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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, EMERGENCY SERVICES, was out of compliance.

C-0884. Equipment, supplies, and medication used in treating emergency cases are kept at the CAH and are readily available for treating emergency cases. Based on observations, interviews, and document review, the facility failed to ensure equipment located on the emergency crash carts (a cart stocked with supplies used in life-threatening emergencies) was in working order and readily available for treating emergency cases in three of three crash carts.

C-0886. Drugs and biologicals commonly used in life-saving procedures, including analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids, antiarrythmics, cardiac glycosides, antihypertensives, diuretics, and electrolytes and replacement solutions. Based on observations, document review, and interviews, the facility failed to stock commonly used drugs used in life-saving procedures. Specifically, the facility stocked succinylcholine (a medication used during surgical procedures that paralyze muscles) but failed to stock the recommended amount of dantrolene, the reversal agent for malignant hyperthermia (a potentially fatal condition characterized by generalized muscle spasms, fever, fast heart rate, fast breathing, and increased demand for oxygen). Additionally, the facility failed to ensure policies and procedures were followed for checking expired medications in one of three crash carts (a cart stocked with supplies used in life-threatening emergencies).

C-0888. 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 equipment and supplies commonly used in life-saving procedures, were available for patient use and not expired. Specifically, the facility failed to ensure expired emergency medical supplies were removed from inventory and not available for patient use in two of three emergency crash carts (a cart used to store medical supplies and medications used during an emergency) and one of one burn kit observed.

Based on observations, interviews, and document review, the facility failed to ensure equipment located on the emergency crash carts (a cart stocked with supplies used in life-threatening emergencies) was in working order and readily available for treating emergency cases in three of three emergency crash carts.

Findings include:

Facility policy:

According to the Emergency Crash Cart and Equipment Maintenance policy, nursing staff, each shift, will check the defibrillator and portable suction on each crash cart to ensure the operability of the equipment. This will be recorded on a log to be kept on the crash cart.

References:

According to the Acute Care Unit (ACU) Crash Cart Check log, the equipment check for the acute care unit crash cart includes checking the defibrillator (a device that applies an electric charge to the heart to restore a heartbeat) and the portable suction machine (a machine used to remove excessive secretions from the patient during an emergency) to ensure both are in working order.

According to the Emergency Department (ED) Crash Cart Check log, the equipment check for the emergency department crash cart includes checking the defibrillator, the portable suction machine, the emergency medical services (EMS) communication radio is on its charger, and the drawers of the cart have locked tags on them.

1. The facility failed to ensure the equipment located on the crash carts were regularly checked in accordance with facility policy to ensure they were in working order and readily available in an emergency.

A. Observations

i. On 8/21/23 at 10:55 a.m., an observation was conducted in the acute care unit for the crash cart. The observation of the crash cart log, located on top of the crash cart, revealed three shifts for the current month were missing the equipment checks (8/12/23 dayshift, 8/13/23 nightshift, and 8/20/23 dayshift).

ii. On 8/24/23 at 11:30 a.m., an observation was conducted in the emergency department to observe the two crash carts in the department. The observation revealed three shifts (8/18/23 dayshift, 8/20/23 dayshift, and 8/20/23 nightshift) for the current month were missing the equipment checks on the crash cart located in the main treatment room of the emergency department. Additionally, observation of the second crash cart, located in the procedural area of the emergency department, revealed the crash cart log was missing four (8/8/23 nightshift, 8/9/23 dayshift, 8/12/23 dayshift, and 8/14/23 nightshift) equipment checks for the current month.

B. Document Review

i. A document review was conducted for the crash cart logs in the acute care unit and emergency department. The document review revealed ten missed checks from 5/1/23 to 8/24/23 for the acute care unit crash cart. Additionally, the document review revealed 26 missed checks for the two crash carts in the emergency room from 5/1/23 to 8/24/23.

These observations and document reviews were in contrast to the facility policy that read nursing staff, each shift, would check the defibrillator and portable suction on each crash cart to ensure the operability of the equipment. The policy further read that the checks would be recorded on a log to be kept on the crash cart.

C. Interviews

i. On 8/30/23 at 11:27 a.m., an interview was conducted with registered nurse (RN) #8. RN #8 stated the crash carts were checked daily by nursing staff on the unit. RN #8 stated she was trained that the checks included looking for outdated supplies kept outside the locked drawers, ensuring the suction machine was working, ensuring the oxygen tank was operational, and the drawers had a lock tag secured in place. RN #8 stated if the lock was not on the drawers at the time of the check, she checked the content in the drawers for expired supplies. RN #8 stated daily crash cart checks were performed to prevent delay of treatment or loss of life. RN #8 stated it was the responsibility of nursing staff to support and ensure the carts were checked.

ii. On 8/24/23 at 11:30 a.m., an interview conducted with director of nursing (DON) #9 revealed RNs checked the crash carts in the acute care unit and emergency departments each shift. DON #9 stated checking the crash carts ensured equipment on the cart was in working order and functioning in the event of an emergency. DON #9 stated not checking crash carts every shift limited the ability for staff to be certain the equipment was functional during an emergency. DON #9 stated other risks included delayed care to patients, including possible death.

Based on observations, document review, and interviews, the facility failed to stock commonly used drugs used in life-saving procedures. Specifically, the facility stocked succinylcholine (a medication used during surgical procedures that paralyze muscles) but failed to stock the recommended amount of dantrolene, the reversal agent for malignant hyperthermia (a potentially fatal condition characterized by generalized muscle spasms, fever, fast heart rate, fast breathing, and increased demand for oxygen). Additionally, the facility failed to ensure policies and procedures were followed for checking expired medications in one of three crash carts (a cart stocked with supplies used in life-threatening emergencies).

Findings include:

Facility policies:

The Succinylcholine Use in Rapid Sequence Intubation (a process where a breathing tube is inserted through the nose or mouth of the person to help them breathe) policy read, it is the facility policy of the facility that to reduce the risks of Malignant Hyperthermia (MH) with the use of Succinylcholine, we will ensure that Succinylcholine is only used in the facility when we have Dantrolene available. References: Malignant Hyperthermia Association of the United States. www.mhaus.org.

The Emergency Crash Cart and Equipment Maintenance policy read, the nursing staff will, on a monthly rotational basis, be scheduled to check the hospital and emergency department crash cars for outdated medication and equipment. In addition to this, inpatient pharmacy staff will also conduct monthly checks of medication for outdates.

Reference:

According to the Malignant Hyperthermia Association of the United States (MHAUS) guideline How Much Dantrolene Should be Available in Facilities Where Volatile Agents are Available or Administered, and Succinylcholine is Only Stocked on Site for Emergency Purposes (2018) provided by the facility, in a small percentage of cases malignant hyperthermia appears to be triggered by succinylcholine alone in the absence of a volatile agent. Dantrolene must be available for all anesthetizing locations where MH trigger agents are used. MHAUS recommends that centers stock a minimum of 36 20-milligram (mg) vials of Dantrium or Revonto (total dose 720 mg), or three 250 mg vials of Ryanodex (total dose 750 mg). These amounts of dantrolene were originally determined by the analysis of MH event data showing that some cases of acute MH required up to or more than 10 mg/kg body weight, and therefore these total dose amounts would suffice for the majority of average-sized patients that develop MH.

The consensus of our experts was that the incidence of MH induced by succinylcholine alone is not rare enough to justify the absence of dantrolene wherever succinylcholine may potentially be administered. Facilities that stock and have the potential to administer any triggering agent, including succinylcholine without volatile agents, should have dantrolene immediately available in the event that a patient in that facility develops MH.

1. The facility failed to stock the recommended amount of dantrolene, a medication used to mitigate the effects of malignant hyperthermia (MH), a possible side effect from the administration of succinylcholine.

a. Observations

i. On 8/21/23 at 3:50 p.m., observations of the emergency department (ED) trauma room medication refrigerator revealed succinylcholine and two 20 mg vials of dantrolene in the intubation kits.

ii. On 8/21/23 at 4:48 p.m., observations of the medication storage area revealed four additional 20 mg vials of dantrolene.

This was in contrast to the Malignant Hyperthermia Association of the United States (MHAUS) guideline, which read, MHAUS recommended that centers stock a minimum of 36 20-mg vials of dantrium or Revonto (total dose 720 mg) or three 250 mg vials of Ryanodex (total dose 750 mg).

b. Interviews

i. On 8/21/23 at 5:11 p.m., an interview with registered nurse (RN) #8 revealed she was not able to speak on what malignant hyperthermia was, how it was treated, or how much medication was necessary to treat an episode of malignant hyperthermia.

ii. On 8/21/23 at 5:17 p.m., an interview with RN #10 revealed succinylcholine was a medication used during the intubation process to keep the patient's airway open, and malignant hyperthermia was a life-threatening reaction to succinylcholine. RN #10 stated dantrolene was used to treat this condition, however, RN #10 stated she was not sure of the amount of dantrolene needed to treat an episode of MH. RN #10 stated the patient was at risk for death if the facility did not have enough dantrolene available to treat an episode of malignant hyperthermia.

iii. On 8/21/23 at 4:48 p.m., an interview with Pharmacist #6 was conducted. Pharmacist #6 stated the facility only had six vials of dantrolene available. Pharmacist #6 stated the facility followed the Malignant Hyperthermia Association of the United States (MHAUS) guidelines for treating malignant hyperthermia. Pharmacist #6 stated dantrolene was a medication used to reverse the potential life-threatening reaction to succinylcholine. Pharmacist #6 stated he was not aware of how much dantrolene was needed to treat an episode of malignant hyperthermia at the facility. Pharmacist #6 stated a patient was at risk for death if the facility did not have enough dantrolene available to treat an episode of malignant hyperthermia.

iv. On 8/21/23 at 5:25 p.m., an interview with the director of nursing (DON) #9 was conducted. DON #9 stated succinylcholine was used during the intubation of a patient, and malignant hyperthermia was a reaction to the use of succinylcholine. DON #9 stated she believed only six vials of dantrolene were needed to treat an episode of malignant hyperthermia at the facility. DON #9 was not able to state the national guidelines the facility followed to treat an episode of MH. DON #9 stated the patient was at risk for death if the facility did not have enough dantrolene available to treat an episode of MH.

2. The facility failed to ensure policies and procedures were followed for ensuring expired medications were removed from the crash carts.

a. On 8/22/23 at 10:40 a.m., an observation conducted on the acute care unit revealed the acute care unit crash cart had expired medications. Two vials of 8.4% Sodium Bicarbonate Injection (a medication used to treat emergency conditions causing the blood to be too acidic) expired on June 1, 2023. There were no unexpired vials available in the crash cart.

b. On 8/22/23 at 10:40 a.m., an interview was conducted with the assistant chief nursing officer (ACNO) #11. ACNO #11 stated nursing personnel completed the process for checking expired supplies after opening the crash cart for an emergency use, and pharmacy personnel checked the crash cart monthly. ACNO #11 stated it was important to check for expired medications so medications were available during an emergency. ACNO #11 stated having outdated medications put patients at risk of not getting the full effects of the medication and potentially causing more harm to the patient.

c. On 8/30/23 at 11:27 a.m., an interview was conducted with registered nurse (RN) #8. RN #8 stated nursing staff checked the crash carts for expired supplies at the end of the month. RN #8 stated pharmacy staff counted the inventory of medications and replaced medications when outdated or expired on a monthly basis. RN #8 stated following emergency use of the crash cart, pharmacy staff checked the crash cart for expired medications at that time. RN #8 stated if nursing staff found expired medications during the checks, they removed the medications and notified pharmacy staff. RN #8 stated expired medications were concerning because the efficacy of the medications were diminished. RN #8 explained that this meant the medication would not work as intended and could result in delayed treatment or possible death.

d. On 8/30/23 at 1:20 p.m., an interview was conducted with Pharmacist #6. Pharmacist #6 stated the monthly process for checking crash carts included a standard work document of multiple tasks and the document did not list specific medications to check in the crash cart. Pharmacist #6 stated pharmacy staff checked all medications in the crash carts. Pharmacist #6 stated following emergency use of the crash cart, pharmacy staff checked the crash carts by the next business day when possible. Pharmacist #6 stated pharmacy staff pulled expiring medications from the crash carts. Pharmacist #6 stated staff performed checks for expired medications to ensure patient safety during medication administration. Pharmacist #6 stated expired medications administered to a patient had a potential lack of efficacy and diminished treatment results for the patient.

This was in contrast to the Emergency Crash Cart and Equipment Maintenance policy which read the nursing staff would, on a monthly rotational basis, be scheduled to check the hospital and emergency department crash cars for outdated medication and equipment. In addition to this, inpatient pharmacy staff would also conduct monthly checks of medication for outdates.

Based on observations, document review, and interviews, the facility failed to ensure equipment and supplies commonly used in life-saving procedures were available for patient use and not expired. Specifically, the facility failed to ensure expired emergency medical supplies were removed from inventory and not available for patient use in two of three emergency crash carts (a cart used to store medical supplies and medications used during an emergency) and one of one burn kit observed.

Findings include:

Facility policies:

The Outdate Checks Policy and Procedure policy read, it is the policy of the facility to check monthly for outdated supplies used for patient care in all areas of the ACU, ECU, and emergency rooms. These checks will be performed approximately at the end of each month to ensure that things that expire on the first of the following month are caught in a timely manner. One nurse will be assigned to each area for every month. The nurse will pull all outdated or close to outdated items from patient care areas.

The Outdated Supplies policy read, in order to ensure that the supplies used for patient care are not outdated, departments will remove and replace all outdated supplies according to the applicable department policies and/or procedures.

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

a. Observations

i. On 8/21/23 at 3:05 p.m., observations of the emergency department (ED) trauma room burn kit revealed one silver-coated 100% silicone Foley insertion tray (a kit used to collect urine) expired on 1/1/2023.

ii. On 8/21/23 at 3:20 p.m., observations of the ED adult crash cart revealed three 20 gauge needles expired on 12/31/22, two 22 gauge safety needles expired on 5/31/23, and two 20 gauge safety needles expired on 4/30/23.

iii. On 8/21/23 at 3:30 p.m., observations of the ED pediatric crash cart revealed one 25 gauge safety needle expired on 11/30/22, one 18 gauge needle expired on 2/28/23, one size 1 supraglottic airway (a device inserted into the pharynx (the throat) to help a person breathe) expired 4/23, one size 1.5 supraglottic airway expired 7/23, two, size 2.5 supraglottic airways expired 2/23, one size 2 supraglottic airway expired 11/22, and one nasopharyngeal airway (a plastic tube inserted through the nose to assist a person with breathing) size 24 french expired on 7/28/23.

This was in contrast to The Outdate Checks Policy and Procedure policy, which read it was the policy to check monthly for outdated supplies used for patient care in all areas of the ACU, ECU, and emergency rooms. The checks were to be performed approximately at the end of each month to ensure expired supplies were caught in a timely manner. One nurse was assigned to each area for every month. The nurse was to pull all outdated or close to outdated items from patient care areas. This was also in contrast to the Outdated Supplies policy which read, in order to ensure supplies used for patient care were not outdated, departments removed and replaced all outdated supplies according to the applicable department policies and/or procedures.

b. Interviews

i. On 8/24/23 at 11:52 a.m., an interview with registered nurse (RN )#7 was conducted. RN #7 stated nursing staff were responsible for checking emergency medical supplies monthly. RN #7 stated each crash cart was checked monthly as well as other medical supplies in the ED. RN #7 stated any expired medical supplies were removed right away and documented on a log for the purchasing department to replace. RN #7 stated a silver-coated Foley tray was used for urinary collection and the silver provided protection from bacterial growth. RN #7 stated the patient was at risk for infection if an expired Foley tray was used in patient care. RN #7 stated needles in the ED were used for collecting blood and injecting medications during emergency situations. RN #7 stated needles might have malfunctioned and broken causing an embolism (obstruction of a blood vessel) or possible death if used after the expiration date in patient care. RN #7 stated supraglottic airways were used to provide quick airway access when an airway was obstructed. RN #7 stated supraglottic airways were important as they provided the quickest way to keep an airway open during an emergency situation. RN #7 stated the patient was at risk for infection, requiring an additional airway insertion, or death if an expired supraglottic airway was used in patient care. RN #7 stated a nasopharyngeal airway was used to keep a person's airway open during distress. RN #7 stated the patient was at risk for the airway to be compromised if an expired nasopharyngeal airway was used in patient care. RN #7 stated expired medical supplies used in patient care placed the patient at risk for infection and injury.

ii. On 8/24/23 at 12:18 p.m., an interview with registered nurse (RN) #8 was conducted. RN #8 stated both the purchasing staff and nursing staff worked together to check medical supplies for expiration dates. RN #8 stated medical supplies were at risk for failure if expired. RN #8 stated the patient was at risk for the supply malfunctioning, not working as intended, and even at risk for harm from the expired supply. RN #8 stated a silver-coated Foley tray was used to drain urine from the bladder and the silver decreased infection risk. RN #8 stated the patient was at risk of the Foley not working as intended and less effective if used in patient care after the expiration date. RN #8 stated needles were used in the ED to administer medications, collect blood, and aspirate fluids. RN #8 stated needles were at risk for breaking and the patient might experience a delay in treatment if they expired and were used in patient care. RN #8 stated a supraglottic airway was used to keep the patient airway open to ensure proper breathing. RN #8 stated the patient was at risk of death if the supraglottic airway was expired and used in patient care.

iii. On 8/24/23 at 12:35 p.m., an interview with the director of nursing (DON) #9 was conducted. DON #9 stated nursing staff checked each crash cart and other medical supplies every month for expiration dates. DON #9 stated nurses checked random areas of the facility weekly for outdated supplies to ensure all areas were checked each month. DON #9 stated outdated medical supplies were documented on a log for the purchasing department to be aware of. DON #9 stated an expired medical supply might not work as intended if used in patient care. DON #9 stated the patient was at risk for injury if an expired medical supply was used in patient care.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.635, PROVISION OF SERVICES, was out of compliance.

C-1049 §485.635(d)(3) All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. Based on observations, interviews, and document review, the facility failed to ensure all patients had a visible means of identification in order to verify their identity in 15 of 17 patients observed during observation of a medication administration.

Based on observations, interviews, and document review, the facility failed to ensure all patients had a visible means of identification in order to verify their identity in 15 of 17 patients observed during observation of a medication administration.

Findings include:

Facility policy:

According to the Medication Administration Policy, the individual administering a medication is responsible for following safety guidelines and assuring accuracy by using the nine rights of medication administration. Prior to administration the patient should be identified using two unique identifiers on identification band or medical record.

1. The facility failed to ensure a process was in place for staff to identify a patient through a visible means of identification placed on the patient during medication administration.

a. On 8/21/23 at 11:50 a.m., an observation was conducted on the inpatient acute care unit to observe registered nurse (RN) #12 perform medication administration to Patient #19 and Patient #20 in the common dining area of the unit. After RN #12 logged into the electronic medical record (EMR) and looked at the medication administration record (MAR), RN #12 opened the medication cart and removed the medication. RN #12 then took the medication to Patient #19 and administered the medication to the patient without verifying the patient's name, date of birth, or other identifiers. RN #12 repeated this process for Patient #20. RN #12 did not perform a two-patient identification check prior to administering the medication to either patient. Additionally, observations revealed 15 of 17 patients in the common dining area did not have a patient identification armband.

These observations were in contrast with facility policy. According to the Medication Administration Policy, staff administering medications were required to use the nine rights of medication administration and two unique identifiers on identification bands or medical records.

b. On 8/21/23 at 12:05 p.m., an interview was conducted with RN #12. RN #12 stated the facility's expected process of using two patient identifiers was inconsistent. RN #12 stated patients wearing identification bands was a new practice and the bands had been newly placed on Patient #19 and Patient #20 on the morning of 8/21/23. RN #12 stated the importance of using two patient identifiers during medication administration was to prevent medication errors. RN #12 stated the risk of not using two patient identifiers was giving the wrong medication to the wrong patient and causing harm to the patient.

c. On 8/21/23 at 1:20 p.m., an interview was conducted with the assistant chief nursing officer (ACNO) #11. ACNO #11 stated the facility identified the need for identifying patients by using patient identification bands approximately one month ago. ACNO #11 stated the new process started on the morning of 8/21/23 by placing patient identification bands on Patient #19 and Patient #20. ACNO #11 stated the project of implementing patient identification bands on all patients still lacked a policy, staff education, and an audit process that ensured compliance. ACNO #11 stated the facility expedited the new process due to the initiation of the state survey on 8/21/23. ACNO #11 stated the importance of using patient identification bands and two patient identifiers was for proper patient identification during medication administration. ACNO #11 stated the risk of not using two patient identifiers was giving the wrong medication, wrong treatment, or wrong procedure to the wrong patient and causing patient harm.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.640, INFECTION PREVENTION AND CONTROL AND ANTIBIOTIC STEWARDSHIP PROGRAMS, was out of compliance.

C-1206 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 food processing equipment, utensils, and other items in contact with food were sanitized in accordance with the manufacturer's instructions for use to avoid sources of transmission of infection in one of one observation of the cleaning of equipment in the kitchen.

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 authorities. Based on observations, document review, and interviews, 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 in three of three instrument cleaning areas observed. 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. Additionally, the facility failed to follow nationally recognized guidelines by providing an area for clean patient supply storage distinctly separated from the soiled utility room in one of one storage rooms observed.

Based on observations, interviews, and document review, the facility failed to ensure food processing equipment, utensils, and other items in contact with food were sanitized in accordance with the manufacturer's instructions for use to avoid sources of transmission of infection in one of one observation of the cleaning of equipment in the kitchen.

Findings include:

Reference:

Intercon Grade A Instructions for Use (IFU) read, to sanitize food processing equipment, utensils, and other food contact articles regulated by 40 CFR §180.950(a) in a three compartment sink, sanitize by immersing articles with a use-solution of 2 oz. of this product per 5 ¾ - 2 7/8 gallons of water for at least 60 seconds.

1. The facility failed to follow the manufacturer's instructions for use in the sanitization phase of washing food processing equipment, utensils, and other items in contact with food.

a. On 8/22/23 at 4:00 p.m., observations were conducted in the dietary department of the facility. Observations revealed Cook #14 manually washed food processing equipment and utensils in the three sink area. Cook #14 used sink #1 to wash the equipment, sink #2 to rinse the equipment, and sink #3 to sanitize the equipment. Cook #14 used Intercon Grade A sanitizer in sink #3 to sanitize the food processing equipment. Cook #14 placed the food processing equipment into sink #3 and returned to sink #1 and washed additional utensils. Cook #14 then removed the food processing equipment from sink #3 less than 30 seconds later and placed it on a rack to dry.

b. On 8/22/23 at 4:05 p.m., an interview was conducted with Cook #14. Cook #14 stated she did not track the time for the food processing equipment in the sanitization phase in sink #3. Cook #14 stated her usual practice was to return to sink #1 to wash additional equipment while she waited for the food processing equipment in sink #3 to complete the sanitizing process. Cook #14 stated she waited approximately 15 seconds for the sanitizing process when there was no need to return to sink #1. Cook #14 stated improperly sanitized food processing equipment could result in patient illness.

c. On 8/22/23 at 4:15 p.m. and 8/31/23 at 10:27 a.m., interviews were conducted with Dietary Director #13. Dietary Director #13 stated the sanitization phase of washing food processing equipment was to ensure the equipment was completely sanitized. Dietary Director #13 stated sanitizing food processing equipment ensured there was no bacteria and other organisms present on the equipment. Dietary Director #13 stated 15 seconds was a reasonable amount of time to complete sanitization. Dietary Director #13 stated the IFU was on the back of the Intercon Grade A sanitizing solution container and staff knew how to use the product.

In the second interview, Dietary Director #13 stated the IFU indicated a two minute soak time for the sanitization phase and thought a minute of soak time in the solution was enough time. Dietary Director #13 stated it was not a significant risk, nor was it imperative that the equipment was left in the sanitizing solution for a designated period of time. Dietary Director #13 stated items were sufficiently sanitized when the staff dipped the food processing equipment into the sanitizing solution. Dietary Director #13 was unable to provide a policy or guidelines from the Food and Drug Administration (FDA) which she stated the facility followed for kitchen practices. Dietary Director #13 stated all FDA guidelines recommended following product IFUs.

This practice was in contrast to the Intercon Grade A IFU that read to sanitize food processing equipment, utensils, and other food contact articles sanitize by immersing articles with a use-solution of 2 oz. of this product per 5 ¾ - 2 7/8 gallons of water for at least 60 seconds.

Based on observations, document review, and interviews, 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 in three of three instrument cleaning areas observed. 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. Additionally, the facility failed to follow nationally recognized guidelines by providing an area for clean patient supply storage distinctly separated from the soiled utility room in one of one storage rooms observed.

Findings include:

Facility policy:

The facility's Instrument Sanitization and Steam Sterilization policy read, the purpose was to be a guide for personnel in preparing instruments for steam sterilization. The first step in the procedure read that before handling any type of biological waste don personal protective equipment (PPE) including disposable isolation gowns, safety glasses, gloves, and closed-toe shoes.

As soon as possible following a procedure in which an instrument is contaminated, transport the instruments to the sink, rinse, and place them in an enzymatic cleaner for sanitization for the appropriate amount of time according to cleaner instructions. Scrub each instrument to decontaminate, rinse well, and lay flat to dry. Package instruments in sterilization envelopes, place internal process indicators inside, and seal them with color change indicator tape. Load packages into the autoclave trays and sterilize them as per the sterilizer instruction manual.

References:

The Enzol enzymatic detergent IFU read, ENZOL detergent is a mild pH detergent formulated for cleaning endoscopic instruments and general equipment. The expiration date is located on the container.

The Integra Miltex instrument IFUs read, manually clean instruments with a neutral pH detergent. Rinse instruments with distilled water to remove all traces of cleansing agents. Use a water-soluble instrument lubricant compatible with sterilization prior to sterilizing instruments as proper lubrication is required for all instruments. Instruments may be packaged in rigid containers or packaging cleared for sterilization. The packaging should ensure the sterility of the instruments until the packaging is opened for use and permit the removal of the instrument without contamination, see ANSI/AAMI ST79.

The McKesson/Argent IFU read, personnel should follow accepted guidelines as recommended in ANSI/AAMI ST79. The decontamination procedure does not sterilize the instruments. Refer to and process the instruments as outlined for sterilization. To preclean, remove gross contaminants with a steady stream of lukewarm/cool water (below 110°F/43°C). Use a neutral pH detergent to avoid corrosion, pitting, and breakage. Rinse all instruments thoroughly with distilled water. Use a water-soluble instrument lubricant on the instruments prior to sterilization as proper lubrication is required for all instruments. The packaging should ensure the sterility of the instruments until the packaging is opened for use and permit the removal of the instrument without contamination.

The ANSI/AAMI ST79:2017 & 2020 Guidelines read, instruments should be positioned to allow the sterilant to come into contact with all surfaces.

The Mpack sterilization pouches IFU read, dimensions of the medical device to sterilize should not exceed ¾ of the pouch space.

The facility's Infection Control Plan 2023 read, the facility supports the Infection Prevention (IP) Program designed to ensure the safety of patients within its healthcare environment. The IP Program is built on the foundations of reducing the risk of acquiring a healthcare-associated infection (HAI) in our patient population. The Infection Prevention/Antimicrobial Stewardship Committee has the authority to institute any surveillance, prevention or control measures, or study when there is a reason to believe that any patient may be at risk of contracting or transmitting infectious disease.

According to the Centers for Disease Control and Prevention (CDC) Healthcare-Associated Infections (HAIs) 4.7.2 (5/4/23), the clean area should be distinctly separate from (by workflow) soiled areas of Sluice rooms (a soiled utility room designed for waste disposal or cleaning of soiled equipment).

1. The facility failed to ensure instruments reprocessed were cleaned according to facility policy and the manufacturer's IFU.

A. Between 8/21/23 and 8/22/23, observations were conducted in areas of the facility where reprocessing of surgical instruments and endoscopes (medical devices with a light attached to look inside a body cavity or organ) occurred.

i. Observations revealed staff did not don the correct PPE before cleaning instruments and scopes according to facility policy. In three of three observations, staff failed to wear face protection. In two of three observations, staff failed to wear a gown to protect themselves during instrument cleaning. For example:

a. Observations on 8/21/23 at 1:02 p.m. in the specialty clinic instrument cleaning room revealed Director #2 cleaned podiatry (foot) instruments without wearing a gown or face protection.

b. Observations on 8/23/23 at 3:10 p.m. in the scope cleaning room revealed medical assistant (MA) #1 performed colonoscope (a medical device with a light at the end to visualize the colon) reprocessing without face protection.

ii. Observations revealed the Enzol enzymatic detergent used to manually clean surgical instruments was not a pH-neutral enzymatic. This was in contrast to both the Miltex and McKesson instrument IFUs which read that a neutral pH enzymatic be used to manually clean instruments.

Further, the Enzol enzymatic detergent was expired in two of the three locations observed:

a. In the specialty clinic instrument cleaning room, the Enzol had an expiration date of 3/31/2022.

b. In the scope cleaning room, the Enzol had an expiration date of 3/30/23.

iii. Observations revealed staff was using tap water that had not been demineralized to rinse instruments in three of three observations. In contrast, the manufacturer's IFUs stated to rinse instruments thoroughly under warm distilled or demineralized water.

iv. Observations in the specialty clinic revealed the instrument lubricant and rust inhibitor solution used to lubricate reprocessed medical instruments expired in February of 2023.

Using the instrument lubricant and rust inhibitor solution was a required step in reprocessing according to both the Miltex and McKesson instrument IFUs, which read that use of a water-soluble instrument lubricant on the instruments prior to sterilization was required for all instruments.

v. Observations on 8/22/23 at 2:13 p.m. of the sterile instrument storage closet off of the procedure room revealed two autoclave pouches, each with more than 10 medical instruments that had been autoclaved together. The two pouches were more than 75% full. Further, multiple hinged instruments were observed to have been autoclaved in the closed position.

Additionally, two other peel pouches in the sterile instrument storage closet were observed to have holes in them which had compromised the sterile integrity of the instruments.

This was in contrast to the ANSI/AAMI ST79:2017 & 2020 Guidelines which read that instruments should have been positioned to allow the sterilant to come into contact with all surfaces. Further, the Mpack sterilization pouches IFU read that the dimensions of the medical device to sterilize should not have exceeded ¾ of the pouch space.


B. Interviews

i. On 8/22/23 at 11:44 a.m., in an interview with the specialty clinic director (Director) #2, she said that if there were questions about how to reprocess instruments, staff should look up the IFUs for the instrumentation and go by the manufacturer's recommendations on how to process the instrumentation. Further, she stated it was important to follow IFUs to ensure staff were caring for the instruments appropriately as well as disinfecting properly before the next patient use to prevent infection to patients and provide the best care for patients.

She stated during the observation of the instrument cleaning process, it was discovered that the Enzol was outdated. She said that if enzymatic detergent was expired it would be concerning because the way that it worked could not be guaranteed. She said that the enzymes in the detergent would not function correctly to break down the bioburden (the number of bacteria living on a surface that has not been sterilized) on the instruments. Additionally, she said it was important to use the correct enzymatic according to IFUs, to be sure erosion of instruments was not occurring and because pH at different ranges killed pathogens more effectively. Furthermore, she said that the use of the expired enzymatic could cause bacteria left from the patient that could have been introduced to another patient.

iii. On 8/22/23 at 12:31 p.m., in an interview with the quality assurance and infection control director (Director) #3, she said it was important to clean instruments correctly to be sure infection was not passed from one patient to the next. She said staff not cleaning the instruments correctly could cause a life-altering infection, or possibly death.

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

A. Personnel files for four of four staff members who were responsible for instrument cleaning revealed no documentation of training for instrument reprocessing. Examples included:

i. A review of the personnel file for medical assistant #16 revealed no documentation of orientation and training to perform instrument reprocessing. A competency for instrument cleaning dated 5/26/21 was provided separately.

ii. A review of the personnel file for medical assistant (MA) #1 revealed no current job description in the file. Further, no documentation of orientation and training in instrument and scope reprocessing was found in her file.

iii. A review of the personnel file for registered nurse (RN) #15 on revealed no documentation of orientation and training to perform instrument and scope reprocessing.

iv. A review of the personnel file for specialty clinic director (Director) #2 revealed no documentation or orientation and training to perform instrument and scope reprocessing. A competency for instrument cleaning dated 5/26/21 was provided separately.

B. Interviews

i. On 08/22/2023 at 1:28 p.m., in an interview with medical assistant #1, she said she received
training for pre-cleaning instruments when she first started working at the facility two years prior. She said she received training from a staff member who was in charge of all the autoclaving (sterilizing) at that time.

ii. On 8/21/23 at 10:58 a.m., during a tour of the specialty clinic instrument cleaning area, specialty clinic director (Director) #2 said that she was trained to use the autoclave two years ago by her manager at the time. Director #2 further stated she trained the other staff on how to use the autoclave.

iii. On 8/21/23 at 1:02 p.m., during a tour of the Procedure Room, Director #2 said education and training for the endoscope cleaning processes was provided by the Olympus representative. She said that training was provided to new staff members by the Olympus representative. Upon request, the facility was unable to provide documentation on when the last time training was provided by the Olympus representative.

iv. On 8/21/23 at 1:02 p.m., an interview with Director #2 revealed the facility had an infection control nurse, however, she was not involved with scope cleaning or instrument cleaning processes.

v. On 08/22/2023 at 12:31 p.m., in an interview with the quality assurance and infection control director (Director) #3, she stated that approximately two years ago there was training on the reprocessing of sterile instruments for clinic staff which included some of the medical assistants, some nurses, and specialty clinic staff. Director #3 stated there had been no further training after the training provided two years prior.

3. The facility failed to provide a separate area for clean patient supplies that were stored in a soiled utility room on the extended care unit.

a. On 8/21/23 at 11:45 a.m., an observation was conducted in the extended care unit. The observation revealed clean patient care supplies stored in a cabinet inside the main entrance to the soiled utility room. The supplies included, but were not limited to, wash basins, commode buckets, skin care products (soap and lotion), mouthwash, denture cups, combs, and cotton-tipped applicators. Inside the soiled utility room were multiple soiled patient care items, such as bedside commodes and patient walkers. In the corner of the soiled utility room was a hopper (a large bowl of water used to rinse supplies and flush patient waste) used by the staff to rinse soiled linens and patient supplies as the first step in cleaning the items. Staff passed by the clean patient care supplies carrying soiled patient care items to place in the soiled area of the room.

b. On 8/21/23 at 11:45 a.m., an interview was conducted with the director of quality assurance and infection control (Director) #3. Director #3 stated environmental staff made the facility aware of the clean patient care supplies stored in the soiled utility room by a concerned environmental services worker approximately one month ago. Director #3 stated she agreed the supplies needed to move, however, there currently was no place to move them to. Director #3 stated it was important to store the clean patient care supplies in a clean area to prevent cross contamination from the dirty items in the soiled utility room. Director #3 stated there was a risk of harming the patient by causing an infection. Director #3 stated the harm of infection to patients was preventable by separating the clean patient care supplies from the soiled utility room.

This interview and observation was in contrast to the CDC guidelines that read, in sluice rooms, the clean area should have been distinctly separate from (by workflow) soiled areas.

Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation, §485.641 PERODIC EVALUATION AND QUALITY ASSURANCE REVIEW was out of compliance.

C-0331 Standard: Perodic Evaluation, the CAH carries out or arranges for a periodic evaluation of its total program. The evaluation is done at least once a year;

Based on document review and interviews, the facility failed to ensure quality assurance (QA) evaluations were performed annually and that the results were reflected in the facility's quality assessment performance improvement (QAPI) plan.

Findings include:

Facility policy:

The District Safety Committee policy read, the committee will follow all regulations and guidelines set forth by the government in regard to patient and employee safety that apply to the hospital district. Safetyh will be reviewed and improved as needed on a continual basis. Further, the scope of the committee will be statistic review, safety surveillance, and process review and update of all District areas; and when safety concerns are presented, the Safety Committee has the authority to implement corrective action as necessary to meet state and federal guidelines.

Facility plans:

The Hospital District Quality Assurance and Performance Improvement (QAPI) plan for 2023 read that the primary goal of the program was to improve the safety and quality of patient care. The program is designed to ensure the safety and quality of care of patients within its healthcare environment by improving processes. The QAPI Program maintains a culture of safety that promotes zero tolerance for noncompliance with established practices Specifically, preventing safety issues for patients through Risk Management program incident reporting with at least one improvement identification on all incident reports. Further, process improvements would occur through root cause analysis investigation. The QAPI Plan is reviewed at least annually by the QAPI Committee and the Director of Quality and Infection Control to maintain consistency with new recommendations and changes within the institution. The Governing Board of Directors has the ultimate responsibility for patient safety and approves the Quality Assurance and Performance Improvement (QAPI) Plan annually. The QAPI Committee has the authority to institute any surveillance, prevention, or study when there is reason to believe that any patient, personnel, or visitor may be at risk of unsafe practices. This authority and responsibility include but may not be limited to the following: Develop and implement a preventative and corrective program(s) designed to minimize hazards, review and approve all policies and procedures related to Quality Assurance activities in all departments/services, collaborate with the organization leadership to institute emergency measures to prevent safety concerns, promote the application of organizational and departmental policies. Evaluation of effectiveness: The QAPI Committee continually evaluates the effectiveness of the QAPI interventions and, as necessary, redesigns the QAPI interventions. This evaluation and revision occurs formally at least annually and whenever risks significantly change. The evaluation addresses changes in the scope of the QAPI program such as new services or new goals. The evaluation also addresses changes in the results of the data submissions, and it addresses emerging and reemerging healthcare issues in the community. The evaluation assesses the success or failure of the interventions. The primary goal of the QAPI Program is to improve the safety and quality of patient care. Through the following: safety audits are completed monthly by Department Directors, provide infection prevention program support, ensure emergency preparedness program support and activities with active participation in simulations, oversee risk management through incident reporting with at least one improvement identification on all incident reports with closed loop communication completed and implement process improvement through root cause analysis investigation.

Reference:

The Quality Assurance Director job description read the quality assurance director provides assistance related to the support of organization-wide efforts in performance improvement, risk management, and regulatory compliance. Essential job duties and responsibilities: chairs the Quality Assurance/Performance Improvement Committee; Trains staff in quality and performance improvement methodologies; Patient complaints, grievances, and occurrences. Provides oversight of regulatory standards and maintains a state of continual readiness; Responsible for collecting data and preparing for different hospital meetings pertaining to quality measures and tracking; Identify and implement an ongoing mechanism for proactive monitoring and auditing; Oversees daily functions of risk management, regulatory, and compliance. Identify safety, or security risks by performing risk evaluations.

1. The facility failed to conduct an annual QA evaluation and implement the results of the evaluation into the QAPI plan.

a. Review of the 2021, 2022, and 2023 QAPI committee meeting minutes and the 2022 and 2023 governing board of directors meeting minutes revealed no evidence the facility had conducted a periodic evaluation of all facility services and the QAPI program.

This was in contrast to the facility's QAPI plan for 2023 which read the QAPI committee would evaluate QAPI initiatives, evaluate and assess the success and effectiveness of the interventions implemented, and identify areas for patient care opportunities and improvements. The evaluation would occur formally at least annually and whenever safety risks significantly changed. The evaluation would address the scope of the QAPI program and review which service and patient care changes were needed.

i. Upon request, the facility was unable to provide evidence quality improvement projects and activities were based on high-risk, problem-prone areas which affected patient safety and quality of care.

Additionally, the facility was unable to provide evidence of how performance and process improvements were identified and how the facility ensured performance and process improvements were sustained throughout the facility.

b. On 8/24/23 at 12:40 p.m., an interview was conducted with the director of quality assurance and infection control (Director) #3. Director #3 stated she oversaw QAPI projects throughout the facility. Director #3 stated the facility had not conducted a QA evaluation.

Director #3 stated the facility did not track and trend data to determine where high-risk problem-prone areas were present within the facility. Director #3 stated the facility had not established performance improvement projects and indicators based on national standards or guidelines, the complexity of the services provided at the facility, or facility specific high-risk problem-prone areas. Director #3 stated patients were at risk of being harmed when the quality of the services provided was not reviewed to identify current and or potential safety concerns in patient care. Furthermore, Director #3 stated the facility had not established quality indicators reflective of the complexity of services provided at the facility.

c. On 8/24/23 at 2:51 p.m., an interview with conducted with the chief executive officer (CEO) #5. CEO #5 stated he was a member of the governing board, the Safety Committee, and the QAPI Committee. CEO #5 stated he was not aware an annual QA evaluation needed to be conducted. CEO #5 further stated he was unable to provide evidence the governing board had reviewed facility specific data identifying high-risk, problem-prone areas.