Brownsville Pulmonary Center Pa

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. 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, review of patient records and confirmed in interview, the laboratory failed to follow its own policy on documenting panic values for two of two patients randomly reviewed from May - June 2024 (random review). Findings include: 1. Review of the laboratory's policy titled "Alert Policy" approved by the laboratory director stated: "The following critical values will be immediately reported to the requesting physician or doctor scheduled in the clinic Arterial Blood Gas: pH less than 7.30 or greater than 7.55 pCO2 less than 20 mmHg or greater than 60 mmHg pO2 less than 59 mmHg When calling the physician the tech will document the Date, time, name of doctor, and plan of action by the doctor." 2. Review of patient final reports determined panic values were not documented per the laboratory's policy for two patients reviewed from May - June 2024 (random review). They were: a) Patient ID: 03271978 Date: 05/06/2024 Result: pCO2: 60.6 (panic value) b) Patient ID: 12041951 Date: 05/29/2024 Result: pH: 7.583 (panic value) 3. Testing person-1 confirmed the findings in an interview on 6/27/2024 at 1037 hours in the testing area. 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 --

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 patient final reports, and confirmed in interview of laboratory personnel, the laboratory failed to provide patient normal ranges for 1 of 2 sample types for blood gas analysis for records reviewed from August 1, 2021 through February 2, 2022. The findings included: 1. Review of laboratory records from August 1, 2021 through February 2, 2022 found the laboratory performed 2 of 110 venous blood gas samples. 2. The laboratory's defined patient normal ranges for arterial blood gas results are as follows: pH 7.35 - 7.45 PCO2 35.0 - 45.0 PO2 80.0 - 100.0 HCO3 20.0 - 28.0 Base excess +/- 2 O2 Saturation 92 - 100% 3. Random review of 110 patient reports from August 1, 2021 through February 7, 2022 found all sample types were performed under the order for an arterial blood gas. The following patient samples were resulted with patient normal ranges for Arterial Blood Gas when a different sample type was tested: Sample #656 Date: 08-13-2021 Sample Type: Venous Sample #894 Date: 02-07-2022 Sample Type: Venous 4. The laboratory was asked to provide documentation of providing patient normal ranges for the 1 additional patient sample types (venous) tested. No documentation was provided. 5. An interview with the testing person on June 6, 2022 at 15:15 hours in the office confirmed the findings. He explained that the venous results would only be resulted if it was a missed arterial stick. Key: pH - measure of acid or base pO2 - partial pressure of oxygen pCO2 - partial pressure carbon dioxide HCO3 - bicarbonate O2 - oxygen 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 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the