Chapter 14: Enforcement Procedures

CHAPTER 14 ENFORCEMENT PROCEDURES

14-1. Basis and Scope (§493.1800) a. Under Title 10, US Code, Chapter 55, DoD is given jurisdictional responsibility under law for the operation of its facilities. b. This chapter sets forth:

(1) The policies and procedures that OASD(HA) and TSG follow to enforce the requirements applicable to laboratories under the DoD Clinical Laboratory Improvement Program; and (2) The review rights of laboratories on which OASD(HA), or TSG imposes sanctions.

14-2. General considerations (§493.1804) a. Enforcement mechanisms are taken to improve the quality of laboratory services available to beneficiaries. As such, all investigation and complaint reports are governed by 10 U.S.C. 1102. Enforcement mechanisms are set forth in this chapter and have the following purposes:

(1) To provide accurate and reliable test results. (2) To protect all individuals served by DoD laboratories against substandard testing of specimens. (3) To safeguard the general public against the health and safety hazards that might result from substandard laboratory activities.

b. TSG's decision to impose sanctions is based on one or more of the following:

(1) Deficiencies found by TSG, or their designee in the conduct of inspections to certify or validate compliance with DoD requirements, or through review of materials submitted by the laboratory (e.g., personnel qualifications). (2) Unsuccessful participation in proficiency testing.

c. OASD(HA), or TSG, may impose one or more of the alternative or principle sanctions specified in paragraph 14-3 below when OASD(HA), or TSG finds that a laboratory has condition level deficiencies.

(1) TSG may impose alternative sanctions in lieu of the principle sanctions. (TSG may impose alternative sanctions on laboratories that have certificates of waiver.) (2) TSG may impose alternative sanctions after the laboratory has had an opportunity to respond through command channels.

d. TSG bases its choice of sanction or sanctions on consideration of one or more factors that include, but are not limited to, the following, as assessed by TSG or their designee:

(1) When the deficiencies pose immediate jeopardy. (2) The nature, incidence, severity, and duration of the deficiencies or noncompliance. (3) Whether the same condition-level deficiencies have been identified repeatedly. (4) The accuracy and extent of laboratory records (e.g. of remedial action) in regard to the noncompliance. (5) The relationship of one deficiency or group of deficiencies to other deficiencies. (6) The overall compliance history of the laboratory including, but not limited to, any period of noncompliance that occurred between certifications of compliance. (7) The corrective and long-term compliance outcomes that TSG hopes to achieve through application of the sanction. (8) Whether the laboratory has made any progress toward improvement following a reasonable opportunity to correct deficiencies. (9) Any recommendations within the chain of command as to which sanctions would be appropriate.

e. The review process for laboratories is set forth in paragraph 14-13 below. 14-3. Available sanctions: All laboratories (§493.1806) a. OASD(HA) or TSG may impose one or more of the sanctions specified in this chapter on a laboratory that is out of compliance with one or more DoD CLIP conditions. b. OASD(HA) or TSG may impose any of the three principal sanctions, which are suspension, limitation, or revocation of any type of DoD CLIP certificate. c. TSG may impose one or more of the following alternative sanctions

(1) Directed plan of correction, as set forth at paragraph 14-9. (2) Directed on-site monitoring as set forth at paragraph 14-10.

14-4. Imposition and lifting of alternative sanctions (§493.1810) a. If TSG or their designee identifies condition level noncompliance in a laboratory, TSG gives the laboratory, through command channels, written notice of the following:

(1) The condition level noncompliance that it has identified. (2) The sanction or sanctions that TSG or their designee proposes to impose against the laboratory. (3) The rationale for the proposed sanction or sanctions. (4) The projected effective date and duration of the proposed sanction or sanctions. (5) The time allowed for the laboratory to respond to the notice.

b. During the period specified in paragraph a(5) above, the laboratory may submit through command channels to TSG or their designee written evidence or other information against the imposition of the proposed sanction or sanctions. c. If sanctions are still to be imposed, after evaluation of data submitted in accordance with paragraph 14-4b, laboratories are notified in writing. The written notice will acknowledge any evidence or information received from the laboratory and specify the following:

(1) The sanction(s) to be imposed against the laboratory. (2) The rationale for imposing the sanction(s). (3) The effective date and duration of sanction(s).

d. Sanctions become effective in the following time frame:

(1) If TSG or their designee determines that the deficiencies pose immediate jeopardy, TSG provides notice at least 5 days before the effective date of the sanction. (2) If TSG or their designee determines that the deficiencies do not pose immediate jeopardy, TSG provides notice at least 15 days before the effective date of the sanction.

e. An alternative sanction continues until the earlier of the following occurs:

(1) The laboratory corrects all condition level deficiencies. (2) TSG or OASD(HA)'s suspension, limitation, or revocation of the laboratory's DoD CLIP certificate becomes effective.

f. Sanction(s) are lifted in the following manner:

(1) General rule. Alternative sanctions are not lifted until a laboratory's compliance with all condition level requirements is verified. (2) Credible allegation of compliance. When a sanctioned laboratory submits a credible allegation of compliance, TSG or their designee determines whether:

(a) It can certify compliance on the basis of the evidence presented by the laboratory in its allegation. (b) It must revisit to verify whether the laboratory has, in fact, achieved compliance.

(3) Compliance achieved before the date of revisit. If during a revisit, the laboratory presents credible evidence (as determined by TSG or their designee) that it achieved compliance before the date of revisit, sanctions are lifted as of that earlier date.

14-5. Action when deficiencies pose immediate jeopardy (§493.1812) If a laboratory's deficiencies pose immediate jeopardy, the following rules apply: a. TSG requires the laboratory to take immediate action to remove the jeopardy and may impose one or more alternative sanctions to help bring the laboratory into compliance. b. If the findings of a revisit indicate that a laboratory has not eliminated the jeopardy, TSG suspends or limits the laboratory's DoD CLIP certificate no earlier than 5 days after the date of notice of suspension or limitation. OASD(HA) or TSG may later revoke the certificate. c. In addition, if TSG or their designee has reason to believe that the continuation of any activity by any laboratory (either the entire laboratory operation or any specialty or subspecialty of testing) would constitute a significant hazard to the health of DoD beneficiaries, TSG or their designee may direct that the activity be immediately discontinued, regardless of the type DoD CLIP certificate the laboratory had been previously issued. 14-6. Actions when deficiencies are at the condition level but do not pose immediate jeopardy (§493.1814) If a laboratory has condition level deficiencies that do not pose immediate jeopardy, the following apply: a. Initial action:

(1) OASD(HA) or TSG may suspend, limit, or revoke the laboratory's DoD CLIP certificate. (2) If TSG or their designee does not impose a principal sanction under paragraph a(1) above, they may impose one or more alternative sanctions. In the case of unsuccessful participation in proficiency testing, TSG or their designee may impose the training and technical assistance requirement set forth at paragraph 14-11 in lieu of, or in addition to, one or more alternative sanctions.

b. If TSG imposes alternative sanctions for condition level deficiencies that do not pose immediate jeopardy, and the laboratory does not correct the condition level deficiencies within 12 months after the last day of inspection, TSG or their designee:

(1) Following a revisit which indicates that the laboratory has not corrected its condition level deficiencies, notifies the laboratory through command channels that it proposes to suspend, limit, or revoke the certificate, as specified in paragraph 14-7b, and the laboratory's right to respond in writing through command channels within 30 days to TSG; and (2) May impose (or continue if already imposed) any alternative sanctions.

c. If a final decision upholds a proposed suspension, limitation, or revocation of a laboratory's DoD CLIP certificate, TSG discontinues any alternative sanctions as of the day the suspension, limitation, or revocation becomes effective. 14-7. Action when deficiencies are not at the condition level (§493.1816) If a laboratory has deficiencies that are not at the condition level, the following rules apply: a. The laboratory must submit through command channels to TSG or their designee, a plan of corrective action that is acceptable to TSG in content and time frames. b. If, on a revisit, it is found that the laboratory has not corrected the deficiencies within 12 months after the last day of inspection, TSG notifies the laboratory of its intent to suspend, limit, or revoke the laboratory's DoD CLIP certificate and of the laboratory's right to respond in writing through command channels to TSG or their designee within 30 days. 14-8. Ensuring timely correction of deficiencies (§493.1820) a. TSG or their designee may visit the laboratory at any time to evaluate progress, and at the end of the period to determine whether all corrections have been made. b. If during a visit, a laboratory produces credible evidence that it achieved compliance before the visit, the sanctions are lifted as of that earlier date. c. If during a visit, it is found that a laboratory has not corrected its deficiencies, TSG or their designee may propose to suspend, limit, or revoke the laboratory's DoD CLIP certificate. d. If at the end of the plan of correction period all condition level deficiencies have been corrected, and there are still deficiencies not at the condition level, TSG may require a revised plan of correction. The revised plan may not extend beyond 12 months from the last day of the inspection that originally identified the cited deficiencies. e. If at the end of the period covered by the plan of correction, the laboratory still has deficiencies, the rules of paragraph 14-6 and paragraph 14-7 apply. 14-9. Directed plan of correction and directed portion of a plan of correction (§493.1832) a. TSG may impose a directed plan of correction or a directed portion of a directed plan of correction as an alternative sanction for any laboratory that has condition level deficiencies. b. Procedures for imposing either course of action are:

(1) When imposing a directed plan of correction, TSG:

(a) Gives the laboratory prior notice of the sanction and opportunity to respond in accordance with paragraph 14-4. (b) Directs the laboratory to take specific corrective action within specific time frames in order to achieve compliance. (c) May direct the laboratory to submit the names of any other laboratory from which specimens are received and analyzed, for notification purposes, as specified in paragraph b(3) below.

(2) When imposing a directed portion of a plan of correction, TSG may decide to notify clients of a sanctioned laboratory because of the seriousness of the noncompliance (e.g., the existence of immediate jeopardy) or for other reasons. When imposing this sanction, TSG takes the following steps:

(a) Directs the laboratory to submit to TSG, within 10 calendar days after the notice of the alternative sanction, for all laboratory clients from outside the laboratory's organization, a list of names and addresses of all physicians, providers, suppliers, and other clients who have used some or all of the services of the laboratory since the last certification inspection or within any other time frame specified by TSG. This list will include any civilian health care providers that have been furnished with laboratory test results under the CHAMPUS program, TRICARE, or as a service to eligible beneficiaries utilizing civilian healthcare providers. Additionally, the names of all laboratories that have sent referred specimens to the sanctioned laboratory, will be provided. (b) Within 30 calendar days of receipt of the information, TSG may send to each laboratory client a notice containing the name and address of the laboratory, the nature of the laboratory's noncompliance, and the kind and effective date of the alternative sanction. (c) Sends to each laboratory client notice of the recision of an adverse action within 30 days of the recision.

(3) If OASD(HA) or TSG may impose a principal sanction following the imposition of an alternative sanction. If a principal sanction is imposed following the imposition of an alternative sanction, and for which TSG has already obtained a list of laboratory clients, OASD(HA) or TSG may use that list to notify the clients of the imposition of the principal sanction.

c. If TSG imposes a directed plan of correction, and on revisit it is found that the laboratory has not corrected the deficiencies within 12 months from the last day of inspection, the following rules apply:

(1) TSG notifies the laboratory of TSG intent to suspend, limit, or revoke the laboratory's DoD CLIP certificate. (2) The directed plan of correction continues in effect until the day suspension, limitation, or revocation of the laboratory's DoD CLIP certificate.

14-10. Directed on-site monitoring (§493.1836) a. TSG may require continuous or intermittent monitoring of a plan of correction by a designated laboratory monitor (an individual or team) to ensure that the laboratory makes the improvements necessary to bring it into compliance with the condition level requirements. (The monitor does not have management authority, that is, cannot hire or fire staff, obligate funds, or otherwise dictate how the laboratory operates. The monitor's responsibility is to oversee whether corrections are made, and to make recommendations to the laboratory director and the facility commander.) b. Before imposing this sanction, TSG provides notice of sanction and opportunity to respond in accordance with paragraph 14-4. c. If TSG imposes on-site monitoring, the sanction continues until:

(1) TSG or their designee determines that the laboratory has the capability to ensure compliance with all condition level requirements. (2) If the laboratory does not correct all deficiencies within 12 months, and a revisit indicates that deficiencies remain, TSG notifies the laboratory of its intent to suspend, limit, or revoke the laboratory's certificate of compliance, registration certificate, or certificate of accreditation, or certificate for PPM procedures.

14-11. Training and technical assistance for unsuccessful participation in proficiency testing (§493.1838) a. If a laboratory's participation in proficiency testing is unsuccessful, TSG may require the laboratory to undertake training of its personnel, or to obtain necessary technical assistance, or both, in order to meet the requirements of the proficiency testing program. This requirement is separate from the principal and alternative sanctions set forth in paragraph 14-3. b. Upon failure to successfully participate in proficiency testing, as defined in chapter 6, the laboratory will take immediate action which may include voluntary cessation for the specialty, subspecialty or analyte that was failed. The accuracy of testing will be verified within 5 days of receiving the proficiency results. The remedial action will be documented and sent to TSG within 30 days of receipt of the proficiency results for review and approval. 14-12. Suspension, limitation, or revocation of any type of DoD CLIP certificate (§493.1840) a. TSG may initiate adverse action to suspend, limit, or revoke any DoD CLIP certificate if TSG finds that a laboratory's commander, director, or one of its employees has:

(1) Been guilty of misrepresentation in obtaining a DoD CLIP certificate. (2) Performed, or represented the laboratory as entitled to perform, a laboratory examination or other procedure that is not within a category of laboratory examinations or other procedures authorized by its DoD CLIP certificate. (3) Failed to comply with the certificate requirements and performance standards. (4) Failed to comply with reasonable requests by TSG or their designee for any information or work on materials that TSG or their designee concludes is necessary to determine the laboratory's continued eligibility for its DoD CLIP certificate. (5) Failed to comply with an alternative sanction imposed under this chapter.

b. If TSG determines that a laboratory has intentionally referred its proficiency testing samples to another laboratory for analysis, TSG may revoke the laboratory's DoD CLIP certificate, and may also initiate administrative or judicial disciplinary action against individuals found responsible for such referral(s). c. Procedures for suspension or limitation of any DoD CLIP certificate:

(1) Except as provided in paragraph c(2) below, TSG does not suspend or limit a DoD CLIP certificate until after personnel responsible for the laboratory have responded to TSG in writing through command channels. (2) Exceptions. TSG or their designee may suspend or limit a DoD CLIP certificate before the written response through command channels in any one of the following circumstances:

(a) The laboratory's deficiencies pose immediate jeopardy. (b) The laboratory has failed to respond to TSG in writing through command channels within 30 days.

d. OASD(HA) or TSG may revoke a DoD CLIP certificate even if it had not previously suspended or limited that certificate. e. TSG or their designee must notify OASD(HA) of any DoD CLIP certificate suspended, limited, or revoked under this section within 30 days of the action. 14-13. Review procedures (§493.1844) a. The following actions are initial determinations and therefore are subject to review in accordance with this section:

(1) The suspension, limitation, or revocation of the laboratory's DoD CLIP certificate by OASD(HA) or TSG because of noncompliance with DoD laboratory requirements. (2) The denial of a DoD CLIP certificate. (3) The imposition of alternative sanctions under this chapter (but not the determination as to which alternative sanction or sanctions to impose).

b. Actions that are not listed in paragraph a above are not initial determinations and therefore are not subject to review under this section. They include, but are not necessarily limited to, the following:

(1) The finding that a laboratory is determined to be in compliance with condition-level requirements but has deficiencies that are not at the condition level. (2) The determination not to reinstate a suspended DoD CLIP certificate because the reason for the suspension has not been removed or there is insufficient assurance that the reason will not recur. (3) The determination as to which alternative sanction or sanctions to impose. (4) The determination that a laboratory's deficiencies pose immediate jeopardy.

c. Effect of requested reviews of action are:

(1) The effective date of an alternative sanction is not delayed because the laboratory has requested review and the final decision is pending. (2) The effect on suspension, limitation, or revocation of a laboratory's DoD certificate are:

(a) Except as provided in paragraph c(2)(b) below, suspension, limitation, or revocation of a DoD CLIP certificate is not effective until after a final decision by OASD(HA) or TSG is issued. (b) Exceptions. If OASD, TSG, or their designee determines that conditions at a laboratory pose immediate jeopardy, the effective date of the suspension or limitation of a DoD CLIP certificate is not delayed because the laboratory has appealed the final decision through command channels.

d. Any laboratory with a suspension, limitation, revocation, or denial of its DoD CLIP certificate, or with the imposition of an alternative sanction under this chapter, is entitled to a re-review of the action to TSG. Such re-review must be in writing and sent through command channels to reach TSG within 30 days. e. Notice of adverse action:

(1) If TSG suspends, limits, or revokes a laboratory's DoD CLIP certificate, TSG gives notice to the laboratory, and may give notice to physicians, providers, suppliers, and other laboratory clients, according to the procedures set forth at paragraph 14-9. In addition, TSG may notify DoD health care beneficiaries each time one of the principal sanctions is imposed. (2) The notice to the laboratory:

(a) Sets forth the reasons for the adverse action, the effective date and effect of that action, and the review process if any. (b) When the certificate is limited, specifies the specialties or subspecialties of tests that the laboratory is no longer authorized to perform.

(3) The notice to other entities includes the same information except the information about the laboratory's review process.

f. Effective date of adverse action:

(1) When the laboratory's deficiencies pose immediate jeopardy, the effective date of the adverse action is no more than 5 days after the date of the notice. (2) When TSG determines that the laboratory's deficiencies do not pose immediate jeopardy, the effective date of the adverse action is no more than 15 days after the date of the notice.

14-14. Laboratory registry (§493.1850) a. Once a year, TSG will make available to OASD (HA), and to DoD health care beneficiaries specific information that is useful in evaluating the performance of laboratories, including the following:

(1) A list of laboratories that have had their DoD CLIP certificates suspended, limited, or revoked, and the reason for the adverse actions. (2) A list of laboratories whose accreditation has been withdrawn or revoked and the reasons for the withdrawal or revocation.

b. The laboratory registry is compiled for the calendar year preceding the date the information is made available and includes appropriate explanatory information to aid in the interpretation of the data. It also contains corrections of any erroneous statements or information in the previous registry.

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