Milwaukee Health Service Systems, Llc

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: The facility was not in compliance with Wisconsin Administrative Code (Wisc. Admin. Code) based on citations noted by the Wisconsin Department of Health Services (DHS) Behavioral Health Certification Section (BHCS) on April 27, 2020. Findings include: 1. Milwaukee Health Service Systems did not comply with the Wisc. Admin.Code ch. DHS 75, Community Substance Abuse Service Standards, based on survey results from April 16, 2020. BHCS cited deficiencies at X1308, X1671, X1697, and X1725 for provider number 1644 on the Wisconsin State 2567. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of laboratory documents, video conference observation of access to and storage of urine specimens, and video conference and telephone interviews with testing personnel, video conference and telephone interview and email correspondence with the regional director, and email correspondence with the laboratory director, the laboratory did not meet the requirements specified in 493.1231 through 493.1252 and 493.1291 through 493.1299. Findings include: 1. Access was Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- not restricted to the storage area where urine specimens are stored before and after testing, and the laboratory has not ensured confidentiality of patient information. See D5201. 2. The laboratory did not follow their written procedures or meet the manufacturer's requirements to ensure optimum integrity of patient specimens. See D5203. 3. The laboratory did not have a system to document all complaints and problems reported to the laboratory. See D5205. 4. The procedure manual did not include step-by-step instructions for responding to analyzer flags, and did not define the specific control materials used for each test performed. See D5403. 5. The laboratory director did not approve, sign, and date the manufacturer instructions used as testing procedures. See D5407. 6. The laboratory did not monitor or document the temperature of the unrefrigerated storage area where the laboratory kept urine specimens prior to testing. See D5413. 7. The cut off value for fentanyl was not consistent between the laboratory procedures, manufacturer's instructions, and the test report. See D5805. 8. The test reports for specimens received from six of the seven facilities in West Virginia did not indicate the testing laboratory's name. See D5805. 9. The test report did not include information necessary for the interpretation of test results. See D5805. 10. The laboratory did not define in writing their time frames for reporting patient results and did not consider the urgency of the tests requested in establishing reporting time frames. See D5815. 11. The laboratory had not monitored, assessed, or corrected problems with turnaround time for reporting patient test results. See D5891. D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on surveyor video conference observation of access to the storage area and the storage area, and interview via video conference with the regional director, access to the area where the laboratory stores urine specimens was not restricted and the laboratory had not ensured confidentiality of patient information. Findings include: 1. Video conference observation of access to the storage area on April 16, 2020 at 9:50 AM revealed two unlocked doors between the storage area and the clinic and laboratory areas of the facility. 2. Video conference observation of the storage area on April 16, 2020 at 9:55 AM revealed the area housed four double-doored refrigerators. Observation of the contents of the refrigerators showed all four filled with specimens from multiple facilities in Wisconsin and West Virginia; the specimen labels included patient information. Further observation revealed more than ten boxes on the floor, each box containing 24 or more urine specimens labeled with patient information. 3. Video conference observation of the hallway door and the door to the storage area on April 16, 2020 at 10:42 AM revealed neither door had locks and did not restrict access to the storage area. 4. Video conference interview with the regional director, staff A, on April 16, 2020 at 10:42 AM confirmed access to the storage area containing patient urine specimens with patient information was not restricted and the laboratory did not ensure confidentiality of patient information. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure -- 2 of 11 -- positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on surveyor video conference observation of storage of untested urine specimens, review of laboratory procedures, manufacturer's instructions, temperature logs, and laboratory reports, video conference interview with testing personnel, and video conference and telephone interview with the regional director, the laboratory has not followed their written procedures and manufacturer's requirements to ensure optimum integrity of thousands of patient specimens since February 2020. Findings include: 1. Video conference interview with the regional director on April 16, 2020 at 10:10 AM revealed the laboratory kept urine samples refrigerated until the laboratory personnel take them to the laboratory for testing. At 10:30 AM, the regional director stated there was no other storage area other than the area the director displayed. 2. Observation of a second aisle of storage by video conference on April 16, 2020 at 12: 20 PM revealed three large shelves and multiple mailboxes on the floor holding delivery boxes and bags. Review of the packages revealed the laboratory received the shipments from April 7 through April 15, 2020. The delivery labels on the packages showed the laboratory received at least 26 of the packages from April 7 through 10, 2020. A representative package from Appleton, Wisconsin contained about 25 samples collected on April 3, 2020, shipped on April 8, 2020, and received on April 10, 2020. Further observation revealed a thermometer at the end of the shelves near the specimens. The thermometer showed the temperature was 62 degrees Fahrenheit (F). 3. Interview via video conference with testing personnel, staff B, on April 16, 2020 at 12:35 PM confirmed the laboratory routinely stored urine specimens on the shelves since February 2020 when staff B was hired. The interview also confirmed the laboratory did not monitor the temperature of the storage area. 4. The laboratory procedure "SOP 1 Daily Laboratory Start-up Functions" includes the following instructions: "7. Urine specimens not processed on date received are to be refrigerated until processing occurs." 5. Review of the manufacturer's instructions for the DRI Ethyl Glucuronide test performed in the laboratory showed, "Urine samples must be stored refrigerated at all times when not in use." 6. Review of the laboratory's temperature monitoring logs showed the acceptable temperature range for refrigerator storage is 36 - 46 F. 7. Review of collection reports listing the specimens collected from April 7 through April 15, 2020 at 19 facilities that refer specimens to this laboratory showed 6,953 specimens collected from the following locations: Location / Number of specimens Appleton /457 Beckley / 277 Beloit / 333 Charleston / 405 Clarksburg / 162 Green Bay / 646 Huntington / 488 Madison East / 657 Madison West / 271 North West / 378 Parkersburg / 145 Racine / 309 Rivers Shore / 389 Sheboygan / 313 Waukesha / 282 Wausau / 448 West Milwaukee / 590 Wheeling / 156 Williamson / 247 8. Interview via video conference with the regional director, staff A, on April 16, 2020 at 12:24 PM confirmed urine specimens collected between April 3 and April 15, 2020 were stored on shelves in an unmonitored area that was not environmentally controlled. Further interview confirmed staff moved samples from the shelves to the refrigerators on April 10, 2020. The director stated there were no records to show what samples staff moved or how long they had been stored without refrigeration before the transfer to refrigerated storage. Interview via telephone on April 17, 2020 at 12:30 PM confirmed the laboratory had not tested most of the samples identified on the collection lists. D5205 COMPLAINT INVESTIGATIONS -- 3 of 11 -- CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on surveyor telephone interview with testing personnel and email correspondence with the regional director, the laboratory did not have a system to document all complaints and problems reported to the laboratory. Findings include: 1. Telephone interview on April 18, 2020 at 10:00 AM with testing personnel, staff B, revealed the laboratory received complaints and concerns by telephone and email. Staff B stated they were not aware of any system to document complaints other than those received via email and further stated the email system deletes emails after one month. 2. Email correspondence with the regional director, staff A, on April 20, 2020 at 5:16 PM confirmed the laboratory did not have a system for documenting complaints reported to the laboratory. 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 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)

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor review of maintenance records and interview with the general supervisor, the laboratory did not document daily and weekly maintenance performed on two AU-640 chemistry analyzers as required by the manufacturer on eleven days of patient testing in May and August 2019. Findings include: 1. Review of maintenance records for the AU-640 chemistry analyzer 1 showed the laboratory did not document daily maintenance on the following dates: May 16 and 17, 2019 May 20 through 24, 2019 August 27 through 30, 2019 The laboratory did not document weekly maintenance from May 20 through 24, 2019. 2. Review of maintenance records for the AU-640 chemistry analyzer 2 showed the laboratory did not document daily maintenance on the following dates: August 27 through 30, 2019 3. Interview with the general supervisor on November 5, 2019 at 11:40AM, confirmed the laboratory did not document daily maintenance performed on AU-640 chemistry analyzer 1 on eleven days and did not document weekly maintenance during one week in May 2019. Further interview confirmed the laboratory did not document daily maintenance on AU-640 analyzers 1 and 2 on four days in August 2019. D5781