Olhs St Mary Place Cardiopulmonary Services

Summary Statement of Deficiencies D0000 A Validation Survey was performed at OLHS ST MARY PLACE CARDIOPULMONARY SERVICES - CLIA # 19D2181512 on January 26, 2023 through January 27, 2023. OLHS ST MARY PLACE CARDIOPULMONARY SERVICES was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1210 CONDITION: Routine Chemistry 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories Performing Moderate Complexity Testing, Technical Consultant D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with personnel, the laboratory failed to ensure Testing Personnel and/or Laboratory Director signed the attestation statement for six (6) of six (6) proficiency testing (PT) events reviewed in 2021 and 2022. Findings: 1. Review of the laboratory's College of American Pathologists (CAP) proficiency testing records from 2021 and 2022 revealed the attestation statements were not signed for the following six (6) of six (6) PT events reviewed: a) SO - A 2021 Blood Oximetry: Laboratory Director did not sign and date AQ - A 2021 Critical Care Blood Gas w/ Chemistry: Laboratory Director did not sign and date b) SO - B 2021 Blood Oximetry: Laboratory Director did not sign and date AQ - B 2021 Critical Care Blood Gas w/ Chemistry: Laboratory Director did not sign and date c) SO - C 2021 Blood Oximetry: Laboratory Director did not sign and date AQ - C 2021 Critical Care Blood Gas w/ Chemistry: Laboratory Director did not sign and date d) SO - A 2022 Blood Oximetry: Laboratory Director Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- and Testing Personnel did not sign and date AQ - A 2022 Critical Care Blood Gas w/ Chemistry: Laboratory Director and Testing Personnel did not sign and date e) SO - B 2022 Blood Oximetry: Laboratory Director and Testing Personnel did not sign and date AQ - B 2022 Critical Care Blood Gas w/ Chemistry: Laboratory Director did not sign and date f) SO - C 2022 Blood Oximetry: Laboratory Director and Testing Personnel did not sign and date AQ - C 2022 Critical Care Blood Gas w/ Chemistry: Laboratory Director and Testing Personnel did not sign and date 2. In interview on January 26, 2023 at 3:10 pm, Testing Personnel 11 confirmed the laboratory's personnel did not sign and date the attestation statements for the identified events above. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of laboratory policy and records as well as interview with personnel, the laboratory failed to ensure the quality of testing in the specialty of Chemistry. Findings: 1. The laboratory failed to establish complete written policies and procedures to assess competency of testing personnel. Refer to 5209. 2. The laboratory failed to establish complete policies and procedures. Refer to 5403. 3. The laboratory failed to ensure patient samples for Arterial Blood Gas testing are analzyed within thirty (30) minutes according to the manufacturer for eighty five (85) of eighty five (85) patients reviewed from December 25, 2022 through December 31, 2022. Refer to D5305. 4. The laboratory failed to perform calibration verification procedures at least every six (6) months for the Radiometer ABL 90 Flex Plus analyzer. Refer to D5439. 5. The laboratory's quality assessment monitors failed to correct issues identified with the analytic system. Refer to D5793. 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 review of the laboratory's policy and procedure and interview with personnel, the laboratory failed to establish complete written policies and procedures to assess competency of testing personnel. Findings: 1. Review of the laboratory policy for "Blood Gas Employee Program" revealed "All employees must have documented competency before performing laboratory procedures without direct observation. If an employee does not have documentation of competency, he/she will not be allowed to work until the requirements are satisfied". 2. Further review of the laboratory policy revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, -- 2 of 14 -- processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 3. In interview on January 26, 2023 at 3:10 pm, Testing Personnel 11 confirmed the laboratory policy did not include the identified information. 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 by surveyors, review of the manufacturer operator's manual, instrument tapes and interview with personnel, the laboratory failed to include the specimen collection time for blood gas testing for eighty five (85) of eighty five (85) patients reviewed from December 25, 2022 through December 31, 2022. Findings: 1. Observation by surveyors during the laboratory tour on January 27, 2023 at 11:00 am revealed the laboratory utilizes the Radiometer ABL 90 Flex Plus analyzer for Arterial Blood Gas patient testing. 2. Review of the Radiometer ABL 90 Flex Plus operator's manual under "Storage and Preparation Prior to Analysis" revealed "If it is not possible to analyze the specimen immediately, analyze it within 30 minutes after collection". 3. In interview on January 27, 2023 at 11:11 am, Personnel 11 stated the laboratory does not capture the collection time so there is no way to show if the Arterial Blood Gases (ABG) are analyzed within the thirty minute time frame. 4. Review of the laboratory's instrument tapes from December 25, 2022 through December 31, 2022 revealed the laboratory did not document the collection time for Arterial Blood Gas patient testing for the following eight five (85) of eighty five (85) patients tested December 25, 2022 through December 31, 2022: a) December 25, 2022 * Patient ID 323822502 performed at 01:58 am * Patient ID 323842609 performed at 04:03 am * Patient ID 323947750 performed at 07:28 am * Patient ID 323947750 performed at 07:29 am * Patient ID 323842609 performed at 09:51 am * Patient ID 323952314 performed at 13:05 pm * Patient ID 323952314 performed at 13:06 pm * Patient ID 323842609 performed at 16:46 pm * Patient ID 322897676 performed at 17:51 pm b) December 26, 2022 * Patient ID 323822502 performed at 01:10 am * Patient ID 322897676 performed at 05:11 am * Patient ID 323842609 performed at 12:05 pm * Patient ID 323842609 performed at 12:15 pm * Patient ID 322897676 performed at 12:24 pm * Patient ID 323994938 performed at 17:28 pm * -- 3 of 14 -- Patient ID 323842609 performed at 18:32 pm * Patient ID 323999558 performed at 18:36 pm * Patient ID 323822502 performed at 23:27 pm c) December 27, 2022 * Patient 322897676 performed at 00:21 am * Patient 323842609 performed at 00:28 am * Patient 322897676 performed at 02:19 am * Patient 322897676 performed at 04: 56 am * Patient 322313663 performed at 05:31 am * Patient 323842609 performed at 06:17 am * Patient 324025079 performed at 08:17 am * Patient 324025079 performed at 08:18 am * Patient 323313602 performed at 10:41 am * Patient 324124968 performed at 13:15 pm * Patient 324124968 performed at 13:16 pm * Patient 324170441 performed at 15:24 pm * Patient 324170441 performed at 15:25 pm * Patient 323842609 performed at 15:57 pm * Patient 324137028 performed at 16:23 pm * Patient 324124968 performed at 17:48 pm * Patient 324172569 performed at 18: 38 pm * Patient 324137028 performed at 19:59 pm d) December 28, 2022 * Patient 324209218 performed at 01:05 am * Patient 324209218 performed at 01:07 am * Patient 324210822 performed at 03:54 am * Patient 323842609 performed at 05:16 am * Patient 324211728 performed at 05:18 am * Patient 324211728 performed at 05: 20 am * Patient 322897676 performed at 05:36 am * Patient 324172569 performed at 08:01 am * Patient 323822502 performed at 12:08 pm * Patient 323842609 performed at 12:12 pm * Patient 324315521 performed at 13:06 pm * Patient 324315521 performed at 13:07 pm * Patient 324172569 performed at 16:32 pm * Patient 323822502 performed at 17:48 pm * Patient 324396101 performed at 19:47 pm * Patient 324396101 performed at 19:49 pm * Patient 324365009 performed at 20:47 pm * Patient 323822502 performed at 23:52 pm e) December 29, 2022 * Patient 323822502 performed at 02:03 am * Patient 322388993 performed at 02:53 am * Patient 322288993 performed at 02:55 am * Patient 322313663 performed at 05:01 am * Patient 324397461 performed at 05:25 am * Patient 323842609 performed at 05: 29 am * Patient 323822502 performed at 12:14 pm * Patient 324388593 performed at 12:24 pm * Patient 324498657 performed at 12:28 pm f) December 30, 2022 * Patient 324586150 performed at 00:35 am * Patient 323822502 performed at 08:48 am * Patient 324670824 performed at 13:25 pm * Patient 324670824 performed at 13:26 pm * Patient 324670824 performed at 13:38 pm * Patient 323842609 performed at 17: 08 pm * Patient 324714546 performed at 17:51 pm * Patient 324714546 performed at 17:52 pm * Patient 324714546 performed at 18:12 pm * Patient 323822502 performed at 18:20 pm * Patient 324716286 performed at 18:30 pm * Patient 324716286 performed at 18:31 pm g) December 31, 2022 * Patient 324714546 performed at 04:57 am * Patient 322897676 performed at 04:58 am * Patient 324670824 performed at 05:03 am * Patient 322313663 performed at 05:15 am * Patient 323842609 performed at 05:28 am * Patient 323822502 performed at 05:37 am * Patient 324748639 performed at 15:12 pm * Patient 324748639 performed at 15: 13 pm * Patient 323842609 performed at 17:43 pm * Patient 323822502 performed at 19:25 pm 5. In interview on January 27, 2023 at 11:11 am, Personnel 11 confirmed the laboratory did not document the collection time so therefore the laboratory could not determine if the patients identified above were analyzed within the thirty (30) minutes required by the manufacturer. 6. Review of the task 1&3 form provided to surveyor revealed the laboratory performs 15,319 ABG tests annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step -- 4 of 14 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)