Choosing the Appropriate Condition

6130.4 - Choosing the Appropriate Condition (Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) Review the regulatory language at each of the conditions, noting the requirements that must be met for the condition to be in compliance. For example: The condition of Bacteriology at 42 CFR §493.1201 (D5002) states the laboratory must meet the requirements at 42 CFR §§493.1230 (D5200) through 493.1256 (D5485), 493.1261 (D5501 - D5507) and 493.1281 (D5775) through 493.1299 (D5893) (covering General Laboratory Systems, Preanalytic Systems, Analytic Systems, and Postanalytic Systems). Serious problems in one or more of these areas can cause the condition of Bacteriology to be out of compliance. In comparison, the condition statement for Preanalytic Systems at 42 CFR §493.1240 (D5300) states the laboratory must meet the requirements at 42 CFR §§493.1241 (D5301 - D5309), 493.1242 (D5311 - D5317), and 493.1249 (D5393) for each specialty or subspecialty of testing. Serious preanalytic deficiencies that are pervasive throughout the laboratory (not related to specific specialties or subspecialties) could cause the condition of Preanalytic Systems to be out of compliance. Caution: An enforcement action based on noncompliance with the condition of General Laboratory Systems, Preanalytic Systems, Analytic Systems or Postanalytic Systems could be a revocation or a suspension of the CLIA certificate and would not necessarily be a limitation of the CLIA certificate for one or more specialties. Standard-level deficiencies written in one subpart cannot be the basis for a condition in another subpart. Deficiencies in Proficiency Testing or Personnel would not be the basis for the condition of Bacteriology to be out of compliance. It is not uncommon for a surveyor to identify issues that crossover between subparts of the regulations. Cite deficiencies at the appropriate area of the regulations that describes the problem. For example, failures in proficiency testing may be caused by an error in specimen identification, test system malfunction, or lack of training for staff. Consider citing the most appropriate citation for the laboratory to come into compliance. Avoid citing multiple citations for the same deficiency unless each citation focuses on a different aspect of the deficiency (instrument malfunction vs. staff training, or quality system vs. laboratory director responsibilities, as discussed above). The surveyor must consider the deficiencies cited when determining the conditions out of compliance, and also the potential enforcement actions should the laboratory not correct the deficiencies. The organization of the regulations and conditions allows the surveyor to write a condition out of compliance according to specialty/subspecialty or to the Systems of testing (General Laboratory Systems, Preanalytic Systems, Analytic Systems, or Postanalytic Systems). EXAMPLE 1: A laboratory has one or more standard-level deficiencies related to Bacteriology testing in Preanalytic Systems 42 CFR §493.1241 through 493.1249 (D5301-D5393), Quality Control Procedures 42 CFR § 493.1256 (D5441-D5485) and the Bacteriology subspecialty 42 CFR § 493.1261 (D5501-D5507). The surveyor may determine the condition of Bacteriology 42 CFR § 493.1201 (D5002) is out of compliance based on the deficiencies written under all three systems, Preanalytic, Analytic and Postanalytic. Even though the laboratory conducts testing in other specialty or subspecialty areas, by citing the deficiencies under the condition of Bacteriology, the certificate could be limited for the subspecialty of Bacteriology instead of the entire CLIA certificate being affected. EXAMPLE 2: A laboratory is cited for one or more standard-level deficiencies in Preanalytic Systems 42 CFR §493.1241 through 493.1249 (D5301-D5393) and the deficiencies are related to practices in all the specialties and subspecialties offered by the laboratory. The surveyor determines the condition of Preanalytic Systems is out of compliance. If the laboratory does not correct the condition-level deficiency in Preanalytic Systems, the enforcement action is against the certificate and not a limitation of a specialty or subspecialty. EXAMPLE 3: A laboratory has deficiencies in Bacteriology in the Control Procedures 42 CFR §493.1256 (D5441-D5485), the Bacteriology subspecialty 42 CFR §493.1261 (D5501- D5507), and Routine Chemistry deficiencies in the Control Procedures 42 CFR §493.1256 (D5441- D5485). All deficiencies are within the Analytic System. The surveyor may determine the condition of Bacteriology 42 CFR §493.1201 (D5002) is out of compliance based on the deficiencies cited in Control Procedures 42 CFR §493.1256 (D5441-D5485) and also deficiencies in subspecialty areas for Bacteriology 42 CFR §493.1261 (D5501-D5507). And the surveyor may determine the condition of Routine Chemistry 42 CFR §493.1210 (D5016) is out of compliance based on deficiencies cited related to Control Procedures 42 CFR §493.1256 (D5441-D5485). Even though the D-tags used to determine condition- level noncompliance in Routine Chemistry are cited in the Control Procedures area, the appropriate condition to mark out of compliance is the applicable subspecialty of Routine Chemistry. If the laboratory performs testing in only the subspecialties of Bacteriology and Routine Chemistry, and if the deficient practices are pervasive, the surveyor may write the condition of Analytic Systems 42 CFR §493.1250 (D5400) out of compliance. When a specialty or subspecialty condition is out of compliance, the enforcement action chosen may be a limitation to the certificate for the specialty or subspecialty out of compliance. This approach allows the laboratory to continue testing in those specialties and subspecialties in which compliance was determined. A condition-level deficiency in one of the Systems (General Laboratory Systems, Preanalytic Systems, Analytic Systems, or Postanalytic Systems) indicates a pervasive situation through all specialties and subspecialties offered by the laboratory.