end of the scope and spilling onto the floor. The ST wiped up the alcohol from the floor and stated that the process was complete.

6. The 2016 Edition of the AORN Guidelines for Perioperative Practice, Guideline for Processing Flexible Endoscopes, Recommendation X, indicated that health care organization should maintain records of flexible endoscope processing and procedures. Records of flexible endoscope processing enable traceability in the event of a processing failure.
Records related to flexible endoscope processing should include the:
· date and time,
· identity of the endoscope and endoscope accessories,
· method and verification of cleaning and results of cleaning verification testing,
· lot numbers of processing solutions,
· disposition of defective items or equipment, and
· maintenance of water systems, endoscopes and endoscope accessories, and processing equipment.

A concurrent interview and record review was conducted with the OR S, on 12/5/16 at 3:16 pm. The flexible endoscope reprocessing log #1 was reviewed. An entry in the log book indicated that on 11/18/16 at 7:50 am, a "colon" was ran but there was no documentation as to which scope was reprocessed. The OR S verified that the log did not indicate which endoscopes had been reprocessed.

7. The 2016 Edition of the AORN Guidelines for Perioperative Practice, Guideline for Processing Flexible Endoscopes, Recommendation X, indicated Records related to flexible endoscope procedures should include the:
· date and time,
· identity of the patient,
· procedure,
· identity of the licensed independent practitioner performing the procedure, and
· identity of the endoscope and endoscope accessories used during the procedure.

Records of flexible endoscope processing enable traceability in the event of a processing failure.
Patient 22's record indicated the patient had a procedure on 11/16/16 in which a flexible endoscope had been used. There was no written documentation as to the which scope that had been used on Patient 22.

Patient 23's record indicated that the patient had undergone a procedure on 10/25/16 in which a flexible endoscope was used. There was no documentation in the record as to which scope was used during the procedure.

Patient 24's record indicated that patient had a procedure in which a flexible endoscope had been used. There was no documentation in the record as to which scope was used on the patient.

On 12/7/16 at 10:15 am, an interview was conducted with the OR S. The OR S was asked what the process was for identifying which scopes were used on which patients in the event of an outbreak. The OR S acknowledged that they had not been documenting this
information.

8. The 2016 Edition of the AORN Guidelines for Perioperative Practice, Guideline for Processing Flexible Endoscopes, Recommendation IX, indicated flexible endoscopes should be clearly identifiable with a distinct visual cue as processed and ready for use. Identifying endoscopes that are ready for use and distinguishing them from unprocessed endoscopes may help prevent use of a contaminated endoscope.

During a tour of the surgical department with the OR S on 12/5/16 at 10:47 am, two flexible endoscopes were observed hanging on a irrigation pole in the sub-sterile room.

An interview was conducted with the OR S on 12/5/16 at 3:16 pm. The OR S was asked if they had a process for tagging the endoscopes that had been reprocessed. The OR S acknowledged there was no process to indicate if the scope had been reprocessed.

9. The 2016 Edition of the AORN Guidelines for Perioperative Practice, Guideline for Processing Flexible Endoscopes, Recommendation IX indicates flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects the device or item from damage. Cabinets used for storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area close to, but not within, the endoscopy procedure room.
Flexible endoscopes should be stored in a drying cabinet. If a drying cabinet is not available, flexible endoscopes may be stored in a closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the flexible endoscopes.
Ventilation promotes continued drying of the endoscope. Using HEPA-filtered air may help prevent bacterial growth in the endoscope. Positive pressure may help prevent contamination of stored endoscopes.

According to chapter 5 of the endoscope's manufacturer's instructions, the endoscope is to be stored in a storage cabinet. "The storage cabinet must be clean, dry, well ventilated and maintained at ambient temperature.

During a concurrent observation and interview with the surgical department with the OR S on 12/5/16 at 10:47 am, two flexible endoscopes were observed hanging on a irrigation pole in the sub-sterile room. The OR S stated that the endoscopes are stored on the irrigation pole but they are reprocessed before each use.

A facility policy and procedure titled, Flexible Endoscopes, Cleaning and Processing, formulated 11/2016, was reviewed. According to the policy, clean flexible endoscopes are stored in a closed cabinet with venting that allows air circulation around the flexible endoscopes with adequate height to allow the scopes to hang without touching the bottom of the cabinet, and sufficient space for storage of multiple endoscopes without touching. Hang in a secure vertical position.

Reprocess flexible endoscopes before use if the endoscope has not been used for more than five days or if evidence of improper drying exists.

The OR S was interviewed 12/5/16 at 3:12 pm, the OR S acknowledged that the way the endoscopes were being stored did not meet AORN standards of practice.

10. According to AORN Guidelines for Perioperative Practice (2016), Guideline for Selection and Use of Packaging Systems for Sterilization, Section V.: 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. Racks or stringers designed and intended for sterilization can be used to maintain instruments in their open position.
· IV.h.1. Racks or stringers designed and intended for sterilization can be used to maintain instruments in their open position.

A concurrent interview and observation was conducted with a Central Sterile staff member (CS), on 12/5/16 at 11:09 am, in the Central Sterile department. A scissor that had been wrapped individually was observed with the jaws of the scissor in the "closed" position. A minor tray that had been resterilized was opened. There was a variety of hinged instruments observed with the jaws that were not separated or opened, that would have allowed all of the surfaces to be exposed to the sterilization process. The CS acknowledged that the jaws of the instruments were not apart.

On 12/7/16 at 10:17 am, an interview was conducted with the OR S. The OR S verified that the minor tray's instruments had been resterilized with the jaws of the instruments in the closed position. He stated he had the same problem at his other job. The OR S acknowledged that the scissors were not in the open position. He stated, "I don't know why they weren't open, we have the cards."

11. An instrument was observed marked with a piece of tape that was brittle and had a brownish red substance where the Central Sterile Technician (CS Tech) had removed the brittle tape.

12. On 12/5/16 at 3:32 pm, the flexible endoscope (scope) disinfection log was reviewed. According to the log, on 11/16/16 at 5:58 am, staff performed a diagnostic check on the machine used to disinfect the scopes. On 11/18/16 at 7:50 am, the log indicated that a scope was disinfected in the machine, but there was no documentation that staff had performed a diagnostic check since 11/16/16 at 5:58 am.

The manufacturer's instructions indicated that the purpose of the "Diagnostic Cycle" is to ensure that the filter and all of the electro-mechanical systems of the machine are functioning correctly. The cycle consists of a series of internal tests which are performed sequentially. A successful Diagnostic Cycle assures the operator that the system operates as designed. Failure of a Diagnostic Cycle tells the operator that the processor must not be used until the problem is corrected and a successful Diagnostic Cycle is run.

On 2/7/16 at 10:05 am, a concurrent interview and review of the scope disinfection log was conducted with the OR S. The OR S verified that a diagnostic test had not been performed prior to using the machine to reprocess a scope for Patient 24.

13. On 12/6/16 at 9:40 am, the Certified Registered Nurse Anesthetist (CRNA) was observed in the procedure room in the surgery department. The CRNA was wearing a top with long sleeves. The sleeves of the garment extended past the short sleeve of the surgical scrub top and the neck line of the garment extended above the neck of the surgical scrub top.

At 9:50 am on 12/6/16, the CRNA was asked about the surgical attire that was being worn. The CRNA stated that she would wear a long sleeved surgical jacket over her long sleeved tops from now on.

According to AORN Guidelines for Perioperative Practice (2016), Guideline for Surgical Attire indicated that changing from street apparel into clean or disposable scrub attire in a designated area assists in maintaining a clean environment and decreases the possibility of transferring microorganisms from street apparel to patients.

Personal clothing that cannot be contained within the scrub attire either should not be worn or should be laundered in a health care-accredited laundry facility after each daily use and when contaminated.

14. According to AORN Guidelines for Perioperative Practice (2016), the Guideline for Cleaning and Care of Surgical Instruments recommended that all instruments and devices used in surgery should be cleared by the US Food and Drug Administration (FDA) for use in surgery and have written, manufacturer-validated cleaning and decontamination instructions for use (IFU).

On 12/5/16 at 11:07 am, a concurrent observation and record review was conducted in the Central Sterile Department with the OR S and a Central Sterile staff member. They were asked to see the written manufacturer's instructions for reprocessing their surgical instruments. The OR S stated they did not have them.

15. According to AORN Guidelines for Perioperative Practice (2016), the Guideline for Prevention of Transmissible Infections, Recommendation VI, read, perioperative (surgery) personnel must remove all PPE before leaving the work area and must place used PPE in an appropriately designated area or container for storage, washing, decontamination, or disposal.

On 12/5/16 at 10:17 am, an interview was conducted with the ST in the surgery department. The ST was asked to explain the "flow" the surgical instruments take from the time they leave the operating room to the place they are resterilized. The ST stated that after surgery, she takes the dirty instruments out the door and into the room labeled "clean-up" room. The ST stated from the operating room to the clean-up room she still wears the gown that was worn in surgery.

On 12/6/16 at 9:50 am, a surgical procedure was observed in the procedure room. At the end of the procedure, the ST left the room with the flexible endoscope. The ST did not remove the yellow gown that had been worn during the surgical procedure. The ST was observed cleaning the scope in the clean-up room wearing the same gown that had been worn during the surgical procedure.

During an interview with the OR S on 12/5/16 at 3 pm, the OR S verified that operating room personnel need to remove their gown and gloves before leaving the operating room suite to help prevent the possibility of cross contamination.

16. According to AORN Guidelines for Perioperative Practice (2016), Guideline for the Environment of Care indicates the health care organization should create and implement a systematic process for monitoring heating, ventilation, and air conditioning (HVAC) performance parameters.
Heating, ventilation, and air conditioning systems control room air quality, temperature, humidity, and air pressure of the room in comparison to the surrounding areas. The HVAC system is intended to reduce the amount of environmental contaminates (e.g., microbial-laden skin cells, dust, lint) in the surgical suite. The HVAC system reduces the amount of environmental contamination by carrying airborne contaminates away from the sterile field and removing these contaminants through the return duct vents located at the periphery of the room.
The AORN guidelines indicated the air changes per hour (ACH) in a semi-restricted area are related to the function performed in that area:
· sterile storage-4 total and 2 outdoor air changes
· decontamination room-6 total and 2 outdoor air changes
IV.c.3. The ACH in an unrestricted area are related to the function performed in that area:
· postanesthesia care unit-6 total and 2 outdoor air changes
· procedure room-15 total and 3 outdoor air changes
· endoscopy procedure room-6 total and 2 outdoor air changes

The restricted area (the operating rooms) should have a positive pressure relationship to the adjacent areas.
IV.g.2. The pressure relationship of the semi-restricted area to the adjacent area should be based on the use of the area:
· sterile storage (central sterile department and the room where the sterile instruments and supplies are stored) -positive
· decontamination room-negative

In a concurrent interview and document review with the Facility's Manager (FM) on 12/7/16 at 1:20 pm, the FM was asked if he monitors the air exchanges and the negative and positive pressures in the surgical department. The FM stated that every three months he monitors this information. The FM produced reports titled, "Air Exchanges in Hospital," dated 5/11/26, 8/10/16, and 11/8/16. The three reports indicated that the operating room and the procedure room were monitored for negative and positive pressures and the number of air exchanges.

The FM was asked if he monitored the sub-sterile room,the decontamination room, or the central services room. The FM stated that he did not.

17. According to AORN Guidelines for Perioperative Practice (2016), the Guideline for the Environment of Care, Recommendation IV, it recommended that the health care organization should create and implement a systematic process for monitoring HVAC performance parameters and a mechanism for resolving variances. Heating, ventilation, and air conditioning systems control room air quality, temperature, humidity, and air pressure of the room in comparison to the surrounding areas. The HVAC system is intended to reduce the amount of environmental contaminates (e.g., microbial-laden skin cells, dust, lint) in the surgical suite. The minimum air changes per hour (ACH) for the operating room was 20.

A document provided by the Facility Manager titled, Operating Rooms, was reviewed. The document contained parameters for the minimum total of Air Changes per Hour (ACH, Air changes per hour is a measure of how many times the air within a defined space is replaced). For the operating rooms, the minimum ACH was 20.

On 12/7/16 at 1:20 pm, the Facility Manager (FM) was interviewed. The FM stated that he monitors the air exchanges every three months.
The FM stated that he was unable to increase the number of air changes with their existing system.
The FM provided a report titled, Air Exchanges in the Hospital for 5/11/16, 8/10/16, and 11/8/16. For the Operating Room, the ACH was as follows:
5/11/16 9.63 exchanges,
8/10/16 9.97 exchanges
11/816 10.8 exchanges
For the Procedure room the ACH was as follows:
5/11/16 8.35 exchanges,
8/10/16 8.15 exchanges
11/816 8.15 exchanges

18. The Centers for Disease Control and Prevention (CDC) is a federal agency that conducts and supports health promotion, prevention and preparedness activities in the United States with the goal of improving overall public health. An article published by the CDC titled, Infection Prevention During Blood Glucose Monitoring and Insulin Administration, dated 2/6/2013, was reviewed. According to the article, the CDC has become increasingly concerned about the risks for transmitting hepatitis B virus and other infectious diseases during assisted blood glucose monitoring and insulin administration. Whenever possible, blood glucose monitors should not be shared.

On 12/5/16 at 11:30 am, Registered Nurse (RN) 2 working in the recovery room was interviewed. RN 2 was asked to see the glucometer that was used for the patients.

In addition, the owner's manual for the glucometer was reviewed. On page one, the manufacturer indicated, "This system is intended to be used by a single person and should not be shared."

During an interview with the OR S on 12/5/16 at 3 pm, the OR S stated that he was in charge of the recovery room. The OR S was asked if he was aware that the recovery room nurses were using a glucometer that was meant for personal use. The OR S stated that he was not aware until today.

19. On 12/6/16 at 10:55 am, the ST was observed in the clean-up room, cleaning a flexible endoscope that had just been used on a surgical procedure. After the ST had manually checked the scope for any leaks, The ST placed the scope in the sink to soak. The ST removed her gloves and put on a new pair. No hand hygiene was performed.

On 12/7/16 at 11:30 am, during an interview with the ST, the ST was asked why she did not perform hand hygiene after she removed her gloves. The ST stated that there wasn't anything to clean her hands with that was available in the room.

A facility policy and procedure titled, Hand Hygiene with a reviewed date of 4/14/16, was reviewed. The purpose of the policy was to provide guidelines to employees for proper and appropriate hand hygiene that will aid in the prevention or transmission of healthcare acquired infections. In part, the policy listed circumstances when hand hygiene should be performed. "Sanitize hands after removing gloves" was listed in their policy.

Based on interview and record review, the hospital failed to ensure that the care was adequately evaluated to ensure the hospital's actual practice reflected their policies and procedures, as well as the law, regulation or standard of practice, as evidenced by:

1. Failure to identify widespread problems in the storage and processing of flexible endoscopes (used to view the inside of the gastrointestinal tract). Refer to C 330, findings 4-9, 12, 15, and 19; and C 337.

2. Failure to identify non-compliance with national standards for the cleaning, processing, and storage of sterile instruments. Refer to C 320, findings 1-3, 10-11, 13-14, and 16-18; and C 337.

3. Failure to identify lack of personal protective equipment (PPE) in the operating room. Refer to C 320, findings 4, 15, and 19; and C 337.

4. Failure to have a robust quality assessment program to identify deficient practices. Refer to C 337.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Quality Review and Periodic Evaluation.

Based on interview and record review, the hospital failed to ensure that all patient care services affecting the health and safety of patients were evaluated.

This failure had the potential for problems to persist and compromise patient care outcomes.

Findings:

On 12/8/16, the quality plan and program was reviewed. On 12/8/16 at 1:20 pm, the Quality Coordinator was asked about performance indicators for the following deficient practices and she acknowledged that they were not reported into the program:

- Compliance with national standards of practice related to the storage, processing, and record keeping for flexible endoscopes (used to visual the the inside of the gastrointestinal tract);
- Compliance with national standards for the storage and processing of sterile equipment;
- Compliance with the use of personal protective equipment in the OR
- Compliance with national standards for operating room (OR) attire;
- Accuracy of the Emergency Department log;
- Adequacy of care planning;
- Compliance with prevention measures for patients at risk of skin integrity problems;
- Preventative maintenance completion;
- Records of problems identified on safety rounds; and
- Completion of physician orders.

In an interview on 10/19/16 at 9 am, QIRM acknowledged the QAPI program would have to be more robust to ensure compliance with the Medicare Conditions of Participation and State licensing requirements.

Based on interview and record review, the hospital failed to ensure that the emergency department (ED) log was accurate for the disposition and discharge date of two of nine sampled ED patients. (Patients 3 and 8).

This failure had the potential for miscommunication that could adversely affect patient care.

Findings:

On 12/6/16, the ED log for 11/13 to 12/4/16 was reviewed. Two of the nine patients had incorrect dispositions identified after patient record review was conducted on 12/6/16.

a. Patient 3 was admitted to the hospital from the ED on 11/4/16 but the ED log listed the disposition as "Left Against Medical Advice (AMA) on 11/7/16." Patient 3's record indicated Patient 3 left the hospital AMA on 11/7/16.

b. Patient 8 was admitted to the hospital from the ED on 11/14/16 but the ED log listed the disposition as "Expired on 11/17/16." Patient 8's record indicated Patient 8 expired in the hospital on 11/17/16.

On 11/7/16 at 3:30 pm, Administrative Nurse E explained that the ED log comes from the electronic record and that they need to work with their software company to fix the codes for the ED disposition and ED disposition date to be different from the hospital on the ED log.

On 12/8/16 at 2:20 pm, Administrative Staff B stated the hospital did not have a policy for the the completion of the ED log.