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Based on record review, observation and interview the facility failed to meet the Condition of Participation by not maintaining machines used to clean surgical instruments according to the manufacturer's recommendations and instructions for use, The facility failed to ensure the sterility of surgical instruments. The facility failed to establish policies and procedures for expiration dates for sterile surgical instruments and sterile instrument trays; and failed to maintain a complete and accurate operating room register.
These deficient practices could lead to surgical complications, infections, delays in treatment, or death for all patients receiving surgical services at this facility.

The findings are:

Refer to Tag A-0951 and A-0958.

Based on observation, record review and interview, the facility failed to ensure that the Washer, Decontamination System (a medical machine using sterile and purified water, detergents, steam and heat to clean and disinfect (but not sterilize) dirty contaminated surgical instruments), or washer/disinfector, used for washing and disinfecting (clean by destroying bacteria, viruses and fungi that may cause infections) surgical instruments and tools were maintained according to the manufacturer's Instructions For Use (IFU); the facility failed to ensure that the sterilized (make free of bacteria and other microorganisms) instruments were packaged, handled, and stored in a manner to ensure sterility; and failed to institute policies and procedures establishing expiration dates for sterilized instruments. These deficient practices are likely to lead to surgical site infections, injury or death for all patients undergoing surgical procedures at this facility.

The findings are:

A. Record review of a facility provided document listing Sterile Processing Department (SPD) equipment revealed that the facility maintains the following washer/disinfectors (a medical machine using sterile and purified water, detergents, steam and heat to clean and disinfect (but not sterilize) dirty contaminated surgical instruments):

1. AMSCO 5052 Washer, Decontamination System Serial Number 3618814006, located on the 1st Floor, SPD
2. AMSCO 5052 Washer, Decontamination System Serial Number 3613721006, located on the 1st Floor, SPD
3. AMSCO 5052 Washer, Decontamination System Serial Number 3610921007, located on the 6th Floor, SPD
4. AMSCO 5052 Washer, Decontamination System Serial Number 3610921006, located on the 6th Floor, SPD

B. Record review of the facility's policy "OR/PACU [Operating Room-a room where surgeries are performed/Post-Anesthesia Care Unit-an area where patients are taken to recover immediately after a surgical procedure]-Cleaning and Care of Surgical Instruments and Powered Equipment" "Effective Date: 04/04/2018", stated: "h) (i) Automated washer decontaminators or disinfectors and washer sterilizers should be used according to the manufacturer's written instructions."

C. Record review of IFU (Instructions For Use-which are manufacturer's instructions) for the "Verify All Clean Test, Washer Indicator Test" "For Monitoring Cleaning Processes", revealed an indicator test strip (formulated to mimic typical soiling of instruments during normal use that would include blood and other body fluids, body tissue, and other materials encountered during surgeries), used daily, prior to the first washing and disinfecting of instruments for that day. Per the IFU, the test strip, which is initially 2 squares of pink coloring, must be completely clear to indicate the washer/disinfector has passed the test and is ready for use. According to the test strip IFU, "Inspect (the indicator test strip) by placing the plastic film against a white background .... If the color remains visible, the result is a fail."

D. A review of a random sample of 60 Verify All Clean Test strip results that were performed on the washers/disinfectors prior to use, from November 1, 2023, through March 18, 2024, found 44 of 60 test strips had residual pink coloring that indicated a failed test. The facility had the tests marked as "Passed" and proceeded to use the machines without performing corrective actions.

E. During an interview on 03/20/2024 at 10:00 am, with Staff (S)9 Sterile Processing Technician, S9 was asked to review a test strip with some residual pink coloring. S9 indicated it was a "pass", in other words, the machine was ready for use. S9 was asked to review a test strip with part of a pink grid remaining on the strip. S9 indicated it was a "pass". S9 stated the test is a "pass" if most of the color is gone or faded. S9 provided a copy of a poster from the office that showed pictures of failed and passed test strip results. The poster clearly showed 2 test strips with residual pink coloring as failed results, and a single test strip that is completely clear as the passed result.

F. During an interview on 03/21/2024, at 1:45 pm, with S11 STERIS Product Representative (the washer/disinfectors and test strips are all STERIS products), S11 confirmed that "any pink left on the strip is a fail." S11 confirmed that when any part of the washer/disinfector does not pass the strip test, the facility should stop using the machine, determine and correct the cause of the failure prior to use.

G. During an observation on 03/18/2024, at 1:55 pm, with S5 Emergency Department (ED) Director and S4 Assistant Chief Nursing Officer, of ED Room A1, the following surgical instrument trays and box were found without the outer plastic covering and in an uncontrolled area (an area that is readily accessible by individuals not authorized to use or handle sterile instruments such as patients or visitors). In other words, there was no way to verify that the trays and box of instruments were sterile.

1. Tracheotomy (making an incision in the windpipe to relieve a blockage to breathing) Tray (this is a tray of sterile instruments used to perform tracheotomies) revealed the tray wrapped as a sterile tray in blue paper, no outer plastic covering, found laying on counter in an uncontrolled area.
2. Finochietto Retractor (a type of retractor specifically designed to separate ribs in thoracic surgery) revealed the tray wrapped as a sterile tray in blue paper, no outer plastic cover, found laying on cabinet shelf in an uncontrolled area.
3. Finochietto Retractor (Small) revealed the tray wrapped as a sterile tray in blue paper, no outer plastic cover, found laying on cabinet shelf in an uncontrolled area.
4. Orange Metal Box labeled "Oral Surgery Set" revealed a red tag that slips through the lock on the box and, when engaged, indicates that the box is sealed until tag is broken. This tag was not engaged and is open, the tag is undamaged and slipped through the lock slot, i.e. the box seal is broken. There was no way to verify that the surgical instruments within the box were sterile. The box was found on a cabinet shelf in an uncontrolled area.

H. During an interview on 03/18/2024 at 1:58 pm, with S4, regarding the wrapped sterile trays, when asked if the trays should be sealed in clear plastic covering, S4 stated "Yes ..." Referring to the orange metal box, S4 was asked if the red tag should be "locked", and S4 confirmed it should be locked. When asked if the contents were sterile, S4 indicated "I don't know." S4 confirmed that the ED room was not a controlled area.

I. During an interview on 03/18/2024 at 3:10 pm, with S7 Administrative Director of Surgical Services, S7 confirmed that sterile instrument trays sent to the ED should be sealed in plastic wrapping unless they are going to a sterile controlled area (a locked room, cabinet or drawer that is only accessible by staff authorized to handle and use sterile surgical instruments) S7 confirmed that the orange metal instrument box is not sterile if the tag is not locked and if it is not there or is broken, the item should be reprocessed. When asked if an SPD technician would ever place a red tag on the box without locking it, he confirmed "No".

J. During an observation on 03/19/2024, at 2:55 pm, of the SPD Sub-Sterile Storage Room 6th Floor, a random spot check of shelves of sterilized instrument trays, instrument boxes, and surgical instruments (for example forceps or scissors) in plastic outer coverings found the following:

1. A right-angle forceps (an instrument that looks like large spoons or tongs) with punctured packaging-causing the contents to lose sterility
2. A second right-angle forceps with punctured packaging-causing the contents to lose sterility
3. A third right-angle forceps with cracked and chipped paint on the finger loop
4. A fourth right-angle forceps with a rubber tip protector

K. During an interview on 03/19/2024, at 2:55 pm, with S7 Administrative Director of Surgical Services, S7 confirmed that the forceps with the punctured packaging were not sterile and removed the instruments. When asked if the cracked and chipped paint on the finger loop of the third forceps could be adequately sterilized, S9 Sterile Processing Technician, who was present at the time, stated that they do take these types of instruments out of use due to concerns about sterilization. When asked if the fourth forceps was sterilized with the rubber tip protector on, S7 stated "No" it was probably placed after sterilization by a tech. When asked if the rubber tip protectors are sterilized, S7 confirmed that they are not sterilized because they are rubber. When asked if the rubber tip protectors would contaminate the sterile forceps, S7 stated "No" the rubber protectors are "clean."

L. Record review of the facility's policy "OR/PACU-Cleaning and Care of Surgical Instruments and Powered Equipment" "Effective Date: 04/04/2018", revealed: "(h) (a) surgical instruments should be inspected for cleanliness and proper working order after decontamination ...corrosion, pitting, burrs, nicks and cracks"; (9) (v) Instruments in disrepair should be tagged or labeled and removed from service until repaired."

M. Record review of the Centers for Disease Control and Prevention (CDC) "Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)", content source: Centers for Disease Control and Prevention for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP); revealed that "cleaning" refers to "the removal of foreign material...the effectiveness of ...sterilization mandates effective cleaning". However, "sterilization destroys all microorganisms on the surface of an article". In other words, the clean rubber tip protector can contaminate the sterile forceps.

N. During an observation on 03/18/2024 at 1:55 pm of the Emergency Department room A1, revealed a Finochietto Retractor sterilization date "7/31/18", and a Finochietto Retractor Small sterilization date "7/31/18". During an observation on 03/19/2024 at 2:55 pm of the SPD Sub-Sterile Storage Room 6th floor, revealed 3 sterile trays with faded indicator tape (tape that turns black when item is sterilized) dated "2018".

O. During an interview with S7 Administrative Director of Surgical Services, S7 stated that if the outer covering of a sterile package is intact and the tray is not wet, then the tray stays sterile "forever." When asked if there is a policy regarding expiration dates and storage of sterile supplies, S7 indicated "no". Facilities are required to have policies for expiration dates of sterilized materials.

Based on record review and interview the facility failed to maintain a complete operating room register with all of the following required information: patient's name; patient's hospital identification number; date of operation; inclusive or total time of the operation; name of the surgeon and any assistant(s); name of nursing personnel (scrub and circulating); type of anesthesia used and name of person administering it; operation performed; pre and post-op diagnosis; and age of patient. The operating room register maintained by the facility is incomplete. This deficient practice could lead to misidentification of patients and procedures, insufficient patient monitoring, and delays in treatment for all patients undergoing surgical procedures at this facility.

The findings are:

A. Record review of the Operating Room Register revealed that it did not contain the following required information: inclusive or total time of the operation; any assistant(s) to the surgeon; name of nursing personnel; type of anesthesia used; and post-op diagnosis.

B. During interview on 03/20/2024, at 8:00 am with Staff (S)7 Administrative Director of Surgical Services, confirmed the Operating Room Register provided to surveyor was the actual document in use.