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Based on observation, interview, and record review, the facility's governing body failed to ensure the facility's operation was conducted in an effective, safe, and organized manner when:

1. A safe, orderly, and sanitary environment was not maintained (Refer to A 0700, A 0701, A 0709, A 0714, A 0722, and A 0724);

2. Nursing services and operations were not provided in a safe and effective manner that would meet the patients' needs, for seven of 91 sample patients (Patients 8, 12, 26, 27, 28, 30, and 31) (Refer to A 0395, A 0397, and A 0398,);

3. Laboratory services and operations were not provided in a safe and effective manner that would meet the patients' needs (Refer to A 0576, A 0582, A 0583, A 0584, and A 0701); and

4. Equipment, supplies, personnels, and resources were not adequate to meet patients' needs (Refer to A 0049).

The cumulative effect of these systemic problems resulted in the ICU (Intensive Care Unit, unit for critically ill patients) and the fifth floor to smell of sewer, the HVAC (Heating, Ventilation, and Air Conditioning) system supplying the Emergency Department to have a possible untreated Legionella bacteria (a type of bacteria which can cause lung infection) contamination, and patients on the second floor to not be monitored safely and for their needs to not be addressed timely. These failures resulted in the facility's governing body to not ensure the patients were receiving quality care in a safe and effective manner.

Based on interview and record review, the facility failed to ensure patients were provided the care and treatment they needed, for seven of 91 sample patients (Patients 8, 12, 26, 27, 28, 30, 34), when

1. For Patients 12, 26, 27, 28, and 30, pain assessments and/or reassessments were not conducted (Refer to A395 and A398);

2. For Patient 26, assessment was not conducted after Patient 26 was transferred to a different nursing unit (Refer to A395);

3. For Patient 34, who was upgraded as an Intensive Care Unit (ICU, specialized unit that provides specialized care to critically ill patients) patient while on the Medical Surgical unit (unit care of the patient with a wide range of medical and surgical conditions), care was not provided by a qualified registered nurse (Refer to A 397).

4. For Patients 26 and 27 antiseptic (substances that prevent the growth of disease-causing microorganisms) baths were not completed (Refer A 398);

5. For Patient 26, assessment was not completed after the patient was transferred to a different nursing unit (Refer A 398);

6. For Patient 26 and 27, who needed assistance with repositioning, repositioning was not implemented (Refer A 398);

7. For Patient 8, a critical lab result was not reported to the provider (Refer A 398); and

8. For Patient 12, a Transthoracic Echocardiogram (a non-invasive imaging test that uses ultrasound to create detailed images of the heart) result was not reported to the provider (Refer A 398).

The cumulative effects of these failures had the potential to impact the quality of care provided to the patients, inadequate pain management, delayed recognition of changes in the patients' condition, and increased risk of pressure injury development. In addition, these failures had the potential for patients to not receive the appropriate care and monitoring which may result in injury and/or death for the patient.

Based on observations, interviews, and record reviews, the facility failed to ensure laboratory services were provided and maintained to meet the patients' needs when:

1. Two out of the six freezers and refrigerators were not maintained in accordance with the manufacturer's instructions for use (Refer to A 0582);

2. The standard laboratory procedure for storing specimens (a sample for medical testing) and reagents (any substance or mixture of substances used to perform a laboratory test) was not implemented (Refer to A 0582);

3. 18 out of 22 laboratory specimens for tests to be sent out for processing by another Laboratory were not completed in a timely manner, for 28 of 91 sample patients (Patients 51, 54 to 68, 70, and 71) (Refer to A 0582);

4. For Patients 51, 55, and 72, the laboratory specimens were not sent to Laboratory (Lab) 3 timely (Refer to A 0582);

5. For Patients 20, 52, and 53, the facility policy and procedure on laboratory services was not implemented (refer to A 0582);

6. For Patient 64, the laboratory test was not entered as ordered on the laboratory requisition form (Refer to A 0582);

7. For Patient 12, the laboratory specimens were not conducted as ordered by physician (Refer to A 0582);

8. For Patient 52, a Stat (an order to be completed immediately) order for Test 14 was not collected timely (Refer to A 0583); and

9. For Patient 53, a Stat order for Test 16 was not collected timely (Refer to A 0583); and

10. the facility's medical staff were not informed of the change in laboratory (Lab) services for the facility from Lab 2 to Lab 3 (Refer to A0584).

The cumulative effect of these failures resulted in a delay in obtaining the result of laboratory tests ordered for the patients and had the potential to produce erroneous laboratory results and cause a delay in the diagnosis and treatment of patients.



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Based on observation, interview, and record review, the facility failed to ensure the facility's physical environment was maintained when:

1. Ceiling tiles were observed with brownish stains in the storage and waiting rooms (Refer to A 00701);

2. Sewer smell was observed in ICU-A and in the dirty utility room and patient Rooms A, B, C, D, E, i, J, K, L, M, N, O, P, and Q (Refer to A 701);

3. For fourteen out of 91 sample patients (Patient 24, 36, 37, 38, 39, 40, 41, 42, 43, 44, 74, 75, 76, and 90), a system for use to call if assistance is needed and continuous telemetry (remote monitoring of the patients' heart rates and rhythms) monitoring were not provided in accordance with the physician's order (Refer to A 0701);

4. Four pharmaceutical (pertaining to medications)/sharps waste bins (containers for disposals of needles and other sharp items) in the Intensive care unit (ICU, a specialized unit that provides monitoring for patients with life-threatening conditions) were overfilled to the brim (Refer to A 0701);

5. Two out of seven freezers at the laboratory were not maintained in accordance with the manufacturer's instructions for use. In addition, the condition of the alarm battery of the freezer was not maintained (Refer to A 701);

6. For Patient 73, who was on airborne isolation, the temporary plastic magnetic door in front of the patient's room was not installed securely (Refer to A 0701);

7. Water retesting was not performed for the Mammoth cooling tower for the HVAC Systems supplying the heating and air-conditioning system to the Emergency Department, after the water tested positive for Legionella bacteria (a type of bacteria that could cause respiratory illness) on September 4, 2024 (Refer to A 0701);

8. The fire-release (a fire door that is designed to automatically close in response to a fire alarm or other emergency signal, preventing the spread of fire and smoke) double doors separating the Definitive Observation Unit (DOU, a unit which provides a high level of care for patients who don't need intensive care) and Coronary Care Unit (CCU, a unit that treats patients with critical heart conditions) was obstructed (Refer to A 0709);

9. The Smith Cot (a piece of equipment used for evacuating non ambulatory patients) was not readily accessible for emergency use (Refer to A 0714);

10. The elevators cars (Cars 1, 2, 3, 4, 5, and 6) were not maintained in optimal working condition (Refer to A 0724); and

11. An acrylic box for holding the moisture-wicking fabric (fabric with antimicrobial to keep skin folds dry and reduce rubbing and help prevent infection) and a pair of scissors in the box holder were observed to have debris and grime (Refer to A 0724).

The cumulative effects of these failures resulted in an unsafe environment, and had the potential for increased risk of exposure to harmful chemicals, viruses, and bacteria, which could potentially cause danger to the health, safety, and well-being of the already immunocompromised patients at the facility.

Based on interview and record review, the facility's governing body failed to ensure the facility's operation was conducted in an effective, safe, and organized manner when the Chief Nursing Officer (CNO) is also the Director of Operating Room and oversees the nursing education.

This failure resulted in the facility to not have leadership personnel which could lead to patient needs to not be met timely, delayed treatment of patients, and injury to the patients.

Findings:

On March 3, 2025, at 11:10 a.m., the CNO was interviewed. The CNO stated she was away from the facility from December 14, 2024, through February 3, 2025, and it was the Chief Operating Officer (COO) who took over during her absence. The CNO stated, "It is important to have leadership because individual unit must have a present "boot [being physically present]" on the unit for chain of command." The CNO stated, aside for being the CNO, she is also the Director of the Operating Room, and she also oversees the nurses' education. The CNO stated the facility must delegate responsibilities appropriately, and the facility need to have a dedicated person assigned to each unit. The CNO stated, "Staff need the layer of support." The CNO stated the facility must rebuild the facility's leadership team to have more oversight and more cohesive individual units. The CNO stated she reports to the COO and the Chief Medical Officer (CMO) who were aware of the physical environment, laboratory, and provision of care issues in the hospital.

On March 3, 2025, at 2:27 p.m., the COO was interviewed regarding leadership and chain of command. The COO stated, "Leadership is important." The COO stated they have no dedicated person for infection prevention (IP) oversight and is concerned about the state and federal reporting elements for IP.

On March 4, 2025, at 10:02 a.m., Governing Body Member (GBM) was interviewed. GBM stated leadership comes with accountability. GBM stated the COO was the person responsible for the operations in the facility.

A review of the facility's document, "CHIEF NURSING OFFICER", dated January 2012 indicated, "POSITION SUMMARY...The Chief Nursing Officer is responsible for the direction of the hospital's nursing services and participates as a member of the executive management team, sharing authority, accountability and responsibility with other executive managers to assure the provision of quality, cost efficient healthcare to patients presenting for services. The Chief Nursing Officer has the authority, accountability and responsibility to establish nursing policies and procedure, nursing standards of patient care, treatment, and services, and standards of nursing practice and nurse staffing plans for the organization. The incumbent has been empowered to perform the functions listed below and will be held accountable for them...Ensuring adequate and competent nursing staff service and nursing leadership at all levels..."

A review of the facility's document titled, "CHIEF OPERATING OFFICER," dated November 2011, was conducted. The document indicated, "...POSITION SPECIFIC RESPONSIBILITIES...understand and behave positively toward the Corporate's objective by maintaining current insight and knowledge of the social, economic and political climates in which the Corporate must compete for personnel, resources and capital and by ensuring that such environmental factors are appropriately considered and translated into the Corporate's actions and objectives...Attends meetings of the Board of Directors and makes recommendations on administrative and budgetary matters..."

A review of the facility's bylaws titled, "AMENDED AND RESTATED BYLAWS OF KPC GLOBAL MEDICAL CENTERS, INC. [incorporated]," dated March 31, 2021, was conducted. The policy indicated, "...ARTICLE I DEFINITIONS...1.8 Medical Staff Bylaws means the set of written bylaws...set forth standards, criteria and processes for credentialing, disciplining and organizing the practitioners...ARTICLE II SCOPE AND PURPOSE...the Corporations purpose shall include (a) the operation of the Hospitals for the acute and continued care of the sick, injured and disabled, and the promotion of health...(c) doing any and all things necessary, advisable, appropriate or incidental to such purposes..."

Based on interviews and record reviews, the facility failed to ensure patients' rights were promoted when patients were not informed of the change in laboratory (lab) services for the facility from Lab 2 to Lab 3.

This failure had prevented the patients to exercise their right to participate in their care.

Findings:

On February 24, 2025, at 9:33 a.m., an interview was conducted with the Director of Laboratory Services (DLS). The DLS stated Lab 2 terminated their contract with the facility on January 20, 2025. The DLS stated Lab 3 started picking up the facility's specimens for testing on February 14, 2025.

An untitled facility document, dated December 19, 2024, was reviewed. The document indicated, "...To: [Name of DLS]...The 30 day letter is going to be sent to the lab directors today and all are needing to understand that [Name of Lab 2] is giving 30 day notice to find another lab...[Name of Lab 2 Executive]..."

An untitled facility document, dated January 25, 2025, was reviewed. The document indicated, "...This e-mail is final notification that services for the following accounts will be turned us [sic]...sic 5 PM [p.m.], PT [Pacific Time], Monday 01-20-24 [January 20, 2024, sic]...Breach of signed continuous Service Agreement on file...30 day termination letters overnighted as of 12 -19-24 [December 19, 2024], therefore [Name of Group], has had the opportunity to locate needed reference lab..."

There was no documented evidence patients were informed of the change in lab services from Lab 2 to Lab 3 prior to February 24, 2025.

On February 24, 2025, at 12:53 a.m., an interview with the Chief Quality Officer was conducted. The CQO stated they did not inform the patients about the changes in lab services from Lab 2 to Lab 3. The CQO stated the patients should have been informed of the changes in lab services from Lab 2 to Lab 3 when it happened, "It is patient's rights."

A review of facility policy titled, "Patient Rights and Responsibilities," dated April 2021 indicated, "...Patient's Rights are part of the philosophy of the Health Group. In addition to assuring that patients are afforded their rights as set forth in the list of patient's rights and responsibilities..."

A review of an undated facility document titled, "Patient Rights," indicated, "...You have the right to...Receive information about your health status, course of treatment, prospects for recovery and outcomes of care (including unanticipated outcomes) in terms you can understand. You have the right to effective communication and to participate in the development and implementation of your plan of care..."

Based on interview and record review, the facility failed to ensure assessment was conducted, for five of 91 sample patients (Patients 26, 27, 28, and 30) when:

1. For Patients 12, 26, 27, 28, and 30, pain assessments and/or reassessments were not conducted; and

2. For Patient 26, assessment was not conducted after Patient 26 was transferred to a different nursing unit.

These facility failures had the potential to impact the quality of care provided to the patients, inadequate pain management, and delayed recognition of changes in the patients' condition.

Findings:

1a. On February 26, 2025, at 11 a.m., a review of Patient 12's record was conducted with Registered Nurse (RN) 6.

A facility document titled, "History and Physical (H&P)," dated September 30, 2024, at 4:58 p.m., was reviewed. The document indicated Patient 12 was admitted to the facility for persistent disequilibrium (a feeling of imbalance or unsteadiness that lasts for most days), left sided facial droop, and acute right pontine infarction (a blood flow blockage to a part of the brain). The document indicated Patient 12 had a medical history of hypertension (high blood pressure), depression (a mood disorder) and benign prostatic hyperplasia (a condition in which the prostate gland enlarges).

A facility document titled, "Order Inquiry," for Patient 12, dated September 30, 2024, at 5:21 p.m., was reviewed and indicated, "...Acetaminophen (medication used for pain and/or fever)...Dose ...650 mg [milligrams, a unit of measurement]...Tablet...Frequency...as needed...Ord [Ordering] Phys [Physician]...[name of Medical Doctor [MD] 1..."

A facility document titled, "Order Inquiry," was reviewed. The document indicated acetaminophen 650 milligrams was administered to Patient 12 on October 1, 2024, at 6:47 a.m., for headache of seven out of 10 on a pain scale (a pain assessment tool, with 0 meaning no pain, and 10 meaning severe pain).

There was no documented evidence Patient 12's pain was reassessed after acetaminophen was administered on October 1, 2024, at 6:47 a.m.

On February 26, 2025, at 12 p.m., an interview with Registered Nurse (RN) 6 was conducted. RN 6 stated there was no documentation a pain reassessment was conducted on Patient 12 after acetaminophen was administered for pain on October 1, 2024, at 6:47 a.m. RN 6 further stated, "It should have been done."

1b. A review of Patient 26's record was conducted on February 28, 2025, at 1:04 p.m., with the Stroke Coordinator Registered Nurse (SC).

A facility document titled, "History and Physical [H&P]," was reviewed. The document indicated Patient 26 was admitted to the facility on February 23, 2025, for abdominal pain.

A facility document titled, "Medication Administration Record," was reviewed. The document indicated, "...Dilaudid [a pain medication]...1 [one] mg [milligram, a unit of measurement]...IV [intravenous, administered through the vein]...every 3 [three] hours, as needed for pain..."

A facility document titled, "Med [Medication] Admin [Administration]," was reviewed. The document indicated on February 25, 2025, at 4:55 a.m., 1 mg of Dilaudid was administered to Patient 26. The document indicated Patient 26 had a pain scale level of eight of ten at the time of the Dilaudid administration.

There was no documented evidence pain reassessment was conducted after the administration of Dilaudid on February 25, 2025, at 4:55 a.m.

1c. A review of Patient 27's record was conducted on February 28, 2025, at 2:53 p.m., with the SC.

A facility documented titled, "H&P," was reviewed. The document indicated Patient 27 was admitted to the facility on February 17, 2025, for tremors.

A facility document titled, "Medication Administration Record," was reviewed. The document indicated, "...Morphine [a pain medication]...2 [two] mg...IV...every 4 [four] hours, as needed for pain..."

A facility document titled, "Med Admin," was reviewed. The document indicated on February 24, 2025, at 2:07 p.m., February 27, 2025, at 12:39 a.m., February 27, 2025, at 5:04 p.m., and on February 28, 2025, at 10:18 a.m., 2 mg of morphine was administered to Patient 27.

A facility document titled, "Pain Assessment Flow Sheet," was reviewed. The document indicated Patient 27's pain level was assessed during the above-mentioned dates and times at eight of 10, 10 of 10, eight of 10, and eight of 10, respectively.

There was no documented evidence pain was reassessed after morphine was administered to Patient 27 on the above-mentioned dates and times.

1d. A review of Patient 28's record was conducted on March 3, 2025, at 9:45 a.m., with the SC.

A facility documented titled, "H&P," was reviewed. The document indicated Patient 28 was admitted to the facility on February 28, 2025, for shortness of breath.

A facility document titled, "Medication Administration Record," was reviewed. The document indicated, "...Acetaminophen...tablet oral [by mouth] every six hours as needed...for mild pain...650 mg...Tylenol [brand name of acetaminophen] ..."

A facility document titled, "Med Admin," was reviewed. The document indicated on February 28, 2025, at 10:40 p.m., March 1, 2025, at 9:33 a.m., March 2, 2025, at 10:05 a.m., and March 2, 2025, at 4:53 p.m., 650 mg of Tylenol was administered to Patient 28.

A facility document titled, "Pain Assessment Flow Sheet," was reviewed. There was no documented evidence Patient 28's pain level was not assessed or reassessed on the above mentioned administration dates and times.

1e. A review of Patient 30's record was conducted on March 3, 2025, at 10:10 a.m., with the SC.

A facility documented titled, "H&P," was reviewed. The document indicated Patient 30 was admitted to the facility on February 19, 2025, for shortness of breath.

A facility document titled, "Medication Administration Record," was reviewed. The document indicated, "...hydrocodone/acetaminophen [a pain medication] 5 [five]/325 mg ...Norco [brand name of hydrocodone/acetaminophen]...tablet...oral...PRN [as needed]..."

A facility document titled, "Med Admin," was reviewed. The document indicated on February 21, 2025, at 10:01 a.m., one tablet of Norco was administered to Patient 30.

A facility document titled, "Pain Assessment Flow Sheet," was reviewed. The document indicated Patient 30's pain level was 10 of 10 on February 21, 2025, at 10:01 a.m.

There was no documented evidence pain reassessment was conducted on Patient 30 after Norco was administered on February 21, 2025, at 10:01 a.m.

An interview was conducted on March 3, 2025, at 10:45 a.m., with the SC. The SC stated it is important to assess and reassess patients pain levels to know if treatment is effective.

The facility policy and procedure titled "Pain Management," dated September 2024 was reviewed. The policy indicated, "...Routine Reassessment...Patient will be routinely reassessed for pain during the initial daily shift assessment...with new complaints, and as needed. At a minimum, this reassessment shall consist of noting the intensity of the patient's pain...Reassessment Following Treatment for Pain...If a treatment intervention for pain is provided, the response to that intervention should be assessed. Reassessment is recommended to occur within 15 - 60 minutes following treatment..."

2. A review of Patient 26's record was conducted on February 28, 2025, at 1:04 p.m., with the SC.

A facility document titled, "H&P," was reviewed. The document indicated Patient 26 was admitted to the facility on February 23, 2025, for abdominal pain.

A facility document titled, "Daily Floor Census," dated February 27, 2025, was reviewed and indicated Patient 26 was transferred from the ICU (intensive care unit, unit for patients with critical illnesses) to the telemetry unit (a unit for patients needing continuous remote heart rhythm monitoring) on February 27, 2025, at 7 p.m.

A review of the facility flow sheet titled, "Daily," was reviewed and indicated Patient 26 was assessed on Patient 26 on February 27, 2025, at 6 p.m., and then on February 28, 2025, at 8 a.m.

There was no documented evidence Patient 26 was assessed after the patient was transferred to the telemetry unit on February 27, 2025, at 7 p.m., until February 28, 2025, at 8 a.m.

An interview was conducted on February 28, 2025, at 1:15 p.m., with the SC. The SC stated there should have been an assessment overnight for Patient 26 from February 27, 2025, to February 28, 2025.

An interview was conducted on March 3, 2025, at 10:45 a.m., with the SC. The SC stated patients should be assessed a minimum of once per shift. The SC further stated nurses should complete a transfer assessment when patients are transferred to another unit. The SC stated it is important for assessments of patients to be completed to monitor changes in conditions and report them back to the health care team.

The facility policy and procedure titled, "Transferring of Patients (Including In-Unit Transfers," dated September 2024, was reviewed. The policy indicated, "...A transfer assessment shall be completed by a registered nurse within eight (8) hours of transfer to the assigned unit/room..."

Based on interview and record review the facility failed to ensure qualified staff provided care, for one of 91 sampled patients (Patient 34), who was upgraded as an Intensive Care Unit (ICU, specialized unit that provides specialized care to critically ill patients) patient while on the Medical Surgical unit (unit care of the patient with a wide range of medical and surgical conditions).

This failure had the potential for Patient 34 to not receive the appropriate care and monitoring which may result in injury and/or death for the patient.

Findings:

A review of Patient 34's record was conducted on March 3, 2025, at 10:53 a.m., with the Patient Safety Coordinator (PSC). A facility document titled, "History and Physical," dated February 25, 2025, was reviewed. The document indicated Patient 34 was admitted to the facility on February 27, 2025, for generalized weakness and a history of hypertension (high blood pressure), hyperlipidemia (high levels of fat in the blood), and chronic kidney disease (a condition when the kidneys are not functioning well).

A facility document titled, "Labs [laboratory]," dated March 1, 2025, at 8:27 a.m., was reviewed. The document indicated, "...Partial pressure of carbon dioxide [PCO2, amount of carbon dioxide in the blood]...65...H [High]...reference range...35-45...mmHg [millimeters of mercury, unit of measurement]..."

A facility document titled, "Order Inquiry," dated March 1, 2025, at 8:48 a.m., was reviewed. The document indicated, "...Transfer to Intensive Care Unit...start date: 3/1/2025 [March 1, 2025] 08:48 [8:48 a.m.]...priority...Stat [immediately]...possible intubation [inserting a tube in the windpipe to help with breathing]..."

A facility document titled, "Labs," dated March 1, 2025, at 9:50 a.m., was reviewed. The document indicated, "...Partial pressure of carbon dioxide...70...High [H]...reference range...35-45...mmHg..."

A facility document titled, "Code Blue," dated March 1, 2025, at 10:31 a.m., was reviewed. The document indicated, "...Code date 3/1/25...reason for code: abnormal ABG [arterial blood gas, test that measures levels of oxygen in the blood to evaluate breathing]. Planned intubation initiated...felt the patient required emergency intubation..."

An undated facility document titled, "Progress Note," was reviewed. The document indicated, "...3/1/2025 08:36 [8:36 a.m.]...called dr [medical doctor]...with abg...result dr wants pt [Patient 34] transferred to icu...rn [registered nurse] aware and will speak to icu...3/1/2025 09:23 [9:23 a.m.]...Dr...ordered transfer to ICU pH [measure the bodies acid-base balance , with normal value of 7.35-7.45 ] 7.23 pco2 [partial pressure of carbon dioxide] 62 refusing bipap [bilevel positive airway pressure, system that provides pressurized air to assist with breathing] last night...house sup [supervisor]...notified...3/1/2025 11:05 [11:05 a.m.]...unable to give fentanyl [drug used for pain medication and sedation] and versed [drug used for pain medication and sedation] on telemetry [unit where the patients' heart rates and rhythms are continuously monitore remotely] floor, after code [Code Blue], doctors and staff qualified to give left, house supervisor...notified...stated that they would come in 20 minutes 20 minutes ago...3/1/2025 11:38 [11:38 a.m.]...called ccu [Critical Care Unit, unit for specialized care for patients with life threatening conditions] at 11:50 [11:50 a.m.] and said that we can't give sedative on this floor, they said they would come down [to the floor where Patient 34 was]..."

An undated facility document titled, "Encounter Management," was reviewed. The document indicated Patient 34 was transferred to ICU Room H on March 1, 2025, at 12:18 p.m.

A facility document titled "Acknowledgement of Employee Job description/Physical Requirements and Working Conditions Form," dated July 26, 2022, was reviewed. The document indicated, "...Employee Name: RN 1 [Patient 34's primary RN taking care of the patient on the medical surgical floor before and after Patient 34 was upgraded to be transferred to the ICU]...Date 7/26/22 [July 26, 2022]...Job Title...RN...Department...Med/Surg [Medical/Surgical]..."

There was no documented evidence RN 1 has competency to care for an ICU patient.

An interview was conducted on March 3, 2025, at 11:15 a.m., with the PSC. The PSC stated the patient should have been taken care of by a qualified ICU nurse on March 1, 2025, at 8:48 a.m., when the provider ordered the upgrade of Patient 34 to ICU.

An interview was conducted on March 3, 2025, at 11:15 a.m., with the Nursing Supervisor Registered Nurse (NSRN). The NSRN stated the RN 1 was not qualified to take care of an ICU patient. The NSRN stated it was inappropriate for the Medical Surgical/Telemetry Unit to have the ICU patient in the unit. The NSRN stated the Charge Nurse from the ICU should have remained with Patient 34 and took over the patient care.

An interview was conducted on March 4, 2025, at 8:45 a.m., with the Chief Nursing Officer (CNO). The CNO stated she was notified of the changes to Patient 34's condition which required Patient 34 to be transferred to the ICU. The CNO stated she reinforced that Patient 34 was to be transferred to the ICU. The CNO stated she was made aware of the delay in transferring Patient 34 to the ICU. The CNO stated she was not aware RN 1 was providing care to Patient 34 and was not qualified to care for an ICU patient. The CNO stated it is not expected for a medical surgical nurse to provide care for an ICU patient.

An interview was conducted on March 4, 2025, at 9:02 a.m., with the Corporate Quality Officer (CQO). The CQO stated nurses should be competent in the care providing to the patients.

The facility was not able to provide a policy for Registered Nurse competencies.

A facility policy and procedure titled, "Staffing Plan," dated December 2023, was reviewed. The policy indicated, "...criteria and process for assigning patient care responsibilities in accordance with California Department of Public Health and Title 22 nurse...number of qualified RNs required for delivering nursing care to patients requiring a specific level of care..."

Based on interview and record review, the facility failed to ensure the facility's policies and procedures were implemented, for six of 91 sampled patients (Patients 12, 26, 27, 28, and 30), when:

1. For Patients 12, 26, 27, 28, and 30 pain assessments and/or reassessments were not completed;

2. For Patients 26 and 27 antiseptic (substances that prevent the growth of disease-causing microorganisms) baths were not completed;

3. For Patient 26, assessment was not completed after the patient was transferred to a different nursing unit;

4. For Patient 26 and 27, who needed assistance with repositioning, repositioning was not implemented;

5. For Patient 8, a critical lab result was not reported to the provider; and

6. For Patient 12, a Transthoracic Echocardiogram (a non-invasive imaging test that uses ultrasound to create detailed images of the heart) result was not reported to the provider.

These failures had the potential to compromise patient safety, result in inadequate pain management, increase the risk of infection, and increase the risk for pressure injuries (bedsores, injuries to skin and the tissue below the skin that are due to pressure on the skin for a long time).

Findings:

1a. On February 26, 2025, at 11 a.m., a review of Patient 12's record was conducted with Registered Nurse (RN) 6.

A facility document titled, "History and Physical (H&P)," dated September 30, 2024, at 4:58 p.m., was reviewed. The document indicated Patient 12 was admitted to the facility for persistent disequilibrium (a feeling of imbalance or unsteadiness that lasts for most days), left sided facial droop, and acute right pontine infarction (a blood flow blockage to a part of the brain). The document indicated Patient 12 had a medical history of hypertension (high blood pressure), depression (a mood disorder) and benign prostatic hyperplasia (a condition in which the prostate gland enlarges).

A facility document titled, "Order Inquiry," dated September 30, 2024, at 5:21 p.m., was reviewed and indicated, "...Acetaminophen (medication used for pain and/or fever)...Dose ...650 mg [milligrams, a unit of measurement]...Tablet...Frequency...as needed...Ord [Ordering] Phys [Physician]...[name of Medical Doctor [MD] 1..."

A facility document titled, "Order Inquiry," was reviewed. The document indicated acetaminophen 650 milligrams was administered to Patient 12 on October 1, 2024, at 6:47 a.m., for headache of seven out of 10 on a pain scale (a pain assessment tool, with 0 meaning no pain, and 10 meaning severe pain).

There was no documented evidence Patient 12's pain was reassessed after acetaminophen was administered on October 1, 2024, at 6:47 a.m.

On February 26, 2025, at 12 p.m., an interview with Registered Nurse (RN) 6 was conducted. RN 6 stated there was no documentation a pain reassessment was conducted on Patient 12 after acetaminophen was administered for pain on October 1, 2024, at 6:47 a.m. RN 6 further stated, "It should have been done."

1b. A review of Patient 26's record was conducted on February 28, 2025, at 1:04 p.m., with the Stroke Coordinator Registered Nurse (SC).

A facility document titled, "History and Physical [H&P]," was reviewed. The document indicated Patient 26 was admitted to the facility on February 23, 2025, for abdominal pain.

A facility document titled, "Medication Administration Record," was reviewed. The document indicated, "...Dilaudid [a pain medication]...1 [one] mg [milligram, a unit of measurement]...IV [intravenous, administered through the vein]...every 3 [three] hours, as needed for pain..."

A facility document titled, "Med [Medication] Admin [Administration]," was reviewed. The document indicated on February 25, 2025, at 4:55 a.m., 1 mg of Dilaudid was administered to Patient 26. The document indicated Patient 26 had a pain scale level of eight of ten at the time of the Dilaudid administration.

There was no documented evidence pain reassessment was conducted after the administration of Dilaudid on February 25, 2025, at 4:55 a.m.

1c. A review of Patient 27's record was conducted on February 28, 2025, at 2:53 p.m., with the SC.

A facility documented titled, "H&P," was reviewed. The document indicated Patient 27 was admitted to the facility on February 17, 2025, for tremors.

A facility document titled, "Medication Administration Record," was reviewed. The document indicated, "...Morphine [a pain medication]...2 [two] mg...IV...every 4 [four] hours, as needed for pain..."

A facility document titled, "Med Admin," was reviewed. The document indicated on February 24, 2025, at 2:07 p.m., February 27, 2025, at 12:39 a.m., February 27, 2025, at 5:04 p.m., and on February 28, 2025, at 10:18 a.m., 2 mg of morphine was administered to Patient 27.

A facility document titled, "Pain Assessment Flow Sheet," was reviewed. The document indicated Patient 27's pain level was assessed during the above-mentioned dates and times at eight of 10, 10 of 10, eight of 10, and eight of 10, respectively.

There was no documented evidence pain was reassessed after morphine was administered to Patient 27 on the above-mentioned dates and times.

1d. A review of Patient 28's record was conducted on March 3, 2025, at 9:45 a.m., with the SC.

A facility documented titled, "H&P," was reviewed. The document indicated Patient 28 was admitted to the facility on February 28, 2025, for shortness of breath.

A facility document titled, "Medication Administration Record," was reviewed. The document indicated, "...Acetaminophen...tablet oral [by mouth] every six hours as needed...for mild pain...650 mg...Tylenol [brand name of acetaminophen] ..."

A facility document titled, "Med Admin," was reviewed. The document indicated on February 28, 2025, at 10:40 p.m., March 1, 2025, at 9:33 a.m., March 2, 2025, at 10:05 a.m., and March 2, 2025, at 4:53 p.m., 650 mg of Tylenol was administered to Patient 28.

A facility document titled, "Pain Assessment Flow Sheet," was reviewed. There was no documented evidence Patient 28's pain level was not assessed or reassessed on the above mentioned administration dates and times.

1e. A review of Patient 30's record was conducted on March 3, 2025, at 10:10 a.m., with the SC.

A facility documented titled, "H&P," was reviewed. The document indicated Patient 30 was admitted to the facility on February 19, 2025, for shortness of breath.

A facility document titled, "Medication Administration Record," was reviewed. The document indicated, "...hydrocodone/acetaminophen [a pain medication] 5 [five]/325 mg ...Norco [brand name of hydrocodone/acetaminophen]...tablet...oral...PRN [as needed]..."

A facility document titled, "Med Admin," was reviewed. The document indicated on February 21, 2025, at 10:01 a.m., one tablet of Norco was administered to Patient 30.

A facility document titled, "Pain Assessment Flow Sheet," was reviewed. The document indicated Patient 30's pain level was 10 of 10 on February 21, 2025, at 10:01 a.m.

There was no documented evidence pain reassessment was conducted on Patient 30 after Norco was administered on February 21, 2025, at 10:01 a.m.

An interview was conducted on March 3, 2025, at 10:45 a.m., with the SC. The SC stated it is important to assess and reassess patients pain levels to know if treatment is effective.

The facility policy and procedure titled "Pain Management," dated September 2024 was reviewed. The policy indicated, "...Routine Reassessment...Patient will be routinely reassessed for pain during the initial daily shift assessment...with new complaints, and as needed. At a minimum, this reassessment shall consist of noting the intensity of the patient's pain...Reassessment Following Treatment for Pain...If a treatment intervention for pain is provided, the response to that intervention should be assessed. Reassessment is recommended to occur within 15 - 60 minutes following treatment..."

2a. A review of Patient 26's record was conducted on February 28, 2025, at 1:04 p.m., with the SC.

A facility document titled, "History and Physical [H&P]," was reviewed. The document indicated Patient 26 was admitted to the facility on February 23, 2025, for abdominal pain.

A review of the facility flow sheet, "I&O [intake and output, documentation fluid volumes taken in and out of the body]," was conducted. The document indicated Patient 26 had a foley catheter (a plastic tube inserted into the bladder to drain and collect the urine) placed since February 23, 2025.

A review of the facility flow sheet, "Activities of Daily Living," was conducted. The document indicated Patient 26 was provided with a chlorhexidine gluconate (CHG, an antiseptic solution to help reduce the bacteria on the skin) bath on February 23, 2025, February 24, 2025, February 25, 2025, and February 28, 2025. There was no documented evidence a CHG bath was provided to Patient 26 on February 26, 2025, and February 27, 2025.

2b. A review of Patient 27's record was conducted on February 28, 2025, at 2:53 p.m., with the SC.

A facility documented titled, "H&P," was reviewed. The document indicated Patient 27 was admitted to the facility on February 17, 2025, for tremors.

A review of the facility flow sheet, "I&O," was conducted. The document indicated Patient 27 had a foley catheter inserted February 17, 2025, and remained in place until discharge.

A review of the facility flow sheet, "Activities of Daily Living" was conducted. The document indicated Patient 27 was provided with a CHG bath on February 18, 2025, February 19, 2025, February 21, 2025, February 21, 2025, February 20, 2025, February 21, 2025, February 22, 2025, February 23, 2025, February 24, 2025, February 25, 2025, February 27, 2025, and February 28, 2025. The document further indicated Patient 27 refused a CHG bath on February 19, 2025.

There was no documented evidence an CHG bath was provided to Patient 27 on February 26, 2025.

2c. A review of Patient 30's record was conducted on March 3, 2025, at 10:10 a.m., with the SC.

A facility documented titled, "H&P," was reviewed. The document indicated Patient 30 was admitted to the facility on February 19, 2025, for shortness of breath.

A review of the facility flow sheet, "I&O," was conducted. The document indicated Patient 30 had a foley catheter inserted on February 23, 2025, and remained in place until February 28, 2025.

A review of the facility flow sheet, "Activities of Daily Living," was conducted. The documented indicated Patient 30 was provided with a CHG bath on February 23, 2025, February 24, 2025, February 25, 2025, and February 27, 2025.

There was no documented evidence a CHG bath was provided to Patient 30 on February 26, 2025.

An interview was conducted on March 3, 2025, at 10:45 a.m., with the SC. The SC stated CHG bath should be completed once per day for patients with foley catheters. The SC stated CHG baths are important to prevent hospital required infections.

The facility policy and procedure titled, "Bathing with Hospital Approved Skin Antiseptic," dated May 2024, was reviewed. The policy indicated, "...daily bathing with a hospital approved skin antiseptic will be performed...daily...on the following patients...have an indwelling urinary catheter..."

3a. A review of Patient 26's record was conducted on February 28, 2025, at 1:04 p.m., with the SC.

A facility document titled, "H&P," was reviewed. The document indicated Patient 26 was admitted to the facility on February 23, 2025, for abdominal pain.

A facility document titled, "Daily Floor Census," dated February 27, 2025, was reviewed and indicated Patient 26 was transferred from the ICU (intensive care unit, unit for patients with critical illnesses) to the telemetry unit (a unit for patients needing continuous remote heart rhythm monitoring) on February 27, 2025, at 7 p.m.

A review of the facility flow sheet titled, "Daily," was reviewed and indicated Patient 26 was assessed on Patient 26 on February 27, 2025, at 6 p.m., and then on February 28, 2025, at 8 a.m.

There was no documented evidence Patient 26 was assessed after the patient was transferred to the telemetry unit on February 27, 2025, at 7 p.m., until February 28, 2025, at 8 a.m.

An interview was conducted on February 28, 2025, at 1:15 p.m., with the SC. The SC stated there should have been an assessment overnight for Patient 26 from February 27, 2025, to February 28, 2025.

An interview was conducted on March 3, 2025, at 10:45 a.m., with the SC. The SC stated patients should be assessed a minimum of once per shift. The SC further stated nurses should complete a transfer assessment when patients are transferred to another unit. The SC stated it is important for assessments of patients to be completed to monitor changes in conditions and report them back to the health care team.

The facility policy and procedure titled, "Transferring of Patients (Including In-Unit Transfers," dated September 2024, was reviewed. The policy indicated, "...A transfer assessment shall be completed by a registered nurse within eight (8) hours of transfer to the assigned unit/room..."

4a. A review of Patient 26's record was conducted on February 28, 2025, at 1:04 p.m., with the SC.

A facility document titled, "H&P," was reviewed. The document indicated Patient 26 was admitted to the facility on February 23, 2025, for abdominal pain.

The facility flow sheet, "Activities of Daily Living," was reviewed. The document indicated Patient 26 needed assistance to reposition. There was no documented evidence Patient 26 was repositioned every two hours on the following dates and times:

- February 24, 2025, at 10 p.m.;
- February 25, 2025, at 12 a.m.; 2 a.m., 4 a.m., and 6 a.m.; and
- February 27, 2025, at 2 a.m.; 4 a.m., and 6 a.m.

4b. A review of Patient 27's record was conducted on February 28, 2025, at 2:53 p.m., with the SC.

A facility documented titled, "H&P," was reviewed. The document indicated Patient 27 was admitted to the facility on February 17, 2025, for tremors.

A facility document titled, "Wound Management," was reviewed. The document, dated February 17, 2025, was reviewed and indicated, "...Large reddened area with small white area of macerated [occurs when skin is exposed to moisture for too long, causing it to soften, swell, and break down] skin." The document, dated February 20, 2025, was reviewed and indicated, "...non-blanchable [discoloration of the skin that does not turn white when pressed] redness with small open area..."

A facility document titled, "Progress Note," dated February 24, 2025, at 10:54 a.m., was reviewed. the document it indicated, "...Stage 2 [a partial thickness loss of skin presenting as a shallow open ulcer with a red or pink wound bed] in the coccyx [tailbone]..."

The facility flow sheet titled, "Activities of Daily Living," was reviewed. The document indicated Patient 27 needed assistance to reposition. There was no documented evidence Patient 27 was repositioned every two hours on the following dates and times:

- February 18, 2025, at 8 p.m. and 10 p.m.; and
-February 19, 2025, at 12 a.m., 2 a.m., 4 a.m., and 6 a.m.

An interview was conducted on March 3, 2025, at 10:45 a.m., with the SC. The SC stated, if patients need assistance, they should be repositioned every two hours to prevent pressure injuries, and offload pressure. The SC further stated if patients are not repositioned, it could result in pressure injuries.

An interview and concurrent record review was conducted on March 3, 2025, at 2:35 p.m., with the SC. The SC confirmed Patient 26 had a Braden score (a pressure injury risk assessment tool with skin breakdoen risk categories of 19-23: no risk, 15-18: mild risk, 13-14: moderate risk, 10-12: high risk, and 9 and less: very high risk) of 15. The SC confirmed Patient 27 had a Braden score of 12. The SC stated Patient 26 and Patient 27 were at risk of skin breakdown.

The facility policy and procedure titled, "Skin And Wound Care," dated May 2024, was reviewed. The policy indicated, "...Risk factor for skin impairment: Braden Scale of eighteen (18) or less...Pressure injury skin bundle interventions include...Regular repositioning...For patients with intact skin, continue documentation to include interventions for prevention..."

5. On February 26, 2025, at 1:30 p.m., a review of Patient 8's record was conducted with Registered Nurse (RN) 6.

A facility document titled, "History and Physical [H&P]," dated February 23, 2025, at 12:49 a.m., was reviewed. The document indicated Patient 8 was admitted to the facility for altered mental status (a significant change in a person's level of consciousness, awareness, cognition, or behavior). The document indicated Patient 8 had a history of end stage renal disease (condition where the kidneys are severely damaged) on hemodialysis (a procedure to filter and remove waste products from the blood using a machine), seizures (a sudden, temporary disruption in the brain's electrical activity that can cause involuntary movements, changes in behavior, and/or loss of consciousness), diabetes (a condition with abnormal blood sugar levels), and hypertension (high blood pressure). The document indicated Patient 8 was admitted to Intensive Care Unit (ICU, a department of a hospital in which patients who are ill are kept under constant observation).

A facility document titled, "Chemistry," dated February 24, 2025, at 12:25 a.m., was reviewed. The document indicated, "...Calcium...14.1...H [high]...Reference Units...[8.6-10.3 mg/dl [milligrams per deciliter, unit of measurement]..."

A facility document titled, "H&P," dated February 24, 2025, at 12:49 a.m., was reviewed. The document did not indicate a critical calcium level.

There was no documented evidence the physician was notified of Patient 8's critical calcium level on February 24, 2025, at 12:25 a.m.

On February 26, 2025, at 1 p.m., an interview was conducted with RN 6. RN 6 stated, "the critical calcium should have been reported to the doctor." RN 6 stated there was no documentation anyone was notified of Patient 8's critical calcium results or if any new orders for Patient 8 related to the critical calcium level was placed. RN 6 stated the facility's policy was not followed.

On February 26, 2025, a review of the policy titled, "Request for Laboratory Tests," dated April 2021, was conducted. The policy indicated, "...Critical Values...All abnormal test results that appear to be in a range where immediate attention should be given to the patient will be phoned immediately to the appropriate caregiver within 60 minutes..."

6. On February 26, 2025, at 11 a.m., a review of Patient 12's record was conducted with Registered Nurse (RN) 6.

On February 26, 2025, at 11:05 a.m., Patient 12' s record was reviewed with RN 6. A facility document titled, "History and Physical (H&P)," dated September 30, 2024, at 4:58 p.m., was reviewed. The document indicated Patient 12 was admitted to the facility for persistent disequilibrium (a feeling of imbalance or unsteadiness that lasts for most days), left sided facial droop acute right pontine infarction (a blood flow blockage to a part of the brain). The document indicated Patient 12 had a medical history of hypertension (high blood pressure), depression and benign prostatic hyperplasia (a condition in which the prostate gland enlarges). The document further indicated a plan for an echocardiogram (a test of the action of the heart using ultrasound waves to produce a visual display) for Patient 12.

A facility document titled, "Order Inquiry," dated October 1, 2024, at 8:01 a.m., was reviewed and indicated an echocardiogram was ordered by Medical Doctor (MD) 3.

A facility document titled, "Transthoracic Echocardiogram Report [TTE]," dated October 2, 2024, at 12:14 p.m., was reviewed and indicated a TTE was completed on Patient 12.

A facility document titled, "Discharge Summary," dated October 2, 2024, at 4:54 p.m., authored by MD 2, was reviewed. The document indicated Patient 12 was discharged to home with home health (medical and nursing services provided in a patient's residence instead of a hospital or other healthcare facility). The document indicated, "...TTE was done on October 2, 2024, patient wanted to leave and so was discharged shortly after TTE, primary team will follow up on result and inform patient...Disposition...follow up on TTE, PCP [primary care physician] appointment w/in [within] 1-2 [one to two weeks..."

There was no documented evidence the physician and Patient 12 were notified of the results of Patient 12's TTE procedure.

On February 26, 2025, at 11:15 a.m., an interview was conducted with the Nursing Supervisor Registered Nurse (NSRN). The NSRN stated the physician who ordered the test should have been notified of the TTE results. The NSRN stated there was no documentation Patient 12 and MD 3, who ordered the TTE, were notified of the results of Patient 12's TTE procedure.

On February 26, 2025, a review of the facility policy titled, "Echocardiograms," dated April 2021, was conducted. The policy indicated, "...Once an echocardiogram has been interpreted by the reading physician, the report will be filed in the patient's chart, or sent to Medical Records if the patient is discharged...A second copy must be made of the original dictated report and placed in the patient's cardiology folder...A copy of the report will be faxed to the dictating and referring physician upon verification of the report..."

Based on observations, interviews, and record reviews, the facility failed to ensure laboratory services were provided and maintained to meet the patients' needs when:

1. Two out of the six freezers and refrigerators and the freezer alarm battery were not maintained in accordance with the manufacturer's instructions for use (IFU);

2. The standard laboratory procedure for storing specimens (a sample for medical testing) and reagents (any substance or mixture of substances used to perform a laboratory test) was not implemented;

3. 18 out of 22 laboratory specimens for tests to be sent out for processing to Laboratory 2 were not completed in a timely manner for Patients 20, 51, 54, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 70, and 71;

4. For three of 91 sample patients (Patients 51, 55, and 72), the laboratory specimens were not sent to Laboratory (Lab) 3 timely;

5. For three of 91 sample patients (Patients 20, 52, and 53), the facility policy and procedure on laboratory services was not implemented;

6. For one of 91 sample patients (Patient 64), the laboratory test was not entered as ordered on the laboratory requisition form; and

7. For one of 91 sample patients (Patient 12), the laboratory specimens were not conducted as ordered by physician.

These failures resulted in a delay in obtaining the result of laboratory tests and had the potential to produce erroneous (wrong) laboratory results and cause a delay in the diagnosis and treatment of patients.

Findings:

1.On February 24, 2025, at 5:30 p.m., an observation of the laboratory was conducted with the Director of Laboratory Services (DLS).

1a. During an inspection of Freezer 1 in the laboratory, an approximately two-inch thick white tiny ice crystals (frost) were observed in the compartments of Freezer 1.

A review of the manufacturers' Instruction For Use (IFU) for Freezer 1 was conducted with the DFM. The undated document titled, "Installation and Operation Manual [Name of Freezer 1]," was reviewed. The document indicated, "...defrost the freezer once a year or whenever the ice buildup exceeds 3/8" [inch, a unit of measurement]..."

Based on record review, there was no documented evidence Freezer 1 was defrosted in the preventative maintenance (PM, the act of keeping a structure in its as-built condition) sheet provided by the facility.

Based on record review, there was no documented evidence a work order was generated to defrost Freezer 1.

On March 3, 2025, at 4:01 p.m., an interview with concurrent record review were conducted with the Director of Facility Maintenance (DFM). The DFM stated the PM for Freezer 1 did not contain documentation Freezer 1 was defrosted as directed by the IFU. The DFM stated it should have been defrosted.

1b. On February 24, 2025, at 5:30 p.m., an inspection of Refrigerator 1 in the laboratory was conducted with the DLS. An approximately two-inch white crystals were observed in the freezer compartment of Refrigerator 1.

On February 24, 2025, at 5:30 p.m., an interview was conducted with the DLS. The DLS stated the two-inch frost was present in all the compartments of Freezer 1. The DLS stated there should not be frost in the freezer compartments in order "to maintain the stability and integrity of the controls (a sample with a known value that is tested alongside experimental samples) and specimens." The DLS further stated, "We get bad results or erroneous results because of it."

A review of the manufacturer's IFU for Refrigerator 1 was conducted with the DFM. The undated document titled, "Care and Cleaning," was reviewed. The document indicated, "...defrost freezer compartment when frost becomes 1/4" to ½" thick in any area of the freezer..."

Based on record review, there was no documented evidence Refrigerator 1 was defrosted in the PM sheet provided by the facility.

Based on record review, there was no documented evidence a work order was generated to defrost Refrigerator 1.

On March 3, 2025, at 4:01 p.m., an interview was conducted with the DFM. The DFM stated the PM sheet did not have documentation Refrigerator 1 was defrosted as directed by the manufacturer's IFU. The DFM stated it should have been defrosted.

1c. On February 24, 2025, at 5:30 p.m., an observation of the laboratory with concurrent interview were conducted with the Director of Laboratory Services (DLS). The "Alarm battery low" light on the front of Freezer 1 was observed to be on.

On February 24, 2025, at 5:30 p.m., during a concurrent interview, the DLS stated the alarm battery was low. The DLS stated it was time to change the alarm battery, but he has not submitted a work order yet.

On February 25, 2025, at 1:48 p.m., an interview with concurrent record review were conducted with the DFM. A review of the PM for Freezer 1 was conducted with the DFM. The DFM stated there was no documentation on the PM sheet that a visual check was done on the battery for the alarm for Freezer 1. The DFM stated it should have been documented if the battery was checked.

A review of the manufacturer's IFU for the Freezer 1 was conducted with the DFM.

An undated document titled, "Installation and Operation Manual [Name of Freezer 1]," was reviewed and indicated, "...Alarm Battery Maintenance check the condition of the alarm battery at least once a year..."

Based on record review, there was no documented evidence a work order was generated to change Freezer 1's alarm battery prior to February 24, 2025, at 5:30 p.m.

There was no documented evidence the alarm battery on Freezer 1 was inspected prior to February 24, 2025.

A review of the facility policy and procedure titled, "Temperature and Humidity Monitoring of General Lab and Lab equipment," dated August 2024, was conducted. The policy indicated, "...it is the policy of [Name of Facility] to maintain proper temperature and humidity conditions for optimal instrument performance based on manufacturer's guidelines and proper temperatures for all equipment (i.e., freezers, refrigerators, water baths, etc.) involving reagent and chemical storage..."

2. On February 24, 2025, at 5:30 p.m., an observation of the laboratory was conducted with the DLS. During an inspection of Freezer 1 in the laboratory, specimens and reagents were observed to have been stored together in the compartments.

On February 25, 2025, at 9:47 a.m., an interview was conducted with the DLS. The DLS stated the specimens and reagents were mixed together in the same compartment. The DLS stated the specimens and reagents should have been stored in separate compartments.

On February 25, 2025, at 10:15 a.m., an interview was conducted with the Chief Quality Officer (CQO). The CQO stated specimens and reagents cannot be stored mixed together in one compartment for infection control purposes. The CQO stated, "Specimens are dirty, and reagents are clean."

An undated document titled, "Can laboratory reagents be stored in a refrigerator that also contains medications or laboratory specimens," was reviewed with the DLS. The document indicated, "...Laboratory reagents may be stored in the same refrigerator as laboratory specimens...there should be distinctly marked and separated areas in the refrigerator to minimize any risk of contamination from spills. Laboratory reagents should be stored on upper shelves with laboratory specimens on lower shelves..."

3. On February 24, 2025, at 9:33 am, an interview was conducted with the DLS. The DLS stated Lab 2 terminated their contract with the facility on January 20, 2025. The DLS stated Laboratory (Lab) 3 started picking up their specimens for testing on February 14, 2025.

An untitled facility document dated December 19, 2024, was reviewed. The document indicated, "...To: [Name of DLS]...The 30 day letter is going to be sent to the lab directors today and all are needing to understand that [Name of Lab] is giving 30 day notice to find another lab...[Name of Lab 2 Executive]..."

An untitled facility document dated January 25, 2025, was reviewed. The document indicated, "...This e-mail is final notification that services for the following accounts will be turned us [sic] off, [sic] 5 PM [p.m.], PT [Pacific Time], Monday 01-20-24 [January 20, 2024, sic]...Breach of signed continuous Service Agreement on file...30 day termination letters overnighted as of 12-19-24 [December 19, 2024], therefore, [Name of Group] has had the opportunity to locate needed reference lab..."

On February 28, 2025, at 9:57 a.m. a review of laboratory tests completed with concurrent interview were conducted with the DLS and Technical Supervisor (TS):

3a. On February 28, 2025, at 10:07 a.m., a review of Patient 51's record was conducted with the DLS. An untitled and undated facility document was reviewed and indicated Patient 51 was admitted to the facility on January 31, 2025, for septic shock (a severe infection).

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 51]...Ordered: [Name of Test 1...entered: 02/01/2025 [February 1, 2025]- 0010 [12:10 a.m.]...Reg Dr: [Name of Physician (MD 2)]...Coll [Collected]: 02/01/2025 - 0305 [3:05 a.m.]...Recv [Received]: 02/01/2025 - 0713 [7:13 a.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 51]...Received: 02/16/2025 [February 16, 2025]- 01:34 [1:34 a.m.]...Reported: 02/24/2025 [February 24, 2025]- 2323 [11:23 p.m.]...[Name of Test 1]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility 23 days after the lab test was collected.)

On February 28, 2025, at 10:07 a.m., an interview was conducted with the DLS. The DLS stated the lab test result for Test 1 for Patient 51 was late. The DLS stated, "It should have been resulted in three days."

3b. On February 28, 2025, at 10:07 a.m., a review of Patient 54's record was conducted with the DLS. An untitled and undated facility document was reviewed and indicated Patient 54 was admitted to the facility on January 11, 2025, for anemia (a condition in which the body does not have enough healthy red blood cells or hemoglobin).

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 54]...Ordered: [Name of Test 2]...entered: 02/15/2025 [February 15, 2025]- 2104 [9:04 p.m.]...Reg Dr: [Name of MD 16]...Coll: 02/16/2025 [February 16, 2025]- 0346 [3:36 a.m.]...Recv: 02/16/2025- 0403 [4:03 a.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 54]...Received: 02/18/2025 [February 18, 2025]- 0435 [4:35 a.m.]...Reported: 02/20/2025 [February 20, 2025]- 1824 [6:24 p.m.]...[Name of Test 2]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility four days after the lab test was collected.)

On February 28, 2025, at 10:07 a.m., an interview was conducted with the DLS. The DLS stated the lab test result for Test 2 for Patient 54 was late. The DLS stated, "It should have been done in one to three days."

3c. On February 28, 2025, at 11:37 a.m., a review of Patient 56's record was conducted with the DLS. An untitled and undated facility document was reviewed and indicated Patient 56 was admitted to the facility on February 6, 2025, for complicated urinary tact infection (UTI, a bladder infection).

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 56]...Ordered: [Name of Test 3]...entered: 02/06/2025 [February 6, 2025 ]- 0600 [6:00 a.m.]...Reg Dr: [Name of MD 4]...Coll: 02/06/2025 - 1140 [11:40 a.m.]...Recv: 02/06/2025 -1147 [11:47 a.m.]...Results are in as of 2/19/2025 (February 19, 2025)..." (The lab test result was received by the facility 13 days after the lab test was collected.)

On February 28, 2025, at 11:37 a.m., an interview was conducted with the DLS. The DLS stated the lab test result for Test 3 for Patient 56 was late. The DLS stated, "It should have been resulted in one to three days."

3d. On February 28, 2025, at 12:13 p.m., a review of Patient 57's record was conducted with the DLS. An untitled and undated facility document was reviewed and indicated Patient 57 was admitted to the facility on February 7, 2025, for kidney stone.

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 57]...Ordered: [Name of Test 4]...entered: 02/07/2025 [February 7, 2025]-1000 [10:00 a.m.]...Reg Dr: [Name of MD 5]...Coll: 02/07/2025 - 1000 [10 a.m.]...Recv: 02/11/2025 -0904 [9:04 a.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 57]...Received: 02/15/2025- 1309 [1:09 p.m.]...Reported: 02/20/2025 [February 20, 2025]- 2141 [9:41p.m.]...[Name of Test 4]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility 13 days after the lab test was collected.)

On February 28, 2025, at 12:13 p.m., an interview was conducted with the DLS. The DLS stated the specimen was not received on time in their system. The DLS stated it should have been received right away. The DLS stated the lab test result for Test 4 for Patient 57 was late. The DLS stated, "It should have been done in nine days, but it took 13 days."

3e. On February 28, 2025, at 12:34 p.m., a review of Patient 58's record was conducted with the DLS. An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 58]...Admit Date/time: 02/19/2025- 11:38 [11:38 a.m.]...reason for visit: New Hire."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 58]...Ordered: [Name of Test 5]...entered: 02/19/2025-1147 [11:47 a.m.]...Reg Dr: [Name of MD 6]...Coll: 02/19/2025 - 1147 [11:47 a.m.]...Recv: : 02/19/2025-1147 [11:47 a.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 58]...Received: 02/21/2025 [February 21, 2025 ]- 0511 [5:11 a.m.]...Reported: 02/23/2025 [February 23, 2025]- 0523 [5:23 a.m.]...[Name of Test 5]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility four days after the lab test was collected.)

On February 28, 2025, at 12:34 p.m., an interview was conducted with the DLS. The DLS stated the lab test result for Test 5 for Patient 58 was late. The DLS stated, "It should have been resulted in one to three days. It is one day late."

3f. On February 28, 2025, at 1:03 p.m., a review of Patient 59's record was conducted with the DLS. An untitled and undated facility document was reviewed and indicated Patient 59 was admitted to the facility on January 29, 2025, for hepatic encephalopathy (brain dysfunction due to liver dysfunction).

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 59]...Ordered: [Name of Test 6]...entered: 01/30/2025 [January 30, 2025] -1203 [12:03 p.m.]...Reg Dr: [Name of MD 7]...Coll: 01/30/2025 - 1435 [2:45 p.m.]...Recv: 01/30/2025 -1534 [3:34 p.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 59]...Received: 02/16/2025- 0151[1:51 a.m.]...Reported: 02/18/2025- 1728 [5:28 p.m.]...[Name of Test 6]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility 17 days after the lab test was collected.)

On February 28, 2025, at 1:03 p.m., an interview was conducted with the DLS. The DLS stated the lab test result for Test 6 for Patient 59 was late. The DLS stated, "It should have been resulted in one to three days. It was 15 days late."

3g. On February 28, 2025, at 1:19 p.m., a review of Patient 60's record was conducted with the DLS. An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 60]...Admit Date/time: 02/07/2025 [February 7, 2025]- 12:35 [12:35 a.m.]...reason for visit: New Hire."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 60]...Ordered: [Name of Test 5]...entered: 02/07/2025 -1244 [12:44 p.m.]...Reg Dr: [Name of MD 6]...Coll: 02/07/2025 - 1301 [1:01 p.m.]...Recv: 02/07/2025-1335 [1:35 p.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 60]...Received: 02/17/2025 [February 17, 2025] -1830 [6:30 p.m.]...Reported: 02/19/2025- 2037 [8:37 p.m.]...[Name of Test 5]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility 12 days after the lab test was collected.)

On February 28, 2025, at 1:19 p.m., an interview was conducted with the DLS. The DLS stated the lab test result for Test 5 for Patient 60 was late. The DLS stated, "It should have been resulted in one to three days. It's late nine days."

3h. On February 28, 2025, at 1:25 p.m., a review of Patient 61's record was conducted with the DLS. An untitled and undated facility document was reviewed and indicated Patient 61 was admitted to the facility on February 10, 2025, for sepsis secondary to UTI (a life-threatening condition).

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 61]...Ordered: [Name of Test 1]...entered: 02/10/2025 [February 10, 2025]- 1933 [7:33 p.m.]...Reg Dr: [Name of MD 8]...Coll: 02/12/2025 [February 12, 2025] -1953 [7:53p.m.]...Recv: 02/12/2025 -2028 [8:28 p.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 61]...Received: 02/17/2025- 1853 [6:53 p.m.]...Reported: 02/21/ 2025 [February 21, 2025]-1228 [12:28 p.m.]...[Name of Test 1]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility nine days after the lab test was collected.)

On February 28, 2025, at 1:25 p.m., an interview was conducted with the DLS. The DLS stated the lab test result for Test 1 for Patient 61 was late. The DLS stated, "It should have been resulted in two to four days. It's late nine days."

3i. On February 28, 2025, at 1:32 p.m., a review of Patient 62's record was conducted with the DLS. An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 62]...Admit Date/time: 02/06/2025- 09:27 [9:27 a.m.]...reason for visit: New Hire."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 62]...Ordered: [Name of Test 5]...entered: 02/06/2025- 0943 [9:43 a.m.]...Reg Dr: [Name of MD 6]...Coll: 02/06/2025 -0943 [9:43 a.m.]...Recv: 02/06/2025 -9:43 [9:43 a.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 62]...Received: 02/15/2025- 2220 [10:20 p.m.]...Reported: 02/19/2025-1931 [7:31 p.m.]...[Name of Test 5]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility 13 days after the lab test was collected.)

On February 28, 2025, at 1:32p.m., an interview was conducted with the DLS. The DLS stated the lab test result for Test 5 for Patient 62 was late. The DLS stated, "It should have been resulted in three days. It's 10 days late."

3j. On February 28, 2025, at 1:39 p.m., a review of Patient 63's record was conducted with the Technical Supervisor (TS). An untitled and undated facility document was reviewed and indicated Patient 63 was admitted to the facility on February 7, 2025, for kidney stone.

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 63]...Ordered: [Name of Test 4]...entered: 02/07/2025- 1015 [12:10 a.m.]...Reg Dr: [Name of MD 9]...Coll: 02/07/2025 - 1015 [10:15 a.m.]...Recv: 02/11/2025- 0907 [9:07 a.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 63]...Received: 02/15/2025- 1307 [1:07 p.m.]...Reported: 02/20/2025- 2114 [9:14 p.m.]...[Name of Test 4]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility 13 days after the lab test was collected.)

On February 28, 2025, at 1:39 p.m., an interview was conducted with the TS. The TS stated the lab test result for Test 4 for Patient 63 was late. The TS stated, "It should have been resulted in six to nine days. It's four days late."

3k. On February 28, 2025, at 1:45 p.m., a review of Patient 64's record was conducted with the TS. An untitled and undated facility document was reviewed and indicated Patient 64 was admitted to the facility on January 10, 2025, for diabetic ketoacidosis (a life-threatening complication of diabetes).

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 64]...Ordered: [Name of Test 8]...entered: 01/30/2025- 1106 [11:06 a.m.]...Reg Dr: [Name of MD 7]...Coll: 01/30/2025- 1800 [6 p.m.]...Recv: 01/30/2025 -1808 [6:08 p.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 64]...Received: 02/16/2025 [February 16, 2025]- 0533 [5:33 a.m.]...Reported: 02/21/2025- 2037 [8:37 p.m.]...[Name of Test 8]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility 22 days after the lab test was collected.)

On February 28, 2025, at 1:45 p.m., an interview was conducted with the TS. The TS stated the lab test result for Test 8 for Patient 64 was late. The TS stated, "It should have been resulted in five to ten days. It's 11 days late."

3l. On February 28, 2025, at 1:58 p.m., a review of Patient 65's record was conducted with the TS. An untitled and undated facility document was reviewed and indicated Patient 65 was admitted to the facility on February 5, 2025, for hemoptysis (coughing up blood).

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 65]...Ordered: [Name of Test 9]...entered: 02/05/2025 [February 5, 2025]- 12:06 [12:06 a.m.]...Reg Dr: [Name of MD 10]...Coll: 02/06/2025 - 0940 [9:40 a.m.]...Recv: 02/06/2025-1024 [10:24 a.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 65]...Received: 02/15/2025- 2215 [10:15 p.m.]...Reported: 02/18/2025- 1728 [5:28 p.m.]...[Name of Test 9]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility 12 days after the lab test was collected.)

On February 28, 2025, at 1:58 p.m., an interview was conducted with the TS. The TS stated the lab test result for Test 9 for Patient 64 was late. The TS, "It should have been resulted in two to six days. It's late seven days."

3m. On February 28, 2025, at 2:04 p.m., a review of Patient 66's record was conducted with the TS. An untitled and undated facility document was reviewed and indicated Patient 66 was admitted to the facility on February 3, 2025, for acute hyperglycemia (high blood sugar).

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 66]...Ordered: [Name of Test 6]...entered: 02/03/2025 [February 3, 2025]- 1032[10:32 a.m.]...Reg Dr: [Name of MD 7]...Coll: 02/03/2025 - 0209 [2:09 a.m.]...Recv: 02/05/2025 - 1535 [February 5, 2025, at 3:35 p.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 66]...Received: 02/15/2025- 2114 [9:14 p.m.]...Reported: 02/17/2025- 2014 [8:14 p.m.]...[Name of Test 6]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility 14 days after the lab test was collected.)

On February 28, 2025, at 2:04 p.m., an interview was conducted with the TS. The TS stated the lab test result for Test 6 for Patient 66 was late, "It should have been resulted in one to three days. It's late 11 days."

3n. On February 28, 2025, at 2:09 p.m., a review of Patient 67's record was conducted with the TS. An untitled and undated facility document was reviewed and indicated Patient 67 was admitted to the facility on February 9, 2025, for nausea and vomiting.

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 67]...Ordered: [Name of Test 10]...entered: 02/09/2025- 0926 [9:26 a.m.]...Reg Dr: [Name of MD 11]...Coll: 02/09/2025 - 0926 [9:26 a.m.] ...Recv: 02/09/2025 - 0936 [9:36 a.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 67]...Received: 02/15/2025- 1022 [10:22 a.m.]...Reported: 02/21/2025- 1905 [7:05 p.m.]...[Name of Test 10]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility 12 days after the lab test was collected.)

On February 28, 2025, at 2:09 p.m., an interview was conducted with the TS. The TS stated the lab test result for Test 10 for Patient 67 was late. The TS stated, "It should have been resulted in two to five days. It's seven days late."

3o. On February 28, 2025, at 2:14 p.m., a review of Patient 68's record was conducted with the TS. An untitled and undated facility document was reviewed and indicated Patient 68's reason for visit for new hire assessment.

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 68]...Ordered: [Name of Test 5]...entered: 02/07/2025- 1220 [12:20 p.m.]...Reg Dr: [Name of MD 6]...Coll [Collected]: 02/07/2025 - 1227 [12:27 p.m.]...Recv: 02/07/2025-12:41 [12:41 p.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 68]...Received: 02/17/2025- 1849 [6:49 p.m.]...Reported: 02/19/2025- 2037 [8:37 p.m.]...[Name of Test 5] ...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility 12 days after the lab test was collected.)

On February 28, 2025, at 2:14 p.m., an interview was conducted with the TS. The TS stated the lab test result for Test 5 for Patient 68 was late. The TS stated, "It should have been resulted in three days. It's late nine days."

3p. On February 28, 2025, at 2:22 p.m., a review of Patient 20's record was conducted with the TS. An untitled and undated facility document was reviewed and indicated Patient 20 was admitted to the facility on February 11, 2025, for substance overdose.

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 20]...Ordered: [Name of Test 6]...entered: 02/12/2025- 1347 [1:47 a.m.]...Reg Dr [Registered Doctor]: [Name of MD 4]...Coll: 02/12/2025 -1750 [5:50 p.m.]...Received: 02/12/2025 -1758 [5:58 p.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 20]...Received: 02/17/2025- 1549 [at 3:49 p.m.]...Reported: 02/19/2025- 1658 [4:58 p.m.]...[Name of Test 6]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility seven days after the lab test was collected.)

On February 28, 2025, at 2:22 p.m., an interview was conducted with the TS. The TS stated the lab test result for Test 6 for Patient 20 was late. The TS stated, "It should have been reported in seven days. It's late four days."

3q. On February 28, 2025, at 2:29 p.m., a review of Patient 70's record was conducted with the TS. An untitled and undated facility document was reviewed and indicated Patient 70 was admitted to the facility on February 6, 2025, for overdose ingestion.

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 70]...Ordered: [Name of Test 3]...entered 02/06/2025- 1457 [2:57 a.m.]...Reg Dr: [Name of MD 10]...Coll: 02/06 /2025 -2105 [9:05 p.m.]...Recv: 02/06/2025 -2111 [9:11 p.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 70]...Received: 02/15/2025- 2214 [10:14 p.m.]...Reported: 02/19/2025- 1618 [4:18 p.m.]...[Name of Test 3]...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility 13 days after the lab test was collected.)

On February 28, 2025, at 2:29 p.m., an interview was conducted with the TS. The TS stated the lab test result for Test 6 for Patient 70 was late. The TS stated, "It should have been reported in one to three days. It's late 10 days."

3r. On February 28, 2025, at 2:46 p.m., a review of Patient 71's record was conducted with the TS. An untitled and undated facility document was reviewed and indicated Patient 71 was admitted to the facility on February 10, 2025, for upper extremity pain.

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 71]...Ordered: [Name of Test 11]...entered: 02/10/2025- 1037 [10:37 a.m.]...Reg Dr: [Name of MD 12]...Coll: 02/10/2025 - 10:40 [10:40 a.m.]...Recv: 02/10/2025-1117 [11:17a.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 71]...Received: 02/18/2025- 04:46 [4:46 a.m.]...Reported: 02/18/2025 -1130 [11:30 a.m.] ...[Name of Test 11 ...Performing Laboratory information...[Name of Lab 3]..." (The lab test result was received by the facility eight days after the lab test was collected.)

On February 28, 2025, at 2:46 p.m., an interview was conducted with the TS. The TS stated the lab test result for Test 6 for Patient 71 was late. The TS stated, "It should have been reported in two to four days. It's late four days."

4a. On February 28, 2025, at 10:07 a.m., a review of Patient 51's record was conducted with the DLS. An untitled and undated facility document was reviewed and indicated Patient 51 was admitted to the facility on January 31, 2025, for septic shock.

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 51]...Ordered: [Name of Test 12]...entered: 02/01/2025- 1100 [11:00 a.m.]...Reg Dr: [Name of Physician (MD -Doctor of medicine 2)]...Coll: 02/01/2025 - 0305 [3:05 a.m.]...Recv: 02/01/2025 - 1309 [1:09 p.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 51]...Received: 02/15/2025- 11:18 [11:18 a.m.]...Reported: 02/17/2025- 1700 [5 p.m.]...Test not performed...The specimen exceeds stability for the test requested...[Name of Test 12]...Performing Laboratory information...[Name of Lab 3]..."

On March 4, 2025, at 10:35 a.m., an interview was conducted with the DLS. The DLS stated the specimen for Test 12 for Patient 51 was expired because it exceeded Lab 3's specimen storage time. The DLS further stated it was not sent to Lab 3 on time.

b. On February 28, 2025, at 11:24 a.m., a review of Patient 55's record was conducted with the DLS. An untitled and undated facility document was reviewed and indicated Patient 55 was admitted to the facility on January 27, 2025, for hypotension (low blood pressure).

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 55] ...Ordered: [Name of Test 2]...entered:...01/27/2025 [January 27, 2025] - 2155 [9:55 p.m.]...Reg Dr [Registered Doctor]: [Name of MD 1 ] ...Coll: 01/28/2025 [January 28, 2025] - 0927 [9:27 a.m.]...Received: 01/30/2025- 1040 [10:40 a.m.]...cancelled...Did not go out to [Name of Lab 2] cannot send to [Name of Lab 3] specimen stability is expired..."

On March 4, 2025, at 10:41 a.m., an interview was conducted with the DLS. The DLS stated the specimen was expired for Test 2 for Patient 55 because it exceeded Lab 3's specimen storage time. The DLS further stated it was not sent to Lab 3 on time because Lab 2 stopped their services for the facility on January 20, 2025, and Lab 3 began their services for the facility on February 14, 2025.

c. On February 28, 2025, at 2:22 p.m., a review of Patient 72's record was conducted with the DLS. An untitled and undated facility document was reviewed and indicated Patient 72 was admitted to the facility on January 31, 2025, for acute comminuted fracture (when bone shatters into multiple pieces).

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 72]...Ordered: [Name of Test 3]...01/31/2025 [January 31, 2025]- 2026 [8: 26 p.m.]...Reg Dr: [Name of MD 16]...Coll: 01/31/2025- 1750 [5:50 p.m.]...Received: 02/01/2025- 0733 [7:33 a.m.]..."

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 72]...Received: 02/16/2025- 01:34 [1:34 a.m.]...Reported: 02/24/2025 [February 25, 2025] - 2323 [11:23 p.m.]...[Name of Test 3]...not perfor

Based on interviews and record reviews, the facility failed to ensure emergency laboratory services were provided timely in accordance with the facility's policy and procedure when:

1. For Patient 52, a Stat (an order to be completed immediately) order for Test 14 was not collected timely; and

2. For Patient 53, a Stat order for Test 16 was not collected timely.

These failures resulted in delayed results of the laboratory tests sor Patients 52 and 53, and have the potential to delay the patients' treatment.

Findings:

1. On February 27, 2025, at 9:13 a.m., a review of Patient 52's record was conducted with RN (Registered Nurse). An untitled and undated facility document was reviewed and indicated Patient 52 was admitted to the facility on February 25, 2025, for pneumonia (infection of the lung).

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 52]...Ordered: [Name of Test 14]...start date: 02/25/2025 [February 25, 2025] - 1037 [10:37 a.m.]...Ord Phys[Ordering Physician]: [Name of MD 13]...Coll [Collected]: 00/00/0000 a.m.]...Priority: Stat [immediately]...Collected by ..."

Based on record review, there was no documented evidence the specimen for Test 14 for Patient 52 was collected prior to February 27, 2025.

On February 27, 2025, at 9:13 a.m., an interview was conducted with the RN. The RN stated Test 14 for Patient 52 was ordered by the physician on February 25, 2025. The RN stated the specimen for Test 14 for Patient 52 was not collected from February 25, 2025 to February 27, 2025. The RN further stated it should have been done right away. RN stated it is important to do the test right away "to find out what bacteria and what antibiotic to use."

2. On March 3, 2025, at 11:33 a.m., a review of Patient 53's record was conducted with the Stroke Coordinator (SC). An untitled and undated facility document was reviewed and indicated Patient 53 was admitted to the facility on February 21, 2025, for dialysis (a procedure that removes waste and extra fluid from the blood when the kidneys are not working properly).

An untitled and undated facility document was reviewed. The document indicated, "...[Name of Patient 53]...Ordered: [Name of Test 16]...ordered by: [Name of MD 15]...Ordered for: 27-Feb-2025 [February 27, 2025]-08:28 [8:28 a.m.]...Collected: 27-Feb-2025 - 10:00 [10 a.m.]...Priority: Stat...result name... results..."

Based on record review, there was no documented evidence the specimen for Test 16 for Patient 53 was collected prior to February 27, 2025, at 10 a.m.

On March 3, 2025, at 11:33 a.m., an interview was conducted with the SC. The SC stated the specimen was collected on February 27, 2025, at 10 a.m. The SC stated it should have been collected within 10 to 15 minutes of when it was ordered on February 27, 2025, at 8:28 a.m. The SC stated it is important to collect Stat orders on time "to trend patient's lab and to treat abnormal results right away."

A review of the facility policy and procedure titled, "Request for Laboratory Tests," dated April 2021, indicated, "...Priority of requests...the priority of the request, e.g. Routine, STAT, Timed, etc., should be indicated on all order requisitions...STAT: all requests for tests ordered as STAT will be collected within 10 to 15 minutes from the time they were ordered...NOTE: Remember that STAT orders must be called to the lab!..."

Based on interviews and record reviews, the facility failed to ensure the facility's medical staff were informed of the change in laboratory (Lab) services for the facility from Lab 2 to Lab 3.

This failure had the potential to delay the diagnosis and treatment of patients.

Findings:

On February 24, 2025, at 9:33 a.m., an interview was conducted with the Director of Laboratory Services (DLS). The DLS stated Laboratory (Lab) 2 terminated their contract with the facility on January 20, 2025. The DLS stated Laboratory (Lab) 3 started picking up the facility's specimens for testing on February 14, 2025.

An untiled facility document dated December 19, 2024, was reviewed. The document indicated, "...To: [Name of DLS]...The 30 day letter is going to be sent to the lab directors today and all are needing to understand that [Name of Lab] is giving 30 day notice to find another lab...[Name of Lab 2 Executive]..."

An untitled facility document dated January 25, 2025, was reviewed. The document indicated, "...This e-mail is final notification that services for the following accounts will be turned us off [sic]...5 PM [p.m.], PT [Pacific Time], Monday 01-20-24 [January 20, 2024, sic]...Breach of signed continuous Service Agreement on file...30 day termination letters overnighted as of 12-19-24 [December 19, 2024], therefore, [Name of Group] has had the opportunity to locate needed reference lab..."

Based on record review, there was no documented evidence the medical staff were informed of the change in lab services from Lab 2 to Lab 3 prior to February 24, 2025.

On February 24, 2025, at 12:53 p.m., an interview with the Chief Quality Officer was conducted. The CQO stated they did not inform the medical staff about the changes in lab services from Lab 2 to Lab 3. The CQO stated the medical staff should have been informed of the changes in lab services from Lab 2 to Lab 3 when it happened.

On February 26, 2025, at 1:25 p.m., the facility policy on notification of medical staff about changes of laboratory services was requested from the Deputy Regional Director of Quality (DRDQ). The DRDQ stated the facility does not have a policy on notification of medical staff about changes of laboratory services.

Based on observation, interview, and record review, the facility failed to ensure the facility's physical environment was maintained when:

1. Ceiling tiles were observed with brownish stains in the storage and waiting rooms;

2. Sewer smell was observed in ICU-A and in the dirty utility room and patient Rooms A, B, C, D, E, I, J, K, L, M, N, O, P, and Q;

3. For seven of 91 sample patients (Patient 24, 41, 42, 74, 75, 76, and 90), a system for use to call if assistance is needed and continuous telemetry (remote monitoring of the patients' heart rates and rhythms) monitoring were not provided;

4. Four pharmaceutical (pertaining to medications)/sharps waste bins (containers for disposals of needles and other sharp items) in the Intensive care unit (ICU, a specialized unit that provides monitoring for patients with life-threatening conditions) were overfilled to the brim;

5. Two out of seven freezers containing vials of controls (a sample with a known value that is tested alongside experimental samples) at the laboratory were not maintained in accordance with the manufacturer's instructions for use. In addition, the condition of the alarm battery of the freezer was not maintained;

6. For Patient 73, who was on airborne isolation, the temporary plastic magnetic door in front of the patient's room was not installed securely; and

7. Water retesting was not performed for the Mammoth cooling tower for the HVAC (Heating, Ventilation, and Air Conditioning) Systems supplying the heating and air-conditioning system to the Emergency Department, after the water tested positive for Legionella bacteria (a type of bacteria that could cause respiratory illness) on September 4, 2024; and

8. The Smith Cot (a device used for evacuating non ambulatory patients) were readily accessible for emergency use. This failure had the potential to result in patient injury and/or death in case of fire when evacuation of patients is needed.

These failures resulted in an unsafe environment, and had the potential for increased risk of exposure to harmful chemicals, viruses, and bacteria, which could potentially cause danger to the health, safety, and well-being of the already immunocompromised patients at the facility.

Findings:

1. On February 27, 2025, at 1:49 p.m., a facility tour was conducted with the Chief Nursing Officer (CNO) and the Patient Advocate (PA).

On February 27, 2025, at 2:18 p.m., a storage room was identified with brown staining on a ceiling tile.

On February 27, 2025, at 3:14 p.m., the facility tour continued with the Director of Facilities Management (DFM). During the tour, an unoccupied patient room on [nursing unit] was identified with brown staining on two ceiling tiles.

On February 28, 2025, at 9:58 a.m., a facility waiting room was identified with brown staining to three ceiling tiles. Engineer Tech (ET 2) was observed to arrive with a ladder and moved one of the ceiling tiles. During a concurrent interview, ET 2 stated a band (hose clamp) had broken on a pipe in the ceiling and it was leaking.

On March 3, 2025, at 3:52 p.m., an interview was conducted with the DFM and the Deputy Regional Director of Quality (DRDQ). The DFM stated the brown staining on the ceiling tiles were caused by fluid. The DRDQ stated fluid damage could create health hazards.

The facility policy and procedure titled, "Preventative Maintenance Program - Ensuring Operation Ability," dated March 2021, was reviewed. The policy indicated, "...The Facilities Administrator is responsible for the proper and safe functioning of all equipment within the facility and the condition of the facility generally..."

The facility policy and procedure titled, "Infection Control and Construction Safety," dated March 2021 was reviewed. The policy indicated, "...Water damaged materials...Prevention of fungal [molds] growth is of increased importance after any type water damage [sic]...Acoustical tiles and porous materials...Wet acoustical ceiling tiles [tiles designed to absorb sound and lowering the noise level]...may produce fungal spores [microscopic particles which allow fungi to reproduce and disperse to new locations]..."

2. On February 24, 2025, at 8:56 a.m., a tour of the Intensive Care Unit (ICU, a specialized unit that provides monitoring for patients with life-threatening conditions) was conducted with the Chief Nursing Officer (CNO).

On February 24, 2025, at 9:09 a.m., a tour of the medication room on the first floor ICU was conducted with CNO and the Nursing Supervisor (NSRN). A strong obnoxious foul smell of sewage odor was observed in the room. The CNO, and the NSRN stated they observed the foul sewer smell.

On February 24, 2025, at 9:11 a.m., an interview with the NSRN was conducted. The NSRN stated she observed the strong smell which has been there for over a month.

On February 24, 2025, at 9:11 a.m., an interview with the Director of Facility Maintenance (DFM) was conducted. The DRM stated the sewer vent in the wall between the medication room and the nutrition room is cracked which was causing the smell. The DRM stated they are unable to access the cracked pipe without tearing down the wall and that is a two-week process. The DRM stated the sewage smell was discovered one to two weeks ago.

On February 24, 2025, at 9:20 a.m., a tour of the nutrition room and the soiled utility room on the first floor ICU A was conducted with the CNO and NSRN. A strong obnoxious smell of sewage odor was present in both rooms. The CNO and the NSRN stated they observed the sewer smell. The CNO stated she can smell the strong smell of sewer in the soiled utility room.

On February 24, 2025, at 9:30 a.m., an interview with the CNO was conducted. The CNO stated she met with the DRM to discuss a plan to move the patients and close the ICU unit A and repair the pipes. The CNO stated they were waiting until March 2025 to begin the project.

On February 24, 2025, at 9:36 a.m., a tour of the fifth floor telemetry (unit where patients' heart rate and rhythm are continuously monitored remotely)/medical surgical (med surg, unit for patients with varied conditions not necessitating critical or telemetry monitoring) unit was conducted with the Patient Safety Coordinator (PSC) and the Nursing Supervisor Registered Nurse (NSRN).

On February 24, 2025, at 9:45 a.m., a tour of the soiled utility room on the ICU B was conducted. A strong sewer smell was observed when opening the door.

On February 24, 2025, at 10:10 a.m., a tour of the dirty utility room on the fifth floor was conducted with the PSC and the NSRN. A sewage odor was observed present in the room. An observation of the dirty utility room hopper sink (a special sink to empty stool and urine) was conducted with the PSC and the NSRN. Small black, worm-like moving insects were observed at the bottom of the hopper.

On February 24, 2025, at 10:15 a.m., a tour of Rooms A, B, C, D, and E was conducted with the NSRN and the PSC. Sewer smell was observed in each of the rooms.

On February 25, 2025, at 8:30 a.m., the facility work orders were reviewed. A facility document titled, "Work order #: 537992," dated February 4, 2025, was reviewed. The document indicated, "...Area/project: [Unit B]...work order type #: Unscheduled, non-emergency...requested on: 2/4/25 [February 4, 2025]...service requested: replace waste lines in ceiling in break room..."

A facility document titled, "Work Order 537993," dated February 6, 2025, at 11:19 a.m., was reviewed. The document indicated, "...Facility...[name of facility]...Department...Nursing TWR [Tower] 2-5 [two to five]...Location...Nurse Station, Closets, Kitchen...Floor...5...sewer smell in office..." The document indicated, "...Notes...2' [two inches] vent needs to be replaced on sink drain. Pipe is cracked. Pipe is currently under repair in ICU...2/06/25 [February 6, 2025]..."

A facility document titled, "Work order#:538253" dated February 12, 2025, was reviewed. The document indicated, "...Department: Unit A...Work order type#: unscheduled, non-emergency...requested on 2/12/2025 [February 12, 2025]...service requested: Bad odor in med room...service notes...found cracked 2" cast iron vent from sink in Unit A kitchen. This will require removing cabinets and cutting wall open to replace vent..."

A facility document titled, "Work order # [number]: 538171," dated February 16, 2025, was reviewed. The document indicated, "...[Unit B]...work order type #: Unscheduled, Non-Emergency...Requested on...2/16/25 [February 16, 2025], service requested: room 1...notes: broken vent in wall, will work with clinical staff to shut room down..."

A facility document titled, "Work order #: 538196" dated February 20, 2025, was reviewed. The document indicated, "...[Unit B]...Work order type#: Unscheduled, nonemergency...Requested on: 2/20/25 [February 20, 20205]...Service requested: plumbing repair on drain lines in different areas of [Unit A] and [Unit B]...Notes: need to order parts asap [as soon as possible]..."

On February 25, 2025, at 9:46 a.m., a tour of [Unit A] and [Unit B] was conducted with Patient Safety Coordinator (PSC) and the CNO. A foul sewer odor was observed at the nurse's station, the medication room, and the nutrition room of [Unit A]. Construction hammering and pounding sounds were observed to be in progress on the room to the left of the medication room.

On February 25, 2025, at 9:50 a.m., a tour of the Rooms I, J, K, L, M, N, O, P, and Q was conducted with the CNO and the PSC. A sewer smell was observed in each of these rooms.

On February 25, 2025, at 10:30 a.m., an interview was conducted with Anonymous (A) 3. A 3 stated the sewer odor had been observed in the fifth floor unit for at least a year. A 3 stated she was unsure if a work order was completed for the sewer smell issue. A 3 stated there have been gnats (drain flies) in the vicinity of room F, and throughout the Intensive Care Unit (ICU, unit for critically ill patients). A 3 stated the Environmental Services (EVS) has been putting cleaning solution in the sinks to help with the gnats. A 3 stated she was unsure what the issue was because the sewer smell remained after the facility repaired the staff breakroom. A 3 stated she has not been told anything related to what the sewer smell could be, but some of the staff, including her, have been complaining of dizziness and headaches since the odor has been observed. A 3 stated they were told it was a break in a sewer line.

On February 25, 2025, at 10:45 p.m., an interview was conducted with A 4. A 4 stated she was told the sewer smell was from a broken sewer pipe. A 4 stated she had been feeling ill and had dizziness and headaches due to the sewer smell. A 4 stated she knew engineering was fixing a pipe in the breakroom, but the sewer smell never went away. A 4 stated the sewer smell had been there for a long time.

On February 25, 2025, at 11:23 a.m., a tour of the fifth floor was conducted with the PSC and the NSRN. A sewer smell was observed when entering the fifth floor unit and in the hallway. When entering Rooms B and C, a smell of sewer was observed. During a concurrent interview, the NSRN stated she can smell the sewer odor and have been using fragrances to mask the smell. The NSRN stated she notified engineering regarding the sewer smell.

On February 25, 2025, 3:45 p.m., an interview was conducted with the Director of Facility Maintenance (DFM) and the Corporate Quality Officer (CQO). The DFM stated he was first told about the sewer smell on the fifth floor about a month ago. The DFM stated they fixed a waste line leak on the first, second, third, and fourth floor of the facility. The DFM stated the problem is from a waste line (a pipe that carries wastewater from a unit in the facility to the sewer system) in the medication room in the ICU that needs repair. The DFM stated there had been no talk about possible contamination or environmental concerns outside or inside the facility to ensure there is no cross contamination of any possible infectious process and/or environmental concerns for patients and/or staff. The DFM stated the sewer smell follows the cavity/shaft (opening where pipes go through) from the bottom of the facility to the roof. The DFM further stated the sewer smell is traveling upward, and they have been trying to put fragrance in affected areas and assessed the exhaust fans. When shown photos of the small worm-like insects in the hopper taken during an observation on February 24, 2025, at 10:10 a.m., the DFM further stated the image of the black worm like insects in the fifth floor hopper "look like gnat larvae [immature worm-like stage of gnats] from the sewer." The DFM stated the gnat larvae in the hopper could be related to the problem they possibly need to fix on the fifth floor. The CQO stated the Chief Nursing Officer (CNO) and DFM met to discuss the plan of repair for the ICU and the fifth floor. The DFM stated he had a meeting with the CNO, and the plan was to move patients to another area, but they anticipated a validation survey [a surveyof the facility to determine if the facility is complying with the regulations set by the Centers for Medicare and Medicaid (a fedral agency) and wanted to prep for that first prior to conducting the repairs to address the sewer smell. The CQO stated the Chief Operating Officer (COO) was aware of the problem. The CQO stated she was not aware and was not informed of the issue with the sewer smell. The CQO stated she should have been informed of the sewer smell in the ICU and the fifth floor. The CQO stated, if there was a concern about a possible sewer issue in the pipes and possible infection control concerns, she should have been informed because she is also in charge of Infection Prevention in the facility until the position is filled. The CQO stated the DFM should have given her the opportunity to evaluate the impact of the sewer smell to patient safety. The CQO further stated she was only informed of the situation of the sewer smell and possible broken sewer pipes during the ongoing survey of the facility. The CQO stated, "There should be no worms or bugs in any sink in the facility."

On February 25, 2025, at 4 p.m., an interview was conducted with the DFM. The DFM stated he was first notified of the ICU and fifth floor sewer smell two months ago. The DFM stated his department started to get reports about the sewer smell which traveled up and could be smelled on the sixth floor of the facility.

On February 25, 2025, at 7:05 p.m., the survey team identified significant concerns in the facility. Due to the seriousness of the situation, an immediate jeopardy (IJ, a situation with the potential to cause harm to the health and safety of the patients) was called in the presence of the facility's Chief Nursing Officer (CNO), Chief Operating Officer (COO), Corporate Quality Officer (CQO), Deputy Regional Director of Quality (DRDQ), and the Director Facility Maintenance (DFM). They were notified regarding the concern of sewer smell in the Intensive Care Unit (ICU, unit for critically ill patients) and the fifth floor which was due to cracks on a four-inch sewer ventilation pipe located in the wall between medication room and computer room in the ICU A Nursing Station. The smell of sewer was noted by the facility since February 4, 2025, and was still observed in ICU A, ICU B, and on the fifth-floor telemetry (unit where patients' heart rate and rhythms are continuously monitored remotely) and medical surgical unit (unit for patients with various illnesses not necessitating close monitoring) which may aggravate the pulmonary conditions of patients with lung diseases/conditions in the affected units by inhaling sewer gas which may contain toxic gases and cause symptoms ranging from eye irritation, coughing, fluid in the lungs, and loss of consciousness.

On February 28, 2025, at 2:46 p.m., the facility provided a Corrective Action Plan (CAP) for the IJ. The CAP submitted by the facility indicated the following:
- Immediately upon being notified of the IJ, members of the Governing Board and the MEC (Medical Executive Committee) were notified of the findings by the COO via an electronic memo;
- The facility identified all patients and staff impacted/likely to be impacted by the deficiency and is committed to ensuring the deficiency is corrected immediately;
- As soon as the facility was informed of the issuance of an IJ, the facility started developing and implementing this Removal Plan;
- All elective surgeries (non-emergent surgeries) for February 26, 27, and 28, 2025 were cancelled to ensure the availability of Post Anesthesia Unit (PACU, unit where patients recover after a surgery) beds should they be needed to care for relocated ICU patients. Both the patients and surgeons were notified. Elective non emergent surgeries will be cancelled until the facility is able to use the ICU once the repair has been completed and the air quality has been verified to be safe for patients and staff based on testing results by the Industrial Hygienist/their accredited laboratories or an alternative acceptable location has been identified. The facility will continue to notify patients and surgeons of any pending cancellation. The facility will attempt to have these patients rescheduled as soon as it is feasible. The facility applied for a program flex (an approval to waive a regulation) with the California Department of Public Health (a state agency) to be able to use four beds in the Definitive Observation Unit (DOU, stepdown unit for patients who need close monitoring but less than critical care) as temporary ICU beds. The request is pending review. Once approved, the facility will not use PACU to hold ICU patients;
- All ICU patients were evaluated for the appropriateness of safe downgrades. Any downgraded patients were moved to the appropriate level of care as per the MD order. The facility will continue to evaluate those patients that could be safely downgraded;
- On February 25, 2025, and February 26, 2025, the facility Leadership relocated eight ICU patients to the Critical Care Unit (CCU, unit for patients with critical illnesses) and four patients to the PACU to minimize any further exposure. Patients will remain in these new locations until the repair has been completed and the air quality has been verified to be safe by the Industrial Hygienist (a professional who protects worker health and safety by identifying, evaluating, and controlling workplace hazards, such as chemicals, noise, and biological agents) and their contracted laboratories. All appropriate parties were notified of the relocation. ICUs A and B are currently temporarily closed and will remain closed until the repair is completed and the air quality is tested by the environmental hygienist and their accredited laboratories, and the results are deemed safe for both patients and staff. Currently there is one ICU hold in the Emergency Department. The patient is currently cared for by an ICU nurse and will be moved to the CCU by end of shift today;
- On February 25, 2025, ICU B was sealed off and ventilated to the outside to minimize the risk of the gases traveling through the facility. The door is only open during business hours and while staff is present;
- The COO approved additional labor and personnel to facilitate the prompt relocation of patients and repair of the pipe.
- The facility started the repair of the pipe on February 26, 2025, at around 4 am. An additional vendor is currently onsite to help the staff with the repair. The vendor continues to be onsite;
- On February 26, 2025, all patients on fifth floor were relocated to the second floor. The fifth floor will be vacated until the repair is complete and the air quality testing for sewer gases is performed by the industrial hygienist and their approved laboratory is back and verified to be safe for patients and staff;
- On February 26, 2025, all providers (physicians) of the ICU patients were notified of the deficiency, relocation of ICU patients via a phone call and an electronic memo;
- On February 26, 2025, the Leadership Team was educated by the CQO on the Centers for Medicare and Medicaid Conditions of Participations (sets of regulations applicable to the facility) related to Physical Environment using a power point presentation to read and sign.
- On February 26, 2025, the facility-initiated education for Engineering Staff on Physical Environment CoPs. Employees will complete the education on by their first next scheduled shift;
- On February 26, 2025, the Director of Plant Operations reviewed the hospital policy on building maintenance and found it acceptable;
- On February 26, 2025, the ICU staff were informed of the potential sewer gas leak and the need to relocate patients via a memo;
- On February 26, 2025, the facility-initiated patient/ family notification. All alert and oriented patients received a hand delivered letter. The facility continues the process of notifying representatives of patients who were unable to receive the notice (for example, patients who are confused);
- On February 27, 2025, the facility contacted an industrial hygienist to perform the air quality test for the presence of sewer gases. The vendor collected samples for the wrong test. The facility contacted the vendor again to perform the air quality test for sewer gases. The new air quality test for sewer gases was performed on February 27, 2025, in the ICU and the fifth floor. Results are pending.;
- On February 28, 2025, all providers were notified of the temporary decrease in the telemetry capacity at the hospital via an electronic memo; and
- The CEO will continue to update the MEC, medical staff members, on the progress with the repair and the implementation of this Removal Plan.

On February 28, 2025, at 3:55 p.m., the survey team found the CAP for IJ related to the sewer smell in the Intensive Care Unit acceptable and DRDQ, COO, and CQO were notified.

On February 28, 2025, at 4:35 p.m., the IJ related to the sewer smell in the ICU was removed in the presence of the COO, after the CAP was verified onsite through observation, interviews, and record review as implemented.

3. On February 27, 2025, at 9 a.m., a tour of the second floor medical/surgical (med/surg, unit for patients with various illnesses not necessitating close monitoring)/telemetry (tele, unit where the patients' heart rates and rhythm are contiously monitored remotely) unit was conducted with the Chief Nursing Officer (CNO) and the Patient Advocate (PA).

On February 27, 2025, at 9:10 a.m., an interview of the CNO was conducted. The CNO stated the facility moved the patients from the fifth floor to the second floor on February 26, 2025, at approximately 3:30 p.m. The CNO stated 26 patients were moved to the second floor and five patients were downgraded to med/surg (when the physician orders the telemetry monitoring to be discontinued). The CNO stated the registered nurses caring for the patients are sitting near the rooms they are assigned to. The CNO stated they have runners and nurse assistants to assist in watching the cardiac monitors (a device that records the heart's electrical activity) and the patients. The CNO stated all patients had been given a call bell (a device that summons attention by making a sound, alerting someone to a request for assistance) to request assistance from nursing when they were transferred to the second floor from the fifth floor.

On February 27, 2025, at 9:18 a.m., an observation was conducted in Room G. Patient 24's family member (FM 1) was present in the room. Patient 24 is on a telemetry monitor at the bed side. The heart rate monitor was facing toward the patient and away from the door behind the patient's privacy curtains. The display on the monitor is not observed from the patient room's door.

On February 27, 2025, at 9:20 a.m. an interview was conducted with A 5. A 5 stated she has patients on telemetry and currently is unable to see the monitors from the door and must go all the way in the room. A 5 stated the patients in the B bed on the med/surg/tele unit on the second floor are not connected to the central telemetry monitoring system. A 5 stated the patients on the B are hooked to a bed side monitor.

On February 27, 2025, at 11:15 a.m., an observation was conducted in Room G. Patient 24's family member (FM 1) was present in the room and was concurrently interviewed. FM 1 stated Patient 24 needed pain medication on February 27, 2025, at approximately 12 a.m., and did not have access to a call light or a call bell on his bedside to call for assistance. FM 1 stated Patient 24 had to use his personal cell phone to call the facility's operator to be transferred to the second floor nursing station. FM 1 stated Patient 24 did not receive pain medication for one hour after initially calling for assistance using his cell phone. FM 1 stated Patient 24 was instructed to use their cell phone to call the facility and notify the operator to transfer them to the nursing station on the second floor.

On February 27, 2025, at 11:18 a.m., an interview of the Nursing Supervisor Registered Nurse (NSRN) was conducted. The NSRN stated patients on the second floor were given call bells (similar to desk bells which the patient could use to make a sound to call the attention of the staff) to call for help when they were transferred from the fifth floor to the second floor, but they found seven patients without one. The NSRN stated the room call lights that are hooked up to the door notification system were not functioning prior to moving patients from the fifth floor.

On February 27, 2025, at 11:25 a.m., an interview with Patient 74 was conducted. Patient 74 stated he was not given a call bell or nor was he given instruction on how to call for a nurse when he was moved to the second floor. A call light was observed on Patient 74's bedside. The light outside Patient 74's room was observed to be lit prior to Patient 74 pressing the call light button. There was no audible sound observed when Patient 74 pressed the call light button.

On February 27, 2025, at 11:28 a.m., an observation was conducted in Patients 75, 76, and 90's room. There was a safety sitter (a staff observing the patients) observed sitting outside the room observing the three patients. The patients were observed to not have call bells to reach a nurse for assistance.

On February 27, 2025, at 11:30 a.m., the NSRN was interviewed. The NSRN stated there were seven patients (Patient 24, 41, 42 74, 75, 76, and 90) who did not have a call bell at their bedside.

On March 3, 2025, at 9 a.m., an interview was conducted with the DFM. The DFM stated the engineering department was aware of the nonfunctioning call light system on the second floor.

On March 4, 2025, at 9:15 a.m., an interview was conducted with the Chief Quality Officer (CQO). The CQO stated, she was aware of the non-working call light system on the second floor and there was a program flex submitted requesting to waive the necessity of call lights. The CQO stated every patient should have had a means to contact the nurse staff. The CQO stated she had instructed staff to make sure every person had a call bell upon leaving the facility on February 26, 2025.

On March 4, 2025, at 10 a.m., an interview was conducted with a member of the governing body (facility administration body who has ultimate oversight and decision-making authority) (GBM). The GBM stated she did not know about the nonfunctioning call light system on the second floor. The GBM further indicated the facility typically had no patients on the second floor due to lack of patient volume. The GBM stated the governing body should have been made aware of the situations prior to moving the patients during this investigation and it should have been reported to them.

The facility policy and procedure titled, "Nurse Call System Failure," dated April 2021, was reviewed. The policy indicated, "...Policy: To provide a method of communications for patients in the event the nurse call system fails. The nurse call system provides audible communication between patients and nursing staff for assistance in routine and emergency situations...In the event of a malfunction and/or failure of the nurse call system the following procedure will be followed...instruct staff members to set up an alternative method of communication...Identify the cause of the failure and attempt to repair...Notify House Supervisor...Record incident in [name of computer system of resporting]...Determine cause of failure and taken immediate steps to eliminate...Revise as necessary any tests, or changes in preventative maintenance to systems ..."

On February 27, 2025, at 2:48 p.m., the survey team identified significant concerns in the facility. Due to the seriousness of the situation, an immediate jeopardy (IJ, a situation with the potential to cause harm to the health and safety of the patients) was called in the presence of the facility's CNO, COO, CQO, DRDQ, and the DFM. They were notified regarding the facility's failure to ensure a safe environment to take care of medical surgical/ telemetry patients. The facility did not have a system in place to continuously monitor the patients' heart rate and rhythm for patients transferred to the second floor and had orders for telemetry monitoring. 10 patients with telemetry orders did not have continuous monitoring of the cardiac rhythm and had a portable heart monitor at bed side which were not visibly seen upon entering the patients' rooms and were not being continuously monitored. Seven of the patients did not have access to any assistive devise to call for help when needing assistance or in an emergency. One patient (Patient 24) had to use his personal cell phone to call the main hospital number to speak to the nurse on the second floor in order to request for pain medication which was administered one hour after the patient's call was made.

On February 28, 2025, at 12:12 p.m., the facility provided a Corrective Action Plan (CAP) for the IJ. The CAP submitted by the facility indicated the following:
- The facility was unable to determine the impact of the deficiency on patients. However, no adverse effects or complications for any patient have been reported as a result of the use of portable bedside monitors;
- On February 28, 2025, members of the Governing Board and the MEC were notified of the findings by the COO via an electronic memo;
- The facility identified all patients impacted/likely to be impacted by the deficiency.
- As soon as the facility was informed of the issuance of an IJ, the facility started developing and implementing this Removal Plan;
- On February 27, 2025, all patients without a call light were provided with a bell and educated on the purpose of the call light and how to use it. On February 28, 2025, the CNO verified that all patients had bells;
- On February 28, 2025, a letter was sent from the CNO to all the patients and staff on the second floor notifying them of the call light system malfunction and the use of the bells.
- On February 27, 2025, the physicians for patients on telemetry were contacted to explore who can be downgraded safely with a physician order;
- On February 27, 2025, the facility conducted an accurate account for all existing tele monitors, existing patients on tele, potential downgrades from tele and potential discharge from tele to efficiently utilize the system; and
- On February 27, 2025, all patients on the second floor not connected to central tele monitoring (remote monitoring of patient's heart rate and rhythm with one staff assigned to conitnuously watch the monitors) were either relocated to the third floor, safely downgraded or discharged in accordance with the physician orders. The second floor currently has only 16 tele patients who are all being centrally monitored.

On February 28, 2025, at 12:53 p.m., the survey team found the CAP for the third IJ acceptable and the DRDQ was notified. On February 28, 2025, at 1:17 p.m., the third IJ regarding patients with telemetry orders and the patients who did not have access to any assistive devise to call for help, was removed in the presence of the COO, after the CAP implementation was verified onsite through observation, interviews, and record review as implemented.

A facility policy and procedure titled, "Telemetry Monitoring," dated April 20, 2024, was reviewed. The document indicated, "...Notify the Monitor observer [staff assigned to watch the monitor continuously] that the patient is on telemetry...Verify with the monitor observer that the rhythm [he

Based on observation, interview, and record review, the facility failed to ensure fire-release (a fire door that is designed to automatically close in response to a fire alarm or other emergency signal, preventing the spread of fire and smoke) double doors separating the Definitive Observation Unit (DOU, a unit which provides a high level of care for patients who don't need intensive care) and Coronary Care Unit (CCU, a unit that treats patients with critical heart conditions) was not obstructed.

This failure had the potential to compromise patient safety during a fire emergency when the fire-release double doors placed to prevent fire migration are disabled.

Findings:

On February 26, 2025, at 12:07 p.m., the facility's sixth floor was visited for tour and observation of CCU. The double doors separating the CCU and DOU was observed to be open. Upon closer inspection, a gurney (wheeled cot or a stretcher used to transport patients) was observed to be left in place by the double doors to keep the doors ajar.

On February 26, 2025, at 12:19 p.m., the Nurse Supervisor Registered Nurse (NSRN) was interviewed. The NSRN stated a staff came to pick up a patient, brought the patient down on the patient's bed, and left the gurney in the middle of the double doors. The NSRN stated it is a fire release door and supposed to be able to function by automatically closing the doors after passing through. The NSRN stated the gurney was blocking the fire door.

A review of the facility policy and procedure titled, "MANAGEMENT RESPONSIBILITIES AND ENVIRONMENT OF CARE," dated March 2021, was conducted. The policy indicated, "...PURPOSE: To ensure that guidelines are established for management that identifies their responsibilities with respect to the Environment of Care...PROCEDURES...Managers are responsible for the following...Safety...Participates in hazard surveillance...Models commitment to safety procedures and practices at the unit level...Fire Prevention/Life Safety...Understand the concept of smoke compartmentalization (e.g., a department may be used as a temporary smoke compartment as an area or refuge-the area is contained by smoke doors and smoke walls)...Ensures corridors are free for egress, and not used for storage...Enforces "no artificial doorstops"...Keeps exits and stairwells clear/clean..."

Based on observation, interview, and record review, the facility failed to ensure physical environment was maintained and kept in working order when:

1. The elevators cars (Cars 1, 2, 3, 4, 5, and 6) were not maintained in optimal working condition; and

2. An acrylic box for holding the moisture-wicking fabric (fabric with antimicrobial to keep skin folds dry and reduce rubbing and help prevent infection) and a pair of scissors in the box holder were observed to have debris and grime.

This failure had the potential to compromise patient safety, increase the risk of exposure to bacteria, increased risk for infection, and may cause a delay in treatment.

Findings:

1. On February 24, 2025, at 8:50 a.m., a tour and observation of the third floor were conducted with the Patient Advocate (PA) and the Director of Facility Maintenance (DFM). The light over the door of elevator Car 3 was observed to turn on when the elevator call button was pressed. Elevator Cars 1 and 2 were observed to take a while to transport patients, staff, and visitors. During a concurrent interview with the DFM, the DFM stated the facility has two building towers, with each tower having three elevators for patient, staff, and visitors use. The DFM stated Tower 1 has elevator Cars 1, 2, and 3, and Tower 2 has elevators Cars 4, 5, and 6. The DFM stated elevator Car 3 was decommissioned (make inoperative) and elevator Car 4 was always malfunctioning for the last two weeks. The DFM stated the two elevator cars on each tower were functional but slow.

On February 24, 2025, at 1:25 p.m., the Life Safety Officer (LSO) was onsite to conduct a survey for issues regarding the facility elevator. The LSO stated elevator Car 4 had been malfunctioning and was inspected a week and a half ago and is requiring a new motor.

On February 24, 2025, at 4:34 p.m., the LSO was interviewed. The LSO stated he conducted an investigation and had found elevator Car 4 door was "going bad" and waiting for repair. The LSO stated elevator Car 4 is not working well, and the other elevator car doors are connected and may affect all doors to slow down.

On February 25, 2025, at 10:21 a.m., the Corporate Quality Officer (CQO) was interviewed regarding the facility's physical environment and about the malfunctioning elevators. The CQO stated governing body is responsible for leadership of the hospital to ensure the facility environment is kept clean, sanitary, safe, and comfortable. The CQO stated the Governing Body is responsible in ensuring equipment and utilities are adequate and facility have structural integrity (a concept often used in engineering to produce items that will serve their designed purposes and remain functional for a desired service life).

On February 26, 2025, at 11:56 a.m., an observation of the elevator was conducted with the Deputy Regional Director of Quality (DRDQ) on the way to observe the sixth floor. Elevator Car 6 was observed to be the only elevator car functioning. Elevator Cars 4 and 5 was observed to not be working. During a concurrent interview, the DRDQ stated she had not received report regarding the issue with elevator Car 5.

On February 26, 2025, at 1:50 p.m., a walking tour was conducted with three Fire Department Officials, the DRDQ, the Director of Facility Maintenance (DFM), and the LSO, to conduct a floor to floor inspection of the basement up to the sixth floor. The elevator cars have been observed slow. There were patients, staff, and visitors observed waiting to ride in the elevator. The tour group had to utilize the stairs to get to each floor of the facility.

On March 3, 2025, at 2:27 p.m., the Chief Operating Officer (COO) was interviewed regarding the outcome of slow-moving elevators. COO stated, "Result is delay in patient services."

On March 3, 2025, at 3:52 p.m., the DFM was interviewed regarding patient outcome for when the elevator is not working. The DFM stated there would be more wait time and patient services delay.

A review of the facility policy and procedure titled, "ELEVATOR MAINTENANCE," dated March 2021, was conducted. The policy indicated, "...POLICY...To assure safe and continued operation of all facility elevators...PROCEDURE...Maintain a complete service contract with an outside elevator company to include routine maintenance and repairs...Conduct inspections in compliance with State elevator codes and secure permits...Immediately respond to reports of elevator problems and call the elevator service vendor..."


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2.On February 25, 2025, at 9:46 a.m., a tour of the fifth floor was conducted with the Nursing Supervisor Registered Nurse (NSRN).

On February 25, 2025, at 11 a.m., an observation was made of the moisture-wicking fabric box holder on the wall by the exit of the clean utility room. The box was observed to blackish debris and a white power substance in the holder and a pair of scissors with thick buildup of white and brown colored sticky grime were observed in the box.

A interview was conducted on February 25, 2025, at 11:05 a.m., with the NSRN. The NSRN stated the moisture wicking fabric is used to keep the patients with skin folds (large amount of skin that overlaps or creases) dry. The NSRN stated the scissors are used to cut the moisture wicking fabric to the correct length for each patient. The NSRN stated the acrylic box that holds the scissors is dirty with debris. The NSRN stated the pair of scissors are dirty with thick buildup of white and brown colored sticky grime. The NSRN stated the moisture wicking fabric box should be kept clean and free of debris. The NSRN stated the pair of scissors should have been disinfected after each use. The NSRN stated the buildup of dirt in the scissors places the patients at risk for being exposed to bacteria.

A facility policy and procedure titled, "Equipment cleaning ," dated March 23, 2025, was reviewed. The policy indicated, "...Equipment will be cleaned with a hospital approved disinfectant after each patient use, of if visibly soiled and on a regular schedule..."

Based on observation, interview, and record review, the facility failed to ensure the facility's policy and procedure for infection control was implemented when staff was observed not donning [putting on] personal protective equipment (PPE, protective gloves, mask and gown) when entering an isolation room.

This failure has the potential for increased risk of spreading harmful bacteria to other patients.

Findings:

On February 25, 2025, at 10:18 a.m., a sign on Patient 30's door was observed to indicate Patient 30 was in air borne isolation precautions (infection control measures designed to prevent the transmission of infectious agents that spread through the air). Charge Nurse (CN) 1 was observed to walk into Patient 30's room without personal protective equipment on. CN 1 was observed exiting Patient 30's room and took a mask, gloves, and a gown from the isolation cart that was located in front of Patient 30's room. CN 1 was observed to don [put on] the mask, gloves, and gown and went back in Patient 30's room. CN 1 was observed to not put an N95 mask on (a face mask designed to achieve a very close facial fit and very efficient filtration of airborne viruses and bacteria).

An interview was conducted on February 25, 2025, at 10:19 a.m., with CN 1. CN 1 stated Patient 30 is in air borne isolation precautions. CN 1 stated he should have used hand sanitizer and put on the personal protective equipment (PPE) before going in Patient 30's room.

On February 25, 2025, at 10:22 a.m., Patient 30's record was reviewed with Nursing Supervisor Registered Nurse (NSRN). A facility document titled, "History and Physical," dated February 19, 2025, was reviewed. The document indicated Patient 30 was admitted to the facility on February 19, 2025, for shortness of breath and wheezing (high-pitched, whistling sound that occurs when air moves through narrowed airways in the lungs).

A facility document titled, "Final Report Molecular Pathology Report," dated February 21, 2025, was reviewed. The document indicated, "...[Patient 30's name]...Summary of detected results...bacteria...pseudomonas aeruginosa [a type of bacteria]...detected...Staphylococcus epidemidis [type of bacteria in the urine]...detected...methicillin (oxacillin)-resistant Staphylococcus epidermidis [MRSE, type of bactria not easily treated with antibiotics]...Viruses...Ebstein-Barr [a type of contagious virus]...detected...Rhinovirus [virus that could cause respiratory illness]...detected..."

An interview was conducted on February 25, 2025, at 10:25 a.m. with the Nurse Supervisor Registered Nurse (NSRN). The NSRN stated CN 1 should have put on PPE before entering the patient's room.

The facility policy and procedure (P&P) titled, "Standard and Transmission Based Precautions," dated February 2024, was reviewed. The policy indicated, "...To prevent the exposure of patients...communicable and/or infectious diseases...Gloves...clean gloves must be worn when touching...body fluids...gown...must be worn to protect skin...during procedure...patient care activities...potential for splashes...body fluid...are expected..."

The facility P&P titled, "Personal Protection Equipment (PPE) Program," dated April 2021, was reviewed. The policy indicated, "...The procedure of donning (putting on) and removing PPE that will prevent skin or clothing contamination..."