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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.618 Condition of Participation: Emergency Services was out of compliance.

C-0888 Standard: Equipment, Supplies, and Medication (b)(2) Equipment and supplies commonly used in life-saving procedures, including airways, endotracheal tubes, ambu bag/valve/mask, oxygen, tourniquets, immobilization devices, nasogastric tubes, splints, IV therapy supplies, suction machine, defibrillator, cardiac monitor, chest tubes, and indwelling urinary catheters. Based on observations, document review and interviews the facility failed to ensure medical supplies and medications were readily available in emergency situations. Specifically, the facility failed to ensure expired emergency equipment and medications were removed and replaced to provide usable equipment in an emergency situation on five of five crash carts (carts stocked with emergency medications and supplies) observed.

Based on observations, document review and interviews the facility failed to ensure medical supplies and medications were readily available in emergency situations. Specifically, the facility failed to ensure expired emergency equipment and medications were removed and replaced to provide usable equipment in an emergency situation on five of five crash carts (carts stocked with emergency medications and supplies) observed.

Findings include:

Facility policies:

The Crash Carts/Defibrillator Checks policy read, the crash carts and contents were to be checked daily and inventoried monthly and after each use to ensure the equipment was operational and supplies, medications and equipment were not outdated. The checks are completed by a nurse.

The Stocking policy read, materials management and respective departments work together to monitor supplies for outdates. Materials management was to pull items from storage closets immediately before the expiration date and replaced with new stock. Items in emergency carts and expired within the month were to be reported.

1. The facility failed to ensure medications and supplies used in emergencies were not expired and ready for patient use.

A. Observations

i. On 2/13/23 at 3:53 p.m., an observation of the surgical area crash cart revealed the following expired supplies: one package of ECG (electrocardiogram) electrodes expired 7/25/22, one temperature probe expired 3/1/22, one syringe of 10% calcium chloride solution (a solution used during a cardiac emergency) 1000 mg/10 mL expired 2/1/23, seven 0.9% sodium chloride injection sterile solution syringes (used for an infusion to keep a line open) expired 9/30/20, three 0.9% sodium chloride injection sterile solution syringes expired 2/28/22, one set of size 6 ½ sterile surgical gloves expired 10/28/22, one adult tracheostomy tube expired 2/24/21, and one ten foot suction connecting tubing expired 2/2019.

ii. On 2/13/23 at 5:07 p.m., an observation of the adult crash cart in the trauma room of the emergency department revealed one albuterol sulfate inhalation solution (used to help someone having difficulty breathing) 2.5 mg/2 ml expired 1/23, four atropine sulfate syringes (used to help someone with low blood pressure) 10 mg/10 mL expired 1/23, two vials of vasostrict 1 mg single dose expired 1/23, three arterial blood sampling kits with dry lithium heparin expired 11/20/22, one tracheostomy tube expired 9/4/20, three 3 ml syringes expired 2/28/22, one 5 ml syringe expired 12/31/22, one 16 gauge needle expired 6/30/22, one 10 mL syringe expired 1/31/23, one vial of ranitidine 150mg for intravenous (used to help stop the release of gastric juices overwhelming the stomach) expired 6/21, two 5% dextrose injection solution (used to help raise the blood sugar inside the body quickly) 500 ml expired 12/22, one 0.9% sodium chloride injection solution 500 ml expired 9/22, two bags of lidocaine and 5% dextrose injection solutions (used during a cardiac emergency) 250 ml expired 10/22, two bags of dobutamine in 5% dextrose injection (used to raise blood pressure and help with circulation) 250 ml expired 1/1/23, two bottles of nitroglycerin in 5% dextrose solution (used to help with chest pain) 25 mg/250 ml expired 7/22.

iii. On 2/13/23 at 5:45 p.m., observations of the pediatric crash cart in the trauma room of the emergency department revealed two pediatric carbon dioxide detectors 1 kg-15 kg expired 1/11/23, three electrocardiogram monitoring electrodes expired 9/23/21, one foley catheter (a medical device inserted into the bladder to assist with urination) expired 2/17, two lidocaine and 5% dextrose injection solution bags expired 10/22, one atropine sulfate injection 1mg/10mL expired 1/23, one albuterol sulfate inhalation solution 0.083% 2.5 mg/3 ml expired 1/23.

iv. On 2/14/23 at 8:25 a.m., observations of the crash cart on the acute area of the inpatient unit revealed ten iodine cleansing scrub swabsticks (a topical antiseptic) expired 1/23

v. On 2/14/23 at 8:40 a.m., observations of the crash cart on the long-term care area of the inpatient unit revealed one adult nasal cannula expired 7/9/22.

B. Interviews

i. On 2/14/23 at 1:45 p.m., an interview was conducted with registered nurse (RN) #1. RN #1 stated the nurses rotated the monitoring responsibility of each of the crash carts for expired medications and supplies. RN #1 stated the importance of monitoring medical supplies for the expiration date was to ensure the supply was able to give the intended benefit . RN #1 stated the importance of monitoring medications for expiration date was because medication could change in potency and might not work as intended if administered to a patient.

ii. On 2/15/23 at 10:12 a.m., an interview with registered nurse (RN) #2 was conducted. RN #2 stated purchasers of the hospital ordered medical supplies and the pharmacist ordered medications for the facility. RN #2 stated monthly audits occurred for each crash cart on a rotation basis. RN #2 further stated the importance of monitoring medical supplies for the expiration date was to ensure the supply did not break when used or to avoid decreased product quality. RN #2 stated medications once expired might lose efficacy and the stability of the medication might be changed. RN #2 stated the patient was at risk of developing an infection from an expired medical supply if used in patient care. RN #2 stated medications used after the expiration date placed the patient at risk of not receiving the treatment as intended.

iii. On 2/15/23 at 10:40 a.m., an interview with trauma and emergency department coordinator (Coordinator) #3 was conducted. Coordinator #3 stated crash carts were audited monthly for expiration date. Coordinator #3 stated the crash cart audits were randomly assigned to the facility nurses to complete. Coordinator #3 stated she monitored the crash carts audits had been completed each month. Coordinator #3 stated medications used past the expiration date might not give the patient the desired effect. Coordinator #3 stated expired medical supplies might not work as intended if used after expiration date.

iv. On 2/15/23 at 12:45 p.m., an interview with infection control coordinator (Coordinator) #4 was conducted. Coordinator #4 stated crash carts were audited for the expiration date of medical supplies and medications on a monthly basis. Coordinator #4 stated she was responsible for auditing the procedure room crash cart monthly for expiration date. Coordinator #4 stated no documentation existed of the audits performed on the procedure room crash cart. Coordinator #4 stated medications used after expiration date might lose effectiveness and not give the patient the intended benefit. Coordinator #4 stated medical supplies might lose their sterility and degrade if used after the expiration date.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Organizational Structure was out of compliance.

C-0962 Standard: Governing Body or Responsible Individual (a) The CAH has a governing body or an individual that assumes full legal responsibility for determining, implementing and monitoring policies governing the CAH 's total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment. Based on interviews, and document reviews, the governing body (GB) failed to ensure patient care services were provided in a safe manner. Specifically, the governing body failed to ensure staff used the least restrictive and/or alternative measures attempted prior to restraint use and staff discontinued restraints when the patient no longer posed an imminent danger or threat to themselves or others for two of two medical records reviewed of patients who were restrained. (Patient #2 and Patient #4). In addition, the GB failed to ensure staff who restrained patients had received education on safe restraint use.

Based on interviews, and document reviews, the governing body (GB) failed to ensure patient care services were provided in a safe manner. Specifically, the governing body failed to ensure staff used the least restrictive and/or alternative measures attempted prior to restraint use and staff discontinued restraints when the patient no longer posed an imminent danger or threat to themselves or others for two of two medical records reviewed of patients who were restrained. (Patient #2 and Patient #4). In addition, the GB failed to ensure staff who restrained patients had received education on safe restraint use.

Findings include:

Facility policy:

Physical Restraints policy read, restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. Restraints are used only for circumstances in which the patient has: Medical symptoms that warrant the use of restraints or behavioral/psychological symptoms which would cause harm to themselves or others without the use of restraints. Definitions: "Physical restraints" are any manual method or physical or mechanical device, material, or equipment attached or adjacent to the patient's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body. Physical restraints include but are not limited to: soft restraints, side rails up X 4, seclusion, and others. "Convenience" is any action taken by the facility to control patient behavior or maintain patients with a lesser amount of effort by the facility and not in the patient's best interest. Determination: Restraints can be dangerous and should be eliminated except when without the use of restraints, the patient will suffer or inflict harm. Additionally, alternative solutions should have been attempted and failed. Such alternative solutions are: de-escalation techniques, distraction, relaxation techniques, reorientation, therapeutic rapport, and others. Implementation: Restraints can be implemented upon the instance that the patient or others will be harmed without the use of restraints. Such circumstances are limited to medical/surgical reasons or very specific behavioral/psychological problems that threaten harm. Nursing Documentation regarding the necessity of restraints will be entered on the Restraint Log and include: that the patient is continuously assessed for safety, that the patient's basic needs for range of motion (ROM), hydration, nutrition, and elimination are being met, circulation and integumentary status are being monitored, alternative interventions are attempted, restrained are discontinued at the soonest possible opportunity. Education: Education on restraints will be conducted annually and documented.

Facility references:

The Restraint Log read, medical restraints must be checked every 30 minutes, behavioral restraints must be checked every 15 minutes and restraints must be released for the purpose of ROM, hydration, nutrition, and elimination at least every two hours.

The Bylaws read, Governing Board of Directors: All powers, privileges, and duties vested in, or imposed upon, the District by law shall be exercised and performed by and through the Governing Board. whether set forth specifically or implied in these Bylaws. The Governing Board shall have and is invested with all and unlimited powers and authorities, except as may be expressly limited by law, or by these Bylaws, to supervise, control, direct, and manage the property, affairs, and activities of the Hospital District, to determine the policies of the Hospital District. Policies of the Governing Board: It shall be the policy of the Governing Board of the District, consistent with the availability of revenues, personnel, and equipment, to use its best efforts to provide health care services, as authorized under the District Service Plan or bylaw.

1. The GB failed to ensure staff initiated alternative measures to prevent the use of restraints, and removed and discontinued restraints as soon as the patient met the criteria for discontinuation and no longer posed a risk to self or others.

A. Medical record review for Patient #4 revealed Patient #4 was locked in seclusion and physically restrained after the patient no longer posed a danger to herself or others.

a. Patient #4 was brought to the emergency department by local law enforcement on 1/29/23 at 9:00 p.m. According to Patient #4's medical record, Patient #4 had physically assaulted a mental health counselor when the counselor attempted to perform a mental health evaluation.

i. At 9:56 p.m., Patient #4 was placed in a locked seclusion room at the facility and remained until she was discharged on 1/31/23 at 2:08 p.m. (a total of one day, 16 hours, and 12 minutes).

ii. The Restraint Log for Patient #4 was reviewed and revealed Patient #4 was placed in the seclusion room and physically restrained with soft restraints on both of her arms and legs from 1/29/23 at 9:56 p.m., until 1/30/23 at 1:26 a.m. (a total of three hours and 30 minutes)

The Restraint Log revealed Patient #4 was calm and resting and no longer presented a threat to herself or others on 1/30/23 at 12:13 a.m.

iii. Patient #4 was not removed from seclusion and restraints when she met criteria, instead review of the Restraint Log revealed on 1/30/23 at 1:26 a.m., the two soft restraints on her legs only were removed. Patient #4 remained locked in seclusion with soft restraints applied to both of her wrists until 9:45 p.m. (a total of 20 hours and 19 minutes)

iii. According to the Nursing Note documented for 1/30/23 at 1:20 a.m., and 2:20 a.m., revealed Patient #4 was calm and sleeping while physically restrained and locked in a secluded room.

Further review of the Nursing Notes revealed Patient #4 displayed no physically or verbally aggressive behaviors from 1/30/23 at 12:15 a.m. until she was discharged on 1/31/23 at 2:08 p.m. However, Patient #4 remained physically restrained while secluded in a locked room for a total of one day, 13 hours, and 53 minutes.

These examples were in contrast to the Physical Restraints policy which read placement of the patient in restraint or seclusion was dangerous and should not be implemented except in situations in which the patient or others could be seriously harmed without the use of restraints or seclusion. Additionally, restraint and/or seclusion were to be discontinued for patients who no longer presented a danger to themselves or others.

b. Interviews and document reviews revealed a lack of adherence to the restraint policy and lack of restraint education for nursing and medical staff.

i. On 2/16/23 at 3:09 p.m., an interview was conducted with Chief Nursing Officer (CNO) #10. CNO #10 electronically reviewed Patient #4's medical record during the interview. CNO #10 stated Patient #4 had been physically aggressive when local law enforcement presented with her in the ED on 1/29/23.

CNO #10 stated on 1/29/23 at 9:50 p.m., an order was written for Patient #4 to be placed in 4-point soft restraints in the seclusion room. CNO #10 stated Patient #4 remained secluded until she was transferred to a behavioral health facility on 1/31/23.

CNO #10 reviewed the electronic Restraint Log and nursing notes in Patient #4's medical record. CNO #10 stated the documentation present in Patient #4's medical record read Patient #4 was calm, cooperative, and resting from 1/30/23 at 12:15 a.m. until she was discharged on 1/31/23 at 2:08 p.m.

At 3:34 p.m., CNO #10 spoke with the Director of Nursing (DON) #11. CNO #10 asked DON #11 where the nursing staff restraint education could be located. According to CNO #10, nursing staff had not been educated on safe restraint use and monitoring.

ii. The training competencies for six nursing staff were reviewed and revealed no evidence of safe restraint use education.

This was in contrast to facility Bylaws which stated the GB, will ensure staff were provided health care resources to ensure the best health care services were provided.

B. Patient #2's medical record review revealed physical restraints were used without a physician's order for restraint.

a. Patient #2's medical record review revealed from 12/6/22 to 2/1/23, Patient #2 had been physically restrained when he refused hygiene care. Additionally, there was no evidence Patient #2 had been provided restraint alternatives prior to being restrained, and no evidence a physician order had been entered to restrain Patient #2.

i. Document review revealed, on 12/30/22 at 10:40 a.m., email communication from Director of Nursing (DON) #11 was provided to the nursing staff. According to the email communication, the nursing staff were instructed to ensure patients remained clean and dry. The email read patients did not have the right to refuse hygiene care. Additionally, nursing staff who did not perform hygiene care would be considered "contributing to [the] neglect" of the patient and "this type of behavior will not be tolerated". The email communication further read nursing staff was to instruct patients hygiene care would be performed and staff should "get it done as quickly as possible".

ii. Patient #2's medical record revealed on 1/2/23 at 2:30 p.m., two nursing staff members each held one of Patient #2's arms while two additional nursing staff members performed personal hygiene care (cleaning the private areas of incontinent patients) on Patient #2. According to Patient #2's medical record, Patient #2 continuously verbalized his refusal of the hygiene care provided.

On 1/11/23 at 12:26 p.m., Patient #2 was incontinent and soiled his disposable brief. According to Patient #2's medical record, Patient #2 "was non-compliant" and refused to change the soiled disposable brief so three nursing staff performed hygiene care and changed the soiled brief.

On 1/12/23 at 12:00 p.m., staff physically held Patient #2's arms and legs while additional staff removed Patient #2's disposable brief and performed hygiene care to cleanse away the urine present.

b. On 2/15/23 at 7:35 p.m., an interview was conducted with registered nurse (RN) #9. RN #9 stated she had cared for Patient #2 on multiple days. RN #9 stated she observed Patient #2 was at times unable to comprehend what self-care hygiene needs he required.

RN #9 stated Patient #2 became physically and verbally aggressive towards staff whenever staff entered his room and inquired if Patient #2 had been incontinent or needed assistance toileting. RN #9 stated Patient #2 was incontinent and wore a disposable brief and Patient #2 refused to have the disposable brief removed and/or changed when soiled. RN #9 further stated Patient #9 became verbally and physically aggressive when asked if his disposable brief was soiled and if nursing staff could assist him with toileting. RN #9 stated because Patient #2 was incontinent staff were required to provide continued toileting and hygiene care to avoid skin breakdown.

RN #9 stated Patient #2's aggressive behaviors and continuous refusal of toileting assistance and hygiene care were discussed with DON #11 and Chief Medical Officer (CMO) #12. RN #9 stated communication sent from DON #11 instructed nursing staff to manually hold Patient #2 and change his disposable briefs when the brief was soiled. RN #9 stated manual holds were considered a physical restraint and only physicians could order the placement of a patient in physical restraints. RN #9 stated after DON #11's electronic communication was sent, nursing staff manually restrained Patient #2 in order to perform hygiene care. RN #9 stated a physician order for physical restraints had not been provided on 1/2/23 and 1/11/23 when Patient #2 had been manually restrained.

c. On 2/15/23 at 5:06 p.m., an interview was conducted with CMO #12. CMO #12 stated he was the primary physician who cared for Patient #2. CMO #12 stated Patient #2 declined to have hygiene care performed when he was incontinent. CMO #12 stated remaining in soiled disposable briefs for long periods of time was a form of neglect (failure to provide patients with the healthcare service necessary to maintain the patient's health and safety).

CMO #12 stated he had multiple discussions with the nursing staff about Patient #2 and his refusal to have hygiene care performed. CMO #12 stated the decision had been made to not allow Patient #2 to refuse hygiene care to ensure Patient #2 did not experience skin breakdown when he was incontinent. However, CMO #12 stated he had not written an order to physically hold or restrain Patient #2 on 1/2/23 and 1/11/23. CMO #12 stated patients who were restrained were at risk for physical injuries and even death.

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

C-1006 Standard: Patient Care Policies (a)(1) 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 medical supplies were taken out of use when expired. Specifically, the facility failed to ensure expired medical supplies were not available for patient use during three of three observations including the wound care cart, procedure storage cabinets, and the preoperative (preop) and postoperative (PACU) areas according to facility policy.

C-1044 Standard: Services Provided Through Agreements or Arrangements (c)(4) The person principally responsible for the operation of the CAH under §485.627(b)(2) of this chapter is also responsible for the following: (i) Services furnished in the CAH whether or not they are furnished under arrangements or agreements. (ii) Ensuring that a contractor of services (including one for shared services and joint ventures) furnishes services that enable the CAH to comply with all applicable conditions of participation and standards for the contracted services. Based on observations and interviews the facility failed to furnish contractor services under arrangements or agreements and comply with the conditions of participation and standards for the contracted service.

Based on observations, interviews, and document review the facility failed to ensure medical supplies were taken out of use when expired. Specifically, the facility failed to ensure expired medical supplies were not available for patient use during three of three observations including the wound care cart, procedure storage cabinets, and the preoperative (preop) and postoperative (PACU) areas according to facility policy.

Findings include:

Facility policy:

The Stocking policy read, materials management and respective departments work together to monitor supplies for outdates. Materials management was to pull items from storage closets immediately before the expiration date and replaced with new stock. Items in the emergency carts which expired within the month are reported.

1. The facility failed to ensure expired medical supplies were not available for patient use.

A. Observations

i. On 2/13/23 at 2:53 p.m., an observation of the preop and PACU area of the facility revealed five 25 gauge syringes expired 8/19.

ii. On 2/13/23 at 2:58 p.m., an observation of the wound care cart revealed one topical wound dressing tube expired 3/2022, 98 disposable sampling swabs expired 11/24/22, one exufiber silver dressing (a sterile non-woven gelling fiber design with a rapid antimicrobial action for sustained protection against a broad range of bacteria) expired 1/28/22, and one abdominal pad expired 10/21.

iii. On 2/13/23 at 3:18 p.m., observations of the procedure room storage areas revealed one 20 gauge syringe expired 12/31/22, one spare pump intravenous set expired 5/31/22, a second spare pump intravenous set expired 6/30/21, one luer lock connector (a device used to secure a leak-proof connection) expired 7/15, one suction system tubing expired 8/12/20, and 17 60 ml syringes expired 3/19.

B. Interviews

i. On 2/14/23 at 1:45 p.m., an interview was conducted with registered nurse (RN) #1. RN #1 stated the importance of monitoring medical supplies for the expiration date was to ensure the supply integrity was intact and was effective when used. RN #1 stated the patient was at risk of not having the full effectiveness of the medical supply if used once expired.

ii. On 2/15/23 at 10:12 a.m., an interview with RN #2 was conducted. RN #2 stated the monitoring of crash carts for expired supplies was completed monthly by a nurse assigned by Coordinator #3. RN #2 stated the importance of monitoring medical supplies for the expiration date was to ensure the supply did not break when used or to avoid decreased product quality. RN #2 stated the patient was at risk of developing an infection from an expired medical supply if used in patient care.

iii. On 2/15/23 at 12:45 p.m., an interview with infection control coordinator (Coordinator) #4 was conducted. Coordinator #4 stated she was responsible for auditing the wound care cart and the procedure room crash cart monthly for expiration dates, and did not keep a record. Coordinator stated all other crash carts located on the inpatient unit and emergency department were audited for expiration dates monthly by other nurses assigned by Coordinator #3. Coordinator #4 stated medical supplies could lose their sterility and degrade if used after the expiration date.

Based on observations and interviews the facility failed to furnish contractor services under arrangements or agreements and comply with the conditions of participation and standards for the contracted service.

References:

Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality/Quality, Safety & Oversight Group, QSO-19-13-Hospital revised 11/12/21 read, All co-located hospitals must demonstrate independent compliance with the hospital Conditions of Participation's (CoPs). When hospitals choose to co-locate, they should consider the risk to compliance through any shared space or shared service arrangements. Contracted Services: A hospital is responsible for providing services in compliance with the hospital CoPs, which could be provided either directly or under contract or arrangement. These services are provided under the oversight of the hospital's governing body and would be treated as any other service provided directly by the hospital.

When utilizing staffing contracts, under the contracted services standard at §482.12(e) along with other applicable conditions and standards therein incorporated, the governing body is responsible for ensuring: adequacy of staff levels, adequate oversight and periodic evaluation of contracted staff, proper training and education of contracted staff, contracted staff have knowledge of and adheres to the quality and performance improvement standards of the individual hospital, accountability of the contracted staff related to clinical practice requirements.

1. The facility failed to have an agreement in place for contractor services for a leased space located within the facility.

a. Observations conducted on 2/13/23 at 9:50 a.m., revealed an ultrasound procedure room within the radiology department.

At 9:53 a.m., Chief Nursing Officer (CNO) #10 stated ultrasound procedures performed at the facility were contracted out. CNO #10 further stated an agreement was in place with an external medical group since June of 2022. CNO #10 stated the external medical group performed ultrasound procedures at the facility in the ultrasound room once a month.

i. On 2/16/23 at 11:37 a.m., an interview was conducted with Radiology Director (Director) #13. Director #13 stated she managed the services provided in the Radiology Department and she oversaw contracted services provided in the Radiology Department. Director #13 stated she had not procured a contract or agreement to have ultrasound services provided as contracted services. Director #13 stated the facility was responsible to ensure contracted healthcare services and the staff who provided the services were qualified to perform the service. Director #13 further stated the lack of a contract for services provided within the facility placed the safety and care of the patient and the facility at risk.

The observation and interviews conducted were in contrast to QSO-19-13-Hospital which stated facilities were required to remain compliant with CoPs when providing healthcare services furnished within the facility directly or under contract or arrangement. Additionally, healthcare services provided under contract or arrangement will be provided as though the services were directly by the hospital.

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-1206 Standard: Infection prevention and control program organization and policies (a)(2) The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings. Based on observations, interviews and document review, the facility failed to ensure infection prevention and control measures were implemented in order to maintain a clean and sanitary environment to avoid transmission of infection. Specifically, the facility failed to ensure staff reprocessed surgical instruments and scopes according to manufacturer instructions for use (IFU). In addition, the facility failed to ensure the enzymatic solution used to reprocess surgical instruments and scopes was not expired.

C-1239 Standard: Leadership responsibilities (2) The infection prevention and control professional(s) is responsible for:] (iv) Competency-based training and education of CAH personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the CAH, on the practical applications of infection prevention and control guidelines, policies and procedures. Based on document review and interviews, the facility failed to ensure the infection control coordinator who provided oversight of the sterilization and processing department (SPD), was educated on how to reprocess surgical instruments and scopes according to manufacturer instructions for use (IFU) and national guidelines.

Based on observations, interviews and document review, the facility failed to ensure infection prevention and control measures were implemented in order to maintain a clean and sanitary environment to avoid transmission of infection. Specifically, the facility failed to ensure staff reprocessed surgical instruments and scopes according to manufacturer instructions for use (IFU). In addition, the facility failed to ensure the enzymatic solution used to reprocess surgical instruments and scopes was not expired.

Findings include:

Facility Policies:

The Sterilization and Cleaning of Scopes policy read, follow manufacturer's directions for using the Olympus Endoscope Reprocessor OER-Pro.

The Cleaning of Instruments policy read, mix enzymatic detergent solution in warm tap water (110-140 degrees fahrenheit) per manufacturer's instructions. Allow to soak in solution 5-15 minutes.

Reference:

The manufacturer's instructions for use (IFU) for Endozyme AW dual enzymatic detergent (a cleaner used to preclean surgical instruments and scopes prior to being placed into an automated washer) read, soak for two minutes to remove all organic matter. Rinse thoroughly with tap, distilled, or sterile water.

The Association for Professionals in Infection Control and Epidemiology, Inc (APIC) provided by the facility on 2/14/23 read, it was important for the processing staff to be familiar with the principles of cleaning equipment and sterilizers, and the IFU for chemical solutions, cleaning tools, disinfectants, packaging, cleaning, and sterilization monitors. The instructions provide the information necessary to safely use, monitor the efficacy, and conduct preventive maintenance to ensure quality and process reliability. The chemical solution manufacturer's recommendations provide guidance on the selection, use, mixing, and monitoring of the effectiveness of chemical agents and how to select the type of water (tap, deionized, or distilled) required for product use. The IFU must be followed for the expected outcome of safe, functional, and sterile items that prevent transmission of pathogens and surgical site infections (SSIs).

The Olympus Scope Reprocessing Manual Guidance provided by the facility on 2/14/23 for the specific scope models used at the facility read, high-level disinfectant solutions were only effective when used according to the disinfectant manufacturer's instructions. Follow the manufacturer's instructions regarding activation (if required), concentration, temperature, contact time and use life required to achieve high-level disinfection. If the disinfectant solution is reused, check its efficacy with a test strip according to the disinfectant manufacturer's recommendations prior to use.

The Olympus Operations Manual Instructions for Endoscope Reprocessor OER-Pro (an automated washer used to clean scopes to be reused) read, prior to reprocessing, check the concentration of the disinfectant solution using a test strip to verify the concentration of disinfectant solution meets the minimum recommended concentration. Replace the disinfectant solution when it fails to meet the minimum recommended concentration or beyond the specified use life.

1. The facility failed to ensure surgical instruments and scopes were reprocessed according to manufacturer's instructions and ensure the enzymatic solution used to reprocess surgical instruments and scopes was not expired.

A. Observations

a. On 2/13/23 at 4:23 p.m., observations of the decontamination area of the sterile processing department revealed three bottles of expired enzymatic detergent.

i. One open bottle of Endozime AW dual enzymatic detergent was observed next to the sink which had expired in 2/22.

ii. One bottle of Prolystica enzymatic detergent was observed hooked to the STERIS instrument washer had expired on 10/1/16.

iii. A second bottle of Prolystica enzymatic detergent was observed under the counter and had expired on 10/1/16.

b.. Additional observations on 2/14/23 at 9:00 a.m. of the scope processing area revealed no timing device was available to ensure the instruments soaked in the enzymatic solution according to the IFU for the enzymatic detergent.

B. Interviews

i. On 2/14/23 and 2/15/23 interviews were conducted with certified nurse assistant (Assistant) #5. Assistant #5 stated she submerged scopes in the enzymatic solution for five to ten minutes. Assistant #5 stated she was not aware of a specific instruction of recommended soak time for scopes or instruments in the enzymatic solution. Assistant #5 stated the integrity of the scope could be compromised if left in the enzymatic solution longer than the recommended time on the enzymatic IFU. Assistant #5 stated she did not use a timer when soaking instruments in the enzymatic solution. Assistant #5 stated surgical instruments and scopes were at risk for cross-contamination and risked not being cleaned as indicated if the enzymatic solution was expired.

Further interview questions asked of Assistant #5 on 2/14/23 at 11:00 a.m., revealed she conducted no test of the scope washer or used the acecide test strips seen on the side table across from the washer except when the washer was used for a second day with the same chemicals.

During a follow-up interview conducted on 2/15/23 at 10:30 a.m., Assistant #5 stated she followed IFU's for scopes and instruments reprocessed at the facility. Assistant #5 further stated the patient was at risk of infection or the scope might not work as intended if the manufacturer's IFU for the instrument was not followed for sterile processing.

This was in contrast to the manufacturer's instructions for use of the enzymatic solution which read, soak for two minutes. In addition, this was in contrast to the national guidelines the facility referenced for reprocessing of instruments which read, the chemical solution manufacturer's recommendations provide guidance on the selection, use, mixing, and monitoring of the effectiveness of chemical agents and how to select the type of water (tap, deionized, or distilled) required for product use. This was also in contrast to the Olympus Scope Reprocessing Manual Guidance which read, high-level disinfectant solutions were only effective when used according to the disinfectant manufacturer's instructions.

ii. On 2/15/23 at 12:45 p.m., an interview with Coordinator #4 was conducted. Coordinator #4 stated she was responsible for oversight of the sterile processing department at the facility. Coordinator #4 stated IFU's were utilized at the facility. Coordinator #4 stated the IFU was important to follow to ensure a particular instrument was properly cleaned to avoid healthcare associated infections.

Based on document review and interviews, the facility failed to ensure the infection control coordinator who provided oversight of the sterilization and processing department (SPD), was educated on how to reprocess surgical instruments and scopes according to manufacturer instructions for use (IFU) and national guidelines.

Findings include:

References:

The Association for Professionals in Infection Control and Epidemiology, Inc (APIC) provided by the facility on 2/14/23 read, consistent implementation of up-to-date published recommended practices and standards of care and up-to-date IFU will facilitate the achievement of positive patient outcomes and quality services. Orientation and continued educational training on expected practice and regulations are essential for sterilization processing department (SPD) staff. The infection preventionist (IP) should be familiar with these processes when conducting infection control rounds in sterilization processing (SP) as recommended by HICPAC (a federal advisory committee appointed to provide advice and guidance to Department of Health and Human Services(DHHS) and Centers for Disease Control (CDC) regarding the practice of infection control and strategies for surveillance, prevention, and control of healthcare-associated infections, antimicrobial resistance and related events in United States healthcare settings) and should routinely include results of monitoring activities in the infection prevention and control program reports.

The Infection Control Coordinator job description read under job duties, maintains established policies and procedures, objectives, performance improvement program, safety, environmental, and infection control standards, consults with other nursing personnel on the implementation of infection control policies and procedures, identification and isolation of infection, and related problems, makes regular rounds seeking clues of infection and maintains a continuous record of each infection noted, collects statistics and prepares and submits regular reports to the infection control committee, implements infection control measures and teaches and demonstrates infection control to all hospital personnel involved in patient care.

1. The facility failed to ensure the infection control coordinator at the facility had a certification or training related to reprocessing of instruments and scopes.

A. On 12/16/23 at 9:50 a.m., a review of Infection Control Coordinator (Coordinator) #4's personnel file was conducted which included a review of her job description. Coordinator #4's job description read she was responsible for overseeing the facility's infection control program including implementing, teaching, and demonstrating infection control to all personnel involved in patient care. Further review of Coordinator #4's personnel file revealed she had no training or certification in sterile processing of instruments or scopes, nor was it a requirement of her job description.

This was in contrast to the APIC national guidelines utilized by the facility which read, orientation and continued educational training on expected practice and regulations were essential for SPD staff. The IP should be familiar with processes during infection control rounds in SPD regarding the practice of infection control and strategies for surveillance, prevention, and control of healthcare-associated infections, antimicrobial resistance and related events and routinely include results of monitoring activities in the infection prevention and control program report.

B. On 12/15/23 at 12:45 p.m., an interview with Coordinator #4 was conducted. Although her job description read she was responsible for infection control oversight of the SPD, Coordinator #4 stated she had not received any formal training or certification nor had any experience with sterile reprocessing of instruments or scopes. Coordinator #4 stated no process was in place to ensure surgical instruments and scopes were reprocessed according to manufacturer instructions for use and national guidelines followed by the facility. Coordinator #4 stated she had not completed infection control audits related to SPD at the facility. Coordinator #4 stated she had not performed any training with SPD staff related to infection prevention.

C. On 1216/23 at 9:50 a.m., a review of personnel files was conducted. During the review, it was revealed Assistant #5's most recent training completed related to sterile processing occurred in 2019.

During an interview on 2/15/23 at 10:30 a.m., certified nurse assistant (Assistant) #5 stated she performed the cleaning of instruments in SPD. She stated she had completed training with Olympus for scope reprocessing approximately one and a half years ago, but did not acknowledge she had received any training within the past year from Coordinator #4 regarding infection control in the SPD area. Assistant # 5 stated she allowed her certification to reprocess instruments lapse and did not have a current certification.