Every finding on record at Great Lakes Home Health Services, Inc

A Medicare authorized complaint investigation (94710) was conducted by the Michigan Department of Licensing and Regulatory Affairs on 1/18/23 at: Elara Caring 4664 Campus Dr., Suite 101A Kalamazoo, MI 49008

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 record review and interview, it was determined that the Agency failed to ensure the plan of care included appropriate interventions, teaching and reportable parameters for 3 (MR #1, #2, and #3) of 3 patients who required wound care for pressure ulcers, from a total of 3 sampled records reviewed, resulting in the patient not receiving needed care and services and the potential for worsening of health condition. Findings include: MR#2: This patient was admitted to home care on 8/12/21 with diagnoses of Stage 3 pressure ulcers on the right and left heel, heart disease, and chronic obstructive pulmonary disease. During record review on1/18/23, it was noted that the POC ordered the nurse to provide one visit each week for four weeks and for the "skilled trained caregiver" to perform wound care two times weekly and as needed to both the right and left heel pressure ulcers. The POC did not provide details regarding the "skilled trained caregiver". It was unclear if this term was referring to the skilled nurse or the caregiver. It was unclear if the skilled nurse was to provide wound care twice weekly or whether the task was to be split between the nurse and the caregiver. The nurse documented 3 visits dated 6/24/22, 6/28/22, and 7/7/22. On each of these once weekly visits, the nurse notes that wound care was performed by the nurse. There is no documentation to indicate that wound care was performed a second time each week as ordered in the POC. The plan of care failed to include appropriate interventions to ensure wound care was performed twice weekly. The finding was reviewed with and acknowledged by the Branch Director during an interview on 1/18/23 at 2:30 p.m. MR #3: The patient's start of care (SOC) was 8/27/22. The period of review was 12/25/22 through 1/18/23 with diagnoses that included Hypertensive Heart Disease and Pressure Ulcers bilateral Great (Big) toes. During the record review on 1/18/23 at 12:15 p.m., it was noted that the plan of care (POC) ordered Skilled Nursing (SN) to perform the following wound care: "CLEANSE WITH WOUND CLEANSER, PAT DRY WITH GAUZE, APPLY PURACHOL THEN XEROFORM CUT TO FIT WOUND BED, COVER WITH 2X2 ADHESIVE GAUZE PAD AND WRAP TOE WITH ROLL GAUZE AND THEN COBAN. MAY SECURE WITH TAPE. WOUND CARE TO BE PERFORMED BY SKILLED NURSE OR CAREGIVER 3 X WEEKLY AND AS NEEDED IF SOILED OR DISLODGED SKILLED. [sic] DISCONTINUE WOUND CARE SUPPLIES ONCE WOUND IS HEALED." The POC was void of which days the nurse or caregiver would perform wound care and void of any teaching elements that would be provided to the caregiver such as instructions on how to perform wound care procedures with acknowledgement of understanding as well as documenting and reporting any untoward signs or symptoms. During the review, it was discovered that the SN only saw the patient 1x/wk., for a total of 4 visits. Further review revealed that the SN had only performed wound care 3 times at the time of this review. Additionally, there was no documented evidence that the caregiver had performed any wound care procedures as indicated in the POC. The Agency failed to ensure the POC included all of the required elements based on the needs of the patient. These findings were reviewed with and acknowledged by the Branch Director during an interview on 1/18/23 at 3:15 p.m. MR#1: The Start of Care was dated 6/30/2022. The Plan of Care for the Certification Period 6/30/2022 to 8/28/2022 identified diagnoses of Coronary Artery Disease (CAD), Anoxic Brain Damage, Respiratory Failure with Hypoxia, Diabetes Type 2 (DM2) and Pressure Ulcer of Sacral Region. The Plan of Care included orders for Skilled Nursing (SN) to visit 1 time a week for 9 weeks with 3 PRN visits for respiratory, cardiac, GI/GU, Diabetes, Wound, TPN, Trach Complications, Falls or Injuries. The patient was also receiving Physical Therapy, Occupational Therapy, Speech Therapy, and Medical Social Work Services. The Plan of Care included the following orders: "SN for observation/assessment of lower extremities to identify changes or lesions associated with DM2 for early interventions of complication. SN to provide instruction on proper diabetic skin/foot care." "SN or trained Caregiver to provide wound care to coccyx cluster of little wounds using clean technique as follows: Cleanse wound with NS or wound cleanser, pat it dry with gauze, then apply Opti foam to wound bed. Change weekly." There was no indication of who would be performing the wound care once a week, the SN or Caregiver. "SN to assess patient's skin integrity and instruct patient/caregiver on measures to prevent pressure ulcers." On 7/5/2022 it was noted a problem with skin break down related to a condom cath. The intervention ordered by the physician was as follows: "skilled nurse or trained patient caregiver to perform wound care using aseptic technique. Cleanse with wound cleanser, pat dry with gauze, apply triad to wound bed, leave out to open air." The order failed to indicate who would be responsible for this intervention the skilled nurse or the trained patient caregiver. There was no information regarding if the trained caregiver had been trained and performed a teach-back to assure the technique the caregiver provided was correct. On 7/14/2022 it was documented an "unstageable pressure ulcer to the patient's sacrum. The physician order was as follows: "SN using clean technique to cleanse with saline and pat dry with gauze. Apply sure prep to peri wound. Apply Thera honey sheet to wound bed. Cover with border foam dressing. SN to change dressing twice a week and PRN for soilage/displacement. It was noted SN visits were increased to 4xweekx1week, and 2xweekx5weeks. However, wound measurements or description of the wound were only recorded on the wound assessment tool on 5 dates as follows: 6/30, 7/10, 7/29, 8/5, and 8/8. No further wound measurements were noted in the record to determine the status of the wound, i.e., whether the wound was improving or deteriorating. A new order was noted on 8/2/2022 as follows: "Wound to sacrum. Intervention: using clean technique, cleanse with saline and pat dry with gauze. Apply crushed flagyl to wound bed and then cover with Santyl impregnated gauze. cover with ABD pad and secure with tape. Dressing to be changed daily by skilled nurse or trained caregiver." It was noted that there was no information who was responsible for dressing the wound, the SN or trained caregiver. In addition, it was noted there were no documented measurements of the wound. It was noted that on 8/8/2022 a new stage 2 pressure sore inside the right ear included interventions for the SN or trained caregiver to clean the wound with normal saline and pat dry with gauze. Tripple antibiotic ointment was to applied daily and then left to the open air. There was no indication of who was responsible for the wound care, the SN or trained caregiver. These findings were reviewed with and acknowledged by the Branch Director on 1/18/2022 at 3:15 p.m.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to ensure that services were provided as ordered and in accordance with the physician's orders for 2 (MR's #3, #2) of 3 patients who required wound care for treatment of pressure ulcers, from a total of 3 sampled records reviewed, resulting in the potential for worsening of wounds and poor patient outcomes. Findings include: MR#2: This patient was admitted to home care on 8/12/21 with diagnoses of Stage 3 pressure ulcers on the right and left heel, heart disease, and chronic obstructive pulmonary disease. During record review on1/18/23, it was noted that the POC ordered the nurse to provide one visit each week for four weeks and for the "skilled trained caregiver" to perform wound care two times weekly and as needed to both the right and left heel pressure ulcers. The nurse documented 3 visits dated 6/24/22, 6/28/22, and 7/7/22. On each of these once weekly visits, the nurse notes that wound care was performed by the nurse. There is no documentation to indicate that wound care was performed a second time each week (either by the nurse or the caregiver) as ordered in the POC. The finding was reviewed with and acknowledged by the Branch Director during an interview on 1/18/23 at 2:30 p.m. MR #3: The patient's start of care (SOC) was 8/27/22. The period of review was 12/25/22 through 1/18/23 with diagnoses that included Hypertensive Heart Disease and Pressure Ulcers bilateral Great (Big) toes. During the record review on 1/18/23 at 12:15 p.m., it was noted that the plan of care (POC) ordered Skilled Nursing (SN) to perform the following wound care: "CLEANSE WITH WOUND CLEANSER, PAT DRY WITH GAUZE, APPLY PURACHOL THEN XEROFORM CUT TO FIT WOUND BED, COVER WITH 2X2 ADHESIVE GAUZE PAD AND WRAP TOE WITH ROLL GAUZE AND THEN COBAN. MAY SECURE WITH TAPE. WOUND CARE TO BE PERFORMED BY SKILLED NURSE OR CAREGIVER 3 X WEEKLY AND AS NEEDED IF SOILED OR DISLODGED SKILLED. DISCONTINUE WOUND CARE SUPPLIES ONCE WOUND IS HEALED [sic]." During the review, it was discovered that the SN only saw the patient 1x/wk., for a total of 4 visits. Further review revealed that the SN had only performed wound care 3 times at the time of this review. Additionally, there was no documented evidence that the caregiver had performed any wound care procedures as indicated in the POC. The Agency failed to ensure the patient’s wound dressings were changed 3x/wk. as ordered. These findings were reviewed with and acknowledged by the Branch Director during an interview on 1/18/23 at 3:30 p.m., who reported, "We haven't been making sure the wound care is documented or even performed by the caregiver."

On 5/13/21, the Michigan Department of Licensing and Regulatory Affairs conducted a Medicare authorized complaint investigation for complaint MI00119325 along with a focused infection control survey at: Elara Caring 1011 South US-27 Saint Johns, MI 48879 23Q7274004 The parent office: is located at: 900 Cooper Street Jackson, MI 49202 At the time of the survey, the agency has 7 branch offices located at:: 730 Riverside Avenue Adrian, MI 49221 23Q7274001 3100 West Rd., Bldg 2, Suite 110 East Lansing, MI 48823 23Q7274003 1011 South US-27, Suite A Saint Johns, MI 48879 23Q7274004 8273 W. Grand River Rd., Suite 110 Brighton, MI 48114 23Q7274005 630 Kenmoor Ave., Suite 200 Grand Rapids, MI 49546 23Q7274007 4664 Campus Drive., Suite 101 Kalamazoo, MI 49008 23Q7274002 20702 Hall Road Clinton Township, MI 48038 23Q7274008 Records reviewed: 4 records without home visits. The following condition level deficiency was identified during the investigation: 42 CFR §484.60 Care planning, coordination of services, and quality of care. As a result of the Condition level noncompliance on 5/13/21, the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3). The allegations were substantiated.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician was notified of changes in the patient's condition in 1 of 1 record reviewed (MR#2), of a total of 4 records reviewed, in which the patient's colostomy supplies were depleted and feces was allowed to drain into an open abdominal wound, resulting in a poor patient outcome (hospitalization) for this one patient (See G590); failed to ensure professional staff communicated with all of the physicians involved in the patient's colostomy and wound care provided in 1 of 1 record reviewed (MR#2) (See G602); and failed to ensure staff coordinated the provision of colostomy care for 1 of 1 record reviewed (MR#2) in which the patient failed to receive adequate colostomy supplies (See G608). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care and the patient being admitted to hospital for wound infection. Findings include: 1. The professional staff failed to notify the physician that the patient had no colostomy supplies to contain his feces. (See G590). 2. Failed to include all the physicians involved in the plan of care, so staff could notify the surgeon as needed. (See G602). 3. Staff failed to coordinate the patient's colostomy care to provide solutions to lack of supplies, patient changing using supplies to quickly, and ideas to solve these problems. (See G608).

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician was notified of changes in the patient's condition in 1 of 1 record reviewed (MR#2) in which the patient's colostomy supplies were depleted and feces was allowed to drain into an open abdominal wound, resulting in a poor patient outcome (hospitalization) for this one patient. Findings include: **Agency policy "Plan of Care" (dated 7/15/20) stated, "Home care services are furnished under the supervision and direction of the client's physician or allowed practitioner...The plan will be consistently reviewed to ensure that client needs are met...Professional staff shall promptly alert the physician...that suggest a need to alter the Plan of Care." MR#2: This autistic 32-year-old male patient was admitted to home care on 3/31/21 with diagnoses of aftercare following digestive surgery, acute appendicitis with perforation and peritonitis with abscess, and colostomy. The plan of care dated 3/31/21 specified skilled nursing services 3 times a week for wound vac (vacumn) change and colostomy care education. Record review on 5/13/21 revealed the following information. Week 1 and 2 the 3 skilled nursing visits were provided as ordered. Week 3 had 2 skilled nursing visits provided prior to the patient being admitted to hospital on 4/14/21. The patient initial comprehensive assessment was completed on 3/31/21 by RN#5 (registered nurse). The assessment documents that the patient is independent in ADL's (activities of daily living) such as grooming, showering, and eating. The patient was living with his parents while home care was being provided. The mother was primary caretaker but was ill at the same time and had difficulty providing for MR#2 at times. MR#2 was being seen by skilled nursing for colostomy and wound care. The skilled nurses documented MR#2 was using multiple colostomy supplies per day due to frequent bowel movements and leaking. LPN#4 (licensed practical nurse) documented on 4/13/21 home visit the patient had no colostomy bag or wafer present when she arrived. LPN#4 documented, "Patient had also removed ostomy bag and wafer. Field nurse attempted to find wafer and Austin bag to replace but none were available at this time. Nurse assisted patient and covering stoma site. Notifying supervisor and notified patient I think they have to go obtain an ostomy bag ...Mother not present for visit. Patient has appointment with surgeon on the 14th [sic]." The skilled nurse failed to notify the physician regarding the patient having no supplies for the colostomy, resulting in feces infecting the abdominal wound. The above findings were reviewed and acknowledged by VP#7 (regional vice president) during an interview on 5/13/21 at 1600 hours. LPN#4 failed to promptly alert the physician to changes in the status of the patient not having colostomy supplies allowing feces to contaminate the surgical wound, resulting in a wound infection along with hospitalization.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure professional staff communicated with all of the physicians involved in the patient's colostomy and wound care provided in 1 of 1 record reviewed (MR#2) in which the patient failed to receive adequate colostomy care, wound care and supplies, resulting in a poor patient outcome (hospitalization) for this one patient. Findings include: **Agency policy "Plan of Care" (dated 7/15/20) stated, "Home care services are furnished under the supervision and direction of the client's physician or allowed practitioner...The plan will be consistently reviewed to ensure that client needs are met...Professional staff shall promptly alert the physician...that suggest a need to alter the Plan of Care." MR#2: This autistic 32 year old male patient was admitted to home care on 3/31/21 with diagnoses of aftercare following digestive surgery, acute appendicitis with perforation and peritonitis with abscess, and colostomy. Record review on 5/13/21 revealed the following information. The plan of care dated 3/31/21 specified skilled nursing services 3 times a week for wound vac (vacuum) change and colostomy care education. The plan of care was signed by the family physician, failed to include orders the skilled nurse could contact the surgeon for further instructions or orders. Week 1 and 2 the 3 skilled nursing visits were provided as ordered. Week 3 had 2 skilled nursing visits provided prior to the patient being admitted to hospital on 4/14/21. The patient initial comprehensive assessment was completed on 3/31/21 by RN#5 (registered nurse). The assessment documents that the patient is independent in ADL's (activities of daily living) such as grooming, showering, and eating. The patient was living with his parents while home care was being provided. The mother was primary caretaker but was ill at the same time and had difficulty providing for MR#2 at times. MR#2 was being seen by skilled nursing for colostomy and wound care. The skilled nurses documented MR#2 was using multiple colostomy supplies per day due to frequent bowel movements and leaking. On 4/2/21 RN#5 (registered nurse) documented, "Patient is using a Convatec two piece system and now has fourteen bags and fourteen wafers in the home." On 4/7/21 skilled nurse (SN) documented, "Reports colostomy appliance due to be changed today as well. Noted current bag with mod (moderate) amount of loose brown stool. Appliance removed, area cleansed with wipes. Stoma beefy red. Skin Prep applied and SN assisted with appliance application while also encouraging patient to do as much as he can on his own. Patient anxious about every step of appliance change ..." On 4/9/21 SN visit stated, "Colostomy intact WNL (within normal limits). SN educated only changing bag when leakage. Patient expressed understanding." The 4/12/21 registered nurse home visit documented, "Ostomy bag supply is verified and asked me removal completed with patients. Patients mother and patient participated in ostomy training for removal and proper application of device. Patient was nervous and anxious while RN was attempting to complete instruction ...Patient also advise on use of ostomy supplies and frequency of changing ostomy site. Patient's mother reports that patient had problems over weekend which resulted in compromising some of the ostomy supplies patient needs more ostomy supplies. Supplies ordered as indicated for patients need." [sic]. RN#8 (manager registered nurse) on 4/13/21 documented, "1:10 PM received return call from (MR#2 mother's name). CTM (manager) reviewed education process with (name) SN training of (name) and patient ostomy care. CTM informed that (agency name) is short term care to provide education and insurance will not continue to cover large amounts of ostomy supplies in future. (name) verbalized understanding and states they will continue working with nurses to learn how to apply ostomy appliances ..." LPN#4 stated on 4/13/21 visit, "Patient had also removed ostomy bag and wafer. Field nurse attempted to find wafer in Austin bag to replace but none were available at this time nurse assisted patient and covering stoma site. Notifying supervisor and notified patient I think they have to go obtain an ostomy bag [sic]." There were 8 skilled nursing visits provided to the patient from 3/31/21 to 4/13/21. Four different nurses provided the patient services, there failed to be communication with all the physicians regarding the difficulty with the colostomy appliances and the agency's inability to supply all needed for patient care. The above findings were reviewed and acknowledged by VP#7 (regional vice president) during an interview on 5/13/21 at 1600 hours. The agency skilled nurses failed to notify the physicians involved in the patient's care regarding the inability to obtain all of the supplies needed for care.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure staff coordinated the provision of colostomy care for 1 of 1 record reviewed (MR#2) in which the patient failed to receive adequate colostomy supplies of a total of 4 records reviewed, resulting in a poor patient outcome (hospitalization) for this one patient. Findings include: **Agency policy "Plan of Care" (dated 7/15/20) stated, "The Plan of Care shall be completed in full to include: All pertinent diagnosis(es), principle and secondary, including dates of onset...Medical supplies and equipment required." MR#1: This autistic 32 year old male patient was admitted to home care on 3/31/21 with diagnoses of aftercare following digestive surgery, acute appendicitis with perforation and peritonitis with abscess, and colostomy. Record review on 5/13/21 revealed the following information. The plan of care dated 3/31/21 specified skilled nursing services 3 times a week for wound vac change and colostomy care education. Week 1 and 2 the 3 skilled nursing visits were provided as ordered. Week 3 had 2 skilled nursing visits provided prior to the patient being admitted to hospital on 4/14/21. The patient initial comprehensive assessment was completed on 3/31/21 by RN#5 (registered nurse). The assessment documents that the patient is independent in ADL's (activities of daily living) such as grooming, showering, and eating. The patient was living with his parents while home care was being provided. The mother was primary caretaker but was ill at the same time and had difficulty providing for MR#2 at times. MR#2 was being seen by skilled nursing for colostomy and wound care. The skilled nurses documented MR#2 was using multiple colostomy supplies per day due to frequent bowel movements and leaking. On 4/2/21 RN#5 (registered nurse) documented, "Patient is using a Convatec two piece system and now has fourteen bags and fourteen wafers in the home." On 4/7/21 skilled nurse (SN) documented, "Reports colostomy appliance due to be changed today as well. Noted current bag with mod (moderate) amount of loose brown stool. Appliance removed, area cleansed with wipes. Stoma beefy red. Skin Prep applied and SN assisted with appliance application while also encouraging patient to do as much as he can on his own. Patient anxious about every step of appliance change ..." On 4/9/21 SN visit stated, "Colostomy intact WNL (within normal limits). SN educated only changing bag when leakage. Patient expressed understanding." The 4/12/21 registered nurse home visit documented, "Ostomy bag supply is verified and asked me removal completed with patients. Patient's mother and patient participated in ostomy training for removal and proper application of device. Patient was nervous and anxious while RN was attempting to complete instruction ...Patient also advise on use of ostomy supplies and frequency of changing ostomy site. Patient's mother reports that patient had problems over weekend which resulted in compromising some of the ostomy supplies patient needs more ostomy supplies. Supplies ordered as indicated for patients need [sic]. RN#8 (manager registered nurse) on 4/13/21 documented, "1:10 PM-received return call from (MR#2 mother's name). CTM (manager) reviewed education process with (name) SN training of (name) and patient ostomy care. CTM informed that (agency name) is short term care to provide education and insurance will not continue to cover large amounts of ostomy supplies in future. (name) verbalized understanding and states they will continue working with nurses to learn how to apply ostomy appliances ..." LPN#4 stated on 4/13/21 visit, "Patient had also removed ostomy bag and wafer. Field nurse attempted to find wafer in Austin bag to replace but none were available at this time nurse assisted patient and covering stoma site. Notifying supervisor and notified patient I think they have to go obtain an ostomy bag [sic]." There were 8 skilled nursing visits provided to the patient from 3/31/21 to 4/13/21. Four different nurses provided the patient services, there failed to be documentation of coordination of the colostomy problems and the need for referral or consultation to a trained ostomy professional and the physician. The above findings were reviewed and acknowledged by VP#7 (regional vice president) during an interview on 5/13/21 at 1600 hours. The agency skilled nurses failed to coordinate efforts and develop a plan to improve patient colostomy care.