Virginia Regulations for the Licensure of Nursing Facilities Violate Virginia Law

James C. Sherlock

The weaknesses of Virginia’s nursing facility (NF) and skilled nursing facility (SNF) system have been exposed by COVID-19 with deadly consequences. 

Virginia’s licensing regulations applicable to these facilities are both part of the problem and violate Virginia law. 

This essay recommends an straightforward permanent fix that will bring Virginia regulations into compliance with Virginia law, save considerable money and eliminate state standards that conflict with federal standards for the same facilities and thus contribute to regulatory chaos.

Regulations

Virginia regulations must be changed to conform to federal Medicare and Medicaid regulations for long-term care facilities to comply with the clear direction of Code of Virginia § 32.1-127. That law requires that Virginia regulations for hospitals and nursing homes “conform” to “health and safety standards established under provisions of Title XVIII (Medicare) and Title XIX (Medicaid) of the Social Security Act.” 

42 Code of Federal Regulations (CFR) Part 483 – Requirements for States and Long Term Care Facilities regulates Medicare and Medicaid certification pursuant to Title XVIII and Title XIX requirements. 

12 VAC 5-371, Rules and Regulations for the Licensure of Nursing Facilities contains Virginia licensure regulations for the same facilities.

The Virginia licensure regulations not only do not conform to their federal certification counterparts, but are weaker across the board.  

Ninety-Five percent of Virginia NFs and SNF’s seek certification for Medicare and/or Medicaid and thus must comply with the more stringent federal regulations. 

There is no reason that Virginia regulations for licensing the other 5% should be different, and by Virginia law they may not be.

 Waivers

A few of the federal regulations allow for waivers in the presence of verified temporary shortages of health personnel or in the presence of equivalent alternative patient safeguards. 

CMS Medicare SNF waiver authority is re-delegated to the CMS Regional Offices (ROs).  Waivers for NFs to provide licensed personnel on a 24-hour basis repose with the States.   

Life safety code waivers for NFs and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IIDs) are the responsibility of the States [See 42 CFR 483.470(j)(2)(A)].  

Recommendations

I recommend that the Board of Health delete the current contents of 12 VAC 5-371 and incorporate by reference 42 CFR Part 483 to comply with Virginia law.  Incorporation by reference rather that mirroring the language will ensure that they are always in compliance with Virginia law and always up to date.

I also recommend that the Board of Nursing review 18VAC90-19-250. Criteria for Delegation and other nursing practice regulations to ensure they conform to the federal rules for nursing homes and hospitals. Similarly, the Department of Medical Assistance Services (DMAS) should review its regulations for conformity. 

A list of waived and emergency regulations, whether for a single home or for the industry, can be maintained on a web page of the Department of Health.

I have not done the research to determine if the Virginia regulations for hospitals and other health services providers are as deficient in conformity with federal Medicare and Medicaid regulations as are those for long term care facilities, but I consider that likely since those regulations come from the same sources.  

Code of Federal Regulations Title 42 – Public Health, Chapter IV Subchapter G – Standards and Certification, Parts 482, 483, 484, 485, 486, 488, 489, 491, 493, 494, 495, and 498 contain Medicare and Medicaid regulations for every type of healthcare facility and provider.  

The Commonwealth will be well served if all of those are incorporated by reference into the Virginia Administrative Code and the parallel Virginia regulations deleted.

Budget Savings

These changes will save the work and its costs that have historically been expended in drafting, seeking public comments, resolving disagreements and approving and then periodically reviewing Virginia licensure regulations that are, in the main, at best irrelevant and at worst confusing. The positions engaged in this work can be eliminated.

Bottom Line

There is no principled reason to object to creating the conformity that Virginia law demands. No study commission is required.

The changes can be made quickly and easily, and should be accomplished immediately.  


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10 responses to “Virginia Regulations for the Licensure of Nursing Facilities Violate Virginia Law”

  1. Dick Hall-Sizemore Avatar
    Dick Hall-Sizemore

    Jim, you and I have disagreed in the past on whether the Virginia regulations are not in compliance with federal regulations. My perspective is that the federal regulations are so general that Virginia’s are not out of line. I do agree that it would be easier to amend the Virginia regulations so that they would simply reference the CMS regulations. However, I do not think that would result in any improvement in the staffing of the nursing homes. As far as I am concerned, both the CMS regulations and the Virginia regulations are terribly weak.

    As for budget savings, there will be none. Those people at VDH who work on the nursing home regulations also work on other regulations and those positions would not be eliminated. If there were to be any result from changing the Virginia regulations to reference the CMS regs, it would mean those staff could be freed up to work on other regulations, possible speeding up the process for promulgating regulations in other areas.

    1. sherlockj Avatar
      sherlockj

      Dick, you are quite mistaken.
      Go to https://ecfr.io/Title-42/cfr483_main and tell me after you read them that Title 42, CFR 483 REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES is “so general”. It is 73 pages single spaced when downloaded into a document. For example, under nurse staffing, you will find:
      (b) Registered nurse.
      (1) Except when waived under paragraph (e) or (f) of this section, the facility must use the services of a registered nurse for at least 8 consecutive hours a day, 7 days a week.
      (2) Except when waived under paragraph (e) or (f) of this section, the facility must designate a registered nurse to serve as the director of nursing on a full time basis.
      (3) The director of nursing may serve as a charge nurse only when the facility has an average daily occupancy of 60 or fewer residents.
      Then go to Title 12. Health » Agency 5. Department of Health » Chapter 371. Regulations for the Licensure of Nursing Facilities and tell me that Virginia’s regulations conform. You will find no requirement for registered nurse staffing 8 hours a day 7 days a week.
      The Virginia nursing home regulations do not conform to the federal regulations, and it is not a close call. I suspect that the exact same thing is true for hospital regulations because the Virginia regulations come from the same source.
      Fixing the regulations is just a start to improving staffing. This is but the first part of a series. The next one is about inspections. That is so demonstrably broken in Virginia that it requires an investigation.

    2. sherlockj Avatar
      sherlockj

      Dick, as but a single example, compare the long term care facility Infection Control regulations in the Virginia Administrative Code vs. those in the Code of Federal Regulations.
      12VAC5-371-180. Infection Control.
      A. The nursing facility shall establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment and to prevent the development and transmission of disease and infection.
      B. The infection control program shall encompass the entire physical plant and all services.
      C. The infection control program addressing the surveillance, prevention and control of facility wide infections shall include:
      1. Procedures to isolate the infecting organism;
      2. Access to handwashing equipment for staff;
      3. Training of staff in proper handwashing techniques, according to accepted professional standards, to prevent cross contamination;
      4. Implementation of universal precautions by direct resident care staff;
      5. Prohibiting employees with communicable diseases or infections from direct contact with residents or their food, if direct contact will transmit disease;
      6. Monitoring staff performance of infection control practices;
      7. Handling, storing, processing and transporting linens, supplies and equipment in a manner that prevents the spread of infection;
      8. Handling, storing, processing and transporting regulated medical waste in accordance with applicable regulations;
      9. Maintaining an effective pest control program; and
      10. Staff education regarding infection risk-reduction behavior.
      D. The nursing facility shall report promptly to its local health department diseases designated as “reportable” according to 12VAC5-90-80 when such cases are admitted to or are diagnosed in the facility and shall report any outbreak of infectious disease as required by 12VAC5-90. An outbreak is defined as an increase in incidence of any infectious disease above the usual incidence at the facility.

      CFR §483.80   Infection control.
      The facility must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.
      (a) Infection prevention and control program. The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements:
      (1) A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to §483.70(e) and following accepted national standards;
      (2) Written standards, policies, and procedures for the program, which must include, but are not limited to:
      (i) A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;
      (ii) When and to whom possible incidents of communicable disease or infections should be reported;
      (iii) Standard and transmission-based precautions to be followed to prevent spread of infections;
      (iv) When and how isolation should be used for a resident; including but not limited to:
      (A) The type and duration of the isolation, depending upon the infectious agent or organism involved, and
      (B) A requirement that the isolation should be the least restrictive possible for the resident under the circumstances.
      (v) The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and
      (vi) The hand hygiene procedures to be followed by staff involved in direct resident contact.
      (3) An antibiotic stewardship program that includes antibiotic use protocols and a system to monitor antibiotic use.
      (4) A system for recording incidents identified under the facility’s IPCP and the corrective actions taken by the facility.
      (b) Infection preventionist. The facility must designate one or more individual(s) as the infection preventionist(s) (IPs) who are responsible for the facility’s IPCP. The IP must:
      (1) Have primary professional training in nursing, medical technology, microbiology, epidemiology, or other related field;
      (2) Be qualified by education, training, experience or certification;
      (3) Work at least part-time at the facility; and
      (4) Have completed specialized training in infection prevention and control.
      (c) IP participation on quality assessment and assurance committee. The individual designated as the IP, or at least one of the individuals if there is more than one IP, must be a member of the facility’s quality assessment and assurance committee and report to the committee on the IPCP on a regular basis.
      (d) Influenza and pneumococcal immunizations—
      (1) Influenza. The facility must develop policies and procedures to ensure that—
      (i) Before offering the influenza immunization, each resident or the resident’s representative receives education regarding the benefits and potential side effects of the immunization;
      (ii) Each resident is offered an influenza immunization October 1 through March 31 annually, unless the immunization is medically contraindicated or the resident has already been immunized during this time period;
      (iii) The resident or the resident’s representative has the opportunity to refuse immunization; and
      (iv) The resident’s medical record includes documentation that indicates, at a minimum, the following:
      (A) That the resident or resident’s representative was provided education regarding the benefits and potential side effects of influenza immunization; and
      (B) That the resident either received the influenza immunization or did not receive the influenza immunization due to medical contraindications or refusal.
      (2) Pneumococcal disease. The facility must develop policies and procedures to ensure that—
      (i) Before offering the pneumococcal immunization, each resident or the resident’s representative receives education regarding the benefits and potential side effects of the immunization;
      (ii) Each resident is offered a pneumococcal immunization, unless the immunization is medically contraindicated or the resident has already been immunized;
      (iii) The resident or the resident’s representative has the opportunity to refuse immunization; and
      (iv) The resident’s medical record includes documentation that indicates, at a minimum, the following:
      (A) That the resident or resident’s representative was provided education regarding the benefits and potential side effects of pneumococcal immunization; and
      (B) That the resident either received the pneumococcal immunization or did not receive the pneumococcal immunization due to medical contraindication or refusal.
      (e) Linens. Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.
      (f) Annual review. The facility will conduct an annual review of its IPCP and update their program, as necessary.
      (g) COVID-19 reporting. The facility must—
      (1) Electronically report information about COVID-19 in a standardized format specified by the Secretary. This report must include but is not limited to—
      (i) Suspected and confirmed COVID-19 infections among residents and staff, including residents previously treated for COVID-19;
      (ii) Total deaths and COVID-19 deaths among residents and staff;
      (iii) Personal protective equipment and hand hygiene supplies in the facility;
      (iv) Ventilator capacity and supplies in the facility;
      (v) Resident beds and census;
      (vi) Access to COVID-19 testing while the resident is in the facility;
      (vii) Staffing shortages; and
      (viii) Other information specified by the Secretary.
      (2) Provide the information specified in paragraph (g)(1) of this section at a frequency specified by the Secretary, but no less than weekly to the Centers for Disease Control and Prevention’s National Healthcare Safety Network. This information will be posted publicly by CMS to support protecting the health and safety of residents, personnel, and the general public.
      (3) Inform residents, their representatives, and families of those residing in facilities by 5 p.m. the next calendar day following the occurrence of either a single confirmed infection of COVID-19, or three or more residents or staff with new-onset of respiratory symptoms occurring within 72 hours of each other. This information must—
      (i) Not include personally identifiable information;
      (ii) Include information on mitigating actions implemented to prevent or reduce the risk of transmission, including if normal operations of the facility will be altered; and
      (iii) Include any cumulative updates for residents, their representatives, and families at least weekly or by 5 p.m. the next calendar day following the subsequent occurrence of either: Each time a confirmed infection of COVID-19 is identified, or whenever three or more residents or staff with new onset of respiratory symptoms occur within 72 hours of each other.
      [81 FR 68868, Oct. 4, 2016, as amended at 85 FR 27627, May 8, 2020]

  2. Dick Hall-Sizemore Avatar
    Dick Hall-Sizemore

    Jim, you and I have disagreed in the past on whether the Virginia regulations are not in compliance with federal regulations. My perspective is that the federal regulations are so general that Virginia’s are not out of line. I do agree that it would be easier to amend the Virginia regulations so that they would simply reference the CMS regulations. However, I do not think that would result in any improvement in the staffing of the nursing homes. As far as I am concerned, both the CMS regulations and the Virginia regulations are terribly weak.

    As for budget savings, there will be none. Those people at VDH who work on the nursing home regulations also work on other regulations and those positions would not be eliminated. If there were to be any result from changing the Virginia regulations to reference the CMS regs, it would mean those staff could be freed up to work on other regulations, possible speeding up the process for promulgating regulations in other areas.

    1. sherlockj Avatar
      sherlockj

      Dick, you are quite mistaken.
      Go to https://ecfr.io/Title-42/cfr483_main and tell me after you read them that Title 42, CFR 483 REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES is “so general”. It is 73 pages single spaced when downloaded into a document. For example, under nurse staffing, you will find:
      (b) Registered nurse.
      (1) Except when waived under paragraph (e) or (f) of this section, the facility must use the services of a registered nurse for at least 8 consecutive hours a day, 7 days a week.
      (2) Except when waived under paragraph (e) or (f) of this section, the facility must designate a registered nurse to serve as the director of nursing on a full time basis.
      (3) The director of nursing may serve as a charge nurse only when the facility has an average daily occupancy of 60 or fewer residents.
      Then go to Title 12. Health » Agency 5. Department of Health » Chapter 371. Regulations for the Licensure of Nursing Facilities and tell me that Virginia’s regulations conform. You will find no requirement for registered nurse staffing 8 hours a day 7 days a week.
      The Virginia nursing home regulations do not conform to the federal regulations, and it is not a close call. I suspect that the exact same thing is true for hospital regulations because the Virginia regulations come from the same source.
      Fixing the regulations is just a start to improving staffing. This is but the first part of a series. The next one is about inspections. That is so demonstrably broken in Virginia that it requires an investigation.

    2. sherlockj Avatar
      sherlockj

      Dick, as but a single example, compare the long term care facility Infection Control regulations in the Virginia Administrative Code vs. those in the Code of Federal Regulations.
      12VAC5-371-180. Infection Control.
      A. The nursing facility shall establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment and to prevent the development and transmission of disease and infection.
      B. The infection control program shall encompass the entire physical plant and all services.
      C. The infection control program addressing the surveillance, prevention and control of facility wide infections shall include:
      1. Procedures to isolate the infecting organism;
      2. Access to handwashing equipment for staff;
      3. Training of staff in proper handwashing techniques, according to accepted professional standards, to prevent cross contamination;
      4. Implementation of universal precautions by direct resident care staff;
      5. Prohibiting employees with communicable diseases or infections from direct contact with residents or their food, if direct contact will transmit disease;
      6. Monitoring staff performance of infection control practices;
      7. Handling, storing, processing and transporting linens, supplies and equipment in a manner that prevents the spread of infection;
      8. Handling, storing, processing and transporting regulated medical waste in accordance with applicable regulations;
      9. Maintaining an effective pest control program; and
      10. Staff education regarding infection risk-reduction behavior.
      D. The nursing facility shall report promptly to its local health department diseases designated as “reportable” according to 12VAC5-90-80 when such cases are admitted to or are diagnosed in the facility and shall report any outbreak of infectious disease as required by 12VAC5-90. An outbreak is defined as an increase in incidence of any infectious disease above the usual incidence at the facility.

      CFR §483.80   Infection control.
      The facility must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.
      (a) Infection prevention and control program. The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements:
      (1) A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to §483.70(e) and following accepted national standards;
      (2) Written standards, policies, and procedures for the program, which must include, but are not limited to:
      (i) A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;
      (ii) When and to whom possible incidents of communicable disease or infections should be reported;
      (iii) Standard and transmission-based precautions to be followed to prevent spread of infections;
      (iv) When and how isolation should be used for a resident; including but not limited to:
      (A) The type and duration of the isolation, depending upon the infectious agent or organism involved, and
      (B) A requirement that the isolation should be the least restrictive possible for the resident under the circumstances.
      (v) The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and
      (vi) The hand hygiene procedures to be followed by staff involved in direct resident contact.
      (3) An antibiotic stewardship program that includes antibiotic use protocols and a system to monitor antibiotic use.
      (4) A system for recording incidents identified under the facility’s IPCP and the corrective actions taken by the facility.
      (b) Infection preventionist. The facility must designate one or more individual(s) as the infection preventionist(s) (IPs) who are responsible for the facility’s IPCP. The IP must:
      (1) Have primary professional training in nursing, medical technology, microbiology, epidemiology, or other related field;
      (2) Be qualified by education, training, experience or certification;
      (3) Work at least part-time at the facility; and
      (4) Have completed specialized training in infection prevention and control.
      (c) IP participation on quality assessment and assurance committee. The individual designated as the IP, or at least one of the individuals if there is more than one IP, must be a member of the facility’s quality assessment and assurance committee and report to the committee on the IPCP on a regular basis.
      (d) Influenza and pneumococcal immunizations—
      (1) Influenza. The facility must develop policies and procedures to ensure that—
      (i) Before offering the influenza immunization, each resident or the resident’s representative receives education regarding the benefits and potential side effects of the immunization;
      (ii) Each resident is offered an influenza immunization October 1 through March 31 annually, unless the immunization is medically contraindicated or the resident has already been immunized during this time period;
      (iii) The resident or the resident’s representative has the opportunity to refuse immunization; and
      (iv) The resident’s medical record includes documentation that indicates, at a minimum, the following:
      (A) That the resident or resident’s representative was provided education regarding the benefits and potential side effects of influenza immunization; and
      (B) That the resident either received the influenza immunization or did not receive the influenza immunization due to medical contraindications or refusal.
      (2) Pneumococcal disease. The facility must develop policies and procedures to ensure that—
      (i) Before offering the pneumococcal immunization, each resident or the resident’s representative receives education regarding the benefits and potential side effects of the immunization;
      (ii) Each resident is offered a pneumococcal immunization, unless the immunization is medically contraindicated or the resident has already been immunized;
      (iii) The resident or the resident’s representative has the opportunity to refuse immunization; and
      (iv) The resident’s medical record includes documentation that indicates, at a minimum, the following:
      (A) That the resident or resident’s representative was provided education regarding the benefits and potential side effects of pneumococcal immunization; and
      (B) That the resident either received the pneumococcal immunization or did not receive the pneumococcal immunization due to medical contraindication or refusal.
      (e) Linens. Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.
      (f) Annual review. The facility will conduct an annual review of its IPCP and update their program, as necessary.
      (g) COVID-19 reporting. The facility must—
      (1) Electronically report information about COVID-19 in a standardized format specified by the Secretary. This report must include but is not limited to—
      (i) Suspected and confirmed COVID-19 infections among residents and staff, including residents previously treated for COVID-19;
      (ii) Total deaths and COVID-19 deaths among residents and staff;
      (iii) Personal protective equipment and hand hygiene supplies in the facility;
      (iv) Ventilator capacity and supplies in the facility;
      (v) Resident beds and census;
      (vi) Access to COVID-19 testing while the resident is in the facility;
      (vii) Staffing shortages; and
      (viii) Other information specified by the Secretary.
      (2) Provide the information specified in paragraph (g)(1) of this section at a frequency specified by the Secretary, but no less than weekly to the Centers for Disease Control and Prevention’s National Healthcare Safety Network. This information will be posted publicly by CMS to support protecting the health and safety of residents, personnel, and the general public.
      (3) Inform residents, their representatives, and families of those residing in facilities by 5 p.m. the next calendar day following the occurrence of either a single confirmed infection of COVID-19, or three or more residents or staff with new-onset of respiratory symptoms occurring within 72 hours of each other. This information must—
      (i) Not include personally identifiable information;
      (ii) Include information on mitigating actions implemented to prevent or reduce the risk of transmission, including if normal operations of the facility will be altered; and
      (iii) Include any cumulative updates for residents, their representatives, and families at least weekly or by 5 p.m. the next calendar day following the subsequent occurrence of either: Each time a confirmed infection of COVID-19 is identified, or whenever three or more residents or staff with new onset of respiratory symptoms occur within 72 hours of each other.
      [81 FR 68868, Oct. 4, 2016, as amended at 85 FR 27627, May 8, 2020]

  3. Jim S., The current regs are not doing the job. The changes certainly seem to be a big improvement.

    Today, Data.Medicare.gov shows 3537 health deficiencies currently listed on Nursing Home Compare for Virginia.

    1390 of those health citations are from 79 nursing homes owned by 6 companies who paid over $3 million in fines in the past 3 years.

    What would have to happen for the changes to lead to more enforcement and correction of the problems?

    1. sherlockj Avatar
      sherlockj

      We need inspections more cognizant of staffing shortages. There are three specific inspection deficiency tags that cite shortages.
      While long term care inspections in Virginia cite deficiencies, CMS payroll-based data show major staffing shortages that are seldom reported in Virginia Medicare/Medicaid inspections. Those inspections are performed by the VDH Office of Licensure and Certification under contract to CMS. Only inspection citations result in fines, not the payroll data.
      A registered nurse right out of nursing school makes an average of $72,000 in Virginia. That makes the total cost of employment of each north of $100,000. So hiring ten fewer RNs total in those six chains over three years paid back the fines. The rest was profit.

  4. Jim S., The current regs are not doing the job. The changes certainly seem to be a big improvement.

    Today, Data.Medicare.gov shows 3537 health deficiencies currently listed on Nursing Home Compare for Virginia.

    1390 of those health citations are from 79 nursing homes owned by 6 companies who paid over $3 million in fines in the past 3 years.

    What would have to happen for the changes to lead to more enforcement and correction of the problems?

    1. sherlockj Avatar
      sherlockj

      We need inspections more cognizant of staffing shortages. There are three specific inspection deficiency tags that cite shortages.
      While long term care inspections in Virginia cite deficiencies, CMS payroll-based data show major staffing shortages that are seldom reported in Virginia Medicare/Medicaid inspections. Those inspections are performed by the VDH Office of Licensure and Certification under contract to CMS. Only inspection citations result in fines, not the payroll data.
      A registered nurse right out of nursing school makes an average of $72,000 in Virginia. That makes the total cost of employment of each north of $100,000. So hiring ten fewer RNs total in those six chains over three years paid back the fines. The rest was profit.

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