Opinion ID: 718320
Heading Depth: 2
Heading Rank: 2

Heading: Cytology Proficiency Testing

Text: 25 Turning to the second regulation challenged by Consumer Federation and invalidated by the district court--the one regarding cytology proficiency testing--CLIA requires HHS to set a limit on the rate at which cytologists may process slides, in order to prevent labs from forcing their employees to review them too rapidly. H.R.REP. NO. 899 at 31, reprinted in U.S.S.C.A.N. at 3852; S.REP. NO. 561 at 27. It also directs the agency to establish standards for 26 periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytological preparations, including announced and unannounced on-site proficiency testing of such individuals, with such testing to take place, to the extent practicable, under normal working conditions. 27 42 U.S.C. § 263a(f)(4)(B)(iv) (emphasis added). The final rule issued by HHS established a maximum daily work rate of no more than 100 actual patient slides in a 24-hour period, assuming an 8-hour workday--a workload of 12.5 patient slides per hour. 42 C.F.R. § 493.1257(b)(1). The proficiency testing protocol, on the other hand, requires cytologists to review only 10 slides 7 in a 2-hour period (a rate of 5 slides/hour). Between 30% and 60% of these slides must be abnormal, and to pass the technician must correctly identify at least 90% of the slides. 42 C.F.R. §§ 493.855(b), 493.945; 57 Fed.Reg. at 7041. 28 Consumer Federation argued that because the testing rate of 5 slides/hour is substantially less than the 12.5 slides/hour maximum permissible workload, the testing procedure does not conform to normal working conditions. The district court agreed that the testing protocol violated CLIA's statutory mandate that testing take place, to the extent practicable, under normal working conditions and invalidated the regulation. We analyze this regulation under the same rubric as HHS's personnel qualifications regulation. If Congress has spoken clearly to the question of how the agency may conduct proficiency testing, we will give effect to Congress' intent. If not, we will sustain an agency reading of the statutory provision that is a permissible construction of CLIA. 29 Consumer Federation's challenge cannot be resolved under the first step of Chevron review. Although the statute requires HHS to make a reasonable effort to conform its testing protocol to actual working conditions, it does not require a precise replication of the workplace environment--witness the inclusion of the words to the extent practicable in the section. Nor has Congress defined with any precision when the agency may deviate from workplace conditions in the interests of practicality. We therefore turn to the second step of Chevron, and inquire whether the agency's interpretation of its statutory directive is a reasonable one. 30 The agency does not dispute that the testing rate it selected is significantly lower than the maximum daily work rate. The remaining questions, then, are (1) how much does the testing rate deviate from the normal working rate, if the average work rate is less than the maximum rate? and (2) do practical constraints on the administration of proficiency tests warrant such a deviation from normal working conditions? In its final rule, the agency explained the testing rate as follows: 31 We are modelling the scoring system as described in § 493.945 [the regulation implementing the proficiency testing program] after that in use in the State of Maryland. To that end we have changed the minimum passing score to 90 percent.... [W]e have added a maximum time allowed for each testing event, based on the PT program in the State of Maryland. Individuals are given not more than 2 hours to complete a 10-slide test and 4 hours to complete a 20-slide test. These time limits were established to provide for equitable testing on a national scale and to allow individuals sufficient time to complete the test at their normal pace without unduly restricting or extending the time for the examination. 32 57 Fed.Reg. at 7041. This explanation is simply too terse to support the agency's decision to use a testing rate which is less than half the maximum work rate, in the face of statutory language directing it to test under normal working conditions to the extent practicable. HHS first states that it has chosen this rate because it is identical to the rate used in the Maryland proficiency program. It provides no reason, however, as to why it has selected Maryland's program as a prototype, or why Maryland itself uses a testing rate of 5 slides/hour. The agency then claims that its rate allows for equitable testing and gives all cytologists sufficient time for the test. It is decidedly unclear exactly what the agency means by this. What is the average work rate, if it is less than the maximum rate of 10 slides/hour? Is it 5 slides/hour? Or do the slowest cytologists work at this rate? If so, why is it impractical for the agency to test at the average rate, even if some below-average cytologists fail the test as a result? Are there ways in which the demands of a proficiency test differ from normal working conditions--such as the argument proffered in the Collins declaration, discussed below, that a proficiency test includes more abnormal slides than are viewed in a regular workday--and if so, are such departures from normal conditions warranted? Without further definition of normal working conditions and an explanation of why the testing protocol it has selected conforms to these conditions, to the extent practicable, we are at a loss to understand how HHS's proficiency testing regulations reflect a reasonable interpretation of the relevant CLIA provision. 33 HHS did belatedly attempt to remedy this problem. In a supplemental declaration submitted to the district court, an HHS official argued that the slower rate used in the testing protocol was necessitated by the higher percentage of abnormal slides included in the test. In an average workday, approximately 5% of the slides reviewed by a cytologist are abnormal. By contrast, between 30% and 60% of the slides in a proficiency test are abnormal, in order to test the cytologist's knowledge of a wide range of abnormalities. The official also stated that evaluation of an abnormal slide requires more time than examination of a normal slide because the cytologist must classify the specific type of abnormality she sees. Since the testing protocol includes three to six times more abnormal--that is, more time-consuming--slides than occur on an average workday, it is not practical to require cytologists to review them at the normal work rate. See Collins Decl. of July 29, 1993, reprinted in App. at 68, 70-71. 34 Even if this rationale might have passed as sufficient grounds for the agency's decision to use a testing rate of 5 slides/hour, the critical fact is that HHS did not proffer it during the rulemaking process. Instead, the agency submitted the Collins declaration only at the district court stage. Our review of HHS's action can be based only on the administrative record, not some new record made initially in the reviewing court. Camp v. Pitts, 411 U.S. 138, 142, 93 S.Ct. 1241, 1244, 36 L.Ed.2d 106 (1973); see also Center for Auto Safety, 956 F.2d at 314 (rejecting agency's rationale for its bridge inspection regulations as post hoc rationalization not included in administrative record). As the government points out, this court has on occasion flexed the record requirement to allow the admission of agency declarations that  'merely illuminate reasons obscured but implicit in the administrative record.'  Clifford v. Pena, 77 F.3d 1414, 1418 (D.C.Cir.1996) (quoting Appeal of Bolden, 848 F.2d 201, 207 (D.C.Cir.1988)). But the Collins declaration falls on the post hoc side of this administrative divide. Rather than simply providing additional background information about the agency's basic rationale for the proficiency testing protocol, as did the agency's declaration in Clifford, Collins' statement offers an entirely new theory for the testing rate selected by HHS--that a proficiency test should include a higher proportion of abnormal slides than are read in an average day, and that a slower-than-average work rate is appropriate because each of these abnormal slides takes more time to review than a normal slide. The only information along these lines included in the rulemaking record or statement of basis and purpose is a description of the criteria for scoring a proficiency test, from which it is possible to deduce the number of abnormal slides included in a 10 slide proficiency test. Without more, the mere fact that the test includes a higher proportion of abnormal slides than occurs in an average workday tells us little about the agency's choice of a testing rate. Since the agency has not up to now provided an adequate explanation on the record of why its testing protocol represents a permissible interpretation of the pertinent CLIA provision, we remand to the agency to articulate a convincing rationale for its protocol or to continue the rulemaking process it has already commenced for issuing a new one. 8 35 So ordered.