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1303 E HERNDON AVE

FRESNO, CA 93710

PATIENT RIGHTS: NOTICE OF RIGHTS

Tag No.: A0117

Based on interview and record review, the facility failed to obtain two signatures on a Consents to Treat (COT-consent to treat and bill the patient) for one of six patients (Pt 19) when Pt 19's COT did not have a second hospital employee (staff) signature to verify a phone consent according to the hospital's policy and procedure (P&P) titled, "Informed Consent/Consent Forms."

This failure resulted in Pt 19's consent to treat to go unverified by a second witness.

Findings:

During a concurrent interview and record review on 12/5/24 at 11:10 a.m. with Nurse Manager (NM) 7, Pt 19's "Consent to Treat (COT) Part 2," dated 11/9/24 was reviewed. The COT Part 2 indicated, " ...The Patient is unable to sign because: Weakness. If other than patient, indicate relationship: [Name of Family Member] Relative ... Signature of Patient's Representative: Phone consent ... Signature captured at 11/9/24 4:56 p.m. ... Witness Emp ID#: [Name of Staff] ..." NM 7 stated there was one staff signature on the COT Part 2 form.

During a concurrent interview and record review on 12/5/24 at 3:45 p.m. with the Patient Access Supervisor (PAS), Pt 19's "COT Part 2," dated 11/9/24 was reviewed. The PAS stated the COT Part 2 indicated a phone consent was given by Pt 19's family member and there was one staff signature present on the form. The PAS stated hospital staff who obtained the consent should have asked a second hospital staff to witness the consent to treat phone call with the patient's family member. The PAS stated the hospital's second staff should hear the patient's family member give consent. The PAS stated the procedure is for two staff to sign the COT Part 2. The PAS stated there should have been two staff signatures when the phone consent was provided to Pt 19's family. The PAS stated she expected the second staff to sign the COT Part 2 to validate a conversation about treatment was witnessed and a family member had given consent. The PAS stated facility staff should have followed the facility's policy.

During a review of the facility's P&P titled, "Informed Consent/Consent Forms," revised 8/2023, the P&P indicated, " ...PURPOSE: To provide information to the patient regarding their health status, diagnosis, prognosis and appropriate care, treatment and services options allowing the patient to make an informed choice, as well as, to provide guidelines for completing and witnessing consent forms. OUTCOME: Informed consent is obtained after a competent patient (or person legally authorized to make health care decisions on the patient's behalf) is given sufficient information by the treating physician to make an informed choice, understands the information, and voluntarily agrees to be treated (consent) or not to be treated (refusal), thus protecting the patient's fundamental right to autonomy ... GENERAL INFORMATION: ... If a patient is unable to sign the consent, the responsible party may give consent by telephone provided two hospital employees (e.g. RN, Technologist), whose signatures are on the consent form, listen to the phone consent ..."

SUPERVISION OF CONTRACT STAFF

Tag No.: A0398

Based on observation, interview and record review, the facility failed to ensure all licensed nurses (LNs) adhered to the hospital's policies and procedures (P&P), when LNs did not reassess pain after administration of pain medication for one of six patients (Pt 17) according to the facility's P&P titled, "Pain Management Guidelines."

This failure placed Pt 17 at risk for inadequate pain management or oversedation and could negatively affect the physical, emotional, and psychosocial (the influence of both physical and social factors on an individual) well-being of patients.

Findings:

During a review of Pt 17's "History and Physical (H&P-complete patient assessment by physician)," dated 12/2/24, the H&P indicated Pt 17 was a 25-year-old female who was admitted to the Labor and Delivery unit for prolonged decelerations (a sudden and significant decrease in a fetus's heart rate) at 39 weeks and 4 days gestation (the period of time between conception and birth).

During a concurrent interview and record review on 12/4/24 at 2:43 p.m. with Registered Nurse (RN) 4 and Nurse Director 4, Pt 17's "Pain Assessment Flowsheet," dated 12/3/24, and "Medication Administration Record (MAR-where medications given to a patient are documented)," dated 12/3/24 were reviewed. The PAF indicated at 8:02 a.m., Pt 17 had a pain of 6 (moderate) out of 10 (Mild Pain=score of 1-3, Moderate Pain=score of 4-6, Severe Pain=score of 7-10). The MAR indicated Pt 17 was administered ibuprofen 600 milligrams (mg-unit of measure) by mouth at 8:02 a.m. RN 4 stated the PAF indicated Pt 17's pain was not reassessed within one hour after pain medication was administered. RN 4 stated the PAF indicated Pt 17's next pain assessment was completed at 12:45 p.m . (a lapse of 4 hours and 43 minutes) with a pain of 7 (severe). RN 4 stated it was important to reassess the patient's pain to determine if the intervention was effective and if more interventions were necessary. ND 4 stated she expected LNs to reassess the patient's pain within one hour to determine the effectiveness of the intervention.

During a review of the facility's P&P titled, "Pain Management Guidelines," revised 9/2024, the P&P indicated, " ...PURPOSE: To provide guidelines for effective pain management including assessment and education to achieve pain relief with minimal risks and safe outcomes. OUTCOME: Patients are timely assessed/re-assessed for pain, educated on their treatment, and managed appropriately for complications ... POLICY: ... Reassessment criteria will be used to evaluate and respond to the patient's pain ...Documented reassessment will include pain and sedation levels ...Pain reassessment will be done in an appropriate timeframe based on the medication given, and this reassessment documented ... PROCEDURE: ... Assess and reassess pain at regular intervals appropriate for the specific patient including: ... Following pain management interventions, once sufficient time has elapsed for the treatment(s) to be effective ..."

During a professional reference review titled, "Pain management in hospitals: patients' satisfaction and related barriers," dated 9/25/18, (found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6207353/) indicated, " ... Suboptimal pain control has been frequently reported in healthcare settings and documented to negatively impact patients' health. Patients' perception regarding pain management may influence their satisfaction regarding treatment ..."

During a professional reference review titled, "Acute Pain Management Pearls: A Focused Review for the Hospital Clinician," dated 12/22/22, (found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9818465/) indicated, " ... Uncontrolled pain worsens patient outcomes ... Uncontrolled acute pain triggers a complex neurohormonal cascade that is toxic to nearly every organ system, as evidenced by increased rates of renal [kidney] and gastrointestinal [stomach and intestine] dysfunction, infection, cardiopulmonary [heart and lungs] and thrombotic [blood clot] complications, impaired wound healing, adverse psychological effects, and poorer functional recovery and quality of life ... Acute pain management in hospitalized patients should therefore be a clinician and intuitional priority as a key driver of patient outcomes ..."

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observation, interviews, and record review, the facility failed to ensure unusable medications were not available for patient use when one liter of lactated ringers' solution (solution used to replace water and electrolyte loss in patients) was not labeled and dated in the Labor and Delivery (L&D) medication room warmer according to the facility's policy and procedure (P&P) titled, "Warmers: IV, Irrigation, Blanket."

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

Findings:

During a concurrent observation and interview on 12/3/24 at 11:20 a.m. with Nurse Director (ND) 4 and Nurse Manager (NM) 4, in the L&D medication room, one liter of lactated ringers' solution was not labeled and dated in the warmer. NM 4 stated the one liter of lactated ringers' solution was not labeled and dated when placed in the warmer. NM 4 stated it could be in the warmer for 48 hours then thrown away if not used. NM 4 stated operating room (OR- where surgical procedures are performed) technicians were responsible to label and stock the intravenous (IV- within a vein) fluids in the warmer. NM 4 stated licensed nurses (LNs) are expected to check for a label and expiration date before patient use. NM 4 stated it was not safe to use on patients if we do not know the expiration date. ND 4 stated the one liter of lactated ringers' should be thrown away because the expiration date is unknown.

During an interview on 12/6/24 at 9:44 a.m. the Director of Quality and Infection Prevention (QIPD), the QIPD stated the integrity of the lactated ringers could be compromised from being in a dark, moist warm environment which can lead to bacterial growth. The QIPD stated bacteria could then be introduced into the blood stream when used on a patient.

During a review of the facility's P&P titled, "Warmers: IV, Irrigation, Blanket," revised 10/2019, the P&P indicated, "PURPOSE: To provide guidelines for staff to ensure intravenous fluids, irrigation, solutions and blankets which require warming, are kept at an acceptable level. OUTCOME: Temperature is maintained in the warmers appropriate for the types of items being warmed. Items are kept in the warmers based on manufacturer's recommendations. POLICY: ... Once fluids are removed from the warmer, they must be used within 24 hours. If not used, they must be discarded ... Date marked on sticker is the last day the fluid can be in the warmer ... PROCEDURE: ... Intravenous Fluids (volumes greater than 150ml): A. Date intravenous fluids when placed in the fluid warmer. 1) Place date on sticker to avoid fluid contamination. 2) Date marked on sticker is the date the item must be removed from the warmer. 3) Check dates prior to use. B. Leave the IV overwrap intact during the warming period. 1) If an outer wrap is present, fluid is good for 14 days ..."

INFECTION CONTROL SURVEILLANCE, PREVENTION

Tag No.: A0750

Based on observations, interviews, and record review, the facility failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when:

1. Three unopened soda cans and an unopened hand sanitizer were stored in a cabinet in the dirty utility room (a closed space in healthcare facilities that is used to safely dispose of human waste and clean or dispose of used medical supplies).

2. Two empty soda cans were found in a cabinet in the nourishment room (where food and drink for patients are stored).

These failures had the potential for cross contamination (physical movement or transfer of harmful bacteria from one person, object, or place to another) and placed patients at an increased risk for hospital acquired infections (an infection that develops while a person is in a healthcare facility).

Findings:

During a concurrent observation and interview on 12/3/24 at 11:40 a.m. in the 3rd floor West dirty utility room with Nurse Manager (NM) 3, three full, unopened soda cans and one unopened hand sanitizer refill container were stored in a cabinet. NM 3 stated the soda cans and sanitizer container were now dirty, having been in the dirty utility room.

During a concurrent observation and interview on 12/3/24 at 11:45 in the 3rd floor West nourishment room with Registered Nurse (RN) 1, RN 1 stated the used cans should not be stored in the nourishment room cabinet.

During an interview on 12/3/24 at 11:50 a.m. with Infection Preventionist (IP) 1, IP 1 stated the soda cans in the dirty utility room and the empty cans in the nourishment room were considered dirty items and should not be in there.

During an interview on 12/6/24 at 9:44 a.m. with the Quality & Infection Prevention Director (QIPD), the QIPD stated the unopened hand sanitizer and unopened soda cans should not have been stored in the dirty utility room. The QIPD stated unopened cans should have been thrown out because they could have been exposed to bacteria or microbes (tiny organisms invisible to the naked eye). The QIPD stated the used soda cans should not have been stored in the nourishment room because they grow microbes and cross contaminate patient food.

During a review of a professional reference from the Agency for Healthcare Research and Quality (AHRQ) titled, "Infection Prevention (IP)" (undated), "IP" indicated, " ... Providing a sanitary environment ... 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 areas are used for contaminated equipment ...".

During a review of the professional reference titled, "The role of the surface environment in healthcare-associated infections (RS)", dated 8/2013, the "RS" indicated, " ... Hospital surfaces are frequently contaminated with important healthcare-associated pathogens [bacteria]. Contact with the contaminated environment by healthcare personnel is equally as likely as direct contact with a patient to lead to contamination of the healthcare provider's hands or gloves that may result in patient-to-patient transmission of nosocomial [originating from the hospital] pathogens ...".