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Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.635 Provision of Services, was out of compliance.

C-1006 (a)(1) PATIENT CARE POLICIES The CAH's health care services are furnished in accordance with appropriate written policies that are consistent with applicable State law. Based on observations, interviews, and document review, the facility failed to ensure expired medical supplies were not readily available for patient use and were discarded according to the manufacturer's instructions for use (IFUs) and in accordance with facility policy. The failure was observed in one of two medication rooms.

Based on observations, interviews, and document review, the facility failed to ensure expired medical supplies were not readily available for patient use and were discarded according to the manufacturer's instructions for use (IFUs) and in accordance with facility policy. The failure was observed in one of two medication rooms.

Findings include:

Facility policy:

The Outdates/Dated Items policy read, all dated items sterilized by the manufacturer that have reached the "expiration date" must be removed from service or stock and returned to the purchasing section of materials management for credit, exchange and/or proper disposal.

Manufacturer's Instructions for Use (IFU):

The Medex Hi Flo 2 gauge 3-way Stopcocks with MLL IFU read, the device is intended for single use. Do not use if expired.

The Becton Dickinson (BD) Whitacre 22 gauge (22g) Pencil Point Spinal Needle package read, sterile, do not reuse and do not use if expired.

The BD Quincke Type Point Spinal Needle 22g package read, sterile, single use, do not reuse. Do not use if expired.

The BD Safety-Lok 3 mililiter (mL) Syringe package read, sterile, do not use if expired.

1. The facility failed to ensure single-use medical supplies were not expired and were discarded according to facility policy and the manufacturer's IFU.

A. Observations revealed expired medical supplies were readily available for use in the Emergency Department (ED) medication room.

i. On 7/24/23 at 4:05 p.m., an observation of the ED medication room revealed expired medical supplies were present and readily accessible. Examples included:

a. Two Medex Hi Flo two gauge three-way Stopcocks with MLL (a medical device used to connect multiple intravenous [IV] lines) which expired on 7/17/20.

b. Two three milliliter (ml) syringes with expiration dates of 8/31/22 and 4/30/23.

c. Nine 22 gauge Whitacre Needles (specialized needle used to draw fluid from the spine) which expired on 1/31/22.

d. Five 22 gauge Spinal Needles which expired on 3/31/22.

These observations were in contrast to facility policies and the medical supply IFUs, which instructed to not use expired supplies and to remove any expired supplies from the supply inventory..

B. Interviews with staff revealed patient safety was at risk when expired medical supplies were available for use.

i. On 7/26/23 at 4:15 p.m., an interview was conducted with registered nurse (RN) #2. RN #2 stated ED staff were required to check for expired medical supplies nightly. RN #2 stated staff were responsible for ensuring expired medical supplies were identified and removed. RN #2 stated clinical staff did not check the ED medication room for expired supplies, however, RN #2 stated ED staff did obtain medical supplies for patient care from the ED medication room. RN #2 stated she was not sure if someone specific was tasked to look in the medication rooms to see if supplies were expired. RN #2 stated the efficacy of the expired supplies could not be guaranteed. She further stated the sterility of the expired medical supplies was not guaranteed and could be harmful to the patient.

ii. During an interview with interim director of nursing (DON) #3 on 7/26/23 at 4:35 p.m., he stated the medical supplies located in the medication room were not checked regularly for expiration dates.

These interviews were in contrast with the facility's Outdates/Dated Items policy which read, expired medical supplies were not to be readily available for patient use.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.640 Condition of Participation: Infection Prevention and Antibiotic Stewardship Program, was out of compliance.

C-1208 The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health. Based on observations, interviews, and document review, the facility failed to ensure instruments used in patient care were cleaned and reprocessed per the manufacturer's instructions for use (IFU) and national guidelines, and that single-use instruments were not reprocessed for additional use. The facility further failed to ensure all staff responsible for instrument reprocessing and sterilization were trained and determined competent to perform the functions of the role.

Based on observations, interviews, and document review, the facility failed to ensure instruments used in patient care were cleaned and reprocessed per the manufacturer's instructions for use (IFU) and national guidelines, and that single-use instruments were not reprocessed for additional use. The facility further failed to ensure all staff responsible for instrument reprocessing and sterilization were trained and determined competent to perform the functions of the role.

Findings Include:

Reference:

According to The Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2017, provided by the facility, Manufacturer's written IFU: The device manufacturer's current written IFU should be accessible, reviewed, and followed. To help ensure effective decontamination of devices, sterile processing personnel should follow the device manufacturer's written IFU to ensure proper decontamination and disinfection of the device; pretreat the device according to the manufacturer's written IFU; rinse with water of the quality specified by the device manufacturer. Sterile processing personnel: All personnel performing sterile processing activities should be certified within two years of employment and should maintain that certification throughout employment.

Manufacturer's Instructions for Use (IFU):

The IFU for INTEGRA LIFESCIENCES surgical Instruments read, Decontamination/Manual Reprocessing: Immediately after the surgical procedure place the instruments in an instrument tray/container and cover with a towel moistened with sterile distilled water. Thoroughly rinse instruments by immersing them in deionized water and wiping them with a clean, soft cloth. Deionized water is recommended and preferred because it is free of the many compounds which exist in ordinary tap water. Follow the recommendations of the ultrasonic manufacturer regarding cycle times, detergents proper placement of the instrument tray, and conditioning ( degassing") of the cleaning solution etc. Use an ultrasonic cleaner to remove soil from hard-to-reach surfaces such as grooves, crevices, lumens, instruments with moving parts, etc. after gross soil has been removed. Open or disassemble instruments as appropriate. The final rinse should be done with deionized water. Deionized water should be used for the final rinse to better remove detergents.

The IFU for Medline Suture Removal Tray read, do not resterilize. Sterile in unopened, undamaged package. Single-use only.

1. The facility failed to ensure single-use instruments were not reprocessed and instruments reprocessed were cleaned according to the manufacturer's IFU.

a. Observations

i. On 7/25/23 at 11:21 a.m., observations of the central supply area revealed single-use items were reprocessed. Specifically, the forceps and scissors from single-use suture removal trays were manually reprocessed, sterilized, and made readily available for patient care.

This was in contrast to the suture removal tray IFU which instructed that the items were single-use only and were not to be resterilized.

ii. Observations further revealed instruments manually reprocessed were rinsed with tap water to remove the enzymatic cleaning solution. In addition, after the instruments were manually reprocessed they were not placed in an ultrasonic cleaner.

This was in contrast to the instrument IFU which instructed the final rinse should be performed with deionized water. The manufacturer IFU also read, follow the instructions of the ultrasonic manufacturer to remove soil from hard-to-reach surfaces.

iii. Additionally, observations revealed used instruments were transported to the facility's central supply area to be sterilized. During the observation, Material Handler #1 stated she sterilized instruments transported to the facility from another facility and did not manually clean the instruments before placement in the sterilizer. Material Handler #1 stated she was not able to verify if the instruments were decontaminated prior to their arrival at the facility.

b. Interviews

i. On 7/25/23 at 11:21 a.m., an interview with Material Handler #1 revealed the IFUs for all instruments reprocessed at the facility were not readily accessible to staff. Material Handler #1 stated she reprocessed all instruments the same way unless instructed by the doctors. Material Handler #1 stated the risk to the patient was a risk for infection if instruments were not reprocessed according to the IFU.

This was in contrast to The Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2017 which read, Manufacturer's written IFU: The device manufacturer's current written IFU were to be accessible, reviewed, and followed.

ii. On 7/25/23 at 1:50 p.m., an interview with the interim director of nursing (Director) #3 was conducted. Director #3 verified the facility was reprocessing single-use instruments. Director #3 stated patients were at risk for infection if single-use instruments were reprocessed and the package integrity was not intact.

iii. On 7/25/23 at 2:07 p.m., an interview with the director of quality and regulatory (Director) #4 was conducted. Director #4 stated the facility identified the concern related to the sterile processing of single-use instruments prior to the start of the survey. Director #4 stated Director #3 met with nursing staff at the facility on 7/17/23 and notified staff that instruments transported to the central supply area for reprocessing from the emergency department were designated as single-use instruments. However, Director #4 stated Material Handler #1 was not notified of the information nursing staff received during the meeting conducted by Director #3.

2. The facility failed to ensure staff performing reprocessing of instruments were trained and determined competent to perform their role.

a. On 7/25/23 at 11:21 a.m., an interview with Material Handler #1 was conducted. Material Handler #1 stated she began reprocessing instruments eight years ago. Material Handler #1 stated she had not received further updated competencies or training related to the reprocessing of instruments since her initial competency and training. Material Handler #1 stated she was not aware of any audits completed related to monitoring the reprocessing of instruments and she was never observed performing reprocessing of instruments.

i. On 7/25/23, a review of Material Handler #1's personnel file revealed initial competencies and training related to the reprocessing of instruments were completed in April 2018. No further updated competencies or training was provided by the facility related to the reprocessing of instruments for Material Handler #1.

This was in contrast to The Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2017 which read, sterile processing personnel: All personnel performing sterile processing activities should be certified within two years of employment and should maintain that certification throughout employment.

b. On 7/25/23 at 1:50 p.m., an interview with the interim director of nursing (Director) #3 was conducted. Director #3 stated Material Handler #1 was not under his supervision and was under the supervision of the materials management director (Director) #5.

i On 7/25/23, a review of materials management director (Director #5) personnel file revealed the job description had no documentation of required training or competencies related to the reprocessing of instruments. Further review revealed Director #5 the personnel file showed no evidence that Director #5 was responsible for the supervision of staff reprocessing instruments at the facility.

c. On 7/25/23 at 2:07 p.m., an interview with Director #4 was conducted. Director #4 stated Material Handler #1 was in need of additional education related to the reprocessing of instruments. Director #4 further stated sterile processing was not monitored by infection control at the facility.