Quicksilver Scientific Inc

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing provider. The facility was found to be out of compliance with the conditions of the CLIA program. The following condition level deficiencies were found to be out of compliance: 42 C.F.R. 493.803 Condition: Successful Participation [proficiency testing]; D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a routine desk review of the CMS-155 report for proficiency testing performance and review of proficiency testing evaluation reports from the proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- testing provider, WSLH Proficiency Testing, the laboratory failed to achieve satisfactory performance scores for the subspecialty of toxicology for the lead analyte, for two consecutive proficiency testing events (event 3 in 2024 and event 1 in 2025), see D2118 and D2119. D2118 TOXICOLOGY CFR(s): 493.845(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a routine desk review of the CMS-155 report for proficiency testing (PT), and a record review of WSLH PT results, the laboratory failed to achieve a satisfactory score for two consecutive PT events in the subspecialty of toxicology for the lead analyte for event 3 in 2024 and event 1 in 2025. Findings include: 1. A review of the CMS-155 Individual Laboratory Profile on May 30, 2025, at 1:52 PM, revealed the WSLH PT results for lead were 66% in event 3 in 2024, and 0% for event 1 in 2025. 2. A review of the WSLH PT participant evaluation report on May 30, 2025, at 1:54 PM, confirmed the laboratory received a score of 66% for event 3 in 2024, and 0% for event 1 in 2025 for the lead analyte. D2119 TOXICOLOGY CFR(s): 493.845(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a routine desk review of the CMS-155 report for proficiency testing (PT), and a record review of WSLH PT results, the laboratory failed to achieve an overall satisfactory score for two consecutive PT events in the subspecialty of toxicology for event 3 in 2024 and event 1 in 2025 . Findings include: 1. A review of the CMS-155 Individual Laboratory Profile on May 30, 2025, at 1:52 PM, revealed the WSLH PT results for the subspeciality of toxicology were 66% in event 3 in 2024, and 0% for event 1 in 2025, resulting in unsuccessful overall performance in the subspecialty of toxicology. 2. A review of the WSLH PT participant evaluation report on May 30, 2025, at 1:54 PM, confirmed the laboratory received a score of 66% for the subspeciality of toxicology for event 3 in 2024, and 0% for event 1 in 2025, resulting in unsuccessful overall performance in in the subspecialty of toxicology. -- 2 of 2 --

Summary Statement of Deficiencies D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory's personnel records, and an interview with the technical supervisor (TS), and general supervisor #2 (GS #2), the laboratory failed to evaluate and document the competency of five out of five testing personnel (TP) listed on the CMS-209 form semiannually during their first year of employment since the laboratory's last survey was conducted on November 24, 2021. The laboratory performs approximately 9,100 toxicology tests annually. Findings include: 1. A review of the laboratory's personnel files revealed there was no semiannual evaluation of competency documented for five out five TP listed on the CMS-209 form during their first year of employment. 2. An interview with the TS, at approximately 11:30 AM on July 12, 2024, confirmed that the laboratory failed to evaluate and document the competency of five out of five TP listed on the CMS-209 form semiannually during their first year of employment. 3. An interview with GS #2, at approximately 11:32 AM on July 12, 2024, confirmed that the laboratory failed to evaluate and document the competency of five out of five TP listed on the CMS-209 form semiannually during their first year of employment. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the quality assessment (QA) plan, a lack of customer service records, and laboratory director interview, the laboratory failed in 2018 to follow their written procedure to investigate, document, and resolve customer complaints after receiving a complaint regarding the accuracy of the laboratory's reference ranges on patient test reports in April 2018. Findings include: a. On 5-31-18, the Colorado CLIA program received a complaint from a customer of Quicksilver Scientific stating there could be a reporting problem with Lithium at Quicksilver Scientific. b. On 6-5-18 and 6-7-18, the Colorado CLIA program conducted an onsite complaint investigation at Quicksilver Scientific. c. During the survey on 6-5-18 at about 11 a.m., the laboratory director stated he remembered a customer complaint was received by the laboratory a few months earlier and he had discussed the problem with the complainant, but he was unsure whether the problem had been resolved. d. The QA Plan states, "Complaints are documented by the employee receiving the complaint. The documentation may take the form of a