Every finding on record at Divine Health Care Services

Based on the findings of an unannounced onsite Home Health Agency Medicare Recertification Survey conducted September 30, 2025, October 1, 2025, and November 24, 2025, Divine Health Care Services was found to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.

Based on the findings of an unannounced onsite Home Health Agency Medicare Re-Certification Survey conducted September 30, 2025, October 1, 2025, and November 24, 2025, Divine Health Care Services was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

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 a review of clinical records (CR), home health agency (HHA) policies, home visits, and an interview with the administrator, the HHA failed to assure that an accurate and complete medication review occurred or five (5) of seven (7) CR’s reviewed: CR#2, CR#3, CR#4, CR#5, and CR#7. Findings include: The HHA's Policy Medication Profile, Policy No 3-034.1 reviewed on October 1, 2025 at 1:45 PM and again on November 24, 2025 at 2:00 PM states in part, "Upon admission to the Agency, the admitting nurse will initiate a medication review in order to document the current medication regime; The current medication(s) the patient is taking is documented on the Medication Profile. As warranted, conclusions and findings of patient medication use are communicated to the appropriate health team members, including the physician and/or pharmacist; The medication profile is updated as necessary to ensure that it remains current throughout the course of care." Home Visits/Observations were conducted for three (3) patients: CR#2, CR#3, and CR#5 on November 24, 2025 from 10:00 AM to 12:15 PM. A review of CR's was conducted on September 30, 2025 starting at 2:02 PM, and again on October 2, 2025 starting at 9:27 AM and November 24, 2025 starting at 9:10 AM. The start of care (SOC) and Certification Period (CP) are indicated below. CR#2 SOC 07/14/2025, CP 07/14/2025 to 09/11/2025 found that the medication profile contained orders that read, “Lantus Insulin, Inject 30 units at ‘I,’ Route Subcutaneous (Subcut).” There was no evidence that the nurse contacted the physician for order clarification regarding the meaning of ‘I,’ nor when the Lantus insulin was to be administered, i.e., morning, evening or night. Further, the medication profile contained medication orders that read, “Regular Insulin, 10 units ‘with,’ Route: Subcut. Comments: Breakfast” and “Regular Insulin, 10 units ‘with,” Route Subcut. Comments: Dinner.” There was no evidence that the nurse contacted the physician for clarification to the insulin order regarding the meaning of the word ‘with’ and there were no parameters ordered for when the insulin should be held based on blood glucose levels. CR#3 SOC 09/11/2025, CP 09/11/2025 to 11/09/2025 found that the medication profile contained a medication order for "Acetaminophen (Tylenol) 500 mg (milligrams), 1 tablet, 3 times a day by mouth." There was no indication for use of the Tylenol nor was there evidence that the nurse sought clarification from the physician to determine if the Tylenol was intended to be taken as needed (prn) instead of routinely. CR#4 SOC 08/18/2025, CP 08/18/2025 to 10/16/2025 found that the medication profile contained a medication order for "Tylenol" with frequency noted as “see instruction.” There were no instructions evident on the medication profile or in the clinical record, nor was the frequency or indication for use of the Tylenol present. There was no evidence that the nurse sought clarification from the physician regarding the Tylenol order. CR#5 SOC 06/13/2025, CP 08/12/2025 to 10/10/2025 found that the medication profile contained a medication order for "Naloxone, Dosage: 1ml (milliliter), Frequency: inject every 3 min, Route: IM.” There were no orders for an opioid (which is an indication for use of Naloxone in an emergency) and no evidence that the nurse sought clarification from the physician to determine if Naloxone was indeed indicated and if so, obtain appropriate and accurate administration orders. A home visit/observation conducted on 11/24/2025 at approximately 11:45 AM revealed that the patient was not taking an opioid. CR#7 SOC 02/28/2025, CP 06/28/2025 to 08/26/2025 found that the medication profile contained a medication order that read, “Naloxone, 0.4mg/ml only 2 as need; Frequency: 1 as needed; Route: muscle." There were no orders for an opioid (which is an indication for use of Naloxone in an emergency) and no evidence that the nurse sought clarification from the physician to determine if Naloxone was indeed indicated and if so, obtain appropriate and accurate administration orders. The medication profile also contained an order for Tylenol 325mg, two (2) (tablets) every 6 hours by mouth. There was no evidence indicating that the nurse sought clarification from the physician to determine if the Tylenol was to be taken as needed (prn) instead of routinely. An interview conducted with the administrator on November 24, 2025 starting at 3:30 PM confirmed the above findings.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on a review of clinical records (CR), home health agency (HHA) policies, home visits/observations, and an interview with the administrator, the HHA failed to assure that the plan of treatment included the visit frequency and duration for occupational and physical therapy for four (4) of seven (7) CR's reviewed: CR#1, CR#2, CR#6 and CF#7, and included accurate and complete medication orders for five (5) of seven (7) CR’s reviewed: CR#2, CR#3, CR#4, CR#5, and CR#7. Findings include: The HHA's Policy Establishment of the Plan of Care, Policy No. 3-012.1 reviewed on October 2, 2025 at approximately 1:45 PM reads in part, "...Regardless of the format used, information reported on the plan of care will include but not be limited to the following....Orders for services and treatments/interventions including frequency and duration of visits….and medications." The HHA's Policy Occupational Therapy Service, Policy No.3-027.1 reviewed on October 2, 2025 at approximately 2:00 PM states in part, "Information obtained during the initial assessment will be used to assist the physician to develop the plan of care specifying treatment modalities, frequency, and duration..." The HHA's Policy Physical Therapy Service, Policy No. 3-026.1 reviewed on October 2, 2025 at approximately 2:05 PM reads in part, "Information obtained during the initial assessment will be used to assist the physician to develop the plan of care specifying treatment modalities, frequency, and duration..." The HHA's Policy Medical Supervision, Policy No. 3-010.1 reviewed on October 2, 2025 at approximately 2:10 PM states in part, "The physician responsible for medical supervision will establish and sign a plan of care that, at minimum, specifies....treatments/interventions including frequency and duration of visits." Home Visits/Observations were conducted for three (3) patients: CR#2, CR#3, and CR#5 on November 24, 2025 from 10:00 AM to 12:15 PM. A review of CR's was conducted on September 30, 2025 starting at 2:02 PM, and again on October 2, 2025 starting at 9:27 AM and November 24, 2025 starting at 9:10 AM. The start of care (SOC) and Certification Period (CP) are indicated below. CR#1 SOC 07/02/2025, CP 07/02/2025 to 08/30/2025 found that the plan of care (POC) included physician orders as follows: Occupational Therapy (OT) Evaluate and treat patient for ambulatory dysfunction. The patient was treated by OT on the following dates (2025): 7/8, 7/10, 7/15, 7/18, 7/22, 7/24, 7/29, 7/31, 8/5, 8/7, 8/12, 8/14, 8/19, 8/21, 8/26 and 8/28. Subsequent to the initial orders to evaluate and treat the patient, there were no physician orders to indicate the frequency or duration of occupational therapy visits. CR#2 SOC 07/14/2025, CP 07/14/2025 to 09/11/2025 found that the POC included physician orders as follows: OT Evaluate and treat patient for ambulatory dysfunction. The patient was treated by OT on the following dates (2025): 7/16, 7/18, 7/21, 7/25, 7/29, 7/31, 8/5, 8/7, 8/12, 8/14, 8/19, 8/21, 8/26, 8/28, 9/2, 9/4, 9/9, and 9/11. Subsequent to the initial orders to evaluate and treat the patient, there were no physician orders to indicate the frequency or duration of occupational therapy visits. A review of the POC found medication orders that read, “Lantus Insulin, Inject 30 units at ‘I,’ Route Subcutaneous (Subcut).” There was no order clarification regarding the meaning of ‘I,’ nor when the Lantus insulin was to be administered, i.e., morning, evening or night. The medication profile contained the same information as the physician order. Further, CR#2’s parent, who was administering the Lantus insulin to the patient, stated during the home visit that s/he was administering 60 units of Lantus insulin to CR#2 at night. The POC included medication orders that read, “Regular Insulin, 10 units ‘with,’ Route: Subcut. Comments: Breakfast” and “Regular Insulin, 10 units ‘with,” Route Subcut. Comments: Dinner.” There was no clarification to the insulin order regarding the meaning of the word ‘with’ and there were no parameters ordered for when the insulin should be held based on blood glucose levels. The medication profile contained the same information as the physician’s order. A home visit/observation conducted on 11/24/2025 at approximately 11:00 AM revealed that the patient was documenting and monitoring blood glucose levels via the FreeStyle Libre system, a continuous glucose monitoring (CGM) system applied to the upper arm which streams glucose readings automatically to a smartphone so that glucose levels can be monitored at any time with a quick glance at the smartphone. CR#3 SOC 09/11/2025, CP 09/11/2025 to 11/09/2025 found that the POC contained a medication order for "Acetaminophen (Tylenol) 500 mg (milligrams), 1 tablet, 3 times a day by mouth." There was no indication for use of the Tylenol nor clarification from the physician indicating if the order was intended to be as needed (prn) instead of routine. The medication profile contained the same information as the physician’s order. A home visit/observation conducted 11/25/2025 at approximately 10:00 AM revealed that the patient was not routinely taking Tylenol. CR#4 SOC 08/18/2025, CP 08/18/2025 to 10/16/2025 found that the POC contained a medication order for Tylenol with frequency noted as “see instruction.” There were no instructions evident nor was the frequency or indication for use present. The medication profile contained the same information as the physician’s order. CR#5 SOC 06/13/2025, CP 08/12/2025 to 10/10/2025 found that the POC contained a medication order for Naloxone, Dosage: 1ml, Frequency: inject every 3 min, Route: IM.” There was no clarification regarding the indications for Naloxone (which is used for opioid overdose in an emergency) nor the method by which it should be administered, if indicated. The medication profile contained the same information as the physician’s orders. Further review of the orders and medication profile found that there were no medication orders for an opioid which is an indication for use of Naloxone. A home visit/observation conducted on 11/24/2025 at approximately 11:45 AM revealed that the patient was not taking an opioid. CR#6 SOC 02/05/2025, CP 04/06/2025 to 06/04/2025 found that the POC included physician orders as follows: Physical Therapy (PT) Evaluate and treat patient for ambulatory dysfunction, and OT Evaluate and treat patients for ambulatory dysfunction. The patient was treated by PT on the following dates (2025) 4/7, 4/14, 4/23, 4/30, 5/7, 5/14, 5/21, 5/28, and 6/4. The patient was treated by OT on the following dates (2025): 4/9, 4/12, 4/16, 4/19, 4/23, 4/26, 4/30, 5/3, 5/7, 5/10, 5/14, 5/17, 5/21, 5/24, 5/28, and 5/31. Subsequent to the initial orders to evaluate and treat the patient, there were no physician orders to indicate the frequency or duration of either physical therapy or occupational therapy visits. CR#7 SOC 02/28/2025, CP 06/28/2025 to 08/26/2025 found that the POC included physician orders as follows: Continue to evaluate and treatment patient for ambulatory dysfunction. The patient was treated by OT on the following dates (2025): 7/1, 7/3, 7/8, 7/10, 7/15, 7/17, 7/22, 7/24, 7/28, and 8/1. Subsequent to the initial orders to evaluate and treat the patient, there were no physician orders to indicate the frequency or duration of occupational therapy visits. A review of the POC found a medication order that read, “Naloxone, 0.4mg/ml only 2 as need; Frequency: 1 as needed; Route: muscle. There was no clarification regarding the indications for Naloxone (which is used for opioid overdose in an emergency), and if indicated, the method by which it should be administered. The medication profile contained the same information as the physician’s orders. Further review of the orders and medication profile found that there were no medication orders for an opioid which is an indication for use of Naloxone. The POC also included an order for Tylenol 325mg, two (2) every 6 hours by mouth. There was no evidence that the order was clarified to indicate if the Tylenol was to be taken as needed (prn) instead of routinely. An interview conducted with the administrator on November 24, 2025 starting at 3:30 PM confirmed the above findings.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on a review of personnel files (PF), home health agency (HHA) policy, and an interview with the administrator, the HHA failed to assure that a criminal background check was completed upon hire for one (1) of seven (7) PF's reviewed: PF#2. Findings include: The HHA's Policy Criminal History Record Check Policy No.4-005.1 reviewed on October 2, 2025 at approximately 3 PM reads in part, "The agency will complete a criminal history check on all agency employed personnel and contracted professional staff in any position classification. The individual will give signed authorization for the agency to conduct the criminal record check. The administrator will immediately request a criminal background record report directly from the Pennsylvania State Police." A review of PF's was conducted on September 30, 2025 starting at approximately 11:05 AM. The date of hire (DOH) is indicated below. PF#2 DOH 11/13/2023 contained a Pennsylvania Access to Criminal History (PATCH) report that was dated 01/03/2025, fourteen (14) months after the DOH. There was no evidence that a criminal history report was obtained at the time of hire. An interview with the administrator on November 24, 2025 starting at 3:30 PM confirmed the above findings.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on a review of clinical records (CR), home health agency (HHA) policy, and an interview with the administrator, the HHA failed to provide evidence that the plan of care (POC) was signed by the physician within thirty (30) days of the receipt of the physician orders for five (5) of seven (7) CR's reviewed: CR#1, CR#2, CR#5, CR#6 and CR#7. The HHA's Policy Medical Supervision, Policy No. 3-010.1 reviewed on October 2, 2025 at approximately 2:10 PM states in part, "The physician responsible for medical supervision will establish and sign a plan of care... " A review of CR's was conducted on September 30, 2025 starting at approximately 2:02 PM, and again on October 2, 2025 starting at approximately 9:27 AM and November 24, 2025 starting at 9:10 AM. The start of care (SOC) and Certification Period (CP) are indicated below: CR#1 SOC 07/02/2025, CP 07/02/2025 to 08/30/2025 contained a plan of care (POC) that was not signed by the physician until 10/01/2025, three (3) months after the SOC. CR#2 SOC 07/14/2025, CP 07/14/2025 to 09/11/2025 contained a POC that was not signed by the physician until 10/01/2025, almost 3 months after the SOC. CR#5 SOC 06/13/2025, CP 08/12/2025 to 10/10/2025 contained a POC that was neither signed nor dated by the physician. CR#6 SOC 02/05/2025, CP 04/06/2025 to 06/04/2025 contained a POC that was neither signed nor dated by the physician. CR#7 SOC 02/28/2025, CP 06/28/2025 to 08/26/2025 contained a POC that was not signed by the physician until 10/01/2025, 3 months after the start of the CP. An interview with the administrator on November 24, 2025 starting at 3:30 PM confirmed the above 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 a review of clinical records (CR), home health agency (HHA) policy, and an interview with the administrator, the HHA failed to provide evidence that a discharge summary was completed and sent to the physician for one (1) of seven (7) CR's reviewed: CR#6. Findings include: The HHA's Policy Discharge Summary Policy No.3-053.1 reviewed on October 2, 2025 at 2:30 PM reads in part, "A discharge summary will be completed for each client discharged from the agency. A discharge summary will be sent to the physician>' A review of CR's was conducted on September 30, 2025 starting at 2:02 PM, and again on October 2, 2025 starting at 9:27 AM and November 24, 2025 at 9:10 AM. The start of care (SOC) and Discharge Date (DD) are indicated below. CR#6 SOC 02/05/2025, DD 06/04/2025 did not contain evidence that a discharge summary was completed nor sent to the physician. An interview with the administrator conducted on November 24, 2025 starting at 3:30 PM confirmed the above findings.

Based on the findings of an unannounced onsite Medicare recertification survey conducted October 24, 2022 through October 27, 2022, Divine Health Care Services was found not to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on a review of personnel files (PF), agency policies, and an interview with the administrator, the agency failed to document emergency preparedness training every two (2) years for three (3) of six (6) PF’s reviewed: PF#1, PF#2, and PF#4. On October 26, 2022 at approximately 12:30 PM, a review of the following agency policy took place. Policy #S-4.0 Emergency Preparedness/Disaster Plan. The policy states on page 7, section 10, “Divine Health Care Services’ training program shall include all of the following: ….emergency preparedness training at least annually.” A review of personnel files was conducted on October 24, 2022 starting at approximately 12:00 PM The date of hire (DOH) is indicated below. PF#1 DOH 02/09/2006 did not contain any evidence of emergency preparedness training since 2018. PF#2 DOH 09/27/2018 did not contain any evidence of emergency preparedness training since 2019. PF#4 DOH 01/29/2016 did not contain any evidence of emergency preparedness training. The above findings were confirmed in an interview with the administrator conducted on October 27, 2022 starting at 12:00 PM

Based on the findings of an unannounced onsite Medicare recertification survey conducted on October 24, 2022 through October 27, 2022, Divine Health Care Services was found not to be in compliance with the following requirement of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on a review of clinical records (CR), agency policy and an interview with the administrator, the agency failed to ensure that the discharge summary was completed at the time of discharge for one (1) of two (2) discharge records reviewed: CR#6. On October 25, 2022 at approximately 2:00 PM, a review of the following agency policy took place. Policy No. 3-053.1 Discharge Summary states, “A discharge summary will be completed for each client discharged from the agency;” “When a client is discharged from home health services, the registered nurse or therapist will complete a discharge summary;” “The original discharge summary will be filed in the clinical record.” A review of CR was conducted on October 24, 2022 starting at approximately 2:00 PM, October 25, 2022 starting at 9:00 AM, and again on October 26, 2022 starting at approximately 9:30 AM. The start of care (SOC) and Certification Period (CP) are indicated below. CR# 6 SOC 12/10/2021 and CP 02/08/2022 to 04/08/2022 noted that the patient’s last home health visit occurred on 04/06/2022 at which time the patient was discharged. The clinical record did not contain evidence that a discharge summary was completed at the time of discharge. There was no discharge assessment or summary contained in the clinical record. The above findings were confirmed in an interview conducted with the administrator on October 27, 2022 starting at 12:15 PM.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on a review of clinical records (CR), agency policies, and an interview with the administrator, the agency failed to provide care according to the Home Health Certification and Plan of Treatment (POC) for four (4) of seven (7) CR reviewed: CR#1, CR#2, CR#3, and CR#5. On October 24, 2022 at approximately 12:00 PM and October 25, 2022 at approximately 2:00 PM, a review of the following agency policies took place: Policy No. 3-006.1 Initiation of Services states, “When other therapeutic services – physical therapy….are ordered and needed, the supervisor will initiate the referral process to the appropriate discipline. It is expected that the therapist will complete the visit within forty-eight (48) hours to two business days after receipt of the referral;” Policy No. 3-014.1 Coordination of Services states, “The physician is promptly notified of any change in the patient’s condition that suggests the need to alter the plan of care;” policy No. 3-012-1 states, “The physician is promptly notified of any change in the patient’s condition which suggests the need to alter the plan of care. Additions or changes in the plan of care are ordered by the attending physician and confirmed in writing;” Policy No.3-034.1 Medication Profile states, “The clinical record will contain a current accurate Medication Profile.” In an interview conducted with the administrator on October 24, 2022 at approximately 2:15 PM, the administrator stated that CR#1 refused physical therapy services. During the clinical home visit conducted on Tuesday, October 25, 2022 at 10:15 AM for CR#3, it was observed that the nurse checked the patient’s blood glucose level, administered Toujeo Solostar (an injectable medication used to reduce blood glucose levels) and stated that it had been quite some time since the patient’s blood glucose level required administration of Toujeo Solostar. though the Medication Profile contained an order for daily administration of Toujeo Solostar. It was further observed that no other type of insulin was administered to the patient though the medication profile contained an order for Bydureon Bcise (an injectable medication used to reduce blood glucose levels) to be administered once per week on Tuesday’s. In an interview conducted with the administrator on October 26, 2022 at approximately 10:00 AM, and again on October 27, 2022 at approximately 12:00 PM, the administrator confirmed that CR#3 had received Toujeo Solostar (an injectable medication used to reduce blood glucose levels) during the clinical home visit on October 25, 2022 and that the Toujeo Solostar administration was based on protocols or standing orders. The administrator further stated that Bydureon Bcise (an injectable medication used to reduce blood glucose) noted on the medication profile to be administered once per week on Tuesday’s was to be administered once per week on Wednesday’s instead of Tuesday’s. There was no physician’s order to confirm the change in the day of the administration, nor was there an updated medication profile to state that administration of Bydureon Bcise should occur on Wednesday, instead of Tuesday. The administrator confirmed that the nurses’ document blood glucose results and medication administration on the skilled nursing visit flowsheet. A review of CR was conducted on October 24, 2022 starting at approximately 2:00 PM, October 25, 2022 starting at 9:00 AM, and again on October 26, 2022 starting at approximately 9:30 AM. The start of care (SOC) and Certification Period (CP) are indicated below. CR #1 SOC 07/11/2022 and CP 07/11/2022 to 09/08/2022 contained orders via Form CMS-485 Home Health Certification and Plan of Care (POC) for the following: Skilled Nursing (SN) one (1) to three (3) times per week for nine (9) weeks, and for physical therapy to evaluate and teach therapeutic exercises and functional mobility. There were no skilled nursing visits the week of July 24, there was no evidence of a physical therapy evaluation, there was no documentation that the physician was informed of the missed visit nor the patient’s refusal of physical therapy services, and there was no revision to the CMS 485 POC nor evidence of a physician's order to cancel the physical therapy evaluation and treatment. CR#2 SOC 05/19/2022 and CP 09/16/2022 to 11/14/2022 contained orders via Form CMS-485 Home Health Certification and Plan of Care (POC) for skilled nursing visits daily for twenty-one (21) days, then three (3) times per week for six (6) weeks. For the twenty-one days beginning 09/16/2022 and ending 10/06/2022, there were ten (10) missed visits: 9/23/22, 9/24/22, 9/25/22, 9/26/22, 9/28/22, 9/30/22, 10/1/22, 10/2/22, 10/3/22 and 10/5/22. For the time frame from 10/7/2022 to 10/25/2022, there was one (1) missed visit which should have occurred on 10/7/22 or 10/8/22, one (1) missed visit the week of 10/9/22, and one (1) missed visit the week of 10/16/22. There was no documentation pertaining to the missed visits nor was documentation evident that the physician was notified of the missed visits. CR#3 SOC 07/14/2022 and CP 07/14/2022 to 09/11/2022 contained orders via Form CMS-485 Home Health Certification and Plan of Care (POC) for skilled nursing visits daily for nine (9) weeks. There were a total of ten missed visits during the certification period on the following dates: 7/15/22, 7/16/22, 7/17/22, 7/19/22, 7/20/22, 7/21/22, 7/22/22, 7/23/22, 7/24/22, and 7/25/22. There was no documentation pertaining to the missed visits nor was documentation evident to support that the physician was notified of the missed visits. The Medication Profile contained the following orders: Toujeo Solostar 110 units to be injected subcutaneously (beneath the skin) once daily in the morning. A review of the skilled nursing flowsheet and notes pertaining to blood glucose (BG) testing results and Toujeo Solostar administration found that the Toujeo Solostar was not administered on a daily basis per the CMS-485 Home Health Certification and Plan of Care Order or as per the medication profile, nor was there evidence in the clinical record, on the medication profile or via a physician’s order that Toujeo Solostar was to be administered based on a protocol or standing orders. There was also no evidence of communication to the physician regarding blood glucose results except for one day during the certification period. The skilled nursing notes revealed the following: 07/26/2022 BG 244. No documentation of insulin administration 07/30/2022 No documentation of blood glucose level or insulin administration 08/02/2022 BG 217 No documentation of insulin administration 08/08/2022 BG 123 No documentation of insulin administration 08/09/2022 BG 164 No documentation of insulin administration 08/10/2022 BG 206 No documentation of insulin administration 09/01/2022 BG 137 No documentation of insulin administration 09/02/2022 BG 93 No documentation of insulin administration 09/03/2022 BG 123 No documentation of insulin administration 09/04/2022 BG 123 No documentation of insulin administration 09/05/2022 BG 144 No documentation of insulin administration 09/06/2022 BG 83 “MD was notified and ordered to hold all hypoglycemic medications for today. Repeat blood glucose test on 09/07/2022 and administer hypoglycemic medications for blood glucose above 150mg/dl.” 09/07 (Wed) BG 185 “the patient’s once a week Bydureon was injected” 09/08/2022 BG 134 No documentation of insulin administration 09/09/2022 BG 83 Discrepant information on the skilled nursing visit flowsheet. Another section of the flowsheet states BG = 134. No documentation of insulin administration 09/11/2022 BG 104 “blood glucose reading of 104, no insulin was administered” The Medication Profile also contained an order for Bydureon Bcise to be administered once per week on Tuesdays. During the clinical home visit observation on Tuesday, 10/25/2022, there was no evidence that Bydureon Bcise was administered on the prescribed day. CR#5 SOC 04/30/2022 and CP 06/29/2022 to 08/27/2022 contained orders via Form CMS-485 Home Health Certification and Plan of Care (POC) for skilled nursing visits one (1) to two (2) times per week for nine (9) weeks. There was a missed visit the week of 07/24/2022. There was no documentation pertaining to the missed visit nor was documentation evident that the physician was notified of the missed visit. An interview conducted with the administrator on October 27, 2022 starting at 12:15 PM confirmed the above findings.

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 a review of clinical records (CR), agency policies, clinical home visit observations, and an interview with the administrator, the agency failed to follow its policy pertaining to infection control for two (2) of three (3) clinical home visits conducted: CR#2 and CR#3. A review of the following agency policies took place on October 26, 2022 at approximately 10:00 AM: Policy #IC-8.0 Clinical Bag Technique states, “Select a flat secure work surface to place bag and set up work area. Use discretion and consideration when placing bag on patient’s furniture. Never place bag on floor. Place a battier (paper towels, clean newspapers or other appropriate material) on flat surface before setting bag down……Perform hand hygiene according to Standard Precautions….Remove needed items from bag and place on clean barrier,” and Policy #IC-2.0 Standard Precautions states, “Specific policies and procedures for implementation of standard infection control must be followed relative to, but not limited to, handwashing, personal protective equipment, clinical bag technique, general infection control measures appropriate for care/services provided…The standard precautions include but are not limited to the following: all staff members will be provided with paper towels, anti-microbial antiseptic hand soap and alcohol based hand cleaner to be used in patient’s home….hands and other skin surfaces should always be washed immediately before and after patient contact, after any contact with bodily fluids, and after removing gloves….Standard precautions will be followed for all patients.” An on-site clinical home visit was conducted on October 25, 2022 at 11:15 AM at the home of CR#2. The nurse was observed placing the clinical bag on the dining room table with no barrier beneath the bag. The nurse removed a plastic bag which contained various pieces of equipment (blood pressure monitor, thermometer, pulse oximeter) from the clinical bag and placed the plastic bag on the dining room table without a barrier underneath the plastic bag. After using the items in the plastic bag, the nurse cleaned the items, placed them back in the plastic bag, then placed the plastic bag into the clean clinical bag. An on-site clinical home visit was conducted on October 25, 2022 at 10:15 AM at the home of CR#3. The nurse was observed placing the clinical bag on the floor with no barrier beneath the bag. The nurse removed a plastic bag which contained various pieces of equipment (blood pressure monitor, thermometer, pulse oximeter) from the clinical bag and placed the plastic bag on an unoccupied office-type chair without a barrier underneath the plastic bag. After using the items in the plastic bag, the nurse cleaned the items, placed them back in the plastic bag, then placed the plastic bag into the clean clinical bag. The nurse was observed removing and replacing his/her gloves four (4) times without washing or sanitizing his/her hands in-between glove changes. An interview conducted with the administrator on October 27, 2022 starting at 12:15 PM confirmed the above findings.

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on a review of personnel files, agency policy and an interview with the administrator, the agency failed to ensure that the home health aide received at least twelve (12) hours of in-service training during each twelve (12) month period. One (1) of one (1) home health aide file reviewed did not meet the requirement: PF# 5. On October 24, 2022 at approximately 2:00 PM, a review of the following policy took place. Policy No. 4-012.1 states, “All home health aides (HHA) shall attend in-service education programs and maintain a record of such attendance. Ongoing education of HHA will be an agency priority under administrator. HHA’s must participate in twelve (12) hours of in-service education per year. A review of personnel files was conducted on October 24, 2022 starting at approximately 12:00 PM. The date of hire is indicated below. PF#5 DOH 08/22/2017 contained documentation of completion of eleven (11) hours of in-service education in 2020. There was no documentation of completion of twelve (12) hours of in-service training in 2021. The above findings were confirmed with the administrator in an interview conducted on October 27, 2022 starting at 12:15 PM.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on a review of personnel files (PF), agency policies and an interview with the administrator, the agency failed to demonstrate the presence of one or more of the following: criminal background check, orientation training, annual performance evaluation, tuberculosis symptom screen and risk assessment at time of hire, and annual tuberculosis education for six (6) of six (6) personnel files: PF#1, PF#2, PF#3, PF#4, PF#5, and PF#6. On October 25, 2022 at approximately 2:00 PM, a review of the following agency policies took place. Policy No. 4-005-1 Criminal History Record Check states, “the agency will complete a criminal history check on all agency employed personnel and contacted professional staff in any position classification.” Policy No. 4-006.1 Employee Certification, Registration, and/or Certification states, “ Any individual,, whether directly employed or available via a contractual arrangement, who is a member of a profession or seeks employment in a position which requires specialized education, training or prior work experience must submit evidence of the appropriate education, training, certification, work experience, registration and/or license.” Policy No. 4-013.1 states, “Agency staff receive performance appraisals after one year of employment and annually thereafter;” “Every employee receives an evaluation after twelve months of employment and annually thereafter…” In May 2019, the Centers for Disease Control (CDC) updated its recommendation for TB testing of health care personnel. The CDC guidelines state that all Health Care Workers (HCW) should receive 1) baseline tuberculosis screening upon hire using a two-step tuberculin skin test (TST) or a single blood assay for tuberculosis (TB) to test for infection with tuberculosis; 2) Completion of a tuberculosis symptom questionnaire, and 3) Completion of a tuberculosis risk assessment. After baseline testing for infection with tuberculosis, HCW's should receive TB screening annually. HCW's with a baseline positive or newly positive test for tuberculosis infections should receive one chest radiograph result to exclude tuberculosis disease (CDC Guidelines for Preventing Transmission of Mycobacterium Tuberculosis in Health Care Settings, 2005. Morbidity and Mortality World Report 2005, RR-17) (http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf). *Baseline (preplacement) screening and testing, in addition to the IGRA (interferon-gamma release assay) or TST, shall include a symptom screen questionnaire and an individual TB risk assessment. Serial screening and testing not routinely recommended. Annual TB education is recommended. (CDC/MMWR/May 17, 2019/Vol. 68/No. 19). A review of personnel files was conducted on October 24, 2022 starting at approximately 12:00 PM. The date of hire (DOH) is indicated below. PF #1 DOH 02/09/2006 did not contain evidence of annual performance evaluations, competency evaluations, or annual tuberculosis education in 2020 or 2021. PF#2 DOH 09/27/2018 did not contain evidence of annual performance evaluations, competency evaluations or annual tuberculosis education in 2020 or 2021. PF#3 DOH 06/17/2022 did not contain any evidence of completion of a tuberculosis symptom screen questionnaire or tuberculosis risk assessment upon hire. PF#4 DOH 01/29/2016 did not contain evidence of completion of an orientation upon hire, nor any evidence of competency assessments, performance evaluations or annual tuberculosis education in 2020 or 2021. PF#5 DOH 08/22/2017 did not contain evidence of completion of a performance evaluation in 2021, nor any evidence of annual tuberculosis education in 2020 or 2021. PF#6 DOH 02/22/2022 did not contain evidence of completion of a criminal background check nor completion of a tuberculosis symptom screen questionnaire or tuberculosis risk assessment upon hire. The above findings were confirmed in an interview with the administrator conducted on October 27, 2022 starting at 12:15 PM.