O L Matthews Md

Summary Statement of Deficiencies 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 operator's manual review, record review, and interview with the technical consultant (TC), the laboratory failed to follow manufacturer's instructions for the instrument flag for five (#1602, #1606, #1610, #1611, and #1613) of 14 patient samples run on February 16, 2019. Findings include: 1. Record review of patient testing performed revealed the flag "SS" for five of 14 patient samples run on February 16, 2019. The operator's manual states "SS: The assay was cancelled because of insufficient sample. If this flag appears when there is an enough sample, either the sample nozzle or the sample detection sensor may be faulty. If this problem occurs frequently, contact the service department." a. #1602 - thyroid stimulating hormone (TSH), tape reported "SS" error, resulted out on final report as 0.0 b. #1606 - prostate specific antigen (PSA), tape reported 1.31 ng/ml with the error "Sample Shortage Detected", resulted 1.31 ng/ml on the final report c. #1610 - PSA tape reported "SS" error, resulted out on final report as 0.0 d. #1611 - PSA tape reported "SS" error, resulted out on final report as 0.0 e. #1613 - TSH tape reported "SS" error, resulted out on final report as 0.0 2. On March 2, 2019 at approximately 11:45 AM when queried, the TC stated there was no documentation that specimens were rerun prior to reporting. 3. During the interview on March 2, 2019 at approximately 11:45 AM, the TC confirmed the above findings. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(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 3 -- 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 record review and interview with the technical consultant (TC), the laboratory failed to perform the chemistry calibration curve for the thyroid stimulating hormone (TSH) testing for one (January 12, 2019) of five days of patient testing reviewed. Findings include: 1. Record review of patient testing performed on January 12, 2019 revealed the flag "NC" on control 1 (C1) and three (#1201, #1204, and #1206) of four patients for the TSH. The operator's manual states "NC: No result was obtained because there was no calibration curve for the item or lot. Alternatively, the concentration could not be calculated because the calibration curve has expired 60 days ago or earlier. In these cases, create a calibration curve and recalculate to obtain a result." 2. On March 2, 2019 at approximately 12:00 PM when queried, the TC stated there was no documentation that specimens were rerun prior to reporting. 3. During the interview on March 2, 2019 at approximately 12:00 PM, the TC confirmed the above findings. D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 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 postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to meet applicable postanalytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to have the patient's correct spelling of their name on the final test report. Refer to D5801. 2. The laboratory failed to provide accurate and reliable patient test results. Refer to D5801. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical -- 2 of 3 -- consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: . Based on record review, quality control (QC) review, and interview with the technical consultant, the laboratory director failed to ensure the overall operation of the laboratory was maintained for the analytic and postanalytic systems and that accurate results were reported. Findings include: 1. The laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: a. The laboratory failed to follow manufacturer's instructions for the chemistry TOSOH AIA 360 instrument flags. Refer to D5411. b. The laboratory failed to label two (diluent and wash) of three bottles on the TOSOH AIA 360 chemistry/endocrinology instrument with the preparation and/or expiration date when first put into use. Refer to D5415. c. The laboratory failed to perform the chemistry calibration curve for the thyroid stimulating hormone (TSH) testing. Refer to D5437. d. The laboratory failed to test at least two levels of control material each day of patient testing for the endocrinology thyroid stimulating hormone (TSH) testing. Refer to D5447. 2. The laboratory failed to meet applicable postanalytic system requirements and correct identified problems. Findings include: a. The laboratory failed to have the patient's correct spelling of their name on the final test report. Refer to D5801. b. The laboratory failed to report accurate and reliable results. Refer to D5801. 3. During the interview on March 2, 2019 at approximately 12:00 PM, the TC confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: . Based on observation and interview, the laboratory failed to ensure patient confidentiality was maintained for all phases of laboratory testing for four (August to November 2018) of four months audited. Findings include: 1. On November 5, 2018 at approximately 10:05 AM during a tour of the laboratory the surveyor observed there was no documentation of laboratory testing worksheets and patient testing printouts to review. 2. On November 5, 2018 at approximately 11:00 AM when queried, the office manager was not able to provide the surveyor documentation to all phases of laboratory testing. 3. On November 5, 2018 at approximately 11:30 AM, a phone conversation with testing personnel #1 as listed on the CMS-209 confirmed the documentation for all phases of laboratory testing was not available on-site and that all testing was stored at the testing personnel's home. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: 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 -- . Based on observation and interview, the laboratory failed to label two (diluent and wash) of three bottles on the TOSOH chemistry/endocrinology instrument with the preparation and/or expiration date when first put into use. Findings include: 1. On November 5, 2018 at approximately 10:05 AM during a tour of the laboratory, the surveyor observed reagent bottles in use on the chemistry TOSOH instrument that did not have documentation of a preparation and/or expiration date as follows: a. diluent - preparation and/or expiration date b. wash - preparation and/or expiration date 2. On November 5, 2018 at approximately 11:45 AM, a phone conversation with testing personnel #1 as listed on the CMS-209 confirmed the reagent bottles were not labeled. 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 and interview, the laboratory was using the TOSOH chemistry /endocrinology instrument diluent reagent for five (July to November 2018) of five months of testing that had exceeded the manufacturer's expiration date. Findings include: 1. On November 5, 2018 at approximately 10:05 AM during a tour of the laboratory, the surveyor observed TOSOH diluents in the refrigerator that exceeded the manufacturer's expiration date as follows: a. lot # H880045 (2 boxes) - expiration date of July 31, 2018 b. lot # HX80048 - expiration date of September 30, 2018 2. During the interview on November 5, 2018 at approximately 11:45 AM, the office manager confirmed that expired reagents were in use. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to document proficiency testing samples on the daily worksheet and retain the instrument printouts for six (3rd event 2016, 1st - 3rd events 2017, and 1st - 2nd events in 2018) of six events reviewed for the routine chemistry and endocrinology proficiency testing samples. Findings include: 1. On August 1, 2018 at 10:41 AM, record review of the American Proficiency Institute (API) graded proficiency testing documents revealed the laboratory did not document the proficiency testing samples on the daily worksheet and maintain the TOSOH chemistry analyzer printouts for six (3rd event 2016, 1st - 3rd events 2017, and 1st - 2nd events in 2018) of six events reviewed. 2. During the interview on August 1, 2018 at 10:41 AM, testing personnel #1 as listed on the CMS- 209 confirmed the proficiency testing samples were not documented on the daily worksheet and the TOSOH instrument printouts were not maintained. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 and interview, the laboratory failed to retain the daily quality control records and the testing patient results for 19 (January 2017 to July 2018) of 19 months of operation for the TOSOH chemistry analyzer. Findings include: 1. On August 1, 2018 at 12:12 PM, record review of the daily worksheets revealed for 19 (January 2017 to July 2018) of 19 months of operation, the laboratory did not retain the instrument printouts from the TOSOH with the quality control and patient test results. 2. On August 1, 2018 at 12:12 PM when queried, testing personnel #1 as listed on the CMS-209 was unable to provide the surveyor the instrument printouts. 3. During the interview on August 1, 2018 at 12:12 PM, testing personnel #1 confirmed the daily quality control data and patient test results was not retained. 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 ensure that verification of performance specifications were performed and evaluated for the new chemistry TOSOH analyzer. Refer to D5421. 2. The laboratory failed to perform and document calibration verification for the chemistry prostate specific antigen (PSA) and the carcinoembryonic antigen (CEA) testing on the TOSOH analyzer at least once every six months. Refer to D5439. 3. The laboratory failed to test at least two levels of control material each day of patient testing for the chemistry and endocrinology testing. Refer to D5447. 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) 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: -- 2 of 5 -- . Based on record review and interview, the laboratory failed to demonstrate the accuracy, precision, reportable ranges, and verify the normal ranges for the TOSOH chemistry and endocrinology testing for 19 (January 2017 to July 2018) of 19 months of operation. Findings include: 1. On August 1, 2018 at 12:20 PM, record review for the TOSOH chemistry/endocrinology instrument revealed there was no documentation to show the accuracy, precision, reportable ranges, and the verification of normal ranges were performed and documented for 19 of 19 months of operation before reporting patient test results. 2. During the interview on August 1, 2018 at 12:2 PM, testing personnel #1 as listed on the CMS-209 confirmed the performance verification documentation was not available on the day of the survey. 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 record review and interview, the laboratory failed to perform and document calibration verification for the chemistry prostate specific antigen (PSA) and the carcinoembryonic antigen (CEA) testing on the TOSOH analyzer at least once every six months for three (two events in 2017 and one event in 2018) of three six month events. Findings include: 1. On August 1, 2018 at 12:20 PM, lack of records for the calibration verification of the PSA and CEA revealed the laboratory did not perform and document the calibration verification on the TOSOH analyzer as least once every six months for three (two events in 2017 and one event in 2018) of three events. 2. During the interview on August 1, 2018 at 12:20 PM, testing personal #1 as listed on the CMS-209 confirmed the calibration verification was not completed at least every six months in 2017 and 2018. ***Repeat Deficiency from August 6, 2014 survey*** D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 3 of 5 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to test at least two levels of control material each day of patient testing for the chemistry and endocrinology testing for one (#10) of ten patient charts audited on the day of the survey. Findings include: 1. On August 1, 2018 at 1:30 PM, record review of the daily worksheets revealed the laboratory did not have any documentation to show the quality control for the following tests were performed before testing and reporting patient results for one (#10) of ten patient charts audited : a. chemistry - carcinoembryonic antigen (CEA), lipid profile (total cholesterol, high density lipoprotein (HDL), triglycerides, and low density lipoprotein (LDL) b. endocrinology - free thyroxine (FT4) and thyroid stimulating hormone (TSH) 2. On August 1, 2018 at 1:30 PM when queried, testing personnel #1 as listed on the CMS-209 was not able to provide the surveyor the quality control results. 3. During the interview on August 1, 2018 at 1:30 PM, testing personnel #1 confirmed the quality control records were not available on the day of the survey. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on document review and interview, the laboratory failed to have 1) the final chemistry and endocrinology report for two (#6 and #8) of ten patient charts audited and 2) the laboratory failed to establish a system to ensure the computer generated calculations for the low density lipoprotein (LDL) and the very low density lipoprotein (VLDL) and patient test results were periodically checked for accuracy for two (July 2016 to July 2018) of two years of testing. Findings include: 1. On August 1, 2018 at 1:20 PM, document review for two (#6 and #8) of ten patient charts audited revealed the final patient test reports was not available in the patient's paper chart as follows: a. #6 - no thyroid stimulating hormone (TSH) test report in chart b. #8 - no lipid profile (cholesterol [total], high density lipoprotein (HDL), triglycerides, LDL, and VLDL, carcinoembryonic antigen, and TSH 2. On August 1, 2018 at 1:30 PM, document review revealed the laboratory was resulting two (LDL and VLDL) computer generated calculation results in the patient's final report. There was no documentation to show the calculations and patient test results were periodically checked for accuracy for two (July 2016 to July 2018) of two years. 3. During the interview on August 1, 2016 at 1:20 and 1:30 PM, testing personnel #1 as listed on the CMS-209 confirmed the final chemistry and endocrinology test result was not -- 4 of 5 -- included in the patient's paper chart, the LDL and VLDL calculations, and patient test results were not periodically checked for accuracy. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to detect an incorrect laboratory test result reported out for two (#2 and #9) of ten patient charts audited. Findings include: 1. On August 1, 2018 at 1:10 PM, record review for two (#2 and #9) of ten patient charts audited revealed the final laboratory test result in the patient's paper chart was not the same result as recorded on the daily worksheet as follows: a. #2 - carcinoembryonic antigen test b. #9 - prostate specific antigen 2. During the interview on August 1, 2018 at 1:10 PM, testing personnel #1 as listed on the CMS- 209 confirmed the final laboratory test report in the patient's paper chart did not match the result reported on the daily worksheet. -- 5 of 5 --

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) final graded proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte cholesterol, total. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for three out of four proficiency testing events for the chemistry analyte: cholesterol, total. Refer to D2096. 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 2 -- 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: cholesterol-total in three out of four consecutive testing events. Findings include: Unsatisfactory performance for three out of four consecutive proficiency testing events constituting unsuccessful performance for cholesterol-total: cholesterol-total PT event Score 1st event 2018 20% 3rd event 2017 40% 1st event 2017 20% -- 2 of 2 --