Forum Medical Clinics, Pc

Summary Statement of Deficiencies 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 record review and interview with the Technical Consultant, the laboratory failed to follow its policy to ensure optimum integrity of patient Complete Blood Count (CBC) specimens prior to testing for 7 (Patients 2, 17, 47, 99, 67, 38, and 34) of 13 patient test reports reviewed. Findings include: 1. A review of the laboratory's "Medonic M Series Hematology Analyzer Procedure Manual" revealed a section titled "Specimen Requirements/Patient Preparation" stating, "For optimum results, the sample should be gently mixed for 10-15 minutes on a mixer, and should be analyzed between 15 minutes and 6 hours stored at room temperature. Failure to mix properly or count in the required time limit may produce erroneous results" 2. A review of 13 patient CBC test reports revealed the following patients had CBC testing performed beyond 6 hours from the collection date and time: a. Patient #2 had their specimen collected on 3/10/22 at 10:20 am and their CBC performed on 3/11/22 at 2:04 pm. b. Patient #17 had their specimen collected on 4/6/22 at 3:24 pm and their CBC performed on 4/7/22 at 10:46 am. c. Patient #47 had their specimen collected on 7/11 /22 at 9:47 am and their CBC performed on 7/12/22 at 11:27 am. d. Patient #99 had their specimen collected on 8/9/22 at 3:40 pm and their CBC performed on 8/10/22 at 11:51 am. e. Patient #67 had their specimen collected on 9/20/22 at 11:36 am and their CBC performed on 9/21/22 at 10:18 am. f. Patient #38 had their specimen collected on 11/7/22 at 8:54 am and their CBC performed on 11/8/22 at 11:20 am. g. Patient #34 had their specimen collected on 12/5/22 at 9:51 am and their CBC performed on 12/6/22 at 11:25 am. 3. An interview on 1/5/23 at 11:49 am with 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 2 -- Technical Consultant confirmed the patients listed above had been tested beyond the established optimum stability of patient specimens. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to follow its policy to assess competency for its urine qualitative toxicology testing for 1 (Testing Personnel #1) of 1 testing personnel performing testing. Findings include: 1. A review of the laboratory's personnel competency records revealed a lack of competency assessment for Testing Personnel #1 for the performance of urine qualitative toxicology testing using the Medica EasyRA analyzer. 2. A review of the laboratory's "Employee Evaluations" policy revealed a section stating, "All new lab employees will have a competency evaluation after their initial training, at the 6 month interval and every year thereafter." 3. An interview on 1 /5/23 at 12:12 pm with the Technical Consultant revealed the laboratory started testing using the Medica EasyRA test system in January 2022 and competency assessments for Testing Personnel #1 had not been performed according to the laboratory's policy. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Technical Consultant, the laboratory failed to establish maintenance protocols for mechanical pipettes and a centrifuge for 2 (December 2020 to December 2022) of 2 years reviewed. Findings include: 1. A tour of the laboratory on 1/5/23 at 11:01 am revealed two mechanical Thermo Scientific Finnpipette pipettes used in reagent preparation and a Druker Diagnostics centrifuge used in specimen preparation. 2. The surveyor requested maintenance documentation for the mechanical pipettes and centrifuge on 1/5/23 at 11: 16 am and it was not made available. 3. An interview on 1/5/23 at 1:01 pm with the Technical Consultant revealed the laboratory had not established procedures for maintaining mechanical pipettes and the centrifuge. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the chemistry analyte iron. Findings include: The laboratory failed to attain a score of at least 80% of acceptable responses for the chemistry analyte iron, which is unsatisfactory performance. Refer to D2087. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the chemistry analyte iron, which is unsatisfactory performance for 2 (2022 1st and 2nd events) of 2 testing events in 2022. Findings include: PT Event Iron Score 1st event 2022 60% 2nd event 2022 60% -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: urea nitrogen (BUN). Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for 2 of 3 proficiency testing events. Refer to 2096 *** Repeat Deficiency from 11/07/2018 survey*** D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 3 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte: urea nitrogen (BUN) in 2 of 3 consecutive testing events. Findings include: Unsatisfactory performance for 2 of 3 consecutive proficiency testing events constitutes unsuccessful performance for urea nitrogen (BUN). BUN) PT event Score 1st event 2021 40% 3rd event 2021 60% ***Repeat Deficiency from 11/07/2018 survey *** 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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the Laboratory Director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: 1. The Laboratory Director failed to ensure the laboratory successfully participated in a proficiency testing program as required under Subpart H. 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; This STANDARD is not met as evidenced by: . Based on record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the Laboratory Director failed to ensure the laboratory successfully participated in a proficiency testing program as required under Subpart H, resulting in subsequent unsuccessful performance for 2 (1st and 3rd events of 2021) out of 3 consecutive testing events. Findings include: 1. A record review of the CMS database and API proficiency testing reports revealed subsequent unsatisfactory performance for 2 out of 3 consecutive testing events for the chemistry analyte urea nitrogen (BUN): BUN PT Event Score 1st event 2021 40% 3rd event -- 2 of 3 -- 2021 60% 2. A record review of the CMS database revealed initial unsuccessful proficiency testing performance for the chemistry analyte urea nitrogen (BUN): BUN PT event Score 2nd event 2018 60% 3rd event 2018 0% -- 3 of 3 --

Summary Statement of Deficiencies 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: . The laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to verify the performance specifications. Refer to D5421. 2. The laboratory failed to document sample test reactions as part of the verification of performance specifications for the Healgen COVID-19 IgG/IgM Rapid Test Cassette. Refer to D5427. 3. The laboratory failed to determine if calibration verification procedures performed met the laboratory's acceptable limits. Refer to D5439 A. 4. The laboratory failed to perform calibration verification procedures at least once every 6 months for Total Iron Binding Capacity testing. Refer to D5439 B. ***This is a repeated Condition from the 6/3/19 recertification survey*** D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) 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 -- Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to verify the performance specifications for 2 (Testosterone and Prostate Specific Antigen) of 8 assays on the laboratory's Beckman Access II instrument. Findings include: 1. A review of the laboratory's "Test Check List" revealed Testosterone and Prostate Specific Antigen (PSA) were listed as part of the laboratory's test menu. 2. An interview on 7/8/21 at 1:04 pm with TC1 confirmed the Testosterone and PSA assays were added to the test menu since the previous survey. 3. The surveyor requested the laboratory's verification of performance specification data for the Testosterone and PSA assays at 1:04 pm on 7/8/21 and it was not made available. 4. A review of the laboratory's patient testing logs revealed a total of 45 patient testing dates between 1/8/21 and 7/1/21 with 14 patients tested with the Testosterone assay and 69 patients tested with the PSA assay. 5. An interview on 7/8 /21 at 2:00 pm with TC1 confirmed the laboratory did not verify the performance specifications compared to the manufacturer for the Testosterone and PSA assays. ***This is a repeated deficiency from the 12/19/16 recertification survey*** D5427 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(c) (c) Documentation. The laboratory must document all activities specified in this section. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to document sample test reactions as part of the verification of performance specifications for the Healgen COVID-19 IgG/IgM Rapid Test Cassette for 20 of 20 samples tested. Findings include: 1. A review of the laboratory's "Results of Verification Study" revealed the laboratory tested 10 known positive samples and 10 known negative samples and did not document the reactions from each sample cassette tested. 2. A review of the laboratory's "New Method Validation Policy" revealed it did not include a policy for documenting sample test reactions as part of the verification of performance specifications. 3. An interview on 7/8/21 at 9:39 am with TC1 confirmed the laboratory did not document sample test reactions for the verification of performance specifications for the Healgen COVID-19 IgG/IgM Rapid Test Cassette. 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 -- 2 of 3 -- 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: . A. Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to determine if calibration verification procedures performed met the laboratory's acceptable limits for 2 (11/29/19 event and 6/25/20 event) of 4 calibration verification events. Findings include: 1. A review of the laboratory's calibration verification documentation revealed the following analytes listed on the laboratory's test menu did not have calibration verification evaluated to determine if the results were within acceptable limits: a. 11/29/19 calibration verification testing event i. Uric Acid ii. Alanine Aminotransferase (ALT) b. 6/25/20 calibration verification testing event i. Carbon Dioxide (CO2) ii. Blood Urea Nitrogen (BUN) iii. Aspartate Transaminase (AST) 2. The surveyor requested the calibration verification evaluations for the the analytes listed above on 7/8/21 at 11:18 am and they were not made available. 3. A review of the laboratory's "Calibration Verification" policy revealed a section stating, "The calibration verification will be monitored on the monthly QA Review sheet." and did not specify the laboratory's acceptable limits for calibration verification. 4. An interview on 7/8/21 at 11:33 am with TC1 confirmed the laboratory did not ensure calibration verification procedures for the analytes listed above were within acceptable limits. B. Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to perform calibration verification procedures at least once every 6 months for Total Iron Binding Capacity testing for 2 (July 2019 to June 2021) of 2 years. Findings include: 1. A review of the laboratory's calibration verification documentation revealed a lack of records showing the performance of calibration verification procedures for Total Iron Binding Capacity (TIBC) testing at least every 6 months in 2019 and 2020. Below is the list of dates when calibration verification was performed for other chemistry analytes, but not TIBC: a. 11/29/19 b. 6/25/20 c. 12/29/20 2. A review of the laboratory's "Calibration Verification" procedure revealed a section stating, "Calibration verification will be performed every six months. Calibration verification will be performed on all analytes that have less than a three point calibrator." 3. An interview on 7/8/21 at 11:23 am with TC1 revealed the TIBC assay uses two calibrators and calibration verification for the assay had not been performed at least every 6 months. *** This is a repeated deficiency from the 6/3/19 recertification survey*** -- 3 of 3 --

Summary Statement of Deficiencies 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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: sodium (NA). Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for 3 of 4 proficiency testing events. Refer to 2096 ***Repeat Deficiency from 8/11/20 and 4/2/19 surveys*** D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte: sodium (NA) in 3 of 4 consecutive testing events. Findings include: Unsatisfactory performance for 3 of 4 consecutive proficiency testing events constitutes unsuccessful performance for sodium (NA). Records show this is a subsequent unsuccessful performance for sodium (NA). Sodium (NA) PT event Score 1st event 2021 60% 2nd event 2020 60% 1st event 2020 60% ***Repeat Deficiency from 8/11/20 and 4/2/19 surveys*** 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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the Laboratory Director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: 1. The Laboratory Director failed to ensure the laboratory successfully participated in a proficiency testing program as required under Subpart H. 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; This STANDARD is not met as evidenced by: . Based on record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the Laboratory Director failed to ensure the laboratory successfully participated in a proficiency testing program as required under Subpart H, resulting in subsequent unsuccessful performance for 3 (1st and 2nd event 2020 and 1st event 2021) of 4 consecutive testing events. Findings include: 1. A record review of the CMS database and API proficiency testing reports revealed subsequent unsatisfactory performance for 3 out of 4 consecutive testing events for the chemistry analyte sodium: Sodium PT Event Score 1st event 2021 60% 2nd event 2020 60% 1st event 2020 60% -- 2 of 2 --

Summary Statement of Deficiencies 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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the specialty of chemistry analyte sodium. Findings include: Review of the CMS database and the API proficiency testing reports revealed the laboratory failed to achieve satisfactory performance for the specialty of chemistry analyte sodium. Refer to D2096. This is a repeat deficiency from 4/2/2019. D2096 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte sodium in 2 (1st event of 2020 and 2nd event of 2020) of 2 consecutive testing events. Findings include: 1. A review of the CMS database and the API proficiency testing reports revealed the laboratory had unsatisfactory performance for 2 of 2 consecutive proficiency testing events constituting unsuccessful performance for the chemistry analyte sodium: Sodium PT Event Score 1st event 2020 60% 2nd event 2020 60% This is a repeat deficiency from 4/2/2019. 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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the Laboratory Director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: 1. The Laboratory Director failed to ensure the laboratory successfully participated in a proficiency testing program as required under Subpart H. 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; This STANDARD is not met as evidenced by: . Based on record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the Laboratory Director failed to ensure the laboratory successfully participated in a proficiency testing program as required under Subpart H, resulting in subsequent unsuccessful performance for 2 (1st event of 2020 and 2nd event of 2020) out of 2 consecutive testing events. Findings include: 1. A record review of the CMS database and API proficiency testing reports revealed subsequent unsatisfactory performance for 2 out of 2 consecutive testing events for the chemistry analyte sodium: Sodium PT Event Score 1st event 2020 60% 2nd event -- 2 of 3 -- 2020 60% 2. A record review of the CMS database revealed initial unsuccessful proficiency testing performance for the chemistry analyte sodium: Sodium PT event Score 3rd event 2018 60% 1st event 2019 60% -- 3 of 3 --

Summary Statement of Deficiencies 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 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 record review and interview with the Technical Consultant (TC), the laboratory failed to correctly report a test results for 1 (#5) of 10 patient charts audited. Findings include: 1. Record review for 1 of 10 patient charts audited revealed the folate result tested on 10/17/19 did not correlate with the instrument printout. 2. The instrument print out showed a result of 22.40 with the flag OVR (above highest calibration value). The final lab report did not show the result to be >22.40. 3. During the interview on 11/20/19 at 2:30 pm, the TC acknowledged the final report failed to include the (>) greater than sign before the numerical value. 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 --

Summary Statement of Deficiencies 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 review of the CMS database, review of the American Proficiency Institute (API) and American Association of Bioanalysts (AAB) final proficiency testing reports, the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte Chloride. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on CMS database proficiency testing (PT) desk review and the laboratory's graded PT results from American Proficiency Institute (API) and the American Association of Bioanalysts (AAB), the laboratory failed to achieve successful performance for the analyte, Chloride, in two of three consecutive testing events. Findings include: Chloride Event Score 2nd event 2019 60% 3rd event 2018 40% -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with the Technical Consultant (TC), the laboratory failed to retain 1) the chemistry instrument maintenance logs and 2) the chemistry, endocrinology, and immunology quality control records for 2 (May 2017 to May 2019) of 2 years reviewed. Findings include: 1. Record review of the monthly maintenance logs revealed lack of documentation as follows: a. "Mindray BS-200 Maintenance Log" - no June, July, and August 1st-17th 2017 b. Beckman Coulter Access 2 maintenance log - no June and July 2017 2. Record review of the chemistry, endocrinology, and immunology quality control records revealed lack of documentation for the daily quality control for the following patient audits as follows: a. August 3-4, 2017 Patient 8966 - no lipid ("CHOL, TRIG, HDL, and LDL") controls b. October 27, 2017 Patient 9763 - no "CMP" and Vitamin D controls c. December 13, 2017 Patient 5147 - "CMP" and "hs-CRP" controls d. February 14, 2018 Patient 5522 - "Cystatin-C" controls e. May 15, 2018 Patient 6312 - "Cystatin-C" controls 3. During the interview on June 3, 2019 at 12:00 pm, 12:47 pm, and 2:50 pm, the TC acknowledged the maintenance logs and quality control records were not retained for two years. ***Repeat Deficiency from 12/19/16 survey*** D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing 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 -- performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with the Technical Consultant (TC), the laboratory failed to review, evaluate, and provide

Summary Statement of Deficiencies 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 review of the CMS database and review of the American Proficiency Institute (API) and American Association of Bioanalysts (AAB) final graded proficiency testing reports, the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte sodium. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) desk review and the laboratory's graded PT results from American Proficiency Institute (API) and the American Association of Bioanalysts (AAB), the laboratory failed to achieve successful performance for the analyte, Sodium, in two consecutive testing events. Findings include: Sodium Event Score 1st event 2019 60% 3rd event 2018 60% -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the CMS database and review of the American Association of Bioanalysts (AAB) graded proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analytes: uric acid, glucose, and urea nitrogen (BUN). Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory chemistry performance for the following analytes: two of two events for uric acid, two of three events for glucose, and three of four events for BUN. Refer to D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the following chemistry analytes: uric acid in two of two consecutive testing events, glucose in two of three consecutive events, and urea nitrogen (BUN) in three of four consecutive events. Findings include: Unsatisfactory performance for two of two and two of three consecutive proficiency testing events constitutes unsuccessful performance for uric acid and glucose. Unsatisfactory performance for three of four consecutive proficiency testing events constitutes subsequent unsuccessful performance for BUN: uric acid PT event Score 3rd event 2018 0% 2nd event 2018 60% glucose PT event Score 3rd event 2018 40% 1st event 2018 60% BUN PT event Score 3rd event 2018 0% 2nd event 2018 60% 3rd event 2017 60% -- 2 of 2 --