83 FR 52345 - Adopting Standards for Laboratory Requirements
DEPARTMENT OF VETERANS AFFAIRS Federal Register Volume 83, Issue 201 (October 17, 2018)
Federal Register Volume 83, Issue 201 (October 17, 2018)
| Page Range | 52345-52350 | |
| FR Document | 2018-22452 |
[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)] [Proposed Rules] [Pages 52345-52350] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22452] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900-AP64 Adopting Standards for Laboratory Requirements AGENCY: Department of Veterans Affairs. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its medical regulations to establish standards for VA clinical laboratories. The Department of Health and Human Services (HHS) has established standards for the staffing, management, procedures, and oversight of clinical laboratories that perform testing used for the diagnosis, prevention, or treatment of any disease or impairment of, or health assessment of, human beings. VA is required, in consultation with HHS, to establish standards equal to those applicable to other clinical laboratories. As a matter of policy and practice VA has applied HHS standards to its VA laboratory operations, and this proposed rule would formalize this practice. The proposed rule would establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. Specifically, it would address how VA applies regulations as the controlling [[Page 52346]] standards for VA medical facility laboratories. DATES: Comments must be received on or before December 17, 2018. ADDRESSES: Written comments may be submitted through www.regulations.gov; by mail or hand-delivery to the Director, Regulation Policy and Management (00REG), Department of Veterans Affairs, 810 Vermont Ave. NW, Room 1063B, Washington, DC 20420; or by fax to (202) 273-9026. Comments should indicate that they are submitted in response to ``RIN 2900-AP64--Adopting 42 CFR Part 493 Laboratory Requirements.'' Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call (202) 461-4902 for an appointment. (This is not a toll-free number.) In addition, during the comment period, comments may be viewed online through the Federal Docket Management System (FDMS) at http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Quynh Vantu, Health Science Specialist, Pathology and Laboratory Service (10P11P), Office of Specialty Care Services, Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Ave. NW, Room 1063B, Washington, DC 20420, (202) 632-8418. (This is not a toll-free number.) SUPPLEMENTARY INFORMATION: The Clinical Laboratory Improvement Amendments of 1988 (Pub. L. (PL) 100-578) amended section 353 of the Public Health Service Act to establish legal requirements for the staffing, management, procedures, and oversight of clinical laboratories that perform testing used for the diagnosis, prevention, or treatment of any disease or impairment of, or health assessment of, human beings. These statutory requirements are codified at 42 U.S.C. 263a. The term ``laboratory'' or ``clinical laboratory'' are defined at 42 U.S.C. 263a(a) as a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. Centers for Medicare & Medicaid Services (CMS), within HHS, promulgated regulations for the Clinical Laboratory Improvement Amendments (CLIA) at title 42, Code of Federal Regulations (CFR), Part 493. CMS has primary responsibility for the administration of the CLIA program. ``. . . [T]o assure consistent performance of medical facility laboratories under the jurisdiction of the Secretary [of Veterans Affairs] of valid and reliable laboratory examinations and other procedures,'' section 101 of Public Law 102-139 (``1991 Act'') was enacted, requiring VA, within a specified time-frame and in consultation with HHS, ``to establish standards [by regulation] equal to that applicable to other medical facility laboratories in accordance with the requirements of section 353(f) of the Public Health Service Act.'' VA's regulations must ``include appropriate provisions respecting compliance with such requirements [set forth in section 353(f) of the Public Health Service Act]'' and may include appropriate provisions respecting waivers and accreditations described in sections 353(d) and 353(e), respectively, of the Public Health Service Act. As a matter of policy and practice, VA believes it has met these statutory requirements; however, VA is issuing this proposed rule to comply with the requirement for formal rulemaking. Since enactment of section 101(a) of the 1991 Act, VA has collaborated with HHS in reviewing VA requirements and in developing standards for VA's medical facility laboratories that meet the requirements of law. VA policy and practice regarding CLIA compliance was developed in consultation with HHS in 1994 and 1998. VA laboratories are accredited by accrediting organizations granted deeming authority by CMS (i.e., HHS-approved accreditation organization) to ensure its laboratories are in compliance with current CLIA regulations. Based on consultation with CMS in 1994 and 1998, the accreditation organization(s) provide oversight for proficiency testing in VA laboratories, as set forth in CLIA. Deeming authority is granted to an accrediting organization by CMS after a determination that the organization's accreditation oversight program requires that laboratories comply with or exceed CLIA standards. CMS has granted ``deeming authority'' to several other organization allowing them to accredit laboratories and inspect the laboratories in CMS's stead. The history of the process of the development of CLIA equivalent VHA standards in consultation with CMS is documented in the interagency agreement (IAA) between VA and CMS. In 2000, after further consultation, VA and CMS entered into an IAA, which documented the history of the parties' consultations and agreements and granted VA limited authority to act on behalf of CMS. Specifically, the IAA authorized VA to issue CMS CLIA numbers and CLIA certificates to VA laboratories, which requires VA to notify CMS when VA suspends or retires CLIA numbers assigned to VA laboratories. This agreement was renewed in 2010, and CMS and VA have agreed to review and update the interagency agreement as necessary in 2018, and every 6 years thereafter. In addition, CMS and VA agree to meet annually to discuss program issues of mutual importance. To ensure VA remains current with CMS CLIA requirements, VA participates in the CMS Partners in Laboratory Oversight group, consults will CMS as needed, and participates in at least one formal consultative meeting per year. These engagements with CMS facilitates ongoing communication and coordination, and promotes effective oversight necessary to coordinate major activities, and expeditious, effective response to complaints, survey findings, and publicly volatile situations. VA staff attend State Agency Surveyor training, and CLIA surveyor webinars. VA has also convened ad hoc conferences with CMS when the exchange of information on CLIA may be needed. VA provides updates at the annual partners meeting and participates in audio conferences as requested. The CMS CLIA Program Director participates in VA's annual conference in which CMS, VA, and Department of Defense provide updates on laboratory issues and enforcement of laboratory regulations. As discussed below, VA laboratories that perform testing are all accredited and inspected by accrediting organizations granted deeming authority by CMS. As such, VA has documentation that its laboratories meet current CLIA standards. VA provides updated data to CMS for each VA laboratory assigned a CLIA number at least every two years, or as changes occur. VA provides CMS with any requested information regarding the operation and performance of VA laboratories and the operations of the oversight program. Under the 1991 Act, the definition of ``medical facility laboratories'' has the same meaning previously used to define the terms ``laboratory'' or ``clinical laboratory'' pursuant to section 353(a) of the Public Health Service Act, codified at 42 U.S.C. 263a(a). VA concluded that it should adopt 42 CFR part 493 regulations that were applicable to clinical laboratory operations but keep oversight and enforcement of these regulations as applied to VA laboratories within VA, rather than [[Page 52347]] HHS. Under current VA practice, VA fulfills all laboratory oversight of and enforcement functions for VA laboratories that CMS fulfills for HHS with respect to laboratories subject to CLIA. VA has the authority and responsibility to provide enforcement of the CLIA regulations for VA laboratories, including imposing sanctions and discontinuing laboratory testing. VA believes this determination is consistent with the fact that Congress passed an entirely separate law (Pub. L. 102-139) for VA medical facility laboratories under the exclusive jurisdiction and control of the Secretary of Veterans Affairs. The 42 CFR part 493 regulations are very detailed and include multiple subparts that address clinical laboratory tests. The laboratory regulations include requirements for proficiency testing; facility administration; quality systems; personnel qualifications; responsibilities for laboratory personnel, including laboratory directors and testing personnel; laboratory inspections; and enforcement. Several subparts are not directly applicable to VA medical facility laboratories because they address administration of the oversight and enforcement functions performed by CMS under 42 CFR part 493. Sections of 42 CFR part 493 that refer to the interactions with state programs, collections of fees, suspension of payments, creation of an advisory committee, and civil action are not applicable to VA, as discussed in greater detail below. Although the requirement for consultation between HHS and VA was accomplished over 20 years ago, we are now proposing to formalize, document, and update, as necessary, VA's application of the CLIA requirements to VA laboratory operations. VA proposes to amend its medical regulations to reference the portions of 42 CFR part 493 adopted by VA as they apply to VA medical facility laboratories and clinics and to clarify that these standards are subject to VA oversight and enforcement by VA only. In addition, the proposed rule would require VA laboratories to be accredited by an accreditation organization granted deeming authority by CMS, in accordance with the accreditation requirement in CLIA, and participate in an HHS approved proficiency testing program. Through this proposed rulemaking, in accordance with current VA policy and practice, VA can continue to assure that medical facility laboratories across our system perform consistent, accurate and reliable laboratory testing, ensuring the provision of quality testing for our veteran-patients in a manner comparable to non-VA laboratories. We note that, in addition to 42 CFR part 493 standards, VA recognizes and adheres to worker safety standards established by the Occupational Safety and Health Administration (OSHA) and the U.S. Nuclear Regulatory Commission (NRC). In addition, the U.S. Food and Drug Administration (FDA) regulates the collection of blood and blood components intended for transfusion or for further manufacturing use, such as to make clotting factors, and establishes standards for blood and blood products. FDA also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are intended for use in the manufacture of blood or blood products. FDA develops and enforces quality standards, inspects blood establishments, and monitors reports of errors, accidents and adverse clinical events. Those additional standards are beyond the scope of this proposed rule. VA proposes to add a new section 17.3500, ``Adopting 42 CFR Part 493 Laboratory Requirements,'' to its medical regulations. There, we would address CLIA regulations found at 42 CFR part 493, by subpart, and how VA would apply those regulations. We state that all laboratory testing within VA performed for the diagnosis, treatment, and prevention of disease, and assessment of health in patients would comply with the relevant requirements established by HHS under 42 CFR part 493 as enforced by VA. VA laboratory testing must meet, at a minimum, requirements established in 42 CFR part 493. These requirements must be met for any laboratory service offered by a VA medical facility, as well as contracted laboratory services performed on site at VA laboratories, outreach clinics, or testing sites. Provisions that are specific to oversight by state licensure programs are not applicable, since VA as a federal entity is not subject to state licensing requirements. Except as noted in the proposed rule, functions and responsibilities assigned to CMS in 42 CFR part 493 are assumed by VA with respect to laboratories operated by or on behalf of VA. Part 493 subpart A covers general provisions. We propose that all provisions of subpart A would apply to VA with several exceptions intended to reflect that VA has the authority, responsibility, and duty to administer 42 CFR part 493 standards within VA. We state that functions assigned to HHS in this subpart would be performed by VA. This is consistent with an IAA previously entered into between VA and CMS. The regulation would set forth that the respective provisions of 42 CFR part 493 apply to VA laboratories performing waived, moderate, and high complexity tests. Subparts B through D address certificates issued by CMS. Subpart B focuses on Certificates of Waiver. Subpart C addresses Registration Certificates, Certificates for PPM procedures, and Certificates of Compliance. PPM procedures are a select group of moderately complex microscopy tests commonly performed by specific health care providers during patient office visits. Tests included in PPM procedures do not meet the criteria for waiver because they are not simple procedures; they require training and specific skills for test performance. Subpart D focuses on Certificates of Accreditation. These subparts establish standards for CMS-issuance of the listed certificates as well as fees that must be remitted to CMS by regulated laboratories in order to apply for and receive certification. We state that all provisions of these subparts would apply to VA laboratories, except that certificates issued by HHS under these subparts are instead issued by VA pursuant to the previously noted interagency agreement between CMS and VA. As certificates are issued by VA rather than CMS, CMS does not require remittance of a fee from laboratories for any certificate issued by VA under these subparts. Subpart E addresses accreditation by a private, nonprofit accreditation organization or exemption under an approved State laboratory program. Under this subpart, a laboratory may meet individual VA and CLIA program requirements through accreditation by a CMS approved nonprofit accreditation organization (AO). The subpart establishes an application and approval process for an accreditation organization seeking to be granted deeming authority by CMS, as well as a process in which CMS may validate findings of an accreditation organization by reinspection of a laboratory following an inspection by that accreditation organization. CLIA has granted ``deeming authority'' to several accreditation organizations allowing them to accredit laboratories and inspect the laboratories. These accreditation organizations must impose organizations' requirements equal to or more stringent than those contained in 42 CFR part 493 at the condition level. The subpart also establishes standards for CLIA exemptions under an approved State laboratory program. All provisions would apply to VA, to the extent that [[Page 52348]] this subpart addresses accreditation by a private, nonprofit accreditation organization. However, the provisions related to approved State laboratory program do not apply to VA. The proposed rule states that VA would use only accreditation agencies with CMS-granted deeming authority to accredit VA laboratories. This is consistent with current, longstanding, VA practice. CMS has an established process for determining whether an accreditation organization should be granted deeming authority, and experience in making that determination. VA has determined that there is no need to duplicate that process and relying on CMS' approval of an accreditation organization ensures that VA would not reach any conclusions on deeming authority that are inconsistent with CMS. A validation inspection is a quality control measure performed by CMS under Subpart E. It involves CMS reinspection of a laboratory that has recently been inspected by an accreditation organization with deeming authority, to validate that AO's survey findings. We state that validation inspections performed by CMS under subpart E would be performed instead by VA. This is consistent with current practice, and VA's authority under the 1991 Act to provide oversight and enforcement of the requirements set forth in 42 CFR part 493, as oversight and enforcement functions under this subpart as applied to VA laboratories are performed by VA. General administration provisions related to 42 CFR part 493 are found at Subpart F. This subpart sets forth the methodology for determining the amount of fees for issuing the appropriate certificate, and for determining compliance with the applicable standards of the Public Health Service Act and the Federal validation of accredited laboratories. We state that provisions of Subpart F would not be applicable to VA, as CMS does not collect fees for certification of VA laboratories Subpart H addresses participation in proficiency testing for laboratories performing nonwaived testing. Nonwaived testing is the term used by CMS to refer collectively to moderate and high complexity testing. We state that all provisions of this subpart would apply to VA, and VA employs scoring criteria under this subpart. Subpart I focuses on the approval of proficiency testing programs. The proposed rule states that VA would rely on HHS to approve proficiency testing programs. VA would continue to use only HHS approved proficiency testing programs. HHS has an established process for proficiency testing program approval and experience in making that determination. VA has determined that there is no need to duplicate that process and relies on HHS program approvals. Subpart J addresses facility administration for nonwaived testing, and sets standards for facility construction, transfusion services, and records retention. We state that all provisions of this subpart would apply to VA. Subpart K focuses on quality systems for nonwaived testing. Under this subpart, each laboratory that performs nonwaived testing must establish and maintain written policies and procedures that implement and monitor a quality system for all phases of the total testing process (that is, preanalytic, analytic, and postanalytic) as well as general laboratory systems. Laboratory quality systems must include a quality assessment component that ensures continuous improvement of the laboratory's performance and services through ongoing monitoring that identifies, evaluates, and resolves problems. The laboratory's quality system must be appropriate for the specialties and subspecialties of testing that the laboratory performs, services it offers, and clients it serves. This subpart establishes requirements for different specialties and subspecialties of laboratory tests and VA would apply all established requirements. Personnel requirements for performing non-waived testing are addressed in subpart M. All applicable personnel requirements would meet CLIA requirements with the exception of state-specific licensing requirements. Subpart M requires that certain personnel maintain a license in the state in which the laboratory is located. While VA health care providers must be licensed in a state, there is no requirement that the health care provider be licensed in the state where the VA facility at which the provider works is located. See, 38 U.S.C. 7402 (requiring licensure in any state for eligibility to an appointment as VHA health care provider regardless of VHA facility location). Subpart Q establishes inspection requirements for all CLIA- certified and CLIA-exempt state laboratories. We state that all provisions would apply to VA, except that all enforcement and oversight functions that are assigned to HHS in this subpart are performed by VA. Subpart R sets forth enforcement procedures, including the policies and procedures CMS uses to enforce CLIA requirements, as well as appeal rights of laboratories on which CMS imposes sanctions. We state that all provisions would apply to VA with the following exceptions. Suspension of the right to Medicare or Medicaid payments as an available sanction against VA laboratories is not applicable because VA laboratories do not participate in these programs. Enforcement and oversight functions would be performed by VA rather than HHS or CMS. VA is responsible for ensuring its laboratories comply with these CLIA requirements, and taking immediate action in the jeopardy to patients. See, Public Law 102-139, section 101; 42 CFR 493.1218. Due process protections afforded by CMS-certified laboratories facing sanctions would not apply to laboratories operating by or under contract with VA. If VA had a substantial testing issue with a non-VA CMS-certified laboratory, VA would notify CMS of that instant. Laboratories subject to this proposed rule are operated by VA or under contract with VA. Finally, we state that VA would not participate in laboratory registry under 42 CFR 493.1850. This is consistent with longstanding VA policy and practice. The laboratory registry operated by CMS under part 493 includes collection of data that is not applicable to VA. Examples include a list of laboratories that have been convicted, under Federal or State laws relating to fraud and abuse, false billing, or kickbacks; all appeals and hearing decisions; a list of laboratories against which CMS has sued under Sec. 493.1846 and the reasons for those actions; and, a list of laboratories that have been excluded from participation in Medicare or Medicaid and the reasons for the exclusion. VA has made VA laboratory information available to the public in accordance with the Freedom of Information Act, 5 U.S.C. 552. VA believes this would provide the public with greater access to information than that found in the private sector. Subpart T requires HHS to establish a Clinical Laboratory Improvement Advisory Committee (CLIAC) to advise and make recommendations on technical and scientific aspects of the provisions of part 493. The committee is managed by the Centers for Disease Control and Prevention (CDC), provides scientific and technical advice and guidance to HHS. The Committee includes diverse membership across laboratory specialties, professional roles, (laboratory management, technical, physicians, nurses) and practice settings (academic, clinical, public health), and includes a consumer [[Page 52349]] representative. VA benefits from the diversity, broad knowledge, and expertise of government and non-government participants that make up CLIAC, because any issues addressed that result in changes to the part 493 regulations, then also become a requirement for VA. Since VA complies with part 493 regulations, VA ultimately benefits from revisions for improvement to standards initiated by CLIAC. CLIAC is governed by the Federal Advisory Committee Act (FACA), Public Law 92- 463. FACA was enacted in 1972 to establish guidelines on federal advisory committee structures and operations. As VA does not have a similar FACA-level advisory committee, this subpart would not apply to VA. Effect of Rulemaking The Code of Federal Regulations, as proposed to be revised by this proposed rulemaking, would represent the exclusive legal authority on this subject. No contrary rules or procedures would be authorized. All VA guidance would be read to conform with this proposed rulemaking if possible or, if not possible, such guidance would be superseded by this rulemaking. Paperwork Reduction Act This proposed rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). Regulatory Flexibility Act The Secretary hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. It would affect only the operations of VA medical facility laboratories. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking would be exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604. Executive Order 12866, 13563 and 13771 Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a ``significant regulatory action,'' requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as ``any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.'' The economic, interagency, budgetary, legal, and policy implications of this proposed rule have been examined, and it has been determined to be a significant regulatory action under Executive Order 12866, because it raises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/orpm/, by following the link for ``VA Regulations Published From FY 2004 Through Fiscal Year to Date.'' This proposed rule is not expected to be subject to the requirements of E.O. 13771 because this proposed rule is expected to result in no more than de minimis costs using a post-statutory baseline reflecting current practices within VA. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This proposed rule would have no such effect on State, local, and tribal governments, or on the private sector. Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.008--Veterans Domiciliary Care; 64.011--Veterans Dental Care; 64.029--Purchase Care Program; 64.033--VA Supportive Services for Veteran Families Program; 64.040--VA Inpatient Medicine; 64.041--VA Outpatient Specialty Care; 64.042--VA Inpatient Surgery; 64.043--VA Mental Health Residential; 64.044--VA Home Care; 64.045--VA Outpatient Ancillary Services; 64.046--VA Inpatient Psychiatry; 64.047--VA Primary Care; 64.048--VA Mental Health clinics; 64.049--VA Community Living Center; 64.050--VA Diagnostic Care; 64.054--Research and Development. List of Subjects in 38 CFR Part 17 Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Government contracts, Grant programs-health, Grant programs-veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and Dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Reporting and recordkeeping requirements, Travel and transportation expenses, Veterans. Signing Authority The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on September 19, 2017, for publication. Dated: October 11, 2018. Consuela Benjamin, Regulation Development Coordinator, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs. For the reasons set forth in the preamble, VA proposes to amend 38 CFR part 17 as follows: PART 17--MEDICAL 0 1. The authority citation for part 17 is amended by adding a sentence immediately following the statutory authority citation for section 17.655 to read as follows: [[Page 52350]] Authority: 38 U.S.C. 501, and as noted in specific sections: * * * * * Section 17.3500 is also issued under Public Law 102-139 sec. 101. 0 2. Add an undesignated center heading and Sec. 17.3500 to read as follows: Clinical Laboratory Standards Sec. 17.3500 VA application of 42 CFR part 493 standards for clinical laboratory operations. All laboratory testing within VA performed for the diagnosis, prevention, or treatment of any disease or impairment of, or health assessment of, human beings must comply with the listed requirements established by the Department of Health and Human Services (HHS) under the following subparts of 42 CFR part 493 as interpreted, administered, and enforced by VA. VA laboratory testing must meet, at a minimum, requirements established in 42 CFR part 493. These standards must be met for any laboratory service offered within a VA medical facility or outreach clinics, as well as contracted laboratory services performed on site at VA laboratories, outreach clinics, or testing sites. Except as noted below, functions and responsibilities assigned to the Centers for Medicare & Medicaid Services (CMS) in 42 CFR part 493 are assumed by VA. Provisions that are specific to oversight by state licensure programs are not applicable. VA administers the application of the relevant provisions of 42 CFR part 493 to VA laboratories as follows: (a) Subpart A--General provisions. All provisions apply to VA with the following exceptions: (1) Functions assigned to HHS in this subpart are performed by VA. (2) While 42 CFR part 493 requires laboratories that perform waived, moderate and high complexity tests to meet the regulations, VA requires VA laboratories meet or exceed the requirements of 42 CFR part 493. (b) Subpart B--Certificate of waiver. All provisions apply to VA, except that: (1) Certificates issued by HHS under this subpart are instead issued by VA pursuant to an agreement between CMS and VA. (2) CMS does not require remittance of a fee from laboratories for any certificate issued by the VA under this subpart. (c) Subpart C--Registration certificate, certificate for provider- performed microscopy procedures, and certificate of compliance. All provisions apply to VA, except that: (1) Certificates issued by HHS under this subpart are instead issued by VA pursuant to an agreement between CMS and VA. (2) CMS does not require remittance of a fee from laboratories for any certificate issued by VA under this subpart. (d) Subpart D--Certificates of accreditation. All provisions apply to VA, except that: (1) Certificates issued by HHS under this subpart are instead issued by VA pursuant to an agreement between CMS and VA. (2) CMS does not require remittance of a fee from laboratories for any certificate issued by VA under this subpart. (e) Subpart E--Accreditation by a private, nonprofit accreditation organization or exemption under an approved state laboratory program. All provisions apply to VA, to the extent that this subpart addresses accreditation by a private, nonprofit accreditation organization. VA applies this subpart as follows: (1) VA relies on CMS to grant deeming authority for accreditation organizations. VA uses only these accreditation agencies with deeming authority to accredit VA laboratories. (2) VA uses only CMS approved proficiency testing providers. (3) Proficiency testing providers release proficiency testing results directly to VA. (4) VA, rather than CMS, performs validation inspections of VA laboratories. (5) Oversight and enforcement functions under this subpart are performed by VA. (f) Subpart F--General administration. This subpart sets forth the methodology for determining the amount of the fees for issuing the appropriate certificate, and for determining compliance with the applicable standards of the Public Health Service Act and the Federal validation of accredited laboratories and of CLIA-exempt laboratories. This subpart is inapplicable to VA, as CMS does not collect fees for certification of VA laboratories. (g) Subpart H--Participation in proficiency testing for laboratories performing nonwaived testing. All provisions apply to VA, except that all enforcement and oversight functions related to proficiency testing which are assigned to HHS in this subpart are performed by VA. (h) Subpart I--Proficiency testing programs for nonwaived testing. All provisions apply to VA, and VA employs scoring criteria under this subpart. VA uses only CMS approved proficiency testing providers. Enforcement and oversight functions related to proficiency testing which are assigned to HHS in this subpart are performed by VA. (i) Subpart J--Facility administration for nonwaived testing. VA applies standards established in this subpart. (j) Subpart K--Quality system for nonwaived testing. VA applies standards established in this subpart. (k) Subpart M--Personnel for nonwaived testing. VA applies standards established in this subpart, except that requirements regarding maintaining a license in the state where the laboratory is located are not applicable. (l) Subpart Q--Inspection. VA applies standards established in this subpart, except that all enforcement and oversight functions, which are assigned to HHS in this subpart are performed by VA. (m) Subpart R--Enforcement procedures. VA applies standards established in this subpart, except: (1) Enforcement and oversight functions which are assigned to HHS in this subpart are performed by VA. (2) Due process protections afforded by CMS-certified for laboratories facing sanctions are not applicable to laboratories operating under this section. (3) Suspension of the right to Medicare or Medicaid payments as an available sanction is not applicable. VA does not participate in these programs. (4) State onsite monitoring and monetary penalties imposed by CMS as an alternate sanction under 42 CFR 493.1806(c) are not applicable. (5) VA may cease laboratory testing immediately at any site subject to this section upon notification of immediate jeopardy to patients. (6) VA does not participate in laboratory registry under 42 CFR 493.1850. VA may disclose laboratory information useful in evaluating the performance of laboratories under 5 U.S.C. 552. (n) Subpart T--Consultations. This subpart requires HHS to establish a Clinical Laboratory Improvement Advisory Committee (CLIAC) to advise and make recommendations on technical and scientific aspects of the provisions of part 493. This subpart does not apply to VA. [FR Doc. 2018-22452 Filed 10-16-18; 8:45 am] BILLING CODE 8320-01-P
![Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Proposed Rules 52345
Legislative Branch Appropriations which increases the risk that they may these security controls are and remain
highlighted the need for the Office to be damaged, misplaced, mismatched, or effective.
decrease its processing times in its lost. The Office, working with OCIO, plans
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inquiring about the appropriate electronic registration system, the Office Additionally, the Office’s IT
turnaround time for completing a receives the deposit as soon as the infrastructure is being updated to
copyright registration, Chairman Kevin application is submitted. An examiner support increased numbers of digital
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efficient and quicker.’’ 81 It is believed Examiners do not need to move deposits Office’s deposit security as well as any
that this proposal would further around the Office. Electronic deposits additional approaches to this issue.
significantly decrease burdens on both allow examiners to process more claims
copyright owners and the Copyright E. Additional Considerations
per hour, thereby cutting processing
Office by simplifying registration times significantly. The Office is dedicated to developing
requirements and the examination The Office is interested in hearing a robust and efficient registration system
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pendency times. digital approach may or may not considerations that it should take into
When an applicant sends a physical incentivize the routine registration of account during its modernization
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registration, that deposit must be sent efficiency of the registration system. The Dated: October 11, 2018.
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Once the deposit is delivered to the Acting Register of Copyrights and Director
with regard to their compliance with of the U.S. Copyright Office.
Office, the Office’s Receipt Analysis and mandatory deposit.
Control Division (‘‘RAC’’) must [FR Doc. 2018–22486 Filed 10–16–18; 8:45 am]
manually match the physical deposit to 16. Digital Deposit Security BILLING CODE 1410–30–P
its corresponding pending application Any approach that increases the
and deliver the deposit to an deposit of digital formats must be
examiner.82 This time consuming supported by a robust security system. DEPARTMENT OF VETERANS
process can delay examination. And if Users have expressed concern regarding AFFAIRS
the examiner later discovers that the the capacity of the Office’s current IT
applicant submitted an incorrect 38 CFR Part 17
infrastructure to handle an increase in
deposit, this process may be repeated, digital deposits, as well as the Office’s RIN 2900–AP64
which would delay examination and re- mechanisms for securing these deposits.
set the EDR to the date that an The Office currently utilizes a multi- Adopting Standards for Laboratory
acceptable deposit was received by the level security design to ensure the Requirements
Office. Additionally, physical deposits confidentiality, integrity, and
are often heavy and unwieldy. The AGENCY: Department of Veterans Affairs.
availability of the data within the eCO
Office moves these deposits multiple system. The system is certified to ACTION: Proposed rule.
times during the examination process, operate at the National Institute of SUMMARY: The Department of Veterans
80 See
Standards and Technology (‘‘NIST’’) Affairs (VA) proposes to amend its
Legislative Branch Appropriations for
2019, Hearings Before the Subcomm. on Legislative
Moderate security level.83 The entire medical regulations to establish
Branch of the H. Comm. on Appropriations, Part 2, eCO system operates on hardware and standards for VA clinical laboratories.
115th Cong., 2d Sess. 325, 357–359 software dedicated to this system and it The Department of Health and Human
(2018)(statement from Rep. Kevin Yoder, Chairman, does not share any computer or storage
Subcomm. on Legislative Branch concerning Services (HHS) has established
registration processing times, noting ‘‘we really resources. Strict access controls are in standards for the staffing, management,
want the Copyright Office to be successful and [] place throughout the system for public procedures, and oversight of clinical
efficient’’), available at https://www.gpo.gov/fdsys/ users, staff, and system administrators, laboratories that perform testing used
pkg/CHRG-115hhrg30357/pdf/CHRG- enforcing the principle of least
115hhrg30357.pdf. for the diagnosis, prevention, or
81 Legislative Branch Appropriations for 2019, privilege, which means that users in treatment of any disease or impairment
Hearings Before the Subcomm. on Legislative each role may only access what is of, or health assessment of, human
Branch of the H. Comm. on Appropriations, Part 2, needed for their role. The system is also beings. VA is required, in consultation
115th Cong., 2d Sess. at 358 (2018). protected by multiple levels of network
82 When an applicant submits an online with HHS, to establish standards equal
firewalls and other network-based to those applicable to other clinical
application and sends the deposit through the mail,
they are expected to print and attach a ‘‘shipping security, such as anti-malware laboratories. As a matter of policy and
slip’’ to the deposit. This document contains a protection. Finally, the eCO system is practice VA has applied HHS standards
barcode generated by the electronic registration under continuous monitoring, both to its VA laboratory operations, and this
system that is used to connect the deposit with the operational and security, to ensure that
appropriate registration application. Unfortunately, proposed rule would formalize this
large quantities of deposits are submitted without practice. The proposed rule would
daltland on DSKBBV9HB2PROD with PROPOSALS
a shipping slip. In such cases, RAC staff must 83 See National Institute of Standards and
establish quality standards for
correspond with the applicant to obtain the ten- Technology, Minimum Security Requirements for
digit case numbers that have been assigned to all Federal Information and Information Systems, FIPS
laboratory testing performed on
of the applications submitted by that party, and PUB 200, available at https://nvlpubs.nist.gov/ specimens from humans, such as blood,
then search for those applications in the electronic nistpubs/FIPS/NIST.FIPS.200.pdf; National body fluid and tissue, for the purpose of
registration system. Before delivering the deposit to Institute of Standards and Technology, Security and diagnosis, prevention, or treatment of
the examiner for a substantive review, RAC staff Privacy Controls for Information Systems and
must match each application to its corresponding Organizations, SP 800–53, available at https://
disease, or assessment of health.
deposit by manually generating a new shipping slip csrc.nist.gov/CSRC/media//Publications/sp/800-53/ Specifically, it would address how VA
with an identifying barcode. rev-5/draft/documents/sp800-53r5-draft.pdf. applies regulations as the controlling
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![52346 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Proposed Rules
standards for VA medical facility Federal Regulations (CFR), Part 493. consultations and agreements and
laboratories. CMS has primary responsibility for the granted VA limited authority to act on
DATES: Comments must be received on administration of the CLIA program. behalf of CMS. Specifically, the IAA
‘‘. . . [T]o assure consistent authorized VA to issue CMS CLIA
or before December 17, 2018.
performance of medical facility numbers and CLIA certificates to VA
ADDRESSES: Written comments may be laboratories under the jurisdiction of the laboratories, which requires VA to
submitted through www.regulations.gov; Secretary [of Veterans Affairs] of valid notify CMS when VA suspends or
by mail or hand-delivery to the Director, and reliable laboratory examinations retires CLIA numbers assigned to VA
Regulation Policy and Management and other procedures,’’ section 101 of laboratories.
(00REG), Department of Veterans Public Law 102–139 (‘‘1991 Act’’) was This agreement was renewed in 2010,
Affairs, 810 Vermont Ave. NW, Room enacted, requiring VA, within a and CMS and VA have agreed to review
1063B, Washington, DC 20420; or by fax specified time-frame and in consultation and update the interagency agreement
to (202) 273–9026. Comments should with HHS, ‘‘to establish standards [by as necessary in 2018, and every 6 years
indicate that they are submitted in regulation] equal to that applicable to thereafter. In addition, CMS and VA
response to ‘‘RIN 2900–AP64— other medical facility laboratories in agree to meet annually to discuss
Adopting 42 CFR Part 493 Laboratory accordance with the requirements of program issues of mutual importance.
Requirements.’’ Copies of comments section 353(f) of the Public Health To ensure VA remains current with
received will be available for public Service Act.’’ VA’s regulations must CMS CLIA requirements, VA
inspection in the Office of Regulation ‘‘include appropriate provisions participates in the CMS Partners in
Policy and Management, Room 1063B, respecting compliance with such Laboratory Oversight group, consults
between the hours of 8:00 a.m. and 4:30 requirements [set forth in section 353(f) will CMS as needed, and participates in
p.m., Monday through Friday (except of the Public Health Service Act]’’ and at least one formal consultative meeting
holidays). Please call (202) 461–4902 for may include appropriate provisions per year. These engagements with CMS
an appointment. (This is not a toll-free respecting waivers and accreditations facilitates ongoing communication and
number.) In addition, during the described in sections 353(d) and 353(e), coordination, and promotes effective
comment period, comments may be respectively, of the Public Health oversight necessary to coordinate major
viewed online through the Federal Service Act. As a matter of policy and activities, and expeditious, effective
Docket Management System (FDMS) at practice, VA believes it has met these response to complaints, survey findings,
http://www.regulations.gov. statutory requirements; however, VA is and publicly volatile situations. VA staff
FOR FURTHER INFORMATION CONTACT: issuing this proposed rule to comply attend State Agency Surveyor training,
Quynh Vantu, Health Science with the requirement for formal and CLIA surveyor webinars. VA has
Specialist, Pathology and Laboratory rulemaking. Since enactment of section also convened ad hoc conferences with
Service (10P11P), Office of Specialty 101(a) of the 1991 Act, VA has CMS when the exchange of information
Care Services, Veterans Health collaborated with HHS in reviewing VA on CLIA may be needed. VA provides
Administration, Department of Veterans requirements and in developing updates at the annual partners meeting
Affairs, 810 Vermont Ave. NW, Room standards for VA’s medical facility and participates in audio conferences as
1063B, Washington, DC 20420, (202) laboratories that meet the requirements requested. The CMS CLIA Program
632–8418. (This is not a toll-free of law. Director participates in VA’s annual
number.) VA policy and practice regarding conference in which CMS, VA, and
CLIA compliance was developed in Department of Defense provide updates
SUPPLEMENTARY INFORMATION: The consultation with HHS in 1994 and on laboratory issues and enforcement of
Clinical Laboratory Improvement 1998. VA laboratories are accredited by laboratory regulations. As discussed
Amendments of 1988 (Pub. L. (PL) 100– accrediting organizations granted below, VA laboratories that perform
578) amended section 353 of the Public deeming authority by CMS (i.e., HHS- testing are all accredited and inspected
Health Service Act to establish legal approved accreditation organization) to by accrediting organizations granted
requirements for the staffing, ensure its laboratories are in compliance deeming authority by CMS. As such, VA
management, procedures, and oversight with current CLIA regulations. Based on has documentation that its laboratories
of clinical laboratories that perform consultation with CMS in 1994 and meet current CLIA standards.
testing used for the diagnosis, 1998, the accreditation organization(s) VA provides updated data to CMS for
prevention, or treatment of any disease provide oversight for proficiency testing each VA laboratory assigned a CLIA
or impairment of, or health assessment in VA laboratories, as set forth in CLIA. number at least every two years, or as
of, human beings. These statutory Deeming authority is granted to an changes occur. VA provides CMS with
requirements are codified at 42 U.S.C. accrediting organization by CMS after a any requested information regarding the
263a. The term ‘‘laboratory’’ or ‘‘clinical determination that the organization’s operation and performance of VA
laboratory’’ are defined at 42 U.S.C. accreditation oversight program requires laboratories and the operations of the
263a(a) as a facility for the biological, that laboratories comply with or exceed oversight program.
microbiological, serological, chemical, CLIA standards. CMS has granted Under the 1991 Act, the definition of
immuno-hematological, hematological, ‘‘deeming authority’’ to several other ‘‘medical facility laboratories’’ has the
biophysical, cytological, pathological, or organization allowing them to accredit same meaning previously used to define
other examination of materials derived laboratories and inspect the laboratories the terms ‘‘laboratory’’ or ‘‘clinical
from the human body for the purpose of in CMS’s stead. The history of the laboratory’’ pursuant to section 353(a) of
daltland on DSKBBV9HB2PROD with PROPOSALS
providing information for the diagnosis, process of the development of CLIA the Public Health Service Act, codified
prevention, or treatment of any disease equivalent VHA standards in at 42 U.S.C. 263a(a). VA concluded that
or impairment of, or the assessment of consultation with CMS is documented it should adopt 42 CFR part 493
the health of, human beings. Centers for in the interagency agreement (IAA) regulations that were applicable to
Medicare & Medicaid Services (CMS), between VA and CMS. clinical laboratory operations but keep
within HHS, promulgated regulations In 2000, after further consultation, VA oversight and enforcement of these
for the Clinical Laboratory Improvement and CMS entered into an IAA, which regulations as applied to VA
Amendments (CLIA) at title 42, Code of documented the history of the parties’ laboratories within VA, rather than
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![52350 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Proposed Rules
Authority: 38 U.S.C. 501, and as noted in pursuant to an agreement between CMS Enforcement and oversight functions
specific sections: and VA. related to proficiency testing which are
* * * * * (2) CMS does not require remittance assigned to HHS in this subpart are
Section 17.3500 is also issued under Public of a fee from laboratories for any performed by VA.
Law 102–139 sec. 101. certificate issued by VA under this
(i) Subpart J—Facility administration
■ 2. Add an undesignated center subpart.
(d) Subpart D—Certificates of for nonwaived testing. VA applies
heading and § 17.3500 to read as
accreditation. All provisions apply to standards established in this subpart.
follows:
VA, except that: (j) Subpart K—Quality system for
Clinical Laboratory Standards (1) Certificates issued by HHS under nonwaived testing. VA applies
§ 17.3500 VA application of 42 CFR part this subpart are instead issued by VA standards established in this subpart.
493 standards for clinical laboratory pursuant to an agreement between CMS (k) Subpart M—Personnel for
operations. and VA.
nonwaived testing. VA applies
All laboratory testing within VA (2) CMS does not require remittance
of a fee from laboratories for any standards established in this subpart,
performed for the diagnosis, prevention, except that requirements regarding
or treatment of any disease or certificate issued by VA under this
subpart. maintaining a license in the state where
impairment of, or health assessment of,
(e) Subpart E—Accreditation by a the laboratory is located are not
human beings must comply with the
private, nonprofit accreditation applicable.
listed requirements established by the
Department of Health and Human organization or exemption under an (l) Subpart Q—Inspection. VA applies
Services (HHS) under the following approved state laboratory program. All standards established in this subpart,
subparts of 42 CFR part 493 as provisions apply to VA, to the extent except that all enforcement and
interpreted, administered, and enforced that this subpart addresses accreditation oversight functions, which are assigned
by VA. VA laboratory testing must meet, by a private, nonprofit accreditation to HHS in this subpart are performed by
at a minimum, requirements established organization. VA applies this subpart as VA.
in 42 CFR part 493. These standards follows:
(1) VA relies on CMS to grant (m) Subpart R—Enforcement
must be met for any laboratory service
deeming authority for accreditation procedures. VA applies standards
offered within a VA medical facility or
outreach clinics, as well as contracted organizations. VA uses only these established in this subpart, except:
laboratory services performed on site at accreditation agencies with deeming (1) Enforcement and oversight
VA laboratories, outreach clinics, or authority to accredit VA laboratories. functions which are assigned to HHS in
testing sites. Except as noted below, (2) VA uses only CMS approved this subpart are performed by VA.
functions and responsibilities assigned proficiency testing providers.
(3) Proficiency testing providers (2) Due process protections afforded
to the Centers for Medicare & Medicaid by CMS-certified for laboratories facing
Services (CMS) in 42 CFR part 493 are release proficiency testing results
directly to VA. sanctions are not applicable to
assumed by VA. Provisions that are laboratories operating under this
specific to oversight by state licensure (4) VA, rather than CMS, performs
validation inspections of VA section.
programs are not applicable. VA
administers the application of the laboratories. (3) Suspension of the right to
(5) Oversight and enforcement Medicare or Medicaid payments as an
relevant provisions of 42 CFR part 493
functions under this subpart are available sanction is not applicable. VA
to VA laboratories as follows:
(a) Subpart A—General provisions. performed by VA. does not participate in these programs.
(f) Subpart F—General
All provisions apply to VA with the (4) State onsite monitoring and
administration. This subpart sets forth
following exceptions: monetary penalties imposed by CMS as
(1) Functions assigned to HHS in this the methodology for determining the
amount of the fees for issuing the an alternate sanction under 42 CFR
subpart are performed by VA.
(2) While 42 CFR part 493 requires appropriate certificate, and for 493.1806(c) are not applicable.
laboratories that perform waived, determining compliance with the (5) VA may cease laboratory testing
moderate and high complexity tests to applicable standards of the Public immediately at any site subject to this
meet the regulations, VA requires VA Health Service Act and the Federal section upon notification of immediate
laboratories meet or exceed the validation of accredited laboratories and jeopardy to patients.
requirements of 42 CFR part 493. of CLIA-exempt laboratories. This
subpart is inapplicable to VA, as CMS (6) VA does not participate in
(b) Subpart B—Certificate of waiver. laboratory registry under 42 CFR
All provisions apply to VA, except that: does not collect fees for certification of
(1) Certificates issued by HHS under VA laboratories. 493.1850. VA may disclose laboratory
this subpart are instead issued by VA (g) Subpart H—Participation in information useful in evaluating the
pursuant to an agreement between CMS proficiency testing for laboratories performance of laboratories under 5
and VA. performing nonwaived testing. All U.S.C. 552.
(2) CMS does not require remittance provisions apply to VA, except that all (n) Subpart T—Consultations. This
of a fee from laboratories for any enforcement and oversight functions subpart requires HHS to establish a
certificate issued by the VA under this related to proficiency testing which are Clinical Laboratory Improvement
daltland on DSKBBV9HB2PROD with PROPOSALS
subpart. assigned to HHS in this subpart are Advisory Committee (CLIAC) to advise
(c) Subpart C—Registration performed by VA. and make recommendations on
certificate, certificate for provider- (h) Subpart I—Proficiency testing
technical and scientific aspects of the
performed microscopy procedures, and programs for nonwaived testing. All
provisions of part 493. This subpart
certificate of compliance. All provisions provisions apply to VA, and VA
does not apply to VA.
apply to VA, except that: employs scoring criteria under this
(1) Certificates issued by HHS under subpart. VA uses only CMS approved [FR Doc. 2018–22452 Filed 10–16–18; 8:45 am]
this subpart are instead issued by VA proficiency testing providers. BILLING CODE 8320–01–P
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Document Created: 2018-10-17 01:47:28
Document Modified: 2018-10-17 01:47:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule. | |
| Dates | Comments must be received on or before December 17, 2018. | |
| Contact | Quynh Vantu, Health Science Specialist, Pathology and Laboratory Service (10P11P), Office of Specialty Care Services, Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Ave. NW, Room 1063B, Washington, DC 20420, (202) 632-8418. (This is not a toll-free number.) | |
| FR Citation | 83 FR 52345 | |
| RIN Number | 2900-AP64 | |
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