Every finding on record at Community Home Health Care

During the extended recertification survey conducted on August 15, 2023, through August 18, 2023 at Community Home Health Care, Emergency Preparedness was reviewed. Community Home Health Care is in compliance with Emergency Preparedness per Code of Federal Regulations (CFR), 42 Part 484.22, Requirements for Home Health Agencies.

An extended re‑certification survey was conducted on August 15-18, 2023, at Community Home Health Care. The home health agency was not in compliance with Code of Federal Regulations (CFR), 42 Part 484.22, Requirements for Home Health Agencies. The Conditions of Participation at 42 CFR 484.45, Reporting of OASIS Information, G370 and 42 CFR 484.65 Quality Assessment and Performance Improvement (QAPI) were not met. .

Reporting OASIS information CFR(s): 484.45 Condition of participation: HHAs must electronically report all OASIS data collected in accordance with §484.55. This CONDITION is not met as evidenced by: Based on clinical record reviews, interviews, and review of data reports it was determined that the Home Health Agency (HHA) failed to encode and electronically transmit each completed OASIS (Outcome and Assessment Information Set) assessment to the CMS system within 30 days of the assessing clinician completing the assessment of the beneficiary, in order to allow an outside contractor to complete a review of the OASIS data with upcoding of the severity of the patient's health status and failed to ensure the OASIS data transmitted to CMS was accurate at the time of the assessment per CMS OASIS guidelines. The cumulative effect of these systemic practices resulted in the agency’s failure to ensure completed, encoded, locked and accurate OASIS data for each patient was transmitted to the CMS system which impacts the agency’s ability to establish accurate health goals, report accurate data for quality reports to CMS, and to determine accurate payment based on the patient’s health status. (Refer to G0372 and G0374) The findings include: The CMS Outcome and Assessment Information Set OASIS-E Manual, Effective January 01, 2023, indicated in any data-driven system, the quality of the output is only as good as the quality of the data input. OASIS data are used for multiple purposes, including to determine payment, production of quality reports for agencies, and public reports on the Care Compare website. Thus, it is imperative that the OASIS data that HHAs collect and submit be accurate and complete. This language stipulates that the encoded OASIS data must accurately reflect the patient’s status at the time the information is collected. Record reviews, interviews, and review of data reports revealed the agency failed to ensure that the OASIS assessment was transmitted to the CMS system within 30 days of the M0090 (date assessment completed) in order to allow an outside contractor to complete a review of the OASIS data for 3 of 5 sampled Medicare/Medicare Advantage patients, #3, #10, and #12. (Refer to G0372) Record reviews and interviews revealed the agency failed to ensure the OASIS data submitted to CMS accurately reflected the patient’s health status at the time of OASIS data collection by the assessing clinician. The agency allowed an outside contractor to review the OASIS data for upcoding of the severity of the patient’s health status, but the OASIS item M0090 (date of completion) was not updated to reflect the changes to the OASIS data items per CMS guidelines, and the agency did not develop and implement a policy to guide the agency’s process for the accuracy of the OASIS data transmitted to CMS for 5 of 5 Medicare/Medicare Advantage patient’s reviewed, #3, #7, #9, #10, and #12. (Refer to G0374)

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on record reviews, interviews, and review of data reports the agency failed to ensure that the Outcome and Assessment Information Set (OASIS) assessment was transmitted to the CMS system within 30 days of the M0090 (date assessment completed) in order to allow an outside contractor to complete a review of the OASIS data for 3 of 5 sampled Medicare/Medicare Advantage patients, #3, #10, and #12. The findings include: Review of the Internet Quality Improvement Evaluation System (IQIES) Home Health Agency (HHA) Error Summary report for the 2nd quarter, 04/01/2023-06/30/2023, indicated an error rate of 8.40% for the error code 3330, Record Submitted Late (error 3330). A review of the available data for the 3rd quarter to date, 07/01/2023-08/18/2023 revealed an error rate of 46.61%, an increase of 38.21%. In total there were 221 assessments processed with 103 errors, noted as error 3330, record submitted late. Review of the OASIS Agency Final Validation Reports dated 08/02/2023, indicated that 20 of 26 transmitted OASIS had error message 3330. A review of the report dated 08/09/2023 indicated that 16 of 36 transmitted OASIS had error message 3330. According to the Centers for Medicare and Medicaid Services (CMS) OASIS Error Message User Guide dated January 18, 2023, the OASIS Provider Final Validation report is automatically generated within 24 hours of successful submission of a file. All warning errors should be reviewed and corrected if appropriate, to ensure the data uploaded is accurate and complete. Error 3330 message is “Record submitted late: The submission date is more than 30 days after MOO90 on this new record. The potential cause is the assessment was not submitted within CMS timing guidelines. The submission date minus M0090 (date assessment completed) should be no more than 30 days.” CMS suggested actions include to “review the assessment timing schedule in the Current OASIS Guidance Manual and verify that all assessments are submitted in a timely manner.” On 08/18/2023 at 11:20 AM, an interview was conducted with the Administrator regarding the OASIS validation reports. She offered that the agency transmits OASIS data to the CMS system weekly. The OASIS validation reports are reviewed weekly by the business manager. The validation reports indicated a notation of “ok” beside the transmission error messages (error 3330). The Administrator stated the first week of June 2023 the corporate office revised the process for quality review of OASIS assessments. After the assessing clinician completes the assessment, it is reviewed by an off-site Quality Reviewer. After this quality review is complete it is sent for ICD (International Classification of Diseases) coding, and it is then locked and transmitted. The offsite quality reviewers and coders are not employees of the agency, but are employed by the corporation which owns the agency. The agency has no control over this quality assurance process. The corporation’s offsite Quality Reviewers are behind on OASIS reviews. On 08/18/2023 a review of the OASIS Agency Final Validation Report for the OASIS transmission of five Medicare/Medicare Advantage patients with an admission date over 30 days revealed three patients with an OASIS transmission over 30 days. For Patient #3, the RN OASIS admission assessment was completed on 06/17/2023 (M0090 date). According to the OASIS Agency Final Validation Report the OASIS was transmitted on 07/19/2023. This is 33 days after the completion of the OASIS assessment. For Patient #10, the RN OASIS admission assessment was completed on 07/15/2023 (M0090 date). The last modification was 08/09/2023. An interview with the Administrator on 08/18/2023 at 11:20 AM stated the OASIS was locked and transmitted on 08/15/2023. This is 31 days from the M0090 date. For Patient #12, the RN OASIS admission assessment was completed on 06/24/2023 (M0090 date). According to the OASIS Agency Final Validation Report the OASIS was transmitted on 08/02/2023. This is 43 days after the completion of the OASIS assessment. .

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on record reviews and interviews, the agency failed to ensure the OASIS data submitted to CMS accurately reflected the patient’s health status at the time of OASIS collection by the assessing clinician. The agency allowed an outside contractor to review the OASIS data for upcoding of the severity of the patient’s health status, the OASIS item M0090 (date of completion) was not updated to reflect the changes to the OASIS data items per CMS guidelines and the agency did not develop and implement a policy to guide the agency’s process for the accuracy of the OASIS data transmitted to CMS for 5 of 5 Medicare/Medicare Advantage patient’s reviewed, #3, #7, #9, #10, and #12. The findings include: Record review for Patient #3 revealed the Registered Nurse (RN) OASIS Admission was completed on 06/17/2023. The payor source was Medicare Patient-Driven Groupings Model (PDGM). According to CMS, PDGM works by taking the OASIS assessment and combines it with diagnosis coding to determine the reimbursement based on several factors such as referral source, comorbidity adjustment, and functional impairment to determine the case mix weight. The last modification to OASIS data items was completed on 07/11/2023, 24 days later. The M0090 date was not changed from 06/17/2023 to reflect the changes to OASIS data items on 07/11/2023. The CMS Outcome and Assessment Information Set OASIS-E Manual, Effective January 01, 2023, indicated the M0090 - Date Assessment Completed, is the last date that information used to complete the comprehensive assessment and determine OASIS coding was gathered by the assessing clinician and documentation of the specific information/responses was completed. The modifications included the following OASIS items: GG0130A1 eating from 04 (supervision) to 03 (partial/moderate assist). GG0130B1 oral hygiene from 04 (supervision) to 03 (partial/moderate assist). GG0130C1 toileting hygiene from 03 (partial/moderate assist) to 01(dependent). GG0130F1 upper body dressing from 03 (partial/moderate assist) to 01 (dependent). GG0130E1 shower bathe self from 02 (substantial/maximal assist) to 01 (dependent). GG0130G1 lower body dressing from 03 (partial/moderate assist) to 01 (dependent). GG0130H1 put on/take off footwear from 03 (partial/moderate assist) to 01 (dependent). GG0170D1 sit to stand from 05 (set up) to 02(substantial/maximal assist). GG170E1 chair/bed to chair transfer from 05 (set up) to 02 (substantial/maximal assist). G0170C1 Lying to sitting on bed side from 03 (partial/moderate assist) to 02 (substantial/max assist). GG0170E2 chair/bed to chair transfer from 02(substantial/maximal assist) to 03(partial/mod assist). GG0170G1 car transfer from 05 (set up) to 02 (substantial/max assist). GG0170G2 car transfer, discharge goal from 02(substantial/max assist) to 03 (Partial/moderate assist). GG017012 walk 10 feet discharge goal from 04 (supervision) to 03 (partial/moderate assist). GG0170K2 walk 150 feet discharge goal from 04 (supervision) to 09 (NA), GG0170L2 walking 10 feet discharge goal from 02 (substantial/max assist) to 09 (NA), GG0170M2 1 step curb from 04 (supervision) to 09 (NA), GG0170P1 picking up an object from 03 (partial/moderate assist) to 01 (dependent). M1700 cognitive functioning from 2 (requires assist) to 3 (requires considerable assist). M1745 frequency of behavior problems from 3 (several times each month) to 5 (at least daily). M1810 dress upper body from 2 (someone must help) to 3 (depends entirely). M1840 toileting from 1 (when reminded) to 4 (totally dependent). M1845 toileting hygiene from 2 (someone must help) to 3 (patient depends entirely). M1860 ambulation from 3 (walk with assist) to 5 (chairfast). M1033 hospital risk 2+ falls or injury in past year from no to yes. B0200 hearing from 0 (adequate) to 2 (moderate difficulty). B1000 vision from 0 (adequate)to 2 (moderately impaired). M1400 when dyspneic from 2 (with moderate exertion) to 3 (with minimal exertion). M1850 transferring from 2 (able to bear weight and pivot) to 3 (unable to transfer self). M2001 drug regimen review from 0 no issues to 1 yes issue found, N041511 high risk drug from no to yes, The ICD coding was completed on 07/11/2023. Record review for Patient #9, indicated the Physical Therapist (PT) OASIS Admission M0090 date was 07/28/2023. The payor source is Medicare, PDGM. The PT OASIS admission for Patient #9 indicated modifications were completed to the OASIS on 8/15/2023, 18 days after the M0090 date of 07/28/2023. The OASIS modifications by the Quality Reviewer on 08/14/2023 included: GG0100B Prior function-indoor mobility (ambulation) was changed from 3 (independent) to 2 (needed some help); GG0100C-Prior function-Stairs was changed from 3 (independent) to 2 (needed some help); GG0130B1 Oral Hygiene was changed from 05 (setup or clean up assistance) to 04 (supervision); GG0170A1 Roll left, and right was changed from 04 (supervision) to 03 (partial/moderate assist); GG0170D1 sit to stand was changed from 04 (supervision) to 02 (substantial/maximum assist); GG0170E1 chair/bed to chair transfer was changed from 04 (supervision) to 02 (substantial/maximal assist); GG0170F1 toilet transfer was changed from 04 (supervision) to 02 (substantial/maximal assist; GG0170i1 walk 10 feet was changed from 04 (supervision) to 03 (partial/moderate assist); GG070J1 walk 50 feet with two turns was changed from 04 (supervision) to 03 (partial/moderate assist); GG0170K1 walk 150 feet was changed from 04 (supervision) to 02 (substantial/maximal assist); GG0170L1 walking 10 feet uneven surfaces was changed from 03 (partial/moderate assist) to 02 (substantial/maximal assist); GG0170N1 4 steps was changed from 03 (partial/moderate assist) to 02 (substantial/maximal assist); K0520Z1 nutritional approaches was changed from yes to no; K0520D1 nutritional approaches was changed from no to yes and M1700 cognitive functioning was changed from 0 (alert and oriented) to 1 (requires prompting). On 08/15/2023 the ICD coder completed changes to the ICD codes and severity ratings. The M0090 date of 07/28/2023 was not updated to reflect the last date updates to the OASIS for Patient #9. Record review for Patient #7 revealed the RN OASIS Admission was completed on 06/29/2023. The payor source is Medicare, PDGM. The last modification was completed on 07/21/2023, 22 days later. The M0090 date was not changed to 06/29/2023 to reflect the changes to OASIS data items. The modifications included the following OASIS items: M1740 memory deficit from no to yes; M1745 frequency of behaviors) from 0 (never) to 4 (several times a day); GG0170M1- 1 steps curb) from 01 (dependent) to 88 (activity not attempted); GG0170L2 walking 10 feet uneven surface from 03 (partial/moderate assistance to 88 (activity not attempted); GG0170L1 from 01 (dependent) to 88 (activity not attempted); G0170J1 walking 10 feet uneven surfaces from 01 (dependent to 88 (activity not attempted); GG0170F1 toilet transfer from 02 (substantial/maximal assist to 01 (dependent); GG0130F1 upper body dressing from 02 (substantial/maximal assist to 01 (dependent) and GG0130C1 toileting hygiene from 02 (substantial/maximal assist to 01 (dependent). The ICD coding was completed on 07/21/2023. Record review for Patient #10 revealed the RN OASIS Admission was completed on 07/15/2023. The payor source is Medicare Advantage. The last modification was completed on 08/09/2023, 25 days later. The M0090 date was not changed to 07/15/2024 to reflect the changes to OASIS data items. The modifications included the following OASIS items: G0170C1 Lying to sitting on bed side from 05 (set up) to 01 (dependent); G0170C2 Lying to sitting on bed side, discharge goal from 01 (dependent) to 04 (supervision) and M1324 Stage of most problematic pressure ulcer/injury, from Stage 3 to Stage 4. The ICD coding was completed on 08/09/2023. Record review for Patient #12 revealed the RN OASIS Admission was completed on 06/24/2023. The payor source is Medicare, PDGM. The last modification was completed on 07/20/2023, 21 days later. The M0090 date was not changed to 06/24/2023 to reflect the changes to OASIS data items. The modifications included the following OASIS items: M1033 Hospital Risk from no to yes; M1700 cognitive functions from 0 (alert and oriented) to 1 (requires prompting); M1840 toileting from 2 (unable to get to and from) to 1 (when reminded); M1860 ambulation from 2 (requires use of a 2 hand) to 3 (able to walk only with assist); M1870 feeding from 0 (independent) to 1 (set up) and M2020 management of oral meds from 1 (able to take) to 3 (unable to take medications). The ICD coding was completed on 07/20/2023. On 08/17/2023 at 3:30 PM, an interview was conducted with the Quality Reviewer, who stated that she was allowed to change pain, functional status, oxygen and other items on the OASIS and Plan of Care without a physician order. She stated when changes are made, she sends a communication note to the assessing clinician and the clinician has an opportunity to agree or decline the recommendation. She gave an example of this by stating if the assessing clinician documented pain as zero, but another clinician, such as a physical therapist, went out to see the patient and the patient reported pain, the Quality Reviewer would change the pain OASIS item (J0510-J0530), to indicate the patient had pain. She stated she changes the answer to J0510-J0530 based on the physician or other clinician documentation and not collaboration with or between the assessing clinicians, she further stated that she does not update or change the M0090 date (Date Assessment Completed). At this time Patient #9’s OASIS was reviewed with the Quality Reviewer. She indicated the coordination notes would be in the medical record indicating if the clinician agreed or declined the modifications. In review of the coordination notes the Quality Reviewer verified there was not a coordination note indicating the assessing clinician approved the modifications. The surveyor questioned if the M0090 (OASIS completion date) was updated to reflect the changes she made to the OASIS. The Quality Reviewer stated, “No, the M0090 date was not changed on any of the assessments.” She stated the agency was very far behind and confirmed the quality reviews were not completed during the 5-day review period. On 8/17/2023 at 4:00 PM, the Administrator stated the agency did not have a policy for the new QA process to review OASIS. On 8/17/2023 at 7:37 PM, an interview was conducted with staff member A, a Registered Nurse (RN) who stated that when they plug in the pathways for the Plan of Care interventions, errors can be made and the office will correct them or add an intervention. The nurses have the option to disagree or call them with questions on how they made their decisions. The Quality Reviewer (QR) knows the OASIS guidelines, so she knows better. She will ask the nurses to explain why they charted a certain way and explain how it better fits into the guidelines. The QR clarifies what OASIS is actually asking. The office is good about explaining why they think it should be changed, but they respect our opinions because we are in the home. They want to make sure they are scored the way the patients are most of the time; scoring them appropriately. When you come from acute care you score to their highest ability, but you need to ensure that it truly fits the patient. She reported that she sometimes mixes up the goal with the performance and the office will fix this. On 8/17/2023 at 8:06 PM, an interview was conducted with staff member E, RN, who stated she is alerted after the changes are made. “They just show up. I do not have time to do anything but accept them. They just change it." She stated that the OASIS is changed for financial reasons such as the difference between Medicare and Medicare Advantage. "They are making the changes based on the kind of insurance the patient has and I do not have time for that. They change OASIS to meet the guidelines; sometimes there are 20 changes and I do not have time to review them all. I could challenge it more without a doubt but I would not win the battle. I am learning Oasis is complicated and they know more than I do. I do not always know what they are putting in. It is behind the scenes." On 8/18/2023 at 8:24 AM, an interview was conducted with staff member F, a physical therapist (PT), who reported that the OASIS assessments are doubled checked by the office and looked over. He stated he reviewed the suggested changes and can disagree with them if needed. “I think they are making the changes if they see something that is inconsistent with the functionals or diagnoses adding a priority of care. They add diagnoses to make sure they are not missed.” He stated that this does not change the outcomes. He reported that he has been working in OASIS for approximately 4 years and that he has had education. On 8/18/2023 at 8:38 AM, an interview was conducted with staff member H, PT, who reported that the agency has multiple systems that notify the clinicians of the OASIS changes, which he can accept or deny. He stated he has been working in OASIS for approximately 15 years and will sometimes document severity of a diagnosis as a “2” but it should have been a “3” based on the history of the patient. He clarified that the “2” makes them better than they actually were and the “3” makes them worse. He also stated that OASIS is “legal speak” and it is easy to make a mistake. “I like having the backup.” On 08/18/2023 at 9:00 AM, the Administrator confirmed that the policy for the new QA review was still in process and had not been finalized. The new process began approximately June 5, 2023. The Administrator provided a copy of training titled “Patient Care Manager HCHB Workflow Instructions” by the corporate owner, dated 05/17/2023. According to the training, “The physician and assessing clinician must approve modifications made to the add on plan of care unless the changes are to correct misspelled words.” “Changes to M2200 and other OASIS items based on the therapist’s evaluation can only be made if the information was gathered within the allowed timeframe (5 days for a Start of Care - SOC or 2 days for a Resumption of care – ROC).” The training section titled “Workflow-Quality Review” the quality reviewers review and score OASIS using the OASIS audit scoring tool, OASIS guidance and the agency’s data analysis program. The quality reviewer is instructed to document an appropriate rationale for their recommendations in the dialogue box. Review of CMS Outcome and Assessment Information Set OASIS-E Manual, Effective January 01, 2023, indicated the comprehensive assessment is a legal document and when signed by the assessing clinician, the signature serves as an attestation that to the best of their knowledge, the document, including OASIS responses, reflects the patient status as assessed, documented and/or supported in the patient’s clinical record. For OASIS items requiring a patient assessment, the collaborating healthcare providers (e.g., other agency clinical staff: Licensed Practical Nurse (LPN)/Licensed Vocational Nurse (LPN,) Physical Therapist or Therapy Aide (PTA), Certified Occupational therapy assistant (COTA), Medical Social Worker (MSW), and Home Health Aide (HHA) should have had direct in-person contact with the patient or have had some other means of gathering information to contribute to the OASIS data collection (health care monitoring devices, video streaming, review of photograph, phone call, etc.). When collaboration is utilized, the assessing clinician is responsible for considering available information from these other sources and selecting the appropriate OASIS item response(s), within the appropriate timeframe and consistent with data collection guidance. When collaboration is utilized, the M0090 - Date Assessment Completed, is the last date that information used to complete the comprehensive assessment and determine OASIS coding was gathered by the assessing clinician and documentation of the specific information/responses was completed. When used, collaboration must occur within the assessment timeframe and be consistent with data collection guidance. Example: If the assessing clinician gathers additional information during the assessment timeframe that results in changing the coding of one or more OASIS items (for instance, identifies functional or cognitive information more representative of the patient’s usual status than the code originally selected), the M0090 date would be changed to reflect the date the latest information was gathered by the assessing clinician and documentation of the specific information/responses was completed. The CMS Outcome and Assessment Information Set OASIS-E Manual, Effective January 01, 2023, OASIS section GG, functional abilities and goals. This item identifies the patient’s usual ability with everyday activities, prior to the current illness, exacerbation, or injury. This information is collected at Start of Care and Resumption of Care. OASIS items GG0100 items assess the prior functioning of everyday activities to establishes discharge goals. OASIS items GG0130 items assess self-care abilities and GG0170 items assess mobility. Each OASIS item provides the assessing clinician with a “look back period.” For most items, the look back period is the Day of the Assessment. The “Day of Assessment” is defined as the 24 hours immediately preceding the assessment and the time spent by the clinician conducting the assessment. For other items, the look back period is different, such as “in the last 14 days”, or “at the time of or since the most recent SOC/ROC.” For GG0130-GG0170 the assessing clinician would code each activity based on the type and amount of assistance needed to complete the activity safely, not based on the availability of such assistance. Agencies are required to complete a discharge goal for a minimum of one of the following self-care or mobility activities: GG0130A2 - Eating GG0130B2 – Oral Hygiene GG0130C2 – Toileting Hygiene GG0170B2 – Sit to lying GG0170C2 – Lying to sitting on side of bed GG0170D2 – Sit to stand GG0170E2 – Chair/bed-to-chair transfer GG0170F2 – Toilet transfer GG0170J2 – Walk 50 feet with two turns GG0170K2 – Walk 150 feet GG0170R2 – Wheel 50 feet with two turns GG0170S2 – Wheel 150 feet Licensed clinicians can establish a patient’s discharge goal(s) at the SOC/ROC based on the patient’s prior medical condition, SOC/ROC assessment, self-care and mobility status, discussions with the patient and family, professional judgment, and standards of practice, expected treatments, patient motivation to improve, anticipated length of stay, and the patient’s discharge plan. Goals should be established as part of the patient’s care plan. M1700 identifies the patient’s current (at the time of the assessment and in the preceding 24 hours) level of cognitive functioning, including level of alertness, orientation, comprehension, concentration, and immediate memory for simple commands. M1740 identifies specific behaviors associated with significant neurological, development, behavioral or psychiatric disorders. The behaviors are demonstrated at least once a week. M1745 identifies the frequency of any behaviors that are disruptive or dangerous to the patient or the caregivers. M1810 identifies the patient’s ability to dress upper body. Observation/demonstration is the preferred method for coding this item. M1840 identifies the patient’s ability to safely get to and from and transfer on and off the toilet or bedside commode. Observation/demonstration is the preferred method for coding this item. M1845 Identifies the patient’s ability to manage personal hygiene and clothing when toileting. Observation/demonstration is the preferred method for coding this item. M1850 Identifies the patient’s ability to safely transfer from bed to chair (and chair to bed), or position self in bed if bedfast. Observation/demonstration is the preferred method for coding this item. M1860 Identifies the patient’s ability and the type of assistance required to safely ambulate or propel self in a wheelchair over a variety of surfaces. Observation/demonstration is the preferred method for coding this item. M1870 Identifies the patient’s ability to feed themself, including the process of eating, chewing, and swallowing food. The intent of the item is to identify the patient’s ability, not necessarily actual performance. “Willingness” and “adherence” are not the focus of this item. Observation/demonstration is the preferred method to complete this item. M2020 This item is intended to identify the patient’s ability to prepare and take all oral (P.O.) medications reliably and safely on the day of the assessment. Observation/demonstration is the preferred method, followed by patient/caregiver interview, and review of the referral information. .

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 record review and interview, the Home Health Agency failed to ensure that the patients were informed in advance of the disciplines that would provide care and the frequency of the visits proposed for 17 out of 17 sampled patients, (Patients #1-#17). . The findings include: A record review was conducted for Sampled Patient (SP) #1 which revealed a written agreement dated 5/15/23 and an electronic Admission Consent dated 5/15/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #2 which revealed a written agreement dated 5/31/23 and an electronic Admission Consent dated 5/31/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #3 which revealed a written agreement dated 6/17/23 and an electronic Admission Consent dated 6/17/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #4 which revealed a written agreement dated 4/08/23 and an electronic Admission Consent dated 4/08/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #5 which revealed a written agreement dated 8/17/23 and an electronic Admission Consent dated 8/05/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #6 which revealed a written agreement dated 7/31/23 and an electronic Admission Consent dated 7/31/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #7 which revealed a written agreement dated 6/29/23 and an electronic Admission Consent dated 6/29/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #8 which revealed a written agreement that was signed by the patient but was undated, and an electronic Admission Consent dated 8/07/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #9 which revealed an electronic Admission Consent dated 7/28/23, the written agreement was not available for review at the time of the survey. The electronic Admission Consent did not indicate what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #10 which revealed a written agreement dated 7/15/23 and an electronic Admission Consent dated 7/15/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #11 which revealed a written agreement dated 7/07/23 and an electronic Admission Consent dated 7/07/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #12 which revealed a written agreement dated 6/24/23 and an electronic Admission Consent dated 6/24/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #13 which revealed a written agreement dated 4/03/23 and an electronic Admission Consent dated 4/03/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #14 which revealed a written agreement dated 4/21/23 and an electronic Admission Consent dated 4/21/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #15 which revealed a written agreement dated 1/02/23 and an electronic Admission Consent dated 1/02/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #16 which revealed a written agreement dated 3/31/23 and an electronic Admission Consent dated 3/31/23, neither of which included what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. A record review was conducted for Sampled Patient (SP) #17 which revealed an electronic Admission Consent dated 12/02/22, the written agreement was not available for review at the time of the survey. The electronic Admission Consent did not indicate what disciplines would be furnished by the agency nor did the consents contain the frequency of the proposed services to be provided. On 8/16/23 at 3:10 PM, an interview was conducted with the Director of Nursing and the Office Manager who stated that the written agreement is located in the Electronic Medical Record (EMR). They stated that the patient is given information on co-pay, cost of services, and services to be provided verbally before the first visit; however, this is not documented in the EMR. They stated this information is not on the consent. On 8/16/23 at 3:51 PM, the Administrator stated that she had spoken to the Director of Quality and Clinical Informatics who informed her that the written agreement did not have the services to be provided, or their frequencies listed and that a new form was at the vendor being updated. .

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that the comprehensive assessment, including OASIS items, were completed within 5 calendar days of the start of care for 5 of 5 Medicare/Medicare Advantage patient’s reviewed, #3, #7, #9, #10, and #12. The findings include: Review of the clinical record for Patient #9, indicated the Physical Therapist (PT) OASIS Admission start of care date was 07/28/2023. The PT OASIS admission for Patient #9 indicated modifications to the OASIS data items and ICD 10 codes were completed on 8/15/2023, 18 days after the start of care date of 07/28/2023. Record review for Patient #3 revealed the RN OASIS Admission was completed on 06/17/2023. The last modification to the OASIS data items and ICD 10 codes was completed on 07/11/2023, 24 days after the start of care. Record review for Patient #7 revealed the RN OASIS Admission was completed on 06/29/2023. The last modification to the OASIS data items and ICD 10 codes was completed on 07/21/2023, 22 days after the start of care. Record review for Patient #10 revealed the RN OASIS Admission was completed on 07/15/2023. The last modification to the OASIS data items and ICD 10 codes was completed on 08/09/2023, 25 days after the start of care. Record review for Patient #12 revealed the RN OASIS Admission was completed on 06/24/2023. The last modification to the OASIS data items and ICD 10 codes was completed on 07/20/2023, 21 days after the start of care. Review of CMS Outcome and Assessment Information Set OASIS-E Manual, Effective January 01, 2023, indicated when collaboration is utilized, the M0090 - Date Assessment Completed, is the last date that information used to complete the comprehensive assessment and determine OASIS coding was gathered by the assessing clinician and documentation of the specific information/responses was completed. When used, collaboration must occur within the assessment timeframe and be consistent with data collection guidance. On 08/17/2023 at 3:30 PM, an interview was conducted with the Quality Reviewer who stated the agency was very far behind and confirmed the quality reviews were not completed during the 5-day review period. .

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observations, record reviews and interviews, the agency failed to ensure the Plan of Care was followed for 2 of 17 sampled patients, #3 and #4. The findings include: A review was conducted of the Plan of Care for Patient #3; Certification period of 08/16/2023-10/14/2023. The plan of care orders stated Skilled nurse was to obtain ankle circumference every visit by measuring one inch above ankles bony prominence. The patient’s diagnoses include acute and chronic respiratory failure, atrial fibrillation, chronic obstructive pulmonary disease, and hypertensive heart disease with heart failure. On 8/17/2023 at 11:00 AM an observation was conducted of staff member D, Registered Nurse (RN) during a home visit with Patient #3. During the visit the nurse did not measure the patient’s ankle circumference. On 8/17/2023 at 12:00 PM, an interview was conducted with staff member D, RN, at the completion of the home visit. The nurse confirmed there was an order to measure the circumference of the ankles to monitor the patient’s heart failure as she often refuses her Lasix (diuretic) due to urinary incontinence at night. The patient resides in an Assisted Living Facility (ALF) and the ALF weighs the patient once a week instead of daily due to her unsteadiness and being wheelchair bound. The nurse confirmed she did not measure the ankles because she did not have a measuring strip with her during the visit. Also, during the home visit for Patient #3, staff member D, RN, observed a new wound to the patient’s right outer leg. The wound was new with bright red blood. The nurse stated the ALF had removed the patient’s wheelchair legs and the metal appeared to have cut the patient’s leg. The nurse cleansed the wound with wound cleanser and covered with an adhesive foam dressing. She stated she would call the doctor later. A review of the current Plan of Care for Patient #3 effective 08/16/2023, did not indicate an order for the wound care to the right leg. In review of the recertification visit conducted on 08/14/2023, the nurse did not document a wound to the right leg. On 08/17/2023 at approximately 1:45 PM, an interview was conducted with the administrator, who stated there was an old order for a wound to the right leg. This order was dated 08/08/2023, prior to the current recertification order. This wound had healed prior to the recertification on 08/14/2023. The Administrator confirmed there were not current wound care orders for the wound to the right leg. In review of agency policy “Physician orders” updated on 04/01/2023, it stated no treatments would be administered without the order of a qualified physician or practitioner. On 08/16/2023 at 12:00 PM, an interview was conducted with nurse E, RN, prior to the start of the home visit for Patient #4. She stated the patient’s home is very unsanitary with roaches and the staff did not take in equipment due to the unsanitary conditions. She stated the nurse visits weekly to assess the patient’s wound and perform wound care. The patient performs wound care 2 times a week, for wound care a total of 3 times a week. The patient had been in a motor vehicle accident which resulted in multiple wounds. Upon admission, he had IV therapy and a wound vac. Currently, he does not have a wound vac or IV therapy. During the home visit observation on 8/16/2023 at 12:05 PM for Patient #4 with nurse E, RN, the nurse completed wound care and stated the wound measurements were 2 x 1.3 x 0.1. This was an increase from the last measurement completed on 08/02/2023 of 1.5 x 1 x 0.1. At this time an interview was conducted with Patient #4, during which he was asked if he performs the wound care the other 2 times a week. He referenced the hair on his legs and stated he changes the dressing when there is drainage and as needed. Review of the Plan of Care dated 08/06/2023 to 10/04/2023, revealed the wound care orders stated, Skilled nurse to perform wound care once a week. In review of the medical record the wound assessment and wound care was not performed on 7/26/2023 and 08/09/2023 as per the Plan of Care. On 08/17/2023 at 10:45 AM, an interview was conducted with the Administrator who confirmed the skilled procedure is the observation of wound. The nurse should request to re-do the dressing to observe the wound or reschedule the visit. On 08/17/2023 at approximately 1:00 PM the Administrator confirmed there was not a skill provided and the visit for 08/09/2023 was changed from a billable visit to a nonbillable visit. .

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on clinical record review, interviews, and review of data reports it was determined that the Home Health Agency (HHA) failed to develop and implement a policy and procedure to include quality assurance measures for monitoring of the NEW process for the use of off-site contractors to review clinician’s Outcome and Assessment Information Set (OASIS) data items. This resulted in Start of Care OASIS assessments not completed within 5 days, M0090 (date completed) date not updated to reflect the last date of updates to OASIS items for 5 of 5 sampled Medicare/Medicare Advantage patient’s reviewed, #3, #7, # 9, #10, #12, and the OASIS was not transmitted within 30 days for 3 of 5 sampled patients, #3, #10 and #12. The cumulative effect of these systemic practices resulted in the agency’s failure to ensure the quality assurance program included an effective and on-going review of agency process’s to include the new process for off-site contractors to review OASIS data items, including the development of a policy and procedure to guide clinicians in the process to review OASIS data, quality assurance process to monitor the effectiveness of the new process, ensure OASIS accurately reflects the patient’s health status to avoid upcoding of the severity of the patient’s status, and ensure the data reported was accurate as assessed by the clinician within CMS OASIS guidelines. These practices impacted the agency’s ability to establish accurate health goals, report accurate data for quality reports to CMS, and to determine accurate payment based on the patient’s health status. The findings include: Record review of the Comprehensive Assessment with OASIS for patients #3, #7, #9, #10, and #12, indicated there were modifications to the OASIS items from 11 to 25 days after the Start of Care. The modifications included significant changes to OASIS data items. The changes included: Record review for Patient #3 revealed the Registered Nurse (RN) OASIS Admission was completed on 06/17/2023. The payor source was Medicare Patient-Driven Groupings Model (PDGM). According to CMS, PDGM works by taking the OASIS assessment and combines it with diagnosis coding to determine the reimbursement based on several factors such as referral source, comorbidity adjustment, and functional impairment to determine the case mix weight. The last modification to OASIS data items was completed on 07/11/2023, 24 days later. The M0090 date was not changed from 06/17/2023 to reflect the changes to OASIS data items on 07/11/2023. The CMS Outcome and Assessment Information Set OASIS-E Manual, Effective January 01, 2023, indicated the M0090 - Date Assessment Completed, is the last date that information used to complete the comprehensive assessment and determine OASIS coding was gathered by the assessing clinician and documentation of the specific information/responses was completed. The modifications included the following OASIS items: GG0130A1 eating from 04 (supervision) to 03 (partial/moderate assist). GG0130B1 oral hygiene from 04 (supervision) to 03 (partial/moderate assist). GG0130C1 toileting hygiene from 03 (partial/moderate assist) to 01(dependent). GG0130F1 upper body dressing from 03 (partial/moderate assist) to 01 (dependent). GG0130E1 shower bathe self from 02 (substantial/maximal assist) to 01 (dependent). GG0130G1 lower body dressing from 03 (partial/moderate assist) to 01 (dependent). GG0130H1 put on/take off footwear from 03 (partial/moderate assist) to 01 (dependent). GG0170D1 sit to stand from 05 (set up) to 02(substantial/maximal assist). GG170E1 chair/bed to chair transfer from 05 (set up) to 02 (substantial/maximal assist). G0170C1 Lying to sitting on bed side from 03 (partial/moderate assist) to 02 (substantial/max assist). GG0170E2 chair/bed to chair transfer from 02(substantial/maximal assist) to 03(partial/mod assist). GG0170G1 car transfer from 05 (set up) to 02 (substantial/max assist). GG0170G2 car transfer, discharge goal from 02(substantial/max assist) to 03 (Partial/moderate assist). GG017012 walk 10 feet discharge goal from 04 (supervision) to 03 (partial/moderate assist). GG0170K2 walk 150 feet discharge goal from 04 (supervision) to 09, GG0170L2 walking 10 feet discharge goal from 02 to 09 (NA), GG0170M2 1 step curb from 04 (supervision) to 09 (NA), GG0170P1 picking up an object from 03 (partial/moderate assist) to 01 (dependent). M1700 cognitive functioning from 2 (requires assist) to 3 (requires considerable assist). M1745 frequency of behavior problems from 3 (several times each month) to 5 (at least daily). M1810 dress upper body from 2 (someone must help) to 3 (depends entirely). M1840 toileting from 1 (when reminded) to 4 (totally dependent). M1845 toileting hygiene from 2 (someone must help) to 3 (patient depends entirely). M1860 Ambulation from 3 (walk with assist) to 5 (chairfast). M1033 hospital risk 2+ falls or injury in past year from no to yes. B0200 hearing from 0 (adequate) to 2 (moderate difficulty). B1000 vision from 0 (adequate)to 2 (moderately impaired). M1400 when dyspneic from 2 (with moderate exertion) to 3 (with minimal exertion). M1850 transferring from 2 (able to bear weight and pivot) to 3 (unable to transfer self). M2001 drug regimen review from 0 no issues to 1 yes issue found, N041511 high risk drug from no to yes. The ICD coding was completed on 07/11/2023. Record review for Patient #9 indicated the Physical Therapist (PT) OASIS Admission M0090 date was 07/28/2023. The payor source is Medicare, PDGM. The PT OASIS admission for Patient #9 indicated modifications were completed to the OASIS on 8/15/2023, 18 days after the M0090 date of 07/28/2023. The OASIS modifications by the Quality Reviewer on 08/14/2023 included: GG0100B Prior function-indoor mobility (ambulation) was changed from 3 (independent) to 2 (needed some help). GG0100C-Prior function-Stairs was changed from 3 (independent) to 2 (needed some help). GG0130B1 Oral Hygiene was changed from 05 (setup or clean up assistance) to 04 (supervision); GG0170A1 Roll left, and right was changed from 04 (supervision) to 03 (partial/moderate assist); GG0170D1 sit to stand was changed from 04 (supervision) to 02 (substantial/maximum assist); GG0170E1 chair/bed to chair transfer was changed from 04 (supervision) to 02 (substantial/maximal assist). GG0170F1 toilet transfer was changed from 04 (supervision) to 02 (substantial/maximal assist. GG0170i1 walk 10 feet was changed from 04 (supervision) to 03 (partial/moderate assist). GG070J1 walk 50 feet with two turns was changed from 04 (supervision) to 03 (partial/moderate assist); GG0170K1 walk 150 feet was changed from 04 (supervision) to 02 (substantial/maximal assist); GG0170L1 walking 10 feet uneven surfaces was changed from 03 (partial/moderate assist) to 02 (substantial/maximal assist). GG0170N1 4 steps was changed from 03 (partial/moderate assist) to 02 (substantial/maximal assist); K0520Z1 nutritional approaches was changed from yes to no. K0520D1 nutritional approaches was changed from no to yes. M1700 cognitive functioning was changed from 0 (alert and oriented) to 1 (requires prompting). On 08/15/2023 the ICD coder completed changes to the ICD codes and severity ratings. The M0090 date of 07/28/2023 was not updated to reflect the last date updates to the OASIS for Patient #9. Record review for Patient #7 revealed the RN OASIS Admission was completed on 06/29/2023. The payor source is Medicare, PDGM. The last modification was completed on 07/21/2023, 22 days later. The M0090 date was not changed from 06/29/2023 to reflect the changes to OASIS data items. The modifications included the following OASIS items: M1740 memory deficit from no to yes. M1745 frequency of behaviors) from 0 (never) to 4 (several times a day). GG0170M1- 1 steps curb) from 01 (dependent) to 88 (activity not attempted). GG0170L2 walking 10 feet uneven surface from 03 (partial/moderate assistance to 88 (activity not attempted). GG0170L1 from 01 (dependent) to 88 (activity not attempted). GG0170J1 walking 10 feet uneven surfaces from 01 (dependent to 88 (activity not attempted). GG0170F1 toilet transfer from 02 (substantial/maximal assist to 01 (dependent). GG0130F1 upper body dressing from 02 (substantial/maximal assist to 01 (dependent). GG0130C1 toileting hygiene from 02 (substantial/maximal assist to 01 (dependent). The ICD coding was completed on 07/21/2023. Record review for Patient #10 revealed the RN OASIS Admission was completed on 07/15/2023. The payor source is Medicare Advantage. The last modification was completed on 08/09/2023, 25 days later. The M0090 date was not changed from 07/15/2023 to reflect the changes to OASIS data items. The modifications included the following OASIS items: G0170C1 Lying to sitting on bed side from 05 (set up) to 01 (dependent). G0170C2 Lying to sitting on bed side, discharge goal from 01 (dependent) to 04 (supervision). M1324 Stage of most problematic pressure ulcer/injury, from Stage 3 to Stage 4. The ICD coding was completed on 08/09/2023. Record review for Patient #12 revealed the RN OASIS Admission was completed on 06/24/2023. The payor source is Medicare, PDGM. The last modification was completed on 07/20/2023, 21 days later. The M0090 date was not changed from 06/24/2023 to reflect the changes to OASIS data items. The modifications included the following OASIS items: M1033 Hospital Risk from no to yes. M1700 cognitive functions from 0 (alert and oriented) to 1 (requires prompting). M1840 toileting from 2 (unable to get to and from) to 1 (when reminded). M1860 ambulation from 2 (requires use of a 2 hand) to 3 (able to walk only with assist). M1870 feeding from 0 (independent) to 1 (set up). M2020 management of oral meds from 1 (able to take) to 3 (unable to take medications). The ICD coding was completed on 07/20/2023. A review of the Internet Quality Improvement Evaluation System (iQIES) Home Health Agency (HHA) Error Summary report for the 2nd quarter, 04/01/2023-06/30/2023, indicated an error rate of 8.40% for the error code 3330, Record Submitted Late (error 3330). A review of the available data for the 3rd quarter to date, 07/01/2023-08/18/2023 revealed an error rate of 46.61%, an increase of 38.21%. In total there were 221 assessments processed with 103 errors, noted as error 3330, record submitted late. Review of the OASIS Agency Final Validation Reports dated 08/02/2023, indicated that 20 of 26 transmitted OASIS had error message 3330. A review of the report dated 08/09/2023 indicated that 16 of 36 transmitted OASIS had error message 3330. On 8/17/2023 at 4:00 PM, the Administrator stated the corporation began a new process the first week of June for Quality Reviewers to review the comprehensive assessments with OASIS. She stated that the agency does not have a policy for the new Quality Review process. The Administrator provided the current policy dated 01/01/2015, titled “OASIS Accuracy Review” which indicated the comprehensive assessment should be reviewed within 24 hours after the clinician turns in the assessment. The Administrator also provided training from the corporate office, dated 05/17/2023, on the new Quality Review process. On 08/17/2023 at 3:30 PM, an interview was conducted with the Quality Reviewer, who stated that she was allowed to change pain, functional status, oxygen and other items on the OASIS and Plan of Care without a physician order. She stated when changes are made, she sends a communication note to the assessing clinician and the clinician has an opportunity to agree or decline the recommendation. She gave an example of this by stating if the assessing clinician documented pain as zero, but another clinician, such as a physical therapist, went out to see the patient and the patient reported pain, the Quality Reviewer would change the pain OASIS item (J0510-J0530), to indicate the patient had pain. She stated she changes the answer to J0510-J0530 based on the physician or other clinician documentation and not collaboration with or between the assessing clinicians. She further stated that she does not update or change the M0090 date (Date Assessment Completed). At this time Patient #9’s OASIS was reviewed with the Quality Reviewer. She indicated the coordination notes would be in the medical record indicating if the clinician agreed or declined the modifications. In review of the coordination notes the Quality Reviewer verified there was not a coordination note indicating the assessing clinician approved the modifications. The surveyor questioned if the M0090 (OASIS completion date) was updated to reflect the changes she made to the OASIS. The Quality Reviewer stated, “No, the M0090 date was not changed on any of the assessments.” She stated the agency was very far behind and confirmed the quality reviews were not completed during the 5-day review period. The Quality Reviewer provided a worksheet which is used for updating the Plan of Care. It states that the diagnosis, medications, prognosis, activities permitted, orders and goals, rehab potential and discharge plans require collaboration with the clinician. On 8/17/2023 at 7:37 PM, an interview was conducted with staff member A, Registered Nurse (RN) who stated that when they plug in the pathways for the Plan of Care interventions, errors can be made, and the office will correct them or add an intervention. The nurses have the option to disagree or call them with questions on how they made their decisions. The Quality Reviewer (QR) knows the OASIS guidelines, so she knows better. She will ask the nurses to explain why they charted a certain way and explain how it better fits into the guidelines. The QR clarifies what OASIS is actually asking. The office is good about explaining why they think it should be changed but they respect our opinions because we are in the home. They want to make sure they are scored the way the patients are most of the time, scoring them appropriately. When you come from acute care you score to their highest ability, but you need to ensure that it truly fits the patient. She reports that she sometimes mixes up the goal with the performance and the office will fix this. On 8/17/2023 at 8:06 PM, an interview was conducted with staff member E, RN, who stated she is alerted after the changes are made. “They just show up. I do not have time to do anything but accept them; they just change it." She stated that the OASIS is changed for financial reasons such as the difference between Medicare and Medicare advantage. "They are making the changes based on the kind of insurance the patient has and I do not have time for that. They change OASIS to meet the guidelines. Sometimes there are 20 changes and I do not have time to review them all. I could challenge it more, without a doubt, but I would not win the battle. I am learning Oasis is complicated and they know more than I do. I do not always know what they are putting. It is behind the scenes." On 8/18/2023 at 8:24 AM, an interview was conducted with staff member F, a physical therapist (PT), who reported that the OASIS assessments are double checked by the office and looked over. He stated he reviewed the suggested changes and can disagree with them if needed. “I think they are making the changes if they see something that is inconsistent with the functionals or diagnoses adding a priority of care. They add diagnoses to make sure they are not missed.” He stated that this does not change the outcomes. He reported that he has been working in OASIS for approximately 4 years and that he has had education. On 8/18/2023 at 8:38 AM, an interview was conducted with staff member H, PT, who reported that the agency has multiple systems that notify the clinicians of the OASIS changes, which he can accept or deny. He stated he has been working in OASIS for approximately 15 years and will sometimes document severity of a diagnosis as a “2” but it should have been a “3” based on the history of the patient. He clarified that the “2” makes them better than they actually were and the “3” makes them worse. He also stated that OASIS is “legal speak” and it is easy to make a mistake. “I like having the backup.” On 08/18/2023 at 9:00 AM, the Administrator confirmed that the policy for the new QA review was still in process and had not been finalized. The new process began on approximately June 5th. She confirmed there is currently no internal process to monitor this new quality assurance process. On 08/18/2023 at 11:20 AM, a follow-up interview was conducted with the Administrator regarding the OASIS validation reports. She offered that the agency transmits OASIS data to the CMS system weekly. The OASIS validation reports are reviewed weekly by the business manager. The validation reports indicated a notation of “ok” beside the transmission error messages (error 3330). The Administrator stated the first week of June 2023 the corporate office revised the process for quality review of OASIS assessments. After the assessing clinician completes the assessment, it is reviewed by an off-site Quality Reviewer. After this quality review is complete it is sent for ICD coding, and it is then locked and transmitted. The offsite quality reviewers and coders are not employees of the agency but are employed by the corporation which owns the agency. The agency has no control over this quality assurance process. The corporation’s offsite Quality Reviewers are behind on OASIS reviews. On 08/18/2023 at 12:35 PM, an interview was conducted with the Director of Nurses (DON) who stated the agency has some Performance Improvement Plans (PIPs) that they are working on that were established by the corporate leadership, such as readmission rates, however there were no internal PIPs in progress. The agency was bought last year, and a lot of processes had been changed. This has caused some confusion, including with the new Quality Review process. Previously, the Patient Care Manager would follow a patient from initial intake to discharge; however, currently the Patient Care Manager and/or DON do not have a part in the process. The DON reviews the initial intake and the disciplines, then makes sure they are scheduled, after which the system will “bypass” her. The assessment goes to the Quality Review people. The DON cannot see the assessment while it is under quality review. She does get a copy of the notes sent to the clinicians from the Quality Reviewer. When asked if she would then follow up with the clinicians due to the large number of modifications being made to the OASIS, she responded that she did not have time to follow that. It is now the Quality Reviewers' responsibility to educate the clinicians. The Quality Reviewers are behind because they are covering hundreds of patients from several other sites. The Quality Reviewers are not employed by the agency but are contracted with the corporation leadership. On 08/18/2023 at 11:45 AM, an interview was conducted with the Administrator, who stated the corporate Senior Director of Coding and Quality had sent some information on the QAPI process. However, upon review it appeared to be a Center for Medicare Services Frequently Asked Questions (CMS FAQ) document on collaboration. The leadership was not able to provide a policy and procedure for the Quality Review process or the process for monitoring the effectiveness of the new programs. .

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record reviews and interviews, the Home Health Agency's Administrator failed to be responsible for the day-to day operation of the Home Health Agency by failing to maintain an effective and ongoing Quality Assessment Performance Improvement (QAPI) program to ensure the quality and accuracy of comprehensive assessments, including Outcome and Assessment Information Set (OASIS), were monitored after the implementation of a new Quality Review process (cross reference G640). This failure has the potential to affect all patients. The findings include: Review of the Internet Quality Improvement Evaluation System (iQIES) Home Health Agency (HHA) Error Summary report for the 2nd quarter, 04/01/2023-06/30/2023, indicated an error rate of 8.40% for the error code 3330, Record Submitted Late. Review of the available data for the 3rd quarter for the dates 07/01/2023-08/18/2023, revealed an error rate of 46.61%, an increase of 38.21% in 59 days. In total there were 221 assessments processed with 103 noted as error 3330, record submitted late. A review of the OASIS Agency Final Validation Report dated 08/02/2023, indicated that 20 of 26 transmitted OASIS assessments had error message 3330. A review of the report dated 08/09/2023, indicated that 16 of 36 transmitted OASIS had error message 3330. On 08/17/2023 at 3:30 PM, an interview was conducted with the Quality Reviewer, during which she stated that she was allowed to change pain, functional status, oxygen and other items on the OASIS and Plan of Care without a physician order. She stated when changes are made, she sends a communication note to the assessing clinician and the clinician has an opportunity to agree or decline the recommendation. She stated she changes the answers to OASIS assessment responses based on the physician or other clinician documentation and not based on collaboration with or between the assessing clinicians, she further stated that she does not update or change the M0090 date (Date Assessment Completed). On 8/17/2023 at 4:00 PM, the Administrator stated the corporation began a new process the first week of June for Quality Reviewers to review the comprehensive assessments with OASIS. She stated that the agency does not have a policy for the new Quality Review process. The Administrator provided the current policy dated 01/01/2015, titled “OASIS Accuracy Review” which indicated the comprehensive assessment should be reviewed within 24 hours after the clinician turns in the assessment. The Administrator also provided a training from corporate office, dated 05/17/2023, on the new Quality Review process. On 08/18/2023 at 9:00 AM, the Administrator confirmed that the policy for the new QA (Quality Assurance) review was still in process and had not been finalized. The new process began on approximately June 5th. She confirmed there is currently no internal process to monitor this new quality assurance process. The office manager reviews the weekly OASIS Final Validation Reports and makes a notation on the late assessment alerts (error 3330). However, there was nothing they can do about that as it is out of their hands at the corporate level. On 08/18/2023 at 11:20 AM, a follow-up interview was conducted with the Administrator regarding the OASIS validation reports. She offered that the agency transmits OASIS data to the CMS system weekly. The OASIS validation reports are reviewed weekly by the business manager. The validation reports indicated a notation of “ok” beside the transmission error messages (error 3330). The Administrator stated the first week of June 2023 the corporate office revised the process for quality review of OASIS assessments. After the assessing clinician completes the assessment, it is reviewed by an off-site Quality Reviewer. After this quality review is complete it is sent for ICD coding, and it is then locked and transmitted. The offsite quality reviewers and coders are not employees of the agency but are employed by the corporation which owns the agency. The agency has no control over this quality assurance process. The corporation’s offsite Quality Reviewers are behind on OASIS reviews. On 08/18/2023 at 12:35 PM, an interview was conducted with the Director of Nurses (DON) who stated the agency has some Performance Improvement Plans (PIPs) they are working on that were established by the corporate leadership, such as readmission rates; however, there were no internal PIPs in progress. The agency was bought last year and a lot of processes had been changed. This has caused some confusion, including with the new Quality Review process. Previously, the Patient Care Manager would follow a patient from initial intake to discharge; however, currently the Patient Care Manager and/or DON does not have a part in the process. The DON reviews the initial intake and the disciplines, then makes sure they are scheduled, after which the system will “bypass” her. The assessment goes to the Quality Review people. The DON cannot see the assessment while it is under quality review. She does get a copy of the notes sent to the clinicians from the Quality Reviewer. When asked if she then follows up with the clinicians due to the large number of modifications being made to the OASIS, she responded that she did not have time to follow that. It is now the Quality Reviewers' responsibility to educate the clinicians. The Quality Reviewers are behind because they are covering hundreds of patients from several other sites. The Quality Reviewers are not employed by the agency but are contracted with the corporation leadership. A review of the policy titled, “Organizational Responsibilities and Organizational Charts” last updated 4/01/2020 states, “The Executive Director thus assumes full legal authority and responsibility for the agency’s overall management and operations, provision of all home health services, fiscal operations, review of the agency’s budget and operational plans and its quality assessment and performance improvement (QAPI) program. A review of the job description for the Executive Director (Home Health), noted as signed by the Administrator on 1/31/22, revealed under Job Summary, "The Executive Director serves as the Administrator of the entire home health provider and it responsible for the oversight of the day-to-day operations." Under Essential Functions is listed, “Supervises and ensures high quality patient care services throughout the episode of care. This includes overseeing: referral coordination, assuring that patient needs are continually assessed, and assuring the development, implementation, and updates of the patient’s individualized plan of care, ensuring coordination with physician, family and other clinicians involved in care as appropriate. Communicated effectively with staff to ensure they are informed through staff meetings, case conferences and mandatory in-services. Supervises patient care to ensure the delivery of safe, economical, and efficient patient care, which adheres to relevant standards of accepted nursing and medical practice, to include federal and state regulations….to ensure compliance with payer source criteria and LHC policies. This includes ensuring patient care is provided according to the plan of care as ordered by the physician. This includes coordinating and completing assigned projects to effectively support the immediate and long-range objectives of the company, oversight of the eligibility of patients referred to home care services, planning for the services to be provided to patients and supervising their total home health care, implementing and maintaining administrative practices, agency philosophy, goals and policies which assure compliance with applicable state and federal regulations…” “Serves as the governing leader of the provider, leads the QAPI Team according to required timeframes and oversees annual performance improvement projects and annual strategic agency planning ensuring follow up on any required action plans." Under Supervisor/Managerial Responsibility the following is included, "This job has responsibility for this action for conducting performance reviews, assessing training and development needs, and monitoring." The items listed for conducting training and creating long-range plans also include, “This job is asked for an opinion/recommendation but does not make the final decision.”