Summary:
Summary Statement of Deficiencies 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 a review of the test menu, a review of the 2018 - 2019 proficiency testing and quality assurance records, a lack of documentation of enrollment for 2019 - third event of 2020, a review of the policy and procedure for Proficiency Testing (PT), and an interview with Testing Personnel (TP) #1 and the Technical Consultant (TC), the laboratory failed to enroll in PT for Chemistry (Routine and Endocrinology). This affected 2019 and most of 2020. The findings include: 1. During the tour of the laboratory on 11/05/2020 at 9:45 AM, TP #1 stated the laboratory uses the Immulite 1000 and the Ace Alera to perform Chemistry testing. At this time, TP #1 stated the laboratory had not enrolled in proficiency testing in 2019, due to the loss of an employee, who had been responsible for all laboratory processes. 2. A review of the proficiency testing records revealed the laboratory was enrolled with Medical Laboratory Evaluation (MLE) PT provider in 2018; but had no documentation of enrollment for 2019. The laboratory did not timely enroll in PT to receive the usual testing events, until Event # 2020. The laboratory analyzed specimens for remedial events 68 R and 69 R in 2020 and self-evaluated the results. 3. In a quality assurance note, the laboratory documented an eighteen months lapse in PT enrollment. 4. The laboratory's PT policy and procedure indicated the following: "...GENERAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- COMPLIANCE *Enroll in PT for every regulated analyte performed in-house..." 5. On 11/5/2020 at 4:15 PM, the surveyor discussed the concerns of the survey with TP #1 and the TC, who joined via telephone. The TC and TP #1 expressed understanding of the CLIA requirement to maintain PT enrollment for all testing the laboratory seeks recertification. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records, a lack of documentation, a review of the PT policy and procedure, and an interview with Testing Personnel (TP) #1 and the Technical Consultant (TC), the surveyor determined the laboratory failed to self-evaluate results of the Thyroglobulin, which was not graded by API for Chemistry Event #3, 2020. This affected one of five testing events reviewed by the surveyor. The findings include: 1. A review of the proficiency testing records revealed API did not grade the Thyroglobulin results (specimens TM 11 and 12) for Event #3, 2020. The laboratory failed to self-evaluate the results, when they were returned by API without a grade /score. 2. A review of the PT policy and procedure revealed the following: "... ASSESSMENT OF THE PROFICIENCY TESTING REPORT *Evaluate all ungraded responses and perform a self-evaluation to verify the accuracy of analytes that are not graded or that are scored 100 % due to non-consensus or lack of peer group..." 3. In an interview on 11/05/2020 at 4:15 PM, the surveyor discussed the lack of documentation of a self-evaluation, with TP #1 and the TC (via the telephone). The TC stated it was an oversight. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the proficiency testing records, a lack of documentation of