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SNF Regulatory Webinar #5: Review of Top Citation trends Revised Surveyor Guidance’s S&C:14-37-NH Revisions to Appendix PP of the SOM and of the Interpretive.

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Presentation on theme: "SNF Regulatory Webinar #5: Review of Top Citation trends Revised Surveyor Guidance’s S&C:14-37-NH Revisions to Appendix PP of the SOM and of the Interpretive."— Presentation transcript:

1 SNF Regulatory Webinar #5: Review of Top Citation trends Revised Surveyor Guidance’s S&C:14-37-NH Revisions to Appendix PP of the SOM and of the Interpretive Guidelines and Investigative Protocols Incorporating S&C policy memos issued from October 2003 through May 2014 www.cms.gov/regulations-and guidance/manuals/downloads/som107ap_pp_guidelines_ltcf.pdf

2 Assurance of Financial Security - F161 483.10(c)(7) The facility must purchase a surety bond, or otherwise provide assurance satisfactory to the Secretary, to assure the security of all personal funds of residents deposited with the facility. IG - The surety bond is not limited to personal needs allowance funds. Any resident funds that are entrusted to the facility for a resident must be covered by the surety bond, including refundable deposit fees. SP - As part of Phase 2, if the team has any concerns about resident’s funds, check the amount of the surety bond to make sure it is at least equal to the total amount of residents’ funds, as of the most recent quarter. If the SA cannot determine whether or not the facility is in compliance with this requirement, a referral to the State’s fiscal department would be appropriate.

3 IG - If a nursing home discharges a resident or retaliates due to an existing resident’s failure to sign or comply with a binding arbitration agreement, the State and Region may initiate an enforcement action based on a violation of the rules governing resident discharge and transfer. A current resident is not obligated to sign a new admission agreement that contains binding arbitration. SP - During closed record review, evaluate the extent to which the discharge summary and the resident’s physician justify why the facility could not meet the resident’s needs. Look for changes in source of payment coinciding with transfer. Documentation for Transfer and Discharge - F202 483.12(a)(3) When the facility transfers or discharges a resident due to the facility’s inability to meet the resident’s welfare/needs, or when the resident’s health has improved sufficiently and no longer needs the facility services, or when the safety of individuals in the facility is endangered, the resident’s clinical record must be documented … by the resident’s physician

4 Admission Policy - F208 483.12(d)(3) In the case of a person eligible for Medicaid, a nursing facility must not charge, solicit, accept, or receive, in addition to any amount otherwise required to be paid under the State plan, any gift, money, donation, or other consideration as a recondition of admission, expedited admission or continued stay in the facility. However, — A nursing facility may charge a resident who is eligible for Medicaid for items and services the resident has requested and received, and that are not specified in the State plan as included in the term “nursing facility services” so long as the facility gives proper notice of the availability and cost of these services to residents and does not condition the resident’s admission or continued stay on the request for and receipt of such additional services; and A nursing facility may solicit, accept, or receive a charitable, religious, or philanthropic contribution from an organization or from a person unrelated to a Medicaid eligible resident or potential resident, but only to the extent that the contribution is not a condition of admission, expedited admission, or continued stay in the facility for a Medicaid eligible resident.

5 This requirement applies only to Medicaid certified nursing facilities. IG - Facilities may not charge for any service that is included in the definition of “nursing facility services” and, therefore, required to be provided as part of the daily rate. This regulation does not preclude a facility from charging a deposit fee to, or requiring a promissory note from, an individual whose stay is not covered by Medicaid. In instances where the deposit fee is refundable and remains as funds of the resident, the facility must have a surety bond that covers the deposit amount. IG - A nursing facility is permitted to charge an applicant or resident whose Medicaid eligibility is pending, typically in the form of a deposit prior to admission and/or payment for services after admission. Medicaid eligibility will be made retroactive up to 3 months before the month of application if the applicant would have been eligible had he or she applied in any of the retroactive months. IG - In addition, the nursing facility must accept as payment in full the amounts determined by the state for all dates the resident was both Medicaid eligible and a nursing facility resident. Therefore, a nursing facility that charged a recipient for services between the first month of eligibility established by the state and the date notice of eligibility was received is obligated to refund any payments received for that period less the state’s determination of any resident’s share of the nursing facility’s costs for that same period. A nursing facility must prominently display written information in the facility and provide oral and written explanation to applicants or residents about applying for Medicaid, including how to use Medicaid benefits, and how to receive refunds for previous payments covered by such benefits. IG - Under the post-eligibility process, if the Medicaid-eligible resident has income and is required to make a monthly payment to the nursing facility (which is portion of the Medicaid payment amount), then the nursing facility is permitted to retain the amount it is legally owed. However, the nursing facility must not charge administrative fees.

6 Let’s take a pause here for any questions or comments for these Resident Rights and Admission, Transfer & Discharge regulations.

7 Restraints: F221 - Physical 483.13(a) The resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident’s medical symptoms. Overview - Restraints may not be used for staff convenience. However, if the residents needs emergency care, restraints may be used for brief periods to permit medical treatments to proceed unless the facility has a notice indicating that the resent has previously made a valid refusal of the treatment in question. A.The use of side rails as restraints is prohibited unless they are necessary to treat a resident’s medical symptoms or assist with physical functioning. B.It is expected that the process facilities employ to reduce the use of side rails as restraints is systematic and gradual to ensure the resident’s safety while treating the resident’s medical symptom. Before a resident is restrained, the facility must determine the presence of a specific medical symptom that would require the use of restraints, and how their use would treat the medical symptom, protect the resident’s safety, and assist the resident in attaining or maintaining their highest practicable level of physical & psychosocial well- being. This includes the facility’s discussion with the resident, (and/or if indicated) their legal surrogate or representative of potential risks and benefits of all options under consideration including using a restraint, not using a restraint, and alternatives to restraint use. Medical symptoms that warrant the use of restraints must be documented in the resident’s medical record, ongoing assessments and care plans. Physical restraints as an intervention do not treat the underlying causes of medical symptoms and that they should be used temporarily and not be used without also seeking to identify and address the physical or psychosocial condition causing the medical symptoms.

8 While there must be a physician’s order reflecting the presence of a medical symptom, the facility is ultimately accountable for the appropriateness of that determination. A physician’s order alone is not sufficient to warrant the use of the restraint. Falls do not constitute self-injurious behavior or a medical symptom that warrants the use of a physical restraint. Orthotic body devices may be used solely for therapeutic purposes to improve the overall functional capacity of the resident. Before using a device for mobility or transfer, assessment should include a review of the resident’s bed mobility and ability to transfer between positions/surfaces. SP - For sampled residents observed as physically restrained during the survey or whose clinical records show the use of physical restraints within 30 days of the survey; A.determine whether the facility used the restraint for convenience or discipline, or a therapeutic interventions for specific periods to attain and maintain the resident’s highest practicable well-being. B.determine if the facility follows a systematic process of evaluation and care planning prior to using restraints. C.determine if the interdisciplinary team addressed the risk of decline at the time restraint use was initiated and that the care plan reflected measures to minimize a decline. D.determine if the plan of care was consistently implemented

9  SP - Through observation, interview and record review – the surveyor will investigate the following: What are the medical symptoms that led to the use of restraints? Are the symptoms cause by failure to meet the resident’s assessed needs, use rehabilitative/restorative care, provide meaningful activities, or manipulate the resident’s environment, including seating? Has the facility attempted to use alternatives? Does the facility use the least restrictive restraint for the least amount of time? Is this being monitored? Was informed choice sought?

10 Let’s take a pause here for any questions or comments for this Resident Behavior & Facility Practice regulation.

11 Accuracy of Assessment - F278 483.20(i) A registered nurse must sign and certify that the assessment is completed and each individual who completes a portion of the assessment must sign and certify the accuracy of that portion of the assessment. IG - Facilities may use electronic signatures on the MDS when permitted to do so by state and local law and when this is authorized by the long-term care facility’s policy. IG - Facilities must have written policies in place to ensure that they have proper security measures to protect use of an electronic signature by anyone other than to which the electronic signature belongs. IG - The policy must also ensure that access to a hard copy of clinical records is made available to surveyors and others who are authorized access to clinical records by law. IG - Facilities that are not capable of maintaining the MDS signatures electronically must adhere to the current requirements addressing the need for either a hand-written copy or a computer-generated form. IG - Backdating completion dates is not acceptable - not that recording the actual date of completion is not considered backdating. SP - Verify the appropriate certifications are in place, including the RN Coordinator’s certification of completion of an assessment or Correction Request and the individual assessors.

12 Services Provided Meet Professional Standards of Quality - F281 483.20(k)(3)The services provided or arranged by the facility must meet professional standards of quality… IG - “Professional standards of quality” means services that are provided according to accepted standards of clinical practice. SP - Does staff follow facility policies for assuring each resident has a sufficient supply of medications to meet the needs of residents and does the staff adhere to the facility’s system for reordering medications?

13 MDS Data Storage & Maintenance - F286 483.20(d) A facility must maintain all resident assessments completed within the previous 15 months in the resident’s active record. IG - Facilities may maintain MDS data electronically regardless of whether the entire clinical record is maintained electronically and regardless of whether the facility has an electronic signature in place. IG - This is in accordance with state and local law, and when this is authorized by the long- term care facility’s policy.

14 Let’s take a pause here for any questions or comments for these Resident Assessment regulations.

15 Medication Errors - F332 483.25(m)(1) The facility must ensure that it is free of medication error rates of 5 percent or greater IG - “ Medication Error” the observed preparation or administration of medications or biologicals which is not in accordance with: A.The prescriber’s orders B.Manufacturer’s specifications (not recommendations) regarding the preparation and administration of the medication or biological IG - The error rate must be 5% or greater in order to cite F332 – (rounding up is not permitted) IG - A medication error rate of 5% or greater may indicate that the facility has systemic problems with it medication distribution system. IG - Any significant medication error included in the F332 (5% or greater) citation should also be cited at F333.

16 Significant/Non-Significant Medication Errors - F333 483.25(m)(2) The facility must ensure that Residents are free of any significant medication errors. IG - Determining Significance - the relative significance of medication errors is a matter of professional judgment. Considerations include the Resident’s condition, the category of drug, and frequency of errors. IG - Significant medication errors are in the following circumstances: A.When observed during the medication administration – regardless of whether the facility error rate is 5% or greater. B.When identified during the course of a resident record review, including a revisit survey or a complaint investigation.

17 C.Medication Errors due to Failure to Follow Manufacturers Specifications or Accepted Professional Standards: ✓ The failure to “shake” a medication that is labeled “shake well” may lead to an under dose or over dose depending on the product and the elapsed time since the last “shake”. ✓ The crushing of tablets or capsules for which the manufacturer instructs to “do not crush” requires further investigation. Please note there are exceptions to this rule. ✓ Administering medications without adequate fluid when the manufacturer specifies that adequate fluids be take with the medication, i.e. bulk laxatives, NSAIDS, K+ supplements ✓ Medications Administered Via Enteral Feeding Tubes; the placement of the feeding tube should be confirmed in accordance with the facility’s policy (NG, J-tube, G-tube). If the placement of the tube is not checked, it is not a medication error, but should be reviewed under F322- Nasogastric tubes. *Failure to flush before and in between each medication administration is considered a single medication error and would be included in the facility’s medication error rate.

18 Nutritional and Dietary Supplements - Nutritional Supplements are medical foods that are used to complement a resident’s dietary needs, i.e. - ensure, glucerna etc. Herbal and alternative products are considered to be dietary supplements. If a dietary supplement that is given to a resident between meals and has a vitamin(s) as one or more of its ingredients, it should be documented and evaluated as a dietary supplement, rather than a medication. For clinical purposes, it is important document a resident’s intake of such substance elsewhere in the clinical record and to monitor their potential effects, as they can interact with other medications. *Medication errors involving vitamins and/or minerals should be documented at F322 and counted towards the error rate calculation Medication errors involving vitamins and minerals would not be considered to a significant medication error unless the criteria at F333 were met. Medications Instilled into the Eye - eye drops should make full contact with the conjunctival sac, so that the medication is washed over the eye with the resident closes their eyelid. It must contact the eye for a sufficient period of time (3-5 minutes) before the next eye drop is instilled. Systemic effects of eye medications can be reduced by pressing the tear duct for one minute after eye drop administration or by gentle eye closing for approximately three minutes.

19 Sublingual Medications - if the resident persists in swallowing a sublingual tablet despite efforts to train otherwise, the facility should endeavor to seek an alternative dosage form for this medication. Metered Dose Inhalers (MDI - ensuring that a device is administered correctly is vital to optimizing inhalation therapy which includes shaking the container well, positioning the inhaler in front of or in the resident’s mouth (may use a spacer or valved holding chamber). *If more than one puff is required (whether the same medication or a different medication) follow the manufacturer’s product information for administration instructions including the acceptable wait time between inhalations. IG - Medication Errors; Timing, Prescriber’s Orders, Omitted Dose (most frequent type of error) SP - Medication Administration Observation Methodology Do not rely on a paper review to determine medication errors - detection of blank spaces on a MAR does not constitute the detection of actual medication error. Surveyor may ask the person administering medication to describe their system for administering medications. Some times people may share medication carts. Those people should be interviewed about an omitted dose. If the facility is not aware that there is a potential for an interaction between two medications given at same time via an enteral tube and is not monitoring for unwanted side effects, surveyor is directed to consider administration of a med. error failure. Multiple tablets or capsules required to deliver a dose of medication count as one observation. Observe infection prevention practices by staff administering medication, including the procedures used for insulin pens and single dose vial use (F441 may be a concern)

20 Let’s take a pause here for any questions or comments for these Quality of Care regulations.

21 Sanitary Conditions - F371 483.35(i)(1)(2) The facility must procure food from sources approved or considered satisfactory by Federal, State or local authorities and store, prepare, distribute and serve food under sanitary conditions.

22 Frequency of Physician visits - F387 & F388 483.40(c) (1)The residents must be seen by a physician at least once every 30 days for the first 90 days after admission, and at least once every 60 thereafter; (2) a physician visit is considered timely if it occurs not later than 10 days after the date the visit was required. (3) except as provided in paragraphs (c)(4) and (f) of this section, all required physician visits must be made by the physician personally. (4) At the option of the physician, required visits in SNFs, after the initial visit, may alternate between personal visits by the physician and visits by a physician assistant, nurse practitioner or clinical nurse specialists IG - The timing of physician visits is based on the admission date of the resident. In a SNF, the first physician visit (this includes the initial comprehensive visit) must be conducted within the first 30 days and then at 30 day intervals up until 90 days after the admission date. After the first 90 days, visits must be conducted at least once every 60 days thereafter.

23 IG - Permitting up to 10 days slippage of a due date will not affect the next due date. Although the physician may not delegate the responsibility for conducting the initial visit in a SNF, NPP’s (non- physician practitioner i.e. - nurse practitioner, clinical nurse specialist, or physician assistant) may perform other medically necessary visits prior to and after the physician’s initial visit as allowed by State law. IG - After the initial physician visits in SNF’s, a qualified NP, CNS, or PA may make every other required visit. These alternate visits as well as medically necessary visits, may be performed and signed by the NPP. (Physician co-signatures is not required) IG - In a NF, the physician visit requirement may be satisfied in accordance with State law by NP, CNS, or PA who is not an employee of the facility but who is working in collaboration with a physician and who is licensed by the State and performing within the states’ scope of practice. ( Michigan Compiled Law 333.17549) IG - In a facility where beds are dually-certified under Medicare and Medicaid, the facility must determine how the particular resident is being paid in order to identify whether physician delegation of tasks is applicable and if a NPP may perform the tasks. For a resident receiving Part A Medicare benefits for the nursing home stay in a Medicare certified bed, the NPP must follow the requirements for physician services in a SNF. This includes, at the option of a physician, required physician visits alternated between personal visits by the physician and visits by a NPP afar the physician makes the initial first visit. For a resident receiving Medicaid benefits, the NPP must follow the requirements for physician services in a NF. The NPP may perform required physician task for Medicaid beneficiary in a Medicaid stay certified bed. The NPP may not be an employee of the facility and must be working in collaboration with a physician.

24 Physician Delegation of Tasks Performed in SNF/NF - F390 483.40 (f)At the option of the State, any required physician task in a NF (including tasks which the regulations specify must be performed personally by the physician) may also be satisfied when performed by a nurse practitioner, clinical nurse specialists or physician assistant who is not an employee of the facility but who is working in collaboration with a physician. IG - The performance of physician tasks in a NF includes NPP’s (as defined in F388) performing required visits at the option of the State. The resident must be seen every 30 days for the first 90 days and every 60 days thereafter. IG - NPPs that have a direct relationship with a physician and who are not employed by the facility may perform the initial visit, any other required physician visit and other medically necessary visits, and verify and sign orders for a resident of a NF as the State allows.

25 IG - The physician of NPP must review the resident’s total program of care including medications and treatments, at each required visit, write, sign and date progress notes at each visit, and sign and date all orders with the exception of influenza and pneumococcal vaccines, which may be administered per physician-approved facility policy after an assessment for contraindications. IG - The timing of physician visits is based on the admission date of the resident. In a NF, the first physician visit must be conducted within the first 30 days, and then at 30 day intervals up until 90 days after the admission date. After the first 90 days, visits must be at least once every 60 days there after. Permitting up to 10 days slippage of a due date will not affect the next due date. Do not specifically look at the timetables for visits unless there is indication of inadequate medical care. IG - Facility policy that allows an NPP to make required visits, and that allows a 10 day slippage in the time of the visit, does not relieve the physician of the obligation to visit a resident when the resident’s medical condition makes that visit necessary.

26 Authority for NPP to Perform Visits and Sign Orders when Permitted by the State Initial Comprehensive Visit/Orders Other Required Visits Other Medically Necessary Visits and Orders SNF’s PA, NP & CNS employed by the facility May not perform/May not sign May perform alternate visits May perform and sign (except radiology and other diagnostic services) PA, NP & CNS not a facility employee May not perform/May not sign May perform alternate visits May perform and sign (except radiology and other diagnostic services)

27 Authority for NPP to Perform Visits and Sign Orders when Permitted by the State Initial Comprehensive Visit/Orders Other Required Visits Other Medically Necessary Visits and Orders NF’s PA, NP & CNS employed by the facility May not perform/May not sign May not perform May perform and sign PA, NP & CNS not a facility employee May perform/May sign May performMay perform and sign

28 Let’s take a pause here for any questions or comments for these Physician Services regulations.

29 Pharmacy Services - F425 483.60 The facility must provide routine and emergency drugs and biologicals to its residents…provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet he the needs of the resident. IG - Procedures should identify how staff - who are responsible for medication administration: ‣ ensure each resident has a sufficient supply ‣ the system is expected to include a process for timely ordering and reordering of medication ‣ monitor the delivery of medications when they are ordered ‣ determine the appropriate action (e.g. contact the prescriber or pharmacist) when a resident’s medication is not available for administration IG - Foreign Acquired Medication - The Federal Food, Drug, and Cosmetic Act (FFDCA) strictly limits the types of drugs that my be imported into the U.S.

30 SP - if a surveyor becomes aware that a resident has in their possession imported prescription medications, the surveyor should determine whether the facility is aware of the presence of the imported medications. if the facility is unaware of the imported medications, the surveyor should determine whether the medications are delivered to the resident via the facility staff or are self-administered. if the medication are administered by facility staff, the surveyor should cite F425 for unsafe practice. if the resident self-administers the medication without the facility’s knowledge, the surveyor should notify the facility of the unsafe practice. In addition, if it is determined that the facility is providing/obtaining foreign medications for use by the resident that are not FDA approved, the State Agency must make referrals to appropriate agencies such as the FDA, DEA, State Boards of Nursing, Pharmacy, Nursing Home Administrators.

31 IG - Procedures addressing administration of medications include: defining the schedules for administrating medications to maximize the effectiveness of the medication i.e. - antibiotics, antihypertensives, insulins, pain medications, proton pump inhibitors, metered dose inhalers, and medications via enteral feeding tubes and NOT administering medications with known incompatibilities at the same time. defining pertinent techniques and precautions that meet current standards of practice for administering medications through alternate routes such as eyes ear, buccal, injection, intravenous, inhalation therapy or enteral tubes. For example, for enteral feeding tubes, define procedures including but not limited to: types of medications that may be safely administered via enteral feeding tube appropriate dosage forms techniques to monitor and verify that the feeding tube is in the right location before administering medications preparing drugs for enteral administration, administering drugs separately, diluting drugs as appropriate, and flushing the tube appropriately.

32 IG - Disposition of Medication procedures include: Timely identification and removal (from current medication supply) of medications for disposition Identification of storage method for medications awaiting final disposition Control and accountability of medications awaiting final disposition consistent with standards of practice Documentation of actual disposition of medications to include: resident name, medication name, strength, prescription number (as applicable), quantity, date of disposition and involved facility staff, consultant(s) or other applicable individuals and method of disposition (including controlled medications) should prevent diversion and/or accidental exposure and is consistent with applicable state and federal requirements and standards of practice.

33 Drug Regimen Review - F428 483.60(c) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist and the pharmacist must report any irregularities to the attending physician, and the director of nursing, and these reports must be acted upon. Medication Regimen Review The requirement for the MRR applies to each resident, including residents who: ➡ are receiving respite care ➡ are at the end of life or have elected the hospice benefit and are receiving respite care ➡ have an anticipated stay of less than 30 days or ➡ have experienced a change in condition Medication review upon transition of care may prevent errors due to drug-drug interactions, omission, duplication of therapy, or miscommunication during the transition from one team of care providers to another. SP - a determination of noncompliance with F428 does not require a finding of harm to the resident. Noncompliance may include… the pharmacist failed to conduct an MRR at least monthly (or more frequently, as indicated by the resident’s condition).

34 Drug Regimen Review - continued Common Medication-Medication Interactions in Long Term Care Medication 1Medication 2Impact Warfarin NSAIDs such as ibuprofen, naproxen, COX-2 inhibitors Potential for serious gastrointestinal bleeding Warfarin sulfonamides such as trimethoprim/sulfamethoxazole Increased effects of warfarin, with potential for bleeding Warfarin macrolides such as clarithromycin, erythromycin Increase effects of warfare, with potential for bleeding Warfarin fluoroquinolones such as ciprofloxacin, levofloxacin, ofloxacin Increase effects of warfare, with potential for bleeding Warfarinphenytoin Increased effects of warfarin and/or phenytoin ACE inhibitors such as benazepril, captopril, enalapril, and lisinopril potassium supplementsElevated serum potassium levels ACE inhibitors such as benazepril, captopril, enalapril, and lisinopril spironolactoneElevated serum potassium levels digoxinamiodarondigoxin toxicity digoxinverapamildigoxin toxicity theophylline fluroquinolones such as cirpofloxacin, levofloxacin,ofloxacin theophylline toxicity

35 Control, Labeling & Storage of Drugs - F431 483.60 (b)(2)(3)(e)(2)The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected. SP - if during a survey, a concern is identified regarding a controlled medication and the resulting investigation identifies diversion of a resident’s medication, the surveyor must review for F224 - Misappropriation of Resident’s Property. SP - if it is determined that a resident’s medications were diverted for staff use, the State Agency must make referrals to appropriate agencies such as local law enforcement, DEA, State Boards of Nursing, Pharmacy, and possibly Nursing Home Administrators.

36 Let’s take a pause here for any questions or comments for these Pharmacy regulations.

37 Infection Control - F441 483.65 The facility must establish and maintain and Infection Control Program designed to provide a safe, sanitary and comfortable environment and to help prevent the development and transmission of disease and infection.

38 Federal, State, and Local Laws - F492 483.75(b) The facility must operate and provide services in compliance with all applicable Federal, State and Local laws, regulations and codes, and with accepted professional standards and principles that apply to professionals providing services in such a facility. The intent of this regulation is to ensure that a facility is in compliance with Federal, State and local laws, regulations and codes relating to health, safety and sanitation and with accepted professional standards and principles that apply to professionals providing services in facilities. “Accepted professional standards and principles” means the individual State professional licensure practice acts and scope of practice regulations and/or standards. ✓ may include commonly accepted health standards established by national organizations, boards, and councils An authority having jurisdiction may include fire chief, fire marshal, labor and/or health departments, building official, electoral inspector, professional licensure boards, or others having statutory authority. “Final adverse action” means an adverse action imposed by the authority having jurisdiction that is more than a corrective action plan or the impositions of a civil money penalty, such as a ban on admissions, suspension or loss of a facility or professional license etc. and is NOT under appeal or litigation by the facility or the professional providing services in the facility.

39 IG - The State is responsible for making decisions about whether there are violations of State laws and regulations. Licenses, permits and approvals of the facility must be available to the SA upon request. IG - Failure of the facility to meet a Federal, State of local law, regulation, code or accepted professional standards and principles that apply to professionals providing services in facilities may only be cited when the Federal, State or local authority having jurisdiction has both made a determination of non- compliance AND has taken a final adverse action. SP - Do not cite F492 as past non-compliance if at the time of the survey, the facility or professional within the facility is in compliance. SP - If during the survey, there is suspect of an observed non-compliance wit a law, regulation, code etc. which is under the purview of another Federal agency other than CMS, notify the RO. The RO may assist in contacting the appropriate Federal agency to refer the observation/concern to.

40 Clinical Records - F514 483.75(l) The facility must maintain clinical records on each resident in accordance with accepted professional standards and practices that are complete, accurately documented, readily accessible, and systematically organized. IG - Electronic Health Records and Use of Electronic Signatures In cases in which facilities have created the option for an individual’s record to be maintained by computer, rather that hard copy, electronic signatures are acceptable whether or not the record is entirely electronic, and when permitted to do so by state and local low and when this is authorized b the facility’s policies. If a facility implements the use of electronic signatures, they must have policies in place and implemented that identify those who are authorized to sign electronically and describe the security safeguards to prevent unauthorized use of electronic signatures. Such security safeguards (policies) include, but are not limited to: ‣ built-in safeguards to minimize the possibility of fraud ‣ each staff responsible for an attestation has an individual identifier

41 ‣ The date and time is recorded from the computer’s internal clock at the time of entry ‣ an entry is not to be changed after it has been recorded, and; ‣ the computer program controls what sections/areas any individual can access or enter data, based on the individual’s personal identifier (and therefore his/her level of professional qualifications). IG - As there are no regulatory requirements delineating the use of specific Electronic Health Records (EHR)system, a facility may utilize the EHR system that meets their specific needs. IG - The facility must grant access to any medical record, including EHRs when requested by the survey team. IG – If access to an EHR is requested by a surveyor, access the system, respond to any questions or assist the surveyor as needed in accessing electronic information in a timely fashion. Each surveyor will determine the EHR access method that best meets the need for that survey. IG – If the facility is unable to provide direct print capability to the survey team, the provider must make available a printout of any record or part of a record upon request in a timeframe that does not impede the survey process.

42 Safeguard Clinical Records - F516 483.75(l)(3) The facility must safeguard clinical record information against loss, destruction, or unauthorized use IG - Electronic Health Records (EHR) ✓ All providers and suppliers that conduct standard transactions (electronic claims filing, etc.) are “covered entities” and, as such, they must comply with the HIPAA Privacy and Security Rules. ✓ The Department of Health and Human Services Office of Civil Rights has the primary responsibility for enforcing the HIPAA Privacy Rule. ✓ The Office of eHealth Standards and Services within CMS is responsible for enforcing the HIPAA Security rule. ✓ The surveyors’ responsibility is to assess compliance with the provider specific requirements for maintaining the content and confidentiality of the medical record.

43 IG - If access to an EHR is requested by a surveyor, the facility will: provide the surveyor with a tutorial on how to use its particular system and designate an individual who will, when requested by the surveyor, access the system, respond to any questions or assist the surveyor as needed in accessing electronic information in a timely fashion. the facility is unable to provide direct print capability to the survey team, the provider must make available a printout of any record or part of a record upon request in a timeframe that does not impede the survey process. impeding the survey process by unnecessarily delaying or restricting access to the medical records may lead to determinations of noncompliance and enforcement actions. the facility should ensure that data are backed up and secure, and access does not impede the survey process or the provision of care and services to the resident.

44 Let’s take a pause here for any questions or comments for these Administration regulations.

45 Guide to Tag Numbers F-150 Definitions 483.10 Resident Rights F151 Exercise of rights F152 Resident competency F153 Access to records F154 Informed of health status or care F155 Refusal of treatment F156 Medicaid services and changes F157 Notification of changes F158 Protection of resident funds F159 Personal fund management F160 Conveyance upon death F161 Assurance of financial security-surety bond F162 Limitation on charges to personal funds F163 Right to chose a personal physician F164 Person privacy/confidentiality of records F165 Right to voice grievances without reprisal F166 Right to prompt efforts to resolve grievances F167 Right to survey results-readily accessible F168 Right to info from/contact advocate agencies F169 Right to perform facility services or refuse F170 Right to privacy – send/receive unopened mail F171 Access to stationary/postage/pens, etc. F172 Right to/facility provision of visitor access F173 Allow ombudsman to examine resident records F174 Right to telephone access with privacy F175 Right of married couples to share a room F176 Resident self-administer drugs if deemed safe F177 Right to refuse certain transfers 483.12 Admission, Transfer & Discharge F201 Reasons for transfer/discharge of resident F202 Documentation for transfer/discharge of resident F203 Notice requirements before transfer/discharge F204 Preparation for safe/orderly transfer/discharge F205 Notice of bed hold policy F206 Policy to permit readmission beyond bed hold F207 Equal practices regardless of payment source F208 Prohibiting certain admission policies 483.13 Resident Behavior & Facility Practice F221 Physical restraints F222 Chemical restraints F223 Abuse/involuntary seclusion F224 Treatment of resident & their property F225 Report/investigate allegations of abuse F226 Develop/implement Abuse/neglect policies 483.15 Quality of Life F240 Care and environment promotes quality of life F241 Dignity and respect of individuality F242 Self-determination/participation F243 Participate in resident/family group F244 Listen/act on group grievance/recommendation F245 Participate in social/religious act/community F246 Reasonable accommodation of needs/preferences F247 Notification of rooms changes F248 Activities F249 Qualified activity professional F250 Provision of medically related social services F251 Qualification of social worker > 120 beds F252 Safe/clean/comfortable/homelike environment F253 Housekeeping and maintenance services F254 Clean bed/bath linens in good condition F256 Adequate and comfortable lighting levels F257 Comfortable and safe temperature levels F258 Maintenance of comfortable sound levels 483.25 Quality of Care F309 Quality of Care F310 ADL abilities F311 Appropriate treatment & services F312 Care for ADL dependent residents F313 Vision & hearing F314 Pressure sores F315 Urinary incontinence F317 No reduction in ROM F318 Range of motion treatment & services F319 Mental & psychosocial functioning F320 Adjustment difficulty F322 NG treatment/services to prevent aspiration F323 Free of accident hazards/adequate supervision F325 Nutrition F327 Hydration F328 Treatment/care for special needs F332 Medication errors 5% or greater F333 Significant medication error F334 Influenza & pneumococcal immunizations 483.20 Resident Assessment F271 Admission physician orders for immediate care F272 Comprehensive assessments F273 Comprehensive assessment 14 days after admit F274 Comprehensive assessment after significant change F275 Comprehensive assessment at least annually F276 Comprehensive assessment at least quarterly F278 Assessment accuracy/coordination/RN certified F279 Develop comprehensive care plan F280 Right to participate in planning care F281 Services provided meet professional standards F282 Services by qualified persons/per care plan F283 Anticipate discharge: recap stay/final status F284 Anticipate discharge: post-discharge plan of care F285 PASRR requirements for MI/MR F286 Maintain 15 months of resident assessments F287 Encoding/transmitting resident assessments 483.30 Nursing Services F353 Sufficient 24 hour nursing staff per care plan F354 Registered nurse hours F355 SNF waiver for Licensed nurse F356 Posting nursing staff **** Substandard Quality of Care (SQOC) = one or more deficiencies with S/S levels of F, H, I, J, K or L in a red lettered group

46 Guide to Tag Numbers 483.35 Dietary Services F360 Dietary services F361 Qualified Dietician – Director of food services F362 Sufficient dietary support personnel F363 Menus and nutritional adequacy F364 Nutritive value/appear, palatable/preferred temp F365 Food in form to meet individual needs F366 Substitutes of similar nutritive value F367 Therapeutic diet prescribed by physician F368 Frequency of meals/snacks at bedtime F369 Assistive devices F371 Sanitary Conditions F372 Dispose garbage & refuse properly F373 Paid feeding assistants 483.40 Physician Services F385 Resident’s care supervised by a physician F386 Physician visits – review care/notes/orders F387 Frequency & timeliness of physician visits F388 Personal visits by physician, alternate PA/NP F389 Physician for emergency care, available 24 hours F390 Physician delegation of tasks in SNFs & NFs 483.45 Specialized Rehabilitation Services F406 Provision of services F407 Qualifications 483.55 Dental F411 Routine/emergency dental services in SNFs F412 Routine/emergency dental services in NFs 483.60 Pharmacy F425 Pharmacy services/procedures F428 Drug regimen review F431 Control, labeling, & storage of drugs 483.65 Infection Control F441 Infection Control, prevent spread, linen 483.70 Physical Environment F454 Life Safety from fire F455 Emergency electrical power system F456 Essential equipment, safe operating condition F457 Bedrooms accommodate no more than 4 residents F458 Bedrooms measure at least 80 square foot/resident F459 Bedrooms have direct access to exit corridor F460 Bedrooms assure full visual privacy F461 Bedrooms – window/floor at grade level, bed/furniture/closet F462 Bedrooms equipped/near lavatory/toilet F463 Resident call system F464 Dining & resident activities F465 Safe/functional/sanitary/comfortable environment F466 Procedures to ensure water availability F467 Adequate outside ventilation F468 Corridors have firmly secured handrails F469 Maintains effective pest control program 483.75 Administration F490 Effective administration/resident well-being F491 Facility licensed under state and local laws F492 Comply with federal/state/local laws/professional standards F493 Governing body F494 Nurse aide work > 4 mo – training/competency F495 Nurse aide work < 4 mo – training/competency F496 Nurse aide registry verification, retraining F497 Nurse aide performance review – 12 hr/yr inservice F498 Nurse aide demonstrate competency/care needs F499 Employ qualified FT/PT/Consult professions F500 Outside professional resources – arrange/agreement F501 Responsibilities of Medical Director F502 Provide/obtain laboratory services – quality/timely F503 Laboratory requirements F504 Physician ordered laboratory services F505 Promptly notify physician of findings F506 Transportation to/from F507 Lab results in resident medical record F508 Radiology & diagnostic services meets resident needs F509 Radiology & diagnostic requirements F510 MD ordered radiology services F511 Transportation to/from F513 Xray reports in resident medical record F514 Complete/accurate/assessable resident medical records F515 Retention of resident clinical records F516 Safeguard of resident clinical records F517 Written plans to meet emergency/disasters F518 Train all staff-emergencies/disasters F519 Transfer agreement with hospital F520 QAPI F522 Disclosure of Ownership


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