First Priority Lab

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 03/16/2026. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: D2000 - 42 C. F.R. 493.801 Condition: Enrollment and testing of [proficiency testing] samples; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; 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 review of laboratory's submitted Form CMS-116 and test menu, test records, proficiency testing records and staff interview, the laboratory failed to enroll in an HHS approved proficiency testing (PT) program for two of two microbiology subspecialties tested by the laboratory, bacteriology and mycology. Findings included: 1. Review of laboratory's submitted Form CMS-116 and corresponding test menu revealed the laboratory performed testing in microbiology - subspecialties in bacteriology and mycology - with laboratory developed tests using polymerase chain reaction (PCR) to identify microorganisms and determine antimicrobial resistance. 2. Review of laboratory's test records revealed the laboratory started testing patient samples on 10/31/2025 and tested approximately 1500 patient samples from 10/31 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- /2025 through 03/16/2026. 3. The surveyor attempted to review laboratory's proficiency testing records and found there were no such records available for review. Surveyor asked for proficiency testing enrollment documentation, and none was provided. 4. In an interview on 03/16/2026 at 1015 hours in the laboratory, the technical supervisor (as indicated on submitted Form CMS-209) stated that the laboratory has not yet enrolled in a PT program, confirming the findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory's submitted "Laboratory Personnel Report (CLIA)" Form CMS-209, personnel records, policies/procedures and staff interview, the laboratory failed to ensure competency assessment was documented for one of one of the laboratory's technical/general supervisors. Findings included: 1. Review of laboratory's submitted Form CMS-209 revealed the laboratory employed one technical supervisor who also held the position of general supervisor. 2. Review of laboratory's personnel records revealed the technical supervisor/general supervisor (as indicated on submitted Form CMS-209) did not have documentation of competency assessment for these positions. 3. Review of laboratory's policies/procedures revealed the laboratory did not have written protocols in place addressing the specific requirements for competency assessments of technical supervisor or general supervisor. 4. In an interview on 03/16/2026 at 0950 hours in the laboratory, the facility's technical supervisor confirmed the findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A. Based on review of laboratory's test menu, manufacturer's instructions, test establishment studies, policies/procedures, laboratory's quality control records, patient test records and staff interview, the laboratory failed to ensure positive control results are acceptable prior to reporting patient results for one of five reviewed instances where positive control results were unacceptable for the "NOVA UTI (urinary tract infection)/Wound w (with) ABX (antimicrobial resistance) Pathogens Panel" targets. Findings included: 1. Review of laboratory's submitted test menu revealed the laboratory used the NOVA UTI RT (real time) PCR (polymerase chain reaction) Panel for detection of urinary tract infection pathogens and determination of antimicrobial resistance. 2. Review of the manufacturer's instructions for the "NOVA UTI /Wound w ABX Pathogens Panel" (document: UTI Check IFU 11.6.23, Reference NP9603) revealed: "Interpretation of Quality Control Note: The below conditions must be met at the same time, otherwise this experiment is invalid and needs to be repeated. Assessment of sample test results should be performed after the -- 2 of 8 -- positive and negative controls have been determined to be valid. If controls are not valid the patient results cannot be interpreted" 3. Review of laboratory's test establishment studies for the NOVA UTI RT PCR Panel (effective: 10/27/2025) revealed: "Quality Control External Control (Positive Control): Serves as an amplification control intended for the detection of all 18 targets in the UTI panel. The positive control results should show an exponential curve in the designated dye channel for each UTI targets being profiled." 4. Review of laboratory's policy "UTI Pathogen Panel" (document: MOL.1002 Effective Date: 10/15/2025) revealed: "Positive and Negative Test Controls should be added to every experiment plate." 5. Review of random laboratory's quality control records revealed positive control (PTC) results were unacceptable for the following NOVA UTI RT PCR Panel's targets: On 12/18/2025 run 1: PTC Target: Result: Pass/fail: van A UNDETERMINED Failed van B UNDETERMINED Failed blaKPC UNDETERMINED Failed Note: Van A and van B are resistance genes for vancomycin in Enterococci, blaKPC is a gene determining resistance to carbapenems, cephalosporins, penicillins and monobactam drugs in Enterobacteriaceae. 6. Review of random patient original test data and final reports for 12/18/2025 run 1 revealed the laboratory issued following patient reports without an acceptable positive control for van A, van B and blaKPC targets, thus without being able to verify no false negative reports were issued: Accession: 2512100002 Organism detected: K. oxytoca Semi quantitative interpretation: Severe infection Resistance target result: blaKPC - UNDETERMINED Reported resistance result: blaKPC: NEG (Negative) Accession: 2512100005 Organism detected: Enterococcus spp Semi quantitative interpretation: Severe infection Resistance target result: van A - UNDETERMINED van B - UNDETERMINED Reported resistance result: Van-A: NEG Van-B: NEG Accession: 2512100008 Organism detected: C. koseri, E. coli, Enterococcus spp. Semi quantitative interpretation: Moderate infection Resistance target result: blaKPC - UNDETERMINED van A - UNDETERMINED van B - UNDETERMINED Reported resistance result: Van-A: NEG Van-B: NEG blaKPC: NEG Accession: 2512100019 Organism detected: E. coli Semi quantitative interpretation: Severe infection Resistance target result: blaKPC - UNDETERMINED Reported resistance result: blaKPC: NEG Accession: 2512100023 Organism detected: E. coli Semi quantitative interpretation: Moderate infection Resistance target result: blaKPC - UNDETERMINED Reported resistance result: blaKPC: NEG Accession: 2512100025 Organism detected: E. coli Semi quantitative interpretation: Moderate infection Resistance target result: blaKPC - UNDETERMINED Reported resistance result: blaKPC: NEG Accession: 2512100036 Organism detected: Enterococcus spp Semi quantitative interpretation: Severe infection Resistance target result: van A - UNDETERMINED van B - UNDETERMINED Reported resistance result: Van-A: NEG Van-B: NEG Accession: 2512100039 Organism detected: Enterococcus spp Semi quantitative interpretation: Severe infection Resistance target result: van A - UNDETERMINED van B - UNDETERMINED Reported resistance result: Van-A: NEG Van-B: NEG And, Organism detected: E. coli Semi quantitative interpretation: Moderate infection Resistance target result: blaKPC - UNDETERMINED Reported resistance result: blaKPC: NEG 7. In an interview on 03/16/2026 at 1150 hours in the laboratory, the technical supervisor (as indicated on submitted Form CMS-209) confirmed the findings. B. Based on review of laboratory's test menu, manufacturer's instructions, test establishment studies, policies/procedures, laboratory's quality control records, patient test records and staff interview, the laboratory failed to ensure positive control results are acceptable prior to reporting patient results for four of four reviewed instances where positive control results were unacceptable for the "NOVA Fungal Pathogens Panel" targets. Findings included: 1. Review of laboratory's submitted test menu revealed the laboratory used the NOVA Fungal Pathogens Panel for detection of fungal nail infection pathogens. 2. Review of the manufacturer's -- 3 of 8 -- instructions for the "NOVA Fungal Pathogens Panel" (document and/or reference number unavailable) revealed: "Interpretation of Quality Control Note: The below conditions must be met at the same time, otherwise this experiment is invalid and needs to be repeated. o Assessment of sample test results should be performed after the positive and negative controls have been determined to be valid. If controls are not valid the patient results cannot be interpreted" 3. Review of laboratory's test establishment studies for the NOVA Fungal Pathogens Panel (effective: 10/27/2025) revealed: "5. QUALITY CONTROL (QC) MATERIAL 5.1. External Control (Positive Control): Serves as an amplification control intended for the detection of all 17 targets in the Nail fungus panel. The positive control results should show an exponential curve in the designated dye channel for each Nail fungus target being profiled." 4. Review of laboratory's policy "Fungal Pathogen Panel" (document: MOL. 1001 Effective Date: 10/15/2025) revealed: "NOTE: Positive and negative control must be added to all experiments." 5. Review of random laboratory's quality control records for Fungal Pathogen Panel's PCR targets revealed positive control (PTC) results were unacceptable as follows: On 11/25/2025: PTCTarget: Result: Pass/fail: Malassezia UNDETERMINED Failed On 12/03/2025: PTC Target: Result: Pass/fail: Malassezia UNDETERMINED Failed On 12/12/2025: PTC Target: Result: Pass/fail: Malassezia UNDETERMINED Failed On 12/19/2025: PTC Target: Result: Pass/fail: Malassezia UNDETERMINED Failed 6. Review of random patient reports from 11/25 /2025 and 12/03/2025 revealed the laboratory issued following patient reports without acceptable positive control for Malassezia, thus without being able to verify no false negative reports were issued: Accession: 2511200029 Tested: 11/25/2025 Malassezia Target result: Undetermined Reported Result for Malassezia: NEG (Negative) Accession: 2511200089 Tested: 12/03/2025 Malassezia Target result: Undetermined Reported Result for Malassezia: NEG Accession: 2511200105 Tested: 12/03/2025 Malassezia Target result: Undetermined Reported Result for Malassezia: NEG Accession: 2511200107 Tested: 12/03/2025 Malassezia Target result: Undetermined Reported Result for Malassezia: NEG 7. In an interview on 03/16/2026 at 1230 hours in the laboratory, the technical supervisor (as indicated on submitted Form CMS-209) confirmed the findings. D5783