Cliffside Labs Dba Valgen Labs

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to evaluate all ungraded scores for PT event DAI-A-2024 performed with the College of American Pathologists (CAP). The findings include: 1. Specimen DAI-03 for Specific Gravity Qualitative was resulted as "Abnormal" and was graded as "See Note 26". 2. The method interpreation (educational) by Microgenics DRI had a 60.2% frequency for "Abnormal" by peer group analysis. 3. The GS stated on the PT records "educational codes 26 were reviewed with >80% consensus on 3/28/24 for PT event DAI-A-2024. 4. There was no documented evidence for self-evaluation performed for specimen DAI-03 Specific Gravity Qualitative which did not have a >80% consensus. 5. The GS confirmed on 4 /23/24 at 1:20 pm, the laboratory failed to evaluate all ungraded PT scores. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of the Proficiency Testing (PT) records, Procedure Manual (PM) and interview with the General Supervisor (GS), the laboratory failed to have a mechanism for its PT results provided by the College of American Pathologists (CAP), which includes a review of its actual PT results against the PT provider's participant summary results for PT events from 4/1/23 to 4/26/24 The findings include: 1. CAP states "Educational PT/EQA challenges are designated with an evaluation code 26. These challenges are not formally graded, and laboratories should utilize data in the participant summary report to perform a self-evaluation." 2. The laboratory failed to have a procedure for self-evaluation for ungraded PT results which includes acceptability and rejection criteria. 3. The GS confirmed on 4/23/24 at 1:45 pm, the laboratory failed to have a procedure for self-evaluation for ungraded PT results provided by CAP. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Instrument Correlation Records (ICR) and interview with the General Supervisor (GS), the laboratory failed to follow their Instrument to Instrument Verification Procedure (IIVP) that defines the relationship between Routine Chemistry and Toxicology test results performed on the two Beckman Coulter AU680 analyzers from 3/22/24 to 4/26/24. The finding includes: 1. The IIVP states "select 2 previously processed patient samples (preferably a negative and positive sample). Follow the procedure for running samples and the selected samples on both instruments." 2. There was only one previously processed patient sample ran and not two samples as it states for the AU680 IIVP performed on 3 /22/24. 3. The GS confirmed on 4/26/24 at 1:30pm, the laboratory failed to follow the IIVP. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on the lack of Training Records (TR) and interview with the General Supervisor (GS) the Laboratory Director (LD) failed to ensure that all Testing Personnel (TP) received the appropriate training for the type and complexity of the services offered from 1/15/24 to 4/23/24. The findings include: 1. Two out of two TP listed on the CMS 209 form failed to have training records for using the Beckman Coulter AU680 analyzers. 2. The GS confirmed on 4/23/24 at 1:35 pm, the LD failed -- 2 of 3 -- to ensure TP had appropriate training for the type and complexity of the services offered. -- 3 of 3 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the Patient Work Records (PWR) and interview with the General Supervisor (GS), the laboratory failed to documenting all analytic systems activities for Toxicology and Routine Chemistry from 7/11/19 to the date of the survey. The finding includes: 1. From a random sample of five patients PWR 3 out of 5 did not have Quality flag, Sample post dilution/concentration, or Analysis flag headings. 2. The GS confirmed on 10/20/22 at 11:40 am the laboratory failed to documenting all analytic systems activities. 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 surveyor review of the laboratory records, Procedure Manual (PM) and interview with the General Supervisor (GS) the laboratory failed to establish a written 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 -- maintenance procedure for the Horiba ABX Pentra 400 from 7/11/19 to the date of the survey. The GS confirmed on 10/20/22 at 11:30 am that the laboratory did not establish a written maintenance procedure. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of the Horiba ABX Pentra 400 Analyzers Reagent Manufacturers Package Insert (MPI) and interview with the General Supervisors (GS), the laboratory failed to follow the MPI for Specimen Stability from 7/11/19 to the date of survey. The findings include: 1) The MPI for reagent DRI Barbiturate Assay states in "Specimen Collection and Handling"specimens "may be placed into a secure refrigeration unit at 2-8C for up to 7 days. For longer storage prior to analysis or for sample retention after analysis, urine specimens may be stored at -20C." 2) GS stated "specimens are received on ice packs" 3) Patient # 10630 Acc# 17319 collected on 10/6/22 was received by the laboratory 10/18/22. 4) Patient # 10630 Acc# 17319 was run and reported 10/18/22 five days after its stability date. 5) The GS confirmed on 10/20/22 at 12:30 pm the MPI was not followed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor review of Manufactures Package Inserts, observation of the Quality Control material, and interview with the General Supervisor (GS), the laboratory failed to put expiration dates on MAS Drugs Of Abuse Total Control material run on the Horiba ABX Pentra 400 on the date of survey. The GS confirmed on 10/20/22 at 12:00 pm the laboratory failed to put expiration dates on the control material. D5781

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to retain all PT records performed with the American Proficiency Institute for event 2 of 2018. The TP confirmed on 7/11/19 at 10:00 am that the laboratory failed to retain all PT records. 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 surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow the "General Policies for Quality Control" (QC) procedure for urine drug screening tests from 8/24/17 to the date of the survey. The finding includes: 1. The PM stated "new QC will be validated prior to use" but there was no documented evidence new lots of QC were run before using. 2. The TP confirmed 7/11/19 at 10:30 am that the laboratory did not follow the PM. b. Based on surveyor review of the PM and interview with the TP, the laboratory failed to follow the "