Putnam County Memorial Hospital

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the iStat procedure, observation of iStat at nurses station and interview with the general supervisor (GS), the laboratory failed to follow the iStat procedure for room temperature and humidity requirements for 331 of 331 days in 2023. Findings: 1. Review of iStat procedure states "operating temperature 15-40 degrees Celsius; relative humidity 90 percent non-condensing". 2. Observation of iStat at the nurses station showed no room temperature or humidity documented from January 2023 to date November 28, 2023. 3. Interview with the GS on November 28, 2023 at 10:30 AM confirmed the laboratory failed to follow the iStat procedure and document humidity and room temperature at the nurses station. 44735 Based on review of laboratory procedures, refrigerator temperature logs, humidity logs, and interview with the general supervisor (GS), the laboratory personnel failed to follow the established general maintenance procedure for 4 of 332 testing days in 2023. Findings: 1. Review of the laboratory procedure "General Maintenance," states, "Refrigerators/Freezers: Record temperatures on a daily basis." 2. Review of the laboratory's refrigerator temperature logs showed the laboratory personnel failed to record the refrigerator temperature on April 2, 2023, July 23, 2023 and September 30, 2023. 3. Review of the laboratory procedure "General Maintenance" states, "Read and record each day of operation the room temperature and humidity for the laboratory." 4. Review of the laboratory's humidity logs showed the laboratory personnel failed to 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 -- record the humidity for the laboratory on November 12, 2023. 5. Interview with the GS on November 28, 2023 at 10:00 AM confirmed the laboratory personnel failed to follow the established general maintenance procedure. 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 observation of the freezer, review of laboratory temperature logs from January 2023 to date November 28, 2023 and interview with the general supervisor (GS), the laboratory failed to follow manufacturer's instructions for acceptable storage temperature for the chemistry quality control stored in the freezer for 79 of 331 testing days in 2023. Findings: 1. Observation of freezer chemistry quality control stated store at "-20 to -70 degrees Celsius" for the following: -4 bottles BioRad Liquichek cardiac markers plus control LT lot # 67691 expiration 8/31/25 -2 bottles BioRad Liquichek specialty Immunoassay control lot # 64941 expiration 4/30/24 -12 bottles BioRad Liquichek cardiac markers plus control LT lot # 67693 expiration 8/31/25 2. Review of laboratory temperature logs from January 2023 to date November 28, 2023 showed freezer with an unacceptable temperature range for 79 testing days. 3. Interview with the GS on November 28, 2023, 2023 at 10:00 AM confirmed the laboratory failed to follow manufacturer's instructions for acceptable storage temperature for chemistry quality control stored in the freezer. 47802 Based on review of policies, review of temperature logs, and interview with the general supervisor (GS), the laboratory failed to document the temperature and revaluations per minute (RPM) for the MTS incubator and centrifuge workstation. Findings: 1. Review of the policy titled Antibody Screen (Selectogen I & II) states: -Incubate at 37+/- 2C for 15 minutes -Centrifuge the gel card at the pre-set conditions of 895 +/- 25 RPMs for 10 minutes 2. Review of the blood bank temperature and maintenance logs from April 1, 2022 to date November 28, 2023 showed no documentation of temperature and RPM for the MTS incubator and centrifuge workstation. 3. Interview with the GS on November 28, 2023 at 11:30 AM confirmed the laboratory failed to document temperature and RPM for the MTS incubator and centrifuge workstation. 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. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on review of the performance verification procedures for the Ortho Diagnostics Vitros 5600 chemistry analyzer, patient results, and interview with the general supervisor (GS), the laboratory failed to verify performance specifications prior to reporting patient test results. Findings: 1. Review of the performance specifications for the Ortho Diagnostics Vitros 5600 chemistry 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: albumin, alcohol, amylase, alkaline phosphatase, alanine transaminase (ALT), aspartate aminotransferase (AST), direct bilirubin, indirect bilirubin, urea nitrogen (BUN), calcium, creatine kinase, chloride, cholesterol, carbon dioxide (CO2), creatinine, direct low-density lipoprotein (DLDL), glucose, potassium, lactate dehydrogenase (LDH), magnesium, sodium, phosphorus, total bilirubin, total protein, triglycerides, uric acid, lactic acid, brain natriuretic peptide (BNP2), troponin I, creatine kinase MB (CKMB), thyroid-stimulating hormone (TSH), and free thyroxine (Free T3) prior to the beginning of patient testing in June 2022. 2. Review of patient results showed the laboratory performs approximately 45,332 chemistry tests per year. 3. Interview with the GS on November 28, 2023 at 10:00 AM confirmed the laboratory failed to verify performance specifications prior to reporting patient test results. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with testing personnel (TP) #29, the technical consultant (TC) failed to evaluate and document the performance of four of four TP at least semiannually during the first year the individual tests patient specimens in 2023. Findings: 1. Review of performance evaluations showed the TC failed to perform the semiannual competency evaluations for TP #22, TP #25, TP #28 and TP #32. 2. Interview with TP #29 on November 28, 2023 at 11:30 AM, confirmed the TC failed to evaluate and document the performance of four TP at least semiannually during the first year the individual tests patient specimens. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of performance evaluations and interview with the testing personnel (TP) #29, the technical consultant (TC) failed to evaluate and document the annual performance evaluation for two of thirty-two TP. Findings: 1. Review of performance evaluations showed the following: -No annual performance evaluation for TP #18 and TP #28 in 2023 -No annual performance evaluation for TP #18 in 2022. 2. Interview -- 3 of 4 -- with TP #29 on November 28, 2023 at 11:20 AM confirmed the TC failed to evaluate and document the annual performance evaluations for two testing personnel. -- 4 of 4 --

Summary Statement of Deficiencies 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 Ortho Diagnostics Vitros 350 analyzer and quality control (QC) records, Vitros ECiQ analyzer and QC, ACL Elite analyzer, Prothrombin Time (PT) and D-Dimer QC, review of manufacturer's instructions, and interviews, the laboratory failed to meet the condition of analytic systems. The laboratory's lack of blood bank alarm check procedure, failed to follow proficiency testing procedure (Refer to D5401); the laboratory failed to perform Vitros 350 calibration verification (Refer to D5439); the laboratory failed to include two control materials of different concentrations each day of patient testing (Refer to D5447); the laboratory failed to perform positive and negative controls each day of patient testing for serum hCG (Refer to D5449); the laboratory failed to follow established criteria for QC (Refer to 5469); the laboratory failed to include two levels of control material each 8 hours of operation for PT and D-Dimer (Refer to D5545); the laboratory failed to perform blood bank QC each day of patient testing (Refer to 5551); and the laboratory failed to perform quarterly blood bank refrigerator alarm checks (Refer to 5555). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed 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 19 -- 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 procedures, proficiency testing (PT) and interview with the general supervisor (GS), the laboratory failed to follow "Proficiency Testing" procedure. Findings: 1. Review of "Proficiency Testing" procedure states "The Laboratory Director and all staff performing the testing should sign in the attestation spaces provided on the data sheet". 2. Review of the 2020, 2021 and to date March 1, 2022 PT attestations showed the laboratory director (LD) failed to follow procedure and sign the attestation. 3. Interview with the GS on March 1, 2022 at 11:00 AM confirmed the LD failed to follow "Proficiency Testing" procedure. 44735 Based on interview with the general supervisor (GS) and review of blood bank procedures, the laboratory failed to provide a procedure for quarterly blood bank alarm checks. Findings: 1. Interview with the GS on March 1, 2022 at 2:30 PM, the GS stated that the laboratory was not staffed from 5:30 PM to 6:00 AM daily, and that the blood bank refrigerator would alarm in the laboratory and at the nurse's station. 2. Review of blood bank procedures showed no procedure for performing blood bank alarm checks. 3. Interview with the GS on March 1, 2022 at 2:30 PM confirmed that the laboratory failed to provide a procedure for blood bank alarm checks. 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 2020, 2021, and to date March 1, 2022 calibration records for the Ortho Diagnostics Vitros 350 chemistry analyzer and interview with the general supervisor (GS), 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. -- 2 of 19 -- Findings: 1. Review of Vitros 350 calibration records for 2020, 2021, and to date March 1, 2022 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 analyte chloride. 2. Interview with the GS on March 1, 2022 at 2:30 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 for chloride. 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 interview with the general supervisor (GS), review of Vitros 350 quality control (QC) package insert, Ortho Diagnostics Vitros 350 analyzer and January 1, 2022 to March 1, 2022 chemistry QC, the laboratory failed to include two control materials of different concentrations for cholesterol for 5 of 60 patient testing days. Findings: 1. Interview with the GS on March 1, 2022 at 1:45 PM, the GS stated that they use package insert ranges for chemistry QC. 2. Review of Vitros 350 package insert showed: PV1 lot # D8955 cholesterol range as 130.4 - 156.4 PV2 lot # C8821 cholesterol range as 228.2 - 260.2 3. Review of Ortho Diagnostics Vitros 350 analyzer showed: PV1 cholesterol range as 141.6 - 170.4 PV2 cholesterol range as 239 - 277 4. Review of Ortho Vitros 350 cholesterol QC showed two acceptable levels of QC were not performed on February 5, 2022, February 10, 2022, February 16, 2022, February 18, 2022, and February 25, 2022. The laboratory reported 15 patient test results while QC was not acceptable. 5. Interview with the GS on March 1, 2022 at 2:00 PM confirmed the laboratory failed to include two control materials each day of patient testing for cholesterol. 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 serum human chorionic gonadotropin (hCG) quality control (QC) records for 2020, 2021, and to date March 1, 2022 and interview with the general supervisor (GS), the laboratory failed to perform positive and negative controls for serum hCG for 13 of 13 patient testing days. Findings: 1. Review of serum hCG QC records for 2020, 2021, and to date March 1, 2022 showed the laboratory failed to perform a positive and negative QC each day of patient testing. The laboratory -- 3 of 19 -- reported 13 patient tests while QC was not performed. 2. Interview with the GS on March 1, 2022 at 10:30 AM confirmed, the laboratory did not test a positive and negative control each day of patient testing. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on interview with the general supervisor (GS), and review of Ortho Diagnostics Vitros 350 analyzer quality control (QC) records, the laboratory failed to follow established criteria for acceptability of control materials providing quantitative results. Findings: 1. Interview with the GS on March 1, 2022 at 1:45 PM, the GS stated that they use package insert ranges for chemistry QC. 2. Review of Vitros 350 package insert PV1 lot # D8955 showed: cholesterol range as 130.4 - 156.4 alkaline phosphatase as 73 - 124 phosphorus as 3.11 - 3.91 3. Review of Vitros 350 package insert PV2 Lot # C8891 showed: cholesterol range as 228.2 - 260.2 alkaline phosphatase as 308 - 552 phosphorus as 6.53 - 8.13 4. Review of Vitros 350 analyzer showed: PV1 cholesterol range as 141.6 - 170.4 PV2 cholesterol range as 239 - 277 PV1 alkaline phosphatase as 73.4 - 128.6 PV2 alkaline phosphatase as 334 - 586 PV1 phosphorus as 3.03 - 4.15 PV2 phosphorus as 6.39 - 8.79 4. Review of Ortho Vitros 350 cholesterol QC showed two acceptable levels of QC were not performed on February 5, 2022, February 10, 2022, February 16, 2022, February 18, 2022 and February 25, 2022. The laboratory reported 15 patient tests while QC was not acceptable. 5. Interview with the GS on March 1, 2022 at 2:00 PM confirmed the laboratory failed to follow established criteria for acceptability of control materials providing quantitative results. 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 the "Coagulation" procedure, ACL Elite analyzer quality control (QC) records, and interview with the general supervisor (GS), the laboratory failed to -- 4 of 19 -- include two levels of control material each 8 hours of operation for prothrombin time (PT) and D-Dimer for 3 of 60 patient testing days in January, February, and to date March 1, 2022. Findings: 1. Review of the PT and D-Dimer procedure states that "Quality control is usually run once daily but will be repeated if a sample comes in past the 8 hours for the daily run". 2. Review of ACL Elite PT QC showed QC was not performed every 8 hours on January 13, 2022. One patient's PT was reported at 2: 47 PM and the last PT QC was performed at 6:23 AM. 3. Review of ACL Elite PT QC showed QC was not performed every 8 hours on January 28, 2022. One patient's PT was reported at 3:39 PM and the last PT QC was performed at 6:46 AM. 4. Review of ACL Elite D-Dimer QC showed QC was not performed every 8 hours on January 24, 2022. One patient's D-Dimer was reported at 9:49 AM and the last QC performed January 23, 2022 at 10:12 AM. 5. Review of ACL Elite D-Dimer QC showed QC was not performed every 8 hours on January 24, 2022. One patient's D- Dimer was reported at 10:30 PM and the last QC was performed 10:49 AM. 6. Interview with the GS on March 1, 2022 at 2:00 PM confirmed the laboratory failed to include two levels of control material each 8 hours of operation for PT and D-Dimer. 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 general laboratory and blood bank procedures, blood bank patient logs, blood bank quality control (QC) logs, and interview with the general supervisor (GS), the laboratory failed to document quality control for six patient testing days in 2021 and failed to provide a procedure for checking patient history in blood bank. Findings: 1. Review of the laboratory's policy "Quality Control" states "Blood Bank: Quality Control will be run at least once per day of use or as required per manufacturer's instructions after maintenance or instrument problems." 2. Review of 2021 blood bank patient testing logs showed patient testing was performed on April 5, 2021, April 16, 2021, April 19, 2021, April 29, 2021, June 1, 2021 and December 14, 2021.. 3. Review of 2021 blood bank QC show no documented QC for April 5, 2021, April 16, 2021, April 19, 2021, April 29, 2021, June 1, 2021 and December 14, 2021. 4. Review of blood bank procedures showed no procedure for checking patient history prior to performing blood bank procedures. 5. Interview with the GS on March 1, 2022 at 2:00 PM confirmed the laboratory failed to document quality control for six patient testing days in 2021 and failed to provide a blood bank procedure for checking patient history. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) -- 5 of 19 -- (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 lack of blood bank refrigerator alarm checks for 2020, 2021, and to date March 1, 2022 and interview with the general supervisor (GS), the laboratory failed to document quarterly refrigerator alarm inspections. Findings: 1. Lack of blood bank refrigerator alarm checks showed the laboratory did not have documentation for quarterly refrigerator alarm inspections during 2020, 2021, and to date March 1, 2022. 2. Interview with the GS on March 1, 2022 at 10:00 AM confirmed, the laboratory failed to document quarterly refrigerator alarm inspections. 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 review of laboratory procedures, patient reports, and interview with the general supervisor (GS), the laboratory failed to ensure the procedure reference ranges matched the reference ranges on the patient reports. Findings: 1. Review of the Sysmex XN-350 procedure, "Performance Characteristics: Reference Interval" showed the reference ranges as: Neutrophil (Neut) %: Female 34.0 to 71.1 % Lymphocyte (Lymph) %: Female 19.3 to 51.7 % Monocyte (Mono) %: Female 4.7 to 12.5 % Eosinophil (Eo) %: Female 0.7 to 5.8 % Basophil (Baso) %: Female 0.1 to 1.2 % Male 0.2 to 1.2 % Absolute Neut: Female 1.56 to 6.13 x10^3/uL Absolute Lymph: Female 1.18 to 3.74 x10^3/uL Absolute Mono: Female 0.24 to 0.36 x10^3/uL Absolute Eo: Female 0.04 to 0.36 x10^3/uL Red blood cell count (RBC): Female 3.93 to 5.22 x10^3/uL Male 4.63 to 6.08 x10^3/uL Hemoglobin (Hgb): Male 13.7 to 17.5 g /dL Mean corpuscular volume (MCV): Female 79.4 to 94.8 fL Male 79.0 to 92.2 fL Mean corpuscular hemoglobin (MCH): Female 25.6 to 32.2 pg Male 25.7 to 32.2 pg Mean corpuscular hemoglobin concentration (MCHC): Female 32.2 to 35.5 g/dL Male 32.3 to 36.5 g/dL Red cell distribution width (RDW): Female 11.7 to 14.4 % Mean platelet volume (MPV): Female 9.4 to 12.3 fL 2. Review of "Table of Normal & Critical Values" procedure showed the reference ranges as: ALT (SGPT): 9 - 52 U /L adult/child Chloride: 98 - 110 mmol/L adult Creatinine: 0.0 - 1.2 mg/dL adult Glucose: 65 - 105 mg/dL adult Potassium: 3.6 - 5.0 mmol/L adult PT Normal: 10.9 - 13.9 seconds APTT Normal: 27.4 - 32.4 seconds White Blood Cell (WBC): 4,500 - 11,000/mm^3 Hgb: Female 12 - 16 g/dL Hematocrit (Hct): Male 39 - 50 % Female 35 - 45 % Platelet (Plt): 150,000 - 400,000/mm^3 RBC: Male 4.0 - 6.2 M/uL Female 4.0 - 6.2 M/uL 3. Review of patient reports showed the reference ranges as: WBC: Female 3.9 - 10.0 x10^3/uL Male 4.2 - 9.0 x10^3/uL Neut %: Female 34.0 - 67.9 % Lymph %: Female 21.8 - 53.0 % Mono %: Female 5.3 - 12.2% Eo %: Female 0.8 - 7.0 % Baso %: Female 0.0 - 1.2 % Male 0.0 to 1.2 % Absolute Neut: Female 1.78 - 5.38 x10*3/uL Absolute Lymph: Female 1.32 - 3.57 x10*3/uL Absolute Mono: -- 6 of 19 -- Female 0.30 - 0.82 x10*3/uL Absolute Eo: Female 0.04 - 0.54 x10*3/uL RBC: Female 3.3 - 5.2 x10^6/uL Male 3.9 - 6.0 x10^6/uL Hgb: Female 11.2 - 15.7 g/dL Male 14.0 - 18.0 g/dL Hct: Female 34.1 - 44.9 % Male 40.1 - 51.0 % MCV: Female 82.0 - 93.0 fL Male 82.0 - 93.0 fL MCH: Female 26.0 - 34.0 pg Male 26.0 - 34.0 pg MCHC: Female 31.0 - 38.0 g/dL Male 31.0 - 38.0 g/dL RDW: Female 11.6 to 14.4 % Plt: Female 182 - 369 mg/dL Male 163 - 337 mg/dL MPV: Female 9.40 to 12.40 fL ALT (SGPT): 0 - 50 U/L Chloride: 98 - 107 mmol/L Creatinine: 0.6 - 1.2 mg/dL Glucose: 74 - 106 mg/dL Potassium: 3.5 - 5.1 mmol/L PT Normal: 9.92 - 12.80 seconds APTT Normal: 21.62 - 35.78 seconds 4. Interview with the GS on March 1, 2022 at 3:00 PM confirmed that the procedure reference ranges did not match the patient report reference ranges. 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 Ortho Diagnostics Vitros 350, Vitros ECiQ, ACL Elite, blood bank, the laboratory's procedures, proficiency testing and interviews, the laboratory director (LD) failed to provide overall management and direction of the laboratory. The LD failed to review proficiency testing (Refer to D6091); the LD failed to follow procedure for proficiency testing

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the blood bank procedure manual, patient records and blood bank quality control (QC) for August 2019 and interview with the general supervisor, the laboratory failed to follow the manual for performing blood bank QC. Findings: 1. The blood bank procedure manual states, "Blood Bank Quality Control in this laboratory is to be processed on the day a Blood Bank Procedure is requested." 2. Review of patient records revealed the laboratory performed a forward type, reverse type, antibody screen and compatibility test on patient (G) on August 19, 2019. Patient records showed patient (G) received two units of packed red blood cells on August 19, 2019. The laboratory did not have documentation to show blood bank QC was performed / processed on August 19, 2019. 3. Interview on September 4, 2019 at 11:00 AM, the general supervisor confirmed the laboratory did not perform QC on the day the procedure was requested. Interview confirmed the laboratory failed to follow the written blood bank QC procedure. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic 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 -- examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of competency procedure, blood gas competencies and interview with the general supervisor, the laboratory failed to follow competency policy for 23 of 23 testing personnel for blood gases in 2017 and to date April 24, 2018. There was no documentation of direct observations for competency with the laboratory director who is also the technical supervisor's approval. Findings: 1. Review of "Annual Orientation and competency of laboratory staff" policy states "direct observations of routine patient test performance including patient preparation, if applicable, specimen handling, processing and testing". No documentation of direct observation for 23 testing personnel for blood gases. 2. Review of "Annual orientation and competency of laboratory staff" policy states "testing personnel for each test the the individual is approved by the laboratory director". No documentation of laboratory director approval for 23 blood gas testing personnel competencies. 3. Interview with testing personnel #1 for blood gases on April 24, 2018 at 1:30 PM confirmed the laboratory failed to follow policy for blood gas testing personnel competencies. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on review of the toxicology procedure manual, observation of toxicology centrifuge and interview with the testing personnel #2, the laboratory failed to follow instructions for urine toxicology testing. Findings: 1. Review of the toxicology procedure manual showed the laboratory must centrifuge urine for urine toxicology confirmation testing at 13300 revolutions per minute (RPM). 2. Observation of the toxicology centrifuge revealed, the centrifuge spins at 14851 RPM. 3. Interview with the testing personnel #2 on April 24, 2018 at 1:00 PM confirmed, the laboratory failed to centrifuge urine at the speed stated in the procedure manual. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)