Desoto Regional Health System

Summary Statement of Deficiencies D0000 A Recertification Survey was performed May 17, 2021 through May 19, 2021 at DeSoto Regional Health System, CLIA ID # 19D0463228. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 record review and interview with personnel, the laboratory failed to ensure the Laboratory Director signed the attestation statement for two (2) of seven (7) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's American Proficiency Institute (API) Proficiency Testing (PT) records for 2019, 2020, and 2021 revealed the Laboratory Director did not sign the attestation statements for the following two (2) of seven (7) events reviewed: a) 2021 Immunology /Immunohematology 1st event b) 2021 Hematology/Coagulation 1st event 2. In interview on May 17, 2021 at 15:33 pm, Personnel 2 confirmed the Laboratory Director did not sign the attestation statements for the above events. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency 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 -- testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with personnel, the laboratory failed to ensure the Laboratory Director signed the performance evaluation form for one (1) of seven (7) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's American Proficiency Institute (API) PT records for 2019, 2020, and 2021 revealed the Laboratory Director did not sign the performance evaluation form for the following one (1) event: a) 2021 Hematology/Coagulation 1st event 2. In interview on May 17, 2021 at 15:33 pm, Personnel 2 confirmed the Laboratory Director did not sign the above identified PT event. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure that Blood Bank reagents were not used beyond their expiration dates. Findings: 1. Review of the laboratory's "Reagent Quality Control" policy revealed under "Complete the Reagent Identification section of the QC form" that "each day of testing, check all reagents to make sure none are outdated. If the reagent will expire during this shift, put a new lot into use at the time QC is performed and add new date /lot information to the right column". 2. Review of the laboratory's Blood Bank Reagent Quality Control Record from January 1, 2019 through May 17, 2021 revealed the laboratory documented the use of expired reagents for the following dates: a) On June 14, 2020 at 8:00 am, the laboratory documented the use of Thermofisher Blood Bank (BB) Saline (Lot 545477) with the expiration date of June 13, 2020 b) From March 13, 2021 at 8:00 am through March 14, 2021 at 8:00 am, the laboratory documented the use of Immucor Anti-A (Lot 104028-1) with the expiration date of March 12, 2021 3. In interview on May 18, 2021 at 1452 pm, Personnel 2 confirmed the laboratory documented the use of expired BB Saline and Anti-A for the dates cited above. D5785

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at DESOTO REGIONAL HEALTH SYSTEM - CLIA # 19D0463228 on July 16, 2018 through July 19, 2018. DESOTO REGIONAL HEALTH SYSTEM was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1240 CONDITION: Preanalytic Systems 42 CFR 493.1250 CONDITION: Analytic Systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing, Laboratory Director. 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing, Laboratory Director. 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing, Technical Consultant. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it documents all complaints and problems reported to the laboratory. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure for addressing complaints and problems reported to the laboratory. The policy should include a detailed procedure on how to address, document and handle complaints or problems reported to the laboratory. 2. Interview with personnel 4 on July 16, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. D5207 COMMUNICATIONS CFR(s): 493.1234 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 31 -- The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it identifies and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 2. Interview with personnel 4 on July 16, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. 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 observation, record review and interview with personnel, the laboratory system failed to monitor, assess, and correct problems identified with the preanalytic system. Findings: 1. The laboratory failed to maintain test requisitions that included the specimen collection date and time as required for four (4) of thirteen (13) patient requisitions reviewed. Refer to D5305. 2. The laboratory failed to ensure patient samples for Potassium (K), Phosphorous (Phos), and Glucose (Glu) are spun and separated within one (1) hour according to the manufacturer for ensuring the integrity of patient samples for accurate and reliable testing for forty two (42) of one hundred seventeen (117) patients reviewed. Refer to D5311 I. 3. The laboratory failed to ensure patient samples for Calcium (CA), are separated from the red cell promptly according to the manufacturer and Laboratory Policy for ensuring the integrity of patient samples for accurate and reliable testing for forty one (41) of one hundred seventeen (117) patients reviewed. Refer to D5311 II. 4. The laboratory failed to establish detailed written instructions for the facilities the laboratory provides services for to maintain the integrity of samples and ensure accurate and reliable testing. Refer to D5317. 5. The laboratory's system failed to monitor, assess, and correct problems identified with the preanalytic system. Refer to D5393. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the -- 2 of 31 -- name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory failed to maintain test requisitions that included the specimen collection date and time as required for four (4) of thirteen (13) patient requisitions reviewed. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory did not establish a written detailed test requisition policy and procedure that addresses the following required information:: a) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. b) The patient's name or unique patient identifier. c) The sex and age or date of birth of the patient. d) The test(s) to be performed. e) The source of the specimen, when appropriate. f) The date and, if appropriate, time of specimen collection. g) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. h) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. 2. Review of a random selection of Patient Test Requisitions from May 3, 2018 through July 13, 2018 revealed the laboratory failed to obtain a written request with the specimen collection date and time as required for the following four (4) patients: NOTE: Complete Metabolic Panel (BMP) includes: Sodium (NA), Potassium (K), Chloride (CL), Carbon Dioxide (CO2), Glucose (Glu), Blood Urea Nitrogen (BUN), Creatinine (Creat), Total Protein (TP), Albumin (Alb), Calcium (CA), Total Bilirubin (TBil), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST). Basic Metabolic Panel (BMP) includes: NA, K, CL, CO2, Glu, BUN, and CA. Lipid Panel (Lipid) includes: Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Low Density Lipoprotein Cholesterol (LDL) and Triglycerides (Trig). Complete Blood Cell count (CBC) which includes: White Blood Cell count (WBC), Red Blood Cell count (RBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt) and an Automated Differential. On July 13, 2018 the laboratory received Patient 39 for a BMP with no specimen collection date/time. On July 9, 2018 the laboratory received Patient 40 for a CMP, Lipid, Prostate Specific Antigen (PSA) and CBC with no specimen collection date/time. On July 9, 2018 the laboratory received Patient 41 for a CMP and Lipid with no specimen collection date/time. On July 2, 2018 the laboratory received Patient 44 for a CMP, Lipid and Thyroid Stimulating Hormone (TSH) with no specimen collection date/time. 2. Interview with Personnel 4 on July 15, 2018 confirmed the laboratory failed to ensure test requisitions contained all the required information for the four (4) patients cited above. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL -- 3 of 31 -- 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: I. Based on observation, record review and interview with personnel, the laboratory failed to ensure patient samples for Potassium (K), Phosphorous (Phos), and Glucose (Glu) are spun and separated within one (1) hour according to the manufacturer for ensuring the integrity of patient samples for accurate and reliable testing for forty two (42) of one hundred seventeen (117) patients reviewed. Findings: 1. Observation by surveyor on July 16, 2018 revealed the laboratory maintained a Siemens Dimension EXL for : Albumin (Alb), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Ammonia (Ammon), Total Bilirubin (TBil), Calcium (CA), Chloride (CL), Carbon Dioxide (CO2), Creatinine (Creat), Glucose (Glu), Potassium (K), Sodium (NA), Total Protein (TP), Blood Urea Nitrogen (BUN), Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Low Density Lipoprotein Cholesterol (LDL), Triglyceride (Trig), Creatine Phosphokinase (CPK), Creatine Kinase MB (CKMB), Hemoglobin A1C) (HgbA1C), Troponin (Trop), Direct Bilirubin (DBil), Free Thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Amylase (Amy), Lipase (Lip), Magnesium (Mg), Phosphorous (Phos), Prostate Specific Antigen (PSA), Pro- Brain Natriuretic Peptide (Pro-BNP), Iron (Fe), Total Iron Binding Capacity (TIBC), Ferritin (Fer), Folate (Fol), Vitamin B12 (B12), Alcohol (ETOH), Acetaminophen (Acet), Digoxin (Dig), Phenytoin (Dil), Gentamycin (Gent),Vancomycin (Vanco) and Uric Acid (Uric). Further observation by the surveyor on July 16, 2018 noted the laboratory receiving patient samples for laboratory testing from out side facilities. 2. Review of the Laboratory's Instructions given to outside facilities that the laboratory provides services to revealed "all specimens must be brought to the laboratory immediately after collection." 3. Review of the Siemens Dimension package inserts revealed for: a) For Potassium (K) the package insert states under "Specimen Collection and Handling" that "Specimen tubes should be centrifuged unopened and the serum or plasma should be separated within one hour after venipuncture, as prolonged contact with red cells will cause elevated K results." b) For Glucose (Glu) the package insert states under "Specimen Collection and Handling" that "Glycolysis decreased serum glucose by approximately 5% to 7% per hour in normal uncentrifuged coagulated blood at room temperature. In separated, nonhemolyzed sterile serum, the glucose concentration is generally stable for as long as 8 hours at 25 degrees Celsius and up to 72 hours at 4 degrees Celsius; variability stability is observed with longer storage conditions. Glycolysis can be inhibited and glucose stabilized for as long as 3 days at room temperature by addition of sodium iodoacetate or sodium fluoride (NaF) to the specimen." c) For Phosphorous (Phos) the package insert states under "Specimen Collection and Handling" that the "Serum or plasma should be separated from the red cells within 1 hour because erythrocytes contain phosphate concentrations several times greater than those found in the serum." 4. Review of a random selection of Patient Test Records from May 3, 2018 through July 13, 2018 revealed the laboratory failed to reject the following forty two (42) patients for not meeting manufacturer's requirements for K, Phos, and Glu to be spun and have the serum or plasma separated from the cells within 1 hour: Note: Complete -- 4 of 31 -- Metabolic Panel (BMP) includes: Sodium (NA), Potassium (K), Chloride (CL), Carbon Dioxide (CO2), Glucose (Glu), Blood Urea Nitrogen (BUN), Creatinine (Creat), Total Protein (TP), Albumin (Alb), Calcium (CA), Total Bilirubin (TBil), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST). Basic Metabolic Panel (BMP) includes: NA, K, CL, CO2, Glu, BUN, and CA. Renal Panel (Renal) includes: NA, K, CL, CO2, Glu, BUN, Creat, Alb, Phos, and CA. On July 13, 2018 Patient 39 was collected for a BMP at 12: 00 PM and not received into the laboratory to be spun and separated until 13:37 PM exceeding the 1 hour time frame to be centrifuged by 37 minutes. On July 9, 2018 Patient 3 was collected for a BMP at 11:00 AM and not received into the laboratory to be spun and separated until 12:38 PM exceeding the 1 hour time frame to be centrifuged by 38 minutes. On July 6, 2018 Patient 42 was collected for a Renal at 11: 00 AM and not received into the laboratory to be spun and separated until 12:38 PM exceeding the 1 hour time frame to be centrifuged by 38 minutes. On July 2, 2018 Patient 43 was collected for a BMP at 10:30 AM and not received into the laboratory to be spun and separated until 11:53 AM exceeding the 1 hour time frame to be centrifuged by 23 minutes. On July 2, 2018 Patient 45 was collected for a BMP at 17: 13 PM and not received into the laboratory to be spun and separated until 19:10 PM exceeding the 1 hour time frame to be centrifuged by 57 minutes. On June 29, 2018 Patient 81 was collected for a Renal at 11:13 AM and not received in the laboratory to be spun and separated until 17:43 PM exceeding the 1 hour time frame to be centrifuged by 270 minutes. On June 29, 2018 Patient 87 was collected for a Renal at 9:08 AM and not received in the laboratory to be spun and separated until 10:23 PM exceeding the 1 hour time frame to be centrifuged by 15 minutes. On June 29, 2018 Patient 80 was collected for a Renal at 8:43 AM and not received in the laboratory to be spun and separated until 17:44 PM exceeding the 1 hour time frame to be centrifuged by 481 minutes. On June 28, 2018 Patient 79 was collected for a Renal at 11:33 AM and not received in the laboratory to be spun and separated until June 29, 2018 at 8:53 AM exceeding the 1 hour time frame to be centrifuged by 1283 minutes. On June 28, 2018 Patient 86 was collected for a Renal at 11:15 AM and not received in the laboratory to be spun and separated until 12:33 PM exceeding the 1 hour time frame to be centrifuged by 18 minutes. On June 26, 2018 Patient 75 was collected for a Renal at 11:21 AM and not received in the laboratory to be spun and separated until June 27, 2018 at 9:14 AM exceeding the 1 hour time frame to be centrifuged by 1253 minutes. On June 26, 2018 Patient 74 was collected for a Renal at 9:22 AM and not received in the laboratory to be spun and separated until June 27, 2018 at 9:14 AM exceeding the 1 hour time frame to be centrifuged by 1382 minutes. On June 26, 2018 Patient 73 was collected for a Renal at 8:42 AM and not received in the laboratory to be spun and separated until June 27, 2018 at 9:14 AM exceeding the 1 hour time frame to be centrifuged by 1412 minutes. On June 25, 2018 Patient 72 was collected for a Renal at 15:03 PM and not received in the laboratory to be spun and separated until June 26, 2018 at 9:01 AM exceeding the 1 hour time frame to be centrifuged by 1018 minutes. On June 25, 2018 Patient 71 was collected for a Renal at 11:55 AM and not received in the laboratory to be spun and separated until June 26, 2018 at 9:02 AM exceeding the 1 hour time frame to be centrifuged by 1207 minutes. On June 25, 2018 Patient 85 was collected for a Renal at 10:35 AM and not received in the laboratory to be spun and separated until 12:10 PM exceeding the 1 hour time frame to be centrifuged by 35 minutes. On June 22, 2018 Patient 84 was collected for a Renal at 10:10 AM and not received in the laboratory to be spun and separated until 11:18 AM exceeding the 1 hour time frame to be centrifuged by 8 minutes. On June 21, 2018 Patient 70 was collected for a Renal at 14:59 PM and not received in the laboratory to be spun and separated until June 22, 2018 at 10.26 AM exceeding the 1 hour time frame to be centrifuged by 1116 minutes. On June 21, 2018 Patient 69 was collected -- 5 of 31 -- for a Renal at 14:24 PM and not received in the laboratory to be spun and separated until June 22, 2018 at 11:31 AM exceeding the 1 hour time frame to be centrifuged by 1142 minutes. On June 21, 2018 Patient 83 was collected for a Renal at 10:36 AM and not received in the laboratory to be spun and separated until June 22, 2018 at 11:45 PM exceeding the 1 hour time frame to be centrifuged by 1449 minutes. On June 21, 2018 Patient 68 was collected for a Renal at 8:55 AM and not received in the laboratory to be spun and separated until June 22, 2018 at 10:28 PM exceeding the 1 hour time frame to be centrifuged by 1463 minutes. On June 20, 2018 Patient 67 was collected for a Renal at 10:33 AM and not received in the laboratory to be spun and separated until 12:21 PM exceeding the 1 hour time frame to be centrifuged by 48 minutes. On June 20, 2018 Patient 66 was collected for a Renal at 9:30 AM and not received in the laboratory to be spun and separated until 10:44 AM exceeding the 1 hour time frame to be centrifuged by 14 minutes. On June 19, 2018 Patient 65 was collected for a Renal at 15:14 PM and not received in the laboratory to be spun and separated until June 20, 2018 at 8:25 AM exceeding the 1 hour time frame to be centrifuged by 971 minutes. On June 19, 2018 Patient 64 was collected for a Renal at 14:16 PM and not received in the laboratory to be spun and separated until June 20, 2018 at 8:25 AM exceeding the 1 hour time frame to be centrifuged by 1029 minutes. On June 19, 2018 Patient 63 was collected for a Renal at 11:50 AM and not received in the laboratory to be spun and separated until June 20, 2018 at 8:23 AM exceeding the 1 hour time frame to be centrifuged by 1183 minutes. On June 19, 2018 Patient 62 was collected for a Renal at 10:45 AM and not received in the laboratory to be spun and separated until June 20, 2018 at 8:23 AM exceeding the 1 hour time frame to be centrifuged by 1238 minutes. On June 19, 2018 Patient 60 was collected for a Renal at 9:07 AM and not received in the laboratory to be spun and separated until June 20, 2018 at 8:21 AM exceeding the 1 hour time frame to be centrifuged by 1334 minutes. On June 19, 2018 Patient 61 was collected for a Phos at 10:06 AM and not received in the laboratory to be spun and separated until 11:17 AM exceeding the 1 hour time frame to be centrifuged by 11 minutes. On June 18, 2018 Patient 59 was collected for a Renal at 16:19 PM and not received in the laboratory to be spun and separated until June 19, 2018 at 8:40 AM exceeding the 1 hour time frame to be centrifuged by 921 minutes. On June 13, 2018 Patient 82 was collected for a Renal at 12:05 PM and not received in the laboratory to be spun and separated until 13:22 PM exceeding the 1 hour time frame to be centrifuged by 17 minutes. On June 8, 2018 Patient 57 was collected for a Renal at 11:19 AM and not received in the laboratory to be spun and separated until 13:41 PM exceeding the 1 hour time frame to be centrifuged by 81 minutes. On June 8, 2018 Patient 6 was collected for a BMP at 11:19 AM and not received in the laboratory to be spun and separated until 13:41 PM exceeding the 1 hour time frame to be centrifuged by 81 minutes. On June 7, 2018 Patient 56 was collected for a Renal at 14:37 PM and not received in the laboratory to be spun and separated until 17:35 PM exceeding the 1 hour time frame to be centrifuged by 118 minutes. On June 6, 2018 Patient 55 was collected for a Renal at 9:04 AM and not received in the laboratory to be spun and separated until 10:59 AM exceeding the 1 hour time frame to be centrifuged by 55 minutes. On June 5, 2018 Patient 52 was collected for a Renal at 10:02 AM and not received in the laboratory to be spun and separated until 17:39 PM exceeding the 1 hour time frame to be centrifuged by 397 minutes. On June 5, 2018 Patient 53 was collected for a Renal at 12:18 PM and not received in the laboratory to be spun and separated until 17:43 PM exceeding the 1 hour time frame to be centrifuged by 265 minutes. On May 29, 2018 Patient 47 was collected for a BMP at 14:15 PM and not received into the laboratory to be spun and separated until 17:09 PM exceeding the 1 hour time frame to be centrifuged by 114 minutes. On May 8, 2018 Patient 48 was collected for a BMP at 12:20 PM and not received into the laboratory to be spun and separated until 14:01 PM exceeding the 1 -- 6 of 31 -- hour time frame to be centrifuged by 41 minutes. On May 3, 2018 Patient 46 was collected for a BMP at 9:30 AM and not received into the laboratory to be spun and separated until 12:13 PM exceeding the 1 hour time frame to be centrifuged by 103 minutes. On February 13, 2018 Patient 19 was collected for a CMP at 8:35 AM and not received in the laboratory to be spun and separated until 10:04 PM exceeding the 1 hour time frame to be centrifuged by 29 minutes. On February 13, 2018 Patient 21 was collected for a Renal at 10:56 AM and not received in the laboratory to be spun and separated until 17:04 PM exceeding the 1 hour time frame to be centrifuged by 308 minutes. 5. Interviews with Personnel 4 on July 18, 2018 revealed she was unaware of the one hour timeframe for K, Phos, and Glu. Personnel 4 confirmed that the patients cited above exceeded the 1 hour time frame set by the manufacturer. II. Based on observation, record review and interview with personnel, the laboratory failed to ensure patient samples for Calcium (CA), are separated from the red cell promptly according to the manufacturer and Laboratory Policy for ensuring the integrity of patient samples for accurate and reliable testing for forty one (41) of one hundred seventeen (117) patients reviewed. Findings: 1. Observation by surveyor on July 16, 2018 revealed the laboratory maintained a Siemens Dimension EXL for : Albumin (Alb), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Ammonia (Ammon), Total Bilirubin (TBil), Calcium (CA), Chloride (CL), Carbon Dioxide (CO2), Creatinine (Creat), Glucose (Glu), Potassium (K), Sodium (NA), Total Protein (TP), Blood Urea Nitrogen (BUN), Cholesterol (Chol), High Density Lipoprotein Cholesterol (HDL), Low Density Lipoprotein Cholesterol (LDL), Triglyceride (Trig), Creatine Phosphokinase (CPK), Creatine Kinase MB (CKMB), Hemoglobin A1C) (HgbA1C), Troponin (Trop), Direct Bilirubin (DBil), Free Thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Amylase (Amy), Lipase (Lip), Magnesium (Mg), Phosphorous (Phos), Prostate Specific Antigen (PSA), Pro- Brain Natriuretic Peptide (Pro-BNP), Iron (Fe), Total Iron Binding Capacity (TIBC), Ferritin (Fer), Folate (Fol), Vitamin B12 (B12), Alcohol (ETOH), Acetaminophen (Acet), Digoxin (Dig), Phenytoin (Dil), Gentamycin (Gent),Vancomycin (Vanco) and Uric Acid (Uric). Further observation by the surveyor on July 16, 2018 noted the laboratory receiving patient samples for laboratory testing from out side facilities. 2. Review of the Laboratory's Instructions given to outside facilities that the laboratory provides services to revealed "all specimens must be brought to the laboratory immediately after collection." 3. Review of the Siemens Dimension package inserts revealed for Calcium (CA) states under "Specimen Collection and Handling" that the "Serum should be separated from the red cell and analyzed promptly." 4. Review of a random selection of Patient Test Records from May 3, 2018 through July 13, 2018 revealed the laboratory failed to reject the following forty one (41) patients for not meeting manufacturer's requirements for CA to separated the serum/plasma from the red cells promptly. Note: Complete Metabolic Panel (BMP) includes: Sodium (NA), Potassium (K), Chloride (CL), Carbon Dioxide (CO2), Glucose (Glu), Blood Urea Nitrogen (BUN), Creatinine (Creat), Total Protein (TP), Albumin (Alb), Calcium (CA), Total Bilirubin (TBil), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST). Basic Metabolic Panel (BMP) includes: NA, K, CL, CO2, Glu, BUN, and CA. Renal Panel (Renal) includes: NA, K, CL, CO2, Glu, BUN, Creat, Alb, Phos, and CA. On July 13, 2018 Patient 39 was collected for a BMP at 12: 00 PM and not received into the laboratory to be spun and separated until 13:37 PM. On July 9, 2018 Patient 3 was collected for a BMP at 11:00 AM and not received into the laboratory to be spun and separated until 12:38 PM. On July 6, 2018 Patient 42 was collected for a Renal at 11:00 AM and not received into the laboratory to be spun and separated until 12:38 PM. On July 2, 2018 Patient 43 was collected for a BMP at 10:30 AM and not received into the laboratory to be spun and separated until 11:53 -- 7 of 31 -- AM. On July 2, 2018 Patient 45 was collected for a BMP at 17:13 PM and not received into the laboratory to be spun and separated until 19:10 PM. On June 29, 2018 Patient 81 was collected for a Renal at 11:13 AM and not received in the laboratory to be spun and separated until 17:43 PM. On June 29, 2018 Patient 87 was collected for a Renal at 9:08 AM and not received in the laboratory to be spun and separated until 10:23 PM. On June 29, 2018 Patient 80 was collected for a Renal at 8: 43 AM and not received in the laboratory to be spun and separated until 17:44 PM. On June 28, 2018 Patient 79 was collected for a Renal at 11:33 AM and not received in the laboratory to be spun and separated until June 29, 2018 at 8:53 AM. On June 28, 2018 Patient 86 was collected for a Renal at 11:15 AM and not received in the laboratory to be spun and separated until 12:33 PM. On June 26, 2018 Patient 75 was collected for a Renal at 11:21 AM and not received in the laboratory to be spun and separated until June 27, 2018 at 9:14 AM. On June 26, 2018 Patient 74 was collected for a Renal at 9:22 AM and not received in the laboratory to be spun and separated until June 27, 2018 at 9:14 AM. On June 26, 2018 Patient 73 was collected for a Renal at 8:42 AM and not received in the laboratory to be spun and separated until June 27, 2018 at 9:14 AM. On June 25, 2018 Patient 72 was collected for a Renal at 15:03 PM and not received in the laboratory to be spun and separated until June 26, 2018 at 9:01 AM. On June 25, 2018 Patient 71 was collected for a Renal at 11:55 AM and not received in the laboratory to be spun and separated until June 26, 2018 at 9:02 AM. On June 25, 2018 Patient 85 was collected for a Renal at 10:35 AM and not received in the laboratory to be spun and separated until 12:10 PM. On June 22, 2018 Patient 84 was collected for a Renal at 10:10 AM and not received in the laboratory to be spun and separated until 11:18 AM. On June 21, 2018 Patient 70 was collected for a Renal at 14:59 PM and not received in the laboratory to be spun and separated until June 22, 2018 at 10.26 AM. On June 21, 2018 Patient 69 was collected for a Renal at 14:24 PM and not received in the laboratory to be spun and separated until June 22, 2018 at 11:31 AM. On June 21, 2018 Patient 83 was collected for a Renal at 10:36 AM and not received in the laboratory to be spun and separated until June 22, 2018 at 11:45 AM. On June 21, 2018 Patient 68 was collected for a Renal at 8:55 AM and not received in the laboratory to be spun and separated until June 22, 2018 at 10:28 AM On June 20, 2018 Patient 67 was collected for a Renal at 10:33 AM and not received in the laboratory to be spun and separated until 12:21 PM. On June 20, 2018 Patient 66 was collected for a Renal at 9:30 AM and not received in the laboratory to be spun and separated until 10:44 AM. On June 19, 2018 Patient 65 was collected for a Renal at 15:14 PM and not received in the laboratory to be spun and separated until June 20, 2018 at 8:25 AM. On June 19, 2018 Patient 64 was collected for a Renal at 14:16 PM and not received in the laboratory to be spun and separated until June 20, 2018 at 8:25 AM. On June 19, 2018 Patient 63 was collected for a Renal at 11:50 AM and not received in the laboratory to be spun and separated until June 20, 2018 at 8:23 AM. On June 19, 2018 Patient 62 was collected for a Renal at 10:45 AM and not received in the laboratory to be spun and separated until June 20, 2018 at 8:23 AM. On June 19, 2018 Patient 60 was collected for a Renal at 9:07 AM and not received in the laboratory to be spun and separated until June 20, 2018 at 8:21 AM. On June 18, 2018 Patient 59 was collected for a Renal at 16:19 PM and not received in the laboratory to be spun and separated until June 19, 2018 at 8:40 AM. On June 13, 2018 Patient 82 was collected for a Renal at 12:05 PM and not received in the laboratory to be spun and separated until 13:22 PM. On June 8, 2018 Patient 57 was collected for a Renal at 11:19 AM and not received in the laboratory to be spun and separated until 13:41 PM. On June 8, 2018 Patient 6 was collected for a BMP at 11:19 AM and not received in the laboratory to be spun and separated until 13:41 PM. On June 7, 2018 Patient 56 was collected for a Renal at 14:37 PM and not received in the laboratory to be spun and separated until 17:35 PM. On June 6, 2018 Patient 55 was collected for a Renal at -- 8 of 31 -- 9:04 AM and not received in the laboratory to be spun and separated until 10:59 AM. On June 5, 2018 Patient 52 was collected for a Renal at 10:02 AM and not received in the laboratory to be spun and separated until 17:39 PM. On June 5, 2018 Patient 53 was collected for a Renal at 12:18 PM and not received in the laboratory to be spun and separated until 17:43 PM. On May 29, 2018 Patient 47 was collected for a BMP at 14:15 PM and not received into the laboratory to be spun and separated until 17:09 PM. On May 8, 2018 Patient 48 was collected for a BMP at 12:20 PM and not received into the laboratory to be spun and separated until 14:01 PM. On May 3, 2018 Patient 46 was collected for a BMP at 9:30 AM and not received into the laboratory to be spun and separated until 12:13 PM. On February 13, 2018 Patient 19 was collected for a CMP at 8:35 AM and not received in the laboratory to be spun and separated until 10:04 PM. On February 13, 2018 Patient 21 was collected for a Renal at 10:56 AM and not received in the laboratory to be spun and separated until 17:04 PM. 5. Interviews with Personnel 4 on July 18, 2018 revealed laboratory policy was for all samples to be brought to the laboratory immediately for processing. Personnel 2 confirmed the specimens above failed to be spun promptly for CA. Personnel 4 confirmed that the patients cited above exceeded the manufacturer and Laboratory Policy for receiving samples immediately into the laboratory for processing. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Repeat Deficiency from 2/6/2017 Survey. Based on record review and interview with personnel, the laboratory failed to establish detailed written instructions for the facilities the laboratory provides services for to maintain the integrity of samples and ensure accurate and reliable testing. Findings: 1. Review of the Laboratory's Manual for outside facilities that utilized the laboratory for testing revealed the manual failed to include detailed instructions that met the instrumentation requirements utilized by the laboratory for: (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. 2. Interview with personnel 4 on July 19, 2018 confirmed the laboratory did not have or provide a service manual for outside facilities that provided information that was current with the instrumentation utilized by the laboratory. Personnel 2 also confirmed the manual available to outside services did not meet the requirements for maintaining the integrity of patient samples to ensure accurate and reliable testing. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of