Beacon Biomedical Inc

Summary Statement of Deficiencies 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 review of the laboratory's policy and procedure manual and interview with the facility personnel, the laboratory failed to have the current laboratory director approve, sign and date test procedures before use. Findings include: 1. The current laboratory director indicated in the CLIA Federal Database and assigned on the CMS- 209, Laboratory Personnel Form presented for review during the survey has been listed as laboratory director since 11/16/2018. 2. The policy and procedure manual presented for review during the survey conducted on December 17, 2019 was not approved, signed and dated by the current laboratory director. 3. The facility personnel confirmed that the policy and procedure manual indicated above was not approved, signed and dated by the current laboratory director. 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. 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 lack of policies presented for review and interview with the facility personnel, the laboratory failed to establish a policy in regards to monitoring the rpm's and timer of the incubating microplate shakers used in the test process. Findings include: 1. The laboratory performs patient testing in the specialty of Chemistry with an approximate annual test volume of 420. 2. The laboratory utilizes two separate incubating microplate shakers (serial #160913301 and serial #170619005) as part of the procedural steps for the CEA test and the Cripto test. The CEA test includes a procedural step to shake the specimen for 5 minutes at 300 rpm, while the Cripto test requires shaking the specimen for 5 minutes at 250 rpm. 3. No policy was presented for review to indicate the laboratory had a system in place to monitor the timing and speed of each incubating microplate shaker, including the frequency in which they are monitored. 4. The facility personnel acknowledged that there was no documented policy or procedure for monitoring the function of the incubating microplate shakers. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on lack of documentation of a semi-annual competency evaluation for two testing personnel and interview with the facility personnel, the technical supervisor failed to evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individuals tested patient specimens. Findings include: 1. No semi-annual competency evaluation documentation was presented for review for two out of two testing personnel who began patient testing in 2018. 2. The laboratory's established policy titled '9.4. Competency Assessment' states, "Competency Assessment is performed twice in a Lab Personnel's first year and annually thereafter." 3. The facility personnel confirmed that the laboratory failed to have documentation of a semi-annual competency evaluation for the two testing personnel indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of established performance specification documentation for the Elisa Laboratory Developed Test (LDT), BeScreened-CRC, used to test patient blood specimens and interview with the facility personnel, the laboratory failed to demonstrate the effects of the patients' clinical conditions, disease states, and medications as interfering substances that may effect the analytical specificity of the test system. Findings include. 1. During the survey conducted on March 30, 2018, the laboratory presented documentation that demonstrated the effects that matrix components may have on the test system as interfering substances which may limit the ability to detect, identify or quantitate a targeted analyte, but there was no documentation indicating if the patients' clinical conditions, disease states, and any common medications may effect and/or inhibit the analytical specificity of the test system. 2. The facility personnel acknowledged that there was no specific analysis performed that included the effects of the patients' clinical conditions, disease states and common medications as possible interfering substances that may effect analytical specificity of the test system. 3. The laboratory started patient testing using the LDT, 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 -- BeScreened-CRC, in January 2018 and tested approximately 10 patient samples since testing began. -- 2 of 2 --