Leonard J Chabert Medical Center Lab

Summary Statement of Deficiencies D0000 A VALIDATION SURVEY was performed at LEONARD J CHABERT MEDICAL CENTER LAB - CLIA # 19D0648908 on December 3, 2018 through December 7, 2018. LEONARD J CHABERT MEDICAL CENTER LAB was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 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 493.1409 CONDITION: Laboratories performing moderate complexity testing, Technical Consultant. 42 CFR 493.1423 CONDITION: Laboratories performing moderate complexity, Testing Personnel. 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing, Laboratory Director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 47 -- This CONDITION is not met as evidenced by: Based on review of Proficiency Testing records from College of American Pathologist (CAP), and interview with the Blood Bank Supervisor, the laboratory failed to successfully participate in Proficiency Testing as follows: 1. The laboratory failed to achieve a satisfactory score for two of three Proficiency Testing (PT) Events resulting in an initial unsuccessful participation in Compatibility Testing. Refer to D2181. 2. Interview with Personnel 5 on December 3, 2018 confirmed the laboratory failed to achieve a satisfactory score for two of three PT Events for Compatibility Testing. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review, and interview with the Blood Bank Supervisor, the laboratory failed to achieve a satisfactory for two of three Proficiency Testing (PT) Events resulting in an initial unsuccessful participation in Compatibility Testing. Findings: 1. Review of College of American Pathology (CAP) Proficiency Testing records revealed the laboratory received the following scores for Compatibility Testing resulting in failure of two out of three events: a) 2018 Event 1: score of 80% b) 2018 Event 3: score of 60% 2. Interview with Personnel 5 (Blood Bank Supervisor) on December 3, 2018 confirmed the laboratory failed to achieve satisfactory scores for two of three PT Events for Compatibility Testing in 2018. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to address competency for Clinical Consultants and Technical Consultants were complete. Findings: 1. Review off the laboratory's CMS- 209 form (Laboratory Personnel Report) revealed the following personnel serve as Clinical Consultants or Technical Consultants: a) Clinical Consultants: Personnel 21 Personnel 22 Personnel 23 b) Technical Consultants: Personnel 2 Personnel 3 Personnel 4 Personnel 5 Personnel 6 Personnel 17 2. Review of the laboratory's Personnel Competency policy revealed the laboratory did not include competency assessment criteria or frequency for personnel serving as Clinical and Technical Consultants. 3. Review of personnel records for the nine (9) identified personnel revealed the laboratory did not perform competency assessments for the duties of Clinical Consultant or Technical Consultant. 4. In interview on December 3, 2018 at approximately 4:00 pm, Personnel 1 stated he did not perform a competency assessment on the identified Clinical Consultants. Personnel 1 further stated he was -- 2 of 47 -- unaware that a competency assessment was needed for Clinical Consultants. 5. In interview on December 4, 2018 at 9:56 am, Personnel 2 stated the laboratory did not perform competency assessments for the identified six (6) Technical Consultants. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to verify the accuracy of the performance of Procalcitonin Assay at least twice annually. Findings: 1. Review of the Task 1 and 3 Form submitted to surveyors on December 3, 2018 revealed the laboratory performed and reported Procalcitonin. 2. Review of the laboratory's policy and procedure manual revealed the laboratory had a policy for twice a year verification for those tests the laboratory is unable to obtain Proficiency Testing for. 3. Review of twice a year verification revealed the laboratory had performed a check in May 2018; however as of December 7, 2018 the laboratory failed to perform a second verification for procalcitonin in 2018. 4. Interview with Personnel 4 on December 7, 2018 confirmed the laboratory had not performed a second verification for procalcitonin for 2018. Personnel 4 revealed the main campus hospital failed to have enough samples for the laboratory to perform a second verification in 2018. 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 ensure that patient samples for Ammonia testing are separated within fifteen (15) minutes after collection according to the manufacturer's requirements for twenty eight (28) of two hundred and four (204) patients reviewed. Refer to D5311 I. 2. The laboratory failed to ensure that patient samples for Lactic Acid testing are separated within fifteen (15) minutes after collection and analyzed promptly according to laboratory policy and procedure for eighteen (18) of three hundred nineteen (319) patients reviewed. Refer to D5311 II. 3. The laboratory failed to ensure that patient samples for Chemistry testing are platelet poor after centrifugation according to the manufacturer's requirements. Refer to D5311 III. 4. The laboratory failed to establish detailed written instructions for laboratory services provided for inpatient and outpatient testing and for maintaining the integrity of samples and ensuring accurate and reliable testing according to current manufacturers guidelines. Refer to D5317. 5. The laboratory's Quality Assurance -- 3 of 47 -- (QA) system failed to monitor, assess, and correct problems identified with the Pre- analytic system. 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: I. Based on observation, record review and interview with personnel, the laboratory failed to ensure that patient samples for Ammonia testing are separated within fifteen (15) minutes after collection according to the manufacturer's requirements for twenty eight (28) of two hundred and four (204) patients reviewed. Findings: 1. Observation by the surveyor on December 3, 2018 revealed the laboratory was performing Ammonia testing on the Abbott Architect Plus Chemistry Analyzer. 2. Review of the Abbott Architect Ammonia package insert revealed under "Specimen Collection and Handling" that "Rapid separation of plasma from blood cells is critical for obtaining reliable results. The standard recommendation is no more than 15 minutes from sample collection to the start of centrifugation." 3. Review of patient records for Ammonia from June 3, 2018 through December 4, 2018 revealed the laboratory did not separate Ammonia samples within 15 minutes for the following twenty eight (28) patients: On June 19, 2018 Patient 1 was documented as collected at 20:57 pm and received by the laboratory at 21:14 pm - two (2) minutes over the manufacturer's instructions of separation within 15 minutes On June 20, 2018 Patient 2 was documented as collected at 09:40 am and received by the laboratory at 10:00 am - five (5) minutes over the manufacturer's instructions of separation within 15 minutes On June 27, 2018 Patient 3 was documented as collected at 03:17 am and received by the laboratory at 03:39 am - seven (7) minutes over the manufacturer's instructions of separation within 15 minutes On July 12, 2018 Patient 4 was documented as collected at 19:24 pm and received by the laboratory at 19:42 pm - three (3) minutes over the manufacturer's instructions to analyze promptly On August 8, 2018 Patient 5 was documented as collected at 00:12 am and received by the laboratory at 01:01 am - thirty four (34) minutes over the manufacturer's instructions to analyze promptly On August 19, 2018 Patient 6 was documented as collected at 04:54 am and received by the laboratory at 05:10 Am - one (1) minute over the manufacturer's instructions to analyze promptly On August 20, 2018 Patient 7 was documented as collected at 16:14 pm and received by the laboratory at 16:51 pm - twenty two (22) minutes over the manufacturer's instructions to analyze promptly On August 21, 2018 Patient 8 was documented as collected at 05:02 am and received by the laboratory at 05:22 am - five (5) minutes over the manufacturer's instructions to analyze promptly On August 21, 2018 Patient 9 was documented as collected at 17:17 pm and received by the laboratory at 17:54 pm - twenty two (22) minutes over the manufacturer's instructions to analyze promptly On August 26, 2018 Patient 10 was documented as collected at 04:11 am and received by the laboratory at 04:46 am - twenty (20) minutes over the manufacturer's instructions to analyze promptly On August 27, 2018 Patient 11 was documented as collected at 04:29 am and received by the laboratory at 05:09 Am - thirty (30) minutes over the manufacturer's instructions to analyze promptly On -- 4 of 47 -- August 27, 2018 Patient 12 was documented as collected at 17:22 pm and received by the laboratory at 17:51 pm - fourteen (14) minutes over the manufacturer's instructions to analyze promptly On September 2, 2018 Patient 13 was documented as collected at 20:34 pm and received by the laboratory at 22:55 pm - one hundred twenty six (126) minutes over the manufacturer's instructions to analyze promptly On September 6, 2018 Patient 14 was documented as collected at 00:26 am and received by the laboratory at 00:54 am - nine (9) minutes over the manufacturer's instructions to analyze promptly On September 13, 2018 Patient 15 was documented as collected at 19:48 pm and received by the laboratory at 20:04 pm - one (1) minute over the manufacturer's instructions to analyze promptly On September 16, 2018 Patient 16 was documented as collected at 20:50 pm and received by the laboratory at 21:09 pm - four (4) minutes over the manufacturer's instructions to analyze promptly On September 17, 2018 Patient 17 was documented as collected at 10:10 am and received by the laboratory at 10:26 am - one (1) minute over the manufacturer's instructions to analyze promptly On September 20, 2018 Patient 18 was documented as collected at 09:17 am and received by the laboratory at 09:35 am - three (3) minutes over the manufacturer's instructions to analyze promptly On September 21, 2018 Patient 19 was documented as collected at 04:40 am and received by the laboratory at 04:57 am - two (2) minutes over the manufacturer's instructions to analyze promptly On September 21, 2018 Patient 20 was documented as collected at 18:51 pm and received by the laboratory at 19:24 pm - eighteen (18) minutes over the manufacturer's instructions to analyze promptly On September 21, 2018 Patient 21 was documented as collected at 22:18 pm and received by the laboratory at 22:36 pm - three (3) minutes over the manufacturer's instructions to analyze promptly On October 16, 2018 Patient 22 was documented as collected at 11:31 am and received by the laboratory at 12:00 pm - fourteen (14) minutes over the manufacturer's instructions to analyze promptly On October 26, 2018 Patient 23 was documented as collected at 03: 49 am and received by the laboratory at 04:12 am - eight (8) minutes over the manufacturer's instructions to analyze promptly On October 28, 2018 Patient 24 was documented as collected at 10:50 am and received by the laboratory at 11:11 am - six (6) minutes over the manufacturer's instructions to analyze promptly On November 3, 2018 Patient 25 was documented as collected at 22:25 pm and received by the laboratory at 22:42 pm - two (2) minutes over the manufacturer's instructions to analyze promptly On November 29, 2018 Patient 26 was documented as collected at 11:40 am and received by the laboratory at 12:04 pm - nine (9) minutes over the manufacturer's instructions to analyze promptly On December 1, 2018 Patient 27 was documented as collected at 09:16 am and received by the laboratory at 09:36 am - five (5) minutes over the manufacturer's instructions to analyze promptly On December 4, 2018 Patient 28 was documented as collected at 13:29 pm and received by the laboratory at 13:45 pm - one (1) minute over the manufacturer's instructions to analyze promptly 4. Interview with Personnel 3 and 4 on December 5, 2018 confirmed the laboratory did not ensure Ammonia samples were separated within 15 minutes as required by the manufacturer. II. Based on observation, record review and interview with personnel, the laboratory failed to ensure that patient samples for Lactic Acid testing are separated within fifteen (15) minutes after collection and analyzed promptly according to laboratory policy and procedure for eighteen (18) of three hundred nineteen (319) patients reviewed. Findings: 1. Observation by the surveyor on December 3, 2018 revealed the laboratory was performing Lactic Acid testing on the Abbott Architect Plus Chemistry Analyzer. 2. Interview with Personnel 4 on December 5, 2018 revealed that Lactic Acids are to be spun with fifteen (15) minutes and analyzed immediately. 3. Review of patient records for Lactic Acid from November 1, 2018 through December 5, 2018 revealed the laboratory did not separate Lactic Acids samples within 15 minutes for the following eighteen (18) patients: On -- 5 of 47 -- November 1, 2018 Patient 31 was documented as collected at 15:10 pm and received by the laboratory at 15:32 pm - seven (7) minutes over. On November 3, 2018 Patient 32 was documented as collected at 12:50 pm and received by the laboratory at 13:07 pm - two (2) minutes over the manufacturer's instructions to analyze promptly On November 3, 2018 Patient 33 was documented as collected at 23:30 pm and received by the laboratory at 23:47 pm - two (2) minutes over the manufacturer's instructions to analyze promptly On November 5, 2018 Patient 34 was documented as collected at 09: 12 am and received by the laboratory at 09:28 pm - one (1) minute over the manufacturer's instructions to analyze promptly On November 6, 2018 Patient 35 was documented as collected at 13:25 pm and received by the laboratory at 13:44 pm - four (4) minutes over the manufacturer's instructions to analyze promptly On November 6, 2018 Patient 36 was documented as collected at 13:35 pm and received by the laboratory at 13:54 pm - four (4) minutes over the manufacturer's instructions to analyze promptly On November 8, 2018 Patient 37 was documented as collected at 20:12 pm and received by the laboratory at 20:34 pm - seven (7) minutes over the manufacturer's instructions to analyze promptly On November 9, 2018 Patient 38 was documented as collected at 11:07 am and received by the laboratory at 11:28 am - six (6) minutes over the manufacturer's instructions to analyze promptly On November 15, 2018 Patient 39 was documented as collected at 04:45 am and received by the laboratory at 05:09 pm - nine (9) minutes over the manufacturer's instructions to analyze promptly On November 20, 2018 Patient 40 was documented as collected at 08:40 am and received by the laboratory at 09:09 am - fourteen (14) minutes over the manufacturer's instructions to analyze promptly On November 20, 2018 Patient 41 was documented as collected at 14:29 pm and received by the laboratory at 14:52 pm - eight (8) minutes over the manufacturer's instructions to analyze promptly On November 20, 2018 Patient 42 was documented as collected at 16:45 pm and received by the laboratory at 17:03 pm - three (3) minutes over the manufacturer's instructions to analyze promptly On November 23, 2018 Patient 43 was documented as collected at 04:51 am and received by the laboratory at 05:13 am - seven (7) minutes over the manufacturer's instructions to analyze promptly On November 24, 2018 Patient 44 was documented as collected at 20:10 pm and received by the laboratory at 20:42 pm - seventeen (17) minutes over the manufacturer's instructions to analyze promptly On November 2, 2018 Patient 45 was documented as collected at 12:45 pm and received by the laboratory at 13:03 pm - three (3) minutes over the manufacturer's instructions to analyze promptly On December 1, 2018 Patient 46 was documented as collected at 15:36 pm and received by the laboratory at 15:52 pm - one (1) minute over the manufacturer's instructions to analyze promptly On December 4, 2018 Patient 47 was documented as collected at 13:29 pm and received by the laboratory at 13:45 pm - one (1) minute over the manufacturer's instructions to analyze promptly On December 4, 2018 Patient 48 was documented as collected at 14:30 pm and received by the laboratory at 14:46 pm - one (1) minute over the manufacturer's instructions to analyze promptly 4. Interview with Personnel 4 on December 5, 2018 confirmed the laboratory did not ensure Lactic Acid samples were separated within 15 minutes and analyzed promptly. III. Based on observation, record review and interview with personnel, the laboratory failed to ensure that patient samples for Chemistry testing are platelet poor after centrifugation according to the manufacturer's requirements. Findings: 1. Observation by the surveyor on December 3, 2018 revealed the laboratory maintained a Abbott Architect Plus Chemistry Analyzer which performed the following tests: Alanine Aminotransferase (ALT), Albumin (Alb), Alkaline phosphatase (ALP), Ammonia (Ammon), Amylase (Amy), Aspartate Aminotransferase (AST), Direct Bilirubin (DBil), Total Bilirubin (TBil), Calcium (CA), Chloride (CL), Cholesterol (Chol), High Density Lipoprostein Cholesterol (HDL), Carbon Dioxide (CO2), Creatine Kinase (CK), Creatinine (Creat), Glucose -- 6 of 47 -- (Glu), Iron (Fe), Lacate Dehydrogenase (LDH), Lactate, Lipase, Magnesium (Mg), Phosphorous (Phos), Potassium (K), Total Protein (TP), Sodium (NA), Triglyceride (Trig), Uric Acid (Uric), Gamma Glutamyl Transferase (GGT), Blood Urea Nitrogen (BUN), Parathyroid Hormone (PTH), Acetaminophen (Acet), Carbamazepine (CRRBM), Digoxin (Dig), Gentamicin (Gent), Lithium (Li), Phenobarbital (Phenob), Phenytoin (Dil), Prostate Specific Antigen (PSA), Salicylate (Sali), Free thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Transferrin (Trans), Valproic Acid (Valp), Vancomycin (Vanco), Carcinoembryonic Antigen (CEA), Prealbumin (Prealb), Microalbumin (Microalb), Alpha Fetoprotein (AFP), Cortisol, Ferritin, Folate, Vitaminn B12, Blood Alcohol (ETOH), CKMB, Troponin, Hemoglobin A1C (HgbA1C), Brain Natriuretic Peptide (BNP), C Reactive Protein (CRP), Beta Human Chorionic Gonadatropin (BHCG), Tricyclics, Amphetamine (Amph), Barbirurates (Barb), Benzodiazepine (Benzo), Cocaine (COC), Methadone (Meth), Opiates (OPI), Phencyclidine (PCP), and Tetrahydrocanabinol (THC). 2. Review of the following Abbot Architect package inserts states that samples are to be "platelet poor": CK, DBil, Gent, Glu, HDL, Fe, Lactate, LDH, Lipase, Li, Mg, Phos, TBil, TP, Trans, BUN, Valp, and Vanco. 3. Interview with Personnel 4 on December 5, 2018 revealed she was unaware that samples had to be platelet poor. Personnel 4 stated she was unaware of any studies that would have been done to ensure that samples are platelet poor. 4. Review of the Task 1 and 3 Form submitted to surveyors on December 3, 2018 revealed the laboraotry performed the following annual volumes without ensuring that samples are platelet poor: CK - 1200, DBil - 250, Gent - 75, Glu - 55000, HDL - 17000, Fe - 2200, Lactate - 3500, LDH - 575, Lipase - 3100, Li, Mg - 13200, Phos - 13200, TBil - 47000, TP - 47000, Trans, BUN - 55000, Valp - 550, and Vanco - 2000. 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: 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. Surveyors requested from Personnel 2 on December 3, 5, 6 and 7 a copy of the manual available to outside facilities that provides that provide written policies and procedures for each of the following: a) Patient preparation. b) Specimen collection. c) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. d) Specimen storage and preservation. e) Conditions for specimen transportation. f) Specimen processing. g) Specimen acceptability and rejection. h) Specimen referral. 2. Personnel 2 provided to the surveyors on December 7, 2017 the following policies for: APTT, PT, Mixing Studies for PTT and PT, Fibrinogen, D-Dimer, Complete Blood Count, Glucose, Lactic Acid, Ammonia, Comprehensive Metabolic Panel [which includes: Albumin (Alb), Alkaline Phosphatase (ALK), Aspartate Aminotransferase (AST), Total Bilirubin (TBil), Blood Urea Nitrogen (BUN), Calcium (CA), Chloride (CL), Creatinine (Creat), Glucose (Glu), Potassium (K), Sodium (NA), Carbon Dioxide (CO2), Total Protein (TP and Alanine Aminotransferase (ALT)]. The laboratory provides laboratory services to include: Bacteriology, Mycology, Parasitology, Virology, General Immunology, -- 7 of 47 -- Routine Chemistry, Urinalysis, Endocrinology, Toxicology, Hematology, ABO, Rh, Antibody Screen Testing, Antibody Identification Compatibility Testing, Histopathology, Oral Pathology, and Cytology. Not all policies and procedures were provided to the surveyors. The policies provided failed to include: Specimen collection, specimen labeling, including patient name or unique patient identifier, specimen source, specimen storage and preservation, conditions for specimen transportation, and specimen acceptability and rejection. Further review of the policies received revealed that policies failed to meet manufacturer requirements Examples: Complete Metabolic Panel states to transport blood to laboratory within 4 hours. Abbott Architect requires that samples be centrifuged within two (2) hours of collection - 4 hours would not meet this requirement. PT, PTT, Fibrinogen, D-Dimer states to separate plasma and to freeze sample; however it does not state the temperature to be frozen and not to place in a frost free freezer. Glucose states to get to laboratory within two (2) hours. The manufacturer states that Glucose will metabolize 5% per hour. 3. Interview with personnel 2 on December 7, 2018 revealed the laboratory provides instructions online to all outside facilities that the laboratory does testing for. Personnel 2 confirmed the manual does not include all the information required to maintain the integrity of patient samples. Personnel 2 also revealed the laboratory maintained no documentation to support who had access to the instructions and that the outside facilities have read and agree to the instructions provided. 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 observation, record review, and interview with personnel, the laboratory failed to establish written quality assessment policies and procedures for monitoring, identifying and correcting problems identified with the preanalytic system. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory failed to establish written quality assessment policies and procedure for monitoring, identifying and correcting problems identified with preanalytic systems. 2. Problems identified in the Preanalytic System found during the survey that failed to be addressed by the laboratory: a) The laboratory failed to ensure that patient samples for Ammonia testing are separated within fifteen (15) minutes after collection according to the manufacturer's requirements for twenty eight (28) of two hundred and four (204) patients reviewed. Refer to D5311 I. b) The laboratory failed to ensure that patient samples for Lactic Acid testing are separated within fifteen (15) minutes after collection and analyzed promptly according to laboratory policy and procedure for eighteen (18) of three hundred nineteen (319) patients reviewed. Refer to D5311 II. c) The laboratory failed to ensure that patient samples for Chemistry testing are platelet poor after centrifugation according to the manufacturer's requirements. Refer to D5311 III. d) The laboratory failed to establish detailed written instructions for laboratory services provided for inpatient and outpatient testing and for maintaining the integrity of samples and ensuring accurate and reliable testing according to current manufacturers guidelines. Refer to D5317. 2. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory policies and procedures failed to identify, monitor, assess and correct the problems found during the survey. 3. Interview with -- 8 of 47 -- personnel 2, 3, 4 and 5 on December 7, 2018 confirmed the laboratory failed to identify and correct the issue cited above. 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 observatio, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to perform Gram Stain Quality Control each day of patient testing with each testing person reporting a Gram Stain for eleven (11) of thirty seven (37) patients reviewed as required by laboratory policy. Refer to D5401 I. 2. The laboratory failed to ensure the laboratory policy and procedure manual contained complete policies and procedures. Refer to D5401 II. 3. The laboratory failed to follow their policy for documenting the date for Emergency Release of blood units. Refer to D5401 III. 4. The laboratory failed to ensure the laboratory policy and procedure manual contained complete policies and procedures. Refer to D5403. 5. The laboratory failed to ensure that patient samples for Ammonia testing are tested within two (2) hour after collection according to the manufacturer's requirements for two (2) of two hundred and four (204) patients reviewed. Refer to D5411 I. 6. The laboratory failed to use normal donors as required by manufacturer to verify reference intervals and establish their own normal Prothrombin (PT) mean with each new lot of thromboplastin. Refer to D5411 II. 7. The laboratory failed to label Histopathology reagents, and solutions with the strength or concentration of the material, storage requirements, preparation and/or expiration dates. Refer to D5415. 8. The laboratory failed to ensure that Blood Collection tubes, Calibrators and Calibrator Verification material are not used beyond their expiration dates. Refer to D5417. 9. The laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for two (2) of two (2) new Abbott Architect Plus Analyzers. Refer to D5421 I. 10. The laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for two (2) of two (2) new Sysmex XN 2000 Hematology Analyzers. Refer to D5421 II. 11. The laboratory failed to verify the Laboratory Information System (LIS) for accuracy. Refer to D5421 III. 12. The laboratory failed to establish and verify performance specifications for accuracy, precision, reportable and reference ranges, analytical sensitivity, and specificity for Sickle cell Screen, Platelet Function Assay and PT/PTT Mixing Studies performed by the laboratory. Refer to D5423. 13. The laboratory failed to ensure the Daily Maintenance on the Abbott Architect Plus Analyzers I and II were performed as required by the manufacturer, for six (6) of three hundred thirty four (334) days reviewed. Refer to D5429 I. 14. The laboratory failed to ensure the Weekly Maintenance on the Abbott Architect Plus Analyzers I and II were performed as required by the manufacturer, for one (1) of forty eight (48) weeks reviewed. Refer to D5429 II. 15. The laboratory failed to ensure the Maintenance of the Stain for Frozen Sections was performed each day of patient testing for two (2) of five (5) patient test days reviewed. Refer to D5429 III. -- 9 of 47 -- 16. The laboratory failed to perform two levels of control materials each day of patient testing for Cerebrospinal Total Protein (CFTP) performed on the Abbott Architect Plus Analyzer, for one (1) of thirty eight (38) patients reviewed. Refer to D5447. 17. The laboratory failed to perform a positive and negative control each day of patient testing for the Pacific Hemostasis SickleScreen Sickling Hemoglobin Screening Kit for sickle cell disease, for one (1) of ten (10) patients reviewed. Refer to D5449. 18. The laboratory failed to utilize control material of a similar matrix for Urine Ethanol (ETOH) for forty four (44) of forty four (44) patients reviewed. Refer to D5465. 19. The laboratory failed to document visual inspections for each batch /shipment of BD BACTEC Aerobic, Anaerobic and Peds Plus Culture Bottles for six (6) of six (6) lot numbers reviewed. Refer to D5477. 20. The laboratory failed to perform two levels of control materials each eight (8) hours of patient testing for D- Dimer testing performed on the Instrumentation Laboratory (IL) ACL Top 500 Coagulation Analyzer, for six (6) of sixty four (64) patients reviewed. Refer to D5545 I. 21. The laboratory failed to perform two levels of control materials each eight (8) hours of patient testing for Fibrinogen testing performed on the Instrumentation Laboratory (IL) ACL Top 500 Coagulation Analyzer, for three (3) of thirty two (32) patients reviewed. Refer to D5545 II. 22. The laboratory failed to perform two levels of control materials each eight (8) hours of patient testing for Platelet Function (Closure Time) testing performed on the Dade Behring PFA-100 Platelet Function Analyzer, for twelve (12) of twelve (12) patients reviewed. Refer to D5545 III. 23. The laboratory failed to perform two levels of control materials each eight (8) hours of patient testing for PTT Mixing Study testing performed on the Instrumentation Laboratory (IL) ACL Top 500 Coagulation Analyzer, for five (5) of five (5) patients reviewed.Refer to D5545 IV. 24. The laboratory failed to assure the quarterly blood bank alarm checks recorded on the circular temperature charts. Refer to D5555. 25. The laboratory failed to perform and document a control slide of known reactivity for the Hematoxylin and Eosin (H&E) Staining utilized for histopathology slides for twenty (20) of twenty (20) patient test days reviewed. Refer to D5601 I. 26. The laboratory failed to perform and document a positive and negative control slide for Immunohistochemical Staining utilized for histopathology slides for twenty one (21) of twenty one (21) immunohistochemical stains affecting seven (7) patients reviewed. Refer to D5601 II. 27. The laboratory failed to perform and document a control slide of known reactivity for each special stain performed for eight (8) of eight (8) special stains affecting three (3) patients reviewed. Refer to D5601 III. 28. The laboratory failed to perform and document a control slide of known reactivity for Frozen Sections for five (5) of five (5) patients reviewed. Refer to D5601 IV. 29. The the laboratory failed to have a system in place for twice a year comparison testing for the two (2) Abbott Architect Plus Analyzers. Refer to D5775. 30. The laboratory failed to retain instrument printouts for General Immunology, Routine Chemistry, Endocrinology, Toxicology, Hematology and Coagulation. Refer to D5789. 31. The laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the 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. -- 10 of 47 -- This STANDARD is not met as evidenced by: I. Based on observation, record review and interview with personnel, the laboratory failed to perform Gram Stain Quality Control each day of patient testing with each testing person reporting a Gram Stain for eleven (11) of thirty seven (37) patients reviewed as required by laboratory policy. Findings: 1. Observation by the surveyor on December 3, 2018 during the tour of the laboratory noted the laboratory performed Gram Stains. 2. Review of the Laboratory's Policy and Procedure Manual revealed that quality control for Gram Stains is to be performed each day of patient testing and with each testing personnel performing a patient Gram Stain on that day. Quality Control consists of checking for positive and negative reactivity using control organisms. 3. Review of Patient Gram Stain testing and Quality Control records from June 1, 2018 through August 30, 2018 revealed the following eleven (11) patients were tested and reported without having Gram Stain controls performed each day of patient testing and with each testing person reporting a Gram Stain on that day. On June 10, 2018 Patient 120 On June 21, 2018 Patient 121 On June 22, 2018 Patient 122 On June 26, 2018 Patient 123 On July 14, 2018 Patient 124 On July 16, 2018 Patient 125 On July 20, 2018 Patient 126 On July 23, 2018 Patient 127 On August 15, 2018 Patient 128 On August 25, 2018 Patient 129 On August 30, 2018 Patient 130 4. Interview with Personnel 3 and 5 on December 6, 20 18 confirmed the laboratory failed to document the performance of Gram Stain Quality Control each day with each testing person reporting a Gram Stain for the eleven (11) patients cited above. II. Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to ensure the laboratory policy and procedure manual contained complete policies and procedures. Findings: 1. Review of the laboratory policy and procedure manual revealed the laboratory failed to have policies and procedures for: Test Requisitions: what mandated information needs to be on the test requisition: 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) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. Performance specifications to include: a) Detailed policies and procedures for testing personnel that instructed testing personnel what to do for studies for accuracy, precision (day-to-day, run-to-run, and within-run variation, as well as operator variance), reportable and reference ranges and analytical sensitivity and specificity. b) Acceptability criteria for each of the studies for accuracy, precision, reportable and reference ranges and analytical sensitivity and specificity. c) Policies and procedures for when data from the studies for precision, accuracy, reportable range, reference range, analytical sensitivity and analytical specificity fail to meet acceptability criteria. d) Policies on how to maintain the documentation to show that the laboratory participated in the studies. e) Policies for when the laboratory only needs to verify performance specification vs. when the laboratory actually has to establish performance specifications for test systems not FDA approved or introducing a laboratory developed test (LDT). Proficiency Testing (PT): a) Ordering and ensuring that you are enrolled for Proficiency Testing. b) What to do when you receive samples from the PT Provider. c) How to handle the samples; who will test, when to test, how do you assure no inter and intra laboratory communication takes place d) How to record results to send into the PT Provider to be -- 11 of 47 -- scored. e) What records to maintain. f) How to evaluate when you receive your scores from the PT Provider. g) What steps to take if