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Based on interview and record review, the hospital failed to have an effective governing body that is legally responsible for the conduct of the hospital and failed to ensure that medical staff appointments requirements were met when:

1. The GB did not have a system in place to oversee the privileges and reappointments of physicians and ensured GB Bylaws were followed. Medical Doctor (MD) 1 requested reappointment and was granted cardiac surgery privileges without MD 1 meeting the requirements set forth by department and Medical Staff Bylaws. (Refer to A-0340 -1)

2. The GB did not have a system in place to oversee the privileges and credentialing of physicians. MD 2's credential file included Intensive Care Unit (ICU - specialized area within a hospital or healthcare facility dedicated to providing intensive medical care to patients with serious, life-threatening conditions) procedural privileges and the credential file did not include MD 2 to have approved privilege to manage patients in ICU or privileges for EKG interpretations. (Refer to A-0340 -2)

3. The GB did not have a system in place to oversee the privileges and reappointments of physicians and ensured GB Bylaws were followed. MD 3 and MD 4 at the end of their provisional appointment did not have evaluation in accordance with Medical Staff Bylaws. MD 3 and MD 4 did not have required proctoring completed and their appointment was not extended following the process as listed in Medical Staff Bylaws (Refer to A-0340 -3)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide care in a safe and quality manner.

Based on observation, interview and record review, the hospital failed to protect and promote each patient's rights when:

1. One of seven patients (Pt 9) whose preferred language was not English, and a signed consent was not obtained in a language Pt 9 could understand, according to the hospital Policy and Procedure (P&P) titled, "Language Assistance Services Policy" and "Consent, Informed,". (Refer to A-131 Finding 1)

2. One of 12 patients (Pt 15) whose preferred language was not English, the Conditions of Admissions [COA-documents the patient's consent to the general terms and condition for receiving care from the hospital] documents were not provided in the preferred language, in accordance with the hospital P&P titled, "Language Assistance Services Policy" and Conditions of Admissions and/or Registration Form". (Refer to A-131 Finding 2)

3. Staff stored non-compatible products in the warmer located in emergency department (ED) of the hospital and not in accordance with the operating instructions of the warmer. (Refer to A-144 Finding 1)

4. One of one patient (Patient [Pt]5), Lead Nuclear Medical Technologist (LNMT-Lead staff working in Nuclear Medicine Department) 1 failed to verify patient identity prior to the administration of a radiopharmaceutical (drug containing radioactive material). LNMT 1 injected 3 milliliters (ML- a unit of volume measurement) of another patient's (Pt 6's) radioisotope tagged white blood cells (-a small amount of radioactive material attached to the white blood cell [WBC-part of blood], in a special pharmacy) into Pt 5's vein. LNMT 1 failed to follow the hospital P&Ps titled, "Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration", and "Identification: Patient Armband/Patient Verification" and did not follow standards of practice for medication administration. (Refer to A-144 Finding 2)

5. Respiratory Therapist (RT) 2 removed sutures from the tracheostomy (a surgical procedure that creates an opening in the windpipe to allow air to enter the lungs) site for Pt 4 without being trained to competently perform this task. (Refer to A-144 Finding 3)

6. Staff were aware of Pt 7's obstructive sleep apnea (OSA-a sleep disorder that causes breathing to repeatedly stop and start during sleep) and did not assess Pt 7's ability to safely use personal continuous positive airway pressure (CPAP-a machine that uses mild air pressure to keep breathing airways open while you sleep) from home prior to use in the hospital. (Refer to A-144 Finding 4)

7. Staff were aware of Pt 2's chronic obstructive pulmonary disease (COPD-a common lung disease causing restricted airflow and breathing problems) and congestive heart failure (CHF-a condition where the heart is unable to pump blood effectively) and administered CPAP without first obtaining a physician order. Pt 2 was changed from CPAP to bilevel positive airway pressure (BiPAP a non-invasive breathing machine that helps people breathe when they are having trouble) without first obtaining a physician order to establish the setting parameters for the BiPAP. (Refer to A-144 Finding 5)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide care in a safe setting.

Based on the interview and record review hospital failed to ensure that medical staff operated under Bylaws approved by governing board, followed medical staff rules and regulations for privileging, followed policies for periodic evaluation of medical staff and provided quality of medical care to the patients when:

1. Medical Doctor (MD) 1 at reappointment requested and was granted cardiac surgery privileges without MD 1 meeting the requirements set forth by department and Medical Staff ByLaws. MD 1 was reappointed by Medical Executive Committee (MEC) and hospital board with cardiac surgery privileges without documented board certification in cardiac surgery; MD 1 did not complete the proctoring requirement and without MD 1 having the expected volume of cases listed for the procedures in which he was granted privileges. MD 1's specialty specific Ongoing Professional Practice Evaluation (OPPE -A process that identifies and evaluates professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focus on the individual practitioner's performance and competence related to privileges ) data was not available for at minimum every 12-month interval as indicated in Medical staff policy (Refer to A-0340 -1)

2. MD 2's credential file included Intensive Care Unit (ICU - specialized area within a hospital or healthcare facility dedicated to providing intensive medical care to patients with serious, life-threatening conditions) p procedural privileges and the credential file did not include MD 2 to have approved privilege to manage patients in ICU or privileges for EKG interpretations. MD 2 was actively working in ICU, managing patients that require EKG interpretation. MD 2 specialty specific OPPE data was not available for at minimum every 12-month interval as indicated in Medical staff policy (Refer to A-0340 -2)

3. MD 3 and MD 4 at the end of their provisional appointment did not have evaluation in accordance with Med Staff ByLaws. MD 3 and MD 4 did not have required proctoring completed and their appointment was not extended following the process as listed in Medical Staff ByLaws ((Refer to A-0340 -3)

4. Physicians failed to document a progress note for one out of 10 sampled patients Patient (Pt) 25, on a daily basis, during her hospital admission (Refer to A-0347)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care to patients in a safe environment.

Based on observation, interview and record review, the facility failed to have a well-organized and effective nursing service when:

1. Registered Nurses (RNs) failed to create an individualized care plan for Pt 5's severe protein and calorie malnutrition (body not getting enough calories or nutrients) according to the hospital policy and procedure (P&P), titled "Patient Plan of Care" and the hospital "Registered Nurse Job Description". (Refer to A-396 Finding 1)

2. RNs did not develop an individualized care plan for Pt 13's hypertension (high blood pressure). (Refer to A-396 Finding 2)

3. RN 3 received a critical result (a laboratory result falling outside normal range and requiring immediate attention) from the blood bank for one of one patient (Pt 3) and the RN did not notify the surgeon, or Pt 3's primary physician within the 30-minute time frame according to the hospital P&P titled "Laboratory Critical and or Call Values", and did not document a notification to the primary physician per the hospital's P&P titled "Documentation (Charting) for the Patient Health Record". (Refer to A-398 Finding 1)

4. Emergency Department (ED) RNs did not administer pain medications or escalate to a physician when one of 3 patients (Pt 26) reported a pain score of 8 out of 10 in the ED, according to hospital P&P titled, "Pain Management". Pt 26 reported a pain score of 8/10 on three separate occasions and was discharged from the ED with a reported pain score of 8/10, without having her pain addressed by RNs or physicians. (Refer to A-398 Finding 2)

5. One of 10 patients (Pt 5) had an active medical problem of severe protein and calorie malnutrition (body not getting enough nutrients), and RNs and Certified Nursing Assistants (CNA)s failed to document nutritional intake, according to hospital P&P titled, "(Medical) Nutrition Therapy: Meal/Snack Delivery, Pick Up and Intake Recording". (Refer to A-398 Finding 3)

6. RNs did not assess and document a temperature for one of three patients (Pt 25) in the Labor and Delivery (L&D- a specialized unit where babies are born and pregnant patients are treated) Unit every two hours after rupture of membranes (ROM- when the bag of water that surrounds the unborn baby breaks), according to the hospital's P&P titled "Admission of Labor Patient". (Refer to A-398 Finding 4)

7. ED nurses failed to assess Pt 4's skin and implement pressure relieving interventions upon arrival to ED in accordance with hospital policy. Pt 4 stayed in gurney in ED over nine hours and was not turned, or repositioned. Pt 4 upon arrival to Intensive Care Unit (ICU-specialized unit providing advanced care for critically ill or injured patients) had redness and purple discoloration to back/coccyx area. (Refer to A-398 Finding 5)

8. Nursing staff failed to change Pt 4's colostomy bag and do a complete assessment of skin around stoma every three to five days in accordance with facility standards or receive a physician order to leave bag in place. Pt 4's colostomy bag was not changed for 16 days and skin around stoma site was note assess appropriately. (Refer to A-398 Finding 6)

9. One of two patients (Pt 9) did not have an Aldrete assessment (a tool used to assess a patient's readiness for discharge from the Post-Anesthesia Care Unit (PACU-a specialized area in hospitals where patients recover from anesthesia and surgery) after surgery) completed before discharging from the PACU according to the hospital's P&P titled, "Transfer From PACU." (Refer to A-398 Finding 7)

10. One of two patients (Pt 9) did not have a temperature assessed before discharging from the PACU according to the hospital's P&P titled, "Transfer From PACU. (Refer to A-398 Finding 8)

11. One of three patients (Pt 9) did not have an assessment completed when transferred from one unit of the hospital to another. (Refer to A-398 Finding 9)

12. Two of eight patients (Pt 9 and Pt 13) did not have physician notifications for elevated systolic blood pressure (SBP-the pressure in the arteries when the heart contracts) according to the physician order. (Refer to A-398 Finding 10)

13. Two of two patients (Pt 7 and Pt 10) did not have an incision assessment each shift according to the hospital's standard of practice. (Refer to A-398 Finding11)

14. One of one patient (Pt 2) who had a community acquired pressure injury (pressure injuries that develop outside of hospital) was not turned every two hours according to the hospital's P&P titled, "Skin Care: Pressure Related Injury Management." (Refer to A-398 Finding 12)

15. One of two patients (Pt 2) did not have pain assessments completed according to the physician's order. (Refer to A-398 Finding 13)

16. One of two patients (Pt 1) did not have triage vital signs completed when arriving to the emergency department (ED) according to the hospital's P&P titled "Triage Policy." (Refer to A-398 Finding 14)

17. RN 8 did not clamp the normal saline (NS-a mixture of sodium chloride and water) tubing during a blood administration observation according to nursing standards of practice. (Refer to A-398 Finding 15)

The cumulative effect of these system problems resulted in the hospital's inability to provide quality nursing care in a safe setting.

Based on observation, interview and record review, the hospital failed to provide nuclear medicine services in accordance with acceptable standards of practice when:

Lead Nuclear Medicine Technologist (LMNT) 1 transported radioactive material meant for Patient (Pt) 6 to the wrong floor and wrong room in the hospital and administered the radioactive material to Pt 5 without first verifying the correct patient. LMNT 1 administered via injection 3 milliliters of radioisotope tagged white blood cells belonging to Pt 6 into Pt 5's vein and did not follow hospital P&Ps titled, "Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration", and "Identification: Patient Armband/Patient Verification" and standards of practice for medication administration. (Refer to A-1035)

The cumulative effect of this systemic problem resulted in the hospital's inability to provide quality patient care in a safe environment.

Based on interview and record review, the hospital failed to ensure, one out of 13 employees sampled, (Clinical Laboratory Scientist (CLS) 2) completed the required annual abuse training, according to the standard of practice and by state law for California healthcare workers. CLS 2 had not completed the annual training titled, "Reporting Abuse and Neglect", since 3/28/2021.

This failure had the potential to result in CLS 2 failing to understand hospital and State reporting requirements of abuse and neglect for healthcare providers, thereby placing patients of abuse and/or neglect at risk of going unreported by CLS 2.

Findings:

During a concurrent interview and record review on 4/4/25 at 2:40 p.m. with the Director of Human Resources (DHR), Registered Nurse (RN) 7, and Nurse Educator (NE) 7, CLS 2's competency and training documentation, dated 2012 to 2025, was reviewed. The competency and training documentation, indicated, the "Reporting Abuse and Neglect," education module was not completed by CLS 2 for the 2023-2024 year. NE 7 stated the abuse training was an online computer education module and was an annual requirement for CLS 2. NE 7 stated, the last date CLS 2 completed the "Reporting Abuse and Neglect," education module was 3/28/2021. NE 7 stated, CLS 2 should have completed the education module in 2024. NE 7 stated the education module was important because all healthcare workers needed to know how to report abuse and neglect.

During an interview on 4/4/25 at 4: 15 p.m. with the Manager of Accreditation and Licensure (MAL) the MAL stated, the hospital changed the online computer education system to a new provider and the "Reporting Abuse and Neglect," required education module did not flow over for all departments. The MAL stated CLS 2 should have received the annual abuse education.
During a review of a hospital document titled, "List of Job Profiles [LJP]," undated, the "LJP" indicated, 158 hospital employees across 60 departments did not receive the "Reporting Abuse and Neglect," annual education module for the 2023-2024 year.

During a review of a professional reference titled, "Meeting California Training Requirements for Healthcare," undated, the professional reference indicated " ...California is known for its progressive politics with a strong emphasis on social justice, environmental issues, and diverse representation. These unique characteristics influence required California training for healthcare professionals. For example, California requires all employers of five or more employees to provide training to supervisory (two hours of training) and nonsupervisory employees (one hours of training) on sexual harassment and abusive conduct prevention. California also requires all individuals who are considered mandated reporters under California law to receive training. Domestic violence training is required based on licensing ....".

During a review of a professional reference titled, "Mandatory Reporting of Child Abuse and Neglect - California," 5/23, the professional reference indicated, " ... Mandated reporters include the following: ...An adult person whose duties require direct contact with and supervision of minors in the performance of the minors' duties in the workplace is a mandated reporter of sexual abuse, as defined in § 11165.1. ...This training shall include training in child abuse and neglect identification and training in child abuse and neglect reporting. The training requirement may be met by completing the general online training for mandated reporters ...".

During a review of a professional reference titled, "California's New Workplace Violence Prevention Law: The Path to Compliance," dated 1/10/24, the professional reference indicated, " ...California has enacted a new workplace violence prevention law, SB 553/California Labor Code Section 6401.9, requiring nearly all California employers to develop and implement a written workplace violence prevention plan, provide annual training on the plan to employees, and maintain a log of incidents of workplace violence ...".

Based on interview and record review, the hospital failed to consider the rights of two out of 12 sampled patients to receive communication in their preferred language when:

1. One of seven patients (Pt 9) whose preferred language was not English, and a signed consent was not obtained in a language Pt 9 could understand, according to the hospital Policy and Procedure (P&P) titled, "Language Assistance Services Policy" and "Consent, Informed."

This failure denied Pt 9 of her right to make informed consent about her care.

2. One of 12 patients (Pt 15) whose preferred language was not English, the Conditions of Admissions [COA-documents the patient's consent to the general terms and condition for receiving care from the hospital] documents were not provided in the preferred language, in accordance with the hospital P&P titled, "Language Assistance Services Policy" and "Conditions of Admissions and/or Registration Form."

This failure had the potential for Pt 15 to have ineffective communication, misunderstandings, and possible patient harm.

Findings:

1. During a review of Pt 9's "History and Physical (H&P- a complete patient assessment by the physician)," dated 3/18/25, the H&P indicated Pt 9 was recently diagnosed with colon cancer (a type of cancer that develops in the large intestine (colon) and rectum) and was admitted to the hospital for a robotic low anterior resection of rectosigmoid colon (a minimally invasive surgical procedure, using a robotic system, to remove a cancerous portion of the rectum and reconnect the remaining colon) and a loop ileostomy (where a loop of small intestine is pulled out through a cut (incision) in the abdomen, before being opened up and stitched to the skin to form a stoma). Pt 9 had a past medical history of hypertension (HTN-high blood pressure), diabetes mellitus (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing), and coronary artery disease (a common type of heart disease).

During a concurrent interview and record review on 3/27/25 at 1:55 p.m. with Nurse Manager (NM) 4, Pt 9's "Electronic Medical Record (EMR-a digital version of a patient's medical chart), undated, "Verification of Informed Consent to Surgery or Special Procedure (Informed Consent)," dated 3/21/25 and "Interpreter Services Flowsheet (ISF)," dated 3/21/25 were reviewed. The "EMR" indicated Pt 9's primary and preferred language was Farsi. The "Informed Consent" indicated the patient signed the consent form on 3/21/25 at 6:35 a.m. and an interpreter was not used as evidenced by the blank lines under the interpreter's statement. NM 4 stated there was no interpreter information written on the "Informed Consent." NM 4 stated there was no documentation in the "ISF" that an interpreter was used when Pt 9 signed the "Informed Consent." NM 4 stated an interpreter was important to ensure the patient understood in her preferred language what the plan for the procedure was.

During an interview on 4/4/25 at 9:45 a.m. with the Director of Peri-Operative (DPO), the DPO stated he expected nurses to use an interpreter when the patient requires interpreting services.

During an interview on 4/4/25 at 5:10 p.m. with the Chief Nurse Executive (CNE), the CNE stated nurses are expected to make every effort to provide interpretive services and to document when an interpreter is used.

During a review of the hospital's policy and procedure (P&P) titled, "Language Assistance Services Policy," dated 2/19/25, the P&P indicated, " ... DEFINITIONS: ... LEP - Limited English Proficiency: Individuals who are "Limited English Proficient" cannot speak, read, write or understand the English language at a level that permits them to effectively communicate with health care professionals ... PROCEDURES: ... Identifying LEP persons and their language ... The patient's preferred communication language will be documented in the medical record when the patient is registered ... Obtaining a Qualified Interpreter ... The interpreter's responsibilities will include translating the information regarding the recommended medical treatment that the patient or the patient's legal representative needs to receive before deciding whether to give consent, as well as instructions regarding medical care ... Documentation ... Any subsequent use of any interpreter services will be documented in the medical record, using EHR Interpreter Flowsheet: a. Reason for service (i.e., consent for surgery, etc.) b. Agency used ... c. Name and/or ID number of the interpreter..."

During a review of the hospital's P&P titled, "Consent, Informed," dated 2/1/23, the P&P indicated, " ... PURPOSE: A. To give guidance and direction in obtaining informed consent for surgery, therapeutic, or special diagnostic procedures, including blood transfusions ... PROCEDURE: ... After the patient has voiced that he/she understands the medical treatment, and has no further questions, obtain the patient's/patient designee's signature on the "Verification of Informed Consent" form. Document the date, time, witness when applicable, and translator if involved ..."

2. During a concurrent interview and record review on 3/26/25 at 3:48 p.m. with Registered Nurse (RN) 5, Pt 5's "H&P", "Admission Preferred Language (APL)", and "COA," dated 3/25/25 were reviewed. The "H&P" indicated Pt 5 was 39 weeks and one day pregnant who presented to the Labor and Delivery (L&D -Special unit were babies are delivered, and pregnant women are cared for) Unit on 3/25/25 for labor admission due to onset of frequent painful contractions (tightening of muscles in the womb) every two to four minutes. The "H&P" indicated; Pt 5 was admitted to the L&D department for active labor (baby would be delivered soon). The "APL" indicated, Pt 5's preferred language was Spanish. RN 5 stated, the "APL" indicated, an interpreter was needed for communication. RN 5 validated the "COA" document was in English. The "COA" was signed by Pt 5 on 3/25/25 at 11:53 a.m. and an interpreter name and identification number was entered on the form. RN 5 stated, nursing staff were not responsible for the "COA" forms completion, so did not know if the Spanish form was downloaded into the "Electronic Medical Record".

During a concurrent interview and record review on 4/3/25 at 3:10 p.m. with the Manager of Patient Access (MAP) and The Supervisor of Patient Access (SPA), Pt 5's "COA," dated 3/25/25 was reviewed. The SPA stated, when patients were Spanish speaking, a Spanish speaking staff member could interpret and sign the "COA" form, in the interpreter area. The SPA stated the "COA" forms were available in Spanish, and Pt 5 should have received the "COA" in Spanish. The MAP validated Pt 5's "COA" was in English.

During a review of the hospital's P&P titled "Conditions of Admissions and/or Registration Form," dated 3/27/24, indicated, " ...If a patient is identified as having Limited English proficiency (LEP), language assistance will be provided through use of language identification cards, proficient bilingual staff, telephone language interpretation vendor services, and/or other arrangements. A patient, after being informed of the availability of the interpreter service, may choose to use a family member/friend instead ..."

During a review of the hospital's P&P titled, "Language Assistance Services Policy," 2/19/25, indicated, " ...The patient's preferred communication language will be documented in the medical
record when the patient is registered. ...Providing Written Translations 1. Vital documents, including consent forms, presented by hospital staff to a patient will be written in a language that the patient can understand or translated into such a language. 2. Certain documents are also available in frequently encountered languages within the EHR [Electronic Health Record] ..."

Based on observation, interview, and record review, the hospital failed to ensure the rights of patients to receive care in a safe environment when:

1. Staff stored non-compatible products in the warmer located in emergency department (ED) of the hospital and not in accordance with the operating instructions of the warmer.

This failure had the potential for fire or other hazards and did not ensure the right to care in a safe environment.

2. One of one patient (Patient [Pt]5) Lead Nuclear Medical Technologist (LNMT-Lead staff working in Nuclear Medicine Department) 1 failed to verify patient identity prior to the administration of a radiopharmaceutical (drug containing radioactive material). LNMT 1 injected 3 milliliters (mL- a unit of volume measurement) of another patient's (Pt 6's) radioisotope tagged white blood cells (-a small amount of radioactive material attached to the white blood cell [WBC-part of blood], in a special pharmacy) into Pt 5's vein. LNMT 1 failed to follow the hospital P&Ps titled, "Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration", and "Identification: Patient Armband/Patient Verification" and did not follow standards of practice for medication administration.

This failure had the potential to infect Pt 5 with a bloodborne pathogen (disease causing germs found in human blood) from Pt 6's blood, causing illness because, Pt 6 was diagnosed with osteomyelitis (bone infection caused by bacteria) at the time of the incident and had an increased risk for Pt 5 to have a reaction to the blood product injected, leading to fever, chills, hives (raised itchy bumps on the skin), difficulty breathing, requiring a longer hospital stay.

3. Respiratory Therapist (RT) 2 removed sutures from the tracheostomy (a surgical procedure that creates an opening in the windpipe to allow air to enter the lungs) site for Pt 4 without being trained to competently perform this task.

This failure resulted in RT 2 possibly performing tasks outside of RT's scope of practice and had the potential for negative outcome for Pt 4, such as bleeding and surgical site infection.

4. Staff were aware of Pt 7's obstructive sleep apnea (OSA-a sleep disorder that causes breathing to repeatedly stop and start during sleep) and did not assess Pt 7's ability to safely use personal continuous positive airway pressure (CPAP-a machine that uses mild air pressure to keep breathing airways open while you sleep) from home prior to use in the hospital.

This failure had the potential for Pt 7 to experience respiratory distress and be placed on unsafe equipment.

5. Staff were aware of Pt 2's chronic obstructive pulmonary disease (COPD-a common lung disease causing restricted airflow and breathing problems) and congestive heart failure (CHF-a condition where the heart is unable to pump blood effectively) and administered CPAP without first obtaining a physician order. Pt 2 was changed from CPAP to bilevel positive airway pressure (BiPAP a non-invasive breathing machine that helps people breathe when they are having trouble) without first obtaining a physician order to establish the setting parameters for the BiPAP.

This failure had the potential for Pt 2 to be placed on noninvasive (not required instruments into the body) support with wrong settings, ineffective gas exchange and could further complicate her respiratory condition.

Findings:

1. During a concurrent observation and interview on 3/25/25 at 3:16 p.m. in the "Emergency Department (ED) Pod" with the ED Manager (NM 3) and Assistant Nurse Manager (ANM 1) observed [Brand name 1] warmer stocked with rinse free shampoo caps of [Brand name 2] along with [Brand name 1] pre moistened wipes. ANM 1 stated she was not aware of any concerns with stocking [Brand 2] rinse free shampoo caps in the [Brand 1] warmer. ANM 1 stated it was not their normal practice to use [Brand name 1] warmer for both [Brand name 1] & [Brand name 2] products. ANM 1 stated as far as she knows both brand products were compatible with the [Brand name 1] warmer. NM 3 stated she would have to review manufactures instructions for use and was not aware of the compatibility with using the [Brand 2] products in [Brand 1] warmer. NM 3 stated it was not the normal practice at the hospital to stock [Brand 2] products in [Brand 1] warmer.

During an interview on 3/27/25 at 1:52 p.m. with the NM 3, NM 3 stated she had reviewed the [Brand name 1] warmer's operating instructions. NM 3 stated the instructions clearly states that [Brand name 1] warmer was exclusively to be used with same brand [Brand name 1] products. NM 3 stated the hospital was not using the [Brand name 1] warmer in accordance with instructions for use. NM 3 stated she understood the fire risk and risk for other hazards with the use of [Brand name 2] products in the [Brand name 1] warmer. NM 3 stated the practice had been immediately stopped , and all [Brand 2] products were removed from the warmer and going forward, the hospital team will only use [Brand name 1] wipes and products with the [Brand name 1] warmer.

During an interview on 4/4/25 at 5:35 p.m. with the Chief Nurse Executive (CNE), the CNE stated she expected staff to follow the manufacturer's instructions for use and agreed that [Brand 2] products should not be used in [Brand 1] warmer. The CNE stated instructions clearly state using any other brand's product in [Brand 1] warmer could lead to fire and safety hazard.

During a review of [Brand name 1] "Warmer Operating Instructions", undated, the "Warmer Operating Instructions" indicated, " ...Please read and understand these instructions completely prior to operating the warmers ...IMPORTANT SAFETY INSTRUCTIONS This product is to be used SOLELY for warming premoistened cloth and hair care products manufactured by [Brand name 1] LLC. The warmer has been designed and safety tested to be used exclusively with these products. ANY other use of the warmer by the facility including, but not limited to, use with other bathing products, can result in overheating, fire or other hazardous conditions and is expressly forbidden ..."

2. During an observation and interview on 3/26/25 at 10:46 a.m. in the Nuclear Medicine (Nuc Med) Department, with Nuclear Medicine Technologist (NMT) 1, the metal boxes used to carry the radioisotope tagged WBCs to the patient's bedside were observed in the Hot Lab (special room to deliver, store and prepare radioactive materials). NMT 1 stated the metal boxes were made of lead and were called "pigs". NMT 1 stated, the process for preparing a patient for a Nuclear Medicine scan (uses small amounts of radioactive material, called radiotracers, to create images of the inside of the body) with tagged WBCs, began when a Nuclear Medicine Technologist (NMT) received the order from a physician. NMT 1 stated, a NMT would draw a sample of the patient's blood and apply a Nuc Med Department wrist band. NMT 1 stated, the band had numbers on it matching the blood sample labels. NMT 1 stated, the blood was then sent to the Radiopharmacy (pharmacy for radioactive materials) in another town, where the isotopes were added. NMT 1 stated, the dose was brought back within a few hours. NMT 1 stated, the same NMT who drew the blood would administer the dose. NMT 1 stated, the NMT took the "pig" containing the syringe "kit" (dose of tagged WBCs), and the physician order to the patient's bedside. NMT 1 stated, the NMTs were supposed to verify patient identity by checking the wrist band placed earlier, and by verifying name, date of birth (DOB). NMT 1 stated, the patient's "kit" numbers were verified against the wrist band. NMT 1 stated, now the patient's nurse had to sign off to ensure the correct patient was about to receive the dose. NMT 1 stated, the nurse's completing the double check started a few months ago. NMT 1 stated, the double check was important to prevent errors, and ensure the correct patient received the dose. NMT 1 stated, an error injecting the wrong patient could harm the patient not due to the isotopes but due to the blood. NMT 1 stated, patients could go into anaphylactic shock (a severe, life-threatening allergic reaction that could cause a rapid decline in blood pressure and difficulty breathing) due to receiving a blood product not the same type as their own.

During an interview on 3/26/25 at 11:34 a.m. with the Radiology Safety Officer (RSO), the RSO stated, his role as safety officer was to oversee the radioactive material at the hospital and, to ensure patient and employee safety. The RSO stated, he was a practicing Radioactive Oncology Physician. The RSO stated, he remembered the incident regarding LNMT 1 injecting Pt 5 with Pt 6's radioisotope tagged WBCs on 12/9/24. The RSO stated, he was involved with the hospital internal investigation. The RSO stated the incident involved two patients, Pt 5 and Pt 6. The RSO stated, Pt 6 had a physician order for an injection of blood with radioactive isotopes for a nuclear radiologic procedure (scan), and Pt 5 did not have an order for a nuclear radiologic procedure. The RSO stated, Pt 5 was injected with Pt 6's blood by LNMT 1. The RSO stated, when a physician ordered a nuclear scan, a report went to the Nuc Med Department through the Electronic Medical Record (EMR- a digital version of a patient's medical history, including diagnoses, medications, tests, allergies, immunizations, and treatment plans), and the type of scan the physician ordered required a radioisotope be attached to white blood cells. The RSO stated, LNMT 1 went to Pt 6's hospital room and drew a vial of blood. The RSO stated, the vial of blood was sent to an offsite Radiopharmacy in a town one- and one-half hours away by the nuclear pharmacy courier (transporter). The RSO stated, the WBCs were tagged at the nuclear pharmacy then returned to the hospital for injection. RSO stated, LNMT 1 took the blood product to the patient's hospital room and "just didn't identify patient", injecting the radioisotope tagged WBCs into Pt 5 instead of Pt 6. The RSO stated, LNMT 1 got off on the wrong floor and went into the same room number. The RSO, stated LNMT 1 identified his error, "right after the administration". The RSO stated, LNMT 1 reported the error to the nurse, and leadership immediately. The RSO stated, Pt 5's physician was notified as well as the patient and the family. The RSO stated, LNMT 1 "missed the double check", and "just didn't identify patient [did not verify Pt 5's name and date of birth, against the armband]" The RSO stated, Pt 5 could have been harmed by any infections that were present in the blood infected into her. The RSO stated, the radiation was not an issue, it was given to the wrong patient, but it had a short half-life (the time it takes for one of the atoms in the sample to decay [lose energy] one that decays quickly).

During a concurrent interview and record review on 3/28/25 at 9:33 a.m. with Nurse Educator (NE)1, Pt 6's "History & Physical [H&P- an assessment from physician including medical history and exam]," dated 1/1/25 was reviewed. The "H&P" indicated, Pt 6 was a Portuguese speaking 86-year-old with past medical history (PMH) of Type 2 Diabetes Mellitus (disorder characterized by difficulty in blood sugar control and poor wound healing), and hypertension (high blood pressure), presenting to the emergency department (ED) on 12/29/24 for right foot redness, swelling and pain, as well as generalized weakness. The "H&P" indicated, Pt 6 was admitted to the hospital as an inpatient on 12/31/24 for a diabetic ulcer (open sores on the feet, a serious complication of diabetes), and acute osteomyelitis (a bone infection that develops rapidly).

During a concurrent interview and record review on 3/28/25 at 9:40 a.m. with NE 1, Pt 6's "Provider Progress Note [PPN]," dated 1/2/25 to 1/8/25, "Physician Orders [PO]", "Medication Physician Orders [MPO], dated 12/30/24 to 1/3/25, and "Medication Administration Record [MAR]," dated 12/31/24 to 1/3/25, were reviewed. The "PO" indicated, on 12/30/24 at 4:50 p.m. an order for a Nuc Med scan was entered. NE 1 stated, the "PO" indicated the scan was performed on 1/3/25 at 11:38 a.m. and read by the physician on 1/4/25. The "MPO" indicated, on 1/2/25 at 11:05 a.m. an order for "...Radioisotope 12millicuire [a unit of radioactivity]" ...Electronically signed by: [LNMT 1] on 1/2/25 at 1105 [11:05 a.m.] ..." The "MAR" indicated, the radioisotope 12 millicurie was ordered by LNMT 1 on 1/2/25 at 11:05 a.m. but was administered by NMT 1 intravenously on 1/3/25 at 11:38 a.m. The "MAR" had no indication the radioisotope was scanned before administration.

During a review of Pt 5's "H&P," dated 12/31/24, The H&P indicated Pt 5 was a Spanish speaking 96 year-old patient brought into the ED on 12/31/25 at 12:45 p.m. by family, with complaints of right upper quadrant pain (the area of the stomach located on the right side above the belly button) for two weeks. The "H&P" indicated Pt 5 was admitted as an inpatient on 12/31/24 at 8:50 p.m. for a renal abscess (a pocket of pus that forms within the kidney tissue) and moved to the Medical Surgical (MS) Unit at 11:56 p.m.

During a concurrent interview and record review on 3/28/25 at 9:55 a.m. with NE 1 Pt 5's "Provider Progress Note [PPN]," and "Labs", dated 1/2/25 to 1/8/25, "Physician Orders [PO]", "Medication Physician Orders [MPO], dated 12/31/24 to 1/3/25, and "Medication Administration Record [MAR]," dated 12/31/24 to 1/3/25, were reviewed. NE 1 stated, Pt 5's "PO" and "MPO" had no orders indicating a Nuc Med scan, or any radiopharmaceuticals were ordered for Pt 5. NE 1 stated, Pt 5s "MAR" had no documentation indicating Pt 5 was administered isotope tagged WBCs. NE 1 stated, Pt 5's "MAR" would not have documentation, because there were no orders for the patient to have radiopharmaceuticals. The "PPN" dated 1/2/25 indicated, " ...I was informed (01/02/2025) that patient [Pt 5] was (accidentally and erroneously [incorrectly]) injected (by nuclear medicine technologist) another patient's blood product [Pt 6]. This was communicated to the patient's sons ... Active Problems: ...Accidental injection of blood products from another patient - This was reported to the patient's both sons and risks/plans were explained. - Discussed with infection control; source patient [Pt 6] has strep [type of germ] bacteremia [serious infection enters the bloodstream] and Pseudomonas (common bacterial disease-causing organisms) wound infection. -Source patient is being tested for [bloodborne pathogens] ...per Infectious control request. ...Will repeat blood cultures with a.m. labs and follow up ...". NM 1 stated, multiple labs were drawn, and results were negative for bloodborne pathogens.

During an interview on 4/1/25 at 11:42 a.m. with the Director of Imaging (DI), the DI stated, she was a part of the hospital internal investigation of Pt 5 being injected with Pt 6's radioisotope tagged WBCs. The DI stated LNMT 1 failed to use two patient identifiers prior to injecting the radioisotope tagged WBCs for Pt 6 into Pt 5. The DI stated, her expectation was for LNMT 1 to report the error immediately, which he did. The DI stated, the discovery during the investigation was, LNMT1 got off the elevator on the incorrect floor and entered what would be the same room number if he was on the correct floor. The DI stated, Pt 6 and Pt 5 were located on different floors but were in the same room number, and in the same bed location. The DI stated, LNMT 1did draw the correct patient's blood (Pt 6), in the morning around 6 a.m. The DI stated, LNMT 1claimed he only "glanced" at Pt 5's armband, and both patients had similar first names, and both patients were similar in appearance. The DI stated, LNMT 1 did not notice Pt 5 did not have the Nuc Med Department armband applied, and he did not verify the "kit" numbers against the armband, or the patient's name against the physician's order. The DI stated, as soon as LNMT 1realized he injected the wrong patient he called the manager, the house supervisor and both patient's physicians. LNMT 1 stated, Pt 6 needed to be tested for bloodborne pathogens, and be redrawn for the nuclear isotope tagging and rescheduled for the scan, and Pt 5 needed to be monitored for reactions and tested for infections. The DI stated, the incident was reported to the RSO the same day as the event, and there was no concern for harm to Pt 5 due to the radiation dose. The DI stated, Pt 5 receiving Pt 6's blood was concerning but both patients were tested, and the results were negative for any bloodborne pathogens. The DI stated, the Nuc Med Department had label tracking (to scan) into the Nuclear Medicine Information System (NMIS-software designed to manage patient, department, including inventory, dosing and billing), but there was no barcode scanning to scan the "kit" into the main hospital EMR system. The DI stated the NMT's document in the patient's MAR when completing the administration.

During a review of hospital document titled, "Labeling Tracking Record [LTR]," dated 1/2/25, the "LTR" indicated, Pt 5 had blood drawn for WBC tagging by LNMT 1 on 1/2/25 at 6:25 a.m. The "LTR" had a checkmark indicating the "Patient name on all labeling stickers", "Specimen syringe sticker attached to blood specimen container" and "Bracelet attached to patient". The "LTR" indicated, Pt 5's blood was received at the Radiopharmacy on 1/2/25 at 8:30 a.m. The "LTR" indicated, a dual verification of the dose was verified, loaded and sealed in the transporting case. The "LTR" indicated, five separate steps for verification of patient name to ensure correct patient prior to sending the dose to the hospital. The "LTR" indicated, the radioisotope tagged WBCs were delivered to the hospital on 1/2/25 at 11:11 a.m.

During an interview on 4/1/25 at 2:50 p.m. with the Manager of Accreditation and Licensure (MAL), the MAL stated LNMT 1 was as not available to be interviewed because LNMT 1 no longer worked for the hospital.

During an interview on 4/2/25 at 1:19 p.m. with the Healthcare Risk Officer (HRO) the HRO stated, the reason the Nuclear Medicine incident was initially not thought to be reported, and an RCA was not completed was because it did not meet the criteria. The HRO stated, the hospital completed an Intensive analysis, considered one step above a regular investigation but did not rise to the level of a root cause analysis.

During an interview on 4/3/25 at 1:57 p.m. with the DI, the DI stated, the NTs scan the radiopharmaceutical product for the NIMS system at patient's bedside. The DI stated, during the incident with Pt 5 LNMT 1 had trouble logging into the computer workstation at Pt 5's bedside so he attempted to use identifiers, then scanned the label when returning to the Nuc Med department. The DI stated, when he scanned the label, he discovered his error.

During an interview on 4/4/25 at 5:25 p.m. with the Chief Nursing Executive (CNE), the CNE stated, LNMT 1 should have gone to the patient's room and verified the patient's identity, ensuring right patient, right drug, right dose, right route, and right time. The CNE stated the five rights of medication administration should have been followed for this patient to avoid the error.

During a review of the hospital's P&P titled, "Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration," dated 6/8/23, indicated, " ... PURPOSE A. To ensure patient and staff safety during the preparation and administration of radiopharmaceuticals. ...Patient identity shall be verified by comparing patient name and date of birth on identification band with same identifiers on applicable health information documents prior to initiating this policy/procedure ... Maintain adequate shielding throughout the department. Reaction vials are to remain in covered leaded carriers ("pigs"), when not in use. Dose syringes must be in syringe shield or "pig" except when in the dose calibrator. ... Double check vial and syringe labels before injecting. ...Administration ...Establish patient identity before prepping or injecting. Ask patient to state full name (rather than to confirm name) and the date of birth. For inpatients, confirm identification in same manner against identification armband. Nuclear Medicine Technologist will cross-reference patient identification with that printed on NMIS labels and/or registration record. ...Labeling of Blood Products a. On studies that involve invitro tagging of blood cells ... the patient should be carefully identified as above and given a wristband with specific identifiers for the return of the tagged blood cells. b. The same Nuclear Medicine technologist should draw the blood that re- injects the tagged cells. ...Documentation: ...Order radiopharmaceutical in the exam navigator under "orders", with correct information as to drug, route, and time. ...One eMAR [electronic Medication Administration Record] and NMIS computer system, document patient name, date of birth, and medical record number with radiopharmaceutical, manufacturer and lot number, dose, date and time of administration, date and time of expiration and Nuclear Medicine technologist administering ..."

During a review of the hospital's P&P titled, "Identification: Patient Armbands/Patient Verification," dated 2/8/22, indicated, " ...PURPOSE A. To assure accurate identification of all patients at [name of hospital] B. To assure the two approved patient identifiers are used to match service or treatment to that individual in a manner that prevents wrong patient identity. ...Verification of patient identity by comparing patient name and date of birth on identification band with same identifiers on applicable health information documents will occur prior to initiating this procedure ...Applicable patients will have an identification band on at all times. ... Accurate patient identification will occur whenever administering medications or blood products, taking blood samples and other specimens for clinical testing, or providing any other care, treatments or procedures. 1. Accurate identification MUST occur at the "point of care" any time care/treatment is to be provided. 2. Containers used for blood and other specimens are to be labeled in the presence of the patient. ... Whenever patient care is being managed through Order Entry (OE) or other computerized methods, accurate patient identification will occur by comparing patient's full name and date of birth on document being entered (physician's order for example) to patient pulled up in computer application. 1. Using medical record number and/or patient account number can be used to further verify correct patient IN ADDITION to, but not as replacements for, using patient's full name and date of birth. ... Patients who are hospitalized who are unable to participate in verification at time of admission will have identity verified through reliable family member or friend as soon as possible. The name of the family member or friend verifying identity will be entered into admission history to provide reference that identity was initially verified through this reliable source. This is intended to provide reference to subsequent caregivers that identity has been validated. ... VERIFYING PATIENT IDENTITY: POINT OF CARE VERIFICATION AND INFORMATION DOCUMENT COMPARISON 1. Upon first interaction or at beginning of shift with a conscious patient, verify patient identity by asking the patient to state their full name and date of birth. Compare this to same information on patient's identification band and same in health information documents (eMAR, physician orders). 2. Upon all subsequent interactions while assigned to patient within same day, verify identity by checking full name and date of birth on identification band and comparing to same information on applicable health information documents (eMAR, physicians orders, lab results or other documents triggering nursing intervention). ...Non-English speaking: Obtain interpreter and follow same guidelines ..."

During a review of a professional reference titled, "Safe Medication Administration: So Many Considerations," dated July-August 2023, the professional reference indicated, " ... For decades, the five rights for administering medications have been a recognized safety standard (Martyn et al., 2019). The framework of the seminal five rights (i.e., right patient, drug, dose, time, route) has evolved, and other rights considered as additional influences on medication administration processes have been identified in changing healthcare environments ..."

3. During a review of Pt 4's "Emergency Department (ED) Note", dated 2/6/25, the "ED Note" indicated, " ... [Pt 4] is a 43 year old female with [past medical history] significant for fibroids [noncancerous growths that develop in the uterus, often without causing symptoms], prior alcohol abuse, adenocarcinoma [type of cancer that starts in the glands that line organs] of the rectosigmoid colon [lower part of the large intestine] metastatic [cancer that has spread from its original location to other parts of the body] to the liver seen by [hospital name] oncology, diverting colostomy [surgical procedure where a portion of the colon is brought out through an opening in the abdominal wall, creating a stoma, which allows waste to be eliminated into a bag attached to the skin], cirrhotic liver [condition where healthy liver tissue is replaced by scar tissue, leading to impaired liver function], who presents to the ED for evaluation of [altered mental status (AMS)]. Per friend, Per friend, patient did not eat yesterday or take medications. She has been sleeping all day today and was briefly unresponsive for family ... stage IV colorectal rectal cancer [indicates that the cancer has spread from the colon or rectum to other parts of the body] metastatic to liver and bones not a candidate for chemoradiation therapy [cancer treatment] ... discussed with the intensivist [medical doctor who possesses special training and experience in treating critically ill patients] for admission to [Intensive Care Unit (ICU - is a specialized hospital unit providing advanced care for critically ill or injured patients who require constant monitoring, life support, and specialized medical treatments)] ... FINAL DIAGNOSIS ... Septic shock ...Metastatic colon cancer to liver ... Acute kidney injury [sudden decline in kidney function, often reversible, where the kidneys can't filter waste products from the blood] ... Influenza [Flu, an infection of the nose, throat and lungs] ..."

During a concurrent interview and record review on 4/3/25 at 9:07 a.m. with Respiratory Therapist (RT) 3, PT 4's Electronic Medical Record (EMR) was reviewed for the hospital encounter date of 2/6/25. The review of document titled "POST - OP NOTE" dated 2/27/25 at 4:56 p.m. indicated, " ... PROCEDURE: Tracheostomy placement ... We placed a 7.5 ID [internal diameter] cuffed [Brand name] tracheostomy tube [a curved, hollow tube inserted into the trachea (windpipe) to help a person breathe] ... Adequate position confirmed ... the trach was secured with Prolene suture [brand of non-absorbable, synthetic suture made from polypropylene (type of plastic) ] and trach tie ...". The review of flow sheet note filed on 3/8/25 at 11:26 a.m. by RT 2 indicated, " ... Trach sutures removed from each corner at this time. Patient tolerated well without adverse event ..." RT 3 stated RTs do not remove sutures on tracheostomy tubes at the facility and the hospital did not provide any competencies, training or skills validation for respiratory staff to remove sutures. RT 3 stated she was not aware that RTs can remove suture and, in her experience, it was usually physician, nurse practitioner (NP) or physician assistant (PA) that remove sutures on new trach. RT 3 stated she was not aware of any policy or guidelines at the facility for RTs to remove sutures from tracheostomy tube. RT 3 stated she was not sure whether it was in the scope of RTs to remove sutures at this facility and would have to defer to her manager or director for answer.

During an interview on 4/3/25 at 9:46 a.m. with the Manager of Respiratory Therapy (MRT), the MRT stated "We do not have any policies, training or competencies for RCPs to remove trach suture, RT 2 should not have done it". MRT stated RT 2 had no competency or training to remove Pt 4 tracheostomy tube sutures. MRT stated removing sutures from new tracheostomy tube was not part of the scope of RTs at the hospital. MRT stated without training, competencies or skills validation it could potentially cause harm to the patient.

During an interview on 2/4/25 at 9:15 with the Director of Critical Care and Respiratory (DCC), the DCC stated he had reviewed the chart and spoken with the physician in Intensive Care Unit (ICU). The DCC stated RT 2 was working outsider of her scope and should not have removed sutures. The DCC validated that RT 2 had no training, no competency and no skills validations completed for tracheostomy suture removal. The DCC stated hospital did not have a policy, training or competencies for RTs to remove suture. The DCC stated he expects all RTs to follow hospital policy and not perform tasks that are outside their scope of practice. The DCC stated working outside the scope puts patient at harm for adverse outcomes.

4. During a review of Pt 7's "H&P," dated 3/17/25, the "H&P" indicated Pt 13 was admitted to the hospital for an abdominal hysterectomy (a surgical procedure where the uterus is removed through an incision in the abdomen) due to abdominal pressure. The "H&P" indicated Pt 7 had a past medical history of chronic kidney disease (a gradual loss of kidney function over time), hyperlipidemia (an excess of fats in your blood), gastroesophageal reflux disease (GERD-a condition in which stomach acid repeatedly flows back up into the tube connecting the mouth and stomach, called the esophagus) and OSA on CPAP.

During a concurrent interview and record review on 3/26/25 at 2:47 p.m. with Nurse Educator (NE) 1, Pt's 7's "Physician Orders," dated 3/17/25 to 3/26/25 were reviewed. The "Physician Orders" indicated there were no orders for CPAP use. NE 1 validated she was unable to find any active order for CPAP use for Pt 7 and Pt 7 should have been evaluated to determine if a CPAP was needed while hospitalized. NE 1 stated Pt 7 should have had an assessment completed to determine her breathing while sleeping.

During a concurrent observation and interview on 3/27/25 at 9:56 a.m. with Pt 7, in Pt 7's room, a CPAP machine was observed on Pt 7's nightstand. Pt 7 stated she brought her CPAP from home to use at night. Pt 7 stated she did not sign any forms to use her CPAP from home during her stay in the hospital and stated she did not recall anyone assessing her ability to use her home CPAP for safety while used in the hospital. Pt 7 stated no one evaluated or asked her questions about her use of the CPAP.

During an interview on 3/27/25 at 10 a.m. with the Director of Medical Surgical Services (DMS) and Nurse Manager (NM) 5, NM 5 stated respiratory therapy should have come to evaluate the Pt 7's home CPAP and identify any issues. NM 5 stated a physician order should have been entered to evaluate Pt 7 for CPAP use when Pt 7 was admitted. The DMS stated the home CPAP would be on a fixed setting and respiratory therapy needed to come to check the setting before patient use.

During a concurrent interview and record review on 3/27/25 at 10:45 a.m. with NM 4, the hospital's P&P titled, "Obtaining and Using Patient Owned Respiratory Medical Devices," dated 2/16/22, and Pt 7's "Electronic Medical Record (EMR-an electronic version of a patient's medical history)," dated 3/17/25 to 3/27/25 were reviewed. The P&P indicated, " ... POLICY: ... The use of patient-owned medical devices is discouraged. However, due to medical necessity, patient-owned medical devices can be used if: A. A physician order allowing the patient to use their own device has been entered into the EHR ... C. A Release of Liability has been completed and scanned into the EHR. D. For CPAP and BiPAP devices, the licensed staff needs to verify that the patient can use their own device independently. For example, the patient can turn on and off the device and apply and remove the masks interface independently ..." The "EMR" indicated " ... CPAP NIV [non-invasive ventilation-use of breathing support administered through a face mask, nasal mask, or a helmet] - ADULT - OSA ... Patient can use own equipment: Yes ... Order Information ... Order Dat

Based on the interview and record review, the hospital failed to ensure Medical staff conducted appraisals to grant privileges and conducted evaluation of service line specific performance metrics of its members in accordance with Medical Staff ByLaws and Medical staff policy when:

1. Medical Doctor (MD) 1 at reappointment requested and was granted cardiac surgery privileges without MD 1 meeting the requirements set forth by department and Medical Staff ByLaws. MD 1 was reappointed by Medical Executive Committee (MEC) and hospital board with cardiac surgery privileges without documented board certification in cardiac surgery; MD 1 did not complete the proctoring requirement and without MD 1 having the expected volume of cases listed for the procedures in which he was granted privileges. MD 1's specialty specific Ongoing Professional Practice Evaluation (OPPE -A process that identifies and evaluates professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focus on the individual practitioner's performance and competence related to privileges ) data was not available for at minimum every 12-month interval as indicated in Medical staff policy.

2. MD 2's credential file included Intensive Care Unit (ICU - specialized area within a hospital or healthcare facility dedicated to providing intensive medical care to patients with serious, life-threatening conditions) p rocedural privileges and the credential file did not include MD 2 to have approved privilege to manage patients in ICU or privileges for EKG interpretations. MD 2 was actively working in ICU, managing patients that require EKG interpretation. MD 2 specialty specific OPPE data was not available for at minimum every 12-month interval as indicated in Medical staff policy.

3. MD 3 and MD 4 at the end of their provisional appointment did not have evaluation in accordance with Med Staff ByLaws. MD 3 and MD 4 did not have required proctoring completed and their appointment was not extended following the process as listed in Medical Staff ByLaws.

These failures had the potential to result in appointing and granting privileges to Medical staff without first determining qualifications and could affect the quality of care provided to patients.

Findings:

1. During a concurrent interview and record review on 4/4/25 at 10:35 a.m. with Senior System Quality Director (SDQ), Medical Staff Manager (MSM), Medical Staff Coordinator (MSC) 1 and MSC 2, MD 1's credential file was reviewed. MD 1's credential file indicated MD 1 was board certified in General Surgery. MD 1's original appointment was on 9/1/21 and was reappointed on 12/1/24. MD 1 reappointment application for two-year term was approved by Department Chair on 9/19/24. MD 1's credential file indicated Medical Executive Committee (MEC - a decision-making sub-committee of the medical staff composed of physicians and other key medical staff members, that makes decisions related to patient care, clinical policies, and physician performance) approved the reappointment on 10/22/24 and board of directors approved it on 11/7/24. The review of MD 1 reappointment application indicated MD 1 requested and was granted privileges [specific services and procedures a healthcare provider is deemed qualified to provide or perform] for cardiac surgery. The review of criteria for granting privileges under cardiac surgery on reapplication indicated "CRITERIA: Prior to being granted privileges to perform cardiac surgery, the following criteria shall be met: The physician shall be Board Certified in Cardiothoracic Surgery; OR The physician shall have successfully completed a recognized and approved Residency training program within Cardiothoracic Surgery. He/she shall be expected to take the board certification. examination at the earliest possible opportunity and will be allowed two (2) attempts to pass. The physician shall scrub [becoming a member of the sterile surgical team] with Board Certified Cardiothoracic Surgeon for ten (10) cases, as well as being proctored [refers to an experienced surgeon observing and mentoring a colleague during a procedure, often to evaluate competency or provide guidance for new techniques]; AND Obtain letters of reference from the training program addressing independence and competence; AND Submit a copy of the operative report and, in so much as possible, a copy of the history and physical, consultations and discharge note from the most recent fifty (50) pump cases [procedures using cardiopulmonary bypass (CPB), where a heart-lung machine temporarily takes over the heart and lungs' functions] in which the applicant was the primary surgeon; AND Special attention will be directed not only to documentation of technical surgical competence, but also, thorough analysis of cases and on the basis of personal reference, to a demonstration of commitment to careful and precise pre-operative evaluation and work-up and to evidence of commitment to personal post-operative care and management; AND - At the discretion of the Department Chairman [upon recommendation from the reviewing practitioner (s)], these basic materials may be reviewed by an outside source (e.g., Cardiovascular-Thoracic Surgeon and/are Invasive Cardiologist). PROCTORING: Shall be performed by a Board-Certified Cardiothoracic Surgeon, consisting of the first five (5) scheduled adult coronary artery bypass graft cases and the first five (5) scheduled valve replacement cases. An outside physician may be assigned as proctor, at the chairperson's discretion." MSC 1 stated MD 1 was not board certified in cardiothoracic surgery and she was unable to find any documentation regarding proctoring, or number of cases completed as listed in the criteria for granting privileges. MSC 1 stated she was unable to comment on what criteria MEC used to grant these cardiac surgery privileges. MSC 1 validated MD 1's credential file and reapplication does not include any information that indicates MD 1 met the criteria listed for granting cardiac surgery privileges. MSC 1 stated she was also not able to find Focused Professional Practice Evaluation (FPPE- A process whereby the medical staff evaluates the privilege-specific competence of a practitioner who requests a new privilege, or when a practitioner's competence to perform a privilege is questioned) in the physician credential file. MSC 1 stated it was the hospital policy to have FPPE completed when granting new privileges to the provider. MSM and SDQ both validated that MD 1's credential file did not reflect the Medical staff rules and ByLaws were followed in granting privileges and FPPE process for MD 1.

During a concurrent interview and record review on 4/4/25 at 3:20 p.m. with the System Quality and Patient Safety Analyst (QSA), SDQ & MSC 1, MD 1's Ongoing Professional Practice Evaluation ( OPPE - A process that identifies and evaluates professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focus on the individual practitioner's performance and competence related to privileges. ) data dash board was reviewed. The QSA was not able to explain the data listed under "PEER" column and stated would have to research and provide update. The QSA stated she was unable to comment on data for "OR on time" listed as "0". The QSA stated it appears that the system may have a glitch and data pulling in to dashboard was not accurate. The QSA stated she was unable to comment who reviews this OPPE data and how often it gets reviewed. MSC 1 stated the medical staff only looks at the OPPE data at the time of reappointment which was every two years. The QSA was also unable to provide specific service line data for MD 1. The SDQ provided a list of metrics being tracked for each specialty and stated unable to provide any data for MD 1 for surgery specific metrics. The SDQ stated nurses that track and monitor data for OPPE were not available to discuss the data at this time. The SDQ stated the hospital have identified gaps in how they are tracking OPPE and FPPE data and it should be monitored on an ongoing basis and kept updated in physician credential file. The SDQ stated that MD 1's credential file does not reflect FPPE and OPPE was completed in accordance with the hospital policy and Medical Staff ByLaws.

During a review of the hospital Medial Staff Bylaws dated January 2024, the Medical staff Bylaws indicated, " ...After receipt of the application, the department chair or appropriate designee of each department to which the application is submitted, shall review the application and supporting documentation, and may conduct a personal interview with the applicant at the department chair or designee's discretion. The chair or appropriate designee shall evaluate all matters deemed relevant to a recommendation, including but not limited to, information concerning the applicant's judgment, the applicant's provision of services within the scope of privileges granted, including the individual's clinical and/or technical skills indicated in part by the results of quality assessment and improvement activities, as reflected on the physician's reappointment profile ... The Credentials Committee, or designee on behalf of the Credentials Committee, shall review the application, evaluate, and verify the supporting documentation, including clinical privileges, the department chair's recommendations, and other relevant information ... The Medical Executive Committee shall forward to the Board of Directors, a written report and recommendation as to Medical Staff appointment and, if appointment is recommended, as to membership category, department affiliation, and any special conditions to be attached to the appointment ... the Board of Directors concurs in that recommendation; the decision of the Board shall be deemed final action ... Exercise of Privileges Except as otherwise provided in these Bylaws, a member providing clinical services at this Hospital shall be entitled to exercise only those clinical privileges specifically granted. Said privileges and services must be hospital specific, within the scope of any license, certificate, or other legal credential authorizing practice in this State and consistent with any restrictions thereon and shall be subject to the rules and regulations of the clinical department and the authority of the department chair and the Medical Executive Committee. Only an appropriately licensed practitioner with clinical privileges shall be directly responsible for a patient's diagnosis and treatment within the area of his/her privileges ... Criteria for General Competencies ... The Medical Staff shall, in addition to criteria for privileges, also develop areas of "general competencies" by which all hospital practitioners shall be measured for current proficiency. Each department shall define how to measure these general competencies as applicable to that department and use them to monitor and assess each practitioner's current proficiencies on an ongoing basis ... Basis for Privileges Determination ... Requests for clinical privileges shall be evaluated on the basis of the member's education, training, experience, demonstrated current professional competence and judgment. Privilege determinations may also be based on pertinent information concerning clinical performance obtained from other sources, especially other institutions, and health care settings where a member exercises clinical privileges. The decision to grant or deny a privilege and/or to renew an existing privilege shall also be based on peer recommendations addressing the applicant's .... Medical/clinical knowledge ... Technical and clinical skills ... Clinical judgment ... Interpersonal skills ... Communication skills ... Professionalism ... Health status ... Information regarding each practitioner's scope of privileges shall be updated as changes in clinical privileges for each practitioner are made ... Performance Monitoring Generally ... Except as otherwise determined by the Medical Executive Committee and Board of Directors, the Medical Staff shall regularly monitor all members' privileges in accordance with standards and procedures set forth in these Bylaws ... Performance monitoring activities and reports shall be integrated into other quality improvement activities. Any monitoring performed on a practitioner shall be considered in the review of that practitioner associated with granting, renewing, revising, or revoking any of their privilege(s) at hospital ... Ongoing Professional Performance Evaluation ... Each practitioner exercising privilege(s) at hospital shall be monitored and evaluated on a regular basis to identify professional performance trends that impact on quality of care and patient safety. The Medical Staff shall be responsible for establishing the frequency of these regular, ongoing professional performance evaluations ... Ongoing performance reviews shall be factored into the decision to maintain, revise, or revoke existing privilege(s) at the time of renewal. The Medical Staff shall take additional actions as necessary, in accordance with these Bylaws, based on the results of such evaluations. Each department shall recommend, and the Medical Executive Committee shall ultimately approve, the criteria used in the ongoing professional performance evaluations ... Focused Professional Practice Evaluation ... The Medical Staff is responsible for developing a focused professional practice evaluation process that will be used in predetermined situations to evaluate, for a time limited period, a practitioner's competency in performing a specific privilege(s) at hospital. The Medical Staff shall clearly define when such a focused evaluation will occur, what criteria and methods should be used for conducting the focused evaluation, the duration of the evaluation period and requirements for extending the evaluation period, and how the information gathered during the evaluation process will be analyzed and communicated ... A focused professional practice evaluation shall be used in at least the following situations ... When questions arise regarding a practitioner's competency in performing a specific privilege(s) at the hospital ... All initially requested privileges ... As a condition of renewal of privileges, as necessary (for example, when a member requests renewal of a privilege that has been performed so infrequently that it is difficult to assess the member's current competence in that area) ... Proctoring ... General Provisions ... All initial appointees to the Medical Staff, Medical Staff members who have insufficient activity from which to assess current competence, as determined by the Medical Staff, and all members granted new clinical privileges shall be subject to a period of proctoring. Proctoring may also be implemented whenever the Medical Executive Committee determines that additional information is needed to assess a practitioner's performance ... Each appointee or recipient of new clinical privileges shall be assigned to the appropriate department, where performance of an appropriate number of cases as established by the Medical Executive Committee or department, shall be observed by the Department Chair(s) or his or her designee, during the period of proctoring specified in the departments privilege list to determine suitability to continue to exercise the clinical privileges granted ... Departments are responsible for developing and approving the proctoring criteria for their departments based on their applicants' qualifications, requested privileges, and established current competency ... The proctor shall complete the required proctoring paperwork and submit to the Medical Staff Office ...The member shall remain subject to such proctoring until the Medical Executive Committee has been furnished with a recommendation from the department chair(s) to discontinue proctoring. A recommendation to discontinue proctoring must include the following statements: that the applicant appears to meet all of the qualifications for unsupervised practice in the hospital, that the applicant has discharged all of the responsibilities of Medical Staff membership, and that the applicant has not exceeded or abused the prerogatives of the category to which the appointment was made ... When a practitioner is subject to proctoring as a result of a focused professional practice evaluation plan, the department shall set the terms of proctoring in a manner consistent with the Medical Staff Bylaws, Rules and Regulations, and policies and procedures that address focused professional practice evaluation ... Failure to Successfully Complete Proctoring ... Any initial appointee who fails within the time of Provisional membership to complete the proctoring required, or any member exercising new clinical privileges or undergoing proctoring for infrequently performed procedures who fails to complete the required proctoring within the time allowed by the Medical Executive Committee, shall be deemed to have voluntarily relinquished the membership or privileges involved, and he or she shall not be afforded the procedural rights provided in article VIII, unless otherwise required by law. However, the Medical Executive Committee in its sole discretion may extend the time for completing proctoring requirements. The inability to obtain such an extension shall not give rise to procedural rights described in article VIII. Any practitioner whose membership or privileges are relinquished pursuant to this section may not reapply for the privileges involved or, in the case of initial appointees, for membership for one (1) year, unless the Medical Executive Committee makes an exception in its sole discretion for good cause ..."

During a review of the hospital policy and procedure (P&P) titled, " Focused Professional Practice Evaluation (FPPE) and Ongoing Professional Performance Evaluation (OPPE) Policy", with an approval date of, 11/8/23, the "P&P" indicated, "The purpose of this policy is to define Focus Professional Practice Evaluation and Ongoing Professional Performance Evaluation. (FPPE) and (OPPE) are designed to evaluate a practitioner's performance to continuously improve the quality safety and effectiveness of care rendered by the practitioners privileged at [Hospital name) ... A. Focused Professional Practice Evaluation ("FPPE") - A process whereby the medical staff evaluates the privilege-specific competence of a practitioner who requests a new privilege, or when a practitioner's competence to perform a privilege is questioned. FPPE entails the following four components ... Measures used to evaluate whether an FPPE is needed when issues are identified ... Method for establishing the monitoring plan specific to the privilege or expected behavior ... Method to determine the duration of the performance monitoring; and, ... Triggers or issues (single incidents or a trend) to trigger an FPPE ... Ongoing Professional Practice Evaluation ("OPPE") - A process that identifies professional practice trends of practitioners with privileges that impact quality of care and patient safety on an ongoing basis and focuses on the individual practitioner's performance and competence related to privileges. The process evaluates the quality, adequacy and competency of an individual practitioner's performance utilizing specialty-specific performance indicators ... initial FPPE ... Departments will determine the parameters of the review period (type of review, number of cases, and duration of review) based on education, training, experience, and current competence ... Review must continue until competency has been determined for privileges granted ... Upon completion, the Department Chair or designee reviews the activity and evaluations ... The FPPE report is kept in the Credentials file ... FPPE Conclusion ... At the end of the FPPE, a report is created which includes findings and conclusions ... If all or any portion of the review is deemed satisfactory, all or that portion of FPPE are considered concluded ... If all or any portion of the review is deemed unsatisfactory ... The current FPPE may be extended, or A new FPPE may be initiated for any area requiring improvement, or ... Recommend to MEC for corrective action ... The practitioner is notified in writing with the results of the FPPE ... OPPE ... Selection of Practitioner Performance Measures for OPPE ... Practitioner performance measures are selected utilizing the framework of the six areas of "General Competencies" (Patient Care / Medical Knowledge / Practice - Based Learning and Improvement / Interpersonal and Communication Skills / Professionalism / Systems-Based Practice) developed by the Accreditation Council for Graduate Medical Education (ACGME) and the American Board of Medical Specialties (ABMS) joint initiatives ... Practitioner performance measures shall be applicable to the practitioner's specialty ... Practitioner performance measures shall reflect practitioner performance as an individual or part of a related practice group when relevant ... Each department shall recommend practice specific indicators and the MEC shall approve the criteria used in OPPE ... Qualitative and quantitative data may be utilized to gather information for OPPE ... 2. OPPE Report and Practitioner Performance Feedback ... OPPE is intended to look at data on the performance of all practitioners with privileges on an ongoing basis rather than at the reappointment cycle to take steps to improve performance on a timely basis ... After initial granting of privileges, the review of the professional practice data of each practitioner cannot exceed every 12 months. The Quality & Safety Department notifies the Department Chair or designee when the OPPE profiles are available for review. Practitioners do not sign off on their own OPPE ...c. The OPPE Report shall be reviewed by the appropriate Medical Staff Department Chair or designee ... Conclusion codes ... No opportunity for improvement ... Minor opportunity for improvement ... Significant opportunity for improvement ... Rule Indicator ... The OPPE report is retained per policy ... Use of OPPE and FPPE at Reappointment ... At reappointment, the Department Chair or designee will review the OPPE and FPPE data from last re-appointment cycle and document the interpretation and any improvement activities for each indicator that required follow-up ... If no activity is provided, FPPE may be initiated. During the OPPE and FPPE processes, the practitioner is NOT considered to be "under investigation" for purposes of reporting requirements under the Health Care Quality Improvement Act".

2. During a concurrent interview and record review on 4/4/25 at 10:50 a.m. with Senior System Quality Director (SDQ), Medical Staff Manager (MSM), Medical Staff Coordinator (MSC) 1 and MSC 2, MD 2's credential file was reviewed. MD 2's credential file indicated MD 2 was a board certified in Critical Care and Pulmonary Medicine. MD 2's original appointment was on 8/6/15 and was reappointed on 7/31/23. MD 2's reappointment application for two-year term was approved by Department chair on 6/7/23. MD 2's credential file indicated MEC approved the reappointment on 6/20/23 and board of directors approved it on 7/6/23. The review of MD 2 reapplication indicated MD 2 requested and was granted privileges under Critical Care for " ... Intubation [a medical procedure where a tube, usually an endotracheal tube, is inserted through the mouth or nose into the trachea (windpipe) to secure the airway and facilitate breathing], Sedation [using medication to induce a state of calmness, relaxation, or sleepiness, often used to reduce anxiety and discomfort during medical or surgical procedures]/analgesia [ loss of sensation of pain achieved by medication ]for the non-anesthesiologist (moderate), Central venous access [inserting catheter to provide access to the bloodstream for administering fluids, medications, or blood products], Swan Ganz placement [a thin, flexible tube inserted into a vein and threaded through the heart into the pulmonary artery to monitor heart function, blood flow, and pressures, particularly in critically ill patients], Thoracentesis [procedure used to obtain a sample of fluid from the space around the lungs, called the pleural space], Abdominal paracentesis [a procedure to drain fluid from the peritoneal cavity (the space within the abdomen) using a needle or catheter], Lumbar puncture, Joint Aspiration, ICU Bronchoscopy ...". The request for privileges reapplication of MD 2 indicated " ...Other ...Care of patients in ICU/CCU (can only manage patients in area of specialty and/or subspeciality) ..." and EKG interpretation was not requested and was not granted. MSC 1 stated MD 2 has been actively working in ICU and manages patients. MSC 1 stated she was unable to comment and was not certain why this section was not selected under other and EKG [a test to record the electrical signals in the heart] interpretation. MSC 1 stated MD 2 was reappointed and had volume to maintain privileges, but she was unable to comment on department specific metrics for OPPE for MD 2. MSC 1 stated MD 2 was granted privileges under ICU section but the [software name] portal does not reflect section "CRITICAL CARE MEDICINE" was selected. The SDQ stated "the privilege request form for MD 2 was not very clear." The SDQ validated and agreed that reapplication and [software name] portal does not reflect whether MD 2 was granted privileges to take care of patients in ICU or EKG interpretation which were essential for managing patient in ICU. The SDQ stated the [software name] portal was what staff at the hospital uses to validate privileges. The SDQ stated the staff would not be able to validate MD 2's privileges to manage patient in ICU by looking at the [software name] portal. The SDQ stated although MD 2 was board certified in critical care, was granted privileges for ICU procedures, the privilege to manage patients along with EKG should have been selected and granted as well but were not. The SDQ validated with the hospital leadership and stated MD 2 have been managing patients actively in ICU and does not have any reported adverse outcomes related to MD 2's practice. The SDQ stated the privilege request form needs to be reviewed and updated to make it clear whether the privilege to manage patient in ICU were included/bundled with rest of privileges with ICU.

During a phone interview on 4/4/25 at 3:52 p.m. with the Chief of Medical Staff (CMS), the CMS stated the hospital have a process in place for OPPE. The CMS stated every six months report cards for physicians get shared and the chair for each department was responsible for ensuring and reviewing service line indicators. The CMS stated the expectation for every service line is to have their own indicators for OPPE for providers in their service line. The CMS stated he was unable to comment on credentialing for MD 2 or any particular provider, but the process was that credentialing committee reviews the application and final decision was with board of directors. The CMS stated the department chair were expected to review and approve the application for appointments and privilege request to ensure it meets the requirements prior to routing it for MEC or board of director approval. The CMS stated he expected Medical staff office and department chairs to follow the facility Medical Staff ByLaws when approving or granting privileges.

During a review of the hospital Medial Staff ByLaws dated January 2024, the Medical Staff ByLaws indicated, " ...After receipt of the application, the department chair or appropriate designee of each department to which the application is submitted, shall review the application and supporting documentation, and may conduct a personal interview with the applicant at the department chair or designee's discretion. The chair or appropriate designee shall evaluate all matters deemed relevant to a recommendation, including but not limited to, information concerning the applicant's judgment, the applicant's provision of services within the scope of privileges granted, including the individual's clinical and/or technical skills indicated in part by the results of quality assessment and improvement activities, as reflected on the physician's reappointment profile ... The Credentials Committee, or designee on behalf of the Credentials Committee, shall review the application, evaluate, and verify the supporting documentation, including clinical privileges, the department chair's recommendations, and other relevant information ... The Medical Executive Committee shall forward to the Board of Directors, a written report and recommendation as to Medical Staff appointment and, if appointment is recommended, as to membership category, department affiliation, and any special conditions to be attached to the appointment ... the Board of Directors concurs in that recommendation; the decision of the Board shall be deemed final action ... Exercise of Privileges Except as otherwise provided in these Bylaws, a member providing clinical services at this Hospital shall be entitled to exercise only those clinical privileges specifically granted. Said privileges and services must be hospital specific, within the scope of any license, certificate, or other legal credential authorizing practice in this State and consistent with any restrictions thereon and shall be subject to the rules and regulations of the clinical department and the authority of the department chair and the Medical Executive Committee. Only an appropriately licensed practitioner with clinical privileges shall be directly responsible for a patient's diagnosis and treatment within the area of his/her privileges ... Criteria for General Competencies ... The Medical Staff shall, in addition to criteria for privileges, also develop areas of "general competencies" by which all hospital practitioners shall be measured for current proficiency. Each department shall define how to measure these general competencies as applicable to that department and use them to monitor and assess each practitioner's current proficiencies on an ongoing basis ... Basis for Privileges Determination ... Requests for clinical privileges shall be evaluated on the basis of the member's education, training, experience, demonstrated current professional competence and judgment. Privilege determinations may also be based on pertinent information concerning clinical performance obtained from other sources, especially other institutions, and health care settings where a member exercises clinical privileges. The decision to grant or deny a privilege and/or to renew an existing privilege shall also be based on peer recommendations addressing the applicant's ... Medical/clinical knowledge ... Technical and clinical skills ... Clinical judgment ... Interpersonal skills ... Communication skills ... Professionalism ... Health status ... Information regarding each practitioner's scope of privileges shall be updated as changes in clinical privileges for each practitioner are made ... Performance Monitoring Generally ... Except as otherwise determined by the Medical Executive Committee and Board of Directors, the Medical Staff shall regularly monitor all members' privileges in accordance with standards and procedures set forth in these Bylaws ... Performance monitoring activities and reports shall be integrated into other quality improvement activities. Any monitoring performed on a practitioner shall be considered in the review of that practitioner associated with granting, renewing, revising, or revoking any of their privilege(s) at hospital ... Ongoing Professional Performance Evaluation ... Each practitioner exercising privilege(s) at hospital shall be monitored and evaluated on a regular basis to identify professional performance trends that impact on quality of care and patient safety. The Medical Staff shall be responsible for establishing the frequency of these regular, ongoing professional performance evaluations ... Ongoing performance reviews shall be factored into the decision to maintain, revise, or revoke existing privilege(s) at the time of renewal. The Medical Staff shall take additional actions as necessary, in accordance with these Bylaws, based on the results of such evaluations. Each department shall recommend, and the Medical Executive Committee shall ultimately approve, the criteria used in the ongoing professional performance evaluat

Based on interview and record review, the hospital failed to ensure that Medical Staff was accountable for the quality of the medical care provided to the patients and followed the "Medical Staff Rules and Regulations" when Physicians failed to document a progress note for one out of 10 sampled patients Patient (Pt) 25, on a daily basis, during her hospital admission.

This failure had the potential for Pt 25's diagnostic and therapeutic needs to go unmet, and for her physician directed questions to go unanswered, which could lead to psychosocial harm, including anger, fear, and anxiety, due to Pt 25's vulnerable state.

Findings:

During a concurrent interview and record review on 3/27/25 at 2:33 p.m. with Registered Nurse (RN) 6, Pt 25's "History and Physical [H&P- complete patient assessment by physician]," dated 3/23/25, and "Physician Progress Notes [PPN]," dated 3/23/25 to 3/25/25 were reviewed. The "H&P" indicated Pt 25 was admitted on 3/23/25 at 7:37 a.m. for an elective induction of labor (the use of medications or other methods to start labor). RN 6 stated Pt 25 was 40 weeks and 5 days pregnant (upon admission to the Labor and Delivery (L&D) Unit. The "PPN" from 3/23/25 indicated, at 10 a.m. a physician performed an exam on Pt 25. RN 6 stated no progress notes were in Pt 25's electronic medical record (EMR) for 3/24/25 indicating a physician assessment was completed on Pt 25, or any indication Pt 25's labor progression was discussed with her by the physician. The "PPN" from 3/25/25 indicated, at 6:07 a.m. Pt 25's physician was at bedside discussing protracted labor course abnormally slow dilation [opening of womb] or fetal descent [baby head coming out]) and risk for hemorrhage (excessive bleeding after birth). The physician discussed recommending proceeding with cesarean section (CS a surgical procedure used to deliver a baby through a cut in the mother's stomach and womb) due to labor dystocia (slow or abnormal progress of labor) The "PPN" indicated, at 6:24 a.m. an additional to the 6:07 a.m. note, " ...Patient was seen at bedside. She is agreeable to proceed with CS ..." RN 6 stated, physicians should see the patient every day. RN 6 stated, she did not know why there was no progress note documentation in Pt 25's in EMR on 3/24 by a physician, RN 6 stated there should be.

During an interview on 4/2/25 at 10:20 a.m. with the Director of the Family Birth Center (DFBC) the DFBC stated, her expectation was that the physicians, see the patient's and document the progress notes every day.

During a review of the hospital's document titled, "Medical Staff Rules and Regulations," dated, 2/1/24, the hospital document indicated, " ...Patients admitted to the Acute Care units of the hospital will be seen on a daily basis, either by the attending physician or his/her designee ...".

Based on interview and record review, the hospital failed to ensure staff developed and updated a nursing care plan (a comprehensive, interdisciplinary [group of healthcare providers from different fields who work together] approach to patient care from entry into the hospital until discharge) for two of 34 sampled patients (Patient [Pt] 5 and Pt 13), when the staff did not identify patient care needs and did not develop a care plan with interventions or goals to address the identified needs when:

1. Registered Nurses (RNs) failed to create an individualized care plan for Pt 5's severe protein and calorie malnutrition (body not getting enough calories or nutrients) according to the hospital policy and procedure (P&P), titled "Patient Plan of Care" and the hospital "Registered Nurse Job Description".

This failure had the potential to cause weight loss in Pt 5 which placed Pt 5 at an increased risk for skin breakdown, slower wound healing to the open wound on the coccyx (tailbone), and in the gluteal cleft (groove between the buttocks), and a longer hospital admission.

2. RNs did not develop an individualized care plan for Pt 13's hypertension (high blood pressure).

This failure had the potential to cause inconsistent delivery of care, which could result in the decline or lack of improvement for Pt 13's health conditions.

Findings:

1. During a concurrent interview and record review on 3/28/25 at 9:48 a.m. with Nurse Educator (NE) 1, Pt 5's "History & Physical (H&P- a complete patient assessment by the physician)," dated 12/31/24, was reviewed, the H&P indicated Pt 5 was brought into the Emergency Department (ED) on 12/31/25 at 12:45 p.m. by family with complaints of right upper quadrant pain (the area of the stomach located on the right side above the belly button) for two weeks. The H&P indicated, Pt 5 was admitted as an inpatient on 12/31/24 at 8:50 p.m. for a renal abscess (a pocket of pus that forms within the kidney tissue) and moved to the Medical Surgical (MS) Unit at 11:56 p.m.

During a concurrent interview and record review on 3/28/25 at 9:55 a.m. with NE 1, Pt 5's "Hospitalist Progress Note (HPN)," dated 1/2/25, "Care Plan Accordion (CPA)", dated 1/2/25 to 1/8/25 and the "Intake and Output Flowsheet (IOF)", dated 1/2/25 to 1/8/25 was reviewed. The HPN indicated, Pt 5 had an active medical problem identified by the physician of "severe protein and calorie malnutrition". The CPA" indicated; no care plans were entered by LNs for Nutrition Deficiency. NE 1 stated, Pt 5 possibly should have had a care plan for nutritional deficit. The IOF indicated, on 1/2/25 no lunch intake was documented. The IOF indicated, on 1/3/25, 1/4/25, and 1/5/25 no breakfast or lunch documentation were in the medical record. NE 1 stated the Electronic Medical Record (EMR) did not have a cell to document intake for dinner, prior to the system update in February 2025. NE 1 stated, nursing staff (CNAs, RNs) should have documented intake on the IOF when collecting the meal tray. NE 1 stated nursing staff were trained to document intake. NE 1 stated CNAs should have informed the RN when patients were refusing meals or not eating at least 75% of their meals. NE 1 stated nursing staff were supposed to document on the IOF when patients refused meals. NE 1 stated RNs could then notify the Pt's physician. NE 1 stated, the physician could, enter a Registered Dietitian Consult, enter an order for nutrition supplements, or prescribe medications to increase the patient's appetite. NE 1 stated, RNs should also speak to the Pt and the Pt's family because the Pt may have specific foods they prefer from home. NE 1 stated, ensuring Pt 5 was receiving enough nutrition was important for body healing and to improve wound healing.

During a review of Pt 5's "Medical Nutrition Therapy Nutrition (MNTN) Consult," dated 1/2/25, the "MNTN Consult" indicated Pt 5 was four feet eight inches tall and 74 pounds (lbs.- a unit of weight measurement) and 8.3 ounces (oz- a unit of weight measurement). The MNTN Consult indicated, Pt 5 was underweight. The MNTN Consult indicated, Monitoring/Evaluation/Goals, Monitor weight, and tolerance to diet. Pt 5 did not have any additional weights assessed after her admission weight of on 12/31/25.

During a concurrent interview and record review on 4/2/25 at 2:46 p.m. with the Registered Dietitian Supervisor (RDS), Pt 5's "IOF," dated 1/2/25 through 1/8/25, "and "MNTN Consult" dated 1/2/25 were reviewed. The RDS stated, he reviewed Pt 5's medical record prior to the interview. The RDS stated, when Registered Dietitian's (RDs) assess patients for a nutrition consult the RD would look at the weight history as well as, admitting diagnosis, medical history, recent active problems or new diagnosis, diet, intake and output, nausea and vomiting, medications, and labs, to see if there was anything that may be significant. The RDS stated it was important for nutrition intake to be documented accurately, and Pt 5 was missing nutrition documentation. The RDS stated it was important to document accurately, to see progression (was the patient increasing or decreasing intake), and to get an estimate of calorie intake, also to see if the patient needed modification to nutrition (supplements, etcetera).

During an interview on 4/4/2025 at 5:17p.m, with the Chief Nursing Executive (CNE), the CNE stated her expectation was for LNs to customize the care plans to the patient as a part of their care.

During a review of the hospital's P&P titled, "Patient Plan of Care," dated 10/19/20, the P&P indicated, "...Each patient will have a plan of care that is appropriate to his/her specific assessed needs. Care planning begins on admission and is individualized within 24 hours. ...The plan is individualized/revised based on ongoing assessment findings, the patient's response to treatment/interventions and evaluation of progress toward outcomes. Care planning ends at discharge/ transition of care to another facility ... The registered nurse (RN) is accountable for the initiation and coordination of the Patient Plan of Care in collaboration with the inter-professional team members and for its ongoing additions and revision based on identified needs, per professional scope of practice ...".

During a review of the hospital's document titled, "Job Description Registered Nurse II, [Job Description]" dated 3/28/25, the "Job Description" indicated, " ... Accountable for the assessment, coordination delivery and evaluation of nursing care, including direct patient care, patient/family education and transitions of care in an acute patient setting. Delivers holistic and individualized care to all patients in an assigned area. Develops, implements, and coordinates a plan of care that incorporates psychological, sociocultural, spiritual, economic, and life-style factors. Fosters and maintains collaborative relationships between patients, their family/support group, physicians, and other healthcare providers through timely and effective communications. Adheres to hospital polices, industry standards, best practices, and applicable laws and regulations to promote an optimal patient experience ...".

During a review of a professional reference titled, "Nutritional Assessment," dated 4/10/23, (retrieved from https://www.ncbi.nlm.nih.gov/books/NBK580496/) indicated, " ... Evaluation of nutritional status is critical, either to identify if an individual has nutritional imbalance due to an underlying condition or to assess if an individual is likely to develop a pathological [condition related to disease or illness] condition due to nutritional imbalance. ...Nutritional assessment and intervention together break the vicious cycle between malnutrition and various diseases or conditions, in which malnutrition aggravates a disease/condition, and the disease/condition, in turn, precipitates malnutrition. Breaking this cycle helps in improving clinical outcomes. Nutritional and clinical management based on comprehensive nutritional assessment results in positive healthcare outcomes by reducing the recovery period, hospital length of stay, risk of complications, susceptibility to infections, and mortality (a term also used for death rate, or the number of deaths in a certain group of people in a certain period of time) associated with clinical and surgical illnesses. The use of standardized, systematic nutrition risk screening and assessment in the clinical setting also helps in reducing overall healthcare costs ...Nurses also help with early nutritional screening to identify nutrition risk factors and monitor the patient's condition to maintain timely documentation records of clinical status...".

2. During a review of Pt 13's "History and Physical (H&P- a complete patient assessment by the physician)," dated 3/23/25, the H&P indicated, Pt 13 was admitted to the hospital for a left femur (thigh bone) fracture (a break or crack in a bone). The H&P indicated, Pt 13 had a past medical history of diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing) and hypertension.

During a concurrent interview and record review on 3/28/25 at 9:30 a.m. with Nurse Manager (NM) 4, Pt 13's "Care Plan Event Log (CPEL)," dated 3/23/25 to 3/26/25 was reviewed. The "CPEL" indicated, Pt 13 had a care plan to address issues for discharge planning, skin and tissue integrity, fall safety, pain, musculoskeletal (the human body's system of muscles and bones), respiratory (responsible for taking in oxygen and expelling carbon dioxide, essentially enabling us to breathe), genitourinary (the organs related to both reproduction and urination), and metabolic (all the chemical reactions happening in your body to keep you alive), fluid and electrolytes (minerals in your blood and other body fluids). NM 4 stated Pt 13's hypertension was not addressed in the care plan. NM 4 stated there should have been a nursing care plan to address Pt 13's hypertension. NM 4 stated care plans helped to guide nurses to ensure there was a plan of care including interventions to support the patient's care.

During an interview on 4/4/25 at 11:10 a.m. with the Director of Medical Surgical Services (DMS), the DMS stated she expected nurses to individualize care plans to each patient.

During an interview on 4/4/25 at 5:10 p.m. with the Chief Nurse Executive (CNE), the CNE stated she expected nurses to identify the proper body system and customize the care plan to the patient. The CNE stated a care plan should be individualized to meet the patient's needs.

During a review of the hospital's policy and procedure (P&P) titled, "Patient Plan of Care," dated 10/19/20, the P&P indicated, " ... POLICY: A. Each patient will have a plan of care that is appropriate to his his/her specific assessed needs ... The plan is individualized/revised based on ongoing assessment findings, the patient's response to treatment/interventions and evaluation of progress toward outcomes ... Patient Plan of Care: Patient-centric documented plan for care, treatment and services that reflects his/ her specific needs and preferences. It may include individualized goals and services required to meet those goals in the designated setting of care. It is maintained/revised based on the patient's condition, preferences, response to interventions. It is the patient's plan - the centralized plan that drives the priorities and professional processes of care for the inter-professional team to prevent/manage/minimize potential problems and outcomes ... PROCEDURE: ... Planning care starts with learning the patient's history, medical diagnosis and assessment of findings to determine his/her individualized needs and identify the appropriate Clinical Practice Guidelines to initiate on the plan of care ... Reviewing and updating the plan of care occurs on an ongoing basis throughout the patient's hospitalization. Each shift the registered nurse is responsible for reviewing and updating the plan of care after assessing the patient. Additionally, other members of the inter-professional care team will review and update the plan of care as necessary ...".

Based on observation, interview, and record review, the hospital failed to ensure all Licensed nurses (LNs) adhered to the hospital's policies and procedures (P&P) and nursing standards of practice, when:

1. Registered Nurse (RN) 3 received a critical lab result from the blood bank for one of one patient (Pt 3) and the RN did not notify the surgeon, or Pt 3's primary physician within the 30-minute time frame according to the hospital P&P titled "Laboratory Critical and or Call Values", and did not document a notification to the primary physician per the hospital's P&P titled "Documentation (Charting) for the Patient Health Record".

These failures delayed care for Pt 3 by delaying the physician's order to the blood bank for crossmatched (a crucial test performed to ensure donor blood is compatible with recipients' blood to prevent a reaction) blood, by one hour and 40 minutes. The crossmatched blood needed to be ordered from an outside blood bank vendor, and Pt 3 could not go into surgery until the blood was at the hospital and ready for transfusion.

2. Emergency Department (ED) RNs did not administer pain medications or develop a pain management plan when one of 3 patients (Pt 26) reported a pain score of 8 out of 10 in the ED, according to hospital P&P titled, "Pain Management". Pt 26 reported a pain score of 8/10 on three separate occasions and was discharged from the ED with a reported pain score of 8/10, without having her pain addressed by RNs or physicians.

These failures had the potential to affect the physical, emotional, and psychosocial (the influence of both physical and social factors on an individual) well-being of Pt 26, by failing to address her pain.

3. One of 10 patients (Pt 5) had an active medical problem of severe protein and calorie malnutrition (body not getting enough nutrients), and RNs and Certified Nursing Assistants (CNA)s failed to document nutritional intake, according to hospital P&P titled, "(Medical) Nutrition Therapy: Meal/Snack Delivery, Pick Up and Intake Recording".

This failure had the potential to cause weight loss in Pt 5 which placed Pt 5 at an increased risk for skin breakdown, slower wound healing to the open wound on the coccyx (tailbone), and in the gluteal cleft (groove between the buttocks), and a longer hospital admission.

4. RNs did not assess and document a temperature for one of three patients (Pt 25) in the Labor and Delivery (L&D- a specialized unit where babies are born and pregnant patients are treated) Unit every two hours after rupture of membranes (ROM- when the bag of water that surrounds the unborn baby breaks), according to the hospital's P&P titled "Admission of Labor Patient".

This failure placed Pt 25 at risk for infection, to have delayed treatment, and could pose risks to the fetus (unborn baby). Risks include, infection being passed to the fetus, hyperthermia (high level of temperature), fetal distress (low oxygen levels), and brain damage.

5. ED nurses failed to assess Pt 4's skin and implement pressure relieving interventions upon arrival to ED in accordance with hospital P&P titled "Skin Care: Prevention of Hospital-Acquired Pressure Injury- Adults & Pediatrics". Pt 4 stayed on a gurney in the ED over nine hours and was not turned, or repositioned. Pt 4 upon arrival to the Intensive Care Unit (ICU-specialized unit providing advanced care for critically ill or injured patients) had redness and purple discoloration to the back/coccyx area.

This failure led to Pt 4 developing deep tissue injury resulting in a full thickness wound to the coccyx area with bone exposed.

6. Nursing staff failed to change Pt 4's colostomy bag (a waterproof pouch that collects stool from the surgical opening in large intestine through stomach) and do a complete assessment of skin around the stoma (a surgically created opening in the stomach allowing waste to exit the body) every three to five days in accordance with standards of practice or receive a physician order to leave the bag in place. Pt 4's colostomy bag was not changed for 16 days and skin around the stoma site was not assessed appropriately.

This failure had the potential for Pt 4's skin around the stoma site to get irritated, have tears and get infected.

7. One of two patients (Pt 9) did not have an Aldrete assessment (a tool used to assess a patient's readiness for discharge from the Post-Anesthesia Care Unit (PACU-a specialized area in hospitals where patients recover from anesthesia and surgery) completed before discharging from the PACU according to the hospital's P&P titled, "Transfer From PACU."

This failure had the potential for Pt 9 to be discharged from the PACU before meeting discharge criteria and leading to potential complications.

8. One of two patients (Pt 9) did not have a temperature assessed before discharging from the PACU according to the hospital's P&P titled, "Transfer From PACU".

This failure had the potential for Pt 9 to develop complications such as hypothermia (a dangerously low body temperature) or fever which could negatively impact recovery.

9. One of three patients (Pt 9) did not have an assessment completed when transferred from one unit of the hospital to another , according to the hospital P&P titled "Assessment: Admission and Reassessment."

This failure had the potential for nurses to not identify health problems and delay appropriate treatment based on Pt 9's individualized needs.

10. Two of eight patients (Pt 9 and Pt 13) did not have physician notifications for elevated systolic blood pressure (SBP-the pressure in the arteries when the heart contracts) according to the physician order.

This failure had the potential for Pt 9 and Pt 13's elevated SBP to go unresolved and delay treatment resulting in complications such as stroke (when blood flow to part of the brain is disrupted, leading to brain damage) or heart failure (when the heart muscle doesn't pump blood as well as it should).

11. Two of two patients (Pt 7 and Pt 10) did not have an incision assessment each shift according to standard of practice.

This failure had the potential for Pt 7 and Pt 10's incision to have delayed healing, infection, or wound dehiscence.

12. One of one patient (Pt 2) who had a community acquired pressure injury (pressure injuries that develop outside of hospital) was not turned every two hours according to the hospital's P&P titled, "Skin Care: Pressure Related Injury Management."

This failure had the potential for Pt 2's pressure injury to worsen, delayed wound healing, infection, and pain.

13. One of two patients (Pt 2) did not have pain assessments completed according to the physician's order.

This failure had the potential to affect Pt 2's physical, emotional, and psychosocial well-being.

14. One of two patients (Pt 1) did not have triage (process of sorting patients according to urgency) vital signs completed when arriving to the ED according to the hospital's P&P titled "Triage Policy."

This failure had the potential to delay a quick assessment of Pt 1's condition and determine the need for immediate attention.

15. Registered Nurse (RN) 8 did not clamp the normal saline (NS-a mixture of sodium chloride and water) tubing during a blood administration observation according to nursing standards of practice.

This failure had the potential for Pt 28 to receive diluted blood and to not complete the blood transfusion within four hours.

Findings:

1. During a telephone interview on 3/28/25 at 12:49 p.m. with Complainant (CO) 2, CO 2 stated she was Pt 3's daughter and was at the hospital with her father on 12/9/24. CO 2 stated Pt 3 was scheduled for an abdominal surgery because he had a small bowel obstruction (SBO- a blockage in the small intestine can cause inability to pass stool), and he was deteriorating (getting sicker). CO 2 stated the family was notified Pt 3 had antibodies (antibody-proteins in blood to fight germs, need specific blood or immune system will attack the donor blood) in his blood on 12/9/24 in the morning, and that the blood bank had to order blood from an out-of-town blood bank, prior to surgery. CO 2 stated the blood not being at the hospital delayed the surgery, and two other people went to the operating room (OR) ahead of Pt 3. CO 2 stated Pt 3's nurse was asked several times what was taking so long to get the blood and get to surgery. CO 2 stated around 5 p.m., RN 3 called the lab to inquire and reported to the family the blood was on the way to the hospital. CO 2 stated by 8 p.m. the blood had arrived and the "ball started rolling". CO 2 stated not long after the blood arrived her father was taken to surgery, but by then he was having long runs of Supraventricular Tachycardia (SVT- heart rhythm where heart beats rapidly and originates in the upper chambers of the heart). CO 2 stated, she believed Pt 3's bowl ruptured while he was waiting for surgery. CO 2 stated Pt 3 coded (heart stopped beating) in surgery, the OR team achieved return of spontaneous circulation (ROSC-heart pumped blood effectively and had a pulse) and was rushed to the Intensive Care Unit (ICU), but after Pt 3 was transferred to the ICU, he coded again and died. CO 2 stated she believed if Pt 3's blood would have been available sooner there may have been a different outcome.

During a concurrent interview and record review on 3/28/25 at 1:56 p.m. with Nurse Manager (NM) 4, Pt 3's "Emergency Department Physician Note EDPN", dated 12/5/24, and "History and Physical [H&P- complete patient assessment by physician]," dated 12/6/24, was reviewed. The "EDPN"" indicated, Pt 3 was brought in by ambulance to the ED on 12/5/24 for abdominal pain and a cough for two weeks. The "H&P" indicated, Pt 3 was admitted to the hospital as an inpatient on 12/6/24 for septic shock (a life-threatening condition that occurs when a severe infection leads to dangerously low blood pressure, potentially causing organ damage and failure) and a small bowel obstruction (SBO- a blockage in the small intestine can cause inability to pass stool). The "H&P" indicated, Pt 3 was moved to the Intensive Care Unit, (ICU - a specialized hospital unit that provides advanced medical care to critically ill patients) on 12/6/24 at 7:30 a.m.

During a concurrent interview and record review on 4/1/25 at 1:30 p.m. with NM 1 Pt 3's "Progress Notes (PN)", "Care Team Notes (CTN)", "Lab Transfusion Services (LTS)", and "Provider Orders (PO)," dated 12/9/24 to 12/10/24 were reviewed. The "LTS" indicated, on 12/9/25 at 9:18 a.m. staff from the blood bank called RN 3 to report Pt 3 had a critical lab result of a positive antibody screen (a test). NM 1 stated no documentation was entered by RN 3, Pt 3's primary nurse about receipt of a critical lab result from the blood bank, or about contacting the physician for an order for crossmatched blood from the blood bank. The "CTN" from 12/9/25 entered by RN 2, a surgical nurse indicated, " ...0900 [9 a.m.] ...report from inpatient RN [RN 3] for preop [preparation for surgery]. 1055 [10:55 a.m.]- Received call from inpatient RN [RN 3] that patient has antibodies, in blood. Spoke with [Surgeon] and type and crossmatch ordered. 1610 [4:10 p.m.]- called blood bank and blood in process of being sent from [Town Name]. Informed [Surgeon] and OR [Operating Room] crew. Will wait for blood to arrive to send for patient ...". NM 1 stated, Pt 3's medical record on 12/9/24 had no documentation from RN 3 about speaking to Pt 3's primary physician, the surgeon, RN 2, the blood bank, Pt 3 or Pt 3's family regarding Pt 3's blood having antibodies, Pt 3's surgery being delayed, or any updates about the blood in transit. NM 1 stated the RN was made aware by the blood bank that something else needed to be done. NM 1 stated, nurses were aware, when they receive a call about critical lab information, the information needed to be passed to the ordering physician.

During a concurrent interview and record review on 4/1/25 at 3:07 p.m. with RN 3, Pt 3's "CTN", "LTS", and "PO", dated 12/9/24, were reviewed. RN 3 stated, she was Pt 3's primary nurse on 12/9/24 during the day shift. RN 3 stated, she vaguely remembered Pt 3 but had reviewed the patient's Electronic Medical Record [EMR]. RN 3 stated, Pt 3 was supposed to go to surgery in the morning on 12/9/24. RN 3 stated, the blood bank notes from 12/9/24 indicating the blood bank called with a critical lab result of a positive antibody screen at 9:18 a.m. were accurate. RN 3 stated, she called and gave report to the RN in the surgical area (RN 2) when the blood bank called about Pt 3's positive antibody screen. RN 3 stated she did not document in Pt 3's EMR receiving the critical lab value information or reporting the information to RN 2. RN 3 stated, antibodies in the blood were considered a critical lab value and she passed on the information to RN 2 who ordered the crossmatched blood from the blood bank. RN 3 stated critical lab results should be given to the physician as soon as possible. RN 3 stated the information was time sensitive because the blood was coming from another city 1.5 hours away. RN 3 stated she communicated with Pt 3 and Pt 3's family to keep them updated about where the blood was in the process, but she did not document the conversations. RN 3 stated she reported the critical lab antibody information to Pt 3's primary physician but did not document the information. RN 3 stated she should have documented reporting to the physician, and RN 2, as well as updating the family, because "If you didn't document it, you didn't do it".

During a concurrent interview and record review on 4/2/25 at 11:04 a.m. with the Transfusion Supervisor (TS) and Clinical Laboratory Scientist (CLS) 1, Pt 3's "Transfusion Records (TR)", dated 12/9/24 and 12/10/24 were reviewed. The TS stated the process for transfusions was, the blood bank would receive an order in the EMR, and the order also translates into the lab system, the blood bank staff would then identify if a pt had a history in the hospital system to determine if the blood type and if there were special requirements or antibodies. The TS stated the type and cross was completed on the blood bank analyzer equipment (automated system to perform tests on blood samples, primarily for blood typing, antibody screening, and compatibility testing) the staff verified the current blood sample with the history to ensure a match. The TS stated the initial type and screen process took approximately 45 minutes for one sample. The TS stated if the pt had a history of antibodies, or the current screen was positive, the system would give a pop up critical. The TS stated, the CLS would call the patient's nurse to report there may be a possible delay with the blood for transfusion. The TS stated during the initial screening which antibody was not known, or how long the delay would be to get the blood. The TS stated for certain single antibodies the blood may be available in house, and for multiple antibodies the blood could take a while. The TS stated Pt 3 had one antibody, and a possible second antibody, so the blood was not available at the hospital and needed to be ordered from the blood bank supplier in another town 1.5 hours away. The TS stated Pt 3's timeline of events were a type and screen was drawn at 7:33 a.m., resulted at 9:18 a.m., and the CLS called RN 3 and reported a positive antibody screen. The TS stated at 10:29 a.m. the antibody was identified, and at 11 a.m. an order for two units of blood came through the computer system. The TS stated the blood was ordered through the computer to the offsite supplier and the supplier had to find the blood, all orders were patient specific. The TS stated the blood was ordered STAT (immediately). The TS stated the process had about a four to six hour turn around, then the hospital blood bank must confirm the product through testing to ensure Pt 3 would not have a transfusion reaction when the blood was transfused. The TS stated Pt 3's donor blood was received by the hospital at 6:52 p.m. and confirmation (testing) of the blood product was completed at 7:50 p.m. and was available for allocation (distribution) at 8:13 p.m. The TS stated she acknowledged a delay but there was nothing the blood bank could do since Pt 3 had specific antibodies in the blood, and the blood was not in house.

During an interview on 4/2/25 at 2:20 p.m. with RN 2, RN 2 stated, she was the surgical nurse on 12/9/24 who received the call from RN 3 regarding Pt 3 having a positive antibody screen. RN 2 stated she entered the order for Pt 3's blood crossmatch. RN 2 stated, RN 3 called her in the morning around 9 a.m. and gave report about Pt 3 because he was a case (surgery) for an abdominal surgery. RN 2 stated RN 3 called her again around 11 a.m. and asked what she (RN 3) should do, because Pt 3 had a positive antibody screen. RN 2 stated she grabbed a surgeon walking by and got a verbal order for a crossmatch for Pt 3 and entered it. RN 2 stated, she (RN 2) contacted the blood bank one time for an update and reported the information to the surgeon and OR team. RN 2 stated nurses should document in the medical record when speaking to other nurses, receiving critical lab results or when reporting information to the physician, because it helped to track why and how things happened.
During an interview on 4/4/25 at 5:17 p.m. with the Chief Nursing Executive (CNE), the CNE stated her expectation was for RNs to follow timeliness, and documentation standards.

During a review of the hospital's P&P titled, "Laboratory Critical or Call Values," dated 3/14/24, indicated, " ... Purpose: ...To outline laboratory values which have a potentially adverse or life-threatening effects. ...To ensure accurate and timely notification of critical results to the appropriate care provider or physician. ...within 30 minutes from the time the critical result is identified. The Clinical Laboratory Scientist (CLS) will notify any primary care nurse of the unit when the following values are identified ... the CLS must contact the primary care nurse or charge nurse within 30 minutes from the time the critical result is identified. ...The receiver of the critical test results or critical value results will immediately notify the attending physician of the results. ...Transfusion Service: ...Positive Antibody Screen ...".

During a review of the hospital's P&P titled, "Documentation (Charting) for the Patient Health Record", dated 7/12/24, indicated, " ...Policy: A. It is policy that information related to patient assessments, interventions, evaluations, and outcomes is documented tin the electronic health record for all patients admitted or accepted for treatment at [hospital Name]. ...Documentation should be factual, accurate, complete, and timely. ...Documentation should be ... Complete- Document all actions/interventions, including but not limited to, changes in patient condition, patient responses, education, and communication with care team ...Documentation Requirements a. Will include but not limited to: ... Education provided to patient, family, or significant other ...Critical Results i. Will be documented in the EHR [Electronic Health Record] critical value reporting flow sheet and will include type of test and critical result, date/time, full name of person you receive result from, date and time and name of licensed provider the result was reported to. ...Significant events ... Notation of communication with the patient and/or family shall be made in the medical record by the individual communicating the event".

2. During a concurrent interview and record review on 4/2/25 at 10:22 a.m. with the Nurse Informaticist (NI), Pt 26's "Emergency Department Timeline (EDT)" was reviewed. The EDT indicated, Pt 26 arrived in the ED on 1/25/25 at 12:59 p.m. The EDT indicated, on 1/25/25 at 1:32 p.m. Pt 26 had a Medical Screening Exam completed by a Licensed Nurse (LN), and Pt 26 reported a chief complaint of onset of vaginal bleeding in pregnancy less than 20 weeks Estimated Gestation Age (EGA-number of weeks that have elapsed between the first day of the last normal menstrual period and the date of delivery) beginning two hours before. The NI stated Pt 26 indicated she had changed two large pads in the last hour. The "EDT" indicated; Pt 26 also had a chief complaint of abdominal pain in pregnancy less than 20 weeks EGA. The NI state at 1:34 p.m. LNs assigned Pt 26 a patient Emergency Severity Index (ESI-System used in ED to prioritize patient care by severity of illness or injury 5 being lowest and 1 being highest urgency) number of 3 (urgent but stable), and Pt 26's pain score was eight out of 10 (8/10). The NI stated, no pain medications were administered. The "EDT" indicated, an ED Note from 3:54 p.m. where Pt 26 reported an unwitnessed syncopal (fainting) episode in the restroom, and Pt 26's ESI number was updated to a 2 (high-risk requiring immediate nursing assessment, but not necessarily immediate life-saving intervention). The "EDT" indicated, at 5:21 p.m. Pt 26 reported a pain score of 8/10. The NI stated, no pain medications were administered. The "EDT" indicated, at 6:08 p.m. Pt 26 reported a pain score of 8/10. The NI stated no medications were administered. The "EDT" indicated at 6:14 the physician was at bedside. The "EDT" indicated, on 1/25/25 at 6:26 p.m. Pt 26 was provided discharge instructions, and discharged from the ED. The NI stated Pt 26's "EDT" documentation did not have any documentation of LNs requesting medication for pain from the physician.

During a telephone interview on 4/2/25 at 1:31 p.m. with Pt 26, Pt 26 stated, she went to the ED in January because she was around 11 weeks pregnant and began bleeding heavily and having very bad abdominal pain. Pt 26 stated, when she was assessed by the nurse, she reported heavy bleeding and pain, the nurse told her she would try to get her a bed as soon as possible. Pt 26 stated she told the nursing staff multiple times she was having very bad pain and asked for something for pain. Pt 26 stated the nurses told her she would have to wait until she was seen by the physician. Pt 26 stated she waited five hours in the waiting room bleeding heavily and at one point when she went to the bathroom she stood up and fainted, hitting her head on the bathroom stall. Pt 26 stated when she came out of the bathroom the security guard near the bathroom saw her and assisted her to a stool, then got a nurse to help her. Pt 26 stated, a nurse put her in a wheelchair and took her vital signs, then "parked her to the side", where she waited about two more hours to be seen by a physician. Pt 26 stated she reported again to nurses about having pain, still in her abdomen and then also in her head. Pt 26 stated no one addressed the pain to her head and the physician told her pain and bleeding were normal during a miscarriage (an unexpected loss of pregnancy before the 20th week of pregnancy). Pt 26 stated she was discharged home with instructions to follow up with her primary physician. Pt 26 stated she was not administered any pain medication or given any prescriptions for pain medications. Pt 26 stated she felt the nurses and the physician should have addressed her pain during her ED visit. Pt 26 stated she followed up with her primary physician and received orders for imaging testing for her head and neck pain.

During a concurrent interview and record review on 4/4/25 at 10:42 a.m. with Nurse Manager (NM) 3, Pt 26's "EDT", dated 1/25/25, ED Provider Note (EDPN), dated 1/25/25 were reviewed. NM 3 stated, according to the documentation on the "EDT" Pt 26 did not report hitting her head to ED nurses or the physician when she had a syncopal episode. The EDPN indicated, the problems addressed during the visit were, vaginal bleeding in the first trimester (a division of pregnancy into three equal periods of approximately 13 weeks each) NM 3 stated Pt 26's pain was not addressed during the visit on 1/25/25. NM 3 stated Pt 26's pain "possibly could have been addressed." The EDPN indicated, given the testing results the most likely diagnosis was miscarriage (The spontaneous loss of a woman's pregnancy before the 20th week that can be both physically and emotionally painful). The EDPN indicated, no discharge prescriptions were written for Pt 26.

During an interview on 4/4/25 at 5:20 p.m. with the Chief Nursing Executive (CNE), the CNE stated her expectation was for LNs to assess pain and escalate (to refer an issue or problem to a higher authority) to a physician to address Pt 26's pain.
During a review of the hospital's P&P titled, "Pain Management," dated 2/24/25, indicted, " ... Initial Pain Assessment 1. Upon admission to a patient care setting, including Emergency Department visits, patients will be assessed for pain using an appropriate scale. ... Patients experiencing pain will have a comprehensive assessment of pain completed by a Registered Nurse (RN) or Licensed Independent Practitioner (LIP). ...This assessment may include pain score, type, location, stated pain goal, and pain interventions. ... The patient experiencing pain will have a pain management plan developed in collaboration with the patient ... The pain management plan may include ... non-pharmacologic (non- pain medications) pain treatment strategies Pharmacological (pain medications) pain treatment strategies ...The pain management plan may be documented in the care plan and/or interdisciplinary notes. ...Discharge Education for Pain Management Plan: ... The patient/family/caregiver is educated regarding the discharge pain management plan ...Strategies to manage pain at home ....".

During a review of the professional reference titled, "Acute Pain Assessment Inadequacy in the Emergency Department: Patients' Perspective," dated 1/9/24, the professional reference indicated, " ...For many patients, acute pain is a common cause to seek treatment in an Emergency Department (ED). An inadequate assessment could cause inappropriate pain management. ... Patients' perceptions of pain assessment and management have become an important criterion and relevant outcome measure for healthcare institution. Patient' self-assessment is the most reliable and accurate evidence of the existence of pain and should be used whenever possible. ... However, pain management in the ED is challenging, and one of the main aims is to achieve patient satisfaction by reducing discomfort. Crowding EDs, and nurses' lack of knowledge may prevent nurses from performing adequate pain assessment and correct pain management. An inadequate assessment could cause underestimation of the patient's pain, leading to inappropriate pain management. According to governing organizations on pain, and guidelines, patients have the right to be involved in all aspects of their pain management. Previous studies have shown that the accurate assessment of pain is a crucial step in providing effective pain management. Discrepancies between a patient's and nurse's assessments are identified as the most powerful predictor of poor pain management. Previous studies have shown that acute pain management has been concentrated on the components of the pain management process, including the assessment of pain, provision of interventions. ... Acute pain management should include appropriate assessment together with the patient, and usually, resulting in a direct impact on patient pain management satisfaction ...".

3. During a concurrent interview and record review on 3/28/25 at 9:48 a.m. with Nurse Educator (NE) 1, Pt 5's "History & Physical (H&P- a complete patient assessment by the physician)," dated 12/31/24, was reviewed, the H&P indicated Pt 5 was brought into the Emergency Department (ED) on 12/31/25 at 12:45 p.m. by family with complaints of right upper quadrant pain (the area of the stomach located on the right side above the belly button) for two weeks. The H&P indicated, Pt 5 was admitted as an inpatient on 12/31/24 at 8:50 p.m. for a renal abscess (a pocket of pus that forms within the kidney tissue) and moved to the Medical Surgical (MS) Unit at 11:56 p.m.

During a concurrent interview and record review on 3/28/25 at 9:55 a.m. with NE 1, Pt 5's "Hospitalist Progress Note (HPN)," dated 1/2/25, "Care Plan Accordion (CPA)", dated 1/2/25 to 1/8/25 and the "Intake and Output Flowsheet (IOF)", dated 1/2/25 to 1/8/25 was reviewed. The HPN indicated, Pt 5 had an active medical problem identified by the physician of "severe protein and calorie malnutrition". The CPA" indicated; no care plans were entered by LNs for Nutrition Deficiency. NE 1 stated, Pt 5 possibly should have had a care plan for nutritional deficit. The IOF indicated, on 1/2/25 no lunch intake was documented. The IOF indicated, on 1/3/25, 1/4/25, and 1/5/25 no breakfast or lunch documentation were in the medical record. NE 1 stated the Electronic Medical Record (EMR) did not have a cell to document intake for dinner, prior to the system update in February 2025. NE 1 stated, nursing staff (CNAs, RNs) should have documented intake on the IOF when collecting the meal tray. NE 1 stated nursing staff were trained to document intake. NE 1 stated CNAs should have informed the RN when patients were refusing meals or not eating at least 75% of their meals. NE 1 stated nursing staff were supposed to document on the IOF when patients refused meals. NE 1 stated RNs could then notify the Pt's physician. NE 1 stated, the physician could, enter a Registered Dietitian Consult, enter an order for nutrition supplements, or prescribe medications to increase the patient's appetite. NE 1 stated, RNs should also speak to the Pt and the Pt's family because the Pt may have specific foods they prefer from home. NE 1 stated, ensuring Pt 5 was receiving enough nutrition was important for body healing and to improve wound healing.

During a review of Pt 5's "Medical Nutrition Therapy Nutrition (MNTN) Consult," dated 1/2/25, the "MNTN Consult" indicated Pt 5 was four feet eight inches tall and 74 pounds (lbs.- a unit of weight measurement) 8.3 ounces (oz- a unit of weight measurement). The "MNTN Consult" indicated; Pt 5 was underweight. The "MNTN Consult" indicated, Monitoring/Evaluation/Goals", Monitor weight, and tolerance to diet. Pt 5 did not have any additional weights assessed after her admission weight of on 12/31/25.
During a concurrent interview and record review on 4/2/25 at 2:46 p.m. with the Registered Dietitian Supervisor (RDS), Pt 5's "IOF," dated 1/2/25 through 1/8/25, "and "MNTN Consult" dated 1/2/25 were reviewed. The RDS stated, he reviewed Pt 5's medical record prior to the interview. The RDS stated, when Registered Dietitian's (RDs) assess patients for a nutrition consult the RD would look at the weight history as well as, admitting diagnosis, medical history, recent active problems or new diagnosis, diet, intake and output, nausea and vomiting, medications, and labs, to see if there was anything that may be significant. The RDS stated it was important for nutrition intake to be documented accurately, and Pt 5 was missing nutrition documentation. The RDS stated it was important to document accurately, to see progression (was the patient increasing or decreasing intake), and to get an estimate of calorie intake, also to see if the patient needed modification to nutrition (supplements, etcetera).

During an interview on 4/4/2025 at 5:17 with the Chief Nursing Executive (CNE), the CNE stated her expectation was for nursing staff to document nutrition with every meal per policy.

During a review of the hospital's P&P titled, "(Medical) Nutrition Therapy: Meal/Snack Delivery, Pick Up and Intake Recording," dated 8/22/21, indicated, " ...Purpose: ...To ensure timely and safe delivery, pickup and recording of patient intake ...Nursing are responsible for accurately and thoroughly documenting patients' meal, snack and fluid intake upon removal of meal trays or empty food/beverage containers. ...The person picking up will: ...Accurately and appropriately document the intake of the meal/snack using the percentage method and volume of fluids in milliliters. ...Nursing Staff will either transfer the written percent and volume intake to the EHR [Electronic Health Record] or document intake directly into the EHR".

During a review of a professional reference titled, "Nutritional Assessment," dated 4/10/23, (retrieved from https://www.ncbi.nlm.nih.gov/books/NBK580496/) indicated, " ... Evaluation of nutritional status is critical, either to identify if an individual has nutritional imbalance due to an underlying condition or to assess if an individual is likely to develop a pa

Based on observations, interviews and record review, the hospital failed to maintain a clean and sanitary environment in accordance with hospital policy and procedures, CDC, and clinical standards of practice for infection control when:

1.The Respiratory supply room in the Emergency Department had a box of corrugated tubing used for airway devices stored with corrugated tubing hanging out and was touching the supply room floor. The Third-Floor Operating Room Department's clean and sterile supply room had one package of sutures (surgical needle attached to a thread) on the floor. The Gastrointestinal (GI) Department's hallway clean supply room had two surgical filters on the floor, contrary to infection control standards of practice.

2.Expired [Brand name] nasal cannula were stored throughout the hospital with the intent to use on patients needing nasal cannula support in the hospital.

3.Emergency Department staff failed to ensure humidity and temperature was monitored daily in the sterile supplies' storage area when the log in the emergency room for sterile supplies storage area was not completed with temperature and humidity reading on 3/1/25 and 3/23/25.

4.Two of two sharps containers (containers used for the safe disposal of needles and other sharp medical instruments) in the Nuclear Medicine (radioactive substances for medical imaging) Department's Hot Lab (special room where radioactive materials, are prepared, stored, and delivered), were overfilled past the fill line marked on the side of the container, or out of the top of the container, contrary to the hospital's policy and procedure (P&P) titled, "Sharps", and "Nuclear Medicine: Radioactive Decay and Disposal of Radioactive Waste".

5.One opened and used 10 milliliter (mL a measurement of volume) vial (container) of 0.9 % Normal Saline (0.9%NS-common hydration and electrolyte replacement), and one used 12 mL 0.9% NS intravenous (IV-into the vein) flush (push liquid) syringe (a tube with a nozzle and a piston for pushing liquid) with 6 mL of fluid remaining in the syringe, was observed on the counter of the Nuclear Medicine Unit's Hot Lab, contrary to the Center for Disease Control (CDC).

As a result of these failures, all patients and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections.

Findings:

1. During a concurrent observations and interview on 3/25/25 at 2:52 p.m. with the director of critical care & respiratory care (DCC) and Respiratory Therapist (RT) 1 in the clean Respiratory Supply room across from "D- Pod" in the emergency department (ED) noticed box of corrugated tubing with tubing hanging out and touching the floor. The DCC stated the corrugated tubing was used by the RTs for trach (a tube-like structure that connects the larynx (voice box) to the lungs) devices, and airway masks. The DCC stated the corrugated tubing should not be touching the floor. The DCC stated this was not acceptable practice to store the tubing on the floor and would lead to infection issues. The DCC stated tubing would now be considered contaminated (the state of containing unwanted or dangerous substances) and he would ensure that team disposes the contaminated tubing. The DCC stated he expected staff to ensure that supplies were not touching the floor in the clean supply rooms. RT 1 also stated he was not able to comment on why the tubing was on the floor. RT 1 stated it was important to keep the tubing off the floor. RT 1 stated contaminated tubing could lead to infection issues as these corrugated tubing gets used with airway devices.

During an interview on 3/25/25 at 2:43 p.m. with Registered Nurse (RN) 1 in the third-floor Operating Room (OR) Department's clean and sterile patient supply room, one package of sutures were observed on the floor. RN 1 stated, the package of sutures should not be on the floor because the floor was contaminated, and the package was also a sharp. RN 1 stated, the contents of the package should be discarded in the sharps container. RN 1discarded the package.

During an observation on 3/25/25 at 3:23 p.m. with Nurse Manager (NM) 1 in the Gastrointestinal (GI) Department Hallway supply room, two filters used during patient surgery were observed on the floor. NM 1 stated, the surgical filters should not be on the floor, because the floor was considered dirty. NM 1 stated, the filters should be thrown away. NM 1 discarded the filters.

During an interview on 4/4/25 at 5:12 p.m. with the Chief Nursing Executive (CNE), the CNE stated, her expectation was for no clean or sterile patient supplies to be on the floors of the hospital. The CNE stated, by ensuring patient supplies were not on the floor, the hospital could eliminate a potential risk for infection.

During an interview on with the Chief Nurse Executive (CNE) on 4/4/25 at 5:45 p.m., the CNE stated she was made aware of the supplies touching the floor in the RT supply room in ED. The CNE stated the supplies touching the floor was not acceptable as it had the potential for cross contamination (the unintentional transfer of harmful bacteria or other contaminants from one surface, or object to another) and impact patient safety. The CNE stated she expected staff to ensure all patient care supplies are stored off the floor at all times.

During a review of the professional reference titled, "The role of the surface environment in healthcare-associated infections", dated August 2013, the professional reference indicated, " ...Hospital surfaces are frequently contaminated with important healthcare-associated pathogens (bacteria). Contact with the contaminated environment by healthcare personnel is equally as likely as direct contact with a patient to lead to contamination of the healthcare provider's hands or gloves that may result in patient-to-patient transmission of nosocomial (originating from the hospital) pathogens ..."

During a review of the professional reference titled, "Good Storage and Distribution Practices for Medical Products", (retrieved from https://www.who.int/publications/m/item/trs-1025-annex-7) dated 6/17/20, the professional reference indicated, " ...Storage and distribution are important activities in the supply chain management of medical products ... Storage areas should be of sufficient capacity to allow orderly storage of the various categories of medical products ... Storage areas should be appropriately designed, constructed, maintained or adapted. They should be kept clean and there should be sufficient space and lighting ... Materials and medical products should be stored off the floor, away from walls and ceilings, protected from direct sunlight and suitably spaced, to permit ventilation, cleaning and inspection ... Materials and medical products should be handled and stored in such a manner as to prevent contamination, mix-ups and cross-contamination ..."

During a review of the professional reference titled, "Keeping it Sterile: Fundamentals of Sterile Storage," (retrieved from https://www.ormanager.com/keeping-it-sterile-fundamentals-of-sterile-storage/) dated 7/20/23, the professional reference indicated, " ... Using sterile items in surgery is a fundamental practice, not a rudimentary one that can or should be taken for granted. Put simply, using unsterile items can result in a patient infection. If sterile storage conditions are not appropriate, the items can become contaminated. Such contamination may go undetected, rendering items unsafe and unusable. Therefore, healthcare facilities must take action to create an environment that properly protects sterile packages. This includes securing a proper sterile storage environment and developing policies and procedures to help ensure sterile packages are safely stored and handled ... Sterile packages should be handled with care and positioned so they are not crushed, bent, compressed, or punctured. Sterile items should never be stored on floors ..."

2. During a concurrent observation and interview on 3/26/25 at 9:59 a.m. with the DCC, and assistant nurse manager (ANM) 3 in the Intensive Care Unit (ICU - specialized hospital unit that provides advanced medical care to patients with life-threatening illnesses or injuries, requiring constant monitoring and specialized treatment) found supply closet stocked with three [brand name] nasal cannulas with manufacture date of 6/18/20 and two [Brand name] nasal cannulas with manufacture date of 6/28/20. The DCC was unable to locate the expiry date on the individual pack of [Brand name] nasal cannulas. The DCC stated he would have to check with vendor or stock room staff for expiry dates. The DCC stated he was not aware how long these [Brand name] cannulas were ok to use after manufacturer date.

During an interview on 3/27/25 at 8:50 a.m. with the Manager Accreditation and Licensure (MAL), the MAL stated she had reviewed the manufacturer's instructions for [Brand name] nasal cannula and the instructions indicated that [Brand name] cannula was good for three years from the manufacturer date listed on the cannula. The MAL stated all five [Brand name] cannulas stocked in ICU were expired. The MAL stated these cannulas should had been removed from the ICU and should not be used on patients. The MAL stated the hospital supply chain team was working on removing the expired [Brand name] nasal cannulas from rest of the hospital. The MAL stated the hospital staff was not aware that [Brand name] cannulas were good for three years from the manufacturer date and the hospital have the expired cannulas stocked in other parts of the hospital as well.

During an interview on 3/28/25 at 11:30 a.m. with the DCC, the DCC stated that he had reviewed the instructions for use for [Brand name] nasal cannulas. The DCC stated the hospital was using the [Brand name] cannula past three years from the manufacturer date and were not aware of the manufacture recommendations. The DCC stated all expired cannulas now have been pulled from all different floors. The DCC stated ICU had eight cannulas that were expired with manufacturer date of year 2020 and would have been used for the next patient needing [Brand name] nasal cannula. The DCC stated the stock room team have been working on creating a list of expired [Brand name] cannulas as they are being pulled from clean supply storage and ready to be used in different parts of the hospital. The DCC stated expired supplies should never be used on patient. The DCC stated the expired items might be unsafe, deteriorate over time and it could possess a risk for infection and patient health issues.

During a review of letter by "Food and Drug Administration (FDA - government agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices), titled to "Company Name", dated "3/19/20", indicated " ... [Brand Name] Nasal Cannula is intended to be used in a hospital/institutional environment .... intended Use /Indications for Use ... the [Brand name] nasal cannula is a 14-day single use nasal cannula interface for use with specified respiratory gas humidifiers to deliver Nasal High Flow (NHF) [a non-invasive respiratory support method that delivers heated and humidified gas with a controlled oxygen concentration through a nasal cannula] therapy to spontaneously breathing adult patients ... Shelf life ... 3 years ..."

3. During a concurrent observation and interview on 3/25/25 at 2:20 p.m. in the ED with the ED Manager (NM 3) and Assistant Nurse Manager (ANM 1) observed more than 10 surgical trays (to hold surgical instruments), containing instruments and supplies, packaged in peel packs (pouches use to keep instruments and tray inside the pouch free from bacteria or other living microorganisms) stored in the trauma room (room primarily used for trauma patients). NM 3 stated the trays were used by the ED physicians or surgeons to do urgent or emergent procedure at bedside. NM 3 stated the storage of surgical trays have been in place for a long time (unable to comment on the exact time) and have been approved by infection prevention team. NM 3 stated the ED staff monitors temperature and humidity of the room with sterile [free from germs and microorganisms] trays storage daily to ensure that it meets the requirements for sterile supplies.

During a concurrent interview and record review on 3/25/25 at 2:23 p.m. in the ED with NM 3, the ED "temperature and humidity log" for ED trauma room, for the month of March 2025 was reviewed. The "temperature and humidity log" for the trauma room for the month of March 2025 indicated that log was not filled out for Temperature and Humidity reading for 3/1/25 and 3/23/25. NM 3 stated it was not acceptable and should have been filled out daily. NM 3 stated without appropriate temperate and humidity monitoring the integrity of the sterile trays could not be maintained and the trays should not be kept in the trauma room. NM 3 stated temperature or humidity out of range could potentially lead to infection and may cause harm to the patients.

During a concurrent interview and record review on 3/27/25 at 10:45 a.m. with the Sterile Processing Department Manager (SPDM), ED "Temperature and Humidity log" for trauma room was reviewed. The SPDM validated log was missing readings for both temperature and humidity for 3/1/25 and 3/23/25. The SPDM stated she has been working as SPDM for three years. The SPDM stated her team was responsible for cleaning, disinfecting, and sterilizing reusable medical instruments and equipment. The SPDM stated surgical trays with instruments stored in ER were good to use until the package is open, however, it requires temperature and humidity monitoring on daily basis to ensure sterility. The SPDM stated her team does not check on the surgical trays stored in the ED trauma room and the trays were managed by the ED staff. The SPDM stated, temperature and humidity should be monitored in the storage areas for surgical trays on daily basis to ensure sterility of the trays. The SPDM stated she expected the log to be filled out daily with temperature and humidity readings in all storage areas with sterile trays.

During a review of professional article, "Curless, M. S., Bow, L., Lentz, T., Trexler, P., & Maragakis, L. L. (2021). Management and Mitigation of Temperature and Humidity Events in the Perioperative Setting. AORN Journal, 114(6), 563-571. https://doi-org.castatelib.idm.oclc.org/10.1002/aorn.13563", dated, 2021, the article indicated " ... Temperature or relative humidity variations that fall outside the recommended parameters for the perioperative environment can have serious implications for patient safety and satisfaction as well as business continuity. Some pathogenic microbes can thrive in prolonged elevated humidity. Supplies and equipment in perioperative environments exposed to variations in temperature and humidity may become sources of infection or undergo alterations in function, putting patients at increased risk of harm ..."

During a review of professional reference retrieved from https://www.jointcommission.org/standards/standard-faqs/ambulatory/environment-of-care-ec/000001275/, titled "Do we need to monitor the temperature and humidity of the rooms where sterile supplies are stored?", with the last review date of October 19, 2021, the reference indicate, " ... ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following ... Positive air pressure relationship to adjacent areas ... Maximum relative humidity 60% ... Temperature range 72 to 78 F or 22 to 26 C ..."

During a review of professional reference retrieved from https://www.jointcommission.org/standards/standard-faqs/ambulatory/environment-of-care-ec/000001275/, titled "Temperature and Humidity - Monitoring Requirements", dated 4/11/16, the reference indicated, " ... Rooms that are considered critical, like those where invasive procedures are performed or where sterile items are stored, are to be in constant compliance when being used for their intended purpose. Therefore, some reliable strategy is to be implemented to ensure continuous compliance, such as daily readings, real-time indicating devices in the space, alarming through a building automation system, etc. ... Daily monitoring would be acceptable as long as the organization has assessed there to be a reasonable assurance that the snap-shot-in-time selected represents compliant humidity and temperature levels throughout the operational day. Non-continuous, periodically checked conditions are to be logged. All non-compliant conditions are to be documented with corrective actions described. If the room is not in-use and is placed in a non-compliant mode, like for energy conservation, then the room must be validated to be in compliance before a procedure begins; an energy conservation mode must maintain proper relative humidity levels ..."

4. During an observation and interview on 3/26/25 at 10:59 a.m. with the Director of Imaging (DI) and the NMT, the Nuclear Medicine Unit Hot Room counter had one used 10 mL vial of 0.9 % NS, and one used 12 mL NS IV flush on the counter. The 10 mL vial had ¾ of the fluid remaining and the 12 mL NS flush had 6 mL of fluid remaining. The NMT stated, the fluid in the vial was used to prepare "kits-(define)" for the scans (process for taking images of the interior of a body) preformed in the department. The NMT stated, the vials were a onetime use vial and should have been thrown away after preparation of the "kit" for the scan. The NMT stated, if the vial were counter and used for another patient the staff would not know if there were germs on the stopper (plug top) of the vial. The NMT stated, a NS flush was a one-time use, because the flush was used directly on the patient, to push fluids into the IV line (soft flexible tube inserted into a vein, to deliver fluids, medications, or blood products). The DI stated, the vial and the flush should have been discarded after use.

During an interview on 4/2/25 at 12 p.m. with the Infection Prevention Manager (IPM) the IPM stated, the vial used for reconstituting medication and/or scan contrast (define) should be discarded after medication reconstitution. The IPM stated, if the NS flush was used for a previous case (scan or procedure), it should not have been left behind. The IPM stated, the NS flush should have been discarded after use. The IPM stated, the risk for infection by not discarding the NS flush could be, using on the same flush on another patient, or contaminating another surface. The IPM stated, by not discarding the vial of NS, there was a risk of reusing the single-use vial on another patient.

During a review of a professional reference titled, "Preventing Unsafe Injection Practices," dated 3/24/24 (retrieved from https://www.cdc.gov/injection-safety/hcp/clinical-safety/index.html), the professional reference indicated, " ... Safe injection practices are every provider's responsibility. A safe injection does not harm the person, expose the provider to risks or result in hazardous waste for the community. Improper use and disposal of syringes, needles, and medications imposes risks on patients and healthcare providers. ...Unsafe injection practices may result in serious consequences like: ...Transmission of bloodborne pathogens ...Outbreaks of bacterial or fungal infections. ...Safe injection practices include one-time use of needles and syringes and limiting the sharing of medication vials. ... Recommendations ...The following safe injection practices are critical for patient safety: ...Use a new sterile syringe and needle for each patient. Once used, the syringe and needle are both contaminated and must be discarded. ...Do not administer medications from the same syringe to more than one patient ...Never use medications intended for single use for more than one patient. This includes single-dose vials. ...A single-dose vial of liquid medication intended for injection or infusion is only approved for use in a single patient for a single case, procedure or injection. ...".

5. During a concurrent observation and interview on 3/26/25 at 11:10 a.m. with the Director of Imaging (DI) and the NMT in the Nuclear Medicine Department's Hot Lab, two of two sharps' containers were observed on a counter through a window behind a metal shield, overfilled past the fill line. The sharps container on the left side of the counter had sharps filled to approximately one inch (in- a unit of length measurement) below the entry hole in the top. The sharps container on the right side was inside a metal box with a hole cut in the top, there were three used syringes visible coming out of the entry hole to the box. The NMT stated the large metal shield was called an L Block and was made of lead to protect against radioactive material, when preparing the "kit" (a sterile, non-radioactive mixture of substances to add to radioactive) doses. The NMT stated, the sharps container on the right was inside a lead box because the sharps inside were considered "hot [something with high levels of radioactivity]", due to the previous contact with radioactive material. The NMT stated, the containers should be emptied when they got "full" then close the lid. The NMT stated, the sharps from the department were held in the Hot Lab in a lead cabinet due to radiation. The DI stated, the sharps container should not be more than ¾ full, and the NMT should contact the manager whenever the sharps got to the fill line for a new container. The NMT stated, the sharps container should not be full because the staff could get poked.

During an interview on 11:55 a.m. with the IPM, the IPM stated sharps should not exceed the fill line. The IPM stated, overfilled sharps container increases the risk for a sharps injury. The IPM stated, "Hot" sharps should be all the way through the hole on the top under the lead shield.

During a review of the hospital's P&P titled, "Sharps," dated 7/20/22, indicated, " ...To establish a standard for the safe handling, transport and disposal of needles, syringes and other medical sharps. To reduce/sand or eliminate accidental punctures from these devices. ...Sharps containers are to be closed and removed when ¾ full ...If there is some condition which presents a sharps hazard through the container has not yet reached the designated level, the container should be closed and removed. ...You should visually confirm it has dropped completely into the container and do not insert finger near the opening ...".

During a review of the hospital's P&P titled, "Nuclear Medicine: Radioactive Decay and Disposal of Radioactive Waste," dated 8/22/23, indicated, " ...To ensure safe storage and disposal of radioactive materials/supplies received/utilized in the Nuclear Medicine Department. ...Liquid and solid wastes greater than the background will be held for decay until radiation levels, as measures with a low-level survey meter and with all shielding removed, has reached levels not statistically significant as compared with background levels. ...decaying radioactive wastes are stored in the Radiopharmacy Hot Lab, in shielded containers/cabinets ...".

During a review of professional reference titled, "Sharps Safety Guidelines," dated 12/26/22, (found at https://www.infectioncontroltoday.com/view/sharps-safety-guidelines) the professional reference indicated, " ... Punctures and cuts can introduce bloodborne pathogens into the body, such as hepatitis B virus (HPV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) ... Most sharps-related injuries can be prevented and occur during or immediately after use it is important to understand safe sharps waste disposal ...Containers should also be marked with a line to indicate when the container is three-fourths full. Once the container reaches that point, do not place any more sharps in the container-this line is to prevent injuries. One of the leading causes of sharps injuries is overfilled containers. Never force items into the sharps container...".

Based on observation, interview and record review, the hospital failed to transport and use radioactive materials in accordance with professional standards of practice and hospital policy and procedure when Lead Nuclear Medicine Technologist (LMNT) 1 transported radioactive material meant for Patient (Pt) 6 to the wrong floor and wrong room in the hospital and administered the radioactive material to Pt 5 without first verifying the correct patient. LMNT 1 administered via injection 3 milliliters of radioisotope tagged white blood cells belonging to Pt 6 into Pt 5's vein and did not follow hospital P&Ps titled, "Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration", and "Identification: Patient Armband/Patient Verification" and standards of practice for medication administration.

These failures had the potential to infect Pt 5 with a bloodborne pathogen (disease causing germs found in human blood) from Pt 6's blood, causing illness because Pt 6 was diagnosed with osteomyelitis (bone infection caused by bacteria) at the time of the incident. This failure also had the potential for Pt 5 to have a reaction to the blood product injected, leading to fever, chills, hives (raised itchy bumps on the skin), difficulty breathing, requiring a longer hospital stay.

Findings:


During an observation and interview on 3/26/25 at 10:46 a.m. in the Nuclear Medicine (Nuc Med) Department, with Nuclear Medicine Technologist (NMT) 1, the metal boxes used to carry the radioisotope tagged WBCs to the patient's bedside were observed in the Hot Lab (special room to deliver, store and prepare radioactive materials). NMT 1 stated the metal boxes were made of lead and were called "pigs". NMT 1 stated, the process for preparing a patient for a Nuclear Medicine scan (uses small amounts of radioactive material, called radiotracers, to create images of the inside of the body) with tagged WBCs, began when a Nuclear Medicine Technologist (NMT) received the order from a physician. NMT 1 stated, a NMT would draw a sample of the patient's blood and apply a Nuc Med Department wrist band. NMT 1 stated, the band had numbers on it matching the blood sample labels. NMT 1 stated, the blood was then sent to the Radiopharmacy (pharmacy for radioactive materials) in another town, where the isotopes were added. NMT 1 stated, the dose was brought back within a few hours. NMT 1 stated, the same NMT who drew the blood would administer the dose. NMT 1 stated, the NMT took the "pig" containing the syringe "kit" (dose of tagged WBCs), and the physician order to the patient's bedside. NMT 1 stated, the NMTs were supposed to verify patient identity by checking the wrist band placed earlier, and by verifying name, date of birth (DOB). NMT 1 stated, the patient's "kit" numbers were verified against the wrist band. NMT 1 stated, now the patient's nurse had to sign off to ensure the correct patient was about to receive the dose. NMT 1 stated, the nurse's completing the double check started a few months ago. NMT 1 stated, the double check was important to prevent errors, and ensure the correct patient received the dose. NMT 1 stated, an error injecting the wrong patient could harm the patient not due to the isotopes but due to the blood. NMT 1 stated, patients could go into anaphylactic shock (a severe, life-threatening allergic reaction that could cause a rapid decline in blood pressure and difficulty breathing) due to receiving a blood product not the same type as their own.

During an interview on 3/26/25 at 11:34 a.m. with the Radiology Safety Officer (RSO), the RSO stated, his role as safety officer was to oversee the radioactive material at the hospital and, to ensure patient and employee safety. The RSO stated, he was a practicing Radioactive Oncology Physician. The RSO stated, he remembered the incident regarding LNMT 1 injecting Pt 5 with Pt 6's radioisotope tagged WBCs on 12/9/24. The RSO stated, he was involved with the hospital internal investigation. The RSO stated the incident involved two patients, Pt 5 and Pt 6. The RSO stated, Pt 6 had a physician order for an injection of blood with radioactive isotopes for a nuclear radiologic procedure (scan), and Pt 5 did not have an order for a nuclear radiologic procedure. The RSO stated, Pt 5 was injected with Pt 6's blood by LNMT 1. The RSO stated, when a physician ordered a nuclear scan, a report went to the Nuc Med Department through the Electronic Medical Record (EMR- a digital version of a patient's medical history, including diagnoses, medications, tests, allergies, immunizations, and treatment plans), and the type of scan the physician ordered required a radioisotope be attached to white blood cells. The RSO stated, LNMT 1 went to Pt 6's hospital room and drew a vial of blood. The RSO stated, the vial of blood was sent to an offsite Radiopharmacy in a town one- and one-half hours away by the nuclear pharmacy courier (transporter). The RSO stated, the WBCs were tagged at the nuclear pharmacy then returned to the hospital for injection. RSO stated, LNMT 1 took the blood product to the patient's hospital room and "just didn't identify patient", injecting the radioisotope tagged WBCs into Pt 5 instead of Pt 6. The RSO stated, LNMT 1 got off on the wrong floor and went into the same room number. The RSO, stated LNMT 1 identified his error, "right after the administration". The RSO stated, LNMT 1 reported the error to the nurse, and leadership immediately. The RSO stated, Pt 5's physician was notified as well as the patient and the family. The RSO stated, LNMT 1 "missed the double check", and "just didn't identify patient [did not verify Pt 5's name and date of birth, against the armband]" The RSO stated, Pt 5 could have been harmed by any infections that were present in the blood infected into her. The RSO stated, the radiation was not an issue, it was given to the wrong patient, but it had a short half-life (the time it takes for one of the atoms in the sample to decay [lose energy] one that decays quickly).

During a concurrent interview and record review on 3/28/25 at 9:33 a.m. with Nurse Educator (NE)1, Pt 6's "History & Physical [H&P- an assessment from physician including medical history and exam]," dated 1/1/25 was reviewed. The "H&P" indicated, Pt 6 was a Portuguese speaking 86-year-old with past medical history (PMH) of Type 2 Diabetes Mellitus (disorder characterized by difficulty in blood sugar control and poor wound healing), and hypertension (high blood pressure), presenting to the emergency department (ED) on 12/29/24 for right foot redness, swelling and pain, as well as generalized weakness. The "H&P" indicated, Pt 6 was admitted to the hospital as an inpatient on 12/31/24 for a diabetic ulcer (open sores on the feet, a serious complication of diabetes), and acute osteomyelitis (a bone infection that develops rapidly).

During a concurrent interview and record review on 3/28/25 at 9:40 a.m. with NE 1, Pt 6's "Provider Progress Note [PPN]," dated 1/2/25 to 1/8/25, "Physician Orders [PO]", "Medication Physician Orders [MPO], dated 12/30/24 to 1/3/25, and "Medication Administration Record [MAR]," dated 12/31/24 to 1/3/25, were reviewed. The "PO" indicated, on 12/30/24 at 4:50 p.m. an order for a Nuc Med scan was entered. NE 1 stated, the "PO" indicated the scan was performed on 1/3/25 at 11:38 a.m. and read by the physician on 1/4/25. The "MPO" indicated, on 1/2/25 at 11:05 a.m. an order for ... "radioisotope 12millicuire [a unit of radioactivity]" ...Electronically signed by: [LNMT 1] on 1/2/25 at 1105 [11:05 a.m.] ...". The "MAR" indicated, the radioisotope 12 millicurie was ordered by LNMT 1 on 1/2/25 at 11:05 a.m. but was administered by NMT 1 intravenously on 1/3/25 at 11:38 a.m. The "MAR" had no indication the radioisotope was scanned before administration.

During a concurrent interview and record review on 3/28/25 at 9:48 a.m. with Nurse Educator (NE) 1, Pt 5's "H&P," dated 12/31/24, was reviewed, The H&P indicated Pt 5 was a Spanish speaking 96 year-old patient brought into the ED on 12/31/25 at 12:45 p.m. by family with complaints of right upper quadrant pain (the area of the stomach located on the right side above the belly button) for two weeks. The "H&P" indicated Pt 5 was admitted as an inpatient on 12/31/24 at 8:50 p.m. for a renal abscess (a pocket of pus that forms within the kidney tissue) and moved to the Medical Surgical (MS) Unit at 11:56 p.m.

During a concurrent interview and record review on 3/28/25 at 9:55 a.m. with NE 1 Pt 5's "Provider Progress Note [PPN]," and "Labs", dated 1/2/25 to 1/8/25, "Physician Orders [PO]", "Medication Physician Orders [MPO], dated 12/31/24 to 1/3/25, and "Medication Administration Record [MAR]," dated 12/31/24 to 1/3/25, were reviewed. NE 1 stated, Pt 5's "PO" and "MPO" had no orders indicating a Nuc Med scan, or any radiopharmaceuticals were ordered for Pt 5. NE 1 stated, Pt 5s "MAR" had no documentation indicating Pt 5 was administered isotope tagged WBCs. NE 1 stated, Pt 5's "MAR" would not have documentation, because there were no orders for the patient to have radiopharmaceuticals. The "PPN" dated 1/2/25 indicated, " ...I was informed (01/02/2025) that patient [Pt 5] was (accidentally and erroneously [incorrectly]) injected (by nuclear medicine technologist) another patient's blood product [Pt 6]. This was communicated to the patient's sons ... Active Problems: ...Accidental injection of blood products from another patient - This was reported to the patient's both sons and risks/plans were explained. - Discussed with infection control; source patient [Pt 6] has strep [type of germ] bacteremia [serious infection enters the bloodstream] and Pseudomonas (common bacterial disease-causing organisms) wound infection. -Source patient is being tested for [bloodborne pathogens] ...per Infectious control request. ...Will repeat blood cultures with a.m. labs and follow up ...". NM 1 stated, multiple labs were drawn, and results were negative for bloodborne pathogens.

During an interview on 4/1/25 at 11:42 a.m. with the Director of Imaging (DI), the DI stated, she was a part of the hospital internal investigation of Pt 5 being injected with Pt 6's radioisotope tagged WBCs. The DI stated LNMT 1 failed to use two patient identifiers prior to injecting the radioisotope tagged WBCs for Pt 6 into Pt 5. The DI stated, her expectation was for LNMT 1 to report the error immediately, which he did. The DI stated, the discovery during the investigation was, LNMT1 got off the elevator on the incorrect floor and entered what would be the same room number if he was on the correct floor. The DI stated, Pt 6 and Pt 5 were located on different floors but were in the same room number, and in the same bed location. The DI stated, LNMT 1did draw the correct patient's blood (Pt 6), in the morning around 6 a.m. The DI stated, LNMT 1claimed he only "glanced" at Pt 5's armband, and both patients had similar first names, and both patients were similar in appearance. The DI stated, LNMT 1 did not notice Pt 5 did not have the Nuc Med Department armband applied, and he did not verify the "kit" numbers against the armband, or the patient's name against the physician's order. The DI stated, as soon as LNMT 1realized he injected the wrong patient he called the manager, the house supervisor and both patient's physicians. LNMT 1 stated, Pt 6 needed to be tested for bloodborne pathogens, and be redrawn for the nuclear isotope tagging and rescheduled for the scan, and Pt 5 needed to be monitored for reactions and tested for infections. The DI stated, the incident was reported to the RSO the same day as the event, and there was no concern for harm to Pt 5 due to the radiation dose. The DI stated, Pt 5 receiving Pt 6's blood was concerning but both patients were tested, and the results were negative for any bloodborne pathogens. The DI stated, the Nuc Med Department had label tracking (to scan) into the Nuclear Medicine Information System (NMIS-software designed to manage patient, department, including inventory, dosing and billing), but there was no barcode scanning to scan the "kit" into the main hospital EMR system. The DI stated the NMT's document in the patient's MAR when completing the administration.

During a review of hospital document titled, "Labeling Tracking Record [LTR]," dated 1/2/25, the "LTR" indicated, Pt 5 had blood drawn for WBC tagging by LNMT 1 on 1/2/25 at 6:25 a.m. The "LTR" had a checkmark indicating the "Patient name on all labeling stickers", "Specimen syringe sticker attached to blood specimen container" and "Bracelet attached to patient". The "LTR" indicated, Pt 5's blood was received at the Radiopharmacy on 1/2/25 at 8:30 a.m. The "LTR" indicated, a dual verification of the dose was verified, loaded and sealed in the transporting case. The "LTR" indicated, five separate steps for verification of patient name to ensure correct patient prior to sending the dose to the hospital. The "LTR" indicated, the radioisotope tagged WBCs were delivered to the hospital on 1/2/25 at 11:11 a.m.

During an interview on 4/1/25 at 2:50 p.m. with the Manager of Accreditation and Licensure (MAL), the MAL stated LNMT 1 was as not available to be interviewed because LNMT 1no longer worked for the hospital.
During an interview on 4/2/25 at 1:19 p.m. with the Healthcare Risk Officer (HRO) the HRO stated, Reason the Rad incident was not thought to be reported, and an RCA was not completed was because it didn't meet criteria. The HRO stated, the hospital completed an Intensive analysis, considered one step above a regular investigation but did not rise to the level of a root cause analysis.

During an interview on 4/3/25 at 1:57 p.m. with the DI, the DI stated, the NTs scan the radiopharmaceutical product for the NIMS system at patient's bedside. The DI stated, during the incident with Pt 5 LNMT 1 had trouble logging into the computer workstation at Pt 5's bedside so he attempted to use identifiers, then scanned the label when returning to the Nuc Med department. The DI stated, when he scanned the label, he discovered his error.
During an interview on 4/4/25 at 5:25 p.m. with the Chief Nursing Executive (CNE), the CNE stated, LNMT 1 should have gone to the patient's room and verified the patient's identity, ensuring right patient, right drug, right dose, right route, and right time. The CNE stated the five rights of medication administration should have been followed for this patient to avoid the error.

During a review of the hospital's P&P titled, "Nuclear Medicine: Radiopharmaceutical Preparation, Labeling, and Administration," dated 6/8/23, indicated, " ... PURPOSE A. To ensure patient and staff safety during the preparation and administration of radiopharmaceuticals. ...Patient identity shall be verified by comparing patient name and date of birth on identification band with same identifiers on applicable health information documents prior to initiating this policy/procedure ... Maintain adequate shielding throughout the department. Reaction vials are to remain in covered leaded carriers ("pigs"), when not in use. Dose syringes must be in syringe shield or "pig" except when in the dose calibrator. ... Double check vial and syringe labels before injecting. ...Administration ...Establish patient identity before prepping or injecting. Ask patient to state full name (rather than to confirm name) and the date of birth. For inpatients, confirm identification in same manner against identification armband. Nuclear Medicine Technologist will cross-reference patient identification with that printed on NMIS labels and/or registration record. ...Labeling of Blood Products a. On studies that involve invitro tagging of blood cells ... the patient should be carefully identified as above and given a wristband with specific identifiers for the return of the tagged blood cells. b. The same Nuclear Medicine technologist should draw the blood that re- injects the tagged cells. ...Documentation: ...Order radiopharmaceutical in the exam navigator under "orders", with correct information as to drug, route, and time. ...One eMAR [electronic Medication Administration Record] and NMIS computer system, document patient name, date of birth, and medical record number with radiopharmaceutical, manufacturer and lot number, dose, date and time of administration, date and time of expiration and Nuclear Medicine technologist administering ...".

During a review of the hospital's P&P titled, "Identification: Patient Armbands/Patient Verification," dated 2/8/22, indicated, " ...PURPOSE A. To assure accurate identification of all patients at [name of hospital] B. To assure the two approved patient identifiers are used to match service or treatment to that individual in a manner that prevents wrong patient identity. ...Verification of patient identity by comparing patient name and date of birth on identification band with same identifiers on applicable health information documents will occur prior to initiating this procedure ...Applicable patients will have an identification band on at all times. ... Accurate patient identification will occur whenever administering medications or blood products, taking blood samples and other specimens for clinical testing, or providing any other care, treatments or procedures. 1. Accurate identification MUST occur at the "point of care" any time care/treatment is to be provided. 2. Containers used for blood and other specimens are to be labeled in the presence of the patient. ... Whenever patient care is being managed through Order Entry (OE) or other computerized methods, accurate patient identification will occur by comparing patient's full name and date of birth on document being entered (physician's order for example) to patient pulled up in computer application. 1. Using medical record number and/or patient account number can be used to further verify correct patient IN ADDITION to, but not as replacements for, using patient's full name and date of birth. ... Patients who are hospitalized who are unable to participate in verification at time of admission will have identity verified through reliable family member or friend as soon as possible. The name of the family member or friend verifying identity will be entered into admission history to provide reference that identity was initially verified through this reliable source. This is intended to provide reference to subsequent caregivers that identity has been validated. ... VERIFYING PATIENT IDENTITY: POINT OF CARE VERIFICATION AND INFORMATION DOCUMENT COMPARISON 1. Upon first interaction or at beginning of shift with a conscious patient, verify patient identity by asking the patient to state their full name and date of birth. Compare this to same information on patient's identification band and same in health information documents (eMAR, physician orders). 2. Upon all subsequent interactions while assigned to patient within same day, verify identity by checking full name and date of birth on identification band and comparing to same information on applicable health information documents (eMAR, physicians orders, lab results or other documents triggering nursing intervention). ...Non-English speaking: Obtain interpreter and follow same guidelines ...".

During a review of a professional reference titled, "Safe Medication Administration: So Many Considerations," dated July-August 2023, the professional reference indicated, " ... For decades, the five rights for administering medications have been a recognized safety standard (Martyn et al., 2019). The framework of the seminal five rights (i.e., right patient, drug, dose, time, route) has evolved, and other rights considered as additional influences on medication administration processes have been identified in changing healthcare environments ...".