Frio Regional Hospital

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780. A finding of IMMEDIATE JEOPARDY is associated with the following deficiency: 493. 1240 Condition: Pre- Analytic In addition, the following condition level deficiencies were identified: 493. 1217 Condition: Immunohematology 493. 1250 Condition: Analytic 493. 1403 Condition: Laboratory Director; Moderate Complexity 493. 1409 Condition: Technical Consultant 493. 1487 Condition: Testing Personnel; High Complexity NOTE: THE LABORATORY ABATED THE IMMEDIATE JEOPARDY FINDINGS BY PROVIDING A LETTER DATED 10-NOV-22 WHICH STATED THE FACILITY WILL FOLLOW MANUFACTURERS' INSTRUCTIONS FOR SPECIMEN HANDLING AND TESTING REQUIREMENTS. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute's (API) proficiency testing records from 2021 and 2022, and staff interview, it was revealed the laboratory failed to have documentation of laboratory director (or designee) signature on 12 of 20 attestation statements and testing personnel on 1 of 20 attestation statements. The findings include: 1. Based on review of the laboratory's American Proficiency Institute's proficiency testing records from 2021 (Chemistry Core Events 2 and 3, Hematology/Coagulation Events 2 and 3, Microbiology Events 2 and 3, Immunology /Immunohematology Events 2 and 3) and 2022 (Chemistry Core Events 1, 2 and 3, Hematology/Coagulation Events 1 and 2, Microbiology Events 1, 2 and 3, Immunology/Immunohematology Events 1 and 2, and Miscellaneous Chemistry Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 24 -- Events 1 and 2) revealed the laboratory failed to have documentation of the laboratory director (or designee) signature on 12 of 20 attestation statements. They were: 2021 Chemistry Core Event 2 2022 Chemistry Core Event 2 2022 Chemistry Core Event 3 2021 Hematology/Coagulation Event 2 2022 Hematology/Coagulation Event 1 2022 Hematology/Coagulation Event 2 2021 Microbiology Event 2 2022 Microbiology Event 2 2022 Microbiology Event 3 2021 Immunology/Immunohematology Event 2 2022 Immunology/Immunohematology Event 2 2022 Miscellaneous Chemistry Event 2 2. Based on review of the laboratory's American Proficiency Institute's proficiency testing records from 2021 (Chemistry Core Events 2 and 3, Hematology/Coagulation Events 2 and 3, Microbiology Events 2 and 3, Immunology/Immunohematology Events 2 and 3) and 2022 (Chemistry Core Events 1, 2 and 3, Hematology /Coagulation Events 1 and 2, Microbiology Events 1, 2 and 3, Immunology /Immunohematology Events 1 and 2, and Miscellaneous Chemistry Events 1 and 2) revealed the laboratory failed to have documentation of testing personnel signature on 1 of 20 attestation statements. It was: 2022 Microbiology Event 1 C. difficile samples 3. The laboratory was asked to provide documentation of the missing signatures. No documentation was provided. 4. An interview with the laboratory manager on 11/07 /2022 at 1535 hours in the conference room - after his review of the records- confirmed the findings. D3023 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(2) The facility must establish and follow policies to ensure positive identification of a blood or blood product recipient. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of patient transfusion records from August 2022 to October 2022, and staff interview, it was revealed the laboratory failed to follow its policy for having two nurses sign the transfusion record indicating they both positively identified the patient for 2 of 60 transfusions. The findings include: 1. A review of the laboratory's policy titled "Blood Administration Policy and Procedure" (approved by the laboratory director on 01/01/2016) revealed: "7. Two licensed nurses will check blood/blood product for appropriate identification at the patient's bed side. Initial all Patient Identification & Clerical Check STEPS on the form. After verification of all information, the two nurses will sign with the date and time on Blood Transfusion Record and begin transfusion." 2. A review of the laboratory's policy titled "Blood Transfusion and Utilization Review" (approved by the laboratory director on 10/23/2018) revealed: "All units transfused are reviewed for: a. signed doctor's order b. signed consent in medical record c. pre-transfusion criteria d. Two RN signatures before transfusion e. unit started within 30 minutes f. unit transfused within 4 hours g. volume give documented h. all charts not meeting criteria are reviewed by the pathologist i. all data collected is summarized and presented to the pathologist for review monthly. 3. A review of patient transfusion records from August 2022 to October 2022 revealed the form had the following statement: "We certify that before starting the transfusion, we have verified the identification and clerical statements listed above." The form then had spaces for two signatures - Signature of RN handing blood and Signature of RN verifying blood. 4. Further review of the patient transfusion records from August 2022 to October 2022 identified 2 of 60 transfusions where the required nurse's signatures were missing: a) Order 91709 Transfusion date: 09/18/2022 RN hanging blood signature missing RN verifying blood signature missing b) Order 1096 Transfusion date: 10/22/2022 RN -- 2 of 24 -- hanging blood signature missing 5. An interview with the laboratory director on 11/10 /2022 at 1445 hours in the manager's office - after his review of the records- confirmed the findings. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of the nursing policies, review of patient transfusion records from August 2022 to November 11, 2022, and staff interview, it was revealed the laboratory failed to ensure nursing policies matched the laboratory's policies for the identification of potential transfusion reactions. The findings include: 1. A review of the laboratory's policy titled "Blood Administration Policy and Procedure" (approved by the laboratory director on 01/01/2016) revealed: "23. Observe patient for any signs of reaction i.e., urticiaria, itching , hives, chills, fever (report to lab any temperature increase over 2 degrees Fahrenheit.), back pain, change in Blood Pressure +/- 20 mm/hg from baseline, dyspenea, chest tightness, increase in heart rate, flushing, hematuria, or nausea. Observe primarily for circulatory overload, febrile reaction, allergic reaction and hemolytic reaction. If any of these symptoms are noted: a) Stop the transfusion immediately..." 2. A review of the nursing policy titled "Blood and Blood Products" revealed the policy failed to identify and define the signs of transfusion reactions and the steps to take if a potential transfusion was suspected. 3. A review of patient transfusion records from August 2022 to November 11, 2022 identified 15 of 68 transfusions where the patients' vital signs met the laboratory's criteria for a potential transfusion, however the transfusion was not stopped and a potential transfusion reaction was not investigated. They were: a) Order 6049 Transfusion date: 11/09/2022 Pre-transfusion Blood Pressure: 148/84 1 Hour Blood Pressure: 174/77 Increase: 26 mm/hg 2 Hour Blood Pressure: 180/89 Increase: 32 mm/hg b) Order 6050 Transfusion date: 11/09/2022 Pre-transfusion Blood Pressure: 147/72 30 minute Blood Pressure: 182/73 Increase: 35 mm/hg 1 Hour Blood Pressure: 174/75 Increase: 27 mm/hg 3 Hour Blood Pressure: 171/80 Increase: 24 mm/hg c) Order 2972 Transfusion date: 10/29/2022 Pre-transfusion Blood Pressure: 78/26 15 minute Blood Pressure: 132/36 Increase: 54 mm/hg 30 minute Blood Pressure: 128/34 Increase: 50 mm/hg 1 Hour Blood Pressure: 119/36 Increase: 41 mm/hg d) Order 1663 Transfusion date: 10/24/2022 Pre-transfusion Blood Pressure: 132/100 1 Hour Blood Pressure: 98/80 Decrease: 34 mm/hg 2 Hour Blood Pressure: 106/58 Decrease: 26 mm/hg 3 Hour Blood Pressure: 88/52 Decrease: 44 mm /hg e) Order 1664 Transfusion date: 10/24/2022 Pre-transfusion Blood Pressure: 154 /88 15 minute Blood Pressure: 117/82 Decrease: 37 mm/hg 30 minute Blood Pressure: 115/60 Decrease: 39 mm/hg 2 Hour Blood Pressure: 133/82 Decrease: 21 mm/hg f) Order 533 Transfusion date: 10/20/22 Pre-transfusion Blood Pressure: 91/57 15 minute Blood Pressure: 120/85 Increase: 29 mm/hg 30 minute Blood Pressure: 130/74 Increase: 39 mm/hg 1 Hour Blood Pressure: 159/99 Increase: 68 mm/hg 2 Hour Blood Pressure: 153/99 Increase: 62 mm/hg g) Order 99483 Transfusion date: 10/17/2022 Pre-transfusion Blood Pressure: 149/54 1 Hour Blood Pressure: 175/65 Increase: 26 mm/hg 2 Hour Blood Pressure: 124/68 Decrease: 25 mm/hg 3 Hour Blood Pressure: 125/72 Decrease: 24 mm/hg h) Order 96637 Transfusion date: 10/07/2022 Pre- -- 3 of 24 -- transfusion Blood Pressure: 89/58 30 minute Blood Pressure: 117/77 Increase: 28 mm /hg i) Order 91406 Transfusion date: 09/16/2022 Pre-transfusion Blood Pressure: 90 /41 15 minute Blood Pressure: 114/66 Increase: 24 mm/hg 30 minute Blood Pressure: 118/61 Increase: 28 mm/hg 1 Hour Blood Pressure: 118/63 Increase: 28 mm/hg 2 Hour Blood Pressure: 117/60 Increase: 27 mm/hg 3 Hour Blood Pressure: 117/64 Increase: 27 mm/hg j) Order 89582 Transfusion date: 09/09/22 Pre-transfusion Blood Pressure: 115/40 1 Hour Blood Pressure: 85/36 Decrease: 30 mm/hg k) Order 87262 Transfusion date: 08/30/2022 Pre-transfusion Blood Pressure: 111/53 30 minute Blood Pressure: 135/58 Increase: 24 mm/hg 1 Hour Blood Pressure: 144/55 Increase: 33 mm/hg 2 Hour Blood Pressure: 145/55 Increase: 34 mm/hg 3 Hour Blood Pressure: 144/73 Increase: 33 mm/hg l) Order 84101 Transfusion date: 08/19/2022 Pre- transfusion Blood Pressure: 109/63 15 minute Blood Pressure: 136/70 Increase: 27 mm /hg 2 Hour Blood Pressure: 156/79 Increase: 47 mm/hg 3 Hour Blood Pressure: 155 /79 Increase: 46 mm/hg m) Order 84102 Transfusion date: 08/19/2022 Pre-transfusion Blood Pressure: 149/76 3 Hour Blood Pressure: 169/83 Increase: 20 mm/hg n) Order 81139 Transfusion date: 08/09/2022 Pre-transfusion Blood Pressure: 131/53 30 minute Blood Pressure: 100/49 Decrease: 31 mm/hg 1 Hour Blood Pressure: 103/45 Decrease: 28 mm/hg 2 Hour Blood Pressure: 82/43 Increase: 49 mm/hg o) Order 80527 Transfusion date: 08/08/2022 Pre-transfusion Blood Pressure: 132/62 2 Hour Blood Pressure: 112/61 Decrease: 20 mm/hg 4. The laboratory was asked to provide documentation the potential transfusion reactions being investigated. No documentation was provided. 5. An interview with the laboratory director on 11/10 /2022 at 1445 hours in the manager's office - after his review of the records- confirmed the findings. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratory's policies, review of patient transfusion records and staff interview, it was revealed the laboratory failed to meet the requirements for the specialty of Immunohematology. The findings include: 1. The laboratory failed to have documentation of performing 2 of 8 alarm checks as required by its policy (refer to D5555). 2. The laboratory failed to have documentation of reviewing transfusion records to ensure potential transfusion reactions were identified (refer to D5559). D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) 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 review of the laboratory's American Proficiency Institute's (API) proficiency testing records from 2021 and 2022, and staff interview, it was revealed the laboratory failed to have documentation of the review of 4 of 20 proficiency results. The findings include: 1. Based on review of the laboratory's American Proficiency Institute's -- 4 of 24 -- proficiency testing records from 2021 (Chemistry Core Events 2 and 3, Hematology /Coagulation Events 2 and 3, Microbiology Events 2 and 3, Immunology /Immunohematology Events 2 and 3) and 2022 (Chemistry Core Events 1, 2 and 3, Hematology/Coagulation Events 1 and 2, Microbiology Events 1, 2 and 3, Immunology/Immunohematology Events 1 and 2, and Miscellaneous Chemistry Events 1 and 2) revealed the laboratory failed to have documentation of the review of 4 of 20 results. They were: 2022 Microbiology Event 1 2022 Microbiology Event 2 2021 Immunology/Immunohematology Event 3 2022 Immunology /Immunohematology Event 2 2. The laboratory was asked to provide documentation of the identified proficiency results being reviewed. No documentation was provided. 3. An interview with the laboratory manager on 11/07/2022 at 1535 hours in the conference room - after his review of the records- confirmed the findings. 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 American Proficiency Institute's hematology /coagulation proficiency results from 2021 and 2022, and staff interview, it was revealed the laboratory failed to have documentation of evaluating proficiency test results returned as 'not graded' by the proficiency testing agency for 1 of 4 events. The findings include: 1. A review of the laboratory's American Proficiency Institute's hematology/coagulation proficiency results from 2021 (events 2 and 3) and 2022 (events 1 and 2) revealed the laboratory failed to have documentation of evaluating results returned as 'not graded' on 1 of 4 events. It was: 2022 Event 2 Vaginal Wet Prep - Sample VA02 Blood Cell ID - Sample ECI -6 Sample ECI - 7 Sample ECI - 8 Sample ECI - 9 Sample ECI - 10 2. The laboratory was asked to provide documentation of evaluating the identified results returned as 'not graded'. No documentation was provided. 3. An interview with the laboratory manager on 11/07 /2022 at 1535 hours in the conference room - after his review of the records- confirmed the findings. 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. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the manufacturer's instructions, review of the patient test records, review of the laboratory's records, and staff interview, it was revealed the laboratory failed to monitor and correct problems in pre-analytic systems. The finding include: 1. The laboratory failed to identify patient samples for lactic acid testing exceeded the -- 5 of 24 -- manufacturer's required time from collection to testing (refer to D5311 A). 2. The laboratory failed to identify patient samples for partial thromoplastin time testing exceed the manufacturer's required time from collection to testing (refer to D5311 B). 3. The laboratory plan failed to identify patients for Total Prostate-specific Antigen testing did not meet the minimum age requirement as required by the manufacturer (refer to D5311 C). 4. The laboratory's quality assurance plan failed to monitor and correct problems (refer to D5391). 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 review of the manufacturer's instructions Alere Epoc Blood Analysis System, review of the manufacturer's instructions for the HemosIL SynthASil, review of the manufacturer's instructions for the Siemens Dimension Total Prostate Specific Antigen assay, review of patient test records from November 2021 to November 2022, and staff interview, it was revealed the laboratory failed to: A) ensure Lactic Assay testing was performed within 5 minutes of collection, B) ensure Partial Thromboplastin Time (PTT) testing was performed within 4 hours of collection, and C) ensure only samples from patients over the age of 50 were tested for TPSA. The findings include: A) Lactic Acid 1. A review of the manufacturer's instructions for the EPOC Blood Analysis System (51008148 Rev. 04) under the section titled "Sample Collection Details" revealed that for lactic acids samples collected in syringes, lithium heparin evacuated tubes, and capillary tubes, the test had to be performed within 5 minutes to avoid the effects of glycolysis. 2. A review of lactate samples tested on the EPOC Blood Analysis System from August 2022 to October 2022 identified 10 of 283 samples where the time from collection to receipt exceeded 5 minutes, and thus testing could not have occurred within the required timeframe. They were: a) Order 82358 collected: 8/13/2022 0848 hours received: 8/13/2022 0857 hours elapsed time: 9 minutes b) Order 82685 collected: 8/14/2022 1636 hours received: 8/14/2022 1647 hours elapsed time: 11 minutes c) Order 84651 collected: 8/21/2022 1050 hours received: 8/21/2022 1100 hours elapsed time: 10 minutes d) Order 88277 collected: 9 /04/2022 0912 hours received: 9/04/2022 0929 hours elapsed time: 17 minutes e) Order 92418 collected: 9/20/2022 1427 hours received: 9/20/2022 1435 hours elapsed time: 12 minutes f) Order 94623 collected: 9/29/2022 0755 hours received: 9/29/2022 0857 hours elapsed time: 62 minutes g) Order 99202 collected: 10/16/2022 0806 hours received: 10/16/2022 0813 hours elapsed time: 7 minutes h) Order 99944 collected: 10/18/2022 1810 hours received: 10/18/2022 1817 hours elapsed time: 7 minutes i) Order 1027 collected: 10/22/2022 0920 hours received: 10/22/2022 0930 hours elapsed time: 10 minutes j) Order 2958 collected: 10/29/2022 1000 hours received: 10/29/2022 1014 hours elapsed time: 14 minutes 3. An interview with the laboratory manager on 11/08/2022 at 1535 hours in the laboratory - after her review of the records- confirmed the findings. NOTE: THIS IS A REPEAT DEFICIENCY FROM THE SURVEY CONDUCTED 06/01-02/2021 B) Partial Thromboplastin Time (PTT) testing 1. A review of the manufacturer's instructions for the HemosIL -- 6 of 24 -- SynthASil reagent (revision 06/2017) under the section titled "Specimen collection and preparation" revealed: "Nine parts of freshly drawn venous blood are collected one part 3.2% trisodium citrate. Refer to CLSI (formerly NCCLS) Document H21-A5 for further instructions on specimen collection, handling and storage." 2. A review of CLSI document H21-A5 revealed: "Specimens for routine APTT assays from nonheparanized patients can be maintained uncentrifuged or centrifuged, with plasma remaining on top of cells, in an unopened tube kept at room temperature for up to four hours from time of collection." 3. A review of patient test records from July 2022 to October 2022 identified 5 of 175 samples where the time from collection to testing exceeded four hours. They were: a) Order 73890 collected: 7/15/2022 1445 hours tested: 7/15/2022 1954 hours elapsed time: 5 hours 9 minutes b) Order 74007 collected: 7/16/2022 0958 hours tested: 7/16/2022 1421 hours elapsed time: 6 hours 23 minutes c) Order 81402 collected: 8/10/2022 1110 hours tested: 8/10/2022 1604 hours elapsed time: 4 hours 54 minutes d) Order 88004 collected: 9/02/2022 1348 tested: 9/02/2022 1900 elapsed time: 5 hours 12 minutes e) Order 1869 collected: 10 /25/2022 1330 hours tested: 10/25/2022 2016 hours elapsed time: 6 hours 46 hours 4. An interview with the laboratory manager on 10/09/2022 at 1545 hours in the laboratory - after his review of the records- confirmed the findings. C) Total Prostate- specific Antigen 1. A review of the manufacturer's instructions for the Siemens Dimension TPSA (total prostate-specific antigen) reagent cartridge (issue date 2019- 07-29) under the section titled "Intended Use" revealed: "The TPSA method for the Dimension clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure total prostate specific antigen (PSA) in human serum and plasma: as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older..." 2. A review of patient test records from November 2021 to November 2022 (as of the day of the survey) identified 5 of 98 patients who were under the age of 50 and whose samples were tested utilizing the Dimension TPSA test. They were: a) medical number: 337502 tested: 04/15/2022 age: 41 years b) medical number: 337541 tested: 04/16/2022 age: 44 years c) medical number: 341042 tested: 06/15/2022 age: 43 years d) medical number: tested: age: e) medical number: tested: age: 3. An interview with laboratory manager on 11/08/2022 at 1630 hours in his office - after his review of the records - confirmed the findings. NOTE: THIS IS A REPEAT DEFICIENCY FROM THE SURVEY CONDUCTED 06/02/2021. 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 the manufacturer's instructions, review of the patient test records, review of the laboratory's records, and staff interview, it was revealed the laboratory's quality assurance plan failed to monitor and correct problems in pre-analytic systems. The finding include: 1. The laboratory's quality assurance plan failed to identify patient samples for lactic acid testing exceeded the manufacturer's required time from collection to testing (refer to D5311 A). 2. The laboratory's quality assurance plan failed to identify patient samples for partial thromoplastin time testing exceed the manufacturer's required time from collection to testing (refer to D5311 B). 3. The laboratory's quality assurance plan failed to identify patients for Total Prostate- -- 7 of 24 -- specific Antigen testing did not meet the minimum age requirement as required by the manufacturer (refer to D5311 C). D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the manufacturer's instructions, review of the patient test records, review of the laboratory's records, and staff interview, it was revealed the laboratory failed to monitor and correct problems in analytic systems. The finding include: 1. The laboratory failed to ensure its procedure the patient normal range was followed (refer to D5401). 2. The laboratory failed to ensure verification studies were performed (refer to D5421). 3. The laboratory failed to ensure calibration verifications were performed (refer to D5439). 4. The laboratory failed to ensure quality control values were monitored over time (refer to D5441). 5. The laboratory failed to ensure quality control testing was performed each day of patient testing (refer to D5447). 6. The laboratory failed to ensure its Individualized Quality Control Plan was followed (refer to D5449). 7. The laboratory failed to ensure blood bank alarm checks were performed when required (refer to D5555). 8. The laboratory failed to ensure the review of transfusion records to detect potential transfusion reactions (D5559). 9. The laboratory's failed to ensure its quality assurance plan identified and corrected problems in analytic systems (refer to D5791). 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 determining patient normal ranges, review of the laboratory's determination of patient normal means for Prothrombin Time testing done in September 2022, and staff interview, it was revealed the failed to ensure required information was gathered on 20 of 20 study participants. The findings include: 1. A review of the laboratory's Patient Normal Range worksheet revealed the following information was to be collected to ensure patients met the laboratory's criteria to be part of the study: "1. Donors should be generally healthy 2. Donors should not be on any oral anticoagulants (blood thinners) and high dosage of aspirin 3. Donors should not be on hormone replacement or birth control meds and/or estrogen therapy 4. Donors should span the adult range." 2. A review of the laboratory's Patient Normal Range worksheet from September 2022 revealed the laboratory failed to have documentation of the following: a) Donor age for 20 of 20 participants b) Donor -- 8 of 24 -- health for 2 of 20 participants donor 10 and donor 11 c) Donor anticoagulants or high dose aspirin for 2 of 20 participants donor 10 and donor 11 d) Donor hormone/birth control/estrogen for 2 of 20 participants donor 10 and donor 11 3. The laboratory was asked to provide documentation of collecting the required information. No documentation was provided. 4. An interview with the laboratory manager on 11/10 /2022 at 820 hours in his office - after his 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: I. Based on review of the laboratory's instrumentation, review of patient test records, and staff interview, it was revealed the laboratory failed to have documentation of performing verification studies on of 3 Alere Epoc Blood Gas analyzers. The findings include: 1. A review of the laboratory's instrumentation on 11/09/2022 at 1345 hours in the laboratory revealed the laboratory had 3 Alere Epoc Blood Gas analyzers in use for patient testing. They were: Epoc #1: serial number 16184521402331 Epoc #2: serial number 14051521402188 Epoc #3: serial number 17279521400783 2. A review of the laboratory's patient test records from April 2022, May 2022 and June 2022 revealed Epoc #2 was placed into service in June 2022 and Epoc #3 was in use from April 27, 2022 to June 15, 2022. The analytes tested were: pH pCO2 pO2 lactic acid 3. The laboratory was asked to provide documentation of performing the required verification studies (accuracy, precision, reportable range) prior to placing Epoc #2 and Epoc #3 into service. No documentation was provided. 4. A review of patient test records from July 2022 to October 2022 revealed the laboratory performed 68 tests on Epoc #2 (see patient alias list #1). 5. A review of patient test records from April 27, 2022 to June 15, 2022 revealed the laboratory performed 60 tests on Epoc #3 (see patient alias list #2). 6. An interview with the laboratory manager on 11/09/2022 at 1415 hours in the laboratory revealed he wasn't sure if verification studies had been performed on Epoc #2. He stated he had no idea Epoc #3 was ever used in the laboratory. This confirmed the findings. II. Based on review of the laboratory's instrumentation, review of the laboratory's verification studies, review of an email from a Siemen's field installation representative, review of patient test records and staff interview, it was revealed the laboratory failed to have documentation of performing verification studies for Dimension LOCI Vitamin B12 assay on the Siemens Dimension EXL-LM analyzer (serial number DR252069). The findings include: 1. A review of the laboratory's instrumentation revealed the laboratory placed a new Siemens Dimension EXL-LM (serial number DR252069) into use in May 2022. 2. A review of the laboratory's verification records revealed the laboratory failed to have documentation of verification studies for 1 of 26 analytes. It was: Vitamin B12 3. A review of an email from Siemens' technical support dated May 12, 2022 revealed: "I have attached the installation data for DR252069. Vitamin B12 is having errors hydrating. I am in contact with our technical team to figure out why -- 9 of 24 -- specifically VB12 and no other assay causes Reagent Prep Errors. I took ou the VB12 data until this can be resolved... The instrument is ready for you to use (other than VB12)." 4. The laboratory was asked to provide documentation of performing verification studies (accuracy, precision, reportable range) for the Dimension LOCI Vitamin B12 assay. No documentation was provided. 5. A review of patient test records from May 2022 revealed the laboratory performed Vitamin B12 testing on 45 patients from July 14, 2022 to November 8, 2022 (see patient alias list #3). 6. An interview with the laboratory manager on 11/10/2022 at 1015 hours in the prayer room revealed studies had not been completed for Vitamin B12. This confirmed the findings. NOTE: THIS IS A REPEAT DEFICIENCY FROM THE SURVEYS CONDUCTED 01/15/2019 AND 06/01-02/2021 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 the laboratory's calibration verification records from 2020 to 2022, and staff interview, it was revealed the laboratory failed to have documentation of performing required calibration verifications every six months for the analytes Sodium, Potassium, Chloride and A1C on each of its two Dimension chemistry analyzers. The findings include: 1. A review of the laboratory's calibration verification records from 2020 to 2022 revealed the laboratory failed to perform calibration verification for Sodium, Potassium, Chloride, and A1C at the following time: a) Dimension EXL-LM (serial number: 12251139) June 2021 b) Dimension EXL-200 (serial number: DR271890) June 2021 2. A review of the laboratory's records for the listed assays revealed the laboratory utilized 2 or fewer calibrators and performed quality control testing using 2 levels of quality control material, thus calibration verification was required. 3. The laboratory was asked to provide documentation of performing the required calibration verification in June 2021. No documentation was provided. 4. An interview with the laboratory manager on 11/09/2022 at 1400 hours in the office revealed he was unsure if calibration verification was performed two times in 2021. This confirmed the findings. -- 10 of 24 -- D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control records from July 2021 to October 2022, and staff interview, it was revealed the laboratory failed to have documentation of monitoring quality control values over time for testing performed on the Epoc Blood Analysis System analyzers. The findings include: 1. A review of the laboratory's quality control records from July 2021 to October 2022 for blood gas and lactic acid testing performed on the laboratory's three Epoc Blood Analysis System analyzer revealed the laboratory failed to have documentation of monitoring quality control results over time to ensure accuracy and precision. The following analytes were tested on the Epoc systems: pH pCO2 pO2 lactic acid 2. The laboratory was asked to provide documentation of monitoring quality control values over time. No documentation was provided. 3. An interview with the laboratory manager on 11/09 /2022 at 1500 hours in the laboratory revealed the laboratory did to monitor quality control values over time. This confirmed the findings. 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 the laboratory's instrumentation, review of the laboratory's quality control records, review of patient test records and staff interview, it was revealed the laboratory failed to have documentation of performing quality control testing each day of patient testing for the Alere Blood Gas System analyzer identified as Epoc #2 and Epoc #3. The findings include: 1. A review of the laboratory's instrumentation on 11 /09/2022 at 1345 hours in the laboratory revealed the laboratory had 3 Alere Epoc Blood Gas analyzers in use for patient testing. They were: Epoc #1: serial number 16184521402331 Epoc #2: serial number 14051521402188 Epoc #3: serial number 17279521400783 2. A review of the laboratory's records from May 2022 and June 2022 revealed Epoc #2 was placed into service in June 2022 and Epoc #3 was used for patient testing from April 27, 2022 to May 15, 2022. The analytes tested were: pH pCO2 pO2 lactic acid 3. Further review of the laboratory's records revealed the -- 11 of 24 -- laboratory had documentation of performing an Individualized Quality Control Plan (IQCP) for Epoc #1. The laboratory was asked to provide documentation of developing an Individualized Quality Control Plan for Epoc #2 and Epoc #3 to support the modification of the frequency of quality control testing. No documentation was provided. 4. A review of the quality control records from May 2022 to October 2022 revealed quality control testing was performed on the following days: a) Epoc #2 July 4, 2022 July 13, 2022 July 15, 2022 July 22, 2022 July 27, 2022 August 4, 2022 August 10, 2022 August 18, 2022 August 26, 2022 September 07, 2022 September 12, 2022 September 23, 2022 October 3, 2022 October 14, 2022 October 21, 2022 October 27, 2022 b) Epoc #3 May 13, 2022 May 19, 2022 4. A review of patient test records from May 2022 to October 2022 identified the following patient samples tested on days without documentation of quality control testing being performed: a) Epoc #2 July 17, 2022 Patient ID: 74223 July 18, 2022 Patient ID: 342875 (1st test) Patient ID: 342875 (2nd test) Patient ID: 342875 (3rd test) July 26, 2022 Patient ID: 343406 July 30, 2022 Patient ID: 77706 August 6, 2022 Patient ID: 344099 August 9, 2022 Patient ID: 34428 August 15, 2022 Patient ID: 344515 August 27, 2022 Patient ID: 345371 Patient ID: 345320 Patient ID: 344942 August 28, 2022 Patient ID: 345364 Patient ID: 344942 September 20, 2022 Patient ID: 346766 September 22, 2022 Patient ID: 346973 September 29, 2022 Patient ID: 347334 (1st test) Patient ID: 347334 (2nd test) Patient ID: 347334 (3rd test) Patient ID: 347334 (4th test) Patient ID: 347334 (5th test) Patient ID: 347334 (6th test) Patient ID: 347334 (7th test) September 30, 2022 Patient ID: 95112 Patient ID: 347460 Patient ID: 94802 Patient ID: 347504 Patient ID: 95123 October 1, 2022 Patient ID: 347504 (1st test) Patient ID: 347504 (2nd test) Patient ID: 347499 Patient ID: 95367 Patient ID: 347504 (3rd test) Patient ID: 95254 October 2, 2022 Patient ID: 95340 October 13, 2022 Patient ID: 348380 October 15, 2022 Patient ID: 348530 October 16, 2022 Patient ID: 348530 Patient ID: 348537 (1st test) Patient ID: 348537 (2nd test) October 18, 2022 Patient ID: 348687 Patient ID: 348699 October 24, 2022 Patient ID: 349075 October 26, 2022 Patient ID: 349264 (1st test) Patient ID: 349235 Patient ID: 349259 Patient ID: 349265 Patient ID: 349264 (2nd test) Patient ID: 349264 (3rd test) Patient ID: 349276 October 29, 2022 Patient ID: 349420 (1st test) Patient ID: 349420 (2nd test) Patient ID: 349416 Patient ID: 349420 (3rd test) October 30, 2022 Patient ID: 349420 Patient ID: 349502 b) Epoc #3 May 1, 2022 Patient ID: 338369 Patient ID: 338382 Patient ID: 338385 Patient ID: 338394 May 2, 2022 Patient ID: 338481 5. An interview with the laboratory manager on 11/09/2022 at 1430 hours in the laboratory revealed an Individualized Quality Control Plan had not been developed for Epoc #2 or Epoc #3. The laboratory followed the IQCP developed for Epoc #1. This confirmed the findings. 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 review of the laboratory's Individualized Quality Control Plan (IQCP) for the BioFire Torch Respiratory 2.1 assay, review of the laboratory's quality control records from June 2022 to August 2022, review of patient test records, and staff -- 12 of 24 -- interview, it was revealed the laboratory failed to have documentation of performing quality control testing when defined by its IQCP. The findings include: 1. A review of the laboratory's Individualized Quality Control Plan for the BioFire Torch Respiratory 2.1 assay revealed the laboratory's modified frequency of quality control testing was defined as: with each new lot with each shipment, and at least every 30 days. 2. A review of the laboratory's quality control records from June 2022 to August 2022 revealed the laboratory performed quality control testing on the following days: June 3, 2022 June 28, 2022 (25 days later) August 13, 2022 (38 days later) 3. A review of patient test records from July 29, 2022 to August 12, 2022 identified the following 8 patients tested on days when the time since the previous quality control testing exceeded the 30 day period as determined by the laboratory's IQCP: a) July 29, 2022 Sample ID: 77506 b) July 30, 2022 Sample ID: 77685 Sample ID: 77823 c) August 6, 2022 Sample ID: 344107 d) August 7, 2022 Sample ID: 80304 e) August 11, 2022 Sample ID: 81823 Sample ID: 81821 Sample ID: 81883 4. An interview with the laboratory manager on 10/08/2022 at 1140 hours in the laboratory - after his review of the records- confirmed the findings. 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: Based on review of the laboratory's policies, review of the laboratory's alarm checks from 2021 and 2022, and staff interview, it was revealed the laboratory failed to have documentation of performing 2 of 8 alarm checks as required by its policy. The findings include: 1. A review of the laboratory's policy titled "Blood Bank Temperature Alarm Check" revealed alarm checks were to performed every quarter (3 months). 2. A review of the laboratory's alarm check records from 2021 and 2022 revealed the laboratory failed to have documentation of performing the alarm checks for the 3rd quarter of 2021 and 3rd quarter of 2022. 3. The laboratory was asked to provide documentation of performing the required alarm checks. No documentation was provided. 4. An interview with the laboratory manager on 10/10/2022 at 1530 hours in the laboratory - after his review of the records- confirmed the findings. 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 reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures -- 13 of 24 -- performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of the nursing policies, review of patient transfusion records from August 2022 to November 11, 2022, and staff interview, it was revealed the laboratory failed to have documentation of reviewing transfusion records to ensure potential transfusion reactions were identified. The findings include: 1. A review of the laboratory's policy titled "Blood Administration Policy and Procedure" (approved by the laboratory director on 01/01/2016) revealed: "23. Observe patient for any signs of reaction i.e., urticiaria, itching , hives, chills, fever (report to lab any temperature increase over 2 degrees Fahrenheit.), back pain, change in Blood Pressure +/- 20 mm/hg from baseline, dyspenea, chest tightness, increase in heart rate, flushing, hematuria, or nausea. Observe primarily for circulatory overload, febrile reaction, allergic reaction and hemolytic reaction. If any of these symptoms are noted: a) Stop the transfusion immediately..." 2. A review of patient transfusion records from August 2022 to November 11, 2022 identified 15 of 68 transfusions where the patients' vital signs met the laboratory's criteria for a potential transfusion, however the transfusion was not stopped and a potential transfusion reaction was not investigated. They were: a) Order 6049 Transfusion date: 11/09/2022 Pre-transfusion Blood Pressure: 148/84 1 Hour Blood Pressure: 174/77 Increase: 26 mm/hg 2 Hour Blood Pressure: 180/89 Increase: 32 mm/hg b) Order 6050 Transfusion date: 11/09/2022 Pre-transfusion Blood Pressure: 147/72 30 minute Blood Pressure: 182/73 Increase: 35 mm/hg 1 Hour Blood Pressure: 174/75 Increase: 27 mm/hg 3 Hour Blood Pressure: 171/80 Increase: 24 mm/hg c) Order 2972 Transfusion date: 10/29/2022 Pre-transfusion Blood Pressure: 78/26 15 minute Blood Pressure: 132/36 Increase: 54 mm/hg 30 minute Blood Pressure: 128/34 Increase: 50 mm/hg 1 Hour Blood Pressure: 119/36 Increase: 41 mm/hg d) Order 1663 Transfusion date: 10/24/2022 Pre-transfusion Blood Pressure: 132/100 1 Hour Blood Pressure: 98 /80 Decrease: 34 mm/hg 2 Hour Blood Pressure: 106/58 Decrease: 26 mm/hg 3 Hour Blood Pressure: 88/52 Decrease: 44 mm/hg e) Order 1664 Transfusion date: 10/24 /2022 Pre-transfusion Blood Pressure: 154/88 15 minute Blood Pressure: 117/82 Decrease: 37 mm/hg 30 minute Blood Pressure: 115/60 Decrease: 39 mm/hg 2 Hour Blood Pressure: 133/82 Decrease: 21 mm/hg f) Order 533 Transfusion date: 10/20/22 Pre-transfusion Blood Pressure: 91/57 15 minute Blood Pressure: 120/85 Increase: 29 mm/hg 30 minute Blood Pressure: 130/74 Increase: 39 mm/hg 1 Hour Blood Pressure: 159/99 Increase: 68 mm/hg 2 Hour Blood Pressure: 153/99 Increase: 62 mm/hg g) Order 99483 Transfusion date: 10/17/2022 Pre-transfusion Blood Pressure: 149/54 1 Hour Blood Pressure: 175/65 Increase: 26 mm/hg 2 Hour Blood Pressure: 124/68 Decrease: 25 mm/hg 3 Hour Blood Pressure: 125/72 Decrease: 24 mm/hg h) Order 96637 Transfusion date: 10/07/2022 Pre-transfusion Blood Pressure: 89/58 30 minute Blood Pressure: 117/77 Increase: 28 mm/hg i) Order 91406 Transfusion date: 09/16 /2022 Pre-transfusion Blood Pressure: 90/41 15 minute Blood Pressure: 114/66 Increase: 24 mm/hg 30 minute Blood Pressure: 118/61 Increase: 28 mm/hg 1 Hour Blood Pressure: 118/63 Increase: 28 mm/hg 2 Hour Blood Pressure: 117/60 Increase: 27 mm/hg 3 Hour Blood Pressure: 117/64 Increase: 27 mm/hg j) Order 89582 Transfusion date: 09/09/22 Pre-transfusion Blood Pressure: 115/40 1 Hour Blood Pressure: 85/36 Decrease: 30 mm/hg k) Order 87262 Transfusion date: 08/30/2022 Pre-transfusion Blood Pressure: 111/53 30 minute Blood Pressure: 135/58 Increase: 24 mm/hg 1 Hour Blood Pressure: 144/55 Increase: 33 mm/hg 2 Hour Blood Pressure: 145/55 Increase: 34 mm/hg 3 Hour Blood Pressure: 144/73 Increase: 33 mm/hg l) Order 84101 Transfusion date: 08/19/2022 Pre-transfusion Blood Pressure: 109/63 15 minute Blood Pressure: 136/70 Increase: 27 mm/hg 2 Hour Blood Pressure: 156/79 -- 14 of 24 -- Increase: 47 mm/hg 3 Hour Blood Pressure: 155/79 Increase: 46 mm/hg m) Order 84102 Transfusion date: 08/19/2022 Pre-transfusion Blood Pressure: 149/76 3 Hour Blood Pressure: 169/83 Increase: 20 mm/hg n) Order 81139 Transfusion date: 08/09 /2022 Pre-transfusion Blood Pressure: 131/53 30 minute Blood Pressure: 100/49 Decrea

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES resulting in a finding of IMMEDIATE JEOPARDY: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic Systems D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director; moderate complexity The laboratory abated the immediate jeopardy findings with a letter dated June 2, 2021 stating the facility would follow all manufacturer's instructions for specimen collection and stability. 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 D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of manufacturer's instructions, review of patient results, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions to resolve flags on patient results prior to their release to the healthcare provider. The findings were: 1. Review of laboratory policy, "Laboratory Procedure Blood Smear Preparation and Manual Differential" approved by the laboratory director on September 22, 2016 under, "Testing Procedure" it stated, "1. Flags are present on the automated differential report. For the primary hematology analyzer, the Abbott Ruby, flags are addressed in Section 3 of the Operator's Manual, 30-27 through 3-40. Please refer to the Ruby Operator's Manual for detailed descriptions for the differential flags, and 2. Smear review is indicated by an automated note on the instrument report." 2. Review of the manufacturer's instructions for the Abbott Cell-Dyn Ruby (9140547C, December 2008) under "Principles of Operation" it stated, "RBC MORPH: 1. Review a stained smear for abnormal RBC or PLT morphology and follow your laboratory's review criteria. 2. If NRBC or RRBCs are suspected to be present, run the specimen in the CBC+RBC test section." 3. Random review of patient results from January 2019 revealed the following patient results that were flagged with "RBC MORPH" and no stained smear was reviewed as required by the manufacturer: Specimen # 41231 Date: January 1, 2019 Flag: RBC MORPH Specimen # 41234 Date: January 1, 2019 Flag: RBC MORPH Specimen # 41581 Date: January 2, 2019 Flag: RBC MORPH Specimen # 41612 Date: January 2, 2019 Flag: RBC MORPH Specimen # 41621 Date: January 2, 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 -- 2019 Flag: RBC MORPH Specimen # 41624 Date: January 2, 2019 Flag: RBC MORPH 4. An interview with testing personnel one (as listed on Form CMS-209) on January 14, 2019 at 16:30 hours in the laboratory confirmed the findings. He confirmed the laboratory did not review stained smears for the CBC flag "RBC MORPH." Key: NRBC - nucleated red blood cell PLT - platelet CMS - Centers for Medicare and Medicaid Services 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 surveyor observations, review of manufacturer's instructions, and confirmed in interview of facility personnel, the laboratory failed to monitor the temperature of the environment where supplies were located. The findings were: 1. Surveyor observation made on January 15, 2019 of stored supplies located in the Emergency Department revealed the following: a. BD Sodium citrate tubes (Lot B180734): quantity of 99 b. Vaccuette Serum tubes (Lot 8183825): quantity of 100 c. Vaccuette EDTA tubes (Lot 1807E6): quantity of 95 d. Vaccuette Lithium Heparin tubes (Lot B1809385): quantity of 92 e. Copan Specimen Transport System for Aerobes and Anaerobes (Lot 180349400): quantity of 7 2. Review of manufacturer's instructions for BD tubes located on package labeling for vacutainer tubes stated the storage requirement was, "4-25 degrees Celsius." 3. Review of the manufacturer's instructions for Vacccuette tubes located on the package labeling for vacutainer tubes stated the storage requirement was, "4-25 degrees Celsius." 4. Review of manufacturer's instructions for Copan swabs located on package labeling stated the storage requirement was, "5-25 degrees Celsius." 5. Interview with the Director of Emergency Department and Trauma Services on January 15, 2019 at 15:05 hours confirmed the findings. She confirmed that the temperature of the environment where the supplies are located is not documented. Key: EDTA - ethylenediamenetetraacetic acid BD - Becton Dickinson D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation and confirmed in interview of facility personnel, the laboratory failed to label reagents stored in the laboratory. The findings were: 1. -- 2 of 4 -- Surveyor observation on January 14, 2019 at 17:30 hours in the laboratory refrigerator revealed a yellow liquid in a vial with a blue cap. The vial was not labeled with any information. 2. An interview with testing personnel two (as listed on Form CMS-209) on January 14, 2019 at 17:30 hours confirmed the findings. He revealed the vial was filled with analyzer cleaner used for the hematology instrument. He agreed the vial was not labeled. Key: CMS - Centers for Medicare and Medicaid Services 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 manufacturer's instructions, review of validation records, and confirmed in interview of facility, the laboratory failed to perform verification studies on pediatric patients on the ACL Elite coagulation analyzer. The findings were: 1. Review of the manufacturer's instructions for the ACL Elite coagulation analyzer (Rev B, April 2014) under, "Specimen Collection and Preparation" it stated, "Donors should span the adult range. Pediatric ranges should be established separately." 2. Review of verification records revealed the laboratory did not perform a patient normal range study for pediatric ranges. 3. Random review of patient results from September 2018 to December 2018 revealed a PT w/INR and PTT was performed and resulted on the following pediatric patient: Order # 32576 Date: 11-26-2018 Result: PT w/INR = 12.3 seconds, INR = 1.0 Order # 32577 Date: 11-26-2018 Result: PTT = 33.4 4. Interview of the technical consultant in the laboratory on January 15, 2019 at 09:00 hours confirmed the findings. Key: PT - prothrombin time INR - International Normalized Ratio PTT - partial thrombin time 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 review of laboratory policy, review of manufacturer's instructions, review of quality control records, review of patient results, and confirmed in interview of facility personnel, the laboratory failed to perform a positive and negative control each day of testing for Clostridium Difficile Toxin (CDT). The findings were: 1. Based on review of laboratory policy, "CDIFF Immunocard Toxins A & B" under, "External QC" stated, "External QC Frequency: The external controls should be run: with every kit opened, for each day of patient testing, when training new personnel on -- 3 of 4 -- test kit use." 2. Review of the manufacturer's instructions for Imunocard Toxins A & B (Ref. 712050) under, "Quality Control" it stated, "This test should be performed per applicable local, state, or federal regulations or accrediting agencies." 3. Review of patient results from November and December 2018 revealed the following patients were performed on days that quality control was not performed: Order # 299006 Date: November 8, 2018 Result: Negative Order # 33298 Date: November 29, 2018 Result: Negative Order # 33392 Date: November 29, 2018 Result: Negative Order # 33568 Date: November 30, 2019 Result: Negative Order # 34127 Date: December 2, 2018 Result: Negative 4. An interview with the technical consultant on January 14, 2019 at 15:30 hours in the office confirmed the findings. -- 4 of 4 --