Every finding on record at Concordia Visiting Nurses

Based on the findings of an onsite unannounced complaint investigation completed March 27, 2026, Concordia Visiting Nurses 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.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on review of policy, clinical records (CR), observations during a home visit, and staff interview, the agency failed to provide written instructions to the patient outlining the visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA for two (2) of three (3) records reviewed (CR1,& CR2). Review of agency policy on March 27, 2026, at 10:30 a.m. showed, "CONCORDIA VISITING NURSES SUBJECT: Overview of Available Agency Services Policy: IX-1 I. Policy ... Every effort is made to provide a comprehensive approach to care with continuity of care assignment. ... D. Coordination of Care Agency staff work as a team, conferring with each other and establishing goals and the care plan with the patient/caregiver. Coordination is accomplished through complete documentation, care conferences and electronic communication to assure efforts effectively complement one another and support the objectives outlined in the plan of care. All communication is documented in order to establish that effective interchange, reporting and coordinated patient evaluation and care implementation occurs." Review of CR1 on March 26, 2026, at 9:30 a.m. showed a physician ordered plan of care with an initial certification period from 2/28/2026 to 4/28/2026. The patient was ordered physical therapy once per week for 1 week, twice a week for 1 week, and every other week for 2 weeks. After the initial PT start of care visit on 2/28/2026, the patient received PT services on 3/3, 3/6, and 3/9/2026. Further review of CR1 did not show the agency provided, or the patient received, written instructions outlining the visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. Interview with EMP1 at time of review noted that the patient's are mailed their written instructions per an automated "work flow" process. Review of the documented process as described by EMP1 showed, "Event-Stages History Report ... Client Name: [CR1] ... Event ... Patient care coordination ... Print patient instructions and send to patient ... 3/3/2026." The report was in tabular format sorted by date. EMP1 was not able to produce the written instructions that would have been sent to the patient because they are "living documents" and the patient was no longer an active patient. EMP1 confirmed there was no documentation in the clinical record concerning written instructions to the patient other than the "Event-Stages History Report." Review of CR2 on March 26, 2026, at 10:30 a.m. showed a physician ordered plan of care with an initial certification period from 3/11/2026 to 5/9/2026. Orders initially included skilled nursing 3 times per week, physical therapy once per week, occupation therapy 2 times per week, speech therapy once a week, and a social worker visit once a week. For instance, the patient received skilled nursing visits on 3/11 (start of care), 3/13, 3/16, 3/18, 3/19, and 3/23/2026. The clinical record did not show the patient was provided or understood their written instructions concerning frequency of visits by HHA personnel and personnel acting on behalf of the HHA. EMP1 produced a "Patient Instructions Report" dated 3/18/2026 that included frequency of visits by discipline (nursing, physical therapy etc.) that would have been provided to CR2's daughter, but EMP1 was unable to produce the initial written instructions provided to the patient and family or if those initial written instructions provided to the patient and family were understood by the patient and family. A review of documentation at CR2's residence during a home visit with EMP1 present on March 25, 2026, at 12:12 p.m. did not show a visit schedule in the home that included frequency of visits by HHA personnel and personnel acting on behalf of the HHA. Interview with EMP1 at 11 a.m. confirmed above findings. EMP1 noted that the written instructions to the patient, included in the "work flow" process, are mailed to the patients. However, there was no documentation in the medical record to show staff confirmed if patient received and understood their mailed written instructions.

Based on the findings of an onsite unannounced complaint investigation completed February 4, 2026, Concordia Visiting Nurses 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.

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 review of agency policy, clinical records (CR) and staff (EMP) interview, the agency failed to provide services in accordance with the plan of care for three (3) of three (3) patients with venous access devices (CR1-CR3). Findings included: Review of agency policy on February 3, 2026, at 1:45 p.m., "CONCORDIA VISITING NURSES ... Policy: IX-2 ... I. Policy Concordia Visiting Nurses provides nursing services to patients in need of nursing care at home in accordance with the physician's or allowed practitioner's written plan of care." Review of agency policy on February 4, 2026, at 10 a.m. showed, "CONCORDIA VISITING NURSES ... Policy: XII-2 ... I. Policy ... M. Nurses will document all aspects of assessment, teaching, interventions, and appearance of IV site, as well as patient knowledge, and tolerance of IV therapy for each home visit." Review of CR1 on February 3, 2026, at 11 a.m. revealed a physician ordered plan of care for an initial certification period from 9/24/2025 to 11/22/2025. Orders included skilled nursing (SN) to see the patient once a week for care and assessment related to patient's peripherally inserted central catheter (PICC), "Skilled nurse ... for observation / assessment of IV access site." Review of SN visit notes for treatment week beginning 11/16/2025 and ending 11/22/2025 did not show the patient received as skilled nurse visit as ordered that week. A coordination note showed, "CALL DATE: 11/21/2025 CALL TIME: 720 [a.m.] ... [Patient's cousin] CALLED BECAUSE PATIENT CALLED [him/her] AND TOLD [him/her] NO ONE CALLED ABOUT PICC LINE CARE TODAY ... PT [patient] IS ON FOR RECERT IV VISIT TODAY ... RESOLUTION: CALL TO PT TO MAKE [him/her] AWARE THAT [his/her] COUSIN CALED AND THAT [nurse] IS ON THE CALENDAR FOR [his/her] VISIT TODAY AND [agency] WILL TEXT [nurse] TO CALL [patient] WITH VISIT TIME." A coordination note from 11/21/2025 by agency nurse mentioned in above coordination note showed that he/she did not see the patient on 11/21/2025, "REASON FOR THE CHANGE: PT UNABLE NEW DATE REQUESTED: 11.22.25 ... WAS PATIENT NOTIFIED OF THE DATE CHANGE: YES." There was no further documentation to show the patient received a visit on 11/22/2025 or for the treatment week beginning 11/16/2025 CR1's recertification period was from 11/23/2025 to 1/21/2026. Orders included, "SKILLED NURSE ... FOR OBSERVATION / ASSESSMENT OF IV ACCESS SITE ... REGARDING INFUSION PROCEDURE CARE OF INFUSION LINE AND SITE CARE, CARE AND USE OF INFUSION EQUIPMENT ... DRESSING CHANGE FREQUENCY WEEKLY AND [as needed] ... CHANGE END CAPS WEEKLY AND WITH EVERY BLOOD DRAW." Patient was also ordered to have labs done via his/her PICC line. "Lab orders: ... Flush [PICC] with 10-20ml saline before and after each lab draw as needed." During the recertification visit on 11/23/2025, SN obtained labs via venipuncture (needle into vein) instead if using the patient's PICC as ordered, and there was no order to obtain patient's labs via venipuncture. The patient refused the PICC dressing change. There was no evidence the SN changed the end caps. A subsequent SN on 11/28/2025, and during the same treatment week, did not show the SN changed the end caps (documented as done on 11/24 when there was no SN visit), or the PICC dressing. SN obtained labs via venipuncture instead if using the patient's PICC as ordered. A visit on 12/5/2025 showed SN obtained labs via venipuncture instead if using the patient's PICC as ordered. Review of CR2 on February 4, 2026, at 11 a.m. revealed a physician ordered plan of care for an initial certification period from 11/2/2025 to 12/31/2025. Orders included SN to see the patient once a week for care and assessment related to patient's IV access or midline catheter, "Skilled nurse ... for observation / assessment of IV access site." SN provided 13 visits from 11/2-11/28/2025 but failed to conduct a midline IV access assessment for 8 of those visits on 11/3, 11/5, 11/7, 11/12, 11/14, 11/19, 11/21, and 11/26. For instance, the RN documented an unremarkable assessment concerning CR2's midline IV access on 11/9/2025, "NO PROBLEMS WITH SITE," which was a Sunday and the beginning of the treatment week. Subsequent SN visits were conducted on 11/12 and again on 11/14/2025 with no midline IV access assessment to show the IV site was intact and without problems just prior to a hospitalizations concerning problems with the IV site. The 11/14/2025 SN visit was completed at 2:10 p.m. Review of coordination notes showed patient called in the evening of 11/14/2025 at 7:50 p.m., CALLED IN STATING IN STATING THOUGHT IV WAS LEAKING." On 11/15/2025, a coordination note showed the patient's daughter called the agency to report the patient was going to the hospital emergency department because the patient's IV site was leaking during the infusion. A coordination note from 11/17/2025 showed, "CALLED TO CHECK ON PATIENT. STATED HE GOT [his/her] NEW MIDLINE AT THE HOSPITAL THIS WEEKEND. AND WAS WAITING FOR THE NURSE TODAY." Review of CR3 on February 4, 2026, at 10:30 a.m. showed patient was discharged from hospital with a PICC installed (1/20/2026) and admitted to agency on 1/24/2026 for IV antibiotics via PICC. The initial physician ordered plan of care, for certification period from 1/24/2026 to 3/24/2026, included orders for SN to see the patient once a week for care and assessment related to patient's PICC, "Skilled nurse ... for observation / assessment of IV access site." Review of SN initial start of care visit from 1/24/2026 did not show that the registered nurse provided and assessment of patient's PICC or that there was a PICC in place. Interview with EMP3 (administrator) and EMP2 (COO) on February 4, 2026, at 12:30 p.m. confirmed above findings.

Based on the findings of an onsite unannounced complaint investigation completed December 19, 2023, Concordia Visiting Nurses 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. The survey was conducted from the Cabot parent location.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on review of agency policy, clinical records (CR), and staff (EMP) interview, the licensed practical nurse (LPN) and registered nurse (RN) failed to assume responsibility for the patient and failed to ensure an ongoing interdisciplinary assessment of the patient was completed for one (1) of one (1) discharged record with an indwelling urinary catheter who required emergency services (CR1). Review of facility policy on December 19, 2023, at 10:15 a.m. showed: "POSITION DESCRIPTION - REGISTERED NURSE ... DUTIES AND RESPONSIBILITIES ... N. Coordinates total patient care serving as the primary nurse for designated patients and evaluating the effectiveness and the appropriateness of care. ... P. Serves as the primary liasison and coordinator of care when nursing and other services are provided. ... R. Meets with the interdisciplinary team routinely to ensure coordination of care." "POSITION DESCRIPTION - LICENSED PRACTICAL NURSE ... POSITION SUMMARY ... The LPN collaborates patient care with the case managing RN, physician, and patient ... DUTIES AND RESPONSIBILITIES ... F. ... Conducts a comprehensive physical examination and nursing assessment of the patient at each skilled visit." "Skills: Urinary Catheter: Indwelling (Foley) Catheter Care (Home Health Care) ... PROCEDURE ... 13. Inspect urine for color, clarity, and amount ... 24. Document procedure in the patient's record. EXPECTED OUTCOMES ... Urine drains properly ... DOCUMENTATION ... Time of catheter care ... Character, amount, color, and odor of urine." "Skills: Urinary Catheter: Indwelling (Foley) Catheter Care ... 9. Inspect the urine in the collection chamber for color, clarity, and quantity. ... 22. Document the procedure in the patient's record." "Skills: Urinary Catheter: Straight and Indwelling (Foley) Catheter Insertion (Male) (Home Health Care) ... Catheter Insertion ... 9. Perform a patient assessment, including: ... b. Intake and output ... 32. Insert the catheter. a. Indwelling or straight catheter ... iii. Advance the indwelling catheter ... until urine flows through the tubing. ... 42. Observe the characteristics and amount of urine in the drainage system. ... 46. Document the procedure in the patient's record. ... UNEXPECTED OUTCOMES ... No urine in catheter drainage bag. ... DOCUMENTATION ... Amount of urine drained." Review of CR1 on December 20, 2023, at 10 a.m. showed a physician ordered plan of care with a start of care date of 10/19/2023 for an initial certification ending 12/17/2023. The patient's admitting diagnosis was heart disease with a medical history of urinary retention and consequent indwelling urinary catheter (a tube inserted into the body to drain urine from the bladder). Orders included, "Skilled nurse to assess/evaluate co-morbid conditions including ... other conditions that present themselves during the course of the episode to identify changes and intervene to minimize complications ... Skilled nurse to perform observation / assessment of genitourinary status and intervene to minimize complications of disease process. Skilled nurse for insertion of Foley [urinary] catheter maintenance ... change [every] month." The plan of care was signed by the RN on 10/19/2023. Review of CR1's skilled nursing visit notes showed the RN completed the initial comprehensive assessment on 10/19/2023. The RN noted the patient had an indwelling urinary catheter (catheter inserted into bladder for long-term placement), " Has [urinary catheter] in place that SN [skilled nursing] to manage." CR1 received another seven (7) SN visits over a 35-day period before an emergency room visit on 11/25. All the visits were provided by an LPN on 10/24, 10/27, 10/31, 11/3, 11/16, 11/24/2023, and 11/29/2023. During six (6) of seven (7) visits (10/24-11/24/2023) the LPN failed to document the amount of urine in the patient's urinary catheter drainage bag. During the 10/24/2023 and 11/24/2023 visits, the LPN replaced the patient's urinary catheter and simply documented the patient's urinary catheter was last changed on 10/24/2023 for example. Review of CR1's emergency room visit from 11/25/2023 showed patient was registered at 4:42 a.m., "Triage Presenting Complaint and Acuity Level: foley [urinary] catheter not draining bladder scan for over 1,000 [over 1 liter of urine found in bladder] pt reports home health placed a foley today [ was yesterday 11/24/2023] no out put [sic] appreciated through out [sic] the day and night ... ED [emergency department] COURSE: ... 87 year-old ... male presents to the emergency department with acute retention of urine. ... Foley catheter placed yesterday by the home health nurse and the catheter never drained. Patient is in a lot discomfort and is in acute retention of urine. The foley catheter was deflated and pushed back when he started draining and more than a liter if urine has been drained. Patient feels very comfortable after repositioning of the Foley catheter and decompression of the bladder." There was nothing in the above visit notes to show the RN supervised the LPN over the 40-day episode (10/19 to 11/29) to ensure the patient's needs were met or if the LPN was following agency policy concerning urinary catheter care. CR1 was reviewed with EMP1 (administrator), and EMP3 (chief nursing officer) on December 19, 2023, at 1 p.m. EMP3 looked at each LPN visit note and confirmed the LPN failed to document how much urine was in patient's urinary catheter drainage bag from 10/24-11/24/2023 visits, or if urine was obtained when new urinary catheter was inserted on 10/24/2023 and 11/24/2023. EMP3 also confirmed no RN supervision for the entire episode when care was provided by the LPN.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on review of agency policy, clinical records (CR), and staff (EMP) interview, the registered nurse (RN) failed to supervise, monitor and evaluate the performance of the licensed practical nurse (LPN) regarding data collection to ensure the patient's needs were met as delegated by the RN for one (1) of one (1) discharge record with an indwelling urinary catheter who required emergency services (CR1). Review of facility policy on December 19, 2023, at 10:15 a.m. showed: "SUBJECT: Nursing Services Policy: IX-2 I. Policy Concordia Visiting Nurses provides nursing services to patients in need ... The qualified License Practical Nurse (LPN) ... may provide nursing services under the supervision of the registered nurse. A. Provider Care ... The RN is responsible for all aspects of the nursing process including: ... provision of skilled care ... observation of clinical signs and symptoms ... assignment and supervision of the LPN. ... The LPN may provide care under the guidance and supervision of the RN." "POSITION DESCRIPTION - REGISTERED NURSE ... DUTIES AND RESPONSIBILITIES ... H. Supervises and periodically evaluates the care given by the LPN to his/her primary patients to ensure oversight I. Evaluates and manages LPNs ... who are providing services to his/her patients. ... Coordinates total patient care serving as the primary nurse for designated patients and evaluating the effectiveness and the appropriateness of care." "Skills: Urinary Catheter: Indwelling (Foley) Catheter Care (Home Health Care) ... PROCEDURE ... 13. Inspect urine for color, clarity, and amount ... 24. Document procedure in the patient's record. EXPECTED OUTCOMES ... Urine drains properly ... DOCUMENTATION ... Time of catheter care ... Character, amount, color, and odor of urine." "Skills: Urinary Catheter: Indwelling (Foley) Catheter Care ... 9. Inspect the urine in the collection chamber for color, clarity, and quantity. ... 22. Document the procedure in the patient's record." "Skills: Urinary Catheter: Straight and Indwelling (Foley) Catheter Insertion (Male) (Home Health Care) ... Catheter Insertion ... 9. Perform a patient assessment, including: ... b. Intake and output ... 32. Insert the catheter. a. Indwelling or straight catheter ... iii. Advance the indwelling catheter ... until urine flows through the tubing. ... 42. Observe the characteristics and amount of urine in the drainage system. ... 46. Document the procedure in the patient's record. ... UNEXPECTED OUTCOMES ... No urine in catheter drainage bag. ... DOCUMENTATION ... Amount of urine drained." Review of CR1 on December 20, 2023, at 10 a.m. showed a physician ordered plan of care with a start of care date of 10/19/2023 for an initial certification ending 12/17/2023. The patient's admitting diagnosis was heart disease with a medical history of urinary retention and consequent indwelling urinary catheter (a tube inserted into the body to drain urine from the bladder). Orders included, "Skilled nurse to assess/evaluate co-morbid conditions including ... other conditions that present themselves during the course of the episode to identify changes and intervene to minimize complications ... Skilled nurse to perform observation / assessment of genitourinary status and intervene to minimize complications of disease process. Skilled nurse for insertion of Foley [urinary] catheter maintenance ... change [every] month." The plan of care was signed by the RN on 10/19/2023. Review of CR1's skilled nursing visit notes showed the RN completed the initial comprehensive assessment on 10/19/2023. The RN noted the patient had an indwelling urinary catheter (catheter inserted into bladder for long-term placement), " Has [urinary catheter] in place that SN [skilled nursing] to manage." CR1 received another seven (7) SN visits over a 35-day period before an emergency room visit on 11/25. All of the visits were provided by an LPN on 10/24, 10/27, 10/31, 11/3, 11/16, 11/24/2023, and 11/29/2023. During these visits the LPN failed to document the amount of urine in the patient's urinary catheter drainage bag. During the 10/24/2023 and 11/24/2023 SN visits, the LPN replaced the patient's urinary catheter and simply documented the patient's urinary catheter was last changed on 10/24/2023. There was no documentation to show how much urine was in patient's urinary catheter drainage bag, and if urine was obtained when new urinary catheter was inserted. There was nothing in the above visit notes to show the RN supervised the LPN over the 40-day episode (10/19 to 11/29) to ensure the patient's needs were met or if the LPN was following agency policy concerning urinary catheter care. Review of CR1's emergency room visit from 11/25/2023 showed patient was registered at 4:42 a.m., "Triage Presenting Complaint and Acuity Level: Foley [urinary] catheter not draining bladder scan for over 1,000 [over 1 liter of urine found in bladder] pt reports home health placed a foley today [ was yesterday 11/24/2023] no out put [sic] appreciated through out [sic] the day and night ... ED [emergency department] COURSE: ... 87 year-old ... male presents to the emergency department with acute retention of urine. ... Foley catheter placed yesterday by the home health nurse and the catheter never drained. Patient is in a lot discomfort and is in acute retention of urine. The foley catheter was deflated and pushed back when he started draining and more than a liter if urine has been drained. Patient feels very comfortable after repositioning of the Foley catheter and decompression of the bladder." CR1 was reviewed with EMP1 (administrator), and EMP3 (chief nursing officer) on December 19, 2023, at 1 p.m. EMP3 looked at each LPN visit note and confirmed there was no documented supervision by the RN for the entire episode. The patient was discharged by the RN on 12/19/2023.

Based on the findings of an onsite unannounced complaint investigation completed April 13, 2023, Concordia Visiting Nurses 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.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on review of agency policy, clinical records (CR), and staff (EMP) interview, the agency failed to ensure patients were informed and participated in changes in care to be furnished in a manner that was understood by the patient for two (2) of three (3) records reviewed (CR1, & CR2). The agency failed to ensure the patients understood the were to be discharged from agency prior to achieving goals outlined in the plan of care. Findings included: Review of policy on April 13, 2023, at 10:10 a.m. showed, "Policy: X-1 ... The patient/family has a right to participate in the development of the care plan for services and changes made to it." Review of agency policy on April 13, 2023, at 11 a.m. showed, "Policy: VII-4 All Concordia Visiting Nurses patients/caregivers are involved in the coordination of discharge from the agency. ... Staff, in cooperation with the patient's physician and other relevant providers of care, evaluates patient progress toward established goals and work together with the patient/caregiver for a timely discharge based on patient status." Review of CR1 on April 11, 2023, at 10:40 a.m. showed a physician ordered plan of care for an initial certification period from 12/8/2022 to 2/5/2023. Patient was 72 years old and admitted to home health status post surgery to the circulatory system, heart valve replacement, hypertensive heart disease with heart failure, and heart disease. Orders included skilled nursing (SN) to see the patient twice a week initially with visits decreasing to once a week, "DC Plans: DC to self under supervision of MD when alternate caregiver obtained." On 12/15/2022, the licensed practical nurse (LPN) documented, "Patient wife very concerned about BP [blood pressure] today." Per 12/21/2022 SN visit by RN he/she communicated with the physical therapist that agency would discharge the patient after patient's next PCP office visit, "Plan to discharge to therapy next friday after PCP APPT." There was nothing contained in the 12/21/2022 note that showed patient was informed of discharge plans. A SN note by the LPN showed the patient had an visit scheduled with the attending physician (surgeon) on 1/6/2023, and that the patient saw their PCP on 12/29/2022 and was ordered a blood pressure medication. There was nothing in this note that mentioned discharge planning. During a RN visit on 1/3/2023, "Wife voiced concerns with SN DC due to PTS fluctuating BP." On 1/4/2023, the physical therapist completed a planned discharge from agency. During a skilled nursing visit on 1/12/2023, the LPN documented that the patient requested discharge from the agency. The patient was discharged on 1/13/2023 by the physical therapist (PT) who completed the discharge from agency summary that showed patient was discharged secondary to goals met. The discharge summary did not reflect that the patient had requested to be discharged from agency. Review of CR2 on April 12, 2023, at 10:30 a.m. showed a physician ordered plan of care for an initial certification period from 1/25/2023 to 3/25/2023. The patient was status post surgery and the patient's surgeon was the patient's attending physician. Orders included skilled nursing (SN) to see the patient three times per week, "Skilled nurse to observe and assess integumentary status to identify changes and intervene to minimize complications. ... A plan of care will be established that meets all patient's nursing needs and countersigned by physician. ... DC Plans: DC to care of family under supervision of MD when goals are met." During the initial nursing assessment completed on 12/8/2022, the registered nurse (RN) documented the patient had a post-operative incision closed with staples (wound #2). The wound was 14 centimeters (cm) long, 0.1 cm wide, and 0.2 cm deep (14 x 0.1 x 0.2). Five (5) subsequent SN visits from 1/27 to 2/6/2023 showed that nursing staff failed to document how many staples the patient's wound had. Additionally, during three (3) skilled nursing visits the week of 1/29/2023, SN failed to measure the post-operative incision (1/30, 2/1, and 2/3/2023). The patient was discharged on 2/22/2023. Further review of SN from 1/27 to 2/6/2023 did not show the patient understood or was informed of her discharge from the agency based on the below coordination notes. Per RN "Visit Note Report" the agency discharged the patient on 2/21/2023. Review of CR2's "Coordination notes" from skilled nursing staff showed: "1/26/2023 ... Patient was admitted ... Plan for next visit: perform wound care." 2/17/2023 ... Called patient February 17th attempting to do phone discharge. Patient refused stating that she has staples in her hip and needs someone to come out ASAP. Patient was listed for phone discharge as she had called the on-call on the 9th and refused all for the visits." "2/22/2023 ... Patient called in demanding a visit to remove her staples. ... Patient began to scream at [author of note] that someone needs to make this right." Interview with EMP1, and EMP2 on April 13, 2023, at 12 p.m. confirmed above findings.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on review of agency policy, clinical records (CR), and staff (EMP) interview, the registered nurse's comprehensive assessment failed to accurately reflect the patient's status to include care and treatments necessary to meet the needs of the patient for two (2) of three (3) records reviewed (CR1, & CR2). Findings included: Review of agency policy on April 13, 2023, a 10:05 a.m. showed, "Policy: IX-1 ... Every effort is made to provide comprehensive approach to care with continuity of care assignment. ... Admission visits include comprehensive client assessment carried out by a registered nurse, ... A. Plan of Care ... The comprehensive assessment includes the following so that the plan of care can be inclusive of them: ... Other appropriate items." Review of agency policy on April 13, 2023, at 10:57 a.m. showed, "Policy: VII-1 ... The referral information is obtained from the referring physician or the patient's inpatient medical record in the case of a referral from an inpatient facility, ... the referral information is used for the initiation of treatment and to inform the nurse, ... of the reason for home health so proper care can be instituted." Review of CR1 on April 11, 2023, at 10:40 a.m. showed a physician ordered plan of care for an initial certification period from 12/8/2022 to 2/5/2023. Orders included skilled nursing (SN) to see the patient twice a week initially with visits decreasing to once a week, "Skilled nurse to observe and assess integumentary status to identify changes and intervene to minimize complications. ... A plan of care will be established that meets all patient's nursing needs and countersigned by physician." During the initial nursing assessment completed on 12/8/2022, the registered nurse (RN) documented, "Lab Draw ... Did you perform lab draw at this visit ... No." A review of patient's "[Hospital] Discharge Summary" showed the patient had labs that were ordered to be collected on 12/8/2022, "Outpatient Non-med Script(s) Given: Outpatient Lab Script - CBC/BMP Order Date: 12/8/2022." Review of home health referral sent to agency from the discharging hospital on 12/5/2022 showed, "Order placed date 12/5/2022 09:23 [a.m.] Home health referral: homecare nursing Order Details Special Instructions ... Lab work on Thurs [Thursday] 12/8." Review of CR2 on April 12, 2023, at 10:30 a.m. showed a physician ordered plan of care for an initial certification period from 1/25/2023 to 3/25/2023. The patient was status post-surgery and the patient's surgeon was the patient's attending physician. Orders included skilled nursing (SN) to see the patient three times per week, "Skilled nurse to observe and assess integumentary status to identify changes and intervene to minimize complications. ... A plan of care will be established that meets all patient's nursing needs and countersigned by physician." During the initial nursing assessment completed on 1/25/2023, the registered nurse (RN) documented the patient had a post-operative incision closed with staples (wound #2). CR2 contained no orders or treatments concerning patient's postoperative staples. Review of CR2's "Coordination notes" showed, "2/22/2023 ... Patient called in demanding a visit to remove her staples. ... Patient began to scream at [author of note] that someone needs to make this right." The patient was discharge from agency on 2/22/2023 or 27 days after her start of care without having her staples removed necessitating an outpatient office visit for staple removal. There was nothing in CR2 to show agency attempted to contact the physician concerning care and treatment related to patient's staples. Interview with CR2's attending physician on April 12, 2013, at 11:39 a.m. confirmed that agency never contacted him/her concerning the patient's staples. Interview with EMP1 and EMP2 on April 13, 2023, at 12 p.m. confirmed above findings and that agency never completed ordered labs shown on the patient's home health referral.

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 review of agency policy, clinical records (CR), and staff (EMP) interview, the agency failed to coordinate care delivery with the patient and physician to ensure the needs of the patient were met for two (2) of three (3) records reviewed (CR2, & CR3). Findings included: Review of agency policy on April 13, 2023, at 10:05 a.m. showed, "Policy: IX-1 ... Coordination of Care Agency staff work as a team, conferring with each other and establishing goals and the care plan with the patient/caregiver. Coordination is accomplished through complete documentation, care conferences and electronic communication to assure efforts effectively complement one another and support objectives outlined in the plan of care. All communication is documented in order to establish that effective interchange, reporting and coordinated patient evaluation and care implementation occurs." Review of agency policy on April 13, 2023, at 12:30 p.m., "Evaluate the wound healing stage and condition of the wound before suture or staple removal. ... The normal time frame for staple removal is within 5 to 7 days if healing is adequate." Review of CR2 on April 12, 2023, at 10:30 a.m. showed a physician ordered plan of care for an initial certification period from 1/25/2023 to 3/25/2023. The patient was status post-surgery and the patient's surgeon was the patient's attending physician. Orders included skilled nursing (SN) to see the patient three times per week, "Skilled nurse to observe and assess integumentary status to identify changes and intervene to minimize complications. ... A plan of care will be established that meets all patient's nursing needs and countersigned by physician." During the initial nursing assessment completed on 1/25/2023, the registered nurse (RN) documented the patient had a post-operative incision closed with staples (wound #2). The wound was 14 centimeters (cm) long, 0.1 cm wide, and 0.2 cm deep (14 x 0.1 x 0.2). Five (5) subsequent SN visits from 1/27 to 2/6/2023 showed that nursing staff failed to document how many staples the patient's wound had. Additionally, during three (3) skilled nursing visits the week of 1/29/2023, SN failed to measure the post-operative incision (1/30, 2/1, and 2/3/2023). Review of CR2's "Coordination notes" showed, "2/22/2023 ... Patient called in demanding a visit to remove her staples. ... Patient began to scream at [author of note] that someone needs to make this right." There was nothing in CR2 to show agency attempted to contact the physician concerning care and treatment related to patient's staples. Interview with CR2's attending physician on April 12, 2013, at 11:39 a.m. confirmed that agency never contacted him/her concerning the patient's staples. Review of CR3 on April 12, 2023, at 2 p.m. showed a physician ordered plan of care with an initial certification period from 3/27 to 5/25/2023. The plan included SN to see the patient twice a week for the first week and then once a week for assessment and treatment of the patient status post circulatory system surgery. Review of SN visit notes did not show the patient received a visit the week of 4/2/2023. During an interview with patient on 4/12/2023 at 2:05 p.m., the patient said he had a doctor's appointment on 4/5/2023 and was unable to have SN make a visit that day. CR3 said the LPN would call back to reschedule but never did. The record contained nothing to show coordination of care with the patient until entries were added late on 4/12/2023. Note: surveyor became aware of CR3's allegations against agency on 4/12/2023 at 12 p.m. at which time agency was informed of allegations and CR3 was requested for review. Only then did agency add (late) entries into CR3 concerning the above missed visits from 4/5/2023. The record contained two notes concerning the missed visit entered by the LPN, and another noted entered by EMP4 clinical manager concerning a phone call he had with CR3 on 4/7/2023. Both entries were dated on 4/12/2023. Interview with EMP1 and EMP2 on April 12, 2023, at 2:30 p.m. and again on April 13, 2023, at 12 p.m. confirmed findings and that agency added entries into CR3 after it learned of patient's allegations. Interview with EMP10 (director of compliance) on April 13, 2023, at 11 a.m. confirmed wound measurements are to occur weekly.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on review of agency policy, clinical records (CR), and staff (EMP) interview, the licensed practical nurse and the registered nurse failed to ensure there was an ongoing interdisciplinary assessment of the patients' needs for two (2) of three (3) records reviewed (CR1, & CR2). Findings included: Review of agency policy on April 13, 2023, at 10:03 a.m. showed, "Policy: VIII-1 ... Concordia Visiting Nurses Promotes Clear communication between all physicians and the agency to ensure the coordinated delivery of quality care. The cooperative effort of the physician and the agency require a comprehensive exchange of information between the physician and the agency in relation to the treatment goals, clinical interventions, ... the timely exchange of clinical questions and concerns and other relevant matters Review of CR1 on April 11, 2023, at 10:40 a.m. showed a physician ordered plan of care for an initial certification period from 12/8/2022 to 2/5/2023. The patient was status post surgery and the patient's surgeon was his attending. Orders included skilled nursing (SN) to see the patient twice a week initially with visits decreasing to once a week, "Skilled nurse to observe and assess integumentary status to identify changes and intervene to minimize complications. During the initial nursing assessment completed on 12/8/2022, the registered nurse (RN) documented the patient had six (6) wounds. A subsequent nursing visit completed on 12/13/2022 revealed that the licensed practical nurse (LPN) failed to assess the patient's six (6) wounds, "Wounds Assessed ... No, caregiver completed care." Review of CR2 on April 12, 2023, at 10:30 a.m. showed a physician ordered plan of care for an initial certification period from 1/25/2023 to 3/25/2023. The patient was status post surgery and the patient's surgeon was the attending. Orders included skilled nursing (SN) to see the patient three times per week, "Skilled nurse to observe and assess integumentary status to identify changes and intervene to minimize complications. ... A plan of care will be established that meets all patient's nursing needs and countersigned by physician." During the initial nursing assessment completed on 12/8/2022, the registered nurse (RN) documented the patient had a post-operative incision closed with staples (wound #2). The wound was 14 centimeters (cm) long, 0.1 cm wide, and 0.2 cm deep (14 x 0.1 x 0.2). Five (5) subsequent SN visits from 1/27 to 2/6/2023 showed that nursing staff failed to document how many staples the patient's wound had. Additionally, during three (3) skilled nursing visits the week of 1/29/2023, SN failed to measure the post-operative incision (1/30, 2/1, and 2/3/2023). On April 13, 2023, at 11 a.m., phone interviews were conducted with nurses who assessed and provided care to CR2: EMP21 (RN), EMP22 (LPN), and EMP23 (RN). All three (3) nurses were unable to recall how many staples the patient's incision contained. EMP10 (director of compliance) was present during the interviews. Interview with EMP1 and EMP2 on April 13, 2023, at 12 p.m. confirmed above findings.

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on review of agency policy, clinical records (CR), and staff (EMP) interview, the clinical manager failed to coordinate patient care and referrals, failed to assure that patient needs are continually assessed, and failed to ensure the plan of care was developed and implemented for two (2) of two (2) records (CR1, & CR2). Findings included: Review of agency policy on April 13, 2023, at 10:30 a.m. showed, "Policy: IX-13 ... Concordia Visiting Nurses ensures clinical care is provided under the direction of qualified leadership at all times. ... The clinical manager will be responsible for, at a minimum: 1. The direction, coordination, and overall supervision of all services provided by direct care staff ... 2. The clinical manager's oversight must include the following: ... b) Coordinating patient care c) coordinating referrals d) ensuring the needs of the patient are continually assessed e) Ensuring the development and implementation, and updates of the individualized plan of care." Reviews of CR1 on April 11, 2023, at 10:40 a.m. and CR2 on April 12, 2023, at 10:30 a.m. found deficient practice related to coordination of care, patient needs and plan of care development and implementation as outlined in G434, G512, G608, G706, and G1022. Interview with EMP1 and EMP2 on April 13, 2023, at 12 p.m. confirmed above findings.

Contents of clinical record CFR(s): 484.110(a) Standard: Contents of clinical record. The record must include: This STANDARD is not met as evidenced by: Based on review of policy, a clinical record (CR), and staff interview, the agency failed to maintain accurate clinical record information for one (1) of three (3) clinical records (CR3). Findings included: Review of agency policy on April 12, 2013, at 2:16 p.m. showed, "Policy: III-2 It is the policy of Concordia Visiting Nurses to provide continuity of patient care through communication of accurate, thorough and legal documentation of the patient situation. ... Accurate medical records will provide data that allows for investigation into specific quality concerns. ... For electronic documentation: 1. All routine visit notes are to be completed within 24 hours." Review of CR3 on April 12, 2023, at 2 p.m. showed a physician ordered plan of care with an initial certification period from 3/27 to 5/25/2023. The plan included SN to see the patient twice a week for the first week and then once a week for assessment and treatment of the patient status post circulatory system surgery. Review of SN visit notes did not show the patient received a visit the week of 4/2/2023. During an interview with patient on 4/12/2023 at 2:05 p.m., the patient said he had a doctor's appointment on 4/5/2023 and was unable to have SN make a visit that day. CR3 said the LPN would call back to reschedule but never did. Note: surveyor became aware of CR3's allegations against agency on 4/12/2023 at 12 p.m. at which agency was informed of allegations and CR3 was requested for review. Only then did the LPN add (late) an entry into CR3 concerning the above missed visits dated for 4/12/2023. EMP3 (branch manager) also entered a note when he/she spoke to CR3 about not receiving a visit, but he/she made not clinical record entry until 4/12/2023. Interviews with EMP1, EMP2, and EMP4 on April 12, 2023, at approximately 2:30 p.m. confirmed findings. EMP3 (branch manager) confirmed he/she did not make an entry until 4/12/2023 because of the holiday (Easter).

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 review of agency policy, clinical records (CR), and staff (EMP) interview, the agency failed to send a completed discharge summary to other health care professional who will be responsible for providing care and services to the patient after discharge for two (2) of three (3) records (CR1, & CR2). Findings included: Review of agency policy on April 13, 2023, at 11 a.m. showed, "Policy: VII-4 All Concordia Visiting Nurses patients/caregivers are involved in the coordination of discharge from the agency. ... Agency standards for care require a discharge summary to be written for home health patients and sent to physician within five days of discharge." Review of CR1 on April 11, 2023, at 10:40 a.m. showed a physician ordered plan of care for an initial certification period from 12/8/2022 to 2/5/2023. The patient was status-post surgery and the patient's surgeon was his attending. The patient's primary care physician (PCP) was also listed on the plan of care, "Home health may accept orders from the following physicians: ... [MD1]. On 12/29/2022, the patient saw a new PCP [MD2] and orders were received to change some of patient's medications. CR1 was discharge from the agency on 1/13/2023, but no discharge summary was sent to MD2. Review of CR2 on April 12, 2023, at 10:30 a.m. showed a physician ordered plan of care for an initial certification period from 1/25/2023 to 3/25/2023. The patient was status-post surgery and the patient's surgeon was the attending. The patient's PCP was also listed on the plan of care. Per the 1/25/2023 registered nurse start of care visit note, "Indicate if you communicated with other interdisciplinary team members involved in the case: Yes ... What discipline did you communicate with: Physician ... What physician did you communicate with: [MD3/CR2's PCP]." The patient was discharged on 2/22/2023, but no discharge summary was sent to MD2. Interview with EMP1 and EMP2 on April 13, 2023, at 12 p.m. confirmed above findings.

Based on the findings of an onsite unannounced complaint investigation completed October 20, 2022, Concordia Visiting Nurses 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. The survey was conducted at the Cabot location.

HHA can no longer meet the patient's needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient's welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities; This ELEMENT is not met as evidenced by: Based on review of agency policy, a clinical record (CR), and staff (EMP) interview, the agency failed to arrange a safe and appropriate transfer of care to another care entities when the needs of the patient exceeded the HHA's capabilities for one (1) of one (1) clinical record who was discharged (CR1). Findings included: Review of agency policy on October 19, 2022, at 12 p.m. showed, "SUBJECT: Transfer of Patients ... Policy: VII-3 ... I. Policy It shall be the policy of Concordia Visiting Nurses to provide orderly transfer of patients and their records in circumstances where another service provider is need ... Continuity of care is a priority in the event Concordia Visiting Nurses is unable to maintain or deliver Home Health Services. II. Procedure A. Concordia Visiting Nurses patient(s) will be referred to another agency due to any of the following circumstances: 1. If the patient's needs cannot be met by this Agency ... 4. If there are safety concerns for agency staff within the patient's home. 5. If the patient does not meet the Patient Responsibilities as outlined in the Patient Information Booklet. ... J. Transfer of any Agency patients to another level of care: Once the agency becomes aware of the transfer, notification shall be given to the: ... The new service provider. K. Selection of Successor, if applicable: The patient will be given a list of available providers for the selection of a successor. New providers are notified as per procedure." Review of CR1 on October 19, 2022, at 10 a.m. showed a physician ordered plan of care with an initial certification period from 8/19/2022 to 10/17/2022. Patient had private insurance with an admitting diagnoses included wounds, hypertension, diabetes, and below knee amputations. Skilled nursing (SN), physical therapy (PT), and occupational therapy (OT) services were ordered. Per the plan of care, SN was to perform wound care. The patient was to perform wound care on days when agency was not in the home. Eighteen SN visits from start of care on 8/19 to 10/3/2022 showed the patient was self-neglecting and not participating in his care. On 8/27/2022, the patient refused physical therapy evaluation and services. The patient had difficulty walking related to double below knee amputations. On 8/29/2022, the patient refused OT services. During this time the patient refused to follow his plan of care concerning managing his diabetes with blood sugar checks, taking insulin and other ordered medications. The patient refused to participate in his plan of care and refused to perform dressing changes to wounds on days when SN was not providing services. SN nursing provided education throughout the episode concerning the detriments of not following the plan of care and taking prescribed medication but CR1 refused to comply with necessary care. On 9/27/2022, during case conference, it was noted that patient was alert and orientated and could verbalize how to perform dressing changes but that he did not want to do it. The conference noted continued non-compliance with the plan of treatment. Agency decided to move ahead with physician approved patient contract for safety. During a home visit on 9/28/2022, a registered nurse and social worker presented the patient a contract for safety, but he refused to sign. The contract included, "CARE COMPLAINCE CONTRACT ... This agreement is between [CR1] and Concordia Visiting Nurses In an effort to better care for you, the following expectations are required to maintain an effective provider-patient relationship CARE EXPECTATION 1. I understand that I am accountable for my outcomes, if I refuse care or do not follow the plan of care as ordered by my doctor. 2. I understand that I need to be compliant with the current wound care orders. This is to include but not limited to learning wound care, understanding the need for current wound care, and demonstrating ability to perform wound care. 3. I agree to be compliant with testing blood sugars, which will help prevent worsening of my already existing conditions and try to improve my current health status, as well as taking ordered medications as prescribed to aid in preventing exacerbations of current health conditions. 4. I understand that it is my responsibility to permit agency staff to perform assessment that includes examining all skin including buttocks for potential skin breakdown." The social worker documented that she told the patient he would most likely be discharged since he refused to contract for safety. According to physician's order, "Order Date: 10/3/2022 ... Agency DC week of 10/3/2022 following setting up new home health agency for wound care." Per coordination note, "10/5/2022 ... Called MD office to see where we were at with the need for patient to secure referral to another agency. [Attending physician] has notes in system ... he doesn't think going to another agency will change anything and he feels there's no way to make him [patient] more compliant -- however [they] are going to have [case manager] try to set the referral up with [another home health agency]." Per coordination note on 10/6/2022 the patient chose another home health agency but Concordia failed to contact the receiving agency, "Patient called RN following follow up appointment with [new wound clinic doctor] through [another provider associated with another home health agency]. Patient was taken under services with [different] wound care center. Per patient MD was going to make referral to [...] home health per patient's request. RN informed patient he is on RNs schedule for 10/7/2022 for a phone discharge and that RN would call [new wound clinic doctor]'s office in AM to follow up about a new home care agency and would then call patient for DC. RN called [new wound clinic doctor]'s office and spoke with [RN] who stated referral was sent to [...] home care and patient was accepted." Per coordination note from 10/13/2022, wound clinic called agency and noted that they were unable to find patient another agency-- patient is currently back on service with Concordia visiting nurses and remains non-compliant. Interviews with EMP1 and EMP3 on October 19, 2022, from 12 p.m. to 1 p.m., and a phone interview with EMP3 on October 20, 2022, confirmed the above findings and that patient was discharged on 10/7/2022. Concordia Visiting Nurses never made direct contact with the receiving home health agency to coordinate a safe transfer of care but instead relied on staff at wound clinic (a third party) to arrange the referral and transfer to another home health agency. EMP3 confirmed that Concordia was communicating with the wound clinic for patient's referral and that the wound clinic's parent company never sent the referral to the parent company's home health agency. The reliance on a third party for referral and transfer of care instead of coordinating directly with the receiving home health agency caused a delay in patient's care-- 10 days without services.

Provide contact info other services CFR(s): 484.50(d)(5)(iii) (iii) Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care; and This ELEMENT is not met as evidenced by: Based on review of agency policy, a clinical record (CR), and staff (EMP) interview, the agency failed to provide the patient with contact information for other agencies or providers who may be able to provide care prior to discharge for one (1) of one (1) discharged record (CR1). Findings included: Review of agency policy on October 19, 2022, at 12 p.m. showed, "SUBJECT: Discharge Policy .... Policy: VII-4 ... II. Procedure ... E. Discharge occurs in the following situations: ... 12. The patient/caregiver is unable or unwilling to participate in care necessary to support a safe level of care and/or progress towards established goals. The clinical record should reflect: ... There should be evidence in the clinical record that the patient and/or representative was provided information including contact numbers for other agencies or providers that may be able to provide services to the patient. The physician and patient are both notified of this decision both verbally and in writing." "SUBJECT: Transfer of Patients ... Policy: VII-3 ... I. Policy It shall be the policy of Concordia Visiting Nurses to provide orderly transfer of patients and their records in circumstances where another service provider is need ... Continuity of care is a priority in the event Concordia Visiting Nurses is unable to maintain or deliver Home Health Services. ... J. Transfer of any Agency patients to another level of care: ... The patient will be given a list of available providers for the selection of a successor. New providers are notified as per procedure." Review of CR1 on October 19, 2022, at 10 a.m. showed a physician ordered plan of care with an initial certification period from 8/19/2022 to 10/17/2022. Patient had private insurance with an admitting diagnoses included wounds, hypertension, diabetes, and below knee amputations. Skilled nursing (SN), physical therapy (PT), and occupational therapy (OT) services were ordered. Per the plan of care, SN was to perform wound care. The patient was to perform wound care on days when agency was not in the home. Eighteen SN visits from start of care on 8/19 to 10/3/2022 showed the patient was self-neglecting and not participating in his care. On 8/27/2022, the patient refused physical therapy evaluation and services. The patient had difficulty walking related to double below knee amputations. On 8/29/2022, the patient refused OT services. During this time the patient refused to follow his plan of care concerning managing his diabetes with blood sugar checks, taking insulin and other ordered medications. The patient refused to participate in his plan of care and refused to perform dressing changes to wounds on days when SN was not providing services. SN nursing provided education throughout the episode concerning the detriments of not following the plan of care and taking prescribed medication but CR1 refused to comply with necessary care. On 9/27/2022, during case conference, it was noted that patient was alert and orientated and could verbalize how to perform dressing changes but that he does not want to do it. The conference noted continued non-compliance with the plan of treatment. Agency decided to move ahead with physician approved patient contract for safety. During a home visit on 9/28/2022, a registered nurse and social worker presented the patient a contract for safety, but he refused to sign. The contract included, "CARE COMPLAINCE CONTRACT ... This agreement is between [CR1] and Concordia Visiting Nurses In an effort to better care for you, the following expectations are required to maintain an effective provider-patient relationship CARE EXPECTATION 1. I understand that I am accountable for my outcomes, if I refuse care or do not follow the plan of care as ordered by my doctor. 2. I understand that I need to be compliant with the current wound care orders. This is to include but not limited to learning wound care, understanding the need for current wound care, and demonstrating ability to perform wound care. 3. I agree to be compliant with testing blood sugars, which will help prevent worsening of my already existing conditions and try to improve my current health status, as well as taking ordered medications as prescribed to aid in preventing exacerbations of current health conditions. 4. I understand that it is my responsibility to permit agency staff to perform assessment that includes examining all skin including buttocks for potential skin breakdown." The social worker documented that he/she told the patient he would most likely be discharged since he refused to contract for safety. According to physician's order, "Order Date: 10/3/2022 ... Agency DC week of 10/3/2022 following setting up new home health agency for wound care." Per coordination note, "10/6/2022 ... Patient called RN following follow up appointment with [new wound clinic doctor] through [another provider associated with another home health agency]. Patient was taken under services with [different] wound care center. Per patient MD was going to make referral to [...] home health per patient's request. RN informed patient he is on RNs schedule for 10/7/2022 for a phone discharge and that RN would call [new wound clinic doctor]'s office in AM to follow up about a new home care agency and would then call patient for DC. RN called [new wound clinic doctor]'s office and spoke with [RN] who stated referral was sent to [...] home care and patient was accepted." Interviews with EMP1 and EMP3 on October 19, 2022, from 12 p.m. to 1 p.m. confirmed patient was discharged from agency on 10/7/2022 without first receiving contact information for other agencies or providers who may be able to provide 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 review of a clinical record (CR), and staff (EMP) interview, the agency failed coordinate care to meet the needs of the patient for one (1) of one (1) patient who was discharged (CR1). FIndings included: Review of CR1 on October 19, 2022, at 10 a.m. showed a physician ordered plan of care with an initial certification period from 8/19/2022 to 10/17/2022. Patient had private insurance with an admitting diagnoses included wounds, hypertension, diabetes, and below knee amputations. Skilled nursing (SN), physical therapy (PT), and occupational therapy (OT) services were ordered. Per the plan of care, SN was to perform wound care. The patient was to perform wound care on days when agency was not in the home. According to physician's order, "Order Date: 10/3/2022 ... Agency DC week of 10/3/2022 following setting up new home health agency for wound care." Per coordination note, "10/5/2022 ... Called MD office to see where we were at with the need for patient to secure referral to another agency. [Attending physician] has notes in system ... he doesn't think going to another agency will change anything and he feels there's no way to make him [patient] more compliant -- however [they] are going to have [case manager] try to set the referral up with [another home health agency]." Per coordination note, "10/6/2022 ... Patient called RN following follow up appointment with [new wound clinic doctor] through [another provider associated with another home health agency]. Patient was taken under services with [different] wound care center. Per patient MD was going to make referral to [...] home health per patient's request. RN informed patient he is on RNs schedule for 10/7/2022 for a phone discharge and that RN would call [new wound clinic doctor]'s office in AM to follow up about a new home care agency and would then call patient for DC. RN called [new wound clinic doctor]'s office and spoke with [RN] who stated referral was sent to [...] home care and patient was accepted." Per coordination note from 10/13/2022, wound clinic called agency and noted that they were unable to find patient another agency-- patient is currently back on service with Concordia visiting nurses and remains non-compliant. Interviews with EMP1 and EMP3 on October 19, 2022, from 12 p.m. to 1 p.m., and a phone interview with EMP3 on October 20, 2022, confirmed the above findings. Concordia Visiting Nurses never made direct contact with the receiving home health agency to coordinate a safe transfer of care but instead relied on staff at wound clinic (a third party) to arrange for referral and transfer to another home health agency. EMP3 confirmed that Concordia was communicating with the wound clinic for patient's referral and that the wound clinic's parent company never sent the referral to the parent company's home health agency. The reliance on a third party for referral and transfer of care instead of coordinating directly with receiving home health agency caused a delay in patient's care-- 10 days without services.