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Based on observation, record review, and interview, the CAH (Critical Access Hospital) failed to ensure the hospital's Surgical Services department followed acceptable infection control practices governing surgical services as evidenced by:
1) failing to ensure that in the designated surgical suites, the Surgical Services department failed to provide surgical attire for staff and physicians that was laundered in a health care-accredited laundry facility either on-site or through a contracted service,
2) failing to ensure Surgical Services had a policy in place to determine the frequency and extent for the terminal cleaning for unused rooms on rooms not used on non-surgery days and on weekends in the semi-restricted and restricted areas,
3) failing to ensure that the Surgical Services' staff followed the manufacturer's IFU (instructions for use) for the BIs (biological indicators) used to determine sterilization efficacy as evidenced by no documented BI read time when the BIs were run,
4) failing to ensure that Surgical Services' staff followed the manufacturer's IFU for the enzymatic solutions, used in the decontamination of instruments and endoscopes prior to reprocessing, for temperature monitoring and immersion times and failing to document the temperature of the solution and immersion times for each use and,
5) failing to ensure that Surgical Services' staff processed/sterilized surgical supplies according to professional standards for the processing and sterilization of surgical items in paper-plastic peel pouches as evidenced of processed pouches that were not light weight or low profile.

Findings:

1) failing to ensure that in the designated surgical suites, the Surgical Services department failed to provide surgical attire for staff and physicians that was laundered in a health care-accredited laundry facility either on-site or through a contracted service,

An observation on 03/04/19 of the Surgical Services staff revealed that Staff B, C, and D were wearing home laundered scrubs. Staff B and D were not wearing long sleeve cover jackets and Staff C was not wearing the cover jacket completely snapped.

A review of the AORN (Association of periOperative Registered Nurses) Guidelines for Perioperative Practice, 2018 edition - Guideline for Surgical Attire - Recommendation I revealed in part: When in the semi-restricted or restricted surgical areas, all non-scrubbed personnel should wear a freshly laundered or single use long sleeved cover top or jacket snapped closed with the cuffs down to the wrists. Wearing the long-sleeved jacket snapped closed prevents the edges of the front of the jacket from contaminating a skin prep area or the surgical sterile field. Long sleeved attire helps contain skin squames shed from bare arms. All personal clothing, not laundered by a health care-accredited laundry facility, 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 or should be laundered in a health-care-accredited laundry facility after each daily use. Recommendation II revealed in part: Only facility-approved, clean and freshly laundered surgical attire should be donned daily by all personnel entering the semi-restricted and restricted surgical areas to decrease the possibility of cross-contamination. Surgical attire should be laundered in a health care-accredited laundry facility either on-site or through a contracted service which incorporate OSHA (Occupational Safety and Health Administration) and CDC (Centers for Disease Control and Prevention) guidelines and professional association's recommended practices that follow industry standards through the HLAC (Healthcare Laundry Accreditation Council). Home laundering cannot be monitored for quality, consistency or safety, and laundering may not meet the specified measures necessary to achieve a reduction in microbial levels in soiled surgical attire with measures that involve mechanical, thermal, and chemical components.

In an interview on 03/04/19 at 12:10 p.m. with Staff B and C, Staff B indicated that the CAH has a contract laundry service, but it was not utilized for their surgical scrubs. Staff C indicated that they bring their surgical scrubs home to launder.


2) failing to ensure Surgical Services had a policy in place to determine the frequency and extent for the terminal cleaning for unused rooms on rooms not used on non-surgery days and on weekends in the semi-restricted and restricted areas,

A review of the CAH policy titled, "Environmental Sanitation", as provided by administration as a current policy, revealed no documentation of terminal cleaning of the surgical suites at the end of each day for used rooms and there was no documentation of the terminal cleaning frequency schedule for the unused rooms.

In an interview on 03/04/19 at 2:15 p.m. with Staff B, he was asked about the terminal cleaning schedule for the used and unused surgical suites. He indicated that used rooms were terminally cleaned at the end of the surgery schedule for that day either by housekeeping or staff. Staff B indicated that the surgical suites are only used 2-3 days each month. He indicated that he was not sure of the terminal cleaning frequency of the unused rooms on non-surgery days since that was a hospital housekeeping task.

In an interview on 03/05/19 at 9:15 a.m. with Staff E, housekeeping manager, he indicated that housekeeping was responsible for the terminal cleaning of the Surgical Services area. He indicated that the used surgical suites were terminally cleaned only at the end of any scheduled surgery day and not every day of unuse. Staff E indicated that the surgical suites were only used 2-3 times a week and terminal cleaning was only performed on the those surgery days each month. He indicated that the CAH did not have a policy or a schedule in place for the terminal cleaning frequency when the surgical suites were unused for long periods of time or on non-surgery days.

A review of the AORN Guidelines for Perioperative Practice, 2018 edition - Guideline for Environmental Cleaning: Recommendation IV revealed in part: Terminal cleaning and disinfecting of perioperative areas, including sterile processing areas, should be performed daily when areas are used. Terminal cleaning and disinfection of the perioperative environment decreases the number of pathogens, dust, and debris that is created during the day. Terminal cleaning and disinfection of operating and invasive rooms should be done when the scheduled procedures are completed for the day. For terminal cleaning in semi-restricted and restricted areas, a multidisciplinary team should determine the frequency and extent of cleaning required for unused rooms and on weekends. Terminal cleaning of operating rooms and procedure rooms should include cleaning and disinfecting of all exposed surfaces (including wheels and casters) and includes: anesthesia carts, equipment and machines; monitors; OR bed and attachments; reusable table straps; positioning and transfer devices; overhead lights; mobile and fixed equipment; storage cabinets; light switches, telephones and door handles; computer and accessories; chairs and stools; trash and linen receptacles. The floor should be wet with the disinfectant for the dwell time indicated on the manufacturer's directions for use and cleaning should progress from the cleanest to dirtiest areas of the floor. All floors in the perioperative and sterile processing areas should be disinfected.


3) failing to ensure that the Surgical Services' staff followed the manufacturer's IFU (instructions for use) for the BIs (biological indicators) used to determine sterilization efficacy as evidenced by no documented BI read time when the BIs were run,

A review of the manufacturer IFU for the use of the (BI) biological indicator used by the Surgical Services department and provided by Staff D, revealed in part: Activate the processed BI after processing in the autoclave and incubate for 3 (three) hours. Record results after full incubation. Any positive results should be reported immediately and the sterilizer taken out of service until resolved. Each sterilizer to be used shall have appropriate testing performed and documented. Remove "processed" BI (biological indicator) and place in incubator along with the "control" BI. Complete the BI Log. "Read" results in 3 (three) hours and document.

In an interview on 03/04/19 at 2:40 p.m. with Staff D she indicated that she performed the BI tests weekly. Staff D was asked about the documentation of the "read" time after the incubation period. She indicated that she was checking the BI results after 3 hours, but she was not documenting this time on a BI log sheet to indicate the "read" time was 3 hours. Staff D indicated that she had no BI log with the documented "read' time to present.

A review of AORN Guidelines for Perioperative Practice, 2018 edition - Guideline for Sterilization: Recommendation VI revealed in part: A quality monitoring program that includes physical monitors (printouts, digital readings, graphs and gauges), chemical indicators, and biological indicators should be used to verify that conditions necessary for steam sterilization have been met. Attention to sterility monitoring to ensure compliance with recommended guidelines is a critical component of quality assurance. Deviation from recommended practices and recommendations can compromise the quality of sterilization processes. Each sterilization cycle should be monitored to verify that parameters required for sterilization have been met. Biological indicators should be used to monitor sterilizer efficacy and should be performed at least weekly and preferably daily. Recommendation XVIII revealed in part: Accurate and complete records are required for process verification and sterilizer function. Documentation demonstrates compliance with regulations and identifies trends and quality improvement opportunities.



4) failing to ensure that Surgical Services' staff followed the manufacturer's IFU for the enzymatic solutions, used in the decontamination of instruments and endoscopes prior to reprocessing, for temperature monitoring and immersion times and failing to document the temperature of the solution and immersion times for each use

An observation on 03/04/19 of the Surgical Services decontamination areas revealed no instrument/endoscope enzymatic solution log, documenting the length of time the instrument/endoscope was immersed or the temperature of the enzymatic solution prior to the decontamination process.

A review of the manufacturer's IFU on the enzymatic solution used in the decontamination of instruments and endoscopes in the Surgical Services department revealed in part: The instrument/endoscope should be immersed in the enzymatic solution for at least 1-5 minutes with an optimal water temperature of 90-120 degrees Fahrenheit.
In an interview on 03/04/19 at 12:35 p.m. with Staff D, she indicated that she does not document the length of time the instruments or endoscope are immersed nor does she document the temperature of the enzymatic solution prior to the decontamination process. Staff D was unable to verify that the enzymatic solution manufacturer's IFU was followed during the decontamination process of instruments and endoscopes.

The AORN Guidelines for Perioperative Practice, 2018 edition - Guideline for Sterilization. Recommendation IX revealed in part: Surgical instruments and equipment should be cleaned and decontaminated according to the manufacturer's validated, written IFU. Items cannot be assumed to be clean, decontaminated, or sterile unless the manufacturer's IFU are derived from validation testing and the user has followed those instructions. Instructions for use provide users with validated techniques for processing instruments. Cleaning of instruments (i.e., removal of organic and inorganic soil) is the first step in decontamination and can be accomplished through manual or mechanical processes. The instrument and cleaning solution manufacturers have determined the manual or mechanical steps and processes necessary to effectively clean a device. Cleaning solutions should be changed before they become heavily soiled, when the temperature of the solution does not meet the temperature specified in the manufacturer's written IFU, and as needed. Recommendation XIV revealed I part: Documentation of instrument cleaning and disinfection processes should be maintained. Documentation provides data for the identification of trends and demonstration of compliance with regulatory requirements and accreditation agency standards. Effective management and collection of health care information that accurately reflects the patient's care, treatment, and services is a regulatory requirement and accreditation agency standard for both hospitals and ambulatory settings.


5) failing to ensure that Surgical Services' staff processed/sterilized surgical supplies according to professional standards for the processing and sterilization of surgical items in paper-plastic peel pouches as evidenced of processed pouches that were not light weight or low profile.


An observation on 03/04/19 of the Sterile Supply Room, in the presence of Staff B and D revealed several paper-plastic peel pouches containing sterile instruments and supplies that were not low profile or light weight where the sterility of the sterile package and the seal may be compromised by the weight and/or bulkiness of the instruments within the paper-plastic peel pouches.

In an interview on 03/04/19 at 2:30 p.m. with Staff D she indicated that she was mostly responsible for the Sterile Supply Room. She indicated that she was not aware that only low profile and light weight items could only be processed in paper-plastic peel pouches.

A review of the AORN Guidelines for Perioperative Practice, 2018 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 (i.e., properties of the packaging material). The sterility of sterile items is event related and not time related. 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; so the seals are not compromised by the weight and/or bulkiness of the instruments.


In an interview on 03/05/19 at 12:30 p.m., the above Surgical Services breaches were discussed with Staff B. He indicated that the Surgical Services policies reference AORN Guidelines and that Surgical Services followed AORN Guidelines.

Based on record review and interview the CAH failed to ensure that a properly executed Informed Consent was obtained for 1 of 1 (Patient #7) patient medical record reviewed for Informed Consents out of a sample of 20 medical records.

Findings:

A review of the CAH policy titled, "Informed Consent", provided by administration as a current policy, revealed in part: To establish guidelines for Informed Consent and to acknowledge the patient's right to information pertinent to the consent or refusal of treatment. Consents Obtained by Telephone or Fax: 3. The information communicated from the physician is the same by phone as would be otherwise communicated to the patient to make an informed decision. 4. A third person (nurse or another physician) shall listen to the conversation and serve as a witness.

A review of Patient #7 informed consent for a PICC (Peripherally Inserted Central Catheter) placement dated 03/04/19 revealed the informed consent was a telephone consent with the patient's POA (Power of Attorney) and was conducted and witnessed by 2 nurses, Staff G and H. The consent further revealed that the procedure/alternatives, and the risks to the person/persons was explained to whose signature is affixed above. The only signatures affixed above was the POA and the 2 nurses. There was no physician signature noted on the informed consent.

In an interview on 03/05/19 at 11:50 a.m. with Staff G and H (nurses) they indicated that they obtained the informed consent for Patient #7 PICC placement by phone from the patient's POA, and that the physician was not involved in the phone consent.

A review of Patient #7 medical record on 03/06/19 at 10:00 a.m. with Staff F, nurse manager, revealed no physician documentation that the procedure/alternatives, and the risks to the person/persons was explained to the patient or his POA prior to the 2 nurses obtaining the Informed Consent.

Based on record review and interview the CAH failed to ensure that the OPO (Organ Procurement Organization) was notified within 1 (one) hour after a patient expired for 1 (Patient #13) of 2 (Patient #13, 14) patient medical records reviewed for death notification to the OPO.

Findings:

A review of the CAH policy titled, "Care of Expired Patient", as provided by administration as a current policy, revealed in part: All deaths will need to be called in to the OPO within 1 (one) hour of death. Document the OPO referral number in the chart.

A review of Patient #13 medical record on 03/05/19 at 3:25 p.m. with Staff A revealed no documentation that staff notified the OPO of Patient #13 death.

In an interview at 03/05/19 at 3:25 p.m. with Staff A she indicated that she (Staff A) made a notation in her death log that Staff J failed to notify the OPO of Patient #13 death because Staff J indicated that Patient #13 was on Hospice and she (Staff J) did not think OPO had to be notified of a hospice patient's death.