Anesthesiology Coagulation Laboratory

Summary Statement of Deficiencies 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 review of the laboratory's procedures, College of American Pathologists (CAP) proficiency testing (PT) records, and interview with the laboratory director (LD), the laboratory failed to provide 1 of 2 attestation statements for hematology testing events performed in 2022. Findings Include: 1. The Anesthesiology Coagulation Laboratory Policies & Procedures (page 10) states, " All result entry forms, instrument printouts, electronic forms, the Attestation Form and other related PT documentation are posted in the CAP Surveys binder. PT documentation is retained for atleast two years after the initial PT test date." 2. On the day of the survey, 10/19/2023 at 11:34 am, the laboratory could not provide 1 of 2 CAP PT attestation statements for the following hematology testing events in 2022: - CAP Viscoelastic Studies (VES-B 2022) 3. The LD confirmed the finding above on 10/19 /2023 at 01:00 pm. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency assessment records and interview with the laboratory director (LD), the laboratory failed to establish a competency assessment procedure to assess the competency of 1 of 2 clinical consultants (CC) for their supervisory responsibilities in 2022. Findings include: 1. On the day of the survey, 10/19/2023 at 10:51 am, the laboratory could not provide a competency assessment policy to assess the competency of the following personnel for their supervisory responsibilities in 2022: - 1 of 2 CC (CMS 209 CC #2) 2. The laboratory could not provide competency assessment documentation for 1 of 2 CC (CMS 209 CC #2). 3. The LD confirmed the findings above on 10/19/2023 at 01:00 pm. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, College of American Pathologists (CAP) proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to verify the accuracy of the PT results obtained for 3 of 3 CAP hematology testing events reviewed for 2022 and 2023. Findings include: 1. The Anesthesiology Coagulation Laboratory Policies & Procedures (page 11) states, " It is the responsibility of the Director to evaluate results obtained from PT challenges that were intended to be graded, but were not." 2. On the day of survey, 10/19/2023 at 11: 34 am, review of the laboratory's CAP PT records revealed that the laboratory did not verify the accuracy for the following 3 of 3 CAP hematology testing events for 2022 and 2023 that were not graded by the PT agency: - Viscoelastic Studies - VES A 2023 - VES B 2022 - VES A 2022 3. The CAP's actions laboratories should take when a PT result is not graded document states, "the laboratory is required to review participant summary for comparative results and document performance accordingly. Evaluation criteria is not established for educational challenges. Laboratories should determine their own evaluation criteria approved by their laboratory director for self-evaluation." 4. The LD confirmed the findings above on 10/19/2023 at 01:00 pm 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 -- 2 of 4 -- laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plan (IQCP) and interview with the laboratory director (LD), the laboratory failed to provide a complete IQCP for activated clotting time (ACT) testing performed on the Werfen Rotem from 11/17/2021 to the day of the survey. Findings include: 1. On the day of the survey, 10/19/2023 at 12:06 pm, review of the laboratory's individualized quality control plans revealed that the laboratory failed to provide a complete IQCP for the following tests: - 1 of 3 parts of the IQCP for ACT (hematology) testing performed on the Werfen Rotem were incomplete: no documentation provided for the quality control plan. 2. The LD confirmed the findings above on 10/19/2023 at 01:00 pm. D5463 CONTROL PROCEDURES CFR(s): 493.1256(d)(7)(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-- Over time, rotate control material testing among all operators who perform the test. (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 and interviews with the laboratory director (LD) and testing personnel (TP) #3, the laboratory failed to over time rotate control material testing between 7 of 8 TP who performed activated clotting time (hematology) testing on the Werfen Rotem analyzer from 01/01/2022 to 10/19/2023. Findings include: 1. On the date of the survey, 10/19/2023 at 11:45 am, review of the laboratory's QC records for the Werfen Rotem analyzer revealed that 7 of 8 TP (CMS 209 TP #1, #2, #4, #5, #6, #7,and #8) failed to perform QC for activated clotting time testing performed from 01/01/2022 to 10/19/2023. 2. The LD and TP #3 confirmed the findings above on 10/19/2023 at 01:00 pm. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the laboratory director (LD), the laboratory failed to include pertinent reference intervals/normal values on patient test reports for activated clotting time (ACT) examinations performed on the Werfen Rotem analyzer in October 2023. Findings Include: 1. On the day of the survey, 10/19/2023 at 12:50 pm, review of 2 of 2 patient reports revealed that the laboratory failed to include pertinent reference intervals/normal values on the final reports for ACT examinations performed in October 2023 on the Werfen Rotem. 2. The LD confirmed during an interview on 10/19/2023 at 01:00 pm, that the computer system was updated recently and the reference intervals/normal ranges were no longer listed on the patient reports. . -- 3 of 4 -- 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 laboratory procedures, training and competency assessment records, and interview with the laboratory director (LD), the technical consultant (TC) failed to evaluate and document the performance of 1 of 8 testing personnel (TP) responsible for performing activated clotting time (hematology) examinations for their semi-annual competency from 08/03/2021 to the day of survey. Findings include: 1. The laboratory's Anesthesiology Coagulation Laboratory Polices and Procedures (page 6) states, "Competency assessment is conducted by the AC laboratory specialists: after initial user training, six months after the user has performed the first patient test, twelve months after the user has performed the first patient test, and annually thereafter. Training and competency assessment documentation is maintained by the AC Laboratory Specialists. The documentation is maintained for the duration of the tester's employment." 2. On the day of survey, 10/05/2022 at 10:15 am, the laboratory could not provide the semi-annual competency assessment records for 1 of 8 TP (CMS 209 TP # 2) that performed activated clotting time (hematology) examinations on the Werfen Rotem analyzer from 08/03/2021 to 10/19/2023. 3. The LD confirmed the findings above on 10/19/2023 at 01:00 pm. -- 4 of 4 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on review of records, interview of the laboratory director (LD), testing personnel (TP) #1 and #2, the laboratory failed to establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) for Clotting Time testing performed in 2018. Findings Include: 1. On the day of survey, 05/29/2019, the LD stated the laboratory was enrolled in College of American Pathologists (CAP), but was unable to provide proficiency testing (PT) documentation or any other documents regarding demonstration of accuracy for clotting Time in 2018. 2. CAP was contacted Wednesday, May 29, 2019 at 1:42 PM to verify the laboratory's enrollment. The contact stated, " The Thomas Jefferson University Hospital Anesthesia Coagulation Laboratory in Philadelphia did not purchase CAP PT in 2018. 3. In 2018, 1300 clotting time patient tests were analyzed. 4. The LD was contacted by email and phone on Thursday, May 30, 2019 at 7:25 AM to confirm the findings above. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). 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 -- This STANDARD is not met as evidenced by: Based on review of records, interview of the laboratory director (LD), testing personnel (TP) #1 and #2, the laboratory failed to verify the accuracy of Clotting Time tests performed when the laboratory did not receive scores from the College of American Pathologists proficiency testing agency in 2017. Findings Include: 1. On the day of survey, 05/29/2019, the LD stated the laboratory was enrolled in CAP, but were unable to provide PT documentation or any other documents demonstrating the accuracy of clotting time testing performed in 2017. 2. CAP was contacted Wednesday, May 29, 2019 at 1:42 PM to verify the laboratory's enrollment. The contact stated, " The Thomas Jefferson University Hospital Anesthesia Coagulation Laboratory in Philadelphia was last enrolled in CAP PT in 2017. 3. Review of the 2017 the CAP PT records revealed: - Event A: The laboratory did not receive scores, rather received educational Challenge codes. - Event B: Results for this kit were not received. 4. The laboratory did not verify the accuracy of the 2017 events A and B that were not graded. 5. In 2017 (09/07/2017 to 12/31/2017) 425 clotting time patient tests were analyzed. 6. The LD was contacted by email and phone on Thursday, May 30, 2019 at 7:25 AM to confirm the findings above. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of records, interview with the laboratory director (LD), testing personnel (TP) # 1 and #2, the laboratory failed to have a written or electronic request for patient clotting time tests ordered by an authorized personnel from 09/07/2017 to the date of survey. Finding Include: 1. On the day of survey, 05/29/2019, the laboratory could not provide test request forms for patient clotting time tests performed on the Rotem Delta 20 system analyzers in 2017, 2018 and 2019. 2. In 2017 (09/07/2017 to 12/31/2017) 425 clotting time patient tests were analyzed. 3. In 2018, 1300 clotting time patient tests were analyzed. 4. In 2019 (01/01/2019 to 05/29 /2019) 455 clotting time patient tests were analyzed. 5. On 05/29/2019 around 9:50 am, the LD confirmed test request were not documented. 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: Base on review of maintenance records, observation of instrumentation, interview with the laboratory director (LD), testing personnel (TP) #1 and #2, the laboratory failed to perform and document maintenance defined by the manufacturer for 2 of 2 Rotem eLine pipettes, 2 of 2 Rotem Delta 20 system analyzers and 1 of 1 Fisher Scientific Thermometers from 09/07/2017 to the date of survey. Finding Include: 1. The Rotem Manufacturer manual (yearly maintenance section) states " Maintenance -- 2 of 6 -- of the Rotem Delta system must be performed on a yearly basis by authorized service personnel. Please contact your local service provider for yearly maintenance or ask for a maintenance contract". 2. The Rotem Manufacturer manual (functional checks of the Rotem eLIne pipette section) states " Check the Rotem eLine pipette, e.g. every 6-12 months for accuracy and precision, regularly, accordingly the internal regulations (complying with ISO08655)". 3. The Fisher Scientific Thermometer, ISO document stated calibration to be performed every 2 years". 4. On the day of survey, 05/29 /2019, review of laboratory documents and manufacturers documents revealed, the laboratory did not perform the following maintenance: - No documentation of yearly maintenance performed for 2 of 2 Delta 20 system analyzers. - Observation of the Rotem Delta 20 system analyzer # 2591 eLine pipette, revealed a sticker on the pipette stated "calibration due on 11/2016". - Observation of the Rotem Delta 20 system analyzer # 2592 eLine pipette, revealed a sticker on the pipette stated "calibration due on 02/2017". - Observation of the Fisher Scientific Thermometer on the refrigerator, revealed a sticker on the thermometer stated "calibration due on 06/04 /2014". 5. In 2017 (09/07/2017 to 12/31/2017) 425 clotting time patient tests were analyzed. 6. In 2018, 1300 clotting time specimen patient tests were analyzed. 7. In 2019 (01/01/2019 to 05/29/2019) 455 clotting time patient tests were analyzed. 8. The LD confirmed the findings above on 05/29/2018 around 10:00 am. 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 Rotem Delta 20 system analyzer records, interview with the laboratory director (LD), testing personnel #1 and #2, the laboratory failed to perform calibration at least once every 6 months on 2 of 2 Delta 20 system analyzers from 2018 to the date of survey. Findings Include: 1. On the day of survey, 05/29/2019 the laboratory could not provide documentation of calibration performed at least once every 6 months on 2 of 2 Rotem Delta 20 system analyzers used to analyze clotting -- 3 of 6 -- time in 2018 and 2019. 2. In 2018, 1300 clotting time patient tests were analyzed. 3. In 2019 (01/01/2019 to 05/29/2019) 455 clotting time patient tests were analyzed. 3. The LD confirmed the findings above on 05/29/2019 around 9:50 am. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, interview with the laboratory director (LD), testing personnel #1 and #2, the laboratory failed to perform external liquid QC of different concentrations, each day of patient testing for Clotting Time tests analyzed on the Rotem Delta 20 system analyzers from 09/07/2017 to the date of survey. Findings Include: 1. On the day of survey, 05/29/2019, review of the Rotem Delta 20 system analyzers QC records revealed that laboratory performed external QC on a weekly bases. 2. In 2017 (09/07/2017 to 12/31/2017) 425 clotting time patient tests were analyzed. 3. In 2018, 1300 clotting time patient tests were analyzed. 4. In 2019 (01/01/2019 to 05/29/2019) 455 clotting time patient tests were analyzed. 5. The LD confirmed the findings above on 03/07/2019 around 12:30 pm. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of records, interview with the laboratory director (LD), testing personnel #1 and #2, the laboratory failed to perform and evaluate relationship comparison studies between 2 of 2 Rotem Delta 20 analyzers in 2018 and 2019. Findings Include: 1. On the day of survey, 05/29/2019, the laboratory could not provide documentation of relationship comparison studies performed on 2 of 2 Rotem Delta 20 analyzers used to test clotting time from 2018 and 2019. 2. In 2018, 1300 clotting time patient tests were analyzed. 3. In 2019 (01/01/2019 to 05/29/2019) 455 clotting time patient tests were analyzed. 4. The LD confirmed the findings above on 05/29/2019 around 9:45 am. D5781