New Mexico Foot & Ankle Institute

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's "Proficiency and Split Sample Policy for Thermo Quant Flex Testing" (PT Procedure); review of the American Proficiency Institute (API) Microbiology proficiency testing (PT) records; lack of documentation; and interview with the Chief Operating Officer (COO), the laboratory failed to have testing personnel (TP) and the laboratory director (LD) attest to the integration of PT samples with routine testing of patient samples during the API Microbiology 2024 3rd Event, 2025 1st event, and 2025 2nd event. Findings include: 1. Review of the PT Procedure indicated the LD and TP are required to sign the attestation form upon completion of proficiency testing. 2. A review of the API Microbiology PT records revealed no attestation forms for API Microbiology 2024 3rd event, 2025 1st event, and 2025 2nd event. 3. The laboratory failed to produce requested attestation forms signed upon completion of testing. 4. Interview with the COO on 8/26/2025 at 10:27 am confirmed the above findings. 5. The laboratory reports 15840 microbiology tests annually. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on February 05, 2024, at New Mexico Foot & Ankle Institue found the laboratory to be in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. 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 review of American Proficiency Institute (API) Proficiency Testing (PT) records and interview with staff, the laboratory failed to have documentation of verifying the accuracy of analytes that were not graded by the proficiency testing program for 2 of 3 Microbiology Events in 2023. Findings included: 1. Review of the 2023 API proficiency testing records revealed the following events with Not Graded performance scores: API 2023 Microbiology 1st Event The following analytes received a performance score of Not Graded: a. Aspergillus fumigatus. Sample NAF- 02 b. Candida tropicalis. Sample UTI-01 c. Resistance Gene CTX-M. Samples UTI- 01, UTI-03, UTI-04 d. Resistance Gene IMP. Samples UTI-01, UTI-03, UTI-04 e. Resistance Gene mecA. Samples UTI-01, UTI-02, UTI-03, UTI-05 f. Resistance Gene NDM. Samples UTI-01, UTI-03, UTI-04 g. Resistance Gene qnrA. Samples UTI-01, UTI-03, UTI-04 h. Resistance Gene vanA/B. Samples UTI-01, UTI-02, UTI-03, UTI- 04, UTI-05 API 2023 Microbiology 2nd Event The following analytes received a performance score of Not Graded: a. Resistance Gene CTX-M. Samples UTI-07, UTI- 09 b. Resistance Gene IMP. Samples UTI-07, UTI-09 c. Resistance Gene mecA. Samples UTI-06, UTI-07, UTI-08, UTI-09, UTI-10 d. Resistance Gene NDM. Samples UTI-07, UTI-09 e. Resistance Gene qnrA. Samples UTI-07, UTI-09 f. 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 -- Resistance Gene vanA/B. Samples UTI-06, UTI-07, UTI-08, UTI-09, UTI-10 2. In an interview on 02/05/2024 at 01:15 pm, the director of laboratory services was asked to provide documentation of verifying the accuracy of the proficiency testing scores that were not graded. No documentation was provided. This confirmed the above findings. Word Key: CTX-M = Class A extended spectrum beta-lactamase enzymes IMP = Imipenemase mecA = mecA resistance gene NDM = New Delhi metallo-beta- lactamase qnrA = qnrA resistance gene vanA/B = vanA/B resistance genes -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following standard deficiences were cited as the results of a recertification survey on 12/20/2022. This facility was found NOT to be in compliance with the CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures for the Quant Studio 12K Flex Real Time PCR System (PCR test system used for testing nail, wound and respiratory samples for fungal or microbial growth), laboratory quality control (QC) records for 2021 and 2022, and confirmed in an interview with the technical supervisor, the laboratory failed to perform a positive and negative external quality control with each day of patient testing for 54 out of 78 batches/runs for 7 of 12 months in 2021 and 35 out of 63 batches/runs for 5 of 11 months in 2022. Findings included: 1. Review of the laboratory's procedure titled "SOP 11 - DNA Based Pathogen Testing", section labeled "Quality Control Logs", stated: "External and internal QC are run each day of testing." Section labeled "External Controls" stated: "Every extraction plate has a No Template Control (NTC), or Negative Control. Negative controls must pass for the extraction plate to be valid. If a negative control fails, the corresponding extraction plate must be re-extracted .... Every amplification plate has a Positive Control, which contains RNA for every target, resulting in a positive amplification for every target. 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 -- The positive control must pass for the amplification on the plate to be valid. If the positive control fails, then only amplification needs to be repeated (assuming the negative controls from the extraction plates are acceptable)." 2. Review of the laboratory's policy "Calibration and Quality Control", signed by the laboratory director on 03/13/2021, under section titled "Routine QC Procedures" stated: "A. Whenever possible, commercially available controls are selected for use in assessing the assays performed in the laboratory. Control values must address both the normal and abnormal range, or positive or negative values for the assay. These control materials are assayed in the same manner as patient samples." ... Section E., titled "Control Frequency" stated: "2. Run appropriate controls with each run associated with testing." 3. Review of the laboratory's quality control logs titled "QC Log - Daily /Weekly, Monthly Reviews" for 7 of 12 months in 2021 and 5 of 11 months in 2022 showed that external quality control was not performed or was missing the Positive control for 54 out of 78 batches/runs in 2021, and 35 out of 63 batches/runs in 2022. A random review of the laboratory's quality control logs, in which the laboratory tested nail samples for fungal growth, for 2021 & 2022 revealed the following: QC log for the month of November 2021 (11-01-21 to 11-30-21) Batch# Date Neg QC Pos QC 498495 11-05-2021 Passed Not performed 507095 11-11-2021 Passed Not performed 507144 11-12-2021 Not performed Not performed 512852 11-17-2021 Passed Not performed 517436 11-19-2021 Passed Not performed 517506 11-19-2021 Not performed Not performed 521480 11-23-2021 Passed Not performed 522081 11- 24-2021 Passed Not performed 523819 11-24-2021 Not performed Not performed QC log for the month of July 2022 (7-18-22 to 7-29-22) Batch Date Neg QC Pos QC 835587 7-22-2022 Passed Not performed 838098 7-25-2022 Passed Not performed 838681 7-26-2022 Passed Not performed 838927 7-26-2022 Passed Not performed 840458 7-27-2022 Passed Not performed 841665 7-28-2022 Not performed Not performed 841938 7-28-2022 Passed Not performed 841555 7-28-2022 Not performed Not performed 842142 7-28-2022 Passed Not performed 843116 7-29- 2022 Passed Not performed 843332 7-29-2022 Passed Not performed 843555 7-29- 2022 Not performed Not performed 4. In an interview on 12/20/2022 at 2:26 pm the technical supervisor confirmed the above findings. Word Key: RNA = Ribonucleic Acid SOP = Standard Operating Procedure PCR = Polymerase Chain Reaction D5781

Summary Statement of Deficiencies D0000 The following deficiency was cited as the result of an initial survey completed on 02 /05/2020 for 42 CFR part 493 Laboratory Requirements. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on interviews with laboratory staff, review of patient records, laboratory policy, application, validation records and quality assessment records, the laboratory failed to verify the accuracy of the TaqMan assay testing performed on the Applied Biosystems QuantStudio 12K at least twice per year. The laboratory reported performing 132,000 tests per year. Findings are: A. Review of the laboratory's application for a CLIA Certificate of Compliance to perform non-waived testing indicated an effective date of 02/01/19. The application was approved and entered into the CLIA database on 03/18 /19. B. Review of 2020 application, 2019 patient test records and validation records indicated the laboratory used Applied Biosystems QuantStudio 12K Flex TaqMan Array Card Platform (a method using genetic material) to detect fungi (22 species) in nail samples and bacteria (22 species) from wounds. Staphylococcus aureus Acremonium strictum Enterococcus faecalis Aspergillus fumigatus Staphylococcus epidermidis Aspergillus niger Streptococcus pyogenes (Group A Aspergillus terreus Streptococcus agalactiae (Group B Strep) Aspergillus versicolor Escherichia coli Candida albicans Bacteroides fragilis Candida krusei Klebsiella pneumoniae Candida glabrata Proteus mirabilis Candida tropicalis Pseudomonas aeruginosa Epidermophyton floccosum Candida albicans Microsporum audouinii Candida glabrata Microsporum gypseum Candida parpsilosis Microsporum nanum Candida dubliniensis Sarcoptes scabiei Candida tropicalis Scopulariopsis brevicaulis C. 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 -- Review of laboratory policy QA0002.V01 Quality Assurance Program, dated 05/28 /2019, indicated: "For those tests which are not covered by an outside proficiency testing program, a system will be established by the department supervisor/manager for verifying the accuracy and reliability of test results at least twice within a twelve month period." D. During interview on 02/05/2020 at 10:22 am, the Technical Supervisor stated: 1. The laboratory had not participated in proficiency yet due to issues with obtaining samples commercially. 2. The laboratory anticipated a start date for the proficiency testing program to be no later than March 2020. 3. The laboratory had performed split sample testing with another laboratory but it was difficult to obtain positive samples for all organisms tested. 4. A written report had not been created for the split sample testing for the current calendar year. E. Review of split sample testing raw data for 01/31/2020 and 02/03/2020 confirmed that the only positive patient samples were for Trichophyton Rubrum (T. rubrum, a species of fungus) and Bacillus atrophaeus (a species of bacteria). -- 2 of 2 --

Summary Statement of Deficiencies D0000 The New Mexico Department of Health completed a complaint survey on 05/06/19 for 42 CFR Part 493, Laboratory Requirements. Complaint Intake #NM00036877 was substantiated. The laboratory was found out of compliance with the following conditions: 42 CFR Part 493.801 Proficiency Testing Enrollment 42 CFR Part 493.1250 Analytic Systems 42 CFR Part 493.1441 Laboratory Director, High Complexity 42 CFR Part 493.1447 Technical Supervisor 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 2019 patient test records, laboratory validation records, application for certification and e-mail, the laboratory failed to enroll in proficiency testing for all tests performed in the laboratory. Findings are: A. Review of the laboratory's application for a CLIA Certificate of Compliance to perform non-waived testing indicated an effective date of 02/01/19. The application was approved and entered into the CLIA database on 03/18/19. B. Review of 2019 patient test records and validation records indicated the laboratory used Applied Biosystems QuantStudio 12K Flex TaqMan Array Card Platform (a method using genetic material) to detect fungi in nail samples. C. Review of available documents revealed no enrollment in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- proficiency testing or a written policy for proficiency testing for 2019. D. During interview on 05/01/19 at 01:13 pm, the Office Manager stated that she was not aware of any proficiency testing enrollment. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on the review of laboratory policies, validation records, and interviews with laboratory staff, the laboratory failed to have approved, written policies for 1) specimen preservation 2) specimen storage 3) conditions for specimen transportation. 5 patients (P1-P5) were reported on 04/22/19. Findings are: A. The laboratory failed to perform and document studies to establish protocols for the use of Copan eSwab transport media with the Applied Biosystems QuantStudio 12K and TaqMan assays. See D5423 1. The following patients were tested and results reported on 04/22/19. P1 Collected on 03/20/19 Received by the laboratory on 03/25/19, 5 days after collection. P2 Collected on 03/22/19 Received by the laboratory on 03/25/19, 3 days after collection. P3 Collected on 03/18/19 Received by the laboratory on 03/25/19, 7 days after collection. P4 Collected on 03/19/19 Received by the laboratory on 03/25/19, 6 days after collection. P5 Collected on 03/20/19 Received by the laboratory on 03/25 /19, 5 days after collection. 2. Review of the patient log revealed that the laboratory received 13 samples from 03/20/19 to 03/27/19 which were used for validation studies. At least 1 one of these patient samples, P1, was reported by the laboratory on 04/22/19. 3. Review of the validation records indicated that the validation studies started on 03/27/19 (7 days after collection of sample P1) and ended on 04/04/19. 3. During interview on 05/01/19 at 12:45 pm, the Office Manager stated that only 8 patients had been reported since the laboratory began testing but provided only 5 test reports for review. She further stated that all other patients were tested and the results held until the laboratory resolved technical issues. B. During a telephone interview on 05/01/19 at 10:31 am, the Technical Supervisor stated that sample transport container studies were done and summarized in the validation. C. Review of the undated "draft" validation summary "Summary Report for 'Nail Fungus' Microbiota TaqMan Assays on the Applied Biosystems QuantStudio 12K Flex Taqman Array Card(TAC) Platform revealed no reference to specimen preservation, storage or transportation requirement studies performed by the laboratory. a. Review of Section 2.2.2, "Specimen Collection, Processing and Storage Requirements" revealed the following: "Specimens will be collected via nail clippings. Sample collection and handling shall be performed per lab procedure, 'Specimen collection, handling, transport and submission'-SOP Reference." b. Section 2.2.3, "Specimen Rejection Criteria." revealed the following: "Laboratory procedures for collection of nail clippings were developed based on vendor-supplied extraction protocols. See laboratory procedure 'Specimen collection, handling, transport and submission'-SOP Reference." D. The laboratory failed to provide a copy of the laboratory's specimen collection and handling policy when it was requested by the surveyor on 05/01/19 at 9:15 am. -- 2 of 9 -- D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, review of temperature records, laboratory policies, validation records, manufacturer instructions, calibration records and interview with laboratory staff, the laboratory failed to meet the Condition of Analytic Systems. 5 (P1-P5) patients were tested then reported on 04/22/19. Findings are: A. The laboratory failed to 1) establish criteria for specimen collection and handling and 2) validate the laboratory information system (LIS). See D5423 B. The laboratory failed to have an approved procedure manual available to testing personnel. See D5407 C. The laboratory failed to establish and follow policies for monitoring temperatures for the refrigerator, freezer and incubator used in the testing process. See D5413 D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on the review of laboratory procedures, email, and interview with the Office Manager, the laboratory failed to have an approved procedure manual available to testing personnel. Findings are: A. Review of the following undated "draft" laboratory policies and procedures revealed no indication that the Laboratory Director had reviewed and approved the test procedures prior to beginning patient testing. 1. DNA Extraction, prepared by the current, temporary Testing Person on 09 Oct 18. 2. Quality Management Program, prepared by the previous laboratory consultant. 3. Laboratory Operations Manual, prepared by the Technical Supervisor in January 2019. The laboratory name was left blank. 4. Analytical Validation Plan for "Nail Fungus." B. During interview on 05/01/19 at 09:56 am, the Office Manager confirmed that the procedures had not been finalized. C. Review of an email sent by the Office Manager on 05/02/19 confirmed the Laboratory Director had not reviewed and approved the procedures prior to patient testing. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in -- 3 of 9 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, review of temperature records, manufacturer instructions, calibration records and interview with laboratory staff, the laboratory failed to establish and follow policies for monitoring temperatures for the refrigerator, freezer and incubator used in the testing process. Findings are: A. Observation of the laboratory on 05/01/19 at 09:19 am revealed that the laboratory did not have a dedicated thermometer to monitor the room temperature. 1. During interview on 05/01 /19 at 9:19 am, the Office Manager confirmed the observation and further stated that the laboratory had not created temperature logs for recording the refrigerator and freezer temperatures. The Office Manager stated that the temperatures were recorded on a sheet of paper. B. Review of the manufacturer instructions for the use of the Applied Biosystems QuantStudio 12K Flex Real-Time instrument indicated: "Calibrate the QuantStudiio 12K Flex Real-Time PCR instrument at the same ambient temperature at which you will run experiments. Extreme variations in ambient temperature can affect the heating and cooling of the QuantStudio 12K Flex Real- Time PCR instrument, and in extreme cases, influence experimental results." C. Review of the calibration and temperature records indicated calibration was performed on 03/07/19 but the room temperature was not documented. D. Review of the manufacturer's instructions for the MagMax Viral Pathogen Ultra Total Nucleic Acid Extraction kit indicated that processed/prepared samples must be tested immediately, within 1-2 days if refrigerated, or frozen if not tested within 2 days. The instructions also indicated that the Enzyme mix must be frozen at -15 to -25 degrees Celsius. E. Review of the available temperature records indicated: 1. Freezer temperatures (the year is not documented on the record nor is the units of measurement) 5 of 10 days were unacceptable for the storage of the Enzyme mix. 04 /15 = -13.0 04/15 = -14.1 04/18 = -13.7 04/19 = -13.6 04/22 = -11.5 2. Refrigerator temperatures were documented 04/10 - 04/22 but there was no acceptable range on the log. 3. Incubator temperatures 04/16 - 04/18 but there was no acceptable range on the log. 4. There was no record of temperature monitoring on 05/01/19, the day of the survey. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on the review of laboratory policies, manufacturer instructions, validation records, and interviews with the laboratory staff, the laboratory failed to 1) establish criteria for specimen collection and handling and 2) validate the laboratory -- 4 of 9 -- information system (LIS). 5 (P1-P5) patients were tested then reported on 04/22/19. Findings are: A. The laboratory failed to establish policies for the specimen collection and handling of fungal specimens using Copan eSwab transport media. 1. Review of manufacturer instructions for the TaqMan reagents indicated "For Research Use Only. Not for use in diagnostic procedures." 2. The laboratory staff could not find a copy of the manufacturer's instructions for the Copan eSwab transport media but an electronic version (49E Rev.05 Date 2014.07) obtained by the surveyor on the Internet revealed: a. "Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory." b. " The use of this product in association with a rapid diagnostic kit or with diagnostic instrumentation should be previously validated by the user." c. There was no reference indicating that the transport media was suitable for the preservation of fungal species. 2. Review of the Ovation (Laboratory Information System) test files and the laboratory's validation records did not identify any studies performed using the laboratory's chosen specimen transport vial, Copan eSwab. 3. During a telephone interview on 05/01/19 at 10:31 am, the Technical Supervisor stated that sample transport container studies were done and summarized in the validation. 4. Review of the "Summary Report for 'Nail Fungus' Microbiota TaqMan Assays on the Applied Biosystems QuantStudio 12K Flex Taqman Array Card (TAC) Platform" a. Section 2.2.2, "Specimen Collection, Processing and Storage Requirements" revealed the following: "Specimens will be collected via nail clippings. Sample collection and handling shall be performed lab procedure, 'Specimen collection, handling, transport and submission'-SOP Reference." b. Section 2.2.3, "Specimen Rejection Criteria." revealed the following: "Laboratory procedures for collection of nail clippings were developed based on vendor-supplied extraction protocols. See laboratory procedure 'Specimen collection, handling, transport and submission'-SOP Reference." 5. Review of the undated "draft" validation summary "Summary Report for 'Nail Fungus' Microbiota TaqMan Assays on the Applied Biosystems QuantStudio 12K Flex Taqman Array Card(TAC) Platform revealed no reference to laboratory performed studies that established criteria for specimen acceptability such as stability over time, use of the transport media, and temperature requirements. 6. During interview on 05 /01/19 at 09:56 am, the Office Manager confirmed that the laboratory had not finalized the summaries and put the laboratory letterhead on the documents. 7. The following patients were reported on 04/22/19. P1 Collected on 03/20/19 Received by the laboratory on 03/25/19, 5 days after collection. P2 Collected on 03/22/19 Received by the laboratory on 03/25/19, 3 days after collection. P3 Collected on 03/18/19 Received by the laboratory on 03/25/19, 7 days after collection. P4 Collected on 03/19 /19 Received by the laboratory on 03/25/19, 6 days after collection. P5 Collected on 03 /20/19 Received by the laboratory on 03/25/19, 5 days after collection. B. The laboratory failed to validate the the Ovation LIS used to analyze and report patient results. 1. Review of test reports for 5 of 5 (P1-P5) patients revealed the reports had the incorrect laboratory name and address. See D5805 2. During interview on 0501/19 at 12:41 pm, the Office Manager stated that she was unaware of any validation studies performed with the LIS and the analyzer. She also stated that she would contact the manufacturer of the LIS for the studies. As of 05/06/19, the Office Manager had not provided documentation of LIS validation studies. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and -- 5 of 9 -- identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on the review of patient test reports and interview with the Office Manager, the laboratory failed to ensure test reports included the name and address of the laboratory and the test methodology used by the laboratory. Findings are: A. Review of patient test reports revealed 5 of 5 (P1-P5) patient reports and a sample printout that had the name, address, laboratory director, and CLIA number of a laboratory located in California. B. During interview on 05/01/19 at 12:41 pm, the Office Manager stated that she had not noticed the error on the reports. She also confirmed that the report printouts were the same as what was available to the providers. C. Review of the same 5 patient reports indicated that a different methodology, Luminex xMAP multiplex technology, was used to perform patient testing. The laboratory used the Applied Biosystems QuantStudio 12K Flex Taqman Array Platform. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of laboratory policies, personnel records, email, test reports, validation records, and interviews with the laboratory staff, the Laboratory Director failed to provide overall management and direction of the laboratory. The laboratory reported performing 8 patients tests in April 2019. Findings are: A. The Laboratory Director failed to ensure that establishment studies and validation procedures were completed prior to patient testing. See D6086 B. The Laboratory Director failed to ensure that the laboratory was enrolled in a CLIA approved proficiency testing program. See D6088 C. The Laboratory Director failed to approve the procedure manual prior to patient testing. See D6106 D. The Laboratory Director failed to ensure that testing personnel had the appropriate education and training prior to patient testing. See D6102 E. The Laboratory Director failed to specify, in writing, the duties and responsibilities for all laboratory personnel. See D6107 D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on the review of laboratory policies, email, test reports, validation records, and -- 6 of 9 -- interviews with the laboratory staff, the laboratory director failed to ensure that establishment studies and validation procedures were completed prior to patient testing. The laboratory reported performing 8 patients tests. Findings are: A. The laboratory failed to establish specimen collection and handling of fungal specimens using Copan eSwab transport media. See D5243 A B. The laboratory failed to validate the laboratory information system (LIS). See S5243 B and D5805 D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on the review of laboratory policies, and email from the Office Manager, the Laboratory Director failed to ensure that the laboratory was enrolled in a CLIA approved proficiency testing program. Findings are: A. Reveiw of the laboratory's policies revealed no policy or record of enrollment in proficiency testing for fungal testing. See D2000 B. Review of an email dated 05/08/19 from the Office Manager confirmed the laboratory did not have an approved proficiency testing policy. 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 interviews with laboratory staff, the Laboratory Director failed to ensure that testing personnel had the appropriate education and training prior to patient testing. Findings are: A. During interview on 05/01/19 at 09:50 am, the Office Manager stated that she did not have a copy of a diploma or transcript for the current, temporary testing person. The Testing Person showed the surveyor a copy of his Bachelor of Science degree earned in 2015 as a file on his cell phone. B. During interview on 05/01/19 at 09:45 am, the Testing Person stated that he did not get any training at this laboratory other than with the Laboratory Information System. He also stated that he had previous experience with similar instrumentation. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on the review of laboratory procedures, email, and interview with the Office Manager, the Laboratory Director failed to approve the procedure manual prior to -- 7 of 9 -- patient testing. Findings are: Review of the following undated "draft" laboratory policies and procedures revealed no indication that the Laboratory Director had reviewed and approved the test procedures prior to beginning patient testing. 1. DNA Extraction, prepared by the current, temporary Testing Person on 09 Oct 18. 2. Quality Management Program, prepared by the previous laboratory consultant. 3. Laboratory Operations Manual, prepared by the Technical Supervisor in January 2019. The laboratory name was left blank. 4. Analytical Validation Plan for "Nail Fungus." See D5407 D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on the review of personnel records and email from the Office Manager, the Laboratory Director failed to specify, in writing, the duties and responsibilities for all laboratory personnel. Findings are: A. The laboratory did not have job descriptions available for all staff on 05/01/19, the day of the survey. B. The Office Manager provided a copy of the Medical Laboratory Technologist job description on the afternoon of 05/01/19 but it was not dated or signed by the laboratory director. C. The Office Manager sent job descriptions for the General Supervisor, Laboratory Technologist, and Technical Supervisor via email on 05/06/19 at 02/25 pm but they were not signed by the Laboratory Director. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on the review of laboratory policies, laboratory policies, email, test reports, validation records, and interviews with the laboratory staff, the Technical Supervisor failed to provide technical oversight of the laboratory. Findings are: A. The Technical Supervisor failed to ensure that the laboratory was enrolled in a CLIA approved proficiency testing program. See D6116 B. The Technical Supervisor failed to ensure that all establishment and validation studies were completed prior to patient testing. See D6115 D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures -- 8 of 9 -- performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on the review of laboratory policies, email, test reports, validation records, and interviews with the laboratory staff, the Technical Supervisor failed to ensure that all establishment and validation studies were completed prior to patient testing. The laboratory reported testing 8 patients in April 2019. Findings are: The Technical Supervisor failed to ensure that establishment studies and validation procedures were completed prior to patient testing. A. The laboratory failed to establish specimen collection and handling of fungal specimens using Copan eSwab transport media. See D5243 A B. The laboratory failed to validate the laboratory information system (LIS). See S5243 B and D5805 D6116 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(3) The technical supervisor is responsible for 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 the review of laboratory policies, and email from the Office Manager, the Technical Supervisor failed to ensure that the laboratory was enrolled in a CLIA approved proficiency testing program. Findings are: A. Review of the undated "draft" laboratory's policies revealed no policy or record of enrollment in proficiency testing for fungal testing. See D2000 B. Review of an email dated 05/08/19 from the Office Manager indicated the laboratory did not currently have an approved proficiency testing policy. -- 9 of 9 --