Summary:
Summary Statement of Deficiencies D0000 A CLIA COLA validation survey was conducted for the Internal Medicine & Preventive Care PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview with testing person one (TP1) on 8/30/19, the laboratory failed to enroll in an approved proficiency testing (PT) program for each Chemistry specialty and subspecialty as evidenced by the following: 1. Record review conducted on 8/30/19 of the American Proficiency Institute (API) PT records for calendar years 2018 and 2019 revealed: a. The laboratory enrolled late for the API PT program in 2018 and failed to participate in: 2018 Chemistry - Core Chemistry - 1st Event b. The laboratory enrolled late for the API PT program in 2019 and failed to participate in: 2019 Chemistry - Core Chemistry - 1st Event 2019 Chemistry - Core Chemistry - 2nd Event 2019 Chemistry - Miscellaneous - 1st Event 2. TP1 confirmed in an interview on 8/30/19 at 11:42 A.M. that the TC failed to order the PT kits for the above listed events in 2018 and 2019 in a timely manner and therefore PT was not performed. 3. The laboratory performs 17,173 Chemistry tests annually. (Refer to D6041) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with testing person one (TP1), the laboratory failed to establish safety procedures to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials as evidenced by the following: The surveyors toured the laboratory on 8/30/19. The tour revealed the following: 1. An eye wash station was observed. Upon request for maintenance and safety procedures it was revealed that no safety procedure was established for the proper use and maintenance of the eye wash. 2. A fire extinguisher was observed. Upon request for maintenance and safety procedures it was revealed that no safety procedure was established for the proper use and maintenance of the fire extiguisher. TP1 confirmed in an interview on 8/30/19 at 1:32 PM that the laboratory did not have safety procedures established for the use and maintenance of the eye wash and the fire extinguisher to ensure protection from hazards. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on record review and interview with testing person one (TP1) on 8/30/19, the Technical Consultant (TC) failed to enroll and participate in an HHS approved proficiency testing (PT) program commensurate with the services offered as evidenced by the following: 1. Record review conducted on 8/30/19 of the American Proficiency Institute (API) PT records for calendar years 2018 and 2019 revealed: a. The laboratory enrolled late for the API PT program in 2018 and failed to participate in: 2018 Chemistry - Core Chemistry - 1st Event b. The laboratory enrolled late for the API PT program in 2019 and failed to participate in: 2019 Chemistry - Core Chemistry - 1st Event 2019 Chemistry - Core Chemistry - 2nd Event 2019 Chemistry - Miscellaneous - 1st Event 2. TP1 confirmed in an interview on 8/30/19 at 11:42 A. M. that the TC failed to order the PT kits for the above listed events in 2018 and 2019 in a timely manner and therefore PT was not performed. 3. The laboratory performs 17,173 Chemistry tests annually. D6048 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(ii) The procedures for evaluation of the competency of the staff must include, but are not limited to monitoring the recording and reporting of test results. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on record review and interview with testing person one (TP1) on 8/30/19, the Technical Consultant (TC) failed to ensure that the procedures for competency of the staff included assessment of the recording and reporting of test results as evidenced by the following: The surveyors reviewed personnel competency assessment records for TP1 for calendar years 2018 and 2019 on 8/30/19. The review revealed that the competency assessments did not include monitoring the recording and reporting of test results in 2018. TP1 confirmed in an interview on 8/30/19 at 11:04 A.M. that the TC failed to perform and document complete annual competency assessments for TP1 in 2018. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and interview with testing person one (TP1) on 8/30/19, the Technical Consultant (TC) failed to ensure that the procedures for competency of the staff included assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples for testing personnel as evidenced by the following: The surveyors reviewed personnel competency assessment records for TP1 for calendar years 2018 and 2019 on 8/30/19. The review revealed that the competency assessments did not include testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples in 2018 and 2019. TP1 confirmed in an interview on 8/30/19 at 11:04 A.M. that the TC failed to perform and document complete annual competency assessments for TP1 in 2018 and 2019. -- 3 of 3 --