Every finding on record at Blue Hills Therapeutics Inc

The Agency must meet the §484.102 Emergency Preparedness requirements for a Home Health Agency. An Emergency Preparedness Survey was conducted for Blue Hills Therapeutics Inc., located at 290 MA-130 Building 1 unit 11-13, Forestdale, MA 02644 on February 25, 2025, and February 26, 2025. Based on observation, interview, and document review, it was determined that they were in compliance with these requirements. No deficiencies were cited.

A recertification survey was conducted at Blue Hills Therapeutics Inc., located at 290 MA-130 #816, East Forestdale, MA 2644, on February 25, 2025, and February 26, 2025, to determine compliance with the 42 CFR Part 488 requirements for Home Health Agencies. As a result of this survey, it was determined the agency was not in compliance with these requirements. Deficiencies were cited.

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 document review and staff interview, the agency failed to ensure Outcome and Assessment Information Set (OASIS) assessments were transmitted to Centers for Medicare and Medicaid Services (CMS) within 30 days of completing the assessment of the beneficiary, as required. Review of the agency’s Home Health Agency Error Summary Report dated January 1, 2024, through December 31, 2024, indicated that 367 of 598 OASIS Assessments processed were submitted more than 30 days after completion. During an interview on 2/25/25 at 10:00 A.M., the Administrator said that the data on the Error Summary Report was correct, and those 367 OASIS Assessments were submitted late. She said that she did not have access for IQIES/HARP right away last year when she took over as the Facility Administrator after the previous Administrator left.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on clinical record review, interview, and policy review, the agency failed to ensure that clinical notes were completed timely for 2 Patients (#3 and #4), out of a total sample of 7 patients. Findings include: Review of the Agency's policy entitled, Documentation Policy, dated April 2013, indicated the following: *Purpose: To provide guidelines for the timely receipt of visit notes and Outcome and Assessment Information Set (OASIS) documentation. *All field staff will complete visit note documentation within 2 days (48 hours) of the visit. Visits must be signed by the clinician who completed the care within 48 hours of the date of the visit. 1. For Patient #3, the Agency failed to ensure that nursing staff signed and dated their visit notes within 48 hours of the visit. Patient #3 was admitted to the Agency in December 2024 with a diagnosis of Diabetes Mellites, requiring daily insulin injections. Review of the physician orders Home Health Certification Plan of Care (POC), dated 12/19/24 through 2/16/25, and 2/17/25 through 4/17/25, included the following orders: -Effective 12/19/24 - 1 skilled nurse (SN) visit 3 times a week for 1 week, then 7 times a week for 7 weeks. -Effective 2/17/25 - 1 SN visit 6 times a week for 1 week, then 7 times a week for 7 weeks. Review of the clinical record indicated the following: *SN visit made on 12/29/24, however it was not signed and dated until 1/6/25. *SN visit made on 1/3/25, however it was not signed and dated until 1/9/25. *SN visits made on 1/10/25, 1/11/25, 1/17/25, 1/19/25, 1/24/25, 1/26/25, however they were not signed and dated until 1/30/25. *SN visits made on 1/25/25, and 1/31/25, however they were not signed and dated until 2/3/25. *SN visits made on 2/7/25 and 2/8/25, however they were not signed and dated until 2/13/25. *SN visits made on 2/20/25 and 2/21/25, however they were never signed or dated. 2. For Patient #4, the Agency failed to ensure that nursing staff signed and dated their visit notes within 48 hours of the visit. Patient #4 was admitted to the Agency in August 2017 with a diagnosis of PTSD and Bipolar Disorder. Review of the physician orders Home Health Certification Plan of Care (POC), dated 12/30/24 through 2/28/25 included the following orders: -Effective 12/30/24 - 1 skilled nurse (SN) visit 4 times a week for 1 week, then 5 times a week for 8 weeks. Review of the clinical record indicated the following: *SN visit made on 1/3/25, however it was not signed and dated until 1/8/25. *SN visits made 1/10/25, 1/17/25, 1/24/25, however they were not signed and dated until 1/30/25. *SN visits made 1/23/25, and 1/30/25, however they were not signed and dated until 2/3/25. *SN visit was made on 2/7/25, however it was not signed and dated until 2/13/25. *SN visits made on 2/20/25, and 2/21/25, however they were never signed or dated. During an interview on 2/25/25 at 2:30 P.M., the Administrator said staff should sign and date their documentation with 48 hours of the visit.

A recertification survey was conducted at Blue Hills Therapeutics, Inc. from February 16, 2022 through February 24, 2022. At this time, the Agency was found to be in substantial compliance with the Federal Conditions of Participation for Emergency Preparedness.

A recertification survey was conducted at Blue Hills Therapeutics from February 16, 2022 through February 24, 2022. At this time, the Agency was found not to be in substantial compliance with the Federal Conditions of Participation Governing Home Health Agencies. The following standards were not met:

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 record review and staff interview, the agency failed to follow the plan of care for two Patients (HV#2 and RR#3), out of a total sample of seven patients. Findings include: 1. RR #3 was admitted to the agency on 9/11/2020 with diagnoses which included Type 2 diabetes mellitus, hyperlipidemia, hypertension, anxiety, and depressive disorder. According to the Plan of Care, the patient received SNV (skilled nursing visits) 2 x/week for medication management, insulin preparation, and assessment of the patients’ diabetes status. Record review on 2/22/2022 indicated that the patient received insulin along with other medications, twice daily that were prepared by the SN. The insulin was drawn up by the SN and administered by the patient with supervision. Record review on 2/22/2022, indicated that on the morning of 4/21/2021, the SN failed to visit the patient to provide medication management, to assess the patient’s diabetes status, and administer the patients’ insulin, in accordance with the plan of care. The administrator was interviewed on 2/22/2022 at 11:45 A.M. regarding the missed SNV on 4/21/2021. During the interview with the administrator, the administrator said that LPN #1 was scheduled to visit the patient the morning of 4/21/2021. The administrator said that she received a call from the patient on 4/21/2021 at 2:15 P.M., to inform him/her that LPN #1 failed to visit the patient as scheduled that morning. According to the communication note, written by the administrator at 2:39 P.M., the patient was told that a nurse was scheduled to visit the patient that afternoon. The patient informed the administrator that he/she still wanted his/her morning insulin. However, the administrator told him/her that the agency could not give the A.M. dose and evening dose that close together. According to the administrators’ note, the patient became irate and hung up the phone on the administrator. The 4/21/2021 communication note by the administrator indicated that she made a phone call to LPN #1, the nurse who missed the patient’s morning visit. LPN #1 explained that the visit was put on her schedule by accident. The communication note indicated that “She did not call the office to alert us to the missed visit.” The patient was not seen by the HHA (home health agency) agency as required the morning of 4/21/2021. Further interview with the administrator regarding the missed visit, indicated that another SN was not sent to visit the patient until 5:00 P.M. on 4/21/2021. As a result, the patient went approximately 24 hours from the previous visit, the evening of 4/20/21, without an assessment of his/her diabetic and health status, and without insulin and other scheduled medications. The administrator could not say why another SN was not sent immediately to the patient’s home to assess his/her diabetes status, and administer insulin and other medications, upon notification by the patient that the SN missed the scheduled morning visit on 4/21/21. Record review on 2/22/2022 indicated that the patient was visited by a SN on 4/21/2021 at 5:00 P.M. The patient was assessed by the SN to be alert and oriented to person, place, and time. A random blood sugar was obtained which was recorded as 408 mg/dl (milligrams/deciliter), and was higher than the desired range for the patient of 100 to 400 mg/dl. The SN’s note indicated that the patient denied any s/sx (signs or symptoms) of hyperglycemia. According to the SNV note, the SN did not assess any s/sx of hyperglycemia during the visit. The 4/21/2021, 5 P.M., Visit Narrative by the SN, indicated that when she arrived, the patient was screaming from the living room that he/she was coming to open the door. Patient was reportedly “very irritable.” Patient with poor hygiene, stating he/she ate already and is not waiting for her “stupid nurses” to show up. The SN prepped 14 units of Humalog (short-acting) insulin per the MD order, and the patient administered it to the abdomen without incident. The SN administered P.M. po (oral) medications per medication profile without incident. The Visit Narrative indicated that the patient was to administer po PRN (as needed) medications until next SN arrival. All remaining medications were secured in a locked box that was only accessible by the SN. The 4/22/2021 SNV at 7:29 A.M. indicated that upon arrival, the patient was reportedly alert, oriented, and in an anxious and irritated mood. The SN wrote that the patient required moderate encouragement to engage in the visit with the nurse, and redirection, as he/she continued talking over SN (about the missed visit) about the last two days. The patient verbalized that she had episodes of nausea and vomiting throughout the night. He/She verbalized feeling “sick” since the vaccine was given. He/She informed the SN that he/she had received the second dose of the Covid vaccine on Tuesday. The SN and patient discussed side effects of the vaccine and when to seek further help and the SN advised to call MD for further evaluation. The SN’s visit narrative indicated that the patient continued to talk over the nurse about how he/she had been feeling and getting the couch ready with pillows for him/her to lay down after the SNV. The patient reported not being able to “keep anything down.” The SN educated the patient on the importance of staying hydrated and having small meals to maintain adequate blood sugar levels and prevent dehydration. Reportedly, the patient did not drink water, refused any other drinks with electrolyte supplements, and continued to drink his/her diet soda. The patient assessed her blood sugar in the presence of the SN and was 428 mg/dl, above his/her high range of 400 mg/dl. The patient refused the Humalog and told the SN, “I’m not going to take it if I’m not going to eat anything, then my blood sugar will drop.” The SN educated the patient on his/her blood sugar being above the high range and the importance of bringing it down to prevent further complications. According to the SNV note, the patient continued to refuse to take the short-acting Humalog insulin but did agree to take the long-acting Lantus 36 units at that time. The patient informed the SN that he/she would accept the Humalog insulin during the evening visit if he/she felt better and was able to eat. The SN prepped the long-acting Lantus insulin, 36 units, and the patient administered it. The patient’s morning medications were prepped, administered, and taken without incident. The SN indicated that the patient was aware of when and how to contact the SN, the physician, or EMS, for increased concerns or acute change in health status. Further record review on 2/22/2021, indicated that on 4/22/2021 at 6:00 P.M., the SN documented that the patient was in the E.D. (Emergency Department) of the local hospital for DKA. A missed visit note was generated by LPN #1 for the hospitalized patient which noted, “Put on wrong schedule by accident DON aware.” Further record review indicated that the patient was transferred to a Boston area hospital for further management of DKA. The hospital record indicated that the patient was found to have a critically high blood sugar of 535 mg/dl (normal fasting glucose: 80-130 mg/dl), was admitted to the ICU (intensive care unit) and placed on a continuous, intravenous, insulin drip at 3 units/hour. The patient’s A1C ( a test for diabetes) was high at 10.5 (Normal The SN failed to complete a visit to the patient which resulted in the patient not receiving a diabetic assessment, not receiving morning insulin or other medications ordered per the plan of care. The patient was hospitalized and treated for DKA (diabetic ketoacidosis), a serious complication of diabetes caused by the body not having enough insulin. For Patient HV#2, the agency failed to provide daily visits as ordered by the physician. 2. Patient Hv#2 was admitted on 7/1/2020 with diagnosis including bi-polar disorder and panic disorder. The Patient certification period from 12/23/21 through 2/20/22 had a physicians order to receive skilled nurse visits twice daily for 8 weeks. Record review revealed multiple missing skilled visits, including the following dates: 2/1/22, 2/2/22, 2/3/22,2/7/22,2/8/22,2/9/22,2/10/22 and 2/14/22. In addition missed visits were noted 1/1/22, 1/2/22,1/3/22,1/4/22, 1/7/22,1/9/22, 1/10/22,1/24/22,1/25/22,1/26/22,1/27/22 and 1/31/22. During an interview with the Administrator on 2/24/22 at 1:00 P.M., she/he said that they had identified an issue with the staff member regarding submitting progress notes and were working with she/ he to resolve this.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure that all staff are in compliance with COVID-19 vaccination requirements. Findings include: For nine active staff members, the agency granted either a religious exemption or a medical exemption from receiving the COVID-19 vaccination dosage series. The agency's policy titled Vaccination, Testing, and Face Covering, dated 11/08/2021, indicated that exemptions for religious and medical reasons would be considered and granted. Page 5 of this policy addressed the COVID-19 Testing. It stated, "All employees who are not fully vaccinated will be required to comply with this policy for testing. Employees who report to the workplace at least once every seven days: A) must be tested for COVID- 19 once every seven days; and must provide documentation of the most recent COVID-19 test result to the supervisor no later than the seventh day following the date on which the employee last provided the test." The agency was unable to provide the survey team with any documentation of testing for all the unvaccinated employees. During an interview on 2/24/2022 at 3:45 P.M., the agency administrator said the agency did not have any test results for these unvaccinated staff who were active employees.

Participate in the HHA's QAPI program; CFR(s): 484.75(b)(8) Participation in the HHA's QAPI program; and This ELEMENT is not met as evidenced by: Based on record review, document review, and staff interview, the Home Health Agency (HHA) failed to implement a Quality Assurance/Quality Improvement analysis following a missed skilled nursing visit (SNV) involving one patient (RR #3), out of a total of seven sampled records, that resulted in the patient being hospitalized with diabetic ketoacidosis (DKA) (serious complication of diabetes that occurs when your body produces high levels of blood acids called ketones); no QAPI meetings were held since May 2019. Findings include: RR #3 was admitted to the HHA (home health agency) on 9/11/2020 with diagnoses which included Type 2 diabetes mellitus, hyperlipidemia, hypertension, anxiety, and depressive disorder. According to the Plan of Care, the patient received SNV (skilled nursing visits) 2 x/week for medication management, insulin preparation, and assessment of the patients’ diabetes status. Record review on 2/22/2022 indicated that the patient received insulin along with other medications, twice daily that were prepared by the SN. The insulin was drawn up by the SN and administered by the patient with supervision. Record review on 2/22/2022, indicated that on the morning of 4/21/2021, the SN failed to visit the patient to provide medication management, to assess the patient’s diabetes status, and administer the patients’ insulin, in accordance with the plan of care. Record review on 2/22/2022, indicated that on the morning of 4/21/2021, the SN failed to visit the patient to provide medication management, to assess the patient’s diabetes status, and administer the patients’ insulin, in accordance with the plan of care. During interview with the administrator on 2/22/2022 at 11:45 A.M., regarding the missed SNV on 4/21/2021, the administrator said that LPN #1 was scheduled to visit the patient the morning of 4/21/2021, failed to do so, and did not contact the HHA to explain the reason for the missed visit. The administrator said that she did not learn of the missed visit until she received a call from the patient on 4/21/2021 at 2:15 P.M., who informed the administrator that LPN #1 did not show up that morning as scheduled. According to the communication note written by the administrator on 4/21/2021 at 2:39 P.M., the patient was informed that a nurse was scheduled to visit the patient that afternoon. The patient informed the administrator that he/she still wanted his/her morning insulin. However, the administrator told him/her that the agency could not give the A.M. dose and evening doses that close together. According to the administrators’ note, the patient became irate and hung up the phone on the administrator. The communication note, written by the administrator on 4/21/2021 2:39 P.M. after she received a call from the patient about the missed visit, indicated that she called and spoke to LPN #1, the nurse who missed the visit to the patient that morning. LPN #1 explained that the visit was put on her schedule by accident. The communication note by the administrator indicated that “She did not call the office to alert us to the missed visit.” The surveyor requested LPN #1’s schedule of visits for 4/21/21 from the administrator. LPN #’1’s schedule clearly indicated that the patient was to be seen by LPN #1 the morning of 4/21/2021. The administrator said that she did not know why LPN #1 failed to conduct the SN visit or why she did not communicate to the agency that she had not visited the patient. The surveyor questioned the administrator as to why a SN was not sent immediately to the patient’s home to assess the patient’s diabetic status and assess the need for insulin-if ordered by the physician. The administrator said that she did not consider sending a SN to assess the patient at 2:15 P.M. when alerted of the missed visit, because a SN was already scheduled to visit the patient later that evening. The administrator also said that an earlier visit to the patient to assess her diabetes status may have been beneficial. A SNV was made on 4/21/2021 at 5:00 P.M. The SN note indicated that the patient was “very irritable,” stating that he/she had eaten already and “is not waiting for his/her stupid nurse to show up.” The SN’s Visit Narrative for the visit indicated that the SN cued the patient to obtain his/her blood glucose (BG-408 mg/dl, normal fasting 80-130 mg/dl), prepped 14 units of Humalog, per the physician’s order, which the patient administered to the abdomen. The SN note indicated that the patient was given his/her evening medications, and the patient denied signs and symptoms of hypo/hyperglycemia. Further record review on 2/22/2022, indicated that at the morning visit on 4/22/2021, the patient complained of not feeling well since receiving his/her Covid vaccine a few days earlier and was “unable to keep anything down.” The note by the administrator indicated that the patient refused to drink water and continued to drink diet soda. The patient’s blood sugar was 428, he/she refused his/her Humalog insulin as he/she felt his/her blood sugar would drop, despite the SN instructing him/her on its importance. Further record review on 2/22/2021, indicated that on 4/22/2021 at 6:00 P.M., the SN documented that the patient was in the E.D. (Emergency Department) of the local community hospital for DKA (diabetic ketoacidosis). He/She was transferred to a Boston area hospital later that day. According to scientific literature from the Mayo Clinic, Diabetic ketoacidosis is a serious complication of diabetes that occurs when your body produces high levels of blood acids called ketones. Insulin normally plays a key role in helping sugar (glucose) — a major source of energy for your muscles and other tissues — enter your cells. Without enough insulin, your body begins to break down fat as fuel. Symptoms Diabetic ketoacidosis signs and symptoms often develop quickly, sometimes within 24 hours. For some, these signs and symptoms may be the first indication of having diabetes. You may notice: -Excessive thirst -Frequent urination -Nausea and vomiting -Stomach pain -Weakness or fatigue -Shortness of breath -Fruity-scented breath -Confusion The patient was admitted 4/22/21 to a Boston area hospital, treated in the ICU (intensive care unit) for DKA with an insulin drip at 3 units/hour, with blood sugars in the 500’s. The patient’s blood sugars improved down to 240’s while on the insulin drip and the patient was discharged home on 4/25/21 with Lantus and Humalog insulin. During interview with the administrator on 2/16/2021 at 1:00 P.M., the administrator said that no investigation or RCA (root cause analysis), investigation, or Quality Assurance review had been conducted by the agency following the incident. The administrator concurred with the surveyor, that without an analysis or investigation into the cause of the missed visit, the agency was not able to ensure that measures were implemented to prevent other patients of the agency from missing SNVs in the future. 2. The agency was unable to provide the survey team any written minutes of any QAPI meetings since May 2019. During interview with the agency administrator on 2/24/22, she said the agency had not had any meetings since May 2019. During interview on 2/24/22, at 3:45 P.M., with the administrator said the agency had not had any QAPI meetings or any minutes of meetings since May 2019.