Cash Clinical Of Carson City

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on May 21, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 a review of the laboratory's proficiency testing (PT) records and an interview with the laboratory manager, the laboratory director failed to attest to the routine integration of the PT samples into the patient workload using the laboratory's routine methods. Findings include: 1. A review of the American Proficiency Institute (API) PT attestation forms from the second PT events of 2022 through the first PT events of 2024 found that the director and staff failed to sign the attestation forms for the second and third hematology/coagulation PT events of 2022 and 2023. 2. A review of the API PT attestation forms from the second PT events of 2022 through the first PT events of 2024 found that the director failed to sign the attestation forms for the third chemistry core PT event of 2023, as well as the first hematology/coagulation and chemistry core PT events of 2024. 3. An interview with the laboratory manager on May 21, 2024 at approximately 4:00 PM confirmed these findings. This is a repeat deficiency previously cited at the CLIA recertification survey conducted on February 13, 2018. The laboratory performs approximately 36,500 hematology and chemistry tests per year. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiency cited herein, the Condition: [Facility Administration] record retention was not met. The laboratory failed to retain documentation of quality controls for the chemistry tests performed on the Dimension EXL for the required minimum of two years. Refer to D3031 The laboratory performs approximately 29,500 chemistry tests annually. 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 a review of quality control (QC) records from June 2022 through May 2024, and an interview with laboratory manager, the laboratory failed to retain the quality control records for the Siemens Dimension EXL, chemistry analyzer for the required two years. Findings include: 1. A review of quality control results for the Dimension EXL chemistry analyzer, revealed that the laboratory did not retain the QC records for the following analytes: direct bilirubin (DBI), triglycerides (TGL), calcium, hemoglobin A1C, low density lipoprotein (LDL), total protein (TP) and albumin (ALB) prior to May 2023. 2. A review of quality control results for the Dimension EXL chemistry analyzer, revealed that the laboratory did not retain the QC records for the following analytes: alanine transaminase (ALT), cholesterol (CHOL), creatinine, and glucose prior to June 2023. 3. A review of quality control results for the Dimension EXL chemistry analyzer, revealed that the laboratory did not retain the QC records for the following analytes: alkaline phosphatase (AlpI), carbon dioxide (CO2), aspartate transferase (AST), high density lipoprotein (HDL), sodium, potassium, and chloride prior to July 2023. 4. A review of quality control results for the Dimension EXL chemistry analyzer, revealed that the laboratory did not retain the QC records for the following analytes: blood urea nitrogen (BUN) and total bilirubin (TBI) prior to September 2023. 5. An interview with the laboratory manager during the on-site inspection on May 21, 2024 at approximately 11:30 AM confirmed that the laboratory could not locate the printed QC records and could not retrieve the QC records on the chemistry analyzer.The laboratory manager stated that the records had been purged -- 2 of 10 -- from the analyzer's computer. This is a repeat deficiency previously cited at the CLIA recertification performed on February 11, 2020. The laboratory performs approximately 29,500 chemistry tests annually. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedures, a random review of the monthly reports that have been reviewed for accuracy by the laboratory between July 2022 and April 2024, and an interview with the laboratory manager, the laboratory failed to maintain accurate specimen identification throughout the pre-analytical, analytical, and post-analytical stages of testing. Findings include: 1. The laboratory procedure titled, "Procedure for Random Review of Reports", stated that each report will be reviewed to ensure the patient demographics are accurate. 2. A random review of eighteen reports that had been reviewed by the laboratory for accuracy between July 2022 and April 2024 found that the laboratory failed to ensure that the name for patient 44681 was consistent and correct throughout the process. The report for patient number 44681 reviewed by the laboratory in April 2023 contained the following inconsistencies: a. The patient's first name on the review coversheet did not match the doctor's orders or the patient's receipt. b. The patient's last name on the review coversheet did not match the doctor's orders. c. The patient's last name on the doctor's orders did not match the last name on the final report. d. A copy of the patient's driver's license showed the correct name. 3. An interview with the laboratory manager on May 21, 2024 at approximately 4:00 PM confirmed these findings. The laboratory performs approximately 36,500 hematology and chemistry tests annually. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on a random review of eleven patient test requisitions between June 2022 through March 2024, a review of laboratory procedures, and an interview with the laboratory manager, the laboratory failed to obtain provider authorization prior to patient testing. Findings include: 1. A random audit of eleven patient test requisitions between June 2022 through March 2024 revealed that there was no provider authorization on the Self Ordered Test Requisition for patient number 26072 on October 13, 2022. There was a note on the patient receipt stating "Dr. in Mexico." 2. One of eleven patient requisitions reviewed revealed that there was no provider authorization on the Test Requisition completed by Cash Clinical for patient number 11971 on May 26, 2023. There is an ordering physicians name documented, but there is no provider signature or external requisition with provider authorization. 3. One of eleven patient requisitions reviewed revealed that there was no provider authorization -- 3 of 10 -- on the Test Requisition for patient number 42844 on March 15, 2024. There is no ordering physician's name or signature documented. No external requisition with provider authorization could be provided by the laboratory. 4. The laboratory policy titled "Ordering of Tests" states that patient ordered tests must also be ordered by a physician contracted by the laboratory. It also states that a laboratory Test Order Request Form must be completed for all self ordered testing. This form includes a space for the physician's name and signature. 5. The laboratory policy titled Ordering of Tests states that the laboratory must perform tests only at the written request of an authorized person. 6. An interview with the laboratory manager on May 21, 2024 at approximately 4:00 PM confirmed these findings. The laboratory performs approximately 36,500 hematology and chemistry tests annually. 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 laboratory's policies and procedures, and an interview with the office manager, the laboratory director failed to ensure that all policies reflected the current testing instrumentation. Findings include: 1. A review of the laboratory's Quality Control procedure found that on page 2,

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 4/26/2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5303 TEST REQUEST CFR(s): 493.1241(b) The laboratory may accept oral requests for laboratory tests if it solicits a written or electronic authorization within 30 days of the oral request and maintains the authorization or documentation of its efforts to obtain the authorization. This STANDARD is not met as evidenced by: Based on review of laboratory procedure, "Ordering of Tests," review of the laboratory requisition forms randomly selected from May 2020 through March 2022 included in the monthly quality assessment internal audit, and interview with the laboratory assistant on duty on the day of the survey, the laboratory failed to obtain a written or electronic request for tests ordered verbally on 8/09/2020 for patient with initials, SG, Date of Birth 3/19/1980. Findings include: 1. Laboratory procedure, "Ordering of Tests," states, "c. The name of the person who called the verbal order is documented on the Laboratory Request Form. d. The physician/physician's office must send a fax with the verbal order and the fax must be signed." 2. The laboratory requisition form dated 8/9/20, reviewed for patient with initials, SG, Date of Birth 3/19 /1980, noted that the doctor called to add on Complete Blood Count, Lipid, urinalysis, and uric acid. The laboratory was unable to locate during the on-site survey, the faxed, written or electronic request for the tests added on verbally. 3. The laboratory assistant on duty interviewed during the on-site survey on 4/26/2022 at approximately 1:30 PM was not clear on what steps to take for verbal orders, confirmed that the faxed order 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 -- was not filed together with the original requisition form, and indicated that the faxed requisition may be stored in an off-site location. The laboratory performs approximately 29,500 chemistry and 7,000 hematology tests annually. 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 review of laboratory procedure, "Validation Testing (Parallel Testing) Correlation between Instruments or Methods," review of verification studies performed for new test, hemoglobin A1c, on the Dimension Expand, and interview with the laboratory manager, the laboratory personnel failed to follow the director approved, written procedure. Findings include: 1. Laboratory procedure, "Validation Testing (Parallel Testing) Correlation between Instruments or Methods," states, "If a new test is done in house, at least 10 patient samples will be run in house and will also be sent to a reference laboratory and a statistical comparison of the results obtained in house and at the reference laboratory will be done. . . No analyte result on patient sample will be released by Cash Clinical until validation has been satisfactorily completed." 2. Method validation records for hemoglobin A1c on the Dimension Expand performed in December 2020 did not have correlation studies performed for ten patient samples tested in house and at a reference laboratory. 3. The laboratory manager interviewed during the on-site survey on 4/2/2022 at approximately 2:00 PM confirmed the findings. The laboratory performs approximately 29,500 chemistry tests annually. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and interview with the laboratory manager, the technical consultant failed to ensure that competency evaluations were conducted annually for testing personnel performing moderate complexity testing after the first year. Findings include: 1. Review of laboratory personnel records revealed that one of two testing personnel employed for more than one year performing moderate complexity testing did not have competency evaluations performed in 2020 and 2021. 2. The laboratory manager interviewed during the on- site survey on 4/26/2022 at approximately 2:30 PM indicated that the documentation could not be located. The laboratory performs approximately 29,500 chemistry and 7,000 hematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 2/11/2020. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 review of quality control records and interview with laboratory personnel, the laboratory failed to retain the quality control records for the Beckman Coulter ACT 5 Diff, hematology analyzer, for January 2019. Findings include: 1. Review of quality control results for the ACT 5 Diff, hematology analyzer, for January and February 2019, revealed that the laboratory did not retain the QC records for January 2019. 2. Laboratory personnel #1 interviewed during the on-site inspection on 2/11 /2020 at approximately 4:00 PM could not locate the printed QC records and could not retrieve the QC records on the hematology analyzer. The laboratory performs approximately 6,300 hematology tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the ACT 5 Diff CP Maintenance Check List, Dimension Expand Daily, Weekly/Monthly Maintenance logs, and the Dimension Xpand Quiklyte Results, and interview with laboratory personnel, the laboratory failed to ensure equipment maintenance was performed as required. Findings include: 1. Review of the ACT 5 Diff CP Maintenance Check List for January-February 2019 revealed that there were no daily maintenance records on January 21, 22, 28, and 29 and February 4, 5, 6, 18, 20, and 26, 2019 for the hematology analyzer. 2. Review of the Dimension Expand Daily and Weekly/Monthly Maintenance logs from March to July 2019 revealed that: a. there were no daily maintenance records on June 20, 21, 25, 26, 27, 28 and July 1, 3, 5, 17, 25, 26, and 31, 2019; b. there were no weekly maintenance records on 3/25-29, 4/01-05, 4/22-26, 4/29-5/03, 6/17-28, 7/01-05, and 7/22-26/2019; and c. there were no monthly maintenance records for June and July 2019 for the chemistry analyzer. 3. Review of the Dimension Xpand Quiklyte Results from 7/07 /2019 to 1/27/2020 revealed that no dilution check was documented on 9/19/2019. Laboratory personnel #1 interviewed during the on-site survey on 2/11/2020 at approximately 3:45 PM confirmed the findings. The laboratory performs approximately 6,300 hematology and 28,020 chemistry tests annually. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of corrected patient reports, review of Siemens Dimension Expand chemistry analyzer result printouts, and interview with laboratory personnel #1, the laboratory failed to ensure that test results are accurately and reliably sent from the point of data entry to the final report destination. Findings include: 1. Review of corrected patient reports from 4/02/2018 to 4/04/2018 and the Dimension Expand instrument printouts revealed that four of four reports contained chemistry test results on the final patient report that did not match the results on the instrument printouts. a. Accession #34045 tested on 4/02/2018 on the Dimension Expand reported a glucose result of 86 on the instrument printout and the patient report had a result of 66 mg/dL. b. Accession #34055 tested on 4/02/2018 on the Dimension Expand reported a glucose result of 86 on the instrument printout and the patient report had a result of 46 mg/dL. c. Accession #34064 tested on 4/02/2018 on the Dimension Expand reported a Calcium result of 9.3 and a Creatinine of 1.11 on the instrument printout and the patient report had a Calcium result of 9.0 and a Creatinine of 3.00 mg/dL. d. Accession #34092 tested on 4/04/2018 on the Dimension Expand reported a Triglyceride result of 59 on the instrument printout and the patient report had a result of 49 mg/dL. 2. Laboratory personnel #1 interviewed during the on-site survey on 2/11 -- 2 of 5 -- /2020 at approximately 5:00 PM stated that the Dimension Expand is interfaced with the LabDaq laboratory information system (LIS) for the test results to transfer directly to the patient reports. She was unable to explain the discrepancies in the test results from the instrument print out with the patient reports. The laboratory performs approximately 28,020 chemistry tests annually. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on review of corrected patient reports, review of Siemens Dimension Expand chemistry analyzer result printouts, and interview with laboratory personnel #1, the laboratory failed to ensure that corrected reports are issued promptly to the authorized person ordering the test. Findings include: 1. Review of corrected patient reports from samples reported on 4/03/2018 to 4/05/2018 and the Dimension Expand instrument printouts revealed that four of four patient reports did not contain the corrected results. a. The corrected report packet for #34045 did not contain a corrected report for that accession number. The comment, "Corrective results for glucose reported on 4/19/18. FJC PT notified via post card 4/19/18 LSC," was added to accession #34179 instead of accession #34045 which contained the incorrect glucose result. Both accession numbers are from the Sample Patient ID #23658 but collected on different days. #34045 was collected on 3/31/18 and #34179 collected on 4/12/2018 . b. The original patient report for accession #34055 from 4/03/2018 reported a glucose of 46 mg/dL. The corrected report issued on 4/19/2018 reported the same result instead of 86 mg/dL which is on the instrument printout. c. The original patient report for accession #34064 from 4/05/2018 reported a calcium of 9.0 and a creatinine of 3.00 mg/dL. The corrected report issued on 4/19/2018 reported the same calcium and creatinine results instead of 9.3 and 1.11, respectively, which are on the instrument printout. d. The original patient report for accession #34092 from 4/05/2018 reported triglycerides of 49.0 mg/dL. The corrected report issued on 4/19/2018 reported the same result instead of 59 mg/dL which is on the instrument printout. 2. Laboratory personnel #1 interviewed during the on-site inspection on 2/11/2020 at approximately 5:00 PM confirmed that the corrected reports did not contain the correct results for the tests reported in error. The laboratory performs approximately 28,020 chemistry tests annually. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on review of corrected patient reports, equipment maintenance records, review of equipment service records, and the quarterly quality assurance review for the first quarter of 2019, the laboratory director failed to ensure that the established quality assessment (QA) program was maintained to assure the quality of laboratory services provided. Findings include: 1. The QA program failed to identify and provide documented

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review, conducted off-site for your laboratory on 10/08/19. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 desk review of federal database CASPER Report 155D and American Proficiency Institute (API) proficiency testing (PT) evaluation forms on 10/08/19, the 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 -- laboratory did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two out of three testing events for the third testing event of 2018 with a score of 0% and the second testing event of 2019 with a score of 60% resulted in unsuccessful proficiency testing performance for platelet counts. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for platelet counts in the third testing event of 2018 and the second testing event of 2019. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of federal database CASPER Report 155D and API PT evaluation forms on 10/08/19, the laboratory did not successfully participate in a proficiency testing program. Findings include: 1. The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for platelet counts in the third testing event of 2018 and the second testing event of 2019. 2. CASPER Report 155D and the API PT evaluation both reported a score of 0% for the third testing event of 2018 and a score of 60% for the second testing event of 2019. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of federal database CASPER Report 155D and API PT evaluation forms on 10/08/19, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory Director was not met. The laboratory director failed to provide overall management and direction in accordance with CFR 493.1407. Findings include: The laboratory director failed to ensure that the laboratory successfully participated in a PT program approved by CMS; as described in subpart 1 of this part for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on desk review of federal database CASPER Report 155D and API PT evaluation forms on 10/08/19, the laboratory director failed to ensure that proficiency testing samples were tested as required. Findings include: 1. The laboratory failed to achieve satisfactory performance for platelet counts in the third testing event of 2018 and the second testing event of 2019 resulting in unsuccessful PT performance. 2. CASPER Report 155D and the API PT evaluation forms reviewed reported a score of 0% for the third testing event of 2018 and a score of 60% for the second testing event of 2019 for platelet counts. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 2/13/18. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 American Proficiency Institute's (API) proficiency testing (PT) documentation and interview with the laboratory supervisor, the testing personnel and the laboratory director failed to attest to the routine integration of the PT samples into the patient workload using the laboratory's routine methods. Findings include: A review of the API PT attestation forms from 2016 and 2017 revealed the PT attestation statement forms were not signed by both the laboratory director and testing personnel certifying that PT samples were tested in the same manner as patient specimens for the first and second chemistry events of 2017 and the first hematology event of 2017. The PT attestation forms were not signed by the testing personnel for the third chemistry event of 2017 and the second hematology event of 2017. The laboratory supervisor confirmed the finding during the on-site survey on 2/13/18 at approximately 10:15 AM. The laboratory performs approximately 26,560 chemistry and 6000 hematology tests annually. D2010 TESTING OF PROFICIENCY TESTING SAMPLES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's PT documentation and interview with the laboratory supervisor, the laboratory did not test PT samples the same number of times that it routinely tests patient samples. Findings include: A review of the laboratory test reports for the hematology PT samples tested on the Beckman ACT 5 Diff hematology analyzer for the second event of 2017 revealed that Sample PNT-07 was tested four times over a two week span before a complete report was generated. The five PT samples were first tested by personnel #1 on 7/12/17. Sample PNT-07 had no differential results for neutrophils and eosinophils and there was no test report indicating a repeat test for sample PNT-07 on the same day. The laboratory supervisor indicated during the on-site inspection on 2/13/18 at approximately 10:30 AM that patient samples were tested once and may be repeated once for abnormal results after the initial results were reviewed. All five samples were tested again on 7/13/17 by personnel #2 with no indication why all samples were retested. There were no differential results for neutrophils and eosinophils for samples PNT-07 and PNT-08 with this run. Sample PNT-07 was tested twice on 7/26/17 before a complete differential result was reported by the ACT 5 Diff analyzer. The results from the second repeat on 7/26/17 were submitted to API for evaluation of PT. The laboratory performs approximately 6000 hematology tests annually. D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on review of the Dimension XPand Plus Procedure Manual, review of the API PT evaluations, and interview with the laboratory supervisor, the procedure for Free Thyroxine and Total PSA which were discontinued in the first quarter of 2016 did not have the date of discontinuance. Findings include: A review of the API PT evaluations revealed that the laboratory had discontinued testing for free thyroxine and free PSA for the first PT event of 2016. The XPand Plus Procedure Manual contained the procedures for free thyroxine and free PSA and these procedures did not have the date of discontinuance. The laboratory supervisor confirmed during the on- site survey on 2/13/18 at approximately 12:00 PM that these two tests were discontinued. The laboratory performs approximately 800 endocrinology tests annually. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on review of the Wright Giemsa Stain QC log and interview with the laboratory supervisor, the laboratory used expired solution 3 to stain blood smears. Findings include: The Wright Giemsa QC log listed the lot numbers and expiration dates of the reagents used to stain blood smears for manual review. Solution 3, lot #1700913, was recorded with an expiration date of 1/12/18. Quality control slides were stained using the expired solution on 1/19/18 to 2/06/18. The laboratory supervisor stated during the on-site inspection on 2/13/18 at approximately 2:00 PM that quality control slides were stained when patient blood smears were stained and new stains were on order. The office manager indicated that a more recent shipment of solution 3 with a longer expiration date was received and found the stain under the sink. This bottle of solution 3 had an expiration date of 6/15/18. However, the testing personnel failed to recognize the expiration date on the QC log and continued using the solution without any investigation and