Mandatory Citations

6130.5 - Mandatory Citations (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) There are four CLIA condition-level requirements the surveyor must cite if non- compliance is found, regardless of the presence or absence of any negative outcome or potential harm. The four CLIA condition-level requirements are: proficiency testing enrollment, proficiency testing referral, unsuccessful proficiency testing participation and issues related to personnel qualifications. The Mandatory Citations table provides guidance to surveyors for citing the four mandatory CLIA condition-level citations. Citations should include the condition citation and the corresponding D-tag. Where appropriate, surveyors should also provide any Standard -level citations under the condition as well as the standard-level D-tag for those standard-level citations. The mandatory condition-level citations and D-tags and the standard-level citations and D-tags that correspond to the three mandatory PT conditions are: 1. Enrollment in Proficiency Testing (D2000) (42 CFR §493.801) • No minimum standard-level D-tag required. This is the ONLY mandatory condition-level citation where no standard-level D-tag is cited in conjunction with the condition-level D- tag. 2. Proficiency Testing Referral (D2000) (42 CFR §493.801) • At a minimum cite the Standard at D2013 (42 CFR §493.801(b)(4)) 3. Successful Participation in Proficiency Testing (D2016) (42 CFR §493.803) • At a minimum cite the Standard at any of the following as applicable: D2028, D2037, D2046, D2055, D2064, D2074, D2084, D2085, D2096, D2097, D2107, D2108, D2118, D2119, D2130, D2131, D2162, D2163, D2172, D2181, D2190 or D2191. The mandatory condition-level citations and D-tags, and the potential standard-level citations and D-tags that correspond to the condition-level personnel qualifications, are: 1. Laboratory Director PPM (D5980) (42 CFR §493.1355) • At a minimum cite the Standard at D5981(42 CFR §493.1357) 2. Testing Personnel PPM (D5990) (42 CFR §493.1361) • At a minimum cite the Standard at D5991 (42 CFR §493.1363) 3. Laboratory Director Moderate Complexity Testing (D6000) (42 CFR §493.1403) • At a minimum cite the Standard at D6003 (42 CFR §493.1405) 4. Technical consultant Moderate Complexity Testing (D6033) (42 CFR §493.1409) • At a minimum cite the Standard at D6035 (42 CFR §493.1411) 5. Clinical Consultant Moderate Complexity Testing (D6056) (42 CFR §493.1415) • At a minimum cite the Standard at D6057 (42 CFR §493.1417) 6. Testing Personnel Moderate Complexity Testing (D6063) (42 CFR §493.1421) • At a minimum cite the Standard at D6065 (42 CFR §493.1423) 7. Laboratory Director High Complexity Testing (D6076) (42 CFR §493.1441) • At a minimum cite the Standard at D6078 (42 CFR §493.1443) 8. Technical Supervisor High Complexity Testing (D6108) (42 CFR §493.1447) • At a minimum cite the Standard at D6111 (42 CFR §493.1449) 9. Clinical Consultant High Complexity Testing (D6134) (42 CFR §493.1453) • At a minimum cite the Standard at D6135 (42 CFR §493.1455) 10. General Supervisor High Complexity Testing (D6141) (42 CFR §493.1459) • At a minimum cite the Standard at D6143 (42 CFR §493.1461) 11. Cytology General Supervisor (D6153) (42 CFR §493.1467) • At a minimum cite the Standard at D6155 (42 CFR §493.1469) 12. Cytotechnologist (D6162) (42 CFR §493.1481) • At a minimum cite the Standard at D6164 (42 CFR §493.1483) 13. Testing Personnel High Complexity Testing (D6168) (42 CFR §493.1487) • At a minimum cite the Standard at D6171 (42 CFR §493.1489(b)) MANDATORY CITATIONS IF YOU FIND NON-COMPLIANCE WITH. . . YOU MUST AT LEAST CITE THE STANDARD AT D- TAG. . . YOU MUST AT LEAST CITE THE CONDITION AT D- TAG. . . Non-enrollment in Proficiency Testing 42 CFR § 493.801 D2000 Proficiency Testing Referral 42 CFR § 493.801(b)(4) § 493.801(b)(5) D2012 D2013 D2000 Unsuccessful Participation in Proficiency Testing 42 CFR § 493.803 D2028, D2037, D2046, D2055, D2064, D2074, D2084, D2085, D2096, D2097, D2107, D2108, D2118, D2119, D2130, D2131, D2162, D2163, D2172, D2181, D2190, OR D2191 D2016 Personnel Qualifications - Subpart M Laboratory Director PPMP D5981 D5980 Testing Personnel PPMP D5991 D5990 Laboratory Director Moderate Complexity Testing D6003 D6000 Technical Consultant Moderate Complexity Testing D6035 D6033 Clinical Consultant Moderate Complexity Testing D6057 D6056 Testing Personnel Moderate Complexity Testing D6065 D6063 Laboratory Director High Complexity Testing D6078 D6076 Technical Supervisor High Complexity Testing D6111 D6108 Clinical Consultant High Complexity Testing D6135 D6134 General Supervisor High Complexity Testing D6143 D6141 Cytology General Supervisor D6155 D6153 Cytotechnologist D6164 D6162 Testing Personnel High Complexity Testing D6171 D6168