Physicians Laboratories Of America Llc

Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through a review of the CMS-209 form presented at the time of the survey, a review of personnel records for five personnel listed on the form CMS-209, and through interviews with laboratory staff, it was determined five of five testing personnel failed to have written authorization to perform testing without direct supervision. Survey findings include: A. Through a review of the CMS- 209 form, it was determined laboratory personnel # 2, # 3, # 4, # 5, and # 6, were designated as testing personnel. B. A review of personnel records for five testing personnel listed on the form CMS- 209 revealed that five of five failed to have written authorization to perform testing without direct supervision. Laboratory personnel # 2, # 3, # 4, # 5, and # 6, did not have a written authorization to perform testing without direct supervision. C. In an interview at 11:13 a.m. on 7/25/2023, laboratory personnel # 3 (listed on the form CMS-209) confirmed that the laboratory did not have documented authorization for testing for employees performing moderate or high complexity testing. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES 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): 493.1413(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. This STANDARD is not met as evidenced by: Through a review of personnel records for two testing personnel performing general laboratory procedures, liquid chromatograph mass spectrometer (LCMS) operations, V-Twin operation, and technical/general supervisor assessment operations in the laboratory, and through lack of documentation, it was determined the laboratory failed to document competency annually. Survey findings include: A. A review of the personnel file for employee # 2 (listed on the CMS-209 Form) revealed the annual Competency Assessment for Technical Supervisors and Competency Assessment for General Supervisors dated 1/25/2022 and the next date 7/24/2023 was six months late. General Lab Competency and LCMS Operation Competency for emplyee # 2 was last documented 1/26/2022 which was due and is currently six months late. B. A review of the personnel file for employee # 3 (listed on the CMS-209 Form) revealed the annual General Lab Competency and V-Twin Operation Competency dated 1/17/2022 and the next date 4/5/2023 which was due by 1/17/2023 was three months late. C. In an interview, at 13:13 p.m. on 7/25/2023, laboratory employee # 3 confirmed there were no other competency assessments available. -- 2 of 2 --

Summary Statement of Deficiencies 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: Through a review of the laboratory policy and procedure manual, a review of 2018 Temperature/Humidity Record, and interviews with staff it was determined the laboratory criteria for storage of Cerilliant Calibration Standards was not consistent with the manufacturer's instructions. Survey findings include: A. A review of Certificates of Analysis for four Standards used in liquid chromatography / mass spectrophotometry (LC/MS) urine drug confirmations, revealed that three of four Standards (Ketamine Primary Standard, Nordiazepam Primary Standard, and Oxycodone Primary Standard) included storage instructions to "Store unopened in Freezer (-10 degrees to -25 degrees Celsius)". B. The policy and procedure manual for LC/MS states that the laboratory will store Standards at -80 +/- 5 degrees Celsius (not the (-10 to -25 degrees Celsius required by the manufacturer). C. A review of the 2018 Temperature/Humidity Record showed that the acceptable range for the freezer in which the Standards were stored was listed as -70 to -90 degrees Celsius instead of -10 to -25 degrees Celsius required by the manufacturer. D. In an interview, at 1:28 p. m. on 1/31/2019, laboratory employee #2 (as listed on the form CMS-209) confirmed the laboratory criteria for storage of Cerilliant Calibration Standards was not consistent with the manufacturer's instructions. 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 -- D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Through a review of competency assessment documentation on two of two testing personnel, through lack of documentation, and through interviews with laboratory staff, it was determined the technical supervisor failed to evaluate the competency of testing personnel using the required six elements for evaluation. Survey finding follow: A. The competency assessments for three of three testing personnel were documented on a form with columns to indicate the methods of evaluation. B. The 2018 competency assessments for two of two personnel failed to include documentation of evaluation by direct observation , monitoring of recording and reporting of test results, review of records, direct observation of maintenance and function checks, assessment of blind samples, or assessment of problem solving skills as listed at 493.1451(b)(8). C. The 2017 competency assessments for two of two testing personnel included documentation of evaluation by direct observation, but did not include monitoring of recording and reporting of test results, review of records, direct observation of maintenance and function checks, assessment of blind samples, or assessment of problem solving skills as listed at 493.1451(b)(8). D. In an interview, on 1/31/2019 at 3:00 p.m., laboratory employee #2 (listed as the technical supervisor on the form CMS-209) confirmed the methods of competency assessment had not been documented as listed above. -- 2 of 2 --