Every finding on record at Mary Washington Healthcare

An unannounced Home Health Agency recertification survey was conducted on April 12-15, 2021 by three (3) Medical Facilities Inspectors from The Office of Licensure and Certification, Virginia Department of Health. In conjunction with this survey, the agency's emergency preparedness plan was reviewed. The agency was found to be in compliance with 42 CFR 484.102 Conditions of Participation Emergency Preparedness for Home Health Agencies.

An unannounced Medicare/Medicaid Home Health recertification survey was conducted at the above noted agency on April 12-15, 2021 by three (3) Medical Facilities Inspectors from the Virginia Department of Health, Office of Licensure and Certification. Portions of the survey were conducted remotely due to the COVID-19 Public Health Emergency. The agency identified 1806 unduplicated admissions in the last 12 months and does not operate any branches or drop sites. An Immediate Jeopardy (IJ) finding was identified by the MFIs, was reported to the Office of Licensure and Certification (OLC), and reviewed by OLC management staff on April 14, 2021 at 9:30 AM. The Immediate Jeopardy was related to uncontrolled pain with no intervention by agency staff for two (2) patients, #'s1, and 10. These patients' clinical records contained documentation of uncontrolled pain with no intervention to control the pain was noted during record review. Two (2) out of three (3) clinical records of patients experiencing uncontrolled pain failed to demonstrate physician notification or collaboration, or intervention to control pain, or follow-up. At the time immediate jeopardy was identified, two (2) of three (3) clinical records contained documentation of uncontrolled pain. At the completion of record review, three (3) of nine (9) clinical records reviewed in the survey sample contained documentation of uncontrolled pain. The first instance of uncontrolled pain and the date immediate jeopardy began was documented in the clinical record of patient #1 on 7/01/2020 when the patient identified a pain level of 10/10 and the home health agency failed to notify the physician of the pain or complete an intervention to reduce pain. The findings related to immediate jeopardy were reviewed with home health agency management to include the Administrator, the Quality Assurance and Performance Improvement/Education Manager, and the Director of Regulatory Affairs/Risk Management on April 14, 2021 at 10:05 AM. The home health agency submitted an acceptable plan of removal for the IJ at 1:35 PM on April 15, 2021. The MFIs confirmed that the agency had completed the plan for removal and the Immediate Jeopardy was abated on April 15, 2021 at 1:55 PM. The Immediate Jeopardy findings are now cited at the Condition level. All Conditions of Participation for Home Health agencies were reviewed. The agency was found not in compliance with 42 CFR 484 Conditions of Participation for Home Health Agencies. Significant corrections are required due to substantial non-compliance with the following Conditions of Participation: 484.60 Care Planning, and Coordination of Services, and Quality of Care 484.105 Organization and Administration of Services

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on review of clinical records and interview it was determined the agency failed to ensure each patient was advised in advance of providing care the extent to which payment for HHA (home health agency) services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, the charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, and the charges the individual may have to pay before care is initiated. Specifically, two (2) of (17) clinical records reviewed in the survey sample failed to contain the above information. (Clinical record #s 4 and 8). The findings: Seventeen (17) clinical records were reviewed in the agency on 4/12-14/2021 with staff members #1 and #5 as electronic health record navigators with the following findings: 1. The clinical record for Patient #4 with a start of care date of 11/6/2020 contained a consent form that failed to include documentation of their financial liabilities. During the clinical record review on 4/12/2021 at 3:40 PM staff member #1 verified the financial liability section on the consent was left blank. 2. The clinical record for Patient #8 with a start of care date of 3/9/2021 contained a consent form that failed to include documentation of the patient's financial liabilities. During the clinical record review on 4/13/2021 at 4:30 PM staff member #5 verified the financial liability section on the consent was left blank. The lack of documentation in the clinical records regarding the financial liability was acknowledged by staff members #1 and #5 during the clinical record reviews, and again with the Administrator, the Quality Assurance and Performance Improvement/Education Manager, and the Director of Regulatory Affairs/Risk Management at the exit conference of 4/15/2021

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on clinical record review and staff interview, it was determined the agency failed to provide a Home Health Change of Care Notice (HHCCN) to a Medicare patient in advance of reducing/discontinuing services for one (1) of one (1) clinical record's in the survey sample for which a HHCCN was applicable (Clinical record: #3). The findings: Seventeen (17) clinical records were reviewed in the agency on 4/12-14/2021 with staff members #1 and #5 as electronic health record navigators with the following findings: 1. The clinical record for Patient #3 was reviewed for the certification of 11/1/2020 to 12/30/2020. The plan of care contained a physician's order for Skilled Nursing (SN) visits two (2) times a week for one (1) week, then one (1) time a week for eight (8) weeks. The clinical record contained documentation that the SN discontinued services on 12/2/2020 prior to the nine (9) weeks as ordered by physician. The clinical record failed to contain evidence the agency provided the patient an advance notice/Home Health Change of Care Notice (HHCCN) prior to terminating the patient from the agency's services. On 4/12/2020 at 3:05 PM an interview was conducted with staff member #1 regarding the patient's advance notice of early discharge. Staff member #1 stated, "I will look in the basement of the agency this evening and look for it". On 4/13/2020 at 9:00 AM staff member #1 stated, I did not find it. The lack of providing patients a written notice in advance of terminating on-going care was reviewed with staff member #1 during the clinical record review, and again with the Administrator, the Quality Assurance and Performance Improvement/Education Manager, and the Director of Regulatory Affairs/Risk Management at the exit conference of 4/15/2021

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 staff interviews and clinical record review it was determined the agency failed to provide safe care as ordered by a physician. Specifically, the agency failed to ensure that all plans of care were complete and accurate (refer to G574); the agency failed to ensure conformance with physician orders (refer to G578); the agency failed to promptly alert the physician to changes in the patient's status (refer to G590); the agency failed to demonstrate coordination of care (refer to G608). This condition was associated with a finding of Immediate Jeopardy identified by the MFIs (Medical Facilities Inspector), was reported to the Office of Licensure and Certification (OLC), and reviewed by OLC management staff on April 14, 2021 at 9:30 AM. At the time the Immediate Jeopardy was identified it was related to uncontrolled pain with no intervention (pain or symptom management) by agency staff for two (2) patients, #'s1, and 10. The patients clinical records contained documentation of uncontrolled pain with no intervention to control the pain was noted during record review. Two (2) out of three (3) clinical records of patients experiencing uncontrolled pain failed to demonstrate physician notification or collaboration, or interventions to control the pain, or follow-up. At the completion of record review, three (3) of nine (9) clinical records reviewed in the survey sample contained documentation of uncontrolled pain. The first instance of uncontrolled pain and the date immediate jeopardy began was documented in the clinical record of patient #1 on 7/01/2020 when the patient identified a pain level of 10/10 and the home health agency failed to notify the physician of the pain or complete an intervention to reduce pain. On April 15, 2021 at 1:35 PM the home health agency submitted an acceptable plan of removal. The Plan of Removal consisted of a revision to the previous pain management policy to include an alert to the physician within 24 hours of changes in the patient's condition. The plan of care will reflect a realistic pain goal and if not achievable will update the plan of care with a new pain goal. In addition, education was conducted with all clinicians in person and virtually to address the revised pain policy and the plan of care as it relates to each patient and their pain. All education has been completed prior to the exit conference except for the clinicians who are on vacation or medical leave or currently not working. Those clinicians will be required to complete the education before visiting patients. Additionally, the QAPI manager will monitor the clinical records of patients who are identified with active pain to ensure the revised policies are being followed until 100% compliance is achieved. The MFIs have confirmed that the agency has completed the plan for removal and the Immediate Jeopardy was abated on April 15, 2021 at 1:55 PM.

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 a review of clinical records and staff interview it was determined agency staff failed to ensure a plan of care contained the specific location of a surgical wound for wound care that was ordered by the physician. One (1) of nine (9) patients who required wound care failed to have the location of the wound documented in their clinical records and were reviewed as part of the survey sample (Clinical record: #2). The findings: Seventeen (17) clinical records were reviewed in the agency on 4/12-14/2021 with staff members #1 and #5 as electronic health record navigators with the following findings: 1. The clinical record for Patient #2 was reviewed for the certification period of 8/28/2020 to 10/26/2020. The plan of care contained orders for Physical Therapy services as follows: Wound care-Joint replacement skilled assessment of surgical site (Assess surgical wound for healing, signs and symptoms of infection, incision approximation/dehiscence). During the clinical record review on 4/12/2021 at 2:00 PM staff member #1 verified the failure of the surgical wound location to be documented in the plan of care. The above physician's order failed to state where the wound was located.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on review of clinical records and staff interviews it was determined agency staff failed to follow the plan of care as ordered by physician for four (4) out of 17 patients whose clinical records were reviewed in the survey sample (Clinical records #'s: 1, 3, 5 and 16). The findings: Seventeen clinical records were reviewed in the agency on 4/12-14/2021 with staff members #1 and #5 as electronic health record navigators with the following findings: 1. The clinical record for Patient #1 was reviewed for the certification period of 7/1/2020 to 8/29/2020. The plan of care for the above noted timeframe contained orders for Physical Therapy (PT) services two (2) times a week for four (4) weeks and one (1) time a week for two (2) weeks. The clinical record for this time frame contained documentation of two (2) PT missed visits, on 7/7/2020 and on 7/24/2020. During the clinical record review on 4/12/2021 at 1:20 PM staff member #1 verified the physician was not notified of the two missed visits noted above. The clinical record failed to contain documentation that the patient's physician was notified of the visits not being provided in accordance with the patient's plan of care. 2. The clinical record for Patient #3 was reviewed for the certification period of 11/1/2020 to 12/30/2020. The plan of care for the above noted timeframe contained orders for Skilled Nurse (SN) services two (2) times a week for one (1) week and one (1) time a week for eight (8) weeks. For this time frame, the record contained no (0) visit documentation for the week of 11/22/2020 through 11/28/2020 when one visit was ordered. During the clinical record review on 4/12/2021 at 3:05 PM staff member #1 verified the physician was not notified of the above missed visit. The clinical record failed to contain documentation that the patient's physician was notified of the visit not being provided in accordance with the patient's plan of care. 3. The clinical record for Patient #5 with a diagnosis of congestive heart failure was reviewed for the recertification period of 12/20/2020 to 2/17/2021. The plan of care contained physician orders as follows: Parameters to call physician, 2-3 lb weight gain in 24 hours, 5 lb weight gain in 1 week. During the clinical record review on 4/13/2021 at 11:20 AM staff member #5 verified that weights were not documented in the clinical record for this time frame. Staff member #5 provided this Medical Facilities Inspector with a discharge OASIS dated 1/19/2021 to help verify if any patient weights were obtained. The discharge OASIS contained a section under vital signs that read as follows: "Recent Weight Change-Has the patient's weight changed with in the last 3 months?" This section was left blank and staff member #5 verified that this section should have been filled in with a yes or no answer. The clinical record failed to contain documentation that the patient's physician was notified of the patient's weight not being assessed during the above noted time frame. 4. The clinical record for Patient #16 was reviewed for the certification period of 3/27/2021 to 5/25/2021. The plan of care contained physician orders as follows: Wound care-Skilled nurse/Family/Caregiver to perform dressing change to: Left shin skin tear-3 layers of Xeroform (dressing that keeps air out to promote a moist environment) applied to provide moist wound healing and bacteriostatic properties, covered with ABD (bulky dressing) to absorb drainage and protect, secure with wrap gauze 2x weekly. Right shin-small amount of petroleum and small foam dressing 2x weekly. The clinical record revealed the right and left shin were open to air for this entire time frame. The start of care OASIS for 3/27/2021, contained skilled nursing documentation that the patient refused the above ordered dressing to the right and left shin due to the podiatrist wanting to leave the areas open to air. During the clinical record review on 4/13/2021 at 10:50 AM staff member #5 verified the physician was not notified that the right and left shin wounds were left open to air. The clinical record failed to contain documentation that the patient's physician was notified of the wound care not being provided in accordance with the patient's plan of care. The above noted findings regarding the failure of agency's staff to conform with physician's orders was reviewed with staff #1 and #5 during the clinical record review and again with the Administrator, the Quality Assurance and Performance Improvement/Education Manager, and the Director of Regulatory Affairs/Risk Management at the exit conference of 4/15/2021

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 review of clinical records, select policy review and interviews, it was determined the agency failed to ensure the physician was promptly notified of changes in the patient's condition that indicated desired outcomes were not being met or that changes were needed in the plan of care. Specifically, the physician was not notified about uncontrolled pain in three (3) of nine (9) patients whose clinical records were reviewed in the survey sample and who experienced uncontrolled pain (Clinical records #'s 1, 9 and 10). The findings: Seventeen (17) clinical records were reviewed in the agency on 4/12-14/2021 with staff members #1 and #5 as electronic health record navigators with the following findings: 1. The clinical record for Patient #1 contained a plan of care for Physical Therapy services to instruct on pain management techniques and the skilled assessment of pain. The measurable goals for pain included the patient/caregiver/family to report verbal or nonverbal means, a reduction/adequate control of pain by 8/8/2020, with a pain goal of <= (less than or equal to) 3/10. The agency utilized the standard numerical scale for rating pain with zero (0) being no pain and (10) being worse pain. A review of the Physical Therapist clinical notes for the certification period of 7/1/2020 through 8/29/2020 revealed the patient's lowest pain was recorded as a six (6) and at one visit with pain reaching as high as a (10) within a 24 hour time period. Specific details for pain reported by the patient at each therapy visit was recorded as follows: 7/1/2020-(10/10) "burning hard" to left hip down to toes. 7/2/2020-(10/10) back and left leg with documentation of NA (not available) for relieving factors. 7/14/2020-(7/10) ache to back and left leg. 7/17/2020-(8/10) burn to left leg with documentation of NA (not available) for relieving factors. 7/22/2021-(7/10) ache to back and left hip with documentation of NA (not available) for relieving factors. 7/29/2020-(7/10) burn to left hip, 6/10 burn to left leg, 7/10 ache to the back. 8/4/2020-(10/10) throbbing and burning. No location of the pain was documented. The clinical record contained documented pain levels consistently running from (7-10) for most visits as noted above and the patient was discharged from the home health agency on 8/4/2020 with a pain score of 10/10. There was no indication in the record of the therapist having contacted the physician related to the patient's pain or making changes to the plan of care. An interview was conducted on 4/14/2021 at 10:17 AM with the Physical Therapist (staff member #7) who documented Patient #1's start of care and discharge. Staff member #7 called the Administrator's phone to conduct the interview via speaker telephone with the Administrator present. This MFI (Medical Facilities Inspector) asked staff member #7 why was the patient's pain goal a <=3 when it was documented the patient had a pain score of 10/10 on the start of care. Staff member #7 stated, during my initial interview (start of care) she was lively and jovial so her pain goal was a 3/10. The start of care documentation did not reflect this in the visit note. Staff member #7 also stated, at discharge she did improve lumbar flexion but it did not touch the pain, if you read my notes her ability to move significantly improved. This MFI asked staff member #7 why was the plan of care not revised to reflect the patient's pain levels from 6/10 to 10/10 and why wasn't the physician notified of pain not progressing toward the pain goal of 3/10. Staff member #7 stated, I don't understand, her therapy did improve and I disagree with you. 2. The clinical record for Patient #9 contained a plan of care for skilled nurse (SN) services, nurse to perform wound VAC (a suction pump device to remove drainage away from a wound) dressing change to coccyx Monday, Wednesday and Friday with a long term comfort goal measure to promote comfort and was scored as a 0/10. The agency utilized the standard numerical scale for rating pain with zero (0) being no pain and (10) being worse pain. In addition, the plan of care contained physician orders for Oxycontin 20 mg by mouth three times as day, Oxycodone 5 mg by mouth two times a day if needed for moderate pain and a Lidocaine 4% patch to apply topically three times a day if needed for pain. A review of the SN clinical notes for the recertification period of 4/6/2021 through 6/4/2021 revealed the patient's lowest pain was documented as a five (5) at one visit with pain reaching as high as a seven (7) within a 24 hour time period. Specific details about pain reported by the patient at each SN visit as follows: 4/7/2021-(7/10) constant to left hip. No documentation on exacerbating factors or duration of pain episode but documented pain medication as a relieving factor. 4/9/2021-(6/10) achy intermittent generalized with documentation of no exacerbating factors or relieving factors. 4/12/2021-(5/10) achy constant generalized. The clinical record contained interventions for a long term comfort goal that was based on the skilled pain assessment for each of the above visits, however, many of the skilled pain assessments were incomplete. The visit dated 4/7/2021 lacked what the exacerbating factor was or the highest level of pain in the past 24 hours and what pain medication relieved the pain. The clinicians were also not documenting the progression of pain, associated symptoms, pain affects and other areas of the pain assessment tool. Throughout the clinical visit notes, there was no indication of how often the patient was taking the Oxycontin, Oxycodone or the Lidocaine 4% patch for pain. There was no documentation of the SN contacting the physician related to the patient's uncontrolled pain. The interventions documented on each visit note were the same, assess/teach pain management techniques with no progression documented towards the desired outcomes. During the clinical record review on 4/14/2021 at 10:35 AM this MFI asked staff member #1 how can the staff tell if the patient's pain improved with incomplete pain assessments documented such as the visit dated 4/7/2021. The clinician documented pain medications as a relieving factor with a pain level reported as 7/10 when the patient is on two different types of pain medications and a patch for pain or how much medication was given when the SN did not document a complete pain assessment. Staff member #1 did not reply. There was no indication in the record of the SN having contacted the physician related to the patient's pain or making changes to the plan of care. 3. The clinical record for patient #10 was reviewed for the certification period of 2/24/2021-4/24/2021. The record review was conducted on April 12-13, 2021 with staff #5 as the navigator. The plan of care for patient #10 contained interventions and goals for pain however, the goals were not measurable. The goal was listed under all disciplines as "patients initial comfort goal is minimal pain". The long- term goal was listed as "measures to promote comfort will be effective within 8 visits as evidenced by discussion and demonstration. Patients long-term goal is minimal pain". The plan contained orders for Gabapentin 300 mg two (2) times per day for nerve pain and Tramadol/Acetaminophen 37.5-325 mg per tablet 1 (one) tablet every eight (8) hours if needed for moderate pain. Both medications are given by G-tube (a tube inserted through the belly that brings nutrition directly to the stomach) and administered by the caregiver. A review of the clinical notes from nursing revealed the patient had pain rated at eight (8) out of ten (10) on admission. The patient's pain was located in the lower back and further visits through the month of March also revealed pain. A review of the clinical notes from Speech therapy revealed a total of eight (8) visits in the month of March with six (6) visits having pain rated at a six (6) out of ten (10) or higher and two (2) visits with no pain. In April the Speech therapist saw the patient three (3) times with no pain on one visit and two visits with pain at a five (5) out of ten (10). During the visit documented on 3/09/2021, the Speech therapist documented the patient's pain at a seven (7) out of ten (7) and stated the patient had lidocaine patches in the home and the caregiver would put one on the patient. The plan of care and medication profile failed to contain orders for a lidocaine patch. A review of the clinical notes from the physical therapist revealed four visits in the month of March. Three (3) of the four (4) visits had a pain score of five (5) out of ten (10) or greater with one (1) visit documented as no pain. Two (2) visits were conducted in April with both visits having pain rated at five (5) out of ten (10). Many of the clinical notes from all disciplines contained incomplete pain assessments to include the lack of identifying the character, frequency and duration of the pain. The clinicians were also not documenting the progression of pain, associated symptoms, pain affects and other areas of the pain assessment tool. Throughout the clinical visit notes from all disciplines, there was no indication of how often the patient was taking the Tramadol/Acetaminophen for pain. There was also no indication the disciplines coordinated care with each other related to pain management. There was no documentation the disciplines contacted the physician related to the patient's uncontrolled pain. The interventions documented on each visit were the same, assess/teach pain management techniques with no progression towards desired outcomes. A phone interview was conducted with staff #8 on 4/14/2021 at 8:42 AM. Staff #8 opened the patient to services and only saw the patient on one other occasion. The staff member was aware of the patient's pain, was not aware of a pain patch and stated no conversation had taken place with the team related to pain control issues. A phone interview was conducted with staff #15 on 4/14/2021 at 8:53 AM. The staff member acknowledged making the 3/09/2021 visit when the patient's pain was rated a nine (9) out of (10) and reports contacting the physician however, the call to the physician was in regards to the bleeding hemorrhoids. Staff member #15 also stated that the caregiver "is particular about med's (medication), we asked in the beginning and haven't asked in a while". A phone interview was conducted with staff member #14 on 4/14/2021 at 9:05 AM. Staff number #14 did not remember the patient having a pain patch and when asked about the incomplete assessment on 3/02/2021 when the staff member only wrote "back pain", staff #14 replied "if there was a problem I would have put it down". A phone interview was conducted with staff #16 on 4/14/2021 at 9:13 AM. The staff member did not remember the patient being on the lidocaine patch and recalled Tramadol being the primary medication for pain control. Staff #16 stated the patient gets Tramadol at least daily and some days more than once but the exact dose was not known. Staff #16 stated speaking with the nurse about the chronic pain. A phone interview was conducted with staff #12 on 4/14/2021 at 9:43 AM. The staff member stated all staff were aware the patient has chronic back pain and "I think she has used the patch since 2020". A phone interview was conducted with the primary caregiver on 4/14/2021 at 10:50 AM. The caregiver stated the patient is not on a lidocaine patch but is on Salonpas, which is an over the counter patch and the caregiver was not sure if it had lidocaine in it. The caregiver reports the patient is given Tramadol two (2) times a day but can have it three (3) times but never asks for the third dose. The primary caregiver reported asking the physician multiple times for something stronger and does not feel like a patient at this age should have to suffer. The caregiver reports giving up with asking for more medication as "you can only bark up the same tree for so long until your voice gets hoarse". An Internet search for Salonpas revealed it is an over the counter medication and contains Menthol 3%, Methyl Salicylate 10% (non-steroidal anti-inflammatory). Some patches do contain Lidocaine. An interview on 4/16/2021 at 1:45 PM with staff member #11 revealed nursing visited the patient on 4/15/2021 and verified the Salonpas was being used by the patient. The Salonpas in the home did not contain Lidocaine. An interview with staff #5 on 4/13/2021 at 10:20 AM revealed the clinicians in the agency had identified pain as an area where they wanted to focus on and the Quality Improvement committee discussed this in February and were going to start a pain management work group. No actual actions have been taken yet to address pain management. On 4/13/2021 at 4:25 PM the MFI reviewed the agency's pain policy titled, "Pain Management Process". Portions of the policy read as follows: To appropriately alleviate and palliate pain on order to maximize patient comfort by symptom controls and to promote quality of life and the highest function possible for the patient given his/her condition, the clinician will assess the patient's need for pain management comprehensively and consistently. In addition, the policy stated, if the patient rates their pain scale greater than "0", a comprehensive pain assessment must be documented and the physician is informed as needed based upon the patient's condition. The above noted findings regarding the failure of agency staff to notify the physician of the patient's condition as reviewed with staff #1 and #5 during the clinical record review, and were reviewed again with the Administrator, the Quality Assurance and Performance Improvement/Education Manager, and the Director of Regulatory Affairs/Risk Management during the exit conference.

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 a review of clinical records and interviews, it was determined the agency failed to provide coordination of care for three (3) of 17 patients whose clinical records were reviewed in the survey process (Clinical records #'s 1, 9 and 10). The findings: Seventeen (17) clinical records were reviewed in the agency on 4/12-14/2021 with staff members #1 and #5 as electronic health record navigators with the following findings: 1. The clinical record for Patient #1 was reviewed for the certification period of 7/1/2020 to 8/29/2020. The clinical record for this time frame contained documentation of a Physical Therapy Assistant missed visit on 7/24/2020. The visit was declined due to the patient having increased pain. The record failed to contain evidence that the missed visit report was sent to the physician. In addition, the clinical record contained documented pain levels consistently running from (7-10) for most visits. No coordination of care with the physician was ever documented or any follow-up regarding the patient's pain status. On 4/12/2021 at 1:20 PM, the administrator acknowledged the lack of care coordination between staff and the physician during the clinical record review. 2. The clinical record for Patient #9 was reviewed for the recertification period of 4/6/2021 to 6/4/2021. The plan of care contained a long term comfort goal measure to promote comfort and was scored as a 0/10 with physician orders for Oxycontin, Oxycodone or a Lidocaine 4% patch for pain. The clinical record revealed the patient's lowest pain was documented as a five (5) at one visit with pain reaching as high as a seven (7) during the above time frame. The visit dated 4/7/2021 was scored as 7/10 and lacked what the exacerbating factor was or the highest level of pain in the previous 24 hours and what pain medication relieved the pain factors. There was no documentation of SN contacting the physician related to the patient's uncontrolled pain. No coordination of care was ever documented with the physician or any follow-up regarding the patient's pain status. 3. The clinical record for patient #10 revealed the patient had pain identified as a problem on the plan of care. The goal established at the beginning of care was "patients initial comfort goal is minimal pain". The plan contained orders for Gabapentin 300 mg two (2) times per day for nerve pain and Tramadol/Acetaminophen 37.5-325 mg per tablet 1 (one) tablet every eight (8) hours if needed for moderate pain. Both medications are given by G-tube (a tube inserted through the belly that brings nutrition directly to the stomach) and administered by the caregiver. The patient was seen by skilled nursing, physical therapy and speech therapy. Fifteen of twenty-seven visits made by the visiting disciplines revealed the patient had a pain score of five (5) out of ten (10) or greater. There is no evidence in the clinical record that the disciplines coordinated care with each other related to pain management. There is no evidence the disciplines contacted the physician related to the patient's uncontrolled pain. Phone interviews were conducted with staff members #8, 12, 14, 15, and 16 on 4/15/2021. None of the staff reported contacting the physician related to the patient's pain. The case manager staff #8, staff #14, and 16 all reported not being aware the patient had a pain patch. The above noted findings regarding the failure of the agency's staff to coordinate care to meet the patient's needs were reviewed with staff #1 and #5 during the clinical record review, and again with the Administrator, the Quality Assurance and Performance Improvement/Education Manager, and the Director of Regulatory Affairs/Risk Management at the exit conference of 4/15/2021.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation of clinicians during home visits, policy and procedure review, and staff interview, it was determined the agency failed to follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. Specifically, a Medical Facilities Inspector (MFI) observed agency staff's failure to implement standard precautions at three (3) of four (4) home visits where Skilled Nurses (SN) were observed, (the home visits for patients #11, 13, and 14). The findings: Two (2) Medical Facilities Inspectors (MFI) conducted seven (7) home visits for observation of agency staff on April 12 - 13, 2021. 1. The MFI conducted a home visit at Patient #11's home on April 12, 2021 to observe a Skilled Nurse (SN) visit. The MFI was accompanied by a Registered Nurse Clinical Manager (CM), Staff Member #2, and the SN, Staff Member #9. After initiating the visit and performing initial hand hygiene using an alcohol-based hand rub (ABHR), the SN donned a pair of clean gloves. While wearing the gloves the SN placed a face mask on the patient and touched the patient multiple times. After having made direct contact with the patient and the area in the immediate vicinity of the patient, the SN re-entered the clinical bag to retrieve vital sign assessment tools without removing the gloves or performing hand hygiene. The SN re-entered the bag on two (2) additional occasions during the visit wearing the same gloves and without performing hand hygiene to retrieve additional assessment tools. The SN performed a focused skin assessment of Patient #11's lower back and buttocks, including palpation of the area. Following the skin assessment, the SN removed the soiled gloves, but failed to perform hand hygiene before touching the clinical bag and the laptop used during the visit for documentation by the SN. Following the visit, the MFI interviewed the CM regarding the observations made during the visit. The MFI asked the CM if the SN performed hand hygiene prior to re-entering the clinical bag after coming into contact with the patient. The CM confirmed that the SN failed to perform hand hygiene. The MFI asked the CM if the SN performed hand hygiene after removing the soiled gloves during the visit. The CM confirmed that the SN failed to perform hand hygiene after removing the gloves. The MFI requested the agency's policy and procedure for hand hygiene, bag technique, and the provision of wound care on April 12, 2021 from the Quality Assessment and Performance Improvement Manager (QAPIM), Staff Member #5. The QAPIM provided the MFI with a policy titled "Handwashing and Hand Hygiene" on April 12, 2021. the policy read as follows: "Indications for Hand Hygiene and Antisepsis...Use an alcohol-based hand rub routinely for decontaminating hands if hands are not visibly soiled...after contact with a patient's intact skin (e.g. when taking a pulse or blood pressure, and lifting a patient)...after removing gloves and other personal protective equipment (PPE)." The QAPIM provided the MFI with a policy titled "Infection Prevention - Surveillance, Prevention, and Control - MWH Home Health" on April 12, 2021. The policy read as follows: "Clinical bag technique...Keep hand hygiene supplies in outside pocket of clinical bag or a separate container. The inside of the bag is considered clean. Hands are washed before the bag is entered and supplies for the home visit are removed from the bag." The above-noted deficiency was acknowledged during an interview following the home visit by the CM on April 12, 2021 and again during the exit conference on April 15, 2021 by the Administrator, Staff Member #1. 2. A home visit was conducted to the home of patient #14 on 4/13/2021 at 9:15 AM with staff member #10 to observe wound care being performed to the right breast. The Administrator, staff member #1 accompanied the surveyor to observe the visit. The patient had already removed the soiled dressing prior to our arrival. Observation of wound care revealed the nurse cleaning the wound with gloved hands using gauze and normal saline. Without removing the contaminated gloves, staff #11 then proceeded to gather the clean dressing, apply Medihoney to the clean dressing and spread it on the dressing with a gloved fingertip, place the new dressing on the wound and cover it with gauze. The nurse failed to follow infection control guidelines while moving from a dirty area (wound) to a clean area (clean dressing) without performing hand hygiene and donning clean gloves. The nurse put the patient at increased risk of infection by touching the clean dressing and Medihoney with dirty gloves then placing the contaminated dressing on the patient's wound. The deficient practice was acknowledged by staff member #1 after the conclusion of the visit. 3. A home visit was conducted to the home of patient #13 on 4/13/2021 at 1:30 PM with staff member #11 to observe wound care being performed to the left lower leg. The Administrator, staff member #1 accompanied the surveyor to observe the visit. Staff #11 removed the soiled dressing. During the course of removal, the nurse used scissors to cut part of the dressing and put the dirty scissors back on the clean field of supplies. The nurse then cleansed the wound with soap and water. Without changing gloves or performing hand hygiene, the nurse moved to the clean field of supplies to open the packages of dressing supplies needed for re-dressing the wound. It was not until after the packets were open that the nurse removed the soiled gloves and performed hand hygiene prior to applying the new dressing. The nurse touched the packets that were contaminated by dirty gloves and the dirty scissors to cut the dressing to the proper size prior to redressing the wound. When wound care was complete, there were supplies still remaining. The nurse placed them back in the contaminated dressing packages to be saved for later use. The dressing packs were then placed back in a container holding the patients supplies. The nurse failed to follow infection control guidelines while moving from a dirty area (wound) to a clean area (clean dressing supplies) without removing dirty gloves, performing hand hygiene and donning clean gloves. The nurse put the patient at increased risk of infection by touching the contaminated dressing packages to remove supplies and re-dressing the wounds as well as saving the left over supplies and putting them pack in the soiled packages. Staff member #1 was interviewed immediately after the visit and acknowledged the deficit practice. A review of the agencies policy titled "Infection Prevention", under wound care-Procedure for glove use during wound care states in part: A. Gloves should be worn during removal of old/dirty dressing. B. Gloves removed and hand hygiene performed. C. Apply new/clean gloves when applying new dressing. A review of the agencies policy titled "Handwashing and Hand Hygiene" under use an alcohol-based hand rub routinely for decontaminating hands states in part: after contact with body fluids, wound dressings and after removing gloves. Fundamentals of Nursing Mosby, Potter and Perry, 7th Edition St. Louis Missouri, page 654 states in part: Asepsis is the absence of pathogenic (disease producing) microorganisms. Aseptic techniques refers to practices/procedures that assist in reducing the risk for infection. Medical asepsis, or clean technique, includes procedures used to reduce the number of organisms present and prevent the transfer of organisms. Hand hygiene, using clean glove to prevent the transfer of organisms from one client to another or to prevent direct contact with client blood or body fluids and cleaning the environment routinely are examples of medical asepsis. Principles of medical asepsis are commonly followed in the home. After an object becomes unsterile or unclean it is considered contaminated. For example a used dressing is considered to be a contaminated item. During home visits, the nurse broke aseptic technique when moving from a dirty to clean field without changing gloves and performing hand hygiene.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on review of clinical records and staff interview, it was determined the Governing Body and/or Administrator failed to ensure the overall management and organization of resources in order to attain and provide the highest practicable functional status. The agency failed to ensure the coordination of patient care (refer to G962); the agency failed to ensure the patient needs were continually assessed (refer to G966); the agency failed to ensure the implementation of the plan of care (refer to G968); and the agency failed to ensure their clinical expectations with current clinical practice (refer to G984). The cumulative and systemic effect of the lack of the Governing Body/Administrator performing his/her role and duties resulted in the overall failure of the agency to provide quality services and negatively impacted the staff, patients, patient care, and community relationships and responsibilities.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on a review of clinical records, patient and staff interviews it was determined the agency's staff failed to document care coordination for three (3) of nine (9) patients in the survey sample who experienced uncontrolled pain (Clinical record #s 1, 9 and 10). The findings: Seventeen (17) clinical records were reviewed in the agency on 4/12-14/2021 with staff members #1 and #5 as electronic health record navigators with the following findings: 1. The clinical record for Patient #1 was reviewed for the certification period of 7/1/2020 to 8/29/2020. The clinical record for this time frame contained documentation of a Physical Therapy Assistant missed visit on 7/24/2020. The patient declined the visit due to having increased pain; the physician was not informed about the increased pain. In addition, the clinical record contained documented pain levels consistently running from (7-10) for most visits and the patient was discharged from the home health agency on 8/4/2020 with a pain score of 10/10. The discharge visit on 8/4/2020 contained a discharge summary to the physician describing how the patient improved with therapy but remains in significant pain, which we (therapists) were not able to assist. There was no documentation of the therapist contacting the physician related to the patient's uncontrolled pain. No coordination of care was ever documented with the physician or any follow-up care regarding the patient's pain status. 2. The clinical record for Patient #9 was reviewed for the recertification period of 4/6/2021 to 6/4/2021. The clinical record for this time frame contained documentation of a skilled nursing visit on 4/7/2021 that scored the patient's pain at 7/10. The skilled nurse's pain assessment lacked what the exacerbating factor was or the highest level of pain in the past 24 hours and what pain medication relieved the pain factors. The patient was not revisited by the skilled nurse until two days later as a scheduled visit. There was no documentation of the SN contacting the physician related to the patient's uncontrolled pain. No coordination of care was ever documented with the physician or follow-up care regarding the patient's pain status. 3. The clinical record for Patient #10 revealed the patient had pain identified as a problem on the plan of care. The goal established at the beginning of care was "patients initial comfort goal is minimal pain". The plan contained physician orders for Gabapentin 300 mg two (2) times per day for nerve pain and Tramadol/Acetaminophen 37.5-325 mg per tablet 1 (one) tablet every eight (8) hours if needed for moderate pain. The patient was seen by skilled nursing, physical therapy and speech therapy. Fifteen of twenty-seven visits made by the visiting disciplines revealed the patient had a pain score of five (5) out of ten (10) or greater. There is no evidence in the clinical record that the disciplines coordinated care of the patient with each other related to pain management. There is no evidence the disciplines contacted the physician related to the patient's uncontrolled pain. Phone interviews were conducted with staff members #8, 12, 14, 15, and 16 on 4/15/2021. None of the staff reported contacting the physician related to the patient's pain. The case manager staff members #8, 14, and 16 all reported not being aware the patient had a pain patch. The above noted findings regarding the failure of the agency's staff to coordinate care to meet the patient's needs were reviewed with staff #1 and #5 during the clinical record review, and again with the Administrator, the Quality Assurance and Performance Improvement/Education Manager, and the Director of Regulatory Affairs/Risk Management at the exit conference of 4/15/2021.

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on a review of clinical records, the agency's pain policy, patient and staff interviews it was determined agency staff failed to ensure that each patient's needs were continually assessed for three (3) of nine (9) patients whose clinical records were reviewed in the survey sample and who experienced uncontrolled pain (Clinical record #s 1, 9 and 10). The findings: Seventeen (17) clinical records were reviewed in the agency on 4/12-14/2021 with staff members #1 and #5 as electronic health record navigators with the following findings: 1. The clinical record for Patient #1 contained a plan of care for Physical Therapy services to instruct on pain management techniques and a skilled assessment of pain. The measurable goals for pain included the patient/caregiver/family to report verbal or nonverbal means, a reduction/adequate control of pain by 8/8/2020, with a pain goal of <= (less than or equal to) 3/10. The agency utilized the standard numerical scale for rating pain with zero (0) being no pain and (10) being worse pain. A review of the Physical Therapist clinical notes for the certification period of 7/1/2020 through 8/29/2020 revealed the patient's lowest pain was a six (6) at one visit with pain reaching as high as a (10) within a 24 hour time period. Specific details for pain reported by the patient at each therapy visit were recorded as follows: 7/1/2020-(10/10) "burning hard" to left hip down to toes. 7/2/2020-(10/10) back and left leg with documentation of NA (not available) for relieving factors. 7/14/2020-(7/10) ache to back and left leg. 7/17/2020-(8/10) burn to left leg with documentation of NA (not available) for relieving factors. 7/22/2021-(7/10) ache to back and left hip with documentation of NA (not available) for relieving factors. 7/29/2020-(7/10) burn to left hip, 6/10 burn to left leg, 7/10 ache to the back. 8/4/2020-(10/10) throbbing and burning. No location of pain documented. The clinical records contained documented pain levels consistently running from (7-10) for most visits as noted above and the patient was discharged from the home health agency on 8/4/2020 with a pain score of 10/10. There was no indication in the record of the therapist having contacted the physician related to the patient's pain or making changes to the plan of care. The patient's need for pain control was not documented as continually assessed and addressed. A telephone interview was conducted on 4/14/2021 at 10:17 AM with the Physical Therapist (staff member #7) who documented Patient #1's start of care and discharge. Staff member #7 called the Administrator's phone to conduct the interview via speaker telephone with the Administrator present. This MFI asked staff member #7 why wasn't the plan of care revised to reflect the patient's pain levels from 6/10 to 10/10? The therapist was also asked why wasn't the physician called and notified of the patient's pain not progressing toward the pain goal of 3/10. Staff member #7 stated, I don't understand, her therapy did improve and I disagree with you. 2. The clinical record for Patient #9 contained a plan of care for the skilled nurse (SN) to perform a wound VAC (a suction pump device to remove drainage away from a wound) dressing change to coccyx on Monday, Wednesday and Friday with a long term comfort goal measure to promote comfort and was scored as a 0/10. The agency utilized the standard numerical scale for rating pain with zero (0) being no pain and (10) being worse pain. In addition, the plan of care contained orders for Oxycontin 20 mg by mouth three times as day, Oxycodone 5 mg by mouth two times a day if needed for moderate pain and a Lidocaine 4% patch to apply topically three times a day if needed for pain. A review of the SN clinical notes for the recertification period of 4/6/2021 through 6/4/2021 revealed the patient's lowest pain was documented as a five (5) at one visit with pain reaching as high as a seven (7) within a 24 hour time period. Specific details for pain reported by patient at each SN visit were as follows: 4/7/2021-(7/10) constant to left hip. No documentation on exacerbating factors or duration of pain episode but documented pain medication as a relieving factor. 4/9/2021-(6/10) achy intermittent generalized with documentation of no exacerbating factors or relieving factors. 4/12/2021-(5/10) achy constant generalized. The clinical record contained interventions for a long term comfort goal that was based on the skilled pain assessment for each of the above visits, however many of the skilled pain assessments were incomplete. The visit of 4/7/2021 lacked what the exacerbating factor was or the highest level of pain past 24 hours and what pain medication relieved the pain factors. The clinicians were also not documenting the progression of pain, associated symptoms, pain affects and other areas of the pain assessment tool. Throughout the clinical visit notes, there was no indication of how often the patient was taking the Oxycontin, Oxycodone or the Lidocaine 4% patch for pain. There was no documentation of SN contacting the physician related to the patient's uncontrolled pain. The interventions documented on each visit were the same, assess/teach pain management techniques with no progression towards desired outcomes. During the clinical record review on 4/14/2021 at 10:35 AM this MFI asked staff member #1 how can the staff tell if the patient's pain improved with incomplete pain assessments such as the visit dated 4/7/2021 that documented pain medications as a relieving factor with a pain reported 7/10 when the patient is on two different types of pain medications and a patch for pain or how much was given when the SN did not document a complete pain assessment. Staff member #1 did not reply. There was no indication in the record of the SN continually assessing the patient regarding their pain or contacting the physician related to the patient's pain or making changes to the plan of care. Glendenning, Marsha 3. The clinical record for patient #10 was reviewed for the certification period of 2/24/2021-4/24/2021. The record review was conducted on April 12-13, 2021 with staff #5 as the navigator. The plan of care for patient #10 contained interventions and goals for pain however, the goals were not measurable. The goal was listed under all disciplines as "patients initial comfort goal is minimal pain". The long- term goal was listed as "measures to promote comfort will be effective within 8 visits as evidenced by discussion and demonstration. Patients long-term goal is minimal pain". The plan contained physician orders for Gabapentin 300 mg two (2) times per day for nerve pain and Tramadol/Acetaminophen 37.5-325 mg per tablet 1 (one) tablet every eight (8) hours if needed for moderate pain. Both medications are given by G-tube (a tube inserted through the belly that brings nutrition directly to the stomach) and administered by the caregiver. A review of the clinical notes from nursing revealed the patient had pain rated at eight (8) out of ten (10) on admission. The patient's pain was located in the lower back and the patient continued to have pain reported during the month of March. A review of the clinical notes from Speech therapy revealed a total of eight (8) visits in the month of March with six (6) visits having pain rated at a six (6) out of ten (10) or higher and two (2) visits with no pain. In April the Speech therapist saw the patient three (3) times with no pain on one visit and two visits with pain at a five (5) out of ten (10). During the visit on 3/09/2021, the Speech therapist documented the patient's pain at a seven (7) out of ten (7) and stated the patient had lidocaine patches in the home and the caregiver would put one on the patient. The plan of care and medication profile failed to contain orders for a lidocaine patch. A review of the clinical notes from the physical therapist revealed four visits in the month of March. Three (3) of the four (4) visits had a pain score of five (5) out of ten (10) or greater with one (1) visit documented as no pain. Two (2) visits were conducted in April with both visits having pain rated at five (5) out of ten (10). Many of the clinical notes from all disciplines contained incomplete pain assessments to include the lack of identifying the character, frequency and duration of pain. The clinicians were also not documenting the progression of pain, associated symptoms, pain affects and other areas of the pain assessment tool. Throughout the clinical visit notes from all disciplines, there was no indication of how often the patient was taking the Tramadol/Acetaminophen for pain. There was also no indication the disciplines coordinated care with each other related to pain management. There was no documentation the disciplines contacted the physician related to the patient's uncontrolled pain. The interventions documented on each visit were the same, assess/teach pain management techniques with no progression towards desired outcomes. A phone interview was conducted with staff #8 on 4/14/2021 at 8:42 AM. Staff #8 opened the patient to services and only saw the patient on one other occasion. The staff member was aware of the patient's pain but was not aware of a pain patch and stated no conversation was had with the team related to pain control issues. A phone interview was conducted with staff #15 on 4/14/2021 at 8:53 AM. The staff member acknowledged making the 3/09/2021 visit when the patient's pain was rated a nine (9) out of (10) and reports contacting the physician however, the call to the physician was in regards to the bleeding hemorrhoids. Staff member #15 also stated the caregiver "is particular about med's (medication), we asked in the beginning and haven't asked in a while". A phone interview was conducted with staff member #14 on 4/14/2021 at 9:05 AM. Staff number #14 did not remember the patient having a pain patch and when asked about the incomplete assessment on 3/02/2021 when the staff member only wrote "back pain", staff #14 replied "if there was a problem I would have put it down". A phone interview was conducted with staff #16 on 4/14/2021 at 9:13 AM. The staff member did not remember the patient being on the lidocaine patch and recalled Tramadol being the primary medication for pain control. Staff #16 stated the patient gets Tramadol at least daily and some days more than once but the exact dose was not known. Staff #16 stated speaking with the nurse about the chronic pain. A phone interview was conducted with staff #12 was conducted on 4/14/2021 at 9:43 AM. The staff member stated all staff were aware the patient has chronic back pain and "I think she has used the patch since 2020". A phone interview was conducted with the primary caregiver on 4/14/2021 at 10:50 AM. The caregiver stated the patient is not on a lidocaine patch but on Salonpas, which is an over the counter patch and the caregiver was not sure if it had lidocaine in it. The caregiver reports the patient is given Tramadol two (2) times a day but can have it three (3) times but never asks for the third dose. The primary caregiver reports asking the physician multiple times for something stronger and does not feel like a patient this age should have to suffer. The caregiver reports giving up with asking for more medication as "you can only bark up the same tree for so long until your voice gets hoarse". An Internet search for Salonpas revealed it is an over the counter medication and contains Menthol 3%, Methyl Salicylate 10% (non-steroidal anti-inflammatory). Some patches do contain Lidocaine. An interview on 4/16/2021 at 1:45 PM with staff member #11 revealed nursing visited the patient on 4/15/2021 and verified the Salonpas was being used by the patient. The Salonpas in the home did not contain Lidocaine. On 4/13/2021 at 4:25 PM the MFI reviewed the agency's pain policy and procedure titled "Pain Management Process". Portions of the policy read as follows: To appropriately alleviate and palliate pain on order to maximize patient comfort by symptom controls and to promote quality of life and the highest function possible for the patient given his/her condition, the clinician will assess the patient's need for pain management comprehensively and consistently. In addition, the policy stated, if the patient rates their pain scale greater than "0", a comprehensive pain assessment must be documented and the physician is informed as needed based upon the patient's condition. The above noted findings regarding the failure of agency's staff to assess and report to the physician the patient's needs and or condition was reviewed with staff #1 and #5 during the clinical record review, and again with the Administrator, the Quality Assurance and Performance Improvement/Education Manager, and the Director of Regulatory Affairs/Risk Management at the exit conference of 4/15/2021.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on a review of clinical records and staff interview, it was determined the agency failed to ensure that each patients' plan of care was implemented and updated as required in five (5) of (17) clinical records reviewed in the survey sample (Clinical record #s 1, 2, 3, 5 and 16). The findings: Seventeen (17) clinical records were reviewed in the agency on 4/12-14/2021 with staff members #1 and #5 as electronic health record navigators with the following findings: 1. The clinical record for Patient #1 was reviewed for the certification period of 7/1/2020 to 8/29/2020. The plan of care for the above noted timeframe contained orders for Physical Therapy (PT) services two (2) times a week for four (4) weeks and one (1) time a week for two (2) weeks. The clinical record for this time frame contained documentation of two (2) PT missed visits on 7/7/2020 and on 7/24/2020. During the clinical record review on 4/12/2021 at 1:20 PM, staff member #1 verified the physician was not notified of the two missed visits noted above. The clinical record failed to contain documentation that the patient's physician was notified of the visits not being provided in accordance with the patient's plan of care. 2. The clinical record for Patient #2 was reviewed for the certification period of 8/28/2020 to 10/26/2020. The plan of care contained orders for Physical Therapy services as follows: Wound care-Joint replacement skilled assessment of surgical site (Assess surgical wound for healing, signs and symptoms of infection, incision approximation/dehiscence). The physician's order failed to state where the wound was located. During the clinical record review on 4/12/2021 at 2:00 PM staff member #1 verified the failure of the surgical wound location on the plan of care. 3. The clinical record for Patient #3 was reviewed for the certification period of 11/1/2020 to 12/30/2020. The plan of care for the above noted timeframe contained orders for Skilled Nurse (SN) services two (2) times a week for one (1) week and one (1) time a week for eight (8) weeks. The clinical record contained for this time frame contained no (0) visit documentation during the week of 11/22/2020 through 11/28/2020 when one visit was ordered. During the clinical record review on 4/12/2021 at 3:05 PM staff member #1 verified the physician was not notified of the above missed visit. The clinical record failed to contain documentation that the patient's physician was notified of the visit not being provided in accordance with the patient's plan of care. 4. The clinical record for Patient #5 was reviewed for the recertification period of 12/20/2020 to 2/17/2021 with a diagnosis of congestive heart failure. The plan of care contained orders as follows: Parameters to call physician, 2-3 lb weight gain in 24 hours, 5 lb weight gain in 1 week. During the clinical record review on 4/13/2021 at 11:20 AM staff member #5 verified weights were not documented in the clinical record for this time frame. Staff member #5 provided the Medical Facilities Inspector with the discharge OASIS of 1/19/2021 to verify if patient weights were obtained. The discharge OASIS contained a section under vital signs that read as follows: "Recent Weight Change-Has the patient's weight changed with in the last 3 months?" This section was left blank and staff member #5 verified this section should have been filled out with a yes or no answer. The clinical record failed to contain documentation that the patient's physician was notified of the patient's weight not assessed on the above noted time frame. 5. The clinical record for Patient #16 was reviewed for the certification period of 3/27/2021 to 5/25/2021. The plan of care contained orders as follows: Wound care-Skilled nurse/Family/Caregiver to perform dressing change to: 3) Left shin skin tear-3 layers of xeroform (dressing that keeps air out to promote a moist environment) applied to provide moist wound healing and bacteriostatic properties, covered with ABD (bulky dressing) to absorb drainage and protect, secure with wrap gauze 2x weekly. 4) Right shin-small amount of petroleum and small foam dressing 2x weekly. The clinical record revealed the right and left shin was open to air for this entire time frame. The start of care OASIS dated 3/27/2021 contained skilled nurse documentation that the patient refused wound care to the right and left shin due to the podiatrist wanting to leave the areas open to air. During the clinical record review on 4/13/2021 at 10:50 AM staff member #5 verified the physician was not notified of the right and left shin wounds being left open to air. The clinical record failed to contain documentation that the patient's physician was notified of the wound care not being provided in accordance with the patient's plan of care. The above noted findings were reviewed with staff #1 and #5 during the clinical record review, and again with the Administrator, the Quality Assurance and Performance Improvement/Education Manager, and the Director of Regulatory Affairs/Risk Management at the exit conference of 4/15/2021.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interview, it was determined that the home health agency failed to provide services in accordance with current clinical practice guidelines and accepted professional standards of practice in three (3) of (17) clinical records in the survey sample (Clinical record#s: 2, 7 and 17). The findings: Seventeen (17) clinical records were reviewed in the agency on 4/12-14/2021 with staff members #1 and #5 as electronic health record navigators with the following findings: 1. The clinical record for Patient #2 was reviewed for the certification period of 8/28/2020 to 10/26/2020. The plan of care contained orders for Physical Therapy and Occupational Therapy visits and a diagnosis of primary hypertension (high blood pressure). During the clinical record review with staff member #1 it was noted that no vital signs were recorded by the agency's clinicians for the entire certification period. On 4/12/2021 at 2:00 PM, staff member #1 searched for vital signs (measurements of the body's temperature, heart rate, respiration rate and blood pressure) in this patient's record to no avail. The MFI (Medical Facilities Inspector) asked staff member #1 why the therapists did not take/record vital signs. Staff member #1 stated, I don't know because we do expect our clinicians to take vital signs at home visits. 2. The clinical record for Patient #7 was reviewed for the certification period of 2/9/2021 to 4/9/2021. The plan of care contained orders for Physical Therapy and Occupational Therapy visits. During the clinical record review with staff member #5 it was noted that incomplete vital signs were taken/recorded by the agency's clinicians for the certification period. No temperatures were taken except on the dates of 4/9/2021 and 4/12/2021. On 4/13/2021 at 4:00 PM staff member #5 stated, we noticed this was a problem earlier and have given the clinicians education regarding taking vital signs. 3. The clinical record for Patient #17 was reviewed for the certification period of 3/23/2021 to 5/21/2021. The plan of care contained orders for Physical Therapy visits. During the clinical record review with staff member #5 it was noted that incomplete vital signs were taken/recorded by the agency's clinicians for the certification period. No temperatures were recorded. On 4/13/2021 at 4:45 PM staff #5 provided the MFI the agency's assessment policy titled "patient assessment" as requested by the MFI. The policy did not contain any mention of vital signs as part of the patient assessment. On April 14, 2021 at 9:00 AM the MFI reviewed the agency's QAPI (Quality Assurance Performance Improvement), with staff member #5. During the QAPI review the MFI asked staff member #5 what performance improvement projects did the agency work on in 2020 and in the first quarter of 2021? Staff member #5 stated, one area where we identified the need for improvement was with inconsistencies in vital sign assessment and management. We noticed that clinicians were not always collecting vital signs at each visit and not responding to them consistently. A PowerPoint presentation was used to educate therapy staff in the first quarter therapy meeting on 03/31/2021. However, the expectation that vital signs be collected at each visit was shared with all staff in February. The MFI asked staff member #5 if the expectation was that vital signs would be collected by clinicians at each home visit. Staff member #5 confirmed that the expectation was that each clinician obtain vital signs at each home visit. According to the National Center for Biotechnology Information of the United States Library, a branch of the National Institutes of Health, vital signs are the first step of measurements for any health assessment. Vital signs can be influenced by physiologic and pathologic processes and if not done patients may experience long-term patient health outcomes, return emergency room visits, and hospital readmissions (https://www.ncbi.nlm.nih.gov/books/NBK553213/). The above noted findings were reviewed with staff #1 and #5 during the clinical record review, and again with the Administrator, the Quality Assurance and Performance Improvement/Education Manager, and the Director of Regulatory Affairs/Risk Management at the exit conference of 4/15/2021.