Cordell Memorial Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/20,21,22/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief executive officer, technical consultant, and general supervisor #2 during an exit conference performed at the conclusion of the survey. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records, nursing policy, and interview with the technical consultant, the facility failed to ensure written policies were followed for preventing transfusion reactions for four of seven units of packed red-blood cells transfused. Findings include: (1) On 08/22/2024 at 1:30 pm, the technical consultant stated that blood transfusions were performed by nursing staff. (2) On 08/22/2024, a review of the hospital policy titled, "Blood Administration Procedure" defined vitals as temperature, blood pressure, pulse and respirations and stated: (a) "Vital signs before initiation of transfusion"; (b) "Check vitals at least every 15 minutes for the first half hour after the start of the transfusion and then every hour after during the transfusion until transfusion is complete". (3) A review of transfusion records for seven units identified the policy had not been followed for four units as follows; (a) Unit #W091024274731 - The unit was started at 11:39 am and vital signs were not taken until 2:09 pm at the end of the transfusion; (b) Unit #W0910290785 - The unit was started at 2:09 pm and vital signs were not taken until 4:20 pm at the end of the transfusion; (c) Unit #W091024215403 - The unit was started at 11:00 pm and vital signs were taken at 11:33 pm, midnight, 12:15 am, and 1:30 am. The transfusion was 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 -- completed at 1:05 am; (d) Unit #W091024230658 - The unit was started at 1:10 am and vital signs were taken at 1:30 am, 2:15 am, and 3:21 am at the conclusion of the transfusion. (4) The records were reviewed with the technical consultant who stated on 08/22/2024 at 01:30 pm, the vital signs had not been documented according to policy. 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 a review of records, observation, and interview with the technical consultant, the laboratory failed to ensure 14 of 14 boxes of Triage total 5 quality control materials were stored as required by the manufacturer. Findings include: (1) On 08/20/2024 at 11:00 am observation of the contents of the laboratory freezer identified the following materials: (a) Seven boxes of Triage total 5 quality control materials, level one, lot # C3996AN (b) Seven boxes of Triage total 5 quality control materials, level two, lot # C4002AN (2) The storage requirement, as stated on the bottles for the materials was -20 degrees C (Celsius) or colder; (3) On 08/20/2024 at 11:00 am identified the current temperature reading as -18 degrees C; (4) Observation of the freezer temperature logs from November 1, 2023 to December 31, 2023 identified the following: (a) The temperatures were warmer than -20 degrees C for 60 of 61 days reviewed. (4) The findings were reviewed with the technical consultant who stated on 08/20/2024 at 11:00 am, the freezer temperatures were not within the manufacturer's storage requirements. 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 -- 2 of 4 -- 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 a review of records and interview with general supervisors #1 and #2, the laboratory failed to perform calibration verification procedures at least once every six months for the i-STAT1, Cobas Integra, and Cobas E411 test systems during the review period of 08/05/2022 through the current date. Findings include: i-Stat (1) On 08/22/2024 at 2:00 pm, general supervisors #1 and #2 stated that the laboratory performed blood gas (pH, pO2 and pCO2) on the i-STAT1 analyzer (SN375736) using the EG6+ cartridge; (2) A review of records from 08/05/2022 through the current date identified no evidence the calibration verification procedures had been performed for the EG6+ test system; (3) The findings were reviewed with the technical consultant and general supervisor #2, who stated on 08/22/2024 at 2:00 pm, the calibration verification procedures had not been performed every six months as stated above. Cobas Integra (1) On 08/22/2024 at 2:00 pm, the technical consultant stated that the laboratory performed chemistry testing (albumin, bun, calcium, cholesterol, chloride, creatinine, glucose, potassium, lactate, magnesium, sodium, phosphorus, total protein, triglyceride, carbon dioxide, ethanol, ammonia, uric acid, alkaline phosphatase, alt, amylase, AST, creatinine kinase, lactate dehydrogenase, lipase, total bilirubin, and hemoglobin A1c) using the Cobas Integra analyzer. (2) A review of records from 08/05/2022 through the current date identified no evidence that calibration verification procedures had been performed between 1/26/2023 and 05 /21/2024 for the analytes listed above; (3) The findings were reviewed with the technical consultant and general supervisor #2, who stated on 08/22/2024 at 2:00 pm, the calibration verification procedures had not been performed every six months as stated above. Cobas E411 (1) On 08/22/2024 at 2:00 pm, the technical consultant stated that the laboratory performed immunoassay testing (CKMB, troponin-T, myoglobin, ProBNP, TSH, and PSA) using the Cobas E411 analyzer; (2) A review of records from 08/05/2022 through the current date identified no evidence that calibration verification procedures had been performed between 1/26/2023 and 05/21 /2024 for the analytes listed above; (3) The findings were reviewed with the technical consultant and general supervisor #2, who stated on 08/22/2024 at 2:00 pm, the calibration verification procedures had not been performed every six months as stated above. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under -- 3 of 4 -- Subpart H for one of five proficiency testing events reviewed in 2023 and 2024. Findings include: (1) A review of 2023 and 2024 proficiency testing events identified attestation statements had been signed up after the graded evaluation had been received for one of five events reviewed: (a) Third event 2023 Immunology /Immunohematology - The sample testing had been completed on 12/13/2023 and the attestation statement had not been signed by the laboratory director until 04/04/2024. (2) The records were reviewed with the technical consultant who stated on 08/21/2024 at 2:00 pm the attestation statement had not been signed timely as stated above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1407; D6000: Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the second 2023 and first 2024 events, the laboratory 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 2 -- successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three consecutive testing events for the analyte Chloride. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the the laboratory failed to achieve satisfactory performance for the analyte Chloride in two of three consecutive testing events. Findings include: (1) The laboratory received a score of 20% on the second 2023 event and a score of 40% on the first 2024 event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte Chloride in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the second 2023 event and first 2024 event. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte Chloride in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the second 2023 event and first 2024 event. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1407; D6000: Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to successfully participate in a proficiency 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 -- testing program for the specialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three consecutive events for the specialty of Hematology. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for White Blood Cell Differential for %Lymphocytes for two of three consecutive testing events. Findings include: (1) The laboratory received a score of 0% on the third 2022 event and a score of 0% on the second 2023 event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for White Blood Cell Differential for %Lymphocytes in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the third 2022 event and second 2023 event. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for White Blood Cell Differential for %Lymphocytes in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the third 2022 event and second 2023 event. Refer to D6016. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/02,03,04/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant and laboratory manager 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, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for one of three analyzers. Findings include: (1) On 08/02/2022 at 11:50 am, the technical consultant stated the laboratory performed CKMB (Creatine Kinase Isoenzyme), Myoglobin, Pro-BNP (B-type natriuretic peptide), PSA (Prostate Specific Antigen), Troponin T, and TSH (Thyroid Stimulating Hormone) testing using the Cobas e411 analyzer; (2) On 08/04/2022, a review of the manufacturer's maintenance log showed the following manufacturer required weekly maintenance procedures: (a) Clean Incubator and Aspiration Station (b) Clean Sipper probe (3) A review of maintenance logs in October 2021, November 2021, March 2022, and July 2022 revealed the weekly maintenance had not been documented as performed between 10/01/2021 and 11/05/2021; (4) The records were reviewed with the technical consultant who stated on 08/04/2022 at 11:41 am, the above maintenance had not been documented as performed. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to perform function checks as defined by the manufacturer for the iSTAT 1 analyzer 19 of 19 months reviewed. Findings include: (1) On 08/02/2022 at 11:00 am, the technical consultant stated the laboratory performed Blood Gas (pH, pCO2, and pO2) testing using two the iSTAT 1 analyzer and the EG6+ cartridge; (2) A review of the manufacturer's instructions contained in the "iSTAT 1 System Manual" on page 14-2 stated "Check thermal contral system every six months"; (3) On 08/03/2022, a review of records from January 2021 through July 2022 revealed no evidence the thermal probe checks had been performred during the review period; (4) The findings were reviewed with the technical consultant who stated on 08/03/2022 at 11:56 am, the thermal probe checks had not been performed every six months. 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 a review of records and interview with the technical consultant, the laboratory failed to perform calibration verification procedures at least once every 6 months for 27 of 27 analytes. Findings include: (1) On 08/02/2022 at 11:50 am, the technical consultant stated Albumin, Alcohol, Alkaline Phosphatase, ALT (Alanine Aminotransferase), Ammonia, Amylase, AST (Aspartate Aminotransferase), BUN (Blood, Urea, Nitrogen), CO2, Direct Bilirubin, Total Bilirubin, Calcium, Potassium, CK (Creatine Kinase), Chloride, Sodium, Creatinine, Glucose, Lactic Acid, Lipase, -- 2 of 6 -- LD (Lactate Dehydrogenase), Magnesium, Phosphorus, Total Protein, Total Cholesterol, Triglyceride, and Uric Acid testing were performed using the Cobas Integra 400 analyzer; (2) On 08/04/2022, a review of 2022 calibration records revealed that calibration procedures for the above analytes had been performed with two levels of calibrators. Since the calibration procedures included only two levels, calibration verification procedures, using three or more levels of calibration materials that included a low, mid, and high value, were required every six months; (3) A review of calibration verification records performed during 2021 through the current date revealed that calibration verification had not been performed as follows: (a) Albumin, Alcohol, Alkaline Phosphatase, ALT, Ammonia, Amylase, AST, BUN, CO2, Direct Bilirubin, Total Bilirubin, Calcium, Potassium, Chloride, Sodium, Creatinine, Glucose, Lactic Acid, Lipase, LD, Magnesium, Phosphorus, Total Protein, Total Cholesterol, Triglyceride, and Uric Acid - Between 02/12/2021 and 02/10/2022; (b) CK - Since 02/12/2021 (4) The records were reviewed with the technical consultant who stated on 08/04/2022 at 11:28 am, calibration verification had not been performed as stated above. 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 a review of records and interview with the technical consultant, the laboratory failed to ensure quality control results were acceptable before reporting patient test results for pO2 and Oxygen Saturation testing for one of 11 patients reviewed. Findings include: (1) On 08/02/2022 at 11:30 am, the technical consultant stated the following: (a) The laboratory performed arterial and venous blood gas (pH, pCO2, pO2) testing using the EG6+ cartridge and iSTAT 1 analyzer; (b) An IQCP (Individualized Quality Control Program) had not been developed for the test system and the laboratory performed two levels of QC (Quality Control) materials each eight hours of patient testing. (2) On 08/03/2022, a review of QC and patient testing records for testing performed in June 2021, November 2021, January 2022, and May 2022 revealed the results for level one QC for pO2 and Oxygen Saturation was not acceptable for one of 11 patients reviewed as follows: (a) 06/22/2021 - A patient venous blood gas had been tested at 01:56 pm. Although two levels of QC materials had been tested (level one was tested at 01:17 pm and level three was tested at 01:21 pm), the pO2 and Oxygen Saturation results for level one were suppressed (the results were replaced with ***). There was no indication the sample had been retested to ensure acceptable results prior to reporting patient testing. (4) The records were reviewed with the technical consultant who stated on 08/03/2022 at 01:27 pm, the patient Blood Gas results had been reported when level one QC results were not acceptable for pO2 and Oxygen Saturation as stated above. 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 -- 3 of 6 -- 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 a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to have procedures to detect an ABO incompatibility between the donor's cell type and the recipient serum or plasma type for 14 of 22 units crossmatched. Findings include: (1) On 08/02/2022 at 11:20 am, the technical consultant stated the Ortho MTS Anti-IgG gel cards were used to perform patient antibody screen and compatibility testing; (2) On 08/03/2022 a review of the manufacturer's instructions contained in the package insert for the MTS Anti-IgG gel cards stated, "The MTS Anti-IgG Gel Test System can be used in both direct and indirect antiglobulin test systems to detect the presence or absence of IgG on human red blood cells"; (3) A review of patient compatibility testing performed from 11/13 /2021 through 07/26/2022 revealed for 14 of 22 units crossmatched, the laboratory exclusively used the Anti-IgG gel cards to perform patient compatibility testing, and therefore, did not include a method to detect ABO incompatibilities based on IgM antibodies (in order to achieve this, an immediate spin crossmatch, containing the donor's red blood cells and the recipient's serum or plasma, or an electronic crossmatch must be performed in conjunction with the IgG crossmatch); (4) The findings were reviewed with the technical consultant who stated on 08/03/2022 at 04: 00 pm, an immediate spin crossmatch (using the buffer gel card or tube method) had not been performed for the 14 units crossmatched; (5) The specific days of testing were: (a) 04/17/2022 - one unit crossmatched (b) 05/12/2022 - two units crossmatched (c) 05/17/2022 - one unit crossmatched (d) 05/27/2022 - two units crossmatched (e) 06 /07/2022 - two units crossmatched (f) 06/13/2022 - two units crossmatched (g) 07/13 /2022 - two units crossmatched (h) 07/26/2022 - two units crossmatched NOTE: The following reference was published in the CLIA Network Newsletter dated July- August 2009: "The gel card only detects incompatibility based on IgG antibodies. It does not detect incompatibility based on IgM antibodies, which is important in determining ABO compatibility. Therefore, the use of the gel card alone is not adequate to demonstrate incompatibility between the donor's cell type and the recipient's serum type, and the laboratory must also perform an immediate spin or electronic crossmatch to determine ABO compatibility." NOTE: The Interpretive Guidelines at 493.1271 require standard operating procedures for compatibility testing: "Procedures to demonstrate incompatibility between the donor's cell type and the recipients's serum or plasma type. These procedures may consist of a serologic crossmatch, or a computer crossmatch." D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The -- 4 of 6 -- laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (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 a review of written policies and interview with the technical consultant, the laboratory failed to ensure that written policies provided safety for individuals being transfused for three of three patients reviewed. Findings include: (1) On 08/02/2022 at 11:20 am, the technical consultant stated the laboratory stored units of PRBC's (packed red blood cells) in the blood bank refrigerator. The units were to be used for patient transfusions; (2) On 08/03/2022, a review of the hospital policy titled, "Blood Administration Protocol" stated the following: (a) "Check for signed consent for transfusion"; (b) Check vital signs at least every 15 minutes for the first half hour after the start of the transfusion and then every hour after during the transfusion until infusion is complete". (3) A review of records for three patients receiving transfusions in April and July 2022 revealed the policy had not been followed as follows: (a) Patient #9693 - Transfused with one unit of PRBC's (unit #W091022174886) on 04/17 /2022. There was no evidence the vitals had been taken every 15 minutes for the first half hour. The vitals had not been taken between 11:05 am and 11:35 am; (b) Patient #726 - Transfused with two units of PRBC's on 07/13,14/2022. There was no evidence of a signed consent in the patient records; (c) Patient #11828 - Transfused with two units of PRBC's on 07/26/2022. For one of two units (W091022272907), there was no evidence the vitals had been taken every 15 minutes for the first half hour. The vitals had not been taken between 11:40 am and 12:40 pm. (4) The records were reviewed with the technical consultant who stated on 08/03/2022 at 02:30 pm, the policy had not been followed as stated above. NOTE: D5559 was cited on the recertification survey performed on 10/05,06/2020 D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to follow their policy for monitoring the effectiveness of their QCP for the Med Tox Profile II analyzer for two of three years. Findings include: (1) On 08 /03/2022 at 10:00 am, the technical consultant stated the following: (a) Urine Drug Screen testing was performed on the Med Tox Profile II analyzer; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) A review of the QA (Quality Assessment) portion of the IQCP included a schedule for evaluating the QCP (Quality Control Plan) annually to ensure they continued to provide accurate and reliable results; (3) A review of records from January 2020 through July 2022 revealed an annual review of the QCP had not been performed since 01/07/2020; (4) The records were reviewed with the technical consultant who stated on 08/03/2022 at 01:30 pm, the QA reviews had not been performed. -- 5 of 6 -- 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 the technical consultant, the laboratory failed to ensure reference intervals were determined as appropriate for the laboratory's patient population. Findings include: (1) On 08/02/2022 at 11:15 am, the technical consultant stated CBC (Complete Blood Count) testing was performed using the Sysmex 1000i analyzer; (2) On 08/03/2022, two patient CBC reports were reviewed - the first report was for an adult male patient with the testing performed on 03/29/2022 at 08:19 am; the second report was for an adult female patient with the testing performed on 07/01/2022 at 07:27 am. Both reports included the same reference intervals for the CBC parameter of Hemoglobin which was 11.8-15.8 gm/dl; (3) The reports were reviewed with the technical consultant who stated on 08/03/2022 at 12:13 pm, the patient reports did not include a gender specific reference range for Hemoglobin. -- 6 of 6 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/05/2020 and 10/06/2020. The findings were reviewed with hospital administrator/director of nursing, quality /infection control/case management, laboratory/radiology manager, and the technical consultant during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies. 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 the technical consultant, the laboratory failed to follow the manufacturer's instructions for Mycoplasma testing for 1 of 3 days. Findings include: (1) On 10/05/2020 at 11:45 am, the technical consultant stated to the surveyor the ImmunoCard Mycoplasma test kit was used to detect IgM to Mycoplasma pneumoniae in patient serum samples; (2) The surveyor reviewed the manufacturer's instructions (package insert) for the test kit. The section titled, "Test Procedure" stated "Incubate 2 minutes at 22-25 degrees C"; (3) The surveyor reviewed 3 patient reports (testing performed 09/08/2020, 09/11/2020, 10/05/2020) and laboratory temperature logs. The review showed the laboratory had not followed the manufacturer's instructions for incubating at the specified temperature for 1 of 3 patients. The room temperature for the patient tested on 09/08 /2020 had been documented as 20 degrees C (Centigrade); (4) The surveyor reviewed the findings with the technical consultant, who stated on 10/05/2020 at 05:15 pm, the laboratory had not followed the manufacturer's instructions. 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 -- D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (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 the technical consultant, the laboratory failed to perform quality control as stated in the IQCP for PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing on the Hemochron Signature+ analyzer for 1 of 9 months. Findings include: (1) On 10/05/2020 at 11:45 am, the technical consultant stated to the surveyor: (a) PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed on the Hemochron Signature+ analyzer; (i) Two levels of quality control materials were tested monthly, according to the laboratory IQCP (Individualized Quality Control Plan); (ii) The results for two levels of control materials must be acceptable in order to report patient results. (2) The surveyor reviewed PT/INR and PTT quality control records for testing performed from January 2020 through September 2020. The following was identified for 1 of 9 months: (a) Level 2 PTT - not documented as performed between 04/15/2020 and 06 /16/2020. (3) The surveyor reviewed the records with the technical consultant, who stated on 10/06/2020 at 11:10 am quality control had not been performed as stated in the IQCP. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (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 a review of written policies and interview with the technical consultant, the laboratory failed to ensure that written policies provided safety for individuals being transfused for 7 of 16 packed red blood cell units. Findings include: (1) On 10/05 /2021 at 12:25 pm, the technical consultant stated the laboratory stored units of PRBCs (packed red blood cells) in the blood bank refrigerator. The units were to be used for patient transfusions; (2) The surveyor reviewed the Nursing Policy and -- 2 of 5 -- Procedure regarding blood administration. The policy titled, "Blood Administration Procedure" stated the following: (a) "1. Explain procedure to patient. Check for signed consent for transfusion. Advise patient to report any chills, itching, rash, or unusual symptoms immediately."; (b) "7. Take Baseline set of vital signs before beginning transfusion."; (c) "8. Start infusion of the blood product." (i) "e. Check vital signs at least every 15 minutes for the first half hour after the start of the transfusion and then every hour after during the transfusion until infusion is complete.". (d) "10. Blood has been infusing for more than 4 hours must be discontinued to prevent the risk of bacterial contamination." (3) The surveyor reviewed transfusions between 03/09/2020 through 09/28/2020 (a total of 16 units) and identified the following: (a) Consent form for 1 of 5 patients had not been signed by the physician (1) Patient # 263184153 - Transfusions performed on 03/09/2020, 04/06/2020, 05/11/2020, 06/16/2020, 07/07 /2020, 08/03/2020, 08/24/2020, 09/28/2020. (b) Start time of the infusion (1) Patient # 263184153 - Transfused with 1 unit of PRBCs (unit# W091020300203) on 08/03 /2020. There was no documentation indicating the start time of the infusion. (c) Vital signs at least every 15 minutes for the first half hour (1) Patient # 263184153 - Transfused with 1 unit of PRBCs (unit# W091020268122) on 08/03/2020 with a start time of 01:15 pm and vitals taken at 01:30 pm and 02:30 pm (1 hour later); (2) Patient # 263184153 - Transfused with 1 unit of PRBCs (unit# W091020312914) on 08/24 /2020 with a start time of 10:05 am and vitals taken at 10:20 am and 11:20 am (1 hour later); (3) Patient # 263184153 - Transfused with 1 unit of PRBCs (unit# W091020294013) on 08/24/2020 with a start time of 12:55 pm and vitals taken at 01: 10 pm and 02:10 pm (1 hour later); (4) Patient # 263184153 - Transfused with 1 unit of PRBCs (unit# W091020279261) on 09/28/2020 with a start time of 10:00 am and vitals taken at 10:14 am and 11:14 am (1 hour later); (5) Patient # 263184153 - Transfused with 1 unit of PRBCs (unit# W091020245051) on 09/28/2020 with a start time of 03:24 pm and vitals taken at 03:39 pm and 04:39 pm (1 hour later); (d) Infusion lasting longer than 4 hours for 1 of 5 patients (1) Patient # 263184153 - Transfused with 1 unit of PRBCs (unit# W091020186830) on 04/06/2020 with a start time of 12:08 pm and end time of 04:38 pm (4 hours and 30 minutes). (4) The above transfusion records were reviewed with the technical consultant on 10/06/2020 who stated at 01:35 pm the records did not follow the blood administration policy as indicated above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to follow their policy for monitoring the effectiveness of their QCP for the Hemochron Signature+ coagulation analyzer for 1 of 2 years. Findings include: (1) On 10/05/2020 at 11:45 am, the technical consultant stated to the surveyor: (a) PT /INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed on the Hemochron Signature+ analyzer; (b) IQCP's (Individualized Quality Control Plan) had been developed for the test systems. (2) The surveyor reviewed the IQCP. The QA (Quality Assessment) portion of the IQCP included a schedule for evaluating the QCP (Quality Control -- 3 of 5 -- Plan) annually to ensure they continued to provide accurate and reliable results; (3) The surveyor reviewed 2019 and 2020 records and could not locate the QA review for 2019; (4) The surveyor reviewed the records with the technical consultant, who stated on 10/05/2020 at 04:50 pm, the 2019 QA review had not documented as 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 the technical consultant, the laboratory failed to ensure reference intervals were determined as appropriate for the laboratory's patient population. Findings include: (1) On 10/05/2020 at 11:45 am, the technical consultant stated to the surveyor CBC (Complete Blood Count) testing was performed using the Sysmex 1000i analyzer; (2) The surveyor reviewed two patient CBC reports - the first report was for an adult male patient with the testing performed on 06/03/2020 at 07:09 am; the second report was for an adult female patient with the testing performed on 06/03/2020 at 09:52 am. Both reports included the same reference intervals for the CBC parameters of RBC (Red Blood Cell), which were: (a) RBC - 4.20 - 6.10 X 10E12/L. (3) The surveyor reviewed the findings with the technical consultant, who stated on 10/06/2020 at 02:30 pm the patient reports did not include gender specific reference ranges as indicated above. NOTE: Routinely, female reference intervals for the RBC's are lower than male reference intervals. 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 a review of records and interview with the laboratory/radiology manager and the technical consultant, the technical consultant failed to ensure evaluations included all moderate complexity testing performed for 1 of 5 testing persons. Findings include: (1) On 10/05/2020 at 11:45 am, the technical consultant stated to the surveyor PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed on the Hemochron Signature+ analyzer; (2) The surveyor then reviewed the 2018, 2019, and 2020 personnel records for 5 persons performing PT/INR and PTT testing in the laboratory. The records showed that an evaluation had been performed as follows: (a) Testing Person #5 - Performed on 05/01/2020 (3) There was no evidence the evaluation, performed for the above person, included an assessment of PT/INR and PTT testing; (4) The surveyor reviewed the findings with the laboratory/radiology manager and the technical consultant, who stated on 10/05/2020 at 12:30 pm the above evaluation did not include an assessment of PT/INR and PTT testing as indicated above. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES -- 4 of 5 -- CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the technical supervisor failed to ensure testing persons performing high complexity testing had been evaluated at least annually for 2 of 4 testing persons. Findings include: (1) On 10 /05/2020, the surveyor reviewed personnel records for 4 persons who performed testing in 2018, 2019, and 2020. For 2 of the 4 persons (testing person #3 and testing person #4), there was no evidence annual evaluations had been performed in 2018; (2) The surveyor reviewed the findings with the technical consultant who stated on 10/05 /2020 at 12:32 pm the annual evaluations had not been performed as indicated above. High Complexity Testing Includes: 1. Crossmatches, including ABO/Rh typing, Antibody screens, Compatibility testing using the Ortho MTS Gel system -- 5 of 5 --

Summary Statement of Deficiencies D0000 The survey was performed on 07/31/18 through 08/02/18. The laboratory was found out of compliance with the following CLIA regulation: 493.1447; D6108: Technical Supervisor The findings were reviewed with the chief executive officer, quality assessment/risk management nurse, technical consultant/general supervisor #2, and laboratory supervisor during an exit conference performed at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant/general supervisor #2, the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director or designee. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. The following was identified for 4 of 15 testing events: (a) First 2017 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee (b) Second 2017 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee (c) Third 2017 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- Immunohematology Event (i) The attestation was not signed by the laboratory director or designee (d) First 2018 Immunohematology Event (i) The attestation was not signed by the laboratory director or designee (2) The findings were reviewed with technical consultant/general supervisor #2 who stated the attestations were not signed as indicated above. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant/general supervisor #2, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. The following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program) were identified: (a) Second 2017 Chemistry Core Event (i) Albumin - 3 of 5 results exhibited a negative bias (aa) CH - 06 - SDI -2.5 (bb) CH - 08 - SDI -2.0 (cc) CH - 09 - SDI -2.5 (b) Third 2017 Chemistry Core Event (i) WBC (White Blood Cell) - 3 of 5 results exhibited a negative bias (aa) XE - 11 - SDI -2.3 (bb) XE - 12 - SDI -2.8 (cc) XE - 13 - SDI -2.4 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The surveyor reviewed the above findings with technical consultant/general supervisor #2 who stated the biases had not been documented as addressed. 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 the policy and procedure manual and interview with technical consultant/general supervisor #2, the laboratory failed to follow written procedures for Toxicology quality control testing and Immunohematology alarm function check procedure. Findings include: TOXICOLOGY (1) On the first day of the survey, technical consultant/general supervisor #2 stated to the surveyor Toxicology testing was performed using the MedTox Profile II test kit; (2) On the second day of the survey, the surveyor reviewed the written procedure titled, "URINE DRUG SCREEN QC MONTHLY AND NEW BOX LOT CONTROL"; (3) The surveyor reviewed quality control records from January 2017 through June 2018. There was no indication the monthly quality control had been performed during November 2017; (4) The surveyor reviewed the findings with the technical consultant/general supervisor #2 who stated the procedure had not been followed as indicated above. IMMUNOHEMATOLOGY (1) On the first day of the survey, technical consultant /general supervisor #2 stated to the surveyor packed red blood cells were stored in the laboratory Blood Bank Refrigerator 1; (2) On the second day of the survey, the -- 2 of 13 -- surveyor reviewed the written procedure titled, "Alarm Check Procedure" which stated, (a) "The blood storage refrigerator alarm should be checked monthly to be sure that it functions properly." (3) The surveyor reviewed monthly alarm check records from August 2016 through July 2018. For 5 of 24 months there was no indication the laboratory staff followed their written procedure as follows: (a) Monthly Alarm Check had not been performed between 08/16/17 and 02/17/18 (4) The surveyor reviewed the findings with technical consultant/general supervisor #2 who stated that the procedure had not been followed as indicated above. 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 a review of records, manufacturer's instructions, and interview with technical consultant/general supervisor #2, the laboratory failed to ensure an analyzer was stored as required by the manufacturer. Findings include: (1) On the first day of the survey, technical consultant/general supervisor #2 stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed on the Sysmex 1000i analyzer; (2) Later on the first day, the surveyor reviewed the manufacturer's environmental requirements for the analyzer. The manufacturer required the relative humidity be maintained within the range of 30-85%; (3) The surveyor reviewed laboratory humidity records from January 2018 through July 2018 which verified the humidity readings were less than 30% for 2 of 7 months as follows: (a) January - 4 of 31 humidity readings were documented as less than 30% (days 4,5,13,14); (b) February 2018 - 2 of 28 humidity readings was documented as less than 30% (days 7,11). (4) The surveyor reviewed the records with technical consultant/general supervisor #2 who stated the humidity of the laboratory had been maintained below 30% as indicated above. 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 technical consultant/general supervisor #2, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) On the first day of the survey, technical consultant/general supervisor #2 stated to the surveyor TSH (Thyroid Stimulating Hormone), CK-MB, Troponin T, BNP (Brain Natriuretic Peptide), Myoglobin and PSA (Prostate Specific Antigen) testing was -- 3 of 13 -- performed on the Roche Cobas e411 analyzer; (2) On the third day of the survey, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for weekly and every two weeks maintenance were as follows: (a) Weekly (i) Clean Sipper Probe (ii) Clean Incubator and aspiration stations (b) Every Two Weeks (i) Clean Rinse stations (ii) Perform Liquid flow cleaning (3) The surveyor then reviewed maintenance records for 8 months (November 2017 through June 2018). The following was identified: (a) There was no evidence the weekly maintenance had been performed: (a) Between 12/26/17 and 02/01/18 (b) Between 02/22/18 and 03/05/18 (b) There was no evidence the two week maintenance had been performed: (a) Between 01/05/18 and 02/08/18 (b) Between 03/20/18 and 04/09/18 (4) The surveyor reviewed the records with technical consultant/general supervisor #2, who stated the maintenance had not been performed as required. 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 a review of records and interview with technical consultant/general supervisor #2, the laboratory failed to perform calibration verification procedures at least once every 6 months. Findings include: (1) On the first day of the survey, technical consultant/general supervisor #2 stated to the surveyor: (a) PSA (Prostate Specific Antigen) testing was performed on the Roche Cobas e411 analyzer; (b) Albumin, BUN (Blood Urea Nitrogen), Calcium, Cholesterol, Chloride, Creatinine, Glucose, Potassium, Magnesium, Sodium, Triglyceride, ALP (Alkaline Phosphatase), ALT (Alanine Aminotransferase), Amylase, AST( Aspartate Aminotransferase) Lipase, Direct Bilirubin, Total Bilirubin, HDL (High Density Lipoprotein), LDL (Low Density Lipoprotein), Acetaminophen, Digoxin, Phenytoin and Hemoglobin A1C testing were performed on the Roche Cobas Integra 400+ analyzer. (2) On the third day of the survey, the surveyor reviewed calibration verification records for the above testing (since routine calibration procedures were performed using less than three calibrators for the above analytes, calibration verification procedures, using three or -- 4 of 13 -- more levels of calibration materials, were required every 6 months). There was no evidence that calibration verification procedures had been performed: (a) PSA - between 12/04/17 through the third day of the survey (due 06/04/18); (b) Albumin, BUN, Calcium, Cholesterol, Chloride, Creatinine, Glucose, Potassium, Magnesium, Sodium, Triglyceride, ALP, ALT, Amylase, AST, Lipase, Direct Bilirubin, Total Bilirubin, HDL, LDL, Acetaminophen, Digoxin, Phenytoin and Hemoglobin A1C - between 09/14/17 through the third day of the survey (due 03/14/18). (3) The surveyor asked technical consultant/general supervisor #2 if additional calibration verification procedures had been performed. Technical consultant/general supervisor #2 stated calibration verification procedures had not been performed as indicated above. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with technical consultant/general supervisor #2, the laboratory failed to follow the manufacturer's specifications for establishing quality control ranges. Findings include: (1) On the first day of the survey, technical consultant/general supervisor #2 stated the following: (a) The Hemochron Jr. Signature + analyzer was used to perform testing for the analytes PT (Prothrombin Time), INR (International Normalized Ratio) using the Citrate PT cuvettes (venous samples) and PT cuvettes (capillary fingerstick whole blood samples); and PTT (Partial Thromboplastin Time) using the Citrate PTT cuvettes (venous samples); (b) Normal and abnormal controls were tested each month and with new lot numbers of cuvettes. (2) On the second day of the survey, the surveyor reviewed the manufacturer's instructions (package inserts) for the control materials which stated, "ITC recommends that each institution establish its own expected range of response based on the mean +/- 2 standard deviations of at least 20 repeated test results. The local mean values established should fall within the manufacturer's acceptable performance range"; (3) The surveyor then reviewed quality control records from December 2017 through May 2018. For 5 of 5 lot numbers of quality control materials, the laboratory failed to follow the manufacturer's instructions of at least 20 repeated test results. The following was identified: (a) PT/INR - Capillary fingerstick whole blood (i) Normal Control lot# E7DNP005 - put into use 12/01/17 (aa) The laboratory established control ranges using 14 repeated test results (ii) Abnormal Control lot# J7DPA008 - put into use 02 /01/18 (aa) The laboratory established control ranges using 15 repeated test results (b) Citrate PT/INR (i) Normal Control lot# E7DNC008 - put into use 02/01/18 (aa) The laboratory established control ranges using 18 repeated test results (c) Citrate PTT (i) Normal Control lot# E7DNC008 - put into use 02/01/18 (aa) The laboratory established control ranges using 19 repeated test results (ii) Abnormal Control lot# A8DAT001 - put into use 03/15/18 (aa) The laboratory established control ranges using 16 repeated test results (d) Citrate PT/INR (i) Abnormal Control lot# H7DAC008 - put into use 05/15/18 (aa) The laboratory established control ranges using 15 repeated test results (4) The findings were discussed with technical consultant /general supervisor #2 who stated the laboratory had not followed the manufacturer's instructions for establishing quality control ranges. -- 5 of 13 -- D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant/general supervisor #2, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. It was identified for 5 of 15 events, the attestation statements had been signed approximately 1-6 months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) First 2017 Hematology/Coagulation Event - The samples had been tested on 03/27 /17 and the attestation statement had not been signed by the laboratory director until 05 /11/17; (b) Second 2017 Hematology/Coagulation Event - The samples had been tested on 07/27/17 and the attestation statement had not been signed by the laboratory director until 11/10/17; (c) First 2017 Chemistry Miscellaneous Event - The samples had been tested on 05/05/17 and the attestation statement had not been signed by the laboratory director until 11/10/17; (d) Second 2017 Chemistry Core Event - The samples had been tested on 06/06/17 and the attestation statement had not been signed by the laboratory director until 11/10/17; (e) Third 2017 Chemistry Core Event - The samples had been tested on 09/04/17 and the attestation statement had not been signed by the laboratory director until 11/10/17. (2) The surveyor reviewed the findings with technical consultant/general supervisor #2 and explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. 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 a review of records and interview with technical consultant/general supervisor #2, the technical supervisor failed to provide technical supervision in accordance with 493.1447 of this subpart. Findings include: (1) The technical supervisor failed to ensure the individual who performed the duties and responsibilities of the techical supervisor met the educational qualifications. Refer to D6111. D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 -- 6 of 13 -- (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum -- 7 of 13 -- of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology -- 8 of 13 -- with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory -- 9 of 13 -- science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the -- 10 of 13 -- State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-- (l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral -- 11 of 13 -- pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor -- 12 of 13 -- must-- (q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant/general supervisor #2, the technical supervisor failed to ensure the individual who performed the duties and responsibilities of the technical supervisor, met the qualifications. Findings include: (1) On the first day of the survey, the surveyor reviewed records for testing person #4 who performed high complexity testing (ABO/Rh, Antibody Screen and Compatibility testing) in 2017. The records indicated the evaluations for the testing person had been performed by an individual who did not meet the regulatory qualification requirements of the technical supervisor: (a) Testing Person #4 (i) The 02 /20/17 semi-annual evaluation had been performed by a person who qualified as a general supervisor (bachelor degree with at least 2 years of training/experience in high complexity testing). (2) The surveyor explained to technical consultant/general supervisor #2 that all components of the semi-annual competency evaluations must be performed by a person who qualifies as a technical supervisor (493.1449 (q) an individual with an MD or DO with a current medical license in state of laboratory's location and certified in anatomic pathology by ABP or AOBP or equivalent qualifications or resident in a program leading to ABP or AOBP certification in anatomic and clinical pathology who performs duties delegated by the technical supervisor for histopathology). NOTE: The regulations only allow for the general supervisor to perform initial training and annual competency evaluations as stated at 493.1463 "Standard; General supervisor responsibilities: (b)(3) Providing orientation to all testing personnel; and (b)(4) Annually evaluating and documenting the performance of all testing personnel" -- 13 of 13 --