Every finding on record at Immaculate Health Care Services Inc

The State Agency conducted an unannounced Federal Medicare/Medicaid recertification Survey from 03/30/2023 through 04/06/2023 for compliance with Emergency Preparedness requirements for Home Health Agencies. The Home Health Agency's total active census was 190 patients. Based on a review of the Emergency Preparedness Program and an interview with the Home Health Agency's staff, the surveyor found the Home Health Agency in compliance with the requirements for the Emergency Preparedness Program. No deficiencies were cited.

The State Agency conducted an unannounced Federal Medicare/Medicaid Home Health Agency Recertification Survey from 03/30/2023 through 04/06/2023. The Agency reported the number of unduplicated admissions for skilled services during the most recent 12-month period was eight (8) patients. The sample consisted of seven (7) clinical records, 14 personnel records, and two (2) home visits. On the first day of the survey, the Home Health Agency reported the total active census was 190 patients. Standard-level deficiencies were cited based on observations, clinic records review, agency policies review, interviews with agency staff and caregivers, and home visits. Glossary ADLs- Activities of Daily Living BID- Two times a day CFR- Code of Federal Regulations CM- Clinical Modification CMS - Centers for Medicare and Medicaid Services DCMR- District of Columbia Municipal Regulations DME - Durable Medical Equipment ER - Emergency Room G-Tube - Gastrostomy Tube G-J Tube - Gastro-Jejunal Tube HHA- Home Health Aide HHA- Home Health Agency IADLs -Instrumental Activities of Daily Living LPN - Licensed Practical Nurse mg - milligram(s) ml - milliliter(s) OASIS- Outcome and Assessment Information Set Items PCA- Personal Care Aide PRN - As Needed REG- Regulation RN - Registered Nurse SN - Skilled Nurse (ing) SOC - Start of Care WK- week (s) WNL - within normal limits % - Percentage

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on an interview with the Home Health Agency staff, a review of the Agency's CMS Submission Report, and OASIS Validation Report, the Agency's staff failed to electronically transmit each completed OASIS assessment in accordance with the CMS timely guidelines within 30 days for four (4) of ten (10) submitted OASIS assessments records, for the period of 08/15/2022 through 02/21/2023. Findings included: The Home Health Agency was unable to provide its policy relevant to the timely transmission of OASIS Data. The surveyor reviewed the OASIS assessment record submissions and validation reports on 04/05/2023 at approximately 11:00 AM, which showed the following: Patient 1 OASIS assessment record – Effective Date 04/22/2022 transmitted 11/15/2022 > 30 days Patient 2 OASIS assessment record - Effective Date 06/13/2022 transmitted 08/15/2022 > 30 days. Patient 3 OASIS assessment record - Effective Date 07/20/2022 transmitted 10/03/2022 > 30 days. Patient 4 OASIS assessment record - Effective Date 12/01/2022 transmitted 02/09/2023 > 30 days. The Home Health Agency failed to transmit OASIS Validation data within 30 days of a completed OASIS assessment record. During a face-to-face interview with Employee #1 (Administrator) and #2, (Clinical Director) on 04/06/2023, at approximately 3:30 PM. They both acknowledged the findings.

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, clinical record review, policy review, medication review in the patient's homes, and staff interviews, the agency's staff failed to conduct accurate medication reviews for three (3) of five (5) current clinical records reviews including two (2) patients for home visits conducted (Patients # 1, 2 and 5). Findings included... A review of the Home Health Agency’s undated policy titled, "Medication Reconciliation," showed the agency will reconcile all medications prior to admission, at the time of admission, before and after inpatient facility stays, at 60-day reassessment visits, and at the time of discharge. A review of the Home Health Agency’s undated policy titled, “Medication Set Up Policy,” showed that the medication list is current and updated...the medications are reviewed at each visit…if medications are not taken as ordered or not refilled, this will be documented and reported to the physician. A. The surveyor conducted a home visit with Patient #1 on 04/03/2023, at approximately 10:15 AM in the presence of Employees #2, (Clinical Director), and #6, (Licensed Practical Nurse-LPN). During the home visit, the surveyor requested permission from the agency and the patient's caregiver to review all the medications the patient was taking, including those prescribed by a physician, medications purchased over the counter, and herbal supplements. The surveyor observed medications in the patient's home, including the following: i. Abacavir 20 milligrams/milliliter Solution; give 30 milliliters daily per feeding tube, ii. Albuterol 2.5 milligram/3 milliliter; give every six (6) hours as needed (PRN), iii. Baclofen 5 milligrams/milliliter; give three (3) times per day per feeding tube, iv. Calcitriol Solution one (1) microgram/milliliter; give 2.5 milliliters three (3) times per week - Monday, Wednesday, and Friday, v. Darunavir 100 milligram/milliliter; give eight (8) milliliter daily per feeding tube, vi. Diastat Rectal Gel 10 milligram; give one (1) as directed PRN per rectum, vii. Enema Disposal; give one (1) pack once a day as directed PRN per rectum, viii. Glycerin Laxative 2 milligram/tablet; give one (1) once a day per rectum, ix. Keppra 100 milligram/milliliter; give eight (8) milliliters, x. Ketoconazole 2% every 10 days; give topical, xi. Lamivudine 10 milligram/milliliter; give 30 milliliters daily per feeding tube, xii. Miralax 17 grams as needed PRN per feeding tube, xiii. Phenobarbital Solution 64.8 milligram/tablet; give tablet twice a day per feeding tube, xiv. Ritonavir 100 milligram/packet; give one (1) packet daily per feeding tube, xv. Calcium Carbonate 120 milligram/5 milliliter; give 5 milliliters four (4) times a day per feeding tube, xvi. Diazepam 1 milligram/milliliter; give 1.5 milliliters three (3) times a day per feeding tube, xvii. Magnesium Oxide 400 milligram; crush one (1) tablet in 10 milliliters of water and take 2.1 milliliters three (3) times a day per feeding tube, xviii. Potassium Chloride liquid 200 milliequivalent/15 milliliters; give 16.5 milliliters twice a day per feeding tube, and xix. Pulmicort Inhaler Suspension 0.25 milligram/2 milliliter; give one (1) vial twice per day nebulizer. The surveyor conducted a review of Patient #1's clinical record on 03/31/2023, at approximately 11:30 AM. The record showed a Plan of Care with a Start of Care date of 06/01/2020 and a Recertification Period from 03/18/2023 to 05/16/2023. The diagnoses listed on the Plan of Care included Human Immunodeficiency Virus (HIV), Cerebral Palsy, Epilepsy, Asthma, Constipation, Muscle Spasm, Scoliosis, and Vitamin Deficiency. Additional review of the Plan of Care, 'Orders for Discipline and Treatment', directed skilled nursing services 24 hours a day times seven (7) days a week for client assessment, reconciling medication, medication administration as ordered, instructing the caregiver on, regimen dose, indications, side effects, interactions, and report adverse reactions to the physician. The skilled nurse is to determine if the caregiver can identify the correct dose, route, and frequency of each medication. One of the medications (Motrin) listed on the Plan of Care was not observed in the home, and when queried Employee #2 stated the medication was not in the home. B. The surveyor conducted a home visit with Patient #2 on 04/03/2023, at approximately 11:45 AM in the presence of Employees #2, (Clinical Director) and #7, (Licensed Practical Nurse-LPN). During the home visit, the surveyor requested permission from the home health agency and the patient's caregiver to review all the medications the patient was taking, including those prescribed by a physician, medications purchased over the counter, and herbal supplements. The surveyor observed medications in the patient's home, including the following: i. Tegretol 200 milligram tablet; give three (3) tablets (600 milligrams) twice a day per feeding tube, ii. Topiramate 50-milligram tablet; give one (1) 50-milligram tablet in the am and one (1) 50-milligram tablet at bedtime per feeding tube, iii. A and D Topical Ointment; apply the standard amount on each diaper change PRN (diaper rash), iv. Albuterol 2.5 milligram/3 milliliter (0.083%) Inhalation Solution; give one (1) vial (2.5) milligrams every 4-6 hours PRN nebulizer, v. Atopiclair Topical Cream; apply on the affected area twice a day, vi. Baclofen 20 milligram oral tablet; give one (1) tablet three (3) times a day per feeding tube, vii. Cranberry Supplement 450 milligrams; give one (1) tablet daily (mix with 5 milliliters of water per feeding tube, viii. D-Mannose 500-milligram tablet; take one (1) tablet daily (mix with 5 milliliters of water) per feeding tube, ix. Fleet Enema 4 grams sodium (118 milliliters) rectal enema; give one (1) vial once a day PRN per rectum, x. Loratadine 10 milligrams oral tablet; give one (1) tablet daily (dissolved in 5 milliliters of water) per feeding tube, xi. Nasonex 50 micrograms/inhalation nasal spray; give two (2) puffs (100 micrograms) on each nostril daily PRN nasal, xii. Pulmicort Respules 0.5 micrograms/2 milliliter inhalation suspension; give one (1) vial twice a day nebulizer, xiii. Robinul 2-milligram tablet; give one (1) tablet twice a day (crush and dissolve in 5 milliliters of water per feeding tube, xv. Tears Again Gel Drops Ophthalmic Solution; one (1) drop each eye three (3) times per day, and xvi. Tylenol Suspension 325 milligram/10 milliliters; give 10 milliliters every 4 to 6 hours PRN per feeding tube. The surveyor conducted a review of Patient #2's clinical record on 03/31/2023, at approximately 1:00 PM. The record showed a Plan of Care with a Start of Care date of 02/10/2017 and a Recertification Period from 02/13/2023 to 04/13/2023. The diagnoses listed on the Plan of Care included Cerebral Palsy, Asthma, Constipation, Idiopathic Epilepsy, Spastic Quadriplegic Cerebral Palsy, and Retention of Urine. Additional review of the Plan of Care, 'Orders for Discipline and Treatment', directed skilled nursing services seven (7) hours a day, seven (7) days a week for client assessment, and maintain medication and treatment regime. Instruct the caregiver on the medication profile. The skilled nurse is to determine if the caregiver can identify the correct dose, route, and frequency of each medication. One of the medications (Motrin) listed on the Plan of Care was not observed in the home. C. The surveyor conducted a review of Patient #5’s clinical record on 04/05/2023 at approximately 10:30 AM. The record showed a Plan of Care with a Start of Care date of 09/06/2021 and a Recertification Period from 02/28/2023 to 04/28/2023. The diagnoses listed on the Plan of Care include Intellectual Disabilities, Type 1 Diabetes Mellitus, and Hyperlipidemia. A review of the Plan of Care, ‘Medication’, dated 02/27/2023; showed the following: I. Correctional insulin (addition to mealtime insulin), test blood glucose before meals and bedtime, if blood glucose is elevated give an extra dose of Novolog/Humalog/Regular insulin as follows sliding scale 150-199, 200-249, 250-299, 300-349, greater than 350 subcutaneous (SQ), ii. Humalog 100 units/milliliter, 5 units before breakfast, 5 units before lunch, 5 units before dinner subcutaneous (SQ), iii. Lantus insulin 100 units/milliliter, give 10 units before bedtime, 10 units before breakfast subcutaneous (SQ), iv. Atorvastatin Calcium 10 milligram/tablet, give one (1) tablet once a day by mouth (PO), v. Metformin Hydrochloride 1000milligram/tablet, take one (1) tablet twice a day with meals by mouth (PO)’ vi. Trulicity 0.75 milligram/0.5-milliliter subcutaneous solution; give 0.75 milligrams weekly (Wednesday) subcutaneous (SQ). Additional review of the Plan of Care, 'Orders for Discipline and Treatment', directed the Registered Nurse (RN) for monthly and as-needed (PRN) visits to perform physical assessments and chart observation of patient's condition at each visit including reviewing medications and vital signs. Also, in the Plan of Care, ‘Orders for Discipline and Treatment, directed the Licensed Practical Nurse (LPN) visits one (1) hour daily (Monday -Friday) for the patient’s blood glucose monitoring and administration of insulin as ordered. Also, perform blood glucose checks every visit and administer lunchtime dosage of Humalog before meals, and Trulicity subcutaneously weekly on Wednesday as ordered by a medical doctor (MD). The sliding scale is as follows: The client is on a Novolog flex pen 100 units/milliliter, the LPN is to give 8 units before meals with the following instructions: If blood glucose is: 250-299 add 2 more units – 10 units 300-349 add 3 units more = 11 units 350-399 add 4 units more 12 units 400 and above call the doctor. A review of the medical profile, care period 2/28/2023 – 04/28/2023 showed discontinued medications to include Humalog Kwikpen 100 units/milliliter give 8 units three (3) times a day (before meals) subcutaneous (SQ), discontinued 06/01/2022. The Medication Administration Record (MAR) dated January 2023 through March 2023 reflected Patient # 5 is receiving Humulog 5 units as per the physician's order. The clinical record lacked documented evidence that the home health agency nursing staff conducted accurate medication reconciliation or notified the physician regarding the discrepancies. During a face-to-face interview with Employee #1 (Administrator), and #2, (Clinical Director) on 04/06/2023, at approximately 3:30 PM, they both acknowledged and confirmed the findings.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on clinical record review, policy review, and staff interviews, the Home Health Agency failed to ensure the clinician developed an individualized Plan of Care and included all required elements including all pertinent diagnoses, medications, and other required elements relative to the patient for three (3) of the seven (7) active clinical records reviewed (Patient's #1, 2 and 5). Findings included… A review of the Home Health Agency's undated policy titled, "Plan of Care”, showed an individualized Plan of Care signed by a physician will be required for each client receiving home health and personal care services to include all pertinent diagnoses, medications, and treatments. A. The surveyor conducted a review of Patient #1’s clinical record on 03/31/2023, at approximately 11:30 AM. The record showed a Plan of Care with a Start of Care date of 06/01/2020 and a Recertification Period from 03/18/2023 to 05/16/2023. Patient #1's diagnoses listed on the Plan of Care included Human Immunodeficiency Virus (HIV), Cerebral Palsy, Epilepsy, Asthma, Constipation, Muscle Spasm, Scoliosis, and Vitamin Deficiency. A review of the Plan of Care item titled ‘Orders for Discipline and Treatment’ directed skilled nursing 24 hours a day for seven (7) a week for monitoring client, medication administration as ordered, and provide feeding via gastrostomy tube (G-tube). Further review of the Plan of Care item titled 'Nutritional Requirements’, showed enteral nutrition Promote (formula) 60 milliliter/hour per percutaneous endoscopic gastrostomy (PEG) via Pump. In addition, a review of the Plan of Care item titled ‘Goals/Rehabilitation Potential/Discharge Plans showed a narrative note with documentation of medical diagnoses to include Gastrostomy Status. The Plan of Care did not include the Gastrostomy Status in the Primary or Other Diagnoses. B. The Surveyor conducted a review of Patient #2’s clinical record on 03/31/2023 at approximately 1:00 PM. The record showed a Plan of Care with a Start of Care date of 02/10/2017 and a recertification period from 02/13/2023 to 04/13/2023. Patient #2’s diagnoses included Cerebral Palsy, Asthma, Constipation, Idiopathic Epilepsy, Spastic Quadriplegia Cerebral Palsy, and Retention of Urine. A review of the Plan of Care item titled ‘Orders for Discipline and Treatment’ directed skilled nursing services to seven (7) hours a day times seven (7) days a week to maintain medication and treatment regime, and provide gastrostomy tube (G-tube) care every shift and as needed. Check G-tube placement and residual before each feeding. In addition, a review of the Plan of Care item titled ‘Goals/Rehabilitation Potential/Discharge Plans showed a narrative note with documentation of medical diagnoses to include Gastrostomy Status. The Plan of Care did not include the Gastrostomy Status in the Primary or Other Diagnoses. C. The Surveyor conducted a review of Patient #5’s clinical record on 04/05/2023 at approximately 10:30 AM. The record showed a Plan of Care with a Start of Care date of 09/06/2021 and a Recertification Period from 02/28/2023 to 04/28/2023. The diagnoses listed on the Plan of Care included Intellectual Disabilities, Type 1 Diabetes Mellitus, and Hyperlipidemia. Additional review of the Plan of Care, 'Orders for Discipline and Treatment', directed the Registered Nurse (RN) for monthly and as-needed (PRN) visits to perform physical assessments and chart observation of patient's condition at each visit including reviewing medications and vital signs. Also, in the Plan of Care, ‘Orders for Discipline and Treatment, directed the Licensed Practical Nurse (LPN) visits one (1) hour daily (Monday-Friday) for the patient’s blood glucose monitoring and administration of insulin as ordered. In addition, a review of the Plan of Care item titled ‘Goals/Rehabilitation Potential/Discharge Plans showed a narrative note with documentation of medical diagnoses to include unspecified trauma to the head. The Plan of Care did not include Unspecified Trauma to the Head in the Primary or Other Diagnoses. The Plan of Care lacked documented evidence of completion of all required elements, including all pertinent diagnoses, medications, and treatments of the patients identified. During a face-to-face interview with Employee #1 (Administrator), and #2, (Clinical Director) on 04/06/2023, at approximately 3:30 PM, they both acknowledged and confirmed the findings.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on clinical record review, the Home Health Agency's policy review, and staff interviews, the Home Health Agency failed to submit completed discharge summaries within five (5) business days of discharge to the primary care physicians for two (2) of two (2) closed clinical record reviews. (Patients #6 and 7). Findings included… Record review of the Home Health Agency's policy titled, “Discharge/Transfer/Referral of Patients,” revised date 01/27/2022 showed a copy of the discharge summary will be sent to the primary care physician and documentation be placed in the patient record that the physician was notified of the discharge. A. The surveyor reviewed Patient #6's closed clinical record on 04/05/2023 at approximately 10:15 AM. The closed clinical record included a Plan of Care with a Start of Care date of 03/22/2022 and an Initial Certification Period from 03/22/2022 to 05/22/2022. The diagnoses included Pressure Ulcer of the Sacral Region, Stage 4, Muscle Weakness, Peripheral Vascular Disease, Absence of Left Leg Above Knee, and Absence of Right Leg Above Knee. A review of the closed clinical record showed a completed Discharge Summary dated 06/27/2022 with a fax cover sheet dated 06/27/2022. The closed clinical record review lacked documented evidence of a faxed transmittal of the discharge summary submitted to the primary care physician within five (5) business days of discharge. B. The surveyor reviewed Patient #7's closed clinical record on 04/05/2023 at approximately 11:30 AM. The clinical record included a Plan of Care with a Start of Care date of 10/19/2022 and an Initial Certification Period from 10/19/2022 to 12/17/2023. The diagnoses included Cerebral Infarction, Cerebrovascular Disease, Type 2 Diabetes Mellitus, Aphasia, Hypertension, and Hyperlipidemia, A review of the closed clinical record showed a completed Skilled Nurse Discharge Summary dated 12/12/2022 with a fax cover sheet dated 12/12/2022. An additional review of the closed clinical record showed a completed Discharge Summary by Employee #5 (Physical Therapist) dated 01/12/2023 with a fax cover sheet dated 01/12/2023. The closed clinical record review lacked documented evidence of a faxed transmittal of the discharge summary submitted to the primary care physician within five (5) business days of discharge. The surveyor conducted a face-to-face interview with Employee #2 (Clinical Director) on 04/06/2023 at approximately 2:00 PM, related to notifying the physician of a discharge. Employee #2 stated we faxed the discharge summary to the physician, but we do not have a record of the confirmation. The Home Health Agency Staff failed to submit a completed discharge summary to the primary care physician within a specified time for Patients #6 and 7. The surveyor conducted a face-to-face interview with Employees #1 (Administrator) and 2 (Clinical Director) on 04/06/2023 at approximately 3:00 PM. The employees acknowledged the findings.