Abrom Kaplan Memorial Hospital

Summary Statement of Deficiencies D0000 A Recertification Survey was performed June 28, 2021 through July 1, 2021 at Abrom Kaplan Memorial Hospital, CLIA ID # 19D0461318. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 policy and procedure manual and interview with personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of policy and procedure manual revealed the laboratory did not include the following: a) Laboratory Information System (LIS) validation procedure and frequency of performance 2. In interview on July 1, 2021 at 4:03 pm, Personnel 2 stated the laboratory does not perform LIS validations. Personnel 2 confirmed the laboratory's policy manual did not include the identified procedure. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on observation, review of laboratory's Normal Mean Prothrombin Time (NMPT) records, donor questionnaires and interview with personnel, the laboratory failed to utilize acceptable donors as required by the manufacturer to verify reference interval and establish normal Prothrombin Time (PT) mean. Findings: 1. Observation by surveyor during the laboratory tour on June 28, 2021 at 1:30 pm revealed the laboratory utilizes the Siemens Sysmex CA-600 series analyzer for Prothrombin Time (PT) testing. 2. Review of the laboratory's NMPT study revealed the laboratory utilizes the "Verification of Interval (Normal Patient Population)" questionnaire for acceptable normal donor samples to include the following: a) Are you on any medication? (Including aspirin, Birth Control, Estrogen, or Hormone Therapy) ______ Yes _______ No b) Are you in good Health? (ie., No pathological conditions, No pre surgical or hospitalized patient) _______ Yes _______ No 3. Further review of the NMPT records and donor questionnaires revealed the laboratory utilized the following three (3) of forty (40) donors who did not meet the acceptable criteria: a) RT 20-289-1950: documented "NO" for Are you in good health? b) RT 20-293-2052: documented "NO" for Are you in good health? c) RT 20-289-1908: documented "NO" for Are you in good health? 4. In interview on June 30, 2021 at 3:25 pm, Personnel 2 stated that Personnel 3 handles the NMPT study and did not know why non- acceptable donors were used for the study. Personnel 2 confirmed the laboratory used the identified unacceptable donors for the NMPT study. 5. Review of the Task 1 & 3 form provided to surveyor revealed the laboratory performs 1,082 PT/INR tests annually. 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 review of the laboratory's Blood Bank Quality Control log, patient records 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 Blood Bank Quality Control (QC) log from January 2020 through June 2021 revealed the laboratory documented the use of expired reagents for the following one (1) of five hundred forty seven (547) days reviewed: a) On July 3, 2020 at 13:00 pm, the laboratory documented the use of MQC-neg (Lot #2006051QG 2/4) with the expiration date of July 2, 2020. b) On July 3, 2020 at 13:00 pm, the laboratory documented the use of MQC-pos (Lot #2006051QG 1/3) with the expiration date of July 2, 2020. 2. Review of patient records from January 2020 through June 2021 revealed the laboratory did not perform any patient testing on July 3, 2020. 2. In interview on July 1, 2021 at 1:15 pm, Personnel 2 stated the testing personnel did not document the correct lot and expiration date for the change from old Blood Bank QC lot to the new Blood Bank QC lot. Personnel 2 confirmed the laboratory documented the use of expired QC for the identified date. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) -- 2 of 6 -- 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 observation by surveyor, review of the laboratory's performance verification studies and package inserts along with interview with personnel, the laboratory failed to have complete studies for Direct Bilirubin neonatal population. Findings: 1. Observation by surveyor during the laboratory tour on June 28, 2021 at 1:00 pm revealed the laboratory utilizes the Abbott Alinity c analyzer for Direct Bilirubin testing. 2. Review of the Abbott Alinity c package insert for Direct Bilirubin revealed "Abbott Laboratories has not verified the assay performance characteristics with neonatal specimens". 3. In interview on June 29, 2021 at 2:42 pm, Personnel 2 stated the laboratory did not have a pediatric doctor on staff and neonatal specimens are not routinely performed except through emergency room testing. 4. Review of the laboratory's performance verification studies for Direct Bilirubin revealed the laboratory did not perform complete studies for the neonatal population to include accuracy, complete precision, reportable range and reference range. 5. In interview on June 29, 2021 at 2:42 pm, Personnel 2 confirmed the laboratory did not perform Direct Bilirubin performance studies for neonatal specimens. D5781

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at ABROM KAPLAN MEMORIAL HOSPITAL - CLIA # 19D0461318 on October 15, 2018 through October 19, 2018. ABROM KAPLAN MEMORIAL HOSPITAL was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 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. 42 CFR 493.1447 CONDITION: Laboratories performing high complexity testing, Technical Supervisor. 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 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 observation, record review and interview with personnel, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 23 -- failed to document the collection date and time for patient samples performed on the Abbott iSTAT Analyzer for Blood Gas Analysis for sixty (60) of sixty (60) patients reviewed. Findings: 1. Observation by surveyor on October 15, 2018 revealed the laboratory maintained a Abbott iSTAT Blood Analysis System for testing: pH, pCO2, and pO2. 2. Review of the Laboratory's Policy and Procedure revealed that all samples performed on the Abbott iSTAT Blood Analysis System for pH, pCO2 and pO2 are to be analyzed within ten (10) minutes from collection. 3. Review of Patient Test Records from April 6, 2018 through September 28, 2018 revealed the laboratory failed to have documentation of the collection date and time to be able to determine if patient samples were analyzed within the ten (10) minute time frame set by Laboratory Policy for the following sixty (60) patients. NOTE: Arterial Blood Gas (ABG) consists of pH, pO2, and pCO2. On April 6, 2018 Patient 2 was received in the laboratory at 21:14 and analyzed at 21:18. On April 9, 2018 Patient 3 was received in the laboratory at 12:29 and analyzed at 12:30. On April 15, 2018 Patient 4 was received in the laboratory at 04:17 and analyzed at 04:19. On April 16, 2018 Patient 5 was received in the laboratory at 14:32 and analyzed at 14:38. On April 19, 2018 Patient 6 was received in the laboratory at 14:33 and analyzed at 14:36. On April 20, 2018 Patient 7 was received in the laboratory at 05:02 and analyzed at 05:04. On April 20, 2018 Patient 8 was received in the laboratory at 22:09 and analyzed at 22:12. On April 21, 2018 Patient 9 was received in the laboratory at 09:25 and analyzed at 09: 26. On April 22, 2018 Patient 10 was received in the laboratory at 23:41 and analyzed at 23:44. On April 23, 2018 Patient 11 was received in the laboratory at 00:45 and analyzed at 00:48. On April 24, 2018 Patient 12 was received in the laboratory at 01: 17 and analyzed at 01:23. On April 26, 2018 Patient 13 was received in the laboratory at 01:47 and analyzed at 01:48. On April 30, 2018 Patient 14 was received in the laboratory at 11:41 and analyzed at 15:42. On May 17, 2018 Patient 15 was received in the laboratory at 13:39 and analyzed at 13:42. On May 18, 2018 Patient 16 was received in the laboratory at 13:55 and analyzed at 13:56. On May 19, 2018 Patient 17 was received in the laboratory at 07:11 and analyzed at 07:15. On May 23, 2018 Patient 18 was received in the laboratory at 20:14 and analyzed at 20:17. On May 23, 2018 Patient 19 was received in the laboratory at 20:19 and analyzed at 20:22. On May 30, 2018 Patient 20 was received in the laboratory at 05:39 and analyzed at 05: 42. On June 4, 2018 Patient 21 was received in the laboratory at 17:02 and analyzed at 17:05. On June 6, 2018 Patient 22 was received in the laboratory at 15:43 and analyzed at 19:17. On June 8, 2018 Patient 23 was received in the laboratory at 11:26 and analyzed at 11:28. On June 8, 2018 Patient 24 was received in the laboratory at 19: 53 and analyzed at 19:55. On June 11, 2018 Patient 25 was received in the laboratory at 14:58 and analyzed at 15:00. On June 15 2018 Patient 26 was received in the laboratory at 14:36 and analyzed at 14:37. On June 24, 2018 Patient 27 was received in the laboratory at 13:24 and analyzed at 13:29. On June 25, 2018 Patient 28 was received in the laboratory at 08:23 and analyzed at 08:24. On June 30, 2018 Patient 29 was received in the laboratory at 21:16 and analyzed on July 2, 2018 at 13:42. On July 4, 2018 Patient 30 was received in the laboratory at 02:06 and analyzed at 02:08. On July 10, 2018 Patient 31 was received in the laboratory at 10:55 and analyzed at 11: 50. On July 13, 2018 Patient 32 was received in the laboratory at 13:53 and analyzed at 13:55. On July 16, 2018 Patient 33 was received in the laboratory at 17:23 and analyzed at 17:43. On July 16, 2018 Patient 34 was received in the laboratory at 21:30 and analyzed at 21:50. On July 17, 2018 Patient 35 was received in the laboratory at 12:56 and analyzed at 12:57. On July 23, 2018 Patient 36 was received in the laboratory at 10:45 and analyzed at 10:55. On July 24, 2018 Patient 37 was received in the laboratory at 22:20 and analyzed at 22:21. On July 31, 2018 Patient 38 was received in the laboratory at 15:05 and analyzed at 15:18. On August 7, 2018 Patient 39 was received in the laboratory at 14:14 and analyzed at 14:33. On August 7, 2018 -- 2 of 23 -- Patient 40 was received in the laboratory at 22:58 and analyzed at 23:01. On August 8, 2018 Patient 41 was received in the laboratory at 00:33 and analyzed at 00:35. On August 8, 2018 Patient 42 was received in the laboratory at 01:57 and analyzed at 01: 59. On August 8, 2018 Patient 43 was received in the laboratory at 06:04 and analyzed at 06:05. On August 12, 2018 Patient 44 was received in the laboratory at 09: 06 and analyzed at 09:07. On August 13, 2018 Patient 45 was received in the laboratory at 12:01 and analyzed at 12:02. On August 14, 2018 Patient 46 was received in the laboratory at 01:20 and analyzed at 06:50. On August 21, 2018 Patient 47 was received in the laboratory at 13:18 and analyzed at 13:21. On August 27, 2018 Patient 48 was received in the laboratory at 18:10 and analyzed at 18:12. On August 27, 2018 Patient 49 was received in the laboratory at 19:18 and analyzed at 19:21. On August 27, 2018 Patient 50 was received in the laboratory at 21:24 and analyzed at 21: 27. On September 4, 2018 Patient 51 was received in the laboratory at 21:46 and analyzed at 21:47. On September 11, 2018 Patient 52 was received in the laboratory at 19:34 and analyzed at 19:36. On September 11, 2018 Patient 53 was received in the laboratory at 19:34 and analyzed at 19:39. On September 18, 2018 Patient 54 was received in the laboratory at 08:57 and analyzed at 08:59. On September 20, 2018 Patient 55 was received in the laboratory at 20:11 and analyzed at 20:12. On September 20, 2018 Patient 56 was received in the laboratory at 22:07 and analyzed at 22:09. On September 20, 2018 Patient 57 was received in the laboratory at 23:11 and analyzed at 23:40. On September 24, 2018 Patient 58 was received in the laboratory at 10:24 and analyzed at 10:28. On September 24, 2018 Patient 59 was received in the laboratory at 10:24 and analyzed at 10:31. On September 24, 2018 Patient 60 was received in the laboratory at 10:25 and analyzed at 10:33. On September 28, 2018 Patient 61 was received in the laboratory at 09:07 and analyzed at 09:31. 4. Interview with Personnel 2 on October 19, 2018 revealed she was unaware that testing personnel performing ABGs were not documenting the collection date and time. Personnel 2 confirmed testing personnel failed to document the collection date and time for the sixty (60) patients cited above. 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 May 18, 2017** 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 "AKMH Collection Manual" revealed instructions for: a) Specimen labeling b) Specimen Collection Container (tube type) specimen types, and the collection containers for the sample (however not for all analytes the laboratory provides testing for).. c) Specimen Storage and Preservation (however not for all specimen types and not current with manufacturer requirements) d) Specimen Rejection e) Specimen Processing f) Specimen Referral g) Off-Site Specimen Transport: Specimens are to be received into the lab within 2 hours of collection. Further review of the Laboratory's "AKMH Collection Manual" revealed the laboratory failed to: a) Include Laboratory requirements for all analytes the laboratory tests for; Acetaminophen (Acet) Blood Alcohol (ETOH), Digoxin (Dig), Magnesium -- 3 of 23 -- (Mg), Salycilates (Sali), Vancomycin (Vanco), Lipase, Vitamin D (VitD), Prothrombin Time (PT) Partial Thromboplastin Time (PTT) . b) Ensure the laboratory requirements meet the manufacturer's requirements for all analytes; examples of random analytes that the surveyor observed: - Calcium (CA) is to be separated and analyzed promptly. - Potassium (K) needs to be separated within 1 hour of collection - Glucose (Gluc) Glycolysis decreased by approximately 5-7% per hour. - Alanine Amnotransferase (ALT), Creatine Kinase (CK), Creatinine (Creat), Direct Bilirubin (DBil), Total Bilirubin (TBil), Troponin (CTNI), Lipase need to be separated within 2 hours of collection (not received within 2 hours) - Urine Drug Screen (UDS) - are to be received and tested within 24 hours (not just received within 2 hours) otherwise the sample is to be stored frozen. 3. Interviews with personnel 2, and 3 on October 16, 2018 revealed the laboratory provided the Laboratory's "AKMH Specimen Collection Manual" to all outside facilities that the laboratory does testing for. Personnel 2 and 3 confirmed the manual does not include all the information required to maintain the integrity of patient samples. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of