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Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation (CoP) for Governing Body was met as evidenced by:

1. The Governing Body failed to ensure the facility's Pathology Department ensured pathologists (a healthcare provider who looks at bodies and body tissues) consistently followed the facility's policy and procedure for verifying patient identity and specimen before reviewing pathology slides (a thin glass used to hold patient tissues or fluid for microscopic examination).

This deficient practice resulted in Patient 1 undergoing an unnecessary proctectomy (surgery to remove the prostate gland) due to a misdiagnosis and a delayed cancer diagnosis or prognosis for Patient 2 (Patient 2 did not receive treatment at the facility). The deficient practice also had the potential to result in continued diagnostic errors affecting patient misidentification of specimens causing patient harm. (Refer to A-0063)

2. The Governing Body failed to ensure the facility complied with Federal and State regulatory requirements for timely and complete access to records during a health oversight survey (review conducted by regulatory or licensing bodies).

This deficient practice resulted in delayed or altered access to essential evidence related to patient safety incidents and had the potential to impede regulatory oversight and delay corrective action for system deficiencies. (Refer to A-0063)

3. The Governing Body failed to ensure the Pathology Department ensured its Pathology department staff consistently followed the facility's labeling and verification policies to prevent specimen misidentification.

This deficient practice resulted in inconsistent specimen handling practices and had the potential to cause additional patient harm through mislabeled diagnostic materials. (Refer to A-0063)

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

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

1. The facility failed to ensure admitting staff obtained a consent (for treatment) from and to provide information to the appropriate patient's representative for one of 32 sampled patients (Patient 8), when the facility's admitting staff did not inform Patient 8's Durable Power of Attorney (DPOA, an agent appointed by the patient to act on his/her behalf when unable to make medical decision) about the Condition of Admission (COA, a contract between the hospital and patient regarding treatment, payment for services rendered by the facility, etc.), Medicare Outpatient Observation Notice (MOON, given to all Medicare [Federal health insurance for people at a certain age or with specific medical disabilities] beneficiaries, informing that they are outpatients receiving observation services and are not inpatients of a hospital) and the Important Message from Medicare (IMM, given to all Medicare [Federal health insurance for people at a certain age or with specific medical disabilities] beneficiaries, notifying them of their hospital discharge appeal rights), in accordance with the facility's policies regarding patient care related decision-making involving designated Patient care representative or DPOA.

This deficient practice resulted in Patient 8's DPOA not being given the opportunity to provide consent for the facility to treat Patient 8 upon admission, and not knowing their rights including billing, release of information, and financial responsibility during hospitalization. (Refer to A-0117)

2. The facility failed to ensure nursing staff involved the appropriate patient's representative when developing and reviewing plan of care (a document that outlines an individual's assessed needs and the specific support or care required to meet those needs, ensuring the right level of care is provided) for one of 32 sampled patients (Patient 8), in accordance with the facility's policy and procedure regarding plan of care.

This deficient practice resulted in Patient 8's appointed agent not being able to participate in developing and reviewing care plan and participate in setting treatment goals for Patient 8, which may negatively affect the care plan goal for Patient 8 leading to delayed recovery from healthcare condition. (Refer to A-0130)

3. The facility failed to ensure the facility's staff executed the Advance Health Care Directive (written statement of a person's wishes regarding medical treatment made to ensure those wishes are carried out should the person be unable to communicate them to a doctor) and identify the appropriate Durable Power of Attorney (DPOA, an agent appointed by the patient to act on his/her behalf when unable to make medical decision) for one of 32 sampled patients (Patient 8), in accordance with the facility's policy and procedure regarding advance health care directives.

This deficient practice violated Patient 8's rights regarding involvement of DPOA and resulted in an incorrect person being notified of Patient 8's treatment plan, and with Patient 8's DPOA not given the opportunity to provide consent for treatment, to ask questions regarding treatment options and be involved in the development of the plan of care for Patient 8 during Patient 8's hospitalization. This deficient practice may also delay the implementation of Patient 8's treatment plan and results in prolonged hospitalization. (Refer to A-0132)

4. The facility failed to ensure that the protected health information (PHI, any health information that can identify an individual and is in the possession of or transmitted by a "covered entity" or its business associates, relating to a patient's past, present, or future health. This includes patient name, medical record number, etc.) of one of 32 sampled patients (Patient 6), was not photographed using a staff member's personal phone, in accordance with the facility's policy and procedure titled, "Personal Use of Photographic, Video and Recording Equipment at [name of the facility] facilities."

This deficient practice creates a risk for unauthorized access to private health information, accidental disclosure, loss of confidential patient information, and emotional distress for the affected patient/patients. (Refer to A-0143)

5. The facility failed to ensure that a safe environment was provided for one of 32 sampled patients (Patient 14), when medications, including a full vial (container for liquid medication storage) of acetaminophen (a medication used as a pain reliever and fever reducer), containing 1000 milligrams (mg, measuring unit) per 100 milliliters (ml, measuring unit), a 10 mg dose per 5 ml solution (10mg/5 ml) Reglan (medication used to treat nausea), and 50 mg/1 ml Benadryl (medication used to relieve allergy symptoms), were left at Patient 14's bedside, in the Emergency Department (ED, a specialized area of a hospital that provides immediate medical care for very ill people), unattended by the healthcare personnel.

This deficient practice had the potential to jeopardize Patient 14's safety, by increasing the risk of medication error, accidental overdose, or misuse of medication left at the bedside, potentially leading to adverse health outcomes for Patient 14. (Refer to A-0144)

6. The facility failed to ensure that a call light device (a device that allows to alert staff when they need assistance), was placed within patient's reach, for one of 32 sampled patients (Patient 19), who was in the Emergency Department (ED), to ensure the patient (Patient 19) could use the call light device to call for help when needed, in accordance with the facility's fall risk protocol which required that a call light would be within a patient's reach. Patient 19 was identified as a fall risk.

This deficient practice had the potential for Patient 19 not receiving timely assistance and care, compromising Patient 19's safety and well-being by placing Patient 19 at risk for injury such as a fall (an event where a patient comes to rest inadvertently on the ground, floor, or other lower level, whether or not an injury occurs), which may result in complications such as fracture (broken bone), bleed, etc.). (Refer to A-0144)

7. The facility failed to ensure that a safe environment (free of sharp objects) was provided for one of 32 sampled patients (Patient 20) in the Emergency Department (ED), when multiple unused intravenous catheters (IV catheter- short tubes, containing needles, inserted into a vein to deliver medication or fluids) were left at Patient 20's bedside after an intravenous line (IV line, a method of delivering fluids and medications directly into the bloodstream through a vein) was started.

This deficient practice had the potential for Patient 20, staff, and other visitors' safety and well-being to be compromised due to an increased risk of accidental cuts or punctures caused by sharp objects kept/left at Patient 20's bedside. (Refer to A-0144)

8. The facility failed to ensure that two of two sampled clean utility rooms (Utility Rooms 2 and 3, designated areas in a healthcare facility that contain sterile medical supplies, equipment, medical instruments, sharps, and other materials necessary for patient care) and one of one sampled intravenous cart (IV [insertion of a needle into the vein] Cart, a mobile storage unit used to hold and transport intravenous supplies and medications needed for IV administration) parked in the hallway, and intended for use as needed for 145 of 145 sampled ED patients, were kept locked in the Emergency Department (ED), in accordance with the facility's practice of keeping medical supplies in a secured area.

This deficient practice had the potential to compromise safety of all patients (145 patients on 3/18/2025) in the Emergency Department (ED), by not ensuring a secure environment where unlocked access to IV carts and medical supplies could result in misuse and mishandling of medications and equipment, jeopardizing patients' safety and quality of care. (Refer to A-0144)

9. The facility failed to ensure nursing staff initiated a care plan (a document that outlines an individual's assessed needs and the specific support or care required to meet those needs, ensuring the right level of care is provided) for restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) use, in a timely manner, for one of 32 sampled patients (Patient 8), in accordance with the facility's policy and procedure regarding restraints, when Patient 8 was placed on bilateral (both) wrists restraints.

This deficient practice had the potential to result in lack of monitoring regarding restraints use and the potential for inappropriate or prolonged restraints use, which may result in complications such as skin breakdown (damage to the skin and underlying tissue), psychological distress, etc. (Refer to A-0166)

10. The facility failed to ensure one of 32 sampled patients (Patient 24), was monitored every 2 hours, for circulation (blood flow), mental status (includes mood and behavior), feeding or elimination needs, while on mitten restraints (soft glove-like device used to restrict a patient's movement), in accordance with the facility's policy regarding restraints use.

This deficient practice had the potential for circulation problems resulting in skin breakdown (damage to the skin and underlying tissues from prolonged pressure), swelling, or Patient 24's care needs not being met such as hydration (enough water) or hygiene needs. (Refer to A-0175)

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

Based on observation, interview and record review, the facility failed to ensure the Condition of Participation (CoP) for Quality Assessment and Performance Improvement (QAPI, a process by which hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital), was met, as evidenced by:

1. The facility's Quality Assessment and Performance Improvement (QAPI, a process by which hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital) committee, failed to properly gather and analyze information on the incorrect pathology reading for two of 32 sampled patients (Patient 1 and Patient 2), when Patient 1 and Patient 2's prostate core needle biopsy slides (a thin glass used to hold patient tissues or fluid for microscopic examination) were switched and resulted in incorrect pathology report and Patient 1's unnecessary surgery. The QAPI committee also failed to ensure there was a thorough investigation to identify the root cause of the incident and to implement an effective action plan to prevent future occurrence, in accordance with the facility's policy regarding QAPI.

This deficient practice resulted in the facility not having a standardized process developed for all pathologists (medical professionals who specialize in diagnosing diseases by examining tissue and fluid samples) regarding proper patient verification process, which may continue to lead to potential wrong reading of the pathology slides in the future resulting in patient harm such as unnecessary surgical procedures. (Refer to A-0286)

2. The facility's Quality Assessment and Performance Improvement (QAPI, a process by which hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital) committee, failed to communicate in a timely manner with the Governing Body (GB, responsible for guiding the hospital's long-term goals and policies, and assists with strategic planning and decision-making) the event regarding the incorrect pathology reading for two of 32 sampled patients (Patient 1 and Patient 2) when Patient 1 and Patient 2's prostate core needle biopsy slides were switched and resulted in incorrect pathology report and Patient 1's unnecessary surgery.

This deficient practice resulted in delay in notifying the GB members and in disseminating data collected relating to the incident, for GB to evaluate if there was an effective measure put in place in response to the incident, and to hold responsible committees accountable to prevent future occurrence of slide misidentification that may result in patient harm such as unnecessary surgical procedures. (Refer to A-0308)

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

Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation (CoP) for Nursing Services was met as evidenced by:

1. The facility failed to ensure its Registered Nurses (RN) supervised two of three sampled Certified Nursing Assistants (CNA 1 and CNA 2) in performing complete orthostatic vital signs (measurement of blood pressure and heart rate taken while a patient is lying down, sitting up and standing up) check and ensure that the orthostatic vital signs check was accurately done, for one of 32 sampled patients (Patient 10), in accordance with facility's policy and procedure regarding orthostatic vital signs.

This deficient practice had the potential to result in inaccurate vital signs reading to evaluate Patient 10's orthostatic hypotension (a form of low blood pressure that occurs when standing up from a sitting or lying down position. This can cause dizziness or lightheadedness and may result in fainting), which may result in delayed implementation of necessary interventions to address an identified orthostatic hypotension. (Refer to A-0395)

2. The facility failed to ensure one of 32 sampled patient's (Patient 12) individualized nursing care plan (a documented strategy that outlines patient care goals, interventions, and evaluations to address specific health issues and provides a means of communication among health care providers) to address Patient 12's newly identified skin injury, was initiated and updated, in accordance with the facility's policy and procedure regarding developing and implementing care plans.

This deficient practice had the potential for Patient 12's care needs and risks not properly addressed, which may result in delayed implementation of interventions to promote healing of the skin injury and prevent worsening of skin breakdown (damage to the skin and tissues due to prolonged pressure) that could lead to complications such as infection, etc.(Refer to A-0396)

3. The facility failed to ensure one of 32 sampled patients (Patient 1), who had undergone surgery just an hour earlier, and whose respiration rate dropped from 17 breaths per minute to 5 breaths per minute (Normal= 12 to 20 breaths per minute), was properly addressed, in accordance with physician's orders and the facility's policy and procedure regarding "Plan of Care/Assessment/Reassessment of Patients."

This deficient practice increased the risk of respiratory distress (a serious lung condition that causes low blood oxygen) for Patient 1 including delayed emergency response, and potential life-threatening complications such as multiple organ failure and/or death. (Refer to A-0398)

4. The facility failed to ensure one of 32 sampled patients (Patient 7), who was identified as a high fall (an event where a patient comes to rest inadvertently on the ground, floor, or other lower level, whether or not an injury occurs) risk, was properly supervised, in accordance with the facility's policy and procedure regarding "Adult Falls Prevention Policy." Patient 7 entered the bathroom with door closed while connected to an IV (Intravenous- through the vein) pump and an oxygen tank.

This deficient practice increased the risk of falls, entanglement with the medical equipment in a confined space, and delayed assistance in the event of an emergency, thus compromising Patient 7's safety. (Refer to A-0398)

5. The facility failed to ensure one of 32 sampled patient's (Patient 8) vital signs (includes blood pressure, temperature, respiration, and heart rate), were taken per physician's order, and in accordance with the facility's policy regarding obtaining vital signs.

This deficient practice had the potential to result in Patient 8's abnormal vital signs not being monitored properly, remain undetected, or the physician not notified of any changes in vital signs, which may lead to delayed implementation of necessary interventions resulting in complications such as hypotension (low blood pressure), etc. (Refer to A-0398)

6. The facility failed to ensure one of 32 sampled patient's (Patient 10) orthostatic vital signs (measurement of blood pressure and heart rate taken while a patient is lying down, sitting up and standing up) were monitored or checked as ordered by the physician, and in accordance with the facility's policy regarding vital signs check.

This deficient practice had the potential to result in Patient 10's abnormal vital signs going undetected, the physician not being notified for changes in vital signs, which may delay the implementation of necessary interventions to prevent complications such as hypotension (low blood pressure), etc. (Refer to A-0398)

7. The facility failed to ensure that nursing staff documented the peripherally inserted intravenous catheter (PIV, a thin flexible tube inserted into a vein for short-term intravenous access) for one of 32 sampled patients (Patient 20), in Patient 20's electronic medical record (EMR, digital version of paper chart), in accordance with the facility's policy regarding non-central venous access devices (catheters inserted into veins that are not located in the major veins near the heart, but rather in peripheral veins like those in the arms or legs).

This deficient practice had the potential for inadequate monitoring, assessment or intravenous (IV, through the vein) catheter care for patient 20, which may increase the risk of infection at the IV insertion site. (Refer to A-0398)

8. The facility failed to ensure one of 32 sampled patent's (Patient 16) tube feeding (nutritional support provided through a feeding tube directly into the stomach or small intestine), was labeled with the date, time and initials of the staff who initially hung the tube feeding container, in accordance with the facility's policies and procedures regarding tube feeding.

This deficient practice had the potential for compromising Patient 16's safety when using outdated feeding solutions, which can lead to contamination and subsequent infections. (Refer to A-0398)

9. The facility failed to ensure one of 32 sampled patient's (Patient 15) irrigation solution (a sterile fluid, like saline, used to cleanse wounds, body cavities, or surgical sites, removing debris and bacteria to promote healing and prevent infection) containing sterile (completely free from germs) water, was labeled with the date and time of when the sterile solution container was opened, in accordance with the facility's policy and procedure regarding safe medication practices.

This deficient practice had the potential to increase risk of contamination of the irrigation solution which could lead to infections including prolonged hospitalization for Patient 15. (Refer to A-0398)

10. The facility failed to ensure pain medications were given as ordered by the physician for three of 32 sampled patients (Patient 1, Patient 3, and Patient 21), in accordance with the facility's policy regarding medication administration.

This deficient practice had the potential for ineffective pain relief for the patients, which may result to worsening of pain, psychological distress, etc. (Refer to A-0405)

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

Based on observation, interview and record review, the facility failed to ensure that the Condition of Participation (CoP) for Medical Record Services was met as evidenced by:

1. The facility failed to ensure that for one of 32 sampled patients (Patient 3), the electronic medical records (eMR) contained a complete evaluation of respiratory function and pain level along with documentation of interventions and care provided [in response to those assessments], as ordered by physician.

This deficient practice had the potential for Patient 3's psychological and physiological needs not met due to inadequate documentation, potentially leading to delayed interventions and poorly monitored and managed respiratory status and pain level. (Refer to A-0449)

2. The facility failed to ensure that all entries in the medical records, such as physician progress notes, documented by resident physicians for one of 32 sampled patients (Patient 11), were countersigned by supervisory or attending medical staff members, in accordance with the facility's policies that address countersignature requirements.

This deficient practice had the potential for Patient 11 to experience lapses in care and oversight, leading to possible inaccuracies in medical records including incomplete or unauthenticated records that could adversely affect treatment decisions and Patient 11's care outcomes. (Refer to A-0450)

3. The facility failed to ensure that for one of 32 sampled patients (Patient 18), an informed consent (a written form that is signed by the patient, indicating that an informed consent discussion occurred between the physician and the patient, and the patient had the opportunity to ask questions and receive answers), for esophagogastroduodenoscopy (EGD, a medical a medical procedure, also known as an upper endoscopy, that uses a thin, flexible tube with a light and camera [endoscope] to visualize the lining of the esophagus, stomach, and the first part of the small intestine), was obtained and documented on the informed consent form, and retained as a part of the patient's [Patient 18] medical record.

This deficient practice resulted in lack of documentation of Patient 18's attestation that the informed consent discussion occurred with the physician and the patient (Patient 18), which had the potential to compromise Patient 18's right to make autonomous decisions about medical care when they [Patient 18] are not fully informed about the risks, benefits, and alternatives of the proposed treatment. (Refer to A-0466)

4. The facility failed to ensure that the medical records for three (3) of 32 sampled patients (Patient 8, Patient 10, Patient 12), contained the pertinent medical information documented and filed in the patients' medical charts so that the health care staff involved in the patients' care could access and retrieve the information to monitor the patients' condition when:

4.a. The nursing staff did not measure and document vital signs (measurements of the body's most basic function including body temperature, heart rate, blood pressure, respirations and pain level) check for Patient 8 and Patient 10, as per physician order, and in accordance with the facility's policy and procedure regarding vital signs checks.

This deficient practice had the potential for the staff and the physician's inability to monitor and determine a change in Patient 8's and Patient 10's condition, which may result in a delay in the implementation of necessary interventions including obtaining orders in a timely manner from the physician. (Refer to A-0467)

4.b. Patient 12 did not have a documented individualized nursing care plan (a detailed, individualized plan outlining the medical, nursing, and other interventions needed during a patient's stay in a hospital or other inpatient facility, aiming to achieve specific health goals and ensure safe and effective care) to assess, manage, and monitor newly identified skin injuries(wounds), in accordance with the facility's policy regarding care planning.

This deficient practice had the potential for Patient 12's specific goals and interventions tailored to Patient 12's skin needs not to be implemented by all healthcare staff involved in the patient's care, compromising Patient 12's effectiveness of care and health condition monitoring. (Refer to A-0467)

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

Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation (CoP) for Laboratory Services was met as evidenced by:

1. The facility failed to ensure two of five sampled patients (Patient 1 and Patient 2 [who did not receive treatment at the facility), received accurate test results for prostate cancer (a disease where abnormal cells grow in the prostate [a small gland in the male reproductive system that helps produce semen]).

This deficient practice caused Patient 1 to be misdiagnosed with prostate cancer (false positive result) and undergo an unnecessary radical proctectomy (a surgery to completely remove the prostate gland and surrounding tissues to treat prostate cancer). Patient 2, who had prostate cancer, was incorrectly informed of his results (that he was negative for prostate cancer), which delayed the treatment he (Patient 2) needed.
This deficient practice to properly verify patient information also created a risk of other patients getting the wrong diagnosis and possibly receiving the wrong treatment. (Refer to A-0585)

2.The facility failed to Ensure that proper verification of patient identification was conducted before affixing a new label to one of five sampled patients' specimen (a sample of biological material, like blood, tissue, or fluid, collected for laboratory analysis) container (Patient 6). The new label was the patient identification number assigned by the Pathology Department CoPath computer System (a Laboratory Information System [LIS], designed specifically for anatomic [the structure or body of a living thing] pathology laboratories, supporting automation of processing of prehensive computer system) which serves as the permanent identification for the specimen.

This deficient practice increases the risk of mislabeling specimens, incorrect diagnoses, and potential delays in treatment. (Refer to A-0585)

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

Based on observation, interviews, and record review, the facility failed to follow its own policy and procedure titled "HIPAA (Health Insurance Portability and Accountability Act- Federal law that protects patient privacy) Authorization," as well as applicable state and federal laws during a survey investigation. The hospital did not allow surveyors (government inspector who evaluate hospital safety and quality) to take photos of observed concerns and later refused to provide original photos that were taken by staff at the request of the surveyor. The facility submitted altered (changed) and staged (recreated) photos instead. One key photo that was showing the hand of the Director of Laboratory/Chief of Service Pathology (DIR 1) holding a specimen over a cart to document a labeling concern was never provided.

This deficient practice prevented the survey team from verifying observed problems related to specimen labeling and patient identification. This deficient practice interfered with federal oversight process and compromised patient safety by interfering with efforts to confirm and correct labeling errors. Such errors could result in a patient receiving an incorrect diagnosis or treatment.

Findings:

During a concurrent observation and interview on 3/18/2025 at 1:05 p.m. with the Director of Pathology Lab (DIR 1) in the facility's grossing (a laboratory station where tissue samples are prepared for examination), more than 60 specimen containers (plastic jars containing tissue samples from patients) were observed on a cart. Newly printed labels (stickers that include a case number [an assigned identification number which will follow the specimen throughout the steps of tissue processing] assigned by the lab) and requisitions (written orders from healthcare providers requesting laboratory testing) were folded in half and laying on top of specimens' containers.

During the same observation on 3/18/2025 at 1:05 p.m., the Pathology Laboratory Supervisor (SS) 1 was observed applying new labels (a sticker created by the lab to give the specimen a permanent identity number) directly on the specimen containers without checking the corresponding requisition forms. The requisition remained folded and were not used to verify patient identity before labeling.

During the same observation and interview on 3/18/2025 at 1:05 p.m. with the Director of Pathology Lab (DIR 1), it was observed that the original labels on the specimen containers, submitted by the originating facility, included only the patient's name and tissue type. These labels did not include the date of birth (DOB) or medical record number (MRN). The new labels, created by the facility's pathology lab, included the patient 's name, MRN, new case number, collection date, accession date (the date a specimen is received, logged, and assigned and identifier), and type of procedure. DIR 1 confirmed that the only matching information between the original and new labels was the patient's name and tissue type, information that could be identical for more than one patient. DIR 1 stated, "I see how this could be a mix-up if two patients have the same name."

During the same observation on 3/18/2025 at 1:10 p.m., because surveyors were not permitted to take photographs, the surveyor requested that a photo be taken of the specimen over the cart while DIR 1 held the specimen to document the folded requisitions and observed labeling practice. That photo was never provided.

During a concurrent interview and record review on 3/18/2025 at 3:40 p.m. with the Assistant Administrator of Quality Services (AAQ), AAQ stated the facility could not provide the original photos due to HIPPA (federal law that protects patient privacy). Instead, AAQ provided three re-enacted photos (photos that were taken after the fact to look like the originals with grey shading over the labeled).

During an interview on 3/19/205 at 9:33 a.m. with the Assistant Administrator of Quality Services (AAQ) , AAQ stated the photos taken at the accession was taken by a staff that used their personal phone to take the photo, and the other photo in which DIR 1 held the specimen was not included, because the facility did not know who took it. AAQ stated, "We retook the photos for you."

During a review of the facility's policy and procedure (P&P) titled, "HIPAA (Health Insurance Portability and Accountability Act- Federal law that protects patient privacy) Authorization," dated 8/29/2024, the P&P indicated, "Exceptions to HIPAA Authorization Requirement. A HIPAA authorization is not required for the following uses and disclosures: Health oversight agencies for health oversight activities; When necessary to cooperate with law enforcement, subject to applicable [name of the facility] procedures (for additional state-specific information."

During a review of the State Regulation 42 CFR 489.53 (a)(13) (Amended May 12, 1997; last revised February 21, 2024): "CMS may terminate a provider agreement if a hospital refuses to permit photocopying of any records or other information necessary to determine or verify compliance with participation requirements." [Federal Register Vol.62, No.91]

During a review of the State Regulation 42 CFR 1001.1301(Effective July 12, 2002; last revised February 21, 2024): "The Office of Inspector General (OIG) may exclude a provider from federal programs for refusing access to records or facilities." [Federal Register Vol.67, No.137]

During a review of the State Regulation California Health and safety Code 1280 (Originally enacted 1973; most recent amended January 1, 2020): "Facilities are required to comply with both state and federal survey and inspection requirements."

Based on observation, interview, and record review, the facility's Governing Body (the leadership group legally responsible for the facility operations and patient safety) failed to ensure compliance with Federal, State, and the facility's policy and procedure for two of five sampled patients (Patient 1 and Patient 2) when:

1. The Governing Body failed to ensure the facility's Pathology Department ensured pathologists (a healthcare provider who looks at bodies and body tissues) consistently followed the facility's policy and procedure for verifying patient identity and specimen before reviewing pathology slides (a thin glass used to hold patient tissues or fluid for microscopic examination).

This deficient practice resulted in Patient 1 undergoing an unnecessary proctectomy (surgery to remove the prostate gland) due to a misdiagnosis and a delayed cancer diagnosis or prognosis for Patient 2 (Patient 2 did not receive treatment at the facility). The deficient practice also had the potential to result in continued diagnostic errors affecting patient misidentification of specimens causing patient harm.

2. The Governing Body failed to ensure the facility complied with Federal and State regulatory requirements for timely and complete access to records during a health oversight survey (review conducted by regulatory or licensing bodies).

This deficient practice resulted in delayed or altered access to essential evidence related to patient safety incidents and had the potential to impede regulatory oversight and delay corrective action for system deficiencies.

3. The Governing Body failed to ensure the Pathology Department ensured its Pathology department staff consistently followed the facility's labeling and verification policies to prevent specimen misidentification.

This deficient practice resulted in inconsistent specimen handling practices and had the potential to cause additional patient harm through mislabeled diagnostic materials.

Findings:

1. During a review of Patient 1's "Pre- Op (Pre-operative) History and Physical Exam (H&P, a formal and complete assessment of the patient and the problem)," dated 7/31/2024, the "H&P" indicated, Patient 1 had prostate-specific antigen (PSA, a protein produced by the prostate gland that can be measured in a blood test) of 3.8 on 5/20/2024. In the past, Patient 1 had no prior work-up for an elevated PSA. Previous urology (a branch of medicine that focus on the function and disorders of the urinary system) history: no hematuria (the presence of blood in urine), no recurrent urinary tract infection (an infection of the urinary system). The H&P further indicated test result for transrectal ultrasound-guided prostate biopsy (TRUSP, a procedure used to obtain tissue samples from the prostate gland) indicated six areas of the prostate was biopsied, the six areas were categorized by letters: A, B, C, D, and F. All areas had a negative result for cancer except the area labeled F, which indicated, "F ...Prostatic adenocarcinoma (cancer of the prostate). The H&P indicated, "We have had an opportunity to meet at length to discuss his (Patient 1) prostate cancer and the available options, and he (Patient 1) has decided to go forth with robot-assisted laparoscopic radical prostatectomy (a minimally invasive surgery to remove the entire prostate gland and some surrounding tissue, using a robotic system). He (Patient 1) understands that he will need a Foley catheter (a thin, flexible tube inserted into the bladder to drain urine) for 1-2 weeks following the operation, and that he (Patient 1) will have a surgical drain (a tube inserted after surgery to remove excess fluids) as well."

During a review of Patient 1's "Urology (a medical specialty that focuses on the diagnosis, treatment, and prevention of disorders related to the urinary tract and male reproductive system) Service" operative note, dated 7/31/2024, the operative note indicated, Patient 1 "...With prostate cancer. After reviewing all options with the patient (Patient 1), we decided to go forth with robot-assisted laparoscopic radical prostatectomy ... The patient (Patient 1) tolerated the procedure well, was awaken from anesthesia (medicines to prevent pain during surgery and other procedures), and transferred to recovery room in stable condition."

During an interview on 3/18/2025 at 11:58 a.m. with the Director of Laboratory Services (DIR) 4, DIR 4 stated the incident of misdiagnoses occurred due to the two patients' (Patient 1 and Patient 2) slide (hold and display specimens for observation) that should have been on the same deck (flat, binders used to hold slides), "but the slides ended up on both deck, but the pathologist should have caught it and the urology (team) should have caught it."

During an interview on 3/18/2025 at 11:58 a.m. with the Director of laboratory Services (DIR) 4, DIR 4 confirmed the slides (Pathology slides- thin, rectangular glass plates used to hold and display specimens for microscopic examination) were placed in incorrect flats (binders used to hold slides), but stated the error should have been caught by the pathologist.

During an interview on 3/18/2025 at 12:47 p.m. with Pathologist (PA 3), PA 3 stated he (PA 3) used a barcode scanner (a device used to scan a bar code that automatically enters patient information and other critical data into electronic health records [EHR, digital version of patient chart]) to scan the slide to verify patient identity.

During an observation on 3/18/2025 at 2:11 p.m. Pathologist (PA) 4 was observed using the requisition form but not scanning slides for identification.

During an interview on 3/19/2025 at 1:42 p.m. with the Director of Laboratory (DIR 1), DIR 1 stated that slides (thin, rectangular glass plates used to hold and display specimens for microscopic examination) for Patient 1 and Patient 2 were received from the regional laboratory. One slide from each patient (Patient 1 and Patient 2) was accidentally switched. Patient 1's pathology report included slide F2 from Patient 2, resulting in a false cancer diagnosis. DIR 1 stated Pathologist (PA) 1 read and documented the incorrect slide (F2) in Patient 1's report, and PA 2 read and documented slide F1 in Patient 2's report.

During an interview on 3/19/2025 at 2:54 p.m. with Pathologist (PA 2), PA 2 stated he (PA 2) did not have a working barcode scanner and instead used a worklist. He (PA 2) did not notice that slide F1 (belonging to Patient 1) was misassigned in the set.

During an interview on 3/21/2025 at 2:15 p.m. with the Physician Director of Quality (PDQ), the PDQ stated the Governing Body had the responsibility to follow-up with the lower committees to ensure appropriate actions were taken.

During a review of the facility's policy and procedure (P&P) titled, "Hospital Quality and Patient Safety Program Description Annual Work Plan Evaluation," dated 5/28/2024, the P&P indicated "The Board of Directors of [name of the facility], the governing body, through its Quality and Health Improvement Committee ("QHIC"), oversees each hospital's Quality and Patient Safety Program ("Program"). The QHIC assures each hospital's executive and Professional Staff leadership develops the hospital's program consistent with the hospital's mission, vision and values. The hospital leadership is accountable to the QHIC to assure the planning and implementation, including establishing priorities for the Quality and Patient Safety Program with respect to the delivery of existing services and the implementation of new hospital services ... The Patient Safety and Risk Management Committees strive to reduce risk, improve patient safety and quality outcomes in the delivery of health services across all settings of care. These two committees work in tandem to monitor the effectiveness of the corrective actions taken in response to an adverse or sentinel event to ensure that the risk reduction strategies achieve the expected results."

During a review of the facility's policy and procedure (P&P) titled, "Specimen Collection Manual for Pathology," dated 11/19/2024, the P&P indicated "Accurate patient and specimen identification. Verify Patient Information: Generate electronic labels in (name of the facility's electronic system).
1.Verify that the name and MRN on the label match the name and MRN in (name of the facility's electronic system).
2.If the name is different, verify with picture ID and another patient identifier such as DOB, address, etc.
3.KPHC surgical pathology orders and specimen label must include the patient's name, MRN, source and site/side (if applicable).
4.KPHC surgical pathology orders must include pertinent clinical patient information.
Specimen Container Labeling:
1.Patient's name and MRN
2.Date and time
3.Source of specimen
4.Use an alpha letter to indicate which specimen it is, e.g., A, B, C, etc.
5.The label is placed on the SIDE OF CONTAINER. DO NOT PUT ANY LABELS ON LID.
6.The lid of the container must be tightly closed.
7.The biohazard zip lock bag has one pocket for the surgical pathology order and another pocket for the specimen container.
8.Perform a visual check of the specimen in the container and ensure the label matches the patient's name before the patient leaves the procedure room

During a review of the facility's policy and procedure (P&P) titled, "Specimen Identification Integrity," dated 3/12/2025, the P&P indicated "The integrity of patient specimen identification shall be maintained through all phases of processing of tissues and issuing of Pathology Reports. Routine checks shall be made throughout the steps of tissue processing to assure identification integrity ... The pathologist checks the surgical number of the specimen requisition against the number of the slide at the time of first looking at the slide under the microscope. He utilizes the same number when dictating or by typing the diagnoses."

2. During a concurrent observation and interview on 3/18/2025 at 1:05 p.m. with the Director of Pathology Lab (DIR 1) in the facility's grossing station (a laboratory station where tissue samples are prepared for examination), more than 60 specimen containers (plastic jars containing tissue samples from patients) were observed on a cart. Newly printed labels (stickers that include a case number [an assigned identification number which will follow the specimen throughout the steps of tissue processing] assigned by the lab) and requisitions (written orders from healthcare providers requesting laboratory testing) were folded in half and laying on top of specimens' containers.

During the same observation on 3/18/2025 at 1:05 p.m., the Pathology Laboratory Supervisor (SS) 1 was observed applying new labels (a sticker created by the lab to give the specimen a permanent identity number) directly on the specimen containers without checking the corresponding requisition forms. The requisition remained folded and were not used to verify patient identity before labeling.

During the same observation and interview on 3/18/2025 at 1:05 p.m. with the Director of Pathology Lab (DIR 1), it was observed that the original labels on the specimen containers, submitted by the originating facility, included only the patient's name and tissue type. These labels did not include the date of birth (DOB) or medical record number (MRN). The new labels, created by the facility's pathology lab, included the patient 's name, MRN, new case number, collection date, accession date (the date a specimen is received, logged, and assigned and identifier), and type of procedure. DIR 1 confirmed that the only matching information between the original and new labels was the patient's name and tissue type, information that could be identical for more than one patient. DIR 1 stated, "I see how this could be a mix-up if two patients have the same name."
During the same observation on 3/18/2025 at 1:10 p.m., because surveyors were not permitted to take photographs, the surveyor requested that a photo be taken of the specimen over the cart while DIR 1 held the specimen to document the folded requisitions and observed labeling practice. That photo was never provided.
During a concurrent interview and record review on 3/18/2025 at 3:40 p.m. with the Assistant Administrator of Quality Services (AAQ), AAQ stated the facility could not provide original photos taken during the survey due to HIPPA (Health Insurance Portability and Accountability Act- Federal law that protects patient privacy). Instead, altered and re-enacted (photos that were taken after the fact to look like the originals with grey shading over the labeled) photos were submitted, with key photo not provided.

During an interview on 3/19/205 at 9:33 a.m. with the Assistant Administrator of Quality Services (AAQ), AAQ stated the photos taken at the accession was taken by a staff that used their personal phone to take the photo, and the other photo in which DIR 1 held the specimen was not included,

During a review of the facility's policy and procedure (P&P) titled, "HIPAA Authorization," dated 8/29/2024, the P&P indicated, "Exceptions to HIPAA Authorization Requirement. A HIPAA authorization is not required for the following uses and disclosures: Health oversight agencies for health oversight activities; When necessary to cooperate with law enforcement, subject to applicable KP procedures (for additional state-specific information."

During a review of the State Regulation 42 CFR 489.53 (a)(13) (Amended May 12, 1997; last revised February 21, 2024): "CMS may terminate a provider agreement if a hospital refuses to permit photocopying of any records or other information necessary to determine or verify compliance with participation requirements." [Federal Register Vol.62, No.91]

During a review of the State Regulation 42 CFR 1001.1301(Effective July 12,2002; last revised February 21, 2024): "The Office of Inspector General (OIG) may exclude a provider from federal programs for refusing access to records or facilities." [Federal Register Vol.67, No.137]

During a review of the State Regulation California Health and safety Code 1280 (Originally enacted 1973; most recent amended January 1, 2020): "Facilities are required to comply with both state and federal survey and inspection requirements."

3. During an observation on 3/18/2025 at 1:05 p.m., more than 60 specimen containers were observed on a cart. Pathology supervisor (SS)1 was seen labeling specimens without checking the requisition forms (written orders form healthcare providers requesting laboratory testing). The form was folded and not reviewed.

During an interview on 3/21/2025 at 2:30 p.m. with the Director of Laboratory/Chief of Service Pathology (DIR 1), DIR 1 stated that the correct verification process required the person labeling the specimen to compare three elements: (1) The original specimen label, (2) the new label, and (3) the requisition form, also called "tissue card," to ensure proper patient identification. However, this verification process was not observed during the labeling process. SS 1 stated that mislabeling can occur if all three elements of the verification process were not reviewed before placing the final label on the specimen containers.

During an interview on 3/21/2025 at 4:27 p.m. with the Assistant Administrator of Quality Services (AAQ), AAQ stated the event (involving Patient 1 and Patient 2 whose pathology slides were mixed-up) was considered an individual error, and no system-wide process change was made. AAQ further stated the focus would be on reviewing charts to ensure future compliance, rather than implementing standardized process controls.

During an interview on 3/19/2025 at 1:42 p.m. with the Director of Laboratory (DIR 1), DIR 1 stated that pathology slides (thin, rectangular glass plates used to hold and display specimens for microscopic examination) for Patient 1 and Patient 2 were received from the regional laboratory. One slide from each patient (Patient 1 and Patient 2) was accidentally switched. Patient 1's pathology report included slide F2 from Patient 2, resulting in a false cancer diagnosis. DIR 1 stated Pathologist (PA) 1 read and documented the incorrect slide (F2) in Patient 1's report, and PA 2 read and documented slide F1 in Patient 2's report.

During an interview on 3/21/2025 at 2:15 p.m. with the Physician Director of Quality (PDQ), the PDQ stated the Governing Body had the responsibility to follow-up with the lower committees to ensure appropriate actions were taken.

During a review of the facility's policy and procedure (P&P) titled, "Hospital Quality and Patient Safety Program Description Annual Work Plan Evaluation," dated 5/28/2024, the P&P indicated "The Board of Directors of [name of the facility], the governing body, through its Quality and Health Improvement Committee ("QHIC"), oversees each hospital's Quality and Patient Safety Program ("Program"). The QHIC assures each hospital's executive and Professional Staff leadership develops the hospital's program consistent with the hospital's mission, vision and values. The hospital leadership is accountable to the QHIC to assure the planning and implementation, including establishing priorities for the Quality and Patient Safety Program ... The Patient Safety and Risk Management Committees strive to reduce risk, improve patient safety and quality outcomes in the delivery of health services across all settings of care...The purpose of this Plan is to provide the mechanism for improving hospital quality and safety and to ensure that [the facility] ... demonstrate a consistent and collaborative approach to deliver safe, effective, efficient, equitable, patient centered, and timely care within a quality assurance and performance improvement (QAPI) framework ... This plan informs the improvement processes for patient outcomes, reducing and preventing medical errors, and applying remediation strategies in response to system or process failures."

During a review of the facility's policy and procedure (P&P) titled, "Specimen Collection Manual for Pathology," dated 11/19/2024, the P&P indicated "Accurate patient and specimen identification. Verify Patient Information: Generate electronic labels in (name of the facility's electronic system).
1.Verify that the name and MRN on the label match the name and MRN in (name of the facility's electronic system).
2.If the name is different, verify with picture ID and another patient identifier such as DOB, address, etc.
3.KPHC surgical pathology orders and specimen label must include the patient's name, MRN, source and site/side (if applicable).
4.KPHC surgical pathology orders must include pertinent clinical patient information.
Specimen Container Labeling:
1.Patient's name and MRN
2.Date and time
3.Source of specimen
4.Use an alpha letter to indicate which specimen it is, e.g., A, B, C, etc.
5.The label is placed on the SIDE OF CONTAINER. DO NOT PUT ANY LABELS ON LID.
6.The lid of the container must be tightly closed.
7.The biohazard zip lock bag has one pocket for the surgical pathology order and another pocket for the specimen container.
8.Perform a visual check of the specimen in the container and ensure the label matches the patient's name before the patient leaves the procedure room

During a review of the facility's policy and procedure (P&P) titled, "Specimen Identification Integrity," dated 3/12/2025, the P&P indicated "The integrity of patient specimen identification shall be maintained through all phases of processing of tissues and issuing of Pathology Reports. Routine checks shall be made throughout the steps of tissue processing to assure identification integrity ... The pathologist checks the surgical number of the specimen requisition against the number of the slide at the time of first looking at the slide under the microscope. He utilizes the same number when dictating or by typing the diagnoses."

Based on observation, interview and record review, the facility failed to ensure admitting staff obtained a consent (for treatment) from and to provide information to the appropriate patient's representative for one of 32 sampled patients (Patient 8), when the facility's admitting staff did not inform Patient 8's Durable Power of Attorney (DPOA, an agent appointed by the patient to act on his/her behalf when unable to make medical decision) about the Condition of Admission (COA, a contract between the hospital and patient regarding treatment, payment for services rendered by the facility, etc.), Medicare Outpatient Observation Notice (MOON, given to all Medicare [Federal health insurance for people at a certain age or with specific medical disabilities] beneficiaries, informing that they are outpatients receiving observation services and are not inpatients of a hospital) and the Important Message from Medicare (IMM, given to all Medicare [Federal health insurance for people at a certain age or with specific medical disabilities] beneficiaries, notifying them of their hospital discharge appeal rights), in accordance with the facility's policies regarding patient care related decision-making involving designated Patient care representative or DPOA.

This deficient practice resulted in Patient 8's DPOA not being given the opportunity to provide consent for the facility to treat Patient 8 upon admission, and not knowing their rights including billing, release of information, and financial responsibility during hospitalization.

Findings:

During a concurrent observation and interview on 3/18/2025 at 2:15 p.m. with Registered Nurse (RN) 4 in Patient 8's room, Patient 8 was in bed with bilateral (both) wrist restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body). RN 4 stated Patient 8 had dementia (a condition characterized by progressive or persistent loss of intellectual functioning) and unsteady gait (difficulty walking in a smooth, coordinated manner, resulting in imbalance, wobbling, or an increased risk of falling). RN 4 also stated Patient 8 had been agitated (a feeling of severe restlessness or uneasiness) and trying to get out of bed.

During a review of Patient 8's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 3/18/2025, the H&P indicated, Patient 8 was admitted to the facility with diagnoses including but not limited to encephalopathy (a broad term for any brain disease that alters brain function or structure), major depressive disorder (MDD, a mental health disorder characterized by persistently depressed mood or loss of interest in activities, causing significant impairment in daily life), delusional disorder (a mental health condition characterized by persistent false beliefs that are not based on reality), and major neurocognitive disorder (a group of condition that affect a person's abilities of memory, attention, reasoning and problem-solving) due to dementia. The H&P also indicated, Patient 8 did not have decision making capacity (an individual's ability to understand, appreciate and rationally weigh the consequences of a decision, and to communicate and express their choice effectively).

During a concurrent interview and record review on 3/20/2025 at 10:49 a.m. with the Registered Nurse Quality Consultant (QC) 6, Patient 8's Advance Health Care Directive (Advance Directive, written statement of a person's wishes regarding medical treatment made to ensure those wishes are carried out should the person be unable to communicate them to a doctor), dated 12/28/2020, was reviewed. The Advance Directive indicated, "Part 1: Power of Attorney For Health Care ... Designation of agent: I designated the following individuals as co-agents to make health care decisions for me. My co-agents may act separately: (Name 1 [Agent 1]) and (Name 2 [Agent 2])." QC 6 stated Patient 8's Advance Directive was scanned to Patient 8's medical record on 2/5/2024. QC 6 also stated based on Patient 8's Advance Directive, Agent 1 and Agent 2 were Patient 8's DPOA (Durable Power of Attorney- an agent appointed by the patient to act on his/her behalf when unable to make medical decision).

During a concurrent interview and record review on 3/20/2025 at 1:40 p.m. with the Manager of Admitting Department (MAD), Patient 8's "Hospital Condition of Admission (COA, a contract between the hospital and patient regarding treatment, payment for services rendered by the facility, etc.)," "Medicare Outpatient Observation Notice (MOON, given to all Medicare [Federal health insurance for people at a certain age or with specific medical disabilities] beneficiaries, informing that they are outpatients receiving observation services and are not inpatients of a hospital)," and "Important Message from Medicare (IMM, given to all Medicare [Federal health insurance for people at a certain age or with specific medical disabilities] beneficiaries, notifying them of their hospital discharge appeal rights)," dated 3/18/2025, were reviewed. The "Hospital Condition of Admission," "Medicare Outpatient Observation Notice," and "Important Message from Medicare," indicated, all three documents were verbally consented by Patient 8's relative (FM 1). MAD stated admitting staff should contact Agent 1 and Agent 2 instead of FM 1 because Agent 1 and Agent 2 were the appointed DPOA by Patient 8.

During a review of Patient 8's "Hospital Condition of Admission (COA)," dated 3/18/2025, the COA indicated, "This agreement contains the terms and condition related to your treatment by [the facility] and the [Medical Group] ... 1. Consent to Medical Care ... 2. Consent to Telehealth (the use of electronic information and telecommunications technologies to provide healthcare services remotely) ... 3. Educational Consent ... 4. Consent to Photos ... 7. Assignment of Benefits ... 8. Authorized Representative ... 9. Liability for Cost Share ... 10. Direct Payment ... 11. Liability for Non-Covered Services ... 12. Collection Costs ... 14. Release of Information ... 16. Discharge Agreement."

During an interview on 3/21/2025 at 9:07 a.m. with the Director of Accreditation, Regulatory and Licensing (DARL), DARL stated the facility did not have a policy and procedure for condition of admission.

During a review of the facility's policy and procedure (P&P) titled, "The Selection of Health Care Surrogates," dated 5/2023, the P&P indicated, "[Name of the facility] promotes shared health care decision for patient, including those without decision making capacity, and who lack a legally recognized health care decision maker. A procedural approach guides professionals to select a surrogate most likely to represent the patients' values and health care treatment preferences and honors shared decision making ... The Selection of a Decision-Maker for an Adult Patient without Decision Making Capacity ... Decision-Making Priority for Patients without Decision-Making Capacity with a legally recognized health care decision maker (LRHCDM). If an adult patient lacks the capacity to make health care decisions, the following LRHCDMs may make decisions on the patient's behalf in the following descending order: ... the patient's agent under a health care directive or power of attorney for health care ... the conservator or guardian of the patient who has the authority to make health care decisions for the patient."

During a review of the facility's policy and procedure (P&P) titled, "Issuance of 'Important Message from Medicare' and Detailed Notice of Discharge," dated 1/2024, the P&P indicated, "the 'Important Message (IM) from Medicare' will be provided to a Medicare beneficiary who is a Hospital Inpatient to inform her/him of the right to an expedited review by a Quality Improvement Organization (QIO) when the beneficiary is in disagreement with a discharge decision ... Delivery process: ... if a beneficiary does not have decision making capacity the IM from Medicare must be delivered to and signed by the beneficiary's authorized representative."

During a review of the facility's policy and procedure (P&P) titled, "Advance Directives (Advance Health Care Directives)," dated 3/2025, the P&P indicated, "[the facility] supports an adult patient's right to participate in their health care decisions, will honor a patient's right to formulate, review and revise their Advance Health Care Directive (AHCD), and will comply with these directives within professional standards of practice."

Based on observation, interview and record review, the facility failed to ensure nursing staff involved the appropriate patient's representative when developing and reviewing plan of care (a document that outlines an individual's assessed needs and the specific support or care required to meet those needs, ensuring the right level of care is provided) for one of 32 sampled patients (Patient 8), in accordance with the facility's policy and procedure regarding plan of care.

This deficient practice resulted in Patient 8's appointed agent not being able to participate in developing and reviewing care plan and participate in setting treatment goals for Patient 8, which may negatively affect the care plan goal for Patient 8 leading to delayed recovery from healthcare condition.

Findings:

During a concurrent observation and interview on 3/18/2025 at 2:15 p.m. with Registered Nurse (RN) 4 in Patient 8's room, Patient 8 was in bed with bilateral (both) wrist restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body). RN 4 stated Patient 8 had dementia (a condition characterized by progressive or persistent loss of intellectual functioning) and unsteady gait (difficulty walking in a smooth, coordinated manner, resulting in imbalance, wobbling, or an increased risk of falling). RN 4 also stated Patient 8 had been agitated (a feeling of severe restlessness or uneasiness). RN 4 also stated Patient 8 had been agitated (a feeling of severe restlessness or uneasiness) and trying to get out of bed.

During a review of Patient 8's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 3/18/2025, the H&P indicated, Patient 8 was admitted to the facility with diagnoses including but not limited to encephalopathy (a broad term for any brain disease that alters brain function or structure), major depressive disorder (MDD, a mental health disorder characterized by persistently depressed mood or loss of interest in activities, causing significant impairment in daily life), delusional disorder (a mental health condition characterized by persistent false beliefs that are not based on reality), and major neurocognitive disorder (a group of condition that affect a person's abilities of memory, attention, reasoning and problem-solving) due to dementia. The H&P also indicated, Patient 8 did not have decision making capacity (an individual's ability to understand, appreciate and rationally weigh the consequences of a decision, and to communicate and express their choice effectively).

During a concurrent interview and record review on 3/21/2025 at 10:41 a.m. with the Charge Nurse (CN) 5 of Medical-Surgical (Med-Surg, general patient population hospitalized for various causes such as illness and surgery)/Telemetry (a floor in the hospital where patients receive continuous cardiac [heart] monitoring) Unit, Patient 8's Advance Health Care Directive (Advance Directive, written statement of a person's wishes regarding medical treatment made to ensure those wishes are carried out should the person be unable to communicate them to a doctor), dated 12/28/2020, was reviewed. The Advance Directive indicated, "Part 1: Power of Attorney For Health Care ... Designation of agent: I designated the following individuals as co-agents to make health care decisions for me. My co-agents may act separately: (Name 1 [Agent 1]) and (Name 2 [Agent 2])." CN 5 stated Agent 1 and Agent 2 listed on the Advance Directive were Patient 8's DPOA (Durable Power of Attorney- an agent appointed by the patient to act on his/her behalf when unable to make medical decision).

During a concurrent interview and record review on 3/21/2025 at 10:42 a.m. with Charge Nurse (CN) 5, Patient 8's medical record titled, "Shift Medical-Surgical Flowsheet (the flowsheet, designed to efficiently record and monitor various patient assessments and measurements in a consolidated format)," dated 3/18/2025, was reviewed. The flowsheet indicated, "Patient's Daily Goal ... Patient/Family-Specific Goals: Per (Patient 8's family member [FM 1], medicate patient (Patient 8) ... Plan of Care reviewed with family, FM 1, contacted via phone call." CN 5 stated the following: nursing staff should develop plan of care upon admission and involve patient/family when developing plan of care. The purpose of discussing plan of care with patient/family was to know what patient/family want for the goal and adjust the care plan depending on the set goal. Nursing staff should involve Patient 8's DPOA (Agent 1 and Agent 2) instead of FM 1 because the DPOA were the legal appointed agents appointed by Patient 8. They (Agent 1 and Agent 2) were in charge of Patient 8 and they (Agent 1 and Agent 2) should be the main contact person.

During a review of Patient 8's "Multi-Discipline Progress Notes (nurses notes)," dated 3/19/2025, the nurses notes indicated, "spoke with (Name [Agent 1]) DPOA regarding the transfer information and verbalizing understanding. Per (Name [Agent 1]), not to call or inform the [family member [FM 1]) about the transfer ..."

During a review of the facility's policy and procedure (P&P) titled, "The Selection of Health Care Surrogates," dated 5/2023, the P&P indicated, "[the facility] promotes shared health care decision for patient, including those without decision making capacity, and who lack a legally recognized health care decision maker. A procedural approach guides professionals to select a surrogate most likely to represent the patients' values and health care treatment preferences and honors shared decision making ... The Selection of a Decision-Maker for an Adult Patient without Decision Making Capacity ... Decision-Making Priority for Patients without Decision-Making Capacity with a legally recognized health care decision maker (LRHCDM). If an adult patient lacks the capacity to make health care decisions, the following LRHCDMs may make decisions on the patient's behalf in the following descending order: ... the patient's agent under a health care directive or power of attorney for health care ... the conservator or guardian of the patient who has the authority to make health care decisions for the patient."

During a review of the facility's policy and procedure (P&P) titled, "Advance Directives (Advance Health Care Directives)," dated 3/2025, the P&P indicated, "[the facility] supports an adult patient's right to participate in their health care decisions, will honor a patient's right to formulate, review and revise their Advance Health Care Directive (AHCD), and will comply with these directives within professional standards of practice."

During a review of the facility's policy and procedure (P&P) titled, "Plan of Care/Assessment/Reassessment of Patient," dated 1/2022, the P&P indicated, "Each patient's plan of care, treatment and services is individualized and appropriate to the patient's needs, strengths, limitations and goals. Planning for care, treatment, and services includes ... involving patients and/or families in care planning."

Based on observation, interview and record review, the facility failed to ensure the facility's staff executed the Advance Health Care Directive (written statement of a person's wishes regarding medical treatment made to ensure those wishes are carried out should the person be unable to communicate them to a doctor) and identify the appropriate Durable Power of Attorney (DPOA, an agent appointed by the patient to act on his/her behalf when unable to make medical decision) for one of 32 sample patients (Patient 8), in accordance with the facility's policy and procedure regarding advance health care directives.

This deficient practice violated Patient 8's rights regarding involvement of DPOA and resulted in an incorrect person being notified of Patient 8's treatment plan, and with Patient 8's DPOA not given the opportunity to provide consent for treatment, to ask questions regarding treatment options and be involved in the development of the plan of care for Patient 8 during Patient 8's hospitalization.
This deficient practice may also delay the implementation of Patient 8's treatment plan and results in prolonged hospitalization.

Findings:

During a concurrent observation and interview on 3/18/2025 at 2:15 p.m. with Registered Nurse (RN) 4 in Patient 8's room, Patient 8 was in bed with bilateral (both) wrist restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body). RN 4 stated Patient 8 had dementia (a condition characterized by progressive or persistent loss of intellectual functioning) and unsteady gait (difficulty walking in a smooth, coordinated manner, resulting in imbalance, wobbling, or an increased risk of falling). RN 4 also stated Patient 8 had been agitated (a feeling of severe restlessness or uneasiness) and trying to get out of bed.

During a review of Patient 8's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 3/18/2025, the H&P indicated, Patient 8 was admitted to the facility with diagnoses including but not limited to encephalopathy (a broad term for any brain disease that alters brain function or structure), major depressive disorder (MDD, a mental health disorder characterized by persistently depressed mood or loss of interest in activities, causing significant impairment in daily life), delusional disorder (a mental health condition characterized by persistent false beliefs that are not based on reality), and major neurocognitive disorder (a group of condition that affect a person's abilities of memory, attention, reasoning and problem-solving) due to dementia. The H&P also indicated, Patient 8 did not have decision making capacity (an individual's ability to understand, appreciate and rationally weigh the consequences of a decision, and to communicate and express their choice effectively).

During a concurrent interview and record review on 3/20/2025 at 10:49 a.m. with the Registered Nurse Quality Consultant (QC) 6, Patient 8's Advance Health Care Directive (Advance Directive, written statement of a person's wishes regarding medical treatment made to ensure those wishes are carried out should the person be unable to communicate them to a doctor), dated 12/28/2020, was reviewed. The Advance Directive indicated, "Part 1: Power of Attorney For Health Care ... Designation of agent: I designated the following individuals as co-agents to make health care decisions for me. My co-agents may act separately: (Name 1 [Agent 1]) and (Name 2 [Agent 2])." QC 6 stated Patient 8's Advance Directive was scanned to Patient 8's medical record on 2/5/2024. QC 6 also stated based on Patient 8's Advance Directive, Agent 1 and Agent 2 were Patient 8's DPOA (Durable Power of Attorney- an agent appointed by the patient to act on his/her behalf when unable to make medical decision).

During an interview on 3/20/2025 at 11:16 a.m. with the Director of Bioethics (MD 2), MD 2 stated the following: the Advance Directive was a legal document to let the healthcare team know about patient's wishes. The Advance Directive consisted of two parts: first part was to name an agent or person to make medical decision when the patient could not make decision, and second part was to indicate the patient's medical decision. The Advance Directive had no expiration date. The facility would honor a patient's Advance Directive.

During a concurrent interview and record review on 3/20/2025 at 1:40 p.m. with the Manager of Admitting Department (MAD), Patient 8's "Hospital Condition of Admission (COA, a contract between the hospital and patient regarding treatment, payment for services rendered by the facility, etc.)," "Medicare Outpatient Observation Notice (MOON, given to all Medicare [Federal health insurance for people at a certain age or with specific medical disabilities] beneficiaries, informing that they are outpatients receiving observation services and are not inpatients of a hospital)," and "Important Message from Medicare (IMM, given to all Medicare [Federal health insurance for people at a certain age or with specific medical disabilities] beneficiaries, notifying them of their hospital discharge appeal rights)," dated 3/18/2025, were reviewed. The "Hospital Condition of Admission," "Medicare Outpatient Observation Notice," and "Important Message from Medicare," indicated, all three documents were verbally consented by Patient 8's relative (FM 1). MAD stated admitting staff should contact Agent 1 and Agent 2 instead of FM 1 because Agent 1 and Agent 2 were the appointed DPOA by Patient 8.

During a review of Patient 8's "Hospital Condition of Admission (COA)," dated 3/18/2025, the COA indicated, "This agreement contains the terms and condition related to your treatment by [the facility] and the [Medical Group] ... 1. Consent to Medical Care ... 2. Consent to Telehealth (the use of electronic information and telecommunications technologies to provide healthcare services remotely) ... 3. Educational Consent ... 4. Consent to Photos ... 7. Assignment of Benefits ... 8. Authorized Representative ... 9. Liability for Cost Share ... 10. Direct Payment ... 11. Liability for Non-Covered Services ... 12. Collection Costs ... 14. Release of Information ... 16. Discharge Agreement."

During an interview on 3/21/2025 at 9:07 a.m. with the Director of Accreditation, Regulatory and Licensing (DARL), DARL stated the facility did not have a policy and procedure for condition of admission.

During a concurrent interview and record review on 3/21/2025 at 10:41 a.m. with the Charge Nurse (CN) 5 of Medical-Surgical (Med-Surg, general patient population hospitalized for various causes such as illness and surgery)/Telemetry (a floor in the hospital where patients receive continuous cardiac [heart] monitoring) Unit, Patient 8's "Advance Health Care Directive," dated 12/28/2020, was reviewed. The Advance Directive indicated, "Part 1: Power of Attorney For Health Care ... Designation of agent: I designated the following individuals as co-agents to make health care decisions for me. My co-agents may act separately: (Name 1 [Agent 1]) and (Name 2 [Agent 2])." CN 5 stated Agent 1 and Agent 2 listed on the Advance Directive were Patient 8's DPOA.

During a concurrent interview and record review on 3/21/2025 at 10:42 a.m. with Charge Nurse (CN) 5, Patient 8's medical record titled, "Shift Medical-Surgical Flowsheet (the flowsheet, designed to efficiently record and monitor various patient assessments and measurements in a consolidated format)," dated 3/18/2025, was reviewed. The flowsheet indicated, "Patient's Daily Goal ... Patient/Family-Specific Goals: Per (Patient 8's family member [FM 1], medicate patient (Patient 8) ... Plan of Care reviewed with family, FM 1, contacted via phone call." CN 5 stated the following: nursing staff should develop plan of care upon admission and involve patient/family when developing plan of care. The purpose of discussing plan of care with patient/family was to know what patient/family want for the goal and adjust the care plan depending on the set goal. Nursing staff should involve Patient 8's DPOA (Agent 1 and Agent 2) instead of FM 1 because the DPOA was the legal appointed agents appointed by Patient 8. They (Agent 1 and Agent 2) were in charge of Patient 8 and they (Agent 1 and Agent 2) should be the main contact person.

During a review of Patient 8's "Multi-Discipline Progress Notes (nurses notes)," dated 3/19/2025, the nurses notes indicated, "spoke with (Name [Agent 1]) DPOA regarding the transfer information and verbalizing understanding. Per (Name [Agent 1]), not to call or inform the [family member [FM 1]) about the transfer ..."

During a review of the facility's policy and procedure (P&P) titled, "Advance Directives (Advance Health Care Directives)," dated 3/2025, the P&P indicated, "[the facility] supports an adult patient's right to participate in their health care decisions, will honor a patient's right to formulate, review and revise their Advance Health Care Directive (AHCD), and will comply with these directives within professional standards of practice."

During a review of the facility's policy and procedure (P&P) titled, "The Selection of Health Care Surrogates," dated 5/2023, the P&P indicated, "[the facility] promotes shared health care decision for patient, including those without decision making capacity, and who lack a legally recognized health care decision maker. A procedural approach guides professionals to select a surrogate most likely to represent the patients' values and health care treatment preferences and honors shared decision making ... The Selection of a Decision-Maker for an Adult Patient without Decision Making Capacity ... Decision-Making Priority for Patients without Decision-Making Capacity with a legally recognized health care decision maker (LRHCDM). If an adult patient lacks the capacity to make health care decisions, the following LRHCDMs may make decisions on the patient's behalf in the following descending order: ... the patient's agent under a health care directive or power of attorney for health care ... the conservator or guardian of the patient who has the authority to make health care decisions for the patient."

During a review of the facility's policy and procedure (P&P) titled, "Issuance of 'Important Message from Medicare' and Detailed Notice of Discharge," dated 1/2024, the P&P indicated, "the 'Important Message (IM) from Medicare' will be provided to a Medicare beneficiary who is a Hospital Inpatient to inform her/him of the right to an expedited review by a Quality Improvement Organization (QIO) when the beneficiary is in disagreement with a discharge decision ... Delivery process: ... if a beneficiary does not have decision making capacity the IM from Medicare must be delivered to and signed by the beneficiary's authorized representative."

During a review of the facility's policy and procedure (P&P) titled, "Plan of Care/Assessment/Reassessment of Patient," dated 1/2022, the P&P indicated, "Each patient's plan of care, treatment and services is individualized and appropriate to the patient's needs, strengths, limitations and goals. Planning for care, treatment, and services includes ... involving patients and/or families in care planning."

Based on interview, and record review, the facility failed to ensure that the protected health information (PHI, any health information that can identify an individual and is in the possession of or transmitted by a "covered entity" or its business associates, relating to a patient's past, present, or future health. This includes patient name, medical record number, etc.) of one of 32 sampled patients (Patient 6), was not photographed using a staff member's personal phone, in accordance with the facility's policy and procedure titled, "Personal Use of Photographic, Video and Recording Equipment at [name of the facility] facilities."

This deficient practice creates a risk for unauthorized access to private health information, accidental disclosure, loss of confidential patient information, and emotional distress for the affected patient/patients.

Findings:

During a concurrent observation and interview on 3/18/2025 at 1:05 p.m. with the Director of Pathology Laboratory (DIR 1) and the Pathology Laboratory Supervisor (SS) 1, in the facility's grossing station (a laboratory station where tissue samples are prepared for examination), the survey team was not permitted to take photographs directly. As a result, the surveyor requested that facility staff take photographs to document labeling (of specimen) concerns. The SS 1 stated the facility staff member would take Photographs as requested. The photos captured specimen containers (plastic jars used to hold patient tissue samples) with visible patient identifier, including names, specimen type, and other protected information. The photos were requested by the survey team to be taken to document and provide evidence regarding improper labeling practices, specifically the lack of matching identifiers between the original labels, newly generated specimen labels, and the requisition (or tissue card a document used by physicians to request specific pathology tests or procedures on patient samples [tissues, fluids, etc.]).

During an interview on 3/19/2025 at 9:33 a.m. with the Assistant Administrator of Quality Services (AAQ), AAQ confirmed that the staff member who took the photographs used a personal cell phone, not a facility-issued device. AAQ stated, "The employee was not supposed to use their personal phone. It was against policy because she did not have a work phone."

During a review of the facility's policy and procedure (P&P) titled, "Personal Use of Photographic, Video and Recording Equipment at (name of the facility) facilities," dated12/5/2024, the P&P indicated, "(Name of the facility) prohibits use of personal photographic/video and recording equipment by workforce members under the following circumstances: Workforce members may not photograph or record KP equipment showing protected health information, such as (name of the facility) HealthConnect, imaging screens, ED track board etc., or proprietary or personal information."

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

1. Ensure that a safe environment was provided for one of 32 sampled patients (Patient 14), when medications, including a full vial (container for liquid medication storage) of acetaminophen (a medication used as a pain reliever and fever reducer), containing 1000 milligrams (mg, measuring unit) per 100 milliliters (ml, measuring unit), a 10 mg dose per 5 ml solution (10mg/5 ml) Reglan (medication used to treat nausea), and 50 mg/1 ml Benadryl (medication used to relieve allergy symptoms), were left at Patient 14's bedside, in the Emergency Department (ED, a specialized area of a hospital that provides immediate medical care for very ill people), unattended by the healthcare personnel.

This deficient practice had the potential to jeopardize Patient 14's safety, by increasing the risk of medication error, accidental overdose, or misuse of medication left at the bedside, potentially leading to adverse health outcomes for Patient 14.

2. Ensurethat a call light device (a device that allows to alert staff when they need assistance) was placed within patient's reach, for one of 32 sampled patients (Patient 19), who was in the Emergency Department (ED), to ensure the patient (Patient 19) could use the call light device to call for help when needed, in accordance with the facility's fall risk protocol which required that a call light would be within a patient's reach. Patient 19 was identified as a fall risk.

This deficient practice had the potential for Patient 19 not receiving timely assistance and care, compromising Patient 19's safety and well-being by placing Patient 19 at risk for injury such as a fall (an event where a patient comes to rest inadvertently on the ground, floor, or other lower level, whether or not an injury occurs), which may result in complications such as fracture (broken bone), bleed, etc.).

3. Ensure that a safe environment (free of sharp objects) was provided for one of 32 sampled patients (Patient 20) in the Emergency Department (ED), when multiple unused intravenous catheters (IV catheter- short tubes, containing needles, inserted into a vein to deliver medication or fluids) were left at Patient 20's bedside after an intravenous line (IV line, a method of delivering fluids and medications directly into the bloodstream through a vein) was started.

This deficient practice had the potential for Patient 20, staff, and other visitors' safety and well-being to be compromised due to an increased risk of accidental cuts or punctures caused by sharp objects kept/left at Patient 20's bedside.

4. Ensure that two of two sampled clean utility rooms (Utility Rooms 2 and 3, designated areas in a healthcare facility that contain sterile medical supplies, equipment, medical instruments, sharps, and other materials necessary for patient care) and one of one sampled intravenous cart (IV [insertion of a needle into the vein] Cart, a mobile storage unit used to hold and transport intravenous supplies and medications needed for IV administration) parked in the hallway, and intended for use as needed for 145 of 145 sampled ED patients, were kept locked in the Emergency Department (ED), in accordance with the facility's practice of keeping medical supplies in a secured area.

This deficient practice had the potential to compromise safety of all patients (145 patients on 3/18/2025) in the Emergency Department (ED), by not ensuring a secure environment where unlocked access to IV carts and medical supplies could result in misuse and mishandling of medications and equipment, jeopardizing patients' safety and quality of care.

Findings:

1. During an observation on 3/18/2025 at 12:44 p.m. in the Emergency Department (ED, a hospital facility staffed and equipped to provide immediate medical care to patients with serious injuries or illnesses that require urgent attention), medications were observed to be present on the bedside table positioned next to Patient 14's gurney, with Patient 14 lying on the gurney, and a visitor sitting in a chair next to the patient (Patient 14).

During a concurrent observation and interview on 3/18/2025 at 12:44 p.m. with the Director of Emergency Department (Dir 6) and a registered nurse (RN )13, medications left at Patient 14's bedside table were observed. The following medications were left inside Patient 14's room:

-A full vial (liquid medication storage container) of acetaminophen (a medication used as a pain reliever and fever reducer), containing 1000 milligrams (mg, measuring unit) per 100 milliliters (ml, measuring unit)
-An open vial of 10 mg dose per 5 ml (10mg/5 ml) Reglan (medication used to treat nausea- the urge to vomit)
-An open vial of 50 mg/1ml Benadryl (medication used to relieve allergy symptoms).

During the same concurrent observation and interview on 3/18/2025 at 12:44 p.m. with the Director of Emergency Department (Dir 6) and Registered Nurse (RN) 13, RN 13 stated that medications should not be left at bedside. Dir 6 then stated that medications should never be left at the bedside per the facility's practices and for patient safety.

During a review of Patient 14's Medical Record Administration (MAR), dated 3/18/2024, the MAR indicated the following:

-25 mg of Benadryl (50 mg/1 ml) was recorded to be administered intravenously (IV, given directly into the bloodstream) to Patient 14 on 3/18/2025 at 12:34 p.m.
-10 mg of Reglan (10mg/5 ml) was recorded to be administered intravenously to Patient 14 on 3/18/2025 at 12:33 p.m.
Patient 14's MAR record for Benadryl and Reglan were verified by the Director of the Emergency Department.

During a review of Patient 14's medical record (MR) titled, "ED Provider Notes," dated 3/18/2025, the MR indicated that Patient 14 was seen and evaluated in the ED for a pounding headache, nausea, and neck discomfort.

During an interview on 3/20/2025 at 2:09 p.m., with the Director of the ED (Dir 6), Dir 6 stated the following regarding the medications found to be left at Patient 14's bedside on 3/18/2025: "The expectation for the nurses after administering medication is to remove the medication from the room. This practice is implemented for patient safety, as we cannot predict what patients and visitors may do with medications left unsecured."

During an interview on 3/21/2025 at 10:21 a.m. with the facility's pharmacist (Pharm), the Pharm stated the following: "Our policy allows for medications that need to be administered to the patient to be brought to the bedside, but they [medications] should not be left unattended with the patient in the room and should be locked away."

During a review of the facility's policy and procedure (P&P) titled, "Medication Administration," dated 11/2024, the P&P indicated the following: " In general, staff who do not administer medications may not have access to medications except during times when it is necessary to perform their duties ... Drug samples will not be used in the hospital or in other unlicensed, designated patient care areas unless their use is specifically approved by the Pharmacy and Therapeutics Committee ..."

During a review of the facility's policy and procedure (P&P) titled, "Safe Medication Practices: Medication Labeling in the Perioperative and Procedural Settings," dated 12/22/2025, the P&P indicated the following: 5.8. Medications, medication containers, and/or solutions on and off the sterile field will be immediately discarded per policy and procedures if: 5.8.4. At the end of the procedure, there are remaining unused controlled drugs in open vials and ampules.

The facility did not provide a policy regarding medication secure storage. This was confirmed on 3/21/2025 at 4:45 p.m. by the Director of Accreditation, Regulatory and Licensing (DARL).

2. During an observation on 3/18/2025 at 12:42 p.m. with the Director of the Emergency Department (ED, a specialized area within a hospital dedicated to providing immediate medical care) (Dir 6), Patient 19 was observed lying on the gurney and sleeping in the room, in the ED. The call light (a device, often a button or a light, that patients can use to signal healthcare staff when they need assistance or have a concern) was observed positioned on the cabinet behind the gurney and was not within Patient 19's reach. Dir 6 went inside the room, retrieved the call light from the cabinet, and placed it (the call light device) within Patient 19's reach.

During a review of Patient 19's medical record (MR) titled, "ED Physician Progress Notes," dated 3/18/2025, the MR indicated that on 3/18/2025, Patient 19 was seen in the Emergency Department for complaints of weakness, poor appetite, and vomiting. The H&P indicated that Patient 19 was alert and oriented x 3 (A&Ox3, a patient is awake and aware of their person, place, and time).

During a review of Patient 19's medical record (MR) titled, "Patient Care Timeline," dated 3/18/2025, the MR indicated that on 3/18/2025, the following information was documented in Patient 19's Care Timeline:

-10:17 a.m.: Call light is within (Patient 19's) reach (safety intervention).
-10:17 a.m.: Patient 19 educated to call for the nurse and wait for assistance
-10:17 a.m.: Patient 19 was identified as a fall risk patient (someone with an increased susceptibility to falling, potentially leading to physical harm, due to various factors like age, medical conditions, medications, or mobility issues).
-10:17 a.m.: Call light placed within Patient 19's reach due to fall (an event where a patient comes to rest inadvertently on the ground, floor, or other lower level, whether or not an injury occurs) risk.
-10:22 a.m.: Patient 19's fall risk assessment (a procedure that identifies factors increasing a person's likelihood of falling, enabling healthcare professionals to develop personalized care plans to enhance safety and well-being) indicated: Fall Risk and Fall Risk Protocol (a structured set of guidelines and procedures designed to identify, assess, and manage factors that increase the likelihood of a fall, ultimately aiming to prevent falls and reduce associated injuries) was activated.
-12:00 p.m.: Patient 19 is fall risk (repeat assessment)
-12:00 p.m.: Safety Interventions: Call light within reach ...

During an interview on 3/21/2025 at 3:25 p.m. with the Director of Accreditation, Regulatory, and Licensing (DARL), the DARL stated that the facility does not have a policy regarding call lights.

During a review of the facility's policy and procedure (P&P) titled, "Adult Fall Prevention," dated 12/2023, the P&P indicated that all patients will be evaluated for evaluated for fall risk ... Specific interventions will be initiated for patients who are identified as a fall risk ...Universal fall precautions include, but not limited to: call light in reach ...Registered Nurses (RN) are responsible for implementation and oversight of the individualized patient fall prevention care ...

3. During an observation on 3/18/2025 at 1:05 p.m., multiple intravenous (IV) catheters (short, flexible tubes inserted into a vein to deliver medications, fluids, or nutrients directly into the bloodstream), were observed left laying on Patient 20's bedside table in the Emergency Department (ED, a hospital facility staffed and equipped to provide immediate medical care to patients with serious injuries or illnesses that require urgent attention).

During a review of Patient 20's medical record (MR) titled, "ED Provider Notes," dated 3/18/2025, the MR indicated that on 3/18/2025, Patient 20 presented in the Emergency Department (ED) with complaint of gradual onset of lower abdominal pain and loose stools.

During a concurrent observation and interview on 3/18/2025, at 1:10 p.m. with the Director of the ED (Dir 6), the following items were observed on Patient 20's bedside table: 6 new (in a sterile packaging) peripheral intravenous catheters (PIVC also known as IV cannulas and one vacutainer (a sealed container used for collecting blood samples, typically equipped with a vacuum to draw the blood sample into the tube). The Dir 6 stated that the cannulas and the vacutainer should not have been left at Patient 20's bedside and then said that Patient 20's nurse must have just inserted an IV line on Patient 20.

During an interview on 3/21/2025 at 3:35 p.m. with the Director of Accreditation, Regulatory and Licensing Coordinator (DARL), the DARL stated that the facility does not have a policy regarding the secure storage of medical supplies and sharps (any object or device with a sharp point or edge that can puncture or cut the skin. Example: needles, lancets, etc.) such as PIV catheters (IV cannulas).

4. During a concurrent observation and interview on 3/18/2025 at 12:40 p.m. with the Director of the Emergency Department (Dir 6), in the Emergency Department (ED), an intravenous (IV) cart (a mobile storage unit used to hold and transport IV [refers to the administration of fluids, medications, or nutrients directly into a vein] supplies and medications needed for IV insertion and administration), was observed parked in the hallway (accessible to staff, patients, and visitors). The IV cart was not locked and supplies such as sharp needles were observed inside the drawers. The Dir 6 stated the IV cart should be locked, and authorized personnel should use a code to unlock the IV cart. The Dir 6 then proceeded to lock the IV cart.

During an observation on 3/18/2025 at 12:50 p.m., in the Emergency Department (ED, a hospital facility staffed and equipped to provide immediate medical care to patients with serious injuries or illnesses that require urgent attention), Utility Room 2 (a central hub for managing medical supplies, facilitating efficient workflow and ensuring the availability of necessary items for patient care), was observed to have a locking mechanism, but the Utility Room 2 (located in POD 2-refers to a self-contained unit designed to facilitate efficient and effective team-based care), was left unlocked.

During an interview on 3/18/2025 at 12:50 p.m. with the Director of Emergency Department (Dir 6), the Dir 6 stated that the utility room (Utility Room 2) should remain locked.

During a concurrent observation and interview on 3/18/2025 at 1:04 p.m. with the Chief Nursing Officer (CNO) in the Emergency Department (ED), in POD 3, the Utility Room 3 was also found to be unlocked. The CNO stated that the utility room (Utility Room 3) should be locked.

During an interview on 3/21/2025 at 3:25 p.m. with the Director of Accreditation, Regulatory and Licensing Coordinator (DARL), the DARL stated that the facility does not have a policy regarding the secure storage of medical supplies and sharps to ensure they are kept away from unauthorized population in easily accessible areas.

Based on observation, interview and record review, the facility failed to ensure nursing staff initiated a care plan (a document that outlines an individual's assessed needs and the specific support or care required to meet those needs, ensuring the right level of care is provided) for restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) use, in a timely manner, for one of 32 sampled patients (Patient 8), in accordance with the facility's policy and procedure regarding restraints, when Patient 8 was placed on bilateral (both) wrists restraints.

This deficient practice had the potential to result in lack of monitoring regarding restraints use and the potential for inappropriate or prolonged restraints use, which may result in complications such as skin breakdown (damage to the skin and underlying tissue), psychological distress, etc.

Findings:

During a review of Patient 8's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 3/18/2025, the H&P indicated, Patient 8 was admitted to the facility with diagnoses including but not limited to encephalopathy (a broad term for any brain disease that alters brain function or structure), major depressive disorder (MDD, a mental health disorder characterized by persistently depressed mood or loss of interest in activities, causing significant impairment in daily life), delusional disorder (a mental health condition characterized by persistent false beliefs that are not based on reality), and major neurocognitive disorder (a group of condition that affect a person's abilities of memory, attention, reasoning and problem-solving) due to dementia. The H&P also indicated, Patient 8 did not have decision making capacity (an individual's ability to understand, appreciate and rationally weigh the consequences of a decision, and to communicate and express their choice effectively).

During a concurrent observation and interview on 3/18/2025 at 2:15 p.m. with Registered Nurse (RN) 4 in Patient 8's room, Patient 8 was in bed with bilateral (both) wrist restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body). RN 4 stated Patient 8 had dementia (a condition characterized by progressive or persistent loss of intellectual functioning) and unsteady gait (difficulty walking in a smooth, coordinated manner, resulting in imbalance, wobbling, or an increased risk of falling). RN 4 also stated Patient 8 needed the restrains because Patient 8 had been agitated (a feeling of severe restlessness or uneasiness) and trying to get out of bed.

During a concurrent interview and record review on 3/20/2025 at 1:46 p.m. with the Registered Nurse Quality Consultant (QC) 6, Patient 8's "Restraints Non-Violent Flowsheet," dated from 3/18/2025 to 3/19/2025, was reviewed. The restraints flowsheet indicated, Patient 8 had bilateral wrist restraints on 3/18/2025 from 2:30 a.m. to 7:30 a.m. and from 12:39 p.m. to 12 p.m. next day (3/19/2025). QC 6 stated the following: there were two episodes of restraints use for Patient 8. Restraints (episode 1) first started on 3/18/2025 at 2:30 a.m. and removed at 7:30 a.m., then nursing staff re-applied restraints (episode 2) for Patient 8 on 3/18/2025 at 12:29 p.m.

During an interview on 3/20/2025 at 3:50 p.m. with the Charge Nurse (CN) 2 of Medical-Surgical (Med-Surg, general patient population hospitalized for various causes such as illness and surgery)/Telemetry (a floor in the hospital where patients receive continuous cardiac [heart] monitoring) Unit, CN 2 stated the following: a care plan (a document that outlines an individual's assessed needs and the specific support or care required to meet those needs, ensuring the right level of care is provided) should be specific to a patient's problem and diagnosis. Care plan was used to evaluate if a patient was progressing towards the treatment goals. A restraint care plan should be initiated when restraints were applied.

During a concurrent interview and record review on 3/20/2025 at 3:44 p.m. with the Chief Nurse Executive (CNE), Patient 8's care plan, dated on 3/18/2025, was reviewed. The care plan indicated the restraints care plan was initiated on 3/18/2025 at 12:43 p.m. (12 hours after the initial restraint application). CNE stated there was no restraint care plan initiated or developed for restraint episode 1 (from 2:30 a.m. to 7:30 a.m. on 3/18/2025).

During a review of the facility's policy and procedure (P&P) titled, "Restraint Use," dated 9/2022, the P&P indicated, "Registered Nurses (RN), are responsible for the assessment, monitoring and provision of care for patients in restraints. The use of restraints (including drugs or medication used as restraints as well as physical restraint) must be documented in the patient's plan of care ... assess and monitor the patient's condition on an ongoing basis to determine whether restraint can safety be discontinued."

During a review of the facility's policy and procedure (P&P) titled, "Plan of Care/Assessment/ Reassessment," dated 1/ 2022, the P&P indicated, 'Each patient's plan of care, treatment and services is individualized and appropriate to the patient's needs, strengths, limitations and goals. Planning for care, treatment and services includes: Integrating assessment findings in the care-planning process. Developing a plan that includes patient care goals that are reasonable and measurable. Regularly reviewing and revising the plan. Determining how the plan will be provided. Documenting the plan. Monitoring the effectiveness of the plan. Involving patients and/or families in care planning."

Based on observation, interview, and record review, the facility failed to ensure one of 32 sampled patients (Patient 24), was monitored every 2 hours, for circulation (blood flow), mental status (includes mood and behavior), feeding or elimination needs, while on mitten restraints (soft glove-like device used to restrict a patient's movement), in accordance with the facility's policy regarding restraints use.

This deficient practice had the potential for circulation problems resulting in skin breakdown (damage to the skin and underlying tissues from prolonged pressure), swelling, or Patient 24's care needs not being met such as hydration (enough water) or hygiene needs.

Findings:

During an observation on 3/18/2025 at 1:33 p.m., in the Intensive Care Unit (ICU, specialized hospital unit that provides treatment and monitoring for people who are very ill), Patient 24 was observed in bed, asleep, intubated (a tube is inserted into the trachea [windpipe] for ventilation [breathing]) and connected to a ventilator (a machine that delivers breaths to the lungs). Patient 24 wore mitten restraints (soft glove-like device used to restrict a patient's movement) to both hands.

During a concurrent observation and interview on 3/18/2025 at 1:33 p.m. with Registered Nurse (RN) 5, RN 5 stated that Patient 24 wore mittens to both hands to prevent Patient 24 from pulling on his endotracheal tube (a flexible, hallow plastic tube inserted into the windpipe through the mouth or nose to maintain an open airway) and IV (in the vein to give fluid) lines. RN 5 said Mittens were considered restraints and Patient 24 should be monitored every two (2) hours for circulation (blood flow), release of restraints, any safety needs.

During a concurrent interview and record review on 3/20/2025 at 1:54 p.m. with the Assistant Administrator for Telemetry (AAT), the AAT stated the following: Bilateral (both) mittens were initiated on 3/12/2025 at 4 p.m. for Patient 24 for pulling on tubes. Patients on restraints should be monitored every two (2) hours for behavior, mental status (includes mood and behavior), circulation, release of restraints, elimination (urine and stools), range of motion (the extent to which a joint can move in a specific direction), and fluid/food intake. ATT verified that on 3/12/2025 at 10 p.m. and on 3/13/2025 at 6 a.m., Patient 24 was not monitored or assessed every 2 hours per the facility's policy.

During a review of Patient 24's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 2/21/2025, the H&P indicated the following: Patient 24's diagnoses included chronic (long-lasting health condition) obstructive pulmonary disease (COPD, a group of lung disease characterized by persistent airflow obstruction and chronic inflammation of the airways and lungs), pneumonia (infection that inflames air sacs in one or both lungs), urinary tract infection (illness on any part of the urinary tract [includes the bladder- stores the urine in the body and the urethra- the tube that lets the urine leave the body]), left distal femur fracture (a break in the lower part of the thigh bone, near the knee) due to an unwitnessed fall (an event where a person comes to rest inadvertently on the ground, floor, or other lower level), percutaneous endoscopy gastrostomy tube (PEG, a feeding tube that is inserted through the skin and into the stomach, to provide nutrition) in place, and anemia (blood does not have enough health red blood cells to carry oxygen throughout the body) ...

During a review of Patient 24's flowsheets titled, "Restraint Monitoring at Least Every 2 Hours," the flowsheets indicated Patient 24 was not monitored every 2 hours for behavior/mental status, circulation, restraints released/reapplied, ROM (range of motion), fluids, food/meal, and elimination on 3/12/2025 at 10 p.m. and on 3/13/2025 at 6 a.m., as follows:

-On 3/12/2025 at 8 p.m. - Patient 24 was monitored for behavior/mental status, circulation, restraints released/reapplied, ROM (range of motion), fluids, food/meal, and elimination.
-On 3/12/2025 at 10 p.m. - No Documentation of monitoring every 2 hours.
-On 3/12/2025 at 11 p.m. - Patient 24 was monitored for behavior/mental status, circulation, restraints released/reapplied, ROM (range of motion), fluids, food/meal, and elimination.
-On 3/13/2025 at 4 a.m. - Patient 24 was monitored for behavior/mental status, circulation, restraints released/reapplied, ROM (range of motion), fluids, food/meal, and elimination.
-On 3/13/2025 at 6 a.m. - No Documentation of monitoring every 2 hours.
-On 3/13/2025 at 8 a.m. - Patient 24 was monitored for behavior/mental status, circulation, restraints released/reapplied, ROM (range of motion), fluids, food/meal, and elimination.

During a review of the facility's policy and procedure (H&P) titled, "Restraint Use," dated 9/01/2022, the P&P indicated, "Patients in non-behavior restraints are monitored and assessed at least every two (2) hours or sooner, as indicated by the condition of the patient and type of restraint. The assessment will be documented in the medical record. Assessment at least every two (2) hours include: Behavior/mental status; Circulation; Nutritional needs (food/meal); Hydration needs; Elimination needs; Range of Motion (ROM); restraints released and reapplied, one limb at a time."

Based on observation, interview and record review, the facility's Quality Assessment and Performance Improvement (QAPI, a process by which hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital) committee, failed to properly gather and analyze information on the incorrect pathology reading for two of 32 sampled patients (Patient 1 and Patient 2), when Patient 1 and Patient 2's prostate core needle biopsy slides (a thin glass used to hold patient tissues or fluid for microscopic examination) were switched and resulted in incorrect pathology report and Patient 1's unnecessary surgery. The QAPI committee also failed to ensure there was a thorough investigation to identify the root cause of the incident and to implement an effective action plan to prevent future occurrence, in accordance with the facility's policy regarding QAPI.

This deficient practice resulted in the facility not having a standardized process developed for all pathologists (medical professionals who specialize in diagnosing diseases by examining tissue and fluid samples) regarding proper patient verification process, which may continue to lead to potential wrong reading of the pathology slides in the future resulting in patient harm such as unnecessary surgical procedures.

Findings:

During a review of Patient 1's "Pre- Op (Pre-operative) History and Physical Exam (H&P)," dated 7/31/2024, the "H&P" indicated, Patient 1 had prostate-specific antigen (PSA, a protein produced by the prostate gland that can be measured in a blood test) of 3.8 on 5/20/2024. In the past, Patient 1 had no prior work-up for an elevated PSA. Previous urology (a branch of medicine that focus on the function and disorders of the urinary system) history: no hematuria (the presence of blood in urine), no recurrent urinary tract infection (an infection of the urinary system). The H&P further indicated test result for transrectal ultrasound-guided prostate biopsy (TRUSP, a procedure used to obtain tissue samples from the prostate gland) indicated six areas of the prostate was biopsied, the six areas were categorized by letters: A, B, C, D, and F. All areas had a negative result for cancer except the area labeled F, which indicated, "F ...Prostatic adenocarcinoma (cancer of the prostate). The H&P indicated, "We have had an opportunity to meet at length to discuss his (Patient 1) prostate cancer and the available options, and he (Patient 1) has decided to go forth with robot-assisted laparoscopic radical prostatectomy (a minimally invasive surgery to remove the entire prostate gland and some surrounding tissue, using a robotic system). He (Patient 1) understands that he will need a Foley catheter (a thin, flexible tube inserted into the bladder to drain urine) for 1-2 weeks following the operation, and that he (Patient 1) will have a surgical drain (a tube inserted after surgery to remove excess fluids) as well."

During a review of Patient 1's "Urology (a medical specialty that focuses on the diagnosis, treatment, and prevention of disorders related to the urinary tract and male reproductive system) Service" operative note, dated 7/31/2024, the operative note indicated, Patient 1 "...With prostate cancer. After reviewing all options with the patient (Patient 1), we decided to go forth with robot-assisted laparoscopic radical prostatectomy ... The patient (Patient 1) tolerated the procedure well, was awaken from anesthesia (medicines to prevent pain during surgery and other procedures), and transferred to recovery room in stable condition."

During an interview on 3/18/2025 at 11:58 a.m. with the Director of Laboratory Services (DIR) 4, DIR 4 stated the incident of misdiagnoses occurred due to the two patients' (Patient 1 and Patient 2) slide (hold and display specimens for observation) that should have been on the same deck (flat, binders used to hold slides), "but the slides ended up on both deck, but the pathologist should have caught it and the urology (team) should have caught it."

During a concurrent observation and interview on 3/19/2025 at 1:42 p.m. with the Director of Laboratory (DIR 1), DIR 1 stated the following: the pathology report completed after Patient 1 underwent prostatectomy indicated that Patient 1 did not have any cancer. This finding led the department to conduct an internal investigation, which determined that Patient 1's slide (F1) had been switched with Patient 2's slide (F2). DIR 1 displayed both Patient 1's and Patient 2's flats. Each flat contained 12 slides, with each letter representing two slides. While DIR 1 pointed to the two slides labeled with the letter F, DIR 1 stated that these were the misplaced slides.

During the same interview on 3/19/2025 at 1:42 p.m. with the Director of Laboratory (DIR 1), DIR 1 stated that on 6/4/2024, the facility's pathology department received two sets of slides from the regional lab: Set A, which contained six paired slides (A1, B1, C1, D1, E1 and F1) for Patient 1, and Set B, which contained six paired slides (A2, B2, C2 D2, E2 and F2) for Patient 2. Set A was assigned to Pathologist 1(PA 1), and Set B was assigned to Pathologist 2 (PA 2). DIR 1 stated that slide F1 from Patient 1 was mistakenly placed in Set B, and slide F2 from Patient 2 was mistakenly placed in Set A, resulting in an incorrect positive cancer reading for Patient 1. DIR 1 further stated that PA 1 received Set A with slide F2 (A1, B1, C1, D1, E1 and F2), read and interpreted all slides, including F2, and recorded the findings in Patient 1's Surgical Pathology Report (a medical document that describes the characteristics of a tissue specimen, typically after a biopsy or surgery, and is prepared by a pathologist to aid in diagnosis and treatment planning). Similarly, PA 2 received Set B with slide F1(A2, B2, C2, D2, E2 and F1), read slide F1, and recorded the findings in Patient 2's Surgical Pathology Report.

During an interview on 3/19/2025 at 2:54 p.m. with Pathologist (PA 2), PA 2 stated, he (PA 2) found out the slides from the case he (PA 2) reviewed, was mixed with another pathologist case, when the results from the biopsy that was collected after Patient 1 underwent surgery (radical proctectomy) indicated Patient 1 did not have prostate cancer. PA 2 also stated "I do not have a working scanner (a device used to scan a bar code that automatically enters patient information and other critical data into electronic health records [EHR, digital version of paper chart]), I have case of work list. Some of us can scan and some of us will work through the work list. When people do scan, they only scan the first one (referring to the first slide)." PA 2 stated he (PA 2) did not realize slide F1 was mixed in Set B because the slides were placed in order from A through F (A2, B2, C2, D2, E2 and F1). PA 2 read all slides including slide F1 and recorded findings on Patient 2's Surgical Pathology Report.

During an interview on 3/19/2025 at 3 p.m. with Pathologist (PA) 2, PA 2 stated he (PA 2) attended a meeting with Quality Department (QD). During the meeting, PA 2 reported that the QD advised the Pathology department to develop their own corrective plan. PA 2 stated, "We all individually came up with our own (plan)." PA 2 stated his (PA 2) plan was to read all slides in order, from top to bottom. PA 2 confirmed that the facility does not require Pathologists to use the scanner to scan either the slides (a thin, flat piece of glass used to hold tissues or fluid samples for examination) or the requisition (written orders form healthcare providers requesting laboratory testing) before reviewing the slides.

During an interview on 3/21/2025 at 3:08 p.m. with the Assistant Administrator Quality Services (AAQ), AAQ stated the following: the incident (involving Patient 1 and Patient 2) was referred to Quality Department from Risk Management as unusual Occurrence Reporting (UOR, any incident that is not consistent with routine patient care or facility operation and adversely affects or has the potential to affect the health or safety of a patient). A comprehensive systemic analysis (CSA, similar to root cause analysis [a process of discovering the root causes of problems in order to identify appropriate solution]) was done by Risk Management Department, Laboratory and Pathology Department. CSA identified the slides were not put in order by the outside regional lab when sending to the facility's pathology department. There were multiple patients slides on the same flat. Two of Patient 1 and Patient 2's slides (F1 and F2) were mixed up on the row of the flat. There was action plan developed by the regional lab and pathology department. The action plan developed by the pathology department was to continue to monitor compliance by incorporating existing audit of the analytical review and post analytic review of the report. AAQ stated the audit started in 8/2024 and there was no new process being implemented other than auditing.

During an interview on 3/21/2025 at 4:27 p.m. with AAQ, AAQ stated the following: the action plan resulted from CSA focused on charts auditing performed by pathology department to ensure the incident like this would not happen again while the outside regional lab had its own action plan. From CSA, the incident was thought to be an individual deviation of the process. There was no new process implemented at that time. AAQ stated she (AAQ) did not know the scanner of Pathologist (PA 2) did not work.

During a review of the facility's policy and procedure (P&P) titled, "Unusual Occurrence Reporting (UOR)," dated 5/2023, the P&P indicated, "Purpose: To establish and maintain a database for identifying patterns of risk and provide a mechanism to trend, analyze, and report unexpected events and potential risk ...To reduce the risk and severity of unusual occurrences by tracking and trending events ... Risk Management received the UOR, reviews the event, the manager investigation, analysis, follow up actions ... escalate events that require urgent/immediate review to the Risk Management physician and/or responsible Administrator ... Refers quality of care and peer review concerns to the Quality Department."

During a review of the facility's "Quality and Patient Safety program Description Annual Work Plan and Evaluation (QAPI Plan)," dated 5/28/2024, the QAPI Plan indicated, "The purpose of this Plan is to provide the mechanism for improving hospital quality and safety and to ensure that [the facility] ... demonstrate a consistent and collaborative approach to deliver safe, effective, efficient, equitable, patient centered, and timely care within a quality assurance and performance improvement (QAPI) framework ... This plan informs the improvement processes for patient outcomes, reducing and preventing medical errors, and applying remediation strategies in response to system or process failures."

Based on observation, interview and record review, the facility's Quality Assessment and Performance Improvement (QAPI, a process by which hospital can fully examine the quality of care it delivers and then implement specific improvement activities and projects on an ongoing basis for all of the services provided by the hospital) committee, failed to communicate in a timely manner with the Governing Body (GB, responsible for guiding the hospital's long-term goals and policies, and assists with strategic planning and decision-making) the event regarding the incorrect pathology reading for two of 32 sampled patients (Patient 1 and Patient 2) when Patient 1 and Patient 2's prostate core needle biopsy slides were switched and resulted in incorrect pathology report and Patient 1's unnecessary surgery.

This deficient practice resulted in delay in notifying the GB members and in disseminating data collected relating to the incident, for GB to evaluate if there was an effective measure put in place in response to the incident, and to hold responsible committees accountable to prevent future occurrence of slide misidentification that may result in patient harm such as unnecessary surgical procedures.

Findings:

During a review of Patient 1's "Pre- Op (Pre-operative) History and Physical Exam (H&P)," dated 7/31/2024, the "H&P" indicated, Patient 1 had no prior elevated prostate-specific antigen (PSA, a protein produced by the prostate gland that can be measured in a blood test) in the past. Patient 1 had no prior work-up for an elevated PSA. Previous urology (a branch of medicine that focus on the function and disorders of the urinary system) history: no hematuria (the presence of blood in urine), no recurrent urinary tract infection (an infection of the urinary system, which includes the kidneys, ureters [duct by which urine passes], bladder, and urethra [duct by which urine is conveyed out]), and no urinary stone disease (the absence of kidney stones within the urinary tract), no genitourinary (GU, relating to the genital and urinary organs) surgeries or procedures, and no family history of GU cancer, no significant Lower Urinary Tract Symptoms (LUTS, a group of symptoms related to the bladder, urethra, and in men, the prostate) ...H&P further indicated test result for transrectal ultrasound-guided prostate biopsy (TURP, a procedure used to obtain tissue samples from the prostate gland) indicated six areas of the prostate was biopsied, the six areas were categorized by letters: A, B, C, D, and F. All areas had a negative result for cancer except the area labeled F, which indicated, "F ...Prostatic adenocarcinoma (cancer of the prostate) ... We have had an opportunity to meet at length to discuss his (Patient 1) prostate cancer and the available options, and he (Patient 1) has decided to go forth with robot-assisted laparoscopic radical prostatectomy (a minimally invasive surgery to remove the entire prostate gland and some surrounding tissue, using a robotic system). He (Patient 1) understands that he (Patient 1) will need a Foley catheter (a thin, flexible tube inserted into the bladder to drain urine) for 1-2 weeks following the operation, and that he (Patient 1) will have a surgical drain (a tube inserted after surgery to remove excess fluids) as well."

During a review of Patient 1's "Urology Service" operative note, dated 7/31/2024, the operative note indicated, Patient 1 "...With prostate cancer. After reviewing all options with the patient (Patient 1), we decided to go forth with robot-assisted laparoscopic radical prostatectomy ... The patient (Patient 1) tolerated the procedure well, was awaken from anesthesia (medicines to prevent pain during surgery and other procedures), and transferred to recovery room in stable condition."

During an interview on 3/18/2025 at 11:58 a.m. with the Director of Laboratory Services (DIR) 4, DIR 4 stated the incident of misdiagnoses occurred due to the two patients' (Patient 1 and Patient 2) slide (hold and display specimens for observation) that should have been on the same deck (flat, binders used to hold slides), "but the slides ended up on both deck, but the pathologist should have caught it and the urology (team) should have caught it."

During a concurrent observation and interview on 3/19/2025 at 1:42 p.m. with the Director of Laboratory (DIR 1), DIR 1 stated the following: the pathology report completed after Patient 1 underwent prostatectomy indicated that Patient 1 did not have any cancer. This finding led the department to conduct an internal investigation, which determined that Patient 1's slide (F1) had been switched with Patient 2's slide (F2). DIR 1 displayed both Patient 1's and Patient 2's flats. Each flat contained 12 slides, with each letter representing two slides. While DIR 1 pointed to the two slides labeled with the letter F, DIR 1 stated that these were the misplaced slides.

During the same interview on 3/19/2025 at 1:42 p.m. with the Director of Laboratory (DIR 1), DIR 1 stated that on 6/4/2024, the facility's pathology department received two sets of slides from the regional laboratory: Set A, which contained six paired slides (A1, B1, C1, D1, E1 and F1) for Patient 1, and Set B, which contained six paired slides (A2, B2, C2 D2, E2 and F2) for Patient 2. Set A was assigned to Pathologist 1(PA 1), and Set B was assigned to Pathologist 2 (PA 2). DIR 1 stated that slide F1 from Patient 1 was mistakenly placed in Set B, and slide F2 from Patient 2 was mistakenly placed in Set A, resulting in an incorrect positive cancer reading for Patient 1. DIR 1 further stated that PA 1 received Set A with slide F2 (A1, B1, C1, D1, E1 and F2), read and interpreted all slides, including F2, and recorded the findings in Patient 1's Surgical Pathology Report (a medical document that describes the characteristics of a tissue specimen, typically after a biopsy or surgery, and is prepared by a pathologist to aid in diagnosis and treatment planning). Similarly, PA 2 received Set B with slide F1(A2, B2, C2, D2, E2 and F1), read slide F1, and recorded the findings in Patient 2's Surgical Pathology Report.

During an interview on 3/19/2025 at 2:54 p.m. with Pathologist (PA 2), PA 2 stated, he (PA 2) found out the slides from the case he (PA 2) reviewed was mixed with another pathologist case when the results from the biopsy that was collected after Patient 1 underwent surgery (radical proctectomy) indicated Patient 1 did not have prostate cancer. PA 2 also stated "I do not have a working scanner (a device used to scan a bar code that automatically enters patient information and other critical data into electronic health records [EHR, digital version of paper chart]), I have case of work list. Some of us can scan and some of us will work through the work list. When people do scan, they only scan the first one (referring to the first slide)." PA 2 stated he did not realize slide F1 was mixed in Set B because the slides were placed in order from A through F (A2, B2, C2, D2, E2 and F1). PA 2 read all slides including slide F1 and recorded findings on Patient 2's Surgical Pathology Report.

During an interview on 3/19/2025 at 3 p.m. with Pathologist (PA) 2, PA 2 stated he (PA 2) attended a meeting with Quality Department (QD). During the meeting, PA 2 reported that the QD advised the Pathology department to develop their own corrective plan. PA 2 stated, "We all individually came up with our own (plan)." PA 2 stated his (PA 2) plan was to read all slides in order, from top to bottom. PA 2 confirmed that the facility does not require Pathologists to use the scanner to scan either the slides (a thin, flat piece of glass used to hold tissues or fluid samples for examination) or the requisition (written orders form healthcare providers requesting laboratory testing) before reviewing the slides.

During an interview on 3/21/2025 at 3:08 p.m. with the Assistant Administrator Quality Services (AAQ), AAQ stated the following: the incident (involving Patient 1 and Patient 2) was referred to Quality Department from Risk Management as Unusual Occurrence Reporting (UOR, any incident that is not consistent with routine patient care or facility operation and adversely affects or has the potential to affect the health or safety of a patient). A comprehensive systemic analysis (CSA, similar to root cause analysis [a process of discovering the root causes of problems in order to identify appropriate solution]), was performed on 9/4/2024 by Risk Management Department, Laboratory and Pathology Department. CSA identified the slides were not put in order by the outside regional lab when sending to the facility's pathology department. There were multiple patients slides on the same flat. Two of Patient 1 and Patient 2's slides (F1 and F2) were mixed up on the row of the flat. There was action plan developed by the regional lab and the pathology department. The action plan developed by the pathology department was to continue to monitor compliance by incorporating existing audit of the analytical review and post analytic review of the report. AAQ stated the audit started in 8/2024 and there was no new process being implemented other than auditing.

During an interview on 3/21/2025 at 3:56 p.m. with the Director of Quality (DIR 10), DIR 10 stated this incident (involving Patient 1 and Patient 2) had not been reported to the Medical Executive Committee (MEC) yet. DIR 10 stated it would be reported to MEC this month.

During an interview on 3/21/2025 at 4:04 p.m. with the Physician Director for Quality (PDQ), PDQ stated the following: the Medical Executive Committee (MEC) was the governing body for this facility. The MEC would meet monthly and receive reports from the QAPI committee. The MEC would review reports, ask questions and tell different committees what to do. The MEC would provide oversight for all committees and to make sure they were doing what they were supposed to do.

During an interview on 3/21/2025 at 4:12 p.m. with AAQ, AAQ stated the incident would first go through Risk Management Patient Safety Committee (RMPS) first, then would go to Quality Committee (QOC), then finally go to MEC.

During an interview on 3/21/2025 at 5:35 p.m. with AAQ, AAQ stated the incident was reported in Risk Management Patient Safety Committee (RMPS) on 10/7/2024. The RMPS meeting minutes was approved in QOC meeting on 12/12/2024. However, the 10/7/2024 RMPS meeting minutes was not presented in MEC meeting held on 1/27/2025.

During an interview on 3/21/2025 at 5:37 p.m. with the Director of Medical Staff Services (DIR 12), DIR 12 stated she (DIR 12) did not attach 10/7/2024 RMPS meeting minute to the MEC meeting held on 1/27/2025. DIR 12 stated, "It was an oversight. It was missed." DIR 12 stated the 10/7/2024 RMPS meeting minutes would be presented in the next MEC meeting on 3/24/2025 (five months after incident was reported to RMPS).

During a review of the facility's "Quality and Patient Safety program Description Annual Work Plan and Evaluation (QAPI Plan)," dated 5/28/2024, the QAPI Plan indicated, "The purpose of this Plan is to provide the mechanism for improving hospital quality and safety and to ensure that [the facility] ... demonstrate a consistent and collaborative approach to deliver safe, effective, efficient, equitable, patient centered, and timely care within a quality assurance and performance improvement (QAPI) framework ... This plan informs the improvement processes for patient outcomes, reducing and preventing medical errors, and applying remediation strategies in response to system or process failures ... leadership is responsible for utilizing situational leadership behaviors to provide appropriate direction and management for all services and/or departments, ensuring uniform delivery of patient care services provided throughout the hospital, ensuring that systems are in place to promote the integration of services, and to support the patient beyond the hospital walls, adopting committees, work groups, performances improvement teams and other forums to ensure multidisciplinary and interdepartmental collaboration on issues of mutual concerns."

Based on interview and record review, the facility failed to ensure its Registered Nurses (RN) supervised two of three sampled Certified Nursing Assistants (CNA 1 and CNA 2) in performing complete orthostatic vital signs (measurement of blood pressure and heart rate taken while a patient is lying down, sitting up and standing up) check and ensure that the orthostatic vital signs check was accurately done, for one of 32 sampled patients (Patient 10), in accordance with facility's policy and procedure regarding orthostatic vital signs.

This deficient practice had the potential to result in inaccurate vital signs reading to evaluate Patient 10's orthostatic hypotension (a form of low blood pressure that occurs when standing up from a sitting or lying down position. This can cause dizziness or lightheadedness and may result in fainting), which may result in delayed implementation of necessary interventions to address an identified orthostatic hypotension.

Findings:

During an interview on 3/18/2025 at 2:24 p.m. with Patient 10, Patient 10 stated she (Patient 10) came to the facility because of low blood pressure.

During a review of Patient 10's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 3/17/2025, the H&P indicated, Patient 10 came to the facility's emergency room due to lightheadedness (a feeling of being close to passing out). The H&P also indicated, Patient 10 was admitted to the facility with diagnoses including but not limited to hyponatremia (a condition where the sodium [salt] level in the blood is abnormally low), diarrhea (loose stools), and anemia (a condition marked by a deficiency of red blood cells or of hemoglobin [carries oxygenated blood to different organs] in the blood, resulting in pallor [pale] and weariness).

During a review of Patient 10's "Physician Order," dated 3/17/2025, the "Physician Order" indicated, measure orthostatic vital signs (measurement of blood pressure and heart rate taken while a patient is lying down, sitting up and standing up) every shift."

During an interview on 3/20/2025 at 3:59 p.m. with the Chief Nurse Executive (CNE), CNE stated the following: orthostatic vital signs involved taking vital signs when the patient was in lying position, sitting position and standing position. The Certified Nursing Assistant could take the orthostatic vital signs, but the Registered Nurse was responsible to make sure it was done completely and correctly.

During a concurrent interview and record review on 3/20/2025 at 4:05 p.m. with CNE, Patient 10's Orthostatic Vital Signs Flowsheet, dated from 3/17/2025 to 3/18/2025, was reviewed. The "Orthostatic Vital Signs Flowsheet" indicated the following:

-"3/17/2025 at 2:23 p.m., documented by Certified Nursing Assistant (CNA) 1: supine (lying flat) heart rate = 74 beats per minute (bpm, unit of measure) and supine blood pressure = 95/47 millimeters of mercury (mmHg, unit of measure); standing heart rate = 90 bpm and standing blood pressure = 113/47 mmHg;
-3/17/2025 at 5:01 p.m., documented by CNA 2: supine heart rate = 79 bpm and supine blood pressure = 130/67 mmHg;
-3/17/2025 at 5:03 p.m., documented by CNA 2: standing heart rate = 97 bpm and standing blood pressure = 121/69 mmHg."
-The "Orthostatic Vital Signs Flowsheet" also indicated there was no documented orthostatic vital signs by night shift nurse (RN 12) on 3/17/2025."

During the same interview on 3/20/2025 at 4:05 p.m. with Chief Nurse Executive (CNE), the CNE stated the following: the orthostatic vital signs done on 3/17/2025 at 2:23 p.m. and 5:01 p.m. were incomplete because both sets were missing the sitting position vital signs. In addition, Night shift staff did not perform any orthostatic vital signs check on 3/17/2025 (7 p.m. to 7 a.m. next day). It was important to perform orthostatic vital signs check correctly to evaluate if Patient 10 had orthostatic hypotension or not.

During a review of the facility's policy and procedure (P&P) titled, "Orthostatic Vital Signs," dated 1/2023, the P&P indicated, "Orthostatic monitoring shall be done by a Registered Nurse (RN). Orthostatic vital signs may be performed by a RN or Nursing Assistant. The frequency of performing the monitoring is determined by Physician's Orders and/or patient's condition ... Documentation: Record supine (flat), sitting, and upright (stand) blood pressure and pulse readings in electronic medical record."

Based on interview and record review, the facility failed to ensure one of 32 sampled patient's (Patient 12) individualized nursing care plan (a documented strategy that outlines patient care goals, interventions, and evaluations to address specific health issues and provides a means of communication among health care providers) to address Patient 12's newly identified skin injury, was initiated and updated, in accordance with the facility's policy and procedure regarding developing and implementing care plans.

This deficient practice had the potential for Patient 12's care needs and risks not properly addressed, which may result in delayed implementation of interventions to promote healing of the skin injury and prevent worsening of skin breakdown (damage to the skin and tissues due to prolonged pressure) that could lead to complications such as infection, etc.

Findings:

During a review of Patient 12's History and Physical (H&P, the most formal and complete assessment of the patient and the problem), dated 4/15/2024, the H&P indicated that Patient 12 was admitted to the facility's intensive care unit ( ICU, department that provides specialized care for patients with serious illnesses or injuries) on 4/15/2024, with a diagnosis of cardiovascular arrest (a medical emergency where the heart suddenly and unexpectedly stops beating, leading to a lack of blood flow to the brain and other vital organs).

During a review of Patient 12's medical record (MR) titled, "Nursing Initial Assessment (the first comprehensive evaluation a nurse conducts upon a patient's arrival, gathering both subjective and objective data to understand patient's health status and needs, forming the foundation for the care plan)-Integumentary (the skin and its accessory structures)," dated 4/16/2024, the MR indicated that Patient 12 had no skin injuries (skin documented as intact) upon admission to the ICU on 4/16/2024.

During a concurrent interview and record review on 3/20/2025 at 10:16 a.m. with the Quality Coordinator (QC 2), Patient 12's medical record (MR) titled, "Braden Score, (used to predict the risk of developing pressure ulcers [bedsores] by assessing six key factors: sensory perception, moisture, activity, mobility, nutrition, and friction/shear), dated 4/15/2024, was reviewed. The QC stated that Patient 12's recorded Braden score was 10 (indicates high risk for developing a pressure injury).

During a review of Patient 12's medical record (MR) titled, "Care Plan (a documented strategy that outlines patient care goals, interventions, and evaluations to address specific health issues and provides a means of communication among health care providers)," the MR indicated that nursing staff initiated "Skin Injury, Risk (a structured nursing care plan to identify, assess, and manage factors that increase a patient's risk of developing skin injuries or complications, aiming to prevent or minimize such injuries)" preventive care plan on 4/17/2024 (Two days after Patient 12 was admitted and assessed to have a Braden Score of 10).

During a concurrent interview and record review on 3/20/2025 at 10:16 a.m. with the Quality Coordinator (QC 2), Patient 12's medical record (MR) titled, "[Physician's] Orders," dated 4/24/2024, was reviewed. The MR indicated that on 4/24/2024 a wound care consultation (a specialized assessment and treatment plan by a wound care expert, often a nurse, to address complex or non-healing wounds, aiming to promote optimal healing and improve patient outcomes) order, was placed to evaluate Patient 12's newly identified skin issues. The QC 2 stated that on 4/25/2024, a wound care nurse (WCN) evaluated Patient 12, and documented the following: " ...right buttock with intact blood blister ...left tongue trauma (bite) injury .... right ear partial thickness tissue loss (a wound or injury that damages only the outer layers of the skin) ...Please reconsult [WCN] if the wound(s) worsen or condition changes ..."

During an interview on 3/20/2025 at 11:29 a.m., with the Wound Care Nurse (WCN), WCN stated that a skin injury prevention care plan (skin injury, at risk) is initiated based on the initial nursing assessment, any skin anomaly (a deviation from normal skin condition), and the Braden score, and S.K.K.I.N. (Skin care, Kinetic Mobilization, Keep Moving, Incontinence Management, Nutrition) bundle recommendations for interventions. The WCN also stated that for any patient with a Braden score below 18 (at risk for developing skin injury), a nurse should initiate a skin injury prevention care plan.

During the same interview on 3/20/2025 at 11:29 a.m. with the wound care nurse (WCN), the WCN stated that once a skin injury or wound has been identified, the wound care plan must be initiated and customized with interventions specific to the patient's particular skin injury recognized.

During a review of Patient 12's medical record (MR) titled, "Care Plan," dated 4/24/2024 through 5/7/2024, the MR indicated that nursing staff did not initiate a wound(s) new care plan for Patient 12's identified skin injuries on 4/25/2024.
During a review of the facility's policy and procedure (P&P) titled, " Plan of Care/Assessment/Reassessment of Patients," dated 1/2022, the P&P indicated the following: "The care and treatment provided for each patient is based on a determination of the patient's needs as obtained through initial assessment and analysis of data collected by the health care team related to the patient's physical, psychosocial, and spiritual status ... 4.11.1 Each patient's plan for care, treatment and services is individualized and appropriate to the patient's needs, strengths, limitations and goals. 4.11.3 Plan of Care must be evaluated every 24 hours by the RN for nursing and other disciplines as appropriate."

During a review of the facility's policy and procedure (P&P) titled, "Pressure Injuries-Prevention and Treatment," dated 1/2025, the P&P indicated the following: "5.3.1 RN to initiate wound consult and takes picture and measurements of wound. 5.5 The registered nurse will update the plan of care accordingly."

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

1. Ensure one of 32 sampled patients (Patient 1), who had undergone surgery just an hour earlier, and whose respiration rate dropped from 17 breaths per minute to 5 breaths per minute (Normal= 12 to 20 breaths per minute), was properly addressed, in accordance with physician's orders and the facility's policy and procedure regarding "Plan of Care/Assessment/Reassessment of Patients."

This deficient practice increased the risk of respiratory distress (a serious lung condition that causes low blood oxygen) for Patient 1 including delayed emergency response, and potential life-threatening complications such as multiple organ failure and/or death.

2. Ensure one of 32 sampled patients (Patient 7), who was identified as a high fall (an event where a patient comes to rest inadvertently on the ground, floor, or other lower level, whether or not an injury occurs) risk, was properly supervised, in accordance with the facility's policy and procedure regarding "Adult Falls Prevention Policy." Patient 7 entered the bathroom with door closed while connected to an IV (Intravenous- through the vein) pump and an oxygen tank.

This deficient practice increased the risk of falls, entanglement with the medical equipment in a confined space, and delayed assistance in the event of an emergency, thus compromising Patient 7's safety.

3. Ensure one of 32 sampled patient's (Patient 8) vital signs (includes blood pressure, temperature, respiration, and heart rate), were taken per physician's order and in accordance with the facility's policy regarding obtaining vital signs.

This deficient practice had the potential to result in Patient 8's abnormal vital signs not being monitored properly, remain undetected, or the physician not notified of any changes in vital signs, which may lead to delayed implementation of necessary interventions resulting in complications such as hypotension (low blood pressure), etc. 4. Ensure one of 32 sampled patient's (Patient 10) orthostatic vital signs (measurement of blood pressure and heart rate taken while a patient is lying down, sitting up and standing up) were monitored or checked as ordered by the physician, and in accordance with the facility's policy regarding vital signs check. This deficient practice had the potential to result in Patient 10's abnormal vital signs going undetected, the physician not being notified for changes in vital signs, which may delay the implementation of necessary interventions to prevent complications such as hypotension (low blood pressure), etc.

5. Ensure that nursing staff documented the peripherally inserted intravenous catheter (PIV, a thin flexible tube inserted into a vein for short-term intravenous access) for one of 32 sampled patients (Patient 20), in Patient 20's electronic medical record (EMR, digital version of paper chart), in accordance with the facility's policy regarding non-central venous access devices (catheters inserted into veins that are not located in the major veins near the heart, but rather in peripheral veins like those in the arms or legs).

This deficient practice had the potential for inadequate monitoring, assessment or intravenous (IV, through the vein) catheter care for patient 20, which may increase the risk of infection at the IV insertion site.

6. Ensure one of 32 sampled patent's (Patient 16) tube feeding (nutritional support provided through a feeding tube directly into the stomach or small intestine), was labeled with the date, time and initials of the staff who initially hung the tube feeding container, in accordance with the facility's policies and procedures regarding tube feeding.

This deficient practice had the potential for compromising Patient 16's safety when using outdated feeding solutions, which can lead to contamination and subsequent infections.

7. Ensure one of 32 sampled patient's (Patient 15) irrigation solution (a sterile fluid, like saline, used to cleanse wounds, body cavities, or surgical sites, removing debris and bacteria to promote healing and prevent infection) containing sterile (completely free from germs) water, was labeled with the date and time of when the sterile solution container was opened, in accordance with the facility's policy and procedure regarding safe medication practices.

This deficient practice had the potential to increase risk of contamination of the irrigation solution which could lead to infections including prolonged hospitalization for Patient 15.

Findings:

1. During a review of Patient 1's "Pre- Operative History and Physical Exam (H&P, a formal assessment of the patient and the problem)," dated 7/31/2024, the "H&P" indicated, Patient 1's test result for transrectal ultrasound-guided prostate biopsy (TRUSP, a procedure used to obtain tissue samples from the prostate gland) indicated Patient 1's test result was positive for prostatic adenocarcinoma (cancer of the prostate). The H&P further indicated, "We have had an opportunity to meet at length to discuss his (Patient 1) prostate cancer and the available options, and he (Patient 1) has decided to go forth with robot-assisted laparoscopic radical prostatectomy (a minimally invasive surgery to remove the entire prostate gland and some surrounding tissue, using a robotic system). He (Patient 1) understands that he (Patient 1) will need a Foley catheter (a thin, flexible tube inserted into the bladder to drain urine) for 1-2 weeks following the operation, and that he (Patient 1) will have a surgical drain (a tube inserted after surgery to remove excess fluids) as well."

During a review of Patient 1's "Urology (a branch of medicine that focus on the function and disorders of the urinary system) Service" operative note, dated 7/31/2024, the operative note indicated Patient 1 "...With prostate cancer. After reviewing all options with the patient (Patient 1), we decided to go forth with robot-assisted laparoscopic radical prostatectomy ... The patient (Patient 1) tolerated the procedure well, was awaken from anesthesia (medicines to prevent pain during surgery and other procedures), and transferred to recovery room in stable condition."

During a concurrent interview and record review on 3/20/2025 at 1:45 p.m. with the Charge nurse of the Post-Anesthesia Care Unit (PACU, a specialized area where patients are closely monitored after surgery or procedures involving anesthesia) (CN) 3, Patient 1's "Medication Administration Record (MAR)," dated 7/31/2024, was reviewed. The MAR indicated:

-On 7/3/2024 at 11:32 a.m., Hydromorphone (a drug used to treat moderate to severe pain) 0.4 milligram (mg, a unit of measurement) intravenous, was administered for pain level "moderate pain (4-6)."
-On 7/3/2024 at 11:32 a.m., Fentanyl (a powerful drug used in the treatment of severe pain) 25 micrograms (mcg, a unit of measurement) intravenous, was administered for pain level "severe pain (7-10)."

During the same concurrent interview and record review on 3/20/2025 at 1:45 p.m. with CN 3, Patient 1's MAR was reviewed. The MAR indicated, on 7/31/2024, for the 11:32 a.m. Fentanyl administration, both pain medications were administered at the same time for two different orders with different pain level parameters. CN 3 stated both pain medications should not have been given at the same time. CN 3 confirmed that the pain medications should be given based on the physician's order. CN 3 stated after one pain PRN (as needed) medication was given, the patient should be re-evaluated in thirty minutes and if the patient's pain level was higher, then administer the next pain medication dose as ordered.

During a concurrent interview and record review on 3/20/2025 at 2:29 p.m. with the Manager of PACU (MN) 3, Patient 1's "Vital Flowsheet (a document used by doctors and nurses to keep track of a patient's health over time)," dated 7/31/2024, was reviewed. The flowsheet indicated, on 7/31/2025, Patient 1's respiration rate was as follows:

-At 11:45 a.m., respiration rate was at 17 breaths per minute
-At 12:00 p.m., respiration rate was at 15 breaths per minute
-At 12:16 p.m., respiration rate was at 15 breaths per minute
-At 12:30 p.m., respiration rate was at 3 breaths per minute
-At 1:00 p.m., respiration rate was at 5 breaths per minute
-At 1:10 p.m., respiration rate was at 11 breaths per minute

During the same interview on 3/20/2025 at 2:29 p.m. with MN 3, MN 3 confirmed that after reviewing Patient 1's medical record, there was no documented evidence that the abnormal respiration rate was addressed. There was no documented comment that the vital signs were documented in error, and there was no documented evidence that the physician was notified. MN 3 stated, "The process that is expected in this situation is for the RN (Registered Nurse) to fix the monitor and fix the data." MN 3 stated the RN should add a comment or something to indicate it was not a true respiration rate (If that was the case). MN 3 further stated, "Because we want to make sure the patient did not have an event or something and to address it, and to make the chart (patient's medical record) accurate and following care plan."

During an interview on 3/21/2025 at 11:42 p.m. with the Supervisor of Pharmacy Services (PHARM), PHARM stated, "The goal is each medication covers a certain pain level parameter. Should not be given both at once, as it is covering for a different pain parameter." PHARM confirmed that there was a risk of respiratory depression if given more than what was ordered by the physician, and PHARM stated, "We should give medication based on parameters ordered."

During a review of Patient 1's "Order Report," dated 7/31/2024, the order report indicated, Patient 1 had an order that indicated, "Notify anesthesia (a medical specialty focused on the total perioperative care of patients, including anesthesia, pain management, and critical care, before, during, and after surgery) for ...respiratory rate less than 8 or greater than 30," The order started on 7/31/2024 at 11:15 a.m. through 7/31/2024 at 8:19 p.m.

During a review of the facility's policy and procedure (P&P) titled, "Plan of Care/Assessment/Reassessment of Patients," dated 1/2022, the P&P indicated, " The purpose of the patient assessment is: To determine what kind of care is required to meet a patient's initial needs, as well as his or her needs as they change in response to care ... Patients are reassessed by Nursing every shift and as needed. The scope and intensity of further assessments are based on the patient's diagnosis, setting, patient's desire for care, treatment, and services. In addition, a reassessment may be based on the patient's response to any previous care, treatment, and services. Unexpected negative changes in the patient's status will result in the nursing staff contacting the physician. Reassessments by the clinical staff occur at regular intervals, per department policy, to determine a patient's response to care provided. A significant change in a patient's condition or diagnosis will result in a reassessment ... Respiratory Care Services may be indicated when a patient shows a need for increased oxygen support, apnea, shortness of breath, increased work for breathing, cardiac arrest, impending respiratory or ventilatory failure, pulmonary dysfunction due to acute or chronic pulmonary disease, trauma, or postoperative recovery ..."

During a review of the facility's policy and procedure (P&P) titled, "Vital Signs," dated 3/2023, the P&P indicated, "Additional vital signs should be taken for any of the following reasons: Additional vital signs should be taken whenever the physician or Registered Nurse (RN) assesses such a need exists. The Nurse Assistant will notify the RN of vital signs that are not within the normal parameters. Respiration Rate (breaths/minute) Less than 12."

2. During a review of Patient 7's "History and Physical (H&P)," dated 3/17/2025, the "H&P" indicated, Patient 7 had "Pancreatic (a large gland in the back of the belly. It helps with digestion and helps to regulate blood sugar) mass, DM type 2 (Type 2 diabetes mellitus is a chronic (long-lasting) condition where the body does not use insulin effectively or does not produce enough insulin to regulate blood sugar level), HTN (high blood pressure) ...who presented with fatigue associated w(with)/lack of appetite."

During a concurrent observation and interview on 3/18/2025 at 2:30 p.m. with Charge Nurse (CN) 1in the corridor of Patient 7's room, Patient 7 was in the restroom with the door closed, there was a nursing staff standing by the bed in the room. CN 1 stated, if the patient was a high fall (an event where a patient comes to rest inadvertently on the ground, floor, or other lower level, whether or not an injury occurs) risk, the staff must accompany the patient to the restroom or have a crack in the door to have visual of the patient. At 2:33 p.m. Patient 7, hunched over, opened the restroom door, pushing the IV (intravenous- through the veins) pump (a medical device that delivers fluids, medications, or nutrients into a patient's bloodstream) out of the restroom. When Patient 7 took a few steps out of the restroom, that was when nursing staff came to assist.

During an interview on 3/18/2025 at 2:40 p.m. with charge nurse (CN) 2, CN 2 stated Patient 7 required oxygen, thus Patient 7 also had the portable oxygen tank with him (Patient 7) in the restroom. CN 2 stated the restroom door should not be completely closed if the staff did not go inside the restroom with Patient 7. CN 2 stated there must be visual of the patient (Patient 7) for safety.

During a concurrent interview and record review on 3/20/2025 at 11:45 p.m. with the Director of Education for Nursing Services (DIR) 8, Patient 7's Electronic Medical Record (EMR, a digital version of the paper charts in hospitals) document titled, "Hester Davis Fall Risk Assessment (scale for falls risk assessment developed to predict anticipated falls in adult patients)," dated 3/18/2025, was reviewed. The assessment indicated Patient 7 was assigned a score of 19. DIR 8 stated a score greater than or equal to 15 was considered a high fall risk.

During a concurrent interview and record review on 3/19/2025 at 3:40 p.m. with Registered Nurse Quality Coordinator (QC) 3, Patient 7's EMR document titled, "Musculoskeletal," assessment, dated 3/18/2025, was reviewed. The assessment indicated Patient 7 had "generalized weakness." QC 3 confirmed that due to Patient 7 having generalized weakness, this can increase the chance of falling if the Patient 7 was out of bed without assistance and without staff having visual of the patient (Patient 7).

During a review of the facility's policy and procedure (P&P) titled, "Adult Falls Prevention Policy," dated 12/19/2023, the P&P indicated, "To establish a process to identify patients who are at risk for falls and institute an appropriate Plan of Care and management to prevent occurrence of falls ... Registered Nurses are responsible for implementation and oversight of the individualized patient fall prevention care ... Fall risk patients should not be left unattended while toileting and kept within arm's reach."

3. During a review of Patient 8's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 3/18/2025, the H&P indicated, Patient 8 was admitted to the facility with diagnoses including but not limited to encephalopathy (a broad term for any brain disease that alters brain function or structure), major depressive disorder (MDD, a mental health disorder characterized by persistently depressed mood or loss of interest in activities, causing significant impairment in daily life), delusional disorder (a mental health condition characterized by persistent false beliefs that are not based on reality), and major neurocognitive disorder (a group of condition that affect a person's abilities of memory, attention, reasoning and problem-solving) due to dementia.

During a review of Patient 8's "Physician Order," dated 3/18/2025 at 5:15 a.m., the "Physician Order," indicated, assess blood pressure, temperature, pulse, respiratory rate every four (4) hours for initial 24 hours then every eight (8) hours.

During a concurrent interview and record review on 3/20/2025 at 11:26 a.m. with the Registered Nurse Quality Consultant (QC) 6, Patient 8's "Vital Signs Flowsheet (VS flowsheet)," dated on from 3/18/2025 to 3/19/2025, was reviewed. The VS flowsheet indicated nursing staff took Patient 8's vital signs as follows:

-On 3/18/2025 at 4:35 a.m., 8 a.m., 3:26 p.m., 6:52 p.m., 11:33 p.m. and on 3/19/2025 at 7:11 a.m.
-QC 6 stated there were missing vital signs not documented on 3/18/2025 at 12 p.m. and on 3/19/2025 at 3:30 a.m.

During an interview on 3/20/2025 at 3:37 p.m. with the Chief Nurse Executive (CNE), CNE stated nursing staff should notify physician for any reason when vital signs were not taken per physician order. CNE stated there was no documentation in Patient 8's medical record that physician was notified for vital signs not taken. CNE stated it was important to follow physician order to monitor vital signs in order to monitor Patient 8 appropriately.

During a review of the facility's policy and procedure (P&P) titled, "Vital Signs," dated 3/2023, the P&P indicated, "All patients will have routine vital signs (temperature, pulse, respiration, and blood pressure) measured and recorded three times each 24 hours period. Routine vital signs will be measured and recorded per unit protocol and/or more frequently depending on patient's status ... All vital signs should be entered onto the patient's electronic medical record as soon as possible ... Additional vital signs should be taken whenever the physician or Registered Nurse (RN) assesses such a need exists."

4. During an interview on 3/18/2025 at 2:24 p.m. with Patient 10, Patient 10 stated she (Patient 10) came to the facility because of low blood pressure.

During a review of Patient 10's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 3/17/2025, the H&P indicated, Patient 10 came to the facility's emergency room due to lightheadedness (a sensation of being about to pass out). The H&P also indicated, Patient 10 was admitted to the facility with diagnoses including but not limited to hyponatremia (a condition where the sodium [salt] level in the blood is abnormally low), diarrhea (loose stools), and anemia (a condition marked by a deficiency of red blood cells or of hemoglobin [carries oxygenated blood to various organs in the body] in the blood, resulting in pallor [pale] and weariness).

During a review of Patient 10's "Physician Order," dated 3/17/2025, the "Physician Order" indicated, measure orthostatic vital signs (measurement of blood pressure and heart rate taken while a patient is lying down, sitting up and standing up) every shift."

During an interview on 3/20/2025 at 3:59 p.m. with the Chief Nurse Executive (CNE), CNE stated the following: orthostatic vital signs involved taking vital signs when the patient was in lying position, sitting position and standing position. The Certified Nursing Assistant could take the orthostatic vital signs, but the Registered Nurse was responsible to make sure it was done completely and correctly.

During a concurrent interview and record review on 3/20/2025 at 4:05 p.m. with CNE. Patient 10's Orthostatic Vital Signs Flowsheet, dated from 3/17/2025 to 3/18/2025, was reviewed. The "Orthostatic Vital Signs Flowsheet" indicated the following:

-"3/17/2025 at 2:23 p.m., documented by Certified Nursing Assistant (CNA) 1: supine (lying flat) heart rate = 74 beats per minute (bpm, unit of measure) and supine blood pressure = 95/47 millimeters of mercury (mmHg, unit of measure); standing heart rate = 90 bpm and standing blood pressure = 113/47 mmHg;
-3/17/2025 at 5:01 p.m., documented by CNA 2: supine heart rate = 79 bpm and supine blood pressure = 130/67 mmHg;
-3/17/2025 at 5:03 p.m., documented by CNA 2: standing heart rate = 97 bpm and standing blood pressure = 121/69 mmHg." The "Orthostatic Vital Signs Flowsheet" also indicated there was no documented orthostatic vital signs by night shift nurse (RN 12) on 3/17/2025.

During the same interview and record review on 3/20/2025 at 4:05 p.m. with CNE, the CNE stated the following: the orthostatic vital signs done on 3/17/2025 at 2:23 p.m. and at 5:01 p.m. were incomplete because both sets were missing the sitting position vital signs. Night shift did not perform any orthostatic vital signs check on 3/17/2025 (7 p.m. to 7 a.m. next day). It was important to perform orthostatic vital signs check correctly to evaluate if Patient 10 had orthostatic hypotension or not.

During a review of the facility's policy and procedure (P&P) titled, "Orthostatic Vital Signs," dated 1/2023, the P&P indicated, "Orthostatic monitoring shall be done by a Registered Nurse (RN). Orthostatic vital signs may be performed by a RN or Nursing Assistant. The frequency of performing the monitoring is determined by Physician's Orders and/or patient's condition ... Documentation: Record supine (flat), sitting, and upright (stand) blood pressure and pulse readings in electronic medical record."

5. During a review of Patient 20's medical record (MR) titled, "ED Provider Notes," dated 3/18/2025, the MR indicated that on 3/18/2025, Patient 20 presented in the Emergency Department (ED) with complaint of gradual onset of lower abdominal pain and loose stools.

During an observation on 3/18/2025 at 1:05 p.m., multiple intravenous (IV, into the vein) catheters/cannula (short, flexible tubes inserted into a vein to deliver medications, fluids, or nutrients directly into the bloodstream), were observed left lying on Patient 20's bedside table, in the Emergency Department (ED, a hospital facility staffed and equipped to provide immediate medical care to patients with serious injuries or illnesses that require urgent attention). Patient 20 was observed lying on a gurney with a peripheral IV line inserted into the right forearm (right antecubital fossa (the crease of the elbow, common site for placing IV lines).

During a concurrent observation and interview on 3/18/2025 at 1:10 p.m. with the Director of the ED (Dir 6), the Dir 6 stated that the IV cannulas and the vacutainer should not have been left at Patient 20's bedside and then said that Patient 20's nurse must have just inserted an IV line on Patient 20.

During a review of Patient 20's medical record (MR) titled, "ED Notes-Registered Nurse (RN)," dated 3/18/2025, at 11:08 a.m., the MR indicated the following: " ...Patient (Patient 20) in gown, stable ...IV/LABS (laboratory work) done ( refers to IV insertion and or administration of intravenous fluids or medications and laboratory tests that have been performed on blood or other samples collected via an intravenous [IV] line).

During a concurrent interview and record review on 3/20/2025 at 3:01 p.m. with Quality Coordinator (QC 2), Patient 20's medical record (MR) titled, "Documentation Flowsheet-LDA (LDA stands for Lines, Drains, and Airways, referring to medical devices used to administer fluids, remove fluids, or manage a patient's breathing)," dated 3/18/2024, was reviewed. The MR indicated that no documentation of the insertion (peripheral IV catheter documentation which should include: Date and time of insertion, number of attempts, and location; length and gauge [or size] of device, site preparation [CHG stands for chlorhexidine gluconate, a powerful antiseptic agent used to reduce germs on the skin and prevent infections, alcohol, or povidone-iodine, an antiseptic], and type of dressing used after insertion) of the peripheral intravenous (PIV) line, was recorded during Patient 20's stay in the Emergency Department (ED) from 3/18/2025 through 3/19/2025. The QC 2 stated that nursing staff did not document the insertion of the peripheral IV (PIV) line, but documented the removal of the peripheral IV (PIV) line in Patient 20's electronic medical record (eMR) titled, "Documentation Flowsheet-LDA," on 3/19/2025 at 2:51 p.m.

During a review of the facility's policy and procedure (P&P) titled, "Central and Non-Central Venous Access Device Policy," dated 10/2023, the P&P indicated that 5.8.1. Document all insertion, care and maintenance, removal, exchange, and etcetera related elements included on the Lines, Drains, and Airways (LDA, a structured method for documenting and managing various medical devices used in patients, including lines (like IVs and catheters), drains, and airways (like endotracheal tubes) in the electronic medical record (eMR).

6. During a concurrent observation and interview on 3/18/2025 at 2:17 p.m. with Registered Nurse (RN) 6, in Patient 16's room, Patient 16's tube feeding (a method of delivering nutrients to someone who cannot or will not eat or consume enough nutrients by mouth, using a tube to deliver a liquid formula directly into the stomach) container, had no label indicating the date, time, and initials of the nurse who initiated the tube feeding. RN 6 stated the following: "The tube feeding bag should be labeled with the patient's name, room number, and the date and time when it was started because the feeding can only run for 24 hours. I hung the feeding around 8 a.m. this morning (3/18/2025), but I forgot to label the bag." RN 6 then proceeded to label the feeding container for Patient 16 and said that the initiation of feeding for Patient 16 was recorded in Patient 16's electronic medical record (eMR, digital version of paper chart).

During an interview on 3/20/2025 at 4:21 p.m. with the Clinical Educator (CE 1), the CE 1 stated that nurses were required to label the tube feeding container with the time, date, and initials reflecting the start time for the tube feeding. The CE 1 also said that nurses should also document tube feeding administration in the patient's medical records, in addition to labeling the container with the feeding, prior to administration. The CE 1 stated, per policy, both actions were required.

During a review of Patient 16's History and Physical (H&P, the most formal and complete assessment of the patient and the problem," dated 3/14/2025, the H&P indicated that Patient 16 was admitted with a diagnosis of pneumonia (an infection of the lungs that causes inflammation of the air sacs and can lead to accumulation of pus and fluid in the lungs). The H&P also indicated that Patient 16 had gastrostomy tube (G-tube, is a thin, flexible tube inserted through the abdominal wall and into the stomach) placed on 2/28/2025.

During a review of Patient 16's medical record (MR) titled, "[Physician] Orders," dated 3/18/2025, the MR indicated that Patient 16 had a standing order for [Brand] tube feeding to be administered at 55 milliliters (ml, measuring unit) per hour (mL/h) for the duration of 22 hours a day, with a start time at 7:00 a.m. and end time at 5:00 a.m.

During a review of the facility's policy and procedure (P&P) titled, "Gastrostomy/Nasogastric/Jejunostomy Tube Feeding, (Gastrostomy, a surgical procedure used to insert a tube, often referred to as a "G-tube", through the abdomen and into the stomach),/Nasogastric (reaching or supplying the stomach via the nose)/ Jejunostomy (a surgical procedure that creates an opening [stoma] in the jejunum, the middle section of the small intestine)," dated 3/2023, the P&P indicated the following: The purpose of tube feeding is to provide nutrition by administering formula into the stomach when the patient is unable to feed by mouth. Tube feeding bags shall be changed every 24 hours and should be labeled as indicated."

7. During an observation on 3/18/2025 at 1:33 p.m. in Patient 15's room, in the Intensive Care Unit (ICU, a specialized hospital department providing critical care and life support to patients with serious, potentially life-threatening illnesses or injuries, requiring intensive monitoring and treatment), an irrigation solution bottle containing sterile water (used for rinsing, cleansing, or flushing wounds, body cavities, or medical devices) was observed by the sink. The sterile water (purified water that is free of germs) was used for medical purposes to prevent infections. The solution bottle was observed to be halfway full, indicating that it had already been opened and used.

During an interview on 3/18/2025 at 1:33 p.m. with the ICU Manager (NM 4), NM 4 stated that the solution bottle in Patient 15's room should have been labeled after opening. NM 4 also stated that opened bottle solutions were only good for 24 hours (should be discarded after).

During an interview on 3/21/2025 at 10:21 a.m. with the pharmacist (Pharm), the Pharm stated the following: "Typically irrigation solutions are meant for single use only. Sterile water container should be used within 24 hours after opening and then discarded. This is in accordance with our policy."

During a review of Patient 15's History and Physical (H&P, the most formal and complete assessment of the patient and the problem), dated 3/18/2025, the H&P indicated that Patient 15 was admitted to the facility on 3/18/2025 with a diagnosis of encephalopathy (a disease in which the functioning of the brain is affected by some agent or condition, such as viral infection or toxins in the blood).

During a review of the facility's policy and procedure (P&P) titled, "Safe Medication Practices: Medication Labeling in the Perioperative and Procedural Settings," dated 12/22/2025, the P&P indicated the following: At minimum, all medications and solutions should be labeled with the drug name, strength of the medication or solution, amount (if not apparent from the container) expiration date when not used within 24 hours and expiration time occurs in less than 24 hours ... Solutions include chemicals and reagents such as 5.4.2.3 Sterile Water

Based on interview and record review, the facility failed ensure pain medications were given as ordered by the physician for three of 32 sampled patients (Patient 1, Patient 3, and Patient 21), in accordance with the facility's policy regarding medication administration.

This deficient practice had the potential for ineffective pain relief for the patients, which may result to worsening of pain, psychological distress, etc.

Findings:

1. During a review of Patient 1's "Pre- Op (Pre-operative) History and Physical Exam (H&P, a complete assessment of the patient and the problem)," dated 7/31/2024, the "H&P" indicated, Patient 1's test result for transrectal ultrasound-guided prostate biopsy (TRUSP, a procedure used to obtain tissue samples from the prostate gland) indicated Patient 1's test result was positive for prostatic adenocarcinoma (cancer of the prostate). The H&P further indicated, "We have had an opportunity to meet at length to discuss his (Patient 1) prostate cancer and the available options, and he (Patient 1) has decided to go forth with robot-assisted laparoscopic radical prostatectomy (a minimally invasive surgery to remove the entire prostate gland and some surrounding tissue, using a robotic system). He (Patient 1) understands that he (Patient 1) will need a Foley catheter (a thin, flexible tube inserted into the bladder to drain urine) for 1-2 weeks following the operation, and that he (Patient 1) will have a surgical drain (a tube inserted after surgery to remove excess fluids) as well."

During a review of Patient 1's "Urology Service" operative note, dated 7/31/2024, the operative note indicated Patient 1 was "...With prostate cancer. After reviewing all options with the patient (Patient 1), we decided to go forth with robot-assisted laparoscopic radical prostatectomy ... The patient (Patient 1) tolerated the procedure well, was awaken from anesthesia (medicines to prevent pain during surgery and other procedures), and transferred to recovery room in stable condition."

During a concurrent interview and record review on 3/20/2025 at 1:45 p.m. with the Charge nurse of the Post-Anesthesia Care Unit (PACU, a specialized area where patients are closely monitored after surgery or procedures involving anesthesia) (CN) 3, Patient 1's "Medication Administration Record (MAR)," dated 7/31/2024, was reviewed. The MAR indicated:

-On 7/3/2024 at 11:32 a.m., Hydromorphone (a drug used to treat moderate to severe pain) 0.4 milligram (mg, a unit of measurement) intravenous (IV, through the vein), was administered for pain level "moderate pain (4-6)."
-On 7/3/2024 at 11:32 a.m., Fentanyl (a powerful drug used in the treatment of severe pain) 25 micrograms (mcg, a unit of measurement) intravenous, was administered for pain level "severe pain (7-10)."
-The MAR indicated, on 7/31/2024, for the 11:32 a.m., both pain medications were administered at the same time for two different orders' with different pain level parameters. CN 3 stated both pain medications should not have been given at the same time. CN 3 confirmed that the pain medications should be given based on the physician's order. CN 3 stated that after one pain PRN (as needed) medication was given, the patient should be re-evaluated in thirty minutes, and if the patient's pain was higher, then administer the next pain medication dose as ordered.

During an interview on 3/20/2025 at 2:29 p.m. with the Manager of PACU (MN) 3, MN 3 stated, "Two pain medication given at the same time is not a usual practice. If one (PRN pain medication) is not working, we will transition to next one. This is an error that will be looked into."

During an interview on 3/21/2025 at 11:42 p.m. with the Supervisor of Pharmacy Services (PHARM), PHARM stated, "The goal is each medication covers a certain pain level parameter. Should not be given both at once, as it is covering for a different pain parameter." PHARM confirmed that there was a risk of respiratory depression if given more than what was ordered by the physician, and PHARM stated, "We should give medication based on parameters ordered."

During a review of the facility's policy and procedure (P&P) titled, "Medication Administration," dated 11/2024, the P&P indicated, "Ensuring that medications are given safely and accurately following the eight (8) rights of medication administration ...1. Right Patient 2. Right Medication 3. Right Dose 4. Right Time 5. Right Route 6. Right Documentation 7. Right Reason 8. Right Response ... Medications to be administered shall be verified with the prescribing practitioner's orders."

During a review of the facility's policy and procedure (P&P) titled, "Medication Error Reporting," dated 7/30/2024, the P&P indicated, "Medication Error: A preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer ... In the context of this policy, Drug Administration Errors is limited to those errors in administration that actually reach the patient, i.e., a medication is administered to a patient when it should not be, or the wrong dose is administered."

2. During a review of Patient 3's "History and Physical (H&P)," dated 3/9/2025, the "H&P" indicated, Patient 3 was brought to the emergency department (ED, provides immediate medical care for patients needing urgent attention) for low blood pressure, and profound weakness. The H&P further indicated Patient 3's medical history included chronic pancreatitis (a long-lasting inflammation of the pancreas that causes permanent damage), growing pancreatic cyst (a fluid-filled sac that forms on or within the pancreas), and stroke (occur when blood flow to the brain is blocked or there is sudden bleeding in the brain) with right hemiplegia (paralysis affecting one side of the body).

During a concurrent observation and interview on 3/18/2025 at 2:15 p.m. with the Director of Nursing for Adult Services (DIR) 2, in the corridor of Patient 3's room, Patient 3 exhibited labored breathing, including: irregular breathing patterns, and gasping for breath. DIR 2 stated, "The patient (Patient 3) is on comfort care. They should have medication order for labored breathing."

During a concurrent observation and interview on 3/18/2025 at 2:15 p.m. with Registered Nurse (RN) 2, in the corridor of Patient 3's room, RN 2 stated Patient 3 had an order to administer Morphine (a potent pain reliever also used to ease respiratory distress in palliative care [focuses on improving the quality of life for people with serious, life-limiting illnesses]) for respiratory distress (a serious lung condition that causes low blood oxygen). RN 2 assessed Patient 3' breathing, RN 2 stated, "I will administer the Morphine now."

During a concurrent interview and record review on 3/19/2025 at 4:00 p.m. with Registered Nurse Quality Coordinator (QC) 3, Patient 3's "Documentation Flow sheet (document used to record and monitor patient assessments and measurements over time)," dated from 3/14/2025 through 3/18/2025, was reviewed. The flowsheet indicated Patient 3's respiratory assessments were being performed only twice daily (once a shift), with the last recorded assessment on 3/18/2025, which was completed over six hours ago at 8:00 a.m. prior to the observation at 2:15 p.m. QC 3 confirmed that if patients were on comfort care requiring medication for respiratory distress, the patients should have more frequent respiratory assessments.

During a concurrent interview and record review on 3/19/2025 at 4:05 p.m. with Registered Nurse Quality Coordinator (QC) 3, Patient 3's "Medication Administration Record," dated 3/18/2025, was reviewed. The MAR indicated a physician ordered Morphine 2 milligram (mg) dose to be administered for "signs of respiratory distress," every hour, as needed. QC 3 confirmed the last dose was administered at 8:59 a.m. on 3/18/2025 which was over five hours before Patient 3 was observed with labored breathing at 2:15 p.m. on the same day. QC 3 confirmed that patients experiencing respiratory distress should be closely monitored, and medication should be administered promptly as needed.

During an interview on 3/19/2025 at 4:55 p.m. with Palliative Care Registered Nurse (RN) 3, RN 3 stated that Morphine for comfort care in respiratory distress was intended to relax breathing, reduce air hunger and the effort required to breathe. RN 3 stated that it was important that an ongoing assessment was done to ensure timely symptom management.

During a review of the facility's policy and procedure (P&P) titled, "Medication Administration," dated 11/2024, the P&P indicated, "Ensuring that medications are given safely and accurately following the eight (8) rights of medication administration ...1. Right Patient 2. Right Medication 3. Right Dose 4. Right Time 5. Right Route 6. Right Documentation 7. Right Reason 8. Right Response ... Medications to be administered shall be verified with the prescribing practitioner's orders."

During a review of the facility's policy and procedure (P&P) titled, "Palliative Care," dated 3/15/2021, the P&P indicated, "(Name of the facility) provides palliative care to all eligible members through its palliative care program, with the goal of addressing pain and symptoms, and stress of serious illness. Palliative care is specialized care for people with serious illness and is provided by a team comprised of a doctor, nurse, and social worker...Palliative care focuses on providing relief from the symptoms and stress of a serious illness... To provide compassionate interdisciplinary care for those with serious illnesses... Treatment plans, including... Pain and symptom management..."

3. During a concurrent interview and record review on 3/19/2025 at 12:50 p.m. with the Quality Coordinator (QC) 3, QC3 stated that on 7/8/2024, Patient 21 had a laparoscopic cholecystectomy (surgical removal of the gallbladder, involves making small incision in the abdomen to access and remove the gallbladder). On 7/8/2024 at 3:14 p.m., Patient 21 was recovering in the post-anesthesia care unit (or recovery room). Patient 21 complained of abdominal pain, rated at a 10 (worse possible pain). Patient 21 received hydromorphone (or Dilaudid, a narcotic used to relieve pain) 0.2 mg (milligrams- a unit of measurement) at 3:44 p.m. However, hydromorphone 0.2 mg was ordered for a mild pain level of 1 to 3. QC 3 said Patient 21 should have received fentanyl (a powerful lab-made opioid that treats severe pain) 25 mcg (micrograms, a unit of measurement), which was ordered for severe pain of 7 to 10. QC 3 stated that at 4:15 p.m., Patient 21's pain was 5 of 10, pain either returned or was not relieved.

During an interview on 3/19/2025 at 3:34 p.m. with the Chief Nurse Executive (CNE), the CNE verified that Patient 21 had been given hydromorphone (Dilaudid) meant to treat mild pain (1 - 3) for Patient 21's severe pain of 10, instead of giving fentanyl, ordered for severe pain, for effective pain relief. The CNE stated nurses were expected to follow physician's orders and it was a standard of practice.

During a review of Patient 21's History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 7/7/2024, the H&P indicated the following: "Patient 21 with a history of diabetes (high blood sugar), hypertension (high blood pressure) ... presents to the Emergency Department (ED, a hospital facility that provides immediate, unscheduled care to patients who condition require urgent medical attention) with right upper quadrant abdominal pain since yesterday and left-sided abdominal pain for one week."

During a review of Patient 21's Operative Report, dated 7/8/2025, the Operative note indicated Patient 21 was taken to the operating room for a laparoscopic cholecystectomy (surgical removal of the gallbladder, involves making small incision in the abdomen to access and remove the gallbladder).

During a review of Patient 21's Pain Assessment, dated 7/8/2024 at 3:44 p.m., in the PACU (recovery room), the pain assessment indicated Patient 21's pain level or score was 10 of 10 (0 means no pain, 10 means worst possible pain) ...to the abdomen, aching, continuous ...At 4:15 p.m., Patient 2's pain level was 5 of 10 (moderate pain).

During a review of Patient 21's Medication Administration Record (MAR), dated 7/8/2024, the MAR indicated the following in Post-Anesthesia Care Unit (PACU) orders and administration of medications:

-On 7/8/2024 at 3:44 p.m., Hydromorphone 0.2 mg was given to Patient 21.
-The MAR indicated the following pain medication orders:
-Hydromorphone 0.2 mg IV (in the vein) was ordered every 15 minutes as needed, for mild pain (1-3).
-Hydromorphone 0.4 mg IV was ordered every 15 minutes as needed, for moderate pain (4-6).
-Fentanyl 25 mcg IV was ordered every 5 minutes as needed for severe pain (7-10).

During a review of the facility's policy and procedure (H&P) titled, "Medication Administration," dated 11/2022, the P&P indicated the following. Ensuring that medications are given safely and accurately following the eight (8) rights of medication administration: 1. Right Patient 2. Right Medication 3. Right Dose 4. Right Time 5. Right Route 6. Right Documentation 7. Right Reason 8. Right Response.

Based on observation, interview, and record review, the facility failed to ensure that for one of 32 sampled patients (Patient 3), the electronic medical records (eMR) contained a complete evaluation of respiratory function and pain level along with documentation of interventions and care provided [in response to those assessments], as ordered by physician.

This deficient practice had the potential for Patient 3's psychological and physiological needs not met due to inadequate documentation, potentially leading to delayed interventions and poorly monitored and managed respiratory status and pain level.

Findings:

During a review of Patient 3's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 3/9/2025, the "H&P" indicated, Patient 3 was brought to the emergency department for low blood pressure, and profound weakness. The H&P further indicated Patient 3's past medical history (PMH, a patient's previous medical conditions, illnesses, surgeries, hospitalizations, and treatments) included chronic pancreatitis (a long-lasting inflammation of the pancreas [an organ behind the stomach] that causes permanent damage), growing pancreatic cyst (a fluid-filled sac that forms on or within the pancreas), and stroke (occur when blood flow to the brain is blocked or there is sudden bleeding in the brain) with right hemiplegia (paralysis affecting one side of the body).

During a concurrent observation and interview on 3/18/2025 at 2:15 p.m. with the Director of Nursing for Adult Services (DIR) 2, in the corridor of Patient 3's room, Patient 3 exhibited labored breathing (breathing that is difficult, increased in effort, or uncomfortable), including: irregular breathing patterns and gasping for breath. DIR 2 stated, "The patient (Patient 3) is on comfort care (a type of medical care that focuses on providing comfort and support to patients with serious or terminal illnesses). They should have medication order for labored breathing."

During a concurrent observation and interview on 3/18/2025 at 2:15 p.m. with Registered Nurse (RN) 2, in the corridor of Patient 3's room, RN 2 stated Patient 3 had an order for Morphine (a potent pain reliever also used to ease respiratory distress in palliative care [focuses on improving the quality of life for people with serious, life-limiting illnesses]) for respiratory distress (a serious lung condition leading to difficulty breathing). RN 2 assessed Patient 3' breathing, RN 2 stated, "I will administer the Morphine now."

During a concurrent interview and record review on 3/19/2025 at 4:00 p.m. with Registered Nurse Quality Coordinator (QC) 3, Patient 3's "Documentation Flowsheet (document used to record and monitor patient assessments and measurements over time)," dated from 3/14/2025 through 3/18/2025, was reviewed. The flowsheet indicated that Patient 3's respiratory assessments were being performed and documented only twice daily (once a shift), with the last recorded assessment on 3/18/2025, at 8 a.m. [last respiratory assessment completed over six hours ago]. QC 3 confirmed that patients on comfort care should have more frequent respiratory assessments and administration of medications (to relive distress) for respiratory distress.

During a concurrent interview and record review on 3/19/2025 at 4:05 p.m. with Registered Nurse Quality Coordinator (QC) 3, Patient 3's "Medication Administration Record (MAR)," dated 3/18/2025, was reviewed. The MAR indicated that the physician ordered 2 milligrams (mg, measuring unit) of Morphine to be administered for "signs of respiratory distress," every hour, as needed. QC 3 confirmed that the last dose was administered on 3/18/2025, at 8:59 a.m. [ which was over five hours before Patient 3 was observed with labored breathing at 2:15 p.m. on the same day]. QC 3 confirmed that patients experiencing respiratory distress should be closely monitored, and medication should be administered promptly as needed.

During an interview on 3/19/2025 at 4:55 p.m. with Palliative Care Registered Nurse (RN) 3, RN 3 stated that Morphine for comfort care for patients in respiratory distress was intended to relax breathing, reduce air hunger and the effort required to breathe. RN 3 stated that it was important that an ongoing assessment was performed and documented, to ensure timely symptom management.

During a review of the facility's policy and procedure (P&P) titled, "Palliative Care," dated 3/15/2021, the P&P indicated, "(Name of the facility) provides palliative care to all eligible members through its palliative care program, with the goal of addressing pain and symptoms, and stress of serious illness. Palliative care is specialized care for people with serious illness and is provided by a team comprised of a doctor, nurse, and social worker...Palliative care focuses on providing relief from the symptoms and stress of a serious illness... To provide compassionate interdisciplinary care for those with serious illnesses... Treatment plans, including... Pain and symptom management..."

During a review of the facility's policy and procedure (P&P) titled, "Hospital Medical Record Definition," dated 6/2023, the P&P indicated the following: The hospital medical record is the repository for the clinical documentation relevant to the care and treatment of one patient. It is created and maintained for every episode of hospital inpatient care ...The information contained in the Hospital Medical Record must be complete, accurate, legible, timely, accessible, properly filed and retained and protected ...

Based on interview and record review, the facility failed to ensure that all entries in the medical records, such as physician progress notes, documented by resident physicians for one of 32 sampled patients (Patient 11), were countersigned by supervisory or attending medical staff members, in accordance with the facility's policies that address countersignature requirements.

This deficient practice had the potential for Patient 11 to experience lapses in care and oversight, leading to possible inaccuracies in medical records including incomplete or unauthenticated records that could adversely affect treatment decisions and Patient 11's care outcomes.

Findings:

During a review of Patient 11's History and Physical (H&P, the most formal and complete assessment of the patient and the problem), dated 12/3/2023, the H&P indicated that Patient 11 was a direct admit (a hospital admission where a patient bypasses the emergency department (ED) and was admitted directly to an inpatient bed from a doctor's office, clinic, or other healthcare setting) from another hospital. The H&P also indicated that Patient 11 had diagnosis of weakness and required nerve conductions studies (NCS, diagnostic tests that measure how quickly and effectively electrical signals travel through nerves, helping to identify nerve damage or disease) due to a concern for possible chronic (long-term) inflammatory demyelinating polyneuropathy (CIDP, a rare autoimmune disorder that affects the peripheral nerves, causing inflammation and damage to the myelin sheath, the protective covering around the nerves).

During a review of Patient 11's medical record (MR) titled, "Physician, Resident (a licensed doctor who is undergoing post-medical school training in a specific medical specialty) [Internal Medicine] Note," dated 12/19/2023 at 5:21 p.m., the MR indicated that on 12/19/2023, Patient 11 experienced hypotension (abnormally low blood pressure) following abscess draining procedure (an intervention in which abscess [localized collection of pus], is surgically opened and drained to relieve pressure and infection). The MR also indicated that the resident physician (RP 1) evaluated Patient 11 at bedside and placed orders for the nurses to carry out.

During a review of Patient 11's medical record (MR) titled, "Physician, Resident Note," dated 12/19/2023 at 7:25 p.m., the MR indicated that Patient 11's health condition deteriorated (became worse) and resident physician (RP 1) transferred Patient 11 to the Intensive Care Unit (ICU, a specialized hospital department providing critical care and life support to patients with serious, potentially life-threatening illnesses or injuries, requiring intensive monitoring and treatment). The MR also indicated that RP 1 documented to sign-out (the process of transferring patient care information, responsibility, and authority from one healthcare provider to another) to the next covering physician.

During an interview on 3/19/2025 at 10: 57 a.m. with the Quality Coordinator (QC 2), the QC 2 reviewed both progress notes titled, "Physician, Resident Note," dated 12/19/2023, and stated that both progress notes did not contain attestation(a formal declaration that the information provided is accurate and complete) or a co-signature of the supervising physician (which signifies oversight and approval of the resident physician's work).

During an interview on 3/19/2025 at 2:53 p.m. with the attending physician (MD 1, who provides oversight for family medicine resident physicians and, as of 01/2025, holds the title Program Director for the Family Medicine Residency Program), MD 1 stated that daily progress notes by resident physicians require the attending physician to review the notes and sign within 14 days in accordance with the facility's policy. MD 1 then stated the following: "However, there is always an attempt to sign the progress notes in real time, on the day when the progress notes were made."

During the same interview on 3/19/2025 at 2:53 p.m. with the attending physician (MD 1), the MD 1 stated the following: "First year resident physicians may require oversight by third-year resident physicians as well as attending physicians, who are always available to residents when guidance is needed. Medical decisions are reviewed verbally and in person daily; however, there are instances where medical decisions are made by resident physicians without attending involvement or presence. The attending, however, is still required to co-sign all resident physician's notes and is ultimately responsible for the medical care of the patient."

During a review of the facility's policy and procedure (P&P) titled, "Policy-Supervision and Accountability," dated 3/12/2021, the P&P indicated the following:
"Supervision requirements in the hospital: In all resident care cases, the ultimate responsibility rests with the attending physicians who supervise them ...All patient care must be supervised by qualified attending physician ...Specific circumstances which residents must discuss their plan with an attending physician prior to initiation of care include but are not limited to: ...transfer of patients to a higher or lower level of care (higher level of care" refers to more intensive and specialized treatment, often involving 24/7 medical supervision and support, while "lower level of care" signifies less intensive care, like outpatient therapy or support for non-urgent issues) ... Chart documentation in the hospital: All daily progress notes written by a resident must be reviewed and signed by an attending physician ...."

During a review of the facility's regional policy and procedure (P&P) titled, "Graduate Medical Education (GME) Resident Guidelines Manual 2024-2025," the P&P indicated that "As a sponsoring institution, the facility is required to ensure the appropriate supervision of residents and fellows rotating in the facilities ...Medical records of patients cared for by residents are accurately documented and cosigned according to the facility's policies and professional standards ...Attestation guidelines for supervising providers: Charts must be cosigned within 14 days of the patient encounter, but as best practice should be signed within 72 hours to allow timely communication to other healthcare teams and to ensure timely coding and billing of resident/fellow notes ...Documentation of Presence and Participation: Supervising providers must document their presence and participation in the evaluation and management of the patient."

During a review of the facility's policy and procedure (P&P) titled, "Hospital Medical Record Definition," dated 6/2023, the P&P indicated the following: The hospital medical record is the repository for the clinical documentation relevant to the care and treatment of one patient. It is created and maintained for every episode of hospital inpatient care ...The information contained in the hospital Medical Record must be complete, accurate, legible, timely, accessible, properly filed and retained and protected ...The Hospital Medical Record will be maintained in accordance with state and federal laws and regulations ...

During a review of the facility's policy and procedure (P&P) titled, "Medical Record Completion," dated 10/2022, the P&P indicated the following: Upon discharge of the patient from the hospital, the provider is responsible for ensuring that the documentation on a hospital medical record is as complete as possible, including but not limited to: 1.2. Progress notes completed and signed 1.4. Signatures on all reports ...

Based on interview and record review, the facility failed to ensure that for one of 32 sampled patients (Patient 18), an informed consent (a written form that is signed by the patient, indicating that an informed consent discussion occurred between the physician and the patient, and the patient had the opportunity to ask questions and receive answers), for esophagogastroduodenoscopy (EGD, a medical a medical procedure, also known as an upper endoscopy, that uses a thin, flexible tube with a light and camera [endoscope] to visualize the lining of the esophagus, stomach, and the first part of the small intestine), was obtained and documented on the informed consent form, and retained as a part of the patient's [Patient 18] medical record.

This deficient practice resulted in lack of documentation of Patient 18's attestation that the informed consent discussion occurred with the physician and the patient (Patient 18), which had the potential to compromise Patient 18's right to make autonomous decisions about medical care when they [Patient 18] are not fully informed about the risks, benefits, and alternatives of the proposed treatment.

Findings:

During a review of Patient 18's History and Physical (H&P, the most formal and complete assessment of the patient and the problem), dated 3/14/2025, the H&P indicated that Patient 18 was admitted to the facility with a diagnosis of Influenza A (a viral respiratory infection) and septic shock (a life-threatening condition that occurs when an infection triggers a widespread inflammatory response that leads to dangerously low blood pressure and organ damage).

During a review of Patient 18's "Discharge Summary (DS, a crucial document that summarizes a patient's hospital stay, including the reason for admission, diagnostic findings, treatment provided, and the patient's condition upon discharge, ensuring continuity of care)," dated 3/18/2025, the DS indicated that Patient 18 underwent esophagogastroduodenoscopy (EGD) to evaluate esophagitis (a condition where the lining of the esophagus becomes inflamed).

During a review of Patient 18's medical record (MR) titled, "History and Physical (H&P)," dated 3/18/2025, the MR indicated that the communication process between the physician and the patient (Patient 18), regarding the procedure (esophagogastroduodenoscopy [EGD] risks, benefits, and alternatives to the recommended procedure), took place on 3/18/2025, and the patient (Patient 18) agreed to proceed with the procedure (EGD).

During an interview on 3/20/2025 at 2:20 p.m. with the Quality Coordinator (QC 2), the QC 2 stated that a written consent (a written consent form signed by the patient, attests the informed consent discussion occurred with the physician and the patient had an opportunity to ask and have their questions answered) must be signed by the patient for an esophagogastroduodenoscopy (EGD). The QC 2 also stated that the written consent form (paper format) was not available in Patient 18's electronic medical records (eMR), because the consent form had not been scanned into the eMR yet. During a review of the facility's policy and procedure (P&P) titled, "Hospital Medical Record Definition," dated 6/2023, the P&P indicated the following: The hospital medical record is the repository for the clinical documentation relevant to the care and treatment of one patient. It is created and maintained for every episode of hospital inpatient care ...The information contained in the Hospital Medical Record must be complete, accurate, legible, timely, accessible, properly filed and retained and protected ...The Hospital Medical Record will be maintained in accordance with state and federal laws and regulations ...documents that are created outside of the electronic medical record (eMR) may be scanned for retention or be stored as paper documents ...

During a review of the facility's policy and procedure (P&P) titled, "Medical Record Completion," dated 10/2022, the P&P indicated the following: Upon discharge of the patient from the hospital, the provider is responsible for ensuring that the documentation on a hospital medical record is as complete as possible, including but not limited to: 1.2. Progress notes completed and signed 1.4. Signatures on all reports ...

During a review of the facility's policy and procedure (P&P) titled, "Informed Consent, Written Consent and Refusal of Consent," dated 1/2025, the P&P indicated the following: 4.13. A written consent form signed by the patient, attests the informed consent discussion occurred with the physician and the patient had an opportunity to ask and have their questions answered ...
5.2.3 After the discussion, the physician/AHP must document in the patient's medical record that they discussed the proposed procedure with the patient/LRHCDM and obtained informed consent.
5.2.4 For treatments or procedures where signed written consent is required by law or policy, before the treatment or procedure, the patient is asked to sign a consent form attesting that the informed consent discussion occurred with the physician and the patient had an opportunity to ask and have their questions answered.
5.2.8. The signed consent form is included as part of the patient's medical record.
5.5 Procedures that require Informed Consent: All procedures requiring procedural sedation (Moderate/Deep); All endoscopies

Based on interview and record review, the facility failed to ensure that the medical records for three (3) of 32 sampled patients (Patient 8, Patient 10, Patient 12), contained the pertinent medical information documented and filed in the patients' medical charts so that the health care staff involved in the patients' care could access and retrieve the information to monitor the patients' condition when:

1. The nursing staff did not measure and document vital signs (measurements of the body's most basic function including body temperature, heart rate, blood pressure, respirations and pain level) check for Patient 8 and Patient 10, as per physician order and in accordance with the facility's policy and procedure regarding vital signs checks.

This deficient practice had the potential for the staff and the physician's inability to monitor and determine a change in Patient 8's and Patient 10's condition, which may result in a delay in the implementation of necessary interventions including obtaining orders in a timely manner from the physician.

2. Patient 12 did not have a documented individualized nursing care plan (a detailed, individualized plan outlining the medical, nursing, and other interventions needed during a patient's stay in a hospital or other inpatient facility, aiming to achieve specific health goals and ensure safe and effective care) to assess, manage, and monitor newly identified skin injuries(wounds), in accordance with the facility's policy regarding care planning.

This deficient practice had the potential for Patient 12's specific goals and interventions tailored to Patient 12's skin needs not to be implemented by all healthcare staff involved in the patient's care, compromising Patient 12's effectiveness of care and health condition monitoring.

Findings:

1.a. During a review of Patient 8's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 3/18/2025, the H&P indicated, Patient 8 was admitted to the facility with diagnoses including but not limited to encephalopathy (a broad term for any brain disease that alters brain function or structure), major depressive disorder (MDD, a mental health disorder characterized by persistently depressed mood or loss of interest in activities, causing significant impairment in daily life), delusional disorder (a mental health condition characterized by persistent false beliefs that are not based on reality), and major neurocognitive disorder (a group of condition that affect a person's abilities of memory, attention, reasoning and problem-solving) due to dementia.

During a review of Patient 8's "Physician Order," dated 3/18/2025 at 5:15 a.m., the "Physician Order," indicated, assess blood pressure, temperature, pulse, respiratory rate every four (4) hours for initial 24 hours then every eight (8) hours.

During a concurrent interview and record review on 3/20/2025 at 11:26 a.m. with the Registered Nurse Quality Consultant (QC) 6, Patient 8's "Vital Signs Flowsheet (VS flowsheet)," dated on from 3/18/2025 to 3/19/2025, was reviewed. The VS flowsheet indicated nursing staff obtained Patient 8's vital signs as follows:

-On 3/18/2025 at 4:35 a.m., 8 a.m., 3:26 p.m., 6:52 p.m., 11:33 p.m. and on 3/19/2025 at 7:11 a.m.
-QC 6 stated there were missing vital signs documentation on 3/18/2025 at 12 p.m. and on 3/19/2025 at 3:30 a.m.

During an interview on 3/20/2025 at 3:37 p.m. with the Chief Nurse Executive (CNE), CNE stated nursing staff should notify physician for any reason when vital signs were not taken per physician order. CNE stated there was no documentation in Patient 8's medical record that physician was notified regarding vital signs not taken. CNE stated it was important to follow physician order to monitor vital signs in order to monitor Patient 8 appropriately.

During a review of the facility's policy and procedure (P&P) titled, "Vital Signs," dated 3/2023, the P&P indicated, "All patients will have routine vital signs (temperature, pulse, respiration, and blood pressure) measured and recorded three times each 24 hours period. Routine vital signs will be measured and recorded per unit protocol and/or more frequently depending on patient's status ... All vital signs should be entered onto the patient's electronic medical record as soon as possible ... Additional vital signs should be taken whenever the physician or Registered Nurse (RN) assesses such a need exists."

1.b. During an interview on 3/18/2025 at 2:24 p.m. with Patient 10, Patient 10 stated she (Patient 10) came to the facility because of low blood pressure.

During a review of Patient 10's "History and Physical (H&P, a formal and complete assessment of the patient and the problem)," dated 3/17/2025, the H&P indicated, Patient 10 came to the facility's emergency room due to lightheadedness (a feeling of being about to pass out). The H&P also indicated, Patient 10 was admitted to the facility with diagnoses including but not limited to hyponatremia (a condition where the sodium [salt] level in the blood is abnormally low), diarrhea (loose stools), and anemia (a condition marked by a deficiency of red blood cells or of hemoglobin [carries oxygenated blood to other organs in the body] in the blood, resulting in pallor [pale] and weariness).

During a review of Patient 10's "Physician Order," dated 3/17/2025, the "Physician Order" indicated, measure orthostatic vital signs (measurement of blood pressure and heart rate taken while a patient is lying down, sitting up and standing up) every shift."

During an interview on 3/20/2025 at 3:59 p.m. with the Chief Nurse Executive (CNE), CNE stated the following: orthostatic vital signs involved taking vital signs when the patient was in lying position, sitting position and standing position. The Certified Nursing Assistant could take the orthostatic vital signs, but the Registered Nurse was responsible to make sure it was done completely and correctly.

During a concurrent interview and record review on 3/20/2025 at 4:05 p.m. with CNE, Patient 10's Orthostatic Vital Signs Flowsheet, dated from 3/17/2025 to 3/18/2025, was reviewed. The "Orthostatic Vital Signs Flowsheet" indicated the following:

-"3/17/2025 at 2:23 p.m., documented by Certified Nursing Assistant (CNA) 1: supine (lying flat) heart rate = 74 beats per minute (bpm, unit of measure) and supine blood pressure = 95/47 millimeters of mercury (mmHg, unit of measure); standing heart rate = 90 bpm and standing blood pressure = 113/47 mmHg;
-3/17/2025 at 5:01 p.m., documented by CNA 2: supine heart rate = 79 bpm and supine blood pressure = 130/67 mmHg;
-3/17/2025 at 5:03 p.m., documented by CNA 2: standing heart rate = 97 bpm and standing blood pressure = 121/69 mmHg." The "Orthostatic Vital Signs Flowsheet" also indicated there was no documented orthostatic vital signs by night shift nurse (RN 12) on 3/17/2025."

During the same interview and record review on 3/20/2025 at 4:05 p.m. with CNE, CNE stated the following: the orthostatic vital signs done on 3/17/2025 at 2:23 p.m. and at 5:01 p.m. were incomplete because both sets were missing the sitting position vital signs. Night shift did not perform any orthostatic vital signs check on 3/17/2025 (7 p.m. to 7 a.m. next day). It was important to perform orthostatic vital signs check correctly to evaluate if Patient 10 had orthostatic hypotension or not.

During a review of the facility's policy and procedure (P&P) titled, "Orthostatic Vital Signs," dated 1/2023, the P&P indicated, "Orthostatic monitoring shall be done by a Registered Nurse (RN). Orthostatic vital signs may be performed by a RN or Nursing Assistant. The frequency of performing the monitoring is determined by Physician's Orders and/or patient's condition ... Documentation: Record supine (flat), sitting, and upright (stand) blood pressure and pulse readings in electronic medical record."

2. During a review of Patient 12's History and Physical (H&P, the most formal and complete assessment of the patient and the problem), dated 4/15/2024, the H&P indicated that Patient 12 was admitted to the facility's intensive care unit ( ICU, department that provides specialized care for patients with serious illnesses or injuries) on 4/15/2024 with a diagnosis of cardiovascular arrest (a medical emergency where the heart suddenly and unexpectedly stops beating, leading to a lack of blood flow to the brain and other vital organs).

During a review of Patient 12's medical record (MR) titled, "Nursing Initial Assessment (the first comprehensive evaluation a nurse conducts upon a patient's arrival, gathering both subjective and objective data to understand patient's health status and needs, forming the foundation for the care plan)-Integumentary (the skin and its accessory structures)," dated 4/16/2024, the MR indicated that Patient 12 had no skin injuries (skin documented as intact) upon admission to the ICU on 4/16/2024.

During a concurrent interview and record review on 3/20/2025 at 10:16 a.m. with the Quality Coordinator (QC 2), Patient 12's medical record (MR) titled, "Braden Score, (used to predict the risk of developing pressure ulcers (bedsores) by assessing six key factors: sensory perception, moisture, activity, mobility, nutrition, and friction/shear), dated 4/15/202, was reviewed. The QC stated that Patient 12's recorded Braden score was 10 (indicated high risk for developing a pressure injury).

During a review of Patient 12's medical record (MR) titled, "Care Plan," the MR indicated that nursing staff initiated "Skin Injury, Risk (a structured nursing care plan to identify, assess, and manage factors that increase a patient's risk of developing skin injuries or complications, aiming to prevent or minimize such injuries) preventive care plan on 4/17/2024.

During a concurrent interview and record review on 3/20/2025 at 10:16 a.m., with the Quality Coordinator (QC 2), Patient 12's medical record (MR) titled, "[Physician's] Orders," dated 4/24/2024, was reviewed. The MR indicated that on 4/24/2024 a wound care consultation (a specialized assessment and treatment plan by a wound care expert, often a nurse, to address complex or non-healing wounds, aiming to promote optimal healing and improve patient outcomes) order was placed to evaluate Patient 12's newly identified skin issues. The QC 2 stated that on 4/25/2024, a wound care nurse (WCN) evaluated Patient 12, and documented the following: " ...right buttock with intact blood blister ...left tongue trauma (bite) injury .... right ear partial thickness tissue loss (a wound or injury that damages only the outer layers of the skin) ...Please reconsult [WCN] if the wound(s) worsen or condition changes ..."

During an interview on 3/20/2025 at 11:29 a.m. with the Wound Care Nurse (WCN), WCN stated that a skin injury prevention care plan [skin injury, at risk] was initiated based on the initial nursing assessment, any skin anomaly (a deviation from normal skin condition), and the Braden score, and S.K.K.I.N. (Skin care, Kinetic Mobilization, Keep Moving, Incontinence Management, Nutrition) bundle recommendations for interventions. The WCN also stated that for any patient with a Braden score below 18 (at risk for developing skin injury), a nurse should initiate a skin injury prevention care plan.

During the same interview on 3/20/2025 at 11:29 a.m. with the wound care nurse (WCN), the WCN stated that once a skin injury or wound has been identified, the wound care plan must be initiated and customized with interventions specific to the patient's particular skin injury recognized.

During a review of Patient 12's medical record (MR) titled, "Care Plan," dated 4/24/2024 through 5/7/2024, the MR indicated that nursing staff did not initiate a new care plan for Patient 12's identified skin injuries (wounds identified on 4/25/2024) until 5/7/2024, when the care plan for wounds was initiated. This information was verified on 3/20/2025 at 10:16 a.m. by the Quality Coordinator (QC 2) during Patient 12's medical record review.

During a concurrent interview and record review on 3/20/2025 at 10:16 a.m. with the Quality Coordinator (QC 2), Patient 12's medical record (MR) titled, "Inpatient Wound Therapy Consultation," dated 6/17/2024, 6/24/2024, and 7/8/2024, was reviewed. The MR indicated the following:

-On 6/17/2024, Patient 12 was identified to have bilateral ischium (the bony prominence at the bottom of the pelvis on both sides) partial thickness tissue loss (refers to a stage where the skin's dermis [the inner layer of the two main layers of the skin] is exposed, presenting as a shallow open ulcer with a red or pink wound bed) and right ear tragus (small, rounded prominence in the front of the ear canal) partial thickness tissue loss.

-On 6/24/2024, Patient 12 was identified to have developed an injury to the gluteal crease (horizontal skin crease that forms at the junction of the buttocks and the thighs) and right buttock; both marked as the partial thickness tissue loss, and right posterior (refers to the back aspect of the shoulder) shoulder as partial thickness tissue loss.

-On 7/8/2024, Patient 12 was identified to sustain worsening of the right ischium wound from partial thickness tissue loss to pressure injury stage 3 (the wound extends through all layers of the skin, including the epidermis and dermis, reaching the subcutaneous tissue (fat layer) and right buttock was recorded as unstageable (the base of the wound is covered and the true depth and extent of tissue damage cannot be determined, making it impossible to assign a specific stage).

-The QC 2 reviewed Patient 12's nursing care plan documentation and stated that nurses did not initiate new care plans for each wound identified on 6/17/2024 and 6/24/2024. The QC also stated that on 7/8/2024, the wound care plan was initiated for the stage 3 and unstageable pressure injuries that were subsequently identified by the wound care nurse.

During a review of the facility's policy and procedure (P&P) titled, " Plan of Care/Assessment/Reassessment of Patients," dated 1/2022, the P&P indicated the following: "The care and treatment provided for each patient is based on a determination of the patient's needs as obtained through initial assessment and analysis of data collected by the health care team related to the patient's physical, psychosocial, and spiritual status ... 4.11.1 Each patient's plan for care, treatment and services is individualized and appropriate to the patient's needs, strengths, limitations and goals. 4.11.3 Plan of Care must be evaluated every 24 hours by the RN for nursing and other disciplines as appropriate."

During a review of the facility's policy and procedure (P&P) titled, "Pressure Injuries-Prevention and Treatment," dated 1/2025, the P&P indicated the following: "5.3.1 RN to initiate wound consult and takes picture and measurements of wound. 5.5 The registered nurse will update the plan of care accordingly."

During a review of the facility's policy and procedure (P&P), titled "Hospital Medical Record Definition," dated 6/2023, the P&P indicated the following: Documentation in the Hospital Medical Record will comply with [Organization] policies and procedures. 5.2.1 Service documentation. The patient's Hospital Medical Record constitutes an accounting of the services the patient received. 5.2.2 Communication support. As the repository of the patient's clinical documentation, the Hospital Medical Record supports effective communication between the patient's caregivers. 5.2.5 Standards of care. The patient's Hospital Medical Record provides documentation that the services provided are within community standards of care, state and federal laws and regulations, and the requirements of accrediting agencies.

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

1. Ensure two of five sampled patients (Patient 1 and Patient 2 [who did not receive treatment at the facility), received accurate test results for prostate cancer (a disease where abnormal cells grow in the prostate [a small gland in the male reproductive system that helps produce semen]).
This deficient practice caused Patient 1 to be misdiagnosed with prostate cancer (false positive result) and undergo an unnecessary radical proctectomy (a surgery to completely remove the prostate gland and surrounding tissues to treat prostate cancer). Patient 2, who had prostate cancer, was incorrectly informed of his results (that he was negative for prostate cancer), which delayed the treatment he (Patient 2) needed.

This deficient practice to properly verify patient information also created a risk of other patients getting the wrong diagnosis and possibly receiving the wrong treatment.

2. Ensure that proper verification of patient identification was conducted before affixing a new label to one of five sampled patients' specimen (a sample of biological material, like blood, tissue, or fluid, collected for laboratory analysis) container (Patient 6). The new label was the patient identification number assigned by the Pathology Department CoPath computer System (a Laboratory Information System [LIS], designed specifically for anatomic [the structure or body of a living thing] pathology laboratories, supporting automation of processing of prehensive computer system) which serves as the permanent identification for the specimen.

This deficient practice increases the risk of mislabeling specimens, incorrect diagnoses, and potential delays in treatment.

IJ Statement:

On 3/20/2025 at 11:58 a.m., the survey team called an Immediate Jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements have caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient) in the presence of the Senior Vice President (SVP), Regional Senior Director Accreditation Regulation/ Licensing (RSDARL), Assistant Administrator of Quality Services (AAQ), Chief Nurse Executive (CNE), Director of Accreditation, Regulatory and Licensing (DARL), and the Chief Operating Officer (COO). The facility failed to establish a standardized (a clearly defined, repeatable, and uniformly applied approach used to perform a specific task, aiming for accurate, consistency, and efficiency) patient identification process in the pathology department (the branch of medicine that examines tissue samples to diagnose diseases). Pathologist (medical professionals who specialize in diagnosing diseases by examining tissue and fluid samples) used different methods to identify patient specimens. Pathologist (PA) 1 and Pathologist (PA) 2 did not match the pathology slides to the correct patients (Patient 1 and Patient 2), resulting in the misidentification of Patient 1 and Patient 2's prostate specimen (tissue samples taken from prostate gland [an organ in the male reproductive system] to check for abnormalities). As a result, Patient 1 was incorrectly diagnosed with prostate cancer and underwent an unnecessary proctectomy (surgical removal of the prostate gland), while Patient 2's actual prostate cancer diagnosis was delayed.

On 5/29/2024, Patient 1 underwent prostate core biopsy (a procedure where a doctor uses a thin, hollow needle to take small, cylindrical samples [cores] of prostate tissue to examine for cancer or other abnormalities) due to an elevated prostate-specific antigen (PSA, a protein produced by the prostate gland, with elevated levels possibly indicating prostate cancer). Patient 2 also underwent prostate core biopsy on 5/29/2024. A review of Patient 1's "Surgical Pathology" report, dated 6/4/2024, indicated positive for carcinoma (cancer) of the prostate, which was later determined to be incorrect due to the misidentified slides.

A review of Patient 1's "Urology Service (a medical specialty focused on diagnosing and treating diseases and conditions of the male and female urinary tract [the organs that make urine and remove it from the body] and the male reproductive organs [the parts of the body responsible for making sperm, a reproductive cells])" operative note, dated 7/31/2024, indicated Patient 1 underwent robot-assisted laparoscopic (a minimally invasive surgery using robotic assistance to remove the prostate gland). On 3/18/2025 at 1:42 p.m., during an interview with the Director of Laboratory (DIR 1), DIR 1 stated the following: the pathology report completed after Patient 1 underwent prostatectomy indicated that Patient 1 did not have any cancer. It prompted an internal investigation, which determined that Patient 1's slide (a thin, flat piece of glass used to hold tissues or fluid samples for examination) (F1) was switched with Patient 2's slide (F2). During an Interview on 3/18/2025 at 1:35 p.m. with Pathologist (PA) 3, PA 3 stated he (PA 3) scanned the barcode on the slide before reading it. In an interview on 3/19/2025 at 2:11 p.m., PA 4 stated he (PA 4) scanned the requisition form (written orders form healthcare providers requesting laboratory testing) but did not scan the slides before reading them.

During an interview on 3/19/2025 at 2:54 p.m. with Pathologist (PA 2), PA 2 stated "I do not have a working scanner (a device used to scan a bar code that automatically enters patient information and other critical data into electronic health records [EHR]), I have case of work list. Some of us can scan and some of us will work through the work list. When people do scan, they only scan the first one (referring to the first slide)." PA 2 stated he (PA 2) did not realize slide F1 (slide that belongs to Patient 1) was mixed in Set B (slides that belonged to Patient 2) because the slides were placed in order from A through F (A2, B2, C2, D2, E2 and F1). PA 2 read all slides including slide F1 (slide that belongs to Patient 1) and recorded findings on Patient 2's Surgical Pathology Report.

On 3/21/2025 at 6:21 p.m., the IJ was removed in the presence of the Senior Vice President (SVP), Regional Senior Director Accreditation Regulation and Licensing (RSDARL), Assistant Administrator Quality Services (AQS), Chief Nurse Executive (CNE), Director of Accreditation, Regulatory and Licensing (DARL), Chief Operating Officer (COO), Chief of Service Pathology (DIR 1), Physician Director Quality (PDQ), Chief Nursing Officer/ Assistant Administrator Operations (CNOAO), Director of Laboratory (DIR 4), Area Medical Director, Chief of Staff (AMDCS), and Assist Area Medical Director (AMD). The elements of the IJ Removal Plan (interventions to correct the deficient practice) were verified and confirmed by the survey team while onsite through observation, interview and record review. The IJ Removal Plan indicated that for immediate action taken by the facility, on 3/20/2025, a standardized workflow for pathology slide verification was developed to ensure accurate and safe handling of pathology slides, including verification of the case number. The Standardized Pathology Workflow included:

1. Slide Organization & Assignment: Pathologists arrange their stack (flats) of slides to ensure flat contains only one patient's case. The Chief of Service, Pathology, or designee ensures this process is followed.
2. Requisition Matching: The assigned pathologist collates requisition forms with their corresponding cases.
3. Verification & Documentation: The pathologist verifies that all slides match the assigned case and signs off on the CoPthPlus (a comprehensive anatomic pathology laboratory information system [LIS] developed by [name of company] that supports workflow automation, management reporting, and quality assurance functions for pathology labs) log with initials and date.
4. Second Verification: One of the four Lab Supervisors responsible to perform a second verification to ensure all slides correspond to the correct case and requisition. The lab upon verification.
5. Case Review Process: The assigned pathologist scans the QR code on one slide using "Sign-out (electronic)" in CoPathPlus to open a working draft report. The case number on the slide is confirmed to match the requisition and report. Before finalizing the pathology report, the pathologist performs a self-timeout to verify all case details. The pathologist documents in the report: "Self-timeout has been completed, and case number has been verified on each slide." The pathologist completes "Sign out (Electronic)" in CoPathPlus to finalize the pathology report.
6. Pathologist training: Conducted by the Chief of Services, Pathology, on March 20 and 21, 2025. Seven Pathologists were trained, signed attestations, and acknowledged understanding of the workflow.
7. Lab Supervisor Training: Conducted by the Lab Director on March 20 and 21, 2025. Four lab Supervisors were trained, signed attestations, and acknowledged understanding of the verification process.
8. Equipment Check: All pathologists have a working barcode scanner connected to their computer. A spare scanner is available is case of malfunction. Date Completed: March 20, 2025.

Findings:

1. During a review of Patient 1's "Pre- Op (Pre-operative) History and Physical Exam (H&P, a formal and complete assessment of the patient and the problem)," dated 7/31/2024, the "H&P" indicated, Patient 1 had prostate-specific antigen (PSA, a protein produced by the prostate gland that can be measured in a blood test) of 3.8 on 5/20/24. In the past, Patient 1 had no prior work-up for an elevated PSA. Previous urology (a branch of medicine that focus on the function and disorders of the urinary system) history indicated: no hematuria (the presence of blood in urine), no recurrent urinary tract infection (an infection of the urinary system [includes the bladder [stores urine until ready to be expelled out of the body] and the urethra [tube where the urine moves out of the body]). The H&P further indicated test result for transrectal ultrasound-guided prostate biopsy (TRUSP, a procedure used to obtain tissue samples from the prostate gland) indicated six areas of the prostate was biopsied, the six areas were categorized by letters: A, B, C, D, and F. All areas had a negative result for cancer except the area labeled F, which indicated, "F ...Prostatic adenocarcinoma (cancer of the prostate). The H&P also indicated, "We have had an opportunity to meet at length to discuss his (Patient 1) prostate cancer and the available options, and he (Patient 1) has decided to go forth with robot-assisted laparoscopic radical prostatectomy (a minimally invasive surgery to remove the entire prostate gland and some surrounding tissue, using a robotic system). He (Patient 1) understands that he (Patient 1) will need a Foley catheter (a thin, flexible tube inserted into the bladder to drain urine) for 1-2 weeks following the operation, and that he (Patient 1) will have a surgical drain (a tube inserted after surgery to remove excess fluids) as well."

During a review of Patient 1's "Urology Service" operative note dated 7/31/2024, the operative note indicated Patient 1 "...With prostate cancer. After reviewing all options with the patient (Patient 1), we decided to go forth with robot-assisted laparoscopic radical prostatectomy ... The patient (Patient 1) tolerated the procedure well, was awaken from anesthesia (medicines to prevent pain during surgery and other procedures), and transferred to recovery room in stable condition."

During an interview on 3/18/2025 at 11:58 a.m. with the Director of laboratory Services (DIR) 4, DIR 4 stated the incident of misdiagnoses occurred due to the two patients' slide (hold and display specimens for observation) which should have been on the same deck (flat, binders used to hold slides), "but the slides ended up on both deck, but the pathologist should have caught it, (referring to the slide mix-up) and the urology (a branch of medicine that deals with diseases of the male and female urinary tract) should have caught it."

During a concurrent observation and interview on 3/19/2025 at 1:42 p.m. with the Director of Laboratory (DIR 1), DIR 1 stated the following: the pathology report completed after Patient 1 underwent prostatectomy indicated that Patient 1 did not have any cancer. This finding led the department to conduct an internal investigation, which determined that Patient 1's slide (F1) had been switched with Patient 2's slide (F2). DIR 1 displayed both Patient 1's and Patient 2's flats. Each flat contained 12 slides, with each letter representing two slides. While DIR 1 pointed to the two slides labeled with the letter F, DIR 1 stated that these were the misplaced slides.

During the same interview on 3/19/2025 at 1:42 p.m. with the Director of Laboratory (DIR 1), DIR 1 stated that on 6/4/2024, the facility's pathology department received two sets of slides from the regional laboratory: Set A, which contained six paired slides (A1, B1, C1, D1, E1 and F1) for Patient 1, and Set B, which contained six paired slides (A2, B2, C2 D2, E2 and F2) for Patient 2. Set A was assigned to Pathologist 1(PA 1), and Set B was assigned to Pathologist 2 (PA 2). DIR 1 stated that slide F1 from Patient 1 was mistakenly placed in Set B, and slide F2 from Patient 2 was mistakenly placed in Set A, resulting in an incorrect positive cancer reading for Patient 1. DIR 1 further stated that PA 1 received Set A with slide F2 (A1, B1, C1, D1, E1 and F2), read an interpreted all slides, including F2, and recorded the findings in Patient 1's Surgical Pathology Report (a medical document that describes the characteristics of a tissue specimen, typically after a biopsy or surgery, and is prepared by a pathologist to aid in diagnosis and treatment planning). Similarly, PA 2 received Set B with slide F1(A2, B2, C2, D2, E2 and F1), read slide F1, and recorded the findings in Patient 2's Surgical Pathology Report.

During an interview on 3/18/2025 at 12:47 p.m. with Pathologist (PA 3), PA 3 stated he (PA 3) would scan the barcode (the small image of lines [bars] and spaces that is affixed to items to identify a person or item) on the slide, to open the patient's chart on the computer to verify that the correct slide matched the correct patient. PA 3 also stated some pathologists used different methods for verification.

During an interview on 3/18/2025 at 12:48 p.m. with DIR 1, DIR 1 stated some pathologists would scan the requisition form (test order form) to retrieve a patient's chart on the computer (instead of scanning the barcode on the slide).

During a concurrent observation and interview on 3/19/2025 at 2:11 p.m. with Pathologist (PA 4), PA 4 scanned a patient's requisition form to retrieve a patient's chart. PA 4 then proceeded with reading of the slide. PA 4 did not scan the slide prior to reading and recording findings. PA 4 stated he (PA 4) would look for the case number on the computer screen and slide for matching before proceeding with reading of the slides. PA 4 also stated he (PA 4) would not do any scanning for the next slides from the same patient.

During an interview on 3/19/2025 at 2:54 p.m. with Pathologist (PA 2), PA 2 stated, he (PA 2) found out the slides from the case he (PA 2) reviewed was mixed with another pathologist case when the results from the biopsy that was collected after Patient 1 underwent surgery (radical proctectomy) indicated Patient 1 did not have prostate cancer. PA 2 also stated "I do not have a working scanner (a device used to scan a bar code that automatically enters patient information and other critical data into electronic health records [EHR, digital version of paper chart]), I have case of work list. Some of us can scan and some of us will work through the work list. When people do scan, they only scan the first one (referring to the first slide)." PA 2 stated he (PA 2) did not realize slide F1 was mixed in Set B because the slides were placed in order from A through F (A2, B2, C2, D2, E2 and F1). PA 2 read all slides including slide F1 and recorded findings on Patient 2's Surgical Pathology Report.

During a review of the facility's policy and procedure (P&P) titled, "Specimen Collection Manual for Pathology," dated 11/19/2024, the P&P indicated "Accurate patient and specimen identification. Verify Patient Information: Generate electronic labels in KPHC.
1.Verify that the name and MRN (Medical Record Number) on the label match the name and MRN in (name of the facility's electronic system).
2. If the name is different, verify with picture ID and another patient identifier such as DOB (Date of Birth), address, etc.
3. (name of the facility's electronic system) surgical pathology orders and specimen label must include the patient's name, MRN, source and site/side (if applicable).
4. (name of the facility's electronic system) surgical pathology orders must include pertinent clinical patient information.
Specimen Container Labeling:
1. Patient's name and MRN
2.Date and time
3.Source of specimen
4.Use an alpha letter to indicate which specimen it is, e.g., A, B, C, etc.
5.The label is placed on the SIDE OF CONTAINER. DO NOT PUT ANY LABELS ON LID.
6.The lid of the container must be tightly closed.
7.The biohazard zip lock bag has one pocket for the surgical pathology order and another pocket for the specimen container.
8.Perform a visual check of the specimen in the container and ensure the label matches the patient's name before the patient leaves the procedure room

During a review of the facility's policy and procedure (P&P) titled, "Specimen Identification Integrity," dated 3/12/2025, the P&P indicated "The integrity of patient specimen identification shall be maintained through all phases of processing of tissues and issuing of Pathology Reports. Routine checks shall be made throughout the steps of tissue processing to assure identification integrity ... The pathologist checks the surgical number of the specimen requisition against the number of the slide at the time of first looking at the slide under the microscope. He utilizes the same number when dictating or by typing the diagnoses."

2. During a review of Patient 6's "Pathology Requisition (or tissue card, a document used by physicians to request specific pathology tests or procedures on patient samples [tissues, fluids, etc.])," dated 3/13/2025, the requisition indicated there were eight specimens collected for Patient 6 at various areas of the gastrointestinal (a series of organs that process food and nutrients from the moment it enters the mouth until it is eliminated as waste) area, and the test requested for all eight specimen was histology (the study of the microscopic structure of tissues).

During a concurrent observation and interview on 3/18/2025 at 1:05 p.m. with the Pathology Supervisor (SS1), at the Grossing Station (a laboratory station where tissue samples are prepared for examination), more than 60 specimen containers were observed laid out in rows on a cart. On top of the specimens, three stacks of requisition forms and print-out stickers (generated at the accessioning [performs upfront handling, error checking and other preparation work] station when specimens were assigned a case numbers), were placed. However, these newly generated labels were not immediately affixed to the specimen containers. Instead, they were left in a stack on top of the specimen cart, separated from the specimens they were intended for. SS 1 stated that the person grossing the specimen removes the stickers (new labeled generated with assigned case number) from the stack, and places them on the correct specimen, while ensuring the original label remains visible. However, during the observation, SS 1 proceeded to place labels. SS 1 placing the label on the specimens without comparing the new label and original label to the requisition form. The form remained folded in a stack. SS 1further stated that a tissue technician may label all specimens assigned to a single pathologist at a time, which can range from 7 to 15 specimens.

During an interview on 3/21/2025 at 2:30 p.m. with the Director of Laboratory/Chief of Service Pathology (DIR 1), DIR 1 stated that the correct verification process required the person labeling the specimen to compare three elements: (1) The original specimen label, (2) the new label, and (3) the requisition form also called "tissue card" to ensure proper patient identification. However, this verification process was not observed during the labeling process. SS 1 stated that mislabeling can occur if all three elements are not reviewed before placing the final label on the specimen containers.

During the same observation and interview on 3/21/2025 at 2:30 p.m. with the Director of Laboratory/Chief of Service Pathology (DIR 1), observed the original labels on the specimen containers, submitted by the originating facility, included only the patient 's name and tissue type. These labels did not include the date of birth (DOB) or medical record number (MRN). The new labels, created by the facility's pathology lab, included the patient 's name, MRN, new case number, collection date, and accession date (the date a specimen is received, logged, and assigned and identifier). DIR 1 confirmed that the only matching information between the original and new labels was the patient's name and tissue type, information that could be identical for more than one patient. DIR 1 stated, "I see how this could be a mix-up if two patients have the same name."

During a review of the facility's policy and procedure (P&P) titled, "Preparation of Tissue Cassettes for Gross Surgical Cutting," dated 11/19/2024, the P&P indicated, "Tissue cassettes shall be correctly labeled with permanent patient identification number along with a barcode. The patient identification number is assigned by the Pathology Department CoPath Computer System. Assemble the following: Tissue cards correlating to the surgical specimens are placed on the specimen cart. Large specimen containers are placed on a separate cart for the Pathologist Assistant or Pathologist. Once the specimens have been accessioned, the labels (printed with each individual barcode) for the requisition and specimen bottles will automatically print. The tissue technicians will label each requisition and specimen bottle by matching the tissue card, specimen container and specimen label.

During a review of the facility's policy and procedure (P&P) titled, "Specimen Collection Manual for Pathology," dated 11/19/2024, the P&P indicated "Accurate patient and specimen identification. Verify Patient Information: Generate electronic labels in KPHC.
1.Verify that the name and MRN on the label match the name and MRN in (name of the facility's electronic system).
2.If the name is different, verify with picture ID and another patient identifier such as DOB, address, etc.
3. (name of the facility's electronic system) surgical pathology orders and specimen label must include the patient's name, MRN, source and site/side (if applicable).
4. (name of the facility's electronic system) surgical pathology orders must include pertinent clinical patient information.
Specimen Container Labeling:
1.Patient's name and MRN
2.Date and time
3.Source of specimen
4.Use an alpha letter to indicate which specimen it is, e.g., A, B, C, etc.
5.The label is placed on the SIDE OF CONTAINER. DO NOT PUT ANY LABELS ON LID.
6.The lid of the container must be tightly closed.
7.The biohazard zip lock bag has one pocket for the surgical pathology order and another pocket for the specimen container.
8.Perform a visual check of the specimen in the container and ensure the label matches the patient's name before the patient leaves the procedure room