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Based on observation, interview and record review, the hospital failed to inform one of nine patients (Pt 31) in advance of care decisions when interpreter services were not used to communicate, from 10/15/24 to 10/20/24 in a language Pt 31 could understand according to the hospitals policy and procedure (P&P) titled, "Limited English-Proficiency (LEP): Language Access for Patient and Companions."

This failure denied Pt 31 their right to make informed decisions about, participate in their daily care and had the potentially to affect all non-English speaking patients treated at the hospital.

Findings:

During a concurrent interview and record review on 11/12/24 at 3:23 p.m. with Registered Nurse (RN) 7 and the Director of Nursing (DON) Pt 31's "History & Physical [H&P- an assessment from physician including medical history and exam]," and "Face Sheet [FS- a document that contains a summary of a patients' personal information]," dated 10/11/24, were reviewed. The "H&P" indicated, Pt 31 was admitted to the hospital on 10/11/24 at 4:42 p.m. for sepsis (a life-threatening blood infection), and acute kidney injury (AKI- A sudden and often reversible decline in kidney function) after a laminectomy (a surgical cut into the backbone to get access to the structures in the spinal cord). RN 7 stated the "FS" indicated, Pt 31's preferred language was Spanish.

During a concurrent interview and record review on 11/13/24 at 11:03 a.m. with Shift Manager (SM) 3, Pt 31's "Interpreter Services Flowsheet (ISF)," dated 10/11/24 to 11/13/24, were reviewed. SM 3 stated no Licensed Nursing (LN) documentation was present on the "ISF" to indicate a Spanish medical interpreter was used during Pt 31's admission to the Medical Surgical (MS) Unit. SM 3 stated a Spanish medical interpreter should have been used for Pt 31's admission questions. SM 3 stated Pt 31's "ISF" indicated, no Spanish medical interpreter was used to communicate with Pt 31 or his family on 10/15/24 through 10/20/24. SM 3 stated medical interpreters (CMI) should be used to communicate patient education, medications, plan of care, procedures, treatments, and care options. SM 3 stated LNs could access a medical interpreter via computer tablet, telephone, or use an in-person interpreter. SM 3 stated LNs should use medical interpreters for non-English speaking patients and their caregivers/families to ensure the plan of care was understood. SM 3 stated Pt 31's wife also was non-English speaking. SM 3 stated Pt 31 was "often confused" and did not always have family at bedside so, speaking in a language he understood was important. SM 3 stated speaking to Pt 31 in his preferred language could help to prevent Pt 31 from being scared and give him a sense of what was happening to him. SM 3 stated her expectation was for LNs to document use of medical interpreters in the "ISF" according to P&P.

During a concurrent observation and interview on 11/14/24 at 3:45 p.m. with the In-house Spanish Interpreter (ISI), Family Member (FM) 2 and Registered Nurse (RN) 8, in Pt 31's hospital room, Pt 31 was observed lying in his hospital bed at a 90-degree angle with his eyes open. Pt 31's right and left wrist were in soft restraints (padding attached around a limb attached to bedframe that limits a person's movement). Pt 31 had a foley catheter (a flexible tube that drains urine from the bladder into a collection bag). Pt 31's primary RN (RN 8) was in the room at bedside attempting to get a finger-stick blood sugar (poking finger with needle to test blood sugar levels) and vital signs (VS) from Pt 31. RN 8 was speaking to Pt 31 in English. Pt 31's wife (FM 2) was at bedside. FM 2 stated through the ISI that neither Pt 31 nor FM 2 spoke English. Pt 31 stated they only spoke Spanish. FM 2 stated her husband was often confused, because of his illness. FM 2 stated she was not always updated of Pt 31's change in status. FM 2 stated medical interpreters were used sometimes to communicate with her. FM 2 stated she appreciated when medical interpreters were used because she felt better informed in Pt 31's care and treatment.

During an interview on 11/14/24 at 3:53 p.m. with RN 8, RN 8 stated using medical interpreters for non-English speaking patients and their families was important to help them understand the plan of care. RN 8 stated he should have used a medical interpreter to inform FM 2 about Pt 31's change of condition and any new treatment plans.

During an interview on 11/15/24 at 10:12 a.m. with Clinical Manager (CM) 6, CM 6 stated her expectation was, if patients were non-English speaking LNs should use a medical interpreter. CM 6 stated Pt 31's LNs should use a medical interpreter to communicate with him and his family to explain any new plans of care or treatments. CM 6 stated her expectation was for LNs to document when a medical interpreter was used, what was communicated to the patient, and the interpreter's name and/or ID number.

During an interview on 11/15/24 at 3:25 p.m. with the Chief Nursing Officer (CNO), the CNO stated, Medical Interpreter Services should be used when LNs were communicating with patients about plans of care, changes in or new medications, instructions, and treatments. The CNO stated employees who were native speakers of the patient's preferred language could be used as interpreters when asking patients about toileting, fluids, bathing, or nutrition. The CNO stated her expectation was for LNs to follow the P&P and document what was information was interpreted, the interpreter's name, and ID number information. The CNO stated LNs need to use a medical interpreter in the patient's preferred language so patients could understand and ask questions if clarification was needed. The CNO stated interpretation was important so patients could understand their plan of care.

During a review of the hospital's P&P titled, "Limited English Proficiency (LEP): Language Access for Patients and Companions," dated 4/2/23, indicated, " ... utilization of interpreter services. ... Considerations for determining the appropriate model for the delivery of interpreter services will include the patient's preferences, the nature of the clinical interaction, the availability of qualified in-person medical interpreters and the availability of the technology to allow for telephonic or video-conference interpreters ... Providing Interpreter Services for Meaningful Access ... Interpreter services will be provided for any patient who has Limited English Proficiency. ... Interpreter services, including a Qualified Medical interpreter when needed to provide meaningful, equitable access to the Facility's services, are required for patient assessment, consent, education and discharge ... Determining a patient's history or description of ailment [illness] or injury ... Obtaining informed consent or permission for treatment ... Explaining diagnosis or prognosis [likely course of disease or illness] of ailments or injuries ... Explaining procedures, tests, treatment, treatment options or surgery ... Explaining the administration and side effects of medications, including side effects and food or drug interactions [a change in the way a drug acts in the body when taken with other drugs] ... Explaining follow-up treatment, test results, or recovery ... The documentation of the provision [supplying for use] of interpreter services shall be recorded in the patient medical record and shall include ... Name of requestor ... Date and time of interpretation ... Name of [hospital Name] Qualified Medical interpreter or vendor company name and interpreter name, or telephonic interpreter ID number, as applicable; and a ... Brief description of content interpreted ... For limited communications about basic activities of daily living (ADL), such as a request for water or to use the bathroom, employees who are native speakers of the patient's preferred language may communicate with an LEP patient without the use of a Qualified Medical interpreter, but it is recommended that tools such as picture communication boards be available to allow patients to express their needs ...".


During a review of professional reference titled, "Clinicians' Obligations to Use Qualified Medical interpreters When Caring for Patients with Limited English Proficiency," dated 3/2017, (retrieved from https://journalofethics.ama-assn.org/article/clinicians-obligations-use-qualified-medical-interpreters-when-caring-patients-limited-english/2017-03) indicated, " ... Access to language services is a required and foundational component of care for patients with limited English proficiency (LEP) ... In the United States, patients with LEP have a legal right to access health care in their preferred language ...".

Based on interview and record review the hospital failed to ensure patient's right to make informed decisions about care for one of two patients (Pt 24) when discharge instructions were not in a language the patient (Pt 24) could understand and an interpreter was not used to review the discharge instructions according to the facility's policy and procedure (P&P) titled, "Limited English-Proficiency (LEP): Language Access for Patient and Companions."

This failure denied Pt 24 their right to make informed decisions about, participate in their discharge care and had the potentially to affect all non-English speaking patients discharge at the hospital.

Findings:

During a review of Pt 24's "Face Sheet (FS-a list of a patient's information that provides quick access for healthcare providers)," undated, the FS indicated Pt 24's preferred language was Spanish.

During a concurrent interview and record review on 11/13/24 at 1:49 p.m. with Registered Nurse (RN) 7 and Nurse Educator (NE) 3, Pt 24's "Discharge Instructions (DI)," dated 11/13/24 was reviewed. RN 7 stated the DI was written in English.

During a concurrent interview and record review on 11/13/24 at 1:55 p.m. with RN 7 and NE 3, Pt 24's "Interpreter Flowsheet (IF)," dated 11/13/24 and "Nursing Discharge Summary (NDS)," dated 11/13/24 were reviewed. RN 7 stated the "IF" indicated no interpreter was used to give discharge instructions to Pt 24. RN 7 stated the "NDS" indicated no interpreter was used to give discharge instructions to Pt 24. RN 7 stated it was important to provide discharge instructions and education in Pt 24's primary language to ensure Pt 24 understood the information and Pt 24's questions were answered at the time of discharge.

During an interview on 11/14/24 at 3:25 p.m. with Clinical Manager (CM) 5, CM 5 stated Licensed Nurses (LN) are expected to provide discharge instructions in Spanish when the patient's preferred language is Spanish. CM 5 stated LNs are expected to use a qualified translator to provide discharge instructions to patients who have a different preferred language. CM 5 stated LNs are expected to document the use of a translator in the patient's electronic medical record (EMR- a digital version of a patient's medical history).

During an interview on 11/15/24 at 3:13 p.m. with the Chief Nursing Officer (CNO), the CNO stated LNs are expected to use a certified interpreter in the patient's primary language to ensure the patient understands the education and to ask questions if needed.

During a review of the facility's P&P titled, "Limited English-Proficiency (LEP): Language Access for Patient and Companions," revised 3/2023, the P&P indicated, " ...It is the policy of [Name of Hospital] that patients or surrogate decisionmakers (hereafter patients) who are Limited English Proficient (LEP), will have services provided to them in their primary language during the delivery of all significant healthcare services. Interpreter services will be available within a reasonable time during all hours of operation, at no cost to patients ... Patients and companions who are Limited English Proficient (LEP) shall have information and services provided to them in their primary language while receiving healthcare services at all [Name of Hospital] ... Interpreter services, including a Qualified Medical Interpreter when needed to provide meaningful, equitable access to the Facility's services, are required for patient assessment, consent, education and discharge, including but not limited to the following topics ... Providing discharge instructions or discussing plans ... Language Accessible Vital Documents ... a. All Vital Documents shall be printed in the Threshold Languages. Only a qualified translation company that certifies the accuracy of its documents shall be used for written translation for any document that affects a patient's health care. b. Vital Documents that are not produced in a written translation shall be verbally translated to the patient by a Qualified Medical Interpreter. The provision of oral translation of all Vital Documents to patients shall be documented in the medical record ..."

During a review of the facility's P&P titled, "Discharge of the Adult Inpatient," reviewed 6/2022, the P&P indicated, " ...Discharge Packets (Plans and Written Instructions) ... Will be in a form the patient, family and/or caregiver(s) can understand ... The nurse will review the Discharge Instruction Packet with the patient, family and/or appropriate caregivers in order to educate them regarding the anticipated needs for continued care, treatment, and services following discharge ..."

Based on interview, and record review, the hospital failed to ensure one of 25 patients (Patient 1) was provided information about advance directives in accordance with the Policy and Procedure, "Advance Directives / Patient Self-Determination" (Advance Directives -Legal document that states a person's wishes for medical care if they are unable to communicate their preferences.)

This failure resulted in Patient (Pt) 1's rights and wishes to go unidentified in the event of an emergency.

Findings:

During a concurrent interview and record review on 11/13/24 at 3:13 p.m. with Shift Manager (SM) 3, Pt 1's "History and Physical [H&P- an assessment from physician including medical history and exam]" dated 9/4/24, were reviewed. The "H&P" indicated, Pt 1 was admitted as an inpatient on 9/4/24 at 5:47 p.m.

During a concurrent interview and record review on 11/13/24 at 3:17 p.m. with SM 3, Pt 1's "Condition of Admission and Treatment (COA), and "Advance Directive and POLST [physician order for life sustaining treatment] Tracking [ADPT]" dated 9/4/24, were reviewed. SM 3 stated page 5 of the "COA" asked patients questions about Advance Directives. SM 3 stated the "COA" page five was completed by registration staff when patients were admitted. SM 3 stated page five of Pt 1's "COA" did not have any of the advanced directive questions completed by hospital staff. The "COA" indicated, hospital staff must check a box on the form to indicate if the patient had an advanced directive or did not have an advanced directive. The "COA" had additional boxes for hospital staff to check if patients indicated they did or did not want information about advanced directives. The "COA" had a line for hospital staff to sign and date when the form was completed and was signed and dated. SM 3 stated Pt 1's "COA" should have had the boxes checked if Pt 1 received information or declined information about advanced directives. SM 3 stated Pt 1 should have been asked the questions on the "COA" and the "COA" should have been completed. SM 3 stated Pt 1 should have been given information about advanced directives for her to decide if she wanted one. SM 3 stated Pt 1's "ADPT" form was completed by a nurse. SM 3 stated Pt 1's "ADPT" indicated Pt 1 answered no to having an advanced directive. SM 3 stated the "ADPT" had a question on the form to prompt nurses to ask patients if they wanted a visit to complete, change or discuss an Advance Directive. SM 3 stated the area in Pt 1's form was blank. SM 3 stated her expectation was for nurses to complete all admission questions on the "ADPT" form.

During an interview on 11/15/24 at 2:52 p.m. with the Director of Patient Access (DPA), the DPA stated the Patient Access Registration (PAR) staff ask patients about Advanced Directives after admission. The DPA stated if patient's say they have an Advanced Directive the PAR staff request a copy from the patient. The DPA stated when patients do not have an Advanced Directive the PAR staff asked patients if they wanted information.

During a record review of the hospital's policy and procedure titled, "Advance Directives / Patient Self-Determination RI-51), dated 2/23, indicated, " ... The front page of the Advance Directive Statement will be completed ... to document each patient's Advance Directive status by the staff member who initiates the admission process ... Planned admission via Registration Department: Done by the Registration Clerk during the hours the Department is open and by the ER Registration Clerk after hours. ... Direct admission to a patient care unit: Done by the Registration Clerk at the bedside during the hours that the Registration Department is open and by the Nursing staff on the inpatient unit after hours ... Pre-registration of a surgical patient: Done by the Registration Clerk. ... Emergency Department (ED) patient who is admitted: Done by the ED Registration staff when the decision to admit an ED patient is made ...The form is reviewed with the patient and/or his/her legal representative. The appropriate box (es) and space(s) are completed to indicate the current Advance Directive status ... Patients requesting an advance directive document to read and/or prepare are given a blank copy of this document ... Nursing Assessment/Healthcare Team Follow-Up Process ... The nurse who admits the patient will ... Review the front page of the Advance Directive Statement to ascertain the Advance Directive status of the patient ... Completes the Advance Directive section of the Nursing Admission Assessment ... Follow up appropriately ...".

Based on observation, interview and record review, the hospital failed to ensure patients were free from restraints (chemical, physical, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely) and to ensure restraints were discontinued at the earliest possible time, when nurses did not complete restraint assessment monitoring every two-hours for one of three patients (Pt 31) to ensure Pt 31 remained free from injury and to determine if the restraints could be released , in accordance with hospital policy and procedure (P&P).

These failures resulted in Pt 31 to go without restraint monitoring, violated Pt 31's right to be released from restraints at the earliest possible time, and had the potential to cause injury from restraints.


Findings:

During a concurrent interview and record review on 11/12/24 at 3:23 p.m. with Registered Nurse (RN) 7 and the Director of Nursing (DON) Pt 31's "History & Physical [H&P- an assessment from physician including medical history and exam]," dated 10/11/24, was reviewed. The "H&P" indicated, Pt 31 was admitted to the hospital on 10/11/24 at 4:42 p.m. for sepsis (a life-threatening blood infection), and acute kidney injury (AKI- A sudden and often reversible decline in kidney function) after a laminectomy (a surgical cut into the backbone to get access to the structures in the spinal cord).

During a concurrent interview and record review on 11/13/24 at 11:30 a.m. with Shift Manager (SM) 3, Pt 31's "Restraint Monitoring Flowsheet (RMF)," dated 10/16/24 to 11/13/24 were reviewed. The "RMF" indicated Pt 31 was on two-point (a mechanical restraint that restricts a patient's wrist movement) soft limb (soft materials for arm or leg) restraints on 10/25/24. SM 3 stated Pt 31's LN was supposed to document monitoring assessments for Pt 31 every two hours. SM 3 stated Pt 31's "RMF" had no restraint monitoring documentation on 10/25/24 at 6 a.m., and on 10/30/24 at 4 a.m. SM 3 stated Pt 31's "RMF" indicated on 10/28/24 at 6 a.m. and on 10/30/24 at 6 a.m. LNs did not document a complete restraint monitoring assessment. SM 3 stated LNs were supposed to document in the "RMF" a complete restraint monitoring assessment every two hours. SM 3 stated, restraint monitoring assessments included, visual or safety observation, skin, circulation, level of consciousness, toileting, flids or nourishment offered, and response to interventions. SM 3 stated monitoring documentation was absent from Pt 31's "RMF". SM 3 stated monitoring patients in restraints was important to ensure patient's safety and patients were not being injured while in restraints.

During a concurrent interview and record review on 11/13/24 at 11:40 a.m. with SM 3, Pt 31's "Physician Orders (PO)" dated 10/25/24, was reviewed. The "PO" indicated, " ... Restraints-Non Violent/Non Destructive ... 10/25/24 10:00:00 [10 a.m.] ... [every two hours] (interval) ... Soft Limb, Bilateral Wrists, Climbing out of bed/chair risking safety: Pulling at lines, Tubes or Dressings ...Order Comments: RENEW RESTRAINTS DAILY ...". SM 3 stated, every two hours on the "PO" meant to monitor the patient every two hours.

During a concurrent observation and interview on 11/14/24 at 3:45 p.m. with the Spanish Interpreter (SI), and Family Member (FM) 2 in Pt 31's hospital room, Pt 31 was observed lying in his hospital bed at a 90-degree angle with his eyes open. Pt 31's right and left wrist were in soft restraints (padding attached around a limb [wrist] attached to bedframe, that limits a person's movement).

During an interview on 11/15/24 at 10:05 a.m. with Clinical Manager (CM) 6, CM 6 stated LNs should monitor and document restraint assessments every two hours and once per shift to determine if patients needed to remain on restraints. CM 6 stated, at least every two hours LNs should, reposition the patient, offer food or drinks and check circulation (flow of blood) to limbs (arm or leg). CM 6 stated when LNs assess restraints it should be documented.

During an interview on 11/15/24 at 3:43 p.m. with the Chief Nursing Officer (CNO), the CNO stated, her expectation was for LNs to monitor and document non-violent restraints every two hours according to hospital P&P. The CNO stated LNs should, assess for skin breakdown (skin damage), offer food, water, and toileting, and determine if patients could be released from restraints. The CNO stated an assessment of a patient in restraints should happen at least every two hours, to determine if a patient has a compromised (impaired or unable to function) limb, skin breakdown, agitation (tense, irritable, or confused), or a decline in mental status. The CNO stated LNs should assess patients in restraints to determine the earliest time the restraints can be removed.

During a review of the hospital's P&P titled, "Restraint Seclusion (PC-37)", dated 1/24/19, indicated, " ... PATIENT ASSESSMENT AND DOCUMENTATION OF THE NEED FOR NONVIOLENT/NON-SELF-DESTRUCTIVE RESTRAINTS: ... The RN must document the assessment in the EHR at the initiation of restraints ... Patient evaluation will be completed every TWO (2) hours on the even hour throughout the shift and will include but is not limited to ... Perform and Provide ... Vital signs with emphasis on cardiac and respiratory status ... Skin integrity ... Signs of any injury associated with restraint application ... CSM - circulation, sensation, range of motion ... LOC - level of consciousness ... Comfort (response to restraints - restless, calm, agitation) ... Provide nutrition and hydration ... Provide hygiene ... Provide for elimination ... Maintain safe environmental, dignity and safety ... Assess for readiness for discontinuation of restraint or behavior necessitating the continuation of restrains ... Non Violent/Non Self Destructive Restraint orders will not exceed one (1) calendar day ...".

During a review of professional reference titled, Patient Restraint and Seclusion," dated 11/14/22, (retrieved from https://www.ncbi.nlm.nih.gov/books/NBK565873/ f (nih.gov) indicated, " ... Healthcare workers should know that restraint and seclusion can have significant adverse implications on patients and should be deemed a last resort. Healthcare professionals must follow the 4 basic ethical healthcare principles: autonomy [make decisions and act independently without interference from others], justice, beneficence [the doing of good, promoting the well-being of others], and non-maleficence [doing no harm]. Per beneficence - the act of doing good - and non-maleficence - do no harm; healthcare providers must ensure the administration of restraint is implemented as a last resort ... Healthcare workers must also be sure to appropriately monitor the patient following restraint and seclusion to avoid deleterious [causing harm] effects such as pressure ulcers [localized area of damaged skin or tissue that occurs when pressure is applied to skin for a long time], skin breakdown, abrasions [scraping or wearing away] , asphyxia [body deprived of oxygen, suffocation], strangulation, incontinence [involuntary loss of bladder control], depression, social isolation, and drug overdose or interaction ...Document appropriate clinical indications and prepare a standardized checklist for staff to monitor and supply patient needs effectively. Numerous deaths and adverse patient outcomes have been reported due to inappropriate restraint placement and negligent [failing to take proper care] monitoring. After restraint placement, patients should be reevaluated every hour and moved regularly ... Once it is safe, the patient should also be evaluated for medical causes of agitation ...".

Based on interview and record review, the hospital failed to ensure the nursing staff administered blood products according to their policy and procedures (P&P) titled "Blood Products Transfusion", for one of one patient (Patient 9) when documentation was missing for the completion of administration of a blood product, vital signs (measurements of the body's basic functions, such as breathing rate, temperature, pulse, and blood pressure), and a nursing assessment.

This failure had the potential to place Pt 9 at risk for overlooking a possible reaction to the administration of a blood product and negative health outcomes.

Findings:

During a concurrent interview and record review on 11/13/24, at 11:06 a.m., with the Registered Nurse (RN) 1 and Educator Manager (EM), Pt 9's electronic health record (EHR- digital collection of medical information) was reviewed. Pt 9's "History and Physical (H&P -- the formal document that physicians produce through the interview with the patient, the physical exam, and the summary of the testing either obtained or pending)", dated 11/2/2024 at 3:20 a.m. and "Blood Transfusion [Flowsheet]", dated 11/3/2024 and 11/4/24, were reviewed. Pt 9's H&P indicated Pt 9 was brought to the hospital for lethargy and pain with a history of congestive heart failure (a chronic condition that occurs when the heart cannot pump enough blood to the body), chronic obstructive pulmonary disorder (a common lung disease that makes it hard to breath), and chronic alcohol use. Pt 9 was admitted to primarily treat hepatic encephalopathy (a serious but potentially reversible brain disorder that occurs when the liver is unable to filter toxins from the blood), pain, urinary tract infection and severe sepsis (a serious condition in which the body responds improperly to an infection). RN 1 stated, on 11/3/2024, the provider had ordered a total of three units of fresh frozen plasma (FFP) (blood product that contains clotting factors to help patients with a risk of bleeding) and one unit of packed red blood cells (used for treating patients with a low blood count). RN 1 stated, the last unit of FFP was started on 11/4/2024 at 5:03 a.m. RN 1 stated, the nurse did not document the time the FFP had been completed and it should have been documented. RN 1 stated, the nurse should have documented the time of the completion of the FFP, vital signs and if the patient had any adverse effects from the blood product.

During an interview on 11/15/24 at 3:12 p.m., with the Chief Nursing Officer (CNO), the CNO stated she was aware of the case for Pt 9 and her expectations of nurses were to follow the P&P for blood transfusions. The CNO stated it was important to ensure that nurses document per the hospitals policy for the safety of the patient and not miss a possible adverse reaction.

During a review of the hospital's P&P titled, "Blood and/or Blood Products Transfusion (PC-78)", dated 7/24, the P&P stated, " ... 2. The patient's baseline vital signs are to be taken and recorded on the Blood Transfusion Record ... a. Pre transfusion ...b. Within fifteen (15) minutes of starting transfusion ... c. Thirty (30) minutes of starting transfusion ... d. Once when infusion is complete ... e. One (1) hour after infusion is completed...."

Based on observation, interviews, and record review, the facility failed to maintain secure access to locked medication rooms when Registered Nurse (RN) 1 shouted the medication room door lock code across the hall on the 7th floor medical/surgical (M/S) unit.

This failure had the potential to result in unauthorized patients, staff and visitors access to medications in the locked medication room.

Findings:

During a concurrent observation and interview on 11/12/24 at 10:30 a.m. on the 7th floor at the medication room door with Registered Nurse (RN) 2, RN 2 stated the medication room door code had recently been changed throughout the hospital and she could not remember it. RN 2 called out to RN 1 and asked RN 1 to come to the medication room and give her the code, RN 1, who was not visible, yelled the code number to open the medication room door. RN 1 was observed across the next hallway on the other side of the nursing station. When asked if the method of yelling the code was common practice, RN 2 stated, " ... that's why I asked him to come over here ...".

During an interview on 11/12/24 at 10:40 a.m. with RN 1, RN 1 stated it was wrong to yell the medication room door code and there was a risk of visitors hearing the code. RN 1 stated a visitor could then access the medication room.

During an interview on 11/15/24 at 3:15 p.m. with the Chief Nursing Officer (CNO), the CNO stated yelling the medication code out in the hall could lead to unauthorized individuals' access to medications.

During a review of the facility's policy and procedure titled, "Medication Storage and Security (MSS)", dated 4/20/24, the "MSS" indicated, " ... Medications outside the Pharmacy Department will be handled and stored ... maintaining adequate and appropriate security at all times ... Safety and security ... all medications will be maintained in a secure storage area insuring accessibility by authorized individuals only ... Definitions ... Secure--Medications are considered 'secure' when locked or under constant surveillance ...".

During the review of a professional reference titled, "Hospital Medication Security: A guide to protecting controlled substances (HMS)", dated 9/26/24, the "HMS" indicated, " ... Without medication access control systems and surveillance, medications can be stolen or tampered with, leading to potential overdoses, medication errors, or the use of unsafe drugs ...".

Based on observation, interviews, and record review, the facility failed to ensure unusable medications were not available for patient use when an intravenous (IV, in the vein) fluid bag was out of its protective overwrap against professional standards in the storage room on the 6th floor.

This failure had the potential for patients to receive altered, ineffective, and contaminated medications.

Findings:

During a concurrent observation and interview on 11/12/24 at 11:00 a.m. in the 6th floor storage room with Registered Nurse (RN) 3, an IV fluid bag missing its protective overwrap was in the stock of IV fluids available for patient use. RN 3 stated an IV fluid bag that did not have a protective overwrap could not be used for a patient. RN 3 stated the IV fluid bag could have been tampered with or fluid could have evaporated for the bag once the overwrap had been removed. RN 3 stated the exposed IV bag needed to be disposed of.

During a review of a professional reference titled, "Working up a sweat (WUS)", dated 10/2002, the "WUS" indicated, " ... The purpose of the overwrap [for IV bags] is to improve shelf life and to stabilize the drug concentration. What happens then if a bag is removed from its overwrap and remains unused for days or weeks? Over time, the fluid volume inside the bag decreases and the drug concentration per milliliter [ml, a unit of measure] increases ... Don't remove the overwrap from any I.V. bag stored in your unit until you're ready to use the solution ...".

During a review of a professional reference titled, "Expiration dates and removal of i.v. bag overwrap (EDR)", dated 9/1/95, the "EDR" indicated, " ... The overwrap protects against evaporation of the solution, desiccation [removal of moisture] of the container, drug oxidation [common way of degrading a drug], and photochemical [with light] inactivation of the drug. Without a barrier, substantial moisture loss may occur, increasing the drug concentration ... Manufacturers of these products recommend ... removing the overwrap just before the drug or solution is administered ...".

Based on observation, interview, and record review, the hospital failed to maintain a clean and sanitary environment when:

1. Two boxes of N-95 masks (a disposable face mask that covers the user's nose and mouth which offers protection from small solid or liquid droplets found in the air) and a spill kit (spill-response tools and equipment worn by an employee for protection against infectious materials) were stored in the soiled utility room (a room designated to store waste products and dirty surgical instrument carts) of the Emergency Department (ED) not in accordance with hospital's policy and professional standards.

2. An intravenous (IV-tube inserted in the vein) filtered extension set (tubing with a small micron solution filter in the drip chamber or attached to the tubing) was observed to be opened and placed back into the clean supplies in the Emergency Department (ED) medication room not in accordance with professional standards.

3. An expired Y-connector (port used to administer secondary and IV push medications) was observed in the clean supplies and stored for use in the ED medication room not in accordance with professional standards.

4. A normal saline fluid (fluid used to replace water and electrolyte) bag was not labeled with the expiration date in the warmer in the Post-Anesthesia Care Unit (PACU-specialized unit where the patient's vital signs are closely observed) clean utility room (a?room used to store clean medical equipment and supplies) not in accordance with the hospital's policy and procedure titled, "Fluid Warming."

These failures had the potential to place patients at risk for cross contamination (process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and the spread of infection.

Findings:

1. During a concurrent observation and interview on 11/12/24 at 10:30 a.m. with the Emergency Department Clinical Manager (CM) 4, in the Emergency Department Soiled Utility room, a cabinet containing two boxes of N-95 masks (a disposable face mask that covers the user's nose and mouth which offers protection from small solid or liquid droplets found in the air) and a spill kit (spill-response tools and equipment worn by an employee for protection against infectious materials) was observed. CM 4 stated clean items should not be stored in the soiled utility room. CM 4 stated all things in the soiled utility room was considered dirty and should not be used. CM 4 stated when clean items stored in a soiled utility room was used, it could be an infection control issue for patients.

During an interview on 11/15/24 at 9:05 a.m. with the Infection Preventionist Manager (IP), the IP stated clean items should not be stored in the soiled utility room. The IP stated it was important not to store clean items in the soiled utility room due to cross-contamination to patients or staff.

During an interview on 11/15/24 at 3:14 p.m. with the Chief Nursing Officer (CNO), the CNO stated soiled utility room were considered dirty. The CNO stated clean supplies should not be stored in the soiled utility room.

During a review of the facility's P&P titled, "Medical Waste Management Plan," revised 3/2024, the P&P indicated, "Waste containing discarded materials contaminated with excretion, exudate, or secretions from patients that are required to be isolated to protect others from highly communicable diseases employee orientation shall include, but not be limited to: 1. Definitions of Medical Wastes 2. Containment, transportation, and storage of medical waste."

During a review of a professional reference titled, "Infection Control and Prevention (ICP)," undated, by the Agency for Healthcare Research and Quality (AHRQ), (found at https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/patient-safety-resources/resources/esrd/infectioncontrol.pdf), the "ICP" indicated, " ...There is a clear separation of clean and dirty work areas. Clean areas are used for storage and preparation of medications and unused supplies; dirty work areas are used for contaminated equipment."

2. During a concurrent observation and interview on 11/12/24 at 10:25 a.m., with the Emergency Department Clinical Manager (CM) 4, in the ED Medication Room, an opened filtered extension set package was observed in the clean supply cabinet. CM 4 verified the filtered extension set package was opened. CM 4 stated the opened filtered extension set should have been thrown away and not placed back in the clean supplies. CM 4 stated the seal was broken and should not be used on patients, because it was an infection control concern .

During an interview on 11/15/24 at 9:05 a.m. with the Infection Prevention Manager (IP), the IP stated after a filtered extension package was opened, it should not be placed back into the clean supply. The IP stated the opened filtered extension should have been thrown away. The IP stated infection control was a concern when supplies that had been previously opened were used on different patients.

During an interview on 11/15/24 at 3:14 p.m. with the Chief Nursing Officer (CNO), the CNO stated supplies with packaging that has been breached should be discarded.

During a review of a professional reference titled, "Quick Safety: Managing packaged sterile supplies and devices (QS)," dated June 2022, (found at https://www.jointcommission.org/resources/news-and-multimedia/newsletters/newsletters/quick-safety/quick-safety-issue-65/#:~:text=Managing%20commercially%20prepared%20sterile%20supplies,on%20or%20with%20their%20devices.), the QS indicated, " ...In order to protect patients from infection and other potential harm from expired or compromised supplies and devices, organizations must identify the best location to store the supplies so that staff can readily access them, ensure the supplies are being stocked to the most optimal par levels, and that items have not passed their expiration dates. Additionally, the storage area must be maintained so that supplies are stored safely, in a manner where they are kept in good condition while protecting them from contamination. The purpose of this Quick Safety is to provide guidance for managing and storing packaged sterile supplies within your facility with the goal to keep patients safe from infection and other potential harm from expired or compromised supplies and devices ... CMS [Centers for Medicare and Medicaid Services] requires that sterile packages are stored so that sterility is not compromised, and sterile items are inspected for integrity before use ..."

3. During a concurrent observation and interview on 11/12/24 at 10:30 a.m., with Emergency Department Clinical Manager (CM) 4, in the ED medication room, a Y-connector with an expiration date of 7/12/24 was observed. CM 4 verified the expiration date as 7/12/24 on the Y-connector package and stated the package was compromised once expired and should have been thrown away.
During an interview on 11/15/24 at 9:05 a.m. with the Infection Prevention Manager (IP), the IP stated expired supplies should be removed and disposed. The IP stated the integrity of the contents could not be verified if expiration date had passed.
During an interview on 11/15/24 at 3:14 p.m. with the Chief Nursing Officer (CNO), the CNO stated an expired supply should be discarded.

During a review of a professional reference titled, "Quick Safety: Managing packaged sterile supplies and devices (QS)," dated June 2022, (found at https://www.jointcommission.org/resources/news-and-multimedia/newsletters/newsletters/quick-safety/quick-safety-issue-65/#:~:text=Managing%20commercially%20prepared%20sterile%20supplies,on%20or%20with%20their%20devices.), the QS indicated, " ...In order to protect patients from infection and other potential harm from expired or compromised supplies and devices, organizations must identify the best location to store the supplies so that staff can readily access them, ensure the supplies are being stocked to the most optimal par levels, and that items have not passed their expiration dates. The purpose of this Quick Safety is to provide guidance for managing and storing packaged sterile supplies within your facility with the goal to keep patients safe from infection and other potential harm from expired or compromised supplies and devices ..."

4. During a concurrent observation and interview on 11/12/24 at 11:43 a.m. with the Director of Surgical Services (DSS) in the Post-Anesthesia Care Unit (PACU -specialized unit where the patient's vital signs are closely observed) clean utility room, a 3000 milliliter (mL-unit of measure) bag of normal saline solution without a label of the expiration date was found in the warmer. The DSS stated the normal saline solution bag should have been labeled with an expiration date when placed in the warmer. The DSS stated fluid bags should not be in the warmer for longer than 14 days. The DSS stated it was important to label the fluid bags with an expiration date. The DSS stated this was based on the manufacturer's recommendation. The DSS stated there could be changes to the chemicals in the solution if the fluid was warmed too long. The DSS stated all staff who place new fluid bags in the warmer should place a label with the expiration date on it.

During an interview on 11/15/24 at 9:05 a.m. with the Infection Prevention Manager (IP), the IP stated the process for labeling the fluid bag should have been followed. The IP stated if the fluid is warmed too long it can become contaminated with the risk of organism (a microbe, like bacteria, virus, fungus, or parasite, that has the potential to cause an infection) build-up within the fluid. The IP stated the integrity of the fluid would be questionable.

During an interview on 11/15/24 at 3:14 p.m. with the Chief Nursing Officer (CNO), the CNO stated fluid bags should be dated to keep from using fluids that are contaminated.

During a review of the facility's P&P titled "Fluid Warming," reviewed 3/2023, the P&P indicated, " ...Each flexible bag (pouch) or semi rigid pour bottle will be labeled with the date that it expires indicating removal from the warmer ... IV and Irrigation Fluids ... Warming recommendations for Large (150 ml or greater) Volume Intravenous (IV) a. Solution in plastic bags: 1) not to exceed 40 °C (104°F) and for a period no longer than fourteen (14) days ..."