George Regional Hospital

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the Transfusion Service Testing Record from 6/1/2021 through 10 /31/2022, documentation of blood transfusions in patients' electronic medical records, and the laboratory's policy for Administration of Blood and Components, testing personnel responsible for high complexity testing failed to follow the laboratory's policy for Administration of Blood and Components when four units of PRBC were issued for transfusion during this time frame. Findings include: The laboratory's policy for Administration of Blood and Components states, "The initials of the laboratory personnel issuing the blood, the initials of the nurse (RN) to whom the blood is issued and the date and time of issue must be recorded in the BB (Blood Bank) log book." Review of the Transfusion Service Testing Record from 6/1/2021 through 10/31/2022 and documentation of blood transfusions in patients' electronic medical records revealed testing personnel, responsible for high complexity testing, failed to follow the laboratory's policy for Administration of Blood and Components for the four units of PRBC listed below. There was no documentation of the identity of the laboratory personnel who issued these four units: Unit #W2019-21-103157 transfused to Patient #M7690670 on 8/3/2021. Unit #W2011-21-623658 transfused to Patient #M1328 on 10/20/2021. Unit #W2019-21-115753 transfused to Patient #M10286 on 10/21/2021. Unit #W2041-22-673610 transfused to Patient #M537073 on 8/26/2022. D5439 CALIBRATION AND CALIBRATION VERIFICATION 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 -- 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 5/20/2021 and confirmation by Technical Consultant #2, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to document, as performed, calibration verification for testing performed on the two Roche Cobas Integra 400 Plus analyzers and the two Roche Cobas e411 immunoassay systems at least every six months since the last survey on 5/20/2021. Findings include: Review of calibration verification records since the last survey on 5/20/2021 revealed no documentation of calibration verification for testing performed on the two Roche Cobas Integra 400 Plus analyzers and the two Roche Cobas e411 immunoassay systems since the last survey on 5/20/2021 until November 2022. Technical Consultant #2 confirmed there was no documentation of calibration verification from 5 /20/2021 until November 2022. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the Transfusion Service Testing Record from 6/1/2021 through 10 /31/2022 and documentation of blood transfusions in patients' electronic medical records, the laboratory failed to perform blood distribution in accordance with 21 CFR Part 606.160(b)(3)(ii) for four units of packed red blood cells (PRBC) transfused to four patients during this time frame. Findings include: Review of the Transfusion -- 2 of 3 -- Service Testing Record from 6/1/2021 through 10/31/2022 and documentation of blood transfusions in patients' electronic medical records revealed the laboratory failed to document a visual inspection of the following four units of PRBC immediately before distribution for transfusion to the patients listed below: Unit #W2019-21-103157 transfused to Patient #M7690670 on 8/3/2021. Unit #W2011-21- 623658 transfused to Patient #M1328 on 10/20/2021. Unit #W2019-21-115753 transfused to Patient #M10286 on 10/21/2021. Unit #W2041-22-673610 transfused to Patient #M537073 on 8/26/2022. 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 CMS 209 personnel form for respiratory department testing personnel and personnel records since the last survey on 5/20/2021, a qualified technical consultant failed to evaluate and document the performance of Respiratory Department Testing Personnel #11, for moderate complexity testing, at least semiannually during the first year this individual tested patient specimens. Findings include: Review of the CMS 209 personnel form for respiratory department testing personnel and personnel records since 5/20/2021 revealed no semiannual evaluation, for the performance of moderate complexity testing, by a qualified technical consultant for Testing Personnel #11, listed on the CMS 209 respiratory department personnel form. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel form for respiratory department testing personnel and personnel records since the last survey on 5/20/2021, a qualified technical consultant failed to evaluate and document the performance of Respiratory Department Testing Personnel #1 through #10 and #13, for moderate complexity testing, at least annually since the last survey on 5/20/2021. Findings include: Review of the CMS 209 personnel form for respiratory department testing personnel and personnel records since 5/20/2021 revealed no annual evaluations, for the performance of moderate complexity testing, by a qualified technical consultant for Testing Personnel #1 through #10 and #13 since 5/20/2021. -- 3 of 3 --

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 AccuTest and the CASPER report 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 11/17/2022, the laboratory failed to maintain satisfactory performance in two of three testing events (2022 - Events 1 & 3) resulting in unsuccessful performance in Routine Chemistry for the analyte pCO2 Blood Gas. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 AccuTest and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 11/17/2022, the laboratory has not successfully performed proficiency testing for pCO2 Blood Gas in two of three testing events. Findings include: A review of the laboratory records from AccuTest and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for pCO2 Blood Gas: : Year 2022 - 1st Event: 60% Year 2022 - 3rd Event: 60% -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, lack of documentation of speed verification of the Clay Adams Sero-Fuge 2002 centrifuge, used in ABO/Rh testing, and confirmation by the technical consultant, the laboratory failed to follow its "Centrifuge Accuracy Verification of RPM" policy since 12/20/18. Findings include: Review of the laboratory procedure manual revealed the Centrifuge Accuracy Verification of RPM policy states, "The serologic centrifuge RPM accuracy shall be verified upon receipt of a new centrifuge, upon repair affecting the RPM or timer of the centrifuge and/or annually." There was no documentation of speed verification of the Clay Adams Sero-Fuge 2002 centrifuge since 12/20/18. The technical consultant confirmed there was no documentation of speed verification of the centrifuge since 12 /20/18. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the Reference Guide for the Ortho Workstation, used in antibody screening and compatibility testing, lack of documentation of Ortho Workstation centrifuge speed and timing verification, and confirmation by the general supervisor, the laboratory failed to perform and document these function checks since the last survey on 10/17/18. Findings include: Review of the Ortho Workstation Reference Guide revealed the Qualification Procedures state that the centrifuge must not be used if speed is outside of specification or if the timer is out of specification. There was no documentation of Ortho Workstation centrifuge speed and timing verification since the last survey on 10/17/18. The general supervisor confirmed there was no documentation of these function checks. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 1. Based on review of quality control records and the Lab Specimen Log for Clostridium (C.) difficile testing with the Quidel Solana test system from 4/1/21 through 5/15/21, lack of documentation of an Individualized Quality Control Plan (IQCP), and interview with the technical consultant on 5/20/21 at 12:45 p.m., the laboratory failed to include a positive and negative control for seven days of testing during this time frame, when a total of seven patient C. difficile tests were performed and reported. Findings include: Review of quality control records and the Lab Specimen Log for C. difficile testing with the Quidel Solana test system from 4/1/21 through 5/15/21 revealed a positive and negative control were not documented, as performed, for the following days when patient testing was performed and results reported: 4/2/21 - Patient #M005238787. 4/9/21 - Patient #M000017764. 4/16/21 - Patient #M000017045. 4/18/21 - Patient #M008111437. 5/1/21 - Patient #M000001375. 5/9/21 - Patient #M000534366. 5/15/21 - Patient #M000003985. Interview with the technical consultant on 5/20/21 at 12:45 p.m. revealed no IQCP was established for C. difficile testing with the Quidel Solana test system. 2. Based on review of quality control records and the Lab Specimen Log for Respiratory Panel 2.1 testing with the BioFire Film Array Torch test system from 11/20/20 through 5/19/21, lack of documentation of an Individualized Quality Control Plan (IQCP), and interview with the technical consultant on 5/20/21 at 12:45 p.m., the laboratory failed to include a positive and negative control each day of patient testing during this time frame, when a total of 570 patient respiratory panels were performed and reported. Findings include Review of quality control records for the BioFire Film Array Torch test system from 11/20/10 through 5/19/21 revealed a positive and negative control for all twenty-two organisms tested on the Respiratory Panel 2.1 were performed on 12/4 /20, 2/19/21, 3/16/21, and 5/14/21. Review of the Lab Specimen Log revealed a total of 570 patient Respiratory Panel 2.1 tests were performed and results reported on the days quality control was not performed from 11/20/20 through 5/19/21. Interview with the technical consultant on 5/20/21 at 12:45 p.m. revealed no IQCP was established for respiratory panel testing with the BioFire Film Array Torch test system. -- 2 of 3 -- D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records for the Instrumentation Laboratories (IL) ACL-TOP coagulation test system from 9/29/20 through 3/31/21 and lack of documentation of the establishment of acceptable ranges for the controls in use during this time frame, the laboratory failed to document, as performed, the establishment of statistical parameters for acceptable ranges for prothrombin time (PT) and activated partial thromboplastin time (APTT) testing with HemosIL Normal Control Level 1, Lot #N0604779, and HemosIL Abnormal Level 3, Lot #N0604774. Findings include: Review of QC records for the IL ACL-TOP coagulation test system from 9/29/20 through 3/31/21 revealed HemosIL Normal Control Level 1, Lot #N0604779, was put in use 10/20/20, and HemosIL Abnormal Level 3, Lot #N0604774, was put in use 9/29 /20. On the day of the survey, 5/20/21, there was no documentation of the establishment of statistical parameters for the PT and APTT ranges listed on the ACL- TOP coagulation test system QC records.. -- 3 of 3 --

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 9/18/20, the laboratory has not successfully participated in proficiency testing for BACTERIOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for BACTERIOLOGY: PROFICIENCY TESTING PROVIDER: AMERICAN PROFICIENCY INSTITUTE (API) YEAR 2019 3rd Event: 0% YEAR 2020 1st Event: 0% YEAR 2020 2nd Event: 74% Scores less than 80% for this analyte or parameter indicate failure or unsatisfactory performance. A failure of the analyte or 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 -- parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial unsuccessful performance. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 9/18/20, the laboratory has not successfully participated in proficiency testing for BACTERIOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for BACTERIOLOGY: PROFICIENCY TESTING PROVIDER: AMERICAN PROFICIENCY INSTITUTE (API) YEAR 2019 3rd Event: 0% YEAR 2020 1st Event: 0% YEAR 2020 2nd Event: 74% Scores less than 80% for this analyte or parameter indicate failure or 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. Repeat failures are scored as non-initial unsuccessful performance. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on 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 9/18/20, the laboratory director did not provide overall management and direction in accordance with 493.1445 of this subpart. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure 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 (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 9/18/20, the laboratory director failed to ensure the proficiency testing samples were tested as required under subpart H of this part. -- 2 of 2 --

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 PT provider and the Centers for Medicare and Medicaid Services data system) on 4/14/2020, the laboratory had not successfully participated in proficiency testing for BACTERIOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for BACTERIOLOGY: PROFICIENCY TESTING PROVIDER: American Proficiency Institute BACTERIOLOGY: Year 2019, 3rd Event: 0% Year 2020, 1st Event: 0% Scores less 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 -- 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. D2021 BACTERIOLOGY CFR(s): 493.823(b) 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 PT provider and the Centers for Medicare and Medicaid Services data system) on 4/14/2020, the laboratory had not successfully participated in proficiency testing for BACTERIOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for BACTERIOLOGY: PROFICIENCY TESTING PROVIDER: American Proficiency Institute BACTERIOLOGY: Year 2019, 3rd Event: 0% Year 2020, 1st Event: 0% D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 PT provider and the Centers for Medicare and Medicaid Services data system) on 4/14/2020, the laboratory had not successfully participated in proficiency testing for BACTERIOLOGY. Findings include: Our records indicate the following proficiency testing scores for your laboratory for BACTERIOLOGY: PROFICIENCY TESTING PROVIDER: American Proficiency Institute BACTERIOLOGY: Year 2019, 3rd Event: 0% Year 2020, 1st 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 --

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 5/2/19, the laboratory did not successfully participate in proficiency testing for FIBRINOGEN. Findings include: Proficiency Testing Provider: College of American Pathologists (CAP) Our records indicate the following proficiency scores for your laboratory for FIBRINOGEN: Year 2018 2nd Event: 0% Year 2019 1st Event: 60% Scores less than 80% for this analyte or 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 -- 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. 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 5/2/19, the laboratory did not successfully participate in proficiency testing for FIBRINOGEN. Findings include: Proficiency Testing Provider: College of American Pathologists (CAP) Our records indicate the following proficiency scores for your laboratory for FIBRINOGEN: Year 2018 2nd Event: 0% Year 2019 1st Event: 60% Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. 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 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 5/2/19, the laboratory did not successfully participate in proficiency testing for FIBRINOGEN. Findings include: Proficiency Testing Provider: College of American Pathologists (CAP) Our records indicate the following proficiency scores for your laboratory for FIBRINOGEN: Year 2018 2nd Event: 0% Year 2019 1st Event: 60% 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 --