Jackson Medical Center

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory policies, procedures, competency evaluations, and proficiency testing records the laboratory failed to follow policies and perform competencies for the position of technical consultant (refer to D5209) and failed to verify accuracy of non regulated analytes twice yearly (refer to D5217). This is a repeat deficiency previously cited on June 28, 2017. 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 review of the procedure manual, personnel documentation and interview with the testing personnel (TP) #1, the laboratory failed to follow the laboratory policy and perform a competency evaluation for 2018 and to date July 29, 2019 for the position of technical consultant. Findings: 1. Review of 2018, 2019 personnel Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- documentation revealed the laboratory failed to perform 1 of 1 competency assessment for the position of technical consultant. 2. Review of the policy for competency evaluation revealed "The competency of each employee will be documented. Evaluations will be performed twice during the first year of employment and annually thereafter." 3. Interview with the TP #1 on July 29, 2019 at 4:00PM confirmed the laboratory failed to follow and perform annual competencies for 2018 and to date July 29, 2019 for the position of technical consultant. TP #1 stated, "The technical consultant has not been here for one and one-half years." This is a repeat deficiency previously cited on June 28, 2017. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the procedure manual, accuracy verification records, proficiency testing (PT) records for 2017, 2018 and to date July 29, 2019, and interview with the testing personnel #1, the laboratory failed to establish a means to verify the accuracy of the non-regulated analytes: C-reactive protein(CRP), urine microalbumin, potassium hydroxide (KOH) and urine microscopic exam testing twice a year. Findings: 1. Review of the quality assessment program policy showed "Two times per year accuracy verification will be accomplished through in-house look behind or send out to a reference laboratory for comparison testing." 2. Review of CRP PT for the third event of 2017 showed a result of 50 percent. 3. Review of CRP PT for the first event of 2018 showed a result of 0 percent. 4. Review of CRP PT for the second event of 2018 showed a result of 50 percent. 5. Review of CRP PT for the third event of 2018 showed a result of 50 percent. 6. Review of CRP PT for the first event of 2019 showed a result of 0 percent. 7. Review of PT records revealed the laboratory was not enrolled in PT testing to prove accuracy and did not perform accuracy verification procedures for urine microalbumin, KOH, and urine microscopic exam testing. 8. Interview with the testing personnel #1 on July 29, 2019 at 4:00 PM confirmed the laboratory failed to verify the accuracy of the non-regulated analytes: CRP, KOH, urine microalbumin and urine microscopic exam testing twice annually for 2017, 2018 and to date July 29, 2019. This is a repeat deficiency previously cited on June 28, 2017. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the procedure manual, quality control logs, calibration records, and interview, the laboratory failed to follow quality control parallel testing procedure -- 2 of 14 -- (refer to D5401), failed to follow the lab's procedure for calibration verification (refer to D5439), failed to verify quality control ranges (refer to D5441), and failed to follow quality control procedure (refer to D5447). 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 review of Horiba ABX Pentra 400 chemistry procedure, chemistry quality control (QC) and interview with testing personnel #1, the laboratory failed to follow Horiba ABX Pentra QC procedure. Findings: 1. Review of Horiba ABX Pentra 400 chemistry procedure stated "prior to initiating use of any new lot number of controls, new controls must be performed in parallel to assure the viability of the new controls". No parallel testing of QC was documented for 2018 or to date July 29, 2019. 2. Interview with testing personnel #1 on July 29, 2019 at 4:30 PM confirmed the laboratory failed to follow the Horiba ABX Pentra 400 chemistry procedure. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation of two of two centrifuges, the microscope used for urine microscopy, review of the policy and procedure manual, function check documentation, and interview with the testing personnel (TP) #1, the laboratory failed to perform a function check for 2017, 2018 and to date July 29, 2019. Findings: 1. Observation of the microscope used for urine microscopy revealed no function check for 2017, 2018 and to date July 29, 2019. 2. Review of the policy and procedure manual showed a policy "the microscope is to be serviced annually by an outside source." 3. Observation of the urinalysis/serum multi-speed centrifuge and chemistry fixed speed centrifuge revealed no documentation to show the laboratory performed function checks to verify the accuracy of the speed and timer mechanisms. 4. Interview with TP #1 on July 29, 2019 at 4:00 PM confirmed the laboratory failed to perform and document function checks to verify accurate performance of the laboratory centrifuges and the microscope used for urine microscopy. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) -- 3 of 14 -- 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 review of the policy and procedure manual, 2017, 2018, and to date July 29, 2019 calibration verification records for the Tosoh A1A chemistry analyzer and interview with the testing personnel (TP) #1, the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value and a maximum value near the upper limit to verify the laboratory's reportable range for prostatic specific antigen (PSA), testosterone (TEST), triiodothyronine uptake (T3U), thyroid stimulating hormone (TSH), and thyroxine (T4). Findings: 1. Review of the calibration verification policy showed "It is the policy for this company to perform every 6 months a calibration verification on all moderately complex instruments. This includes all non-waived analytes that do not have three or more calibrators." 2. No calibration verification records were available for review for the analytes: PSA, TEST, T4, T3U, TSH on the Tosoh A1A analyzer for 2017, 2018, and to date July 29, 2019. 3. Interview with TP #1 on July 29, 2019 at 4:00 PM confirmed the laboratory failed to perform calibration verification procedures for the analytes: PSA, TEST, T4, T3U, TSH performed on the Tosoh A1A analyzer at least once every six months. 38475 Based on review of policy and procedure manual, Emerald Celldyn hematology calibration verification, Horiba ABX Pentra 400 chemistry calibration verification, and interview with testing personnel (TP) #1 the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range. Findings: 1. Review of the calibration verification policy revealed, "It is the policy for this company to perform every 6 months a calibration verification on all moderately complex instruments. This includes all non-waived analytes that do not have three or more calibrators." 2. Review of Emerald Celldyn hematology calibration revealed no calibration for 2018. 3. Review of Horiba ABX Pentra 400 chemistry calibration for CO2, Blood Urea Nitrogen, Creatinine, Albumin, Glucose, Alkaline phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Total Bilirubin, Total Protein, Cholesterol, Triglycerides, High Density Lipoprotein, Direct Bilirubin, Uric Acid, C-reactive protein, and Low Density Lipoprotein revealed no calibration -- 4 of 14 -- for 2018 and to date July 29, 2019. 4. Interview with TP #1 on July 29, 2019 at 4:30 PM confirmed the laboratory failed to follow calibration verification procedure for the Emerald Celldyn and Horiba ABX Pentra 400. This is a repeat deficiency, previously cited on June 28, 2017. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Horiba ABX Pentra 400 chemistry quality control (QC) for 2018, to date July 29, 2019, and interview with testing personnel (TP) #1 the laboratory failed to monitor the accuracy and precision of QC materials. Findings: 1. Review of Horiba ABX Pentra 400 chemistry procedure states "After running the controls, review the results (the assay values are provided for each parameter specific for the lot number). The recovered values must fall within the limits of the expected values." 2. Review of QC for November 2018 revealed: - The creatinine QC level 1 confidence range (QC range) was 1.0-1.2. - Review of the Levey-Jennings graph revealed creatinine was not within acceptable range on November 6, 7, 10, 16, 17, 19, 27 and 28, 2018. The laboratory was unable to provide the QC package insert. 3. Review of QC for November 2018 revealed: - The glucose QC level 1 confidence range (QC range) was 26-277. - The mean was 255. - The standard deviation was 4. The laboratory failed to identify an accurate confidence range. The laboratory was unable to provide the QC package insert. 4. Review of QC for June 2019 revealed: - The glucose level 1 confidence range (QC range) was 26-277. - The mean was 243. - The standard deviation was 11. The laboratory failed to identify an accurate confidence range. The laboratory was unable to provide the QC package insert. 5. The laboratory could not provide documentation for Horiba ABX Pentra 400 chemistry QC in February 2018, May 2018, June 2018, August 2018, September 2018, October 2018, December 2018, and March 2019. Approximately patients were tested and those results were reported to ordering providers. 6. Interview with TP #1 on July 29, 2019 at 4:30 PM confirmed the laboratory failed to monitor the accuracy and precision of QC materials for 2018 and 2019. 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. -- 5 of 14 -- This STANDARD is not met as evidenced by: Based on review of the policy and procedure manual, quality control (QC) logs, and interview with testing personnel (TP) #1, the laboratory failed to perform and document at least two levels of external controls each day of patient testing for urine microalbumin testing performed on the Afinion. Findings: 1. Review of the quality assessment policy revealed "perform and document two levels of control material each day patient samples are tested." 2. No QC documentation was available for review for 2017, 2018, and to date July 29, 2019. 3. 750 patients were tested and those results were reported to ordering providers. 4. Interview with TP #1 on July 29, 2019 stated "I cannot locate the QC for microalbumin from 2017 to now on the Afinion." 38475 Based on review of the Emerald Celldyn hematology procedure, quality control (QC) for 2018, 2019, Horiba ABX Pentra 400 chemistry procedure, and interview with testing personnel (TP) #1, the laboratory failed to document two QC materials of different concentrations each day of patient testing for 24 of 24 patient testing days in June 2019 for hematology, eight of twelve months in 2018 for chemistry, and one of seven months in 2019 for chemistry. Findings: 1. Review of Emerald Celldyn hematology QC procedure states "There are three levels of controls for the Emerald. At least two levels must be within range to report patient results". 2. Review of hematology QC showed no documentation of QC 6/2/19 through 6/30/19 and aproximately 130 patient results were reported. 3. Review of Horiba ABX Pentra 400 quality control protocol states "There are two levels of control for each analyze being ran on the Pentra. At least one control must be within range to report patient results." 4. Review of chemistry QC revealed no documentation of Horiba ABX Pentra 400 QC for the analytes: CO2, Blood Urea Nitrogen, Creatinine, Albumin, Glucose, Alkaline phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Total Bilirubin, Total Protein, Cholesterol, Triglycerides, High Density Lipoproteins, Direct Bilirubin, Uric, c-reactive protein, Low Density Lipoproteins and for February, April, May, June August, September October and December 2018 and March 2019 and approximately 1416 patients samples were tested and those results were reported to ordering providers. 5. Interview with TP #1 on July 29, 2019 at 4:30 PM confirmed the laboratory failed to document two QC materials of different concentrations each day of patient testing. 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 review of quality control and quality assessment policies and procedures, personnel policies, and interviews, the director failed to provide overall management and direction; failed to ensure the appointed responsibilities for the technical consultant were properly performed (refer to D6004); failed to evaluate proficiency testing to identify problems (refer to D6018); failed to maintain the quality control program (refer to D6020); failed to maintain the quality assessment program (refer to D6021); and failed to ensure the quality control and quality assessment programs are established and maintained to identify failures (refer to D6022). This is a repeat deficiency previously cited on June 28, 2017. -- 6 of 14 -- D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the policy and procedure manual and interview with the testing personnel (TP) #1 and the laboratory director, the laboratory director failed to ensure the responsibilities of the technical consultant (TC) were properly performed. Findings: 1. Review of the policy and procedure manual revealed a policy for technical consultant responsibilities "the technical consultant must be accessible to the laboratory...the technical consultant is responsible for the following: Establishing a quality control program and ensuring that is carried out. Resolving technical problems and ensuring that remedial actions are carried out. Ensuring that patient test results are not reported until the test systems are functioning properly. Evaluating competency of testing personnel." 2. Interview with the TP #1 on July 29, 2019 at 1:30 PM stated "the technical consultant has not been here for one and one-half years." and "The quality control has not been reviewed by the technical consultant for that time." 3. Review of competency evaluations showed the TC failed to perform one of three competencies for moderate complexity testing (refer to D6046). 4. Review of quality control documentation showed the TC failed to review, monitor, and address QC problems (refer to D5441 and D5447). 5. Interview with the laboratory director on July 29, 2019 at 4:30 PM confirmed the TC has not been at the laboratory for one and one-half years and has not performed his duties. The laboratory director failed to ensure the TC performed his appointed duties. 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