Schafer Medical Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/05/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and testing person #1 during an exit conference performed at the conclusion of the survey. 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 a review of records, policies and procedures, and interview with the laboratory director and testing person #1, the laboratory failed to follow their written policy for establishing the means for new lot numbers of control materials prior to implementation for 12 of 12 lot numbers used during the review period of 01/04/2023 through 11/30/2023. Findings include: (1) On 01/04/2024 at 9:50 am, testing person #1 stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Sysmex XP-300 hematology analyzer; (b) Three levels of EIGHTCHECK-3WP X-TRA QC (Quality Control) materials were tested each day of patient testing; (c) Laboratory established means and historic SD's (standard deviations) were used to determine acceptability of quality control results. (2) A review of the procedure manual titled, "Sysmex XP-300" under the section "Setting mean and standard deviation procedure" stated the following: (a) "1. The stated values correspond to the method and instrument used by the laboratory, by running parelle runs with new lot for five days- twice a day for 5 days. 2. The means obtained after 10 runs reflects the manufacturer stated assay range for temporary mean.3. Calculate at two standard deviation range with minium 3 months runs incorporated this SD range 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 -- around new temporary mean. 4. The controls will be run 20 times to establish new mean and will be monitor throughout the date of the control." (3) A review of records for 12 control lot numbers used from 01/04/2023 through 11/30/2023 identified the laboratory did not follow their policy as follows: (a) Lot #23620710, 23620711, and 23620712 used from 01/04/2023 through 03/29/2023 - The controls had been tested nine times over six days as follows: (i) Twice on 01/04/2023 (ii) Once on 01/05/2023 (iii) Once on 01/06/2023 (iv) Once on 01/09/2023 (iv) Once on 01/10/2023 (iiv) Three times on 01/11/2023 (b) Lot #30810710, 30810711, and 30810712 used from 03 /22/2023 through 05/31/2023 - The controls had been tested ten times over six days as follows: (i) Once on 03/22/2023 (ii) Twice on 03/23/2023 (iii) Twice on 03/24/2023 (iv) Once on 03/27/2023 (iv) Twice on 03/28/2023 (iiv) Twice on 03/29/2023 (c) Lot #31650710, 31650711, and 31650712 used from 06/15/2023 through 09/28/2023 - The controls had been tested ten times over three days as follows: (i) Twice on 09/15 /2023 (ii) Twice on 09/16/2023 (iii) six times on 09/19/2023 (d) Lot #32490710, 32490711, and 32490712 used from 10/02/2023 through 11/30/2023 - The controls had been tested nine times over four days as follows: (i) Once on 09/07/2023 (ii) Once on 09/11/2023 (iii) Twice on 09/12/2023 (iv) Five times on 09/13/2023 (4) The findings were reviewed with the laboratory director and testing person #1 who stated on 01/04/2024 at 12:00 pm, the laboratory did not follow their written policy. 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 a review of records, manufacturer's instructions, and interview with testing person #1, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for one of two analyzers reviewed from January through December 2023. Findings include: (1) On 01/05/2024 at 09:50 am, testing person #1 stated Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), BUN, Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin. Total Protein, Total Cholesterol, HDL Cholesterol, and Triglyceride testing were performed using the Envoy 500 analyzer; (2) A review of the manufacturer's maintenance log showed the following required weekly maintenance procedures: (a) "Clean Sample Needles with Alcohol Swab" (b) "Perform EXTRA WASH CUVETTES" (c ) Perform Shutdown of Operating Systems" (3) A review of maintenance logs from January 2023 through December 2023 identified no documentation weekly maintenance had been performed between: (a) 05/22/2023 and 06/05/2023 (b) 10/23/2023 and 11/06/2023 (4) The records were reviewed with testing person #1 who stated on 01/05/2024 at 12:00 pm, the weekly maintenance had not been documented as performed as shown above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/18/2021. The findings were reviewed with testing person #1 and the laboratory director at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with testing person #1, the laboratory failed to follow the manufacturer's instructions for verifying automated differential flags for 8 of 9 patient reports. Findings include: (1) On 11/18 /2021 at 09:45 am, testing person #1 stated to the surveyor that CBC (Complete Blood Count) testing was performed on the Sysmex XP-300 analyzer; (2) The surveyor reviewed the manufacturer's operator's manual for information regarding flagged results. The following was identified: (a) For [AG] flag the instructions stated, "Check smear, etc."; (3) The surveyor then reviewed patient records and identified that for 8 of 9 records reviewed, the laboratory had not verified the results when automated differential flags were obtained as follows: (a) [AG] flag obtained on a patient sample tested on 01/04/2021 at 09:11 am; (b) [AG] flag obtained on a patient sample tested on 01/08/2021 at 11:18 am; (c) [AG] flag obtained on a patient sample tested on 01/11 /2021 at 10:08 am; (d) [AG] flag obtained on a patient sample tested on 01/20/2021 at 10:22 am; (e) [AG] flag obtained on a patient sample tested on 01/20/2021 at 10:24 am; (f) [AG] flag obtained on a patient sample tested on 01/20/2021 at 10:25 am; (g) [AG] flag obtained on a patient sample tested on 01/22/2021 at 11:21 am; (h) [AG] flag obtained on a patient sample tested on 01/29/2021 at 11:44 am. (5) The findings 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 -- were reviewed with testing person #1 who stated on 11/18/2021 at 12:45 pm, the laboratory had not followed the manufacturer's instructions as indicated above. 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 a review of records and interview with testing person #1, the laboratory failed to perform at least two levels of control materials each day of patient hematology testing using the Sysmex XP-300 analyzer for 1 of 23 days of patient testing. Findings include: (1) On 11/18/2021 at 09:50 am, testing person #1 stated to the surveyor: (a) The laboratory performed hematology testing using the Sysmex XP- 300 analyzer; (b) Three levels of Eightcheck - 3WP X-TRA quality control (QC) materials were performed each day of patient testing. (2) The surveyor reviewed QC and patient testing records from 03/01/2021 through 03/31/2021; The documentation showed at least two levels of QC testing had not been performed each day of patient CBC testing for 1 of 23 days of patient testing. The specific day was 03/17/2021; (3) The surveyor reviewed the records with testing person #1. Testing person #1 stated on 11/18/2021 at 01:00 pm, at least two levels of QC materials had not been performed each day of patient CBC testing as indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/13/19. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director/technical consultant, testing person #1, and testing person #2 at the conclusion of the survey. 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 a review of records, written policies, and interview with testing person #2, the laboratory failed to have a written clinical consultant and technical consultant competency policy based the job responsibilities as listed in Subpart M. Findings include: (1) During the survey, the surveyor reviewed the manual titled "Policy Manual" and could not locate a written policy to evaluate the clinical consultant and technical consultant based on job responsibilities; (2) The surveyor asked testing person #2 if a written policy to evaluate the clinical consultant and technical consultant based on job responsibilities (to include the frequency of the competency assessments) was available and if competency assessments had been performed during 2018 and to date in 2019. Testing person #2 showed the surveyor documentation that competencies had been performed for the clinical consultant and technical consultant on 08/05/19. In addition, testing person #2 stated to the surveyor a policy to evaluate the clinical consultant and technical consultant, based on job responsibilities, had not been written. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 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 a review of records and interview with testing person #2, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) At the beginning of the survey, testing person #2 stated to the surveyor CMP (Comprehensive Metabolic Panel)*, Lipid Profile*, and Direct Bilirubin testing were performed on the Envoy 500 analyzer; (2) The surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs for the analyzer, which required the following quarterly maintenance: (a) Replace ISE Tubing Set (b) Replace K Electrode (c) Replace Cl Electrode (d) Replace CO2 Electrode (3) The surveyor then reviewed maintenance records for 2018 and 2019. There was no documentation the quarterly maintenance had been performed as follows: (a) Replace ISE Tubing - Not performed between 08 /10/18 and 03/05/19 (b) Replace K Electrode - Not performed between 08/29/18 and 03/05/19 (c) Replace Cl Electrode - Not performed between 08/09/08 and 03/05/19 (d) Replace CO2 Electrode - Not performed between 08/14/18 and 03/05/19 (4) The surveyor reviewed the records with testing person #2, who stated the quarterly maintenance had not been performed, as indicated above. *CMP - Albumin, Alkaline Phosphatase, ALT, AST, BUN, Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin and Total Protein *Lipid Profile - Total Cholesterol, HDL Cholesterol, Triglyceride Liver Profile - albumin, total protein, total bilirubin, alkaline phosphatase, ALT, AST, GGT -- 2 of 2 --

Summary Statement of Deficiencies D0000 The findings were reviewed with testing person #1 and testing person #2 at the conclusion of the survey. 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 a review of records, and interview with testing person #1 and testing person #2, the laboratory failed to perform the manufacturers' required maintenance procedures on analyzers used for patient testing. Findings include: ENVOY 500 CHEMISTRY ANALYZER (1) At the beginning of the survey, testing person #1 stated to the surveyor the laboratory performed Chemistry testing (i.e., Albumin, Cl (Chloride), CO2 (Carbon Dioxide), Glucose, K (Potassium), Na (Sodium), Total Cholesterol, Direct Bilirubin, etc.) using the Envoy 500 chemistry analyzer; (2) The surveyor reviewed records from 08/01/16 through 12/31/17 and identified the maintenance procedures required by the manufacturer, as recorded on the maintenance log: (a) Weekly: (i) Clean Sample Needles w/alcohol swab (ii) Perform EXTRA WASH CUVETTES (iii) View Levey-Jennings Charts (iv) Perform Shutdown of Operating System (b) Monthly: (i) Print Levey-Jennings charts for review by Director QC (Quality Control) (ii) Backup QC Data (if no LIS) (iii) Purge Patient Archive (suggested) (iv) Check mouse/keyboard batteries (v) Replace Bypass /GND Tubing (c) Quarterly: (i) Replace ISE Tubing Set (ii) Replace K Electrode (iii) Replace Cl- Electrode (iv) Replace CO2 Electrode (3) From the review, the surveyor identified maintenance procedures which had not been documented as having been performed. The specific findings follow: (a) Weekly - Had not been documented as having been performed: (i) Between 10/24/16 and 11/07/16 (ii) Between 11/21/16 and 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 -- 12/04/16 (iii) Between 03/13/17 and 03/27/17 (b) Monthly - During 3 of the 16 months reviewed, the following procedures had not been documented as having been performed: (i) September 2016: (aa) Print Levey-Jennings charts for review by Director QC (bb) Backup QC Data (cc) Purge Patient Archive (dd) Check mouse /keyboard batteries (ii) October 2016: (aa) Print Levey-Jennings charts for review by Director QC (bb) Backup QC Data (cc) Purge Patient Archive (ee) Check mouse /keyboard batteries (ff) Replace Bypass/GND Tubing (iii) November 2016: (aa) Print Levey-Jennings charts for review by Director QC (bb) Backup QC Data (cc) Purge Patient Archive (dd) Check mouse/keyboard batteries (c) Quarterly - During 1 quarter (4th quarter 2017) of the 5 quarters reviewed, the required maintenance procedure had not been documented as having been performed. (4) The surveyor reviewed the findings with testing person #1 and testing person #2 and asked if additional documentation was available which proved the required maintenance procedures listed above had been performed. Testing person #1 and testing person #2 could not locate additional information which proved the maintenance procedures listed above had been performed. SYSMEX XP-300 HEMATOLOGY ANALYZER (1) At the beginning of the survey, testing person #1 stated to the surveyor the laboratory performed CBC (Complete Blood Count) testing (i.e., WBC-White Blood Count; RBC-Red Blood Count; Hemoglobin, Hematocrit, Platelet Count, etc.) using the Sysmex XP-300 hematology analyzer; (2) The surveyor reviewed records from 08/01 /16 through 12/31/17 and identified the manufacturer required the following weekly maintenance procedure, as recorded on the maintenance log: (a) Clean SRV (Sample rotor valve) tray (3) From the review, the surveyor identified the required weekly maintenance procedure had not been documented as having been performed: (a) Between 01/09/17 and 02/06/17 (b) Between 07/17/17 and 08/07/17 (c) Between 11/01 /17 and 11/13/17 (4) The surveyor reviewed the findings with testing person #1 and testing person #2 and asked if additional documentation was available which proved the weekly maintenance procedure had been performed as required. Testing person #1 and testing person #2 could not locate additional information which proved the maintenance procedure listed above had been performed. 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 a review of records, and interview with testing person #1 and testing person #2, the laboratory failed to provide reference intervals appropriate for the patient population serviced by the laboratory. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor the laboratory performed CBC (Complete Blood Count) (i.e., RBC-Red Blood Count, Hgb-Hemoglobin, Hct- Hematocrit, etc.) testing using the Sysmex XP-300 hematology analyzer; (2) The surveyor reviewed four patient CBC reports as follows: (a) Patient #1: Adult male. Testing performed on 10/31/16 (b) Patient #2: Adult female. Testing performed on 10 /31/16 (c) Patient #3: Adult female. Testing performed 11/29/17 (d) Patient #4: Adult male. Testing performed on 11/30/17 (3) The four test reports included the same reference intervals for the following CBC analytes: (a) RBC: 4.20 - 6.30 (b) Hgb: 12.0 - 18.0 (c) Hct: 37.0 - 51.0 (4) The surveyor reviewed the findings with testing person #1 and testing person #2 and asked if the laboratory had gender specific CBC -- 2 of 3 -- reference intervals. Testing person #1 and testing person #2 verified the laboratory did not have gender specific reference intervals for the CBC analytes listed above. NOTE: Routinely, female reference intervals for analytes RBC, Hemoglobin, and Hematocrit are lower than male reference intervals. -- 3 of 3 --