Columbus Ltach, Llc

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) and interview with the Technical Consultant (TC), the laboratory failed to follow their policy for "Controls" from 1/18/18 to the date of survey. The findings include: 1. The control policy stated "All new shipments of cartridges and Tri-Controls that are received will have testing done by analyzing two (2) levels of Tri-Controls (Level I and Level 3) on the appropriate number of cartridges utilizing a representative sample of each new lot and comparing the results to the expected values published in the Value Assignment Sheets." 2. There was no documented evidence that the above mentioned procedure was followed. 3. The TC confirmed on 12/21/2021 at 1:21 pm the aforementioned policies were not followed. 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 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 -- 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 the Quality Control (QC) records and interview with the Technical Consultant (TC), the laboratory failed to verify that the assayed QC materials were within the acceptable ranges before they were put into use for tests performed on the iSTATanalyzer from 1/18/18 to the date of survey. The TC confirmed on 12/21/21 at 1:00 pm that the laboratory did not verify QC material. Note: this was cited 5/26/19 -- 2 of 2 --

Summary Statement of Deficiencies 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, review of the personnel files and interview with the Testing Personnel (TP), the laboratory failed to perform a CA on fourteen out of twenty four TP in the Calendar year 2018. The TP #24 on CMS form 209 confirmed on 5/29/19 at 10:00 am that a CA was not performed on the TP. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- 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 perform and document two level of controls on each day of patient testing for Arterial Blood Gas (ABG) testing performed on the iSTAT analyzer. The findings include: 1. Controls were not run on 7 /4/18, 7/16/18, 7/19/18, 7/20/18, 7/23/18, 7/24/18 and 7/30/18. 2. Approximately fifty 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 -- eight patients were run and reported each day QC was not done. 3. The TP #24 listed on CMS form 209 confirmed on 5/29/19 at 11:00 am that two levels of QC were not performed every 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: Based on surveyor review of the Quality Control (QC) records and interview with the Technical Consultant (TC), the laboratory failed to verify that the assayed QC materials were within the acceptable ranges before they were put into use for tests performed on the iSTATanalyzer from 1/18/18 to the date of survey. The TP #24 listed on CMS form 209 confirmed on 5/29/19 at 11:00 am that the laboratory did not verify QC material. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 Proficiency Testing (PT) records and interview with the General Supervisor (GS) the laboratory failed to maintain copies of all PT records for Blood Gas testing performed with the American Proficiency Institute (API) in 2017. The finding includes: 1. A review of PT revealed the laboratory didn't maintain work records for events 2 and 3 in 2017. 2. The GS #2 listed on CMS form 209 confirmed on 1/18/18 at 11:05 am that all PT records were not maintained. 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records, Procedure Manual and interview with the General Supervisor (GS), the laboratory failed to retain the Manufacturer's Package Inserts (MPI) for Blood Gas cartridges and QC material used on the Abbott iSTAT analyzer from May 2017 to the date of survey. The GS #2 listed on CMS form 209 confirmed on 1/18/18 at 10:00 am that the MPI were not retained. 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) and interview with the General Supervisor (GS), the laboratory failed to have a written procedure for lot to lot Quality Control (QC) verification for all tests performed on the Abbott iSTAT analyzer from May 2017 to the date of survey. The GS #2 listed on CMS form 209 confirmed on 1/18/18 at 11:00 am that the procedure mentioned above was not in the PM. 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 lack of Performance Specifications (PS) records and interview with the General Supervisor (GS), the laboratory failed to verify accuracy, precision and reportable range on Blood Gas tests performed on the Abbott iSTAT analyzer before reporting patient test results from May 2017 to the date of survey. The GS #2 on the CMS form 209 confirmed on 1/18/18 at 11:50 am PS were done. 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 -- 2 of 5 -- acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the General Supervisor (GS), the laboratory failed to include the name and address of the laboratory where Blood Gas testing was performed from May 2017 to the date of the survey. The GS #2 on CMS form 209 confirmed on 1/18/18 at 11:50 am the laboratory location was not on the FR. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the General Supervisor (GS), the laboratory failed to include the Normal Reference Intervals (NRI) for Blood Gas tests performed on the Abbott iSTAT analyzer from May 2017 to the date of survey. The GS #2 listed on CMS form 209 confirmed on 1/18/18 at 11: 55 am that the laboratory failed to include the NRI on the FR. 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 General Supervisor (GS), the Laboratory Director failed to ensure that a QC program was established for laboratory services provided from May 2017 to the date of the survey. The GS #2 listed on CMS form 209 confirmed on 1/18/18 at 11:20 am the LD did not ensure a QC plan was established. 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. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on the lack of a Quality Assessment (QA) program and interview with the General Supervisor (GS), the Laboratory Director failed to ensure that a QA program was established from May 2017 to the date of survey. The GS #2 listed on CMS form 209 confirmed on 1/18/18 at 11:25 am that the laboratory did not have a QA program. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of Personnel Files (PF) and interview with the General Supervisor (GS), the Laboratory Director failed to have education records for 27 out of 27 Testing Personnel from May 2017 to the date of the survey. The GS #2 listed on CMS form 209 confirmed on 1/18/18 at 9:40 am that there were no education records. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) 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 and interview with the General Supervisor (GS), the Laboratory Director failed to establish a Competency Assessment (CA) procedure with the required elements for Testing Personnel from May 2017 to the date of the survey. The GS #2 listed on CMS form 209 confirmed on 1/18/18 at 10:10 am that a CA procedure was not established. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 4 of 5 -- 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the General Supervisor (GS), the Laboratory Director failed to ensure that an approved procedure manual was available for Blood Gas testing from May 2017 to the date of the survey. The GS #2 listed on CMS form 209 confirmed on 1/18/18 at 9:45 am that an approved PM was not available. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the General Supervisor (GS), the Laboratory Director (LD) did not specify in writing the duties and responsibilities of Testing Personnel (TP) engaged in the performance of preanalytic, analytic and post analytic phases of Abbot iSTAT Blood Gas tests from May 2017 to the date of survey. The GS #2 listed on CMS form 209 confirmed on 1 /18/18 at 10:20 am that the LD did not specify the duties and responsibilities of TP. -- 5 of 5 --