Starr County Memorial Hospital

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. D3015 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103 A facility that provides transfusion services must meet all of the requirements of this section and document all transfusion-related activities. This STANDARD is not met as evidenced by: Based on a review of the facility's policies, patient transfusion records, and staff interview, the facility failed to follow its own policy for documenting patient vitals during a transfusion for three of ten random transfusions reviewed in 2023 and 2024. Findings include: 1. A review of the facility's policy titled 'Blood Product Administration' revealed the following: "- Take baseline vitals before starting transfusion and record in Transfusion Record. After blood has started infusing, stay with the patient for at least 15 minutes to check for a transfusion reaction. Repeat vital signs at 15 minutes and at one hour after the start of transfusion, and hourly thereafter for the duration of the transfusion, and then at the ed of the transfusion." 2. A random review of patient transfusion records from 2023 and 2024 revealed the follow 3 transfusions were missing patient vital sign documentation at 15 minutes, per the facility's policy: - Patient #: 10491735 Unit #: W03622307728200L Baseline vitals taken: 5/19/23 at 01:10 Next time vials were taken: 5/19/23 at 01:45 Elapsed time: 35 minutes - Patient #: 10532672 Unit #: W041124017845005 Baseline vitals taken: 2/16 /24 at 17:30 Next time vitals were taken: 2/16/24 at 18:00 Elapsed time: 30 minutes - Patient #: 10532672 Unit #: W04112401521400P Baseline vitals taken: 2/17/24 at 11: 05 Next time vitals were taken: 2/17/24 at 11:45 Elapsed time: 40 minutes 3. In an interview on 12/4/24 at 11:30 a.m. in the conference room, after review of the records, the technical consultant confirmed the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the Blood Bank Alarm Checks for 2023 and 2024, a review of the chart recorder graphs, surveyor observation, and staff interview, the laboratory failed to ensure the changes in temperature were recorded on the chart recorder graphs when the Blood Bank refrigerator temperatures fell outside of the acceptable range during nine of ten alarm checks performed in 2023 and 2024. Findings include: 1. A review of the laboratory's policy titled 'Blood Bank Alarm Check' revealed the following: "The blood bank refrigerator is equipped with an alarm to sound off should the temperature of the refrigerator not be within the specified range. This alarm must be checked quarterly to ensure that it is working properly. Temperature range is +1 to +6 ." 2. A review of the Blood Bank Alarm Checks for 2023 and 2024 revealed the laboratory performed the alarm checks on the following days: - 1/10/23 Beeps at 1.5C and 5.5C - 4/18/23 Beeps at 1.5C and 5.5C - 7/11/23 Beeps at 1.5C and 5.5C - 10/4/23 Beeps at 1.5C and 5.5C - 12/5/23 Beeps at 1.5C and 5.5C - 1/7/24 Beeps at 1.5C and 5.5C - 4/5/24 Beeps at 1.5C and 5.5C - 7/6/24 Beeps at 1.5C and 5.5C - 10/2/24 Beeps at 1.6C and 5.5C - 12/2/24 Beeps at 1.5C and 5.5C 3. A review of the chart recorder graphs for the dates above revealed the following nine alarm checks found no change in temperatures were recorded on the chart recorder graphs: - 1/10/23 - 4/18/23 - 7/11/23 - 10/4/23 - 1/7/24 - 4/5/24 - 7/6/24 - 10/2 /24 - 12/2/24 4. Testing person #7 was asked on 12/4/24 at 11:20 a.m. to perform an alarm check. Surveyor observation of the Blood Bank refrigerator revealed the alarm sounded and the temperatures were recorded on the chart recorder graphs when the temperatures fell outside of the acceptable range. 5. In an interview on 12/4/24 at 11: 25 a.m. in the conference room, after review of the records, the technical consultant confirmed the above findings. Key: C = Degrees Celsius D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, a review of the laboratory's Incoming Specimen Logs, and staff interview, the laboratory failed to define the acceptability criteria for 11 of 11 specimens received at "Room Temp" from January to November 2024. Findings include: 1. A review of the laboratory's policies revealed the laboratory failed to have documentation of a policy defining the acceptability criteria for specimens received at "Room Temp". 2. A review of the laboratory's Incoming -- 2 of 11 -- Specimen Logs from January to November 2024 revealed the following patient's specimens were documented as received at "Room Temp", with no defined acceptability criteria: Date: 1/6/24 Patient #: 10526306 Date: 7/3/24 Patient #: 10553698 Date: 7/26/24 Patient #: 10557355 Date: 7/29/24 Patient #: 10557656 Date: 8/14/24 Patient #: 10560082 Date: 8/19/24 Patient #: 10560744 Date: 10/15/24 Patient #: 10570263 Date: 10/22/24 Patient #: 10571344 Date: 10/22/24 Patient #: 10571343 Date: 10/22/24 Patient #: 10571357 Date: 11/14/24 Patient #: 10575037 3. In an interview on 12/4/24 at 3:10 p.m. in the conference room, after review of the records, the technical consultant confirmed the above findings. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on the review of the manufacturer's instructions for the Siemens' Dimension Lactic Acid assay, review of patient test records from November 16, 2024 to November 20, 2024, and staff interview, the laboratory's quality assurance plan failed to identify that collection times for ----- of ------ lactic acid tests were not being recorded correctly and, therefore, the laboratory could not ensure samples were processed in the required timeframe. The findings included: 1. A review of the manufacturer's instructions for the Siemens' Dimension Lactic Acid assay (Issue date: 2019-04-01) under the section titled "Specimen Collection and Handling" identified: '.....followed by the immediate chilling of the specimen and separation of the cells within 15 minutes." 2. A review of patient test records from November 16, 2024 to November 20, 2024 identified 18 of 30 lactic acid tests where the recorded collection time was identical to the recorded time the sample was received in the laboratory despite the samples being collected in various parts of the hospital and transported to the lab. They were: Order: 76355 Date: 11/16/2024 Documented collection time: 0611 Documented received time: 0611 Order:76584 Date: 11/16/2024 Documented collection time: 1255 Documented received time: 1255 Order:76661 Date: 11/16/2024 Documented collection time: 1648 Documented received time: 1648 Order:76693 Date: 11/16/2024 Documented collection time: 2014 Documented received time: 2014 Order:77124 Date: 11/167/2024 Documented collection time: 2107 Documented received time: 2107 Order:77586 Date: 11/18/2024 Documented collection time: 1450 Documented received time: 1450 Order:77257 Date: 11/18/2024 Documented collection time: 0017 Documented received time: 0017 Order:77733 Date: 11/18/2024 Documented collection time: 1853 Documented received time: 1853 Order:77719 Date: 11/18/2024 Documented collection time: 1812 Documented received time: 1812 Order:77792 Date: 11/19/2024 Documented collection time: 0439 Documented received time: 0439 Order:78153 Date: 11/19/2024 Documented collection time: 1248 Documented received time: 1248 Order:78089 Date: 11/19/2024 Documented collection time: 1125 Documented received time: 1125 Order:78000 Date: 11/19/2024 Documented collection time: 0922 Documented received time: 0922 Order:78930 Date: 11/20/2024 Documented collection time: 1347 Documented received time: 1347 Order:78949 Date: 11/20/2024 Documented collection time: 1448 Documented received time: 1448 Order:79059 Date: 11/20/2024 Documented collection time: 1745 Documented received time: 1745 Order:78843 Date: 11/20/2024 Documented collection time: 1245 Documented received time: 1245 Order:78936 Date: 11/20/2024 -- 3 of 11 -- Documented collection time: 1545 Documented received time: 1545 3. The technical consultant confirmed that samples were collected throughout the hospital and then brought to the laboratory where they were received into the LIS during an interview conducted on 12/04/2024 at 1600 hours in the conference room. She stated the received time was used as the collection time inappropriately. She then agreed that without the correct collection time, the laboratory could not ensure samples for lactic acid testing were processed within 15 minutes as required by the manufacturer. 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: I. Based on a review of the ASI Color Mono II Test Instructions for Use, a review of the laboratory's Mono Logs, and staff interview, the laboratory failed to ensure the patient's samples used for Infectious Mononucleosis antibody testing were rotated for the correct time for 105 of 118 patient test records reviewed from March 2023 to March 2024. Findings include: 1. A review of the ASI Color Mono II Test Instructions for Use (6004-450, Rev 12/2018) revealed the following: "Gently rotate the card for 2 minutes." 2. A review of the Mono Logs from March 2023 to March 2024 revealed the laboratory documented the rotation time as 8 minutes, not 2 minutes per the manufacturer's requirements, for the following patients: Patient #s for patients tested using the ASI Color Mono II Test from 3/2/23 to 3/14/24: 10480278, 10480299, 10480537, 10480616, 10480987, 10482038, 10482050, 10482067, 10483058, 10483259, 10483312, 10484061, 10484126, 10484199, 10483692, 10485101, 10486194, 10486021, 10486356, 10486487, 10486535, 10486957, 10486987, 10488039, 10488266, 10488297, 10488297, 10488750, 10489156, 10489158, 10489483, 10490233, 10491389, 10491616, 10491884, 10492449, 10492574, 10492678, 10492736, 10486451, 10490468, 10493413, 10493581, 10493579, 10493908, 10494028, 10494328, 10494574, 10496088, 10495825, 10496465, 10496297, 10497528, 10497593, 10500456, 10503729, 10506555, 10507996, 10508106, 10509012, 10509017, 10508928, 10509835, 10510491, 10511532, 10511880, 10517492, 10512495, 10513438, 10516123, 10516782, 10518142, 10518152, 10518515, 10518906, 10518266, 10520854, 10521032, 10521134, 10521202, 10521988, 10522324, 10522348, 10523229, 10523277, 10523367, 10523599, 10524538, 10524874, 10525299, 10525300, 10526058, 10526300, 10526310, 10526827, 10534330, 10534536, 10534608, 10534977, 10535637, 10535852, 10535902, 10536023, 10536786, 10536798 3. In an interview on 12/4/24 at 3:00 p.m. in the conference room, after review of the records, the technical consultant confirmed the above findings. II. Based on a review of the Medline Mono Test Cassette Instructions for Use, surveyor observation, a review of the Sorvall Legend X1 centrifuge settings, a review of the laboratory's Mono Logs, and staff interview, the laboratory failed to ensure the patient's samples were centrifuged at the correct speed and time for Infectious Mononucleosis antibody testing for 66 of 66 patient test records reviewed from March to December 2024. Findings include: 1. A review of the Medline Mono Test Cassette Instructions for Use revealed the following: "Serum or Plasma: - centrifuged at 1500 x g for ten minutes at room temperature." 2. Surveyor observation of the laboratory on 12/4/24 at 3:00 p.m. -- 4 of 11 -- revealed the laboratory used one Thermo Scientific Sorvall Legend X1 centrifuge (serial number: 41870083) to centrifuge all laboratory specimens. 3. A review of the Thermo Scientific Sorvall Legend X1 centrifuge's settings revealed the following pre- programmed settings for patient specimens: 1. 1620 RPM 5 minutes 2. 3500 RPM 10 minutes 3. 3500 RPM 4 minutes 4. 1500 RPM 15 minutes 5. 3000 RPM 15 minutes *There was not a pre-programmed setting that matched the requirements for the Medline Mono Test Cassette of 1500 RPM for 10 minutes. 4. A review of the laboratory's Mono Logs from March to December 2024 revealed the laboratory failed to centrifuge the following patient samples at the correct speed and time: Patient #s for patients tested using the Medline Mono Test Cassette Test from 3/15/24 to 12/3 /24: 10537052, 10537346, 10537349, 10537347, 10539097, 10539102, 10539100, 10539103, 10539107, 10539135, 10539172, 10539773, 10539940, 10540600, 10540801, 10541148, 10542413, 10543489, 10543932, 10544897, 10545878, 10546114, 10546322, 10546836, 10547152, 10547470, 10547607, 10548404, 10549220, 10550864, 10551141, 10552035, 10552494, 10552842, 10554000, 10548483, 10559997, 10560049, 10560178, 10560306, 10560469, 10560654, 10560657, 10562499, 10562606, 10565746, 10565961, 10566960, 10569471, 10570041, 10570556, 10570805, 10571620, 10571724, 10571724, 10572298, 10572706, 10572095, 10573817, 10573819, 10575288, 10576190, 10576851, 10577004, 10577517, 10577798 5. In an interview on 12/4/24 at 3:00 p.m. in the conference room, after review of the records, the technical consultant confirmed the above findings. Key: RPM = Revolutions per minute D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of the laboratory's records and staff interview, the laboratory failed to have documentation of performing two of four verification studies (accuracy and precision) for Infectious Mononucleosis (Mono) testing using the Medline Mono Test Cassette in March 2024. Findings include: 1. A review of the laboratory's records revealed the laboratory started Mono testing using the Medline Mono Test Cassette on 3/15/24. 2. Further review of the laboratory's records revealed the laboratory failed to have documentation of an accuracy and precision study for Mono testing using the Medline Mono Test Cassette. 3. In an interview on 12/4/24 at 10:20 a.m. in the conference room, after review of the records, the technical consultant confirmed the above findings. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a -- 5 of 11 -- function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the maintenance records for the Sorvall Cell Washer from 2023 to 2024, the laboratory's records, and staff interview, the laboratory failed to ensure the cell washer: a) delivered the proper amount of saline to the blood bank tubes for 640 of 640 days between March 2023 to November 2024. b) was spinning at the appropriate revolutions per minute (RPMs) for four of four times quarterly maintenance was performed in 2024. Findings include: 1. A review of the laboratory's policy titled 'Cell Washer Preventative Maintenance' revealed the following: "Daily: Check saline fill volume - Using the CALIBRATE key and a graduated cylinder, make sure that the washer delivers 54 mls of saline to the 12x75 tubes. Every 3 months: Check motor speed - Set the power to ON and press the HOLD key. Allow the motor to accelerate to speed. Shine a stroboscope or tachometer through the viewport in the cover to verify the speed. RPM 3400 - 3600" 2. A review of the Maintenance for Sorvall Cell Washer records revealed the following: a) From March 2023 to November 2024, the laboratory performed the daily saline volume check and for all 640 days, the saline volume was documented below 54 mls. b) In 2024, the laboratory performed the quarterly RPM checks on the following dates and the RPMs were below the acceptable range of 3400 - 3600: - Date: 3/2/24 3000 RPM - Date: 6/5/24 3000 RPM - Date: 9/24/24 3000 RPM - Date: 12/3/24 3000 RPM 3. A review of the laboratory's records revealed the laboratory estimated performing 4,500 immunohematology tests annually. 4. In an interview on 12/4/24 at 11:15 a.m. in the conference room, after review of the records, the technical consultant confirmed the above findings. Key: mls = milliliters ***NOTE: This is a repeat deficiency from the survey performed on 2/15/23*** 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 -- 6 of 11 -- calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's calibration verification records for the ABL90 blood gas analyzers from 2023 and 2024 and staff interview, the laboratory failed to have documentation of performing calibration verifications every six months for 2 of 2 analyzers. The findings included: 1. A review of the laboratory's calibration verification records for the ABL90 blood gas analyzers (serial number 092R0348N017 and 092R0348N020) determined calibration verification records were performed on following times: a) 092R0348N017 April 2023 July 2023 (4 months later) March 2024 (8 months later) October 2024 (7 months later) Tests: pH, TCO2, pO2, tHb, SO2, Ca+ b) 092R0348N020 April 2023 July 2023 (4 months later) March 2024 (8 months later) October 2024 (7 months later) Tests: pH, TCO2, pO2, tHb, SO2, Ca+ 2. The technical consultant confirmed the findings in an interview conducted on 12/03/2024 at 1525 hours in the conference room. 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: Based on a review of the laboratory's quality control records, a review of the laboratory's Mono Logs, and staff interview, the laboratory failed to have documentation of running a negative and positive quality control each day of patient testing for 54 of 54 days from March to December 2024 on the Medline Mono Test Cassette. Findings include: 1. A review of the laboratory's quality control records from March to December 2024 revealed the following days the laboratory failed to have documentation of running a negative and positive control when patients were tested: 3/15/24, 3/18/24, 3/29/24, 3/30/24, 3/31/24, 4/3/24, 4/4/24, 4/9/24, 4/10/24, 4 /12/24, 4/19/24, 4/28/24, 4/30/24, 5/6/24, 5/12/24, 5/13/24, 5/15/24, 5/17/24, 5/20/24, 5/22/24, 5/28/24, 6/3/24, 6/13/24, 6/15/24, 6/21/24, 6/25/24, 6/27/24, 7/5/24, 7/15/24, 8/14/24, 8/15/24, 8/16/24, 8/18/24, 8/28/24, 8/29/24, 9/17/24, 9/18/24, 9/24/24, 10/10 /24, 10/14/24, 10/17/24, 10/19/24, 10/23/24, 10/24/24, 10/28/24, 10/30/24, 11/7/24, 11 /10/24, 11/15/24, 11/21/24, 11/26/24, 11/27/24, 12/2/24, 12/3/24 2. A review of the laboratory's Mono Logs from March to December 2024 revealed the following patient's samples were run on days when the laboratory failed to have documentation of running a negative and positive control: 10537052, 10537346, 10537349, 10537347, 10539097, 10539102, 10539100, 10539103, 10539107, 10539135, 10539172, 10539773, 10539940, 10540600, 10540801, 10541148, 10542413, 10543489, 10543932, 10544897, 10545878, 10546114, 10546322, 10546836, 10547152, 10547470, 10547607, 10548404, 10549220, 10550864, 10551141, 10552035, 10552494, 10552842, 10554000, 10548483, 10559997, 10560049, 10560178, 10560306, 10560469, 10560654, 10560657, 10562499, 10562606, 10565746, 10565961, 10566960, 10569471, 10570041, 10570556, 10570805, 10571620, 10571724, 10571724, 10572298, 10572706, 10572095, 10573817, 10573819, 10575288, 10576190, 10576851, 10577004, 10577517, 10577798 3. In an -- 7 of 11 -- interview on 12/4/24 at 3:00 p.m. in the conference room, after review of the records, the technical consultant confirmed the above findings. 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 the laboratory's test menu, review of the laboratory's records from 2023 and staff interview, the laboratory failed to have documentation of performing instrument comparisons for 2 of 2 tests. The findings included: 1. A review of the laboratory's test menu determined the laboratory performed Strep A and C. diff testing on the following two analyzers in 2023: a) Cephid Gene Xpert b) Meridian Bioscience Revogene 2. A review of the laboratory's records determined the laboratory failed to have documentation of performed twice annual instrument comparisons for the tests in 2023. 3. The technical consultant confirmed the findings in an interview conducted on 12/03/2024 at 1130 hours in the conference room. D5785

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP). The laboratory was found to be NOT in compliance with the CLIA program based on the following CONDITION LEVEL DEFICIENCIES: 493.803 Successful participation [proficiency testing] 493.1403 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 a desk review of proficiency testing records obtained from the CMS (Center 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 -- for Medicare Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP), the laboratory failed to successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of parasitology resulting in a non-initial proficiency testing failure (refer to D2055). D2055 PARASITOLOGY CFR(s): 493.829(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 a desk review of the CMS 155 report and proficiency testing records from College of American Pathologists (CAP), the laboratory failed to achieve satifactory performance for the same subspecialty in four of six testing events for parasitology. The findings include: 1. A review of the CMS 155 report revealed the laboratory received the following unsatisfactory scores (passing = >80%) for the subspecialty parasitology: Third testing event 2021: 33% Second testing event 2022: 66% First testing event 2023: 66% Second testing event 2023: 66% 2. A desk review of the laboratory's College of American Pathologists results from the third event of 2021, the second event of 2022, first event of 2023, and second event of 2023 revealed the following scores: Third testing event 2021: 33% Second testing event 2022: 66% First testing event 2023: 66% Second testing event 2023: 66% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance 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: -- 2 of 3 -- Based on a desk review of proficiency testing results 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 D2055). -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's test records and staff interview, it was revealed that the laboratory failed to have documentation of performing twice annual accuracy assessments in 2022 for three unregulated analytes tested on the Dimension EXL chemistry analyzer. Findings include: 1. A review of the laboratory's test records revealed the laboratory tested for the following 3 analytes on the Dimension EXL chemistry analyzer: Vitamin B12 Folate C-Reactive Protein 2. The laboratory was asked to provide documentation of assessing the accuracy, twice annually, for Vitamin B12, Folate, and C-Reactive Protein. No documentation was provided. 3. Further review of the laboratory's test records revealed the laboratory performed 24 Vitamin B12 tests, 5 Folate tests, and 715 C-Reactive protein tests in 2022. 4. An interview with the technical consultant on 2/14/23 at 2:43 p.m. in the conference room, after review of the records, confirmed that the laboratory overlooked these three tests when re-enrolling for proficiency testing samples in 2022. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the Dimension Lactic Acid assay, a random sampling of patient lactic acid results from September 2022, and staff interview it was revealed the laboratory failed to centrifuge 1 of 10 specimens within 15 minutes of collection as required by the manufacturer. The findings include: 1. A review of the manufacturer's instructions for the Dimension Lactic Acid assay (issue date: 2019-04-01) under the section titled "Specimen Collection and Handling" revealed: "Blood is best collected without statis 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 random sampling of patient test records from September 2022 identified 1 of 10 patient samples for which the time from collection to receipt exceeded 15 minutes and thus, the sample could not have been centrifuged within 15 minutes. It was: Date: 09/18/2022 Patient ID: 10455979 Collected: 09/19 /2022 0415 Received: 09/19/2022 0458 Elapsed time: 43 minutes 3. An interview with the technical consultant on 02/15/2023 at 1350 hours in the conference room - after her review of the records- confirmed the findings. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of the laboratory's incoming specimens logs from February 1, 2023 to February 13, 2023, and staff interview, it was revealed the laboratory's quality assessment failed to identify that sample temperatures were not being monitored to ensure they were transported and received a the required temperatures. The findings include: 1. Based on review of the manufacturer's instructions for the Siemens Dimension ECO2 assay (issue date: 2019- 04-01) under the section titled "Specimen Collection and Handling" revealed: "Unopened, separated samples may be stored for 8 hours at room temperature, 2 days at 2-8C." 2. A review of the manufacturer's instructions for the Siemens Dimension CA assay (issue date: 2019-05-21) under the section titled "Specimen Collection and Handling" revealed: "Specimens are stable for 8 hours at room temperature, 2 days at 2-8C." 3. A review of the manufacturer's instructions for the Siemens Dimension ALB assay (issue date: 2019-04-22) under the section titled "Specimen Collection and Handling" revealed: "Specimens are stable for 8 hours at room temperature, 2 days at 2-8C." 4. A review of the manufacturer's instructions for the Siemens Dimension TP assay (issue date: 2019-05-21) under the section titled "Specimen Collection and Handling" revealed:"Separated specimens are stable for 8 hours at room temperature, 72 hours at 2-8C." 5. A review of the laboratory's Incoming specimens logs from February 1, 2023 to February 13, 2023 revealed the laboratory failed to have documentation of monitoring the temperature of samples from 140 patients received from another facility. Thus, the laboratory could not ensure samples were received at -- 2 of 12 -- the required temperature for testing. 6. An interview with the technical consultant on 02/14/2023 at 1500 hours in the conference room revealed the laboratory had monitored the temperature of samples in the past, but someone had updated the logs and the laboratory no longer documented the temperature of specimens. This confirmed the findings. 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's procedure for platelet poor studies, review of the laboratory's procedure for determining patient normal means, review of the laboratory's records, and staff interview, it was revealed the laboratory failed to follow its policies for: A) performing platelet poor studies annually in 2022, and B) ensuring 5 of 20 volunteers for patient normal mean studies were healthy. The findings include: A) Platelet poor studies 1. A review of the laboratory's procedure titled "Platelet Poor Study" (approved 03/28/2019) revealed: "Platelet poor study must be performed once a year." 2. The laboratory was asked to provide documentation of the required platelet poor study being performed in 2022. No documentation was provided. 3. An interview with the technical consultant on 02/15/2023 at 1320 hours in the laboratory revealed the laboratory could not find any documentation to show the study had been performed. This confirmed the findings. B) Patient normal mean 1. A review of the laboratory's policy titled "Normal Patient Study for Coagulation" (approved 4/25 /2028) revealed: "A series of questions must be answered by the volunteer to determine eligibility to participate. Volunteer must have a clean records and be completely healthy." 2. A review of the laboratory's patient normal mean study performed in May 2022 revealed 5 of 20 volunteers failed to answer the question about their overall health, however, their samples were still included in the study. They were: Volunteer 1 Volunteer 3 Volunteer 11 Volunteer 18 Volunteer 19 3. An interview with the technical consultant on 02/15/2023 at 1330 hours in the conference room - after her review of the records- confirmed the findings. 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: I. Based on review of the manufacturer's instructions for the BD Macro-Vue RPR Card Tests, surveyor observation of equipment available in the laboratory, and staff interview, it was revealed the laboratory failed to have the required equipment for the interpretation of the test results. The findings include: 1. A review of the manufacturer's instructions for the BD Macro-Vue RPR Card Tests (0212013JAA -- 3 of 12 -- (05), 2021-05) under the section titled "Procedures and Results" revealed: "Immediately read macroscopically in the "wet" state under a high intensity incandescent lamp or strong daylight." 2. Surveyor observation on 02/15/2023 at 1500 hours in the area where RPR testing was performed revealed the laboratory interpreted the Test Cards under regular room light. The facility did not utilize a high intensity incandescent lamp or strong daylight. 3. The laboratory reported performing 567 tests since May 2022 when the test kit was placed into use in laboratory. 4. An interview with the technical consultant on 02/15/2023 at 1500 hours in the conference room confirmed the findings. 41687 II. Based on a review of the Vidas D-Dimer Exclusion II Instructions for Use, surveyor observation, and staff interview, it was revealed that the laboratory failed to follow the manufacturer's instructions by not ensuring seven patient samples were centrifuged at the proper speed and then decanted into a plastic tube prior to testing. Findings include: 1. A review of the Vidas D-Dimer Exclusion II Instructions for Use (14219 B, 06/2011) revealed the following: "Centrifuge for 15 minutes at 3,000 rpm and decant plasma into a plastic tube. This separation should be carried out as soon as possible after collection." 2. Surveyor observation of the sample processing area on 2/15/23 at 3:00 p.m. revealed the laboratory's centrifuge had a pre- programmed setting for coagulation samples (setting number 4) that spun samples for 15 minutes at 1,500 rpm (not 3,000 rpm as required by the manufacturer). 3. Surveyor observation of the laboratory on 2/15/23 at 3:05 p.m. revealed the following 7 patient samples had been tested for D-Dimer using the Vidas analyzer and were not centrifuged at the proper speed and the plasma was not decanted into a plastic tube prior to testing: Patient ID: 10477512 Patient ID: 10477620 Patient ID: 10477679 Patient ID: 10477756 Patient ID: 10477738 Patient ID: 10477774 Patient ID: 10478034 4. An interview with the technical consultant on 2/15/23 at 3:15 p.m. in the conference room, after review of the records, confirmed the above findings. Key: rpm - revolutions per minute D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the BD Macro-Vue RPR Card Test, review of the laboratory's room temperature records from October 2022 to February 2023, review of patient test records from October 2022 to February 2023, and staff interview, it was revealed the laboratory failed to ensure the testing was performed within the manufacturer's acceptable temperature range for 30 of 155 test days. The findings include: 1. A review of the manufacturer's instructions for the BD Macro=Vue RPR Card Test (0212013JAA(05), 2021-05) under the section titled "Antigen" revealed: "upon removal from the refrigerator, allow the antigen to warm to room temperature (23 to 29C) before use." 2. A review of the laboratory's room temperature records from October 2022 to February 2023 (as of the day of the survey) revealed the laboratory's defined acceptable room temperature range was 20-30C. 3. Further review of the room temperature records revealed the following 30 of 155 -- 4 of 12 -- testing days when the documented room temperature was outside the manufacturer's acceptable range: Date Temperature 10/26 22.7C 10/30 22.5C 10/31 22.5C 11/14 22.3 C 11/17 22.3C 11/18 22.5C 11/19 22.1C 11/20 22.0C 11/21 22.2C 11/22 22.7C 11/24 22.5C 11/25 22.7C 11/26 22.9C 11/27 22.6C 11/28 22.7C 12/1 22.5C 12/2 22.5C 12 /23 22.5C 12/24 21.7C 12/25 21.4C 12/26 22.3C 12/27 22.5C 12/28 22.5C 2/1 22.9C 2 /3 22.9C 2/9 22.7C 2/10 22.5C 2/11 21.9C 2/12 21.1C 2/13 22.5C 3. A review of patient test records from October 2022 to February 2023 identified the following 64 patients whose samples were tested when the room temperature was documented outside the manufacturer's acceptable range: Date Patient ID 10/26 10463482 10462517 10462537 10462560 10/30 10463114 10/31 10463328 11/14 10465354 10465368 10465541 11/17 10465932 10466004 11/18 10466046 11/19 10466198 10466201 10466047 11/20 10466277 10466292 10466304 10466308 11/21 10466316 10466378 10466423 10466441 11/22 10466565 10466568 10466579 11/24 10466693 11/25 10466760 10466788 10466798 11/26 10466876 11/27 10466909 10466958 11 /28 10467038 10467020 10467057 12/1 10467677 10467689 12/2 10467806 10467855 12/24 10470763 10470768 12/25 10470810 12/26 10470874 10470888 10470905 10470958 12/27 10471119 12/28 10471133 10471233 2/1 10476059 10476091 2/3 10476364 2/9 10477147 10477201 10477228 2/10 10477042 2/11 10477168 2/12 10477582 2/13 10477681 4. An interview with the technical consultant on 02/15/2023 at 1515 hours in the conference room - after her review of the records- confirmed the findings. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory's test menu, review of the laboratory's records, and staff interview, it was revealed the laboratory failed to have documentation of performing verification studies for the BD Macro-Vue RPR Card Test. The findings include: 1. A review of the laboratory's test menu revealed the laboratory implemented the BD Macro-Vue RPR Card Test in May 2022. 2. A review of the laboratory's records revealed the laboratory failed to have documentation performing verification studies for the BD Macro-Vue RPR Card Test. 3. The laboratory was asked to provide documentation of performing the required studies. No documentation was provided. 4. The laboratory reported performing 583 tests utilizing the BD Macro- Vue RPR Card Test kit. 5. An interview with the laboratory manager on 02/15/2023 at 1515 hours in her office revealed verification studies had not been performed. This confirmed the findings. 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 -- 5 of 12 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the laboratory's maintenance records for the Sysmex CA 2500 analyzer from January 2022 to January 2023 and staff interview, it was revealed the laboratory failed to have documentation of performing monthly maintenance for 8 of 13 months. The findings include: 1. A review of the laboratory's maintenance records for the Sysmex CA 2500 analyzer from January 2022 to January 2023 revealed the following maintenance was required to be performed monthly: Clean the Filter 2. Further review of the laboratory's Sysmex CA 2500 maintenance records from January 2022 to January 2023 revealed the laboratory failed to have documentation of performing the required monthly maintenance for 8 of 13 months. The months without documentation of monthly maintenance being performed were: January 2022 February 2022 March 2022 April 2022 May 2022 June 2022 July 2022 August 2022 3. The laboratory was asked to provide documentation of the maintenance being performed. No documentation was provided. 4. An interview with the technical consultant on 02/15/2023 at 1315 hours in the conference room - after her review of the records- confirmed the findings. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the maintenance records for the Sorvall Cell Washer from June 2022 to February 2023, and staff interview, it was revealed that the laboratory failed to ensure the cell washer: a) delivered the proper amount of saline to the blood bank tubes for 229 of 260 days between June 2022 to February 2023. b) was spinning at the appropriate RPMs for four of four times quarterly maintenance was performed between July 2022 to January 2023. Findings include: 1. A review of the laboratory's policy titled 'Cell Washer Preventative Maintenance' revealed the following: "Daily: Check saline fill volume - Using the CALIBRATE key and a graduated cylinder, make sure that the washer delivers 54 mls of saline to the 12x75 tubes. Every 3 months: Check motor speed - Set the power to ON and press the HOLD key. Allow the motor to accelerate to speed. Shine a stroboscope or tachometer through the viewport in the cover to verify the speed. RPM 3400 - 3600" 2. A review of the Maintenance for Sorvall Cell Washer records revealed the following: a) From June 2022 to February 2023 revealed the following 229 days where the saline volume check was documented below 54 mls: - 30 days in June 2022 - 31 days in August 2022 - 30 days in September 2022 - 31 days in October 2022 - 30 days in November 2022 - 31 days in December 2022 - 31 days in January 2023 - 15 days in February 2023 (2/1/23 - 2/15/23) b) From July 2022 to January 2023 revealed the following dates when the motor speed was checked and the RPMs were below -- 6 of 12 -- 3400: - 7/1/22 3000 RPM - 10/1/22 3000 RPM - 12/1/22 3000 RPM - 1/1/23 3000 RPM 3. An interview with the technical consultant on 2/15/23 at 3:15 p.m. in the conference room, after review of the records, confirmed the above findings. Key: mls - milliliters RPM - revolutions per minute D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: I. Based on a review of the laboratory's policies, the laboratory's Media Quality Control forms, and staff interview, it was revealed that the laboratory failed to check each new lot number or new shipment of testing media for its ability to support growth for one of five lots of Chocolate agar in 2022. Findings include: 1. A review of the laboratory's policy titled 'Bacteriology Quality Control' revealed the following: "Quality controls for Chocolate or Thayer Martin should be performed with each new shipment or lot number." 2. A review of the laboratory's Media Quality Control forms for 2022 revealed the following lot number of Chocolate agar failed to have documentation of quality control being tested: Chocolate agar lot number: 429752 expire: 4/5/22 3. An interview with the technical consultant on 2/14/23 at 4:00 p.m. in the conference room, after review of the records, confirmed the above findings. II. Based on a review of the laboratory's Media Quality Control records from 2022 and staff interview, it was revealed the laboratory failed to provide documentation of checking each new lot number or shipment of media for sterility for six of ten lot numbers reviewed. Findings include: 1. A review of the Media Quality Control records for 2022 revealed the laboratory received 6 new lot numbers or shipments of the following media: - GN broth Lot number: 488021 expiration date: 5/5/23 - Thayer Martin agar Lot number: 593459 expiration date: 2/9/23 - Chocolate agar Lot number: 429752 expiration date: 4/5/22 - Blood agar (TSA w/Sheep Blood) Lot number: 491645 expiration date: 11/10/22 - Blood agar (TSA w/Sheep Blood) Lot number: 616315 expiration date: 3/29/23 - EMB agar (Levine) Lot number: 616299 expiration date: 4/5/23 2. An interview with the technical consultant on 2/14/23 at 4:00 p.m. in the conference room, after review of the records, confirmed the above findings. Key: GN - gram negative EMB - eosin methylene blue 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 -- 7 of 12 -- 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: I. Based on a review of the nursing and laboratory's policies, patient transfusion records, and staff interview, it was revealed that the laboratory failed to have documentation of reviewing transfusion records to ensure potential transfusion reactions were identified in eight of nine patient's transfusion records reviewed between July 2022 to December 2022. Findings include: 1. A review of the nursing policy titled 'Blood/Blood Components- Transfusion: Deglycerized or Washed Red Blood Cells' revealed the following: "Observe for transfusion reactions up to one (1) hour after infusion of blood products: -Rash -Flushed feeling (hot) -Chills -Shortness of breath -Headache -Fever (>100.4) -Decreased blood pressure (>20 mm Hg Systolic and >10 mm Hg Diastolic) -Other reactions (see Blood/Blood Components - Transfusion Reaction policy) If a reaction occurs, stop the transfusion immediately!" 2. A review of the laboratory's policies revealed no policy that included the laboratory's role in investigating transfusion reactions. 3. A random review of patient transfusion records from July 2022 to December 2022 identified the following eight transfusions where the patients' vital signs met the criteria for a potential transfusion, however the transfusion was not stopped and a potential transfusion reaction was not investigated: a) Patient ID: 100480 Transfusion date: 7/1/22 Pre-transfusion blood pressure: 119/60 15 minute blood pressure: 108/42 Decrease in Diastolic blood pressure by 18 mm b) Patient ID: 126181 Transfusion date: 7/26/22 Pre-transfusion blood pressure: 136/69 1 Hour blood pressure: 117/56 Decrease in Diastolic blood pressure by 19 mm c) Patient ID: 022158 Transfusion date: 9/20/22 Pre-transfusion blood pressure: 124/82 15 minute blood pressure: 121/59 Decrease in Diastolic blood pressure by 23 mm 30 minute blood pressure: 118/61 Decrease in Diastolic blood pressure by 21 mm 1 Hour blood pressure: 107/59 Decrease in Diastolic blood pressure by 23 mm 2 Hour blood pressure: 118/66 Decrease in Diastolic blood pressure by 16 mm d) Patient ID: 119864 Transfusion date: 10/6/22 Pre-transfusion blood pressure: 144/58 30 minute blood pressure: 119/41 Decrease in Systolic blood pressure by 25 mm Decrease in Diastolic blood pressure by 17 mm 2 Hour blood pressure: 117/47 Decrease in Systolic blood pressure by 27 mm Decrease in Diastolic blood pressure by 11 mm e) Patient ID: 064101 Transfusion date: 11/20/22 (second unit) Pre-transfusion blood pressure: 141/66 15 minute blood pressure: 114/58 Decrease in Systolic blood pressure by 27 mm 30 minute blood pressure: 118/62 Decrease in Systolic blood pressure by 23 mm 1 Hour blood pressure: 114/64 Decrease in Systolic blood pressure by 27 mm f) Patient ID: 064101 Transfusion date: 11/20/22 (first unit) Pre-transfusion blood pressure: 147/71 1 Hour blood pressure: 116 /71 Decrease in Systolic blood pressure by 31 mm 2 Hour blood pressure: 101/71 Decrease in Systolic blood pressure by 46 mm g) Patient ID: 114138 Transfusion date: 12/2/22 Pre-transfusion blood pressure: 119/81 1 Hour blood pressure: 118/67 Decrease in Diastolic blood pressure by 14 mm h) Patient ID: 124292 Transfusion date: 12/13/22 Pre-transfusion blood pressure: 171/84 1 Hour blood pressure: 178/69 Decrease in Diastolic blood pressure by 15 mm 4. An interview with the technical consultant on 2/15/23 at 4:20 p.m. in the conference room, after review of the records, confirmed the above findings. II. Based on a review of the nursing and laboratory's policies, patient transfusion records, and staff interview, it was revealed that the laboratory failed to ensure blood products were released from the laboratory and transfused within fifteen minutes for two of nine pateint's transfusions reviewed from July 2022 to December 2022. Findings include: 1. A review of the nursing policy -- 8 of 12 -- titled 'Blood/Blood Components- Transfusion: Deglycerized or Washed Red Blood Cells' revealed the following: "Blood product shall be used within 15 minutes from time it was signed out of the Blood Bank." 2. A review of the laboratory's policies revealed no policy that included instructed the laboratory to ensure blood products were transfused within 15 minutes from the time it was signed out of the Blood Bank. 3. A random review of patient test records from July 2022 to December 2022 revealed the following two blood products were transfused to patients beyond the 15 minute time frame: - Patient ID: 108617 Transfusion Date: 12/13/22 Time blood product was signed out of Blood Bank: 01:25 Time blood product transfused: 01:45 Elapsed time: 20 minutes - Patient ID: 124292 Transfusion Daate: 12/13/22 Time blood product was signed out of Blood Bank: 15:19 Time blood product transfused: 16:00 Elapsed time: 41 minutes 4. An interview with the technical consultant on 2/15/23 at 4:20 p.m. in the conference room, after review of the records, confirmed the above findings. D5781

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on November 8, 2022, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and College of American Pathologists (CAP) evaluation reports, the laboratory failed to achieve satisfactory 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 -- performance in two of three consecutive testing events for Parasitology, resulting in an initial unsuccessful performance (refer to D2047). D2047 PARASITOLOGY CFR(s): 493.829(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and College of American Pathologists (CAP) evaluation reports, the laboratory failed to achieve satisfactory performance in two of three consecutive testing events for Parasitology from 2021 (event 3) and 2022 (event 2), resulting in an initial unsuccessful performance. The findings included: 1. Based on review of the CASPER Report 155 and CAP proficiency testing records for Parasitology third event of 2021 and second event of 2022, the laboratory received the following scores: a. 2021 (3rd event) Parasitology: laboratory received a score of 33% On specimen P-16, the laboratory reported Giardia duodenalis. The expected result was Dientamoeba fragilis; the performance was unacceptable. On specimen P-17, the laboratory reported Ascaris lumbricoides eggs, Trichuris trichiura eggs, and Hookworm eggs. The expected result was Blastocystis species; the performance was unacceptable. The laboratory received unacceptable values on 2 of 3 specimens. A third specimen was not graded due to lack of consensus. b. 2022 (2nd event) Parasitology: laboratory received a score of 67% On specimen P-12, the laboratory reported Chilomastix mesnili. The expected result was Giardia duodenalis; the performance was unacceptable. The laboratory received unacceptable values on 1 of 3 specimens. Two other specimens were not graded due the laboratory not testing the specimen type. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the laboratory's College of American Pathologists (CAP) proficiency testing records, the laboratory failed to attain a score of at least 80 percent of acceptable responses in 2022 (event 2) for the analytes PO2 Blood Gas and Sodium in Routine Chemistry. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory the laboratory received the following scores for 2022 (event 2): Routine Chemistry - Second Event - Analyte #0325 (PO2): 40% Routine Chemistry - Second Event - Analyte #0475 (Sodium): 40% 2. Based on review of the CAP proficiency testing performance evaluation reports: Routine Chemistry - Second Event - Analyte #0325 (PO2): 40% Sample Reported Result Expected Performance AQ-08 66 70 - 88 Unacceptable AQ-09 75 83 - 12 Unacceptable AQ-10 81 88 - 106 Unacceptable Routine Chemistry - Second Event - Analyte #0475 (Sodium): 40% Sample Reported Result Expected Performance CHM- -- 2 of 4 -- 06 166 155 - 164 Unacceptable CHM-08 154 144 - 153 Unacceptable CHM-09 171 161 - 170 Unacceptable D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and College of American Pathologists (CAP) proficiency testing records, the laboratory the laboratory failed to attain a score of at least 80 percent for one of one overall testing score in 2022 (event 2) in Hematology. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory the laboratory received a score of 75% for overall Hematology (event 2) testing event. 2. Based on review of the College of American Pathologists (CAP) records for the second event of 2022, the laboratory received a score of 75% for overall Hematology (event 2) testing event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and College of American Pathologists (CAP) evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for Parasitology for two of three events between 2021 and 2022, resulting in an initial unsuccessful performance (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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and College of American Pathologists (CAP) evaluation reports, the laboratory director failed to ensure -- 3 of 4 -- successful participation in an HHS approved proficiency testing program for Parasitology for two of three events between 2021 and 2022, resulting in an initial unsuccessful performance (refer to D2047). -- 4 of 4 --

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D6063 - 42 C.F.R. 493.1412 Condition: Testing Personnel; moderate complexity Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS- 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the