Cypress Pointe Surgical Hospital

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at Cypress Pointe Surgical Hospital - CLIA # 19D2014831 on May 7, 2018 through May 10, 2018. Cypress Pointe Surgical Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic Systems. 42 CFR 493.1403 CONDITION: Laboratory Director performing moderate complexity testing. 42 CFR 493.1409 CONDITION: Technical Consultant performing moderate complexity testing. 42 CFR 493.1441 CONDITION: Laboratory Director performing high complexity testing. 42 CFR 493.1459 CONDITION: General Supervisor performing high complexity testing. 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 the Technical Consultant, Technical Supervisor, and General Supervisor were complete. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 3 and Personnel 4 serve as Technical Consultants. 2. Further review of the laboratory's CMS-209 (Laboratory Personnel Report) revealed Personnel 20 served as Technical Consultant, Technical Supervisor, and General Supervisor. 3. Review of the laboratory's policy manual revealed the laboratory did have a policy for competency assessement for the Technical Consultant, Technical Supervisor, and General Supervisor; However, the policy did not include the frequency the assessments are performed. 4. Review of the personnel records for Personnel 3, 4, and 20 revealed competency assessments for the duties of Technical Consultant, Technical Supervisor, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 20 -- and General Supervisor were performed. 5. In interview on May 8, 2018 at 8:22 am, Personnel 4 confirmed the laboratory policy did not include the frequency competency assessments are performed. 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 record review and interview with personnel, the laboratory failed to include the specimen collection time and specimen receipt time for Arterial Blood Gas and ACT testing. Findings: 1. Review of the laboratory's "Ordering, Collecting, Receiving Specimens in the LIS Policy" revealed under "Collecting - All samples collected must have the date and time of collection on both the sample and documented in CPSI; Be specific with this information" and under "Receiving - All samples received in the laboratory must have the date and time of receipt documented in CPSI; Be specific with this information." 2. Review of the manufacturer's instructions revealed the laboratory must test samples for Arterial Blood Gas testing within ten (10) minutes of collection and samples for ACT testing within thiry (30) minutes of collection. 3. Review of patient records for Arterial Blood Gas testing revealed the laboratory did not document the accurate collection time and receipt time into the laboratory for the following eighteen (18) of twenty (20) patients reviewed: a. Patient 1 - collected on November 18, 2017 at 03:19 am; no receipt time documented; result time of November 18, 2017 at 07:03 am (sample resulted 3 hours 34 minutes over time of collection) b. Patient 1 - collected on November 18, 2017 at 05:08 am; no receipt time documented; result time of November 18, 2017 at 07:07 am (sample resulted 1 hour 49 minutes over time of collection) c. Patient 1 - collected on November 18, 2017 at 07:00 am; no receipt time documented; result time of November 20, 2017 at 06:02 am (sample resulted 46 hours 52 minutes over time of collection) d. Patient 3 - collected on December 13, 2017 at 11:07 am; no receipt time documented; result time of December 14, 2017 at 08:32 am (sample resulted 22 hours 15 minutes over time of collection) e. Patient 3 - collected on December 13, 2017 at 11:13 am; no receipt time documented; result time of December 14, 2017 at 08:33 am (sample resulted 22 hours 10 minutes over time of collection) f. Patient 3 - collected on December 13, 2017 at 11:17 am; no receipt time documented; result time of December 14, 2017 at 08:35 am (sample resulted 22 hours 8 minutes over time of collection) g. Patient 4 - collected on December 14, 2017 at 15:16 pm; no receipt time documented; result time of December 14, 2017 at 15:30 pm (sample resulted 5 minutes over time of collection) h. Patient 5 - collected on January 17, 2018 at 11:03 am; no receipt time documented; -- 2 of 20 -- result time of January 18, 2018 at 07:44 am (sample resulted 20 hours 31 minutes over time of collection) i. Patient 6 - collected on January 21, 2018 at 04:30 am; no receipt time documented; result time of January 21, 2018 at 06:13 am (sample resulted 1 hour 33 minutes over time of collection) j. Patient 6 - collected on January 21, 2018 at 05: 39 am; no receipt time documented; result time of January 21, 2018 at 06:12 am (sample resulted 22 minutes over time of collection) k. Patient 6 - collected on January 21, 2018 at 08:33 am; no receipt time documented; result time of January 22, 2018 at 05:52 am (sample resulted 21 hours 9 minutes over time of collection) l. Patient 6 - collected on January 22, 2018 at 05:00 am; no receipt time documented; result time of January 22, 2018 at 05:50 am (sample resulted 40 minutes over time of collection) m. Patient 8 - collected on February 5, 2018 at 06:38 am; no receipt time documented; result time of February 5, 2018 at 06:51 am (sample resulted 3 minutes over time of collection) n. Patient 9 - collected on February 8, 2018 at 09:09 am; no receipt time documented; result time of February 8, 2018 at 17:53 pm (sample resulted 8 hours 34 minutes over time of collection) o. Patient 9 - collected on February 8, 2018 at 09:21 am; no receipt time documented; result time of February 8, 2018 at 11:23 am (sample resulted 1 hour 52 minutes over time of collection) p. Patient 9 - collected on February 8, 2018 at 09:39 am; no receipt time documented; result time of February 8, 2018 at 11:24 am (sample resulted 1 hour 35 minutes over time of collection) q. Patient 9 - collected on February 8, 2018 at 10:14 am; no receipt time documented; result time of February 8, 2018 at 11:26 am (sample resulted 1 hour 2 minutes over time of collection) r. Patient 9 - collected on February 8, 2018 at 11:00 am; no receipt time documented; result time of February 8, 2018 at 11:27 am (sample resulted 17 minutes over time of collection) 4. Review of patient records for ACT testing revealed the laboratory did not document the accurate collection time and receipt time into the laboratory for the following twenty five (25) of thirty (30) patients reviewed: a. Patient 11 - collected on December 14, 2017 at 09:31 am; no receipt time documented; result time of December 14, 2017 at 12:47 pm (sample resulted 2 hours 46 minutes over time of collection) b. Patient 11 - collected on December 14, 2017 at 10:45 am; no receipt time documented; result time of December 14, 2017 at 11:57 am (sample resulted 42 minutes over time of collection) c. Patient 12 - collected on December 14, 2017 at 11:12 am; no receipt time documented; result time of December 14, 2017 at 12:52 pm (sample resulted 1 hour 10 minutes over time of collection d. Patient 13 - collected on December 27, 2017 at 11:57 am; no receipt time documented; result time of December 28, 2017 at 09:18 am (sample resulted 20 hours 51 minutes over time of collection) e. Patient 13 - collected on December 27, 2017 at 13:25 pm; no receipt time documented; result time of December 27, 2017 at 14:28 pm (sample resulted 33 minutes over time of collection) f. Patient 14 - collected on December 13, 2017 at 09:17 am; no receipt time documented; result time of December 14, 2017 at 08:37 am (sample resulted 22 hours 50 minutes over time of collection) g. Patient 15 - collected on December 27, 2017 at 11:57 am; no receipt time documented; result time of December 28, 2017 at 09:19 am (sample resulted 20 hours 52 minutes over time of collection) h. Patient 16 - collected on December 28, 2017 at 11:30 am; no receipt time documented; result time of December 28, 2017 at 14:28 pm (sample resulted 2 hours 28 minutes over time of collection) i. Patient 18 - collected on January 26, 2018 at 09:05 am; no receipt time documented; result time of January 26, 2018 at 12:33 pm (sample resulted 2 hours 58 minutes over time of collection) j. Patient 19 - collected on January 18, 2018 at 13:10 pm; no receipt time documented; result time of January 18, 2018 at 15:46 pm (sample resulted 2 hours 6 minutes over time of collection) k. Patient 19 - collected on January 18, 2018 at 13:37 pm; no receipt time documented; result time of January 18, 2018 at 15:46 pm (sample resulted 1 hour 39 minutes over time of collection) l. Patient 20 - collected on February 8, 2018 at 11:08 am; no receipt time documented; result time of -- 3 of 20 -- February 8, 2018 at 13:15 pm (sample resulted 1 hour 37 minutes over time of collection) m. Patient 20 - collected on February 8, 2018 at 11:44 am; no receipt time documented; result time of February 8, 2018 at 13:15 pm (sample resulted 1 hour 1 minute over time of collection) n. Patient 20 - collected on January 25, 2018 at 1215: pm; no receipt time documented; result time of January 25, 2018 at 16:05 pm (sample resulted 3 hours 20 minutes over time of collection) o. Patient 20 - collected on January 25, 2018 at 13:02 pm; no receipt time documented; result time of January 26, 2018 at 12:35 pm (sample resulted 23 hours 3 minutes over time of collection) p. Patient 21 - collected on February 7, 2018 at 13:56 am; no receipt time documented; result time of February 7, 2018 at 15:07 pm (sample resulted 41 minutes over time of collection) q. Patient 23 - collected on February 21, 2018 at 11:02 am; no receipt time documented; result time of February 21, 2018 at 11:41 am (sample resulted 9 minues over time of collection) r. Patient 24 - collected on February 20, 2018 at 10:21 am; no receipt time documented; result time of February 20, 2018 at 11:53 am (sample resulted 1 hour 2 minutes over time of collection) s. Patient 25 - collected on March 21, 2018 at 10:13 am; no receipt time documented; result time of March 21, 2018 at 11:13 am (sample resulted 30 minutes over time of collection) t. Patient 27 - collected on April 2, 2018 at 09:54 am; no receipt time documented; result time of April 2, 2018 at 12:20 pm (sample resulted 1 hour 56 minutes over time of collection) u. Patient 28 - collected on April 3, 2018 at 11:51 am; no receipt time documented; result time of April 3, 2018 at 16:24 pm (sample resulted 4 hours 3 minutes over time of collection) v. Patient 29 - collected on April 16, 2018 at 09:56 am; no receipt time documented; result time of April 16, 2018 at 12:45 pm (sample resulted 2 hours 19 minutes over time of collection) w. Patient 29 - collected on April 16, 2018 at 09:28 am; no receipt time documented; result time of April 16, 2018 at 12:45 pm (sample resulted 2 hours 47 minutes over time of collection) x. Patient 30 - collected on May 1, 2018 at 09:20 am; no receipt time documented; result time of May 1, 2018 at 10:03 am (sample resulted 13 minutes over time of collection) y. Patient 31 - collected on May 2, 2018 at 11:35 am; no receipt time documented; result time of May 2, 2018 at 13:30 pm (sample resulted 1 hour 25 minutes over time of collection) 5. In interview on May 8, 2018 at 1:07 pm, Personnel 4 stated the Arterial Blood Gas and ACT testing is performed by the nursing staff and the results are given to the lab to input the results into the LIS system. Personnel 4 further stated the iSTAT insturment tapes show the patient result times but the actual collection and receipt times are not always documented. Personnel 4 confirmed the laboratory did not document collection and receipt times for the above patients. 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 observation, 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 ensure the procedure manual contained complete policies and procedures. Refer to D5403. 2. The laboratory failed to perform a one hundred twenty -- 4 of 20 -- (120) patient study for Prothrombin Time (PT) normal mean and to utilize acceptable patient donors per manufacturer requirements. Refer to D5411. 3. The laboratory failed to ensure supplies have not exceeded their expiration date. Refer to D5417. 4. The laboratory failed to have complete performance specification verification studies for the Sysmex Ca 620 instrument. Refer to D5421. 5. The laboratory failed to ensure quarterly maintenance for the Sysmex Ca 620 instrument was performed and documented. Refer to D5429 I. 6. The laboratory failed to ensure quarterly maintenance for the Blood Bank alarm checks was performed and documented as required by laboratory policy. Refer to D5429 II. 7. The laboratory failed to perform calibration as required by the manufacturer for the Horiba Pentra XL80 analyzer. Refer to D5437. 8. The laboratory failed to have a complete Individualized Quality Control Plan (IQCP) to support the reduction in frequency of quality control (QC). Refer to D5445. 9. The laboratory failed to perform two (2) levels of Quality Control prior to patient testing. Refer to D5447. 10. The laboratory failed to perform a positive and negative control each day of patient testing for Serum Pregnancy for one (1) of fourteen (14) patients reviewed. Refer to D5449. 11. The laboratory failed to test control material in the same manner as patient testing for nine (9) of two hundred eleven (211) days reviewed. Refer to D5465. 12. The laboratory failed to perform and document visual inspections for each batch/shipment of MRSA Select culture medium. Refer to D5477. 13. The laboratory failed to take