Montecito Post Acute And Rehabilitation

CLIA Laboratory Citation Details

3
Total Citations
7
Total Deficiencyies
7
Unique D-Tags
CMS Certification Number 03D0529155
Address 51 S 48th St, Mesa, AZ, 85206
City Mesa
State AZ
Zip Code85206
Phone(480) 832-8333

Citation History (3 surveys)

Survey - July 12, 2023

Survey Type: Standard

Survey Event ID: XA3R11

Deficiency Tags: D5807

Summary:

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of the approved reference ranges in the laboratory procedure manual, and interview with the technical consultant (TC), the laboratory failed to ensure the test report included pertinent normal valuues as determined by the laboratory. Two of the eight blood gas parameters listed on the laboratory information system (LIS) report differed from those in the approved procedure manual. Findings: 1. Review of the patient report from the LIS system revealed the analytes of partial pressure of oxygen (pO2) and oxygen saturation percentage (SO2) for chemistry blood gas testing failed to correctly match those reference ranges in the procedure manual. LIS patient report Procedure manual pO2 83-108 mmHg 80-105 mmHg SO2 94-100 % 95-98% 2. Interview with the TC on July 12, 2023, at 2:30 PM confirmed the laboratory failed to ensure correct reference ranges for pO2 and SO2 approved in the procedure manual were included on the LIS patient report. 3. The laboratory reports approximately 4800 blood gas patient tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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Survey - March 4, 2021

Survey Type: Standard

Survey Event ID: Q2ME11

Deficiency Tags: D2009

Summary:

Summary Statement of Deficiencies 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 the review of proficiency testing (PT) records for testing performed in the subspecialty of Routine Chemistry and interview with the facility personnel, the laboratory failed to provide a completed attestation statement for review for the third event of 2020 . Findings include: 1. The laboratory performs Blood Gas testing in the subspecialty of Routine Chemistry, with an approximate annual test volume of 1050. 2. No PT attestation statement was presented for review for the third event of 2020 for Blood Gas Testing in the subspecialty of Routine Chemistry. 3. The facility personnel acknowledged that the PT attestation statement indicated above could not be located. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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Survey - November 20, 2018

Survey Type: Standard

Survey Event ID: T7BF11

Deficiency Tags: D2096 D6000 D2016 D5891 D6016

Summary:

Summary Statement of Deficiencies 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. This CONDITION is not met as evidenced by: Based on Proficiency Testing (PT) reports for 2018 sent to the state agency and review of documentation presented during the survey conducted on November 20, 2018, the laboratory failed to successfully participate in a PT program for the regulated analyte, pH (Blood Gas) under the sub-specialty of Routine Chemistry. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 2nd event of 2018 for the regulated analyte, pH Blood Gas, with a score of 60%. 2. The laboratory's PT Performance was unsatisfactory for the 3rd event of 2018 for the regulated analyte, pH Blood Gas, with a score of 20%. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, pH Blood Gas, for the 2nd and 3rd event of 2018 resulting in unsuccessful PT performance. See D2016 for findings. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on view of three patient test reports (18397, 18357, 17905) from 09/14/2018, 06 /26/2018 and 03/09/2018 respectively, and interview with the laboratory personnel, the laboratory failed to scan each test report into the relevant patient's medical record as required by the laboratory's policy. Findings include: 1. The three reports listed above could not be located in the electronic medical records of the patients. 2. The laboratory personnel indicated that reports were consistently not being scanned per laboratory policy. 3. There was no

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