Lawton Urology

Summary Statement of Deficiencies D0000 The inital survey was performed on 02/19/2020. The findings were reviewed with the laboratory director and testing person #1 during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1250; D5400: Analytic Systems 493.1403; D6000: Laboratory Director, Moderate Complexity 493.1409; D6033: Technical Consultant 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 a review of records, and interview with testing person #1, the laboratory failed to verify the accuracy of Post Vasectomy Semen Analysis (present or absent), PSA (Prostate Specific Antigen), and Testosterone testing at least twice annually for 2 of 2 years. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor that the following was performed in the laboratory: (a) Post Vasectomy Semen Analysis (present or absent); (b) PSA (Prostate Specific Antigen) testing using the Qualigen FastPack analyzer; (c) Testosterone testing using the Qualigen FastPack analyzer. (2) Later during the survey, the surveyor asked testing person #1 for the 2018 and 2019 proficiency testing records. Testing person #1 stated the laboratory had not enrolled and participated in a proficiency testing program for Post Vasectomy Semen Analysis, PSA, and Testosterone testing; (3) Since the laboratory was not enrolled in proficiency testing (participation in a proficiency testing program is not required for Post Vasectomy Semen Analysis, PSA, and Testosterone testing; these are not regulated analytes), the surveyor asked testing person #1 to explain how the testing was verified for accuracy during 2018 and 2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- Testing person #1 stated to the surveyor that Post Vasectomy Semen Analysis, PSA, and Testosterone testing had not been performed for accuracy during 2018 and 2019 and to date in 2020 (02/19/20); 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 a review of records, written policy and procedure manual, and interview with testing person #1, the laboratory failed to monitor and evaluate the overall quality of analytic systems and correct identified problems for the subspecialty of testing performed. Findings include: (1) The laboratory failed to ensure the laboratory director approved, signed, and dated the written procedure manual. Refer to D5407; (2) The laboratory failed to demonstrate the performance specifications for a replacement analyzer. Refer to D5421; (3) The laboratory failed to define a function check protocol to ensure the centrifuge was functioning properly. Refer to D5435; (4) The laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for 25 of 25 months. Refer to D5441; (5) The laboratory failed to perform at least two levels of control material testing at least once a day patient specimens were tested for 16 of 62 days of PSA (Prostate Specific Antigen) testing and for 12 of 62 days of Testosterone testing. Refer to D5447; (6) The laboratory failed to verify the stated value of control materials before they were put into use for 2 of 2 lots. Refer to D5469; (7) The laboratory failed to ensure quality control results were acceptable before reporting patient test results for 5 of 10 days of patient testing. Refer to D5481; (8) The laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the written procedure manual and interview with testing person #1, the laboratory director failed to approve, sign, and date the written procedure manual. Findings include: (1) During the survey, the surveyor reviewed the procedure manual for PSA (Prostate Specific Antigen) and Testosterone testing using the Qualigen FastPack analyzer. There was no evidence the manual had been signed and dated as approved by the laboratory director; (2) The surveyor reviewed the manual with testing person #1, who stated it had not been signed and dated by the laboratory director. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE -- 2 of 11 -- 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: Based on a review of records and interview with testing person #1, the laboratory failed to demonstrate the performance specifications for a replacement analyzer. Findings include: (1) During the survey, testing person #1 stated to the surveyor a replacement Qualigen FastPack analyzer (put into use for patient testing on 01/16/20), was used to perform PSA (Prostate Specific Antigen) testing and Testosterone testing; (2) The surveyor asked testing person #1 for the implementation records for the replacement analyzer. Testing person #1 was not able to locate the records; (3) The surveyor asked testing person #1 if the performance specifications had been demonstrated for the replacement analyzer. Testing person #1 stated performance specifications had not been demonstrated for the replacement analyzer; (4) The surveyor then reviewed laboratory records and identified that patient testing had been performed and reported for 14 patients using the replacement analyzer as follows: (a) Patient #1 - Testing performed on 01/16/20 at 12:40 pm (b) Patient #2 - Testing performed on 01/17/20 at 08:48 am (c) Patient #3 - Testing performed on 01/17/20 at 09:46 am (d) Patient #4 - Testing performed on 01/21/20 at 01:46 pm (e) Patient #5 - Testing performed on 01/22/20 at 09:46 am (f ) Patient #6 - Testing performed on 01 /23/20 at 11:29 am (g) Patient #7 - Testing performed on 01/23/20 at 12:38 pm (h) Patient #8 -Testing performed on 01/23/20 at 03:30 pm (i) Patient #9 - Testing performed on 01/24/20 at 04:19 pm (j) Patient #10 - Testing performed on 01/27/20 at 01:49 pm (k) Patient #11 - Testing performed on 01/29/20 at 11:53 am (l) Patient #12 - Testing performed on 01/29/20 at 12:07 pm (m) Patient #13 -Testing performed on 01/29/20 at 01:36 pm (n) Patient #14 - Testing performed on 02/04/20 at 10:01 am D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with testing person #1, the laboratory failed to define a function check protocol to ensure the centrifuge was functioning properly. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor that the following was performed in -- 3 of 11 -- the laboratory: (a) PSA (Prostate Specific Antigen) testing using the Qualigen FastPack analyzer; (b) Testosterone testing using the Qualigen FastPack analyzer. (2) Later during the survey, testing person #1 stated the specimens were processed in the Costway 800-1 centrifuge at a speed of 3000 rpm (revolutions per minute) for 3 minutes; (3) The surveyor reviewed the laboratory's written policy and procedure manual and was not able to locate a procedure describing how to check the speed and time; and the frequency the checks were to be performed; (4) The surveyor asked testing person #1 if a function check procedure had been written. Testing person #1 stated a function check procedure had not be written to ensure the centrifuge was working properly. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for 25 of 25 months. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor that the following was performed in the laboratory: (a) PSA (Prostate Specific Antigen) testing using the Qualigen FastPack analyzer; (b) Testosterone testing using the Qualigen FastPack analyzer. (2) Testing person #1 stated to the surveyor two levels of Qualigen FastPack control materials were tested each day of patient testing; (3) The surveyor asked testing person #1 to explain how QC (quality control) results were monitored for variances (e.g., biases, shifts, trends). Testing person #1 stated the laboratory did not have a method for monitoring QC results for variances; (4) Since there was no documented evidence the QC data had been reviewed for variances during the review period of 02/02/18 through the day of the survey (02/19/20), the surveyor determined the laboratory did not have an effective method of monitoring QC results for variances. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- 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. -- 4 of 11 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to perform at least two levels of control materials at least once a day patient specimens were tested for 16 of 62 days of PSA (Prostate Specific Antigen) testing and for 12 of 62 days of Testosterone testing. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor that the following was performed in the laboratory: (a) PSA (Prostate Specific Antigen) testing using the Qualigen FastPack analyzer; (b) Testosterone testing using the Qualigen FastPack analyzer; (c) Two levels (low and high) of Qualigen FastPack quality control (QC) materials were to be tested each day of patient testing. (2) Later during the survey, the surveyor reviewed QC and patient records for PSA testing performed between January 2019 through December 2019. It was identified QC testing had not been performed each day of patient testing for 16 of 62 days: (a) Patient #15 - Testing performed on 01/02/19 at 02:34 pm; (b) Patient #16 - Testing performed on 01/08/19 at 12:07 pm; (c) Patient #17 - Testing performed on 04/02/19 at 10:12 am; (d) Patient #18 - Testing performed on 04/18/19 at 04:21 pm; (e) Patient #19 - Testing performed on 04/23/19 at 01:07 pm; (f) Patient #20 - Testing performed on 04/23/19 at 01:46 pm; (g) Patient #21 - Testing performed on 04/23/19 at 02:17 pm; (h) Patient #22 - Testing performed on 04/24/19 at 01:43 pm; (i) Patient #23 - Testing performed on 04 /30/19 at 11:18 am; (j) Patient #24 - Testing performed on 04/30/19 at 03:50 pm; (k) Patient #25 - Testing performed on 06/03/19 at 04:03 pm; (l) Patient #26 - Testing performed on 06/03/19 at 04:50 pm; (m) Patient #27 - Testing performed on 07/02/19 at 03:16 pm; (n) Patient #28 - Testing performed on 07/22/19 at 09:16 pm; (o) Patient #29 - Testing performed on 08/22/19 at 03:28 pm; (p) Patient #30 - Testing performed on 11/05/19 at 11:54 am; (q) Patient #31 - Testing performed on 11/05/19 at 04:37 pm; (r) Patient #32 - Testing performed on 11/12/19 at 03:52 pm; (s) Patient #33 - Testing performed on 11/14/19 at 01:03 pm; (t) Patient #34 - Testing performed on 11 /19/19 at 12:12 pm; (u) Patient #35 - Testing performed on 11/20/19 at 10:53 am; (v) Patient #36 - Testing performed on 11/26/19 at 11:20 am; (w) Patient # 37- Testing performed on 11/26/19 at 01:51 pm. (3) The surveyor reviewed QC and patient records for Testosterone testing performed between January 2019 through December 2019. It was identified QC testing had not been performed each day of patient testing for 12 of 62 days: (a) Patient #38 - Testing performed on 01/08/19 at 11:16 am; (b) Patient #39 - Testing performed on 01/08/19 at 05:44 pm; (c) Patient #40 - Testing performed on 01/09/19 at 01:26 pm; (d) Patient #41 - Testing performed on 03/05/19 at 03:49 pm; (e) Patient #42 - Testing performed on 03/06/19 at 11:18 am; (f) Patient #43 - Testing performed on 04/11/19 at 02:45 pm; (g) Patient #44 - Testing performed on 05/01/19 at 12:51 pm; (h) Patient #45 - Testing performed on 05/10/19 at 10:19 am; (i) Patient #46 - Testing performed on 06/03/19 at 04:03 pm; (j) Patient #47 - Testing performed on 07/16/19 at 02:05 pm; (k) Patient #48 - Testing performed on 07 /16/19 at 04:19 pm; (l) Patient #49 - Testing performed on 07/16/19 at 04:43 pm; (m) Patient #50 - Testing performed on 11/19/19 at 10:26 am; (n) Patient #51 - Testing performed on 12/04/19 at 11:13 am; (o) Patient #52 - Testing performed on 12/09/19 at 10:51 am; (p) Patient #53 - Testing performed on 12/09/19 at 03:49 pm. (4) The surveyor reviewed the records with testing person #1. Testing person #1 stated QC testing had not been performed each day of patient PSA and Testosterone testing as indicated above. 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-- -- 5 of 11 -- 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 a review of records and interview with testing person #1, the laboratory failed to verify the stated value of control materials before they were put into use for 2 of 2 lots. Findings include: (1) At the beginning of the survey, testing person #1 stated the following to the surveyor: (a) The laboratory performed PSA (Prostate Specific Antigen) and Testosterone testing using the Qualigen FastPack analyzer; (b) Two levels of manufacturer control materials were analyzed each day of patient testing; (c) The manufacturer's provided ranges were used to determine acceptability of quality control results. (2) Later during the survey, the surveyor reviewed records for 2 control lot numbers. There was no evidence the provided ranges were verified before the lot numbers were put into use for 2 of 2 lot numbers as follows: (a) Low control lot #1811041-11P and high control lot #1811041-11P- Put into use on 04/03/19 and used through 05/10/19. (3) The findings were reviewed with testing person #1 who stated the manufacturer's ranges had not been verified before the above lot numbers had been put into use. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to ensure quality control results were acceptable before reporting patient test results for 5 of 10 days of patient testing. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor that the following was performed in the laboratory: (a) PSA (Prostate Specific Antigen) testing using the Qualigen FastPack analyzer; (b) Testosterone testing using the Qualigen FastPack analyzer. (2) Later during the survey, the surveyor reviewed QC (quality control) records between 03/14/19 through 05/06/19 for the analyzer (QC was performed using 2 levels of control materials each day of patient use) and identified unacceptable QC values for the following: (a) PSA - Level 2 (lot# 1809017-8P) QC range was 7.9 to 18.4 ng/ml and the laboratory obtained a value of 5.2 ng/ml on 03/19/19; (b) PSA - Level 1 (lot# 1809017-8P) QC range was 0.95 to 2.2 ng/ml and the laboratory obtained a value of 0.24 ng/ml on 04/09/19; (c) PSA - Level 1 (lot# 1811041-11P) QC range was 0.54 to 1.3 ng/ml and the laboratory obtained a value of 0.16 ng/ml on 04/10/19; (d) PSA - Level 2 (lot# 1811041-11P) QC range was 6.8 to 15.9 ng/ml and the laboratory obtained a value of 6.0 ng/ml on 04/12/19; (e) PSA - Level 1 (lot# 1811041-11P) QC -- 6 of 11 -- range was 0.54 to 1.3 ng/ml and the laboratory obtained a value of 0.36 ng/ml on 05/04 /19; (f) PSA - Level 2 (lot# 1811041-11P) QC range was 6.8 to 15.9 ng/ml and the laboratory obtained a value of 5.2 ng/ml on 05/04/19. (3) The surveyor reviewed the records with testing person #1 and asked if the failed QC values had been identified and addressed, (i.e.,repeat testing to obtain an acceptable result and/or take and document