Lamonda Internal Medicine

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 the lack of assay information for toxicology testing and interview with the technical consultant, the laboratory failed to retain manufacturer's assay information at least two years for four of four calibration materials and two of two quality control materials. Findings: 1. The laboratory did not have manufacturer's assay information available for the following calibration materials in use: a.) calibration material # 1, lot 9A528UL-J1 b.) calibration material #2, lot 9A548UL-J1 c.) calibration material #3, lot 9A568UL-J1 d.) calibration material #4, lot 9A588UL-J1 2. The laboratory did not have manufacturer's assay information available for the following control materials in use: a.) control material (bottle #0) lot 9A508UL-J2 b.) control material (bottle#5) lot 9A608UL-J2 3. Interview with the technical consultant on February 20, 2018 at 10:45 AM confirmed the laboratory failed to retain the manufacturer's assay information for at least two years. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of two of two patient test reports, three of three 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 -- (PT) records for 2017 and interview with testing personnel #1, the laboratory failed to verify the accuracy of urine creatinine testing twice annually for 2017. Findings: 1. Review of two patient test reports showed the laboratory reports a quantitative urine creatinine result. 2. Review of three PT records showed the laboratory verified accuracy for one PT sample for urine creatinine for first event of 2017. PT documentation showed the urine creatinine test was not included on the second or third testing event of 2017. The laboratory did not have documentation to show it verified the accuracy at least twice during 2017 3. Interview with testing personnel #1 on February 20, 2018 at 10:45 AM confirmed, the laboratory reports a quantitative urine creatinine result on patient test reports. Interview confirmed the laboratory did not verify the accuracy of the unregulated analyte at least twice annually. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of manufacturer's instructions, observation of quality control (QC) and calibration processes, observation of reagents and interview with testing personnel #1 and the technical consultant, the laboratory failed to follow manufacturer's instructions for reagent storage (refer to #D5411); failed to define criteria for proper storage of reagents consistent with the manufacturer's instructions (refer to #D5413); failed to ensure QC and calibration materials did not exceed their expiration date (refer to #D5417); failed to verify acceptable limits of calibration materials (refer to #D5437) and failed to verify acceptability of QC materials (refer to #D5469). D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, observation of the toxicology instrument containing five of five onboard reagents, observation of five of five boxes of reagents stored in the laboratory refrigerator and interview with testing personnel # 1, the laboratory failed to follow manufacturer's instructions for handling reagents during 2017 and to date 2018. Findings: 1. The manufacturer's assay instructions state, "when not in use reagents must be stored at 2 to 8 degrees Celsius (C) ( 36-46 degrees Fahrenheit (F). Improper storage of reagents can affect assay performance." 2. Observation of the toxicology instrument revealed five onboard refrigerated reagents on a reagent carousel. Laboratory personnel could not display a numerical temperature -- 2 of 6 -- reading on the instrument for the refrigerated carousel containing onboard reagents. No documentation was available to show the onboard refrigerated carousel met temperature requirements. Observation of the laboratory refrigerator showed five boxes of reagent. No documentation was available to show the laboratory monitored or documented the temperature of the refrigerator. 3. Interview with testing personnel # 1 on February 20, 2018 at 10:45 AM confirmed, the laboratory did not follow instructions for proper storage of reagents. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, lack of documentation and interview with testing personnel #1, the laboratory failed to define criteria consistent with manufacturers instructions for reagent storage for 2017 and to date 2018. Findings: 1. The manufacturer's instructions state, "when not in use reagents must be stored at 2 to 8 degrees (C) 36-46 degrees (F) 2. No documentation was available to show the laboratory defined criteria consistent with the manufacturer's instructions for refrigerated reagent storage. No documentation was available to show the laboratory monitored and documented temperature of the laboratory refrigerator used to store reagents. 3. Interview with testing personnel #1 on February 20, 2018 at 10:45 AM confirmed the laboratory failed to define criteria consistent with manufacturer's instructions for refrigerated reagent storage and document those conditions. 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. This STANDARD is not met as evidenced by: Based on observation of six of six control/calibration material on February 20, 2018 and interview with technical consultant, the laboratory failed to ensure control and calibration material did not exceed their expiration date. Findings: 1. The following calibration material expired and available for use: a.) calibration material # 1, lot 9A528UL-J1 expired March 11, 2017 b.) calibration material #2, lot 9A548UL-J1 expired December 11, 2016 c.) calibration material #3, lot 9A568UL-J1 expired December 18, 2016 d.) calibration material #4, lot 9A588UL-J1 expired December 18, 2016 2. The following control material expired and available for use: a.) control material #0 lot 9A508UL-J2 expired April 22, 2017 b.) control material #5 lot -- 3 of 6 -- 9A608UL-J2 expired January 29, 2017 3. Interview with the technical consultant on February 20, 2018 at 10:45 AM confirmed the laboratory used expired calibration and control materials when testing patient specimens during 2017 and to date 2018. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration records and interview with testing personnel #1 on February 20, 2017 at 10:45 AM confirmed, the laboratory failed to have documentation/ manufacturer's assay information to verify acceptable limits for four of four calibration materials in use. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and interview with testing personnel # 1 on February 20, 2018 at 10:45 AM confirmed, the laboratory failed to have documentation/manufacturer's assay information to verify acceptability for two of two control materials in use. 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 -- 4 of 6 -- with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the quality control and quality assessment programs and interview with the technical consultant, the laboratory director failed to provide overall management and direction; failed to ensure testing personnel performed the test methods as required for accurate and reliable results (refer to #D6014) and failed to establish and maintain the quality control and quality assessment programs and identify failures as they occur (refer to #D6022). D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of toxicology testing procedures and interview with the technical consultant, the laboratory director failed to ensure testing personnel perform toxicology testing as required for accurate and reliable results during 2017 and to date 2018. Findings: 1. Review of toxicology testing procedures revealed testing personnel used expired calibration and control materials, failed to retain assay information required to verify acceptablility of the calibration and control material and failed to store reagents per manufacturer's instructions. 2. Interview with the technical consultant on February 20, 2018 at 10:45 AM confirmed the laboratory director failed to ensure testing personnel perform and report quality patient results. D6022 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 and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the quality control (QC) program, QC and calibration material in use for testing in 2017 and to date 2018, lack of a cohesive quality assessment (QA) program , patient records and interview with the technical consultant, the laboratory director failed to maintain the QC and QA programs. Findings: 1. Review of the QC program revealed the laboratory must monitor control procedures, acceptable QC ranges, expiration dates and ensure that appropriate QC and calibration materials are used for testing and QC / calibration materials are stored properly. 2. Review of QC and calibration material showed the laboratory failed to detect expired material in use -- 5 of 6 -- during 2017 and to date 2018, failed to retain assay information required to verify acceptability of QC and calibration material and failed to store the material at 2 to 8 degrees per manufacturer's instructions. 3. The laboratory did not have a written cohesive QA program to detect/ identify failures in quality as they occur. 4. The laboratory performs 3,750 patient toxicology tests annually. 5. Interview with the technical consultant on February 20, 2018 at 10:45 AM confirmed, the laboratory director failed to establish and maintain QC and QA programs to assure quality of laboratory services. -- 6 of 6 --