Lesley A Fein Md

Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to maintain Work Records (WR), Attestation Statements (AS) and graded results for Hematology tests performed with the Medical Laboratory Evaluation (MLE) in M1 and M2 2020 events. The findings include: 1. The laboratory did not document handling, processing and each step in the testing and reporting of PT samples. 2. There was no raw data to substantiate reported results for event M2. 3. There were no graded results available for M1 and M2 events 4. There were no attestation statements for M1 and M2 events. 5. The TP confirmed on 11/17/20 at 10:30 am that the laboratory did not maintain records for PT events M1 and M2. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a 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 -- 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: Based on surveyor review of the Proficiency Testing (PT) evaluation records, work records and interview with Testing Personnel the laboratory failed to participate in PT for the third event in 2020 for Hematology tests with the Medical Laboratory Evaluation. D2123 HEMATOLOGY CFR(s): 493.851(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: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to participate in Medical Laboratories Evaluation (MLE) PT for the third event of 2020 for Hematology tests. The TP confirmed on 11/17/20 at 1:00 pm that the laboratory did not participate in the third event of 2020. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: -- 2 of 11 -- Based on the lack of a procedure manual, surveyor review of the Quality Control (QC) records, proficiency testing records and interview with the Testing Personnel (TP), the laboratory failed to ensure that quality systems for the pre-analytic, analytic and post-analytical phases of Hematology testing were monitored at the date of survey. 1. The laboratory failed to maintain Proficiency Testing (PT) records. Cross refer to D2015 2. The laboratory failed to participate in PT event 3 of 2020. Cross refer to D2123. 3. The Laboratory failed to evaluate PT. Cross refer to D5211 4. The laboratory failed to monitor temperature and humidity where testing was performed. Cross refer to D5413 5. The laboratory failed to perform maintenance on the Sysmex XP-300 analyzer as required by the manufacture. Cross refer to D5429 6. The laboratory failed to perform calibration on the Sysmex XP-300 analyzer. Cross refer to D5439. 7. The laboratory failed to perform QC verification on new lots of QC. Cross refer to D5469 8. The laboratory did not maintain an accession log. Cross Refer to D5787 9. The laboratory failed to establish a procedure to verify new QC. Cross refer to D5791. 10. The laboratory failed to identify the proper TP performing testing on the Test Report. Cross refer to D5891 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 the lack of Competency Assessment (CA) records and interview with the Testing Personnel (TP) and Laboratory Director (LD), the laboratory failed to establish and follow written procedures to perform a CA on one out of one TP from 3 /27/19 to the date of survey. The LD confirmed on 11/17/20 at 12:00 pm that the CA was not performed as stated above. 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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to review and evaluate PT results obtained from Medical Laboratory Evaluation (MLE) for Hematology with Auto Differential events performed in 2020. The findings include: 1. There was no evidence of evaluation documentated. the "CMS performance summery" was not signed and dated for MLE-M1, M2, and M3 2. The TP confirmed on 11/17/20 at 10:45 pm that the laboratory did not review and evaluate all PT results. 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 -- 3 of 11 -- may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the lack of the Procedure Manual, Sysmex XP-300 operators manual and interview with the testing personnel (TP), the laboratory failed to have written procedures for Hematology tests, assays, and examinations performed by the laboratory from 3/27/19 to the date of survey. The TP confirmed on 11/17/20 at 11:00 am that the laboratory did not have written procedures for all tests, assays, and examinations performed by the laboratory. 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 surveyor review of temperature logs and interview with the Testing personnel (TP) the laboratory failed to monitor and document room temperature and humidity, and refrigerator temperature were Hematology testing were performed from 3/20/20 to the date of survey. The TP confirmed on 11/17/20 at 12:00 pm that the laboratory did not document temperature and humidity. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor review of Manufactures Package Insert, observation of the Quality Control material, and interview with the Testing Personnel (TP), the laboratory failed to put open and new expiration dates on Hematology Control material used on the Sysmex XP-300 on the date of the survey. The TP confirmed on 11/17/20 at 1:10 pm the laboratory failed to put open and new expiration dates on the control material. 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 -- 4 of 11 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on lack of Maintenance Records (MR) and interview with the Testing personnel (TP), the laboratory failed to perform and document maintenance as specified by the manufacturer on the Sysmex XP-300 analyzer used for Hematology tests from 3/27/19 to the date of survey. The finding includes: 1. There was no documented evidence daily, weekly or monthly maintenance was performed. 2. Approximately 10 to 15 samples were run per day. 3. The TP confirmed on 11/17/20 at 11:35 am that maintenance as specified by the manufacturer was not performed. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of Calibration records and interview with the Testing Personnel (TP), the laboratory failed to perform and document Calibration procedures at least once every six months for Hematology Tests performed on the Sysmex XP- 300 from April 2019 to the date of the survey. The TP confirmed on 11/17/20 at 11:30 am Calibration was not performed every six months. 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-- 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 the lack of Quality Control (QC) records and interview with the Testing -- 5 of 11 -- Personnel (TP), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment of Eightcheck-3WP X-TRA control material performed on the Sysmex XP-300 from 3/27/19 until the date of survey. The TP confirmed on 11 /17/20 at 10:15 am that the assayed values of QC material were not verified before putting in use. D5779

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to retain QC records for tests performed on the Envoy 500 analyzer from January 2018 to the date of survey. The finding includes: 1. The QC records for Sodium, Chloride, Total Protein, Total Iron were not retained from 4/1/18 - 4/30/2018. 2. The QC records for low-density lipoproteins, Creatine Kinase, Uric Acid, Cholesterol, Direct bilirubin, Total Iron, were not retained from 1/1/18 - 9/18/18. 3. The TP # 1 listed on the CMS form 209 confirmed on 3/27/19 at 10:00 AM that the QC records were not retained. b) Based on the lack of Calibration Records (CR) records and interview with the TP, the laboratory failed to retain CR for tests performed on the Envoy 500 analyzer from 4/11/17 to the date of survey. The TP # 1 listed on the CMS form 209 confirmed on 3/27/19 at 11:00 am that the CR were not retained. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to evaluate results when they 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 -- received an unacceptable score in Chemistry with Medical Laboratory Evaluation (MLE) in the 1st event of 2018. The findings include: 1. There was no evaluation documented when the laboratory received an unacceptable grade for Iron sample CH- 1 - 5, Creatine Kinase CH-2 - 5, Uric Acid CH-1, CH-2, CH-4, Cholesterol CH-2 - 5, in 1-2018. 2. There was no documented evidence the laboratory evaluated the failures. 3. The TP#1 confirmed on 3/24/18 at 10:20 am that the laboratory did not perform and document an evaluation of unacceptable PT results. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor review of Manufactures Package Insert, observation of the Quality Control (QC) material, and interview with the Testing Personnel (TP), the laboratory failed to put open and new expiration dates on Hematology Control vials from August 2018 to the date of survey. The findings include. 1. The MPI for Eightcheck -3WP X- TRA Controls stated that QC vials for Hematology expired 14 days after opening if stored at 2 to 8 degrees Celsius. 2. The TP was not aware that QC vials expired 14 days after opening. 3. The TP #1 on CMS form 209 confirmed on 3/27/19 /19 at 10:30 am the laboratory failed to put new expiration dates on the control vials. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE 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 surveyor review of the Performance Specification (PS) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that PS procedures were performed on the Sysmex XP 300 analyzer from August 2018 to the date of survey. The finding includes: 1. There was no documented evidence Accuracy and Reportable Range Verification was performed. 2. The TP #1 listed on the CMS form 209 confirmed on 3/28/19 at 11:15 am that PS records were performed. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 2 of 5 -- 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. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with Testing Personnel (TP), the laboratory failed to ensure two levels of QC was required in range on each day of patient testing for Chemistry tests performed on the Envoy +500 from 12/4/18 to the date of survey. The findings include: 1. A review of the QC records revealed that controls were out of range as follows: a. 12/4/18 - Blood urea nitrogen low control . b. 12/11/18- Carbon dioxide low control. c. 12/18/18 - Creatine Kinase low control d. 12/20/18 - Serum Glutamic-Oxaloacetic Transaminase low and high control. e. 12/28/18 - Serum Glutamic-Oxaloacetic Transaminase high control. f. 12/28/18 - Blood urea nitrogen high control. g. 2/1/19 - Calcium low control h. 2/26 /19 - Blood urea nitrogen high control. 2. Approximately one to three patients were run and reported each with one level of QC in range. 3. The TP#1 listed on CMS form 209 confirmed on 3/27/19 at 10:50 am that laboratory failed to have to ensure two levels of QC was required in range on each day of patient testing. 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-- 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: a) Based on surveyor review of Quality Control (QC) records, Manufacture's Package Insert (MPI) and interview with the Testing Personnel (TP), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment for Hematology testing performed on the Sysmex XP300 analyzer from August 2018 to the date of survey. The TP #1 lisetd on CMS form 209 confirmed on 3/27/2019 at 12: 00 pm that the QC materials were not verified before putting in use. b) Based on surveyor review of Quality Control (QC) records, Manufacture's Package Insert (MPI) and interview with the Testing Personnel (TP), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment for Routine Chemistry testing performed on the Envoy 500+ analyzer from 4/11/17 to the date of survey. The TP #1 lisetd on CMS form 209 confirmed on 3/27/2019 at 12:00 pm that the QC materials were not verified before putting in use. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 3 of 5 -- 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: Based on an surveyors review of the laboratory's records, procedures and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to provide overall management and direction to the laboratory to ensure that laboratory testing is performed satisfactorily and in compliance with the CLIA regulations from 4/11/17 to the date of the survey. 1. The LD failed to ensure PT results were reviewed. Cross Refer to D6018. 2. The LD failed to ensure a Quality Control program was maintained. Cross Refer to D6020. 3. The LD failed to ensure a Quality Assessment program was maintained. Cross Refer to D6021. 4. The LD failed to establish a Competency Assessment procedure with the applicable elements. Cross Refer to D6103. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Quality Control (QC) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure a Quality Control (QC) program was maintained for Hematology and Chemistry Testing from 4/11/17 to the date of survey. The findings include: 1) The PM stated that "Levy-Jennings charts for all analytes must be printed at the end of month for review by the Technical Supervisor and/or Director". 2) Levy Jennings Charts for Total Protein, Albumin, Globulin, Creatine Kinase, Blood urea nitrogen, Creatinie, Date range 1/1/18 - 7/31/2018 had not QC results for 9/18/2018. 3) There was no evidence of monthly QC review. 4) The TP #1 listed on CMS from 209 confirmed on 3/27/19 at 11:00 am that a QC program was not maintained. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Quality Assurance (QA) policy and interview with the Testing Personnel (TP), the Laboratory Director failed to ensure that a QA program was maintained from 4/11/17 to the date of survey. The findings include: 1. The QA procedure stated the Technical Supervisor and or Laboratory Director will complete a "Monthly review tracking sheet". 2. The QA procedure stated the Technical Supervisor and or Laboratory Director will complete a "Case study review". 3. The QA procedure stated "Quality Assurance meeting - The Laboratory Director, Technical Supervisor and all Technical Staff will meet quarterly to assess the performance of the laboratory" 4. The QA procedure stated "Semi- Annually: Split samples analysis. The Laboratory will send 5 samples to an outside laboratory using the same or similar methodology to ascertain the reliability of the results" 5. The QA procedure stated that "Annually: Reference Range review Reference Ranges for assays performed in lab must be reviewed annually and/or with any instrument change or change in the patient population" 6. There was no documented evidence that a above procedures were completed. 7. The TP #1 listed on CMS form 209 confirmed on 3/27/19 at 11:50 am that the laboratory did not maintain the QA program. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the Laboratory Director failed to establish a Competency Assessment (CA) procedure with the elements for TP from 4/11/17 to the date of survey. The TP # 1 listed on CMS form 209 confirmed on 3/27/19 at 10:30 am that a CA procedure was not established. -- 5 of 5 --

Summary Statement of Deficiencies 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: Based on an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve a score of at least 80% or more in two out of three events for Total Bilirubin tests with Medical Laboratory Evaluation. 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. 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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to to achieve at least 80% for the Total Bilirubin test. The finding includes: 1. The laboratory scored a 40% in 1-18 and 3-18 PT events with Medical Laboratory Evaluation. 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: Based on an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with CLIA regulations are maintained. -- 2 of 2 --