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The Key to Past Non-Compliance PNC Potential Implications of Uncontested Survey Findings in Civil Litigation

Disclaimer. These materials have been prepared by HeathCap and Kitch Drutchas Wagner Valitutti

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The Key to Past Non-Compliance PNC Potential Implications of Uncontested Survey Findings in Civil Litigation

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    1. The Key to “Past Non-Compliance” (PNC) & Potential Implications of Uncontested Survey Findings in Civil Litigation Angie Szumlinski, NHA, RNC Director, HealthCap RMS Angie.szumlinski@chelsearhone.com 734-996-2700 John Paul Hessburg Kitch Drutchas Wagner Valitutti & Sherbrook John.hessburg@kitch.com 313-965-6696

    2. Disclaimer These materials have been prepared by HeathCap and Kitch Drutchas Wagner Valitutti & Sherbrook PC, for informational purposes only and are not legal advice. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Readers should not act upon this information without seeking professional counsel. Photographs, articles, records, pleadings, etc., are for dramatization purposes only.

    3. OBJECTIVES Define what is required to determine past non-compliance Explain the role of the Quality Assurance Committee in establishing past non-compliance Explain the importance of maintaining compliance with the plan of correction Explain the potential relevance of survey findings to civil litigation

    4. OVERVIEW Past non-compliance may be cited on Health and Life Safety Code surveys in nursing homes Past non-compliance may be cited on any type of survey (standard recertification, abbreviated standard, e.g., complaint and revisit) Data about past non-compliance tags are not carried forward to subsequent revisit surveys IDRs will be allowed for past non-compliance tags

    5. DISCONTINUED USE OF TAG F-698 The use of the generic survey data tag F698 for all past non-compliance citations was discontinued for all surveys with a survey exit date beginning on or after November 1, 2005

    8. NEW SYSTEM CMS has modified the data system so that the specific nursing home survey data tag (F-tags for health deficiencies or K-tags for life safety code deficiencies) for which there was a finding of past non-compliance may be identified appropriately

    9. WHAT IS PAST NON-COMPLIANCE? In plain English? An unusual event occurs A pattern of deficient practice is identified resulting in negative a outcome or with a high probability of a negative outcome The Quality Assurance Committee develops a plan of correction to address the deficient practice and initiates the plan

    10. THREE CRITERIA REQUIRED The facility was not in compliance with the specific regulatory requirement(s) (as referenced by the specific F-tag or K-tag) at the time the situation occurred The non-compliance occurred after the exit date of the last standard re-certification survey and before the survey (standard, complaint, or revisit)( currently being conducted) and There is sufficient evidence that the facility corrected the non-compliance and is in substantial compliance at the time of the current survey for the specific regulatory requirement(s) as referenced by the specific F-tag or K-tag Whew…..lots of words…..let’s take a look at each criteria!

    11. CRITERIA #1 The facility was not in compliance with the specific regulatory requirement(s) (as referenced by the specific F-tag or K-tag) at the time the situation occurred. Examples include:

    12. CRITERIA #1 EXAMPLES A resident fall occurs; the investigation reveals the resident was not assessed for risk of falls (per facility policy) and preventive interventions were not initiated A resident is injured during a transfer using a mechanical lift; the investigation reveals that the staff member was never trained on safe use of the mechanical lift In-house acquired pressure sores is another area commonly identified with past non-compliance

    13. CRITERIA #2 The non-compliance occurred after the exit date of the last standard re-certification survey and before the survey (standard, complaint, or revisit) currently being conducted

    14. CRITERIA #2 - EXAMPLES To Cite past non-compliance there must have been a: Deficient practice identified after the last standard survey Evidence that it was corrected before the current survey visit Currently in compliance with the same regulatory requirement

    15. CRITERIA #3 There is sufficient evidence that the facility corrected the non-compliance and is in substantial compliance at the time of the current survey for the specific regulatory requirement(s) as referenced by the specific F-tag or K-tag

    16. CRITERIA #3 - EXAMPLES Like a Plan of Correction to a Statement of Deficiencies The Quality Assurance Committee develops a Plan of Correction (POC) The interdisciplinary team implements the interventions in the POC and monitors through the Quality Assurance Committee This is key; facilities who are not successful with past non-compliance attempts have often failed to monitor ongoing per the plan

    17. Documentation of Past Non-Compliance 1. Past Non-Compliance that is not an Immediate Jeopardy and for which a quality assurance program has corrected the non-compliance should not be cited NOTE: The facility needs to bring this to the attention of the surveyor The facility must provide evidence to the surveyor who will contact their manager to review the information and make a determination if the evidence meets the criteria for past non-compliance

    18. Documentation of Past Non-Compliance (cont.) 2. Past Non-Compliance identified as Immediate Jeopardy is entered on CMS 2567 under the specific deficiency tag, scope and severity with supporting documentation 3. The CMS 2567 should include the appropriate F-tag, date of deficiency, the date of past non-compliance, the evidence of past non-compliance and implementation of a plan of correction so that the civil money penalty can be determined

    19. SURVEY – DETERMINING PNC The surveyors may interview facility staff (i.e., administrator, nursing staff, social services, medical director, QA committee members, etc.) to determine what procedures, systems, structures, and processes have been changed since the deficient practice was identified

    20. SURVEY – DETERMINING PNC The surveyors may review how the facility identified and implemented interventions to address the non-compliance including but not limited to: Interviews Observations Record review

    21. INTERVENTIONS The facility’s review, revision or development of policies and/or procedures to address the areas of deficient practice

    22. INTERVENTIONS EXAMPLE The facility QI report flags for weight loss The policy and procedure for monthly weights does not indicate that a re-weight should be obtained if there is a 5# gain/loss The policy does not state that the registered dietitian should be notified of all weight changes The policy was updated to reflect these interventions Staff were inserviced on the new weight protocol

    23. INTERVENTIONS The provision and use of new equipment as necessary; example:

    24. INTERVENTIONS EXAMPLE The facility flags on the QI report for weight loss An investigation reveals that the weight loss data may be inaccurate A new scale is purchased Weights begin to stabilize It is determined that the scale was at issue and this was the corrective intervention

    25. INTERVENTIONS The provision of staff training required to ensure ongoing compliance for the implementation and use of new and/or revised policies, procedures and/or equipment, especially with new and/or temporary staff

    26. INTERVENTIONS EXAMPLE Resident is injured during a transfer using a mechanical lift It is determined that the staff member performing the transfer had not been properly trained on the equipment Training is provided to all direct care staff to ensure the equipment is used safely

    27. INTERVENTIONS The provision of additional staffing, changes in assignments or deployment of staff as needed

    28. INTERVENTIONS EXAMPLE Additional staff or changes in deployment has proven to be very effective especially if an acuity study is performed and it is determined that basic care needs are much higher than previously thought Many facilities will successfully initiate “permanent assignments”

    29. INTERVENTIONS The provision of a monitoring mechanism to assure that the changes made are being supervised, evaluated and reinforced by responsible facility staff Remember, this is a QA system and QA systems require ongoing monitoring if they are to be effective NOTE: FOLLOW THE MONITORING PLAN TO THE LETTER!

    30. TRAP TO AVOID Avoid naming specific team members for ongoing monitoring. Use “Director of Nursing OR DESIGNEE”, “Administrator OR DESIGNEE” Avoid locking yourself into a system where compliance cannot be maintained ongoing Be sure to include an end date: i.e., will monitor weekly x 4 weeks then monthly x 3 months. This will allow you to stop the ongoing monitoring if the system is working well after 3 months

    31. QUALITY ASSURANCE COMMITTEE Another area that is reviewed by surveyors when determining past non-compliance is to evaluate whether the committee is functioning well and:

    32. QUALITY ASSURANCE COMMITTEE A well functioning committee will: Identifying quality issues Providing timely response to determine the cause of quality issues Implementing corrective actions Monitoring for ongoing compliance

    33. MONITORING The world according to Angie….this is the key! The monitoring mechanisms must ensure continued correction and revision of approaches as necessary to eliminate the potential risk of occurrence to other residents and to ensure continued compliance In other words, if the plan isn’t working it is okay to revise it!

    34. TO SUMMARIZE The deficient practice/violation must have been identified at or near the time it occurred The event occurred after the last standard survey The current survey information must indicate the facility is in compliance with the same tag Corrective action was taken utilizing the four step plan of correction process The plan of correction must have been completed prior to the current survey

    35. STATEMENT OF DEFICIENCIES The 2567 will have a “new look” The facility is not required to provide a plan of correction for a deficiency cited as past non-compliance as the deficiency is already corrected The survey team will document the facility’s corrective actions on the CMS-2567 ASPEN will print tags cited as past non-compliance in tag number order on the CMS-2567

    36. STATEMENT OF DEFICIENCIES The Provider’s Plan of Correction column will print “Past non-compliance: no plan of correction required” for past non-compliance tags The Survey Team enters a correction date The correction date must be before the survey start date of the visit identifying past non-compliance

    37. PLAN OF CORRECTION A deficiency that is cited as “past non-compliance” does not require the nursing home to provide a plan of correction The survey team documents the facility’s corrective actions on the CMS 2567 (similar to when an IJ is abated)

    38. ENFORCEMENT Recommend the imposition of a Civil Money Penalty (CMP) for past non-compliance cited at the level of Immediate Jeopardy Per Day fines Per-Instance CMP when it is difficult to accurately establish when the past non-compliance occurred

    39. CIVIL MONEY PENALTY (CMP) Civil money penalty is the only applicable enforcement action for a past non-compliance citation Past non-compliance that is not Immediate Jeopardy for which a quality assurance program has corrected the non-compliance should not be cited

    40. When Past Non Compliance is Not Successful - Post Survey Considerations Traditional Concerns CMP’s to Termination Maintaining post POC compliance Litigation Relevance – tags / 2567 Evidence of negligence Admission(s) against interest Rebuttable Maybe… Maybe not….

    41. 45 CFR 2 - How Could it Effect Us? Background Bush administration quietly enacted a new rule for State and Federal Surveyors Rule makes them all Federal employees Traditionally, a Federal employee is shielded from providing evidence for either side during civil litigation

    42. Scope of the Rule Does not apply to documents Records are publicly available to anyone New rule still allows for the access to records and reports Testimony It is the policy of the DHHS to maintain “strict impartiality” ? Not allowed to testify 45 CFR 2.1(b)

    43. Testimony “No current or former DHHS employee may provide testimony or produce documents in any proceedings to which this rule applies” 45 CFR 2.3

    44. What type of Information is effected? Information is barred if it: Was acquired in the course of performing official duties Because of the person’s official relationship with the DHHS 45 CFR 2.3

    45. Exceptions to the Rule Any proceeding (State or Federal) in which the U.S or Federal agency is a part Congressional requests Consultative services Employees serving as expert witnesses (giving their personal opinion) Employees testifying in a private capacity not relating to DHHS Matters involving FDA regulations 45 CFR 2.1(d)(1-7)

    46. Exceptions to the Rule Agency can authorize an employee or former employee to testify This will only occur when the agency head determines it is in the best interest of the agency for the employee to do so 45 CFR 2.3

    47. Implications

    48. Response to New Legislation Post survey handling more important than ever Appeal citations – state and federal Substantive appeal Delete cite altogether Lower scope and severity Out of substandard quality of care Non harm Unfounded conclusions

    49. Summary Consider PNC before the State walks in Be careful what we write in POC, IDR, etc. Consider IDR / Fed Appeal Re the SOD language Re the merits of the tag(s) Educate defense counsel Surprises are not fun

    50. The Key to “Past Non-Compliance” (PNC) & Potential Implications of Uncontested Survey Findings in Civil Litigation Angie Szumlinski, NHA, RNC Director, HealthCap RMS Angie.szumlinski@chelsearhone.com 734-996-2700 John Paul Hessburg Kitch Drutchas Wagner Valitutti & Sherbrook John.hessburg@kitch.com 313-965-6696

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