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Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation for Patient Rights was met as evidenced by:

1. The facility failed to ensure one of 31 sampled patients (Patient 15), received care in a safe setting when, Patient 15 who was on seizure (a sudden, uncontrollable activity in the brain causing the body to have dangerously muscle twitches, spasm, abnormal sensations, passing out, or changes in memory) precaution, had all four (4) side rails, not padded in accordance with the facility's Seizure Management policy and procedure.

This deficient practice had the potential for Patient 15 to suffer from an injury after a seizure activity. (Refer to A-0144)

2. The facility failed to ensure for one (1) of four (4) sampled patients (Patient 23), the use of restraint (a manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely) was ordered by the physician when, all four side rails of Patient 23 were raised.

This deficient practice resulted in an appropriate use of restraints and had the potential for Patient 23 to have compromise patient safety with complications such as strangulation (obstruction of blood vessels and/or airflow in the neck resulting in asphyxia [lack of oxygen], skin tear, etc. (Refer to A-0168)


3. The facility failed to ensure one (1) of four (4) sampled patients (Patient 11), was assessed and monitored after bilateral (both sides) soft wrist restraint (a manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely) was applied, in accordance with the facility's policy and procedure regarding restraints use.

This deficient practice had the potential to result in Patient 11's inappropriate, unnecessary, and prolonged use of restraints, and had the potential to violate the patients' rights. (Refer to A-0175)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality health care in a safe environment.

Based on observation, interview, and record review, the facility failed to ensure one of 31 sampled patients (Patient 15), received care in a safe setting when, Patient 15 who was on seizure (a sudden, uncontrollable activity in the brain causing the body to have dangerously muscle twitches, spasm, abnormal sensations, passing out, or changes in memory) precaution, had all four (4) side rails, not padded in accordance with the facility's Seizure Management policy and procedure.

This deficient practice had the potential for Patient 15 to suffer from an injury after a seizure activity.

Findings:

During a concurrent observation and interview on 8/19/24 at 2:39 p.m., in Patient 15's room, with Registered Nurse (RN) 4, Patient 15 was observed in bed with the right side of the bed positioned against the wall. The side rails of the right side of Patient 15's bed did not have a padded equipment. RN 4 stated Patient 15 was on seizure precaution for safety and all side rails of the bed should have padding equipment to protect Patient 15 from injury.

During a review of Patient 15's History and Physical (H&P, the most formal and complete assessment of the patient and the problem), dated 8/15/24, the H&P indicated, Patient 15 was admitted to the facility with a chief complaint of slurred speech and right sided weakness. Patient 15 had a witnessed seizure and was placed on observation for seizures (a sudden, uncontrollable activity in the brain causing the body to have dangerously muscle twitches, spasm, abnormal sensations, passing out, or changes in memory).

During a review of Patient 15's Care Plan (a plan that provides a framework for evaluating and providing patient care needs related to the nursing process), dated 8/19/2024, the Care Plan indicated, Patient 15 had seizure related injury.

During a review of the facility's policy and procedure (P&P) titled, "Seizure Management," dated 12/11/2023, the P&P indicated, "Seizures are paroxysmal events associated with abnormal, excessive, or synchronous electrical discharges of neurons in the brain. When a patient has a generalized motor seizure, nursing care aims to protect the patient from injury and prevent serious complications. Preparation of Equipment: If the patient is at risk for seizures, pad the patient's side rails and have IV equipment, suction equipment, and oxygen administration equipment available at the patient's bedside. Make sure that emergency equipment is functioning properly and readily available. Complications associated with a seizure may include injury, scrapes and bruises, traumatic injury to the tongue and cheek caused by biting, respiratory distress, aspiration, airway obstruction hypoxemia cognitive impairment."

Based on observation, interview, and record review, the facility failed to ensure for one (1) of four (4) sampled patients (Patient 23), the use of restraint (a manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely) was ordered by the physician when, all four side rails of Patient 23 were raised.

This deficient practice resulted in an appropriate use of restraints and had the potential for Patient 23 to have compromise patient safety with complications such as strangulation (obstruction of blood vessels and/or airflow in the neck resulting in asphyxia [lack of oxygen], skin tear, etc.

Findings:

During a concurrent observation and interview, on 8/20/24 at 3:14 p.m., with Nurse Manager 3 (NM 3), Patient 23 was observed in bed, awake, and unattended with 4 side rails of the bed raised. Patient 23's one side of the bed was placed by the wall. NM 3 stated Patient 23's 4 side rails should not have been raised because it is considered a restraint (a manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely).

During a concurrent observation and interview on 8/20/2024 at 3:16 p.m., with Certified Nurse Assistant 1 (CNA 1), CNA 1 was observed to enter Patient 23's room and put down one of the patient's (Patient 23) side rails. CNA 1 stated she (CNA 1) was not aware Patient 23's all 4 side rails were up.
During a review of Patient 23's "History & Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 8/19/2024, the "History and Physical" indicated, Patient 23 was admitted with a chief of complaint of shortness of breath (difficulty breathing) and sore throat.

During an interview, on 8/21/24 at 10:04 a.m., with Charge Nurse (CHN5). CHN5 stated Patient 23's all 4 side rails up were considered a restraint and would need a physician's order.

During a review on 8/21/24 at 2:30 p.m., with Risk Management Manager 1 (RMM 1), Patient 23's record was reviewed. RMM 1 stated Patient 23 did not have a physician's order for restraint of all 4 side rails up.

During a review of the facility's policy and procedure (P&P) titled, "Restraint for NON-VIOLENT/Non-Self-Destructive Behavior," revised in 5/2022, the P&P indicated, "Restraint for non-violent, non-self-destructive behavior may include, but are not limited to ...Side rails x 4 (raise all 4 side rails) when intended as restraint, i.e., used to prevent patient from voluntarily getting out of bed ...Licensed Independent Practitioner/provider-any physician or other practitioner permitted by State law and hospital policy to order restraint or seclusion independently for patients."

Based on observation, interview, and record review, the facility failed to ensure one (1) of four (4) sampled patients (Patient 11), was assessed and monitored after bilateral (both sides) soft wrist restraint (a manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely) was applied, in accordance with the facility's policy and procedure (P&P).

This deficient practice had the potential to result in Patient 11's inappropriate, unnecessary, and prolonged use of restraints, and had the potential to violate the patients' rights.

Findings:

During an observation on 8/19/24 at 1:36 p.m., in Patient 11's room, with Registered Nurse (RN) 11, Patient 11 was observed lying in bed with eyes closed. Patient 11 had a bilateral soft wrists restraint (a manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely) applied.

During a review of Patient 11's History and Physical (H&P, the most formal and complete assessment of the patient and the problem), dated 8/18/2024, the H&P indicated Patient 11 was admitted to the facility with a chief complaint of left sided weakness with facial droop (when the muscles on one or both sides of the face does not work properly).

During a review of Patient 11's "Patient Order," dated 8/19/24, the Patient Order indicated soft restraint to be applied on Patient 11's left and right upper extremities (part of the body that includes the arm, forearm, wrist, and hand).

During a concurrent interview and record review on 8/21/24, at 10:56 a.m., with Registered Nurse (RN) 3, Patient 11's Restraint Assessment, dated 8/20/24 was reviewed. The Restraint Assessment indicated Patient 11's Restraint Assessment from 2 p.m. to 8 p.m., was not done. RN 3 stated she was the RN assigned to Patient 11 on 8/20/24 from 2 p.m. to 8 p.m. RN 3 stated there was no documentation of Patient 11's Restraint Assessment on 8/20/24 from 2 p.m. to 8 p.m. RN 3 stated she "forgot to document" because she "was busy." RN 3 stated Patient 11 was still on restraint and should be assessed and monitored every two hours.

During an interview on 8/21/24 at 11:04 a.m., with Intensive Care Unit Assistant Manager (ICU AM) 1, ICU AM 1 stated restraint monitoring should be done every two hours. ICU AM 1 stated, it is important to make sure Patient 11 was safely monitored during restraint use.

During a review of the facility's policy and procedure (P&P), titled, "Restraint for Non-Violent/Non-Self-Destructive Behavior," dated 5/2022, the P&P indicated, "This policy covers restraint use for non-violent/non-self-destructive behavior in the acute care setting in areas where restraint is used to ensure the physical safety of the patient. Monitoring and reassessment of well-being, patient needs, and continued need of restraint -To ensure the well-being of the patient and the continued needs for restraint, an ongoing process including assessment, intervention, evaluation and re¿intervention will be carried out. A. The RN assesses on initiation and reassesses the patient's status and response to restraints at intervals not greater than two hours."

Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation for nursing services was met as evidence by:

1. The facility failed to ensure the pain of two of 31 sampled patients (Patient 19 and 12) were assessed after pain medication was administered in accordance with the facility's policy and procedure regarding pain management standard of care.

This deficient practice had the potential for Patient 19's and 12's pain to not be managed in a timely manner and may result in delayed treatment, which could worsen the patients' (Patient 19 and 12) pain level. (Refer to A-0395)

2. The facility failed to ensure the Peripheral Inserted Central Catheter (PICC, a catheter [a flexible tube] inserted through a peripheral vein, often in the arm, into a larger vein in the body where the tip of the catheter is position in a location at the superior vena cava [a large vein that carries deoxygenated blood], and used for intravenous [into a vein] treatment that is required over a long period) dressing of one (1) of two (2) patient (Patient 28) was clean and dry in accordance with the facility's policy and procedure regarding comprehensive vascular access management.

This deficient practice had the potential to result in complications such as a central line (a long, flexible tube that is inserted into a large vein) bloodstream infection (CLABSI, occurs when bacteria or other germs enter the patient's central line and then enter their bloodstream) that may lead to the patient's deterioration of medical condition and prolonged hospital stay. (Refer to A-0398)

3. The facility failed to ensure the Oxycodone (narcotic pain medication) for one of 31 sampled patient (Patients 24) was administered as ordered by the physician.

This deficient practice resulted in delay of treatment and had the potential to cause adverse health outcomes which could negatively affect Patient 24's health and safety due to unsafe medication administration and may lead to prolonged hospitalization. (Refer to A-0405)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality care in a safe environment.

Based on interview and record review, the facility failed to ensure the pain of two of 31 sampled patients (Patient 19 and 12) were assessed after pain medication was administered in accordance with the facility's policy and procedure regarding pain management standard of care.

This deficient practice had the potential for Patient 19's and Patient 12's pain to not be managed in a timely manner and may result in delayed treatment, which could worsen the patients' (Patient 19 and 12) pain level.

Findings:

1. During a review of Patient 19's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 8/20/2024, the History and Physical indicated Patient 19 was admitted for abdominal pain and for a planned robotic assisted laparoscopic (a surgical technique using a camera to allow surgeon to visualize the abdomen) right inguinal hernia (occurs when abdominal tissue pushes through the lower abdominal wall) repair.

During an interview and review of Patient 19's "Medication Administration Records (MAR)" on 8/21/24 at 2:10 p.m., with Risk Management Manager 1 (RMM 1), Patient 19's "Medication Administration Records (MAR)" indicated a physician order of Hydrocodone-Acetaminophen (Norco, medication use to relieve moderate to severe pain) 5-325 milligram (mg) per 1 tablet oral (by mouth) every 4 hours PRN (as needed) for moderate pain (pain scale of 4 to 7) and severe pain (pain scale of 8 to 10). RMM 1 verified in the MAR that Patient 1 was administered Norco 5-325mg 1 tablet on 8/20/24 at 4:52 p.m. RMM 1 stated there was no documentation of Patient 19's pain re-assessment after the pain medication was given.

During an interview on 8/21/24 at 2:18 p.m., with Nurse Manager 2 (NM 2), NM 2 stated pain assessment should be done before and after pain medication administration. NM2 stated, pain re-assessment was important to determine if a patient would still need more pain medication.

During a review of the facility's policy and procedure (P&P) titled, "Pain Management Standard of Care," dated 12/2022, the P&P indicated, "The purpose of this policy is to describe the care of patients regarding pain assessment, management, and education. Pain is a complex, subjective, and unpleasant sensory or emotional experience caused by a physical, neurological (relating to the nervous system) or emotional response to noxious (harmful or unpleasant) stimuli (something that causes a reaction). Pain can be acute (sudden) or chronic (continuing or occurring again and again for a long time) in nature. The most reliable indication of the existence and intensity of pain is the patient's self-report. The patient's rights to pain management is an essential aspect of quality and safety. The pain intensity and pain relief will be assessed and documented: After each pain management intervention based on method of administration (within 45 minutes for IV [intravenous or into the vein], within 75 minutes for all other methods of administration)."


2. During a review of Patient 12's History and Physical (H&P, the most formal and complete assessment of the patient and the problem), dated 8/14/24, the H&P indicated Patient 12 was admitted to the facility with a chief complaint of abdominal pain. Patient 1's "Assessment and Plan" was to continue with pain control.

During a concurrent interview and record review on 8/21/24, at 2:13 p.m., with the Quality Specialist (QS) 1, Patient 12' Medication Administration Information, dated 8/19/2024 was reviewed. QS 1 stated the record indicated, on 8/19/24, at 2:44 p.m., Patient 12 was given morphine (pain medication), and "See the effectiveness of the medication given to the patient."

In the same concurrent interview and record review on 8/21/24, at 2:13 p.m., with QS 1, Patient 12's Pain Assessment records, dated 8/19/24, was reviewed. The record indicated, on 8/19/24, at 2:44 p.m., Patient 12 's pain level was recorded 5/10 (pain level 5 indicated moderate pain, pain level 10 indicated severe pain); the next pain assessment was completed at 8 p.m. (5 hours after Patient 12 was administered pain medication [morphine]). QS 1 stated Patient 12's pain reassessment after the morphine given was late. QS 1 stated whenever patients received pain medication, their pain level should be reassessed to know the effectiveness of the pain medication given to the patient.

During a concurrent interview and record review on 8/22/24, at 11:11 a.m., with the Med Surg Unit Manager (MSUM) 1, Patient 12's pain reassessment record was reviewed. MSUM 1 stated Patient 12's pain reassessment was not done timely after receiving morphine on 8/19/24 at 2:44 p.m. MSUM 1 stated pain reassessment was important to see how pain medication worked for the patient. MSUM 1 stated the nurses did not follow the reassessment policy.

During a review of the facility's policy and procedure (P&P) titled, "Pain Management Standard of Care," dated 12/2022, the P&P indicated, "The purpose of this policy is to describe the care of patients regarding pain assessment, management, and education. Pain is a complex, subjective, and unpleasant sensory or emotional experience caused by a physical, neurological (relating to the nervous system) or emotional response to noxious (harmful or unpleasant) stimuli (something that causes a reaction). Pain can be acute (sudden) or chronic (continuing or occurring again and again for a long time) in nature. The most reliable indication of the existence and intensity of pain is the patient's self-report. The patient's rights to pain management is an essential aspect of quality and safety. The pain intensity and pain relief will be assessed and documented: After each pain management intervention based on method of administration (within 45 minutes for IV [intravenous or into the vein], within 75 minutes for all other methods of administration)."

Based on observation, interview, and record review, The facility failed to ensure the Peripheral Inserted Central Catheter (PICC, a catheter [a flexible tube] inserted through a peripheral vein, often in the arm, into a larger vein in the body where the tip of the catheter is position in a location at the superior vena cava [a large vein that carries deoxygenated blood], and used for intravenous [into a vein] treatment that is required over a long period) dressing of one (1) of two (2) patient (Patient 28) was clean and dry in accordance with the facility's policy and procedure regarding comprehensive vascular access management.

This deficient practice had the potential to result in complications such as a central line (a long, flexible tube that is inserted into a large vein) bloodstream infection (CLABSI, occurs when bacteria or other germs enter the patient's central line and then enter into their bloodstream) that may lead to the patient's deterioration of medical condition and prolonged hospital stay.

Findings:

During an observation and interview, on 8/20/24 at 3:17 p.m., with Registered Nurse 20 (RN 20), Patient 28 was observed in bed, awake and oriented. Patient 28 had a PICC line on the right arm. Patient 28's PICC line was covered with a transparent dressing, the PICC dressing was covered with dry blood about the size of a quarter coin. RN 20, who was Patient 28's assigned RN, verified the PICC line dressing had dry blood. RN 20 stated Patient 28's soiled PICC line dressing could attract bacteria for infection and that it is important to change the PICC dressing, if the dressing was soiled with blood.

During an interview, on 8/22/24 at 11:58 a.m., with Charge Nurse 6 (CHN 6), CHN 6 stated for patients with PICC line dressing that was soiled, the dressing should be changed immediately because leaving blood under the dressing would increase the risk of infection. CHN 6 stated the PICC line site should be clean and intact for patient safety.

During a review of Patient 28's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 8/19/24, the H&P indicated Patient 28 was admitted to the facility for esophageal cancer (cancer of the tube that runs from the throat to the stomach).

During a review of Patient 28's "Procedure: Insertion of Peripherally Inserted Central Catheter (PICC)," dated 8/16/24, the "Procedure: Insertion of Peripherally Inserted Central Catheter (PICC)," indicated Patient 28's PICC was well positioned and ready to use.

During a review of the facility's policy and procedure (P&P) titled, "Comprehensive Vascular Access Management," revised in May 2023, the P&P indicated, "Central line dressing change, a transparent, semipermeable membrane dressing is changed every seven days or when the dressing integrity is compromised (damp, loosened, or visibly soiled), if moisture, drainage, or blood is present under the dressing, or for further assessment."

Based on observation, interview and record review, the facility failed to ensure the Oxycodone (a narcotic pain medication) for one of 31 sampled patients (Patients 24) was administered as ordered by the physician.

This deficient practice resulted in delay of treatment and had the potential to cause adverse health outcomes which could negatively affect Patient 24's health and safety due to unsafe medication administration and may lead to prolonged hospitalization.

Findings:

During a review of Patient 24's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 8/20/24, the H&P indicated Patient 24 had a medical history of left knee pain.

During a review of Patient 24's "Medication Administration Report (MAR)," dated 8/21/24, the MAR indicated a physician's order for Patient 24 to receive the following:

-Oxycodone (Roxicodone, pain medication) 5-10 milligram (mg-a unit of measurement) 1 tablet by mouth every 4 hours as needed (PRN) for severe pain (pain score 8 to 10 is severe pain), with a start date of 8/19/24; and,

-Tramadol (Ultram, pain medication) 50-100 milligram (mg-a unit of measurement) 1 tablet by mouth every 4 hours PRN for moderate pain (pain score 4 to 6 is moderate pain) with a start date of 8/19/24.

During a concurrent interview and record review on 8/22/24 at 03:03 p.m., with the Charge Nurse 6 (CHN 6), of Patient 24's MAR, Patient 24's MAR indicated on 8/21/24 at 8:19 a.m., Patient 24 was given Oxycodone 5 mg 1 tablet by mouth. The corresponding pain assessment indicated Patient 24's pain level was 5 (moderate pain). CHN 6 stated Patient 24's record review was accurate.

In the same interview on 8/22/24 at 3:03 p.m., CHN 6 stated Patient 24 should have received tramadol for moderate pain as ordered by the physician. CHN 6 stated it is important to give the right medication for the patient's pain level. CHN6 stated the patient can become overly sedated and their vitals sign (measures the basic functions of the body and includes the pulse rate and blood pressure) can be affected by having bradycardia (less than 60 heart beats per minute) and/or low blood pressure (low blood pressure is a reading below 90/60) if given the wrong pain medication.

During a review of the facility's policy and procedure (P&P) titled, "Medication Management," revised on 7/2023, the P&P indicated, "Prior to administration of any medication or intravenous fluid, verify the five rights (right patient, right drug (medication), right dose, right time, and right route)."

Based on observation, interview, and record review, the Condition of Participation for Infection Control and Antibiotic Stewardship Programs was not met as evidenced by:

1. The facility failed to ensure the sterilization (the process of making something free from bacteria or living microorganisms) process of the surgical instruments for one (1) of 31 sampled patients (Patient 1) was implemented prior to Patient 1's surgery.

This deficient practice resulted in the use of unsterilized laparoscopic endoscope (long flexible tube with a camera and light attached used during abdominal surgeries) being introduced into Patient 1's abdominal cavity which may increase the probability of spreading infection and may lead to the patient's death. (Refer to A-0749)

2. The facility failed to ensure the surgical sterile (free of germs) gloves in the Operating Room (OR) supply room that were available for use, were not expired.

This deficient practice had the potential for facility staff to use a compromised surgical sterile glove that could increase the risk of infection and have a negative effect on the patients' provision of care. (Refer to A-0772)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality care in a safe environment.

Based on observation, interview, and record review, the facility failed to ensure the sterilization (the process of making something free from bacteria or living microorganisms) process of the surgical instruments for one (1) of 31 sampled patients (Patient 1) was implemented prior to Patient 1's surgery.

This deficient practice resulted in the use of unsterilized laparoscopic endoscope (long flexible tube with a camera and light attached used during abdominal surgeries) being introduced into Patient 1's abdominal cavity which may increase the probability of spreading infection and may lead to the patient's death.

Findings:

During a review of Patient 1's "Internal Medicine History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 8/8/24, the H&P indicated on 8/7/24, Patient 1 was presented to the emergency department (ED) with a complaint of abdominal pain and tenderness on the right lower quadrant (RLQ) abdomen. Patient 1 had a Computed Tomography scan (CT, imaging procedure that uses x-rays and computers to create detailed images of the inside of the body) of the abdomen and pelvis that showed result of appendicitis (infection to the tube-shaped sac attached to the lower end of the large intestine). Patient 1 was admitted to the facility for acute appendicitis and consented for "Laparoscopic Possible Open Appendectomy," (surgical procedure to remove the appendix [a small organ in the lower right abdomen], when it becomes infected) that was performed on 8/8/24 at 1:23 p.m.

During a review of Patient 1's "Progress Note," dated 8/8/24 at 6:22 p.m., the note indicated Surgeon 1 was informed on 8/8/24 at 4 p.m. that the surgical instruments Surgeon 1 used during Patient 1's "Laparoscopic Possible Open Appendectomy" on 8/8/24 had not been sterilized. Patient 1 was started on antibiotics (medications that treat and prevent bacterial infections by killing bacteria or stopping their growth) as preventive measure for possible infection.

During an interview on 8/20/24 at 2:55 p.m., the Perioperative Director stated the load number sticker (identifies surgical instruments with appropriate patient) was not placed on the tray containing the surgical instruments used during Patient 1's "Laparoscopic Possible Open Appendectomy" on 8/8/2024. The Perioperative Director stated this was discovered after the conclusion of the procedure (Laparoscopic Possible Open Appendectomy) by a surgical technician (not identified), after the tray was taken to the Sterile Processing Department (SPD). The Perioperative Director stated she was uncertain how the tray missed the sterilization process.

During an interview on 8/21/24 at 8:33 a.m., the Perioperative Director stated she assumed the tray containing the surgical instruments used for Patient 1's "Laparoscopic Possible Open Appendectomy" was placed on a cooling rack outside the sterilizer and therefore, assumed to be sterilized. The Perioperative Director stated this facility did not have a written system to verify surgical instruments were sterile before use.

During an interview on 8/21/24 at 10:31 a.m., with the Surgical Tech (ST) 1, ST 1 stated she (ST 1) was the ST (surgical technician) during Patient 1's surgery on 8/8/2024. ST 1 stated she (ST 1) was responsible for bringing Patient 1's surgical trays (containing surgical instruments) into the operating room from the cart that was prepared from the Operating Room (OR) supply room. ST 1 stated it was her responsibility to ensure the surgical instruments were sterile by checking the indicators (to indicate the tray with surgical instruments was sterilized) for sterilization.

In the same interview on 8/21/24 at 10:31 a.m., ST 1 stated she was very busy when she brought the surgical tray into the OR for Patient 1's "Laparoscopic Possible Open Appendectomy" on 8/8/24. ST 1 stated she was not certain she observed any color change of the indicators (to indicate the tray with surgical instruments was sterilized) on the outside of the surgical tray used in Patient 1's surgery. ST 1 stated she did not recall verifying the sterility of the tray with the circulating Registered Nurse (RN) before preparing the surgical instruments for Patient 1's operation.

During an interview on 8/22/24 at 11:07 a.m., with the Infection Preventionist 1 (IP, a professional responsible for ensuring facility infection practices are followed) stated the facility did not have a policy or written procedure for verifying sterility of trays or surgical instruments but the facility followed the Association of Perioperative Registered Nurses (AORN, an organization responsible for producing professional standards in the operating room) guidelines. IP 1 was unable to produce said standards at this time.

During a review of Patient 1's medical record (in general) showed there was an attachment to the surgical record, indicating the "Stryker Laparoscopy Tray" should have been sterilized on 8/7/2024 using Sterilizer Number 2 at 2:47 p.m.

Based on observation, interview, and record review, the facility failed to ensure the surgical sterile (free of germs) gloves in the Operating Room (OR) supply room that were available for use, were not expired.

This deficient practice had the potential for facility staff to use a compromised surgical sterile glove that could increase the risk of infection and have a negative effect on the patients' provision of care.

Findings:

During a concurrent observation and interview on 8/20/24 at 10:57 a.m., with the Director of Surgical Services (DSS), the surgical sterile gloves (25 pieces [pcs]), size 8 ½, with expiration date of 6/2024 and located on the lower shelves front of the bin were observed in the OR supply room. The DSS removed the expired surgical sterile gloves and handed them over to Senior Inventory Control (SIC). The DSS stated expired surgical sterile gloves should not be in the supply room and expired items are to be thrown in the trash.

During an interview on 8/21/24 at 9:58 a.m., with Director of Services (DSS), the DSS stated the expectation was for the staff (in general) to check all surgical supplies for expiration date.

During a review of the facility's policy & procedure (P&P) titled, " Outdates (Expired Goods Products)- Oracle," dated 3/14/2022, the P&P indicated, "Ensure items nearing expiration (within 60 days) are moved to where they're most likely to be used or to a facility with higher usage rate ...to accomplish these goals without excessively burdening the staff, start by implementing a quarterly expiration monitoring program to ensure all supply storage locations are supported for outdates and soon-to-expire items regularly ...1. Implement quarterly storage checks to rotate items and document accordingly, each quarter assign material handling staff to check and rearrange items in storage so the oldest products (those set to expire first) are clearly positioned in the front. During this check, staff should remove any expired items they find and document their actions in detail."

Based on observation, interview, and record review, the Condition of Participation for Surgical Services was not met as evidence by:

1. The facility failed to ensure for one of 31 sampled patients (Patients 1), the surgical instruments used during Patient 1's surgery were verified to be sterilized (a process that uses heat to remove microbial life, such as bacteria, viruses, and fungal spores, from a substance).

This deficient practice resulted in the use of unsterilized laparoscopic endoscope (long flexible tube with a camera and light attached used during abdominal surgeries) being introduced into Patient 1's abdominal cavity which may increase the probability of spreading infection and may lead to the patient's death. (Refer to A-0951)

2. The facility failed to ensure the high-temperature sterilization process was implemented when, two of the four surgical instrument loads (Load 4 and Load 7) did not have a Biological Indicator (B.I., contain viable microorganisms with a defined resistance to a specific sterilization process and are used to test for effective sterilization) test results after the loads were sterilized.

This deficient practice had the potential to result in not determining if the sterilization of the surgical instruments were effective which could negatively affect surgical patients and may cause adverse health outcomes such as infection, organ damage, prolonged hospitalization and/or death. (Refer to A-0951)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality health care in a safe environment.

Based on observation, interview, and record review the facility failed to:

1. Ensure for one of 31 sampled patients (Patients 1), the surgical instruments used during Patient 1's surgery were verified to be sterilized (a process that uses heat to remove microbial life, such as bacteria, viruses, and fungal spores, from a substance).

This deficient practice resulted in the use of unsterilized laparoscopic endoscope (long flexible tube with a camera and light attached used during abdominal surgeries) being introduced into Patient 1's abdominal cavity which may increase the probability of spreading infection and may lead to the patient's death.

2. Ensure the high-temperature sterilization process was implemented when, two of the four surgical instrument loads (Load 4 and Load 7) did not have a Biological Indicator (B.I., contain viable microorganisms with a defined resistance to a specific sterilization process and are used to test for effective sterilization) test results after the loads were sterilized.

This deficient practice had the potential to result in not determining if the sterilization of the surgical instruments were effective which could negatively affect surgical patients and may cause adverse health outcomes such as infection, organ damage, prolonged hospitalization and/or death.

On 8/22/24 at 4:42 p.m., the survey team called an Immediate Jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements has caused, or is likely to cause a serious injury, harm, impairment, or death to a patient) in the presence of the following facility members: Chief Executive Officer (CEO), Director of Risk & Regulatory (DRR 1), Executive Director of Critical Care Services (EDCCS 1), Executive Director of Perioperative Services (Perioperative Director), Risk Manager (RM 1), Quality Manager, Chief Administrator, and the Regulatory and Accreditation Program Manager (RAPM 1).

The IJ was related to failure of the facility to implement a process to ensure sterilized surgical instruments used during Patient 1's surgery were verified to be sterilized. Record review identified the instruments used to perform a "Laparoscopic Possible Open Appendectomy" (procedure where a guided scope is used to excise the affected organ/opening of the abdominal cavity to remove the affected organ) was not sterilized before Patient 1's surgery began. This deficient practice could result in Patient 1 and other subsequent similar surgery patients to develop infections after surgery and possibly death.

On 8/23/24 at 5:43 p.m., while onsite, the IJ was removed after verifying and confirming the facility's implementation of the IJ Removal Plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely) through observation, interview, and record review, in the presence of the following facility members: Executive Director of Critical Care Services (EDCCS 1), Executive Director of Perioperative Services (Perioperative Director), Chief Administrator, Regulatory and Accreditation Program Manager (RAPM 1), Chief Nursing Officer (CNO), Executive Director of Quality (EDQ), and the Infection Preventionist (IP 2).

The IJ Removal Plan indicated the following:

The Sterile Processing Department (SPD, a dedicated space for cleaning and removal of harmful organisms from surgical instruments and supplies) leader huddled with SPD staff (on 8/8/2024) and discussed visually inspecting sterile indicators (adhesive paper which changes color, indicating sterilization is complete) before being brought to the operating room for use. The SPD staff were instructed to inspect the three indicators for sterility: autoclave (sterilizer) tape, tray label insert card, and the tray plastic lock. The SPD staff will verify sterility by observing color change of these three indicators.

On 8/9/24, the Operating Room (OR) Leader huddled with operating room staff and verified that the operating room staff understood by validating these three indicators for sterility (autoclave tape, tray label insert card, and the tray plastic lock) before opening and using the surgical instruments on the sterile field (designated area free of microorganisms that could infect someone).

On 8/23/24 at 4:10 p.m., SPD Tech 1 explained how he prepares a just cleaned tray of instruments for sterilization: When a clean instrument tray arrives from the "dirty" side of the Sterile Processing Department (SPD), the SPD Tech takes the instruments/tray from the tray upon which it transferred, places the identifying label and indicator strip on the tray; the tray is then sterilized whereupon the tray is removed from the sterilizer; in 24 minutes there will be a change in the appearance of the biological indicator to show it is sterile. If the tray does not show sterile, then the tray goes through the process of sterilization again. When the tray is confirmed to be sterile, then the tray is placed on a rack to be taken to a room upstairs for storage.

On 8/23/24 at 4:40 p.m. in operating room (OR), the OR Manager stated a circulator nurse (a Registered Nurse [RN], who prepares for an operation and continually monitors the patient and staff during an operation) and a surgical technician (person who prepares the operating room, arrange equipment, and assist in surgeries) are responsible for verifying sterility of instrument trays. At that time, the Circulator (circulating nurse) and Scrub Tech 1 demonstrated this process: Both staff Circulator and Scrub Tech 1) verified that color changes on indicators placed inside the tray, and outside the tray indicated the tray tested sterile. During this process an "Instrument Sterility Confirmation Case Log" is used by the SPD Tech to certify that the instrument or tray is sterile by attaching the chemical indicator to the log. This form also consists of attestation, by the circulating nurse and surgical technician, that the chemical indicator showed a pass or fail. The Circulator stated that if the instruments are not sterile, then they are returned to be sterilized.

Findings:

1. During a concurrent observation and interview on 8/19/24 at 1:40 p.m., with Sterile Processing Department Technician 1 (SPD 1), SPD 1 demonstrated the process of sterilizing the surgical instruments. SPD Tech 1 stated clean instruments were received from the washer, transferred and arranged in a surgical tray based on the type of surgical procedure. SPD Tech 1 positioned 2 strips of indicators on both ends of the tray, then the tray was put in a case. Then, SPD Tech 1 placed the 4 blue round paper indicators on the top and bottom of the interior of the case. SPD Tech 1 stated after the case was locked, a sticker label would be applied on the outside of the tray, indicating the type of surgical tray being sterilized and to which sterilizer machine it will go. SPD Tech 1 stated, after placing the outside tray label, he would place the lock on the tray which also has an indicator attached to verify the tray has been sterilized. SPD Tech 1 recorded the specifics of the details of this process on a log.

In the same observation and interview on 8/19/24 at 1:40 p.m., SPD Tech 1 stated once the tray was sterilized, the tray would be placed in a cart and would be transported to the Operating Room (OR) supply room. SPD Tech 1 stated the staff transporting the sterilized tray would check the indicators from the outside tray (tray locked indicator or sterilized tape indicator or strip indicator) to ensure only sterilized instruments were brought to the OR supply room.

During an interview on 8/20/24 at 1:48 p.m., with the Case Picker Supply Chain (CPSC), the CPSC stated his main role was to prepare surgical tray for each OR case. The CPSC stated he handles all the OR cases and will put together the surgical instruments needed for each case. The CPSC stated the lock indicator or the tape indicator for each surgical tray would be checked to see if the tray was sterilized prior to loading the tray on the cart. The CPSC stated once the tray was prepared in the cart, the cart will then be placed on the hallway outside the designated OR suite room. The CPSC stated this process was to ensure each surgical tray, that was ready for use, was not tampered and was sterile.

During an interview on 8/20/24 at 10:22 a.m., with Surgical Technician 1 (ST 1), ST 1 stated after she reads her surgical case, she would get the surgical instrument(s), in the cart that was prepared for her by the hallway, to put in the surgical table. ST 1 said before opening the surgical tray, she would check each of the tray for the sterilization indicators (the sterile tape and the sterile lock). ST 1 stated she would ensure each of the tray were sterile and not tampered. ST 1 stated after opening each of the trays, she would look for the strip indicators and the blue paper indicator inside the surgical tray. ST 1 stated she would have the Circulator (circulating Registered Nurse [RN]) verified that the indicators showed the tray instruments were sterile.

During an interview on 8/21/24 at 10:31 a.m., with the Surgical Tech, The Surgical Tech stated she was the surgical technician during Patient 1's surgery on 8/8/2024. The Surgical Tech stated she was responsible for bringing Patient 1's surgical trays into the operating room from the cart that was prepared from the OR supply room. The Surgical Tech stated it was her responsibility to ensure the surgical instruments were sterile by checking the indicators for sterilization.

In the same interview on 8/21/24 at 10:31 a.m., the Surgical Tech stated she was very busy when she brought the surgical tray into the OR for Patient 1's "Laparoscopic Possible Open Appendectomy" on 8/8/24. The Surgical Tech stated she was not certain she observed any color change of the indicators (to indicate the tray was sterilized) on the outside of the surgical tray used in Patient 1's surgery. The Surgical Tech said she did not recall verifying the sterility of the tray with the circulating RN before preparing the surgical instruments for Patient 1's operation.

During an interview on 8/22/24 at 12:45 p.m., with the OR Director, the OR Director stated after Patient 1's surgery (on 8/8/24), the laparoscopic instrument and tray used during the procedure was brought to Sterile Processing Department (SPD) and the SPD technician who cleaned the tray used in Patient 1's surgery reported that the tray had not been sterilized as evidenced by the white colored indicator strip on the tray.

During an interview on 8/22/24 at 11:07 a.m., with the Infection Preventionist 1 (IP, a professional responsible for ensuring facility infection practices are followed), IP 1 stated the facility did not have a policy or written procedure for verifying sterility of trays or surgical instruments, but the facility followed the Association of Perioperative Registered Nurses (AORN, organization responsible for producing professional standards in the operating room) guidelines. IP 1 was unable to produce said standards at this time.

During a review of Patient 1's "Internal Medicine History and Physical (H&P)," dated 8/8/24, the H&P indicated on 8/7/24, Patient 1 was presented to the emergency department (ED) with a complaint of abdominal pain and tenderness on the right lower quadrant (RLQ) abdomen. Patient 1 had a Computed Tomography scan (CT, imaging procedure that uses x-rays and computers to create detailed images of the inside of the body) of the abdomen and pelvis that showed result of appendicitis (infection to the tube-shaped sac attached to the lower end of the large intestine). Patient 1 was admitted to the facility for acute appendicitis and consented for "Laparoscopic Possible Open Appendectomy," that was performed on 8/8/24 at 1:23 p.m.

During a review of Patient 1's "Progress Note," dated 8/8/2024 at 6:22 p.m., the note indicated Surgeon 1 was informed on 8/8/2024 at 4 PM that the instruments Surgeon 1 used during Patient 1's "Laparoscopic Possible Open Appendectomy" on 8/8/2024 had not been sterilized. Patient 1's was started on antibiotics (medications that treat and prevent bacterial infections by killing bacteria or stopping their growth) as preventive measure for possible infection.


2. During an interview on 8/19/24 at 1:51 p.m., with the Sterile Processing Lead (SPL), the SPL stated each of the surgical instrument load will have the B.I. kit included when the load undergoes the sterilization process. The SPL stated after the load was sterilized, the BI kit included in the load will be tested to see if the sterilization process was effective. The SPL stated once the B.I. test was complete, the test result should be documented for accuracy. SPL stated when BI test had a passing result, the sterilized surgical instrument would be sent to the Operating Room supply room. The SPL stated if the B.I. test failed, the surgical instrument load will need to reprocess (sterilized) again.

During a concurrent interview and record review, on 8/19/24 at 1:51 p.m., with the SPL, the facility document titled, "Multi-Record Envelope (MRE)," dated 8/19/24, was reviewed. The MRE indicated the following:

- For Load 4, the box for "B.I. Results," indicating the "end time; total time; Results (POS/NEG [positive/negative]) were blank.

- For Load 7, the box for "B.I. Results," indicating the "end time; total time; Results (POS/NEG [positive/negative]) were blank.

The SPL verified for Load 4 and Load 7, the B.I. test results were not documented. SPL stated the Load 4 and Load 7 should have results documented once the B.I. test was completed.

During a review of the facility's guideline titled, "Standard Work: Sterilization Quality Assurance Check for Sterile Processing," dated January 2024, the guideline indicated "Biological monitoring- Document the biological and chemical integrator results for the load."

During a review of the facility's guideline titled, "3M Attest Super Rapid 5 Steam Plus Challenge Pack 41482V," the guideline indicated "If utilized fill out the required information on the record keeping card. Record the 1492V BI result when available ...Record the processed and control BI lot codes and results. Act immediately on any positive results for processed biological indicators. Determine the cause of the positive biological indicator following facility policies and procedures."