Simpson General Hospital

Summary Statement of Deficiencies 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 review of chemistry laboratory records from 7/22/2021 through 1/19/2023 and confirmation by the respiratory supervisor/testing personnel (TP) #8 at 2:00 p.m. on 1/19/2023, the laboratory failed to document as performed calibration verification (CVM) on the Siemens Rapid Point 500e blood gas analyzer every 6 months for pCO2, pH, pO2. Findings include: 1. Calibration verification is required every 6 months on any assay which is calibrated using less than 3 levels of calibration 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 -- material. 2. The Siemens Rapid Point 500e Blood Gas Analyzer does not use 3 levels of calibration material during routine calibration. 3. The Siemens Rapid Point 500e procedure indicates the 6 month calibration verification (CVM) will be run every March and September for pH, pCO2, and pO2. 3. Calibration verification was last performed on the Siemens Rapid Point 500e for pH, pCO2 and pO2 during installation on 3/9/2021. 4. The Respiratory supervisor/TP #8 confirmed in an interview at 2:00 p.m. on 1/19/2023 that the CVM (calibration verification) on pH, pCO2 and pO2 was not performed every 6 months as stated in the instructions and had not been performed since installation on 3/9/2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 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 laboratory proficiency records from 2019, 2020, and 2021 and interview with the technical consultant (TC) at 2:30 p.m. on 7/23/21, the laboratory failed to verify the accuracy of phosphorous testing at least twice annually for the year of 2020. Findings Include: 1. Review of the proficiency records from 2019, 2020 and 2021 revealed that phosphorous had not been twice verified as accurate for the year of 2020. 2. During an interview TC at 2:30 p.m. on 7/23/21, the TC confirmed that accuracy had not been verified in 2020 for the phosphorous analyte performed on the Vitros 5600 chemistry analyzer. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on review of installation records for the RAPID Point 500 E blood gas analyzer, lack of documentation of verification of performance specifications, and interview with the Respiratory Supervisor (Testing Personnel #8) at 5:30 p.m. on 7/23 /21, the respiratory department failed to ensure that performance specifications included performing comparison studies on the blood gas analyzer. The RAPID Point 500 E was installed on 3/9/21. Findings: 1. Review of installation records for the RAPID Point 500 E, installed on 3/9/21, revealed no documentation of a method comparison study performed after installation. In the installation records the Service representative stated: "Customer will perform method comparison study. TAS will complete the comparison data analysis report. 20 samples recommended." 2. Interview with Respiratory Supervisor/TP #8 on at 5:30 p.m. on 7/23/21 revealed no method comparison had been performed for the blood gas testing on the RAPID Point 500 E blood gas analyzer before testing patients on 5/27/21. 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 least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the RAPID Point 500 E blood gas analyzer procedure manual and interview with the Respiratory supervisor/testing personnel (TP) #8 listed on the CMS (Center for Medicare & Medicaid Services) 209 personnel form at 5:30 p.m. on 7/23 /21, the laboratory (respiratory department) failed to document as performed maintenance on the RAPID Point 500 E blood gas analyzer as required by the manufacturer. Findings include: 1. Review of the Rapid Point 500 E procedure manual revealed the following maintenance is required by the manufacturer to be performed every 10 days: a. Wash/Waste Cartridge change: The wash/waste cartridge is stable for ten days after installation on the system and contains the wash reagent which cleans the sample path after analysis and calibration and it also stores liquid waste. The cartridge should be replaced after 10 days on the instrument. There was no documentation of this maintenance performed every 10 days after cartridge install either on the maintenance log or printed from the blood gas analyzer since install on 3 /9/21. 2. Interview with the Respiratory Supervisor/TP#8 at 5:30 p.m. on 7/23/21 confirmed no maintenance log was written or printed to document when the 10 day wash/waste cartridge replacement was performed on the RAPID Point 500 E. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 4/9/21, the laboratory has not successfully participated in proficiency testing for CK ISOENZYME (CK-MB). Findings include: Our records indicate the following proficiency testing scores for your laboratory for CK ISOENZYME (CK-MB): PROFICIENCY TESTING PROVIDER: American Proficiency Institute Year 2020 3rd Event 20% Year 2021 1st Event 40% Scores less 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 -- than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 4/9/21, the laboratory has not successfully participated in proficiency testing for CK ISOENZYME (CK-MB). Findings include: Our records indicate the following proficiency testing scores for your laboratory for CK ISOENZYME (CK-MB): PROFICIENCY TESTING PROVIDER: American Proficiency Institute Year 2020 3rd Event 20% Year 2021 1st Event 40% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 11/4/20, the laboratory has not successfully participated in proficiency testing for TOTAL BILIRUBIN. Findings include: Our records indicate the following proficiency testing scores for your laboratory for TOTAL BILIRUBIN: PROFICIENCY TESTING PROVIDER: American Proficiency Institute Year 2020 2nd Event 40% Year 2020 3rd Event 40% Scores less than 80% 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 -- for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 11/4/20, the laboratory has not successfully participated in proficiency testing for TOTAL BILIRUBIN. Findings include: Our records indicate the following proficiency testing scores for your laboratory for TOTAL BILIRUBIN: PROFICIENCY TESTING PROVIDER: American Proficiency Institute Year 2020 2nd Event 40% Year 2020 3rd Event 40% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: 1. Based on observation of Bio-Rad Liquichek Specialty Immunoassay controls in use by the laboratory on 11-19-18 at 10:45 a.m., review of quality control (QC) records for the Ortho Clinical Vitros 5600 Integrated System from 7-1-18 through 11-19-18, and patient Vitamin D reports, Bio-Rad Liquichek Specialty Immunoassay controls, Level 1 (Lot #57491) and Level 2 (Lot #57492), were used for quality control testing for 27 days after they had exceeded their expiration date of 8-31-18, with a total of 31 patient Vitamin D results reported on these days. Findings include: Observation of Bio-Rad Liquichek Specialty Immunoassay controls, Lot #57491 and Lot #57492, in use by the laboratory on 11-19-18 at 10:45 a.m., revealed these lots had an expiration date of 8-31-18. Review of QC records for the Ortho Clinical Vitros 5600 Integrated System from 7-1-18 through 11-19-18 and patient Vitamin D reports revealed Lot #57491 and Lot #57492 were used for quality control testing for 27 days from 9-1-18 through 11-16-18, after they had exceeded their expiration date, when a total of 31 patient Vitamin D results were reported. 2. Based on review of quality control (QC) records for the Beckman Coulter AcT Diff 2 hematology analyzer from 8-1-18 through 10-31-18, manufacturer's package inserts, and lab test order logs, Coulter 4C- ES Cell hematology controls (Lots #069700, #079700, and #089700) were used for quality control testing for 14 days after they had exceeded their expiration date of 8- 13-18, with a total of 206 patient CBC results reported during this time frame. Findings include: Review of the manufacturer's package inserts for Coulter 4C-ES Cell hematology controls (Lots #069700, #079700, and #089700) revealed these lots had an expiration date of 8-13-18. Review of QC records for the Beckman Coulter 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 -- AcT Diff 2 hematology analyzer from 8-1-18 through 10-31-18 and lab test order logs revealed Coulter 4C-ES Cell hematology controls, Lots #069700, #079700, and #089700, were used for quality control testing from 8-14-18 through 8-27-18 after they had exceeded their expiration date, when a total of 206 patient CBC results were reported. 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 review of calibration and calibration verification records for the Ortho Clinical Vitros 5600 Integrated system since the last survey on 12-20-16 and interview with the technical consultant on 11-20-18 at 2:30 p.m., the laboratory failed to document, as performed, calibration verification for sodium, potassium, and chloride tests at least once every six months since 12-20-16. Findings include: Review of calibration records for the Ortho Clinical Vitros 5600 Integrated system revealed the sodium, potassium, and chloride tests performed on the integrated system have fewer than three calibrators. Review of calibration verification records revealed no documentation of calibration verification performed for the sodium, potassium, and chloride tests on the Vitros 5600 Integrated system since the last survey on 12-20-16. In an interview on 11-20-18 at 2:30 p.m., the technical consultant confirmed calibration verification has not been performed for sodium, potassium, and chloride since 12-20-16. -- 2 of 2 --