Cigna Healthspring Livingwell Center

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 proficiency testing (PT) record review and interview with testing personnel (TP), the laboratory failed to ensure that the laboratory director (LD) signed PT attestation statements, attesting that PT specimens were run in the same way as patient samples. Findings: 1. A review of hematology and chemistry PT records from 2022 showed that the LD did not sign the attestation statements for 2 out of 2 events in hematology and 2 out of 3 events in chemistry. 2. During an interview on 10/17/2022 at 2:00 PM, TP #1 confirmed that the attestation statements were not signed by the LD. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on quality control (QC) record review and interview with testing personnel (TP), the laboratory did not ensure that State and Federal requirements were followed when performing QC on the i-STAT handheld blood analyzer. Findings: 1. The laboratory performs chemistry and hematology testing on 2 i-STAT blood analyzers, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- labeled as "India" (serial #330942) and "Hotel" (serial #330621) 5 days a week. The laboratory performs testing using cartridges for brain natriuretic peptide (BNP), cardiac troponin I (cTnI), CHEM8+ (Sodium, Potassium, Chloride, TCO2, Ionized Calcium, Glucose, Urea Nitrogen/Urea Creatinine, and Hematocrit), and PT/INR (prothrombin time/international normalized ratio). 2. A review of QC records for the i- STAT analyzer between January and October 2022 showed that QC for these tests was run weekly from 01/07/2022 through 05/13/2022. There was a 2 week gap between running QC from 06/03/2022 to 06/17/2022; 06/30/2022 to 07/08/2022; and 08/19/2022 to 09/02/2022. There was a 3 week gap between running QC from 09/02 /2022 to 09/21/2022 and 09/21/2022 to 10/10/2022. 3. Code of Maryland Regulations- COMAR 10.10.06 Medical Laboratories-Quality Assurance, .06 Quality Control - Single-Use Test Devices, B. Standards, (6) Quality Control Tests, (a) Quantitative Test Systems states, "A licensee shall ensure that quality control testing for a quantitative test system is performed and documented using at least two levels of control material before patient testing" "At least weekly for each lot of a single-use test device used for patient testing." 4. During an interview on 10/17/2022 at 2:00 PM, TP #1 confirmed that the laboratory was not in compliance with the State requirements to run QC at least weekly when performing patient testing. 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 laboratory record review and interview with testing personnel (TP), the laboratory failed to retain all analytic systems records for at least 2 years. Findings: 1. A review of quality control (QC) records from 12/3/2021 through 10/10/2022 for the i- STAT handheld blood analyzer showed that there were no instrument printouts for QC present at the time of the survey. 2. A review of calibration records from 2020 to 2022 showed that there were no instrument printouts for calibrations run on the i- STAT present at the time of the survey. 3. During an interview on 10/17/2022 at 9:40 AM, TP #1 stated that they copy the QC and calibration information on to a separate form and do not print out and save the results. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with testing personnel (TP), the laboratory did not ensure that a copy of all PT documents was maintained by the laboratory for a minimum of two years from the date of the PT testing event. Findings: 1. A review of PT records from 2022 showed that PT results and scores from the PT provider were not available at the time of the survey for 2 out of 2 events in hematology and 3 out of 3 events in chemistry. 2. During an interview on 10/17 /2022 at 11:40 AM, TP #1 confirmed that the laboratory did not maintain all PT documents for a minimum of two years from the date of the PT testing event. -- 2 of 8 -- 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 calibration record review and interview with testing personnel (TP), the laboratory failed to perform and document calibration verification procedures for the i- STAT handheld blood analyzer at least once every 6 months. Findings: 1. The laboratory performs chemistry and hematology testing on 2 i-STAT blood analyzers, labeled as "India" (serial #330942) and "Hotel" (serial #330621). The laboratory performs testing using cartridges for brain natriuretic peptide (BNP), cardiac troponin I (cTnI), CHEM8+ (Sodium, Potassium, Chloride, TCO2, Ionized Calcium, Glucose, Urea Nitrogen/Urea Creatinine, and Hematocrit), and PT/INR (prothrombin time /international normalized ratio). 2. A review of calibration records from 2020 to 2022 showed that testing personnel hand-wrote the calibration results for BNP, cTnI, and CHEM8+ on a "Calibration Verification" sheet. No calibration reference sheets or instrument printouts were available at the time of the survey and there was no way to confirm that the calibration verification was successful. 3. "Calibration Verification" sheets were reviewed for 2/2020 (cTnI, BNP); 9/2020 (cTnI, BNP, CHEM8+); 5/2021 (cTnI, BNP, CHEM8+); 11/2021 (BNP, CHEM8+); 6/2022 (cTnI, CHEM8+); and 7 /2022 (BNP). There was 1 "Calibration Verification" sheet for each cartridge for each date of testing for the 2 analyzers. During an interview at 11:20 AM on the day of the survey, TP #1 stated that they would run the BNP calibration on 1 i-STAT and cTnI on the second i-STAT because the test "takes so long." 4. The "Calibration Verification" sheets were not labeled with the name of the i-STAT analyzer which was calibrated. There was no way to identify which test cartridge had been calibrated on which analyzer. TP #1 confirmed that each test had not been calibrated on each i- STAT analyzer although both i-STAT analyzers are used to perform all the tests available. 5. Record review showed that there were no "Calibration Verification" sheets for PT/INR. TP #1 stated at 11:20 AM that calibrations were not performed on the i-STAT for the test PT/INR. 6. During an interview on 10/17/2022 at 2:00 PM, TP -- 3 of 8 -- #1 confirmed that the laboratory failed to perform and document calibration verification procedures for each i-STAT handheld blood analyzer least once every 6 months. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) record review and interview with testing personnel (TP), the laboratory did not run 2 levels of QC each day of patient testing and failed to establish an Individualized Quality Control Plan (IQCP) for performing testing on the i-STAT handheld blood analyzer. Findings: 1. The laboratory performs chemistry and hematology testing on 2 i-STAT blood analyzers, labeled as "India" (serial #330942) and "Hotel" (serial #330621) 5 days a week. QC record review from January through October 2022 showed that the laboratory failed to run 2 levels of QC each day of patient testing. Refer to D3009 for details. 2. During an interview on 10/17/2022 at 9: 40 AM, TP #1 stated that the laboratory did not have an IQCP in place to reduce the amount of QC required when performing testing on the i-STAT and confirmed that the laboratory failed to run 2 levels of QC each day of patient testing on each analyzer. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on procedure manual and record review and interview with testing personnel (TP), the laboratory failed to evaluate and define the relationship between test results using different instruments twice a year, and to document all test result comparison activities. Findings: 1. The laboratory performs chemistry and hematology testing on 2 i-STAT blood analyzers, labeled as "India" (serial #330942) and "Hotel" (serial #330621). See D3009 for details. 2. Procedure manual review showed that the laboratory had no written policy for performing and evaluating the correlations between the two analyzers twice a year; and 3. The procedure should include, but is not limited to: the details of whom the samples will be exchanged with, how often split samples will be tested, what the acceptable limits of the comparison are, and remedial actions to be taken when the results are not within acceptable limits. 4. -- 4 of 8 -- Record review showed that there was no documentation that test result comparisons had been performed between the 2 analyzers. This was confirmed by TP #1 during an interview on 10/17/2022 at 10:10 AM. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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 review of the written procedure manual, interview with the laboratory director (LD), and the testing person, the laboratory director did not perform and maintain quality assessment (QA) procedures for performing coagulation procedures. Findings: 1. The LD director did not document QA during the year 2017 up to the time of the survey. 2. The laboratory QA procedures states that the laboratory will monitor laboratory functions and processes for patient test management, quality control procedures, proficiency testing, patient information/test results, personnel assessments, communications, complaint investigations, QA review of staff, and QA of laboratory records. 3. The LD confirmed that QA reviews for the QA program and monitoring indicators were not performed and documented as reviewed. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the written procedure manual, interview with the laboratory director, and the testing person, the laboratory director (LD) acting as the technical consultant (TC) did not perform annual competency procedures for laboratory personnel performing coagulation testing. Findings: 1. The LD acting as the TC did not perform annual competency procedures during the year 2017. 2. The laboratory quality assurance procedures states that laboratory staff will have ongoing training, monitoring, and competency procedures to maintain performance. 3. The TC did not utilize training procedures and checklists that were stored in the laboratory procedure manual. 4. The TC stated that he was unaware that such procedures and checklists were available 5. The TC confirmed that annual competency procedures were not performed. . -- 2 of 2 --