Health inspection·February 11, 2025

Clearwater Healthcare Center A citation FRI #: CA00923281. Event ID FKSY11 1/21/25 F760 State A citation was written Regulations: Code of Federal Regulations, Title 42, Section 483.45(d) - Unnecessary Drugs-General. (d) Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used- (1) In excessive dose (including duplicate drug therapy); or Code of Federal Regulations, Title 42, Section 483.45(f)(2) - Medication errors (f) The facility must ensure that its- (2) Residents are free of any significant medication errors. California Code of Regulations, Title 22, Section 72311 - Nursing Service - General. (a) Nursing service shall include, but not be limited to, the following: (1) Planning of patient care, which shall include at least the following: (A) Identification of care needs based upon an initial written and continuing assessment of the patient's needs with input, as necessary, from health professionals involved in the care of the patient. Initial assessments shall commence at the time of admission of the patient and be completed within seven days after admission. (B) Development of an individual, written patient care plan which indicates the care to be given, the objectives to be accomplished and the professional discipline responsible for each element of care. Objectives shall be measurable and time-limited. (C) Reviewing, evaluating and updating of the patient care plan as necessary by the nursing staff and other professional personnel involved in the care of the patient at least quarterly, and more often if there is a change in the patient's condition. (2) Implementing of each patient's care plan according to the methods indicated. Each patient's care shall be based on this plan. (3) Notifying the attending licensed healthcare practitioner acting within the scope of his or her professional licensure promptly of: (F) Any error in the administration of a medication or treatment to a patient which is life threatening and presents a risk to the patient. California Code of Regulations, Title 22, Section 72313 - Nursing Service-Administration of Medications and Treatments (a) Medications and treatments shall be administered as follows: (2) Medications and treatments shall be administered as prescribed. (b) No medication shall be used for any patient other than the patient for whom it was prescribed. California Code of Regulations, Title 22, section 72523 - Patient Care Policies and Procedures (a) Written patient care and policies and procedures shall be established and implemented to ensure that patient related goals and facility objectives are achieved. On 1/21/25, an unannounced visit was conducted at the facility to investigate a Facility Reported Incident of medication error. The department determined the facility failed to ensure safe medication use and practices when Resident 1 received duplicate blood thinner medications concurrently (drugs with potential to cause significant internal bleeding) for 3.5 days after admission to the facility, and failed to seek clarification before continuing with the blood thinning therapy after the staff identified the error on 9/17/24. These failures resulted in Resident 1 having a critically high Prothrombin Time/International Normalized Ratio (PT/INR: blood tests used to measure bleeding and clotting times- high levels indicate blood takes longer to clot). Resident 1 was transferred to the Emergency Department (ED) at Hospital B on 9/18/24 and suffered complications that included decreased hemoglobin (Hgb: a protein in red blood cells that carries oxygen throughout the body), two episodes of Melena (black tarry stool caused by internal bleeding), and cardiogenic shock (when the heart is unable to pump enough blood to meet the body's needs, resulting in severely low blood pressure and inadequate oxygen delivery to vital organs), which led to Resident 1's death on 9/25/24. Review of facility clinical record "ADMISSION RECORD," with a printed date of 10/16/24, indicated Resident 1 was admitted to the facility on 9/12/24, with diagnosis included: pulmonary embolism ( a condition when blood clots get stuck in an artery in the lung, blocking blood flow to part of the lung); acute respiratory failure with hypoxia (a medical condition where the lungs are unable to adequately provide oxygen to the body, resulting in a dangerously low level of oxygen in the blood); paroxysmal atrial fibrillation upper chambers of the heart) beat irregularly and rapidly for a short period of time); severe persistent asthma (a chronic lung condition characterized by persistent and severe symptoms of inflammation and narrowing of airway that are difficult to control with standard treatments); end stage chronic kidney disease (the final stage of chronic kidney disease, when the kidneys can no longer function on their own). During a review of Resident 1's electronic medical record (from Hospital A) titled, "History and Physical", dated 9/12/24, the record indicated Resident 1 was transferred to the facility from Hospital A after gallbladder (a pear-shaped organ that stores and releases digestive fluid that help to digest fats in the food) rupture and subsequent surgical complications including infection, blood clot in the lung, abnormal heart rhythm, kidney failure and breathing issues. During a review of Resident 1's electronic medical record titled, "Discharge Summary" from Hospital A, dated 9/12/24, the record indicated the following blood thinner drugs to be given in the facility: "(Start) Rivaroxaban ... [Brand name Xarelto, a blood thinner drug] 2.5 mg (milligram, a unit of measure); Take 6 tablets by mouth 2 times a day with meals for 20 days," and "Dabigatran ... 150 mg [Brand name Pradaxa; a blood thinner drug;] Start taking on October 2, 2024; Take 1 capsule by mouth 2 times a day ..." During a review of Resident 1's facility electronic medical record titled, "Medication Administration Record" (MAR- this document lists medication given by the nursing staff), dated 9/12/24, the record indicated the same start date for the two blood thinners, and they were given concurrently as follows: a. "Rivaroxaban ... Tablet 2.5 mg ...Give 6 tablet by mouth two times a day ...for 20 Days -Start Date-09/13/2024 0900 [9 AM]." Rivaroxaban was administered to Resident 1 twice daily from 9/13/24 to 9/18/24. b. "Dabigatran ... Capsule 150 mg ... Give 1 capsule by mouth two times a day ...Start Date-9/13/2024 1700 [5 PM] -D/C Date- 09/17/2024 1614 [4:14 PM] ..." Dabigatran was administered to Resident 1 twice daily, on 9/14/24 thru 9/16/24 and at 9 AM on 9/17/24. During a review of Resident 1's electronic medical record titled, "Progress Notes", with a date range of 9/13/24 to 9/17/24, the record did not indicate any communication with the medical doctor for the concurrent use of the two blood thinners. Review of Resident 1's electronic medical record titled, "Change of Condition (COC) Alert", dated 9/18/24, at 4:15 PM, indicated laboratory test results were critically high, "...Resident's PT [prothrombin time: a blood test that measures how long it takes for blood to clot] greater than 100 [normal is 12-13] and INR [International Normalized Ratio: a blood test that measures how long it takes for blood to clot] greater than 8 [therapeutic, or the level which is used to treat disorders, is 2.0-3.5] ..." The COC record under, "Immediate & New Interventions" indicated, " ... Called doctor [MD 1] office immediately and informed of lab results [laboratory blood test]. MD 1 requested resident be sent to ER [Emergency Room]." Review of Resident 1's medical record from Hospital B titled, "History and Physical," dated 9/19/24, indicated, " ...Anticoagulation [use of blood thinning medication to prevent clotting] was started during a recent hospitalization at [Hospital A] ...such that Xarelto was to be given for 20 days, after which Pradaxa was to be substituted for Xarelto. Today, the nursing staff noted a prolonged anticoagulation profile after the nursing staff had inadvertently administered both Xarelto and Pradaxa during the past 3 days ...The patient will be given 2 units of PRBC [packed red blood cells-a blood transfusion] ..." Review of Resident 1's medical record from Hospital B titled, "Consultation," dated 9/19/24, indicated, " ...Initially No signs of bleeding ...Patient subsequently had 2 episodes of Melena ..." Review of Resident 1's medical record from Hospital B titled, "Discharge Summary," dated 9/26/24, indicated once in the ED on 9/18/24, Resident 1 had a very low blood pressure, irregular heartbeat, lower Hgb level of 7.1 gm/dL (grams per deciliter, a unit of measure; a normal hemoglobin level for adult is between 12 and 16 grams per deciliter) than a week earlier on 9/12/24 when the Hgb level was 7.3 gm/dL. The record further indicated, "The patient was managed in the Intensive Care Unit from 9/19/24 to 9/25/24. The patient expired on 9/25/24 from complications of cardiogenic shock, acute hypoxemic respiratory failure [unable to breath when the body is not getting enough oxygen in the blood due to a sudden impairment in lung function], Atrial Fibrillation with rapid ventricular response [A-Fib: rapid and irregular heart beat], acute kidney injury Superimposed on chronic kidney disease [sudden worsening of kidney function], and supratherapeutic anticoagulation [when a drug is given at levels greater than would normally be used to treat a medical condition and results in too much anticoagulation which increases the risk of bleeding] ..." In an interview with Licensed Nurse (LN) 1, at Nursing Station 1, on 10/15/24, at 5:06 PM, LN 1 described the admission process and stated the information packet from the hospital for new resident admission were processed by the admission nurse. The admission nurse entered the signed hospital orders in the electronic health record. The orders, including medication orders, were double checked by the nursing supervisor, and activated in the computer system for the nurse to see the orders in the MAR. LN 1 stated the "Order Summary Report" then printed out for the facility's doctor to sign. In an interview with the Assistant Director of Nursing (ADON), in her office, on 10/29/24, at 10:37 AM, the ADON stated Resident 1's medication orders from the hospital were sent to the provider pharmacy for timely medication delivery. The ADON stated the "Order Summary Report" was reviewed and signed by MD 1. The ADON stated Resident 1's orders were additionally reviewed for nursing care plan, monitoring needs, and other required documentation after admission. The ADON stated when the indication for Resident 1's blood thinner was updated to include a blood clot diagnosis, the computer system reset the order's start date and that was how the dabigatran (Pradaxa) start date was changed from 10/3/24 to 9/13/24. The ADON stated this error was not realized until 9/17/24 after morning doses were administered. In a telephone interview with MD 1, on 12/2/24, at 2:43 PM, MD 1 stated his office received a fax communication (electronically transmitting scanned printed documents) from the facility's ADON at the end of day on 9/17/24 and he saw the fax note late the next day on 9/18/24 when he ordered to hold both blood thinners. MD 1 stated for urgent issues the facility should have made a phone call rather than sending a fax note. During a concurrent phone interview with the ADON on 12/13/24 at 12:10 PM, and review of the Provider Pharmacy's (Pharmacy A) medication dispensing record for Resident 1 (an email communication provided by Pharmacy A on 11/22/24), the record indicated Pharmacy A delivered rivaroxaban (Xarelto) to the facility on 9/12/24 and sent dabigatran (Pradaxa) to the facility on 9/17/24 (the day the duplication error was discovered). The ADON stated she did not know if the nursing staff used another resident's dabigatran to give to Resident 1. In an interview with LN 2, on 1/17/25, at 12:46 PM, LN 2 stated her workflow on medication administration followed their computer system prompts for giving the medications when it was due. LN 2 stated she marked the medication administration when she verified accuracy of the MAR and medications to be given. LN 2 could not recall Resident 1, for whom she documented giving two blood thinners at the same time. LN 2 stated she looked at the medication or duplication alerts if the computer alerted her. LN 2 stated she found the medications either in a bubble pack format (a card that individually packaged pills) or in a bottle from the top drawer of the medication cart. In a concurrent inspection of the medication cart and interview with LN 3, on 1/17/25, at 1 PM, LN 3 stated she could not recall Resident 1, for whom she documented giving two blood thinners at the same time. LN 3 stated she followed doctor's orders in the computer and tried to give the medications on time. LN 3 stated the medications for each resident were placed in the cart based on the room number and some were on the top drawer in a bottle. In a concurrent interview with the facility's Director of Nursing (DON) and Administrator (Admin), on 1/17/25, at 2:17 PM, the DON stated the duplicate use of blood thinner was a result of a clerical error in the system and the computer's response to an order clarification. The Admin stated there was a delay in contacting the MD 1 for addressing the clinical aspect of the error and they had to call the Medical Director (MD 2) to get orders to transfer Resident 1 to the hospital ED. In a telephone interview with MD 2, on 1/17/25, at 3:39 PM, MD 2 stated he recalled Resident 1 was "over-anticoagulated" (too much blood thinner medications given) and was sent to the hospital. MD 2 stated he recalled Resident 1 did not have any obvious bleeding while in the facility. MD 2 stated once the error was recognized, both medications should have been stopped until full assessment was completed by medical providers. Review of the facility policy titled, "Administering Medications", dated 4/2019, indicated, "Medications are administered in a safe and timely manner and as prescribed." The policy on Section 4 indicated, "Medications administered in accordance with prescriber's order, including any required time frame." The policy on Section 10 indicated, "The individual administering the medication checks the label three times to verify the right resident, right medication, right dosage, right time, and right method or route of administration before giving the medication." The policy on Section 26 indicated, "Medications ordered for a particular resident may not be administered to another resident ... " Review of the facility's policy titled, "Medical Director", dated 7/2016, indicated, " ...Medical director function also includes, but are not limited to, ... acting as a liaison between administration and attending physicians ... Acting as a consultant to the Director of Nursing Services in matters relating to resident care services ... Assuring that physician services comply with current rules, regulation, and guidelines concerning long term care." The facility failed to ensure safe medication use and practices when Resident 1 received duplicate blood thinner medications concurrently for 3.5 days after admission to the facility, and failed to seek clarification before continuing with the blood thinning therapy after the staff identified the error on 9/17/24. These failures resulted in Resident 1's critically high PT/INR. Resident 1 was transferred to the ED at Hospital B on 9/18/24, where he suffered over coagulation complications that included decreased Hgb, two episodes of Melena, and cardiogenic shock, which led to Resident 1's death on 9/25/24. These violations presented either imminent danger that death or serious harm would result or a substantial probability that death or serious physical harm would result to Resident 1.