Syringa Hospital & Clinics

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory procedures, training and competency assessment records and an interview with the laboratory manager on 2/4/2025, the laboratory failed to follow written procedures to assess testing personnel competency and to establish a procedure for competency assessments for the technical supervisor (TS) and general supervisor (GS) in 2023 and 2024. The findings include: 1. The CMS 209 identified six (6) testing personnel (TP) performing moderate and high complexity testing of which four (4) were new since the last inspection on 12/06/2022. 2. A review of laboratory procedures identified that the laboratory established a procedure to assess TP initial training, semiannual and annual competency but failed to establish a procedure for competency assessment performance for the TS and GS. 3. A review of training and competency assessment records identified that the laboratory failed to have an annual competency assessment for one (1) of two (2) TP in 2023. 4. A review of training and competency assessment records identified that the laboratory failed to have competency assessments for the TS and GS performed by the laboratory director in 2023 and 2024. 5. An interview with the laboratory manager on 2/4/2025 at 1:58 pm confirmed the above findings. 6. The laboratory reports performing 174,461 tests annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) 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 -- 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 proficiency testing (PT) documents from American Proficiency Institute (API) and an interview with the laboratory manager on 2/5/2025, the laboratory failed to review and evaluate PT scores that were less than 100% in 2024. The findings include: 1. A review of PT documents from API for the specialty of hematology for 2024 event two identified that the laboratory failed to evaluate results for sample XE-10 for basophils, eosinophils, IG absolute. IG percent, neutrophils, RDW-CV and RDW-SD with unacceptable results. 2. A review of PT documents from API for the specialty of chemistry for 2024 event two identified that the laboratory failed to evaluate results for sample BG-08 for glucose blood gas, sample CM-10 for creatine kinase-MB and sample CH-08 for total iron binding capacity with unacceptable results. 3. An interview with the laboratory manager on 2/5/2025 at 11: 32 am confirmed that the laboratory failed to evaluate PT scores that were less than 100% in 2024. 4. The facility reports performing 6,446 complete blood count tests and 120,804 chemistry tests annually. 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). This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documents from the American Proficiency Institute (API) and an interview with the laboratory manager on 2/5/2025, the laboratory failed to review and evaluate PT scores that were given an artificial score of 100% in 2024. The findings include: 1. A review of PT documents from API for the specialty of chemistry for 2024 event two identified that the laboratory failed to evaluate results for total iron sample CH-08 that was given an artificial score of 100% due to result variance. 2. A review of PT documents from API for the specialty of hematology for 2024 event two identified that the laboratory failed to evaluate results for vaginal wet preparation sample UA-04 that was given an artificial score of 100% due to no consensus. 3. An interview with the laboratory manager on 2/5/2025 at 11:36 am confirmed that the laboratory failed to evaluate PT scores that were given an artificial score. 4. The laboratory reports performing 117 total iron and 56 vaginal wet preparations tests annually. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. -- 2 of 5 -- 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of patient test records, laboratory policies, manufacturer's instructions, and interview with the laboratory manger on 2/5/2025, the laboratory failed to meet the requirements for the preanalytic system for forty-one of one hundred and eighty lactic acid specimens reviewed and one of twenty-three ammonia specimens reviewed. The findings include: 1. The laboratory failed to follow laboratory policies and manufacturer's instructions for specimen collection and handling: removing plasma from cells within 15 minutes after collection prior to analysis for forty-one of one hundred and eighty lactic acid specimens and within 30 minutes for one of twenty-three ammonia specimens in November 2024, December 2024, January 2025 and the first four days of February. See D5311 D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of patient test records, laboratory policies, manufacturer's instructions, and interview with the laboratory manager on 2/5/2025, the laboratory failed to follow laboratory policy and manufacturer's instructions for specimen collection and handling: removing plasma from cells within the required time after collection prior to analysis for forty-one of one hundred and eighty lactic acid specimens and one of twenty-three ammonia specimens in November 2024, December 2024, January 2025 and the first four days in February. The findings include: Ammonia: 1. The manufacturer's instructions for use (Siemens EXL200 ) for ammonia states "the tube should be completely filled, stored tightly capped on ice and centrifuged without delay. Samples should be analyzed within 30 minutes of centrifugation." 2. A review of the laboratory's policy confirmed that the laboratory uses the manufacturer's instructions as part of their policy. 3. Patient test records were reviewed for November 2024, December 2024, January 2025 and the first four days of February. The following one of twenty-three reviewed patient reports were outside the 30 minute time frame: a. patient #03-25-023-0024 collected 1/23/2025 at 0900 received into the laboratory at 0933, 33 minutes. 4. An interview with the laboratory manager on 2/5/2025 at 3:50 pm confirmed the above findings. 5. The laboratory reports performing 80 ammonia test annually. Lactic Acid: 1. The manufacturer's instructions for use (Siemens EXL200 ) for lactic acid states "collect without stasis in a container of sodium fluoride/potassium oxalate, followed by immediate chilling of the specimen and separation of the cells within 15 minutes." 2. A review of the laboratory's policy confirmed that the laboratory uses the manufacturer's instructions as part of their policy. 3. Patient test records were reviewed for November 2024, December 2024, January 2025 and the first four days of February. The following forty- one of one hundred and eighty reviewed patient reports were outside the 15 minute time frame: a. patient # 03-25-027-0002 collected on 1/27/2025 at 0620 received in -- 3 of 5 -- the laboratory at 0628, 28 minutes. b. patient # 03-25-024-0052 collected on 1/24 /2025 at 1325 received in the laboratory at 1354, 29 minutes. c. patient # 03-24-316- 0007 collected on 11/11/2024 at 0143 received in the laboratory at 0615, 4 hours and 32 minutes. d. patient # 03-25-007-0003 collected on 1/7/2025 at 0115 received in the laboratory at 0138, 23 minutes. e. patient # 03-25-010-0045 collected on 1/10/2025 at 1324 received in the laboratory at 1343, 19 minutes. f. patient # 03-25-014-0039 collected on 1/14/2025 at 1012 received in the laboratory at 1032, 20 minutes. g. patient # 03-24-340-0072 collected on 12/5/2024 at 1620 received in the laboratory at 1045, 25 minutes. h. patient # 03-24-313-0008 collected on 11/8/2024 at 0616 received in the laboratory at 0633, 17 minutes. i. patient # 03-24-314-0005 collected on 11/9/2024 at 0605 received in the laboratory at 0624, 19 minutes. j. patient # 03-25- 029-0072 collected on 1/29/2025 at 1228 received in the laboratory at 1314, 46 minutes. k. patient # 03-24-340-0007 collected on 12/5/2024 at 0801 received in the laboratory at 0831, 30 minutes. l. patient # 03-24-331-0120 collected on 11/26/2024 at 1753 received in the laboratory at 1810, 17 minutes. m. patient # 03-24-358-0009 collected on 12/23/2024 at 0600 received in the laboratory at 0618, 18 minutes. n. patient # 03-24-341-0003 collected on 12/6/2024 at 0040 received in the laboratory at 0100, 30 minutes. o. patient # 03-24-317-0053 collected on 11/12/2024 at 1128 received in the laboratory at 1155, 27 minutes. p. patient #03-24-348-0002 collected on 12/13/2025 at 0629 received in the laboratory at 0655, 26 minutes. q. patient #03- 25-032-0016 collected on 2/1/2025 at 0600 received in the laboratory at 0643, 43 minutes. r. patient #03-25-033-0004 collected on 2/2/2025 at 0600 received in the laboratory at 0809, 2 hours and 9 minutes. s. patient #03-25-035-0006 collected on 2/4 /2025 at 0611 received in the laboratory at 0645, 34 minutes. t. patient #03-25-036- 0014 collected on 2/5/2025 at 0623 received in the laboratory at 0645, 22 minutes. u. patient #03-25-029-0094 collected on 1/29/2025 at 1353 received in the laboratory at 1417, 24 minutes. v. patient #03-25-030-0006 collected on 1/29/2025 at 0600 received in the laboratory at 0749, 1 hour and 49 minutes. w. patient #03-24-330-0091 collected on 11/25/24 at 1715 received in the laboratory at 1759, 44 minutes. x. patient #03-24-357-0007 collected on 12/22/2024 at 2119 received in the laboratory at 2142, 23 minutes. y. patient #03-24-349-0003 collected on 12/14/2024 at 0625 received in the laboratory at 0643, 18 minutes. z. patient #03-25-350-0002 collected on 12/15/2024 at 0620 received in the laboratory at 0657, 37 minutes. aa. patient # 03- 24-352-0010 collected on 12/17/2024 at 0617 received in the laboratory at 0638, 21 minutes. bb. patient # 03-24-366-0016 collected on 12/31/2024 at 0630 received in the laboratory at 0718, 48 minutes. cc. patient # 03-24-354-0016 collected on 12/19/2024 at 0808 received in the laboratory at 0825, 17 minutes. dd. patient # 03-25-004-0027 collected on 1/4/2025 at 2218 received in the laboratory at 2248, 30 minutes. ee. patient # 03-24-353-0003 collected on 12/17/2024 at 0622 received in the laboratory at 0642, 20 minutes. ff. patient # 03-24-347-0037 collected on 12/12/2024 at 1249 received in the laboratory at 1325, 36 minutes. gg. patient # 03-24-306-0073 collected on 11/1/2024 at 1619 received in the laboratory at 1716, 57 minutes. hh. patient # 03- 25-030-0080 collected on 1/30/2025 at 1633 received in the laboratory at 1653, 20 minutes. ii. patient # 03-24-356-0006 collected on 12/21/2024 at 0058 received in the laboratory at 0132, 34 minutes. jj. patient # 03-24-356-0009 collected on 12/21/2024 at 0304 received in the laboratory at 0322, 18 minutes. kk. patient # 03-24-361-0059 collected on 12/26/2024 at 1655 received in the laboratory at 1722, 27 minutes. ll. patient # 03-25-011-0008 collected on 1/11/2025 at 0630 received in the laboratory at 0648, 18 minutes. mm. patient # 03-24-312-0035 collected on 11/7/2024 at 1026 received in the laboratory at 1048, 22 minutes. nn. patient # 03-25-029-0007 collected on 1/29/2025 at 0609 received in the laboratory at 0632, 23 minutes. oo. patient # 03- 24-340-0050 collected on 12/5/2024 at 1328 received in the laboratory at 1350, 30 minutes. 4. An interview with the laboratory manager on 2/5/2025 at 3:50 pm -- 4 of 5 -- confirmed the above findings.. 5. The laboratory reports performing 693 lactic acid test annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and an interview with the laboratory manager on 12/5/2022, the laboratory director failed to approve, sign and date laboratory policies and procedures for the Cepheid. The findings include: 1. A record review of laboratory policies and procedures identified that the laboratory director failed to approve, sign and date the Cepheid individual quality control plan (IQCP), Cepheid Xpert CT-NG procedure and Xpert Xpress SARS-COV-2 proccedure. 2. An interview with the laboratory manager on 12/6/202 at 8:23 am, confirmed that the laboratory director has not approved, signed and dated the above Cepheid laboratory policies and procedures. 3. The laboratory reports performing 257 Cepheid tests annually. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of hematology quality control (QC) documentation, patient logs, and an interview with the laboratory manager on 12/5/2022, the laboratory failed to perform two levels of QC material every day of patient testing. The findings include: 1. A random record review of complete blood count (CBC) QC identified that the laboratory failed to perform two levels of QC when patient testing occurred on 8/4 /2022. 2. A review of the laboratory's patient results identified 19 patient CBC reported on 8/4/2022. 3. An interview with the laboratory manager on 12/5/2022 at 12: 30 pm confirmed that the laboratory failed to perform two levels of CBC QC on 8/4 /2022. 4. The laboratory reports performing 6,132 CBC tests annually. -- 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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Association of Bioanalysts (AAB), the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2021 and 2022 for the specialty of hematology. D2130 HEMATOLOGY CFR(s): 493.851(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 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 Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Association of Bioanalysts (AAB) and telephone interview with the laboratory manageron 10/18/2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2021 and 2022 for the specialty of hematology for the analyte white blood cell (WBC) differential. The findings include: 1. A PT desk review of Report 155D and graded PT results from AAB identified that the laboratory failed to achieve overall satisfactory scores for event three (3) in 2021 and event two (2) in 2022 for the specialty of hematology for the analyte WBC differential. Analyte Year Event Score WBC Differential 2021 3 60% WBC Differential 2022 2 60% 2. A telephone interview with the laboratory manager on 10/18/2022 at 1:44 pm confirmed the above findings. 3. The laboratory reports performing 8,400 Complete Blood Cell Count Tests annually. -- 2 of 2 --

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 record review and an interview with the laboratory manager on 05/20/2021, the laboratory failed to follow the manufacturers instructions for the Medtox Scan instrument for testing drugs of abuse. The findings include: 1. A record review of the Medtox Scan package insert, page 3, the laboratory failed to follow the manufactures instructions and failed to report positive results as preliminary positive results. 2. An interview with the laboratory manager on 05/20/2021 at 09:45 AM confirmed the laboratory failed to follow the manufacturer's instructions. 3. The laboratory reports performing 576 drug of abuse patient tests annually on the Medtox Scan instrument. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: 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 -- Based on an observation of the immunohematology thermometer alarm system and corresponding documentation, and an interview with the laboratory manager on 05/20 /2021, the laboratory failed to document inspecting the alarm system for the refrigerator temperature where blood and blood products are stored. The findings include: 1. An observation of the laboratory's alarm system documentation on 05/20 /2021 at 1:30 PM revealed that the laboratory failed to document the regular inspection of the immunohematology refrigerator alarm system since the time of the previous survey on 02/26/2019. 2. An interview with the laboratory manager on 05/20 /2021 at 1:30 PM confirmed that the laboratory failed to document the inspection of the immunohematology refrigerator alarm since the time of the last survey on 02/26 /2019. 3. The laboratory reports performing 340 immunohematology patient tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records and an interview with the laboratory manager, the laboratory failed to document the