Ehpn - Hematology Oncology

Summary Statement of Deficiencies 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: Based on surveyor review of the Procedure Manual (PM), Work Records (WR) and interview with the Techincal Consultant (TC), the laboratory failed to have a procedure for Complete Blood Count (CBC) results with flags from 8/20/22 to the date of survey. The TC confirmed on 2/28/24 at 11:30 am that the laboratory failed to have the aforementioned procedure. 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 Complete Blood Cell (CBC) and automated differential Performance Specification (PS) records and interview with the Techincal Consultant 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 -- (TC), the laboratory failed to ensure that all PS records were adequate for all analytes run on the Beckman Coulter DxH520 Analyzer from 8/20/22 to the date of survey. The findings include: 1. There was no source cited for Normal Patient Range. 2. There was no documented evidence that Liniaritry was perfomed.. 3. The TC confirmed on 2 /28/24 at 11:30 am that the laboratory failed to ensure that all PS records were adequate. 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 Verification(CV) records, Operators Manual (OM) and interview with the Techincal Consultant (TC), the laboratory failed to perform and document Calibration procedures at least once every six months for Hematology Tests performed on the Beckman Coulter DxH520 analyzer from 8/20/22 to the date of the survey. The finding includes: 1. A review of CV records revealed that the laboratory did not perform Carryover or reproducibility on the dates CV was documented. 2. The TC confirmed on 2/28 at 10:30 am that the laboratory failed to perform Carryover or reproducibility. Note: This was previously cited 8/12/21 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 surveyor review of Quality Control (QC) records and interview with the Techincal Consultant (TC), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment of Hematology QC used on the Beckman -- 2 of 3 -- Coulter DxH520 analyzer from July 2021 to the date of survey. The findings include: 1. There is no documented evidence that QC material was verified. 2. The TC confirmed on 2/28/24 at 11:00 am that all assayed QC material was not verified before putting in use. Note: This was previously cited 8/12/21 -- 3 of 3 --

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) and Attestation Statements (AS) signed by the laboratory director for Hematology tests performed with the American Proficiency Institute (API) in 2020 and 2021. The findings include: 1. There was no AS for API - Hematology - 3rd event 2020. 2. There was no WR for API - Hematology - 1st event 2021. 3 . The TP #1 listed on CMS form 209 confirmed on 8/12/21 at 2:15 pm that the laboratory did not maintain complete records for PT. 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to follow written procedures to perform a CA on one of one Technical Consultants for the calendar year 2020. The TP #1 listed on CMS from 209 confirmed on 8/12/21 at 1:40 pm that the CA procedure was not followed. 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 review and evaluate results when they received an unacceptable score in Hematology tests performed with the American Association of Bioanalysts (AAB), for the offcycle event 10/25/19. The findings include: 1. The laboratory received an 60% Grade for Hematocrit. 2. There was no documented evidence that the laboratory investigated the failure. 3. The TP #1 listed on CMS form 209 confirmed on 8/12/21 at 2:45 pm that the laboratory did not review and document an evaluation of unacceptable 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 may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow their PM policy for flagging of Hematology results run on the Beckman Coulter AcT Diff 2 from 2/28/19 to the date of survey. The findings include: 1) The PM stated "X,+, and * flags will be rerun once" but a review of results with X, + and * revealed 20 out of 20 samples were not repeated. 2) The PM stated "1,2,3,4 or M differential flags are to be rerun once. If the parameter flagged is deemed unnecessary for treatment, the ordering physician may elect to forgo a rerun and have that result crossed out on the raw data print-out with a comment that says "not for diagnostic use". but a review of 20 out of 20 samples were not repeated or documented with the statement "not for diagnostic use". 3) The TP #1 listed on CMS form 209 confirmed on 8/12/21 at 2:20 pm the PM was not followed. Note: This deficiency was cited on surveys performed 2/8/17 and 2/28/19. b) Based on surveyor review of the PM, Quality Control (QC) records and interview with the TP, the laboratory failed to follow their policy for "Quality Control" performed on the Beckman Coulter AcT Diff 2 analyzer from 2/28/19 to the date of survey. The findings include: 1) The PM stated "Quality control value Levy Jennings (LJ) charts are reviewed by the technician on a weekly basis" 2) There was no documented evidence that LJ charts were reviewed on a weekly basis. 3) The PM stated "Quality -- 2 of 6 -- control Levy Jennings charts are reviewed by the Technical Consultant (TC) and the Laboratory Director (LD) on a monthly basis." 4) There was no documented evidence that LJ charts were reviewed by the LD. 5) There was no documented evidence that LJ charts were reviewed by the TC from 8/17/19 through December 2020. 6). The TP #1 listed on CMS form 209 confirmed on 8/12/21 at 2:50 pm the QC procedure was not being followed. 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 Verification(CV) records, Operators Manual (OM) 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 Beckman Coulter Act2 Diff analyzer from 2/28/19 to the date of the survey. The finding includes: 1. A review of CV records revealed that the laboratory did not perform Carryover or Calibration on the dates CV was documented. 2. The TP #1 of CMS form 209 confirmed on 8/12/21 at 2:30 pm that the laboratory failed to perform and document CV. 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 surveyor review of Quality Control records and interview with the Testing Personnel (TP), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment of Hematology QC used on the Beckman Coulter Act -- 3 of 6 -- Diff 2 analyzer from April 2021 to July 2021. The findings include: 1. Coulter 4C-ES Cell Controls lot 067600 put in use in April 2021 had no documented evidence that QC verification was performed. 2. Coulter 4C-ES Cell Control lots expire every three months. 3. The TP#1 listed on CMS form 209 confirmed on 8/12/21 at 2:00 pm that all assayed QC material was not verified before putting in use. 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 surveyor review of the Laboratory records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to provide overall management and direction to the laboratory from 2/28/19 to the date of survey. The findings include: 1. The LD failed to ensure that the QC program is maintained. Cross refer to D6020. 2. The Laboratory failed to follow their PM policy for flagging of Hematology results. Cross refer D5401. a) Note: This deficiency was cited on surveys performed 2/8/17 and 2/28/19. b) The Allegation Of Compliance(AOC) for the survey performed 2/8/17 stated: "The TP was briefed to perform repeat testing on patient specimens that have results with a asterisk (*). This will be reviewed by the TC at the end of each calendar month and after reviewed and signed by the LD. " c) The AOC for the survey performed 2/28/19 stated: Evaluation of analyzer flags: As part of the QA plan to be implemented by new TC, reference ranges and flags will be reviewed at least annually. As part of competency assessment, follow-up of flags will be reviewed when results are reviewed " d) There was no evidence the laboratory followed the AOC's 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 Quality Control (QC) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that the QC program is maintained for laboratory services provided from 2/28/19 to the date of the survey. The findings include: 1. There was no documented evidence that the LD reviewed Complete Blood Count (CBC) QC. 2. The TP # 1 listed on CMS form 209 confirmed on 8/12/21 at 2:00 pm the LD did not ensure the QC program was maintained. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 -- 4 of 6 -- The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor review of laboratory records, Quality Control (QC), Procedure Manual (PM) and personnel records and interview with the Testing Personnel (TP), the Technical Consultant (TC) failed to provide oversight and fulfill the requirements listed with 493.1413. 1. The TC failed to ensure that the QC programs were maintained. Cross refer to D6042 2. The TC failed to properly train staff. Cross refer to D6045 3. The TC failed to unsure TP followed the PM. Cross refer to D5401 D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on surveyor review the Quality Control (QC) records, Calibration records, Package Inserts (PI) and interview with the Testing Personnel (TP), the Technical Consultant (TC) failed to ensure that the QC programs were maintained from 8/14/19 to the date of survey. The findings include: 1. There was no evidence of QC review from 8/14/19 to January 2021. 2. QC verification was not run on Coulter 4C-ES Cell Controls lot 067600. 3. The laboratory did not perform Carryover or Calibration on the dates CV was documented. 4. The TP #1 listed on CMS from 209 confirmed on 8 /12/21 at 2:30 pm that the QC programs were not maintained. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on surveyor review of the Training Records (TR) and interview with the Testing Personnel (TP), the Technical Consultant failed to have appropriate training on one out of one TP performing patient testing from 8/14/19 to the date of the survey. The findings include: 1) The TP was not trained properly on how to perform Calibration Verification (CV). a) A review of CV records revealed that the laboratory did not perform Carryover or Calibration on the dates CV was documented. 2) The TP#1 on CMS form 209 confirmed on 8/12/21 at 2:05 pm that the TC did not appropriately train TP on CV. -- 5 of 6 -- D6074 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(5) Each individual performing moderate complexity testing must be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the technical consultant, clinical consultant or director. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the TP failed to identify problems that may affect test performance by not reviewing and evaluating trends and/or shifts for tests performed on the Beckman Coulter AcT diff 2 analyzer from 2/28/19 to the date of survey. The TP #1 listed on CMS form 209 confirmed on 8/12/21 at 1:35 pm that trends and shifts were not reviewed. -- 6 of 6 --

Summary Statement of Deficiencies 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 American Proficiency Institute PT for the second event of 2019 for Hematology tests. The TP confirmed on 6/19/19 at 1:00 pm that the laboratory did not participate in the second event of 2019. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for 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 -- acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Reports (FR) and interview with the Office Manager (OM), the laboratory failed to include all the required information on the FR from May 2019 to the date of survey. The finding includes: 1. Ten out of ten FR did not have the reference laboratory full name and address. 2. The OM confirmed on 6/19 /19 at 1 pm the FR did not have all the required information. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to retain all PT records performed with the American Proficiency Institute for events 1 & 3 of 2017. The TP #3 listed on CMS for 209 confirmed on 2/28/19 at 1:00 pm that the laboratory failed to retain all PT records. 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 surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to follow its policies and procedures for assessing the competency of the TP in the calendar years 2017 and 2018. The finding includes: 1) The laboratory CA policy stated "for new employees, an evaluation will be done after a 6 month probationary period and thereafter for the first year of continued employment. A yearly evaluation shall then follow" but there was no evidence of CA being performed on three out of three TP. 2) This deficiency was cited on the last survey 2/8/17. 3) The Allegation of Compliance stated "Immediately following the survey records of CA will be kept in a binder." 4) The TP 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 -- #3 listed on CMS form 209 confirmed on 2/28/19 at 12:25 pm that CA was not performed in 2017 and 2018. 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: a) Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow their PM policy for flagging of Hematology results run on the Beckman Coulter AcT diff 2 in the calendar year 2019. The finding includes: 1) The PM stated to repeat any sample with an asterisk, X, 1,2,3,4,and M but a review of results with asterisks, X, 1,2,3,4,and M revealed 16 out of 16 samples were not repeated. 2) This deficiency was cited on the last survey 2/8 /17. 3) The Allegation of Compliance (AOC) stated "The TP after the inspection on 2 /8/17 shall begin to pro-actively follow the procedure manual and be diligent in repeating the tested specimens that have asterisks on their result" 4) The TP #3 listed on CMS form 209 confirmed on 2/28/19 at 1:20 pm the pm was not followed. b) Based on surveyor review of the PM, Quality Control (QC) records and interview with the TP, the laboratory failed to follow their policy for QC verification for the Beckman Coulter AcT diff 2 analyzer from 1/3/17 to the date of survey. The findings include: 1) The PM stated "Test the new lot in parallel with old lot one time a day for a minimum of 3 days" but the laboratory did not test the new lot numbers. 2) The laboraotry did not perform any lot QC verification since 1/13/17. 3) This deficiency was cited on the last survey 2/8/17. 4) The AOC stated "The new lot # shall be ran in parallel with the old lot once per day for three consecutive days" 5). The TP #3 listed on CMS form 209 confirmed on at 1:50 pm the QC procedure was not being followed. 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 observation of the Quality Control (QC) material in use and interview with the Testing Personnel (TP), the laboratory failed to label the control material used in Hematology testing with an open and new expiration date after opening on the date of the survey. The findings include: 1) There was no open and expiration date written on the QC material. 2) This deficiency was cited on the last survey 2/8/17. 3) The Allegation of Compliance stated, "Post-inspection the lab is now enforcing the labeling of each control reagents,diluents and calibrators with the -- 2 of 5 -- following: date opened, expiration date and TP initials in compliance with CLIA regulation" 4) The TP #3 listed on CMS form 209 confirmed on 2/28/19 at 1:45 pm controls were not labeled. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of Calibration Verification (CV) records and interview with the Testing Personnel (TP), the laboratory failed to perform and document CV procedures at least once every six months for Hematology Testing on the Beckman Coulter Act diff 2 analyzer in the calendar year 2018. The finding includes: 1. The laboratory did not perform CV twice in 2018. 2. The TP #3 listed on CMS form 209 confirmed on 2/28/19 at 11:00 am CV was not performed every six months. 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 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 3/6/15 to the date of the survey. 1. The LD failed to ensure failed to ensure that PT samples were tested. Cross Refer to D6016. 2. The LD failed to ensure PT results were reviewed. Cross Refer to D6018 3. The LD failed to ensure a Quality Control program was established and maintained. Cross Refer to D6020. 4. The LD failed to ensure a -- 3 of 5 -- Quality Assessment program was established and maintained. Cross Refer to D6021. 5. This deficiency was cited on the last survey 2/8/17. 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 surveyor review of Proficiency Testing (PT) results and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that PT samples were tested for Hematology in the 2nd event of 2017 with American Proficiency Institute (API). The TP #3 listed on CMS form 209 confirmed on 2/28/19 at 1:30 pm that the LD did not ensure that PT samples were tested. 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