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Based on record reviews, observations, and interviews, the hospital failed to ensure its system for controlling infections and communicable diseases of patients and personnel was implemented as evidenced by failing to mitigate risks contributing to healthcare-associated infections by failing to:

1) Failing to have documented evidence of training and competency evaluations of contracted staff who perform terminal cleaning of the OR daily by hospital qualified staff for 4 (S9ESA, S12ESA, S18ESA, S21ESA) of 4 contracted staff's personnel files reviewed for training and competency evaluation for performing terminal cleaning.


2) Failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted areas as evidenced by multiple observations of surgical attire breaches on 05/15/18 from 12:05 p.m. to 2:30 p.m.

Findings:

1) Failing to have documented evidence of training and competency evaluations of contracted staff who perform terminal cleaning of the OR daily:

Review of the personnel files of S9ESA, S12ESA, and S18ESA revealed no documented evidence of training related to terminal cleaning of the OR and a competency evaluation conducted by a qualified hospital employee. There was no personnel file for S21ESA to review.

Review of the "Terminal Cleaning Of OR Rooms...", presented by S2RS as the list of duties associated with terminal cleaning of the OR, revealed the following tasks were included: cleaning ceilings and walls top to bottom and side to side; wiping and sanitizing outside the wall vents, the clock and timer, the door and window seals, the surgical light and hanging cables and wires, all fixed equipment in the center of the room, mechanical arms, and stools, the video monitor boom including the mount and white tubes and mechanical arms, the foot pedal, the patient bed and safety straps, the wheels of steel tables, mayo stands, ring stands, linen carts, and trash cans; and disinfecting and mopping the OR floor.

In an interview on 05/16/18 at 1:40 p.m., S8HR indicated the leadership team for environmental services is contracted through Company A, and Company A is presently in the process of developing competency plans for the staff. She confirmed she has no documented evidence to present of training and a competency evaluation for S9ESA, S12ESA, S18ESA, and S21ESA that was performed by a hospital-employed qualified staff member.

In an interview on 05/16/18 at 1:40 p.m., S4SND, who was present during the review of the personnel files, confirmed the contracted staff who performed daily terminal cleaning of the OR had not been trained by or evaluated for competency by a hospital-employed qualified staff member.

In an interview on 05/16/18 at 2:30 p.m., S8HR indicated S21ESA is contracted through Company B to provide environmental services and works in conjunction with Company A. She confirmed doesn't have a personnel file for S21ESA.


2) Failing to ensure that staff adhered to acceptable standards of professional practice in surgical attire in the restricted areas:

Review of the hospital policy titled "Surgical Scrub Attire", presented as a current policy by S2RS, revealed the policy refers to all persons entering the semi-restricted and restricted areas of Surgical Services. Surgical scrub attire consists of Ochsner Medical Center provided scrub pants and shirts or dresses. Other garments worn in the restricted and semi-restricted areas should be contained completely within or covered by the surgical scrub attire. Efforts should be made to have the scrub shirts completely cover short sleeved tee shirts to the extent possible. Scrub jackets should be worn over long sleeved shirts. All head and facial hair (including sideburns and necklines) should be covered while in the semi-restricted and restricted areas of Surgical Services. Cloth reusable caps should be covered with a disposable cap when entering semi-restricted and restricted areas and will be laundered daily. Further review revealed the section related to personal tee shirts did not meet AORN's guidelines.

Review of AORN's "2018 Edition Guidelines For Perioperative Practice" revealed 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. Further review revealed construction workers should don surgical attire if they are required to enter the semi-restricted area. An external reference used for hospital policies was the "AORN Standards, Recommended Practices, and Guidelines" as evidenced by referencing the AORN's "Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment" in the IUSS policy.


Observation in the Sterile Processing Department on 05/15/18 from 12:05 p.m. to 2:30 p.m. revealed the following breaches in surgical attire:

S4SND had a personal T-shirt exposed at the neck of her scrub top.

S15ORA's moustache was not covered when leaving Sterile Storage.

S19SSP had hair exposed from her surgical hat.

S17SPT and S13SPT had hair exposed at their sideburns and nape of the neck. S13SPT had her personal T-shirt exposed from her scrub top with the gown hanging loosely around the neck. Continuous observation revealed S13SPT reached inside her scrub gown to get her glasses, placed her glasses on her face, and continued marking wrapped trays without changing gloves and performing hand hygiene.

S10ST was wearing a personal cloth skull cap with a surgical hat over it. Her hair was exposed at the forehead from the cloth hat, and her cloth skull cap was exposed from the bouffant surgical hat.

S14SPT's facial hair was exposed from his mask.

1A contractor was present servicing the Steris equipment and had work coveralls on with his beard exposed when he removed his helmet that was not covered with a surgical hat.

In an interview on 05/15/18 at 2:30 p.m., S2RS confirmed she was present during the above observations. She confirmed the observations were breaches in the hospital's policy for surgical attire.

Based on record reviews, observations, and interviews, the hospital failed to meet the requirement for the Condition of Participation of Surgical Services. The hospital failed to ensure the hospital's Surgical Services followed acceptable professional standards of practice and hospital policies governing surgical services as evidenced by:

1) Failing to ensure that surgical instruments were available in a quantity that was commensurate with the hospital's expected daily procedure volume, as evidenced by the hospital's routine use of IUSS of surgical instruments for surgical procedures.

2) Failing to ensure that staff followed manufacturer's directions for use for the enzymatic agent used during manual washing of contaminated instruments as evidenced by not adhering to the manufacturer's instructions for temperature monitoring and assurance of the proper water to enzymatic agent concentration of the solution prior to use. Contaminated surgical instruments that underwent IUSS had to be manually washed prior to sterilization.

(See findings in tag A0951)

Based on record reviews and interview, the hospital failed to ensure surgical services was provided by qualified personnel as evidenced by failure to have documented evidence of competency evaluations in performing the duties of sterile processing in the personnel files of 3 (S13SPT, S14SPT, S16SSP) of 6 (S11CSPT, S13SPT, S14SPT, S16SSP, S17SPT, S19SSP) sterile processing staff personnel files.


Findings:

A review of AORN Guidelines for Perioperative Practice, 2018 edition revealed education regarding cleaning and care of surgical instruments should include adherence to manufacturer's indications for use, methods of cleaning and verification of cleaning, the types of contamination of medical devices, methods of decontamination, safe use of cleaning chemicals and equipment, how to verify washer cleaning efficacy, use of personal protective equipment during instrument processing, corrective actions to employ in the event of a cleaning failure, and corrective actions to employ in the event of an equipment or instrument failure.

Review of the personnel files of S13SPT and S16SSP revealed no documented evidence of a competency evaluation conducted to determine their competency in performing the duties of sterile processing.

Review of the personnel file of S14SPT, a contracted SPT, revealed no documented evidence of a competency evaluation conducted by a qualified hospital employee.


In an interview on 05/16/18 at 2:07 p.m., S8HR indicated there was no competency evaluation conducted by a qualified hospital employee in the personnel files of S13SPT, S14SPT, and S16SSP.

Based on observations, record reviews, and interviews, the hospital failed to ensure the hospital's Surgical Services followed acceptable professional standards of practice and hospital policies governing surgical services as evidenced by:

1) Failing to ensure that surgical instruments were available in a quantity that was commensurate with the hospital's expected daily procedure volume, as evidenced by the hospital's routine use of IUSS of surgical instruments for surgical procedures.

2) Failing to ensure that staff followed manufacturer's directions for use for the enzymatic agent used during manual washing of contaminated instruments as evidenced by not adhering to the manufacturer's instructions for temperature monitoring and assurance of the proper water to enzymatic agent concentration of the solution prior to use.


Findings:

1) Failing to ensure that surgical instruments were available in a quantity that was commensurate with the hospital's expected daily procedure volume, as evidenced by the hospital's routine use of IUSS of surgical instruments for surgical procedures:

A review of AORN Guidelines for Perioperative Practice, 2018 edition - Guideline for Sterilization: Recommendation VII revealed IUSS should be kept to a minimum and should only be used in selected clinical situations and in a controlled manner. Immediate use is considered the shortest time possible between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field. IUSS should only be used when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. IUSS should not be used as a substitute for sufficient inventory.

Review of the hospital policy titled "Immediate Use Steam Sterilization (IUSS)", presented as a current policy by S2RS, revealed IUSS is kept to a minimum and used only in selected clinical situations and in a controlled manner. IUSS is used only when there is insufficient time to process items by the recommended standard method. Review of the policy revealed an external reference used for the policy was the "AORN Standards, Recommended Practices, and Guidelines. Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment."

Review of 2017's AAM I's guidelines related to IUSS revealed IUSS should not be used for purposes of convenience or as a substitute for sufficient instrumentation. Instrument inventories should be sufficient to meet anticipated surgical volume and to ensure there is enough time to complete all critical elements of reprocessing. IUSS should be kept to a minimum and should be used only in urgent clinical situations.

Review of the hospital's IUSS usage, presented as the year's IUSS rate by S6DPS, revealed the target goal was 5%. Further review revealed the following afrtes by month:

June 2017 - 18%
July 2017 - 14%
August 2017 - 13%
September 2017 - 13%
October 2017 - 14%
November 2017 - 15%
December 2017 - 22%
January 2018 - 16%
February 2018 - 11%
March 2018 - 12%
April 2018 14%
May 2018 - 15%

Review of the "Sterility Assurance Record" (used to document IUSS), presented by S6DPS, revealed IUSS was performed due to "turnover" for "Smith's Specials" (neuro instruments) on 04/01/18, 04/03/18, 04/04/18 (2 times), 04/05/18 (2 times), and 05/01/18 (2 times). Further review revealed IUSS was performed 8 times on 04/03/18, 6 which were due to turnover. Further review revealed IUSS was performed 19 times on 04/05/18, 8 which were due to turnover.

Review of the surgery schedule for 04/03/18 revealed 3 neurological (brain) surgery procedures were scheduled back-to-back. Further review revealed on 04/05/18 3 craniotomies were scheduled back-to-back.

In an interview on 05/15/18 at 10:23 a.m., S24CC indicated they only have one Smith Specials set, and the neurosurgeon uses it for his craniotomy procedures. She further indicated "turnover" as it relates to the "Sterility Assurance Record" usually means they don't have enough instruments for the next surgical procedure.

In an interview on 05/16/18 at 11:45 a.m with S4SND and S7VPPS present, S7VPPS indicated their assessment revealed an estimate of needing to spend $700,000 for instruments to get the hospital to reach their goal of getting their IUSS rate to 5%. She confirmed that a part of the issue with having a high IUSS rate was due to needing more pans/instruments.


2) Failing to ensure that staff followed manufacturer's directions for use for the enzymatic agent used during manual washing of contaminated instruments:
Observation on 05/15/18 at 1:15 p.m. revealed S14SPT, a contracted staff member, was manually washing contaminated instruments. There was no observation of a mark in the sink to denote the amount of water to be used with the enzymatic agent to assure the proper concentration of agent to water. There was no observation of a measuring utensil to be used for measuring water to add to the sink or a thermometer to test the temperature of the solution used to wash the instruments. Further observation revealed a white cloth was in the sink being used as a stopper.

Review of the manufacturer's "Product Specification" for Renuzyme Ultra, the enzymatic agent used for manually washing contaminated surgical instruments and in the automated washers, revealed Renuzyme Ultra is a high performance enzyme detergent specifically formulated for use at lower temperatures (65 to 140 degress Fahrenheit).

Review of a letter from Company C, presented by S6DPS as the directions for use of Renuzyme Ultra, revealed in addition to being excellent automatic washing detergents, Company C's concentrated enzymatic cleaners can be used manually in presoaking and hand washing applications. To presoak or hand wash, dilute 1/4 to 1/2 ounces of renuzyme Ultra per gallon of water. For soaking applications, a minimum soak time of 2 minutes should be used. heavily soiled loads, dried soiled loads, and low solution temperature may necessitate longer soaking times of 5 minutes or more. Solution temperature should not exceed 140 degrees fahrenheit. This product is most effective between 70 to 130 degrees Fahrenheit.

In an interview on 05/15/18 at 1:15 p.m., S14SPT indicated the sink automatically fills with water while the enzymatic agent is added. He confirmed there was no manual measurement of the amount of water to enzymatic agent. He confirmed he did not have a thermometer to measure the temperature of the solution used to wash the instruments.

In an interview on 05/15/18 at 1:41 p.m., S22SPT indicated they used to have stickers on the sink showing the appropriate water level. She further indicated the sinks were replaced and don't work the same. She indicated now they just fill the sink to a level so the water solution covers the tray. She further indicated they were supposed to check the water temperature.

In an interview on 05/15/18 at 1:44 p.m., S23SSP indicated the enzymatic agent automatically fills but not the water. She offered no explanation for not having a means of measuring the water level or the temperature of the solution.

In an interview on 05/15/18 at 1:54 p.m., S14SPT confirmed a cloth was used as a stopper in the sink. He indicated the stopper broke "a couple of days ago and hasn't been replaced." He confirmed he used the same cloth as a stopper for multiple washings.

In an interview on 05/16/18 at 11:45 a.m. with S4SND, S5ICO, and S7VPPS present, S4SND and S5ICO confirmed the observations made on 05/15/18 of the manual washing of contaminated surgical instruments reflected that the manufacturer guidelines for use were not followed. They confirmed the instruments are manually washed prior to IUSS. S7VPPS indicated S6DPS indicated the amount of enzymatic agent is automatically dispensed with the volume of the water coming out the faucet. She further indicated the vendor came out 3 weeks ago and tested it for accuracy. A request was made at this time by the surveyor to view the documentation of this process by the manufacturer and evidence of assessment with results from the visit made 3 weeks ago.

As of the time of exit on 05/16/18 at 3:35 p.m., no documentation was presented regarding the automatic process of dispensing the enzymatic agent with running water and the assessment results of the visit made to assure the accuracy of the system.