Cox Barton County Hospital

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of laboratory procedures, interview with the laboratory consultant, and interview with the technical supervisor (TS) #6, the laboratory failed to test proficiency testing samples in the same manner as it tests patient specimens. Findings: 1. Review of the the laboratory procedure "Proficiency Testing Program" states "A final check for clerical errors is performed by another testing personnel and documented." 2. Interview with the laboratory consultant on October 8, 2024 at 1:00 PM stated "They do not perform a final clerical check for patients prior to reporting results." 3. Interview with the technical supervisor (TS) #6 on October 8, 2024 at 1:30 PM confirmed the laboratory failed to test proficiency testing samples in the same manner as it tests patient specimens. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 review of the performance specifications procedures for the Sysmex XN- 550 hematology analyzer, performance specifications procedures for the iSTAT blood gas analyzer, laboratory's submitted CMS 116 form, and interview with the technical supervisor (TS) #6, the laboratory failed to verify performance specifications prior to reporting patient test results in 2023. Findings: 1. Review of the performance specifications for the Sysmex XN-550 hematology analyzer showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population for the analytes: red blood cell, hematocrit, hemoglobin, white blood cell, platelet count and differential prior to patient testing in June 2023. 2. Review of the performance specifications for the iSTAT blood gas analyzer showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population for the analytes: pH, pCO2, pO2, and lactate prior to patient testing in April 2023. 3. Review of the laboratory's submitted CMS 116 form showed the laboratory performs approximately 90,344 hematology tests and approximately 186,816 chemistry tests annually. 4. Interview with the technical supervisor #6 on October 8, 2024 at 1:30 PM confirmed the laboratory failed to verify performance specifications prior to reporting patient test results on the Sysmex XN- 550 hematology analyzer, and the iSTAT blood gas analyzer. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Clostridium difficile (C.diff) Quik Chek Complete kit test quality control (QC) records for 2023 to date October 8, 2023, patient results and interview with the technical supervisor (TS) #6, the laboratory failed to perform positive and negative controls for C.diff for 138 of 144 patient testing days. Findings: 1. Review of C.diff Quik Chek Complete kit test QC records from February 2023 to date October 8, 2024 showed the laboratory failed to perform a positive and negative QC for 138 of 144 patient testing days. 2. Review of patient results showed the laboratory performed 166 C.diff patient tests while QC was not performed. 3. Interview with the technical supervisor #6 on October 8, 2024 at 1:30 PM confirmed the laboratory failed to perform a positive and negative control each day of patient testing. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) -- 2 of 4 -- (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: Based on review of gram stain quality control (QC) records, and interview with technical supervisor #6, the laboratory failed to document positive and negative reactivity each week of use for gram stains for 1 of 28 weeks. Findings: 1. Review of gram stain QC showed no gram stain QC performed the week of October 16, 2023. 2. Interview with the technical supervisor #6 on October 8, 2024 at 1:30 PM confirmed the laboratory failed to document positive and negative reactivity each week of use for gram stains. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of laboratory analyzers, review of instrument comparisons, and interview with the technical supervisor (TS) #6, the laboratory failed to evaluate and define the relationship between test results using different instruments two times a year in 2023. Findings: 1. Observation of laboratory analyzers revealed two iStat analyzers that perform pH, pCO2, and PO2. 2. Review of instrument comparisons showed the laboratory had no documentation to evaluate and define the relationship between the iStat analyzers twice a year in 2023. 3. Review of laboratory analyzers revealed iStat analyzer and Siemens Dimension EXL 200 analyzer that perform lactic. 4. Review of instrument comparisons showed the laboratory had no documentation to evaluate and define the relationship between the iStat analyzer and Siemens Dimension EXL 200 analyzer twice a year in 2023. 5. Interview with the TS #6 on October 8, 2024 at 1:30 PM, confirmed the laboratory failed to evaluate and define the relationship between test results using different instruments two times a year in 2023. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the Siemens Dimension EXL 200 chemistry analyzer quality control (QC) records for alkaline phosphatase and interview with the technical supervisor (TS) #6, the laboratory director failed to ensure the quality control program was maintained to assure the quality of laboratory services and to identify failures in quality as they occur. Findings: 1. Review of the Siemens Dimension EXL 200 QC records showed the laboratory used unassayed ChemTrak QC. The laboratory started -- 3 of 4 -- a new lot number CHU25121 of QC in August 2024. 2. Review of assayed QC on the Siemens Dimension EXL 200 analyzer showed alkaline phosphatase level 1 QC range of 38-52. 3. Review of QC revealed alkaline phosphatase QC was accepted and the QC values did flag as "L" in the computer on the following date: August 9, 2024 alkaline phosphatase level 1 QC results 36, 34, 35, and 37 all 4 results were flagged as "L". The laboratory could not provide documentation of why QC was accepted when results were not within established acceptable limits. 4. Review of QC revealed alkaline phosphatase QC was flagged as "H" in the computer on the following dates but QC results were within the acceptable range: August 10, 2024 alkaline phosphatase level 1 QC result 41 and 38 August 11, 2024 alkaline phosphatase level 1 QC result 42 and 43 August 12, 2024 alkaline phosphatase level 1 QC result 45, 46, 39 and 43 The laboratory could not provide documentation of why QC was flagging "H" but was within established acceptable limits. 5. Review of QC revealed alkaline phosphatase QC was accepted and the QC values did not flag in the computer on the following dates but QC results were not within the acceptable range: August 10, 2024 alkaline phosphatase level 1 QC result 34 August 11, 2024 alkaline phosphatase level 1 QC result 35 August 12, 2024 alkaline phosphatase level 1 QC result 35 The laboratory could not provide documentation of why QC was accepted when results were not within established acceptable limits. 6. Interview with the TS #6 on October 8, 2024 at 1:30 PM confirmed the laboratory director failed to ensure the quality control program was maintained to assure the quality of laboratory services and to identify failures in quality as they occur. -- 4 of 4 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) records for 2022 and to date March 1, 2023, and interview with the technical supervisor (TS) #2, the laboratory failed to enroll in an approved PT program for the sub-specialty of Bacteriology listed in subpart I. Findings: 1. Review of 2022 and to date March 1, 2023 PT records showed no enrollment in an approved PT program for the analyte: gram stain. 2. Interview with the TS #2 on March 1, 2023, at 2:30 PM confirmed the laboratory failed to enroll in an approved PT program for the sub-specialty of Bacteriology. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This CONDITION is not met as evidenced by: Based on review of blood bank temperature logs, calibration records for the Dimension EXL w/LM Chemistry analyzer, calibration records for the Sysmex KX21N Hematology Analyzer, Gram stain quality control (QC) logs, blood bank QC, and blood bank alarm checks; the laboratory failed to review "BB Temp logs" (D5413); failed to perform calibration verification procedures at least once every 6 months to include minimum point, mid-point, and upper limit for sodium, potassium, and chloride on the chemistry analyzer and all analytes on the hematology analyzer (D5439); failed to perform weekly gram stain quality controls (D5503); failed to document blood bank QC for all days of patient testing (D5551) and the laboratory failed to perform 2 of 7 blood bank refrigerator and freezer alarm checks (D5555). D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of blood bank continuous monitoring temperature logs and interview with technical supervisor (TS) #2, the laboratory failed to document continuous temperature monitoring and document when temperatures were outside of acceptable range for the refrigerator and freezer in blood bank. Findings: 1. Review of blood bank continuous monitoring temperature logs showed the laboratory failed to have the temperature continually monitored at the following times: February 10, 2021 at 12:00 PM to February 11, 2021 at 1:30 PM no temperature reading for the refrigerator December 1, 2021 at 12:00 PM to December 3, 2021 at 3:00 AM no temperature reading for the refrigerator December 21, 2022 at 12:00 PM to December 22, 2022 at 6:00 AM, no temperature reading for refrigerator and freezer 2. Review of blood bank continuous monitoring logs showed the laboratory failed to document when the temperature were outside of acceptable range for the refrigerator and freezer in blood bank for the following dates: January 27, 2021 July 29, 2021 October 28, 2021 May 20, 2022 3. Interview with the TS #2 on March 1, 2023 at 1:00 PM confirmed the laboratory failed to document continuous temperature monitoring and document reasons for fluctuations in temperature monitoring for the refrigerator and freezer in blood bank. 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 -- 2 of 7 -- 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 records for the Sysmex KX21N hematology analyzer, review of calibration verification documentation for the Dimension EXL w/LM chemistry analyzer, and interview with the technical supervisor (TS) #2, 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 on the Dimension EXL -200 chemistry analyzer and on the Sysmex KX21N hematology analyzer. Findings: 1. Review of the Sysmex KX21N hematology analyzer calibration records for 2021, 2022 and to date March 1, 2023 showed no calibration for December 2021 and June 2022 for the following analytes; white blood count, red blood count, hemoglobin, hematocrit, and platelets. Documentation provided for calibration performed December 2022. 2. Review of Dimension EXL w/LM chemistry analyzer calibration records for 2021 to date March 3, 2023 showed no calibration 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 the analytes: sodium, potassium and chloride. 3. Interview with TS #2 on March 1, 2023 at 1:00 PM confirmed 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 on the Dimension EXL -200 chemistry analyzer and on the Sysmex KX21N hematology analyzer. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: Based on review of patient gram stain logs, gram stain quality control (QC) logs, and interview with the technical supervisor (TS) #2, the laboratory failed to perform a positive and negative QC each week. Findings: 1. Review of gram stain QC logs showed "frequency: Daily with patient testing". 2. Review of patient gram stain logs showed one gram stain was performed on January 24, 2023 and no QC was documented. The laboratory could not provide patient gram stain logs for 2021 and -- 3 of 7 -- 2022. 3. Review of 2021 and 2022 gram stain QC logs showed no gram stain QC weekly on: June 21, 2021 July 25, 2021 August 1, 2021 August 8, 2021 August 21, 2021 September 27, 2021 October 8, 2021 October 19, 2021 October 28, 2021 November 1, 2021 November 8, 2021 December 13, 2021 January 11, 2022 January 28, 2022 February 1, 2022 March 9, 2022 April 22, 2022 May 22, 2022 June 1, 2022 June 8, 2022 June 15, 2022 June 28, 2022 July 19, 2022 August 10, 2022 August 26, 2022 September 27, 2022 October 24, 2022 4. Interview with the TS #2 on March 1, 2023 at 1:00 PM confirmed the laboratory failed to perform a positive and negative gram stain QC each week. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of blood bank procedures, blood bank patient logs for 14 of 26 months, blood bank quality control (QC) logs for 14 of 26 months, and interview with the technical supervisor (TS) #2, the laboratory failed to document quality control (QC) for fourteen patient testing days. Findings: 1. Review of the laboratory's blood bank procedure "Reagent Quality Control" states, "Reagents need quality control run on days that patient samples are being run." 2. Review of blood bank patient testing logs showed patient testing was performed on June 7, 2021, June 28, 2021, October 7, 2021, November 30, 2021, December 16, 2021, December 19, 2021, January 4, 2022, January 18, 2022, January 23, 2022, January 29, 2022, March 11, 2022, May 2, 2022, September 20, 2022, and January 20, 2023. 3. Review of blood bank QC logs showed no documented QC on June 7, 2021, June 28, 2021, October 7, 2021, November 30, 2021, December 16, 2021, December 19, 2021, January 4, 2022, January 18, 2022, January 23, 2022, January 29, 2022, March 11, 2022, May 2, 2022, September 20, 2022, and January 20, 2023. 4. Interview with the TS #2 on March 1, 2023 at 2:30 PM, confirmed the laboratory failed to document quality control for 14 patient testing days. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. -- 4 of 7 -- This STANDARD is not met as evidenced by: Based on review of blood bank "high/low alarm testing worksheet", and interview with the technical supervisor (TS) #2, the laboratory failed to perform 2 of 7 refrigerator and freezer alarm inspections. Findings: 1. Review of refrigerator and freezer blood bank alarm testing worksheet showed no refrigerator alarm inspections for second and third quarter 2021. 3. Interview with the TS #2 on March 1, 2023 at 10: 00 AM confirmed, the laboratory failed to perform blood bank refrigerator and freezer alarm inspections. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) results in 2021/2022 and review of quality control, the laboratory director (LD) failed to provide overall management and direction of the laboratory. The LD failed to ensure the laboratory was enrolled in PT for Gram Stains (D6088); failed to ensure the appropriate staff evaluated ungraded PT results in 2022 (D6091); and failed to ensure quality control programs are maintained (D6093). D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records for 2022 and to date March 1, 2023 and interview with the technical supervisor (TS) #2, the laboratory director (LD) failed to ensure the laboratory was enrolled in an approved PT program for the sub- specialty of Bacteriology listed in subpart I. Findings: 1. Review of PT records for 2022 and to date March 1, 2023 showed the LD failed to ensure that gram stain testing was enrolled in an approved PT program for the sub-specialty of Bacteriology listed in subpart I. 2. Interview with the TS #2 confirmed the laboratory director (LD) failed to ensure the laboratory was enrolled in an approved PT program for the sub-specialty of Bacteriology listed in subpart I. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of 2019/2020/2021 quality control (QC) records for hematology, and interview with the manager of laboratory services, the laboratory failed to retain quality control records for at least 2 years. Findings: 1. Review of QC records for hematology showed the laboratory failed to retain prothombin-time, partial thromboplastin time and d-dimer QC records for 2019 to August 2020. 2. Interview with the manager of laboratory services on April 14, 2021 at 2:00 PM confirmed the laboratory failed to retain quality control records for at least 2 years. 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 performance specifications for the Cobas U411 urine analyzer, Alcor Scientific mini iSED, Cerner Laboratory Information System (LIS), function Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- check documentation for Thermo Scientific mySPIN 12 mini centrifuge, function check documentation for the HemoCue StatSpin centrifuge, calibration records for the Siemens Dimension EXL chemistry analyzer, calibration records for the Sysmex XS1000i hematology analyzer, Siemens Dimension EXL quality control (QC) records, gram stain QC records, coagulation QC records, Immunohematology procedure manual, and hematology instrument comparisons documentation, the laboratory failed to meet the condition of analytic systems. The laboratory failed to verify performance specifications prior to reporting patient test results for the Cobas U411 urine analyzer, Alcor Scientific mini iSED, and Cerner Laboratory Information System (LIS) (Refer to D5421), failed to perform and document function checks on the Thermo Scientific mySPIN 12 mini centrifuge and the HemoCue StatSpin centrifuge (Refer to D5435), failed to perform a calibration every six months for the Sysmex XS1000i hematology analyzer (Refer to D5437), failed to perform at least a three point calibration (a minimal, mid-point, and maximum) verification every six months for the Siemens Dimension EXL chemistry analyzer (Refer to D5439), failed to ensure alkaline phosphatase (ALP) QC met criteria for acceptability before reporting patient results (Refer to D5481), failed to document positive and negative reactivity each week of use for gram stains (Refer to D5503), failed to include two levels of control material each 8 hours of operation for PT and PTT (Refer to D5545), failed to provide an up-to-date procedure for reviewing patient antibody history (Refer to D5551), failed to correctly perform refrigerator alarm inspections according to the laboratory's established policy (Refer to D5555), and failed to evaluate and define the relationship between hematology test results using two different methodologies twice a year (Refer to D5775). 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 review of the performance specifications for the Cobas U411 urine analyzer, Alcor Scientific mini iSED, Cerner Laboratory Information System (LIS) and interview with the technical supervisor (TS) #1, the laboratory failed to verify performance specifications prior to reporting patient test results. Findings: 1. Review of the performance specifications for the Cobas U411 urine analyzer showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population. 2. Review of the performance specifications for the Alcor Scientific mini iSED showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population. 3. Review of the performance specifications for the Cerner LIS showed the laboratory failed to verify the LIS performed acceptably before it was integrated into routine operation. 4. Interview with the technical supervisor #1 on April 14, 2021 at 2:00 PM confirmed the laboratory failed to verify performance specifications prior to reporting patient test results. -- 2 of 9 -- 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 lack of documentation for 2019/2020/2021 function checks and interview with technical supervisor (TS) #1, the laboratory failed to perform and document function checks on the Thermo Scientific mySPIN 12 mini centrifuge and the HemoCue StatSpin centrifuge. Findings: 1. Review of the Thermo Scientific mySPIN 12 mini centrifuge showed no documentation of centrifuge function checks in 2019, 2020 and to date April 14, 2021. 2. Review of the HemoCue StatSpin centrifuge showed no documentation for centrifuge function checks in 2019, 2020 and to date April 14, 2021. 3. Interview with the technical supervisor #1 on April 14, 2021 at 9:30 AM confirmed that the laboratory failed to perform and document function checks in 2019, 2020 and to date April 14, 2021. 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 review of 2019/2020/2021 calibration records for the Sysmex XS1000i hematology analyzer and interview with technical supervisor (TS) #1, the laboratory failed to perform a calibration every six months in 2019. Findings: 1. Review of 2019, 2020 and 2021 calibration records for the Sysmex XS1000i hematology analyzer for the analytes: white blood cell, red blood cell, hemoglobin, hematocrit and platelet revealed the laboratory failed to perform a calibration every six months in 2019. 2. Interview with the TS #1 on April 14, 2021 at 2:00 PM confirmed the laboratory failed to perform a calibration of the Sysmex XS1000i hematology analyzer every six months in 2019. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) -- 3 of 9 -- 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 2019/2020/2021 calibration records for the Siemens Dimension EXL chemistry analyzer and interview with technical supervisor (TS) #1, the laboratory failed to perform at least a three point calibration (a minimal, mid-point, and maximum) verification every six months. Findings: 1. Review of 2019, 2020 and 2021 calibration records for the Siemens Dimension EXL chemistry analyzer for the analytes: sodium, potassium, and chloride, revealed the laboratory failed to perform a calibration including a minimal, midpoint, and maximum value for each analyte every six months in 2020 and to date April 14, 2021. 2. Interview with the TS #1 on April 14, 2021 at 2:00 PM confirmed the laboratory failed to perform at least a 3 point calibration of the electrolytes on the Siemens Dimension EXL chemistry analyzer every six months. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Siemens Dimension EXL quality control (QC) and interview with testing personnel (TP) #1, the laboratory failed to ensure alkaline phosphatase (ALP) QC met criteria for acceptability before reporting patient results. Findings: 1. Review of ALP QC showed on March 26, 2021 ALP QC level 1 was not within laboratory's acceptability, 16 ALP patient test results were resulted while QC was unacceptable. 2. Review of ALP QC showed on March 30, 2021 ALP QC level 1 was not within laboratory's acceptability, 20 ALP patient test results were resulted while -- 4 of 9 -- QC was unacceptable. 3. Interview with TP #1 on April 14, 2021 at 1:00 PM confirmed the laboratory failed to ensure ALP QC met criteria for acceptability before reporting patient results. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: Based on lack of documentation of gram stain quality control records, interview with testing personnel (TP) #2 and technical supervisor #1, the laboratory failed to document positive and negative reactivity each week of use for gram stains in 2019 /2020/2021. Findings: 1. No documentation of gram stain quality control in 2019, 2020 and to date April 14, 2021. 2. Interview with testing personnel #2 on April 14, 2021 at 1:30 PM, TP #2 stated "They do not record or document gram stain quality control anywhere." 3. Interview with technical supervisor #1 on April 14, 2021 at 1:40 PM confirmed the laboratory failed to document positive and negative reactivity each week of use for gram stains. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of Sysmex CA600 procedure, prothrombin time (PT) quality control (QC), partial thromboplastin time (PTT) QC and interview with the technical supervisor (TS) #1, the laboratory failed to include two levels of control material each 8 hours of operation for PT and PTT. Findings: 1. Review of Sysmex CA600 procedure states "controls should be tested at the initiation of each eight-hour shift". 2. Review of Sysmex CA600 PT QC showed QC was not performed every 8 hours on 1 /15/21. PT QC was performed at 3:45 AM and not again until 2:22 PM. From 11:45 AM until 2:22 PM, 2 patient's were resulted. 2. Review of Sysmex CA600 PT QC showed QC was not performed every 8 hours on 1/21/21. PT QC was performed at 3: 33 AM and not again until 4:37 PM. From 11:33 AM until 4:37 PM, 5 patient's were resulted. 3. Review of Sysmex CA600 PTT QC showed QC was not performed every 8 hours on 1/15/21. PTT QC was performed at 3:45 AM and not again until 2:22 PM. From 11:45 AM until 2:22 PM, 1 patient was resulted. 4. Review of Sysmex CA600 PTT QC showed QC was not performed every 8 hours on 1/21/21. PTT QC was performed at 3:33 AM and not again until 4:37 PM. From 11:33 AM until 4:37 PM, 1 patient was resulted. 5. Review of Sysmex CA600 PT QC showed QC level 2 was completed on 2/11/21, no level 1 control was performed and 1 patient was resulted. 6. Interview with testing personnel #1 on April 14, 2021 at 1:20 PM confirmed the laboratory failed to include two levels of PT and PTT QC material each 8 hours of operation. -- 5 of 9 -- D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of Immunohematology procedures, interview with testing personnel (TP) #1, TP #3 and manager of laboratory services, the laboratory failed to provide an up-to-date procedure for reviewing patient antibody history. Findings: 1. Review of Immunohematology procedure, "ABO Grouping" states "Patient history is checked every time a sample is received." 2. In August 2020, the laboratory started using Cerner Laboratory Information System (LIS), no previous patient antibody history was uploaded into Cerner LIS from file folders. 3. Interview with testing personnel #1 on April 14, 2021 at 1:00 PM, TP #1 stated that "For patient history, they check both the file folders and then they check the computer for patient antibody history." 4. Interview with testing personnel #3 on April 14, 2021 at 12:50 PM, TP #2 stated that "They used to check the file folders for patient history but now they only check the computer." 5. Interview with manager of laboratory services on April 14, 2021 at 1:15 PM confirmed that the laboratory failed to provide an up-to-date procedure for correctly reviewing patient antibody history. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the blood bank procedure manual, interview with testing personnel (TP) #3 and technical supervisor (TS) #1, the laboratory failed to correctly perform refrigerator alarm inspections according to the laboratory's established policy. Findings: 1. Review of blood bank procedure, "Alarm Check" states," Immerse the plastic bottle containing the probe in a container of water along with one of the temperature bottles from the refrigerator. Slowly add ice and salt to cool the temperature of the water below 1 C." and "Allow the temperature to return to normal, then slowly add warm water to the container to raise the temperature above 5.5 C." 2. Interview with testing personnel #3 on April 14, 2021 at 10:30 AM, TP stated that "The BioMed department told her to just lower and raise the temperature on the -- 6 of 9 -- refrigerator and freezer by pushing the up and down temperature buttons on the refrigerator and freezer and that she did not need to use cold or warm water any longer." 3. Interview with the technical supervisor #1 on April 14, 2021 at 11:40 AM confirmed, the laboratory failed to correctly perform refrigerator alarm inspections according to the laboratory's established policy. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of hematology analyzers, lack of hematology instrument comparisons and interview with the technical supervisor (TS) #1, the laboratory failed to evaluate and define the relationship between hematology test results using two different methodologies twice a year in 2019, 2020 and to date April 14, 2021. Findings: 1. Observation of the laboratory revealed a Sysmex XS1000i hematology analyzer and a backup Sysmex KX-21N for performing complete blood counts (CBC). 2. Review of instrument comparisons showed no documentation to evaluate and define the relationship between the Sysmex XS1000i hematology analyzer and a backup Sysmex KX-21N hematology analyzer twice a year in 2019, 2020 and to date April 14, 2021. 3. Interview with the TS #1 on April 14, 2021 at 1:00 PM, confirmed the laboratory failed to evaluate and define the relationship between hematology test results using two different methodologies twice a year in 2019, 2020 and to date April 14, 2021. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on review of chemistry quality control (QC), hematology QC, bacteriology QC and 2019/2020/2021 personnel performance evaluations, the technical supervisors (TS) failed to fulfill the technical supervisor responsibilities. The technical supervisors failed to provide technical and scientific oversight of the laboratory (Refer to D6112), failed to establish the parameters for acceptable levels of analytic performance and ensure that these levels are maintained throughout the entire testing process (Refer to D6117), failed to ensure