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Based on observations, interviews and record reviews the Hospital failed to meet the requirements of the Condition of Participation in Infection Control as evidenced by:

1) failing to ensure that the designated Infection Control Officer was qualified through experience, ongoing education and/or training to develop and implement an effective Infection Control Program. (see A-0748)
2) the Infection Control program failed to identify, prevent, and control infection control issues and/or breaches by failing to implement an effective infection control risk assessment consistent with acceptable professional standards governing surgical services and acceptable infection control standards of practice in order to identify potential infection control issues/breaches and/or to mitigate risks associated with potential infection control risks. (see A-0749)
3) the Hospital leadership failed to take steps to assure that corrective actions were implemented to ensure an effective Infection Control Program was in place. (see A-0756)



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Based on record reviews and interviews, the Hospital failed to ensure that the designated Infection Control Officer was qualified through experience, ongoing education and/or training to develop and implement an effective Infection Control Program.
Findings:
A review of the Infection Control Officer's employee file (SF9RN/IC), as provided by SF1CEO as the most current, revealed that SF9RN/IC was the designated Infection Control Officer and further revealed that SF9RN/IC was a prior emergency room nurse. SF9RN/IC's infection control training/experience and/or qualifications, as noted in her employee file, included in part: 5 (five) CEUs (continuing educational units) for 2015 to include: 1 (one) CEU in Construction and Renovation Projects, 1 (one) CEU in Skin Antiseptic Sterility, 1 (one) CEU in PPE (personnel protective equipment), 1 (one) CEU in NHSN (National Healthcare Safety Network) Update, and 1 (one) CEU in Challenges of Disinfecting Porous and Nonporous Surfaces. A further review of SF9RN/IC employee file revealed no further documented evidence of any infection control training since the recertification survey was conducted in December 2015. There was no documentation to indicate that SF9RN/IC had received ongoing education or training specific to the implementation of a hospital wide infection control program.
In an interview on 01/27/16 at 9:30 a.m. with SF9RN/IC she indicated that she has had no further infection control training since the recertification survey in December 2015.
In an interview on 01/28/16 at 4:00 p.m. with SF1CEO and SF2CNO they indicated that SF9RN/IC has had no further training in infection control since the recertification survey was conducted in December 2015. SF1CEO and SF2CNO indicated that they were waiting until SF9RN/IC had attended an Infection Control Seminar in April 2016.


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Based on record reviews, observations and interviews, the Hospital's Infection Control program failed to identify, prevent, and control infection control issues and/or breaches by failing to implement an effective infection control risk assessment consistent with acceptable professional standards governing surgical services and acceptable infection control standards of practice in order to identify potential infection control issues/breaches and/or to mitigate risks associated with potential infection control risks.
Findings:
The AORN (Association of periOperative Registered Nurses) Guidelines for Perioperative Practice, 2015 edition - Guideline for Surgical Attire:

Recommendation I revealed in part: All individuals entering the restricted surgical area should wear a surgical mask when scrubbed personnel, sterile supplies and/or sterile equipment are present. A surgical mask protects the patient from transfer of microorganisms. The mask should cover the mouth and nose and be secured in a manner to prevent venting. A mask that is securely tied at the back of the head and behind the neck decreases the risk of staff transmitting nasopharyngeal and respiratory microorganisms to patients. Surgical masks are intended to contain and filter droplets from the nasopharynx. The filter portion of the surgical mask harbors bacteria collected from the nasopharyngeal airway. Surgical masks should be tied securely and discarded after each procedure or when soiled and should not be worn hanging from the neck. Recommendation I further revealed in part: When in the semi-restricted or restricted surgical areas all personal clothing should be completely covered by the surgical attire. Undergarments such as T-shirts with a V-neck, and shirts with sleeves which can be contained underneath the scrub top, may be worn; personal clothing that extends above the scrub top neckline or below the sleeve of the surgical attire should not be worn. Personnel clothing is not laundered by a health care-accredited laundry facility.

Recommendation IX revealed in part: Restricted areas in a surgical suite includes the O.R. (operating room) and procedure rooms, the clean core and the scrub sink areas. People in the restricted areas are required to wear full surgical attire (scrub attire, head coverings, masks, and shoe covers as applicable). The Semi-Restricted areas include the peripheral support areas of the surgical suite, the storage areas, the work areas, and corridors leading to the restricted areas of the surgical suite.

A review of the AORN Guidelines for Perioperative Practice, 2015 edition- Guideline for Packaging Systems:
Recommendation III revealed in part: Sterilized items should be considered sterile until an event occurs to compromise the sterility of the sterile item such as, moisture penetration or unacceptable storage conditions, exposure to airborne or other environmental contaminants and properties of the packaging material.
Recommendation VII revealed in part: Paper-plastic pouch packages should be used according to manufacturer ' s written instructions. Paper-plastic pouch packages should be used only for small, lightweight, low-profile items. Double paper-plastic pouch packaging may be used to facilitate containment of multiple small items to be sterilized. Double paper-plastic pouch packages should be used in such a manner to avoid folding the inner package to fit into the outer package. Folding the edges of the inner peel packages may entrap air and inhibit the sterilization process.

A review of AORN Guidelines for Perioperative Practice, 2015 edition - Guideline for High-Level Disinfectant, Recommendation IV revealed in part: High-Level Disinfectant (HLD) should occur at appropriate temperatures, contact time, and length of use. Improper use of HLD can cause contamination and lead to outbreaks.

A review of AORN Guidelines for Perioperative Practice, 2015 edition- Guideline for Sterilization:
Recommendation III revealed in part: A controlled environment is intended to facilitate effective decontamination, assembly, sterilization and storage and to minimize environmental contamination and maintain sterility of sterilized items. Functional workflow patterns should be established to create and maintain physical separation between the decontamination and sterilization areas. Room temperature, humidity and ventilation must be controlled and monitored in accordance with regulation. Controlled conditions reduce the risk of contamination. Functional workflow patterns should be established in the following order: from potentially high contamination areas to clean areas to prevent recontamination. Recommendation III further revealed in part: Items to be sterilized should be cleaned, decontaminated, inspected, sterilized, and stored in a controlled environment. Room temperature, humidity and ventilation must be controlled and monitored. The decontamination area should have a negative airflow with a minimum number of at least 6 air exchanges (FGI- Facilities Guideline Institute) per hour and a temperature of 60 - 65 degrees F (Fahrenheit) and humidity between 20% - 60%. The preparation/packaging area and the sterilizer loading/unloading area should have a positive airflow with a minimum number of 10 air exchanges and a temperature of 68 - 73 degrees F (Fahrenheit) and humidity between 20% - 60%.
Recommendation VII revealed in part: Rigid sterilization containers designed and intended for IUSS (Immediate Use Steam Sterilization) should be used. Rigid IUSS containers protect items so as to reduce the risk of contamination during transport of items to the point of use and facilitates ease of presentation to the sterile field to prevent contamination.

Observations including record reviews and interviews revealed the following infection control breaches:
Observations on 01/26/16 from 2:00 p.m. to 4:00 p.m. with accompanying record reviews and interviews:
An observation of three sets of double scrub sink located in the semi-restricted surgical suite area with visibly dirty floor mats (6 feet by 4 feet) in front of them.
In an interview on 01/26/16 at 2:30 p.m. with SF7ORCood she indicated that the scrubs sinks were located in a semi-restricted area and that SF10Tech mopped the floor mats at the end of the day. SF7ORCood indicated that a contract service picked up the mats and cleaned them once a week.
An observation of three out of five surgical cautery units in the O.R.s (operating rooms) with visible pitting and peeling finishes and rust noted on the cautery cart and on the wheel casings.
In an interview on 01/26/16 at 2:40 p.m. with SF7ORCood she indicated that the O.R. had five cautery units and three of them had peeling finishes with rust spots. She further indicated that the O.R. staff disinfected them as best they could between patient ' s surgical procedures.
An observation of SF6CRNA with the surgical mask tied incorrectly in the O.R. (the bottom string was secured on the top of head and the top string was secured around neck) causing venting of the mask.
An observation of SF6CRNA picking up the anesthesia cables cords and wires from off the O.R. floor, after a surgical procedure, and placing them on the anesthesia cart on top of the clean anesthesia circuits on the anesthesia machine (neither the anesthesia cable cords/wires or the O.R. floor had been disinfected yet).
In an interview on 01/26/16 at 2:50 p.m. with SF7ORCood she indicated that all the CRNAs were in-serviced on the proper use of O.R. attire and disinfectant protocols.
An observation of a sign on the Decontamination Room door in the O.R. which read in part: Medical Representatives and outside personnel are required to wash (decontaminate) their own instruments.
In an interview on 01/26/16 at 3:00 p.m. with SF11Central she indicated that she was responsible for the O.R. Decontamination room. She was asked about the signage on the Decontamination room door. SF11Central indicated that medical representatives blamed surgery staff when their instruments were lost or broken, so she required the medical representatives to decontaminate their own instruments. SF11Central was asked if the medical representatives had documented evidence of instrument decontamination competency. She indicated that the medical representatives had no documented evidence of instrument decontamination competency with the hospital.
An observation of several heavy sterile surgical instruments, in the Sterile Central Supply room, packed in peel packages where the seal on the peeled packages was being sterilized; was compromised due the weight of the surgical instruments.
An observation of several sterile surgical instruments, in the Sterile Central Supply room, packed in double peel packages where the inner peel pack was folded.
An observation of several sterile surgical instruments, in the Sterile Central Supply room, packed in peel packages where the peel package was yellowed and with areas on the package seals that were no longer sealed.
An observation of multiple sterile packaged items, in the Sterile Central Supply room, that were not labeled with an appropriate autoclave label indicating the autoclave number used, the load number, the initials of the staff who processed the item and the date when the item(s) were autoclaved).
In an interview on 01/26/16 at 3:15 p.m. with SF11Central she indicated that she was responsible for the O.R. Sterile Central Supply room. She was asked about the peel packaged items. SF11Central indicated that the surveyor ' s observations did reveal sterile items (available for patient ' s surgical procedures) that were compromised. She further indicated that all the sterile packages should have labels (stickers) on them, with the appropriate labeling and that the stickers probably just fell off.
An observation of large plastic hampers, used by staff to place sterile surgical equipment and supplies for patient ' s surgical procedures, being stored on the floor in the Sterile Central Supply room.
In an interview on 01/26/16 at 3:30 p.m. with SF7ORCood she indicated that the staff used the plastic hampers to place sterile surgical supplies and instruments for patient ' s surgical procedures for the following day ' s surgery cases and that the hampers probably should not be stored on the floor.
Observations on 01/27/16 from 12:30 p.m. to 4:00 p.m.
An observation of SF12MD with his surgical mask hanging around his neck and an exposed t-shirt under his surgical attire.
An observation of metal sterilizer containers (2 small and 2 medium) being used as IUSS sterilizing pans that were not labeled as approved for use in IUSS.
In an interview on 01/27/16 at 3:30 p.m. with SF7ORCood and SF11Central they indicated that the metal pans were used in the IUSS of instruments. SF7ORCood further indicated that she was not aware that instrument sterilizer containers used for IUSS had to be specific and approved for IUSS use.
Observations on 01/28/16 from 10:30 a.m. to 2:30 p.m.
An observation of the Endoscopy suite ' s decontamination room (approximately 5 feet wide and 9 feet long), containing a dirty and a clean area, not physically separated, with a workflow pattern that went from dirty to clean to dirty and with 1 (one) door used for both entering and exiting. The door was directly across from the dirty sink area. The endoscopy's HLD (high level disinfectant) re-processor was located inside the room toward the back wall.
A review of the HLD log for the endoscopic re-processor revealed that the temperature monitoring section had a section labeled " temperature approximately 35 degrees C (centigrade) " .
A review of the MFU (manufacturer ' s instruction for use) for the HLD solution used in the endoscopic re-processor indicated the temperature should be 35 degrees C. A review of the hospital policy on HLD indicated that the hospital would follow the MFU.
In an interview on 01/28/16 at 10:30 a.m. with SF13ST, SF14ST and SF9RN/IC they indicated that they mostly worked the endoscopy suite area. SF13ST and SF14ST indicated that they were responsible for decontaminating the endoscopes after use and then processing (HLD) them for the next endoscopic procedure. They indicated that they exited the room with an endoscope (uncovered) after it had been HLD and they had to pass in front of the decontamination sink. SF13ST and SF14ST indicated that they monitored the temperature of the HLD solution daily and checked off that it was approximately 35 degrees C as per the monitoring sheet. They further indicated that the temperature could be greater than or less than 35 degrees C, as long as it was close to 35 degrees C. SF9RN/IC indicated that she worked in the endoscopy suites and that she had not performed any infection control risk assessment for the endoscopy room.
An observation of SF16ST performing a surgical hand scrub (prior to donning sterile gown and gloves in a surgical procedure) without following the MFU instructions. SF16ST was observed using 3 pumps of the surgical hand scrub and applying it simultaneously on both her hands and forearms.
A review of the MFU on the surgical hand scrub used by the O.R. when performing a surgical hand scrub prior to aseptic gowning and gloving, prior to a patient's surgical procedure revealed in part: Dispense one pump into palm of hand. Dip fingers into the hand prep and work under the nails. Spread the remaining hand prep over the hand and up to just above the elbows covering all surfaces. Using a second pump, repeat for the other hand. Dispense a third pump into either hand and reapply to all aspects of both hands up to the wrist. Allow to dry before donning surgical attire.
An observation of SF4CRNA exiting a surgical procedure with his used surgical mask in his hand and his disposable bouffant cap was not completing covering his home laundered cloth skull cap or his ears. SF4CRNA was later observed with a surgical mask where both strings (top and bottom strings) were tied together around his neck.
An observation of SF15RN/OR in the restricted area with the bottom string of her mask untied and dangling around her neck.
An observation of SF5CRNA carrying his used surgical mask in his hands after he exited the restricted and semi-restricted surgical areas.
An observation of the Cystoscopy O.R., where patient cystoscopy procedures were performed, that included a decontamination area and a HLD area within the same room that were not physically separated.
An observation of the HLD solution pans (x3), used in disinfecting the cystoscopy instruments after use, located on a long metal table in the Cystoscopy O.R. directly across from the cystoscopy table used for patient ' s procedures. The HLD solution pans (x3) were not noted to be located under or near any ventilation vents, thereby exposing staff and patients to excess fumes. The HLD solution pans (x3) were noted to contain HLD solution with a 28 day expiration date label.
A review of the HLD solution log book for the HLD solution used in disinfecting the cystoscopy instruments revealed that staff were not monitoring the temperature of the HLD solution each day or prior to use.
A review of the MFU for the HLD solution, used for the cystoscopy instruments, indicated the temperature should be 20 degrees C or higher prior to use and the HLD solution used should be used in a well ventilated area.
In an interview on 01/28/16 at 2:20 p.m. with SF17RN/OR and SF18ST they indicated that all O.R. staff were trained to work in the Cystoscopy suites and that they worked in the Cystoscopy suite that day. They indicated that the decontamination area and the HLD area had always been located within the Cystoscopy O.R. SF17RN/OR and SF18ST further indicated that they were not aware that the MFU indicated for the HLD solution had to temperature monitored prior to use. SF17RN/OR and SF18ST indicated that the HLD solution could be used up to 28 days before it expired.
In an interview on 01/28/16 at 3:25 p.m. with SF20FM he indicated that he was the Facility Manager. He was asked about the negative/positive air pressure in the decontamination rooms (O.R., endoscopy area, cystoscopy area), He indicated that he was not monitoring negative/positive air pressure in any the decontamination rooms. SF20FM further indicated that he was also not monitoring negative/positive air pressure in the Endoscopy suite or in the Cystoscopy suite and did not know what the air pressure was in those rooms. He further indicated that the room next to the Cystoscopy suite was under renovation and the air pressure in the Cystoscopy suite was probably altered.
In an interview on 01/28/16 at 3:00 p.m. with SF9RN/IC she indicated that she was the Infection Control Officer. SF9RN/IC was asked about the infection control activities since the recertification survey. SF9RN/IC indicated that she revised the Infection Control and Occupational Exposure Checklist to include the infection control issues that were identified during the recertification survey in December 2015. She further indicated that she had not begun utilizing the revised Infection Control and Occupational Exposure Checklist. SF9RN/IC indicated that her present infection control activities consisted of monitoring the infection control breaches identified during the last survey and that she had not conducted any infection control risk assessments. SF9RN/IC was made aware of the infection control breaches and the identified infection control risks identified by the surveyor during the follow up survey. SF9RN/IC indicated that she had not identified any of the infection control breaches or risks that were identified by the surveyor during the follow up survey.
In an interview on 01/28/16 at 4:00 p.m. with SF1CEO and SF2CNO they were made aware of the infection control breaches and the identified infection control risks identified by the surveyor during the follow up survey. SF1CEO and SF2CNO indicated that SF9RN/IC has had no further training in infection control since the recertification survey was conducted in December 2015. They further indicated that they were waiting until SF9RN/IC had attended an Infection Control Seminar in April 2016.


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Based on record reviews, observations and interviews, the Hospital leadership failed to take steps to assure that corrective actions were implemented to ensure an effective Infection Control Program was in place.
Findings:
A review of the Infection Control Officer's employee file (SF9RN/IC), as provided by SF1CEO as the most current, revealed that SF9RN/IC was the designated Infection Control Officer. A further review of SF9RN/IC employee file revealed no documented evidence of any infection control training since the recertification survey was conducted in December 2015.
In an interview on 01/28/16 at 3:00 p.m. with SF9RN/IC she indicated that she has had no further infection control training since the recertification survey in December 2015. SF9RN/IC indicated that her infection control activities following the recertification survey in December 2015 consisted mostly of monitoring the infection control breaches identified during the recertification survey and revising the Infection Control and Occupational Exposure Checklist with the help of her new assistant, SF19RN. She indicated that the Infection Control and Occupational Exposure Checklist was revised to include the infection control issues that were identified during the recertification survey in December 2015. She further indicated that she had not begun utilizing the revised Infection Control and Occupational Exposure Checklist and that no infection control risk assessments had been performed since the recertification survey. SF9RN/IC was made aware of the infection control breaches and potential infection control risks observed and identified by the surveyor during the follow up survey. SF9RN/IC indicated that she had not identified any of the infection control breaches or risks that were observed and identified by the surveyor during the follow up survey.
In an interview on 01/28/16 at 4:00 p.m. with SF1CEO and SF2CNO they indicated that SF9RN/IC has had no further training in infection control since the recertification survey was conducted in December 2015. They indicated that another nurse had been assigned to assist SF9RN/IC in infection control, SF19RN, and indicated that SF19RN did not have any prior infection control experience. SF1CEO and SF2CNO further indicated that no other infection control risk assessments had been performed since the recertification survey by the Infection Control department. SF1CEO and SF2CNO indicated that they were waiting until SF9RN/IC had attended an Infection Control Seminar in April 2016.



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