American Health Associates, Inc.

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, interview, and record review, the facility failed to ensure infection prevention procedures were followed for thirteen of thirteen sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 9, Patient 10, Patient 11, Patient 12, Patient 13) when expired sterile (free from germs) supplies were in the supply cabinets. This failure had the potential for sterile medical items to lose sterility and cause infections. During a concurrent observation and interview on 7/15/24 at 9:44 a.m. with Registered Nurse (RN) 2 near the supply cabinets, an unopened IV (catheter used to deliver fluids or medications into a vein) start kit was noted to have an expiration date of 2/28/23. RN 2 confirmed the IV start kit had expired. During a review of the Center for Disease Control (CDC) guidelines “Sterilizing Practices/Infection Control,” dated 11/28/23, the guidelines indicated, “Any item that has been sterilized should not be used after the expiration date has been exceeded or if the sterilized package is wet, torn, or punctured.” During a review of the facility’s policy and procedure (P&P) titled, “INFECTION CONTROL PLAN,” dated 4/2019, the P&P indicated, “To delineate an infection control plan to meet the following goals: Establish the mechanisms by which the organization will address surveillance, prevention, identification, control and reporting of infections.” During an interview on 7/15/24 at 9:30 a.m. with Registered Nurse (RN) 2, RN 2 stated they checked expiration dates “now and then.” During a concurrent observation and interview on 7/15/24 at 10 a.m. with RN 2 near the supply storage cabinets, the following supplies were observed to be expired (exp.): IV Start Kit exp. 2/28/23 CloraPrep Triple Swabstick (sterile chlorhexidine gluconate and alcohol solution) exp. 2/24 x 2 packages CloraPrep Triple Swabstick exp. 12/21 x 4 packages Coram PICC /Midline Dressing Change Kit exp. 3/31/22 BD Instyte Autoguard 24-gauge (IV start needle) exp. 7/31/2020 BD Instyte Autoguard 22-gauge exp. 7/31/2022 BD Instyte Autoguard 24-gauge exp. 01/2019 BD Instyte Autoguard 24-gauge exp. 2/29/2020 BD Instyte Autoguard 20-gauge exp. 11/2017 BD Instyte Autoguard 24-gauge exp. 12/31/2020. RN 2 stated the supplies were outdated. During an interview on 7/15/24 at 3:37 p.m. with the Director of Patient Care Services (DPCS), DPCS stated it was her responsibility to remove expired supplies from the supply cabinet. DPCS stated she should have removed the expired supplies but had not done so recently.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on interview and record review, the facility failed to ensure: “Home Health Certification and Plan of Care” (HHCPOC) was signed in a timely manner by physicians for six of 13 sampled patients (Patient 4, Patient 5, Patient 7. Patient 11, Patient 12, and Patient 13). This failure resulted in lack of authentication (signature to ensure accuracy) by physicians and had the potential to result in the implementation of inaccurate physician’s orders due to lack of physician oversite. OASIS was signed by the Registered Nurse (RN) upon completion for two of 13 sampled patients (Patient 2 and Patient 12). This failure resulted in lack of authentication of the comprehensive assessment. Findings: 1. During a concurrent interview and record review on 7/18/24 at 9:25 a.m. with Director of Patient Care Services (DPCS), Patient 11’s HHCPOCs, dated 3/3/24 to 5/1/24 and 5/2/24 to 6/30/24, were reviewed. DPCS was unable to provide evidence of HHCPOCs Patient 11’s paper medical record. The HHCPOCs in Patient 11’s electronic medical record indicated the physician had not signed the HHCPOCs (no physician’s signatures). DPCS stated the HHCPOCs were supposed to be signed by the physician within 30 days of the start date. DPCS stated this was the protocol. During a concurrent interview and record review on 7/18/24 at 9:50 a.m. with DPCS, the facility’s policy and procedure (P&P) titled, “Verification of Physician Orders Policy No. 2-020,” dated 2009 was reviewed. The P&P indicated, “10. Signed orders will be placed in the clinical record and within 30 days of the initiation of the order, unless otherwise specified by applicable stated law and regulation. The unsigned copy of the order will be removed from the record.” DPCS stated the HHCPOCs were physician’s orders and should have been signed within 30 days. During a concurrent interview and record review on 7/18/24 at 11:17 am with DPCS, the following HHCPOCs were reviewed for Patient 4, Patient 5, Patient 7, Patient 12, and Patient 13: Patient 4’s HHCPOC- certification period dated 11/1/23 to 12/30/23- signed by physician 12/29/23 Patient 5’s HHCPOC- certification period dated 10/23/23 to 12/21/23- signed by physician 1/22/24 Patient 7’s HHCPOC- certification period dated 1/17/24 to 3/16/24- signed by physician 3/14/24 Patient 12’s HHCPOC- certification period dated 12/9/23 to 2/6/24- signed by physician 1/30/24 Patient 13’s HCCPOC- certification period dated 5/23/24 to 7/21/24- signed by physician 7/2/24 Patient 13’s HCCPOC- certification period dated 3/24/24 to 5/22/24- signed by physician 5/9/24. DPCS verified dates that the HCCPOCs were signed by the physician and stated that all reviewed records were signed late. During a review of the facility’s P&P titled, “Contents of the Clinical Record Policy No. 5-005.1,” dated 2009, the P&P indicated, “1. The following information will be available in the clinical record, as applicable to care and services provided: . . . E. Legible, complete, and individualized diagnostic and therapeutic orders authenticated within the time frame defined by the organization, or according to law and regulation. (See “Verification of Physician Orders Policy No. 2-020.)” 2. During a review of Patient 2’s Outcome and Assessment Information Set (OASIS), dated 7/11/24, the OASIS indicated, “I have personally reviewed all of the above information and hereby, certify, affirm, and declare that the above information is complete, true, accurate, and correct.” The OASIS indicated there was no signature of the registered nurse completing the assessment. During a review of Patient 12’s Outcome and Assessment Information Set (OASIS), dated 6/5/24, the OASIS indicated there was no signature of the registered nurse completing the assessment. During an interview on 7/18/24 at 9:55 a.m. with DPCS, DPCS stated she understood completing the OASIS form would include signing it. During a review of the facility’s policy and procedure (P&P) titled, “Entries into the Clinical Record Policy No. 5-006,” dated 2009, the P&P indicated, “7. The clinical note will include: . . . E. Signature of the clinician and his/her credentials. 8. Signature authorization of clinical documentation will include staff member’s name and credentials (as specified on professional licenses and/or certification documents).””

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview and record review, the agency failed to ensure for four of 13 sampled patients (Patient 2, Patient 3, Patient 4, and Patient 5) a medication reconciliation (review of all medications used) was conducted on each skilled nurse or therapist’s visit. These failures resulted in the agency being unaware of patients not taking medications as prescribed, adverse reactions, ineffective drug therapy, side effects, and drug interactions. Findings: During a review of Patient 4’s “PHYSICIAN ORDER (PO),” dated 6/26/24, the PO indicated, “Aspirin [medication to prevent blood clots] 81 mg 1 tab once a day by mouth. . . Clopidogrel Bisulfate [medication to prevent blood clots] 75 mg 1 tab once a day by mouth.” During a review of Patient 4’s “PLAN OF CARE (POC),” dated 6/28/24 – 8/26/24, the POC indicated, “Aspirin 81 mg 1 tab by mouth once a day-PREVENT BLOOD CLOT. . . Clopidogrel Bisulfate 75 mg 1 tab by mouth once a day – PREVENT BLOOD CLOT.” During a concurrent observation and interview on 7/16/24 at 12:04 p.m. with Patient 4, Patient 4’s medications were reviewed. Two medications, Clopidogrel 75 mg., and Aspirin 81 mg. were among Patient 4’s medications. Patient 4 stated he stopped taking the Clopidogrel and Aspirin approximately ten days prior. Patient 4 stated the agency nurses do not talk to him about his medications except to ask if he has taken his psychiatric medications. During an interview on 7/16/24 at 3:30 p.m. with Director of Patient Care Services (DPCS), DPCS stated it was her expectation that a medication reconciliation be done at every skilled nurse visit. DPCS stated if the patient was refusing to take any medications there should be documentation in the visit notes regarding the missed doses. During a review of Patient 4’s “CLINICAL NURSING NOTE (CNN),” dated 7/8/24, the CNN indicated, “Patient taking meds as listed in med profile.” During a review of Patient 4’s CNN, dated 7/10/24, the CNN indicated, “MEDICATION. . . No Change.” During a review of Patient 4’s CNN, dated 7/15/24, the CNN indicated, “Patient taking meds as listed in med profile.” During a review of the facility’s policy and procedure (P&P) titled, “Medication Management,” dated 4/2020, the P&P indicated, “During subsequent [visits made after admission] home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen. . . Deviations in taking medications as ordered will be documented in clinical notes, and the physician (or other authorized licensed independent practitioner) will be notified.” During a review of the agency policy titled, “Medication Profile,” revised April 2020, the policy indicates in part, “Patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications…During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen. This includes, but will not be limited to: Using the medication profile, in conjunction with other pertinent data, to evaluate the use of the drugs in the home setting…” During an observation on 7/15/24 beginning at 2:15 p.m. at the home of Patient 2, Licensed Vocational Nurse (LVN) 1 briefly looked through a box of medications and identified Morphine (narcotic) 15 milligrams (mg), Ativan (antianxiety) 0.5 mg and 2 mg, Morphine 20 mg, gabapentin (anticonvulsant) 330 mg, Protonix (for gastroesophageal reflux) 40 mg, Elavil (antidepressant) 10 mg, senna plus (for constipation) 8.6/50 mg, Gas-x (for bloating), and Dulcolax suppositories (for constipation). After LVN 1 left the home, the surveyor took another look at the medication box and also found Naloxone (treats narcotic overdose) nasal spray, and fentanyl (potent opioid pain medication) transdermal patch 25 micrograms/hour. During a review of the current physician orders for Patient 2, the only Morphine ordered was 10 mg., and Ativan was only ordered at 2 mg. Also, folic acid (vitamin) 1 mg and lactulose (laxative) 10 grams were ordered. Elavil was not ordered. During an interview on 7/16/24, at 11:04 a.m., with LVN 1, LVN 1 stated the medication box referenced above is “their box, they don’t have to let me look at it.” When it was mentioned that the box was available to look at on 7/15/24, LVN 1 replied “No comment.” 2. During an observation on 7/16/24 beginning at 1:55 p.m. at the home of Patient 5, Physical Therapist 1 did not look at the medications taken by the patient. After PT 1 left the home, the surveyor took a look at the medications which consisted of Glucosamine (joint supplement), Lysine (amino acid), Calcium/Vitamin D, Refresh Tears (for dry eyes), Vitamin B-12, Vitamin C, Loratidine (for allergies), Iron, folic acid, Cleocin (antiinfective), simvastatin (for high cholesterol), Peridex (topical antiseptic), polyethylene glycol (laxative), triamcinolone (treats a variety of skin conditions), petrolatum (topical ointment), aquaphor (topical ointment), and fungi-nail (antifungal). During a review of the current physician orders for Patient 5, the orders included Vitamin D3, and Zofran (for nausea). The orders did not include glucosamine, lysine, cleocin, peridex, polyethylene glycol, Aquaphor, triamcinolone, petrolatum, or fungi-nail. During an interview on 7/16/24, at 3 p.m. with Family Member (FM) 1, FM 1 stated, PT 1 “may ask, how is it going, any changes (in medication)?” During an interview on 7/17/24, at 10:35 a.m. with PT 1, PT 1 stated, “I just ask (the patient) if he took his medication that morning.” During an interview on 7/16/24, at 4:20 p.m., with the Director of Patient Care Services (DPCS), the DPCS stated, therapists check the medications of their patients. Findings: During an observation on 7/16/24 at 11:23 a.m. with Registered Nurse (RN) 1 in Patient 3’s home, RN 1 asked Patient 3 if there were any changes to his medications. Patient 3’s wife answered that there were no changes and Patient 3 takes his medications on his own. RN 1 did not ask to see the medication bottles to compare with Patient 1’s current medication list or ask about each medication individually. During an interview on 7/16/24 at 11:46 a.m. with RN 1, RN 1 stated he does not do a medication reconciliation at every visit. RN 1 stated he asks patients if they are taking medications as ordered. RN 1 stated he would only do a reconciliation comparing medications in the home to medications listed in the physician orders on admission, after the patient had visited their doctor, or with a change in condition. During a concurrent interview and record review on 7/16/24 at 3:22 p.m. with Director of Patient Care Services (DPCS), the facility’s policy and procedure (P&P) titled, “Medication Profile Policy No.3-002,” dated 2009, was reviewed. The P&P indicated, “POLICY Patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. . . PROCEDURE . . . 4. During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen. This includes, but will not be limited to: A. Using the medication profile, in conjunction with other pertinent data, to evaluate the drugs in the home setting. B. Using the medication profile to teach the purpose of medication, dosages, routes, administration times, side effects, and contraindications. C. Using the medication profile as a communication tool for other clinicians involved in care.” DPCS stated the policy was for nurses to do medication reconciliation at every home visit. DPCS stated this identifies if a patient is noncompliant with taking their medications as ordered and would prompt the facility to take extra measures if needed. DPCS stated just asking the patient if they are taking their medications as ordered does not follow the policy and does not give the nurse the opportunity to provide teaching or evaluate how the patient is taking their medications.”

“Incorporate OASIS items CFR(s): 484.55(c)(8) Incorporation of the current version of the Outcome and Assessment Information Set (OASIS) items, using the language and groupings of the OASIS items, as specified by the Secretary. The OASIS data items determined by the Secretary must include: clinical record items, demographics and patient history, living arrangements, supportive assistance, sensory status, integumentary status, respiratory status, elimination status, neuro/emotional/behavioral status, activities of daily living, medications, equipment management, emergent care, and data items collected at inpatient facility admission or discharge only. This Element is not met as evidenced by: Based on interview and record review, the facility failed to ensure for three of 13 sampled patients’ (Patient 2, Patient 8, and Patient 12) Advance Directive information was completed on the Outcome and Assessment Information Set (OASIS). These failures resulted in lack of information regarding naming a patient representative, code status, organ donor wishes, and/or funeral arrangements. During an interview on 7/17/24 at 3:40 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated a comment should have been made on the OASIS as to why the advance directive sections were left blank. During a review of the facility’s policy and procedure (P&P) titled, “Initial and Comprehensive Assessment,” revised April 2019, the P&P indicated, “During the initial and comprehensive patient assessments, all baseline data to be used in measuring the patient’s progress toward goals and other relevant information will be documented in the patient’s clinical record, including at least the following information, if applicable: J. Presence of any Advance Directives for care or discussions with patient and, as appropriate, family/caregiver, regarding the withholding of resuscitative services or the withdrawal of life-sustaining treatment.” Findings: During a review of Patient 2’s Outcome and Assessment Information Set (OASIS), recertification dated 7/14/24 to 9/11/24, the OASIS indicated the section titled “Advance Directives” was not completed and contained no comments explaining why it was not completed. During a review of Patient 8’s Outcome and Assessment Information Set (OASIS), dated 5/2/24, the OASIS indicated the section titled “Advance Directives” was not completed and contained no comments explaining why it was not completed. During a review of Patient 12’s Outcome and Assessment Information Set (OASIS), recertification dated 6/6/24 to 8/4/24, the OASIS indicated the section titled “Advance Directives” was not completed and contained no comments explaining why it was not completed. During a review of the facility’s policy and procedure (P&P) titled, “Contents of the Clinical Record Policy No 5-005,” dated 2009, the P&P indicated, “ PROCEDURE 1. The following information will be available in the clinical record, as applicable to care and services provided: . . . AA. Advance Directive information and documentation, as required by organization policy.””

“Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This Element is not met as evidenced by: Based on interview and record review, the agency failed to revise the plan of care (POC) for one of 13 sampled patients (Patient 2). This failure had the potential to create confusion for staff assessing patient response to the POC. Findings: During an interview on 7/15/24 at 2:30 p.m. with Patient 2, Patient 2 stated she is not diabetic. Licensed Vocational Nurse (LVN) 1 stated he checked Patient 2’s blood glucose because of endocrine cancer about one time a month. During a review Patient 2’s POC, the POC indicated the Patient 2’s principal diagnosis was “Type 2 Diabetes Mellitus with diabetic neuropathy.” The POC indicated Patient 2’s supplies included “diabetic care supplies.” The POC indicated Patient 2’s goals included, “Patient/PCG (patient care giver) will monitor blood sugar daily…” During an interview on 7/16/24 at 11:04 a.m. with LVN , LVN stated he believed the Patient 2’s principal diagnosis was endocrine cancer. LVN stated Patient 2 does not have a glucometer (device used to monitor blood sugar). During an interview on 7/18/24 at 9:45 a.m. with Director of Patient Care Services (DPCS), DPCS stated LVN 1 should have let the case manager know about the discrepancies on the POC so it could be revised. During a review of the facility’s policy and procedure (P&P) titled, “Initial and Comprehensive Assessment,” revised April 2019, the P&P indicated, the clinical supervisor or designee will be responsible for the review of the plan of care.”