Adc, Pllc, North Laboratory, The

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, the laboratory's policy and procedure, on-line service manual, observation, instrument print-outs, patient reports, and interview, the laboratory failed to ensure specimens were performed within 4 hours of collection for the Complete Blood Count (CBC) performed on the Sysmex XN-2000 (XN-20/XN-10) for 6 of 18 outpatient samples reviewed from October 3, 2023. Finding follow. A. Review of the Sysmex XN Series (XN-2000) Instructions for Use, CJ410539 rev 09/2017, on page 148 at 9.2 Prepare the Sample, 9.2.1 Sample types and handling under Handling whole blood stated, "The sample should be analyzed within 4 hours after collection. If it is not possible to analyze the sample within 4 hours, store it in a refrigerator at 2 to 8 degrees Celsius until it can be analyzed." And on page 398 at Chapter 15 Technical Information under Whole blood stability stated, "Long term stability is determined by comparing the results of the initial analysis (within 2 hours of collection) to results from samples stored at controlled room temperature (18-26 degrees Celsius) for 24 hours and refrigerated temperature for 48 hours." B. Review of the Sysmex Resource Manual for the Sysmex 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 -- XN-series, doc no 1002-LSS Rev 2 01/2013, on page 10 of Section 5 Additional Studies for Reference under Stability Study stated, " Stability studies may be performed to determine the readiness of a sample for CBC, differential and reticulocyte count analysis. Short term stability may be performed with fresh samples drawn and analyzed at intervals within one (1) hour. Long term stability is conducted under storage conditions over a period of time defined by the laboratory as acceptable specimen analysis..." C. Review of the laboratory's policy and procedure titled Whole Blood and Synovial Fluid Analysis, approved 03/23/2021, under E. Specimen Stability and Storage stated, "1. Stored at 2-8 degrees Celsius, EDTA whole blood samples with normal results may be analyzed up to 48 hours without significant loss of differential stability. 2. Whole blood stability at room temperature is 24 hours..." D. Review of the on-line Order Choice Catalog in Harvest for the CBC w/auto diff under Specimen Storage and preservation stated, "Room Temperature (20 to 25 degrees Celsius) 24 hours Refrigerated (2 to 8 degrees Celsius) 48 hours." E. On October 3, 2023 at 1500, the surveyor observed in the laboratory posted at the Hematology work station, a Hematology Sample Stability Chart that stated for the CBC "24 hrs at RT (room temperature) and 48 hrs refrigerated." F. Review of out-patient instrument print- outs that showed the date and time performed against the patient reports that showed date and time of collection for out-patient specimens run on October 3, 2023 revealed 6 of 18 exceeded the manufacturer's stability of 4 hours as listed by Sample No, date and time of collection, date and time of run, and elapsed time: Sample Number Collection date and time Run date and time Elapsed Time 1. 10691898 10/03/2023 1200 10/03/2023 1648 4 hours 48 minutes 2. 10718457 10/03/2023 1027 10/03/2023 1646 6 hours 19 minutes 3. 10719135 10/03/2023 1015 10/03/2023 1647 6 hours 32 minutes 4. 10474529 10/03/2023 0703 10/03/2023 1123 4 hours 20 minutes 5. 10711627 10/03/2023 1111 10/03/2023 1546 4 hours 35 minutes 6. 10662690 10/03 /2023 0704 10/03/2023 1124 4 hours 20 minutes G. Interview with general supervisor #3 (as listed on the CMS form 209) on October 3 2023 at 1430 hours confirmed a stability study to exceed the 4 hour stability of the CBC was not performed. 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 examining specimens. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policy and procedure, quality control records, validation records, and interview, the laboratory failed to follow its procedure for establishing the standard deviation (SD) used for Activated Partial Thromboplastin Time (APTT) on the ACL Elite Pro for 20 of 20 months reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Quality Control and Calibration of PT/APTT, approved 08/16/2016, under Quality Control stated "Two levels of control are recommended for a complete quality control program. Each laboratory should establish its own mean and standard deviation." Under Changing Lot Number of Control stated, "3. A control assay range must be established with every new lot number of controls or reagents. It is important to correctly establish a control assay range for every test that the laboratory will perform. 4. To be statistically significant, a minimum of 20 values on each control are needed. The mean, standard deviation, and %CV are calculated ... 6. Control ranges on the package -- 2 of 5 -- insert are only guidelines. Each individual laboratory must determine target values." B. Review of the analyzer for the current lot, N0138360/N0139022, showed the following SD were used for the quality control of APTT: Control SD Level 1 1.500 Level 3 2.000 C. Review of the validation records showed the previous lot, N0613545 /N0512850, showed the following SD for the quality control of APTT: Control SD Level 1 1.500 Level 3 2.000 D. Review of the laboratory's historical performance of QC from 10/08/21 to 06/05/23 showed the laboratory's SD over 20 months of data for APTT: Control SD Level 1 0.52 Level 3 1.1 E. Interview with technical supervisor # x on October 4, 2023 at 1030 hours acknowledged the SD was established at validation on 03/25/2019, but does not have the statistical data to support the established SDs. II. Based on review of the laboratory's policy and procedure, quality control records, validation records, and interview, the laboratory failed to follow its procedure for establishing the standard deviation (SD) used for Prothrombin Time (PT) on the ACL Elite Pro for 20 of 20 months reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Quality Control and Calibration of PT/APTT, approved 08/16/2016, under Quality Control stated "Two levels of control are recommended for a complete quality control program. Each laboratory should establish its own mean and standard deviation." Under Changing Lot Number of Control stated, "3. A control assay range must be established with every new lot number of controls or reagents. It is important to correctly establish a control assay range for every test that the laboratory will perform. 4. To be statistically significant, a minimum of 20 values on each control are needed. The mean, standard deviation, and %CV are calculated ... 6. Control ranges on the package insert are only guidelines. Each individual laboratory must determine target values." B. Review of the analyzer for the current lot, N0138360/N0139022, showed the following SD were used for the quality control of PT: Control SD Level 1 0.500 Level 3 2.000 C. Review of the validation records showed the previous lot, N0613545/N0512850, showed the following SD for the quality control of PT: Control SD Level 1 0.500 Level 3 2.000 D. Review of the laboratory's historical performance of QC from 10/08/21 to 06/05/23 showed the laboratory's SD over 20 months of data for PT: Control SD Level 1 0.3 Level 3 1.6 E. Interview with general supervisor #3 (as listed on the CMS form 209) on October 4, 2023 at 1030 hours acknowledged the SD was established at validation on 03/25/2019, but does not have the statistical data to support the established SDs. 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 review of the manufacturer's instructions, humidity logs, patient reports, and interview, the laboratory failed to ensure the humidity was within manufacturers specifications on the Beckman Coulter MicroScan WalkAway 96 plus used for urine cultures 17 out of 269 days reviewed. Findings follow. A. Review of the on-board Microscan WalkAway Instrument Guide, April 2018, in the Appendix A: WalkAway Instrument Components and Specifications under WalkAway Instrument Technical -- 3 of 5 -- Specifications for the Recommended Laboratory Environmental Conditions stated, "humidity 30 to 80% RH (no condensation)". B. Review of the Microscan Temperature/Humidity Chart from January 2023 - September 2023 showed 17 out of 269 days the humidity exceeded the manufacturer's recommendations as listed by date and humidity in percent: Date Humidity % 1. 01/14/23 32 2. 01/19/23 31 3. 01/20/23 30 4. 01/21/23 34 5. 01/23/23 32 6. 01/24/23 34 7. 01/26/23 34 8. 01/27/23 33 9. 02/02 /23 31 10. 02/11/23 32 11. 02/13/23 30 12. 02/17/23 32 13. 02/18/23 29 14. 03/14/23 34 15. 03/18/23 34 16. 03/19/23 33 17. 03/20/23 33 C. Random review of patient reports showed testing was performed on the above dates as shown by date of testing and the last 9 numerals of the patient ID: Date of testing Patient ID 1. 01/14/23 800389741 2. 01/19/23 703105786 3. 01/20/23 703015167 4. 01/21/23 703023015 5. 01/26/23 703021217 703109825 6. 01/27/23 701138693 702589572 7. 02/11/23 702981374 8. 02/13/23 800365179 9. 02/17/23 702998821 10. 02/18/23 702984485 703023957 11. 03/18/23 703109978 703014500 800275825 702999864 800226601 703014846 703025413 12. 03/19/23 703209697 703031866 703080777 800420356 13. 03/20/23 700633447 703014947 D. Interview with testing personnel #16 (as listed on the CMS form 209) on October 4, 2023 at 1515 hours confirmed the humidity was too low on a few days. D5783

Summary Statement of Deficiencies D0000 An onsite survey conducted January 11, 2022 through January 13, 2022 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on review of the histopathology case slides and interview, the laboratory failed to ensure histopathology slides were retained and accounted for in one of nine cases reviewed between 02/2015 - 12/2021. Findings follow. A. Review of one of nine cases showed Specimen S204947 from 2020 was missing the slide for the case. B. Interview with the histotech on January 12, 2022 at 1130 hours in the hall where slides were kept confirmed the slide was missing and acknowledged sometimes the pathologist would check out slides but not let the histotechs know who document the tracking of the slides. 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. 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 -- This STANDARD is not met as evidenced by: I. Based on review of the manufacturer's instructions, the laboratory's policy and procedure, temperature charts, patient testing records, and interview, the laboratory failed to ensure the temperature was within manufacturer' s requirements for four out of eight days of RPR (Rapid Plasma Reagin) testing using the BD Macro-Vue RPR Card Test for Syphilis testing in March 2021. Findings follow. A. Review of the BD Macro-Vue RPR Card Test package insert (0210745JAA(04), 2018-08), under Warnings and Precautions stated, "Controls and RPR card antigen suspension should be at room temperature (23 to 29 degrees Celsius when used)". B. Review of the laboratory's policy and procedure titled Macro Vue Rapid Plasma Reagin (RPR) Card Test revision May 27, 2020 under Warnings and Precautions stated, "Immediate use of a refrigerated antigen may result in decreased sensitivity of the test. Therefore, upon removal from the refrigerator, allow the antigen to warm to room temperature (23 to 29 degrees Celsius) before use." And under Procedure at Preliminary Preparations stated, "Controls, RPR Card antigen suspension and test specimens should be at room temperature (23 to 29 degrees Celsius) when used." C. Review of the temperature charts from 2021 showed the acceptable room temperature range was 17.0 - 27.0 degrees Celsius. Review of March 2021 showed the following testing dates with temperatures outside 23 to 29 degrees Celsius: 1. 03/05: 20.3 2. 03/09: 20.6 3. 03/16: 20.8 4. 03/25: 20.8 D. Review of patient testing records showed the following patients were tested as listed by sample ID: 1. 03/05: 9863177 2. 03/05: 9862983 3. 03/09: 9865727 4. 03/16: 9872564 5. 03/25: 9880559. E. Interview with testing personnel #7, listed on the CMS Form 209, on January 13, 2022 at 1130 hours in the laboratory confirmed the acceptable temperature range is outside the manufacturer's requirements and patient testing had been performed outside the acceptable range. 36342 II. Based on review of the ACL Elite Operator's manual, review of lot rollover records, surveyor observations, review of patient records, and interview with facility personnel, the laboratory failed to follow manufacturer instructions for changing the reference value used to calculate the international normalized ratio (INR) for 282 of 282 patient results tested between August 30, 2021 and January 11, 2022. The findings included: 1. Based on review of the ACL Elite Operator's manual, on page 4.30 under Setup and Utility, states the following: "PT NORMAL = Mean of the Normal Range (on the ACL Elite/Elite Pro this is called the Reference Value" and; "5. Select CALCULATION SETUP and the instrument will show in the right part of the screen the selection of the REFERENCE VALUE. This represents the Mean of the Normal Population value in SECONDS, which is used as the DENOMINATOR in the RATIO and INR CALCULATION." The manual's warning stated, "If the INR calculation is not properly setup, then erroneous patient results may be reported." 2. Based on review of lot rollover records from July 2021, the laboratory established a geometric mean of the normal patient range (MNPT) of 11.2 seconds for lot N0897673 of RecombiPlasTin 2G. 3. Based on surveyor observations at 16:17 hours on 1/11/2022 in the laboratory, the surveyor observed the reference value (MNPT) to be 11.50 seconds in the ACL Elite instrument software. 4. Based on review of patient records, the new lot of RecombiPlasTin 2G(N0897673) had been in use for patient testing since August 30, 2021. In total, 282 patient results were reported with the MNPT/Reference value from the previous lot (11.5 seconds). 5. In an interview at 16:17 hours on 1/11/2022 in the laboratory, the General Section Supervisor confirmed the Reference Value in the instrument software was not the reference value the laboratory had established in July 2021 and the value was not accurate for the current lot of RecombiPlasTin 2G reagent. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) -- 2 of 3 -- 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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, the laboratory's policy and procedures, quality control (QC) records, LIS query, and interview, the laboratory failed to ensure a negative control was performed when they ran QC on the BD Affirm VPIII Microbial Identification Test used to test the presence or absence of Gardnerella vaginalis, Trichomonas vaginalis, and Candida species for 24 of 24 months reviewed in 2020 and 2021. Findings follow. A. Review of the BD Affirm VPIII Microbial Identification Test (version 670160JAA(04), 2019-06) Instructions for Use, under Quality Control stated "Quality Control requirements must be performed in accordance with applicable local, state, and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent CLSI guidance and CLIA regulations for appropriate Quality Control practices." B. Review of the laboratory's policy and procedure titled Affirm VPIII Microbial Identification Test revised 12/01 /2015 under Quality Control at Tri-Valent Swab stated, "the Tri-Valent swab serves as an external control and is performed once weekly and when a new lot or shipment is opened." The negative external control was not included in the policy. C. Review of QC records from Jan 2020 - Dec 2021 showed only the positive external control was run weekly. D. Interview with testing personnel #15, listed on the CMS Form 209, on January 12, 2022 at 1620 hours in the laboratory confirmed no negative swab was tested for external QC. Interview with Technical Supervisor #3, listed on the CMS Form 209, on January 13, 2022 at 0915 hours in her office confirmed only the positive control had ever been tested for external QC on the BD Affirm. E. LIS query of the annual patient testing volume was 332 for 2021. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D6063 - 42 C.F.R. 493.1412 Condition: Testing Personnel; moderate complexity Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS- 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP) , it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of toxicology for carbamazepine, digoxin, phenytoin and valproic acid. Refer to D2119. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and CAP records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for Cholesterol - HDL. Findings: 1. CAP 2016 - 2nd event the laboratory received the unsatisfactory score of 0% for cholesterol HDL. D2111 TOXICOLOGY CFR(s): 493.845(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Review of the CMS report 155 and CAP proficiency testing records found that the laboratory failed to participate in the 2018 1st Testing Event and the 2018 2nd Testing Event for Toxicology, resulting in a score of 0% for all regulated analytes for the speciality of Toxicology, constituting unsatisfactory performance. Findings: 1. Laboratory received the following scores from CAP 2018 - 1st event: Carbamazepine - 0% Digoxin - 0% Phenytoin - 0% Valproic Acid - 0% 2. Laboratory received the following scores from CAP 2018 - 2nd event: Carbamazepine - 0% Digoxin - 0% Phenytoin - 0% Valproic Acid - 0% D2115 TOXICOLOGY CFR(s): 493.845(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. -- 2 of 4 -- This STANDARD is not met as evidenced by: Review of the CMS report 155 and CAP proficiency testing records found that the laboratory failed to participate in the 2018 1st and 2nd Testing Events for Toxicology, resulting in an event score of 0%, constituting unsatisfactory performance. Findings: 1. CAP 2018 - 1st event the laboratory received an unsatisfactory event score of 0%. 2. CAP 2018 - 2nd event the laboratory received an unsatisfactory event score of 0%. D2118 TOXICOLOGY CFR(s): 493.845(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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Toxicology for the analytes carbamazepine, digoxin, phenytoin and valproic acid. Two out of three unsatisfactory scores results in unsuccessful PT performance. 1. Laboratory received the following scores from CAP 2018 - 1st event: Carbamazepine - 0% Digoxin - 0% Phenytoin - 0% Valproic Acid - 0% 2. Laboratory received the following scores from CAP 2018 - 2nd event: Carbamazepine - 0% Digoxin - 0% Phenytoin - 0% Valproic Acid - 0% D2119 TOXICOLOGY CFR(s): 493.845(g) Failure to achieve an overall testing event score of satisfactory performance for 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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the speciality of Toxicology in two consecutive testing events or two out of three consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. CAP 2018 - 1st event the laboratory received an unsatisfactory event score of 0%. 2. CAP 2018 - 2nd event the laboratory received an unsatisfactory event score of 0%. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: -- 3 of 4 -- Based on a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2118 and D2119 -- 4 of 4 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --