CLIA Laboratory Citation Details
25D1047462
Survey Type: Special
Survey Event ID: VGTP11
Deficiency Tags: D0000 D2096 D6000 D2016 D6016
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 verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation (proficiency testing) D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (graded copies from the American Proficiency Institute (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 3/18/2024, the laboratory failed to maintain satisfactory performance in three of four testing events (2023-Event 1, 2023-Event 2 & 2024-Event 1) resulting in unsuccessful participation for 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 surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 3/18/2024, the laboratory failed to achieve satisfactory performance for CHLORIDE in three of four testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for CHLORIDE: Year 2023 - 1st Event: 40% Year 2023 - 2nd Event: 0% Year 2024 - 1st Event: 40% 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 surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 3/18/2024, the laboratory director failed to provide overall management and direction of the laboratory services. 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 surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and CASPER report 0153D/0155D -- 2 of 3 -- from the Centers for Medicare and Medicaid Services data system) on 3/18/2024, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --
Get full access to the detailed deficiency summary for this facility
Survey Type: Standard
Survey Event ID: YBMJ11
Deficiency Tags: D5411 D5439 D5559 D6042 D6092 D6117
Summary Statement of 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 review of manufacturer's instructions for the Instrumentation Laboratories (IL) HemosIL normal and abnormal controls and ACL Elite Patient and Quality Control (QC) Worksheets from 3/1/2023 through 1/3/2024, the laboratory failed to follow manufacturer's instructions for establishing target values and acceptance ranges for HemosIL Normal Control, Lot #N0320752, and HemosIL Abnormal Control, Lot #N0321366, when the current lot of RecombiPlasTin 2G prothrombin time reagent, Lot #N1127272, was put in use on 3/28/2023, for performing prothrombin time (PT) testing on the ACL Elite coagulation system. Findings include: 1. The manufacturer's instructions for the IL HemosIL normal and abnormal controls state, "The mean of the control range determined in your laboratory may vary due to the lot of reagent used. Due to differences in reagents and instrumentation, each laboratory should establish its own target value and acceptance range." 2. There was no documentation available on the day of the survey, 1/4/2024, of the establishment of ranges for the current lots of HemosIL Normal Control, Lot #N0320752, and HemosIL Abnormal Control, Lot #N0321366, when the current lot of RecombiPlasTin 2G PT reagent, Lot #N1127272, was put in use on 3/28/2023, for performing prothrombin time (PT) testing on the ACL Elite coagulation system. These lots of normal and abnormal control were used for ten months without establishing acceptance ranges for the current lot of RecombiPlasTin 2G PT reagent, 3. Review of ACL Elite Patient and QC Worksheets from 3/1/2023 through 1/3/2024 revealed the acceptance ranges for HemosIL Normal Control, Lot #N0320752, and HemosIL Abnormal Control, Lot #N0321366, were the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- ranges established for RecombiPlasTin 2G PT reagent, Lot # N0512868, taken out of use on 3/28/2023. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration verification records since the last survey on 3/30/2022 and confirmation by the general supervisor on 1/4/2024 at 4:30 p.m., the laboratory failed to perform calibration verification on the Instrumentation Laboratories (IL) GEM Premier 3500 analyzer for blood gas testing - pH, pO2, and pCO2 - at least every six months since the last survey on 3/30/2022. The laboratory's annual volume for blood gases is 270. Findings include: 1. Review of calibration verification records since the last survey on 3/30/2022 revealed calibration verification was not documented as performed for blood gas testing on the IL GEM Premier 3500 analyzer for ten months, from 3/30/2022 until 2/1/2023, and for eleven months, from 2/1/2023 through the day of the survey on 1/4/2024. 2. The general supervisor confirmed in an interview on 1/4/2024 at 4:30 p.m. that there was no documentation of calibration verification for the IL GEM Premier 3500 analyzer from 3/30/2022 until 2/1/2023, and no documentation of calibration verification from 2/1/2023 through 1/4/2024. The laboratory's annual volume for blood gases is 270. 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 -- 2 of 4 -- 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: Fortenberry, Deborah Based on review of the Transfusion Service Testing Record and blood bank reagent quality control (QC) records from 4/19/2022 through 12/21/2023, the laboratory failed to document performance of quality control for the reagents used for ABO grouping, Rh typing, antibody detection, and compatibility testing for two of four days, during this time frame, when testing was performed on two patients with one unit of packed red blood cells (PRBC) issued for transfusion to each of these patients. Findings include: Review of the Transfusion Service Testing Record and blood bank reagent QC records from 4/19/2022 through 12/21/2023 revealed that quality control for the blood bank reagents was not documented, as performed, on the following days when ABO grouping, Rh typing, antibody detection (Ab screen), and compatibility testing were performed on two patients: 4/19/2022--ABO/Rh, Ab screen, and compatibility testing performed on Patient #000237198 for one unit of PRBC transfused on 4/19/2022. 1/10/2023--ABO/Rh, Ab screen, and compatibility testing performed on Patient #000240051 for one unit of PRBC transfused on 1/10 /2023. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: 1. Based on review of manufacturer's instructions for the Instrumentation Laboratories (IL) HemosIL normal and abnormal controls and ACL Elite Patient and Quality Control (QC) Worksheets from 3/1/2023 through 1/3/2024, the technical consultant failed to ensure the prothrombin time (PT) quality control program was maintained throughout the entire testing process when the laboratory failed to follow manufacturer's instructions for establishing target values and acceptance ranges for HemosIL Normal Control, Lot #N0320752, and HemosIL Abnormal Control, Lot #N0321366, for ten months after the current lot of RecombiPlasTin 2G prothrombin time reagent, Lot #N1127272, was put in use on 3/28/2023, for performing prothrombin time (PT) testing on the ACL Elite coagulation system. Refer to D5411 (Failure to follow manufacturer's instructions for establishing quality control acceptance ranges). 2. Based on review of calibration verification records since the last survey on 3/30/2022 and confirmation by the general supervisor on 1/4/2024 at 4: 30 p.m., the technical consultant failed to ensure the blood gas testing quality control program, to include calibration verification on the Instrumentation Laboratories (IL) GEM Premier 3500 analyzer, was maintained throughout the entire testing process when calibration verification was not performed for blood gas testing for ten months, from 3/30/2022 until 2/1/2023, and for eleven months, from 2/1/2023 through the day of the survey on 1/4/2024. Refer to D5439 (Failure to perform calibration verification at least every six months). -- 3 of 4 -- D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved
Get full access to the detailed deficiency summary for this facility
Survey Type: Special
Survey Event ID: H7JY11
Deficiency Tags: D0000 D2016 D2096
Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 7/24/2023, the laboratory failed to maintain satisfactory performance in two of two testing events (2023-Event 1 and 2023-Event 2) resulting in unsuccessful participation in routine chemistry for the analyte Chloride. Refer to D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 7 /24/2023, the laboratory has not successfully performed proficiency testing for Chloride in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for Chloride: Chloride: Year 2023-1st Event 40% Year 2023-2nd Event 0% -- 2 of 2 --
Get full access to the detailed deficiency summary for this facility
Survey Type: Standard
Survey Event ID: JNFJ11
Deficiency Tags: D5481 D6049 D6053 D6054
Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of prothrombin time (PT) and activated partial thromboplastin time (APTT) quality control results and patient logs from 7-1-19 through 9-30-19 and the laboratory's established quality control ranges for PT and APTT testing on the Instrumentation Laboratories ACL 7000 coagulation system, the laboratory failed to ensure at least two levels of control results met the laboratory's criteria for acceptability before reporting patient PT and APTT results on seventeen days during this time frame when a total of twenty-two patient results were reported. Findings include: 1. Review of the laboratory's established quality control ranges, PT quality control results, and patient logs from 7-1-19 through 9-30-19 revealed at least one of two PT controls was outside the laboratory's established ranges on the following days when patient PT results were reported: 8-4-19--Patient #M000175420. 9-5-10--Patient #M000004845. 2. Review of the laboratory's established quality control ranges, APTT quality control results, and patient logs from 7-1-19 through 9-30-19 revealed at least one of two APTT controls was outside the laboratory's established ranges on the following days when patient APTT results were reported: 7-10-19--Patient #M000189891. 7-12-19--Patients #M000011237, #M000195269. 7-15-19--Patients #M000217776, #M000190754. 7-16-19--Patients #M000221705, #M000177236. 7- 29-19--Patient #M000015205. 7-30-19--Patient #M000222167. 8-10-19--Patient #M000222296. 8-11-19--Patient #M006905632. 8-21-19--Patient #M007539018. 8- 22-19--Patient #M007884604. 9-4-19--Patients #M000186276, #M000008624. 9-5- 19--Patient #M000004845. 9-16-19--Patient #M000181087. 9-23-19--Patient #M000012437. 9-24-19--Patient #M007795545. 9-30-19--Patient #M000213602. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of quality control records, to include calibration and calibration verification records, and preventive maintenance records for moderate complexity testing, a qualified technical consultant failed to document review of quality control and preventive maintenance records, in evaluating the competency of testing personnel, from March 2018 through the day of the survey on 1-9-20. Findings include: Review of quality control records, to include calibration and calibration verification records, and preventive maintenance records revealed no documentation of review by a qualified technical consultant from March 2018 through the day of the survey on 1-9-20 for the following records: 1. Quality control records, to include calibration and calibration verification records, for the ACL-7000 coagulation system, Sysmex KX-21N hematology analyzer, Roche Integra 400 Plus chemistry system, Roche Cobas e411 immunoassay system, and GEM Premier 3000 blood gas analyzer. 2. Preventive maintenance records for the ACL-7000 coagulation system, Sysmex KX- 21N hematology analyzer, Roche Integra 400 Plus chemistry system, Roche Cobas e411 immunoassay system, and GEM Premier 3000 blood gas analyzer. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and personnel records since the last survey on 12-14-17, a qualified technical consultant failed to evaluate and document the performance of Testing Personnel #2 and #6 for moderate complexity testing, at least semiannually during the first year these individual tested patient specimens. Findings include: Review of the CMS 209 personnel form and personnel records since 12-14-17 revealed no semiannual evaluation, for the performance of moderate complexity testing, by a qualified technical consultant for the following testing personnel: Testing Personnel #2, since initial evaluation of 10-8-18. Testing Personnel #6, since initial evaluation of 4-30-18. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel form and personnel records since the last survey on 12-14-17, a qualified technical consultant failed to evaluate and document the performance of Testing Personnel #2 through #6 for moderate complexity testing, at least annually. Findings include: Review of the CMS 209 personnel form and personnel records since 12-14-17 revealed no annual evaluation, for the performance of moderate complexity testing, by a qualified technical consultant for the following testing personnel: Testing Personnel #2, since initial evaluation of 10-8-18. Testing Personnel #3, since the last survey on 12-14-17. Testing Personnel #4, since 1-15-18. Testing Personnel #5, since the last survey on 12-14-17. Testing Personnel #6, since initial evaluation of 4-30-18. -- 3 of 3 --
Get full access to the detailed deficiency summary for this facility
Survey Type: Special
Survey Event ID: V12R11
Deficiency Tags: D2016 D2123 D2131
Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 9/14/18, the laboratory has not successfully participated in proficiency testing for HEMATOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY. PROFICIENCY TESTING PROVIDER: American Proficiency Institute HEMATOLOGY/WBC,RBC,Hemoglobin,Hematocrit,Platelets,WBC Diff: Year 2018 1st Event 0% Year 2018 2nd Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 9/14/18, the laboratory has not successfully participated in proficiency testing for HEMATOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY. PROFICIENCY TESTING PROVIDER: American Proficiency Institute HEMATOLOGY/WBC,RBC,Hemoglobin,Hematocrit,Platelets,WBC Diff: Year 2018 1st Event 0% Year 2018 2nd Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 9/14/18, the laboratory has not successfully participated in proficiency testing for HEMATOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY. PROFICIENCY TESTING PROVIDER: American Proficiency Institute HEMATOLOGY/WBC,RBC,Hemoglobin,Hematocrit,Platelets,WBC Diff: Year 2018 1st Event 0% Year 2018 2nd Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --
Get full access to the detailed deficiency summary for this facility