Sobel Family Medicine

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of calibration verification documentation for testing performed on the i- Stat analyzer and the Beckman Coulter DXH 520 analyzer and interview with the facility personnel, the laboratory failed to perform and document calibration verification procedures as required. Findings include: 1. The laboratory performs Chem8+ testing on the i-Stat analyzer under the specialty of Chemistry, and performs Complete Blood Count (CBC) testing on the Beckman Coulter DXH 520 analyzer 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 -- under the specialty of Hematology. The laboratory's approximate annual test volume for each specialty is 25,000. 2. No documentation was presented for review to indicate the laboratory performed a calibration verification on the i-Stat analyzer at least once every six months during 2021 and 2022, including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results. 3. Calibration verification documentation reviewed during the survey conducted on 4/26/2023 for the i-Stat analyzer indicated the lab performed a calibration verification on 7/01/2020, with the next calibration verification performed on 10/05/2022. 4. No documentation was presented for review to indicate the laboratory performed a calibration verification on the DXH 520 analyzer at least once every six months during 2022, including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results. 5. Calibration verification documentation reviewed during the survey conducted on 4/26/2023 for the DXH 520 analyzer indicated the lab performed a calibration verification in November 2022, with the previous calibration verification performed in July 2021. 6. The facility personnel interviewed on 4/26/2023 at 2:55pm acknowledged that calibration verification was not performed every 6 months on the I-stat analyzer and the DXH 520 analyzer as required. -- 2 of 2 --

Summary Statement of Deficiencies 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 proficiency testing (PT) records from 2020 and interview with the technical consultant, the laboratory director failed to sign the PT attestation statement. Findings include: 1. The laboratory participates in PT for testing performed in the specialty of Chemistry, with an approximate annual test volume of 1,300. 2. The Chemistry PT attestation statement presented for review for the third event of 2020 lacked the director's signature. 3. The technical consultant confirmed that the PT attestation statement indicated above was not signed by the laboratory director. 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. 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 -- This CONDITION is not met as evidenced by: Based on review of SARS-CoV-2 test results from patient testing and interview with the facility personnel, the Condition: Facility Administration was found to be not met. The laboratory failed to report SARS-CoV-2 (COVID-19) test results to the Arizona State Health Department. Findings include: 1. The laboratory began patient testing using the Healgen Biosys IgG/IgM Covid test (lot# 2006167) on approximately May 20, 2020. The number of patients tested with this COVID-19 test could not be determined at the time of the survey. 2. No evidence was presented for review during the survey conducted on October 8, 2020 to indicate the laboratory reported SARS- CoV-2 (COVID-19) test results from patient testing performed by the laboratory to the Arizona State Health Department. 3. The 'Conditions of Authorization For the Laboratory' listed in the manufacturer's Instructions For Use (IFU) state, "Authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 4. The facility personnel confirmed that the laboratory failed to have a system in place at the time of the survey to report COVID-19 test results to the Arizona State Health Department as required. 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 review of I-stat instrument printouts, I-stat testing process and interview with the facility personnel, the laboratory failed to establish policies and procedures to ensure positive identification of the patient's specimen from the time of collection through completion of testing and reporting of results. Findings include: 1. The laboratory performs patient testing on the I-Stat analyzer in the sub-specialty of Routine Chemistry, with an approximate annual test volume of 1,300. 2. Interview with the facility personnel during the survey revealed that the testing personnel run the patient specimen on the I-Stat and affix a patient label to the instrument printout once testing is complete. The testing personnel perform other duties in the laboratory while the instrument is analyzing the sample. The facility personnel stated that no patient specific information is entered into the I-stat analyzer prior to testing, such as patient name or a unique patient ID which would be indicated on the instrument printout. 3. I-stat test results (instrument printout) were reviewed during the survey for patient# 150558 (test date 10-8-20). The instrument printout for this patient did not have a patient label affixed to it and instead contained the patient's name which was handwritten by testing personnel. 4. No documentation was presented for review during the survey to indicate the laboratory established policies and procedures to maintain positive patient identification on patient specimens throughout the entire testing process for the I-stat analyzer. 5. The facility personnel confirmed that the laboratory did not have established policies and procedures related to the I-stat analyzer to ensure positive patient identification throughout the entire testing process. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 -- 2 of 6 -- 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 the severity and number of deficiencies cited for quality control practices identified during the survey conducted on October 8, 2020, it was determined that the laboratory failed to monitor the overall quality of the analytic systems and correct problems as specified in 493.1289 for COVID-19 testing performed by the laboratory in the specialty of Diagnostic Immunology. See D5441 and D5791 for findings. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of established control procedure documentation and interview with the facility personnel, the laboratory failed to establish, perform and document control procedures for COVID-19 testing performed using the Healgen Biosys IgG/IgM COVID-19 test kit. Findings include: 1. The laboratory began patient testing using the Healgen Biosys IgG/IgM COVID-19 test (lot# 2006167) on approximately May 20, 2020. The number of patients tested using this COVID-19 test could not be determined at the time of the survey. 2. No evidence was presented for review during the survey conducted on October 8, 2020 to indicate the laboratory established control procedures for the Healgen Biosys IgG/IgM COVID-19 test kit. 3. No evidence was presented for review during the survey to indicate the laboratory performed Quality Control (QC) each day of patient testing, from the date the test was initially put into use through the date of the survey. 4. The manufacturer's Instructions For Use (IFU) state, "Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance. Additional controls may be required according to guidelines or local, state, and/or federal regulations (such as 42 CFR 493.1256) or accrediting organizations". 5. The facility personnel confirmed that the laboratory did not have documentation of an approved QC procedure for this test and did not perform QC from the time the test was initially put into use through the date of the survey. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT -- 3 of 6 -- CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA) policies and interview with the technical consultant, the laboratory failed to follow policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the analytic systems. Findings include: 1. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed or identified problems found with the lack of quality control policies, procedures and performance for the Healgen Biosys IgG/IgM COVID-19 test kit. See D5441 for findings. 2. The technical consultant confirmed that the laboratory failed to identify problems found in the analytic systems as indicated above. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on lack of policy for review, review of patient test reports and interview with the technical consultant, the laboratory failed to establish a policy for maintaining patient test reports in an electronic record system. Findings include: 1. The laboratory performs patient testing in the specialties of Diagnostic Immunology, Chemistry and Hematology with an approximate annual test volume of 44,980. The laboratory utilizes an electronic medical record (EMR) system to maintain patient records. During the survey, the technical consultant stated that it was the practice of the laboratory to scan patient test results into the EMR, however some test results were contained within the paper chart, depending on the practice of the ordering provider. 2. Three out of eight patient test results reviewed during the survey (patient# 1132200, # 213137 and #150558) were not scanned into the EMR. 3. On the date of the survey, 10/08/20, no documentation was presented for review to indicate the laboratory had established policies and procedures for accurately and reliably entering patient test results into an electronic system. 4. The technical consultant confirmed that the laboratory failed to have an established policy for accurately and reliably entering patient test results into an electronic system. 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. -- 4 of 6 -- This CONDITION is not met as evidenced by: Based on the number and severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing; Laboratory Director was not met. The laboratory director failed to ensure a quality control program was established to assure the quality of SARS CoV-2 serology testing (see D6020); failed to ensure quality assessment policies and procedures were established and followed for analytic systems and post-analytic systems (see D6021); and failed to 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 (see D6029). D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on lack of Quality Control documentation for review for Covid Antibody testing performed using the Healgen Biosys IgG/IgM COVID-19 test kit, the laboratory director failed to ensure that a quality control program is established and maintained to assure the quality of laboratory services provided. See D5441 for findings. 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. This STANDARD is not met as evidenced by: Based on a lack of quality assessment documentation, the laboratory director failed to ensure that quality assessment programs are maintained to assure the quality of laboratory services provided. See D5791 and D5891 for findings. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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 -- 5 of 6 -- director must-- (e)(11) 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 lack of education credentials and training documentation for testing personnel and interview with the technical consultant, (A) the laboratory director failed to ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience for the type and complexity of services offered and (B) the laboratory director failed to ensure that all testing personnel receive the appropriate training for the testing performed, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. Findings include: A1. No evidence of education credentials was presented for review for one out of one testing personnel who began patient testing on approximately January 16, 2020. A2. The technical consultant confirmed that the laboratory failed to provide a copy of the education credentials for the testing personnel indicated above. B1. No documentation was presented for review to indicate the testing personnel received the appropriate training for the Healgen Biosys IgG/IgM COVID-19 test kit prior to testing patient specimens. B2. The laboratory began using the Healgen Biosys IgG /IgM COVID-19 test kit on approximately 5/20/20. The laboratory listed 7 testing personnel on the CMS-209, Laboratory Personnel Form, however the number of testing personnel who performed COVID-19 testing using this test kit could not be determined at the time of the survey. B3. The technical consultant confirmed that there was no documentation of initial training for personnel who performed testing on the Healgen Biosys IgG/IgM COVID-19 test kit. -- 6 of 6 --

Summary Statement of Deficiencies 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 proficiency testing (PT) records from 2017 for testing performed in the specialty of Hematology and interview with the facility personnel, the laboratory director and the individual testing the samples failed to sign the PT attestation statement. Findings include: 1. The laboratory performs patient testing in the specialty of Hematology, with an approximate annual test volume of 40,000. 2. The PT attestation statement presented for review for the second testing event of 2017 lacked the director's signature and the testing personnel's signature. 3. The facility personnel confirmed that the PT attestation statement indicated above was not signed by the laboratory director and testing personnel. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --