Urologic Specialists Of Oklahoma Inc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/25/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager and the administrator at the conclusion of the survey. 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 a review of records and interview with the laboratory manager, the laboratory failed to ensure a proficiency testing attestation statement had been signed by the laboratory director for one of six events reviewed during 2021, 2022, and to date in 2023. Findings include: (1) A review of the third 2021; first, second, and third 2022; and first and second 2023 Chemistry Core proficiency testing records identified the following for one of six events: (a) Third 2022 Event - The attestation statement had not been signed by the laboratory director. (2) The findings were reviewed with the laboratory manager who stated on 10/25/2023 at 10:45 am, the attestation statement had not been signed by the laboratory director. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 -- CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with the laboratory manager, the laboratory director failed to assess the competency of the technical consultant based on the position responsibilities as listed in subpart M. Findings include: (1) A review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the technical consultant, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of October 2021 through the current date identified competencies, based on job responsibilities, had not been performed for the technical consultant listed on the CMS-209; (3) The findings were reviewed with the laboratory manager on 10/25/2023 at 11:30 am there was no policy and competencies were not performed for the technical consultant during the review period of October 2021 to the current date. 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 a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to ensure the humidity was maintained as required by the manufacturer of the Beckman Coulter Access 2 analyzer for four of nine months reviewed in 2023. Findings include: (1) On 10/25/2023 at 10:00 am, the laboratory manager stated PSA, Free PSA, and Testosterone testing were performed using the Beckman Coulter Access 2 analyzer; (2) A review of the manual for the analyzer titled, "Instructions for Use" in Section 1.13 "System Overview" stated "Operational humidity should be in the range of 20% to 80%"; (3) A review of laboratory humidity records from January through September 2023 identified humidity readings were less than 20% for four of nine months as follows: (a) January - 15 of 21 humidity readings were documented as less than 20%; (b) February - Seven of 20 humidity readings were documented as less than 20%; (c) March - Three of 20 humidity readings were documented as less than 20%; (d) April - Two of 20 humidity readings were documented as less than 20%. (4) The records were reviewed with the laboratory manager who stated on 10/25/2023 at 03:10 pm, the laboratory humidity had not been maintained as required by the manufacturer as shown above. 48517 Based on observation and interview with the laboratory manager, the laboratory failed to ensure two of two types of blood collection tubes were stored as required by the -- 2 of 6 -- manufacturer, in a room denoted as the central supply supply room. Findings include: (1) Observation of the central supply room and interview with the laboratory manager on 10/25/2023 at 10:05 am, identified the following: (a) 1300 BD Vacutainer EDTA tubes, lot # 3136174, storage temperature of 4-25 degrees Celsius; (b) 1650 Greiner Vacuette serum separator clot activator tubes, lot # B230333T, storage temperature of 4-25 degrees Celsius. (2) Interview with the laboratory manager on 10/25/2023 at 10: 05 am confirmed the laboratory was not monitoring the temperature of the central supply room. 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 with the laboratory manager, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 10/25/2023 at 09:30 am, identified the following expired supplies that appeared to be available for use: (a) 50 Copan Eswab LQ - lot # N20336800 with an expiration date of 09/30/2023; (b) One gallon of Citronox - lot # C9EO with an expiration date of 05/2022; (c) One gallon of High purity reagent grade water - lot # 2124408 with an expiration date of 09/07/2022; (d) One liter of Contrad 70 - lot # 81911 with an expiration date of 05/04/2021; (e) One gallon of Cytorich - lot # 9120937 with an expiration date of 03/31/2022. (2) Interview with the laboratory manager on 10/25/2023 at 09:30 am confirmed the expired supplies were available for use. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of manufacturer's instructions, maintenance records, and interview with the laboratory manager, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures during the review period of 01/01/2022 through 09/30/2023. Findings include: (1) On 10/25/2023 at 10: 00 am, the laboratory manager stated PSA, Free PSA, and Testosterone testing were performed using the Beckman Coulter Access 2 analyzer; (2) A review of the manual for the analyzer titled, "Instructions for Use" in Section 6.6 "Weekly Maintenance Steps" stated the following required maintenance procedures: (a) "Clean the Instrument Exterior" (b) "Inspect the Liquid Water Bottle for Wear" (c) "Check for Fluid in the Waste Filter Bottle" (d) "Inspect and Clean the Primary Probe" (e) "Replace and Clean the Aspirate Probe" (f) "Run Daily Maintenance" (g) "Run System Check" (3) A review of maintenance logs from on 01/01/2022 through 09/30 /2023 identified no documentation weekly maintenance had been performed between 11/2/2022 and 01/05/2023; (4) The records were reviewed with the laboratory -- 3 of 6 -- manager who stated on 10/25/2023 at 03:12 pm, weekly maintenance had not been documented as performed as shown above. 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, policies and procedures, and interview with the laboratory manager, the laboratory failed to follow their written protocol for ensuring the urine centrifuges were functioning properly for two of two annual function checks performed during the review period of October 2021 through the current date. Finding include: (1) On 10/25/2023 at 2:00 pm, the laboratory manager stated the following: (a) Urine sediment examinations were performed as a PPM (Provider Performed Microscopy) procedure in areas denoted as pods; (b) The specimens were processed in Unico centrifuges at a speed of 1800 rpm (revolutions per minute) +/- 100 RPM for 5 minutes; (2) A review of the centrifuge function check records confirmed the centrifuge speed and timer were last checked on 01/10/2021; (3) A review of the procedure titled, "Centrifuge use and maintenance", stated "After initial placement the lab will verify the speed every year and the timer every year or anytime the speed or time is questioned"; (4) A review of centrifuge function check records during 2021 through the current date identified the centrifuge speed and time had not been checked for nine of nine Unico centrifuges since 01/10/2021; (5) The records were reviewed with the laboratory manager, who stated on 10/25/2023 at 2:00 pm, the laboratory had not followed their policy. 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 the laboratory manager, the laboratory failed to have control procedures that monitored the accuracy and precision -- 4 of 6 -- of the complete analytic process for seven of seven months reviewed. Findings include: LEVEY JENNINGS NOT PRINTED (1) On 10/25/2023 at 10:00 am, the laboratory manager stated the following: (a) The laboratory performed PSA, Free PSA, and Testosterone testing using the Beckman Coulter Access 2 analyzer; (b) Two levels of QC (quality control) materials were tested each day of patient testing. (2) On 10/25/2023 a review of records from January 2023 through July 2023 identified no evidence, such as Levey-Jennings graphs and cumulative statistical data, to prove that QC results had been monitored for variances (i.e., biases, shifts, trends) between 03/31 /2023 through 05/01/2023; (3) Interview with the laboratory manager on 10/25/2023 at 3:12 pm confirmed that QC data to include Levey-Jennings graphs and cumulative statistical data had not been printed and reviewed for the period stated above. BIASES NOT IDENTIFIED (1) On 10/25/2023 at 10:00 am, the laboratory manager stated the following: (a) The laboratory performed PSA, Free PSA, and Testosterone testing using the Beckman Coulter Access 2 analyzer; (b) Two levels of QC (quality control) materials were tested each day of patient testing. (2) A review of quality control records for testing performed between 01/01/2023 through 03/01/2023 and between 05 /01/2023 through 07/31/2023 identified the following biases: (a) Free PSA (Level 3 lot # 85303) - 69 out of 83 control results were consistently above the established mean; (b) PSA (Level 3 lot # 85303) - 94 out of 98 control results were consistently above the established mean; (c) Testosterone (Level 1 lot # 85301) - 55 out of 60 control results were consistently above the established mean. (3) There was no evidence in the records the control biases had been identified and addressed; (4) The records were reviewed with the laboratory manager who stated the biases had not been identified and addressed. 48517 Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for three of three months reviewed for testing performed using the the Ortho Vitros 350 analyzer. Findings include: (1) On 10/25/2023 at 2:30 pm, the laboratory manager stated the following: (a) The laboratory used the OrthoVitros 350 to perform Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase, AST (Aspartate Aminotransferase), BUN, Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin, Total Protein, and Direct Bilirubin; (b) Three levels of QC (quality control) materials were tested each day of patient testing. (2) A review of records from July 2023 through September 2023 identified the following biases; (a) Aspartate Aminotransferase (AST) (control level NPV1N1) - 80 of 93 control results were consistently below the established mean; (b) Glucose (GLU) (control level NPV1N1) - 54 of 61 control results were consistently below the established mean; (c) Potassium (K+) (control level NPV1N1) - 61 of 66 control results were consistently below the established mean. (3) There was no evidence in the records the control biases had been identified and addressed; (4) The records were reviewed with the laboratory manager who stated on 10/25/2023 at 2:30 pm, the biases had not been identified and addressed. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/13/2021. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with technical consultant #2 and the laboratory manager at the conclusion of the survey. 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, manufacturer's package insert, and interview with technical consultant #2 and the laboratory manager, the laboratory failed to have control procedures that would detect immediate errors that would occur due to test system failure, adverse environmental conditions, and operator performance for Albumin and Total Protein testing. Findings include: (1) On 09/13/2021 at 10:45, the laboratory manager stated the followingto the surveyor: (a) Albumin and Total Protein testing were performed on the Ortho Vitros 350 analyzer; (b) Two levels of Vitros Performance Verifier quality control (QC) materials were performed each day of patient testing for the analytes listed above. (2) The surveyor reviewed the package inserts for the control materials. The manufacturer provided a standard deviation (SD) for the laboratory to utilize for each level of control and analyte; and a range of means 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 -- for the laboratory to use as a guide when establishing their means; (3) The surveyor reviewed QC records for testing performed from 01/01/2021 through 08/01/2021. The review showed the laboratory was using SD's that were greater than the package insert provided SD's for Albumin and Total Protein as follows: (a) Vitros Performance Verifier level 1 (lot #N7648) and level 2 (lot #L7425) (i) Albumin (aa) Level 1 - The package insert SD was 0.090. A SD of 0.700 had been used to evaluate QC results; (bb) Level 2 - The package insert SD was 0.110. A SD of 0.139 had been used to evaluate QC results. (ii) Total Protein (aa) Level 1 - The package insert SD was 0.150. A SD of 0.920 had been used to evaluate QC results. (4) The surveyor reviewed the findings with technical consultant #2 and the laboratory manager. Both stated on 09/13 /2021 at 04:15 pm the laboratory was using SD's beyond the package insert SD's as shown above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/16/19 and 07/17/19. The findings were reviewed with laboratory manager and the microbiology general supervisor at the conclusion of the survey. The laboratory was found in compliance with standard- level deficiencies cited. 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 a review of records and interview with the laboratory manager, the laboratory director failed to sign proficiency testing attestation statements for 2 of 11 testing events. Findings include: (1) On the first day of the survey, the surveyor reviewed 2018 and 2019 proficiency testing records and identified the following for 2 of 11 events: (a) First 2019 Chemistry Miscellaneous Event - The attestation statement had not been signed by the laboratory director; (b) First 2019 Microbiology Event - The attestation statement had not been signed by the laboratory director. (2) The surveyor reviewed the findings with the laboratory manager, who stated the attestation statements had not been signed by the laboratory director. 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 -- D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to review and evaluate proficiency testing results for 1 of 11 testing events. Findings include: (1) On the first day of the survey, the surveyor reviewed 2018 and 2019 proficiency testing records and identified the following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) First 2019 Chemistry Core Event (i) Alkaline Phosphatase - 5 of 5 results exhibited a negative bias (aa) CH-01 - SDI of -3.6 (bb) CH-02 - SDI of -3.4 (cc) CH-03 - SDI of -3.5 (dd) CH-04 - SDI of -2.2 (ee) CH-05 - SDI of -2.9 (2) The surveyor further reviewed the records and could not locate documentation verifying the biases had been identified and addressed; (3) The surveyor then reviewed the records with the laboratory manager, and asked if the biases had been addressed. The laboratory manager stated the biases had not been addressed. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and microbiology general supervisor, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results for 1 of 11 events. Findings include: (1) On the first day of the survey, the surveyor reviewed 2018 and 2019 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) Microbiology (i) 2018 Second Event (aa) UR- 10 Urine Colony Count (A Quantitative Loop with any agar) (2) The surveyor further reviewed the records and could not locate documentation verifying the laboratory had performed a self-evaluation of the non-graded result; (3) The surveyor asked the laboratory manager and microbiology general supervisor if the result had been documented as evaluated. The laboratory manager and microbiology general supervisor reviewed the records and stated the non-graded result had not been documented as reviewed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or -- 2 of 6 -- examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the laboratory manager, the laboratory failed to follow their written procedures. Findings include: HEMATOLOGY CALIBRATION (1) On the first day of the survey, the laboratory manager stated to the surveyor CBC (Complete Blood Count) testing was performed using the Beckman Coulter Act Diff 2 analyzer; (2) The surveyor reviewed the written procedure titled, "Calibration Guidelines" which stated: (a) "All moderate complexity analyzers must be calibrated at least every six months or more often it recommended by the manufacturer; (b) "Hematology - Our calibrators are shipped to us every six months on a standing order through Henry Schein". (3) The surveyor then reviewed 2017 through 2019 calibration records for the analyzer. There was no evidence a calibration had been performed every six months as required by policy. Calibration had not been performed: (a) Between 08/21/17 and 02/05/19 (due January 2019) (4) The surveyor reviewed the findings with the laboratory manager. The laboratory manager stated calibrations had not been performed every six months as indicated above. CENTRIFUGE FUNCTION CHECK FOR RPM (1) On the second day of the survey, the laboratory manager stated the following: (a) Urine Microscopic testing was performed as a PPM (Provider Performed Microscopy) procedure on the first floor of the facility at 11 stations, denoted as Pods (Pod A, Pod B, Pod C, Pod D, Pod E, Pod F, Pod G, Pod H, Pod J, Pod K, and the Procedure Area Pod); (2) The surveyor reviewed the written procedure title, "Centrifuge Use and Maintenance" which stated: (a) "After initial placement the lab will verify the speed every six months and the timer every three months or anytime the speed or time is questioned". (3) The surveyor then reviewed 2017 through 2019 centrifuge records and identified the following: (a) Speed - Checks had not been performed for each centrifuge in each pod between 07/17/17 and 04/29/19 (b) Time - Checks had not been performed for each centrifuge in each pod between 07/17/17 and 04/29/19 (4) The surveyor reviewed the findings with the laboratory manager. The laboratory manager stated the procedure had not been followed as indicated above. CENTRIFUGE FUNCTION CHECK FOR GENERAL LABORATORY (1) On the second day of the survey, the laboratory manager stated the laboratory performed Urine Microscopic testing; (2) The surveyor reviewed the written procedure title, "Centrifuge Use and Maintenance" which stated: (a) "After initial placement the lab will verify the speed every six months and the timer every three months or anytime the speed or time is questioned". (3) The surveyor then reviewed 2017 through 2019 centrifuge records and identified the following: (a) Speed - Checks had not been performed for each centrifuge in each pod between 07/17/17 and 04/29/19 (b) Time - Checks had not been performed for each centrifuge in each pod between 07/17/17 and 04/29/19 (4) The surveyor reviewed the findings with the laboratory manager. The laboratory manager stated the procedure had not been followed as indicated above. 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 -- 3 of 6 -- 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 the laboratory manager, the laboratory failed to have control procedures that monitored the accuracy and precision of the analytic process for Platelets 3 of 3 months. Findings include: (1) On the second day of the survey, the laboratory manager stated the following to the surveyor: (a) Platelet testing was performed using the Beckman Coulter Act Diff 2 analyzer; (b) Three levels (Low, Normal, high) of Coulter 4C-ES Cell control materials were performed each day of patient testing. (2) The surveyor reviewed quality control records for testing performed between 04/01/19 through 06/30/19. A bias was identified as follows: (a) Platelet (Normal Level lot#079500) - 57 out of 68 control results were consistently above the established mean. (3) There was no evidence in the records the control biases had been identified and addressed; (4) The surveyor reviewed the records with the laboratory manager and asked if there was documentation to prove the bias had been identified and addressed. The laboratory manager stated the bias had not been addressed; (5) Since the above bias had not been identified and addressed, the surveyor determined the laboratory failed to have control procedures that monitored the accuracy of testing for the above analyte. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, written policies, and interview with the laboratory manager and the microbiology general supervisor, the laboratory failed to follow their written quality control policy of the IQCP (Individualized Quality Control Plan). Findings include: (1) On the second day of the survey, the microbiology general supervisor stated to the surveyor the laboratory performed: (a) Urine culture testing, with presumptive identifications reported, using Remel TSA (Tryptic Soy Agar) 5% Sheep Blood/EMB (Eosin Metholylene Blue) Agar biplates; (b) AST (Antimicrobial Susceptibility Testing), using the Kirby-Bauer method and Remel Mueller Hinton Agar plates; (c) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) The surveyor reviewed the IQCP for the test system and identified the QCP (Quality Control Plan) stated the following: (a) "Testing of appropriate ATCC QC strains on each AST media type weekly". (3) The surveyor reviewed quality control records from 01/01/2018 through 07/07/19 (first day of the survey) and identified quality control testing had not been performed weekly as follows: (a) Escherichia coli ATCC (American Type Culture Collection) Strain 25922 -- 4 of 6 -- (i) Not performed between 01/06/19 and 01/20/19 (ii) Not performed between 04/20 /19 and 05/05/19 (b) Staphlococcus aureus ATCC Strain 25923 (i) Not performed between 07/12/18 and 07/22/18 (ii) Not performed between 11/18/18 and 12/02/18 (iii) Not performed between 04/14/19 and 04/21/19 (c) Pseudomonas aeruginosa ATCC Strain 27853 (i) Not performed between 04/21/19 and 05/05/19 (4) The surveyor reviewed the findings with the laboratory manager and microbiology general supervisor, who stated the QCP had not been followed as indicated above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and the microbiology general supervisor, the laboratory failed to have a policy for monitoring the effectiveness of their IQCPs. Findings include: (1) On the second day of the survey, the microbiology general supervisor stated to the surveyor the laboratory performed: (a) Urine culture testing, with presumptive identifications reported, using Remel TSA (Tryptic Soy Agar) 5% Sheep Blood/EMB (Eosin Metholylene Blue) Agar biplates; (b) Susceptibility testing, using the Kirby-Bauer method and Remel Mueller Hinton Agar plates. (c) An IQCP's (Individualized Quality Control Plan) had been developed for the test systems; (2) The surveyor reviewed the IQCP's (dated as approved 09/15/17). The QA (Quality Assessment) portion of the IQCP's did not include a schedule for evaluating the QCP's (Quality Control Plan) to ensure they continued to provide accurate and reliable results; (3) The surveyor reviewed the records with laboratory manager and microbiology general supervisor and asked if there was a policy to address how the laboratory will monitor the IQCP's, including the frequency of the reviews. The laboratory manager and microbiology general supervisor stated to the surveyor a policy had not been written. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director failed to ensure that a person performing moderate complexity testing had the appropriate training for 1 of 3 testing persons. Findings include: (1) On the first day of the survey, the surveyor reviewed personnel records. The following -- 5 of 6 -- was identified: (a) Testing Person #2 - This person was hired to perform patient testing on 12/31/18. There was no documentation this person had been initially trained. A competency evaluation had not been documented as performed until 06/26 /19. (2) The surveyor reviewed the findings with the laboratory manager. The laboratory manager stated there was no additional documentation to prove the above person had been initially trained to perform moderate complexity testing. -- 6 of 6 --